123

Test Report issued under the responsibility of:
TEST REPORT
IEC 60601-1-2
Medical Electrical Equipment
PART 1-2: General Requirements for Basic Safety
and Essential Performance
Collateral Standard: Electromagnetic Compatibility
Report Number. .............................. : GZES200702328001
Date of issue ................................... : 2021-11-18
Total number of pages .................... 216
CB Testing Laboratory ................... : SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou
Branch
Address ........................................... : 198 Kezhu Road, Science City, Economic & Technology
Development Area, Guangzhou, Guangdong, China
............................ : Shenzhen Comen Medical Instruments Co., Ltd
Address ........................................... : Floor 10, Floor 11 and Section C of Floor 12 of Building 1A &
Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building,
Nanhuan Avenue, Matian Sub-district, Guangming District,
Shenzhen, Guangdong, 518106, P.R. China
Test specification:
IEC 60601-1-2:2014, IEC 60601-2-26:2019 Clause 201.17 & 202,
IEC 60601-2-27:2011 Clause 201.17 & 202, IEC 80601-2-
30:2018 Clause 201.17 & 202, IEC 60601-2-34:2011 Clause 202,
Standard .......................................... : IEC 60601-2-40:2016 Clause 201.17 & 202, ISO 80601-2-
55:2018 Clause 201.17 & 202, ISO 80601-2-56:2017 + A1:2018
Clause 201.17 & 202, ISO 80601-2-61:2017 Clause 201.17 &
202.
Test procedure ............................... : SGS-CSTC
Non-standard test method............. : N/A
Test Report Form No. ..................... : IEC60601_1_2DEMC
Test Report Form(s) Originator..... : UL
Master TRF ...................................... : Dated 2014-12
Copyright © 2014 IEC System of Conformity Assessment Schemes for Electrotechnical
Equipment and Components (IECEE System). All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting
from the reader's interpretation of the reproduced material due to its placement and context.
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory
and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.
General disclaimer:
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing CB Testing Laboratory. The authenticity of
this Test Report and its contents can be verified by contacting the NCB, responsible for this Test Report.
Page 2 of 216 SGS Report Ref. No GZES200702328001
1.0 Testing Program Details
Test item description ....................... : Patient Monitor

Trade Mark ........................................ : Comen
Manufacturer .................................... : Same as applicant
Model/Type reference ...................... : K12 Pro, K12A Pro
Ratings .............................................. : Input: 100-240V~, 50/60Hz; 1.5A-0.75A
Internal lithium-ion battery pack: DC 10.95V; 5500mAh
Responsible Testing Laboratory (as applicable), testing procedure and testing location(s):
Testing Laboratory: SGS-CSTC Standards Technical Services Co., Ltd.

Guangzhou Branch
Testing location/ address............................. : 198 Kezhu Road, Science City, Economic & Technology
Development Area, Guangzhou, Guangdong, China
Associated Testing Laboratory: N/A
Testing location/ address............................. :
Tested by (name, function, signature) ........ : Darren Fu
Approved by (name, function, signature) ... : Fvan Tu
Testing procedure: TMP/CTF Stage 1: N/A

Tested by (name, function, signature) ........ :
Approved by (name, function, signature) ... :
Testing procedure: WMT/CTF Stage 2: N/A

Tested by (name + signature) ...................... :
Witnessed by (name, function, signature) . :
Testing procedure: N/A

SMT/CTF Stage 3 or 4:
Tested by (name, function, signature) ........ :
Witnessed by (name, function, signature) . :
Supervised by (name, function, signature) :
TRF No. IEC60601_1_2DEMC

Page 3 of 216 SGS Report Ref. No. GZES200702328001
Summary of testing:
Tests performed (name of test and test clause): Testing location:

Electromagnetic Interference (EMI): SGS-CSTC Standards Technical Services Co.,
Ltd. Guangzhou Branch.
Conducted Emission
(150 kHz to 30 MHz)
Radiated Emission
(30 MHz to 1 GHz)
Harmonic Emission on AC
Flicker Emission on AC
Electromagnetic Susceptibility (EMS):
Electrostatic Discharge
Radiated Immunity
(80 MHz to 2700 MHz)
Radiated Immunity to proximity fields
Electrical Fast Transients (Burst)
Surge Immunity
Injected Currents
(150 kHz to 80 MHz)
Power-frequency magnetic field immunity
Voltage Dips and Interruptions
Summary of compliance with National Differences:
List of countries addressed:
N/A
The product fulfils the requirements of
IEC 60601-1-2:2014, IEC 60601-2-26:2019 Clause 201.17 & 202, IEC 60601-2-27:2011 Clause 201.17
& 202, IEC 80601-2-30:2018 Clause 201.17 & 202, IEC 60601-2-34:2011 Clause 202, IEC 60601-2-
40:2016 Clause 201.17 & 202, ISO 80601-2-55:2018 Clause 201.17 & 202, ISO 80601-2-56:2017 +
A1:2018 Clause 201.17 & 202, ISO 80601-2-61:2017 Clause 201.17 & 202.

Possible test case verdicts:

- test case does not apply to the test object ........... : N/A
- test object does meet the requirement.................. : P (Pass)
- test object does not meet the requirement ........... : F (Fail)
Testing.......................................................................... :
Date of receipt of test item ........................................ : 2020-09-01
Date (s) of performance of tests ............................... : 2020-09-02 to 2020-09-22
General remarks:
"(See Enclosure #)" refers to additional information appended to the report.
"(See appended table)" refers to a table appended to the report.
The test results presented in this report relate only to the object tested.
The results contained in this report reflect the results for this particular model and serial number.
It is the responsibility of the manufacturer to ensure that all production models meet the intent of
the requirements detailed within this report.
This report shall not be reproduced, except in full, without the written approval of the Issuing
testing laboratory.
List of test equipment must be kept on file and available for review.
Additional test data and/or information provided in the attachments to this report.
This document is issued by the Company subject to its General Conditions of Service available
on request or accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic
format documents, subject to Terms and Conditions for Electronic Documents at
http://www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx. Attention is drawn to the
limitation of liability, indemnification and jurisdiction issues defined therein.
ponsibility is to its Client and this document does not exonerate parties to a
transaction from exercising all their rights and obligations under the transaction documents. This
document cannot be reproduced except in full, without prior written approval of the Company. Any
unauthorized alteration, forgery or falsification of the content or appearance of this document is
unlawful and offenders may be prosecuted to the fullest extent of the law.
Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and
such sample(s) are retained for 30 days only.
Throughout this report a comma / point is used as the decimal separator.
Name and address of factory (ies):
Same as applicant

General product information:

Refer to the relevant safety report IEC 60601-1.
KPro series patient monitor is a multi-parameter physiological patient monitor intended for use in
multiple areas and intrahospital transport within a professional healthcare facility. The monitors
support multiple non-invasive and invasive measurements, including ECG (3-lead, 5-lead, 6-lead or
12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, interpretation of
resting 12-lead ECG, Heart Rate (HR), Respiration rate(impedance respiration and CO2 airway gas),
Temperature(Temp), Pulse Rate (PR), Pulse Oxygen Saturation (SpO2), Masimo Rainbow SpO2,
Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge
Pressure (PAWP), Cardiac Output (C.O.), Impedance Cardiograph (ICG), Bispectral Index (BIS),
SedLine EEG, Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT),
Regional Oxygen Saturation (rSO2), Carbon Dioxide (CO2), Anesthesia gas (AG) and Oxygen (O2)
respiratory gas monitoring.
The monitors are to be used in healthcare facilities by clinical professionals or under their
guidance.
The equipment connects to supply mains directly through appliance coupler and is classified as
class I ME equipment. it can also be internally powered by rechargeable Li-ion battery pack.
It can connect to K1/K1A or KPM module and specified plug-in modules through slots. These
to the main unit. K1, K1A or KPM can be plug-in to the equipment one at a time. One specified
printer module is configured for recording and printing reports.
K1/K1A can work as a stand-alone patient monitor, refer to test report GZES200702332201 for
details.
Classification of applied part:

Defibrillation-proof type CF: ECG cable and electrode, IBP transducer sensor, NIBP cuff,
SpO2probe, Temperature probe, C.O. cable and catheter, NMT sensor and electrode.
Defibrillation-proof type BF: ICG cable and electrode, O3 Regional Oximetry sensor,BIS electrode,
SedLine EEGelectrode, AG/CO2 sampling tube and adaptor set, O2 sensor and sampling kit,
respiratorymechanical monitoring flow sensor and Wakeup sensor.
The optional configuration of patient monitor and plug-in modules:

K1/K1A/KPM module supports monitoring of ECG, Respiration rate, SpO2, NIBP, IBP(IBP1 and
IBP2), Pulse Rate, Temperature (T1 and T2) and CO2.
External modules can be plugged into the module rack (Z03) to establish communication with
patient monitor. There are 22 plug-in modules as table below:
No. REF/PN Description Applied part / Accessories Applied

part type
1 C-01 Double IBP plug-in IBP1, IBP2 Type CF
115-003995-00 module IBP transducer sensor
2 C-03/ C.O. plug-in module C.O. cable and catheter Type CF
115-003989-00
3 C-05/ Wake/O2 apnea Wakeup sensor, O2 sensor and Type BF
115-0004492-00 plug-in module sampling kit
4 C-07/ ICG plug-in module ICG Cable and electrode Type BF
115-003991-00

5 C-11/ Mainstream CO2 CO2 sampling tube and adaptor Type BF

115-003993-00 plug-in module set
RGM module1):
Masimo IRMA mainstream CO2
module (REF: 200101)
Respironics mainstream CO2
module (REF: 1015928)
COMEN mainstream CO2 module
(REF: M-01)
6 C-12/ Comen sidestream CO2 sampling tube and adaptor Type BF
115-004493-00 CO2 plug-in module set
7 C-13/ Masimo ISA CO2 sampling tube and adaptor Type BF
115-003994-00 sidestream CO2 set
plug-in module
8 C-14/ Masimo Capno CO2 sampling tube and adaptor Type BF
plug-in module
9 C-15/ Respironics CO2 sampling tube and adaptor Type BF
115-004495-00 CapnoTrak set
sidestream CO2
plug-in module
10 C-16/ Respironics LoFlo CO2 sampling tube and adaptor Type BF
plug-in module
11 C-21/ Nellcor SpO2 plug- SpO2probe Type CF
115-004496-00 in module
12 C-22/ Masimo MS-2040 SpO2probe Type CF
115-004497-00 SpO2 plug-in
module
13 C-23/ Masimo Rainbow Rainbow SpO2probe Type CF
115-004505-00 SpO2 plug-in
module
14 C-25/ Masimo AG sampling tube and adaptor set Type BF
115-005993-00 mainstream AG
RGM module: Masimo IRMA
plug-in module
mainstream AG module (REF:
200601)
15 C-26/ Masimo ISA AX+ AG sampling tube and adaptor set Type BF
115-003990-00 sidestream plug-in
module
16 C-28/ Masimo ISA OR+ AG sampling tube and adaptor set Type BF
115-004499-00 sidestream plug-in
module
17 C-31/ COVIDIEN BIS plug- BIS electrode Type BF
115-003992-00 in module COVIDIEN BIS module (REF: 186-
0195-SF)
18 C-32/ Masimo SedLine SedLine EEGelectrode Type BF
115-004504-00 EEG plug-in SedLine MOC-
module patient cable (REF: 4298)
19 C-36/ Comen RM plug-in Respiratorymechanical monitoring Type BF
115-004500-00 module flow sensor
20 C-37/ ARTEMA SPIRIT Respiratorymechanical monitoring Type BF
115-004501-00 Respiratory flow sensor
Mechanics Analysis
plug-in module

21 C-41/ XAVANT NMT plug- NMT sensor and electrode Type CF

115-004502-00 in module
22 C-46/ Masimo O3 O3 Regional Oximetry sensor Type BF
115-004503-00 ReginalOximetry
plug-in module
Note:
1) Only one extended CO2 module can be connected to a plug-in module.
2)For CO2 plug-in modules, only one CO2 module can be activated for use at a time.
3) For AG plug-in modules, only one AG module can be activated for use at a time.
4)For SpO2 plug-in modules, only one SpO2module can be activated for use at a time.
5) For RM plug-in modules, only one RMmodule can be activated for use at a time.
External interface:
When the patient monitor is connected to the specified external equipment, they constitute an ME
system:
- The secondary display can be connected to the patient monitor through HDMI port to provide an
adaptive duplicate image of the primary display, while the extender view is not specified for
monitoring or diagnostic purpose.
- The monitors can interact with several compatible patient monitor locally at other bedside and
supports view on another bed.
- The monitors have an Ethernet interface or wireless supporting network connection with Central
Monitoring System (CMS).
- The monitors have nurse call connector connecting to the nurse call system as Distributed
Information System.
- The monitors can connect to external printer for printing reports. The printer should complied
with relevant IEC/ISO safety standards.
- The monitors have USB connectors supporting USB devices such as U-DISK
Model difference:
Models K12Pro, K12APro are the same except for the model name and optional functional
configuration of ICG plug-in modules. Model K12APro has no configuration of ICG plug-in module
while Model K12Pro has full configuration.
After reviewing, model K12Pro was selected as the representative model tested in the report.
Intended Use:
Specify environment: Professional healthcare facility environment.
Any deviations from the Basic EMC standards or from this collateral standard: None.

