Report No.

: EED33N00022303 Page 1 of 16

TEST REPORT
IEC 60601-2-22
Medical electrical equipment
Part 2: Particular requirements for basic safety and essential performance of
surgical, cosmetic, therapeutic and diagnostic laser equipment
Report Reference No........................ : EED33N00022303

Tested by.............................................. : Jim Liu ...........................................................

Reviewed by......................................... : Macy Yang ...........................................................

Approved by..........................................: Shine yang ...........................................................

Lab Supervisor
Date of issue.........................................: Dec. 28, 2021
Testing Laboratory............................: Centre Testing International Group Co., Ltd.
Address................................................. : Hongwei Industrial Zone, Bao’an 70 District, Shenzhen,
Guangdong, China
Applicant’s name...............................: Beijing ADSS Development Co., Ltd.
Address................................................. : F2, Building 1, Jinyuan Road 36, Daxing Economic Development
Zone, 102628 Beijing, PEOPLE’ S REPUBLIC OF CHINA
Test specification:
Standard................................................: IEC 60601-2-22: 2019
Test procedure..................................... : Test report only
Non-standard test method…………..: N/A
Test Report Form No........................ : IEC60601_2_22F

Test Report Form(s) Originator......... : UL(US)

Master TRF...........................................: Dated 2020-03-20
Test item description........................: Picosecond Laser System
Trade Mark............................................:

Manufacturer.........................................: Beijing ADSS Development Co., Ltd.

Address................................................. : Fuda Road - Tongsheng Road, Southern Area of Industrial Park,
Gu’ an Country, 065599 Langfang City, Hebei Province,
PEOPLE’ S REPUBLIC OF CHINA
Model/Type reference......................... : PS10-A, PS10-B
Ratings...................................................: 230V~, 50Hz,1800VA
Check No.: 3177447843
Report No.: EED33N00022303 Page 2 of 16

List of Attachments (including a total number of pages in each attachment):

None
Summary of testing:

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

All applicable tests were performed, and test result Centre Testing International Group Co., Ltd.
comply with this standard requirement. Hongwei Industrial Zone, Bao’ an 70 District,
Shenzhen, Guangdong, China
Exceptions:
The following clause/ collaterals were not evaluated:
Clause 201.10.4a), b), c), e), f), h), i) PROTECTION
AGAINST UNWANTED AND EXCESSIVE
RADIATION HAZARDS

Summary of compliance with National Differences:

List of countries addressed
None

Copy of marking plate:

The artwork below may be only a draft. The use of certification marks on a product must be
authorized by the respective NCBs that own these marks.

Refer to IEC 60601-1:2005+A1:2012 Test report No.:EED33N00022301

Report No.: EED33N00022303 Page 3 of 16
Test item particulars..................................................... :
Classification of installation and use: See Mobile
IEC 60 601-1 TRF, General Information.................:
Supply connection .....................................................: Appliance coupler
LASER Class as defined in 3.41 and 3.18 through Class 4
3.23 of IEC 60825-1 .................................................... :
LASER OUTPUT (power or energy)............................. : 1064nm: 500mJ, 532nm: 250mJ
Accessories and detachable parts included in Power cord
the evaluation ............................................................. :
Options included ........................................................: None
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........................................... : 2021-05-06
Date (s) of performance of tests................................. : 2021-08-10 to 2021-11-25

General remarks:
This report shall not be reproduced except in full without the written approval of the testing laboratory.
The test results presented in this report relate only to the item tested.
”(see remark #)" refers to a remark appended to the report.
"(see Annex #)" refers to an annex appended to the report.
Throughout this report, a point (comma) is used as the decimal separator.
This Test Report Form is intended for the investigation of diagnostic and therapeutic laser
equipment in accordance with IEC 60601-2-22. It can only be used together with IEC 60601-1
Report.
Name and address of factory (ies)............................ : Beijing ADSS Development Co., Ltd.
Fuda Road - Tongsheng Road, Southern Area of
Industrial Park, Gu’ an Country, 065599 Langfang
City, Hebei Province, PEOPLE’ S REPUBLIC OF
CHINA
General product information:
Refer to IEC 60601-1:2005+A1:2012 Test report No.: EED33N00022301
Report No.: EED33N00022303 Page 4 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTS P

