Nothing Special   »   [go: up one dir, main page]

Manual - PHASE3 - Ingl

Download as pdf or txt
Download as pdf or txt
You are on page 1of 186

Phase 3

Defibrillator and Transcutaneous Pacemaker Analyzer

Operating Manual
Phase 3
Defibrillator and Transcutaneous Pacemaker Analyzer
Operating Manual

© 2007 Datrend Systems Inc.


Unit #1 - 3531 Jacombs Road
Richmond, BC • CANADA. • V6V 1Z8
Tel: 800.667.6557 (North America Only) or
604.291.7747 • Fax 604.294.2355
e-mail: customerservice@datrend.com
To order this manual, use Part Number 6100-440 Revision History
Revision Description Date

D AED Waveform Changes 15-June-2007

Copyright
Datrend System s Inc. (“DSI”) agrees to a lim ited copyright release that allows you to reproduce m anuals and other
printed m aterials for use in service training program s and other technical publications. If you would like other
reproductions or distributions, subm it a written request to Datrend System s Inc.

Unpacking and Inspection


Follow standard receiving practices upon receipt of the instrum ent. Check the shipping carton for dam age. If
dam age is found, stop unpacking the instrum ent. Notify the freight carrier and ask for an agent to be present while
the instrum ent is unpacked. There are no special unpacking instructions, but be careful not to dam age the
instrum ent when unpacking it. Inspect the instrum ent for physical dam age such as bent or broken parts, dents, or
scratches.

Claim s
Our routine m ethod of shipm ent is via com m on carrier. Upon delivery, if physical dam age is found, retain all packing
m aterials in their original condition and contact the carrier im m ediately to file a claim .
If the instrum ent is delivered in good physical condition but does not operate within specifications, or if there are any
other problem s not caused by shipping dam age, please contact your local sales representative or DSI im m ediately.

Standard Terms and Conditions

Refunds & Credits


Please note only serialized products (products labelled with a distinct serial num ber) and accessories are eligible for
partial refund and/or credit. Non-serialized parts and accessory item s (cables, carrying cases, auxiliary m odules,
etc.) are not eligible for return or refund. In order to receive a partial refund/credit, the product m ust not have been
dam aged, and m ust be returned com plete (m eaning all m anuals, cables, accessories, etc.) within 90 days of original
purchase and in “as new” and resalable condition. The Return Procedure m ust be followed.

Return Procedure
Every product returned for refund/credit m ust be accom panied by a Return Material Authorization (RMA) num ber,
obtained from Datrend Custom er Service. All item s being returned m ust be sent prepaid (freight, duty, brokerage,
and taxes) to our factory location.

Restocking Charges
Products returned within 30 days of original purchase are subject to a m inim um restocking fee of 15%. Products
returned in excess of 30 days after purchase, but prior to 90 days, are subject to a m inim um restocking fee of 20%.
Additional charges for damage and/or m issing parts and accessories will be applied to all returns. Products which
are not in “as new” and resalable condition, are not eligible for credit return and will be returned to the custom er at
their expense.

Certification
This instrum ent was thoroughly tested and inspected and found to m eet DSI’s m anufacturing specifications when it
was shipped from the factory. Calibration m easurem ents are traceable to the National Research Council of Canada
(NRC) and/or the National Institute of Standards and Technology (NIST). Devices for which there are no NRC/NIST
calibration standards are m easured against in-house perform ance standards using accepted test procedures.

Page i
W arranty

W arranty and Product Support


Datrend System s Inc. ("DSI") warrants this instrum ent to be free from defects in m aterials and workm anship under
norm al use and service for two (2) years from the date of original purchase, providing the instrum ent is calibrated in
accordance with Chapter 7 of this m anual. During the warranty period DSI will, at our option, either repair or replace
a product at no charge that proves to be defective; provided you return the product (shipping, duty, brokerage and
taxes prepaid) to DSI. Any and all transportation charges incurred are the responsibility of the purchaser and are not
included within this warranty. This warranty extends only to the original purchaser and does not cover dam age from
abuse, neglect, accident or m isuse or as the result of service or m odification by other than DSI. IN NO EVENT
SHALL DATREND SYSTEMS INC. BE LIABLE FOR CONSEQUENTIAL DAMAGES.

No warranty shall apply when dam age is caused by any of the following:
! Discharge of a defibrillator into any term inal, interface connection or port, other than the specified Defibrillator
Input term inals of the instrum ent,
! Discharge of a transcutaneous pacem aker into any term inal, interface connection or port, other than the specified
Pacer Input term inals of the instrum ent,
! Use of an AC power supply adapter other than the AC adapter supplied with the instrum ent,
! Power failure, surges, or spikes,
! Dam age in transit or when m oving the instrum ent,
! Im proper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,
! Accident, alteration, abuse or m isuse of the instrum ent,
! Fire, water dam age, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc.

Only serialized products (those item s bearing a distinct serial num ber tag) and their accessory item s are covered
under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED
UNDER THE W ARRANTY. Item s such as cables and non-serialized m odules are not covered under this warranty.

This warranty gives you specific legal rights and you m ay have other rights, which vary from province to province,
state to state, or country to country. This warranty is lim ited to repairing the instrum ent to DSI's specifications.

W hen you return an instrum ent to DSI for service, repair or calibration, we recom m end shipm ent using the original
shipping foam and container. If the original packing m aterials are not available, we recom m end the following guide
for repackaging:
! Use a double-walled carton of sufficient strength for the weight being shipped.
! Use heavy paper or cardboard to protect all instrum ent surfaces. Use nonabrasive m aterial around all projecting
parts.
! Use at least four inches of tightly packed, industrial-approved, shock-absorbent m aterial all around the
instrum ent.

DSI will not be responsible for lost shipm ents or instrum ents received in dam aged condition due to im proper
packaging or handling. All warranty claim shipm ents m ust be m ade on a prepaid basis (freight, duty, brokerage, and
taxes). No returns will be accepted without a Return Materials Authorization ("RMA) num ber. Please contact
Datrend (see Chapter 7) to obtain an RMA num ber and receive help with shipping/custom s docum entation.

Recalibration of instrum ents, which have a recom m ended annual calibration frequency, is not covered under the
warranty.

W arranty Disclaimer
Should you elect to have your instrum ent serviced and/or calibrated by som eone other than Datrend System s,
please be advised that the original warranty covering your product becom es void when the tam per-resistant Quality
Seal is rem oved or broken without proper factory authorization. W e strongly recom m end, therefore, that you send
your instrum ent to Datrend System s for service and calibration, especially during the original warranty period.
In all cases, breaking the tam per-resistant Quality Seal should be avoided at all cost, as this seal is the key to your
original instrum ent warranty. In the event that the seal m ust be broken to gain internal access to the instrum ent (e.g.,
in the case of a custom er-installed firm ware upgrade), you m ust first contact Datrend System s (see Chapter 7). You
will be required to provide us with the serial num ber for your instrum ent as well as a valid reason for breaking the
Quality Seal. You should break this seal only after you have received factory authorization. Do not break the Quality
Seal before you have contacted us! Following these steps will help ensure that you will retain the original warranty on
your instrum ent without interruption.

Page ii
W ARNING
Unauthorized user m odifications or application beyond the published specifications m ay result in electrical shock
hazards or im proper operation. Datrend System s will not be responsible for any injuries sustained due to
unauthorized equipm ent m odifications.

DSI DISCLAIM S ALL OTHER W ARRANTIES, EXPRESSED OR IM PLIED, INCLUDING ANY W ARRANTY OF
M ERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

THIS PRODUCT CONTAINS NO USER-SERVICEABLE COM PONENTS.


UNAUTHORIZED REM OVAL OF THE INSTRUM ENT COVER SHALL VOID
THIS AND ALL OTHER EXPRESSED OR IM PLIED W ARRANTIES.

Multipulse Biowave® is a registered tradem ark of SCHILLER AG


Lifepak® is a registered tradem ark of Medtronic Inc.
HP Code Master® is a registered tradem ark of Hewlett Packard Inc.
W indows® is a registered tradem ark of Microsoft Corp.

Page iii
EC Declaration of Conformity

Classification

The Phase 3 Defibrillator and Transcutaneous Pacemaker Analyzer from


Datrend Systems Inc. is designed to be used for functional testing of
Defibrillators and Transcutaneous Pacemakers in a service environment. The
Phase 3 is intended for performance verification and is designed to satisfy
certain applicable test standards.

While the Phase 3 may be used in a clinical environment, the Phase 3 is not to
be used to verify the performance of any device which is connected to a
patient.

The Phase 3 from Datrend Systems Inc. has been designed to conform to the
following standards:

Electromagnetic Compatibility Standards

EN55022:1994 Class B
EN61000-4-3 Level A
IEC 801-2 Level B
IEC 801-4 Level B

General Electrical Safety

EN61010-1
IEC 61010-1

Page iv
Phase 3 OPERATING MANUAL

Table of Contents

1 SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Tests Performed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Performance Specifications.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.1 Energy Measurement, General.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.2 Defibrillator High Range Energy Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.3 Defibrillator Low Range Energy Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.4 Defibrillator Charge Time Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.5 Defibrillator Cardioversion Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.6 AED Performance Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.7 Pacemaker Pulse Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.8 Pacemaker Noise Immunity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2.9 Pacemaker Sensitivity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2.10 Pacemaker Refractory Period Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 ECG Simulator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.1 Performance Test Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.2 Normal Sinus Rhythm.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.3 Cardioversion, Shock Advisory and AED Test Waveforms. . . . . . . . . . . . . . . . . . . 5
1.3.4 Arrhythmia Simulations.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.5 Pacemaker Test Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.6 Performance Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Non-Volatile Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4.1 Memory Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4.2 Data Capacity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4.3 Test Record Content. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4.4 Waveform Record Content. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.1 User Interface.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.2 Defibrillator Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.3 Pacemaker Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.4 ECG Simulator Outputs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.5 Defibrillator/Pacer Waveform Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.6 High-Level ECG Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.7 USB Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.8 Serial (RS-232) Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.9 Keyboard Port.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.10 Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.6 Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.7 Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.8 Accessories.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.8.1 Standard Accessories.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.8.2 Optional Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Table of Contents # Page v


Phase 3 OPERATING MANUAL

2 OVERVIEW.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1 General Description.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.1 Test Capabilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.2 Data Log.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.1.3 Automated Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.4 Connectivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.5 Viewing and Saving Defibrillator Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.6 Principle of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2 Controls and Interface Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3 SETUP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.1 Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.2 Optional Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2.1 High-Level ECG Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2.2 Waveform Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2.3 Serial (RS-232) Input/Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.4 Keyboard Port.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.2.5 USB Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.3 Setting Up a HyperTerminal Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

4 OPERATION AND RELATED DISPLAYS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29


4.1 General Features of the User Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.1.1 Keypad and Display Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.1.2 Clip Record.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.1.3 CANCEL Key Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.1.4 User Preference Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.2 Powering Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.3 Main Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.3.1 Test Pulse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.3.2 Phase 3 ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.3.3 Set Clock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.4 Manual Test Menu.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.4.1 DUT ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.4.2 Restarting Manual Tests.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
4.5 Defibrillator Test Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.5.1 Defibrillator Energy Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.5.1.1 Selecting the Energy Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.5.1.2 Setting the ECG Simulator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.5.1.3 Setting a Target and Tolerance.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.5.1.4 Performing the Energy Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.5.1.5 Viewing and Saving Defibrillator Waveforms.. . . . . . . . . . . . . . . . . . . . . . 59
4.5.1.6 Capturing the Defibrillator Waveform in Real-Time. . . . . . . . . . . . . . . . . . 62
4.5.2 Defibrillator Charge Time Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.5.2.1 Selecting the Charge Time Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Table of Contents # Page vi


Phase 3 OPERATING MANUAL

4.5.2.2 Performing the Charge Time Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64


4.5.3 Defibrillator Cardioversion Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.5.3.1 Selecting the Cardioversion Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.5.3.2 Performing the Cardioversion Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.6 ECG Test Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
4.6.1 Selecting the ECG Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
4.6.2 Performing the ECG Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.7 Pacemaker Test Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.7.1 Pacemaker Load Selection.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.7.2 Pacemaker Pulse Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.7.2.1 Selecting the Pulse Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.7.2.2 Performing the Pulse Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.7.2.3 Capturing the Pacemaker Waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
4.7.3 Pacemaker Refractory Period Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.7.3.1 Selecting the Refractory Period Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.7.3.2 Performing the Refractory Period Test. . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.7.4 Pacemaker Noise Immunity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
4.7.4.1 Selecting the Noise Immunity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
4.7.4.2 Performing the Noise Immunity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4.7.5 Pacemaker Sensitivity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4.7.5.1 Selecting the Sensitivity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4.7.5.2 Performing the Sensitivity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
4.8 AED Test Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.8.1 Selecting the AED Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.8.2 Performing the AED Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
4.9 Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
4.9.1 Viewing and Storing the Clip Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
4.9.2 Recalling and Viewing Test Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
4.9.2.1 Selecting a Test Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
4.9.2.2 Printing a Test Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
4.10 Automated Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
4.10.1 AutoSequence Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
4.10.2 Selecting an AutoSequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
4.10.3 Running a Defib/Pacer AutoSequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
4.10.3.1 Automated Defibrillator Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
4.10.3.2 Automated ECG Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
4.10.3.3Automated Pacemaker Tests.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
4.10.4 Running an AED AutoSequence.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
4.10.5 AutoSequence Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
4.11 Self-Test Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
4.11.1 Critical Self-Test Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
4.11.2 Non-Critical Self-Test Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

5 REMOTE CONTROL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117


5.1 General Description.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Table of Contents # Page vii


Phase 3 OPERATING MANUAL

5.2 Remote Interface Mode.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118


5.3 Command Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
5.3.1 ECG Configuration Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
5.3.2 Defib Energy Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
5.3.3 Defib Charge Time Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
5.3.4 Defib Sync (Cardioversion) Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
5.3.5 Pacer Load Select Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
5.3.6 Pacer Pulse Command.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
5.3.7 Pacer Refractory Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
5.3.8 Pacer Noise Immunity Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
5.3.9 Pacer Sensitivity Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
5.3.10 Phase 3 ID Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
5.3.11 Clear Last Test Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
5.3.12 Clear Wave Records Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
5.3.13 Clear Test Records Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
5.3.14 Acquire Waveform Data Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
5.3.15 Number of Test Records Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
5.3.16 Send Test Report Command. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

6 Phase3pc SOFTWARE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135


6.1 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
6.1.1 Installing Phase3pc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
6.1.2 Installing USB Drivers.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
6.2 Phase 3 Remote Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
6.3 AutoSequence Editor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
6.3.1 Creating an AutoSequence.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
6.3.2 Editing an AutoSequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
6.3.3 Copying and Deleting AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
6.3.4 Uploading and Downloading AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . 140
6.3.5 Printing AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
6.3.6 AutoSequence Editor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
6.3.6.1 Editing the AutoSequence Title. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
6.3.6.2 Selecting the Device Under Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
6.3.6.3 Editing Defibrillator Energy Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
6.3.6.4 Editing the Charge Time Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
6.3.6.5 Editing Cardioversion Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
6.3.6.6 Editing ECG Performance Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
6.3.6.7 Editing Pacer Tests.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
6.3.6.8 Editing the Pacer Load. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
6.3.6.9 Editing Pacer Pulse Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
6.3.6.10 Editing the Noise Immunity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
6.3.6.11 Editing Demand Sensitivity Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
6.3.6.12 Editing Refractory Period Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
6.3.6.13 Editing Advanced Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
6.3.6.14 Editing AED Energy Tests.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Table of Contents # Page viii


Phase 3 OPERATING MANUAL

6.4 Test Report Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148


6.4.1 Downloading Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
6.4.2 Viewing Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
6.4.3 Saving Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
6.4.3.1 Saving as a Text File. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
6.4.3.2 Saving as a CSV File. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
6.4.3.3 Saving as a MUP File. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
6.4.4 Searching for Test Reports.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
6.4.5 Opening Existing Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
6.4.6 Printing Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
6.5 Waveform Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
6.5.1 Downloading Wave Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
6.5.2 Viewing Wave Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
6.5.3 Capturing High-Resolution Waveforms.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
6.5.4 Opening Existing Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
6.5.5 Using the Waveform Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
6.5.5.1 Zooming In and Out. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
6.5.5.2 Panning the Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
6.5.5.3 Undo Zoom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
6.5.5.4 Data Points On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
6.5.5.5 Setting the Chart Axes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
6.5.5.6 Saving Waveform Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
6.5.5.7 Printing Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
6.5.5.8 Editing the Device ID Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
6.5.5.9 Hot Key Summary.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

7 TROUBLESHOOTING AND MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

APPENDIX A. DEFAULT AUTOSEQUENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

APPENDIX B. SAMPLE TEST REPORT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Table of Contents # Page ix


Phase 3 OPERATING MANUAL

Table of Contents # Page x


Phase 3 OPERATING MANUAL

Abbreviations, Definitions and Symbols


The following abbreviations, terms and acronyms are used throughout this manual:

AED Automated External Defibrillator

AAMI American Association of Medical Instrumentation

Arrhythmia An abnormal rhythm of the cardiac muscle; an abnormal


pattern or rate of heart beats.
AutoSequence A series of measurements or test operations that are run
automatically in a predefined order, with or without user
involvement.
BPM (ECG) Beats Per Minute

Cardioversion A medical procedure in which an electrical discharge is


applied to a patient to correct a cardiac arrhythmia,
specifically tachycardia or atrial fibrillation. The procedure
requires a defibrillator which can be set to synchronize its
discharge to the electrocardiogram.

Clip Record Temporary (volatile) memory where device information and


test data is accumulated, until the data is saved as a Test
Record.
Defib A defibrillator; or, the act of defibrillating.

Demand Mode In reference to pacemakers, a mode of operation in which


the pacemaker is responsive to an ECG input signal. Also
referred to as "synchronous mode". When operating in
demand mode, the pacemaker generates pacing pulses in
the absence of ECG activity.

DUT Defibrillator Under Test, or Device Under Test

ECG Electrocardiogram. Equivalent to EKG.

Hz Hertz

IEC International Electrotechnical Commission

LA Left arm ECG lead

LL Left leg ECG lead

Definitions # Page xi
Phase 3 OPERATING MANUAL

Non-Demand Mode In reference to pacemakers, a mode of operation in which


the pacemaker is not responsive to an ECG input signal.
Also referred to as "asynchronous mode". When operating
in non-demand mode, the pacemaker generates pacing
pulses regardless of whether there is ECG activity or not.
Paced Refractory Period Immediately after generation of a pacing pulse, paced
refractory period (PRP) is the time interval over which the
pacemaker remains insensitive to the ECG. If a QRS
occurs within the PRP following output of a pacing pulse,
the pacemaker ignores this QRS.

Pacer A transcutaneous pacemaker

PPM (Pacemaker) Pulses Per Minute

QRS complex A specific segment of the electrocardiogram signal,


comprising the Q, R and S waves, which corresponds to
the heart systole.

RA Right arm ECG lead

RL Right leg ECG lead

Refractory Period When a pacemaker is operating in synchronous or


demand mode, the refractory period is the time interval
during which the pacemaker is insensitive to an ECG input
signal, and in particular, the QRS complex of the ECG.
Sensed Refractory Period The time interval after a detected QRS during which a
pacemaker remains insensitive to the ECG. If a QRS
occurs within the refractory period following a detected
QRS, the pacemaker then ignores this second QRS.

Test Record Test result data which has been saved to the non-volatile
Data Log as a record of all tests performed on a particular
defibrillator or pacemaker, as identified by I.D. or control
number. A Test Record may be recalled from the Data Log
for viewing on the LCD or printing. Test Records can be
downloaded in bulk to a PC using Phase3pc software.
Transcutaneous Pacemaker A pacemaker which stimulates cardiac muscle via
electrodes applied to the outside of the body, usually the
chest. Many defibrillators incorporate a transcutaneous
pacemaker.
V1-V6 Precordial ECG leads

Definitions # Page xii


Phase 3 OPERATING MANUAL

The following symbols appear on the labelling of Phase 3, and throughout this manual:

The operating manual provides valuable information on the proper use of Phase 3.
It is highly recommended that the operator read the instructions thoroughly before
operating the device. It is possible to damage the Device Under Test (DUT) and/or
cause harm to the operator if Phase 3 is used incorrectly

CAUTION: Electrical Shock Hazard, Refer servicing to qualified personnel


CAUTION: Consult Accompanying Documents

These warnings appear on the serial number label of Phase 3. Phase 3 measures hazardous
electrical voltages which MAY BE present when the covers are removed. The operator should read
the Operating Manual to determine what actions to take in the event of failure of Phase 3. Refer to
the Troubleshooting and Maintenance section of the Operating Manual.

In order to ensure ongoing performance accuracy, a TEST mode is provided on the Main Menu
(refer to section 4.3.1). It is recommended that this feature be used on a routine basis, or any time
a test result is in question.

NOTE: Protection of the operator may be compromised if the instructions in this


manual are not followed, or if Phase 3 is used for a purpose not specified in this
manual.

CAUTION: This device measures high voltage signals. For protection of the
operator, inspect the Paddle Adapter and the interconnecting Paddle Adapter Cables
on a regular basis for nicks, cracks or other damage that may compromise the
insulating properties of the housing, wire or connectors. Replace any damaged or
worn components immediately.

Definitions # Page xiii


Phase 3 OPERATING MANUAL

Typographic Conventions Used in this Manual

Style Example Definition

CANCEL Softkeys which appear on the Phase 3 unit display

TEST RESULTS Text which appear on the Phase 3 unit display

Add Test Text which appears on the PC screen when running Phase3pc software, or
text which describes the action of an icon located on the PC screen.

|{} Represents an actual key on a computer keyboard.

b +T Represents the simultaneous pressing of the specified key combination on a


computer keyboard.
, Represents clickable icons which appear on the PC screen when running
Phase3pc software
, , ,
Represent ,
special function keys located on the front panel of the Phase 3 unit.
Refer to section 4.1.1 for a detailed explanation of how these keys are used.
>, ?, <, =

Definitions # Page xiv


Phase 3 OPERATING MANUAL

1 SPECIFICATIONS

1.1 Tests Performed

• Defibrillator Energy
• Defibrillator Charge Time
• Defibrillator Cardioversion
• Automated External Defibrillator (AED) Performance
• ECG Monitor Performance
• Pacer Pulse Characteristics
• Pacer Noise Immunity
• Pacer Sensitivity
• Pacer Refractory Periods

1.2 Performance Specifications

1.2.1 Energy Measurement, General


• Load resistance: 50 ohms ±1%, non-inductive
• Signal sampling interval: 11.4 microseconds
• Measurement time window: 58.368 milliseconds
• ECG amplitude at defib pads: 1 mV QRS
• WAVEFORM (oscilloscope) Output
High Range: 1000:1 amplitude attenuation
Low Range: 200:1 amplitude attenuation
• Waveform Playback: Captured discharge can be viewed via
ECG outputs and paddles, with 200:1
time base expansion

Specifications/Chapter 1 # Page 1
Phase 3 OPERATING MANUAL

1.2.2 Defibrillator High Range Energy Test


• Energy Measurement:
Range: 0.0 to 400.0 Joules
Accuracy: ±1% ±2 LSD
• Voltage Measurement:
Range: 0 to 5000 Volts
Accuracy: ±1% ±2 LSD
• Current Measurement:
Range: 0.0 to 100.0 Amps
Accuracy: ±1% ±2 LSD
• Pulse Width Measurement:
Range: 0.10 to 58.36 milliseconds
Accuracy: ±1% ±2 LSD
• Trigger Level: 80 Volts
• Playback Amplitude: 1 millivolt per 1000 volts on Lead II;
1 millivolt per 2000 volts at defib pads
• Test Pulse: 126 Joules ±10%

1.2.3 Defibrillator Low Range Energy Test


• Energy Measurement:
Range: 0.0 to 50.0 Joules
Accuracy: ±1% ±2 LSD
• Voltage Measurement:
Range: 0 to 1000 Volts
Accuracy: ±1% ±2 LSD
• Current Measurement:
Range: 0.0 to 20.0 Amps
Accuracy: ±1% ±2 LSD
• Pulse Width Measurement:
Range: 0.10 to 58.36 milliseconds
Accuracy: ±1% ±2 LSD
• Trigger Level: 16 Volts
• Playback Amplitude: 1 millivolt per 200 volts on Lead II;
1 millivolt per 400 volts at defib paddles
• Test Pulse: 46 Joules ±10%

Specifications/Chapter 1 # Page 2
Phase 3 OPERATING MANUAL

1.2.4 Defibrillator Charge Time Test


• Energy, Voltage, Current and Pulse Width specifications per 1.2.1.
• Charge Time Measurement:
Range: 0.0 to 99.9 seconds
Accuracy: ±1 LSD

1.2.5 Defibrillator Cardioversion Test


• Energy, Voltage, Current and Pulse Width specifications per 1.2.1, 1.2.2.
• Sync Delay Measurement:
Range: -200 to +800 milliseconds
Accuracy: ±1 LSD
• Delay Target: +20 to +65 msec window when enabled
• Sync Point: Selectable, peak of ECG Q or R wave

1.2.6 AED Performance Test


• Energy specifications per 1.2.1.
• Test Method: Verification of AED shock advisory
report for specified ECG arrhythmia

1.2.7 Pacemaker Pulse Test


• Pulse Amplitude Measurement:
Range: 4 to 250 milliamps, all loads
Accuracy: ±1% ±1 LSD
• Pulse Rate Measurement:
Range: 20 to 220 pulses per minute (PPM)
Accuracy: ±1% ±1 LSD
• Pulse Width Measurement:
Range: 0.5 to 58.36 milliseconds
Accuracy: ±1% ±2 LSD
• Test Load Range: 50 to 1600 ohms, in 50 ohm steps
• WAVEFORM output: 50 milliamps per volt, all loads
• Measurement Methods: Average, leading edge, trailing edge, peak
• Test Pulse: 125 mA ±10%

Specifications/Chapter 1 # Page 3
Phase 3 OPERATING MANUAL

1.2.8 Pacemaker Noise Immunity Test


• Test Waveform: 50Hz or 60Hz sine wave
• Noise Amplitude Range: 0.00 to 6.00 millivolts peak-to-peak
• Noise Amplitude Precision: 0.023 millivolts

1.2.9 Pacemaker Sensitivity Test


• Test Waveform: Square (SQRP), Triangle (TRIP) or
Haversine (SSQP) pulse
• Waveform Width: 10, 25, 40, 100, or 200 milliseconds
• Amplitude Range: 0.00 to 3.00 millivolts peak

1.2.10 Pacemaker Refractory Period Test


• Paced Refractory Period (PRP):
Range: 50 to 750 milliseconds
Accuracy: ±1 LSD
• Sensed Refractory Period (SRP):
Range: 50 to 750 milliseconds
Accuracy: ±1 LSD

Specifications/Chapter 1 # Page 4
Phase 3 OPERATING MANUAL

1.3 ECG Simulator

1.3.1 Performance Test Waveforms


• DC Pulse, 4 seconds
• Square Wave, 2 Hz
• Triangle Wave, 2 Hz
• Sine Wave @ 0.1, 0.5, 10, 20, 40, 50, 60, 70, or 100 Hz

1.3.2 Normal Sinus Rhythm


• 30, 60, 90, 120, 150, 180, 240 or 300 BPM

1.3.3 Cardioversion, Shock Advisory and AED Test Waveforms


• Atrial Fibrillation, Coarse (AFIB1)
• Atrial Fibrillation, Fine AFIB2)
• Asystole (ASYS1) (random, low-frequency baseline fluctuation)
• Asystole - Flat (ASYS2) (flat line/zero volts)
• Supraventricular Tachycardia (SVTACH)
• Ventricular Tachycardia at 140 BPM (VTACH1)
• Ventricular Tachycardia at 160 BPM (VTACH2)
• Ventricular Tachycardia at 190 BPM (VTACH3)
• Torsades de Pointes at 200 BPM (PVTACH)
• Coarse Ventricular Fibrillation (VFIB1)
• Fine Ventricular Fibrillation (VFIB2)

1.3.4 Arrhythmia Simulations


• Second Degree A-V Block
• Premature Atrial Contraction (PAC)
• Right Bundle Branch Block (RBBB)
• Premature Ventricular Contraction (PVC)
• R-on-T PVC
• Multifocal PVC
• Run of 5 PVC
• Bigeminy
• Trigeminy

1.3.5 Pacemaker Test Waveforms


• SQRP (square) Pacer Trigger, width = 10, 25, 40, 100 or 200 msec
• TRIP (triangle) Pacer Trigger, width = 10, 25, 40, 100 or 200 msec
• SSQP (haversine) Pacer Trigger, width = 10, 25, 40, 100 or 200 msec

Specifications/Chapter 1 # Page 5
Phase 3 OPERATING MANUAL

1.3.6 Performance Specifications


• Output Level: Selectable, 1 millivolt, 2 millivolt or 0.5 millivolt into ECG Lead II
• Impedance: 500 ohms
• Accuracy:
Rate: ±0.2%
Amplitude: ±2%

1.4 Non-Volatile Memory

1.4.1 Memory Type


• EEPROM

1.4.2 Data Capacity


• 80 Test Records
• 10 Defibrillator Waveform Records
• 32 Automated Test Sequences

1.4.3 Test Record Content


• Device ID (equipment control number)
• Time/date of test
• Test type (manual or AutoSequence test)
• Device type (standard defibrillator, or AED)
• Up to 10 defibrillator energy tests (or 32 AED energy tests)
• 1 defibrillator charge time test
• Up to 4 defibrillator cardioversion tests
• Up to 12 ECG performance tests
• Up to 10 pacer pulse tests
• 1 pacer noise immunity test
• Up to 2 pacer sensitivity tests
• Up to 2 pacer refractory period tests

1.4.4 Waveform Record Content


• Device ID (equipment control number)
• Time/date of test
• Energy, voltage, current, and pulse width of captured discharge
• Discharge waveform data

Specifications/Chapter 1 # Page 6
Phase 3 OPERATING MANUAL

1.5 Interface

1.5.1 User Interface


• LCD (5.2" x 1.5"; 40 characters x 8 lines text; 240 x 64 pixel graphics)
• 4 front panel soft-keys + 4 navigation keys
• Audio beeper
• LCD contrast adjustment (side panel)

1.5.2 Defibrillator Input


• Molex 42820-3212

1.5.3 Pacemaker Input


• 2 x safety-style banana jack (red (+)/black (-))

1.5.4 ECG Simulator Outputs


• 10 x safety-style banana jack (RA; RL; LA; LL; V1-V6)

1.5.5 Defibrillator/Pacer Waveform Output


• 1/8" monaural phono jack with signal on tip, sleeve ground

1.5.6 High-Level ECG Output


• 1/8" monaural phono jack with signal on tip, sleeve ground

1.5.7 USB Port


• Connector: Type "B"
• Protocol: USB 1.1 or USB 2.0 compatible
• Data Transfer Rate: 64 bytes per millisecond

1.5.8 Serial (RS-232) Port


• Connector: DB9 Male
• Protocol: RS-232C; bidirectional; CTS handshaking;
9600 baud; 8 data bits; no parity bit;
1 stop bit

1.5.9 Keyboard Port


• Connector: PS/2 (6-pin miniDIN female)
• Protocol: Per PS/2 standard

Specifications/Chapter 1 # Page 7
Phase 3 OPERATING MANUAL

1.5.10 Power Supply


• Battery: Internal 12.5V/1.4A-h NiCad, P/N 3310-007
• Battery Life: 24 hours of use between charges
• Battery Charger: See AC adapter, section 1.8.1
• DC Voltage Input: 18VDC, 0.8A max

1.6 Environment
• 15EC to 40EC
• 10% to 90% RH
• Altitude: 2000m max.
• Indoor Use Only
• Category II
• Pollution Degree 2

1.7 Dimensions
• 9.5" (24cm) W x 8" (20cm) H x 5.5" (14cm) D
• Weight 3 lbs. (1.4 kg)

1.8 Accessories

1.8.1 Standard Accessories

• Adult Paddle Adapter (P/N 7400-442)


• Adult Paddle Adapter Cable (P/N 7200-444)
• USB Cable (A-B Male) (P/N 3140-440)
• Phase3pc Software on CDROM (P/N 6950-004)
• Operator's Manual on CDROM (P/N 6950-004)
• AC Adapter, one of:
- North America: 120VAC/60Hz to 15VDC/1A (P/N 3000-500)
- UK: 240VAC/50Hz to 15VDC/0.8A (P/N 3000-501)
- Europe: 100-264VAC 50/60Hz to 18VDC/0.8A (3000-440 + 3000-442)
- Australia: 100-264VAC 50/60Hz to 18VDC/0.8A (3000-440 + 3000-441)

Specifications/Chapter 1 # Page 8
Phase 3 OPERATING MANUAL

1.8.2 Optional Accessories

• ECG-to-Banana Adapter Set (P/N 7500-425 - Set of 10)


• Internal Paddle Adapter Set (P/N 7400-443)
• Variable Load Module (P/N 7900-460)
• Variable Load Module Software on CDROM (P/N 6950-004)
• Unterminated Defibrillator Adapter Cable (P/N 7200-445)
• Unterminated Pacemaker Adapter Cable (P/N 7200-446)
• Terminated Defibrillator Adapter Cable - Banana Jacks (P/N 7200-448)
• Computer Interface Cable (RS-232), DB9F - DB9F (P/N 3140-400)
• Computer Interface Adapter (RS-232), DB9M - DB25F (P/N 3140-401)
• Printer Interface Adapter, DB9M - DB25M (P/N 3140-402)
• Citizen iDP-3110 Serial Printer (P/N 7050-055)
• Barcode Pen Reader, RS-232 (P/N 7050-050)
• Barcode CCD Scanner, RS-232 (P/N 7600-051)
• Barcode CCD Scanner, PS/2 (P/N 7600-052)

Compliance With Standards


Phase 3 has been certified to meet the following safety standards:

CAN/CSA-C22.2 No. 61010-1-(2nd Edition) - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use, Part 1: General Requirements

UL Std. No. 61010-1 (2nd Edition) - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1: General Requirements

IEC/EN 61010-1 (Ed.2.0) - Safety requirements for electrical equipment for measurement, control,
and laboratory use - Part 1: General requirement

Following manufacture, all units are subjected to, and have passed the requirements of the ‘Routine
Tests’ defined in Annex F of the above Standard(s).