Measurement Uncertainty
No. Item Measurement Uncertainty

Conducted Disturbance Voltage at Mains ±3.63dB (9kHz to 150kHz)
1
Terminals ±3.22dB (150kHz to 30MHz)
2 Disturbance Power ±3.78dB
±5.0dB (30MHz-1GHz)
3 Radiated Emissions
±5.0dB (1GHz-6GHz)
4 Radiated Immunity ±2.18dB(80MHz-3GHz)
5 Conducted Immunity ±3.5dB(150kHz-230MHz)
6 Electrostatic Discharge ±6 %
7 EFT (Electrical Fast Transients) ±4 %
8 Surge Immunity ±6%
9 Voltage Dips and Interruptions ±4 %
10 Temperature ±0.4°C
11 Humidity ±1.3%
12 DC power ±0.5 %

Report Index:
Item Description
1.0 Testing Program Details 2
1.1 Equipment Description 10
1.1.1 Equipment Used During Test 10
1.1.2 Input/Output Ports 10
1.1.3 Power Interface 10
1.2 EUT Operation Modes 11
1.3 EUT Configuration Modes 11
1.4 Immunity Performance Criteria 11
1.5 Compliance Summary 19
1.6 Result Summary 21
1.7 Test Conditions and Results Conducted Emissions 22
1.8 Test Conditions and Results Radiated Emissions 29
1.9 Test Conditions and Results Disturbance Power Emissions 36
1.10 Test Conditions And Results Limits for Harmonics Current Emissions 37
1.11 Test Conditions And Results Limits for Voltage Fluctuations and 41
Flicker
1.12 Test Conditions and Results Immunity to electrostatic discharges 44
1.13 Test Conditions and Results Immunity to RF electromagnetic fields 47
1.14 Test Conditions and Results Proximity fields from RF wireless 51
communications equipment
1.15 Test Conditions and Results Electrical Fast Transients Immunity 56
1.16 Test Conditions and Results Surge Immunity 58
1.17 Test Conditions and Results Conducted Disturbances Immunity 61
1.18 Test Conditions and Results Power Frequency Magnetic Immunity 64
1.19 Test Conditions and Results Voltage Dips, Interruptions Immunity 66
1.20 Test Conditions and Results Electrical transient conduction along 69
supply lines
Annex EUT Constructional Details 71

1.1 Equipment Description
Patient Monitor
1.1.1 Supporting Equipment Used During Test:
Use* Product Type Manufacturer Model Comments

Shenzhen Comen
EUT Patient Monitor Medical Instruments Co., K12 Pro None
Ltd
Non-Invasive Blood
SIM Fluke Bppump2M None
Pressure Simulator
Pulse Oximeter
SIM Fluke INDEX-2XLFE None
Simulator
MULTPARRAMETER
SIM Fluke MPS450 None
SIMULATOR
Note: * Use one of the following:

EUT - Equipment Under Test
AE - Auxiliary/Associated Equipment
SIM - Simulator (Not Subjected to Test) *Note: Use abbreviations:
1.1.2 Input/output Ports:
Port Name Type* Cable Cable Comments

No. Max. >3m Shielded (Sip/Sop lines must include
description of use)
0 Enclosure N/E None
1 Power in AC 1.8m Unshielded None
2 Adapter cable DC 1.4m Unshielded None
3 ECG cable PC 3.7m Shielded None
4 BLT SpO2 cable PC 3.7m Shielded None
5 Masimo SpO2 cable PC 4.5m Shielded None
6 Nellcor SpO2 cable PC 3.2m Shielded None
7 Temp cable PC 4.0m Shielded None
8 CO2 extension cable PC 2.2m Shielded None
9 IBP cable PC 3.0m Shielded None

Supplementary information: none.

*Note: AC = AC Power Port DC = DC Power Port N/E = Non-Electrical
Batt=Battery Sip/Sop = Signal Input/output Port PC Patient-Coupled Cable
TP = Telecommunication Ports
1.1.3 Power Interface
Mode Voltage Current Power Frequency Phases Comments

No. (V) (A) (W) (DC/AC-Hz) (No.)
1 100-240V AC: 50/60-Hz Single None
(Internal rechargeable Li-ion
2 10.95V - - DC -
battery)
1.2 EUT Operation Modes:
Mode # Description
1# Test the EUT in the monitor mode with all parameters measuring and powering by internal battery.
Test the EUT in the monitor mode with all parameters measuring, in which the mains is supplied
2#
and the internal power is charged.
Test the EUT in the monitor mode with all parameters measuring, in which the Power adapter is
3#
supplied and the internal power is charged.
4# Test the EUT in data transmitting mode.
5# Test the EUT in standby mode.

Remark:
During all emission tests, the EUT was configured to measure its highest possible emission level
EUT was configured to have its highest possible susceptibility against the tested phenomena.
1.3 EUT Configuration Modes
Mode # Description
The EUT had been test as full configuration (any one possible configuration). The test
1
conditions were adapted accordingly in reference to the instruction for use.

1.4 Basic Safety, Essential Performance and Immunity Pass/Fail Criteria as determined by the
Manufacturer
Description of BASIC SAFETY and ESSENTIAL PERFORMANCE

Basic safety:
Meet the requirement of IEC 60601-1:2005+A1:2012 and particular standards of IEC 60601-2-25:2011/ IEC
80601-2-26:2019/ IEC 60601-2-27:2011/ IEC 80601-2-30:2018/ IEC 60601-2-34:2011/ IEC 60601-2-40:2016/
IEC 80601-2-49:2018/ ISO 80601-2-55:2018/ ISO 80601-2-56:2017+A1 2018 and ISO 80601-2-61:2017, no
hazardous situation according to IEC 60601-1:2005+A1:2012 Clause 13.2 occur.
Essential performance:
Function item Essential performance requirement

General Electrosurgery interference
Defibrillation proof
Interruption of the power supply/supply mains to ME equipment
Protection against depletion of battery
Multifunction Displaying data according primary operating functions
patient monitor Determination of alarm conditions and assignment of priority
Indication of validity of measured values
Or generating a technical alarm condition
or failure that is readily identifiable by the operator
ECG (for Essential performance:
diagnostic Requirements for amplitude measurements
purposes) Requirements for absolute interval and wave duration measurements
Requirements for interval measurements on biological ECGS
Indication of inoperable electrocardiograph
Filters (including line frequency interference filters)
Electrostatic discharge
Electric fast transients and bursts
Conducted disturbances
ECG (for Essential performance:
monitoring) Accuracy of signal reproduction
Input dynamic range and differential offset voltage
Input impedance
Input noise
Multichannel crosstalk
Gain control and stability
Sweep speed
Frequency and impulse response
Gain indicator
Common mode rejection
Baseline reset
Pacemaker pulse display capability
Rejection of pacemaker pulses
Synchronizing pulse for cardioversion
Heart rate range, accuracy, and QRS detection range
Channel height and aspect ratio
Tall T-wave rejection capability
Time to alarm for heart rate alarm
Technical alarm conditions indicating inoperable ME equipment
BIS / EEG Accuracy of amplitude and rate of variation
Input dynamic range and differential offset voltage
Input noise

Frequency response
Common mode rejection
Indication of invalid data
Invasive pressure Accuracy of pressure measurements
measurement (IBP) Delays to or from a distributed alarm system
Physiological alarm conditions, alarm limits and delay time of physiological
alarm signals
Detection of transducers and transducer cable fault
Detection of disconnected catheter
NIBP Limits of the error of the manometer
or generation of a technical alarm condition
Reproducibility of the blood pressure determination
Low and high blood pressure physiological alarm conditions
or generation of a technical alarm condition
Respiratory Gases Measurement accuracy and alarm condition for gas reading
(CO2, O2, N2O, or generation of a technical alarm condition
Anesthetic Agents)
Temperature Accuracy of the clinical thermometer
Or generation of a technical alarm condition
not providing an output temperature
SpO2 SpO2 accuracy
Pulse rate accuracy
Physiological alarm conditions
Or generation of a technical alarm condition, concerning signal inadequate, low
SpO2 level, detection of probe fault and probe cable extender fault
Respiration Measurement of respiration rate within specified accuracy
Generate physiological alarm condition of apnea alarm and respiration rate
C.O. Measurement of blood temperature within ±0.1°C.
Measurement of cardiac output accuracy is within ±5% or ±0.1 l/min, whichever
is greater.
Generate a physiological alarm condition of blood temperature
NMT Measurement of Train-Of-Four, Post-Tetanic-Count, Double-Burst and Single-
Twitch stimulation responses.

Description how the BASIC SAFETY and ESSENTIAL PERFORMANCE were monitored during each test
(Note: for some basic safety this monitoring might be carried out before and after the test)
Immunity Pass/Fail Criteria
During and after non-transient phenomena, The EUT maintained the basic safety and essential
performance during the test.
The following degradations are not found during the rest:
1) component failures;
2) changes in programmable parameters or settings;
3) reset to default settings;
4) change of operating mode;
5) initiation of an unintended operation;
6) change in clamed accuracy at any point in the rated output range greater than stated and without the
generation of either a technical alarm conditions or physiological alarm conditions or an indication of
abnormal operation. Such as measured heart rate, temperature output, %SpO2, pulse rate and blood
pressure.
7) change in the reading for the measurement of the cuff pressure at any point of the normal
measurement range greater than 2 mmHg (0.3 kPa):
1) during and after exposure to non-transient phenomena; and 2) after exposure to transient
phenomena.
8) interference is readily identifiable by the operator, such as large noise on the ECG waveform, heavily
and rapidly fluctuating numeric values. In the event of disruption during immunity tests, the patient
monitor shall recover from any disruption within 10 s.
Within 30 s after the transient electromagnetic phenomena are discontinued, multifunction patient
monitors
- shall resume normal operation without operator intervention, without loss of any operator settings
or stored data; and
- shall provide basic safety and essential performance, and continue to perform its intended function,
including measurement and monitoring of ECG, heart rate, arrhythmia, ST, QT, respiration rate,
SpO2, pulse rate, temperature, IBP, NIBP, C.O., ICG, EEG, BIS, rSO2, O2, CO2 and gas analysis, RM
and NMT module operation and the alarm system functionality.
During the test, set up the EUT for normal use as specified in IFU, used patient cables, lead wire,
transducer, sensors, probes, accessories and settings recommended by manufacturer under maximum
configuration. With the use of patient physiological simulation for simulated signal input, the patient
monitors collect the data and work as intended.
Parameters Verification/ monitoring method

General for Visual inspection and functional test that:
multifunction Displaying data according to primary operating functions of ECG waveform and HR,
patient ST, QT numerical values, respiration rate, %SpO2, SpMet, SpCO, SpOC, SpHb, PVI,
monitor PR, Temperature (T1 and T2), systolic pressure, diastolic pressure and mean arterial
pressure through NIBP and IBP measurement, FiO2, EtCO2, N2O, EtAA (through AG
gas analyzer), C.O., TFC, Bispectral Index (BIS), SQI, Patient State Index (PSI), rSO2,
TOF, PEEP and MVe (through RM module), TOF, waveform and alarm signals.
No interruption or cessation of current operating mode
Additional indication of invalid measured values, to distinguish from normal values
Indication of power supply and the remaining capacity of internal battery source is
available.
Generate an information signal to indicate a switchover to internal battery.
When the battery is near depletion, generate a high priority alarm condition of power
failure.
When the supply mains is interrupted for less than 30s and after restore, the monitors
continue in the same mode of operation with the setting and stores patient data is
preserved unchanged.
For NIBP function, the NIBP cuff pressure deflates within 30s to less than 5 mmHg.
For NMT module operation, the electrical stimulators are disabled upon power reset.

Manual intervention is required to re-start the stimulation.

When the supply mains is interrupted longer than 30s, the patient monitor reversion
to the last settings used, according to the startup setting.
Following exposed to the defibrillation voltage and defibrillation recovery time of 10s
(5s for ECG and IBP), the patient monitors resume normal operation in the previous
operating mode, without loss of any operator settings or stored data.
The patient monitors return to the previous operating mode within 10 s after exposure
to the field produced by the HF surgical equipment, without loss of any stored data.
This is one of the immunity tests. The test procedures can be derived from particular
standards IEC 60601-2-25, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-34, IEC 80601-
2-49.
ECG Connect the ECG signal generator to the EUT via the specified patient cables through
the general test circuit of Figure 201.105 of IEC 60601-2-27. Set the gain to 10 mm/mV
and the sweep speed to 25 mm/s. Adjust the signal generator to generate an input
signal produces an output amplitude of 80% of the full scale channel height. Apply a
d.c. offset voltage of +/-300 mV each time, then measure the time varying output
signal amplitude. Verify that this amplitude is within ±10% of the previously recorded
amplitude over the specified d.c. offset voltage range.
Adjust the signal generator to apply a 2 mV peak-to-valley input 20 Hz sinusoidal
signa. Verify that the output signal is completely visible and the resulting peak-to-
valley amplitude is between 16-24 mm.
Adjust the input signal rate from 0 1/min to 200 1/min for adult use and to 250 1/min
for neonatal or use, verify the displayed heart rate is within ±10% or ±1 bpm,
whichever is greater, of the input signal rate.
Adjust the signal generator to provide a 10 Hz signal. Apply a 10 Hz, 1 mV signal
superimposed on a d.c. voltage variable from 5 V to +5 V, verify the generation of a
technical alarm conditions indicating inoperable of the patient monitor.
Generate physiological alarm condition of Asystole, and heart rate limit violation
within delay time of 10s.
Detection of VFIB and generate an alarm condition
Feed the Calibration ECGs of CAL05000, start 12-lead resting ECG resting analysis,
and check the global interval and wave duration measurements on ECG report. The
amplitude measurement does not deviate from the reference value by more than ±25
Impedance Connect the vital sign simulator to the EUT and generate test signal of respiratory rate
respiratory of 30 rpm, 60 rpm and 100 rpm, and verify the displayed result is within ± 1 rpm.
rate Set the respiratory rate to zero and wait for the set no breath time. Verify the patient
monitor generate an alarm condition of apnea.
Alarm on respiration rate limit violation.
Temperature Place the temperature probe to a water bath and set temperature of 5°C and 50°C.
Confirm that the measurement error within ±0.2°C.
Alarming on temperature limit violation.
NIBP Connect the EUT to the patient simulator by means of a T-piece connector and hoses.
Set up the patient simulator to simulate a blood pressure of 100/70 mmHg ± 10 mmHg.
After test, confirm that displayed parameters on the monitor have returned to their
pre-test readings.
Setup the patient monitors to operate on automatic cycling mode such as continuous
operation mode and interval mode. Verify the monitor make pressure determination
as intended.
Simulator the cuff loose during inflation, verify the monitor generate a technical alarm
condition.
Alarming on systolic, diastolic and mean blood pressure limit violations.
IBP Setup the patient monitors and IBP simulator according to the test configuration in
Figure 201.108 of IEC 60601-2-34. Apply output pressure on IBP transducer of -50
mmHg, 100 mmHg and 350 mmHg.

