EED32K003314 EMC Report

Report No.
: EED32K003314 Page 1 of 27
EMC TEST REPORT

Product : pulse oximeter
Trade mark : N/A
Model/Type reference : YM101, YM102, YM103, YM201, YM301
Serial number : N/A
Ratings : DC 3V(2×1.5V AAA alkaline batteries)
Report number : EED32K003314
Date of issue : Apr. 26, 2019
Regulations : See below
Test Standards Results
IEC 60601-1-2:2014 PASS
EN 60601-1-2:2015 PASS
IEC 60601-1-11:2015(Clause 12) PASS
ISO 80601-2-61:2017 (Clause 202) PASS
Prepared for:
Shenzhen Yimi Life Technology Co.,Ltd
305, Building A, Tengbo Industrial Park, Changshangjiang Street,
Longbei Village, Pingshan District, Shenzhen, 518118, China
Prepared by:
Centre Testing International Group Co., Ltd.
Hongwei Industrial Zone, Bao’an 70 District,
Shenzhen, Guangdong, China
TEL: +86-755-3368 3668
FAX: +86-755-3368 3385
Compiled by: Reviewed by:
Approved by: Date of issue: Apr. 26, 2019

David Wang Check No.: 3177489357
Report No. : EED32K003314 Page 2 of 27
Modification Record
No. Last Report No. Modification Description
1 EED32K003314 Initial report
TABLE OF CONTENTS
1. GENERAL INFORMATION.........................................................................................................4
2. COMPLIANCE SUMMARY.........................................................................................................4
3. MEASUREMENT UNCERTAINTY............................................................................................ 7
4. PRODUCT INFORMATION AND TEST SETUP.....................................................................7
4.1 PRODUCT INFORMATION.................................................................................................. 7
4.2 TEST SETUP CONFIGURATION........................................................................................8
4.3 SUPPORT EQUIPMENT....................................................................................................... 8
5. FACILITIES AND ACCREDITATIONS..................................................................................... 8
5.1 TEST FACLITY....................................................................................................................... 8
5.2 TEST EQUIPMENT LIST...................................................................................................... 9
5.3 LABORATORY ACCREDITATIONS AND LISTINGS...................................................10
6. RADIATION DISTURBANCE...................................................................................................11
6.1 LIMITS.................................................................................................................................... 11
6.2 BLOCK DIAGRAM OF TEST SETUP.............................................................................. 11
6.3 TEST PROCEDURE............................................................................................................ 11
6.4 GRAPHS AND DATA.......................................................................................................... 12
7. IMMUNITY TEST........................................................................................................................ 14
7.1 ELECTROSTATIC DISCHARGE...................................................................................... 16
7.1.1 TEST SPECIFICATION................................................................................................16
7.1.2 BLOCK DIAGRAM OF TEST SETUP........................................................................ 16
7.1.3 TEST PROCEDURE.....................................................................................................16
7.1.4 RESULTS & PERFORMANCE................................................................................... 17
7.2 RADIO FREQUENCY ELECTROMAGNETIC FIELDS................................................. 18
7.2.2 BLOCK DIAGRAM OF TEST SETUP........................................................................18
7.2.3 TEST PROCEDURE.....................................................................................................19
7.2.4 RESULT & PERFORMANCE......................................................................................19
7.3 POWER-FREQUENCY MAGNETIC FIELDS..................................................................21
7.3.2 BLOCK DIAGRAM OF TEST SETUP........................................................................21
7.3.3 TEST PROCEDURE.....................................................................................................21
7.3.4 RESULTS & PERFORMANCE................................................................................... 21
APPENDIX 1 PHOTOGRAPHS OF TEST SETUP................................................................... 22
APPENDIX 2 PHOTOGRAPHS OF PRODUCT........................................................................24
(Note: N/A means not applicable)
1. GENERAL INFORMATION
Applicant: Shenzhen Yimi Life Technology Co.,Ltd
305,Building A,Tengbo Industrial Park, Changshangjiang Street,
Village, Pingshan District, Shenzhen, 518118, China
Manufacturer: Shenzhen Yimi Life Technology Co.,Ltd
305,Building A,Tengbo Industrial Park, Changshangjiang Street,
Product: pulse oximeter
Trade mark: N/A
Model/Type reference: YM101, YM102, YM103, YM201, YM301
Serial number: N/A
Report number: EED32K003314
State of Sample(s): Normal
Sample Received Date: Dec. 13, 2018
Sample tested Date: Dec. 13, 2018 to Feb. 20, 2019
The tested sample(s) and the sample information are provided by the client.
2. COMPLIANCE SUMMARY
IEC 60601-1-2:2014 & EN 60601-1-2:2015
Clause Requirement + Test Result - Remark Verdict
5 Identification, Marking And Documents Pass

