Life Stat Rev2013-06
Life Stat Rev2013-06
Life Stat Rev2013-06
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Copyright
PROTECTED UNDER ONE
Copyright © OR MORE OF THE
FOLLOWING U.S. PATENTS:
6,171,267 5,743,864
M
Michigan Instruments, Inc.
4717 Talon Court SE
Grand Rapids, MI 49512 USA
P
|
ProCare / Lode BV
Zernikepark 16a C
9747 AN GRONINGEN 0297
The Netherlands
Phone: +31(0)50 57 15074
C
CE Mark & Notified Body ID#
f Serial Number
i D
Consult Instructions for Use – Do Not Reuse - Dispose after use.
additional information available.
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Contents
1-Introduction .......................................................................................................................................................................... 5
1.1 The Life-Stat® Model 1008MII Instructions for Use (IFU) .............................................................................................. 5
1.2 Use of Warnings, Cautions, and Notes .......................................................................................................................... 5
1.3 Indication for Use .......................................................................................................................................................... 6
1.4 Contraindication............................................................................................................................................................. 6
1.5 Benefits of Mechanical CPR .......................................................................................................................................... 6
1.6 General Warnings and Cautions .................................................................................................................................... 7
2-Product Description .............................................................................................................................................................. 9
2.1 Life-Stat® Cardiopulmonary Resuscitator...................................................................................................................... 9
2.2 General Description ....................................................................................................................................................... 9
2.3 Life-Stat® System Components and Accessories ........................................................................................................... 9
2.3.1 Life-Stat® System .................................................................................................................................................. 10
2.3.2 Controls and Labeling ........................................................................................................................................... 11
2.3.3 Battery Power Supply ........................................................................................................................................... 13
2.4 Important Safety Features ............................................................................................................................................ 14
2.5 The BackBoard............................................................................................................................................................. 15
2.6 Mobile Oxygen Carrier (MOC), or Appropriate Wall Access Adapter ....................................................................... 15
2.7 The Carrying/Storage Case .......................................................................................................................................... 16
3-Setup and Operation ........................................................................................................................................................... 17
3.1 Precautions ................................................................................................................................................................... 17
3.2 Recommendations ........................................................................................................................................................ 18
3.3 Positioning the Patient ................................................................................................................................................. 19
3.4 Life-Stat® Deployment................................................................................................................................................. 20
3.4.1 Life-Stat® Setup: ................................................................................................................................................... 20
3.4.2 Life-Stat® Application to the Patient: ................................................................................................................... 21
3.4.3 Determine Compression Depth: ............................................................................................................................ 22
3.4.4 Life-Stat® Activation: ........................................................................................................................................... 22
3.4.5 Life-Stat® Ventilator- Patient Demand Valve (PDV) Activation: ........................................................................ 24
3.4.6 Procedure to Interrupt (Suspend) Compressions:.................................................................................................. 25
3.5 To Remove the Life-Stat® from the Patient: ................................................................................................................ 25
4-Storage and Shipping .......................................................................................................................................................... 27
4.1 Storage ......................................................................................................................................................................... 27
4.2 Shipping ....................................................................................................................................................................... 27
4.3 Disposal ....................................................................................................................................................................... 27
5-Care, Cleaning, and Disinfection ........................................................................................................................................ 29
5.1 General Care ................................................................................................................................................................ 29
5.2 Avoiding Contamination .............................................................................................................................................. 29
5.3 General Cleaning ......................................................................................................................................................... 29
5.4 Disinfection Guidelines ............................................................................................................................................... 29
5.5 Cleaning and Disinfecting the Patient Demand Valve ................................................................................................. 30
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5.6 Mobile Oxygen Carrier (MOC) ................................................................................................................................... 31
5.7 Periodic Preventive Maintenance................................................................................................................................. 31
5.8 Shift Check .................................................................................................................................................................. 33
5.9 Functional Check ......................................................................................................................................................... 35
5.10 Troubleshooting Guide: ............................................................................................................................................. 37
5.11 Life-Stat® Model 1008MII Detailed Specifications ...................................................................................................... 38
5.12 Electromagnetic Environmental Declaration. ............................................................................................................ 39
5.13 Parts List (Life-Stat®) ................................................................................................................................................ 42
6-Warranty and Factory Service Information ........................................................................................................................ 43
6.1 Model 1008MII Life-Stat® Cardiopulmonary Resuscitator Warranty Agreement.......................................................... 43
6.2 Purchase Records ......................................................................................................................................................... 43
6.3 Factory Service Policy ................................................................................................................................................. 44
6.3.1 What to do if the Life-Stat® CPR System requires service: .................................................................................. 44
6.3.2 Additional Terms: ................................................................................................................................................. 45
6.4 Warranty Repairs ......................................................................................................................................................... 45
GLOSSARY .......................................................................................................................................................................... 47
TERMS USED IN MANUAL ............................................................................................................................................... 47
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1-Introduction
NOTE: The purpose of this manual is to explain the use, care, and user
maintenance of the device, not to teach cardiopulmonary resuscitation.
Proper use of the Life-Stat® requires a thorough understanding of this manual, appropriate training,
and adequate practice with the device. This manual contains important information on all aspects of
operating and maintaining the device. After a complete review, use it as a guide to practice with the
Life-Stat® until completely confident and comfortable with its operation.
Keep this manual in a location where it is available for quick reference. The format is designed to
allow each section to be scanned quickly for answers to specific questions. The Table of Contents can
be used to find major headings and topics. For example, the Setup and Operation section will guide a
new user through the proper procedures for using the equipment. The Care, Cleaning, and
Disinfection section can be used to plan an effective preventive maintenance program.
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1.3 Indication for Use
The Life-Stat® CPR System is used to perform Cardiopulmonary Resuscitation (CPR) on adult
patients only in cases of clinical death, as defined by a lack of spontaneous breathing and pulse.