Check the displayed values are within ± 4 % of reading or ± 0.5 kPa (± 4 mmHg),
whichever is greater, compared to the reference measurement.
Set the reference pressure measuring system (RPMS) has a systolic pressure of 120
mmHg and a diastolic pressure of 60 mmHg. Verify that the readings of the patient
monitor are within 120 mmHg ± 4 mmHg for systolic pressure and 60 mmHg ± 4 mmHg
for diastolic pressure
Check the pulse rate within ±10% or ±5 bpm, whichever is greater.
Check if any waveform deflection at normal sensitivity of 25mm/mV negative effect
the measurement.
Alarming on systolic, diastolic and mean blood pressure limit violations. The delay
time is less than 20s.
When disconnection of IBP transducer, catheter detected, the monitors generate a
technical alarm condition.
When IBP transducer or transducer cable fault, the monitor generate a technical alarm
condition or the failure that is readily identifiable by the operator.
SpO2 Connect the patient monitor, pulse oximeter probe and cable extender to SpO2
function tester. SpO2 and pulse rate signal are derived from a patient simulator:
- setting the SpO2 within the calibrated range to be 90%.
- setting the pulse rate to be 80 bpm, within the specified range of the pulse rate
display.
Verify the SpO2 (Functional Oxygen Saturation) accuracy is root-means quare
difference of less than or equal to 2.0% SpO2 over the range of 70% to 100% SaO2.
Pulse rate accuracy is root-mean-square difference of less than or equal to 2 bpm.
Alarming on oxygen saturation and pulse rate limit violation.
Detection of the oximeter probe fault and generate a technical alarm condition.
Rainbow Connect the patient monitor, pulse oximeter probe and cable extender to SpO2
SpO2 function tester. Set the simulated signal and verify that:
SpO2 (Functional Oxygen Saturation) Accuracy shall be root-mean-square difference
of less than or equal to 2.0% SpO2 over the range of 70% to 100% SaO2
SpCO (carboxyhemoglobin saturation) Accuracy shall be root-mean-square difference
of less than or equal to 3.0% SpCO over the range of 0% to 100% without motion.
SpMet (methemoglobin saturation) Accuracy shall be root-mean-square difference of
less than or equal to 1.0% SpMet over the range of 0% to 100% without motion
SpHb (total hemoglobin) Accuracy shall be root-mean-square difference of less than
or equal to 1.0% SpHb over the range of0-25 g/dl without motion.
BPM (pulse rate) Accuracy shall be root-mean-square difference of less than or equal
to 3 bpm over the range of 25-240 bpm without motion.
Alarming on limit violation of the respective parameters.
Respiratory Set up and calibrate the CO2/AG gas analyzer and oxygen sensor, use the appropriate
Gases (CO2, test gas mixture specified in Table 201.103 of ISO 80601-2-55, Take gas reading at the
O2, N2O, specified gas levels for each gas is within the stated measurement accuracy as
Anesthetic following:
Agents) Masimo IRMA CO2 mainstream/ Masimo ISA/Capno CO2 sidestream: 0-114 mmHg:
±(2.25mmHg+4%*reading)
Respironics CAPNOSTAT 5 mainstream CO2, Comen mainstream CO2 module:
0 mmHg-40 mmHg, ± 2 mmHg; 41 mmHg-70 mmHg, ± 5% of the reading;
71 mmHg-100 mmHg, ± 8% of the reading; 101 mmHg-150 mmHg, ± 10% of the
reading.
Respironics LoFlo sidestream, Comen sidestream CO2:
0 mmHg-40 mmHg, ± 2 mmHg; 41 mmHg-70 mmHg, ± 5% of the reading;
71 mmHg-100 mmHg, ± 8% of the reading; 101 mmHg-150 mmHg, ± 10% of the
reading.
Respironics Capno sidestream CO2: 0 mmHg-38 mmHg, ± 2 mmHg; 39 mmHg-99
mmHg, ± 10% of the reading;
Masimo AG (mainstream and sidestream):
CO2: 0%-15%: ±(0.2%+2% of reading);
N2O: 0%-100% ±(2%+2% of reading)

HAL, ENF, ISO: 0%-8%: ±(0.15%+5% of reading);

SEF: 0%-10%: ±(0.15%+5% of reading);
DES: 0%-22%: ±(0.15%+5% of reading);
O2: 0-100%: ±(1%+2% of reading)
Oxygen sensor: 0%-40%: ±1%; 41%-60%: ±2%; 61%-80%: ±3%; 81%-100%: ±4%.
Measurement of airway respiration rate within specified accuracy/error limits: ± 1rpm.
Alarming on apnea, airway respiration rate and respiratory gas limit violation.
BIS Measurement of Bispectral Index (BIS).
Alarming on BIS limit violation
EEG Measurement of Patient State Index (PSI, %), Density Spectral Array (DSA), EEG
waveforms (L1, R1, L2, and R2), EMG Index (EMG, %), Suppression Ratio (SR, %) and
Artifact (ARTF, %).
Cardiac Connect the patient monitor to patient simulator start C.O. measurement. Verify the
output measured blood temperature accuracy is within ±0.1°C.
The measured cardiac output accuracy is within ±5% or ±0.1 l/min, whichever is
greater.
Alarming on blood temperature limit violations.
NMT With nominal resistance of 5kohm, the patient monitors with NMT module can operate
under Train-Of-Four, Post-Tetanic-Count, Double-Burst and Single-Twitch stimulation
mode, and measurement of TOF(%).
Alarming on TOF Count limit violation

1. IMMUNITY Pass/Fail Criteria

Test Pass/Fail Criteria description Part 2 reference
Description
Electrostatic --malfunction; IEC60601-2-25:2011
Discharges --non-operation when operation is required; IEC60601-2-27:2011
--unwanted operation when no operation is IEC60601-2-34:2011
required; IEC80601-2-49:2018
--deviation from normal operation that poses an ISO80601-2-55:2018
unacceptable RISK to the PATIENT or OPERATOR; ISO80601-2-
--component failures; 56:2017+A1:2018
--change in programmable parameters; ISO80601-2-61:2017
Radiated RF -- /
EM Fields --change of operating mode;
--a FALSE POSITIVE ALARM CONDITION;
--a FALSE NEGATIVE ALARM CONDITION(failure to
alarm);
Proximity --cessation or interruption of any intended /
Wireless operation, even if accompanied by an ALRAM
fields SIGNAL;
--initiation of any unintended operation, including
unintended or uncontrolled motion, even if
Electrical IEC60601-2-25:2011
accompanied by an ALARM SIGNAL;
Fast IEC60601-2-27:2011
--error of a displayed numerical value sufficiently
Transients IEC60601-2-34:2011
large to affect diagnosis or treatment;
and bursts IEC80601-2-49:2018
--noise on a waveform in which the noise would
Surges ISO80601-2-55:2018
interfere with diagnosis, treatment or monitoring;
Conducted ISO80601-2-
--artefact or distortion in an image in which the
Disturbances, artifact would interfere with diagnosis, treatment or 56:2017+A1:2018
induced by ISO80601-2-61:2017
monitoring;
RF fields --Wireless Functions shall be self-recoverable:
Shall operate as intended after recovering;
Voltage Dips Shall be no degradation of performance; ISO80601-2-55:2018
and Shall be no loss of stored data or user ISO80601-2-
Interruptions programmable functions. 56:2017+A1:2018
--failure of automatic diagnosis or treatment ME
EQUIPMENT or ME SYSTEM to diagnose or treat,
Rated Power- even if accompanied by an ALARM SIGNAL. /
frequency
Magnetic
Field
Note: Specific, detailed IMMUNITY pass/fail criteria, shall be based on applicable part two
standards or RISK MANAGEMENT, for IMMUNITY with regard to EM DISTURBANCES. These
pass/fail criteria shall be included in the RISK MANAGEMENT FILE.

1.5 Compliance Summary
IEC 60601-1-2
Clause Requirement + Test Result - Remark Verdict
4 GENERAL REQUIREMENTS
4.1 Risk management process for ME equipment and ME P
systems.
5 IDENTIFICATION, MARKING AND DOCUMENTS

5.1 Equipment specified for use only in shielded location N/A
has appropriate marking/warning labels
5.2 Accompanying Documents
5.2.1 Instructions for use
5.2.1.1 General
a) A statement of the environments the ME equipment P
will be used. Relevant exclusions, as determined by
Risk Analysis, shall also be listed.
b) The essential performance of ME equipment and a P
description of what the operator can expect if the
Essential Performance is lost or degraded due to EM
disturbances.
c) A warning regarding stacking and location close to P
other equipment
d) List of cables, transducers and accessories P
e) A warning that other cables and accessories may P
negatively affect EMC performance
f) A statement that portable RF communications P
equipment. Including antennas, can effect medical
electrical equipment. The warning should include a
cm (12 inches) to any part of the [ME EQUIPMENT

or ME SYSTEM], including cables specified by the
5.2.1.2 Required statement from standard for Class A P

equipment
5.2.2 Technical description
5.2.2.1 All equipment and systems
Describe precautions to be taken to prevent adverse P
events to the Patient and Operator due to
electromagnetic disturbances
a) Compliance information for each test P
b) Statement of any deviations from standards used N/A

c) Statements to maintain basic safety and essential P

performance in regards to EMC
5.2.2.2 ME Equipment specified for use only in shielded location
a) A warning that equipment should be used only in the N/A
specified type of shielded location
b) Specifications for shielded location including: N/A
minimum RF shielding effectiveness;
for each cable that enters or exits the shielded
location, the minimum RF filter attenuation; and
the frequency range(s) over which the
specifications apply
c) Test methods for measurement of RF shielding N/A
effectiveness and RF filter attenuation
d) Required statement(s) from standard and N/A
recommended notice for information post at entrance.
5.2.2.3 ME Equipment that intentionally receive RF energy N/A
shall include: frequency and/or band and bandwidth
of receiving section
5.2.2.4 ME Equipment that include transmitters shall include N/A
frequency and/or band, modulation, and ERP
5.2.2.5 Large ME Equipment that are permanently installed
a) A statement that an exemption has been used and N/A
that the equipment has not been tested for radiated
RF immunity over the entire frequency range 80 MHz
to 6 GHz
b) A warning that the ME equipment has been tested for N/A
radiated RF immunity only at selected frequencies
c) A list of the frequencies and modulations tested N/A
5.2.2.6 ME equipment that claim compatibility with HF N/A
surgical equipment shall include statement of
compatibility and conditions of intended use during
HR surgery

1.6 Result Summary
Requirement Test Result/Comments Verdict

Clause 7 - Emissions
Classification
Class A or B ................................................................... : Class A
Group 1 or 2 .................................................................. : Group 1
CISPR 11, 14-1, 32 or ISO 7137 ................................... : CISPR 11
Conducted RF Emissions .............................................. : Compliant P
Radiated RF Emissions ................................................. Compliant P
Disturbance Power (if applicable) .................................. : N/A N/A
Harmonic Distortion per IEC61000-3-2 (Class A, B, C, D): Compliant P
Voltage Fluctuations and Flicker per IEC61000-3-3 ..... Compliant P
Clause 8 - Immunity
Electrostatic Discharges ................................................ Compliant P
Radiated RF EM Fields and Proximity Wireless fields .. Compliant P
Electrical Fast Transients and bursts ............................ Compliant P
Surges ........................................................................... Compliant P
Conducted Disturbances, induced by RF fields ............ Compliant P
Voltage Dips and Interruptions ...................................... Compliant P
Rated Power-frequency Magnetic Field ........................ Compliant P

1.7 Test Conditions and Results Conducted Emissions
CISPR 11 TEST: Limits of mains terminal disturbance voltage Verdict

Method: The AMN placed 0.8 m from the boundary of the unit under test and bonded to a
ground reference plane. This distance was between the closest points of the AMN and the
EUT. All other units of the EUT and associated equipment were at least 0.8 m from the AMN. P
All power was connected to the system through Artificial Mains Network (AMN). Conducted
voltage measurements on mains lines were made at the output of the AMN.
Laboratory Parameters Required prior to the test During the test
Ambient Temperature 15 to 35 °C 23 °C
Relative Humidity 30 to 60 % 52 %
Fully configured sample scanned Frequency range on each side of line Measurement Point
over the following frequency
150kHz to 30MHz Mains
range