5.1 Marking on the outside of ME equipment or N/A
ME equipment parts
5.2 Accompanying documents Please refer to user Pass
manual.
5.2.1 Instructions for use Please refer to user Pass
manual.
5.2.1.1 Requirements applicable to all ME equipment Pass
and ME systems
5.2.1.2 Requirements applicable to all ME equipment N/A
and ME systems for which the connector
testing exemption specified in 6.2.2.2.c) is
used
5.2.2 Technical description Please refer to user Pass
manual.
IEC 60601-1-2:2014 & EN 60601-1-2:2015

Clause Requirement + Test Result - Remark Verdict
5.2.2.1 Requirements applicable for all ME Please refer to user Pass

equipment and ME systems manual.
5.2.2.2 Requirements applicable to ME equipment N/A
and ME systems other than those specified
for use only in shielded location
and ME systems specified for use only in
shielded location
and ME systems that intentionally apply RF
energy for diagnosis or treatment
and ME systems that intentionally receive RF
electromagnetic energy for the purpose of
their operation
and ME systems that include RF transmitters
Requirement – Test Result/Comments Verdict

Emissions
Classification
Class A or B................................................. : Class B —
Group 1 or 2.................................................: Group 1 —
CISPR 11, 14-1, or 15................................ : CISPR 11 —
Limits of mains terminal disturbance voltage : Yes Pass
Limits for radiated disturbance..................: Yes Pass
Limits for disturbance power (if applicable) : N/A —
Harmonic Current Emissions per N/A —
IEC 61000-3-2..:
Voltage Fluctuations and Flicker per N/A —
IEC 61000-3-3
Immunity
Electrostatic Discharges (ESD)................ : Yes Pass
Radiated RF electromagnetic Fields……………..: Yes Pass

Electrical Fast Transients and bursts.......: N/A —
Surges...........................................................: N/A —
Conducted Disturbances, induced by RF fields : Yes Pass
Voltage Dips, Interruptions, and variations : N/A —
Power-frequency Magnetic Fields............ : Yes Pass
3. MEASUREMENT UNCERTAINTY
Where relevant, the following measurement uncertainty levels have been estimated
for tests performed on the Product as specified in CISPR 16-4-2. This uncertainty
represents an expanded uncertainty expressed at approximately the 95% confidence level
using a coverage factor of k=2.
Test item Value (dB)
Continuous disturbance 3.1
Radiation disturbance 4.9
4. PRODUCT INFORMATION AND TEST SETUP

4.1 PRODUCT INFORMATION
Ratings: DC 3V(2×1.5V AAA alkaline batteries)
Model difference: All the models have the same circuit diagram and critical
component.all the models are identical for the internal except for the
following difference, The test model is YM201 and the test results are
applicable to the others.
Model YM101 YM102 YM103 YM201 YM301
Screen size 1.5inch 1.5inch 1.5inch 0.96inch 1.3inch
LED colour Red Green White Yellow, Blue
Blue
Use environment: Professional healthcare facility environment.