Specifications/Chapter 1 # Page 9
Phase 3 OPERATING MANUAL

Specifications/Chapter 1 # Page 10
Phase 3 OPERATING MANUAL

2 OVERVIEW

2.1 General Description

2.1.1 Test Capabilities

Phase 3 is a portable, automated system for verifying performance of defibrillators and


transcutaneous pacemakers of all types, including defibrillators which produce monophasic,
biphasic, and Multipulse Biowave® discharges. Phase 3 provides menu-driven procedures which
allow you to test:

Delivered Energy Measure the output energy of a defibrillator when it is discharged


into Phase 3. Along with energy in joules, also measures peak
voltage, current and duration of the discharge pulse.
Charge Time Measure the time required for a defibrillator to charge up to its
maximum energy setting. After charging, measures the energy
delivered when the defibrillator is discharged into Phase 3.

Cardioversion Verify the ability of a defibrillator to correctly synchronize its


discharge to the QRS complex of the electrocardiogram.
Monitor Performance Check the ECG monitor and chart recorder of a defibrillator with
performance waves, normal sinus rhythms, and a wide variety of
arrhythmias provided by the full-featured ECG simulator of
Phase 3.

AED Performance Verify the ability of an Automated External Defibrillator (AED) to


correctly recognize life-threatening arrhythmias and advise delivery
of a shock at the appropriate energy.
Pulse Characteristics Measure amplitude, rate and width of pulses generated by the
transcutaneous pacemaker of a defibrillator.

Overview/Chapter 2 # Page 11
Phase 3 OPERATING MANUAL

Noise Immunity Verify the ability of a transcutaneous pacemaker to reject line


frequency interference in the electrocardiogram.
Sensitivity Determine the smallest QRS complex that a transcutaneous
pacemaker will recognize as valid.
Refractory Period Determine the paced refractory period (PRP) and sensed refractory
period (SRP) of a transcutaneous pacemaker.

Phase 3 incorporates one fixed 50 ohm load for defibrillator testing, and a variable load for pacer
testing that may be set from 50 to 1600 ohms in 50 ohm steps. To accommodate requirements of
the IEC60601-2-4 standard for defibrillators, the Variable Load Module (VLM) may be added to
Phase 3 as an optional accessory, allowing the user to perform energy tests with an alternative
defibrillator load ranging from 25 to 175 ohms in 25 ohm steps.

Phase 3 may be powered from its internal NiCad battery or from AC power using the accessory
adapter provided with the unit. The rechargeable battery can provide up to 24 hours of continuous
operation.

Phase 3 is small and light-weight, allowing you to easily carry the analyzer to institutional areas
where defibrillators are located. As you perform each test, results can be saved to the non-volatile
Data Log of Phase 3, for later review on the LCD, output to an attached printer, or download to a
personal computer.

2.1.2 Data Log

Phase 3 incorporates a non-volatile memory or "data log" which is used to save test results or Test
Records. For each defibrillator tested, Phase 3 can create a Test Record containing energy, charge
time and cardioversion test results, which may be combined with results from ECG and
transcutaneous pacemaker tests. The non-volatile memory of Phase 3 provides storage for up to 80
such Test Records, each Record being identified by the control number of the defibrillator tested.
The non-volatile memory can also be used to store up to 10 defibrillator discharge waveforms as
Wave Records. Test Records and Wave Records can be downloaded to a personal computer by
means of Phase3pc software, included on CDROM with the analyzer.

Overview/Chapter 2 # Page 12
Phase 3 OPERATING MANUAL

2.1.3 Automated Testing

For fully automated testing, Phase 3 provides 32 AutoSequences which may be user-programmed
by means of Phase3pc software. An AutoSequence test may include steps for measuring
defibrillator energy, charge time, and synchronization delay; ECG performance; and pacemaker
pulse characteristics, noise immunity, sensitivity, and refractory periods. Phase 3 comes equipped
with pre-programmed AutoSequences loaded into its non-volatile memory, which can be modified
or supplemented as desired via Phase3pc software.

For each test or measurement performed in an AutoSequence, the expected value of the result or
target is specified, so that Phase 3 will automatically pass or fail the result depending on an
acceptance range derived from the target and a selected tolerance. In manual tests, target and
tolerance parameters may be optionally entered "on the fly", while measurements are being taken.

2.1.4 Connectivity

Phase 3 has two communication ports: Serial I/O and USB. The Serial I/O interface is an RS-232
Port that may be connected to a personal computer, accessory barcode reader, serial printer, or
automated testing system such as the ES601Plus Automated Safety Analyzer. The USB Port is
intended solely for rapid data transfer to a personal computer using the accessory Phase3pc
software. To permit rapid data entry of equipment control numbers, Phase 3 also provides a PS/2
Port which may be connected to a standard PS/2 keyboard, or to a PS/2 barcode reader.

2.1.5 Viewing and Saving Defibrillator Waveforms

In addition to providing an analog output suitable for connection to a conventional oscilloscope,


Phase 3 provides a number of unique features related to defibrillator waveform capture and
examination, including:

Show Waveform After discharging a defibrillator into Phase 3, view the captured
waveform on the Phase 3 graphical LCD. Three selections for both
vertical and horizontal axes are provided, allowing you examine the
waveform in greater detail.
Playback Play back the captured defibrillator waveform into the ECG monitor
or chart recorder of the defibrillator, with 200:1 timebase expansion.
Phase 3 may be configured to automatically playback the waveform
following detection of a valid defibrillator discharge.

Overview/Chapter 2 # Page 13
Phase 3 OPERATING MANUAL

Wave Records Save the captured waveform as a Wave Record, for later download
and graphical plotting by the accessory Phase3pc software
(included). To allow a greater number of Wave Records to be stored,
the signal data is compressed by Phase 3 before saving.

Real-Time Capture Capture high-resolution signal data immediately after a defibrillator


discharge, by rapid data transfer via USB to a personal computer
running Phase3pc software. Real-time wave capture may also be
performed via RS-232 when Phase 3 is operating in remote control
mode.

Wave Records are meant to provide a qualitative "snap shot" of the defibrillator signal, but for some
types of discharges, data resolution of the compressed waveform may be insufficient for detailed
numerical analysis such as might be required in a laboratory investigation or research. As an
alternative to Wave Records, Phase 3 in conjunction with Phase3pc software can provide real-time
waveform capture of a discharge. With real-time capture, Phase3pc can produce a graphic chart of
the waveform data on the PC screen immediately after a discharge, accompanied by the analysis
results such as energy, voltage, current and pulse duration. High-resolution waveform data can then
be saved as a file on the PC for later recall, or for export to other data analysis programs such as a
spreadsheet.

2.1.6 Principle of Operation

In principle, Phase 3 is a waveform analyzer that determines the characteristics of an electrical


discharge signal produced by a defibrillator and/or transcutaneous pacemaker. These
characterizations include: signal energy, peak current, peak voltage, pulse width, pulse rate, and
refractory intervals.

Measurements are accomplished by sampling the defibrillator signal from the defib pads or from the
pacer terminals at a high speed. Sampling is triggered by either the rising or falling edge of the input
signal, ensuring the waveform will be captured even if the operator connects the defib or pacer to
Phase 3 with reversed polarity.

Once Phase 3 is triggered, the signal is digitized with 13 bits of precision and approximately 58
milliseconds of signal data having a sample interval of 11.4 microseconds are then stored. After
acquiring the signal data, Phase 3 calculates test results based on the samples. As each measurement
result is derived (energy; voltage; current; and so on), the result is temporarily stored in the Clip
Record which is located in volatile memory (RAM). Once all tests have been completed, the user
can save the test results by entering an equipment control number for identification and then
transferring the contents of the Clip Record to a Test Record in the non-volatile Data Log.

Overview/Chapter 2 # Page 14
Phase 3 OPERATING MANUAL

2.2 Controls and Interface Connections

Figure 1 illustrates the user controls and electrical interfaces of Phase 3. The electrical interfaces are
described in Chapter 3 of this manual. Operation of Phase 3 via the keypad and LCD is described in
Chapter 4.

Figure 1: Controls and Interfaces

1. Liquid Crystal Display (LCD) 8. ECG Outputs (RA; RL; LA; LL; V1)
2. Keypad 9. ECG Outputs (V2; V3; V4; V5; V6)
3. Defibrillator Input 10. Pacemaker Input
4. Power ON/OFF Switch 11. USB Port
5. DC Power Input 12. PS/2 Keyboard Port
6. High-Level ECG Output (1V QRS) 13. Serial I/O Port (RS-232)
7. Waveform Output (to oscilloscope) 14. Carrying Handle

Overview/Chapter 2 # Page 15
Phase 3 OPERATING MANUAL

Overview/Chapter 2 # Page 16
Phase 3 OPERATING MANUAL

3 SETUP

3.1 Connections

a. Place Phase 3 on a stable surface and insert the plug of the provided AC adapter into
the power input jack located on the right side panel (Figure 1). Plug the adapter into
an AC outlet.

IMPORTANT:

YOUR Phase 3 HAS BEEN PROVIDED WITH ONE OF THE


FOLLOWING AC ADAPTERS:

North America: P/N 3000-500


120VAC/60Hz to 15VDC/0.6A; NEMA 5-15P plug

Europe: P/N 3000-440 + 3000-442


230VAC/50Hz to 15VDC/0.8A;CEE 7/16 plug

United Kingdom: P/N 3000-501


240VAC/60Hz to 15VDC/0.8A; BS 1363 plug

Australia: P/N 3000-400 + 3000-441


100-264VAC 50/60Hz to 18VDC/0.8A

USE ONLY THE AC ADAPTER PROVIDED WITH YOUR


INSTRUMENT. SUBSTITUTION OR USE OF AN ALTERNATE AC
ADAPTER MAY DAMAGE Phase 3 AND VOID THE WARRANTY.

Setup/Chapter 3 # Page 17
Phase 3 OPERATING MANUAL

b. If you wish to test a defibrillator having external paddles, connect the Adult Paddle
Adapter included with Phase 3 to the Defibrillator Input using the Paddle Adapter
Cable (Figure 2). At each end of the cable, depress the catch on the plug, fit the plug all
the way into the mating receptacle, then release the catch to lock the cable securely in
place.

Figure 2 - Connection to defibrillator under test.

Alternatively, for hands-free testing, you may connect the output of the defibrillator
directly to the Defibrillator Input of Phase 3 by means of a suitable adapter cable. An
unterminated defibrillator adapter cable is available as an optional accessory (Datrend
P/N 7200-445).

Setup/Chapter 3 # Page 18
Phase 3 OPERATING MANUAL

NOTE:

When using unterminated cable 7200-445, you should observe


polarity of the connection as indicated on the Defibrillator Input
label [STERNUM(-); APEX(+)]. Reverse polarity connection
cannot damage Phase 3 or produce incorrect measurement
results, however, the defibrillator waveform may appear inverted
if viewed on the Phase 3 LCD.

An adapter set for testing internal paddles is also available as an optional accessory
(Datrend P/N 7400-443). Refer to the information sheet supplied with the Internal
Paddle Adapter Set for instructions on how to fit these adapters to the pads on the
Adult Paddle Adapter.

c. Connect ECG leads from the defibrillator under test (DUT) to the ECG simulator
outputs located on left and right side panels of Phase 3 (Figure 1). Connections for
standard 3- or 5-wire ECG patient cables (RA; RL; LA; LL; V) are provided on the
right side panel of Phase 3; optional chest connections (V2-V6) for diagnostic ECG are
located on the left side panel. Phase 3 accepts standard or safety-style banana plugs for
the ECG connections. An Adapter Set which can interface Phase 3 to snap-style ECG
patient leads is available as an optional accessory (Datrend P/N 7500-425).

d. If testing of a transcutaneous pacemaker is required, connect the pacemaker output to


the PACER INPUT terminals located on the left side panel of Phase 3 (Figure 3). The
PACER INPUT connections will accept standard or safety-style banana leads. An
unterminated pacemaker adapter cable is available as an optional accessory (Datrend
P/N 7200-446).

Setup/Chapter 3 # Page 19
Phase 3 OPERATING MANUAL

Figure 3 - Connection for pacemaker testing.

IMPORTANT:

DO NOT DISCHARGE A DEFIBRILLATOR


INTO THE PACER INPUT OF Phase 3.

DOING SO WILL DAMAGE Phase 3 AND WILL


VOID THE WARRANTY.

Setup/Chapter 3 # Page 20
Phase 3 OPERATING MANUAL

3.2 Optional Connections

Refer to Figure 1 to locate the optional interface connections described in this section.

3.2.1 High-Level ECG Output

A high-level analog output signal from the Phase 3 ECG simulator is available at the 1V ECG jack
located on the right side panel. This is a 1/8" monaural phono jack having the signal on the tip
connection and ground on the sleeve. This output is capable of driving a load of 10k ohms or
higher.

The signal amplitude observed at the 1V ECG jack depends on the SCALE setting of the ECG
simulator. At this jack, the QRS complex of the ECG will have 1 volt peak amplitude when the
simulator is set to "x1 scale"; 2 volt amplitude on "x2 scale"; and 0.5 volt amplitude on "x0.5 scale".

3.2.2 Waveform Output

The WAVEFORM output is located on the right side panel of Phase 3 and is intended for
connection of an oscilloscope or similar instrument. The WAVEFORM output is a 1/8" monaural
phono jack having the signal on the tip connection and ground on the sleeve.

When performing defibrillator tests, the WAVEFORM output will provide a scaled analog signal
representative of the defibrillator discharge. When LOW RANGE energy measurement is selected,
the WAVEFORM output provides 1 volt output per 200 volts at the Phase 3 Defibrillator Input
(200:1 attenuation). When HIGH RANGE energy measurement is selected, the WAVEFORM
output provides 1 volt output per 1000 volts at the Defibrillator Input (1000:1 attenuation).

When performing pacemaker tests, the WAVEFORM output provides a scaled analog signal
representative of the pacemaker pulse train. In this case, the WAVEFORM output provides 1 volt
output per 50mA at the Phase 3 PACER INPUT. The WAVEFORM scale remains constant
regardless of the pacemaker load selected for the test.

Setup/Chapter 3 # Page 21
Phase 3 OPERATING MANUAL

3.2.3 Serial (RS-232) Input/Output

The Serial I/O Port of Phase 3 can be used to interface to any one of the following RS-232
peripheral devices.

Personal • Controls Phase 3 remotely through a COM port


Computer using the remote command instruction set.
• Downloads test result data (Test Records) stored
in the Phase 3 memory.
Serial Printer • Generates a hard copy printout of Test Records
stored in non-volatile Data Log of Phase 3.
Barcode • Enables rapid entry of an equipment control
Reader or number as scanned from a barcode label on the
Scanner defibrillator under test.
Automated • Controls Phase 3 using the remote command
Test System instruction set.

The multifunction Serial Port is realized through a DB9 male connector whose pinout is shown in
Figure 4. The protocol of the Serial Port is 9600 baud, N, 8, 1.

Figure 4: Serial I/O Port (front view)

Barcode readers which are compatible with the Phase 3 RS-232 Port are available as optional
accessories (RS-232 Pen Reader: Datrend P/N 7050-050; RS-232 CCD Scanner: Datrend P/N
7600-051).

Optional accessory cables are also available to connect other peripheral devices to Phase 3:

• Connection from Phase 3 to a DB9 PC COM port is achieved using a DB9F to DB9F NULL
MODEM cable (Datrend P/N 3140-400).

Setup/Chapter 3 # Page 22
Phase 3 OPERATING MANUAL

• Connection from Phase 3 to a DB25 COM port is achieved using a NULL MODEM cable,
noted above, in combination with a DB9M to DB25F adapter (Datrend P/Ns 3140-400 +
3140-401)

• Connection from Phase 3 to the accessory Citizen serial printer (Datrend P/N 7050-055) is
achieved using a NULL MODEM cable, noted above, in combination with a DB9M to
DB25M adapter (Datrend P/Ns 3140-400 + 3140-402).

Alternatively, cables made to the specifications listed in Table 3-1 may be used to connect Phase 3
to a peripheral device. Connectors specified in the table are for the cables, and shaded cells in the
table indicate no connection.

Table 3-1: RS-232 Interface Cable Specifications


Phase 3 PC PC/MedTester Serial Printer
(DB9F) (DB9F) (DB25F) (DB25M)
2 - RXD 3 - TXD 2 - TXD
3 - TXD 2 - RXD 3 - RXD 3 - RXD
5 - GND 5 - GND 7 - GND 7 - GND
9 - VCCOUT
6 - BUSY 4 - DTR 20 - DTR 20 - DTR

IMPORTANT:

Never connect a RS-232 Barcode Reader to Phase 3 if the power


is on. The Barcode Reader is powered from Phase 3 and may be
damaged if “hot-plugged”. Always turn Phase 3 off BEFORE
connecting a RS-232 Barcode Reader to the Serial I/O Port.

Setup/Chapter 3 # Page 23
Phase 3 OPERATING MANUAL

3.2.4 Keyboard Port

The Keyboard Port of Phase 3 is intended for optional connection of a PS/2 personal computer
keyboard, or alternatively, a PS/2-compatible Barcode Scanner (Datrend P/N 7600-052; optional
accessory).

Connection of a PS/2 keyboard or barcode scanner to Phase 3 is optional but simplifies entry of an
ID, such as an equipment control number, for the defibrillator under test (DUT). Alternatively, the
keypad of Phase 3 may be used to enter a DUT ID if an external keyboard or barcode scanner is
not available.

IMPORTANT:

Never connect a PS/2 device (Keyboard or Barcode Scanner) to


Phase 3 if the power is on. The PS/2 device is powered from
Phase 3 and may be damaged if "hot-plugged". Always turn
Phase 3 off before connecting a PS/2 device.

3.2.5 USB Port

The USB Port of Phase 3 is intended to work specifically with Phase3pc software, supplied with
Phase 3 on CD ROM as a standard accessory (Datrend P/N 6950-004). A USB cable is also
provided with Phase 3 as a standard accessory (Datrend P/N 3140-440).

Phase 3 may be "hot-plugged" to the PC using the supplied USB cable at any time while the
instrument is running. Once Phase3pc successfully detects Phase 3, data may be transferred to or
from the PC via the high-speed USB connection.

With Phase3pc sofware, you can:

• Create, modify, save, and print automated sequences of defibrillator and pacemaker tests
("AutoSequences"). AutoSequences created with Phase3pc can be uploaded into the non-
volatile memory of Phase 3. AutoSequences stored in Phase 3 can be downloaded to
Phase3pc for editing and re-uploading to Phase 3.

• Download Test Records stored in the non-volatile Data Log of Phase 3. Phase3pc generates
Test Report documents from the Test Records, which you can then print, save to disk, or
export to equipment management software.

Setup/Chapter 3 # Page 24
Phase 3 OPERATING MANUAL

• Download Wave Records stored in the non-volatile memory of Phase 3. Phase3pc generates
graphical plots of the waveform data which you can then print or save to disk.

• Acquire high-resolution samples of defibrillator discharge waveforms, using the real-time


waveform capture mode.

Refer to Chapter 6 of this manual for more information on installing and using Phase3pc software.

Setup/Chapter 3 # Page 25
Phase 3 OPERATING MANUAL

3.3 Setting Up a HyperTerminal Connection

As described in Section 3.2.3, the Serial I/O Port of Phase 3 may be connected to the serial
communications port (COM port) of a personal computer. A terminal program (i.e., Windows
98/2000/XP HyperTerminal or equivalent) running on the PC may then be used to receive Phase 3
Test Reports and save them to a text file. Follow the instructions below to set up HyperTerminal
for use with Phase 3.

a. Open HyperTerminal: In Windows XP, click Start, point to All Programs, point to
Accessories, point to Communications and click on HyperTerminal.

b. You will be prompted to enter a name for the HyperTerminal connection and select an
icon associated with this new connection (Figure 5). Enter a suitable name, select the
desired icon, and click on OK. Next time, click on this icon from Explorer or the Start
menu to avoid having to set up a new connection every time you wish to use
HyperTerminal.

Figure 5 - New connection for Phase 3.

c. A dialogue box will appear asking which port to connect to. Select the appropriate
COM port and click OK.

d. Another dialogue box appears to configure the port settings. Configure the port
settings as shown in Figure 6 and click OK.

Setup/Chapter 3 # Page 26
Phase 3 OPERATING MANUAL

Figure 6 - HyperTerminal COM port

In the HyperTerminal program window, click on Transfer in the menu bar and click on Capture
Text to save all Test Records to a file. In the File box, type a descriptive name for the file, and then
click Start.

e. HyperTerminal is now ready to receive data sent from Phase 3 to the PC. Refer to
Section 4.9.2.2 for instructions on how to initiate RS-232 transmission of Test Reports
from Phase 3.

f. Once all Test Reports have been transferred, stop capturing text. In the Transfer
menu, point to Capture Text and click on Stop.

Setup/Chapter 3 # Page 27
Phase 3 OPERATING MANUAL

Setup/Chapter 3 # Page 28
Phase 3 OPERATING MANUAL

4 OPERATION AND RELATED DISPLAYS

4.1 General Features of the User Interface

4.1.1 Keypad and Display Operation

The keypad and display of Phase 3 are shown in Figure 7. The keypad comprises four general-
purpose keys that have functions defined by the Phase 3 software, as represented by labels which
are shown on the display immediately above each key. In this manual, these keys are referred to as
"softkeys". Four additional keys labelled with arrows take specific functions depending on the state
of the display.

Figure 7 - Phase 3 keypad functions.

Operation/Chapter 4 # Page 29
Phase 3 OPERATING MANUAL

These keys are used to respectively increment or decrement displayed data.


Alternatively, these keys may be used to scroll through a list of displayed items.
These buttons will have a repeating action if pressed and held down. When these
keys are active, >? symbols will appear on the LCD display at the far right.
These keys will remain inactive until the > ? symbols are displayed.
Press this button to access additional softkey functions "on the right". This
button becomes active whenever a < symbol appears on the display at the
bottom righthand corner, for example, as shown in Figure 7.
Press this button to access additional softkey functions "on the left". This button
becomes active whenever a = symbol appears on the display at the bottom
lefthand corner.

4.1.2 Clip Record

As defibrillator and pacemaker tests are performed with Phase 3, the individual test results are
collected in a temporary area of memory which is designated the Clip Record. When testing is
complete and results are to be saved, the contents of the Clip Record are then copied to a Test
Record, which resides in non-volatile memory. When a Test Record is recalled from non-volatile
memory for viewing or printing, the Record data is placed in the Clip Record.

The Clip Record is in volatile memory and any data stored in it will be lost if Phase 3 power is
interrupted before the Clip Record data is saved as a Test Record. Test Records saved in non-
volatile memory are retained when the power to Phase 3 is switched off.

As Phase 3 is used to perform individual measurements and tests, the Clip Record will progressively
accumulate the following data:

• Device ID (equipment control number)


• Date and Time of test
• Defibrillator test data (energies, charge time, cardioversion sync delays)
• ECG test data (waveform and test result)
• Pacemaker test data (test load, pulse characteristics, and results of immunity, sensitivity
and refractory period tests)

Data accumulated in the Clip Record may be reviewed at any point during the manual testing
process by pressing the VIEW button on the MANUAL TEST menu (see Section 4.4).

Operation/Chapter 4 # Page 30
Phase 3 OPERATING MANUAL

4.1.3 CANCEL Key Operation

CANCEL is a special softkey that is used throughout the operator interface of Phase 3. CANCEL
allows the user to cancel a measurement in progress, or a series of previously-acquired
measurements, and return the operator interface to a higher level menu from which various types of
measurements are selected.

Pressing CANCEL can lead to erasure of selected test data in the Clip Record. The amount and
type of data erased will depend on which user interface menu is being displayed when CANCEL is
pressed. CANCEL has increasing impact on the Clip Record data as the level of the menu in the
user interface increases.

At the lowest level, if CANCEL is pressed immediately after a measurement is taken, then the
result of that single measurement is discarded without confirmation, and will not be copied to the
Clip Record. For example, if you measure a defibrillator energy, you may press CANCEL
immediately after the measurement is displayed to discard that single result. You may then repeat the
energy measurement. If a softkey other than CANCEL is pressed following an energy
measurement, then the energy result is copied to a designated location in the Clip Record.

If CANCEL is pressed before a measurement is taken, but after a number of measurements of the
same type have been performed, then all measurements of that type will be deleted from the Clip
Record, but only if you confirm the cancellation when prompted by Phase 3 (see Figure 8).

CANCEL TESTING

Cancel testing? (the current


test will be deleted from the Clip
Record).

YES NO
Figure 8 - Confirmation prompt for CANCEL keypress.

For example, if you measure a series of defibrillator energies and then press CANCEL before
completing the next energy measurement, then all energy measurement data accumulated in the Clip
Record will be deleted if YES is pressed in response to the prompt of Figure 8.

Operation/Chapter 4 # Page 31
Phase 3 OPERATING MANUAL

Various types of defibrillator tests, including energy, charge time and cardioversion, are selected via
the DEFIBRILLATOR TEST menu which is described in Section 4.5 of this manual. If CANCEL
is pressed on the DEFIBRILLATOR TEST menu, then all energy, charge time and cardioversion
results being held in the Clip Record will be deleted, but only if you confirm the cancellation by
pressing YES when prompted by Phase 3 (Figure 8). However, only the defibrillator test data will
be affected; ECG and pacemaker results that may also be present in the Clip Record are not
disturbed if CANCEL on the DEFIBRILLATOR TEST menu is pressed and confirmed. The
CANCEL softkey has similar deletion scope on the ECG and PACER TEST menus, as described
later in this manual.

If CANCEL is pressed and confirmed at the highest level of menu in the user interface, for example
the MANUAL TEST menu (Section 4.4), then all test data currently stored in the Clip Record will
be deleted.

If CANCEL is pressed on a menu which is used for entering data or setting a test parameter, the
effect of CANCEL is to discard any changes that may have been made to the parameter being
edited. Examples include menus for the ECG simulator, data entry of target and tolerance, and ID
(control number) entry. In these cases, pressing CANCEL has no effect on the contents of the Clip
Record.

The deletion scope of the CANCEL softkey is explicitly specified in each Section of this manual
which discusses a user interface screen having a cancel function. When in doubt, refer to the
pertinent Section to determine exactly what potential effect CANCEL may have on the Clip
Record.

4.1.4 User Preference Settings

Certain parameters or settings in the Phase 3 are meant to be set to the operator's test preference.
These parameters, once set, will remain at that setting until specifically changed by the operator.
These parameters will retain their setting after the power is turned off, and will be in effect the next
time power is applied. The parameters that exhibit this behaviour are:

• ECG Simulator MODE (refer to section 4.5.1.2)


• Playback length (refer to section 4.5.1.2)
• Pacer amplitude measurement METHOD (refer to section 4.7.2)
• Pacer Load (refer to section 4.7.1)
• Refractory Test ECG WAVE (refer to section 4.7.3)
• Refractory Test ECG scale (refer to section 4.7.3)
• Pacer Noise Immunity Frequency (refer to section 4.7.4.1)

Operation/Chapter 4 # Page 32
Phase 3 OPERATING MANUAL

4.2 Powering Up

a. Set the power switch on the left side panel of Phase 3 to the ON position. The Phase 3
LCD will display a power-up screen while performing a number of internal self-tests
(Figure 9). The firmware version of the instrument will be shown on this screen while
the self-test is in progress.

Datrend Systems Inc.


Phase 3 Defib Analyzer

Version: 1.30 (c) DSI 2007


Self-test:..............................
Figure 9 - Power-on screen during self-test.

b. If required, adjust the LCD contrast control on the right side panel of Phase 3 using a
trimpot adjustment tool (see Figure 1).

c. Upon completion of the self-test, the screen illustrated in Figure 10 will appear,
reporting the self-test results as follows:

SELF-TEST RESULTS

SELF-TEST: Pass
BATTERY: Charging
CLOCK: JUN 15 2006 13:04:25
TEST RECORDS: (0/80) used
WAVE RECORDS: (0/10) used
OK
Figure 10 - Self-test results.