1.4 Contraindication
There are situations where CPR is not the appropriate method of intervention. Familiarity with
accepted medical practices in your area is very important. Always consult local protocol for the
proper integration of the Life-Stat® into your cardiac arrest management regimen of care.
"... they can 1) standardize the technique of CPR, 2) eliminate user fatigue, 3) free
trained persons to participate in the delivery of ACLS when there is a limited
number of rescuers, and 4) assure adequacy of compression when a patient requires
continued resuscitation during transportation."
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1.6 General Warnings and Cautions
WARNING: Federal law restricts this device to sales to, or on the order
of, a licensed medical practitioner.
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2-Product Description
• 30:2 mode will provide thirty (30) chest compressions, then pause compressions to deliver two
(2) ventilations. This 30 to 2 pattern will repeat continuously.
• CCV mode will provide continuous compressions with asynchronous ventilations delivered at 9
breaths per minute.
The Life-Stat® is a mechanical “automatic” CPR device that can be set up in seconds. The chest
compressor is powered by compressed Oxygen while timing is controlled by a 9V electronic circuit.
The device is electrically insulated, allowing it to be freely and safely used in conjunction with routine
patient monitoring, external pacing and defibrillation procedures. The Life-Stat®, once correctly
applied over the patient’s sternum, is designed to measure the patient’s anterior-posterior (A-P) chest
diameter and deliver the equivalent sternal deflection of 20% of that diameter.
A fourth component, the Carrying/Storage Case is available to transport/store the device when not in
use.
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2.3.1 Life-Stat® System
The Arm and Column positions the Piston and Massager Pad correctly over the patient’s sternum. It is
designed to provide a sternal deflection percentage based on the patient A-P chest diameter. Sternal
deflection is nominally set to 20% of the A-P diameter. The depth of each chest compression is easily
monitored using the markings on the Dome surrounding the Piston. The Column also serves as a
storage tank that holds sufficient Oxygen to continue to drive the Life-Stat® for several compressions
during an Oxygen source change.
Patient
Pressure Demand Valve Piston
Indicator (PDV) (inside Dome)
Handle Dome
Sternal
Deflection
A-P Diameter
Number
Sternal Deflection
Number
Massager
Arm Pad
Lock
O2
Arm Supply
Battery Hose
Compartment BackBoard
(1 of 2)
Column
Base
O2 Supply Connector
The Life-Stat® System
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2.3.2 Controls and Labeling
Control Panel
1. SYSTEM CONTROL (Control#1): This membrane keypad is used to control the Life-Stat®. It
is comprised of 5 electronic buttons, described below.
START/ON button. Pressing this button will activate the electronic control module
and perform a self test. The green LED indicator next to the button will illuminate to
indicate that the unit is on after completion of a successful self test.
STOP/OFF button. Pressing this button will return the chest compressor piston to the
‘up’ position, turn off the ventilator and shut down the electronic control module.
30:2 button. Pressing this button will activate the 30 compressions to 2 ventilations
operating mode and the blue LED indicator next to the button will illuminate.
CCV button. Pressing this button will activate the Continuous Compressions/
Ventilations operating mode and the blue LED indicator next to the button will
illuminate.
PAUSE button. Pressing this button will return the chest compressor piston to the ‘up’
position and pause compressions. Ventilations will continue and the yellow LED
indicator next to the button will illuminate. To resume compressions, press the desired
mode button (30:2 or CCV).
LOW BATTERY indicator. The red LED indicator will illuminate when the battery
voltage is too low to sufficiently power the device. When the power level reaches a
critical stage, an auto shutdown will bring the chest compressor piston to the ‘up’
position; turn off the ventilator and the electronic control module.
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2. COMPRESSION DEPTH (Control #2): This control is used
for setting the depth of compression on the patient. The depth is
set to correspond to the measured A-P diameter shown on the
scale located on the back of the Column. As indicated by the
arrow, turn the knob clockwise to increase the compression
depth and counterclockwise to decrease compression depth.
A
B
B C
NOTE: After the massager pad has been lowered to the patient's chest, the correct patient A-P
chest diameter is determined by locating the number on the back of the Column (A) just above
the Arm where the white arrows (B) are located. Set the compression depth to the
corresponding indicator number on the Dome (C) to match the A-P diameter number
indicated on the Column.
WARNING: Before operation, ensure that all controls are in the “OFF” or
“decreased” (fully counterclockwise) position before connecting to an Oxygen supply
or placing the unit on the patient. By verifying the position of all controls the
operator is assured of proper operation.
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2.3.3 Battery Power Supply
The Life-Stat® electronic control module is powered by two (2) 9V alkaline batteries.
CAUTION: Do NOT use excessive force to install the battery in the tray. Ensure the
polarity is oriented per the label and to the diagram embossed on the bottom of the tray (+
on left, - on right). Failure to install either battery in the correct position will prevent the
device from operating and may lead to failure of the device which will void the warranty.
The batteries that power the electronic module are located on either side of
the Arm.
• Always use name brand batteries of the same brand and type. Never install generic and/or
differing brand batteries together.
• Always replace BOTH batteries with fresh new ones. Never install just one fresh battery and
leave a used battery in the opposite side.
• ALWAYS operate the device with BOTH batteries installed and of equal strength.
WARNING: Operating the device with only one battery installed is not advised. If
only one battery is installed and coincidentally removed during operation when
performing a “Hot Swap”, the device could possibly stop in a “piston down” position
requiring removal of O2 Supply Hose from the base of the device to release the
piston. ALWAYS OPERATE the device with BOTH BATTERIES INSTALLED.
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• If stored for extended periods with batteries installed, inspect both batteries prior to use to
ensure they have not corroded.
• Dispose of used batteries properly.