Home healthcare environment.
Special environment.
EUT description: Intended use:
The pulse oximeter is intended for measure oxygen saturation and
pulse rate of adult patients in hospital, hospital type facilities.
Test mode: ON(Spot checking mode)
Main Performance and Technical Specification：

General
Product Name: pulse oximeter
Model: YM201
Measurement range: 0~100%
SpO2: Resolution:1%
Accuracy: 70 to 100%: ±2%
0% to 69%: unspecified.
Measurement range: 25~250bpm
Pulse Rate:
Resolution:1 bpm
Accuracy: ±3bpm
Width*Height*Depth: 57×31×30 mm
Max. weight <28 g (without the batteries)

Temperature (ºC):15 to 40
Operating conditions: Humidity (non-condensing):15% to 95%
Atmospheric pressure (kPa):70 to 106
Temperature (ºC):-20 to 60
Storage/transportation
Humidity (non-condensing):10% to 95%
Conditions:
Atmospheric pressure (kPa):50 to 107.4
4.2 TEST SETUP CONFIGURATION

See test photographs attached in Appendix 1 for the actual connections between Product
and support equipment.
4.3 SUPPORT EQUIPMENT

No. Device Type Brand Model Series No. Data Cable Power Cord
1. Spo2 simulator FLUKE INDEX 2XLFE 1519028 --- ---
Notes:
1. All the equipment/cables were placed in the worst-case configuration to maximize the emission during
the test.
2. Grounding was established in accordance with the manufacturer’s requirements and conditions for the
intended use.
5. FACILITIES AND ACCREDITATIONS

5.1 TEST FACLITY
All measurement facilities used to collect the measurement data are located at Hongwei
Industrial Zone, 70 Area, Bao’an District, Shenzhen, Guangdong, China. The site and
apparatus are constructed in conformance with the requirements of ANSI C63.4 and CISPR
16-1-1 other equivalent standards.
The test facility is recognized, certified, or accredited by the following organizations:
CNAS-Lab Code: L1910

Centre Testing International Group Co., Ltd. has been assessed and proved to be in
compliance with CNAS-CL01 Accreditation Criteria for Testing and Laboratories (identical to
ISO/IEC 17025: 2005 General Requirements) for the Competence of Testing and
Calibration Laboratories.
A2LA-Lab Cert. No. 3061.01

Centre Testing International Group Co., Ltd. EMC Laboratory has been accredited by
A2LA for technical competence in the field of electrical testing, and proved to be in
compliance with ISO/IEC 17025: 2005 General Requirements for the Competence of
Testing and Calibration Laboratories and any additional program requirements in the
identified field of testing.
IC-Registration No.: 7408A

The 3m Alternate Test Site of Centre Testing International Group Co., Ltd. has been
registered by Certification and Engineering Bureau of Industry Canada for the performance
of radiated measurements.
IC-Registration No.: 7408B

The 10m Alternate Test Site of Centre Testing International Group Co., Ltd. has been
registered by Certification and Engineering Bureau of Industry Canada for the performance
of radiated measurements.
VCCI
Centre Testing International Group Co., Ltd.
Mains Ports Conducted Interference Measurement VCCI Registration No. is C-20007.
Telecommunication Ports Conducted Disturbance Measurement VCCI Registration No. is
T-20008.
3m Alternate
Radiated Emission from 30MHz to 1GHz VCCI Registration No. is R-20006.
Radiated Emission from 1GHz to 6GHz VCCI Registration No. is G-20021.
10m Alternate
Radiated Emission from 30MHz to 1GHz VCCI Registration No. is R-20005.
Radiated Emission from 1GHz to 6GHz VCCI Registration No. is G-10758.
5.2 TEST EQUIPMENT LIST

Instrumentation: The following list contains equipments used at CTI for testing.
The calibrations of the measuring instruments, including any accessories that may effect
such calibration, are checked frequently to assure their accuracy. Adjustments are made
and correction factors applied in accordance with instructions contained in the manual for
the measuring instrument.
Equipment used during the tests:

3M Semi-anechoic Chamber (1)- Radiated disturbance Test
Equipment Manufacturer Model Serial No. Due Date
3M Chamber &
ETS-LINDGREN FACT-3 3510 06/04/2019
Accessory Equipment
Spectrum Analyzer Agilent E4443A MY45300910 10/31/2019
Receiver R&S ESCI 100009 05/24/2019
TRILOG Broadband
schwarzbeck VULB 9163 484 06/04/2019
Antenna
Multi device Controller ETS-LINGREN 2090 00057230 /
Shielding Room No. 3 - Electrostatic discharge Test (IEC 61000-4-2)