Operation/Chapter 4 # Page 33
Phase 3 OPERATING MANUAL

• SELF-TEST: Pass means all internal hardware checks have passed


their respective tests. If there is a hardware failure,
Phase 3 will report the fault by means of an alarm
tone and message on the display. Refer to Section
4.11 if this should happen.
• BATTERY: Charging means Phase 3 is being powered by the AC
adapter, and that the internal battery is being
charged.
• BATTERY: xx.xV means Phase 3 is being powered by its internal
battery. The terminal voltage of the battery is
indicated on the LCD as "xx.x" volts. The
indication for a charged battery will range from
12.5 to 14.5 volts.
• TEST RECORDS: (n/80) USED represents the number of Test Records "n"
currently stored in the non-volatile Data Log of
Phase 3. The maximum number of Test Records
that Phase 3 can hold is 80, as indicated.
• WAVE RECORDS: (n/10) USED represents the number of Wave Records "n"
currently stored in the non-volatile Data Log of
Phase 3. The maximum number of Wave Records
that Phase 3 can hold is 10, as indicated.

d. The label displayed on the LCD above each front panel key corresponds to the
function of the key for the currently-viewed screen. In this manual, these keys are
referred to as "softkeys".

e. Upon successful conclusion of the self-test, press the OK softkey to proceed to the
main operating menu of Phase 3.

Operation/Chapter 4 # Page 34
Phase 3 OPERATING MANUAL

4.3 Main Menu

Referring to Figure 11, functions available on the MAIN MENU of Phase 3 are:

MAIN MENU

AUTO: Run Defib/Pacer Autosequence


MANUAL: Run manual defib/pacer tests
DATA LOG: View/print Test Records
REMOTE: Remote control & configuration

AUTO MANUAL DATA LOG REMOTE >


Figure 11 - Main menu of Phase 3.

AUTO Press to view a list of automated test sequences ("AutoSequences") stored in the
non-volatile memory of Phase 3. See Section 4.10 for further information on
automated testing.
MANUAL Press to enter the MANUAL TEST menu, from which manually-conducted
defibrillator, ECG, or pacemaker tests may be selected. See Section 4.4 for
further information on manual testing.
DATA LOG Press to view a list of Test Records currently stored in the Data Log. See Section
4.9 for information related to Test Record viewing and printing.
REMOTE Press to activate Remote Mode. In this mode, Phase 3 may be controlled via
RS-232 from a PC, or from a safety analyzer such as ES601Plus, to perform
various types of measurements and acquire the data from such measurements.
This mode is also used to configure AutoSequences, via a USB connection, with
the assistance of Phase3pc software supplied with Phase 3. Refer to Chapter 5
for more information on Remote Mode, and Chapter 6 for information on
installation and use of Phase3pc.

< Press to access additional softkey functions as shown in Figure 12, and as
described below.

< TEST ID SET CLK


Figure 12 - Alternate softkeys of Main Menu.

Operation/Chapter 4 # Page 35
Phase 3 OPERATING MANUAL

TEST Press to trigger a self-test of the data acquisition hardware. Refer to Section 4.3.1.

ID Press to input an optional ID for Phase 3, such as a control number to identify


Phase 3 in an equipment management system. Refer to Section 4.3.2.

SET CLK Press to set local time and date. Refer to Section 4.3.3.

= Press to restore softkey functions as shown in Figure 11.

4.3.1 Test Pulse

When selected from the MAIN MENU, the TEST PULSE function automatically triggers a series
of internal test pulses which are captured by the data acquisition system and are then analyzed,
thereby simulating the measurement of a defibrillator or pacemaker discharge. This automated self-
check procedure requires a few seconds to complete. While the procedure is in progress, the
CANCEL softkey may be pressed to abort the test.

Once the test pulses have been analyzed, the results are displayed and compared to 'expected values'
which are determined at the time of manufacture of your Phase 3 unit (Figure 13).

TESTING COMPLETED

MEASURED EXPECTED RESULT


DEFIB HI: 126.1J 126.4J ±5% PASS
DEFIB LO: 45.3J 45.5J ±5% PASS
PACER: 144.1mA 144.6mA ±5% PASS

OK
Figure 13 - Test Pulse results.

A result within the acceptance range is indicated as "PASS" on the display of Figure 13. Any result
outside the acceptance range is indicated as "FAIL". A "FAIL" result is suggestive of a
corresponding hardware defect inside the instrument. In the event of a "FAIL", refer to Chapter 7
of this manual.

It is recommended that this test be performed on a regular basis, or any time a test result is in
question. Press OK to continue with the use of the tester.

Operation/Chapter 4 # Page 36
Phase 3 OPERATING MANUAL

NOTE:

The TEST PULSE function of Phase 3 provides a functional


check of the data acquisition hardware. A "PASS" does not
indicate that Phase 3 is within calibration.

Regardless of results obtained for the TEST PULSE,


calibration is still required at the intervals specified in the
WARRANTY section of this manual. When calibration is due,
contact Datrend Customer Service to determine the
authorized service facility nearest you. See Chapter 7 of this
manual.

4.3.2 Phase 3 ID

Pressing ID on the MAIN MENU allows you to enter information, such as a control number, for
uniquely identifying Phase 3 within an equipment management system. After downloading Test
Record data from Phase 3 into Phase3pc software, this ID will then appear in Test Report
documents that are automatically generated by the software.

Phase 3 ID
Enter a unique ID / control number
using the ? > = <, or by means of an >
attached barcode reader or PS/2 kbd.

Phase 3 ID: ----------------- ?


^
CLEAR <--- ---> CANCEL
Figure 14 - Entry of Phase 3 ID.

Referring to Figure 14, the softkeys operate as follows on the ID entry screen:

²÷ Move the ^ cursor left/right.

CLEAR Clear the displayed ID and show ------------------ . Changes to ENTER if any
characters are input.

Operation/Chapter 4 # Page 37
Phase 3 OPERATING MANUAL

ENTER Save the displayed ID in the non-volatile memory of Phase 3.

CANCEL Do not save to memory of Phase 3; discard changes.

The > ? keys to the right of the LCD display are used to increment/decrement the character
shown above the ^ cursor.

If a RS-232 or PS/2 barcode reader (wand or scanner) is plugged into the appropriate port of
Phase 3, then power will be applied to the reader when this menu is entered. A barcode may be
scanned which will then appear on this display. Press ENTER to store the displayed information as
the ID, See Sections 3.2.3 and 3.2.4 for barcode reader connection instructions.

In Manual Entry mode, the ID is input by placing the ^ character below a - using the ² ÷ keys and
scrolling through available characters using the v w keys. The ID displayed on the screen may be
cleared by pressing CLEAR, accepted by pressing ENTER, or CANCEL to discard the data and
return to the MAIN MENU.

If a barcode scanner is attached and is used to scan a barcode representing the ID, the screen of
4.1.2 will be displayed and the ID will be automatically accepted when the AUTO-ENTER timer
reaches zero.

Phase 3 ID
Enter a unique ID / control number
using the ? > = <, or by means of an >
attached barcode reader or PS/2 kbd.
PHASE 3 ID : XCV16652------- ?
AUTO-ENTER in 6 sec.
ENTER CANCEL

Figure 15 - Phase 3 ID menu barcode entry.

If the Phase 3 is attached to a PS/2 keyboard, the entire softkey row will be blanked after you start
typing on the keyboard. When data entry is complete, press ENTER or ESC on the keyboard
(replaces ENTER and CANCEL on the softkey row) to complete the action.

Operation/Chapter 4 # Page 38
Phase 3 OPERATING MANUAL

4.3.3 Set Clock

Pressing SET CLK on the MAIN MENU allows you to set the time and date of the real-time clock.
The clock is maintained by a lithium backup battery when the Phase 3 power is switched off.

SET DATE AND TIME

>
JUN 15 2006 11:23:02
^^^
?

ENTER <--- ---> CANCEL


Figure 16 - Setting the real-time clock.

Referring to Figure 16, the softkeys operate as follows on the SET CLK screen:

²÷ Move the ^ cursor left/right.

ENTER Set the clock of Phase 3 to the time and date shown on the display.

CANCEL Do not change the current setting of the clock, discard any changes.

The > ? keys to the right of the LCD display are used to increment/decrement the item shown
above the ^ cursor.

Operation/Chapter 4 # Page 39
Phase 3 OPERATING MANUAL

4.4 Manual Test Menu

Pressing the MANUAL softkey on the MAIN MENU causes Phase 3 to display the MANUAL
TEST menu (Figure 17). Functions available on the MANUAL TEST menu are:

MANUAL TESTS

DEFIB: Test defib energy/chg time/sync


ECG: Test ECG monitor performance
PACER: Test transcutaneous pacemaker
AED: Test AED energy and ECG analysis

DEFIB ECG PACER AED >


Figure 17 - Manual Test menu.

DEFIB Press to enter a menu for manually testing defibrillator energy output, charge
time to maximum energy, and synchronization of the discharge to the ECG.
Refer to Section 4.5.
ECG Press to enter a menu for manually controlling the ECG simulator, to allow the
monitor of a defibrillator to be tested. Refer to Section 4.6.
PACER Press to enter a menu for manually testing a defibrillator's transcutaneous
pacemaker, including measurement of pacer pulse characteristics and refractory
intervals. Refer to Section 4.7.
AED Press to enter a menu for manually testing output energy and ECG pattern
analysis of an Automated External Defibrillator (AED). Refer to Section 4.8.

< Press to access additional softkey functions as shown in Figure 18, and as
described below.

< VIEW STORE I.D. CANCEL


Figure 18 - Alternate softkeys of Manual Test menu.

VIEW Press to view measurement data currently stored in the Clip Record. Refer to
Section 4.9.

Operation/Chapter 4 # Page 40
Phase 3 OPERATING MANUAL

STORE Press to copy the current contents of the Clip Record to a Test Record in the
non-volatile memory. If an ID for the defibrillator under test has not been
entered when STORE is pressed, you will be prompted to enter an ID per
Section 4.4.1.
I.D. At any time during the manual test process, press I.D. to input identification
information, such as a control number, for the defibrillator or pacemaker under
test. Refer to Section 4.4.1.
CANCEL Cancel the manual test and return to the MAIN MENU. All measurement data
in the Clip Record will be deleted if you press YES in response to the
cancellation confirmation which will be displayed. For additional information on
CANCEL, see Section 4.1.3.

= Press to restore softkey functions as shown in Figure 17.

4.4.1 DUT ID

Pressing I.D. on the MANUAL TEST menu allows you to enter information, such as a control
number, for uniquely identifying the defibrillator under test (DUT). Test Records stored in the non-
volatile Data Log of Phase 3 are identified by DUT ID, as are the Test Report documents which are
generated by Phase3pc software when the Test Record data is downloaded from Phase 3 to the PC.

DEFIBRILLATOR ID
Enter a device ID / control number
using the ? > = <, or by means of an v
attached barcode reader or PS/2 kbd.

DEFIB ID: ----------------- w


^
CLEAR <--- ---> CANCEL

Figure 19 - Entry of DUT ID.

Operation/Chapter 4 # Page 41
Phase 3 OPERATING MANUAL

Referring to Figure 19, Figure 20, the softkeys operate as follows on the ID entry screen:

²÷ Move the ^ cursor left/right.

CLEAR Clear the displayed ID and show ------------------ . Changes to ENTER if any
characters are input.
ENTER Save the displayed ID in the Clip Record.

CANCEL Do not save to Clip Record; discard changes.

The > ? keys to the right of the LCD display are used to increment/decrement the character
shown above the ^ cursor.

In Manual Entry mode, the ID is input by placing the ^ character below a - using the ² ÷ keys and
scrolling through available characters using the v w keys. The ID displayed on the screen may be
cleared by pressing CLEAR, accepted by pressing ENTER, or CANCEL to discard the data and
return to the MAIN MENU.

If a barcode scanner is attached and is used to scan a barcode representing the ID, the screen of
Figure 20 will be displayed and the ID will be automatically accepted when the AUTO-ENTER
timer reaches zero.

DEFIBRILLATOR ID
Enter a device ID / control number
using the ? > = <, or by means of an v
attached barcode reader or PS/2 kbd.

DEFIB ID: XCV16652--------- w


AUTO-ENTER in 6 sec.
ENTER <--- ---> CANCEL

Figure 20 - Phase3 ID menu barcode entry

If the Phase 3 is attached to a PS/2 keyboard, the entire softkey row will be blanked after you start
typing on the keyboard. When data entry is complete, press ENTER or ESC on the keyboard
(replaces ENTER and CANCEL on the softkey row) to complete the action.

Operation/Chapter 4 # Page 42
Phase 3 OPERATING MANUAL

4.4.2 Restarting Manual Tests

If you select DEFIB, ECG, PACER or AED from the MANUAL TEST menu, and the Clip
Record already contains measurement data corresponding to that type of test, Phase 3 will prompt
you to confirm overwriting the existing test results with new results from the test you have selected
(Figure 21).

OVERWRITE EXISTING TEST DATA

Re-start this test? (All existing data


for this test will be erased).

YES NO
Figure 21 - Confirmation for restarting a test.

Press YES to proceed with the selected manual test, or NO to retain the current contents of the
Clip Record and return to the MANUAL TEST menu.

Once you have started testing a defibrillator or pacemaker and have collected measurement data in
the Clip Record for these types of DUT, you cannot then change to testing an Automated External
Defibrillator (AED). This is because AED measurement data is incompatible with the measurement
data obtained from testing a conventional defibrillator/pacemaker. If AED is selected from the
MANUAL TEST menu, and the Clip Record already contains measurement data from defibrillator
and/or pacemaker tests, then the error message of Figure 22 is displayed.

CANNOT PERFORM THIS TEST

The Clip Record currently contains test


results that are incompatible with the
test you are trying to perform. Consult
the operator's manual for more details.

OK
Figure 22 - Data Incompatibility Error.

The message of Figure 22 will also be displayed if you have collected AED measurement data in
the Clip Record, and then try to initiate defibrillator or pacemaker tests by pressing DEFIB or
PACER respectively.

Operation/Chapter 4 # Page 43
Phase 3 OPERATING MANUAL

If the display of Figure 22 appears, press OK to acknowledge the error and return to the
MANUAL TEST menu. Save the current contents of the Clip Record by pressing STORE. Then,
initiate a new test by pressing the desired softkey on the MANUAL TEST menu.

4.5 Defibrillator Test Menu

Press the DEFIB softkey on the MANUAL TEST menu to enter the DEFIBRILLATOR TEST
menu (Figure 23). Functions available on this menu are:

DEFIBRILLATOR TESTS

ENERGY: Test defib output energy


CHG TIME: Test charge time to max energy
SYNC: Test defib synchronization
(cardioversion test)
DONE: Return to Manual Test menu
ENERGY CHG TIME SYNC DONE >
Figure 23 - Defibrillator Test menu.

ENERGY Press to measure delivered energy, peak voltage and current, and discharge pulse
width. Refer to Section 4.5.1.
CHG TIME Press to measure charge time at maximum output energy. Refer to Section 4.5.2.

SYNC Press to measure synchronization of the defibrillator discharge to either the


R-wave or Q-wave of the simulated ECG. If the ECG simulation happens to be
set to "atrial fibrillation", then the Sync Test may also be referred to as a
cardioversion test. Refer to Section 4.5.3.
DONE Press to return to the MANUAL TEST menu. Defibrillator measurement data in
the Clip Record are retained.

< Press to access additional softkey functions as shown in Figure 24, and as
described below.

< CANCEL
Figure 24 - Alternate softkeys of Defibrillator Test menu.

Operation/Chapter 4 # Page 44
Phase 3 OPERATING MANUAL

CANCEL Cancel the defibrillator test and return to the MAIN MENU. Defibrillator
measurement data in the Clip Record will be deleted if you press YES in
response to the cancellation confirmation which will be displayed. All other data
in the Clip Record will be retained. For additional information on CANCEL, see
Section 4.1.3.

= Press to restore softkey functions as shown in Figure 23.

4.5.1 Defibrillator Energy Test

4.5.1.1 Selecting the Energy Test

Press the ENERGY softkey on the DEFIBRILLATOR TEST menu to enter the DEFIB
ENERGY test menu (Figure 25). Functions available on this menu are:

DEFIB ENERGY TEST(01/10)


WAITING FOR DISCHARGE
ENERGY: ---.-J TARGET: ---.-J TOL: --%
PEAK I: --.--A PEAK V: ---- V RNG: HI
WIDTH @10%: --.-- msec @50%: --.-- msec
ECG Wave: VFIB1 (x1 scale)

RANGE ECG TARGET DONE >


Figure 25 - Defibrillator Energy Test menu.

RANGE Press to toggle between LOW and HIGH range energy measurement. The range
currently in use is indicated on the display as either RNG: LO or RNG: HI
respectively. Select the range based on the energy setting of the defibrillator under
test (DUT), as follows:

• LOW range: Select if measuring energy below 50 joules.


• HIGH range: Select if measuring energy of 50 joules or higher,
up to 400 joules maximum input.

Operation/Chapter 4 # Page 45
Phase 3 OPERATING MANUAL

ECG Press to enter a menu for setting up the ECG simulator. Note the waveform
setting and the amplitude scale of the simulator are shown on the display, to the
right of ECG Wave. According to Figure 25, the default setting of the simulator
for energy tests is coarse ventricular fibrillation (VFIB1) with amplitude set to x1
scale (1mV QRS on ECG Lead II). There are several options available for the
operation of the tester after an energy pulse has been measured. Refer to Section
4.5.1.2 for instructions describing operation of the ECG simulator and the settings
available.
TARGET Press to enter optional energy target and tolerance settings which will allow
Phase 3 to automatically pass or fail the energy measured when the defibrillator
is discharged. The current settings of the energy target (in joules) and the tolerance
about the target (in per-cent) are shown on the display as TARGET and TOL
respectively. According to Figure 25, by default the target and tolerance are
disabled until values are entered by the user, which then enables the automatic
pass/fail feature of the ENERGY TEST menu. Refer to Section 4.5.1.3 for
instructions on how to input a target and tolerance.
DONE Press to return to the DEFIBRILLATOR TEST menu. Energy measurement data
in the Clip Record are retained.

< Press to access additional softkey functions as shown in Figure 26, and as
described below.

< CANCEL

Figure 26 - Alternate softkeys of Defibrillator Energy Test menu.

CANCEL Cancel the energy test and return to the DEFIBRILLATOR TEST menu. Energy
measurement data in the Clip Record will be deleted if you press YES in response
to the cancellation confirmation which will be displayed. All other data in the Clip
Record will be retained. For additional information on CANCEL, see Section
4.1.3.

= Press to restore softkey functions as shown in Figure 25.

Operation/Chapter 4 # Page 46
Phase 3 OPERATING MANUAL

4.5.1.2 Setting the ECG Simulator

Pressing the ECG softkey on the ENERGY TEST menu causes Phase 3 to display a menu for
setting up the ECG simulator (Figure 27, page 50). The ECG simulator provides a total of 55
Waveforms which are organised in seven Wave Banks. Depending on the test being performed,
certain banks may be disabled as the waveforms contained within those banks are not applicable to
the test.

The display of Figure 27 shows the WAVE BANK and the full title of the WAVEFORM currently in
effect, as well as an abbreviated waveform title which is shown on the display immediately below the
full title. The abbreviated waveform title (e.g. VFIB1) may be used in place of the full title on some
displays of the Phase 3 operator interface. Table 4-1 lists all of the available Banks and Waveforms,
and whether or not the waveform is available on the ECG SETUP menu for specified defibrillator,
pacemaker and AED tests.

Operation/Chapter 4 # Page 47
Phase 3 OPERATING MANUAL

Table 4-1: ECG Simulator Banks and Waveforms


! indicates ECG waveform is selectable for test
Wave Bank Waveform Short Title Defib Defib Defib ECG AED Pacer
Energy Chg Sync Test Test Tests
Test Test Test

Off Off Off ! ! ! !

Coarse AFIB AFIB1 ! ! ! ! !

Fine AFIB AFIB2 ! ! ! ! !

Asystole ASYS1 ! ! ! !

Asystole - Flat ASYS2 ! ! ! !

SupraVent Tachycardia SVTACH ! ! ! !

Shock Advisory/AED Ventricular Tachy 140 BPM VTACH1 ! ! ! !

Ventricular Tachy 160 BPM VTACH2 ! ! ! !

Ventricular Tachy 190 BPM VTACH3 ! ! ! !

Torsades de Pointes 200 BPM PVTACH ! ! ! !

Coarse VFIB VFIB1 ! ! ! !

Fine VFIB VFIB2 ! ! ! !

Pulse, 10 msec SQRP10 ! !

Pulse, 25 msec SQRP25 ! !

Square Pacer Trigger Pulse, 40 msec SQRP40 ! !

Pulse, 100 msec SQRP100 ! !

Pulse, 200 msec SQRP200 ! !

Pulse, 10 msec TRIP10 ! !

Pulse, 25 msec TRIP25 ! !

Triangle Pacer Trigger Pulse, 40 msec TRIP40 ! !

Pulse, 100 msec TRIP100 ! !

Pulse, 200 msec TRIP200 ! !

Pulse, 10 msec SSQP10 ! !

Pulse, 25 msec SSQP25 ! !

Haversine Pacer Trigger Pulse, 40 msec SSQP40 ! !

Pulse, 100 msec SSQP100 ! !

Pulse, 200 msec SSQP200 ! !

Performance DC Pulse, 4 sec PULSE !

Operation/Chapter 4 # Page 48
Phase 3 OPERATING MANUAL

Wave Bank Waveform Short Title Defib Defib Defib ECG AED Pacer
Energy Chg Sync Test Test Tests
Test Test Test

Square Wave, 2 Hz SQR2HZ !

Triangle Wave, 2 Hz TRI2HZ !

Sinewave, 0.1 Hz SIN01 !

Sinewave, 0.5 Hz SIN05 !

Sinewave, 10 Hz SIN10 !

Sinewave, 20 Hz SIN20 !

Sinewave, 40 Hz SIN40 !

Sinewave, 50 Hz SIN50 !

Sinewave, 60 Hz SIN60 !

Sinewave, 70 Hz SIN70 !

Sinewave, 100 Hz SIN100 !

ECG 30 BPM ECG30 !

ECG 60 BPM ECG60 ! !

ECG 90 BPM ECG90 ! !

ECG 120 BPM ECG120 ! !


Sinus Rhythm
ECG 150 BPM ECG150 !

ECG 180 BPM ECG180 !

ECG 240 BPM ECG240 !

ECG 300 BPM ECG300 !

2nd deg. AV Block BLKII !

Prem Atrial Contraction PAC !

Rt Bundle Br Block RBBB !

Prem Ventr Contraction PVC !

Arrhythmia R-on-T PVC RONT !

Multifocal PVC MFPVC !

Run of 5 PVC RUN5 !

Bigeminy BIGEM !

Trigeminy TRGEM !

Operation/Chapter 4 # Page 49
Phase 3 OPERATING MANUAL

ECG SIMULATOR SETUP

WAVE BANK: Shock Advisory/AED


WAVEFORM: Coarse VFIB
(VFIB1)
Relative SCALE: x1 (1.0mV QRS Lead II)

OK BANK WAVEFORM SCALE >


Figure 27 - Setup menu for the ECG simulator.

Referring to the ECG SETUP menu shown in Figure 27, functions available on the menu are:

OK Press to accept the ECG simulator settings as shown on the display and return
to the previous menu. Note: The ECG waveform does not change until OK is
pressed.
BANK Press to modify the Wave Bank of the ECG simulator. Refer to Table 4-1 to
determine which Wave Banks will be enabled for the type of test being
performed.
WAVEFORM Press to modify the Waveform for the selected Bank. Refer to Table 4-1 to
determine which Waveforms will be enabled for the type of test being
performed.
SCALE Press to set the simulator's amplitude scale to one of these choices:

• x1 (corresponding to 1mV QRS amplitude on ECG Lead II)


• x2 (corresponding to 2mV QRS amplitude on ECG Lead II)
• x0.5 (corresponding to 0.5mV QRS amplitude on ECG Lead II)

< Press to access additional softkey functions as shown in Figure 28, and as
described below.

< OK MODE PLAYBACK CANCEL


Figure 28 - Alternate softkeys of ECG Setup menu.

Operation/Chapter 4 # Page 50
Phase 3 OPERATING MANUAL

MODE Press to select the response of the ECG simulator to a discharge from the
defibrillator under test, as follows:

OFF After a defibrillation pulse is detected, Phase3 continues to output


the selected waveform. When this option is selected, the LCD will
display:

“DO NOT respond to defib discharge”

>NSR60 The instant that a defibrillation pulse is detected, Phase3


automatically changes to normal sinus rhythm at 60 BPM. This
option is indicated on the LCD as:

“Revert to sinus rhythm at 60 BPM after


shock detected”

This is the default setting of the SIMULATOR MODE.

PLAYBK After a defibrillation pulse is detected and the energy is displayed


on the LCD, the ECG simulator then plays back the defibrillator
waveform (either 1/3 of the waveform data, or the full
waveform), after which the simulator returns to outputting the
selected ECG waveform. The duration of the playback is
governed by the PLAYBACK MODE, as described below. This
option is indicated on the LCD as:

“Play back defib waveform after shock


detected”

PB+NSR After a defibrillation pulse is detected and the energy is displayed


on the LCD, the ECG simulator then plays back the defibrillator
waveform (either 1/3 of the waveform data, or the full
waveform), and then changes to normal sinus rhythm at 60 BPM
after the playback is completed. The duration of the playback is
governed by the PLAYBACK MODE, as described below. This
option is indicated on the LCD as:

“Play back waveform after shock detected,


then revert to NSR60”

See Figure 29

Operation/Chapter 4 # Page 51
Phase 3 OPERATING MANUAL

PLAYBACK Press to toggle between the two available choices for simulator playback of an
acquired defibrillator waveform:

• 1/3 waveform (4-second playback time). This is the default setting.


• Full waveform (12-second playback time)

See Figure 29
CANCEL Press to discard any changes made to ECG simulator settings and return to
the previous menu.

= Press to restore softkey functions as shown in Figure 27.

Note: The MODE and PLAYBACK selections are User Preference Settings that will remain in
effect until changed by the operator. When operating the Phase 3 in manual test mode, the
changes made here will apply to the defibrillator test currently in progress as well as to future
tests, even if the Phase 3 power is switched off and then back on.

ECG SIMULATOR SETUP

SIMULATOR MODE:
Revert to sinus rhythm at 60 BPM
after shock detected.
PLAYBACK MODE:
1/3 waveform (4 sec play time)
< OK MODE PLAYBACK CANCEL
Figure 29 - Simulator Mode settings.

4.5.1.3 Setting a Target and Tolerance

Phase 3 allows you to optionally specify a target or expected value for a measurement to be made,
and a tolerance or acceptance range which spans either side of the target. If a target and tolerance
have been entered, Phase 3 will automatically compare the measurement result to the target when
the measurement is performed. If the difference between the measurement result and the target lies
within the tolerance range, Phase 3 will automatically assign a "PASS" to the result. If the difference
lies outside the tolerance, Phase 3 will automatically assign a "FAIL" to the result.

Operation/Chapter 4 # Page 52
Phase 3 OPERATING MANUAL

Entering tolerances and targets for manual measurements is always optional. If you do not wish to
enter a target and tolerance, you can simply "PASS" or "FAIL" any test result yourself, via
corresponding softkeys provided on the Phase 3 keypad, and thereby manually store the result with
your pass/fail assessment in the Clip Record.

Press the TARGET softkey on the ENERGY TEST menu to display a menu for inputting an
energy target and tolerance (Figure 30).

ENERGY TARGET AND TOLERANCE

ENERGY TARGET: 150.0 Joules >


^
TARGET RANGE: 1 - 400 Joules
TOLERANCE: ±10% ?

ENTER <--- ---> TOL ±% >


Figure 30 - Entry of energy target and tolerance.

On this menu, the softkeys assume the following functions:

²÷ Move the ^ cursor left/right.

>? Increment/decrement the digit shown above the ^ cursor. Phase 3 will not allow
you to set the target value outside the permitted range which is shown closer to
the bottom of the display.
ENTER Save the displayed target value and tolerance.

TOL ±% Press to modify the displayed tolerance. Choices available are:

±5%
±10%
±15%
±20%
OFF (disables automatic pass/fail assessment)

< Press to access additional softkey functions as shown in Figure 31, and described
as follows:

Operation/Chapter 4 # Page 53
Phase 3 OPERATING MANUAL

< ENTER <--- ---> CANCEL

Figure 31 - Alternate softkeys of target/tolerance menu.

CANCEL Press to discard any changes made to target and tolerance settings and return to
the previous menu.

= Press to restore softkey functions as shown in Figure 30.

4.5.1.4 Performing the Energy Test

The purpose of the energy test is to verify that a defibrillator accurately delivers the amount of
energy which has been selected by the operator. In addition to delivered energy, the test reports
other parameters of the defibrillator discharge, such as voltage, current and pulse width, so that
conformance to manufacturer's specifications can be confirmed. Normally, a number of different
energy settings will be tested, for example: 10, 20, 50, 100, 200, 300 and 360 joules.

To perform a defibrillator energy test:

a. Connect the defibrillator under test (DUT) to Phase 3 according to Section 3.1.

b. Optionally, if you would like to capture high-resolution waveform data in real-time,


connect the USB Port of Phase 3 to a personal computer using the supplied USB cable,
then run Phase3pc software on the PC (see Chapter 6 for more information on
installing and using Phase3pc software).

c. On the DEFIBRILLATOR TEST menu, press ENERGY. The display of Figure 32


will appear.

DEFIB ENERGY TEST(01/10)


WAITING FOR DISCHARGE
ENERGY: ---.-J TARGET: ---.-J TOL: --%
PEAK I: --.--A PEAK V: ---- V RNG: HI
WIDTH @10%: --.-- msec @50%: --.-- msec
ECG Wave: VFIB1 (x1 scale)

RANGE ECG TARGET DONE >


Figure 32 - Defibrillator Energy Test menu.

Operation/Chapter 4 # Page 54
Phase 3 OPERATING MANUAL

d. Set the DUT to the desired energy level.

e. On Phase 3, press RANGE to modify the energy measurement range as required.


Select "LO" range if the DUT is set to less than 50 joules, otherwise, select "HI" range.

f. Optionally, if you would like to change the waveform of the ECG simulator, press ECG
to view the ECG setup menu. Refer to Section 4.5.1.2.

g. Optionally, if you would like to have Phase 3 automatically pass or fail the measurement
you are about to take, press TARGET, enter a target energy, and select a tolerance.
Refer to Section 4.5.1.3.

h. If using external or internal paddles, apply the paddles firmly to the Phase 3 Paddle
Adapter.

i. Charge the DUT.

j. Discharge the DUT into Phase 3. Peak current and voltage readings will appear on the
display immediately after the discharge. Phase 3 will calculate the energy and display
the result in Joules. The energy calculation will require approximately four seconds to
complete. Depending on the ECG MODE settings (see section 4.5.1.2), Phase 3 may
automatically play back the defibrillator pulse waveform to the ECG terminals and
paddle plates, then change the ECG output to normal sinus rhythm ("NSR60").

k. If the measurement is being performed on LOW range, and Phase 3 detects distortion
(clipping) in the acquired waveform data, Phase 3 will produce an alarm message on the
display (Figure 33). The measurement results are invalid if this alarm is displayed.
Acknowledge the alarm by pressing the OK softkey, then repeat the measurement after
selecting HIGH range on the menu of Figure 32.

LOW RANGE ALARM

WARNING: Signal distortion detected.


Repeat the measurement on HIGH RANGE.