Changing a battery during operation -- Should a low battery level occur during resuscitation
efforts, either battery may be removed and replaced, (one at a time), from its compartment and a fresh
battery can be “hot swapped’ providing uninterrupted CPR.
1. Remove only one battery tray from either side of the Life-Stat® allowing the battery installed
on the opposing side to continue to power the device.
2. Remove the used battery by pushing it back against the retaining spring and lifting up.
3. Insert a fresh battery in its place ensuring it is oriented properly (+ on left, - on right) per the
diagram embossed on the bottom of the tray.
4. Re-insert the tray until a click is heard to ensure it is seated properly.
5. Discard the used battery appropriately when convenient.
The opposing battery may be ‘hot-swapped’ also following the above steps at this time. If it is not
replaced immediately, install a fresh battery as soon as possible to ensure both batteries are fresh.
After replacement of either or both batteries, the LOW BATT LED will remain illuminated for
approximately 2 - 5 minutes.
Auto Shutdown feature-- When the batteries reach a critical low level condition, the Life-Stat® will
initiate an auto shutdown procedure. If the Life-Stat® is not physically turned off via the STOP/OFF
button on the System Control (#1) keypad –or- the batteries are not ‘hot-swapped’ out as explained
above, the compressor piston will return to the ‘up’ position, the ventilator will turn off, and the
electronic control module will automatically shut down.
Also, if the unit is turned on (the START/ON button is pressed) but no CPR mode (30;2 or CCV) is
selected within 16 minutes, the device will shutdown to conserve the batteries.
Service Interval Indicator— After the Life-Stat® has delivered over 1,000,000 (1 million) cycles, the
START/ON LED indicator will flash. It is recommended to return the device to the factory for service
after this occurs. The Life-Stat® will continue to function, however diminished performance may
result if the recommended service is not performed to replace potentially worn components.
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2.5 The BackBoard
The BackBoard is intended for either manual or mechanical CPR. It is designed to provide a firm,
non-rebounding surface upon which CPR can be performed, and introduces a slight hyperextension of
the patient’s neck to facilitate upper airway management. It allows use of the Life-Stat® on either side
of the patient. Two shoulder straps help immobilize the patient securing them to the BackBoard. The
cross strap helps to keep the shoulder straps from separating and indicates the position of the head
relative to the BackBoard.
Cross Strap
Shoulder
Straps
The BackBoard
The Mobile Oxygen Carrier is an Oxygen tank carrier, available in two configurations, which provide
constant pressure and high flow source gas for the Life-Stat® and an additional DISS outlet. It is
designed to power the Life-Stat® whenever the device is in use where no Oxygen pipeline source is
available (for example, when transporting a cardiac arrest patient from the scene to the ambulance and
from the ambulance to the hospital). One of the two outlets is dedicated to accept the Life-Stat® O2
Supply Hose, while the other DISS outlet is available to supply other Oxygen-driven devices. MOC
regulator(s) are preset to satisfy Life-Stat® requirements.
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Single tank carrier for “DD” carbon fiber
cylinder (Regulator available separately)
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3-Setup and Operation
3.1 Precautions
Before setting up and using the Life-Stat®, there are several important precautions that must be
observed at all times.
1. The Life-Stat® must only be used in cases of clinical death as defined by lack of spontaneous
breathing and pulse.
2. Manual CPR should be started on the patient immediately. Do not postpone CPR while waiting
for the Life-Stat®. The Life-Stat® can be easily set up and applied to the patient without
interrupting manual CPR efforts.
3. The Life-Stat® may be used in all cases with adult patients where manual CPR would normally be
initiated. However, there are situations where CPR is not the appropriate method of intervention.
Familiarity with accepted medical practices in your area is very important.
4. Personnel certified in manual CPR must always be present to monitor the patient during Life-Stat®
operation in the event of a mechanical failure.
5. When transporting a patient with the Life-Stat® in operation using the BackBoard, ensure the patient is
secured snugly to the BackBoard using the provided shoulder straps. Also, ensure the patient is
properly secured (using retention straps) to the stretcher as well. Failure to do so can allow the Life-
Stat® and BackBoard to shift position on the patient possibly causing the Massager Pad to wander off
of the patient’s sternum.
6. When applying the Life-Stat® to an obese patient, place the arm of the patient around the Life-Stat® so
that the Column is positioned near the arm pit of the patient. This will better facilitate positioning the
Massager Pad directly over the patient’s sternum.
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3.2 Recommendations
It is recommended that the Arm/Column of the Life-Stat®
be attached to the Base while stored in the Carrying/Storage
Case.
When placing the BackBoard under the patient, ensure the cross strap is positioned under the patient's
neck. Do not position the cross strap over the neck of the patient.
Correct Cross
Strap Position
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3.3 Positioning the Patient
The following steps are provided as a recommendation.
1. When applying the BackBoard, “Log roll” the patient into position, taking care to keep the cervical
spine immobilized.
2. Place the BackBoard under the patient orienting the head of the patient in the direction indicated by
the HEAD marking on the cross strap. Ensure the cross strap is positioned under the patient's neck.
Connect the retaining straps over the shoulder and under the arm pit of the patient, then buckle and
tighten the straps securely on both sides of the patient.
3. Secure the patient to the spine board with retention straps at the forehead, hips and feet.
4. Manual CPR can begin on the patient immediately. There is no need to postpone CPR while
waiting for Life-Stat® deployment and application to the patient.
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3.4 Life-Stat® Deployment
3.4.1 Life-Stat® Setup:
A. Remove the Life-Stat® from the Case.
Press for
OFF
G. Verify that the green Pressure Indicator located on the top of the
column shows an adequate input pressure is available.
