Boaray 7005. IEC60601IEC60601-1

TEST REPORT
IEC 60601 -1
Medical electrical equipment
Part 1: General requirements for safety
Report reference No.................... TRS09070042
Compiled by (+ signature) ........... Ivy.chen ...................................................
Reviewed by (+ signature)........... Terry.zhang ...................................................
Approved by (+ signature) ........... Kathy.Guo ...................................................

Date of issue................................ 2010-08-02
Testing laboratory........................ SHENZHEN HUATONGWEI INTERNATIONAL INSPECTION Co., Ltd.
Address ....................................... Keji Nan No.12 Road, Hi-tech Park, Shenzhen ,China
Testing location ........................... Shenzhen City ,China
Applicant...................................... Shenzhen probe science & technology Co.,Ltd.
Address ....................................... JinLiMei Factory Building, No. 37, Yanshan Road, Nanshan District,
Shenzhen, P.R.China
Standard ...................................... IEC 60601-1:1988+ A1:1991 + A2:1995
Test Report Form No................... I601-1_C/97-04
TRF Originator............................. Underwriters Laboratories Inc.
Master TRF.................................. dated 97-04
Copyright blank test report .......... The bodies participating in the Committee of Certification Bodies
(CCB). This report is based on a blank test report that was prepared
by KEMA using information obtained from the TRF originator.
Test procedure ............................ Test report only
Procedure deviation..................... N
Non-standard test method........... N
Type of test object ....................... Anesthesia Machine
Trademark ...................................
Model/type reference................... Boaray 600, Boaray 700

Manufacturer ............................... Shenzhen probe science & technology Co.,Ltd.
Address ....................................... JinLiMei Factory Building, No. 37, Yanshan Road, Nanshan District,
Shenzhen, P.R.China
Rating .......................................... 100-240Vac, 50/60Hz, 10A( Auxiliary output:100-240Vac, 50/60Hz,
2A×3)
Battery: 18.5V, 4000mAh
Page 2 of 50 Report No. TRS09070042
Copy of marking plate

GENERAL INFORMATION
Test item particulars (see also clause 5):
Classification of installation and use ....................................... : Mobile
Supply connection ...................................................................: Appliance coupler
Accessories and detachables parts included in the evaluation ---
..................................................................................................:
Options included ......................................................................: ---
Possible test case verdicts:

- test case does not apply to the test object ..................:N / A N
- test object does meet the requirement ........................:Pass P
- test object does not meet the requirement ..................:Fail F
Abbreviations used in the report:
- normal condition...........................................................:N.C. - single fault condition................... :S.F.C.
- operational insulation ...................................................:OP - basic insulation........................... :BI
- basic insulation between parts of opposite polarity .....:BOP - supplementary insulation ........... :SI
- double insulation ..........................................................:DI - reinforced insulation ................... :RI
General remarks:
"This report is not valid as a CB Test Report unless appended to a CB Test Certificate issued by a
NCB, in accordance with IECEE 02".
"(see Attachment #)" refers to additional information appended to the report.
"(see appended table)" refers to a table appended to the report.
Throughout this report a point is used as the decimal separator.
The tests 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 testing laboratory.
List of test equipment must be kept on file and available for review.
Summary of contents provided on the last page of this report.
General product information and considerations:
The flowmeter of Boaray 700 is electronic and the flowmeter of Boaray 600 are six tubes. And there are a
few differences on the CO2 and Anesthesia Modules. The CO2 and Anesthesia Modules of Boaray 600
are Mainstream Option (Built-in); and they are Mainstream or sidestream Option (Plug-in) on Boaray 700.
The test sample is Boaray 700.
IEC 60601+ Am. 1 & 2
Clause Requirement + Test Result - Remark Verdict
3 GENERAL REQUIREMENTS P
3.1 Equipment when transported, stored, installed, P
operated in normal use and maintained according
to the instructions of the manufacturer, causes no
safety hazard which could reasonably be foreseen
and which is not connected with its intended
application in normal condition (N.C.) and in single
fault condition (S.F.C.)
3.4 An alternative means of construction is used to No such means N
that detailed in this standard and it can be
demonstrated that an equivalent degree of safety
is obtained
5 CLASSIFICATION P
5.1 Type of protection against electric shock P
Class I equipment P
Class II equipment N
Internally powered equipment N
5.2 Degree of protection against electric shock P
Type B applied part Type B P
Type BF applied part N
Type CF applied part N
Not classified - no applied parts N
5.3 Classification according to the degree of The total Unit is Ordinarily P
protection against ingress of water as detailed in equipment
the current edition of IEC 529 (see 6.1.1)............... ::
5.4 Methods of sterilization or desinfection Recommended by P
manufacturer
5.5 Equipment not suitable for use in the presence of P
flammable mixtures
Category AP equipment N
Category APG equipment N
5.6 Mode of operation: P
-continuous operation P
-short-time operation, specified operation; period.. : —
-intermittent operation, specified operation; rest —
period ....................................................................... :
-continuous operation with short-time, stated —
permissible loading time.......................................... ::
-continuous operation with intermittent, stated —
permissible loading/rest time .................................. :
INSULATION DIAGRAM
Table: to insulation diagram P