OK
Figure 33 - Warning if signal distortion detected.

Operation/Chapter 4 # Page 55
Phase 3 OPERATING MANUAL

l. If the measurement is being performed on HIGH range, and Phase 3 detects distortion
(clipping) in the acquired waveform data, Phase 3 will produce an alarm message on the
display. The alarm title will be “HIGH RANGE ALARM”, and the warning message
is:

“WARNING: Signal distortion detected. Signal exceeds maximum input level”.

m. If the acquired signal data is valid, but a target has not been entered, Phase 3 will
display the results according to Figure 34.

DEFIB ENERGY TEST(01/10)


WAITING FOR DISCHARGE
ENERGY: 358.6J TARGET: ---.-J TOL: --%
PEAK I: 38.71A PEAK V: 3565 V RNG: HI
WIDTH @10%: 14.34 msec @50%: 8.11 msec
ECG Wave: VFIB1 (x1 scale)

PASS FAIL SAVE SHOW WAV>


Figure 34 - Energy test results: no target specified.

Functions available on this display are:

PASS Save the displayed measurement data (energy, current, voltage, and
pulse widths) to the Clip Record with a "PASS" assessment. The test
counter shown at the top right corner of the display will increment,
until a maximum of 10 energy tests have been accumulated in the
Clip Record. If PASS is pressed after 10 energy results have been
stored, then each new result will overwrite the Clip Record location
reserved for energy test #10.
FAIL As described above for the PASS softkey, except that a "FAIL"
assessment will be saved in the Clip Record with the data, rather
than a "PASS".
SAVE Simply save the measurement results to the Clip Record, with
neither a "PASS" nor a "FAIL". The test counter displayed at top
right is incremented, as described above for PASS.
SHOW WAV Press to view the captured defibrillator waveform on the LCD. Refer
to Section 4.5.1.5.

Operation/Chapter 4 # Page 56
Phase 3 OPERATING MANUAL

< Press to access additional softkey functions as shown in Figure 35,


and as described below.

<SAVE WAV PLAYBACK CANCEL


Figure 35 - Alternate softkeys of Energy Test result, with no target.

SAVE WAV Press to save the captured defibrillator waveform as a Wave


Record. Refer to Section 4.5.1.5.
PLAYBACK Press to play back the captured defibrillator waveform into the ECG
monitor or chart recorder of the DUT, via the ECG simulator. Refer
to Section 4.5.1.5. The play back time will be either 4 or 12 seconds,
as set by the PLAYBACK MODE function (see section 4.5.1.2)
CANCEL Press to discard the measurement results shown on the display of
Figure 34. The results on the display are not saved to the Clip
Record and the test counter shown on the LCD is not incremented.
The Clip Record is otherwise unaffected.

= Press to restore softkey functions as shown in Figure 34.

n. If a target and tolerance have been entered per Section 4.5.1.3, Phase 3 will display the
results according to Figure 36.

DEFIB ENERGY TEST(01/10)


WAITING FOR DISCHARGE
ENERGY: 345.1J TARGET: 360.0J TOL: 10%
PEAK I: 37.24A PEAK V: 3310 V RNG: HI
WIDTH @10%: 14.25 msec @50%: 8.09 msec
ECG Wave: VFIB1 (x1 scale)
***************** PASS *****************
OK SHOW WAV SAVE WAV PLAYBACK>
Figure 36 - Energy test results: target specified.

Operation/Chapter 4 # Page 57
Phase 3 OPERATING MANUAL

Functions available on this display are:

OK Accept the pass/fail assessment as determined by Phase 3 and save


the assessment with the measurement results to the Clip Record.
The test counter shown at the top right corner of the display will
increment, until a maximum of 10 energy tests have been
accumulated in the Clip Record. If OK is pressed after 10 energy
results have been stored, then each new result will overwrite the
Clip Record location reserved for energy test #10.
SHOW WAV These softkeys provide the same functions as described above for
SAVE WAV the case when no target has been specified.
PLAYBACK

o. While showing the results of an energy discharge, Phase 3 is ready to process another
discharge without any further operator intervention. The display screen ( Figure 34 or
Figure 36) will be indicating "WAITING FOR DISCHARGE". If the defibrillator is
discharged at this time, without pressing a PASS, FAIL, SAVE, or OK softkey,
Phase 3 will automatically SAVE the measurement results currently being displayed,
and will then proceed to process the new discharge. This allows a series of manual
energy tests to be performed without the need to press any keys on Phase 3 .

p. Repeat steps (d) to (o) as required until the desired number of DUT energy levels have
been tested, up to a maximum of 10 energies. More than 10 energy levels can be tested,
however, if such results are saved to the Clip Record via PASS, FAIL, SAVE, or OK
softkeys, then the Clip Record location reserved for energy test #10 will be overwritten
with each new result.

q. When all tests have been completed, press DONE (see Figure 32). Energy results
accumulated in the Clip Record are retained and may be supplemented with data from
other defibrillator, ECG and pacemaker tests.

Operation/Chapter 4 # Page 58
Phase 3 OPERATING MANUAL

4.5.1.5 Viewing and Saving Defibrillator Waveforms

Phase 3 provides unique features for viewing and saving the waveform of a defibrillator discharge.
These features are enabled after completion of each energy measurement, via the PLAYBACK,
SHOW WAV and SAVE WAV softkeys described in the preceding Section.

PLAYBACK After an energy measurement, press this softkey to play back the captured
defibrillator waveform into the ECG monitor or chart recorder of the DUT, via the
ECG simulator of Phase 3. The display will appear as shown in Figure 37 as the
playback progresses. To stop a playback in progress, press the CANCEL softkey at
any time.
DEFIB ENERGY TEST(01/10)

ENERGY: 358.6J TARGET: ---.-J TOL: --%


PEAK I: 38.71A PEAK V: 3565 V RNG: HI
WIDTH @10%: 14.34 msec @50%: 8.11 msec
ECG Wave: PLAYBACK....................

CANCEL
Figure 37 - Playback of captured waveform via ECG simulator.

If the energy measurement was performed on HIGH range, an ECG monitor set to
Lead II will show 1mV for each 1000V of defibrillator signal, or 1mV for each
2000V if the signal is being observed at the contact pads of the Phase 3 Paddle
Adapter. If the measurement was performed on LOW range, an ECG monitor on
Lead II will show 1mV per 200V of defib signal, or 1mV per 400V at the Paddle
Adapter. Each second of signal shown on the ECG monitor or chart recorder will
correspond to 5 milliseconds of the defibrillator waveform (200:1 timebase
expansion).

The length of the play back will be determined by the PLAYBACK MODE setting
(refer to section 4.1.5.2). Play back of the entire waveform requires approximately
12 seconds. The alternative PLAYBACK MODE will play back the first 1/3 of the
waveform data, which will require approximately 4 seconds. In most cases, this will
display the complete signal of interest.

Waveform playback may also be initiated automatically after a defibrillator discharge,


by selecting the appropriate option for the SIMULATOR MODE of the ECG
SETTINGS function (refer to section 4.1.5.2). In this mode, playback will occur
immediately after the waveform parameters have been calculated and displayed on
the LCD.

Operation/Chapter 4 # Page 59
Phase 3 OPERATING MANUAL

SHOW WAV After an energy measurement, press this softkey to view the captured defibrillator
waveform on the Phase 3 display (Figure 38).

Figure 38 - Example of captured waveform display.

When viewing a defibrillator waveform with the SHOW WAV function, the
Phase 3 keypad operates as follows:

?> Contract/expand the vertical scale. The available choices depend on the
energy measurement range, as follows:

HIGH range LOW range


• 0 to ±25 Amps • 0 to ±5 Amps
• 0 to ±50 Amps • 0 to ±10 Amps
• 0 to ±100 Amps (default) • 0 to ±20 Amps (default)

=< Contract/expand the horizontal scale. The available choices are:

• 0 to 20 milliseconds
• 0 to 40 milliseconds
• 0 to 60 milliseconds (default)

Press any key other than ?>=< to return the display to the previous menu.

Operation/Chapter 4 # Page 60
Phase 3 OPERATING MANUAL

SAVE WAV After an energy measurement, press this softkey to save the defibrillator waveform
in the non-volatile memory as a Wave Record. If you have not yet entered an ID
for the defibrillator under test (DUT) when SAVE WAV is pressed, you will be
prompted to enter an ID (see Section 4.4.1). Once a DUT ID has been provided
to Phase 3, the screen of Figure 39 will be shown.

SAVE WAVEFORM RECORD(05/10)

DEFIB ID: CN3416


DEFIB RANGE: HIGH
RECORD LENGTH: 58.4msec at Ts=45.6usec
DATE/TIME: JUN 15 2006 13:04:48

LENGTH DELETE STORE CANCEL


Figure 39 - Saving a Wave Record.

The functions provided by the SAVE WAVEFORM menu are:

LENGTH This button changes the amount of data to be saved in the


Wave Record, toggling between 14.692 msec of waveform data
(with sample interval Ts=11.4usec), or 58.368 msec of data
(Ts=45.6usec, or every 4th data point). The default is 58.368
msec of data.
DELETE Delete the last Wave Record that was saved to the non-volatile
memory. A prompt requiring you to confirm the deletion will
be displayed if this softkey is pressed. This function allows you
to replace a previously-saved waveform with the current
waveform.
STORE Save the waveform data to the non-volatile memory as a Wave
Record. The record counter shown at the top right corner of
the display will be incremented by one. The maximum number
of waveforms that can be saved is 10. This softkey will not
appear on the display once there are ten Wave Records in
memory. If the memory is full, use the DELETE softkey to
remove unwanted Records to make space for new Records.
CANCEL Return to the previous menu without saving the Wave Record.

Operation/Chapter 4 # Page 61
Phase 3 OPERATING MANUAL

NOTE:

The defibrillator waveform data is always compressed when


Phase 3 creates a Wave Record, in order to conserve memory
space. The compressed signal data adequately represents a
defibrillator waveform for qualitative purposes, such as graphing
a picture of the waveform. For detailed numerical analysis of the
waveform data, such as might be done in a laboratory-based
investigation or research, the real-time waveform capture mode
should be used. Refer to Section 4.5.1.6.

Once Wave Records have been saved to the non-volatile memory, the Records may later be
downloaded into Phase3pc software for graphical plotting and printing. Refer to Chapter 6 for
details.

4.5.1.6 Capturing the Defibrillator Waveform in Real-Time

Phase 3 with Phase3pc software provides a feature for capturing high-resolution waveform data on
a personal computer. The data can be acquired after each defibrillator energy measurement is
completed, while the display is in the state shown in Figure 34 or Figure 36.

Clicking the Waveform Capture icon in Phase3pc causes the detailed waveform data to be
rapidly transferred to the PC via the USB connection. After a waveform graph is plotted, Phase3pc
allows the user to print the graph or save the detailed data to a file for further numerical analysis.
Refer to Section 6.5.3 for additional details.

Defibrillator waveform capture may also be performed via RS-232 when Phase 3 is operating in
remote control mode. Refer to Chapter 5 for details.

Operation/Chapter 4 # Page 62
Phase 3 OPERATING MANUAL

4.5.2 Defibrillator Charge Time Test

4.5.2.1 Selecting the Charge Time Test

Press the CHG TIME softkey on the DEFIBRILLATOR TEST menu to enter the CHARGE
TIME menu (Figure 40). Functions available on this menu are:

CHARGE TIME Discharges:xx


Charge to MAXIMUM ENERGY and Discharge,
or press START to measure Charge Time
ENERGY: ---.-J TARGET: ---.-J TOL: --%
CHARGE TIME: --.-sec MAX TIME: 99.9sec
ECG Wave: VFIB1 (x1 scale)

START ECG MAX TIME TARGET >


Figure 40 - Defibrillator Charge Time menu.

The intent of this test is to determine if the battery of the defibrillator is in reasonable condition and
will be able to charge the defibrillator, even when under some stress from clinical use. The
defibrillator should first be unplugged from the AC power. Prior to beginning the actual charge
time test, the defibrillator may now be discharged into Phase 3 several times. The number of pre-
test discharges will be tracked and reported in the upper right corner of the screen. These pre-test
discharges are counted, but they are not analyzed. When the requisite number of pre-test discharges
have been made, the actual charge time measurement can be initiated by pressing the START
softkey. The number of pre-test discharges will be reported in the final test report.

START Press to start the measurement of the charge time.

ECG Press to enter a menu for setting up the ECG simulator. Refer to Section 4.5.1.2 for
instructions describing operation of the ECG simulator.
MAX Press to input an upper limit for the charge time determined by this test. Choices
TIME available are: 5, 10, 15, 20, 25, 30, 35, 40 and 99.9 seconds. If an upper limit less
than 99.9 seconds is selected, the charge time obtained by the test will be compared
to the limit and automatically passed or failed by Phase 3 accordingly.

TARGET Press to enter optional energy target and tolerance settings which will allow Phase 3
to automatically pass or fail the energy measured when the defibrillator is
discharged. Refer to Section 4.5.1.3 for instructions on how to input a target and
tolerance.

Operation/Chapter 4 # Page 63
Phase 3 OPERATING MANUAL

< Press to access additional softkey functions as shown in Figure 41, and as described
below.

< CANCEL
Figure 41 - Alternate softkeys of Defibrillator Charge Time menu.

CANCEL Cancel the charge time test and return to the DEFIBRILLATOR TEST menu.
Charge time data in the Clip Record will be deleted if you press YES in response to
the cancellation confirmation which will be displayed. All other data in the Clip
Record will be retained. For additional information on CANCEL, see Section 4.1.3.

= Press to restore softkey functions as shown in Figure 40.

4.5.2.2 Performing the Charge Time Test

The purpose of a charge time test is to determine the length of time a defibrillator requires to charge
up to its maximum energy. To simulate a worst-case operating condition, the test is normally done
with the defibrillator powered by its internal battery.

Note that real-time waveform capture via USB is inhibited in this test mode. Use the energy test
described in Section 4.5.1 to capture defibrillator waveform data in real-time.

To perform a charge time test:

a. Connect the defibrillator under test (DUT) to Phase 3 according to Section 3.1.

b. On the DEFIBRILLATOR TEST menu, press CHG TIME. The display of Figure 40
will appear.

c. Set the DUT to its MAXIMUM energy setting.

d. Disconnect the DUT from the AC line so that the DUT is operating from its internal
battery supply. This simulates a worst-case operating condition for the DUT.

e. On Phase 3, optionally press ECG to modify the settings of the ECG Simulator as
desired. Refer to Section 4.5.1.2.

f. Optionally, if you would like to have Phase 3 automatically pass or fail the measured
charge time, press MAX TIME to select the desired upper limit.

Operation/Chapter 4 # Page 64
Phase 3 OPERATING MANUAL

g. Optionally, if you would like to have Phase 3 automatically pass or fail the measured
energy, press TARGET, enter a target value for the maximum energy, and select a
tolerance. Refer to Section 4.5.1.3.

h. Optionally, discharge the DUT several times into Phase 3 before starting the actual
charge time test to exercise the battery. The number of pre-test discharges performed
will appear at the top right corner of the LCD display.

i. Press the START softkey. A timer will be displayed which will start counting down
from 5 seconds.

j. Apply the paddles firmly to the Phase 3 Paddle Adapter. You have 5 seconds to get
ready.

k. Charge the DUT when the countdown timer reaches zero and Phase 3 emits a beep
tone. Phase 3 will also display: CHARGE THEN DISCHARGE as an additional prompt
to you.

l. Discharge the DUT as soon as it reaches full charge. The measured charge time will be
displayed, after which Phase 3 will calculate and display the energy delivered.

m. If a MAX TIME has not been entered and an energy TARGET has not been entered,
Phase 3 will display the results according to Figure 42.

CHARGE TIME
TEST RESULTS:

ENERGY: 362.0J TARGET: ---.-J TOL: --%


CHARGE TIME: 11.2sec MAX TIME: 99.9sec
ECG Wave: VFIB1 (x1 scale)

PASS FAIL SAVE SHOW WAV>

<SAVE WAV PLAYBACK CANCEL


Figure 42 - Charge time results: no target or time limit specified.

n. Refer to Section 4.5.1.4 for an explanation of the softkey functions appearing on this
display.

Operation/Chapter 4 # Page 65
Phase 3 OPERATING MANUAL

o. If either a MAX TIME or an energy TARGET has been entered, Phase 3 will display
the results according to Figure 43. If both targets are specified, charge time and energy
results must both lie within their respective acceptance ranges in order to obtain a
"PASS", otherwise the overall result assigned by Phase 3 will be a "FAIL".

CHARGE TIME
TEST RESULTS:

ENERGY: 362.0J TARGET: 360.0J TOL: 10%


CHARGE TIME: 9.8sec MAX TIME: 10.0sec
ECG Wave: VFIB1 (x1 scale)
***************** PASS *****************
OK SHOW WAV SAVE WAV PLAYBACK>

< CANCEL
Figure 43 - Charge time results: Target and MAX TIME specified.

p. Refer to Section 4.5.1.4 for an explanation of the softkey functions appearing on the
display of Figure 43.

Operation/Chapter 4 # Page 66
Phase 3 OPERATING MANUAL

4.5.3 Defibrillator Cardioversion Test

4.5.3.1 Selecting the Cardioversion Test

Press the SYNC softkey on the DEFIBRILLATOR TEST menu to enter the cardioversion or
"SYNC TEST" menu (Figure 44). Functions available on this menu are:

SYNC TEST TEST(01/04)


WAITING FOR DISCHARGE
ENERGY: ---.-J TARGET: ---.-J TOL: --%
DELAY: ----ms TARGET: ---- to ---- ms
SYNC TO: Q wave RNG: HI
ECG Wave: AFIB1 (x1 scale) > NSR60

RANGE ECG SYNC TO DONE >


Figure 44 - Defibrillator Cardioversion Test menu.

RANGE Press to select either LOW or HIGH energy measurement range as required. Refer
to Section 4.5.1.
ECG Press to enter a menu for setting up the ECG simulator. Refer to Section 4.5.1.2
for instructions describing operation of the ECG simulator. According to
Figure 44, note the default simulator settings for this test will cause the ECG to
automatically switch from coarse atrial fibrillation to normal sinus rhythm at 60
BPM when Phase 3 detects the defibrillator discharge.

SYNC TO Press to select the time reference with respect to which the defibrillator
synchronization delay will be measured. Options available are:
• Q wave of simulated ECG (default)
• R wave of simulated ECG
DONE Press to return to the DEFIBRILLATOR TEST menu. Cardioversion test results
in the Clip Record are retained.

< Press to access additional softkey functions as shown in Figure 45, and as
described below.

+-----TARGET-------+
< ENERGY DELAY CANCEL
Figure 45 - Alternate softkeys of Defibrillator Cardioversion Test menu.

Operation/Chapter 4 # Page 67
Phase 3 OPERATING MANUAL

TARGET Press to enter optional energy target and tolerance settings which will allow
ENERGY Phase 3 to automatically pass or fail the energy measured when the defibrillator is
discharged. Refer to Section 4.5.1.3 for instructions on how to input a target and
tolerance.
TARGET Press to enable or disable comparison of the measured sync delay to a predefined
DELAY acceptance range of +20 to +65 milliseconds. This acceptance range is derived
from specifications appearing in Section 104 of the IEC60601-2-4 standard for
defibrillators. If the delay target is enabled, Phase 3 will automatically pass or fail
the measured sync delay accordingly.
CANCEL Cancel the cardioversion test and return to the DEFIBRILLATOR TEST menu.
Cardioversion test data in the Clip Record will be deleted if you press YES in
response to the cancellation confirmation which will be displayed. All other data in
the Clip Record will be retained. For additional information on CANCEL, see
Section 4.1.3.

= Press to restore softkey functions as shown in Figure 44.

4.5.3.2 Performing the Cardioversion Test

The purpose of a cardioversion test is to verify that a defibrillator can correctly synchronize its
discharge to the electrocardiogram. Phase 3 measures synchronization delay from a specified point
on the ECG QRS complex to the beginning of the defibrillator discharge. Phase 3 provides space in
the Clip Record for up to four cardioversion tests, allowing you to record the results for different
types of ECG waveform, or at various energy levels.

Note that real-time waveform capture via USB is inhibited in this test mode. Use the energy test
described in Section 4.5.1 to capture defibrillator waveform data in real-time.

To perform a cardioversion test:

a. Connect the defibrillator under test (DUT) to Phase 3 according to Section 3.1.

b. On the DEFIBRILLATOR TEST menu, press SYNC. The display of Figure 44 will
appear.

c. Set the DUT to the desired energy level.

Operation/Chapter 4 # Page 68
Phase 3 OPERATING MANUAL

d. Activate "SYNC" operation or the equivalent functional mode on the DUT. The ECG
monitor of the DUT may now show indicator marks on the ECG trace, marking each
detected QRS in the ECG.

e. On Phase 3, press RANGE to modify the energy measurement range as required.


Select "LO" range if the DUT is set to less than 50 joules, otherwise, select "HI" range.

f. Optionally, if you would like to change the waveform or mode of the ECG simulator,
press ECG to view the ECG setup menu. Refer to Section 4.5.1.2.

g. Press SYNC TO if required to choose the timing reference on the simulated ECG for
measurement of the delay time.

h. Optionally, if you would like to have Phase 3 automatically pass or fail the measured
energy, press TARGET ENERGY, enter a target value for the energy, and select a
tolerance. Refer to Section 4.5.1.3.

i. Optionally, if you would like to have Phase 3 automatically pass or fail the measured sync
delay, press TARGET DELAY to enable the sync acceptance range.

j. If using external or internal paddles, apply the paddles firmly to the Phase 3 Paddle
Adapter.

k. Charge the DUT.

l. Discharge the DUT into Phase 3. The timing of the discharge with respect to the
simulated QRS will be displayed immediately, and the ECG simulator will change
automatically to a normal sinus rhythm at 60 BPM. Phase 3 will then calculate the
energy and display the result.

m. If the measurement is being performed on LOW range, and Phase 3 detects distortion
(clipping) in the acquired waveform data, Phase 3 will produce an alarm message on the
display (Figure 46). The measurement results are invalid if this alarm is displayed.
Acknowledge the alarm by pressing the OK softkey, then repeat the measurement after
selecting HIGH range via the menu of Figure 44.

Operation/Chapter 4 # Page 69
Phase 3 OPERATING MANUAL

LOW RANGE ALARM

WARNING: Signal distortion detected.


Repeat the measurement on HIGH RANGE.

OK
Figure 46 - Warning if signal distortion detected.

n. If the delay target has not been enabled and an energy target has not been entered,
Phase 3 will display the results according to Figure 47. Refer to Section 4.5.1.4 for an
explanation of the softkey functions appearing on this display.

SYNC TEST TEST:(01/04)


WAITING FOR DISCHARGE
ENERGY: 102.0J TARGET: ---.-J TOL: --%
DELAY: +48ms TARGET: ---- to ---- ms
SYNC TO: Q wave RNG: HI
ECG Wave: ECG 60 BPM (x1 scale)

PASS FAIL SAVE SHOW WAV>


Figure 47 - Defibrillator Cardioversion Test result: no targets specified.

o. If either a delay target or an energy target has been entered, Phase 3 will display the
results according to Figure 48. If both targets are specified, sync delay and energy
results must both lie within their respective acceptance ranges in order to obtain a
"PASS", otherwise the overall result assigned by Phase 3 will be a "FAIL". Refer to
Section 4.5.1.4 for an explanation of the softkey functions appearing on the display of
Figure 48.

Operation/Chapter 4 # Page 70
Phase 3 OPERATING MANUAL

SYNC TEST TEST(01/04)


WAITING FOR DISCHARGE
ENERGY: 104.9J TARGET: ---.-J TOL: --%
DELAY: +35ms TARGET: +20 to +65 ms
SYNC TO: Q wave RNG: HI
ECG Wave: ECG 60 BPM (x1 scale)
***************** PASS *****************
OK SHOW WAV SAVE WAV PLAYBACK>
Figure 48 - Defibrillator Cardioversion Test result: delay target specified.

p. Similarly to the ENERGY test, while showing the results of an SYNC energy discharge,
Phase 3 is ready to process another discharge without any further operator intervention.
The display screen (Figure 47 or Figure 48) will be indicating "WAITING FOR
DISCHARGE". If the defibrillator is discharged at this time, without pressing a PASS,
FAIL, SAVE, or OK softkey, Phase 3 will automatically SAVE the measurement
results currently being displayed, and will then proceed to process the new discharge.
This allows a series of manual SYNC tests to be performed without the need to press
any keys on Phase 3 .

q. Repeat steps (c) to (o) as required until the desired number of cardioversion tests have
been performed, up to a maximum of 4. More than 4 tests can be done, however, if
such results are saved to the Clip Record via PASS, FAIL, SAVE, or OK softkeys,
then the Clip Record location reserved for cardioversion test #4 will be overwritten
with each new result.

r. When all tests have been completed, press DONE (see Figure 44). Cardioversion test
results accumulated in the Clip Record are retained and may be supplemented with data
from other defibrillator, ECG and pacemaker tests.

Operation/Chapter 4 # Page 71
Phase 3 OPERATING MANUAL

4.6 ECG Test Menu

4.6.1 Selecting the ECG Test

Press the ECG softkey on the MANUAL TEST menu to enter the ECG TEST menu (Figure 49).
The ECG simulator provides a total of 55 Waveforms which are organised in seven Wave Banks.
The display of Figure 49 shows the WAVE BANK and the full title of the WAVEFORM currently in
effect, as well as an abbreviated waveform title which is shown on the display immediately below the
full title. Refer to Table 4-1 of Section 4.5.1.2 for a listing of Banks and Waveforms provided by the
ECG simulator of Phase 3.

ECG TEST TEST(01/12)

WAVE BANK: Sinus Rhythm


WAVEFORM: ECG 60 BPM
(ECG60)
Relative SCALE: x1 (1.0mV QRS Lead II)

BANK WAVEFORM SCALE DONE >


Figure 49 - ECG Test menu.

Functions available on the ECG TEST menu are:

BANK Press to modify the Wave Bank of the ECG simulator. Refer to Table 4-1 of
Section 4.5.1.2.
WAVEFORM Press to modify the Waveform for the selected Bank. Refer to Table 4-1 of
Section 4.5.1.2.
SCALE Press to set the simulator's amplitude scale to one of these choices:

• x1 (corresponding to 1mV QRS amplitude on ECG Lead II)


• x2 (corresponding to 2mV QRS amplitude on ECG Lead II)
• x0.5 (corresponding to 0.5mV QRS amplitude on ECG Lead II)
DONE Press to return to the MANUAL TEST menu. ECG test results in the Clip
Record are retained.

< Press to access additional softkey functions as shown in Figure 50, and as
described below.

Operation/Chapter 4 # Page 72
Phase 3 OPERATING MANUAL

<WAVEFORM PASS FAIL CANCEL


Figure 50 - Alternate softkeys of ECG Test menu.

PASS Save the ECG waveform to the Clip Record along with a "PASS" mark. The
test counter shown at the top right corner of the display will increment, until a
maximum of 12 ECG tests have been accumulated in the Clip Record. If
PASS is pressed after 12 ECG results have been stored, then the new result
will overwrite the Clip Record location reserved for ECG test #12.
FAIL As described above for PASS, except save a "FAIL" mark to the Clip Record
with the ECG waveform.
CANCEL Cancel the ECG test and return to the MANUAL TEST menu. ECG results
in the Clip Record will be deleted if you press YES in response to the
cancellation confirmation which will be displayed. All other data in the Clip
Record will be retained. For additional information on CANCEL, see Section
4.1.3.

= Press to restore softkey functions as shown in Figure 49.

Operation/Chapter 4 # Page 73
Phase 3 OPERATING MANUAL

4.6.2 Performing the ECG Test

The purpose of an ECG test is to verify that the ECG monitor and/or strip chart recorder of a
defibrillator is functioning according to the manufacturer's performance specifications. Tests
typically performed on a defibrillator ECG monitor could include those listed in Table 4-2:

Table 4-2: ECG Monitor Tests


Monitor/Chart Recorder Test Test Waveform(s)
Low-frequency response DC Pulse, 4 seconds (Performance Wave Bank)

Gain and damping Square Wave, 2 Hz (Performance Wave Bank)

Linearity Triangle Wave, 2 Hz (Performance Wave Bank)

R-wave detection Triangle or Haversine Pulse, 10-200msec, 60BPM


(Triangle/Haversine Trigger Pacemaker Bank)

Wideband frequency response Sine Wave, 0.1 - 100 Hz (Performance Wave Bank)

Line frequency rejection Sine Wave, 50 Hz or 60 Hz (Performance Wave Bank)

Rate accuracy and R-wave recognition All waveforms of Sinus Rhythm Bank, 30-300 BPM

Arrhythmia detection and classification All waveforms of Arrhythmia Bank

Shock advisory reporting All waveforms of Shock Advisory/AED Bank

To perform an ECG test:

a. Connect the defibrillator under test (DUT) to Phase 3 according to Section 3.1.

b. On the MANUAL TEST menu, press ECG. The display of Figure 49 will appear.

c. On the Phase 3, select the desired ECG Bank and Waveform.

d. Observe the response of the monitor and/or chart recorder and press PASS or FAIL
as appropriate to record the waveform tested and the test result.

e. Repeat steps (c) and (d) as required until the desired number of ECG tests have been
performed, up to a maximum of 12. More than 12 tests can be done, however, if such
results are saved to the Clip Record via PASS or FAIL softkeys, then the Clip Record
location reserved for ECG test #12 will be overwritten with each new result.

f. When all tests have been completed, press DONE. ECG test results accumulated in the
Clip Record are retained and may be supplemented with data from manual defibrillator
and pacemaker tests.

Operation/Chapter 4 # Page 74
Phase 3 OPERATING MANUAL

4.7 Pacemaker Test Menu

Press the PACER softkey on the MANUAL TEST menu to enter the PACER TEST menu
(Figure 51). Functions available on this menu are:

PACER TESTS

LOAD: Set Pacer Load Value


PULSE: Pacer Pulse Measurement
REFRACT: Sensed/Paced Refractory Period
DONE: Return to Manual Test menu

LOAD PULSE REFRACT DONE >


Figure 51 - Pacemaker Test menu.

LOAD Press to set the load resistor that will be used in all pacemaker tests. Refer to
Section 4.7.1.
PULSE Press to measure pacemaker pulse characteristics, such as amplitude, rate and
pulse width. Refer to Section 4.7.2.
REFRACT Press to measure the pacemaker's refractory periods. Refer to Section 4.7.3.

DONE Press to return to the MANUAL TEST menu. Pacemaker measurement data in
the Clip Record are retained.

< Press to access additional softkey functions as shown in Figure 52, and as
described below.

<IMMUNITY SENS CANCEL


Figure 52 - Alternate softkeys of Pacemaker Test menu.

IMMUNITY Press to measure a pacemaker's immunity to line-frequency noise. Refer to


Section 4.7.4.
SENS Press to measure sensitivity of the pacemaker to the ECG signal. Refer to
Section 4.7.5.

Operation/Chapter 4 # Page 75
Phase 3 OPERATING MANUAL

CANCEL Cancel the pacemaker test and return to the MAIN MENU. Pacemaker
measurement data in the Clip Record will be deleted if you press YES in
response to the cancellation confirmation which will be displayed. All other data
in the Clip Record will be retained. For additional information on CANCEL, see
Section 4.1.3.