Test Equipment Used

Conducted Emission
Cal. date Cal.Due date
No. Test Equipment Manufacturer Model No. Serial No.
(YYYY-MM-DD) (YYYY-MM-DD)
3
EMC0306 Shielding Room Zhong Yu 8 x 3 x 3.8 m N/A 2019-12-26 2022-12-25
EMC0118 Two-line v-netwok R&S ENV216 100359 2022-01-18 2023-01-17
EMC2135 Two-line v-netwok R&S ENV216 102259 2021-09-14 2022-09-13
EMC0203 LISN AFJ LS16-OPT001 116019831056 2022-01-07 2023-01-06
EMC0506 EMI Test Receiver Rohde & Schwarz ESCS30 100085 2021-11-17 2022-11-16
EMC0107 Coaxial Cable SGS 2m N/A 2021-07-21 2023-07-20
EMC0106 Voltage Probe SGS N/A N/A 2020-04-03 2022-04-02
SCHWARZBECK
NTFM 8158
EMC2123 8 Line ISN Cat 6 MESS- NTFM 8158 2021-05-27 2022-05-26
0151
ELEKTRONIK
SCHWARZBECK
EMC2124 8 Line ISN Cat 5 MESS- CAT5 8158 CAT5 8158-188 2021-05-27 2022-05-26
ELEKTRONIK
SCHWARZBECK
CAT38158-
EMC2126 8 Line ISN Cat 3 MESS- CAT3 8158 2021-05-27 2022-05-26
0081
ELEKTRONIK
SCHWARZBECK
EMC2122 ISN S8 MESS- ISN S8 57 2021-05-27 2022-05-26
ELEKTRONIK
SCHWARZBECK
EMC2121 ISN S1 MESS- ISN S1 10 2021-05-27 2022-05-26
ELEKTRONIK
SCHWARZBECK
EMC2125 2 wires ISN MESS- NTFM 8131 8131-198 2021-05-27 2022-05-26
ELEKTRONIK
Elektronik-
EMC2047 CDN L-801:AF2 2793 2020-09-28 2022-09-27
Feinmechanik
Elektronik-
EMC2048 CDN L-801:M2/M3 2738 2021-08-12 2023-08-11
Feinmechanik
EMC2062 6dB Attenuator HP 8491A 24487 2020-04-03 2022-04-02
EMC0167 Conical metal housing SGS-EMC N/A N/A 2020-04-18 2022-04-17

Photo of test setup for Mains Terminal Disturbance Voltage

Tabulated Results for Mains Terminal Disturbance Voltage

Test voltage: 100V/60Hz Operation mode: mode 1
Line (Live) :
Line (Neutral) :

Graphical representation of Mains Terminal Disturbance Voltage Measurement
Line (Live) :
Line (Neutral) :

Tabulated Results for Mains Terminal Disturbance Voltage

Line (Live) :
Line (Neutral) :

Graphical representation of Mains Terminal Disturbance Voltage Measurement
Line (Live) :
Line (Neutral) :

1.8 Test Conditions and Results Radiated Emissions
CISPR 11 TEST: Limits for radiated disturbance 30 MHz 1 GHz Verdict

Method: Measurements were made in a 10-meter semi-anechoic chamber or Open Area Test
Site that complies to CISPR 16. Preliminary (peak) measurements were performed at an
antenna to EUT separation distance of listed below. The EUT was rotated 360° about its
azimuth with the receive antenna located at various heights in horizontal and vertical polarities. P
Final measurements (quasi-peak) were then performed by rotating the EUT 360° and adjusting
the receive antenna height from 1 to 4 m. All frequencies were investigated in both horizontal
and vertical antenna polarity, where applicable.
Laboratory Parameters: Required prior to the test During the test
Fully configured sample Frequency range on each side of line Measurement Point
scanned over the following
30MHz 1GHz 10 m measurement distance
frequency range

Test Equipment Used

RE in Chamber
10m Semi- ChangZhou
EMC0530 N/A N/A 2019-06-18 2022-06-17
Anechoic Chamber ZhongYu
EMC0522 EMI Test Receiver Rohde & Schwarz ESIB26 100283 2021-02-18 2023-01-17
EMC0056 EMI Test Receiver Rohde & Schwarz ESCI 100236 2022-01-18 2023-01-17
SCHWARZBECK
Trilog Broadband
EMC2025 MESS- VULB 9160 9160-3372 2019-09-06 2022-09-05
Antenna 30-1000MHz
ELEKTRONIK
SCHWARZBECK
SEM003- Trilog Broadband
MESS- VULB 9168 665 2019-06-29 2022-06-28
18 Antenna 25-2000MHz
ELEKTRONIK
EMC0524 Bi-log Type Antenna Schaffner -Chase CBL6112B 2966 2019-09-06 2022-09-05
EMC0519 Bilog Type Antenna Schaffner -Chase CBL6143 5070 2020-05-03 2023-05-02
SCHWARZBECK
Horn Antenna
EMC2026 MESS- BBHA 9120D 9120D-841 2019-09-06 2022-09-05
1-18GHz
ELEKTRONIK
1-26.5 GHz
EMC0521 Agilent 8449B 3008A01649 2022-01-07 2023-01-06
Pre-Amplifier
EMC2065 Amplifier HP 8447F N/A 2021-05-27 2022-05-26
PRE AMPLIFIER
EMC2086 ANRITSU CORP MH648A N/A 2021-11-16 2022-11-15
MH648A
EMC0523 Active Loop Antenna EMCO 6502 42963 2022-03-03 2024-03-02
Broad-Band SCHWARZBECK
Horn Antenna MESS- BBHA 9170 9170-375 2020-05-20 2023-05-19
EMC2041
(14)15-26.5(40)GHz ELEKTRONI
High Pass
EMC2079 FSY MICROWAVE HM1465-9SS 009 2022-01-17 2023-01-16
Filter(915MHz)
966 Anechoic
EMC2142 C.R.T 9mX6mX6m NA 2021-12-17 2023-12-16
Chamber
EMC2139 MXE EMI Receiver Keysight N9038A MY57290121 2021-11-16 2022-11-15
EMC2138 EXA Signal Analyzer Keysight N9010A MY57120105 2021-11-16 2022-11-15
EMC2069 2.4GHz Filter Micro-Tronics BRM 50702 149 2022-01-07 2023-01-06

Photo of test setup for Radiated Disturbance

Tabulated Results for Radiated Disturbance

Polarity (Vertical)
Polarity (Horizontal)

Graphical representation of Radiated Disturbance Measurement
Vertical:
Horizontal:

Tabulated Results for Radiated Disturbance

Polarity (Vertical)
Polarity (Horizontal)

Graphical representation of Radiated Disturbance Measurement
Vertical:
Horizontal:

1.9 Test Conditions and Results Disturbance Power Emissions
CISPR 14-1 TEST: Limits of disturbance power Verdict

Method: Measurements were made on a ground plane that extends 1-meter minimum beyond
all sides of the system under test. All power was connected to the system through Line
Impedance Stabilization Networks (LISN). The lead to be measured on is stretched in a straight
N/A
line for a distance sufficient to accommodate the absorbing clamp, and to permit the necessary
measuring adjustment of position for tuning. The clamp is placed around the lead so as to
measure a quantity proportional to the disturbance on the lead.
Ambient Temperature 15 to 35 °C °C
Relative Humidity 30 to 60 % %
Fully configured sample scanned Frequency range Measurement point
over the following frequency range
30 MHz to 300 MHz Mains
Test Equipment Used

Description Manufacturer Model Identifier Cal. Date Cal. Due
Photo of test setup for Disturbance Power Emissions
Graphical representation of Disturbance Power Emissions Measurement
Tabulated Results for disturbance power

1.10 Test Conditions and Results Harmonic Distortion
61000-3-2 TEST: Limits for Harmonic current emissions (IEC 61000-3-2:2005 A1:2008 Verdict
A2:2009)
Method: This test consists on the measurement of harmonics components of the input current
which may be produced by equipment having an input current up to and including 16 A per
P
phase, and intended to be connected to public low-voltage distribution systems. The equipment
is tested under specified conditions of operation.
Classification of Equipment ...................................................................... : Class A
Supplementary information: None.
Test Equipment Used

Harmonics / Flicker test
EMC0608 AC Power Source California 50001iX 56627 2021-04-06 2022-04-05
EMC0607 Power Analyzer California PACS 72400 2021-04-06 2022-04-05

Photo of test setup for Harmonic Current Emissions

Tabulated Results for Harmonic Current Emissions

Harmonics Class-A (Run time)
Test Result: Pass Source qualification: Normal
Current & voltage waveforms
3 300
2 200
V o lta g e ( V o lts )
C u rre n t (A m p s )
1 100
0 0
-1 -10 0
-2 -20 0
-3 -30 0
Harmonics and Class A limit line European Limits
3 .5
C u rre n t R M S (A m p s )
3 .0
2 .5
2 .0
1 .5
1 .0
0 .5
0 .0
4 8 12 16 20 24 28 32 36 40
H a r m o n ic #
Test result: Pass Worst harmonics H15-36.1% of 150% limit, H15-53.1% of 100% limit

Tabulated Results for Harmonic Current Emissions

Current Test Result Summary (Run time)
Test Result: Pass Source qualification: Normal
THC(A): 0.419 I-THD(%): 189.5 POHC(A): 0.046 POHC Limit(A): 0.251
Highest parameter values during test:

V_RMS (Volts): 230.07 Frequency(Hz): 50.00
I_Peak (Amps): 2.010 I_RMS (Amps): 0.489
I_Fund (Amps): 0.221 Crest Factor: 4.235
Power (Watts): 49.5 Power Factor: 0.453
Harm# Harms(avg) 100%Limit %of Limit Harms(max) 150%Limit %of Limit Status
2 0.003 1.080 N/A 0.006 1.620 N/A Pass

3 0.207 2.300 9.0 0.210 3.450 6.1 Pass
4 0.003 0.430 N/A 0.006 0.645 N/A Pass
5 0.194 1.140 17.0 0.196 1.710 11.5 Pass
6 0.003 0.300 N/A 0.006 0.450 N/A Pass
7 0.176 0.770 22.9 0.178 1.155 15.4 Pass
8 0.003 0.230 N/A 0.005 0.345 N/A Pass
9 0.154 0.400 38.6 0.156 0.600 26.0 Pass
10 0.003 0.184 N/A 0.005 0.276 N/A Pass
11 0.130 0.330 39.4 0.132 0.495 26.6 Pass
12 0.002 0.153 N/A 0.004 0.230 N/A Pass
13 0.105 0.210 49.8 0.106 0.315 33.7 Pass
14 0.002 0.131 N/A 0.004 0.197 N/A Pass
15 0.080 0.150 53.1 0.081 0.225 36.1 Pass
16 0.002 0.115 N/A 0.003 0.173 N/A Pass
17 0.056 0.132 42.8 0.058 0.198 29.3 Pass
18 0.001 0.102 N/A 0.002 0.153 N/A Pass
19 0.036 0.118 30.8 0.038 0.178 21.5 Pass
20 0.001 0.092 N/A 0.002 0.138 N/A Pass
21 0.021 0.107 19.7 0.023 0.161 14.1 Pass
22 0.001 0.084 N/A 0.001 0.125 N/A Pass
23 0.014 0.098 13.8 0.014 0.147 9.5 Pass
24 0.001 0.077 N/A 0.001 0.115 N/A Pass
25 0.014 0.090 16.0 0.015 0.135 11.4 Pass
26 0.001 0.071 N/A 0.001 0.107 N/A Pass
27 0.017 0.083 20.6 0.018 0.125 14.4 Pass
28 0.001 0.066 N/A 0.001 0.099 N/A Pass
29 0.018 0.078 23.4 0.019 0.116 15.9 Pass
30 0.001 0.061 N/A 0.001 0.092 N/A Pass
31 0.017 0.073 23.3 0.017 0.109 15.8 Pass
32 0.001 0.058 N/A 0.001 0.086 N/A Pass
33 0.014 0.068 20.6 0.014 0.102 14.1 Pass
34 0.001 0.054 N/A 0.001 0.081 N/A Pass
35 0.010 0.064 15.7 0.011 0.096 11.2 Pass
36 0.000 0.051 N/A 0.001 0.077 N/A Pass
37 0.006 0.061 9.9 0.007 0.091 7.5 Pass
38 0.000 0.048 N/A 0.001 0.073 N/A Pass
39 0.003 0.058 N/A 0.004 0.087 N/A Pass
40 0.000 0.046 N/A 0.001 0.069 N/A Pass

1.11 Test Conditions and Results Voltage Fluctuations and Flicker
61000-3-3 TEST: Limitation of Voltage Fluctuations And Flicker Verdict