201.7.2 Marking on the outside of me equipment or me equipment parts P
201.7.2.101 a) Laser equipment carry labels in accordance Clearly marked on the ME equipment P
with 7.3, 7.6 or 7.7 of IEC 60825-1 as applicable. (Refer to copy of marking plate)
These labels are visible from the normal operating P
position.
b) With the exception of Class 1C laser P
equipment, laser equipment provided with a label
positioned as close as practicable to each laser
aperture
Label in accordance with 7.8 of IEC 60825- P
1:2014
Applicators subject to disinfection or sterilizing No such used N/A
and fibre-optics exempted from the above but are
affixed in a prominent position with either
- Statement that the laser APERTURE is on the end N/A
of the fibre/applicator; or
- Symbol number 113 in Table D.1 N/A
c) CLASS 1C laser equipment additionally include N/A
the class of the ENCLOSED LASER in the
explanatory label
201.7.9 ACCOMPANYING DOCUMENTS P
201.7.9.1 ACCOMPANYING DOCUMENTS provide adequate Refer to the used manual P
instructions for proper operation including clear
warnings concerning precautions to avoid
possible exposure to hazardous laser radiation....:
201.7.9.2 INSTRUCTIONS FOR USE...............................................: See below P
201.7.9.2.1 Maintenance P
3
Instructions for maintenance include clear Refer to the chapter 7.6 “Precautions P
warnings concerning precautions to avoid during treatment” in user manual
possible exposure to hazardous LASER RADIATION
201.7.9.2.1 LASER specific information for the RESPONSIBLE See below P
01 ORGANIZATION and for the LASER OPERATOR........... :

Instructions for use include the following P

information as applicable:
a) Information on the NOMINAL OCULAR HAZARD Refer to the chapter 13.2 “Laser P
DISTANCE (NOHD) for the laser equipment in warning” in user manual
NORMAL USE with each appropriate ACCESSORY;
Report No.: EED33N00022303 Page 5 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

b) A statement in SI units of BEAM DIVERGENCE, Refer to the chapter 8.3 “Technical P

PULSE DURATION, and maximum LASER OUTPUT of parameters” in user manual
laser radiation with the magnitudes of cumulative
measurement uncertainty and any expected
increase in the measured quantities after
manufacture added to the values measured at the
time of manufacture;
c) Where a single pulse is made up of a pulse No such used N/A
train, the technical details described in the
information for the laser user;
d) The potential variation in wavelength stated ; P
e) Legible reproduction (colour optional) of all Refer to the chapter 1 “Label P
required laser labels and HAZARD warnings affixed Identification Descriptior” in user
to the laser equipment;. manual
f) Information and guidance for regular calibration Refer to the chapter 10 “Daily P
of the LASER OUTPUT in accordance with 201.12.1; Maintenance Cleaning and
Maintenance” in user manual
g) Clear indication of all locations of laser P
APERTURES;

h) Listing of controls, adjustments and procedures Refer to the chapter 13.2 “Laser P
for operation and maintenance by the responsible warning” in user manual
ORGANIZATION , including the warning “Caution –
Use of controls or adjustments or performance of
procedures other than those specified herein may
result in HAZARDOUS radiation exposure.”
i) A description of the BEAM DELIVERY SYSTEMS P
including the characteristics of the LASER OUTPUT
j) CLASS 1C laser equipment provided with detailed Not class 1C laser equipment N/A
technical description of the interlocks, a description
of possible limitations and malfunction following
false positioning of the applicator, a
comprehensive description of how to position the
applicator properly, a warning about possible
usage conditions which may result in hazardous ;
k) Statement saying the laser equipment protected Refer to the chapter 13.1 “Electrical P
against unauthorized use; safety warning” in user manual
l) Specification of eye protection, except for CLASS Refer to the chapter 13.2 “Laser P
1C laser equipment warning” in user manual
m) Specification for fume and plume extraction, P
including cautionary statement “Caution – Laser
fume and/or plume may contain viable tissue
particulates”;
Report No.: EED33N00022303 Page 6 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