= Press to restore softkey functions as shown in Figure 51.

4.7.1 Pacemaker Load Selection

Press the LOAD softkey on the PACER TEST menu to view or change the pacemaker test load
(Figure 53). Functions available on this menu are:

SET PACER LOAD RESISTOR

LOAD: 50 ohms

LOAD RANGE: 50 - 1600 ohms

SELECT LOAD+50 LOAD-50 CANCEL >


Figure 53 - Selection of Pacemaker Test Load.

SELECT Press to set the load to the displayed resistance and return to the PACER TEST
menu.
LOAD+50 Press to increase the load by 50 ohms. Adjustment is limited to the range of 50 to
1600 ohms, as shown on the display.
LOAD-50 Press to decrease the load by 50 ohms.

CANCEL Press to return to the PACER TEST menu without changing the load.

Operation/Chapter 4 # Page 76
Phase 3 OPERATING MANUAL

< Press to access additional softkey functions as shown in Figure 54, and as
described below.

< SELECT LOAD+200 LOAD-200 CANCEL

Figure 54 - Alternate softkeys of Pacemaker Test Load selection

LOAD+200 Press to increase the load by 200 ohms.

LOAD-200 Press to decrease the load by 200 ohms.

= Press to restore softkey functions as shown in Figure 53.

Note: The pacer load selection is a User Preference Setting that will remain in effect until changed
by the operator. When operating the Phase 3 in manual test mode, the changes made here
will apply to the pacer test currently in progress as well as to future tests, even if the
Phase 3 power is switched off and then back on.

NOTE:
All pacemaker tests must be performed with the same load
resistor. Always choose the load before beginning a series of
pacer tests.

If the Clip Record contains pacemaker test data when the LOAD
softkey on the PACER TEST menu is pressed, Phase 3 will warn
you that changing the load will cause pacemaker results in the
Clip Record to be erased (see Figure 55).

In this case, you may press the NO softkey to return to the


PACER TEST menu without affecting data in the Clip Record.
Or, you can press YES to erase the pacer results and then
proceed to change the load resistor as required.

Operation/Chapter 4 # Page 77
Phase 3 OPERATING MANUAL

ERASE PACER MEASUREMENTS IN CLIP RECORD


Warning: all pacer tests must be
performed with the same pacer load.
Changing the load at this point will
invalidate all existing measurements in
the Clip Record and they will be erased.
Press YES to change load, NO to abort.
YES NO
Figure 55 - Warning when changing load after acquiring test results.

4.7.2 Pacemaker Pulse Test

4.7.2.1 Selecting the Pulse Test

Press the PULSE softkey on the PACER TEST menu to enter a menu for determining the
characteristics of the pacemaker pulse (Figure 56). The selected test load will appear on the top line
of the display as shown in the figure. Functions available on the PACER PULSE menu are:

PACER PULSE 50 ohms TEST(01/10)


Set up Pacer, then press START
AMPL: ---.-mA TARGET: --- TOL: --%
WIDTH: --.--msec TARGET: --- TOL: --%
RATE: ---.-PPM TARGET: --- TOL: --%
Method: Average

START AMPL RATE DONE >


Figure 56 - Pacemaker Pulse Test menu.

START Press to start the measurement. The pacemaker should be running in


asynchronous or non-demand mode before this key is pressed.
AMPL Press to enter optional target and tolerance settings for the pulse amplitude,
which will allow Phase 3 to automatically pass or fail the measured amplitude
when the pacemaker pulse train is detected. Entering a pacer amplitude target
is very similar to entering an energy target during a defibrillator test. Refer to
Section 4.5.1.3 for instructions on how to input a target and tolerance.

Operation/Chapter 4 # Page 78
Phase 3 OPERATING MANUAL

RATE Press to enter optional target and tolerance settings for the pulse rate, which
will allow Phase 3 to automatically pass or fail the measured rate when the
pacemaker pulse train is detected. Entering a pacer rate target is very similar to
entering an energy target during a defibrillator test. Refer to Section 4.5.1.3 for
instructions on how to input a target and tolerance.
DONE Press to return to the PACER TEST menu. Pulse test results in the Clip
Record are retained.

< Press to access additional softkey functions as shown in Figure 57, and as
described below.

< START WIDTH METHOD CANCEL


Figure 57 - Alternate softkeys of Pacer Pulse Test menu.

WIDTH Press to enter optional target and tolerance settings for the pulse width, which
will allow Phase 3 to automatically pass or fail the measured width when the
pacemaker pulse train is detected. Entering a pacer width target is very similar
to entering an energy target during a defibrillator test. Refer to Section 4.5.1.3
for instructions on how to input a target and tolerance.
METHOD Press to select the method to be applied in determining the pulse amplitude.
The choices available are:

• Average - amplitude is averaged across the pulse's width


• Leading edge - amplitude is taken from the pulse's rising edge
• Trailing edge - amplitude is taken from the pulse's falling edge
• Peak value - amplitude is the peak value seen during the pulse
CANCEL Cancel the pulse test and return to the PACER TEST menu. Pulse Test data in
the Clip Record will be deleted if you press YES in response to the
cancellation confirmation which will be displayed. All other data in the Clip
Record will be retained. For additional information on CANCEL, see Section
4.1.3.

= Press to restore softkey functions as shown in Figure 56.

Note: The selection for amplitude METHOD is a User Preference Setting that will remain in
effect until changed by the operator. When operating the Phase 3 in manual test mode, the
changes made here will apply to the pacer test currently in progress as well as to future
tests, even if the Phase 3 power is switched off and then back on.

Operation/Chapter 4 # Page 79
Phase 3 OPERATING MANUAL

4.7.2.2 Performing the Pulse Test

The purpose of a pacemaker pulse test is to verify that the pacemaker output signal is in
conformance with manufacturer's specifications for a given load resistance. Phase 3 provides space
in the Clip Record for up to 10 pulse tests, allowing you to record the results for different settings of
pacemaker output current and pulse rate.

To perform a pacemaker pulse test:

a. Connect the output from the transcutaneous pacemaker of the defibrillator under test
(DUT) to Phase 3 according to Section 3.1.

b. Select the pacemaker load (Section 4.7.1) according to testing requirements specified by
the DUT manufacturer. Typically, the load corresponds to the largest resistance into
which the pacemaker can deliver its maximum rated output current. Refer to the
manufacturer's service manual for the DUT to determine the required load.

c. On the PACER TEST menu, press PULSE. The display of Figure 56 will appear.

d. Set the DUT to asynchronous or non-demand operating mode.

e. Set the output current and pulse rate on the DUT to the desired values.

f. Optionally, if you would like Phase 3 to automatically pass or fail the measured pulse
amplitude, press AMPL and enter a target value and tolerance.

g. Optionally, if you would like Phase 3 to automatically pass or fail the measured rate,
press RATE and enter a target value and tolerance.

h. Optionally, if you would like Phase 3 to automatically pass or fail the measured pulse
width, press WIDTH and enter a target value and tolerance.

i. Select the amplitude measurement METHOD. The required method may be specified
by the manufacturer in the DUT service manual. If the manufacturer does not specify a
method, or if the DUT service manual is not available, choose "Average".

j. Press START to measure the pacemaker pulse. The START softkey will be changed
to a STOP softkey (Figure 58). The first measurement will be completed and the
results displayed after two successive pacemaker pulses are detected. Phase 3 will
continue to acquire and analyze pacer pulses until the STOP softkey is pressed. Each
time the results are displayed on the screen, Phase 3 will emit an audible 'click'.

Operation/Chapter 4 # Page 80
Phase 3 OPERATING MANUAL

NOTE: the audible 'click' is not an indication of the pacer rate, only an indication that new
data is on the display. Generally, the 'click' will occur every 2 to 3 pacer pulses, depending
on the rate. For a given rate, the 'click' will be periodic and a missing 'click' may indicate
Phase 3 encountered a pulse that was difficult to analyze. Frequent missing 'clicks' may be
an indication that the pacer pulses are of an abnormal shape or inconsistent rate.

PACER PULSE 50 ohms TEST(01/10)


Measuring pacer pulses properties
AMPL: 120.5mA TARGET: --- TOL: --%
WIDTH: 20.06msec TARGET: --- TOL: --%
RATE: 91.0PPM TARGET: --- TOL: --%
Method: Average

STOP CANCEL
Figure 58 - Pacemaker Pulse Test in progress: no targets specified.

k. If no targets (amplitude, rate or width) have been entered when STOP is pressed,
Phase 3 will display the results for the last pacer pulse acquired according toFigure 59.
Refer to Section 4.5.1.4 for an explanation of the softkey functions appearing on this
display.

PACER PULSE 50 ohms TEST(01/10)


Pacer Results
AMPL: 120.5mA TARGET: --- TOL: --%
WIDTH: 20.06msec TARGET: --- TOL: --%
RATE: 91.0PPM TARGET: --- TOL: --%
Method: Average

PASS FAIL SAVE CANCEL


Figure 59 - Pacemaker Pulse Test result: no targets specified.

l. If any of the three available targets has been entered (amplitude, rate or width), Phase 3
will display the results according to Figure 60. If more than one target has been
specified, then all corresponding results must lie within their respective acceptance
ranges in order to obtain a "PASS", otherwise the overall result assigned by Phase 3 will
be a "FAIL". Refer to Section 4.5.1.4 for an explanation of the softkey functions
appearing on the display of Figure 60.

Operation/Chapter 4 # Page 81
Phase 3 OPERATING MANUAL

PACER PULSE 50 ohms TEST(01/10)


Pacer Results
AMPL: 101.9mA TARGET: 100 TOL: 10%
WIDTH: 19.98msec TARGET: --- TOL: --%
RATE: 59.9PPM TARGET: 60 TOL: 05%
Method: Average
***************** PASS *****************
OK CANCEL
Figure 60 - Pacemaker Pulse Test results: amplitude & rate targets specified.

m. Repeat steps (e) to (l) as required until the desired number of pulse tests have been
performed, up to a maximum of 10. More than 10 tests can be done, however, if such
results are saved to the Clip Record via PASS, FAIL, SAVE, or OK softkeys, then the
Clip Record location reserved for pacemaker pulse test #10 will be overwritten with
each new result.

n. When all tests have been completed, press DONE (see Figure 56). Pacemaker pulse
test results accumulated in the Clip Record are retained and may be supplemented with
data from other pacemaker, ECG and defibrillator tests.

4.7.2.3 Capturing the Pacemaker Waveform

Phase 3 with Phase3pc software provides a feature for capturing high-resolution waveform data on
a personal computer. The data can be acquired after the STOP softkey has been pressed, while the
display is in the state shown in Figure 58 or Figure 59.

Clicking the Waveform Capture icon in Phase3pc causes the detailed waveform data to be
rapidly transferred to the PC via the USB connection. After a waveform graph is plotted, Phase3pc
allows the user to print the graph or save the detailed data to a file for further numerical analysis.
Refer to Section 6.5.3 for additional details.

Pacemaker waveform capture may also be performed via RS-232 when Phase 3 is operating in
remote control mode. Refer to Chapter 5 for details.

Operation/Chapter 4 # Page 82
Phase 3 OPERATING MANUAL

4.7.3 Pacemaker Refractory Period Test

4.7.3.1 Selecting the Refractory Period Test

Press the REFRACT softkey on the PACER TEST menu to enter a menu for determining
refractory intervals of a pacemaker (Figure 61). The selected test load will appear on the top line of
the display as shown in the figure. Functions available on the PACER REFRACTORY menu are:

PACER REFRACTORY 50 ohms TEST(01/02)


Start Pacer, then press START
REFRACTORY MIN: --- msec MAX: --- msec
REFRACTORY PRP: --- msec SRP: --- msec
ECG WAVE: TRIP40 (x2 Scale)
PACER RATE: --- PPM

START ECG DONE >


Figure 61 - Pacemaker Refractory Test menu.

START Press to start the test. The pacemaker should be running in synchronous or demand
mode before this key is pressed.
ECG Press to enter a menu for setting up the ECG simulator. Refer to Section 4.5.1.2 for
instructions describing operation of the ECG simulator.
DONE Press to return to the PACER TEST menu. Refractory measurement data in the
Clip Record are retained.

< Press to access additional softkey functions as shown in Figure 62, and as described
below.

< START MIN MAX CANCEL


Figure 62 - Alternate softkeys of Pacer Refractory Test menu.

MIN Press to enter an optional minimum permitted value for the refractory periods,
which will allow Phase 3 to automatically pass or fail the measured periods at the
end of the test. Both the paced and sensed refractory periods will be compared to
this minimum limit if a limit is entered. Entering a minimum limit is very similar to
entering an energy target during a defibrillator test. Refer to Section 4.5.1.3 for
instructions on how to input a target. The MIN limit range is 50 - 750 msec.

Operation/Chapter 4 # Page 83
Phase 3 OPERATING MANUAL

MAX Press to enter an optional maximum permitted value for the refractory periods,
which will allow Phase 3 to automatically pass or fail the measured periods at the
end of the test. Both the paced and sensed refractory periods will be compared to
this maximum limit if a limit is entered. Entering a maximum limit is very similar to
entering an energy target during a defibrillator test. Refer to Section 4.5.1.3 for
instructions on how to input a target. The MAX limit range is 50 - 750 msec.
CANCEL Cancel the refractory period test and return to the PACER TEST menu. Refractory
period data in the Clip Record will be deleted if you press YES in response to the
cancellation confirmation which will be displayed. All other data in the Clip Record
will be retained. For additional information on CANCEL, see Section 4.1.3.

= Press to restore softkey functions as shown in Figure 61.

Note: The "ECG WAVE" and "Scale" for the refractory test, set by means of the ECG menu, are
User Preference Settings that will remain in effect until changed by the operator. When
operating the Phase 3 in manual test mode, the changes made here will apply to the
refractory test currently in progress as well as to future tests, even if the Phase 3 power is
switched off and then back on.

4.7.3.2 Performing the Refractory Period Test

The purpose of a pacemaker refractory period test is to verify that paced and sensed refractory
periods are per manufacturer's specifications for the DUT. These intervals are defined as follows:

• Refractory Period: When a pacemaker is operating in synchronous or demand


mode, the "refractory period" is the time interval during
which the pacemaker is insensitive to an ECG input signal,
and in particular, the QRS complex of the ECG.
• Paced Refractory Period (PRP): Immediately after generation of a pacing pulse, PRP is the
time interval over which the pacemaker remains insensitive
to the ECG. If a QRS occurs within the PRP following
output of a pacing pulse, the pacemaker ignores this QRS.
• Sensed Refractory Period (SRP): SRP is the time interval after a detected QRS during which
the pacemaker remains insensitive to the ECG. If a QRS
occurs within the SRP following a detected QRS, the
pacemaker then ignores this second QRS.

Operation/Chapter 4 # Page 84
Phase 3 OPERATING MANUAL

Phase 3 provides space in the Clip Record for up to 2 refractory period tests, allowing you to record
results for different rate settings on the pacemaker, or for different trigger waveforms on the
Phase 3 ECG simulator.

To perform a refractory period test:

a. Connect the output from the transcutaneous pacemaker of the defibrillator under test
(DUT) to Phase 3 according to Section 3.1.

b. If no pacemaker tests have yet been performed, select the pacemaker load (Section
4.7.1) according to testing requirements specified by the DUT manufacturer. Do not
change the load if the Clip Record contains data from previous pacemaker tests.

c. On the PACER TEST menu, press REFRACT. The display of Figure 61 will appear.

d. Set the DUT to synchronous or demand operating mode.

e. Set the output current and pulse rate on the DUT. The output current should be set to
approximately mid-range. A pacer rate ranging from 60 to 120 PPM is recommended.
Rates in excess of 120 PPM should be avoided.

f. On Phase 3, optionally press ECG to modify the settings of the ECG simulator as
desired. Refer to Section 4.5.1.2.

g. Optionally, if you would like Phase 3 to automatically pass or fail the measured refractory
intervals, press MIN and enter a minimum allowed refractory period, then press MAX
and enter the maximum allowed period.

h. Press START to start the test. The test proceeds as a number of successive pacemaker
pulses are acquired. First, Phase 3 determines the pacemaker's pulse rate, which is
displayed on the LCD as PACER RATE. Then, Phase 3 will determine the PRP by
outputting ECG trigger pulses after each pacing pulse is detected. Following
determination and display of PRP, Phase 3 then proceeds to determine the SRP.
During the test, Phase 3 will display a progress indicator just above the softkey row. At
a pacer rate of 90 PPM, the entire test will require about 30 seconds to complete.

i. If neither a minimum limit nor a maximum limit has been entered, Phase 3 will display
the results according to Figure 63. Refer to Section 4.5.1.4 for an explanation of the
softkey functions appearing on this display.

Operation/Chapter 4 # Page 85
Phase 3 OPERATING MANUAL

PACER REFRACTORY 50 ohms TEST(01/02)

REFRACTORY MIN: --- msec MAX: --- msec


REFRACTORY PRP: 284 msec SRP: 262 msec
ECG WAVE: TRIP40 (x2 Scale)
PACER RATE: 90 PPM

PASS FAIL SAVE CANCEL


Figure 63 - Pacemaker Refractory Test results: no limits specified.

j. If either limit has been entered, Phase 3 will display the results according to Figure 64.
If limits have been specified, then both refractory periods must lie within the limits in
order to obtain a "PASS", otherwise the overall result assigned by Phase 3 will be a
"FAIL". Refer to Section 4.5.1.4 for an explanation of the softkey functions appearing
on the display of Figure 64.

PACER REFRACTORY 50 ohms TEST(01/02)

REFRACTORY MIN: 200 msec MAX: 300 msec


REFRACTORY PRP: 284 msec SRP: 262 msec
ECG WAVE: TRIP40 (x2 Scale)
PACER RATE: 90 PPM
***************** PASS *****************
OK CANCEL
Figure 64 - Pacemaker Refractory Test results: min/max limits specified.

k. Repeat steps (e) to (j) if desired. More than two tests can be done, however, if such
results are saved to the Clip Record via PASS, FAIL, SAVE, or OK softkeys, then the
Clip Record location reserved for pacemaker refractory test #2 will be overwritten with
each new result.

l. When all tests have been completed, press DONE (see Figure 61). Refractory period
results accumulated in the Clip Record are retained and may be supplemented with data
from other pacemaker, ECG and defibrillator tests.

Operation/Chapter 4 # Page 86
Phase 3 OPERATING MANUAL

4.7.4 Pacemaker Noise Immunity Test

4.7.4.1 Selecting the Noise Immunity Test

Press the IMMUNITY softkey on the PACER TEST menu to enter a menu for determining
immunity of a pacemaker to line-frequency noise (Figure 65). The selected test load will appear on
the top line of the display as shown in the figure. Functions available on the PACER NOISE
IMMUNITY menu are:

PACER NOISE IMMUNITY 50 ohms


Set Pacer to DEMAND MODE and press START
to begin test...
NOISE FREQUENCY: 60Hz
NOISE AMPLITUDE: -.--mV

START NOISE CANCEL


Figure 65 - Pacemaker Immunity Test menu.

START Press to start the test. The pacemaker should be running in synchronous or
demand mode before this key is pressed.
NOISE Press to toggle the noise frequency between 50 Hz and 60 Hz.

CANCEL Cancel the noise test and return to the PACER TEST menu. Noise Test data in
the Clip Record will be deleted if you press YES in response to the cancellation
confirmation which will be displayed. All other data in the Clip Record will be
retained. For additional information on CANCEL, see Section 4.1.3.

Note: The NOISE frequency is a User Preference Setting that will remain in effect until changed
by the operator. When operating the Phase 3 in manual test mode, the changes made here
will apply to the immunity test currently in progress as well as to future tests, even if the
Phase 3 power is switched off and then back on.

Operation/Chapter 4 # Page 87
Phase 3 OPERATING MANUAL

4.7.4.2 Performing the Noise Immunity Test

The purpose of the noise immunity test is to verify that a pacemaker operating in demand mode
does not respond to line frequency noise at its ECG input.

In this test, Phase 3 outputs a line frequency sine wave via the ECG simulator and observes the
effect on the pacemaker. The test automatically passes if the pacemaker continues to pace at its set
rate when the output of the ECG simulator is set to maximum (6 millivolts peak-to-peak). The test
automatically fails if the pacemaker ceases pacing for a sine wave amplitude less than 6 millivolts.

To perform the noise immunity test:

a. Connect the output from the transcutaneous pacemaker of the defibrillator under test
(DUT) to Phase 3 according to Section 3.1.

b. If no pacemaker tests have yet been performed, select the pacemaker load (Section
4.7.1) according to testing requirements specified by the DUT manufacturer. Do not
change the load if the Clip Record contains data from previous pacemaker tests.

c. On the PACER TEST menu, press IMMUNITY. The display of Figure 65 will appear.

d. Set the DUT to synchronous or demand operating mode.

e. Set the output current and pulse rate on the DUT. The output current should be set to
approximately mid-range. A pacer rate ranging from 60 to 120 PPM is recommended.
Rates in excess of 120 PPM should be avoided.

f. On Phase 3, set the noise frequency to either 50 or 60 Hz as required.

g. Press START to start the test. The test proceeds as a number of successive pacemaker
pulses are acquired. First, Phase 3 determines the pacemaker's pulse rate. After
measuring the rate, Phase 3 will then begin to output a sine wave to the pacemaker via
the ECG simulator.

h. As each pacer pulse is detected, Phase 3 introduces an audible 'click' and increases the
noise signal amplitude by 0.0845 mV. The test will pass if the pacemaker does not react
to a 6 millivolt sine wave (Figure 66). If there is no activity from the pacer for 4
seconds for any noise level less than 6 mV, the test will fail. At 90PPM, the test will
require about 50 seconds to complete if the pacemaker passes, or less if it fails.

i. Press OK to save the immunity result in the Clip Record, or CANCEL to discard the
result.

Operation/Chapter 4 # Page 88
Phase 3 OPERATING MANUAL

PACER NOISE IMMUNITY 50 ohms


Test Results

NOISE FREQUENCY: 60Hz


NOISE AMPLITUDE: 6.00mV

***************** PASS *****************


OK CANCEL
Figure 66 - Pacemaker Immunity Test result.

4.7.5 Pacemaker Sensitivity Test

4.7.5.1 Selecting the Sensitivity Test

Press the SENS softkey on the PACER TEST menu to enter a menu for determining sensitivity of
a pacemaker to the ECG amplitude (Figure 67). The selected test load will appear on the top line of
the display as shown in the figure. Functions available on the PACER SENSITIVITY menu are:

PACER SENSITIVITY 50 ohms TEST(01/02)


Start Pacer, then press START

AMPL: -.--mV SENSITIVITY LIMIT: -.--mV


ECG WAVE: TRIP40
PACER RATE: --- PPM

START LIMIT ECG DONE >


Figure 67 - Pacemaker Sensitivity Test menu.

START Press to start the test. The pacemaker should be running in synchronous or
demand mode before this key is pressed.
LIMIT Press to enter an optional maximum permitted value for the sensitivity, which will
allow Phase 3 to automatically pass the AMPL result at the end of the test,
provided the AMPL result is less than the limit. Entering this limit is very similar to
entering an energy target during a defibrillator test. Refer to Section 4.5.1.3 for
instructions on how to input a target.
DONE Press to return to the PACER TEST menu. Sensitivity measurement data in the
Clip Record are retained.

Operation/Chapter 4 # Page 89
Phase 3 OPERATING MANUAL

< Press to access additional softkey functions as shown in Figure 68, and as
described below.

< CANCEL
Figure 68 - Alternate softkeys of Pacer Sensitivity Test menu.

CANCEL Cancel the sensitivity test and return to the PACER TEST menu. Sensitivity Test
data in the Clip Record will be deleted if you press YES in response to the
cancellation confirmation which will be displayed. All other data in the Clip
Record will be retained. For additional information on CANCEL, see
Section 4.1.3.

= Press to restore softkey functions as shown in Figure 67.

4.7.5.2 Performing the Sensitivity Test

The purpose of the sensitivity test is to determine the smallest ECG signal that will reliably trigger a
pacemaker, and to verify this signal level is in accordance with manufacturer's specifications.
Phase 3 provides space in the Clip Record for up to 2 sensitivity tests, allowing you to record results
for different trigger waveforms on the Phase 3 ECG simulator.

To perform the sensitivity test:

a. Connect the output from the transcutaneous pacemaker of the defibrillator under test
(DUT) to Phase 3 according to Section 3.1.

b. If no pacemaker tests have yet been performed, select the pacemaker load
(Section 4.7.1) according to testing requirements specified by the DUT manufacturer.
Do not change the load if the Clip Record contains data from previous pacemaker tests.

c. On the PACER TEST menu, press SENS. The display of Figure 67 will appear.

d. Set the DUT to synchronous or demand operating mode.

e. Set the output current and pulse rate on the DUT. The output current should be set to
approximately mid-range. A pacer rate ranging from 60 to 120 PPM is recommended.
Rates in excess of 120 PPM should be avoided.

Operation/Chapter 4 # Page 90
Phase 3 OPERATING MANUAL

f. On Phase 3, optionally press ECG to modify the settings of the ECG simulator as
desired. Refer to Section 4.5.1.2.

g. Optionally, if you would like Phase 3 to automatically pass or fail the measured
sensitivity, press LIMIT and enter a maximum permitted value for the test result.

h. Press START to start the test. The test proceeds as a number of successive pacemaker
pulses are acquired. First, Phase 3 determines the pacemaker's pulse rate, which is
displayed on the LCD as PACER RATE. Then, Phase 3 will determine the sensitivity by
outputting ECG trigger pulses of variable amplitude after each pacing pulse is detected.
During the test, Phase 3 will display a progress indicator (a rotating line) just above the
softkey row.

i. As each pacer pulse is detected, Phase 3 will emit an audible 'click'. For each detected
pacer pulse, Phase 3 will increase the ECG signal level in steps of 0.045mV until the
pacer is inhibited. After the pacer is inhibited, the ECG level is reduced and then
increased in steps of 0.015mV until the pacer is again inhibited. The test will stop when
the pacer is inhibited by the ECG signal, or a maximum ECG level of 3 mV is reached.
For a pacer having a sensitivity of nominally 1 mV, and at a rate of 90PPM, the
sensitivity test will require about 20 seconds.

j. If a sensitivity limit has not been entered, Phase 3 will display the results according to
Figure 69. Refer to Section 4.5.1.4 for an explanation of the softkey functions
appearing on this display.

PACER SENSITIVITY 50 ohms TEST(01/02)

AMPL: 0.62mV SENSITIVITY LIMIT: -.--mV


ECG WAVE: TRIP40
PACER RATE: 90 PPM

PASS FAIL SAVE CANCEL


Figure 69 - Pacemaker Sensitivity Test result: no sensitivity limit.

k. If a sensitivity limit has been entered, Phase 3 will display the results according to
Figure 70. Refer to Section 4.5.1.4 for an explanation of the softkey functions
appearing on this display.

Operation/Chapter 4 # Page 91
Phase 3 OPERATING MANUAL

PACER SENSITIVITY 50 ohms TEST(01/02)

AMPL: 0.42mV SENSITIVITY LIMIT: 0.75mV


ECG WAVE: TRIP40
PACER RATE: 90 PPM
***************** PASS *****************
OK CANCEL
Figure 70 - Pacemaker Sensitivity Test result: limit specified.

l. Repeat steps (e) to (j) if desired. More than two tests can be done, however, if such
results are saved to the Clip Record via PASS, FAIL, SAVE, or OK softkeys, then the
Clip Record location reserved for sensitivity test #2 will be overwritten with each new
result.

m. When all tests have been completed, press DONE (see Figure 67). Sensitivity results
accumulated in the Clip Record are retained and may be supplemented with data from
other pacemaker, ECG and defibrillator tests.

Operation/Chapter 4 # Page 92
Phase 3 OPERATING MANUAL

4.8 AED Test Menu

4.8.1 Selecting the AED Test

Press the AED softkey on the MANUAL TEST menu to enter a menu for testing Automated
External Defibrillators or "AEDs" (Figure 71). Functions available on this menu are:

AED PERFORMANCE TEST(01/32)


Trigger Shock or press NO SHOCK to
conclude each test.
ENERGY: ---.-J
ECG WAVE: AFIB1 (x1 Scale)
ECG TYPE: UNSHOCKABLE

NO SHOCK ECG AUTO-NSR DONE >


Figure 71 - AED Test menu.

NO SHOCK Press this softkey if the AED audibly and/or visually advises the user that the
AED cannot or should not be discharged.
ECG Press to enter a menu for setting up the ECG simulator. Refer to Section
4.5.1.2 for instructions describing operation of the ECG simulator.
AUTO-NSR Press this softkey to enable or disable automatic response of the ECG simulator
to a defibrillator discharge. If AUTO-NSR is enabled, "> NSR60" will appear
on the LCD to the right of the ECG WAVE, in which case a defibrillator
discharge will cause the simulator to automatically change to a normal sinus
rhythm at 60BPM. Once triggered by a discharge, the NSR60 simulation will
remain in effect for subsequent tests, until changed via the ECG softkey
described above.
DONE Press to return to the MANUAL TEST menu. AED measurement data in the
Clip Record are retained.

< Press to access additional softkey functions as shown in Figure 72, and as
described below.

< CANCEL
Figure 72 - Alternate softkeys of AED Test menu.

Operation/Chapter 4 # Page 93
Phase 3 OPERATING MANUAL

CANCEL Cancel the AED test and return to the MANUAL TEST menu. AED Test data
in the Clip Record will be deleted if you press YES in response to the
cancellation confirmation which will be displayed. All other data in the Clip
Record will be retained. For additional information on CANCEL, see Section
4.1.3.

= Press to restore softkey functions as shown in Figure 71.

4.8.2 Performing the AED Test

The primary purpose of the AED test is to determine whether an AED can analyze and correctly
classify an input ECG signal as shockable or not shockable. A second purpose of the test is to
record the energy of the discharge when the AED advises the user to administer a shock, and a
shock is then triggered. Phase 3 provides space in the Clip Record for up to 32 AED test
measurements, allowing you to record results for different ECG waveforms, AED shock series, and
AED energy levels.

In an AED test, the Phase 3 ECG simulator is limited to the waveforms listed in Table 4-1 of
Section 4.5.1.2. These ECG waveforms are classified according to AAMI guidelines1 as follows:

Phase 3 ECG Waveform Waveform Classification

AFIB1 Coarse Atrial Fibrillation Not shockable

AFIB2 Fine Atrial Fibrillation Not shockable

ASYS1 Asystole (baseline > 0.1 mV) Not shockable

ASYS2 Asystole - Flat Not shockable

SVTACH Supraventricular Tachycardia Not shockable

VTACH1 Ventricular Tachycardia @ 140BPM Not shockable

VTACH2 Ventricular Tachycardia @ 160BPM Shockable (depends on AED)

VTACH3 Ventricular Tachycardia @ 190BPM Shockable (depends on AED)

PVTACH Torsades de Pointes @ 200BPM Shockable (depends on AED)

VFIB1 Coarse Ventricular Fibrillation Shockable

VFIB2 Fine Ventricular Fibrillation Report only; do not classify as


shockable or not shockable

NSR60 Normal sinus rhythm at 60BPM Not shockable


1. Circulation 1997; V.95:1677-1682 AAMI

Operation/Chapter 4 # Page 94
Phase 3 OPERATING MANUAL

According the preceding table, an AED which operates according to AAMI guidelines1 for
sensitivity and specificity should advise a shock only if the ECG clearly indicates ventricular
fibrillation (> 100 ìV), or a wide complex ventricular tachycardia in excess of 150 BPM.