(IEC 61000-3-3:2013)
Method: The test circuit consists of a test supply voltage, reference impedance, the
equipment under test and a flicker meter compliant with IEC 60868. The equipment shall P
be tested in the condition in which the manufacturer supplies it.
Control Method of Equipment (see below) .................................. : Method 2
1 - without additional conditions
2 - switched manually, or
switched automatically more frequently than twice per day, and also has either a delayed restart (the
delay being not less than a few tens of seconds), or manual restart, after a power supply interruption.
3 - attended while in use (for example: hair dryers, vacuum cleaners, kitchen equipment such as mixers,
garden equipment such as lawn mowers, portable tools such as electric drills), or
switched on automatically, or is intended to be switched on manually, no more than twice per day, and
also has either a delayed restart (the delay being not less than a few tens of seconds) or manual restart,
after a power supply interruption.
Supplementary Information: None.
Test Equipment Used

Harmonics / Flicker test
EMC0608 AC Power Source California 50001iX 56627 2021-04-06 2022-04-05
EMC0607 Power Analyzer California PACS 72400 2021-04-06 2022-04-05

Photo of test setup for Voltage Fluctuations And Flicker

Tabulated Results for Voltage Fluctuations And Flicker
Test Result: Pass
Psti and limit line European Limits
1 .0 0
0 .7 5
P st
0 .5 0
0 .2 5
1 4 :2 4 :2 2
Parameter values recorded during the test:

Vrms at the end of test (Volt): 229.93
T-max (mS): 0 Test limit (mS): 500.0 Pass
Highest dc (%): 0.00 Test limit (%): 3.30 Pass
Highest dmax (%): 0.00 Test limit (%): 4.00 Pass
Highest Pst (10 min. period): 0.064 Test limit: 1.000 Pass

1.12 Test Conditions and Results Immunity to Electrostatic Discharges
61000-4-2 TEST: Electrostatic discharges (IEC 61000-4-2:2008) Verdict

Method: The test is intended to demonstrate the immunity of equipment subjected to static
electricity discharges from operators directly and to adjacent objects. The table top equipment
under test is placed on a wooden table, 0.8 m high, standing on the ground reference plane. A
horizontal coupling plane (HCP), 1.6 x 0.8 m, is placed on the table. The EUT and the cables are
P
isolated from the coupling plane by an insulating support 0.5 mm thick. The floor standing equipment
is isolated from the ground reference plane by an insulating support about 0.1 m thick. The vertical
coupling plane (VCP) of dimensions 0.5 m x 0.5 m is placed parallel to, and positioned at a distance
of 0.1 m from, the EUT.
Test Levels
Discharge Level (kV)
Number of discharges per location (each polarity)
Discharge type
Positive Negative
Air Direct 2,4,8,15 2,4,8,15 10
Contact Direct 8 8 10
Contact Indirect 8 8 10
See photo documentation of the test set-up
Discharge location All external locations accessible by hand, Horizontal plate (HCP)
Vertical coupling plate (VCP)
Supplementary information: EUT powered at one of the Nominal input voltages and frequencies
Test Equipment Used
Electrostatic Discharge
EMC2071 ESD Simulator TESEQ AG NSG 435 6739 2021-07-03 2022-07-02
EMC2186 ESD Simulator EMTEST NX30 23107 2022-02-28 2023-02-27

Photo of test setup for Immunity to Electrostatic Discharges

Tabulated Results for Electrostatic Discharges

Direct discharges: Air and Contact
Air discharge
Discharge location Polarity Result
voltage (kV)
2 Positive 1
2 Negative 1
4 Positive 1
4 Negative 1
All insulated enclosure & seams
8 Positive 1
8 Negative 1
15 Positive 1
15 Negative 1
Contact
Discharge location discharge Polarity Result
voltage (kV)
All accessible metal parts of the 8 Positive 2
enclosure with discharge resistor used 8 Negative 2
Indirect discharges
Contact
Discharge location discharge Polarity Result
voltage (kV)
HCP - Front 8 Positive 2
HCP - Left 8 Negative 2
HCP - Right 8 Positive 2
HCP - Rear 8 Negative 2
VCP - Front 8 Positive 2
VCP - Left 8 Negative 2
VCP - Right 8 Positive 2
VCP - Rear 8 Negative 2
Results Descriptions:
X - Not Performed nor required.
1 Compliant - No perceived discharge, no observed response from EUT.
2 Compliant Discharge observed, no observed response from EUT.
Note: Description of the response should detail observations during testing.

1.13 Test Conditions and Results - Immunity to Radio Frequency Electromagnetic Fields
61000-4-3 TEST: RF electromagnetic fields (IEC 61000-4-3:2006 A1:2007 A2:2010) Verdict

Method: The test allows estimating of the radiated immunity of electrical and
electronic equipment to electromagnetic disturbances coming from intended radio-
frequency (RF) transmitters in the frequency range 80 MHz to 2500 MHz. The P
interference is applied on the enclosure of the equipment by using transmitting
antennas.
Test specifications
1.5 m x 1.5 m, 16 points with a minimum UFA size
Uniform 0.5 m x 0.5 m
Calibration Requirements field area 75 % of calibration points within specifications if
(UFA) UFA is larger than 0.5 m x 0.5 m. 100 % (all 4
points) in the specifications for 0.5 x 0.5 m UFA
Frequency bandwidth 80 MHz to 2700 MHz
Modulation 80% AM at 1kHz*
Professional Healthcare 3 V/m

Environment
Level
Home Healthcare 10 V/m

Environment
Frequency step 1%
Supplementary information:
EUT powered at one of the Nominal input voltages and frequencies.
Dwell time minimum 1 s. Actual dwell time noted in results table.
Actual test level noted in results table.
Note * - Testing may be performed at other modulation frequencies identified by the Risk Management
Process.

Test Equipment Used

Radiated Immunity
Compact 3m Semi- Changzhou
EMC0525 N/A N/A 2019-12-03 2022-12-02
Anechoic Chamber zhongyu
EMC2055 Oscilloscope Tektronix TDS3052C C011815 2022-01-07 2023-01-06
Broadband Amplifier
EMC2091 R&S BBA150 102036 2022-01-07 2023-01-06
80M~1GHZ/250W)
Broadband Amplifier
EMC2092 R&S BBA150 102047 2022-01-07 2023-01-06
800M~3GHZ/110W)
EMC2093 Signal Generator R&S SMB100A 113083 2022-01-07 2023-01-06
RF Microwave
EMC2094 Laser probe FL7006 0345061 2021-03-11 2022-03-10
Instrumentation
NRP-Z91 Power
EMC2095 R&S NPR-Z91 103354 2022-01-07 2023-01-06
Sensor 6GHZ
NRP-Z91 Power
EMC2096 R&S NPR-Z91 103355 2022-01-07 2023-01-06
Sensor 6GHZ
High-Gain Log-periodic
EMC2097 R&S HL046E 100203 2020-02-14 2023-02-13
Antenna
EMC2098 RI Cable R&S 7m N/A 2021-05-20 2022-05-19
Stacked Logarithmic-
SCHWARZBECK
SEM003- Periodic Broadband
MESS - STLP 9149 356 2021-09-17 2024-09-16
21 Antenna
ELEKTRONIK
(0.7~9GHz)/300W

Photo of test setup for Radio Frequency Electromagnetic Fields

Tabulated Results for RF Electromagnetic Field

80 MHz to 2700 MHz
Side of the
Test Level Antenna Dwell Time
equipment under Result
(V/m) polarization (V/H) (second)
test
Front 3 H 1S 1
3 V 1S 1
Back 3 H 1S 1
3 V 1S 1
Left 3 H 1S 1
3 V 1S 1
Right 3 H 1S 1
3 V 1S 1
X - Not performed nor required.
1 Compliant - No observed response from EUT.

1.14 Test Conditions and Results Proximity fields from RF wireless communications equipment
61000-4-3 TEST: Proximity fields from RF wireless communications equipment Verdict

(IEC 61000-4-3:2006 A1:2007 A2:2010)
Method: The test allows estimating of the radiated immunity of electrical and electronic
equipment to electromagnetic disturbances coming from RF communications equipment. The P
interference is applied on the enclosure of the equipment by using transmitting antennas.
Test specifications
1.5 m x 1.5 m, 16 points with a minimum UFA size
Uniform / 0.5 m x 0.5 m
Calibration Requirements field area 75 % of calibration points within specifications if
(UFA) UFA is larger than 0.5 m x 0.5 m. 100 % (all 4
points) in the specifications for 0.5 x 0.5 m UFA
Frequency Range and Level: RF wireless communication equipment

Immunity Level
Test Frequency (MHz) Modulation
(V/m)
385 **Pulse Modulation: 18Hz 27
450 *FM 28
+ 5Hz deviation: 1kHz sine
745
780
870
930
1845
1970
5500
5785
Dwell time minimum 1 s. Actual dwell time noted in results table.
Note * - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.
Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal.

Test Equipment Used

Radiated Immunity
Compact 3m Semi- Changzhou
EMC0525 N/A N/A 2019-12-03 2022-12-02
Anechoic Chamber zhongyu
EMC2055 Oscilloscope Tektronix TDS3052C C011815 2022-01-07 2023-01-06
Broadband Amplifier
EMC2091 R&S BBA150 102036 2022-01-07 2023-01-06
80M~1GHZ/250W)
Broadband Amplifier
EMC2092 R&S BBA150 102047 2022-01-07 2023-01-06
800M~3GHZ/110W)
EMC2093 Signal Generator R&S SMB100A 113083 2022-01-07 2023-01-06
RF Microwave
EMC2094 Laser probe FL7006 0345061 2021-03-11 2022-03-10
Instrumentation
NRP-Z91 Power
EMC2095 R&S NPR-Z91 103354 2022-01-07 2023-01-06
Sensor 6GHZ
NRP-Z91 Power
EMC2096 R&S NPR-Z91 103355 2022-01-07 2023-01-06
Sensor 6GHZ
High-Gain Log-periodic
EMC2097 R&S HL046E 100203 2020-02-14 2023-02-13
Antenna
EMC2098 RI Cable R&S 7m N/A 2021-05-20 2022-05-19

Stacked Logarithmic-
SCHWARZBECK
SEM003- Periodic Broadband
MESS - STLP 9149 356 2021-09-17 2024-09-16
21 Antenna
ELEKTRONIK
(0.7~9GHz)/300W

Photo of test setup for Proximity fields from RF wireless communications equipment

Tabulated Results for Proximity Fields From RF Wireless Communications Equipment
Side of the
Frequency Band Antenna Dwell Time
(MHz) polarization (V/H) (second)
test
Front 380 390 H 1S 1
430 470 H 1S 1
704 787 H 1S 1
800 960 H 1S 1
1700 1990 H 1S 1
2400 2570 H 1S 1
5100 5800 H 1S 1
Front 380 390 V 1S 1
430 470 V 1S 1
704 787 V 1S 1
800 960 V 1S 1
1700 1990 V 1S 1
2400 2570 V 1S 1
5100 5800 V 1S 1
Back 380 390 H 1S 1
430 470 H 1S 1
704 787 H 1S 1
800 960 H 1S 1
1700 1990 H 1S 1
2400 2570 H 1S 1
5100 5800 H 1S 1
Back 380 390 V 1S 1
430 470 V 1S 1
704 787 V 1S 1
800 960 V 1S 1
1700 1990 V 1S 1
2400 2570 V 1S 1
5100 5800 V 1S 1
Left 380 390 H 1S 1
430 470 H 1S 1
704 787 H 1S 1
800 960 H 1S 1

Tabulated Results for Proximity Fields From RF Wireless Communications Equipment
Side of the
Frequency Band Antenna Dwell Time
(MHz) polarization (V/H) (second)
test
1700 1990 H 1S 1
2400 2570 H 1S 1
5100 5800 H 1S 1
Left 380 390 V 1S 1
430 470 V 1S 1
704 787 V 1S 1
800 960 V 1S 1
1700 1990 V 1S 1
2400 2570 V 1S 1
5100 5800 V 1S 1
Right 380 380 H 1S 1
430 470 H 1S 1
704 787 H 1S 1
800 960 H 1S 1
1700 1990 H 1S 1
2400 2570 H 1S 1
5100 5800 H 1S 1
Right 380 390 V 1S 1
430 470 V 1S 1
704 787 V 1S 1
800 960 V 1S 1
1700 1990 V 1S 1
2400 2570 V 1S 1
5100 5800 V 1S 1

1.15 Test Conditions and Results Electrical Fast Transients
61000-4-4 TEST: Fast Transients (IEC61000-4-4:2012) Verdict

Method: Measurements were made on a ground plane that extends 1-meter minimum
beyond all sides of the system under test. Mains power tests were conducted with the
product connected to a Coupling/Decoupling Network (CDN). I/O lines were tested in a P
Capacitive Coupling Clamp. One of each unique interface was tested for a period of
one (1) minute per polarity.
Measurement Point
Fully configured sample Input a.c. Power Ports
subject to the levels shown
below. Input d.c. Power Ports
Signal Input/Output Ports
Applied Level
Application Point (kV) Coupling Method Repetition Frequency (kHz)
Input a.c. Power Ports ±2 Direct Injection 100

Input d.c. Power Ports ±2 Direct Injection 100
Signal Input/Output Ports* ±1 Capacitive Clamp 100
Input d.c. Power ports See ISO 7637-2
(transportation)
Note* - SIP/SOPS whose maximum cable length is less than 3m are excluded
Test Equipment Used

EFT, Surge, Voltage dips and Interruption
Modular lmpulse
EMC2059 EMC PARTNER MIG0603EN 259 2022-01-07 2023-01-06
Surge Generator
High speed signal
EMC2060 EMC PARTNER CDN-UTP CDN-UTP0089 2022-01-07 2023-01-06
Surge CDN
NSG
EMC Immunity Test 3060&CDN306 1580 &1466
EMC2072 TESEQ AG 2022-01-07 2023-01-06
System 1&INA 6502 &222
CIB
EMC2055 Oscilloscope 500MHz Tektronix TDS3052C C011815 2022-01-07 2023-01-06