n) Information about the potential HAZARDS when No such used N/A

inserting, sharply bending or improperly securing
the fibre optics, stating that not following the
recommendations of the manufacturer may lead to
damage to the fibre or BEAM DELIVERY SYSTEM
and/or harm to the PATIENT or LASER OPERATOR;
o) instructions for checking the integrity of the BEAM Refer to the chapter 13.1 “Electrical P
DELIVERY SYSTEM; safety warning” in user manual
p) information on non-laser HAZARDS; Refer to the chapter 13.1 “Electrical P
safety warning” in user manual
q) information on safe procedures which ensure a Refer to the chapter 7 “Treatment P
minimum of acceptable side effects to the Procedures” in user manual
PATIENTS, including a list of counter-indications and
including a list of all conditions which would render
the balance of the expected success of treatment
and the non-avoidable side-effects non-
acceptable;
r) information on separate equipment which would Refer to the user manual P
be useful to assess the favourable conditions
which are acceptable for treatment or to assess
the unfavourable conditions which would render a
treatment unacceptable or HAZARDOUS;
s) checklists and forms which help the user collect Refer to the user manual P
the information necessary to assess the favourable
conditions of treatment;
t) information about the applicable national Refer to the user manual P
regulations, e.g. on professional cosmetic
applications of laser equipment;
u) description of procedures to ensure that sterile No such accessories used N/A
ACCESSORIES remain sterile;

v) information about ACCESSORIES such as fibre- No such fibre-optics used N/A

optics which are compatible with the laser
equipment;
w) if the laser equipment is installed with or No such used N/A
connected to other medical devices or equipment
to operate as required for its intended purpose,
sufficient details of its characteristics to identify the
correct devices or equipment to use in order to
obtain a safe combination are provided;
Report No.: EED33N00022303 Page 7 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

x) if the ACCESSORY to the laser equipment is Refer to the chapter 10 “Daily P

reusable, information on the appropriate processes Maintenance Cleaning and
to allow reuse, including cleaning, disinfection, Maintenance” in user manual
packaging and, where appropriate, the method of
sterilization of the device to be re-sterilized, and
any restriction on the number of reuses is
provided. Where ACCESSORIES are supplied with
the intention that they be sterilized before use, the
instructions for cleaning and sterilization are such
that, if correctly followed, the ACCESSORY will still
comply with the requirements of this document;
y) if the ACCESSORY bears an indication that the Not single used N/A
ACCESSORY is for single use, information on known
characteristics and technical factors known to the
manufacturer that could pose a risk if the device
were to be re-used are provided. If no instructions
for use are needed, the information is made
available to the user upon request. The possibility
of this request and provisions for obtaining the
requested information is described;
z) details of any further treatment or handling P
needed before the ACCESSORY can be used;
aa) Precautions to be taken in the event of Refer to the user manual P
changes in performance of the laser equipment;
bb) Precautions to be taken, as regards Refer to the chapter 13 “Warning, P
malfunction of laser equipment due to exposure, Prompt Description and Identification
in reasonably foreseeable environment conditions, Explanation” in user manual
to magnetic fields, external electrical influences,
electrostatic discharge, pressure or variations in
pressure, accelerations, thermal ignition sources,
etc;
cc) degree of accuracy claimed for ACCESSORIES No such used N/A
with a measuring function
dd) understandable explanation of symbols, Refer to the chapter 1“Label P
controls, instructions, operating or adjustment Identification Description” in user
parameters when required for the operation of the manual
laser equipment.
Report No.: EED33N00022303 Page 8 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