To perform the AED test:

a. Connect the AED to Phase 3 according to Section 3.1.

b. On the MANUAL TEST menu, press AED. The display of Figure 71 will appear.

c. Optionally, if you would like to change the ECG waveform, press ECG to modify the
settings of the ECG simulator. Refer to Section 4.5.1.2.

d. If necessary, press the "ANALYZE" or equivalent button on the AED, or set the AED
to automatically analyze and report on the ECG waveform.

e. If the AED analyzes the waveform and advises you not to shock, press the NO
SHOCK softkey on Phase 3. If this is the correct AED response given the type of
ECG waveform being simulated, Phase 3 will automatically assign a "PASS" to the test
result (Figure 73). The result of the test will be displayed for 3 seconds, a zero energy
result will be saved in the Clip Rec ord, and then the Phase 3 will go back to the screen
of Figure 71 . If the AED' s response is not correct for the selected ECG waveform,
Phase 3 will automatically assign a "FAIL" to the result.

AED PERFORMANCE TEST(01/32)


Test Results

ENERGY: ---.-J
ECG WAVE: AFIB1 (x1 Scale)
ECG TYPE: UNSHOCKABLE
***************** PASS *****************

Figure 73 - AED test result: correctly recognized unshockable ECG wave.

f. If the AED advises you 'to shock', discharge the AED into Phase 3. If this is the
correct response for the type of ECG waveform being simulated, Phase 3 will assign a
"PASS" to the test result (Figure 74). If AUTO-NSR is enabled, the ECG simulator
will output a normal sinus rhythm at 60BPM. The results of the test will be displayed
for 5 seconds, the energy result will be saved in the Clip Record, and then the system
will go back to the screen of Figure 71. If the AED' s response is not correct for the
selected ECG waveform, Phase 3 will assign a "FAIL" to the result.

Operation/Chapter 4 # Page 95
Phase 3 OPERATING MANUAL

AED PERFORMANCE TEST(02/32)


Test Results

ENERGY: 150.8J
ECG WAVE: VFIB1 (x1 Scale)
ECG TYPE: SHOCKABLE
***************** PASS *****************

Figure 74 - AED test result: correctly recognized shockable ECG wave.

g. If the AED advises a shock, but this conflicts with the ECG TYPE displayed on
Phase 3, discharge the AED into Phase 3 regardless. Phase 3 will automatically assign a
"FAIL" to this type of test result (Figure 75).

AED PERFORMANCE TEST(03/32)


Test Results

ENERGY: 149.6J
ECG WAVE: VTACH1 (x2 Scale)
ECG TYPE: UNSHOCKABLE
***************** FAIL *****************

Figure 75 - AED test result: incorrectly recognized unshockable ECG.

h. Repeat steps (c) to (g) as required until the desired number of AED tests have been
performed, up to a maximum of 32.

i. When all tests have been completed, press DONE (see Figure 71). AED test results
accumulated in the Clip Record are retained and may be supplemented with data from
additional ECG tests. However, additional defibrillator and pacemaker tests cannot be
done since the Clip Record now contains AED results (see Section 4.4.2). The Clip
Record contents must be saved to the non-volatile memory before new defibrillator
and/or pacemaker tests can be initiated.

Operation/Chapter 4 # Page 96
Phase 3 OPERATING MANUAL

4.9 Data Log

4.9.1 Viewing and Storing the Clip Record

As defibrillator, ECG and pacemaker tests are executed from the MANUAL TEST menu (see
Section 4.4), measurement data produced by these tests are accumulated in the Clip Record. The
alternate softkey set of the MANUAL TEST menu (Figure 76) provides means for viewing the
current contents of the Clip Record, or saving the Clip Record to a Test Record in the non-volatile
Data Log.

MANUAL TESTS

VIEW: View Clip Record Contents


STORE: Save Clip Record
I.D.: Enter defib ID / control number
CANCEL: Return to Main Menu

< VIEW STORE I.D. CANCEL


Figure 76 - Manual Test menu: alternate softkey set.

The softkey functions provided on the menu of Figure 76 are:

VIEW Press to view measurement data currently stored in the Clip Record. Phase 3 will
format the measurement data into a viewable TEST REPORT document, and will
place the TEST REPORT on the display. The display will then appear similar to the
example shown in Figure 77.

Phase 3 Defibrillator Analyzer


Datrend Systems Inc.

TEST REPORT
DATE: June 15 2006 TIME: 13:45:13
DEFIB ID: CN1234

Figure 77 - Viewing the contents of the Clip Record.

Operation/Chapter 4 # Page 97
Phase 3 OPERATING MANUAL

Press the ? > keys to scroll down/up through the TEST REPORT which is
shown on the display. Press any other key to exit the Clip Record viewer and return
to the MANUAL TEST menu.
STORE Press to copy the current contents of the Clip Record to a Test Record in the non-
volatile memory. If an ID for the defibrillator under test has not been entered when
STORE is pressed, you will be prompted to enter an ID per Section 4.4.1.
I.D. At any time during the manual test process, press I.D. to input identification
information, such as a control number, for the defibrillator or pacemaker under test.
Refer to Section 4.4.1.
CANCEL Cancel the manual test and return to the MAIN MENU. All measurement data in
the Clip Record will be deleted if you press YES in response to the cancellation
confirmation which will be displayed. For additional information on CANCEL, see
Section 4.1.3.

4.9.2 Recalling and Viewing Test Records

The non-volatile Data Log is accessed from the MAIN MENU of Phase 3 (see Section 4.3). The
display will appear as shown in Figure 78 when DATA LOG on the MAIN MENU is pressed. As
shown in the figure, the number of Test Records currently stored in the Data Log is indicated at the
top right corner. The VIEW and PRINT softkeys will not be visible unless a Clip Record has been
loaded into memory.

DATA LOG USED(07/80)

LOAD: Clip Record from storage memory


VIEW: Clip Record
PRINT: Clip Record
DELETE: Last Record in storage memory

LOAD VIEW PRINT DELETE >


Figure 78 - Data Log menu.

Operation/Chapter 4 # Page 98
Phase 3 OPERATING MANUAL

The softkey functions provided by the Data Log menu are:

LOAD Press to select a Test Record from the Data Log, and then load the Test Record
into the Clip Record for viewing or printing. Refer to Section 4.9.2.1.
VIEW Press to view the current contents of the Clip Record. This softkey will not be
visible until a Test Record has been loaded from the Data Log. Phase 3 will
format the measurement data into a TEST REPORT document, and will place the
TEST REPORT on the display. The display will then appear similar to the
example shown in Figure 77. Press the ? > keys to scroll down/up through the
TEST REPORT which is shown on the display. Press any other key to exit the
Clip Record viewer and return to the MANUAL TEST menu.
PRINT Press to print a TEST REPORT document via the Serial I/O Port of Phase 3.
Refer to Section 4.9.2.2. This softkey will not be visible until a Test Record has
been loaded from the Data Log.
DELETE Press to delete the last Test Record that was saved to the Data Log. A prompt
requiring you to confirm the deletion will be displayed if you press the DELETE
key.

< Press to access additional softkey functions as shown in Figure 79, and as
described below:

< DEL WAV DEL ALL CANCEL


Figure 79 - Alternate softkeys of Data Log menu.

DEL WAV Press to delete all Waveform Records in the Data Log. A prompt requiring you to
confirm the deletion will be displayed if you press the DEL WAV key.
DEL ALL Press to delete all Test Records and Wave Records currently stored in the Data
Log. A prompt requiring you to confirm the deletion will be displayed if you press
the DEL ALL key.
CANCEL Press to return to the MAIN MENU.

= Press to restore softkey functions as shown in Figure 78.

Operation/Chapter 4 # Page 99
Phase 3 OPERATING MANUAL

4.9.2.1 Selecting a Test Record

Press the LOAD softkey on the DATA LOG menu to enter a menu for selecting a Test Record for
viewing or printing (Figure 80). Press the ? > keys to scroll down/up through the list of Test
Records one record at a time. The Test Records are displayed on the screen with the most recent
test first. Other softkey functions provided on this menu are:

DATA LOG USED(07/80)


Select Test Record From List
No. DATE TIME DEFIB ID >
__007 Jun 12 14:55 CN3412_______________
006 Jun 12 14:02 CN3418
005 Jun 10 11:38 CN0115 ?
004 Jun 08 08:47 CN4437
PAGE DN PAGE UP SELECT CANCEL
Figure 80 - Selecting a Test Record from the Data Log.

PAGE DN Press to move the displayed list down by four Test Records.

PAGE UP Press to move the displayed list up by four Test Records.

SELECT Press to select the Test Record highlighted at the top of the list. The Test Record
will be loaded into the Clip Record, and can then be viewed or printed
respectively via VIEW or PRINT softkeys on the DATA LOG menu.
CANCEL Do not select a Test Record; return to the DATA LOG menu.

4.9.2.2 Printing a Test Record

Phase 3 can transmit a TEST REPORT document from its DB9 Serial I/O Port to receiving
devices having a RS-232 serial port, such as a serial printer or a personal computer. Before
attempting to print, connect the receiving device to the Serial I/O Port of Phase 3 according to the
instructions in Section 3.2.3. Note the serial protocol of Phase 3 is 9600 baud, No parity, 8 data bits,
1 stop bit (9600, N, 8, 1).

Operation/Chapter 4 # Page 100


Phase 3 OPERATING MANUAL

After loading a Test Record from the Data Log, press the PRINT softkey on the DATA LOG
menu to print the TEST REPORT document. The TEST REPORT is 40 characters wide and will
comprise a variable number of lines, depending on what tests were performed. While the document
is being printed, the Phase 3 display will appear as shown in Figure 81.

Printing Report...

CANCEL: Abort printout

CANCEL
Figure 81 - Test Report printout in progress.

CANCEL may be pressed to abort the printout in progress. When the printout is completed, the
display will automatically return to the DATA LOG menu.

If Phase 3 detects that the receiving device is off-line, an alarm message will be shown (Figure 82).
Correct the problem with the receiving device, then press OK. The display will return to the DATA
LOG menu, from which a new printout can be initiated via the PRINT softkey.

PRINTER ERROR

Printer offline. Check printer


connection and power, then retry.

OK
Figure 82 - Off-line error during printout.

Operation/Chapter 4 # Page 101


Phase 3 OPERATING MANUAL

4.10 Automated Testing

4.10.1 AutoSequence Overview

For fully automated testing, Phase 3 provides 32 AutoSequences which may be user-programmed
by means of the accessory Phase3pc software (included on the CD ROM supplied with your
Phase 3). An AutoSequence test may include steps for measuring defibrillator energy, charge time,
and synchronization delay; ECG performance; and pacemaker pulse characteristics, noise immunity,
sensitivity, and refractory periods. Phase 3 comes equipped with pre-programmed AutoSequences
loaded into its non-volatile memory, which are provided as examples, and should be modified or
supplemented to meet the users needs via Phase3pc software.

For each test or measurement performed in an AutoSequence, the expected value of the result or
target is specified, so that Phase 3 will automatically pass or fail the result depending on an
acceptance range derived from the target and a selected tolerance.

There are two basic types of AutoSequence provided by Phase 3: Defib/Pacer and AED. In a
Defib/Pacer AutoSequence, the order of test execution is:

• Defib Energy
• Defib Charge Time
• Defib Cardioversion (Sync)
• ECG Tests
• Pacer Pulse
• Pacer Noise Immunity
• Pacer Sensitivity
• Pacer Refractory

In an AED AutoSequence, the only type of test that can be performed is the "shock/no shock"
energy test (see Section 4.8). Charge time, cardioversion, and pacemaker tests cannot be performed
if the "DUT Type" of the AutoSequence has been set, via Phase3pc software, to "AED".

When an AutoSequence is selected from the AutoSequence menu of Phase 3, the Clip Record is
erased. As each step of the AutoSequence is completed, the measurement data is accumulated in the
Clip Record. At the end of the AutoSequence, you will be prompted to enter an ID for the
defibrillator under test (DUT), after which a Test Record containing the results will then be saved to
the non-volatile Data Log.

Operation/Chapter 4 # Page 102


Phase 3 OPERATING MANUAL

4.10.2 Selecting an AutoSequence

Press the AUTO softkey on the Phase 3 MAIN MENU (Section 4.3) to enter a menu for selecting
an AutoSequence (Figure 83). Press the ? > keys to scroll down/up through the list of
AutoSequences one sequence at a time.

AUTOSEQUENCE TESTS
---------- SELECT TEST ----------
Test# Title >
>001 HP CODEMASTER
002 LAERDAL 2000
003 MARQUETTE 1500 ?
004 PHYSIO LP9
PAGE DN PAGE UP SELECT CANCEL
Figure 83 - Selecting an AutoSequence.

Other softkey functions provided on this menu are:

PAGE DN Press to move the displayed list down by four AutoSequences.

PAGE UP Press to move the displayed list up by four AutoSequences.

SELECT Press to select the AutoSequence indicated by the > cursor. The Clip Record will
be erased, then the AutoSequence will begin execution.
CANCEL Do not select an AutoSequence; return to the MAIN MENU.

NOTE:
If the Test Record portion of the Data Log is full when the AUTO softkey on the MAIN
MENU is pressed, an error message is displayed (Figure 84).

The Data Log must not be full when attempting to run an AutoSequence. Pressing
OK on the display of Figure 84 will return Phase 3 to the MAIN MENU. The Data Log
contents may then be downloaded and saved via Phase3pc software (see Chapter
6). After downloading, the Data Log may be partially or completely erased via the
DATA LOG menu (see Section 4.9).

Operation/Chapter 4 # Page 103


Phase 3 OPERATING MANUAL

TEST RECORD MEMORY FULL

Cannot save test results as the non-


volatile memory is full. Delete
existing tests from memory before
attempting to run an autosequence.

OK
Figure 84 - AutoSequence execution prevented due to full Data Log.

4.10.3 Running a Defib/Pacer AutoSequence

4.10.3.1 Automated Defibrillator Tests

When running an AutoSequence for a defib/pacer, Phase 3 will display test setup instructions for
each step of the sequence, similar to the example of Figure 85 for a defibrillator energy test. The
type of test being performed at any step in the sequence is indicated at the top left of the display
(DEFIB ENERGY in the example of Figure 85). The test count (01) and number of tests to be
performed in the sequence (in this example, 07) are shown at top right.

Any Phase 3 Autosequence can be programmed by the user to have an automatic timeout/advance
feature. At each test step, the Auto-Test Timer of Phase 3 will move the sequence forward from
the user prompt to the measurement automatically, provided there is no operator input before a
user-set delay time expires. After each measurement is completed, the Auto-Test Timer causes the
user prompt for the next step of the sequence to be displayed. The Auto-Test Timer of a
Autosequence may be set to "OFF", or it may be programmed for a 3, 5 or 9-second delay by means
of the Phase3pc software. For example, Figure 85 shows the first energy test of an Autosequence
for which the Auto-Test Timer has been enabled with a delay of 5 seconds. The operator may press
TEST to run the indicated test, or the user can wait for the Auto-Test Timer to count down to zero
at which point the energy measurement screen, Figure 86, will be displayed automatically.

Operation/Chapter 4 # Page 104


Phase 3 OPERATING MANUAL

DEFIB ENERGY (01/07)

SET DEFIB ENERGY TO: 10.0 JOULES

Test will begin in 5 seconds...


TEST SKIP BACK ABORT
Figure 85 - AutoSequence example: first defib energy test of seven.

During AutoSequence execution, the softkeys provide these functions:

TEST Press this softkey after setting the DUT as instructed, and proceed with the test
measurement indicated at top left on the display.
SKIP Press to skip the test indicated on the display and increment Phase 3 to the next step
of the sequence. Pressing this softkey will not affect any data stored in the Clip
Record for the step number indicated at the top right corner of the display.
BACK Press to make Phase 3 go back to the immediately previous step of the sequence.
Pressing this softkey will not affect any data stored in the Clip Record for the step
number indicated at the top right corner of the display.
ABORT Press to abort the sequence in progress. A prompt will be displayed asking you to
confirm the abort. Pressing YES in response to this prompt will abort the sequence
and return Phase 3 to the MAIN MENU.

If TEST of Figure 85 is pressed, Phase 3 will then display a screen corresponding to the type of
measurement which is to be performed. For the case of a defib energy test, the display will appear
similar to the example of Figure 86. On this display, the BACK softkey may be pressed to restore
the instruction screen shown in Figure 85.

DEFIB ENERGY TEST(01/07)


WAITING FOR DISCHARGE
ENERGY: ---.-J TARGET: 10.0J TOL: 10%
PEAK I: --.--A PEAK V: ---- V RNG: LO
WIDTH @10%: --.-- msec @50%: --.-- msec
ECG Wave: VFIB1 (x1 scale)

BACK
Figure 86 - Energy Test display during an AutoSequence.

Operation/Chapter 4 # Page 105


Phase 3 OPERATING MANUAL

When a defibrillator discharge is detected, Phase 3 will calculate and display the results, including a
pass/fail assessment which is based on the target and tolerance which have been defined for this
step of the sequence. If the Auto-Test Timer is enabled, wait for approximately 4 seconds for
Phase 3 to automatically save the results and then advance to the next test step. The softkeys will be
blanked if the Auto-Test Timer is enabled.

If the Auto-Test Timer is disabled, Phase 3 will then provide the softkeys shown in Figure 87.
Press OK to save the displayed result to the Clip Record and advance the sequence to the next step.
Refer to Section 4.5.1.4 for a description of the other softkey functions appearing on the display of
Figure 87.

DEFIB ENERGY TEST(01/07)

ENERGY: 9.7J TARGET: 10.0J TOL: 10%


PEAK I: 6.31A PEAK V: 316 V RNG: LO
WIDTH @10%: 15.13 msec @50%: 7.84 msec
ECG Wave: VFIB1 (x1 scale)
***************** PASS *****************
OK SHOW WAVE SAVE WAV PLAYBACK
Figure 87 - Defib energy result during an AutoSequence.

For charge time and cardioversion tests, instructions similar to Figure 85 are shown immediately
prior to each test step. The appearance of the display following acknowledgement of the instructions
will then be similar to the displays shown for manual charge time and cardioversion tests (see
Sections 4.5.2 and 4.5.3 respectively). After the defibrillator discharge, the results are displayed and
the softkeys will appear as shown in Figure 87.

Charge Time and Cardioversion (SYNC) tests operate in a similar manner, subject to the
descriptions in sections 4.5.2 and 4.5.3 respectively.

Operation/Chapter 4 # Page 106


Phase 3 OPERATING MANUAL

4.10.3.2 Automated ECG Tests

If the AutoSequence includes ECG tests, then this part of the sequence will be preceded by the
instruction display shown in Figure 88. If the Auto-Test Timer has been enabled, the delay
countdown will appear on the LCD per Figure 88.

ECG TEST

CONNECT Phase 3 ECG SIMULATOR SIGNALS


TO ECG MONITOR OF DEFIB

Test will begin in 5 seconds...


TEST SKIP BACK ABORT
Figure 88 - AutoSequence incorporating ECG tests.

The softkey functions provided by this menu are:

TEST Press this softkey to proceed with the ECG tests.

SKIP Press this softkey to skip over ALL ECG tests that have been specified in the
AutoSequence. If pacemaker tests have been enabled, the next display that will be
shown will be instructions for the pacer tests.
BACK Press this softkey to decrement the sequencer to the immediately previous defib test
(cardioversion, charge time, or energy - depending on what has been enabled in the
AutoSequence) and show the instruction screen appropriate for that measurement.
ABORT Press to abort the sequence in progress. A prompt will be displayed asking you to
confirm the abort. Pressing YES in response to this prompt will abort the sequence
and return Phase 3 to the MAIN MENU.

If TEST of Figure 88 is pressed, Phase 3 will then set the ECG simulator to the first waveform
which has been specified in the sequence (Figure 89). The operator must press one of the softkeys
to proceed, the auto-timer has no effect in this screen. The softkeys shown in the figure will then
operate as follows:

Operation/Chapter 4 # Page 107


Phase 3 OPERATING MANUAL

ECG TEST TEST(01/08)

WAVE BANK: Performance


WAVEFORM: DC Pulse, 4 sec
(PULSE)
Relative SCALE: x1 (1.0mV QRS Lead II)

PASS FAIL BACK


Figure 89 - AutoSequence ECG test.

PASS Record a "PASS" in the Clip Record as the result for the displayed waveform, and
increment the sequence to the next ECG waveform, or alternatively to the first of
the pacer measurements if the current ECG waveform is the last waveform in the
sequence.
FAIL Record a "FAIL" in the Clip Record as the result, and increment the sequence to the
next ECG waveform.
BACK Return the sequence to the screen of Figure 88. Current contents of the Clip
Record are not affected.

Operation/Chapter 4 # Page 108


Phase 3 OPERATING MANUAL

4.10.3.3 Automated Pacemaker Tests

If the AutoSequence includes pacemaker pulse tests, then this part of the sequence will be preceded
by an instruction display which will be similar to the example shown in Figure 90. As indicated in
the figure, the pacer test load which has been specified in the AutoSequence setup is indicated on
the top line of the display. Softkeys appearing on the display of Figure 90 provide the same
functions as described previously for defibrillator energy tests (see Section 4.10.3.1). The Auto-Test
Timer, if enabled, will not appear on the display of Figure 90 , but the timer will cause the sequence
to automatically advance to the next measurement after a 4-second delay once the pacer pulse test
has been stopped.

PACER PULSE 1000 ohms (01/06)

SET PACING MODE TO: ASYNCHRONOUS


SET PACER OUTPUT TO: 200 mA
SET PACER RATE TO: 60 PPM

Activate Pacer and press "TEST"


TEST SKIP BACK ABORT
Figure 90 - AutoSequence example: first pacer pulse test of six.

Press TEST after the pacemaker has been set up as instructed on the display of Figure 90. The
display will then appear as shown in Figure 91 below. The test will begin immediately after the
TEST key is pressed. Press BACK to review the instructions of Figure 90, or alternatively press
STOP to halt the measurement.

PACER PULSE 1000 ohms TEST(01/06)


Measuring pacer pulse properties
AMPL: ---.-mA TARGET: 200 TOL: 10%
WIDTH: --.--msec TARGET: --- TOL: --%
RATE: --.-PPM TARGET: 60 TOL: 10%
Method: Average

STOP BACK
Figure 91 - Start of pacer pulse test during an AutoSequence.

Operation/Chapter 4 # Page 109


Phase 3 OPERATING MANUAL

When STOP is pressed, the measurement will be halted and the results displayed in a manner
similar to the example shown in Figure 92. If the Auto-Test Timer is enabled, wait approximately 4
seconds for Phase 3 to automatically save the results and advance to the next test step. The softkeys
will all be blanked if the Auto-Test Timer is enabled. If the Auto-Test Timer is disabled, press the
OK softkey to save the data to the Clip Record and advance Phase 3 to the next step of the
sequence.

PACER PULSE 1000 ohms TEST(01/06)


Pacer Results
AMPL: 204.1mA TARGET: 200 TOL: 10%
WIDTH: 20.49msec TARGET: --- TOL: --%
RATE: 59.9PPM TARGET: 60 TOL: 10%
Method: Average
***************** PASS *****************
OK
Figure 92 - Pacemaker pulse result during an AutoSequence.

Instructional displays for pacer noise immunity, sensitivity and refractory tests will appear similar to
the screen of Figure 93. The softkeys on this display operate as previously described for the pacer
pulse test.

PACER REFRACTORY 1000 ohms (01/01)

SET PACING MODE TO: DEMAND


SET PACER OUTPUT TO: 1/2 MAXIMUM
SET PACER RATE TO: APPROX 90 PPM

Activate Pacer and press "TEST"


TEST SKIP BACK ABORT
Figure 93 - AutoSequence example: pacer refractory test.

The pacer test procedure will be performed and the results displayed in a manner similar to the case
of a manual test performed with targets (see Figure 94). Note that noise immunity, sensitivity, and
refractory tests will each require some time to complete, ranging from about 10 seconds to 60
seconds, depending on the test and the rate setting of the pacemaker. When the test is complete and
the result is displayed, press the OK softkey to save the data to the Clip Record and advance
Phase 3 to the next step of the sequence, or wait for an automatic save if the Auto-Test Timer is
enabled. If the Auto-Test Timer is enabled, the softkeys will be blanked when the measurement is
completed.

Operation/Chapter 4 # Page 110


Phase 3 OPERATING MANUAL

PACER REFRACTORY 1000 ohms TEST(01/01)

REFRACTORY MIN: +100msec MAX: +250msec


REFRACTORY PRP: +231msec SRP: +115msec
ECG WAVE: TRIP40 (x1 Scale)
PACER RATE: 90 PPM
***************** PASS *****************
OK
Figure 94 - Pacemaker refractory result during an AutoSequence.

4.10.4 Running an AED AutoSequence

When running an AutoSequence for an AED, Phase 3 will operate similarly as described in
Section 4.8 for a manual AED test. The primary difference between a manual AED test and an
AutoSequence AED test is that the ECG waveforms are defined in the setup of an AED
AutoSequence. The Auto-Test Timer cannot be enabled in AED Autosequences.

As in the manual mode, the ECG waveform may be set to revert to NSR60 after a discharge has
been detected. This setting may be toggled using the AUTO-NSR key. After the test result has
been accepted with the OK key, the ECG waveform will change to the setting dictated by the next
step in the AutoSequence.

Upon selecting an AED AutoSequence, the display of Phase 3 will appear as shown in Figure 95.
The softkeys will then assume the following functions:

AED PERFORMANCE TEST(01/09)


Trigger Shock or press NO SHOCK to
conclude each test.
ENERGY: ---.-J
ECG WAVE: VTACH2 (x1 Scale)
ECG TYPE: SHOCKABLE

NO SHOCK AUTO-NSR BACK ABORT


Figure 95 - AutoSequence AED test.

Operation/Chapter 4 # Page 111


Phase 3 OPERATING MANUAL

NO SHOCK Press this softkey if the AED audibly and/or visually advises the user that the
AED cannot or should not be discharged. For further details, see Section 4.8.
AUTO-NSR Press this softkey to toggle between changing to NSR60 after a discharge is
detected, and, retaining the current ECG WAVE after a discharge is detected.
The ECG WAVE will change to the next waveform in the sequence when the
results are accepted with the OK key.
BACK Press this softkey to decrement the sequencer to the immediately previous AED
test step.
ABORT Press to abort the sequence in progress. A prompt will be displayed asking you
to confirm the abort. Pressing YES in response to this prompt will abort the
sequence and return Phase 3 to the MAIN MENU.

If NO SHOCK is pressed, or if a discharge is detected, Phase 3 will automatically assess the result
as shown in the example display of Figure 96. When the result is displayed, press OK to save the
result to the Clip Record and advance to the next step of the sequence.

AED PERFORMANCE TEST(01/09)


Test Results

ENERGY: 150.8J
ECG WAVE: VTACH2 (x1 Scale)
ECG TYPE: SHOCKABLE
***************** PASS *****************
OK
Figure 96 - AED test result during an AutoSequence.

If the AED has delivered a shock, and if the AED has been configured to automatically execute a
"shock series", you should press the OK key before the AED announces that the ECG is being
analyzed. For a shockable ECG waveform, enabling the AUTO-NSR feature of Phase 3 before
activating the "ANALYZE" function on the AED should inhibit the AED's "shock series" after the
first discharge, in which case you will then have more time to respond to the test result with the OK
key. Alternatively, when a shock is delivered be prepared to press OK as soon as the energy result is
displayed; this will depend on the particular shock protocol developed by the manufacturer of the
AED.

Operation/Chapter 4 # Page 112


Phase 3 OPERATING MANUAL

4.10.5 AutoSequence Conclusion

After all measurements in the AutoSequence have been completed, the operator will be prompted to
save the results to a Test Record via the menus of Figure 97, Figure 98.

SAVE RECORD

SAVE TEST RECORD, OR PRESS 'BACK'


TO RETURN TO TESTING

NOTE: 'SAVE' will require you to


enter an I.D. for the DUT.
SAVE BACK ABORT
Figure 97 - Prompt displayed at end of AutoSequence.

Softkeys on this menu provide the following functions:

SAVE Press to save the measurement data acquired during the AutoSequence to a Test
Record in the non-volatile Data Log. You will be prompted to enter an ID
(e.g. control number) for the defibrillator under test. Refer to Section 4.4.1 for
instructions regarding ID entry.
BACK Press this softkey to return Phase 3 to the last test performed in the AutoSequence.

ABORT Press to abort the sequence and discard all data acquired. A prompt will be displayed
asking you to confirm the abort. Pressing YES in response to this prompt will abort
the sequence and return Phase 3 to the MAIN MENU.

After the results have been saved, the screen of Figure 99 will be displayed. Press OK to exit the
AutoSequence.
AUTOSEQUENCE TEST RESULTS SAVED

Test results have been saved into non-


volatile memory at:
Record xx/80

Press OK to continue.
OK
Figure 98 - Prompt displayed at end of AutoSequence.

Operation/Chapter 4 # Page 113


Phase 3 OPERATING MANUAL

4.11 Self-Test Error Messages

When Phase 3 is powered up, it will conduct a self-test as described in Section 4.2. Normally the
self-test will pass, allowing the user to access the MAIN MENU of Phase 3.

Failures encountered during the self-test are reported via the display, accompanied by an alarm tone.
Critical failures will prevent further operation of the instrument. For non-critical self-test failures,
Phase 3 will report the fault but will remain operable after the alarm is acknowledged by the user.

4.11.1 Critical Self-Test Failures

CALIBRATION ERROR The factory calibration parameters stored in the instrument's


non-volatile memory (EEPROM) have been corrupted. The
instrument should be returned to an authorized service facility
for re-calibration. Refer to Chapter 7 of this manual.
HARDWARE FAILURE The internal analog-to-digital converter has failed its auto-zero
calibration cycle. The instrument should be returned to an
authorized service facility for repairs. Refer to Chapter 7 of this
manual.
BATTERY DISCHARGED Phase 3 is being operated from the internal NiCad battery, but
the battery is close to full discharge. In this case, the instrument
will automatically shut itself off if left on for more than a few
seconds. Switch off the power to Phase 3 immediately, connect
the AC adapter, and then power up. Phase 3 may be operated
while the battery is being recharged.

Operation/Chapter 4 # Page 114


Phase 3 OPERATING MANUAL

4.11.2 Non-Critical Self-Test Failures

BATTERY LOW WARNING Phase 3 is being operated from the internal NiCad battery, but
the battery has less than 20 minutes of usage remaining, before
Phase 3 will automatically shut itself off. The AC adapter
should be connected to Phase 3 as soon as possible. Phase 3
may be operated while the battery is being recharged.
CLOCK WARNING The time/date setting of the internal real-time clock was found
to be invalid. After this alarm is acknowledged, the user will be
prompted to set the clock. This self-test alarm may indicate the
lithium battery which powers the clock should be replaced. The
clock backup battery is not a user-serviceable item. Refer to
Chapter 7 of this manual.