Photo of test setup for Electrical Fast Transients
Tabulated Results for Electrical Fast Transients

Point of application Results
Mains 1

1.16 Test Conditions and Results Surge Immunity
61000-4-5 TEST: Surge Immunity Test (IEC61000-4-5:2005) Verdict

Method: Mains power tests were conducted with the product connected to a Coupling/
Decoupling Network (CDN). The test voltage was increased from the lowest indicated level up to
the maximum level. Five (5) positive surges and five (5) negative surges were applied at each of
P
phases of the a.c. waveform: 0°, 90°, 180° and 270°. Each surge was applied 60 seconds after
the previous surge. Signal and Telecommunications ports were subject to five (5) positive and
five (negative) surges applied through the appropriate Coupling/Decoupling Network (CDN).
Laboratory Parameters: Required prior to the During the test
test
Fully configured sample subject to the Measurement Point
levels shown below.
Input AC and DC Power Ports
Applied Level
Application Point [kV] Required Surge Waveform
0.5 and 1.0 Combination Wave
Input Power (Line to Line) (1.2µs x 50µs Voltage, 8µs x 20µs Current)
Ports 0.5, 1.0 and 2.0 Combination Wave
(Line to Earth) (1.2µs x 50µs Voltage, 8µs x 20µs Current)
Signal 2.0 Combination Wave
input/output* (Line to Earth) (1.2µs x 50µs Voltage, 8µs x 20µs Current)
ME EQUIPMENT and ME SYSTEMS that do not have a surge protection device in the primary power
circuit may be tested only at 2 kV line(s) to earth and 1 kV line(s) to line(s).
Note* - Applicable to output lines intended to connect directly to outdoor cables
Test Equipment Used

Modular lmpulse
Surge Generator
High speed signal
Surge CDN
NSG
EMC2072 TESEQ AG 2022-01-07 2023-01-06
CIB

Photo of test setup for Surge Immunity

Tabulated Results for Surge - Mains

Mode of Application Level Polarity Results
Positive 1
0.5kV
Negative 1
Line 1 to Line 2
(Differential mode) Positive 1
1.0kV
Negative 1
Positive 1
0.5kV
Negative 1
Positive 1
Line 1 to Earth
1.0kV
(Common mode) Negative 1
Positive 1
2.0kV
Negative 1
Positive 1
0.5kV
Negative 1
Positive 1
Line 2 to Earth
1.0kV
(Common mode) Negative 1
Positive 1
2.0kV
Negative 1
Tabulated Results for Surge Signal Input/output Lines Directly Connected to Outdoor Lines
Mode of Application Level Polarity Results
Line 1 to Earth Positive X
2kV
(Common mode) Negative X
Line 2 to Earth Positive X
2kV
(Common mode) Negative X

1.17 Test Conditions and Results Conducted Disturbances Immunity
61000-4-6 TEST: RF Continuous Conducted (IEC61000-4-6:2013) Verdict

Method: Measurements were made on a ground plane that extends 0.5-meter minimum beyond
all sides of the system under test. The EUT was located 10cm above the reference ground plane
and any associated I/O cables attached to the EUT were located between 30mm and 50mm P
above the ground plane. The indicated field was pre-calibrated prior to placement of the system
under test.
Test Specifications: Frequency range Measurement Point
Input a.c. Power Ports
Fully configured sample scanned Input d.c. Power Ports
over the following frequency 150kHz to 80MHz
range Signal Input/output Ports
Patient Connected Ports
Home Healthcare 3 V RMS outside the ISM band, 6 V RMS in the ISM and amateur
Environment radio bands
Level
Professional 3 V RMS outside the ISM band, 6 V RMS in the ISM band
Healthcare
Environment
Frequency step 1%
Modulation 80% Am at 1kHz*
Dwell time minimum 1 s.
Note * - Testing may be performed at other modulation frequencies identified by the Risk Management
Process.

Test Equipment Used

Conducted Immunity
EMC2115 TEST SYSTEM OF CI TESEQ AG NSG 4070B-80 46144 2021-07-04 2022-07-03
EMC2116 6dB Attenuator TESEQ AG ATN 6075 45823 2021-07-21 2022-07-20
EMC2113 CDN S502A TESEQ CDN S502A 46206 2019-06-19 2022-06-18
EMC2112 CDN ST08A TESEQ CDN ST08A 36631 2019-07-03 2022-07-02
EMC2114 CDN USB3.0 TESEQ CDN USB3.0 45777 2019-06-19 2022-06-18
Dual Directional
EMC1105 Werlatone Inc. C1795 6635 2021-05-27 2022-05-26
coupler
Elektronik-
EMC2048 CDN L-801:M2/M3 2738 2021-08-12 2022-08-11
Feinmechanik
Coupling Decoupling
EMC2169 TESEQ CDN M016 46989 2021-08-09 2022-08-08
Network
EMC1107 CDN M2 Schaffner Chase CDN-M2-16 9863 2020-10-25 2023-10-25
EMC1116 Current Probe Schaffner Chase CIP9136 1155 2020-10-25 2023-10-25
EMC1117 Current Probe Schaffner Chase CSP8445 18 2020-10-25 2023-10-25
Photo of test setup for Conducted Disturbances

Tabulated Results for Conducted Disturbances

Point of Dwell Time
Results
Application (second)
Mains 1 1S
ECG cable 1 1s
BLT SpO2 cable 1 1s
Masimo SpO2 1 1s
cable
Nellcor SpO2 cable 1 1s
Temp cable 1 1s
CO2 extension 1 1s
cable
IBP cable 1 1s

Note: Delete rows not used
Note: Describe each port tested

1.18 Test Conditions and Results Power- Frequency Magnetic Fields
61000-4-8 TEST: Power-frequency magnetic field (IEC61000-4-8:2009) Verdict

Method: Measurements were made on a ground plane that extends 1-meter minimum beyond sides of
the system under test. Table top EUT is located 80cm above the reference ground plane and floor-
P
standing EUT is located 10cm above the reference ground plane. The indicated field was pre-calibrated
prior to placement of the EUT under test.
Fully configured sample tested at the power Frequency Application Point
line frequency (See Note 1)
50Hz and 60 Hz Enclosure
Test Level 30 (A/m)
EUT powered at one of the Nominal input voltages and frequency of either 50Hz or 60Hz. During the test, the
frequency of the field and line frequency of the ME equipment shall be the same.
Test Equipment Used

Power Frequency Magnetic Field Immunity
NSG
EMC2072 TESEQ AG 2022-01-07 2023-01-06
CIB
Power Frequency
EVERFINE YY100376N111
EMC2061 Magnetic Field EMS61000-8K 2021-08-19 2023-08-18
CO.LTD. 00003
Immunity Test System
KANETEC CO.,
EMC2078 Tesla Meter TM-701 14444 2021-11-24 2024-11-23
LTD.
Fischer Custom
Magnetic Field F-1000-4-8-
EMC0704 Communications N/A 2019-04-25 2022-04-24
Immunity Loop 9/10-L-1M
Inc.

Photo of test setup for Power- Frequency Magnetic Fields
Tabulated Results for Power Frequency Magnetic Field

X-Axis 1
Y-Axis 1
Z-Axis 1

1.19 Test Conditions and Results Voltage Dips, Interruptions, and Variations
61000-4-11 TEST: Voltage Dips and Interruptions (IEC61000-4-11:2004) Verdict

Method: The product was subjected to voltage dips and interruptions. Testing was
performed with the product connected directly to a generator capable of simulating the P
voltage drops and interrupts as described.
Fully configured subjected to Measurement Point
the levels indicated below.
Input A.C. Power Ports
Applied Levels
Voltage Dips
Cycles Sync Angle (degrees)
% UT
>95 0.5* 0,45,90,135,180,225,270,315
>95 1 0
30 25 (50Hz) 0
30 (60Hz)
Voltage Interruption
Cycles Sync Angle [degrees]
% UT
>95 250 (50Hz),300 (60Hz) 0
If the Rated voltage range <25% of the lowest rated input voltage, one rated input voltage. Otherwise,
minimum and maximum rated voltage. EUT powered at one of the Nominal input frequencies.
ME EQUIPMENT and ME SYSTEMS with power input voltage selection by transformer taps shall be tested at
only one tap setting.
Note* - Only applicable to ME equipment with single phase a.c. mains
Supply Voltage Range Difference of Max 25% of Lowest Rated Test at Min/Max
Voltage Min input Voltage Voltages required (Y/N)
Voltage
100-240V 140V 25V Y

Test Equipment Used

Modular lmpulse
Surge Generator
High speed signal
Surge CDN
NSG
EMC2072 TESEQ AG 2022-01-07 2023-01-06
CIB
Photo of test setup for Voltage Dips, Interruptions, and Variations

Tabulated Results for Voltage Dips and Interruptions

Minimum Rated Voltage (V) .... 100
Frequency (Hz) ......................... 60
Point of application Voltage Dips Period (Cycles) Results
Mains >95 0.5 1
Mains >95 1 1
Mains 30 25/30 (50/60Hz) 1
Point of application Voltage Period (Cycles) Results
Interruptions
Mains >95 250/300 (50/60Hz) 1
2 During test the EUT was power off, after test it can be restorable to the pre-test state with
OPERATOR intervention and remains safe, no component failures.
Tabulated Results for Voltage Dips and Interruptions (for all models)
Maximum Rated Voltage (V) ... 240
Frequency (Hz) ......................... 50
Point of application Voltage reduction Period (Cycles) Results
Mains >95 0.5 1
Mains >95 1 1
Mains 30 25/30 (50/60Hz) 1
Point of application Voltage Period (Cycles) Results
Interruptions
Mains >95 250/300 (50/60Hz) 1
X Not performed nor required.
1 Compliant No observed response from EUT.
2 During test the EUT was power off, after test it can be restorable to the pre-test state with
OPERATOR intervention and remains safe, no component failures.

1.20 Test Conditions and Results Electrical transient conduction along supply lines
ISO 7637-2 TEST: Electrical transient conduction along supply lines Verdict
Method: The DUT shall be placed on a non- r
support with a thickness of (50 ± 5) mm. Grounding of the DUT case to the ground plane
shall reflect the vehicle installation. Preferably, the load simulator shall be placed directly on
N/A
the ground plane. If the load simulator has a metallic case, this case shall be bonded to the
ground plane. The peak voltage Us shall be adjusted to be the required test level with the
tolerances of +10 % and 0 %.
Laboratory Required prior to the test During the test
Parameters:
Ambient 15 to 35 °C °C
Temperature
Relative Humidity 30 to 60 % %
Applied Level
Application Point Test pulse and level Coupling Method
1 (-150V) Direct Injection
2a (+112V) Direct Injection
Input d.c. Power
ports 2b (10V for 12V system; 20V for 24V system) Direct Injection
(transportation)
3a (-220V for 12V system; -300V for 24Vsystem) Direct Injection
3b (+150V for 12V system; +300 for 24V system) Direct Injection
Supplementary information: For ME EQUIPMENT and ME SYSTEMS intended to be installed in passenger
cars and light commercial vehicles including ambulances fitted with 12 V electrical systems or commercial
vehicles including ambulances fitted with 24 V electrical systems.
Test Equipment Used

Description Manufacturer Model Identifier Cal. Date Cal. Due

Photo of test setup for Electrical Transient Conduction Along Supply Lines
Tabulated Results for Electrical Transient Conduction Along Supply Lines

Mains Pulse 1
Mains Pulse 2a
Mains Pulse 2b
Mains Pulse 3a
Mains Pulse 3b

Annex EUT Constructional Details
Details of: K12Pro
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: K12Pro
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: K12Pro
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: K12Pro
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: K12Pro
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: K12Pro
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Inside construction
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: SMPS
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: PCB view
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: SMPS
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Rear view of SMPS
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Rear PCB view
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Double IBP plug-in module (C-01 / 115-003995-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: C.O. plug-in module (C-03 / 115-003989-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Wake/O2 apnea plug-in module (C-05 / 115-0004492-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: ICG plug-in module (C-07 / 115-003991-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Mainstream CO2 plug-in module (C-11 / 115-003993-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Comen sidestream CO2 plug-in module (C-12 / 115-004493-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo ISA sidestream CO2 plug-in module (C-13 / 115-003994-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo Capno sidestream CO2 plug-in module (C-14 / 115-004494-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Respironics CapnoTrak sidestream CO2 plug-in module (C-15 / 115-004495-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Respironics LoFlo sidestream CO2 plug-in module (C-16 / 115-003996-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Nellcor SpO2 plug-in module (C-21 / 115-004496-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
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[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo MS-2040 SpO2 plug-in module (C-22 / 115-004497-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo Rainbow SpO2 plug-in module (C-23 / 115-004505-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo mainstream AG plug-in module (C-25 / 115-005993-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
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[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
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[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo ISA AX+ sidestream plug-in module (C-26 / 115-003990-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo ISA OR+ sidestream plug-in module (C-28 / 115-004499-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: COVIDIEN BIS plug-in module (C-31 / 115-003992-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
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[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo SedLine EEG plug-in module (C-32 / 115-004504-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: COMEN RM plug-in module (C-36 / 115-004500-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: PCB view after removing the cover
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
ARTEMA SPIRIT Respiratory Mechanics Analysis plug-in module (C-37 / 115-004501-