ESD Simulator TESEQ NSG437 1182 07/24/2019
3M Full-anechoic Chamber - Radio-frequency electromagnetic field Test (IEC 61000-4-3)

3M Chamber &
ETS-LINDGREN FACT-3 3510 06/04/2019
Accessory Equipment
ESG Vector signal
Agilent E4438C MY42082153 01/17/2020
generators
Power Amplifier AR 150W1000 0322288 01/17/2020
Power Amplifier AR 25S1G4A 0321112 01/17/2020
Stacked double Log.-Per. STLP 9128 E
schwarzbeck 9128ES-110 /
Antenna special
Horn Antenna AR ATH800M5GA 0342530 /
BCJJ55BTA00
5GHz Indoor Booster --- JJ55BTA /
0022
Shielding Room No. 2 - Power-frequency magnetic fields Test (IEC 61000-4-8)

Compact Generator EM-Test UCS500M/6B V0603101093 06/26/2019
Induction Coil EM-Test MS100 0106-47 01/15/2020
Current Transformer EM-Test MC2630 0106-02 01/15/2020
5.3 LABORATORY ACCREDITATIONS AND LISTINGS

The measuring equipment utilized to perform the tests documented in this report has been
calibrated once a year or in accordance with the manufacturer's recommendations, and is
traceable under the ISO/IEC/EN 17025 to international or national standards. Equipment has
been calibrated by accredited calibration laboratories.
6. RADIATION DISTURBANCE
6.1 LIMITS
Limits for Group 1 class B Equipment
Quasi-peak limits at 3m
Frequency (MHz)
dB(μV/m)
30-230 40
230-1000 47
NOTE: The lower limit shall apply at the transition frequencies.
6.2 BLOCK DIAGRAM OF TEST SETUP
6.3 TEST PROCEDURE
a. The Product was placed on the non-conductive turntable 0.8m above the ground at a
chamber.
b. Set the spectrum analyzer/receiver in Peak detector, Max Hold mode, and 120 kHz RBW.
Record the maximum field strength of all the pre-scan process in the full band when the
antenna is varied between 1~4 m in both horizontal and vertical, and the turntable is rotated
from 0 to 360 degrees.
c. For each frequency whose maximum record was higher or close to limit, measure its QP
value: vary the antenna’s height and rotate the turntable from 0 to 360 degrees to find the
height and degree where Product radiated the maximum emission, then set the test
frequency analyzer/receiver to QP Detector and specified bandwidth with Maximum Hold
Mode, and record the maximum value.
6.4 GRAPHS AND DATA

Model/Type reference : YM201 Temperature : 22℃
Power : DC 3V Humidity : 50%
Mode : ON Polarization : Horizontal

Model/Type reference : YM201 Temperature : 22℃
Power : DC 3V Humidity : 50%
Mode : ON Polarization : Vertical
7. IMMUNITY TEST
Immunity Performance Criteria
Required by IEC 60601-1-2:2014
During the immunity tests, the EUT was operated under conditions specified by clause 4.1
of this report.
The particular performance criterion for the immunity tests are specified by manufacturer,
with reference to the exampls in Annex I of IEC 60601-1-2:2014.
The equipment or system shall be able to provide the essential performance and remain
safe. The following degradations associated with essential performance and safety shall
not be allowed:
– malfunction;
– non-operation when operation is required;
– unwanted operation when no operation is required;
– deviation from normal operation that poses an unacceptable RISK to the PATIENT or
OPERATOR;
– component failures;
– change in programmable parameters;
– reset to factory defaults (MANUFACTURER’s presets);
– change of operating mode;
– a FALSE POSITIVE ALARM CONDITION;
– a FALSE NEGATIVE ALARM CONDITION (failure to alarm);
– cessation or interruption of any intended operation, even if accompanied by an ALARM
SIGNAL;
– initiation of any unintended operation, including unintended or uncontrolled motion,
even if accompanied by an ALARM SIGNAL;
– error of a displayed numerical value sufficiently large to affect diagnosis or treatment;
– noise on a waveform in which the noise would interfere with diagnosis, treatment or
monitoring;
– artefact or distortion in an image in which the artefact would interfere with diagnosis,
treatment or monitoring;
– failure of automatic diagnosis or treatment ME EQUIPMENT or ME SYSTEM to
diagnose or treat, even if accompanied by an ALARM SIGNAL.
For equipment and systems with multiple functions, the criteria apply to each function,
parameter and channel.
The equipment and systems may exhibit degradation of performance (e.g. deviation from
manufacturer’s specifications) that does not affect essential performance or safety.
Required by ISO 80601-2-61:2017(Clause 202 )