Operation/Chapter 4 # Page 115


Phase 3 OPERATING MANUAL

Operation/Chapter 4 # Page 116


Phase 3 OPERATING MANUAL

5 REMOTE CONTROL

5.1 General Description

The Serial I/O Port provides a RS-232 interface for controlling Phase 3 remotely using an external
device such as a personal computer or automated test system. Phase 3 will recognize a predefined
set of commands issued to its Serial I/O Port allowing the external device to start a test, stop a test,
or retrieve test results automatically.

Remote commands allow the creation of simple programs on a personal computer that will
automatically perform and document a defibrillator and/or pacemaker test according to a desired
protocol. The command set is also compatible with automated test instrumentation, such as the
ES601Plus Automated Safety Analyzer. Refer to the Operating Manual for your automated test
instrument, especially with regard to port settings, cable wiring, data transmission format and data
packet length. Note the serial protocol of Phase 3 is 9600 Baud, 8 Data Bits, No Parity, 1 Stop Bit
(9600, N, 8, 1).

The following sections present the remote control command set of Phase 3. When using these
commands, it is assumed the user has connected the DUT to Phase 3 prior to enabling the
controlling device, and the controlling device is connected to Phase 3 using the appropriate interface
cable as described in Section 3.2.3. If using a program on a personal computer to command Phase 3,
allow a delay of at least 100 milliseconds between consecutive remote commands to provide enough
time for Phase 3 to process and respond to each received command.

Remote Control/Chapter 5 # Page 117


Phase 3 OPERATING MANUAL

5.2 Remote Interface Mode

In order for Phase 3 to respond to remote control commands, it must first be placed in Remote Mode.
Phase 3 will ignore all commands sent unless the instrument is running the Remote Mode interface.

To enter Remote Mode, press the REMOTE softkey on the MAIN MENU of Phase 3. The display
will then appear as shown in Figure 99. Commands received via the Serial I/O Port are displayed
on the LCD, as are the data which are returned in response to the commands. Phase 3 also displays
a counter which increments each time a valid command is received and processed. Between
commands, CANCEL may be pressed to exit Remote Mode to the MAIN MENU of Phase 3.

REMOTE MODE MENU

STATUS: Waiting PORT: RS232


COMMAND: COUNT: 1

CANCEL
Figure 99 - Remote Mode menu.

5.3 Command Set

There are 16 commands in the remote control command set of Phase 3. Each command consists of
a string of upper-case ASCII characters and numerals, terminated by a carriage return character
(<CR> or \r).

If Phase 3 receives a valid RS-232 command, it will execute the command, and return either an
asterisk character followed by a carriage return (*<CR>) or a packet of data back to the controlling
device depending on the type of command issued. With many of the measurement-related
commands, a substantial amount of time may elapse before any data, for example energy test results,
are returned to the controlling device.

If a command is syntactically incorrect, or is not recognized by Phase 3, a question mark character


followed by a carriage return (?<CR>) is transmitted back to the controlling device.

Remote Control/Chapter 5 # Page 118


Phase 3 OPERATING MANUAL

5.3.1 ECG Configuration Command

Description: The ECG configuration command sets the waveform, amplitude scale and discharge
response mode of the ECG simulator. Typically, this command would be sent prior
to other commands which invoke defibrillator or pacemaker measurements.

Syntax: ECG<code><scale><mode><CR>

where: <code> is a two letter code designating the Wave Bank and Waveform of
the simulator. See table below for the Bank and Waveform letter codes.

<scale> is: 0 - for ECG simulator OFF


1 - for x1 amplitude scale
2 - for x2 amplitude scale
3 - for x0.5 amplitude scale

<mode> is: 0 - to disable response to defib discharge


1 - revert to NSR60 on detection of defib discharge
2 - play back the discharge waveform at the set playback time
(4 or 12 sec), but do not change ECG waveform
3 - play back the discharge waveform at the set playback time
(4 or 12 sec) and then revert to NSR60

Example: "ECGDJ10\r" Select Coarse VFIB simulation, x1 scale (waveform code DJ


is from the table below)

Returns: (1) "*\r" Acknowledge; ECG simulator has been set


(2) "?\r" Syntax error/invalid command

Notes: To stop the simulation corresponding to waveform codes AF-AL, press the STOP
softkey which will be displayed once the simulation has been started, or alternatively
transmit an ASCII <Escape> character (0x1B) to Phase 3 via the communications
connection to abort the simulation and permit Phase 3 to receive and process
subsequent commands.

Remote Control/Chapter 5 # Page 119


Phase 3 OPERATING MANUAL

Wave Bank Waveform ECG Wave Code

DC Pulse, 4sec AA

Square Wave, 2 Hz AB

Triangle, 2 Hz AC

Sinewave, 0.1 Hz AD

Sinewave, 0.5 Hz AE

Sinewave, 10 Hz AF

Sinewave, 20 Hz AG

Sinewave, 40 Hz AH

Sinewave, 50 Hz AI

Sinewave, 60 Hz AJ

Sinewave, 70 Hz AK

Sinewave, 100 Hz AL

ECG NSR, 30 BPM BA

ECG NSR, 60 BPM BB

ECG NSR, 90 BPM BC

ECG NSR, 120 BPM BD


Sinus Rhythm
ECG NSR, 150 BPM BE

ECG NSR, 180 BPM BF

ECG NSR, 240 BPM BG

ECG NSR, 300 BPM BH

2nd deg. AV-Block CA

Premature Atrial Contraction CB

Right Bundle Branch Block CC

Premature Ventricular Contraction CD

Arrhythmia R-on-T PVC CE

Multifocal PVC CF

Run of 5 PVC CG

Bigeminy CH

Trigeminy CI

Remote Control/Chapter 5 # Page 120


Phase 3 OPERATING MANUAL

Wave Bank Waveform ECG Wave Code

Coarse Atrial Fibrillation DA

Fine Atrial Fibrillation DB

Asystole (noise) DC

Asystole (flatline) DD

SupraVent. Tachycardia DE
Shock Advisory/AED
Ventricular Tachycardia, 140BPM DF

Ventricular Tachycardia, 160BPM DG

Ventricular Tachycardia, 190BPM DH

Torsades de Pointes, 200BPM DI

Coarse VFIB DJ

Fine VFIB DK

10msec / 60BPM EA

25msec / 60BPM EB

Square Pacer Trigger 40msec / 60BPM EC

100msec / 60BPM ED

200msec / 60BPM EE

10msec / 60BPM FA

25msec / 60BPM FB

Triangle Pacer Trigger 40msec / 60BPM FC

100msec / 60BPM FD

200msec / 60BPM FE

10msec / 60BPM GA

25msec / 60BPM GB

Haversine Pacer Trig. 40msec / 60BPM GC

100msec / 60BPM GD

200msec / 60BPM GE

OFF Turn ECG waveform OFF (0 VDC) AX

Remote Control/Chapter 5 # Page 121


Phase 3 OPERATING MANUAL

5.3.2 Defib Energy Command

Description: The defib energy command configures Phase 3 to perform an energy test. Phase 3
will return data in one of two possible formats after a discharge is acquired. See
Section 4.5.1 for further information on the defib energy test.

Syntax: DE<range><return_data_format><CR>

where: <range> is: H - for High Range


L - for Low Range

<return_data_format> is:
C - for comma-separated variables (CSV) format
T - for "text" format

Example: "DEHT\r"

Run defib energy test; high range; return data in text format.

Returns: (1) For CSV formatted data:


"<energy>,<peak_volts>,<peak_amps>,<width_10><width_50>\r"

where: <energy> is delivered energy, format "xxx.yJ"


<peak_volts> is peak voltage, format "xxxxV"
<peak_amps> is peak current, format "xx.yyA"
<width_10> is 10% pulse width, format "xx.yyms"
<width_50> is 50% pulse width, format "xx.yyms"

(2) For "text" format data:


"ENERGY=<energy>\r"

where: <energy> is delivered energy, format "xxx.yJ"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before a defibrillator discharge is
measured.

Notes: Energy value will be returned as "XXX.XJ" if the measurement is performed on


LOW range, and signal distortion (clipping) is detected in the acquired waveform
data. Repeat test using HIGH range. See Section 4.5.1.4.

Remote Control/Chapter 5 # Page 122


Phase 3 OPERATING MANUAL

5.3.3 Defib Charge Time Command

Description: The defib charge time command configures Phase 3 to perform a charge time test.
Receipt of this command will initiate the 5-second countdown timer shown on the
display. Phase 3 will return data in one two possible formats, after a discharge is
acquired. See Section 4.5.2 for further information on the defib charge time test.

Syntax: DCH<return_data_format><CR>

where: <return_data_format> is:


C - for comma-separated variables (CSV) format
T - for "text" format

Example: "DCHC\r"

Run defib charge time test; return data in CSV format.

Returns: (1) For CSV formatted data:


"<energy>,<charge_time>\r"

where: <energy> is delivered energy, format "xxx.yJ"


<charge_time> is the charge time, format "xx.ysec"

(2) For "text" format data:


"ENERGY=<energy> CHARGE=<charge_time>\r"

where: <energy> is delivered energy, format "xxx.yJ"


<charge_time> is the charge time, format "xx.ysec"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before a charge time is measured.

Notes: Charge Time measurements are normally preceded by one or more discharges of the
defibrillator with the AC power disconnected. This portion of the test must be
simulated in the remote mode by performing regular energy discharges. The
programmer must keep track of the number of pre-test discharges performed.

Remote Control/Chapter 5 # Page 123


Phase 3 OPERATING MANUAL

5.3.4 Defib Sync (Cardioversion) Command

Description: The defib sync command configures Phase 3 to perform a discharge sync/
cardioversion test. Phase 3 will return data in one of two possible formats after a
discharge is acquired. See Section 4.5.3 for further information on the defib
cardioversion test. If the current ECG WAVE setting is not appropriate for this
test, the ECG WAVE will be set to AFIB x1 automatically.

Syntax: DS<range><sync><return_data_format><CR>

where: <range> is: H - for High Range


L - for Low Range

<sync> is: Q - for Q-wave sync timing reference


R - for R-wave sync timing reference

<return_data_format> is:
C - for comma-separated variables (CSV) format
T - for "text" format

Example: "DSHQT\r"

Run defib sync test; high range; Q-wave sync; return data in "text" format

Returns: (1) For CSV formatted data:


"<energy>,<delay_time>\r"

where: <energy> is delivered energy, format "xxx.yJ"


<delay_time> is the sync delay time, format "xxxxmsec"
("----msec" if no sync)

(2) For "text" format data:


"ENERGY=<energy> CHARGE=<charge_time>\r"

where: <energy> is delivered energy, format "xxx.yJ"


<charge_time> is the charge time, format "xx.ysec"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before a defibrillator discharge is
measured.

Remote Control/Chapter 5 # Page 124


Phase 3 OPERATING MANUAL

Notes: Energy will be returned as "XXX.XJ" if the measurement is performed on LOW


range, and signal distortion (clipping) is detected in the acquired waveform data.
Repeat test using HIGH range. See Section 4.5.1.4.

5.3.5 Pacer Load Select Command

Description: The pacer load select command sets the load resistor for pacemaker tests. Typically,
this command would be sent prior to other commands which invoke pacemaker
measurements.

Syntax: PLD<code><CR>

where: <code> is a single-letter code designating the load resistor. See table below
for the resistor letter codes.

Example: "PLDd\r"

Select 1500 ohm pacer load

Returns: (1) "*\r" Acknowledge; pacer load has been set


(2) "?\r" Syntax error/invalid command

Pacer Letter Pacer Letter Pacer Letter Pacer Letter


Load Code Load Code Load Code Load Code

50Ù A 450Ù I 850Ù Q 1250Ù Y

100Ù B 500Ù J 900Ù R 1300Ù Z

150Ù C 550Ù K 950Ù S 1350Ù a

200Ù D 600Ù L 1000Ù T 1400Ù b

250Ù E 650Ù M 1050Ù U 1450Ù c

300Ù F 700Ù N 1100Ù V 1500Ù d

350Ù G 750Ù O 1150Ù W 1550Ù e

400Ù H 800Ù P 1200Ù X 1600Ù f

Remote Control/Chapter 5 # Page 125


Phase 3 OPERATING MANUAL

5.3.6 Pacer Pulse Command

Description: The pacer pulse command configures Phase 3 to perform a pacer pulse test. Phase 3
will return data in one of two possible formats after at least two consecutive pacer
pulses have been acquired. See Section 4.7.2 for further information on the pacer
pulse test.

Syntax: PP<method><return_data_format><CR>

where: <method> is: A - for average


L - for leading edge
T - for trailing edge
P - for peak value

<return_data_format> is:
C - for comma-separated variables (CSV) format
T - for "text" format

Example: "PPLC\r" Run pacer pulse test; leading edge method; return data in
CSV format.

Returns: (1) For CSV formatted data:


"<current>,<width>,<rate>\r"

where: <current> is pacer pulse current, format "xxx.ymA"


<width> is pacer pulse width, format "xx.yymsec"
<rate> is pacer pulse rate, format "xxx.yPPM"

(2) For "text" format data:


"PULSE=<current> RATE=<rate>\r"

where: <current> is pacer pulse current, format "xxx.ymA"


<rate> is pacer pulse rate, format "xxx.yPPM"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before a pacer pulse is measured.

(5) "PACE TIMEOUT\r" if a pacer pulse is not detected within 3 seconds of


receiving the command.

Remote Control/Chapter 5 # Page 126


Phase 3 OPERATING MANUAL

5.3.7 Pacer Refractory Command

Description: The pacer refractory command configures Phase 3 to determine both paced and
sensed refractory intervals (PRP and SRP). Phase 3 will return data in one of two
possible formats, after both the PRP and SRP have been measured; this will require
about 40 seconds at a pacer rate of 90 PPM. See Section 4.7.3 for further
information on the pacer refractory test. If the current ECG WAVE setting is not
appropriate for this test, the ECG WAVE will be set to TRIP40 x2 automatically.

Syntax: PRF<return_data_format><CR>

where: <return_data_format> is:


C - for comma-separated variables (CSV) format
T - for "text" format

Example: "PRFT\r" Run pacer refractory test; return data in text format.

Returns: (1) For CSV formatted data:


"<rate>,<prp>,<srp>\r"

where: <rate> is pacer pulse rate, format "xxx.yPPM"


<prp> is paced refractory period, format "xxxmsec"
<srp> is sensed refractory period, format "xxxmsec"

(2) For "text" format data:


"RATE=<rate> PRP=<prp> SRP=<prp>\r"

where: <rate> is pacer pulse rate, format "xxx.yPPM"


<prp> is paced refractory period, format "±xxxxmsec"
<srp> is sensed refractory period, format "±xxxxmsec"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before PRP and SRP are measured.

(5) "PACE TIMEOUT\r" if a pacer pulse is not detected within 3 seconds of


receiving the command.

Remote Control/Chapter 5 # Page 127


Phase 3 OPERATING MANUAL

5.3.8 Pacer Noise Immunity Command

Description: The pacer noise immunity command configures Phase 3 to perform a noise
immunity test. Phase 3 will return data in one of two possible formats after the test is
completed; if the test passes, this will require about 60 seconds at a pacer rate of 90
PPM. See Section 4.7.4 for further information on the pacer noise immunity test.

Syntax: PN<freq><return_data_format><CR>

where: <freq> is: A - for 60 Hz noise


B - for 50 Hz noise

<return_data_format> is:
C - for comma-separated variables (CSV) format
T - for "text" format

Example: "PNAT\r"

Run pacer noise immunity test; noise frequency = 60 Hz; return data in text format.

Returns: (1) For CSV formatted data:


"<freq>,<threshold>\r"

where: <freq> is the noise frequency, format "60Hz" or "50Hz"


<threshold> is noise threshold amplitude, format "x.yymV"

(2) For "text" format data:


"FREQ=<freq> NOISE=<threshold>\r"

where: <freq> is the noise frequency, format "60Hz" or "50Hz"


<threshold> is noise threshold amplitude, format "x.yymV"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before the noise immunity has been
measured.

Remote Control/Chapter 5 # Page 128


Phase 3 OPERATING MANUAL

5.3.9 Pacer Sensitivity Command

Description: The pacer sensitivity command configures Phase 3 to perform a pacer sensitivity
test. Phase 3 will return data in one two possible formats, after the test is completed;
this will require about 20 seconds at a pacer rate of 90 PPM. See Section 4.7.5 for
further information on the pacer sensitivity test.. If the current ECG WAVE setting
is not appropriate for this test, the ECG WAVE will be set to TRIP40 automatically
(scale not required).

Syntax: PSN<return_data_format><CR>

where: <return_data_format> is:


C - for comma-separated variables (CSV) format
T - for "text" format

Example: "PSNT\r"

Run pacer sensitivity test; return data in text format.

Returns: (1) For CSV formatted data:


"<rate>,<sens>\r"

where: <rate> is pacer pulse rate, format "xxx.yPPM"


<sens> is ECG amplitude for sensitivity, format "x.yymV"

(2) For "text" format data:


"RATE=<rate> SENS=<sens>\r"

where: <rate> is pacer pulse rate, format "xxx.yPPM"


<sens> is ECG amplitude for sensitivity, format "x.yymV"

(3) "?\r" Syntax error/invalid command

(4) "TEST CANCELLED\r" if operator presses CANCEL key on Phase 3


after this command is received but before the sensitivity has been measured.

(5) "PACE TIMEOUT\r" if a pacer pulse is not detected within 3 seconds of


receiving the command.

Remote Control/Chapter 5 # Page 129


Phase 3 OPERATING MANUAL

5.3.10 Phase 3 ID Command

Description: The ID command causes Phase 3 to return its name to the controlling device. This
command can be used to check for connection of Phase 3 to the controlling device,
and to verify that Phase 3 is operating in Remote Mode.

Syntax: IDENT<CR>

Example: "IDENT\r"

Get ID of test instrument.

Returns: (1) "Phase 3\r" Command received and understood.


(2) "?\r" Syntax error/invalid command

5.3.11 Clear Last Test Command

Description: The CLT command causes Phase 3 to delete the last test record stored in EEPROM

Syntax: CLT<CR>

Example: "CLT\r"

Deletes last test record.

Returns: (1) "*\r" Command received and understood.


(2) "?\r" Syntax error/invalid command

Remote Control/Chapter 5 # Page 130


Phase 3 OPERATING MANUAL

5.3.12 Clear Wave Records Command

Description: The CWV command causes Phase 3 to delete all Wave Records stored in EEPROM.

Syntax: CWV<CR>

Example: "CWV\r"

Delete Wave Records from memory.

Returns: (1) "*\r" Command received and understood.


(2) "?\r" Syntax error/invalid command

5.3.13 Clear Test Records Command

Description: The CTR command causes Phase 3 to delete ALL Test and Wave Records stored in
EEPROM.

Syntax: CTR<CR>

Example: "CTR\r"

Delete all Test and Wave Records from memory.

Returns: (1) "*" Command received and understood.


(2) "?\r" Syntax error/invalid command

Remote Control/Chapter 5 # Page 131


Phase 3 OPERATING MANUAL

5.3.14 Acquire Waveform Data Command

Description: The WAV command causes Phase 3 to return the waveform data currently held in
the data acquisition buffer via the RS-232 port.

This command works ONLY after completion of a successful “DE” (defib energy
test) or “PP” (pacer pulse test) command. The data returned in response to “WAV”
will represent a defibrillator discharge waveform after a “DE” command, or a single
pacer pulse after a “PP” command.

Syntax: WAV<length><sample_rate><format><CR>

where: <length> is:


‘1’ to ‘6’ - corresponding to 10 to 60 msec of waveform data
<sample_rate> is:
L - low - corresponding to 45.6usec sample interval
M - medium - corresponding to 22.8 usec sample interval
H - high - corresponding to 11.4 usec sample interval
<format> is:
A - for ASCII format
B - for binary format

Example: "WAV3HA\r"

Return 30 msec of waveform data at a sampling interval of 11.4 usec, in ASCII


format.

Returns: The returned signal sample data are signed values. For a defib waveform, the data
correspond to current in units of amperes x 100 (e.g. a value of -1579 corresponds to
a signal sample equal to -15.79 amperes). For a pacer waveform, the data correspond
to current in units of milliamps x 10 (e.g. a value of +453 corresponds to +45.3
milliamps).

(1) For ASCII return format, each signal sample is represented as a string of
ASCII digits, preceded by a ‘+’ or ‘-’ character to convey the sign as
appropriate, and terminated with a carriage return character (‘\r’). After all
requested signal data have been returned, a form feed character (‘\f’) is then
sent and can be used to detect conclusion of the waveform download in
ASCII mode.

Remote Control/Chapter 5 # Page 132


Phase 3 OPERATING MANUAL

(2) For binary return format, each data value is sent as a signed short (16-bit)
integer, sent in low byte/high byte order. The requesting host can detect
end-of-download via a timeout mechanism, or by waiting for the expected
number of data values to be received. The number of data points conveyed
in the download depends on the command parameters and is listed in the
following table.

<sample_rate>
<length> ‘L’ ‘M’ ‘H’
‘1’ 220 440 880
‘2’ 440 880 1760
‘3’ 660 1320 2640
‘4’ 880 1760 3520
‘5’ 1100 2200 4400
‘6’ 1320 2640 5280

(3) "?\r" Syntax error/invalid command

5.3.15 Number of Test Records Command

Description: The MEM command causes Phase 3 to return the number of Test Records currently
stored in the EEPROM memory.

Syntax: MEM<CR>

Example: "MEM\r"

Send the number of Test Records currently in memory.

Returns: (1) "nnn\r" where nnn is " 0" to " 80" (note leading whitespace).
(2) "?\r" Syntax error/invalid command

Remote Control/Chapter 5 # Page 133


Phase 3 OPERATING MANUAL

5.3.16 Send Test Report Command

Description: The STR command causes Phase 3 to return the Test Record requested, in the
format of a printed Test Report (see section 4.9.2.2).

Syntax: STR <record_number><CR>

Example: "STR16\r"

Get Test Report 16 from memory and send to PC in print format.

Returns: (1) "ASCII printed report" There is no 'end-of-file ' marker. User must
monitor for a specific text string (such as
Date:), or time out to end the transmission.
(2) "e\r" Record does not exist.
(3) "?\r" Syntax error/invalid command

Remote Control/Chapter 5 # Page 134


Phase 3 OPERATING MANUAL

6 Phase3pc SOFTWARE
Datrend Phase3pc software provides a communication utility for Phase 3 which allows the user to
configure AutoSequences, download Test Records and Wave Records, and capture waveform data
in real-time. Phase3pc is a self-contained Windows® application which is supplied as a standard
accessory on CD ROM.

6.1 Installation

6.1.1 Installing Phase3pc

To install Phase3pc to your computer, place the Phase3pc CDROM into your computer's
CDROM drive and close the drive. The installation application will begin automatically
(Figure 100), unless your computer is set to ignore autorun applications.

Figure 100 - Installation of Phase3pc.

Phase3pc/Chapter 6 # Page 135


Phase 3 OPERATING MANUAL

In the event the installation program does not start automatically, use the file explorer utility on your
computer to locate the CDROM drive. Browse this drive to locate the file called
Phase3pcNNSetup.exe . Double-click or otherwise execute this file and the installer will guide you
through the installation process. We recommend that all default installation locations be left intact
so future upgrades and enhancements will run smoothly.

At the end of the short installation process, you will be presented with a notification that the
software has been installed, at which time you may either select or deselect the checkbox which asks
if you would like to run Phase3pc upon closing the dialogue box. The computer does not have to
be restarted before running Phase3pc

6.1.2 Installing USB Drivers

When installation of Phase3pc is complete, connect Phase 3 to your PC using the USB cable
provided with your instrument. When Phase 3 is connected to the PC for the first time, Windows
should detect the connection and then automatically launch the New Hardware Wizard which will
prompt you for the USB driver (Figure 101).

Figure 101 - New Hardware Wizard

The USB drivers for Phase 3 are provided with Phase3pc software. When the Hardware Wizard
asks for the files, direct the Hardware Wizard to your CD drive, or to the location where the files
were downloaded. The Wizard should then find and install the required driver files.

Phase3pc/Chapter 6 # Page 136


Phase 3 OPERATING MANUAL

NOTE:

During installation of the USB drivers, Windows XP


users may receive a warning message that the driver
has not been "Logo Tested" (Figure 102). Please
ignore this warning and clear the message by clicking
the "Continue Anyway" button.

Figure 102 - Click "continue anyway". Figure 103 - Driver installation in progress.

6.2 Phase 3 Remote Mode

In order for Phase 3 to work with Phase3pc, it must first be placed in Remote Mode. To enter
Remote Mode, press the REMOTE softkey on the MAIN MENU of Phase 3. The display will then
appear as shown in Figure 104. CANCEL may be pressed at any time to exit Remote Mode to the
MAIN MENU of Phase 3.

REMOTE MODE MENU

STATUS: Waiting PORT: RS232


COMMAND: COUNT: 1

CANCEL
Figure 104 - Remote Mode menu of Phase 3.

Phase3pc/Chapter 6 # Page 137


Phase 3 OPERATING MANUAL

6.3 AutoSequence Editor

When Phase3pc is run for the first time, the program starts up by displaying a library of
AutoSequences which are stored locally on the computer (Figure 105). Each row in the grid
represents one AutoSequence, as identified by a title and the type of device to be tested
(defibrillator/pacer, or AED).

Figure 105 - Phase3pc AutoSequence listing.

An AutoSequence is a sequence of steps which automates the testing of a defibrillator or pacemaker


(see Section 4.10 for further details). Phase3pc can easily create, edit, and organize up to 32
AutoSequences. AutoSequences can then be uploaded from the software to Phase 3 for storage in
the non-volatile memory. Alternatively, AutoSequences stored in Phase 3 can be downloaded into
the software for editing, and then re-uploaded to the instrument. The AutoSequence toolbar of
Phase3pc is shown in Figure 106.

Phase3pc/Chapter 6 # Page 138


Phase 3 OPERATING MANUAL

Figure 106 - AutoSequence Editor toolbar.

6.3.1 Creating an AutoSequence

Create a new AutoSequence by clicking New Autosequence on the AutoSequence toolbar, or by


pressing b +N on the keyboard. A new AutoSequence will appear at the bottom of the
AutoSequence grid. This new AutoSequence will be blank, that is, none of the tests provided by the
AutoSequence will be enabled.

6.3.2 Editing an AutoSequence

Edit an AutoSequence by double-clicking an entry in the AutoSequence grid. The AutoSequence


Editor will appear. See Section 6.3.6 for more information.

6.3.3 Copying and Deleting AutoSequences

To copy AutoSequences, select any number of AutoSequences in the grid by dragging the mouse
over them. Then, click Copy AutoSequences, or press b +C on the keyboard. If the
resulting number of AutoSequences is 32 or less, the copied AutoSequences will appear at the
bottom of the grid.

To delete AutoSequences, select any number of AutoSequences in the grid by dragging the mouse
over them. Then, click Delete Autosequences, or press c on the keyboard. A warning will
appear requiring you to confirm the action. Click Yes to delete the AutoSequences.

Phase3pc/Chapter 6 # Page 139


Phase 3 OPERATING MANUAL

6.3.4 Uploading and Downloading AutoSequences

AutoSequences can be transferred to Phase 3 via a USB connection. Before attempting to upload or
download, make sure Phase 3 is connected to the PC and that Phase 3 is running in Remote Mode
(see Section 6.2).

To upload AutoSequences into Phase 3, click the Upload Autosequences button, or press
b +U on the keyboard. To download AutoSequences stored in Phase 3 to the PC, click the
Download Autosequences button, or press b +D on the keyboard. In both instances, a
communications progress window will appear. When the transfer has completed, click “OK”.

6.3.5 Printing AutoSequences

Phase3pc allows you to print all the AutoSequences, or a selected number of AutoSequences. To
print one AutoSequence, highlight it in the grid. To print a range of AutoSequences, select the
desired sequences by dragging the mouse over them.

Click Print Autosequences, or press b +P on the keyboard. The Print window will appear.
Choose to print either the selected AutoSequence(s) or all of the AutoSequences, via the radio
buttons which are provided on the Print dialog.

6.3.6 AutoSequence Editor

AutoSequences are comprised of different types of test, including:

• defibrillator energy, charge time, and synchronization delay;


• ECG monitor/chart recorder performance;
• pacemaker pulse, refractory, immunity and sensitivity; and
• AED performance.

Some test types, such as defibrillator energy, can be repeated a number of times with different
configurations for each test. The AutoSequence Editor provides each test type with its own tab. If
the test is a repeatable type, a list box will appear on the left-hand side of the Editor window, with
Add and Delete buttons located below the list (Figure 107). The test options will appear
on the right-hand side of the Editor window.

Phase3pc/Chapter 6 # Page 140


Phase 3 OPERATING MANUAL

Figure 107 - Editing defib energy test#5.

To add a new test to the list, press the Add test button below the list box. Select a test in the
list box by clicking on it. The parameters of the selected test will then appear in the text boxes on
the right. Delete a test from the list by selecting the test in the list box and clicking the Delete test
button, or pressing c on the keyboard.

6.3.6.1 Editing the AutoSequence Title

Edit the title of the AutoSequence in the Autosequence Title text field on the top of the
Autosequence Editor. Normally, you would choose a title that represents the make and model of the
defibrillator. The title can be a maximum of 16 characters.

Phase3pc/Chapter 6 # Page 141


Phase 3 OPERATING MANUAL

6.3.6.2 Selecting the Device Under Test

To test either a defibrillator and/or transcutaneous pacemaker, select Defibrillator in the Device
Under Test combo box. To test an automated external defibrillator (AED), select AED in the
Device Under Test combo box.

6.3.6.3 Editing Defibrillator Energy Tests

A defibrillator energy test measures the energy delivered by a defibrillator when it is discharged. The
test is normally repeated several times, with the defibrillator set to different energy levels for each
test. In an AutoSequence, each measured energy is compared a target value corresponding to the
energy setting on the defibrillator. The tolerance of the test defines a range of acceptance for the
measured energy. If the measured energy falls within the acceptance range defined by the
AutoSequence settings for target and tolerance, Phase 3 automatically passes the measured energy.

To begin editing defibrillator tests, select the Defib Energy tab (Figure 107). The maximum
number of energy tests than can be performed in an AutoSequence is 10. Add tests if required, via
the button as previously described. Select a test from the list on the left. Enter the Target
Energy for this test (i.e., the energy setting on the defibrillator), and choose a Tolerance. Set up
the Phase 3 ECG simulator for this test by first choosing the simulator Wave Bank, and then
selecting the Wave (waveform). The amplitude scale of the Wave can also be changed by selecting a
value in the Scale combo box.

6.3.6.4 Editing the Charge Time Test

A charge time test measures the time required for a defibrillator to charge up to a specified energy
level, which is typically the maximum energy provided by the device.

To begin editing the charge time test, select the Charge Time tab on the AutoSequence Editor.
An AutoSequence provides only one charge time test. To enable this test, click the Enable
Charge Time Test checkbox. Enter the Target Energy for this test (i.e., the maximum energy
setting on the defibrillator), and choose a Tolerance. Enter an upper limit for the measured charge
time in the Measured Charge Time box. Set up the Phase 3 ECG simulator for this test by first
choosing the simulator Wave Bank, and then selecting the Wave (waveform). The amplitude
scale of the Wave can also be changed by selecting a value in the Scale combo box.