Details of:
00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: XAVANT NMT plug-in module (C-41 / 115-004502-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo O3 ReginalOximetry plug-in module (C-46 / 115-004503-00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 3-Lead, ECG trunk cable (98ME01EB046 / 040-000413)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 3-Lead ECG lead wire (98ME01AC658 / 040-000492)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 3-lead ECG one-piece cable (98ME01AD473 / 040-000908)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 5-lead ECG one-piece cable/ clip /AHA identifiers (98ME01AD474 / 040-000909)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 12-lead ECG one-piece cable / clip /AHA identifiers (98ME01AD475 / 040-000910)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 3-lead ECG one-piece cable/ clip/IEC identifiers (98ME01EB477 / 040-000911)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 5-lead ECG one-piece cable/ clip /IEC identifiers (98ME01EB478 / 040-000912)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 12-lead ECG one-piece cable / clip /IEC identifiers (98ME01EB479 / 040-000913)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 3-lead split type ECG cable/clip/ AHA identifier (98ME01AC458 / 040-000479)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 5-lead split type ECG cable/clip/ AHA identifier (98ME01AC457 / 040-000480)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 12-lead split type ECG cable/clip/ AHA identifier (98ME01AB076 / 040-000481)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 3-lead split type ECG cable/clip/ IEC identifier (98ME01EC681 / 040-000485)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 5-lead split type ECG cable/clip/ IEC identifier (98ME01EC680 / 040-000486)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 12-lead split type ECG cable/clip/ IEC identifier (98ME01EB075 / 040-000487)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 3-lead ECG one-piece cable/ clip/AHA identifiers (A3105-EC1 / 040-000914)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 5-lead ECG one-piece cable/ clip /AHA identifiers (A5105-EC1 / 040-000915)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 12-lead ECG one-piece cable / clip /AHA identifiers (A4020-EE1 / 040-000916)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 3-lead ECG one-piece cable/ clip/IEC identifiers (A3105-EC0 / 040-000917)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 5-lead ECG one-piece cable/ clip /IEC identifiers (A5105-EC0 / 040-000918)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 12-lead ECG one-piece cable / clip /IEC identifiers (A4020-EE0 / 040-000919)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: 6-Lead, ECG trunk cable (A600C-EK2D / 040-001424)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: 6-Lead, ECG lead wire / clip/ AHA identifiers (A6196-EL1 / 040-001425)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: IBP cable extender (Dual type) (CMK12-212 / 040-001332)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: ECG electrode (FS-TC1/040-000868)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: ECG electrode (T-401 / 040-000204)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: IBP cable extender- Abbott connector (MC06-141110-01 / 040-000360)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: IBP cable extender- UTMS connector (MC06-141111-01 / 040-000453)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: IBP cable extender- Edward connector (MC06-141112-01 / 040-000454)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

IBP cable extender- B. Braun Melsungen AG connector (MC06-141115-01 / 040-

Details of:
000455)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: IBP cable extender- BD connector (MC06-141113-01 / 040-000456)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: IBP transducer sensor-UTMS connector (PT-1 1100 / 040-000945)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: IBP transducer sensor-B. Braun Melsungen AG connector (PT-1 1200 / 040-000987)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: IBP transducer sensor- BD connector (PT-1 1300 / 040-000946)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: IBP transducer sensor- Edward connector (PT-1 1400 / 040-000986)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: IBP transducer sensor- Abbott connector (PT-1 1500 / 040-000870)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP extension tube / Length: 2m (CMANOB02 / 040-000808)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP extension tube / Length: 3m (CMANOB01 / 040-000626)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP cuff /25-35 cm (U1880S / 040-000592)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff /18-26cm (U1881S / 040-000593)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
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Details of: NIBP cuff/ 46-66cm (U1884S / 040-000596)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff / 20-28cm (U1885S / 040-000597)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP cuff / 33-47 cm (U1869S / 040-000598)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff /33-47 cm (U1889S / 040-000599)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff / 4-8cm (U1682S / 040-000744)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP cuff/ 6-11cm (U1683S / 040-000745)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff/7-13cm (U1684S / 040-000746)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP cuff/8-15cm (U1685S / 040-000747)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff / 12-19cm (98-0084-95 / 040-001133)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff / 12-19cm (98-0600-E1 / 040-001137)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff /3-6 cm (98-0400-99 / 040-000934)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP cuff /4-8 cm (98-0400-96/ 040-000935)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff/6-11 cm (98-0400-97 / 040-000936)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NIBP cuff/7-13cm (98-0400-98 / 040-000937)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NIBP cuff/8-15cm (98-0400-90 / 040-000938)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: ComenSpO2 cable extender (SLZ122/ 040-000769)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Comen SpO2 probe (SAS104 / 040-000726)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Comen SpO2 probe (SAL104 / 040-000312)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Comen SpO2 probe (SES104 / 040-000730)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Comen SpO2 probe (A0816-SA105PV / 040-000869)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NellcorSpO2 cable extender (SLZ068 / 040-000243)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Nellcor SpO2 sensor (DS100A / 040-000010)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Nellcor Y-type bundled SpO2 probe (D-YS / 040-000075)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo SpO2 M-LNCS series patient cable extender (S-A1202026 / 040-000313)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo SpO2 RD-SET series patient cable extender (CM12-RD-L / 040-001431)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo SpO2 sensor (M-LNCS DCI / 040-000203)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo SpO2 sensor (Y- type) (M-LNCS YI / 040-000361)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo Adult Reusable finger clip SpO2 sensor (RD SET DCI / 040-001415)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Padiatric/Slender digit Reusable finger clip SpO2 sensor (RD SET DCI-P / 040-
Details of:
001416)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo SpO2 sensor (Y- type) (RD SET DCI YI / 040-001417)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Neonatal Pulse Oximeter Adhesive sensor (RD SET NeoPt CS-2 / 040-001418)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Neonatal Pulse Oximeter Adhesive sensor (RD SET NeoPt / 040-001419)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Neonatal/Adult Pulse Oximeter Adhesive sensor (RD SET Neo CS-2 / 040-001420)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Neonatal/Adult Pulse Oximeter Adhesive sensor (RD SET Neo / 040-001421)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo SpO2 Y-shaped sheath (049-000256)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Temperature probe (TAS03-09 / 040-000246)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Temperature probe (TPS03-03 / 040-000387)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Temperature probe (TPE03-01 / 040-000386)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Temperature probe (TAE03-04 / 040-000385)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo RGM module interface cable (98ME07GC968 / 040-000400)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Nomoline Airway Adapter Sets with Luer (REF: 3827 / 040-001362)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Nomoline CO2 sampling tube with Nasal Cannula (REF: 3830 / 040-001365)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Nomoline CO2 sampling tubewithNasal Cannula (REF: 3831 / 040-001366)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Nomoline CO2 sampling tubewithNasal Cannula (REF: 3832 / 040-001367)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Nomoline CO2 sampling tubewith nasal/oral Cannula (REF: 3833 / 040-001368)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Nomoline CO2 sampling tubewith nasal/oral Cannula - O2 delivery (REF: 3834 / 040-
Details of:
001369)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of:
001370)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Nomoline CO2 sampling tubewith nasal/oral Cannula (REF: 3836 / 040-001371)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of:
001372)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of:
001373)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Nomoline CO2 sampling tubewith single nasal prong (REF: 3839 / 040-001374)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo IRMA Airway adapter (REF: 106220 / 040-000216)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo IRMA Airway adapter (REF: 106260 / 040-000217)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Respironics CO2 module interface cable (98ME07GC067 / 040-000242)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Water Filter Assembly (REF: 1103416 / 040-001054)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Dehumidification Tubing (REF: 1103417 / 040-001055)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Large Airway Adapter Set (REF: 1103414 / 040-001058)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Small Airway Adapter Set (REF: 1103415 / 040-001063)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Large CO2 Nasal Cannula (REF: 1103408 / 040-001057)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Medium CO2 Nasal Cannula (REF: 1103409 / 040-001064)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Small CO2 Nasal Cannula (REF: 1103410 / 040-001065)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Mainstream CO2 airway adapter (REF: 6063-00 / 040-000021)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Mainstream CO2 airway adapter (REF: 6312-00 / 040-000022)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Loflo Airway adapter kit w/ Dehumidification tubing (REF:3473ADU-00 / 040-000024-

Details of:
00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Loflo Airway adapter kit w/ Dehumidification tubing (REF:3473INF-00 / 040-000026-

Details of:
00)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Cardiac output Interface cable (98ME07GB106 / 040-000306)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Neonatal wakeup sensor (A0916-C05 / 040-000443)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Oxygen sensor connection cable (A0916-C06 / 040-000401)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Oxygen sensor (MOX-3 / 040-000196)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Oxygen sensor cover (043-000373)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: ICG patient cable with electrode wires (ICG / 040-000460)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: ICG electrode (N1201-5 / 040-000461)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo IRMA mainstream CO2 module (200101 / 099-000006)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Respironics mainstream CO2 module (1015928 / 099-000005)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: COMEN mainstream CO2 module (M-01 / 115-006486)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo rainbow R1 25 Adult Adhesive Sensor (REF: 3792 / 040-001146)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo rainbow R1 20 Pediatric Adhesive Sensor (REF:3793 / 040-001147)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo rainbow R1 25L Adult Adhesive Sensor (REF:2414 / 040-001148)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo Rainbow DCI Adult Reusable Sensor (REF: 2696 / 040-001149)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo Rainbow DCI-P Reusable Pediatric Sensor (REF: 2697 / 040-001150)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo Rainbow SpO2 patient cable (Rainbow RC-12, REF: 2404 / 040-001152)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: COVIDIEN BIS module (REF: 186-0195-SF / 099-000132)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: BIS adult 4-electrode sensor (186-0106 / 040-000630)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: BIS Pediatric 4-electrode sensor (186-0200 / 040-001145)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo SedLine MOC- - -001155)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo SedLine Patient Cable (REF 4298 / 040-001119)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo SedLine Sensor (REF: 2479 / 040-001118)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: ARTEMA SPIRIT Spirometry flow sensor (REF 040-001949-00 / 040-000722)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: ARTEMA SPIRIT Spirometry flow sensor (REF 040-001950-00 / 040-000723)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: NMT sensor (CEA121B / 040-001331)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: NMBA (Neuromuscular Blocking Agents) electrode (XT-45008 / 040-001143)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: O3 Regional Oximeter MOC-9 Module (REF: 9637 / 051-001154)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom

Details of: Masimo O3 Regional Adult Oximetry Sensor (REF: 3756 / 040-001120)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Details of: Masimo O3 Regional Pediatric Oximetry Sensor (REF: 4235 / 040-001121)
View:
[ ] general
[ ] front
[ ] rear
[ ] right
[ ] left
[ ] top
[ ] bottom
Attachment 3: Accessories list

No. Description Model/REF Type Intended patient
population/Parts of
body applied
1. 3-Lead, ECG trunk cable 98ME01EB046 Reusable /
2. 3-Lead, ECG lead wire Infant and neonatal
/mini clip/ IEC identifiers 98ME01AC658 Reusable
Trunk/limbs
3. 3-lead ECG one-piece Adult and pediatric
cable/ clip/AHA 98ME01AD473 Reusable
Trunk/limbs
identifiers
cable/ clip /AHA 98ME01AD474 Reusable
Trunk/limbs
identifiers
cable / clip /AHA 98ME01AD475 Reusable
Trunk/limbs
identifiers
cable/ clip/IEC 98ME01EB477 Reusable
Trunk/limbs
identifiers
cable/ clip /IEC 98ME01EB478 Reusable
Trunk/limbs
identifiers
cable / clip /IEC 98ME01EB479 Reusable
Trunk/limbs
identifiers
9. 3-lead split type ECG Adult and pediatric
cable/clip/ AHA 98ME01AC458 Reusable
Trunk/limbs
identifier
cable/clip/ AHA 98ME01AC457 Reusable
Trunk/limbs
identifier
cable/clip/ AHA 98ME01AB076 Reusable
Trunk/limbs
identifier
98ME01EC681 Reusable
cable/clip/ IEC identifier Trunk/limbs
98ME01EC680 Reusable
98ME01EB075 Reusable
cable/ clip/AHA A3105-EC1 Reusable
Trunk/limbs
identifiers
cable/ clip /AHA A5105-EC1 Reusable
Trunk/limbs
identifiers
cable / clip /AHA A4020-EE1 Reusable
Trunk/limbs
identifiers

population/Parts of
body applied
cable/ clip/IEC A3105-EC0 Reusable
Trunk/limbs
identifiers
cable/ clip /IEC A5105-EC0 Reusable
Trunk/limbs
identifiers
cable / clip /IEC A4020-EE0 Reusable
Trunk/limbs
identifiers
21. 6-Lead, ECG trunk cable A600C-EK2D Reusable /
22. 6-Lead, ECG lead wire / Adult and pediatric
clip/ AHA identifiers A6196-EL1 Reusable
Trunk/limbs
A6196-EL0 Reusable
clip/ IEC identifiers Trunk/limbs
snap/ AHA identifiers A6096-EL1 Reusable
Trunk/limbs
25. 6-Lead, ECG lead wire / Adult / pediatric
A6096-EL0 Reusable
snap/ IEC identifiers Trunk/limbs
26. FS-TC1 Disposal Adult /pediatric
ECG electrode
Trunk/limb/ intact skin
27. T-401 Disposal Neonatal/ infant
ECG electrode
Trunk/limb/ intact skin
28. IBP cable extender /
CMK12-212 Reusable
(Dual type)
29. IBP cable extender- /
MC06-141110-01 Reusable
Abbott connector
UTMS connector
Edward connector
32. IBP cable extender- B. /
Braun Melsungen AG MC06-141115-01 Reusable
connector
33. IBP cable extender- BD /
connector
34. IBP transducer sensor- Disposal /
PT-1 1100
UTMS connector