IEC 60601‐1‐2:2014 applies except as follows:
202.4.3.1 Configurations
Amendment (replace the second dash of 4.3.1 with):
– setting the SpO2 within the calibrated range to be at least 5 % different from that of a
noiseinduced value and less than (100 % minus the SpO2 ACCURACY of the PULSE
OXIMETER EQUIPMENT).
This shall apply to IMMUNITY testing of PULSE OXIMETER EQUIPMENT.
NOTE The noise‐induced value could be a value, e.g. where R = 1 or R is the ratio of the
gain from the IR channel to the gain from the red channel. Other noise‐induced values
have been observed.
– setting the pulse rate to be different from that of the noise‐induced signal frequency and
within the specified range of the pulse rate display.
The SpO2 and pulse rate signal may be derived from a PATIENT simulator for these tests.
202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS

Amendment (add note to list element b) ):
NOTE The requirements of this document are not considered deviations or allowances.
Additional subclause:
202.8.1.101 Additional general requirements
Under the IMMUNITY TEST LEVELS specified in IEC 60601‐1‐2:2014, 8.9, PULSE
OXIMETER EQUIPMENT shall be able to
provide BASIC SAFETY and ESSENTIAL PERFORMANCE.
The following degradations, if associated with BASIC SAFETY or ESSENTIAL
PERFORMANCE shall not be allowed:
– component failures;
– changes in programmable parameters or settings;
– reset to default settings; and
– change of operating mode.
The PULSE OXIMETER EQUIPMENT may exhibit temporary degradation of performance
(e.g. deviation from the performance indicated in the instructions for use during IMMUNITY
testing) that does not affect BASIC SAFETY or ESSENTIAL PERFORMANCE providing
the PULSE OXIMETER EQUIPMENT recovers from any disruption within 30 s without
OPERATOR intervention.
202.8.2 PATIENT physiological simulation
Amendment (add between the first and second paragraph):
During IMMUNITY testing, the PULSE OXIMETER EQUIPMENT shall be tested at an
SpO2 reading within the calibrated range that is at least 5 % different from that of a noise
‐induced value and less than (100 % minus the SpO2 ACCURACY of the PULSE
OXIMETER EQUIPMENT).
NOTE 2 The noise‐induced value could be a value, e.g. where R = 1 or R is the ratio of the
gain from the IR channel to the gain from the red channel. Other noise‐induced values
have been observed.
The pulse rate shall be different from that of the noise‐induced signal frequency and
within the specified range of the pulse rate display.
The SpO2 and pulse rate signal may be derived from a PATIENT simulator for these tests.
7.1 ELECTROSTATIC DISCHARGE