201.8 PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT P

201.8.5 OEM (Original Equipment Manufacturer) product Not exempted from the differing N/A
exempted from the differing requirements of IEC requirements of IEC 60601-1
60601-1 when the OEM product containing the
laser and/or the OEM laser product containing a
power supply complied with IEC 61010-1,
Exemption applies to subclause 8.6, 8.8 and 8.9
for MEANS OF OPERATOR PROTECTION, not for
MEANS OF PATIENT PROTECTION . ..........................:

201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS N/A

201.8.7.3 – Laser equipment considered as PERMANENTLY Non-permanently installed equipment N/A
INSTALLED equipment when connected to SUPPLY
MAINS by means of a MAINS PLUG mechanically
secured against unintentional loosening, and
– when POWER SUPPLY CORD non-detachable and N/A
– when cross-sectional area of POWER SUPPLY N/A
CORD conductors not less than 2,5 mm2 .

201.8.10 Component and wiring P

201.8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated control P
devices
201.8.10.4. Foot-operated laser emission control switch Complied P
101 (wired or wireless) is shrouded to prevent
unintentional operation
Force required to actuate the switch was  10 N 25N P
and  50 N, applied over an area of 625 mm2
anywhere on the operating surface of the
footswitch (N).................................................................:
201.8.11 MAINS PARTS, COMPONENTS AND LAYOUT P
201.8.11.1 Conductivity of liquid used in laser equipment in P
01 NORMAL USE for cooling and as basic insulation to
SUPPLY MAINS was such that LEAKAGE CURRENT
values of 8.7 were not exceeded:
The conductivity of the liquid was continuously Not exceed N/A
monitored by the laser equipment.
When leakage current values of 8.7 exceeded, N/A
laser equipment was automatically switched off
from SUPPLY MAINS.
201.10 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZARDS N
201.10.4 Lasers N/E
201.10.4 IEC 60825-1:2014 applied Refer to IEC 60825:2014 test report N/E
201.10.4.1 General requirements N/E
01
Report No.: EED33N00022303 Page 9 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

Laser equipment complied with the following Refer to IEC 60825:2014 test report N/E
requirements:
a) REMOTE INTERLOCK CONNECTOR complied with N/E
6.4 of IEC 60825-1:2014: except for battery
powered hand-held medical laser equipment and
CLASS 1C laser equipment;

b) Key control complied with 6.6 of IEC 60825- N/E

1:2014;
c) Viewing optics complied with 6.10 of IEC 60825- N/E
1:2014;
d) Laser equipment incorporates a visible LASER N/E
READY INDICATOR illuminated when emission of
WORKING BEAM is possible upon actuation of the
control switch;
e) CLASS 3B and 4 and CLASS 1C laser equipment N/E
incorporating an ENCLOSED LASER of CLASS 3B or
4 equipped with a visible and an audible signal
clearly indicating that emission of laser radiation
in excess of the AEL for CLASS 3R is taking place
LASER READY INDICATOR and visible LASER N/E
EMISSION INDICATOR were visible through laser
protective eyewear as specified in 201.7.9.2.101.
The 2 m distance requirement of 4.7.3 of IEC N/E
60825-1:2014 was not applied as one of the
LASER EMISSION INDICATORS was clearly visible or
audible
LASER EMISSION INDICATOR recognizable by the N/E
LASER OPERATOR and by persons in the vicinity of
the operational control or laser APERTURE, the 2 m
distance requirement of 4.7.3 of IEC 60825-
1:2014 not applicable.
LASER EMISSION INDICATOR FAIL SAFE or redundant. N/E
f) TARGET INDICATING DEVICE N/E
Location where LASER OUTPUt was to effect
indicated prior to emission of the WORKING
BEAM …

TARGET INDICATING DEVICE is a light beam, point of N/E

impact indicated by TARGET INDICATING DEVICE
was concentric with the WORKING BEAM within the
tolerance: lateral offsets of the centres of the two
beams was less than 50% of the diameter of the
working beam………………………..
Report No.: EED33N00022303 Page 10 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