B. Braun Melsungen AG PT-1 1200
connector
PT-1 1300
BD connector

population/Parts of
body applied
PT-1 1400
Edward connector
PT-1 1500
Abbott connector
39. NIBP extension tube / Reusable /
CMANOB02
Length: 2m
40. NIBP extension tube / Reusable /
CMANOB01
Length: 3m
41. NIBP cuff /25-35 cm U1880S Reusable Adult,
42. NIBP cuff /18-26cm U1881S Reusable Pediatric
43. NIBP cuff /10-19cm U1882S Reusable Neonatal
44. NIBP cuff /6-11cm U1883S Reusable Neonatal
45. NIBP cuff/ 46-66cm U1884S Reusable Adult, thigh,
46. NIBP cuff / 20-28cm U1885S Reusable Adult, arm
47. NIBP cuff / 33-47 cm U1869S Reusable Adult,
48. NIBP cuff /33-47 cm U1889S Reusable Adult,
49. NIBP cuff /3-6cm U1681S Disposal Neonatal
50. NIBP cuff / 4-8cm U1682S Disposal Neonatal
51. NIBP cuff/ 6-11cm U1683S Disposal Neonatal
52. NIBP cuff/7-13cm U1684S Disposal Neonatal
53. NIBP cuff/8-15cm U1685S Disposal Neonatal
54. NIBP cuff / 12-19cm 98-0084-95 Reusable Pediatric,
55. NIBP cuff / 17-25cm 98-0084-96 Reusable Adult,
58. NIBP cuff / 12-19cm 98-0600-E1 Reusable Pediatric,
59. NIBP cuff / 17-25cm 98-0600-E3 Reusable Adult,
62. NIBP cuff /4-8 cm 98-0400-96 Reusable Neonatal
63. NIBP cuff/6-11 cm 98-0400-97 Reusable Neonatal
64. NIBP cuff/7-13cm 98-0400-98 Reusable Neonatal
65. NIBP cuff/8-15cm 98-0400-90 Reusable Neonatal
66. NIBP cuff / 25-35cm CM1203 Reusable Adult,
67. NIBP cuff / 18-26cm CM1202 Reusable Paediatric
68. NIBP cuff / 10-19cm CM1201 Reusable Infant
69. NIBP cuff / 6-11cm CM1200 Reusable Neonatal
70. NIBP cuff / 46-66cm CM1205 Reusable Adult
population/Parts of
body applied
71. NIBP cuff / 33-47cm CM1204 Reusable Adult
72. Comen SpO2 cable Reusable /
SLZ122
extender
73. Comen SpO2 probe SAS104 Reusable Adult, finger
74. Comen SpO2 probe SAL104 Reusable Adult, finger
75. Reusable Paediatric, infant,
Comen SpO2 probe SES104
finger, toe
76. Comen SpO2 probe A0816-SA105PV Reusable Adult, finger
77. Nellcor SpO2 cable Reusable /
SLZ068
extender
78. Nellcor SpO2 sensor DS100A Reusable Adult (>40kg), finger
79. Reusable Adult, Pediatric and
Nellcor Y-type bundled
D-YS infant (>1kg), multi-site
SpO2 probe
(usually finger, toe)
80. Masimo SpO2 M-LNCS Reusable /
series patient cable S-A1202026
extender
81. Masimo SpO2 RD-SET CM12-RD-L Reusable /
series patient cable
extender
82. Masimo SpO2 sensor Reusable Adult (>30kg), finger or
M-LNCS DCI
toe
83. Masimo SpO2 sensor Reusable Adult, Pediatric and
(Y- type) M-LNCS YI infant (>1kg), multi-site
(usually finger or toe)
84. Masimo Adult Reusable RD SET DCI Reusable Adult (>30kg), finger or
finger clip SpO2 sensor toe
85. Padiatric/Slender digit RD SET DCI-P Reusable Pediatric or adult (10-
Reusable finger clip 50kg)
SpO2 sensor
finger or toe
86. Masimo SpO2 sensor RD SET DCI YI Reusable Neonatal/Adult (>1 kg)
(Y- type)
87. Neonatal Pulse RD SET NeoPt CS-2 Single Neonatal (<1kg)
Oximeter Adhesive patient use
feet
sensor
88. Neonatal Pulse RD SET NeoPt Single Neonatal (<1kg)
Oximeter Adhesive patient use
feet
sensor
89. Neonatal/Adult Pulse RD SET Neo CS-2 Single Neonatal/Adult <3kg
Oximeter Adhesive patient use or >40kg
sensor
finger, feet

population/Parts of
body applied
90. Neonatal/Adult Pulse RD SET Neo Single Neonatal/Adult <3kg
Oximeter Adhesive patient use or >40kg
sensor
Adult finger or toe,
neonatal hand or feet
91. Masimo SpO2 Y-shaped 049-000256 Single /
sheath patient use
92. Reusable Adult
Temperature probe TAS03-09
Surface
93. Reusable Adult
Temperature probe TPS03-03
Body cavity
94. Reusable Adult/pediatric/
Temperature probe TPE03-01 neonatal
Surface
95. Reusable Adult/pediatric/
Temperature probe TAE03-04 neonatal
Body cavity
96. Masimo RGM module 98ME07GC968 Reusable /
interface cable
97. Nomoline Airway Disposal Adult/pediatric
3827
Adapter Sets with Luer Intubated type
98. Nomoline Airway Disposal Adult/pediatric
3828
99. Nomoline Airway Disposal Infant
3829
100. Nomoline CO2 sampling Disposal Adult/pediatric
tube with Nasal Cannula
3830
Nasal
101. Nomoline CO2 sampling Disposal Pediatric (10-20kg)
tube with Nasal Cannula 3831
Nasal
102. Nomoline CO2 sampling Disposal
tube with Nasal Cannula 3832
Nasal cannula
103. Disposal Adult/pediatric
Nomoline CO2 sampling
tube with nasal/oral 3833
Cannula
Nasal/Oral Cannula
tube with nasal/oral 3834 Nasal/Oral Cannula
Cannula - O2 delivery

population/Parts of
body applied
Nasal/Oral Cannula
Cannula
Nasal/Oral Cannula
tube with single nasal 3839
prong
Nasal
110. Masimo IRMA Airway Disposal Adult/pediatric
106220
adapter
111. Masimo IRMA Airway Disposal Infant
106260
adapter
112. Respironics CO2 Reusable /
98ME07GC067
module interface cable
113. Single /
Water Filter Assembly 1103416
patient use
114. Dehumidification Single /
1103417
Tubing patient use
115. Large Airway Adapter Disposal Adult / pediatric
1103414
Set Intubated type
116. Small Airway Adapter Disposal Infant
1103415
Set Intubated type
117. Large CO2 Nasal Disposal Adult
1103408
Cannula Nasal Cannula
118. Medium CO2 Nasal Disposal Adult / pediatric
1103409
119. Small CO2 Nasal Disposal Infant
1103410
120. Mainstream CO2 airway Single Adult / pediatric
6063-00 patient use
adapter Intubated type
121. Mainstream CO2 airway Single Infant
REF: 6312-00 patient use
adapter Intubated type

population/Parts of
body applied
122. Loflo Airway adapter kit Single Adult / pediatric
w/ Dehumidification 3473ADU-00 patient use
Intubated type
tubing
123. Loflo Airway adapter kit Single Infant
w/ Dehumidification 3473INF-00 patient use
Intubated type
tubing
124. Cardiac output Interface Reusable /
98ME07GB106
cable
125. Neonatal wakeup Reusable Infant and neonatal
A0916-C05
sensor Abdomen
126. Bandage for wakeup Disposal Infant and neonatal
040-000199
sensor Abdomen
127. Oxygen sensor Reusable /
A0916-C06
connection cable
128. Oxygen sensor MOX-3 Reusable All patient / airway
129. Oxygen sensor cover 043-000373 Reusable All patient / airway
130. ICG patient cable with Reusable Adult/ pediatric
ICG
electrode wires
131. ICG electrode N1201-5 Disposal Adult/pediatric Trunk
132. Masimo IRMA Reusable /
mainstream CO2 200101
module
133. Respironics mainstream Reusable /
1015928
CO2 module
134. COMEN mainstream Reusable /
M-01
CO2 module
135. Masimo rainbow R1 25 Single Adult (>30 kg)
3792 patient use
Adult Adhesive Sensor Finger
136. Masimo rainbow R1 20 Single Pediatric (10-50 kg)
Pediatric Adhesive 3793 patient use
Finger
Sensor
137. Single Adult/Neonatal (>30kg
Masimo rainbow R1 25L patient use or <3kg)
2414
Adult Adhesive Sensor Finger/neonatal hand
or foot
138. Masimo Rainbow DCI Reusable Adult
2696
Adult Reusable Sensor Finger
139. Masimo Rainbow DCI- Reusable Pediatric
P Reusable Pediatric 2697
Finger
Sensor
140. Masimo Rainbow SpO2 Rainbow RC-12 Reusable /
patient cable 2404

population/Parts of
body applied
141. COVIDIEN BIS module 186-0195-SF Reusable /
142. BIS adult 4-electrode Disposal Adult / forehead
186-0106
sensor
143. BIS Pediatric 4- Disposal Pediatric/ forehead
186-0200
electrode sensor
144. Masimo SedLine MOC- SedLine MOC- Reusable /
Module
145. Masimo SedLine Patient Reusable /
4298
Cable
146. Single Adults
Masimo SedLine Sensor 2479 patient use
Forehead
147. ARTEMA SPIRIT Single Adult
040-001949-00 patient use
Spirometry flow sensor Airway
148. ARTEMA SPIRIT Single Neonatal
040-001950-00 patient use
Spirometry flow sensor Airway
149. NMT sensor CEA121B Reusable /
150. NMBA (Neuromuscular Disposal All patient
Blocking Agents) XT-45008
Waist
electrode
151. O3 Regional Oximeter Reusable /
9637
MOC-9 Module
152. Masimo O3 Regional Single Adult
3756 patient use
Adult Oximetry Sensor Forehead
153. Masimo O3 Regional Single Pediatric
Pediatric Oximetry 4235 patient use
Forehead
Sensor
154. Masimo IRMA Reusable /
200601
mainstream AG module
- - End of test report - -

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Test Report issued under the responsibility of:

Test item description ....................... : Patient Monitor

Internal lithium-ion battery pack: DC 10.95V; 5500mAh

Testing Laboratory: SGS-CSTC Standards Technical Services Co., Ltd.

Testing procedure: TMP/CTF Stage 1: N/A

Testing procedure: WMT/CTF Stage 2: N/A

Testing procedure: N/A

TRF No. IEC60601_1_2DEMC

Tests performed (name of test and test clause): Testing location:

TRF No. IEC60601_1_2DEMC

Possible test case verdicts:

TRF No. IEC60601_1_2DEMC

General product information:

Classification of applied part:

The optional configuration of patient monitor and plug-in modules:

No. REF/PN Description Applied part / Accessories Applied

TRF No. IEC60601_1_2DEMC

5 C-11/ Mainstream CO2 CO2 sampling tube and adaptor Type BF

TRF No. IEC60601_1_2DEMC

21 C-41/ XAVANT NMT plug- NMT sensor and electrode Type CF

while Model K12Pro has full configuration.

TRF No. IEC60601_1_2DEMC

No. Item Measurement Uncertainty

TRF No. IEC60601_1_2DEMC

TRF No. IEC60601_1_2DEMC

1.1 Equipment Description

1.1.1 Supporting Equipment Used During Test:

Use* Product Type Manufacturer Model Comments

Note: * Use one of the following:

1.1.2 Input/output Ports:

Port Name Type* Cable Cable Comments

3 ECG cable PC 3.7m Shielded None

4 BLT SpO2 cable PC 3.7m Shielded None

5 Masimo SpO2 cable PC 4.5m Shielded None

6 Nellcor SpO2 cable PC 3.2m Shielded None

7 Temp cable PC 4.0m Shielded None

8 CO2 extension cable PC 2.2m Shielded None

9 IBP cable PC 3.0m Shielded None

TRF No. IEC60601_1_2DEMC

Supplementary information: none.

1.1.3 Power Interface

Mode Voltage Current Power Frequency Phases Comments

Supplementary information: none.

1.2 EUT Operation Modes:

Supplementary information: none.

1.3 EUT Configuration Modes

Supplementary information: none.

TRF No. IEC60601_1_2DEMC

Description of BASIC SAFETY and ESSENTIAL PERFORMANCE

Function item Essential performance requirement

TRF No. IEC60601_1_2DEMC

TRF No. IEC60601_1_2DEMC

Parameters Verification/ monitoring method

TRF No. IEC60601_1_2DEMC

Manual intervention is required to re-start the stimulation.

TRF No. IEC60601_1_2DEMC

TRF No. IEC60601_1_2DEMC

HAL, ENF, ISO: 0%-8%: ±(0.15%+5% of reading);

TRF No. IEC60601_1_2DEMC

1. IMMUNITY Pass/Fail Criteria