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CAUTION: The Life-Stat® requires a medical grade Oxygen source capable of
delivering pressure from 50 to 90 psi (3.515 to 6.327 kgf/cm2), with a minimum flow
rate of at least 45 LPM. Always follow safe Oxygen handling practices with Oxygen
cylinders and regulators.
B. Insert the Base into the side slot of the BackBoard on whichever
side of the patient is most convenient.
C. With the Base fully inserted into the BackBoard and during a
pause in the manual CPR effort, loosen the Arm Lock and swing
the Arm over the patient’s chest locating the Massager Pad over
the sternum, as you would for the heel of your hand when
performing manual CPR.
D. Lower the Arm until the Massager Pad contacts the patient’s
chest. Then, apply slight downward pressure on the Arm to
position the Piston inside the Dome to align with the “-” mark on
the Dome. Tighten the Arm Lock Lever.
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WARNING: Injury to patient may occur if Arm is adjusted too low,
as indicated by the top of the Piston moving up beyond “-” on the
Dome.
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WARNING: Failure to ensure that the VENTILATION VOLUME knob
(Control #3) is turned fully counterclockwise upon initial application to the
patient and prior to selecting a CPR mode via the SYSTEM CONTROL #1
will deliver ventilations to the patient (if the breathing hose is applied to the
patient) at the tidal volume last set by Control #3. This setting may not be
correct and could deliver either excessive or insufficient tidal volumes to the
patient.
B. Press the START/ON button on the SYSTEM CONTROL (#1) keypad. The system will
perform a quick self check. When the system is ready the green LED indicator next to the
START/ON button will illuminate.
C. Choose the desired CPR mode by pressing the desired mode button (30:2 or CCV). The blue
LED indicator near the selected mode button will illuminate.
D. Rotate COMPRESSION DEPTH knob (#2) clockwise until sufficient compression depth is
demonstrated by viewing the Piston at eye level. Increase the depth until the top of the Piston
reaches the A-P Diameter Sternal Deflection Number on the Dome corresponding to the Sternal
Deflection Number reading taken from the scale on the back of the Column. This will deliver the
recommended A-P Diameter for the patient.
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3.4.5 Life-Stat® Ventilator- Patient Demand Valve (PDV) Activation:
A. Rotate the VENTILATION VOLUME knob (#3) clockwise in accordance with AHA
guidelines, and/or local protocol to desired volume (mL).
B. Apply the Breathing Hose/Non Re-breathing Valve to the patient via mask or ET tube.
C. The ventilator contains a Pressure Limit Alarm that will sound an audible alarm when the
airway pressure exceeds 55cm H2O. Monitor the patient airway to identify the cause for the
increased pressure and take the appropriate corrective action.
WARNING: Should the blue rubber diaphragm blow outward from the
Pressure Limit Alarm's relief ports, discontinue the use of the Life-Stat®
ventilator. It is recommended to manually ventilate the patient until
such time that a spare replacement alarm can be installed.
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3.4.6 Procedure to Interrupt (Suspend) Compressions:
To perform pulse checks or perform analysis with an AED (and/or defibrillate manually), simply press
the PAUSE button. This will interrupt compressions only, while ventilations continue at the previous
rate and volume setting. To resume compressions, press the desired mode button (30:2 or CCV). The
same depth of compression previously set by the COMPRESSION DEPTH knob will be delivered. If
stopping the delivery of ventilations is desired temporarily, rotate the VENTILATION VOLUME
knob fully counterclockwise. To resume ventilations, rotate the VENTILATION VOLUME knob
clockwise to the desired volume.
CAUTION: Disconnecting the Oxygen hose from the Oxygen source end
first may not allow the device to properly vent the internal pneumatic
ports. Always disconnect the O2 Supply Hose from the Life-Stat® first.
NOTE: Upon detaching the O2 Supply Hose from the Life-Stat®, an abrupt and
loud release of Oxygen from the Column Buffer will occur. This is intentional
and required to purge the Life-Stat® of its reserve Oxygen.
E. Remove the Breathing Hose/Non Re-breathing Valve from the patient and the PDV. Discard
the Breathing Hose. Discard the Non Re-breathing Valve if a single use type.
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F. Loosen the Arm Lock Lever and raise the Arm on the Column high enough to clear the patient.
Tighten the Arm Lock Lever.
G. Remove the Life-Stat® from the BackBoard.
H. Clean and inspect the Life-Stat® per the recommended Shift Check (Daily or after each use).
D
WARNING: The Breathing Hose (h h 14669) and Non Re-
breathing Valve (hh 14384) supplied with the device is intended
for single use only. Do not re-use.
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4-Storage and Shipping
4.1 Storage
Careful storage of the Life-Stat® is important. It should be stored in a location that is easily accessible
and in a manner that does not allow dirt, debris, or moisture to get into the device or its accessories.
For storage during normal transportation, the Carrying/Storage Case holds the basic components of the
system and allows quick access to the Life-Stat® at an emergency site.
A Life-Stat® that is stored assembled (for example, in a hospital ER setting) should be placed on a
“crash cart” or other surface where it will be used. The Arm should be positioned near the middle of
the Column and locked into place positioned over the Base. Coil a Breathing Hose/Non Re-breathing
Valve and the O2 Supply Hose on the Base for easy access.
4.2 Shipping
If the Life-Stat® must be shipped for any reason, a factory carton with protective foam inserts is
recommended to protect the device. Replacement cartons are available from Michigan Instruments,
Inc.
Refer to additional information and recommendations in the Factory Service Policy in Section
F when returning the device for service.
4.3 Disposal
D
The corrugated breathing hose and Non Re-breathing Valve (NRV) are one-use items and are
to be disposed after use on a single patient.
The Life-Stat® is designed for years of dependable service. When disposal is required, we
recommend returning to the factory for recycling. The Life-Stat® contains electronic
components that must be disposed of according to local laws.
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5-Care, Cleaning, and Disinfection
NOTE: This section comprises the extent of serviceable items for the Life-Stat®.