Phase3pc/Chapter 6 # Page 142


Phase 3 OPERATING MANUAL

6.3.6.5 Editing Cardioversion Tests

A cardioversion test verifies the ability of a defibrillator to synchronize its discharge to the QRS
complex of the ECG.

To begin editing cardioversion tests, click the Cardioversion tab of the AutoSequence Editor.
When the first cardioversion test is enabled, the ECG simulator will be configured so that it reverts
to normal sinus rhythm when a discharge is detected. If desired, disable this option under the
Advanced tab of the AutoSequence Editor.

The maximum number of cardioversion tests than can be performed in an AutoSequence is 4. Add
tests if required, via the button as previously described. Select a test from the list on the left.
Click the Enable Delay Target checkbox if you want Phase 3 to pass or fail the measured sync
delay. Enter the Target Energy for this test (i.e., the energy setting on the defibrillator), and
choose a Tolerance. Set up the Phase 3 ECG simulator for this test by first choosing the simulator
Wave Bank, and then selecting the Wave (waveform). The amplitude scale of the Wave can also
be changed by selecting a value in the Scale combo box. In the Sync To combo box, select the
timing reference that will be used to measure the synchronization delay (Q or R wave).

6.3.6.6 Editing ECG Performance Tests

An ECG test verifies operation and performance of the monitor and/or chart recorder of a
defibrillator. To begin editing ECG performance tests, click the ECG Performance tab of the
AutoSequence Editor (Figure 108).

Figure 108 - Editing an ECG test.

Phase3pc/Chapter 6 # Page 143


Phase 3 OPERATING MANUAL

The maximum number of ECG tests that can be performed in an AutoSequence is 12. Select the
ECG signal amplitude via the Scale combo box; the same amplitude will be used for all waveforms
in the ECG sequence. Set the ECG simulator for each step of the sequence by first choosing the
simulator Wave Bank, and then selecting the Wave (waveform).

6.3.6.7 Editing Pacer Tests

To begin editing pacer tests, click the Pacer tab of the AutoSequence Editor. The pacer sub menu
will appear below the main tab menu (Figure 109). Click on the buttons of the pacer sub menu to
navigate the various pacer tests described in the following sections.

6.3.6.8 Editing the Pacer Load

The pacer load is the load value which will be used by Phase 3 in all pacer tests of an AutoSequence.
Click the up or down arrow to respectively increase or decrease the resistance in 50 ohm increments.

6.3.6.9 Editing Pacer Pulse Tests

A pacer pulse test measures amplitude, rate and width of the pulses generated by a pacemaker
(Figure 109). The maximum number of pulse tests that can be performed in an AutoSequence is 10.

To edit pacer pulse tests, click the "Pacer" tab and then click the "Pulse" button on the pacer sub
menu. Select a test in the list on the left by clicking on it. For the selected test, enter a "Target
Current" and Pulse Rate in the text fields provided on the right. A target for pulse width is
optional, and can be enabled by clicking the checkbox next to the Target Pulse Width text field.
Select the measuring method for pulse amplitude via the Measuring Method combo box. For
more information on amplitude measuring methods, see Section 4.7.2.

Phase3pc/Chapter 6 # Page 144


Phase 3 OPERATING MANUAL

Figure 109 - Editing pacer tests (pulse test).

6.3.6.10 Editing the Noise Immunity Test

A noise immunity test verifies that a pacer will not respond to line frequency noise injected into its
ECG input. An AutoSequence can include only one noise immunity test.

To edit the noise immunity test, click the Pacer tab and then click the Noise Immunity button
on the pacer sub menu. To enable the test, click the Enable Noise Immunity checkbox. Select
the frequency of the noise signal via the Test Type combo box.

6.3.6.11 Editing Demand Sensitivity Tests

A demand sensitivity test determines the smallest ECG signal that will reliably trigger a pacer when
the pacer is operating in demand mode. The maximum number of sensitivity tests that can be
performed in an AutoSequence is two.

To edit the sensitivity test, click the Pacer tab and then click the Demand Sensitivity button on
the pacer sub menu. Select a test in the list on the left by clicking on it. For the selected test, enter a
Sensitivity Limit in the text field provided on the right. This limit is the largest ECG signal that
can be accepted to result in a passing test. Set up the Phase 3 ECG simulator for this test by first
choosing the simulator Wave Bank, and then selecting the Wave (waveform).

Phase3pc/Chapter 6 # Page 145


Phase 3 OPERATING MANUAL

6.3.6.12 Editing Refractory Period Tests

A refractory period test determines the two refractory periods of the pacemaker under test. The
paced refractory period (PRP) is the time interval following a pacer pulse during which ECG QRS
complexes are ignored. The sensed refractory period (SRP) is the time interval following a detected
QRS where a subsequent QRS is ignored. The maximum number of refractory tests that can be
performed in an AutoSequence is two.

To edit the refractory test, click the Pacer tab and then click the Refractory Period button on
the pacer sub menu. Select a test in the list on the left by clicking on it. For the selected test, enter
maximum and minimum limits for both PRP and SRP in the text fields provided. Set up the Phase 3
ECG simulator for this test by first choosing the simulator Wave Bank, and then selecting the
Wave (waveform).

6.3.6.13 Editing Advanced Options

The ECG Trigger Mode listbox allows selection of one of four possible responses of the ECG
simulator to a defibrillator discharge. Phase 3 may automatically change its waveform to normal
sinus rhythm when a discharge is detected from the defibrillator under test. Alternatively or in
addition, Phase 3 can play back the discharge waveform into the paddles or ECG leads of the
defibrillator. See section 4.5.1.2 for more details on the MODE settings.

The Auto-Test Timer listbox allows selection of the length of time Phase 3 will wait before
proceeding to the next step in an AutoSequence, where appropriate. The Auto-Test Timer allows
the operator time to read or respond to data or messages on the display screen, and may be turned
OFF if full manual control of the Autosequence is desired. See section (ref 4.10.3.1) for more details
on the Auto-Test Timer.

Phase3pc/Chapter 6 # Page 146


Phase 3 OPERATING MANUAL

6.3.6.14 Editing AED Energy Tests

If the device under test is an AED, select "AED" in the Device Under Test combo box at the
top of the AutoSequence Editor. The AED Energy test options will appear, while defibrillator and
pacer test options will be hidden (Figure 110).

The maximum number of energy measurements that can be performed in an AED AutoSequence
is 32. Select a test in the list on the left by clicking on it. Set up the Phase 3 ECG simulator for this
test by first choosing the simulator Wave Bank, and then selecting the Wave (waveform). The
amplitude scale of the Wave can also be changed by selecting a value in the Scale combo box. The
Shockable field displays the expected outcome of the test according to AAMI guidelines (see
Section 4.8).

Figure 110 - Editing an AED sequence.

Phase3pc/Chapter 6 # Page 147


Phase 3 OPERATING MANUAL

6.4 Test Report Generator

After a test is completed with Phase 3, results of the test can be stored as a Test Record in the non-
volatile Data Log. Later, the test data can be downloaded into Phase3pc and viewed as Test Report
documents. Test Reports can be saved in text, CSV, and Sentinel32 MUP formats.

Start working with test reports by clicking the Test Reports button on the main menu of
Phase3pc. This will activate the Test Report toolbar (Figure 111).

Figure 111 - Test Report toolbar.

6.4.1 Downloading Test Reports

Test Report data can be transferred from Phase 3 via a USB connection. Before attempting to
download, make sure Phase 3 is connected to the PC and that Phase 3 is running in Remote Mode
(see Section 6.2). To download Test Reports, click the Download Test Reports button, or press
b +D on the keyboard. A communications progress window will appear. When the transfer has
completed, click "OK". The downloaded Reports will appear in a grid display below the Test Report
toolbar (Figure 112).

Phase3pc/Chapter 6 # Page 148


Phase 3 OPERATING MANUAL

Figure 112 - Test Report listing following a


download.

6.4.2 Viewing Test Reports

To view one or more Test Reports, simply select the desired Test Reports in the main Test Report
grid (Figure 112) by dragging the mouse over them. Click the View Test Reports button. The
Test Report Viewer will appear showing the test data from the selected Test Reports.
Double-clicking on a single Test Report will also open the Test Report Viewer, which will then
show only the selected Report (Figure 113 .

Figure 113 - Viewing a Test Report.

Phase3pc/Chapter 6 # Page 149


Phase 3 OPERATING MANUAL

6.4.3 Saving Test Reports

6.4.3.1 Saving as a Text File

In the Test Report Viewer, Test Reports can be saved in both TXT (Text) and CSV (Comma
Separated Values) formats. To save the viewed Test Report(s) in text format, click the "Save To
Text" button of the Test Report Viewer. A directory browser will appear. Select the directory where
the Test Reports should be saved. A file for each individual Test Report in the Viewer will now be
created, where each file will be automatically assigned a filename according to:

DeviceID.YYYY_MM_DD.hh_mm_ss.txt

Above, DeviceID is the defibrillator ID (equipment control number or other ID), YYYY is the
year, MM is the month, DD is the day, hh is the hour, mm is the minute, and ss is the second in
which the Test Report file was created on the PC.

6.4.3.2 Saving as a CSV File

Saving Test Reports in CSV format produces the same result as saving to text format, except a CSV
file is also created listing each device and a path to the Test Report text file for that device. Each line
of the CSV file thus consists of:

"Device ID", "Test Date and Time", "Test Type", "Device Under Test","Overall Pass",
"Filename and Path of Test Report"

Before creating the CSV file, a save file dialog will appear. Select the desired directory and specify a
name for the CSV file. The CSV file and all corresponding Test Report text files will be saved in the
chosen directory.

Phase3pc/Chapter 6 # Page 150


Phase 3 OPERATING MANUAL

6.4.3.3 Saving as a MUP File

To save the viewed Test Reports in Sentinel32 MUP format, select the Save To MUP option
under the File menu of the Test Report Viewer. Select a location and either accept the default
filename which is generated automatically, or enter an alternative filename on the Save dialog. By
default, Phase3pc automatically generates a "medTester-style" filename which is intended to
facilitate direct import into Sentinel32 through the medTester Communication dialog of that
program. The format of the default MUP filename is:

MMDDhhmm.mup

where MM is the month, DD is the day, hh is the hour and mm is the minute in which the MUP file
was created on the PC.

6.4.4 Searching for Test Reports

In the main Test Report window of Phase3pc, there is a search text box in the upper right hand
corner (Figure 114). Use this to filter the downloaded Test Reports by Device ID, Device Under
Test, Date, and Test Type. The search is real-time, so the results will display as the characters are
typed into the search box. To cancel a search, click the Cancel Search button to the right of the
search box, or press the | key on the keyboard.

Figure 114 - Search box for Reports.


Tip: Quickly focus the cursor on the search box by pressing b +F on the keyboard.

6.4.5 Opening Existing Test Reports

To open a previously-saved Test Report for viewing, click the Open Test Report Button, or
press b +O on the keyboard. Browse for the Test Report file to view.

6.4.6 Printing Test Reports

When viewing Test Report(s) in the Test Report Viewer, click the "Print" button to show the print
dialog. Select the printer and click "OK" to print all Test Reports currently being shown in the
Viewer. Clicking "Cancel" will close the print dialogue without printing.

Phase3pc/Chapter 6 # Page 151


Phase 3 OPERATING MANUAL

6.5 Waveform Viewer

Wave Records can be saved by Phase 3 while testing a defibrillator (for more information on Wave
Records, see Section 4.5.1.5). A total of 10 low-resolution waveforms can be stored as individual
Wave Records in the non-volatile Data Log of Phase 3. Later, these waveforms can be downloaded
to Phase3pc for plotting as graphs.

High-resolution waveforms can also be captured in real-time by Phase3pc, immediately following a


Defibrillator Energy measurement, or a Pacer Pulse measurement. Low-resolution and high-
resolution waveforms can be viewed, saved, and printed.

Start working with waveforms by clicking the Waveforms button on the main menu of Phase3pc.
This will activate the Waveform toolbar (Figure 115).

Figure 115 - Waveform toolbar.

6.5.1 Downloading Wave Records

Wave Record data can be transferred from Phase 3 via a USB connection. Before attempting to
download, make sure Phase 3 is connected to the PC and that Phase 3 is running in Remote Mode
(see Section 6.2). To download Wave Records, click the Download Test Reports button, or
press b +D on the keyboard. A communications progress window will appear. When the
transfer has completed, click "OK". The downloaded Wave Records will appear in a grid display
below the Waveform toolbar (Figure 116).

Phase3pc/Chapter 6 # Page 152


Phase 3 OPERATING MANUAL

Figure 116 - Wave Record listing following a download.

6.5.2 Viewing Wave Records

To view a Wave Record, double-click on an entry in the main waveform grid. The Waveform
Viewer will then appear (Figure 117). See Using The Waveform Viewer (Section 6.5.5) for more
information.

Figure 117 - Waveform Viewer.

Phase3pc/Chapter 6 # Page 153


Phase 3 OPERATING MANUAL

6.5.3 Capturing High-Resolution Waveforms

After making a Defibrillator Energy measurement or Pacer Pulse measurement with Phase 3
according to Section 4.5.1.4, the waveform from the test can then be captured by Phase3pc.

Phase 3 does not need to be running in Remote Mode for this to work. Simply make sure Phase 3 is
connected to the PC via USB, then click the Capture Waveform button, or press b +W on
the keyboard.

Note: be sure to use a high quality, shielded USB 2.0 type cable (i.e. Datrend P/N 3140-440)
connected to a USB port on the computer which is not on an extension cable from the main board.
Defibrillator discharges may cause a disconnection of the USB device driver if the shield and
grounding are not adequate. If disconnection occurs, Exit the program, unplug and re-plug the USB
cable and re-start Phase3pc .

After the data transfer is complete, the Waveform Viewer will appear immediately with the resulting
defibrillator discharge or pacer pulse waveform. Based on the content of the data received by
Phase3pc, the display will format the results and graph to match a defibrillator energy discharge or a
pacer pulse. See Using The Waveform Viewer (Section 6.5.5) for more information on
manipulating the graph characteristics.

6.5.4 Opening Existing Waveforms

To open a previously saved waveform for viewing, click the Open Waveform Button, or press
b +O on the keyboard. Browse for the waveform file to view.

6.5.5 Using the Waveform Viewer

Opening a Wave Record or waveform data file, or capturing a high-resolution waveform, activates
the Waveform Viewer toolbar of Phase3pc (Figure 118). Waveform viewing and printing features
are described in this section.

Figure 118 - Waveform Viewer toolbar.

Phase3pc/Chapter 6 # Page 154


Phase 3 OPERATING MANUAL

6.5.5.1 Zooming In and Out

Zoom in by clicking the Zoom In button, or by pressing b += on the keyboard. Zoom out by
clicking the Zoom Out button, or by pressing b +- on the keyboard. Zoom into a particular
region of the chart by clicking the Zoom Rectangle button. The mouse cursor will change into a
cross symbol. Select a zoom area by holding the left mouse button down and dragging, creating a
rectangular area on the chart. Then, release the mouse button to see the changes. Note: The zoom
area rectangle must not go left of the Y-Axis Zero Position.

6.5.5.2 Panning the Chart

Following a zoom-in or zoom-out, the chart may be panned in any direction.

Click the Zoom Rectangle button if this button is not already depressed. Pan the chart by
holding down the left mouse button and dragging inside the chart area. The Zoom Rectangle
button must be depressed to enable the drag-panning feature.

6.5.5.3 Undo Zoom

Click the Undo Zoom button, or press b +Z on the keyboard to restore the chart to its
original view.

6.5.5.4 Data Points On/Off

Click the Show Data Points button, or press b +T on the keyboard to activate or de-
activate markers on the individual data points which form the waveform trace.

6.5.5.5 Setting the Chart Axes

To explicitly set one or both chart axes, select Set Chart Axis from the Edit pull-down menu
above the toolbar, or press b +H on the keyboard. Alternatively, you can right-click the chart
and then select Set Chart Axis. This will activate the Set Chart Axis form (Figure 119). Type
minimum and maximum values for the time axis and the current axis in the text boxes provided,
then click "OK". The chart will be re-drawn with the axes you have selected.

Phase3pc/Chapter 6 # Page 155


Phase 3 OPERATING MANUAL

Figure 119 - Setting the chart axes.

6.5.5.6 Saving Waveform Data

A waveform being viewed can be saved in CSV format by clicking the Save button on the
Waveform Viewer toolbar, or by pressing b +S on the keyboard. A Save Dialog will appear.
Select the directory, enter a filename and click "OK". Each data point in the CSV file will be
represented on its own line, in the following format:

[time],[current]

6.5.5.7 Printing Waveforms

A waveform being viewed can be printed. To print the waveform, click the Print button on the
Viewer toolbar, or press b +P on the keyboard. A print dialog will appear. Select the printer
and click "OK". The waveform will be printed as it appears in the chart, i.e., with the existing
zoom/axis settings.

The waveform can be printed either with or without the test data shown at left in the Wave
Information Panel of the Viewer. To toggle the information panel on or off, click Show Wave
Info on the View pull-down menu above the toolbar, or press b +I on the keyboard.

Phase3pc/Chapter 6 # Page 156


Phase 3 OPERATING MANUAL

6.5.5.8 Editing the Device ID Field

After capturing a high-resolution waveform, you may wish to input a device ID to identify the
device which produced the waveform. To edit the device ID, select the Device ID item under the
Edit pull-down menu above the toolbar. Alternatively, click on the Device ID field in the Wave
Information Panel. The Device ID field will become an editable field. Type the new device ID into
the field, then press e on the keyboard.

6.5.5.9 Hot Key Summary

b +C Copy

b +D Download

b +F Search / Find

b +H Edit Chart Axes

b +I Toggle Information On/Off

b +N New

b +O Open

b +P Print

b +S Save

b +T Toggle Data Points On/Off

b +U Upload

b +W Capture Waveform

b +Z Undo Zoom

b += Zoom In

b +- Zoom Out

c Delete

| Cancel Search

Phase3pc/Chapter 6 # Page 157


Phase 3 OPERATING MANUAL

Phase3pc/Chapter 6 # Page 158


Phase 3 OPERATING MANUAL

7 TROUBLESHOOTING AND MAINTENANCE


Calibration of Phase 3 by an authorized Datrend Service Facility is required on an annual basis to
maintain the 2 year factory warranty. Refer to the Calibration Decal applied to the rear panel of the
unit to determine calibration status of your Phase 3.

In the event of battery discharge, connect Phase 3 to the AC adapter/charger supplied with your
instrument. Refer to Section 3.1 for further information on the AC adapter/charger. A fully
depleted battery will require a minimum of 14 hours to recharge. Phase 3 may be operated from the
AC adapter while the battery is being charged.

Phase 3 contains no user-serviceable parts. Opening the case of Phase 3 for any
reason will void the warranty and may compromise user safety. Refer servicing to
qualified personnel.

NOTE:
Protection of the operator may be compromised if the
instructions in this manual are not followed, or if Phase 3 is
used for a purpose not specified in this manual.

For service assistance or calibration, contact Datrend Systems for a Return Materials Authorization
(RMA) number and the location of the nearest Service Facility.

Datrend Systems Inc.


Unit #1 - 3531 Jacombs Road
Richmond, BC • CANADA • V6V 1Z8
Tel: 800-667-6557 (North America Only) or
604-291-7747 • Fax 604-294-2355
e-mail: customerservice@datrend.com
www.datrend.com

Troubleshooting/Chapter 7 # Page 159


Phase 3 OPERATING MANUAL

Phase 3 should be cleaned with a soft, lint-free, damp cloth using a mild detergent. Use of other
cleaning agents is prohibited.

CAUTION: This device measures high voltage signals. For protection of the
operator, inspect the Paddle Adapter and the interconnecting Paddle Adapter
Cables on a regular basis for nicks, cracks or other damage that may compromise
the insulating properties of the housing, wire or connectors. Replace any
damaged or worn components immediately.

Troubleshooting/Chapter 7 # Page 160


Phase 3 OPERATING MANUAL

APPENDIX A. DEFAULT AUTOSEQUENCES

Phase 3 comes equipped with AutoSequences stored in its non-volatile memory to provide
examples of various test parameters configured by an AutoSequence. Default AutoSequences are
installed with Phase3pc when the application is installed. Phase3pc permits the default
AutoSequences to be modified or supplemented as desired; refer to Chapter 6 for instructions. The
following AutoSequences are examples only to highlight some of the possible settings, and may not
match those installed in your Phase 3 . They may be modified at any time by Datrend in future
releases of Phase 3 or Phase3pc . These AutoSequences should be reviewed by the end user to
determine if they are suitable for their purposes. Datrend takes no responsibility for the
inappropriate use of these examples.

Autosequence Title: Generic Defib


Device Under Test: Defibrillator

ECG Trigger Mode: Change to NSR60 after shock


Auto-Test Timer: 5 seconds

Defib Energy Test 1


Target Energy: 20 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 2
Target Energy: 50 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 3
Target Energy: 100 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 4
Target Energy: 200 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 5
Target Energy: 300 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1

Appendix A # Page 161


Phase 3 OPERATING MANUAL

Charge Time Test


Target Energy: 360 J
Tolerance: +/-15%
Max Charge: 15 sec
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1

Autosequence Title: HeartStream AED


Device Under Test: AED

AED Energy Test 1


Waveform: Atrial Fibrillation, Coarse (AFIB1) - x1
Shock Type: Not Shockable
AED Energy Test 2
Waveform: Atrial Fibrillation, Fine (AFIB2) - x1
Shock Type: Not Shockable
AED Energy Test 3
Waveform: Asytole, Random baseline (ASYS1) - x1
Shock Type: Not Shockable
AED Energy Test 4
Waveform: Asytole - Flat line (ASYS2) - x1
Shock Type: Not Shockable
AED Energy Test 5
Waveform: Supraventricular Tachycardia (SVTACH) - x1
Shock Type: Not Shockable
AED Energy Test 6
Waveform: Ventricular Tachycardia 140 BPM (VTACH1) - x1
Shock Type: Not Shockable
AED Energy Test 7
Waveform Ventricular Tachycardia 140 BPM (VTACH1) - x1
Shock Type: Not Shockable
AED Energy Test 8
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Shock Type: Shockable
AED Energy Test 9
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Shock Type: Shockable
AED Energy Test 10
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Shock Type: Shockable
AED Energy Test 11
Waveform: Asytole, Random baseline (ASYS1) - x1
Shock Type: Not Shockable
AED Energy Test 12
Waveform: Ventricular Tachycardia 160 BPM (VTACH2) - x1
Shock Type: Shockable
AED Energy Test 13
Waveform: Ventricular Tachycardia 160 BPM (VTACH2) - x1
Shock Type: Shockable
AED Energy Test 14
Waveform: Ventricular Tachycardia 160 BPM (VTACH2) - x1
Shock Type: Shockable
AED Energy Test 15
Waveform: Supraventricular Tachycardia (SVTACH) - x1
Shock Type: Not Shockable

Appendix A # Page 162


Phase 3 OPERATING MANUAL

Autosequence Title: Lifepak12 w/Pace


Device Under Test: Defibrillator

ECG Trigger Mode: Change to NSR60 after shock


Auto-Test Timer: 5 seconds

Defib Energy Test 1


Target Energy: 2 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 2
Target Energy: 5 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 3
Target Energy: 10 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 4
Target Energy: 20 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 5
Target Energy: 50 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 6
Target Energy: 100 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 7
Target Energy: 200 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 8
Target Energy: 300 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Defib Energy Test 9
Target Energy: 360 J
Tolerance: +/-15%
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Charge Time Test
Target Energy: 360 J
Tolerance: +/-15%
Max Charge: 15 sec
Waveform: Ventricular Fibrillation, Coarse (VFIB1) - x1
Cardioversion Test 1
Target Energy: 30 J
Tolerance: +/-15%
Waveform: ECG 120 BPM (ECG120) - x1
Sync Method: ECG R Wave

Cardioversion Test 2
Target Energy: 100 J
Tolerance: +/-15%
Waveform: Atrial Fibrillation, Coarse (AFIB1) - x1

Appendix A # Page 163


Phase 3 OPERATING MANUAL

Sync Method: ECG R Wave

ECG Test
1. Square Wave, 2 Hz (SQR2HZ) - x1
2. DC Pulse, 4 sec (PULSE) - x1
3. Triangle Wave, 2 Hz (TRI2HZ) - x1
4. Sinewave, 10 Hz (SIN10) - x1
5. Sinewave, 40 Hz (SIN40) - x1
6. Sinewave, 60 Hz (SIN60) - x1
7. Sinewave, 100 Hz (SIN100) - x1
8. ECG 60 BPM (ECG60) - x1
9. ECG 30 BPM (ECG30) - x1
10. ECG 120 BPM (ECG120) - x1
11. ECG 180 BPM (ECG180) - x1
12. ECG 240 BPM (ECG240) - x1
Pacer Pulse Test 1
Target Current: 55 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 40 PPM
Tolerance On Rate: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 2
Target Current: 55 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 60 PPM
Tolerance On Rate: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 3
Target Current: 55 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 100 PPM
Tolerance On Rate: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 4
Target Current: 55 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 140 PPM
Tolerance On Rate: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 5
Target Current: 55 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 170 PPM
Tolerance On Rate: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 6
Target Current: 100 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 80 PPM
Tolerance On Rate: +/-10%
Target Pulse Width: 20 msec
Tolerance On Width: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 7
Target Current: 130 mA
Tolerance On Current: +/-10%
Target Pulse Rate: 80 PPM

Appendix A # Page 164


Phase 3 OPERATING MANUAL

Tolerance On Rate: +/-10%


Target Pulse Width: 20 msec
Tolerance On Width: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 8
Target Current: 150 mA
Tolerance On Current: +/-15%
Target Pulse Rate: 80 PPM
Tolerance On Rate: +/-10%
Target Pulse Width: 20 msec
Tolerance On Width: +/-10%
Measuring Method: Peak Current
Pacer Pulse Test 9
Target Current: 200 mA
Tolerance On Current: +/-15%
Target Pulse Rate: 80 PPM
Tolerance On Rate: +/-10%
Target Pulse Width: 20 msec
Tolerance On Width: +/-10%
Measuring Method: Peak Current
Noise Immunity: 60 Hz
Pacer Sensitivity Test 1
Sensitivity Limit: 1 mV
Trigger Waveform: Pulse, 40 msec (TRIP40)
Pacer Refractory Test 1
Minimum Refractory: 100 msec
Maximum Refractory: 350 msec
Trigger Waveform: Pulse, 25 msec (SQRP25)
Pacer Load: 200 ohms

Appendix A # Page 165


Phase 3 OPERATING MANUAL

Appendix A # Page 166


Phase 3 OPERATING MANUAL

APPENDIX B. SAMPLE TEST REPORT

Below is an example of a Test Report document created by Phase3pc. Phase 3 itself has the capability of generating a
simplified report document containing similar information, which can be transmitted via the Serial I/O Port to a serial
printer or personal computer. Refer to Section 4.9.2.2 for instructions on how to output a Test Report via the Serial I/O
Port of Phase 3.

The results in the Report shown below were obtained from an AutoSequence performed on a Medtronic (nee Physio-
Control) LifePak model 9P. The Report incorporates results from defibrillator energy, charge time, and cardioversion
tests, as well as pacemaker pulse and refractory tests.

Phase 3 DEFIBRILLATOR ANALYZER


Datrend Systems Inc.

TEST REPORT No. 4

DATE OF TEST: May 29, 2006


TIME OF TEST: 02:31:29 PM
Phase 3 I.D.: MY PHASE3
DEVICE I.D.: CN0427
DUT TYPE: Defibrillator
TEST TYPE: AutoSequence 4

********************************************************************************

1.0 DEFIB TESTS

1.1 Energy

Tests performed: 8/10

TEST RNG PEAK PULSE WIDTH ECG


AMPLITUDE @10% @50% SIMULATOR ENERGY TARGET TOL RESULT
-----------(V)---(A)---(msec)-(msec)--Wave--Scale---(J)-----(J)---(%)---------
1 H 1557 31.20 5.77 2.72 VFIB1 x1 99.7 100.0 10 PASS
2 H 2180 43.68 5.81 2.72 VFIB1 x1 196.9 200.0 10 PASS
3 H 2664 53.38 5.84 2.73 VFIB1 x1 295.0 300.0 10 PASS
4 H 2927 58.65 5.87 2.72 VFIB1 x1 357.1 360.0 10 PASS
5 H 1091 21.86 5.71 2.72 VFIB1 x1 49.0 50.0 10 PASS
6 L 420 8.41 8.02 3.71 VFIB1 x1 9.9 10.0 10 PASS
7 L 297 5.95 8.04 3.75 VFIB1 x1 5.0 5.0 10 PASS
8 L 134 2.68 8.51 3.79 VFIB1 x1 1.0 1.0 10 PASS

1.2 Charge Time

Pre-test Discharges: 5

RNG CHARGE MAXIMUM ECG


TIME CHARGE TIME SIMULATOR ENERGY TARGET TOL RESULT
-------(sec)------(sec)-----Wave--Scale----(J)-----(J)---(%)----------
H 5.5 99.0 VFIB1 x1 196.3 200.0 10 PASS

Appendix B # Page 167


Phase 3 OPERATING MANUAL

1.3 Cardioversion (Sync)

Tests performed: 1/4

TEST RNG SYNC SYNC SYNC ECG


TO: DELAY LIMITS SIMULATOR ENERGY TARGET TOL RESULT
--------------------(msec)--(msec)----Wave--Scale---(J)-----(J)---(%)---------
1 H Q-Wave +36 ----- AFIB1 x1 49.8 50.0 10 PASS

********************************************************************************

3.0 TRANSCUTANEOUS PACEMAKER TESTS

LOAD RESISTANCE: 50 ohms

3.1 Pacer Pulse Measurements

Tests performed: 6/10

TEST TEST PULSE TARGET AMP PULSE TARGET WIDTH PULSE TARGET RATE RESULT
METHOD AMPL. AMPL. TOL WIDTH WIDTH TOL RATE RATE TOL
-------------(mA)---(mA)--(%)---(msec)-(msec)--(%)---(PPM)--(PPM)-(%)---------
1 AVG. 18.7 20 10 19.93 --.-- -- 60.5 60 10 PASS
1 AVG. 47.1 50 10 19.92 --.-- -- 60.6 60 10 PASS
1 AVG. 94.2 100 10 19.92 --.-- -- 60.6 60 10 PASS
1 AVG. 47.2 50 10 19.93 --.-- -- 30.2 30 10 PASS
1 AVG. 47.1 50 10 19.92 --.-- -- 120.9 120 10 PASS
1 AVG. 47.2 50 10 19.93 --.-- -- 181.4 180 10 PASS

3.4 Paced/Sensed Refractory Period

Tests performed: 1/2

TEST TRIGGER PACED REFR SENSED REFR MINIMUM MAXIMUM


WAVEFORM PERIOD PERIOD REFR PERIOD REFR PERIOD RESULT
--------------------(msec)------(msec)--------(msec)-------(msec)----------
1 TRIP40 +54 +254 +40 +350 PASS

Technician: _________________________________________ Date: ____________________

Appendix B # Page 168

You might also like