7.1.1 TEST SPECIFICATION
Basic Standard : IEC 61000-4-2:2008
Test Port : Enclosure port
Discharge Impedance : 330 ohm / 150 pF
Discharge Mode : Single Discharge
Discharge Period : one second between each discharge
7.1.2 BLOCK DIAGRAM OF TEST SETUP
7.1.3 TEST PROCEDURE

a. Electrostatic discharges were applied only to those points and surfaces of the Product
that are accessible to users during normal operation.
b. The test was performed with at least ten single discharges on the pre-selected points in
the most sensitive polarity.
c. The time interval between two successive single discharges was at least 1 second.
d. The ESD generator was held perpendicularly to the surface to which the discharge was
applied and the return cable was at least 0.2 meters from the Product.
e. Contact discharges were applied to the non-insulating coating, with the pointed tip of the
generator penetrating the coating and contacting the conducting substrate.
f. Air discharges were applied with the round discharge tip of the discharge electrode
approaching the Product as fast as possible (without causing mechanical damage) to touch
the Product. After each discharge, the ESD generator was removed from the Product and
re-triggered for a new single discharge. The test was repeated until all discharges were
complete.
g. At least ten single discharges (in the most sensitive polarity) were applied to the
Horizontal Coupling Plane at points on each side of the Product. The ESD generator was
positioned vertically at a distance of 0.1 meters from the Product with the discharge
electrode touching the HCP.
h. At least ten single discharges (in the most sensitive polarity) were applied to the center of
one vertical edge of the Vertical Coupling Plane in sufficiently different positions that the four
faces of the Product were completely illuminated. The VCP (dimensions 0.5m x 0.5m) was
placed vertically to and 0.1 meters from the Product.
7.1.4 RESULTS & PERFORMANCE

Model/Type reference : YM201
Power : DC 3V Temperature : 24℃
Mode : ON Humidity : 56%
Min. No. of
Discharge Voltage Discharge per Meet the Immunity
Discharge Position
Method (±kV) polarity Performance Criteria
(Each Point)
Conductive Surfaces 8 10
Contact
Indirect Discharge VCP 8 10
Discharge
EUT Operated as intended, no
Indirect Discharge HCP 8 10 degradation of function
Air Slots, Apertures, and

2,4,8,15* 10
Discharge Insulating Surfaces
*:The product restart by air discharge 15KV in USB port.
Device-Specific Pass/Fail Detection/Testing Method

Device-Specific
Criteria (Immunity pass/fail (how to monitor Test results
Function
criteria) device-specific functions)
SpO2 Accuracy Accuracy: ±2%（70%~100%）
Spo2 simulator Within Range
Pulse Rate:Accuracy: ±3bpm
7.2 RADIO FREQUENCY ELECTROMAGNETIC FIELDS

Basic Standard : IEC 61000-4-3:2006+A1:2007+A2:2010
Step Size : 1%
Modulation : 1kHz, 80% AM
Dwell Time : 1 second
Polarization : Horizontal & Vertical
Below 1GHz:
Above 1GHz:

a. The testing was performed in a fully-anechoic chamber. The transmit antenna was
located at a distance of 3 meters from the Product.
b. The frequency range is swept from 80MHz to 2700MHz, with the signal 80% amplitude
modulated with a 1 kHz sine wave. The rate of sweep did not exceed 1.5x 10-3 decade/s.
Where the frequency range is swept incrementally, the step size was 1%.
c. The test was performed with the Product exposed to both vertically and horizontally
polarized fields on each of the four sides.
7.2.4 RESULT & PERFORMANCE

Frequency Field Strength Meet the Immunity

Position
(MHz) (V/m) Performance Criteria
Front, Right, EUT Operated as intended, no

80 - 2700 10
Back, Left degradation of function.
Front, Right, EUT Operated as intended, no

See the Figure 1 See the Figure 1
Back, Left degradation of function.
 There was no observable degradation in performance.

Device-Specific
Function
Figure 1
7.3 POWER-FREQUENCY MAGNETIC FIELDS

Basic Standard : IEC 61000-4-8:2009
Power Frequency : 50Hz/60Hz
Duration : 5 Min
Direction : X axis Y axis Z axis

a. The Product and support units were located on a table, 0.8m away from ground floor.
b. The Product is configured and connected to satisfy its functional requirements. It shall be
place on the GRP with the interposition of a 0.1m thickness insulating support (e.g. dry
wood)
c. Setting the parameter of tests and then perform the test software of test simulator.
d. The induction coil shall enclose the Product placed at its centre.
7.3.4 RESULTS & PERFORMANCE

Field Strength Duration Meet the Immunity

Direction
(A/m) (Min) Performance Criteria
X axis 30 5
EUT Operated as intended, no
Y axis 30 5
degradation of function.
Z axis 30 5
 There was no observable degradation in performance.