NO SERVICE, REPAIR or MAINTENANCE other than what is explained in this
section should be performed by the user. Any service, repair or maintenance not
listed in this section is to be PERFORMED ONLY by FACTORY
AUTHORIZED SERVICE PERSONNEL.
If stains remain, repeat the procedure. As with any stain, the longer it is allowed to set, the harder
it may be to remove.
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5.5 Cleaning and Disinfecting the Patient Demand Valve
C. Immerse the Hose Adaptor, Lip Valve and Pressure Limit Alarm in a disinfectant solution for a
minimum of 10 minutes. Rinse thoroughly with clean water repeatedly to ensure that all
disinfectant solution is removed. Set aside to dry thoroughly.
D. Using a cleaning cloth lightly dampened with the disinfectant solution, wipe the threads and
exposed end of the PDV. Allow to stand for 10 minutes then wipe repeatedly with a cleaning
cloth dampened lightly with clean water to remove any remaining disinfectant solution.
E. Once all items are completely dry, carefully examine the Hose Adaptor, Lip Valve and
Pressure Limit Alarm. Discard any cracked or damaged parts and replace as necessary.
F. Install the Pressure Limit Alarm on the PDV and tighten snugly. Properly center the Lip Valve
inside the Pressure Limit Alarm and ensure it is seated uniformly. Install the Hose Adaptor on
the Pressure Limit Alarm and tighten snugly.
G. After cleaning/disinfecting the PDV, it is recommended to verify its operation. Turn Control
#2 and Control #3 fully counterclockwise and ensure the SYSTEM CONTROL #1 is OFF.
Attach the O2 Supply Hose to an energized Oxygen source first, and then connect the opposite
end to the Life-Stat®. Turn the device on using the START/ON button on the System Control
(#1), select CCV and turn VENTILATION VOLUME (#3) to 1000ml. Allow the ventilator to
cycle several times to blow out any remaining cleaning/disinfecting solution. Wipe any
residue expelled from the PDV and the device covers. During a ventilation cycle, block the
end of the Hose Adaptor on the PDV and ensure the Pressure Limit Alarm sounds indicating it
is operating properly.
I. Return the device and related accessories to the Carrying/Storage Case or preferred method of
storage.
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5.6 Mobile Oxygen Carrier (MOC)
• Should you require maintenance of the regulator(s) used in the MOC, contact the manufacturer
of the regulator to arrange for service. Vendor information is provided with the MOC
regulator at the time of purchase.
• Ensure the regulator(s) contain the Oxygen seal when replacing Oxygen cylinder(s).
• Monitor pressure of the cylinder(s) regularly to ensure enough Oxygen supply is available.
• For the dual carrier, it is recommended to have only one cylinder open when powering the
Life-Stat®. When the Oxygen level is low, the other cylinder can then be opened and the low
cylinder closed.
• Refer to additional Warnings listed in the General Warnings, Cautions and Notes section on
the use of Oxygen-related equipment.
NOTE: There are no user-serviceable parts inside the Life-Stat® and no calibrations
or adjustments are needed for routine use. However, the general readiness and
function of the system can, and should, be evaluated on a regular basis. These checks
are performed on three levels.
1. Shift check – A series of checks that should be done after each use and at the start of every
shift. (See procedure below.)
2. Functional check – A complete visual and functional check of the Life-Stat®. (See
procedure below.)
The schedule for performing these procedures should be determined by the user, taking into
consideration specific circumstances and frequency of use. Use the table below as a guide.
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Factory-Recommended Maintenance/Service Intervals
Factory
Life-Stat® Use Shift Check Functional Check Service
Heavy use: Daily After each use Monthly Every 2
years
Frequent use: 10 - 15 times per month After each use Quarterly Every 3 - 4
years
Infrequent use: < 10 times per month After each use Semi annually Every 5
years
(Use based on a 20 minute average run time.)
In addition to the procedures for the Shift Check and Functional Check, checklists are also provided to
document these procedures. It is recommended to complete the checklists when these procedures are
performed to provide a document trail to demonstrate that the proper recommended maintenance is
being performed at the recommended/user determined intervals.
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5.8 Shift Check
Procedure:
A. Visual inspection
1. Make sure that the device and all accessories are clean and free of any contaminants.
2. Check the device and all accessories for any worn, loose or damaged parts.
3. Discard any used Breathing Hose (and Non Re-breathing Valve, if single use). Clean and disinfect the PDV
components if necessary.
CAUTION: Replace the straps (h 15440) on the BackBoard when they show signs
of wear or fraying. Otherwise, the ability to adequately secure the system to the
patient will be jeopardized.
CAUTION: Inspect the Massager Pad (h 14780). Replace if damaged (cover loose,
peeling away, punctured, etc.)
B. Set up for operation--(Ensure System Control#1 is set to OFF, Controls #2 and #3 are turned fully
counterclockwise (ccw) before continuing)
4. Loosen the Arm Lock Lever and check that the Arm moves freely on the Column. Raise Arm to bring the white arrow
to the 6 position and tighten the Arm Lock Lever.
5. Inspect the O2 Supply Hose for kinks, cracks, cuts, worn hose or damaged connectors. Connect the O2 Supply Hose to
the Oxygen source first, and then connect it to the Life-Stat®.
6. Turn the System Control #1 ON then select the CCV position. Verify that the green Pressure Indicator at the top of
the Column is extended. Verify the LOW BATT LED is not blinking or illuminated.
7. Attach a Breathing Hose/Non Re-breathing Valve to the PDV. Turn Control #3 to 800ml. Verify that a ventilation is
delivered. Block the end of the Non Re-breathing Valve and turn Control #3 to 1000ml. Verify that the Pressure
Limit Alarm sounds on the next ventilation.