Additionally, the diameter of the AIMING LASER N/E

beam was not larger than twice the diameter of
the working laser
beam. ………………………………….
TARGET INDICATING DEVICE is an electronic N/E
indication, its centre did not deviate from the
centre of the WORKING BEAM by more than 50% of
the diameter of the WORKING BEAM……………….
When a VISIBLE AIMING BEAM was chosen, its spot N/E
was recognizable through the laser protective
eyewear as specified in 201.7.9.2.101.
TARGET INDICATING DEVICE in the form of an AIMING N/E
BEAM emitted from the LASER APERTURE and
generated by an AIMING LASER or by an attenuated
WORKING BEAM, did not exceed AEL for CLASS 3R
with the following exceptions:
-Ophthalmic AIMING LASER, the AIMING BEAM did N/E
not exceed AEL for CLASS 2 without deliberate and
positive action of the LASER OPERATOR.
TARGET INDICATING DEVICE not required for CLASS N/E
1C laser equipment .
g) Laser equipment provided with STAND-BY/ N/E
READY DEVICE.

STAND-BY/ READY DEVICE capable of disabling the N/E

WORKING BEAM.

The LASER PRODUCT default enters to STAND-BY N/E

mode upon initial switch the LASER PRODUCT to
SUPPLY MAINS.

Transition from STAND-BY to READY not possible N/E

when the LASER EMISSION CONTROL SWITCH
activated.
h) ENCLOSURES complied with the following N/E
clauses of 60825-1:2014:
-6.2 Protective housing – 6.2.1 General; N/E
-6.2 Protective housing - 6.2.2 Service N/E
-6.3 Access panels and safety interlocks N/E
i) LASER OUTPUT limited to the amount necessary N/E
for the laser equipment to enable its intended
medical, surgical or diagnostic functions.
Consideration about limits of LASER OUTPUT Refer to RISK MANAGEMENT FILE N/E
included in the RISK MANAGEMENT PROCESS per 4.2
of the base standard.
Report No.: EED33N00022303 Page 11 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

201.10.4.1 Interlock system of laser equipment of CLASS 1C N/A

02
CLASS 1C LASER PRODUCT incorporating an Not class 1C laser N/A
ENCLOSED LASEr of CLASS 3B or 4 equipped with an
interlock system capable of detecting whether
GOOD CONTACT with the biological skin tissue
established.
Continuous action by the user necessary to N/A
maintain the enabled status, the laser keeps
emitting unless GOOD CONTACT with the skin is lost.
While continuous action is maintained, any loss of N/A
GOOD CONTACT detected by the interlock system
and laser emission shut off.
Time interval between loss of good contact with N/A
the skin and disabling the triggering of the lase
emission not exceeding 0,1 s provided that the
requirement for CLASS 1C met.
Automatic resumption of emission when GOOD N/A
CONTACt is re-established within a maximum of 10
s
(s)……………………………………………………….
For time greater than 10 s, laser equipment N/A
required active retriggering by the user to resume
emission.
Interlock systems containing programmable See Attachment # N/A
electronic circuits, software incorporates measures
to control the fault/error conditions specified in
201.13.2. Also refer to Clause 14 of the general
standard………………………………………………..
:
201.10.4.1 Laser radiation filter in view optics N/A
03
Laser equipment incorporating viewing orptics No such used N/A
equipped with an OPERATOR PROTECTIVE FILTER.
OPERATOR PROTECTIVE FILTER in place during the N/A
time intervals when the working laser is emitting.
OPERATOR PROTECTIVE FILTER prevented radiation N/A
of the working laser being transmitted through the
eyepiece exceeding of MPE.
Function of the TARGET INDICATING DEVICE not N/A
compromised.
ME EQUIPMENT used projectors or monitors for N/A
viewing exempted from above requirements
Report No.: EED33N00022303 Page 12 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