Device-Specific
Function
APPENDIX 1 PHOTOGRAPHS OF TEST SETUP
Radiation Disturbance Test Setup
Electrostatic Discharge Test Setup

Radio Frequency Electromagnetic Fields Test Setup
Power-frequency magnetic fields

APPENDIX 2 PHOTOGRAPHS OF PRODUCT
View of Product-1
View of Product-2
View of Product-3
View of Product-4
View of Product-5
View of Product-6
View of Product-7
*** End of Report ***

The test report is effective only with both signature and specialized stamp. The result(s) shown in this
report refer only to the sample(s) tested. Without written approval of CTI, this report can’t be reproduced
except in full.

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Report No.

EMC TEST REPORT

Compiled by: Reviewed by:

Approved by: Date of issue: Apr. 26, 2019

5 Identification, Marking And Documents Pass

IEC 60601-1-2:2014 & EN 60601-1-2:2015

5.2.2.1 Requirements applicable for all ME Please refer to user Pass

Requirement – Test Result/Comments Verdict

Radiated RF electromagnetic Fields……………..: Yes Pass

4. PRODUCT INFORMATION AND TEST SETUP

Use environment: Professional healthcare facility environment.

Test mode: ON(Spot checking mode)

Main Performance and Technical Specification：

Max. weight <28 g (without the batteries)

4.2 TEST SETUP CONFIGURATION

4.3 SUPPORT EQUIPMENT

1. Spo2 simulator FLUKE INDEX 2XLFE 1519028 --- ---

5. FACILITIES AND ACCREDITATIONS

CNAS-Lab Code: L1910

A2LA-Lab Cert. No. 3061.01

IC-Registration No.: 7408A

IC-Registration No.: 7408B

5.2 TEST EQUIPMENT LIST

Equipment used during the tests:

Shielding Room No. 3 - Electrostatic discharge Test (IEC 61000-4-2)

3M Full-anechoic Chamber - Radio-frequency electromagnetic field Test (IEC 61000-4-3)

Shielding Room No. 2 - Power-frequency magnetic fields Test (IEC 61000-4-8)

5.3 LABORATORY ACCREDITATIONS AND LISTINGS

6.2 BLOCK DIAGRAM OF TEST SETUP

6.3 TEST PROCEDURE

6.4 GRAPHS AND DATA

Product : pulse oximeter

Required by ISO 80601-2-61:2017(Clause 202 )

202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS

7.1 ELECTROSTATIC DISCHARGE

7.1.2 BLOCK DIAGRAM OF TEST SETUP

7.1.3 TEST PROCEDURE

7.1.4 RESULTS & PERFORMANCE

Air Slots, Apertures, and

*:The product restart by air discharge 15KV in USB port.

Device-Specific Pass/Fail Detection/Testing Method

7.2 RADIO FREQUENCY ELECTROMAGNETIC FIELDS

7.2.2 BLOCK DIAGRAM OF TEST SETUP

7.2.3 TEST PROCEDURE

7.2.4 RESULT & PERFORMANCE

Product : pulse oximeter

Frequency Field Strength Meet the Immunity

Front, Right, EUT Operated as intended, no

Front, Right, EUT Operated as intended, no

 There was no observable degradation in performance.

Device-Specific Pass/Fail Detection/Testing Method

7.3 POWER-FREQUENCY MAGNETIC FIELDS

7.3.2 BLOCK DIAGRAM OF TEST SETUP

7.3.3 TEST PROCEDURE

7.3.4 RESULTS & PERFORMANCE

Field Strength Duration Meet the Immunity

Device-Specific Pass/Fail Detection/Testing Method

APPENDIX 1 PHOTOGRAPHS OF TEST SETUP

Radiation Disturbance Test Setup

* End of Report *