8. Turn Control #3 fully counterclockwise and remove the Breathing Hose/Non Re-breathing Valve. Ensure Control #3
turns smoothly and is not loose. Turn System Control #1 OFF.
9. Remove the O2 Supply Hose from the Life-Stat® first, then from the Oxygen source.
10. With the O2 Supply Hose disconnected, verify that the Compression Depth Control #2 turns smoothly and is not loose.
11. Ensure System Control #1 is OFF, Control #2 and Control #3 are turned fully counterclockwise.
12. Check that all accessories and supplies are available: O2 Supply Hose, Breathing Hoses/Non Re-breathing Valves,
BackBoard, fresh spare 9V batteries, etc.
13. Ensure Oxygen cylinder(s) in the MOC have an adequate Oxygen supply.
14. Place the Life-Stat®, supplies and accessories into the Carrying/Storage Case.
REV: 2013-06 33
Shift Check of Life-Stat® (Daily, or after each use)
At the beginning of each shift, inspect the device. Indicate whether all requirements have been met. Note any
corrective actions taken. Sign the form.
If yes, explain in the remarks section and submit this form and the device
to the authorized personnel in your organization responsible for the
coordination of equipment service requests.
Signature: __________________________________
REV: 2013-06 34
5.9 Functional Check
Procedure:
4. Ventilation/Compression test-- (Ensure Control#1 is set to OFF and Controls#2 & #3 are turned fully
counterclockwise (ccw) before continuing)
Set up the Life-Stat® simulating use on a patient using either a test spring (MII P/N T106) or a suitable CPR
training manikin. Do not use a pillow, it will not provide the needed force (via a test spring or manikin) to properly
perform the compression test.
a. Lower the Arm until the Massager Pad contacts the test spring or manikin then apply slight downward pressure until the Piston
reads “-” on the Dome. Tighten the Arm Lock Lever.
Attach the O2 Supply Hose to the Oxygen source first.
b. Check the operation of the O2 Supply Hose by connecting and disconnecting the Life-Stat® end of the supply hose a few times.
The connector should attach and release smoothly.
c. Verify that when the O2 Supply Hose is connected the green Pressure Indicator at the top of the Column is functional.
d. Attach a Breathing Hose/Non Re-breathing Valve to the PDV. Turn Control #1 to the START/ON position and Control #3 to
800ml. Select CCV mode. Verify that ventilation is delivered. Block the end of the Non Re-breathing Valve and turn Control
#3 to 1000ml. Verify that the Pressure Limit Alarm sounds on the next ventilation.
e. Turn Control #3 fully ccw. Verify the Green ON indicator LED is lit. Select 30:2 and CCV mode ensuring the blue LED is lit
for each mode. Select the PAUSE mode ensuring the yellow LED is lit. Verify the LOW BATT LED is not blinking or
illuminated.
f. Remove the Breathing Hose/Non Re-breathing Valve. Ensure Control #3 turns smoothly and is not loose.
Select CCV mode to activate the chest compressor.
Set the Compression Depth Control #2 as close to the “4” mark as possible. Allow the system to
operate for 4 - 5 minutes, while monitoring the chest compression depth.
g. Verify that the Compression Depth Control (#2) works smoothly and allows proper adjustment of the compression depth.
h. Verify that the Piston motion is smooth and consistent.
i. While monitoring the compression depth, ensure the Piston does not exceed “5” nor should it be less than “3½”.
1. Press the STOP/OFF button on Control #1 and turn Controls #2 & #3 fully counterclockwise.
2. Remove the O2 Supply Hose from the Life-Stat® first then from the Oxygen source.
3. Check that all accessories and supplies are available: O2 Supply Hose, Breathing Hoses/Non Re-breathing Valves,
BackBoard, spare fresh 9V batteries, etc.
4. Ensure Oxygen cylinder(s) in the MOC have an adequate Oxygen supply.
5. Place the Life-Stat®, supplies and accessories into the Carrying/Storage Case.
REV: 2013-06 35
Functional Check of Life-Stat® (Weekly, monthly, or per determined schedule)
Per the determined schedule, inspect the device. Indicate whether all requirements have been met. Note any corrective actions
taken. Sign the form.
If yes, explain in the remarks section and submit this form and the device to
the authorized personnel in your organization responsible for the
coordination of equipment service requests.
Signature: __________________________________
REV: 2013-06 36
5.10 Troubleshooting Guide:
Should the device fail to operate properly at any time refer to the following Troubleshooting Guide. Disconnect the
ventilator from the patient any time the unit does not appear to be operating properly. If unable to determine the cause of
problem, contact Michigan Instruments for service.
START/ON LED blinking Service Interval Indicator Return to factory for service
No function with Oxygen source Inadequate O2 supply Verify O2 supply is ON
connected, Control #1 in START/ON Verify O2 supply tank is not empty or low
position and either 30:2 or CCV mode Verify O2 Supply Hose connections are secure
selected Verify proper input pressure of 50-90 psi (3.515 to
6.327 kgf/cm2) by checking Pressure Indicator is
up and green
Software malfunction
Release BOTH battery compartments in tandem
and re-seat
Seized internal pneumatic component
Return to factory for service
No compressions with increase of No mode selected Select either 30:2 or CCV mode
Control #2
No ventilation with increase of No mode selected Select wither 30:2 or CCV mode
Control #3
No compressions with increase of Control #2 knob not secured to valve Verify Control #2 knob is secured to shaft
Control #2 shaft
No ventilation with increase of Control #3 knob not secured to valve Verify Control #3 knob is secured to shaft
Control #3 shaft
CAUTION: If Control #3 is found loose on the shaft and subsequently tightened, the indicator on the knob may not be
properly aligned to deliver the true volume indicated. Proper ventilation tidal volumes must then be determined by
monitoring chest rise during ventilation. Returning device to the factory to calibrate Control #3 is recommended.