201.11 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS P

201.11.8.1 CLASS 4 laser equipment provided with a manual P
01 reset enabling resumption of laser radiation
emission after interruption of emission caused by
use of a remote interlock on CLASS 4 laser
equipment or unexpected loss of SUPPLY MAINS
201.12 ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTION AGAINST P
HAZARDOUS OUTPUTS
201.12.1 Accuracy of controls and instruments P
201.12.1.1 Laser equipment incorporates a means for the P
01 indication of the pre-set level of the output of the
WORKING BEAM in SI units

The actual LASER OUTPUT measured in the Refer to the appended table P
WORKING AREA did not deviate from the pre-set 201.12.1.101
value by more than ±20%(% deviation).............. :
The LASER OUTPUT fixed by the manufacturer and Laser output is adjustable N/A
is not adjustable. Fixed LASER OUTPUT specified
on the label.
The actual PULSE DURATION did not deviate the Laser output is adjustable N/A
manufacturer specified PULSE DURATION or PULSE
DURATION set by the operator by more than
±20%(% deviation)................................................. :
201.12.4 Protection against hazardous output P
201.12.4.2 The iLASER OUTPUT emitted by the laser No more than ±20 % P
equipment did not deviate from the preset value
by more than ±20 % (%
deviation)………………………………. :
A quantity, electrical or optical, directly related to P
the LASER OUTPUT generated, is monitored during
operation
Monitoring carried out at intervals shorter than the P
failure tolerance time
System calibrated at regular intervals against the P
LASER POWER (or LASER ENERGY) actually emitted
on the WORKING AREA, and an appropriate method
is described in the instructions for use in
accordance with 201.7.9.2.101f............................... :
201.12.4.4 Incorrect output P
201.12.4.4. - stops the emission of LASER OUTPUT as fast as Emergency laser stop is provided P
101 possible to prevent danger to any person
- it is independent of all other laser stop systems P
Report No.: EED33N00022303 Page 13 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

A red push-button switch readily visible and easily Red push-button P

and quickly reachable by the LASER OPERATOR
from the operating position is provided.................:
”Laser Stop” or the symbol per Table DI, symbol Laser Stop marked on near the push- P
101, is marked on or near the push-button.......... : button
EMERGENCY LASER STOP not provided because an EMERGENCY LASER STOP is provided N/A
emergency stop according to IEC 60947-3 is
incorporated in the laser equipment......................:
CLASS 3B LASERS for non-surgical or non- N/A
ophthalmic use within the wavelength range of
600 nm to 1400 nm exempted from this
requirement under the following conditions
a) emitting less than five times the MPE for the N/A
skin and not more than 50 mW average power.... :
b) not exceeding the MPE for the skin..................... : N/A
CLASS 1C laser equipment expect form this N/A
requirement
201.12.4.4. Spectral impurities P
102
Manufacturer addressed in the RISK MANAGEMENT Refer to RISK MANAGEMENT FILE P
PROCESS risks associated with spectral impurities
of the LASER OUTPUT.
201.13 HAZARDOUS SITUATIONS AND FAULT CONDITIONS FOR ME EQUIPMENT P
201.13.1 The following specific HAZARDOUS SITUATIONS taken into consideration: P
201.13.1.1 Manufacturer addressed in in RISK MANAGEMENT Refer to RISK MANAGEMENT FILE P
01 PROCESS RISKS resulting from faults which may
cause the following situations:
a) Emission of excessive LASER OUTPUT P
b) faulty release of the WORKING BEAM P
c) failure of the cut-off of the WORKING BEAM P
d) hazardous laser emissions into free air for N
CLASS 1C LASER PRODUCT

201.13.2 SINGLE FAULT CONDITIONS P

201.13.2.1 Laser equipment designed that if a single fault No such situation occurred during the P
01 condition does result in an increase in accessible test of single fault condition, please
output, a visible and audible out-of-tolerance refer to appended table 13.2 in the
warning given when the laser output exceeded IEC 60601-1 report.
the + 20% tolerance.
Output restricted to below + 50%. No resulting in an increase in P
accessible output greater than 50%
Report No.: EED33N00022303 Page 14 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

Output not restricted to below + 50%, risk N/A

assessment indicates a higher percentage up to
100% maximum acceptable
Laser emission terminated when LASER OUTPUT N/A
exceeded limit.