No compressions with increase of Inadequate O2 supply Verify O2 supply is ON
Control #2
Verify proper input pressure of 50-90 psi (3.515 to
-or- 6.327 kgf/cm2) by checking Pressure Indicator is
up and green
No ventilation with increase of
Control #3 Verify Oxygen source is delivering proper
minimum flow of 45 LPM
Inadequate Ventilation to patient Control #3 knob setting Verify Control #3 setting. Increase to provide
sufficient ventilation as evidenced by chest rise
REV: 2013-06 37
5.11 Life-Stat® Model 1008MII Detailed Specifications
Input:
- Compressed O2 at 50 to 90 psi (3.515 to 6.327 kgf/cm2)
- Gas Consumption: Maximum 45 LPM (11.88 gal/min.)
- Indicator to show adequate input pressure: 50 ± 3 psi (3.515 ±0.211 kgf/cm2)
- Pressure relief valve set at 100 ± 5 psi (7.030 ± 0.351 kgf/cm2)
- Filters to prevent contamination
- Oxygen checked quick connector (provided on O2 Input Hose)
Compression:
- Compression Frequency: 100 ± 6 compressions per minute
- Compression Stroke Range: Continuously Adjustable, 0 to 8 cm (0.0 to 3.15 in)
- Compression to Ventilation Ratio: 30:2 (30:2 mode)
- Continuous Compression with simultaneous Ventilation (CCV mode)
- Relaxation Force range: Upstroke force of at least 1.361 kg (3.0 lbs)
- Duty Cycle: constant at 50:50 (Systolic:Diastolic)
- Chest Compression waveform:
Exponential waveform with a time constant of less than 60.0 msec
Ventilation:
- Time-cycled, constant-flow ventilator
- Calibrated Volume Control: 0-1000 ± 100 mL; adjustable from 0 - 1000 mL
(0. - 0.317 ± 0.026 gal; adjustable 0 - 0.317 gal)
- Deliver 95% ± 5% Oxygen to the patient
- Inspiratory Time: 1.0 ± 0.25 seconds
- Inspiratory Flowrate: 0 to 50.0 ± 2.5 LPM (0 to 13.20 ±0.66 gal)
- Inspiratory:Expiratory (I:E) ratio: (30:2) – 1:1.5
- Inspiratory:Expiratory (I:E) ratio: (CCV) – 1:5.5
- Pressure Relief Valve: < 55.0 cm H20 (0.782 psi)
Controls:
- System Control membrane switch pad
START/ON / 30:2 / CCV / PAUSE / STOP/OFF
- Compression Control: Continuous Compression Depth
- Ventilation Control: Calibrated Tidal Volume
- Low Battery indicator
- Service interval indicator
Environmental:
- Operating Environment: -20 °C to 45 °C (-4 °F to 131 °F)
- Storage Environment: -30 °C to 60 °C (-22 °F to 140 °F)
- Humidity: 0 to 98% RH (non-condensing)
- Sealed piston shaft and bearing to prevent contamination
Dimensions:
Height: 22-1/2” (57.2cm) Width: 7-5/8” (19.4cm) Length: 18-1/4” (46.4cm)
Weight: 16 lbs (7.26kg) 19.5 lbs (8.85kg) (with base attached)
REV: 2013-06 38
5.12 Electromagnetic Environmental Declaration
NOTE: The Life-Stat is powered by 9V DC batteries and does not use a Public Mains Power Network.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
REV: 2013-06 39
Guidance and manufacturer’s declaration- electromagnetic immunity
The Life-Stat is intended for use in the electromagnetic environment specified below. The customer or the
user of the Life-Stat should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Electromagnetic environment-guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of the Life-Stat,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz
to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in
calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Life-Stat is used exceeds the applicable RF compliance level above, the Life-Stat should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the Life-Stat.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than (Not applicable) V/m.
REV: 2013-06 40
Recommended separation distances between
portable and mobile RF communications equipment and the Life-Stat
The Life-Stat is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of the Life-Stat can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Life-Stat as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum output 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
power of transmitter outside ISM bands in ISM bands d = 1.2 d = 2.3
W
Not Applicable Not Applicable
0.01 Not Applicable Not Applicable 0.12 0.23
0.1 Not Applicable Not Applicable 0.38 0.73
1 Not Applicable Not Applicable 1.2 2.3
10 Not Applicable Not Applicable 3.8 7.27
100 Not Applicable Not Applicable 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;
26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
NOTE 3 An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters
in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects,
and people.
REV: 2013-06 41
5.13 Parts List (Life-Stat®)
h
Part No. Description |
Resuscitation
16000Y Life-Stat® Model 1008MII (Yellow)
14790-01 BackBoard
14850 Carrying/Storage Case (shoulder strap)
15450 CPR Carrying Case- Backpack
Replacement Parts
16005 Life-Stat® Instructions for Use (IFU) Manual
15440 BackBoard Replacement “H” Strap Kit
14910 O2 Supply Hose 10 Ft.
14950 O2 Supply Hose 15 Ft.
14780 Massager Pad Assembly, Urethane
14669 Breathing Hose – disposable
14384 Non Re-breathing Valve (NRV) – disposable (5/pkg)
14682 Pressure Limit Alarm
14781 PDV Replacement Lip Valve
14785 PDV Replacement Cap (Hose Adaptor)
Oxygen Management
15290 MOC Dual D Tank Soft Case
15300 MOC Dual E Tank Soft Case
11732 Aluminum Oxygen Tank "D" size
11733 Aluminum Oxygen Tank "E" size
For pricing or to place an order, please contact our customer service department at (800) 530-9939.
REV: 2013-06 42
6-Warranty and Factory Service Information
6.1 Model 1008MII Life-Stat® Cardiopulmonary Resuscitator Warranty Agreement
Your CARDIOPULMONARY RESUSCITATOR ( Model 1008MII) is warranted by Michigan
Instruments, Inc., Grand Rapids, Michigan to be free of defects in material and workmanship for a
period of two (2) years from the date of receipt by the end purchaser or 1,000,000 (1 million) cycles,
whichever comes first. (The 1,000,000 (1 million) cycles is indicated by the START/ON green LED
blinking.)
All repairs necessitated by malfunction of this equipment during the warranty period when in normal
use in accordance with instructions provided will be accomplished at the Michigan Instruments, Inc.
factory, or authorized service facility, without charge other than the cost of transportation to the
factory or authorized service facility. Michigan Instruments, Inc. hereby reserves the right to perform
warranty repairs with used and/or reconditioned components that meet or exceed the original
component specifications. Michigan Instruments, Inc. undertakes NO LIABILITY HEREUNDER
FOR SPECIAL OR CONSEQUENTIAL DAMAGES, or any other expense liability beyond the
furnishing of materials and labor for the repairs covered hereby. This warranty does not cover mars
and blemishes, scratches, or dents, which may result from normal use of this equipment or
malfunctions due to mishandling or improper packaging. This warranty does not cover batteries.
If the warranty registration IS NOT PERFORMED, the warranty period will begin the DATE THE
INSTRUMENT WAS SHIPPED FROM THE FACTORY. For Warranty Registration information
refer to the Warranty Agreement supplied with the device. Visit www.life-stat.com or
www.michinst.com for on-line registration.
This warranty is IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED, and shall be
void as to any products which have been repaired or altered by others or have been subject to misuse
or abuse. Buyer agrees that this written warranty constitutes the entire agreement as to warranties
between the parties. Any prior or contemporaneous oral statements, which have not been written into
this agreement, are not binding and this contract shall not be rescinded or modified except by a signed
writing.
6.2 Purchase Records (fill in the following information for your records)
SERIAL NUMBER:
DATE OF RECEIPT:
PURCHASED FROM:
REV: 2013-06 43
6.3 Factory Service Policy
The Life-Stat® CPR System is manufactured to very demanding quality standards. It is designed to
provide years of trouble-free service if proper care is taken in its operation and required preventive
maintenance procedures are performed regularly. In addition to the regular maintenance performed by
the user, factory service is recommended after the device has delivered1,000,000 (1 million) cycles as
indicated by the START/ON green LED flashing continuously. Refer to the table titled “Factory
Recommended Maintenance/Service Intervals” in the Periodic Preventive Maintenance portion for
recommended intervals.
A. Do not attempt repairs that are not outlined in this manual. Many components are critical to the
proper operation of the device and MUST be serviced at the factory.
B. If you find that factory service is required, call the Michigan Instruments, Inc. Service Department
at (800) 530-9939 between the hours of 9:00am and 5:00pm EST. Please have available the model
number, serial number, and a description of the problem. An RMA Number will be issued at that
time. Requests for repair parts or any service related questions should also be directed to the
Service Department.
C. If your Life-Stat® CPR System must be returned to Michigan Instruments, Inc., please observe the
following procedures:
1. First and foremost, clean and sterilize the device to remove any contaminants or body fluids.
Failure to do so will result in additional charges. If contamination is severe, the unit will be
returned, at customer’s expense, to remove contamination and resubmit for service.
2. Use the original carton and packing material. It will provide maximum protection during
shipping. (Shipping cartons may be purchased from Michigan Instruments, Inc.) DO NOT
USE THE CARRYING/STORAGE CASE AS A SHIPPING CONTAINER. It is not
designed to withstand rigorous handling during shipping. Returning the Case is not necessary
unless it also requires repair. The Case should be packaged separately, if returned.
3. Return only those items that require service and specify the service requested on a packing list.
4. Place all components in plastic bags before putting them in the shipping container. This will
keep dirt and other debris from entering the device through unprotected openings.
REV: 2013-06 44
6. Ship via your preferred carrier (FedEx, UPS, etc) PREPAID and insured to:
Upon receipt the device will be evaluated and a repair estimate prepared for approval. Written
approval and/or a purchase order are required before any repairs will be started. After approval
is received a completion date will be established.
All non-warranty devices returned to Michigan Instruments, Inc. must be evaluated and require an
evaluation fee plus return shipping charges. This fee will be charged ONLY if repairs are not
authorized and the device must be returned unrepaired. We are obligated to label and tag as
"unusable" any Life-Stat® CPR System that requires authorized factory service.
Michigan Instruments, Inc. reserves the right to install used/refurbished components that meet or
exceed original manufacture specifications when performing repairs.
All repairs, parts and labor, are covered by a factory service warranty for 90 days. The warranty is
subject to the same limitations and conditions of the original warranty. The factory service warranty
applies only to those components repaired, rebuilt or replaced at time of service.
The customer is not responsible for the evaluation fee, but is required to pay for shipping charges to
the factory or repair facility.
REV: 2013-06 45
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REV: 2013-06 46
GLOSSARY
TERMS USED IN MANUAL
A-P Diameter Anterior-Posterior dimension of the chest. Thickness of chest over the sternum
measured front to back.
Cardiac Arrest Cessation of cardiac function with disappearance of arterial blood flow.
Clinical Death Condition where all external signs of death are present although the body cells may
still be viable. Specifically, clinical death is manifested by:
1. Lack of breathing
2. Lack of pulse and heart sounds.
ECG (Electrocardiogram) A graphic tracing of the electrical current caused by contraction of the
heart muscle.
Protocol The timing and sequencing of the various steps of cardiopulmonary resuscitation. (Meaning
as used in this Manual.)
Xiphoid Process The pointed process of cartilage, supported by a core of bone, connected to the
lower end of the sternum.
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