201.13.2.1 Failure of exposure termination N/A

02
Protection against SINGLE FAULT CONDITIONS No such used N/A
provided by a safety device independent of the
timer and activated when the set time is exceeded
by 20 % when the exposure terminates by means
of a timer
The safety device terminates the LASER OUTPUT N/A
and prevents further timer-dependent operation of
the equipment
Exempted from the requirements of 201.13.2.101 N/A
and 201,13,2,102 are
a) components regarded as FAIL SAFE and N/A
subjected to preventive maintenance;
b) components of monitoring circuits checked N/A
during every start-up procedure of the laser
equipment;
c) CLASS 3B LASERS for non-surgical or non- N/A
ophthalmic use within the wavelength range of
600 nm to 1 400 nm,
- emitting less than five times the MPE for the skin N/A
and not more than 50 mW average power, or
- not exceeding the MPE for the skin N/A
d) CLASS 1C laser equipment with an ENCLOSED N/A
LASER below CLASS 4

201.13.2.1 Failure of exposure termination after loss of gooD CONTACT N/A

03
signal chain towards exposure termination or Not Class 1C ME equipment N/A
components FAIL SAFE or redundant for CLASS 1C
laser equipment when exposure terminated for
loss of GOOD CONTACT.
201.13.2.1 Failure of critical components P
04
The following considered when evaluating risks: RISK MANAGEMENT FILE. P
Document: CX010-JL06 Version: B/0
Report No.: EED33N00022303 Page 15 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

a) any electronic, opto-electronic and/or P

mechanical means which allows LASER POWER
or LASER ENERGY to be emitted or prevents it
from being emitted (e.g. shutter);
b) optical attenuators including the OPERATOR No such part used N/A
PROTECTIVE FILTER and their mechanisms;
c) LASER EMISSION CONTROL SWITCH; P
d) components of monitoring circuits; P
e) CLASS 1C laser equipment skin contact Not Class 1C ME equipment N/A
sensing interlocks;
f) in systems with exchangeable fibre optic BEAM No such used N/A
DELIVERY SYSTEMS, the sensor for detecting
the presence of the fibre optic BEAM DELIVERY
SYSTEM.
Report No.: EED33N00022303 Page 16 of 16
IEC 60601-2-22
Clause Requirement + Test Result - Remark Verdict

201.12.1.101 Indication of laser output P

Max measured
Working mode The wavelength (nm) power or Remark
energy
Pulse frequency: 1Hz
Max error: +4.80% <
Energy density: 0.50J/cm ² 1064 15.72mJ
±20%
Energy: 15mJ
Pulse frequency: 1Hz
Max error: +3.78%<
Energy density: 0.80J/cm ² 1064 518.90mJ
±20%
Energy: 500mJ
Pulse frequency: 10Hz
Max error: +15%<
Energy density: 0.50J/cm ² 1064 14.42mJ
±20%
Energy: 15mJ
Pulse frequency: 10Hz
Max error: -3.87%<
Energy density: 0.80J/cm ² 1064 494.8mJ
±20%
Energy: 500mJ
Pulse frequency: 1Hz
Max error: -4.36%<
Energy density: 1.0J/cm ² 532 29.65mJ
±20%
Energy: 31mJ²
Pulse frequency: 1Hz
Energy density: 8.0J/cm ² Max error: -2.12%<
532 244.7mJ
±20%
Energy: 250mJ²
Pulse frequency: 10Hz
Energy density: 1.0J/cm ² Max error: -3.17%<
532 30.02mJ
±20%
Energy: 31mJ²
Pulse frequency: 10Hz
Max error: -2.28%<
Energy density: 8.0J/cm ² 532 244.3mJ
±20%
Energy: 250mJ²

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.
*** End of report ***