Insulation type: Referenc Required Required Measured Measured
Area operational / basic e voltage creepage clearance creepage clearance Remarks
/ supplementary / (V) (mm) (mm) (mm) (mm)
double /
reinforced
A BOP (A-f) 240 3 1.6 4.2 4.2 Power inlet
Mains to earthing
B BI (A-a1) 240 4 2.5 6.2 6.2
enclosure
Applied part to earthing
C BI (B-d) 240 4 2.5 >10 >10 enclosure, probe no bare
part
Primary wirings to
D RI/DI (A-e) 240 8 5 8.4 8.4
secondary wirings
D1 SI (A-c) 240 4 2.5 4.2 4.2 Primary wirings to core
Secondary wirings to
D2 BI (A-b) 240 4 2.5 4.2 4.2
core
E RI/DI (B-a) 240 8 5 >10 >10 Mains to probe
F BI (B-d) 240 4 2.5 >8 >8 Probe to SIP/SOP
Mains to plastic
G RI/DI (A-a2) 240 8 5 >8 >8
enclosure
Supplementary information:
INSULATION DIAGRAM CONVENTIONS

Insulation diagram is a graphical representation of equipment insulation barriers, protective
impedance and protective earthing. If feasible, use the following conventions to generate the diagram:
1) All isolation barriers are identified by letters between separate parts of diagram, for example separate
transformer windings, optocouplers, wire insulation, creepage and clearance distances.
2) Parts connected to earth with large dots are protectively earthed. Other connections to earth are
functional
3) Applied parts are extended beyond the equipment enclosure and terminated with an arrow.
4) Parts accessible to the operator only are extended outside of the enclosure, but are not terminated with
an arrow.
5) Blocks containing the letter “Z” indicate protective impedance.
6) Operational Insulation (OP) - indicates insulation that may be required for function of the equipment, but
is not required or relied on for compliance with the requirements of clauses 17, 20 and 57.
IEC 60601+ Am. 1 & 2
6 IDENTIFICATION, MARKING AND DOCUMENTS P

6.1 Marking on the outside of equipment or equipment parts P
c) Markings of the specific power supply affixed Not used specific power N
d) If marking is not practicable due to size or All marking on the equipment N
nature of enclosure, information is included in
accompanying documents
e) Name and/or trademark of the manufacturer or P
supplier .....................................................................:
f) Model or type reference........................................: Boaray 600, Boaray 700 P
g) Rated supply voltages or voltage range(s) 100-240V P
Number of phases....................................................: Single phase P
Type of current .........................................................: AC P
h) Rated frequency or rated frequency range(s) 50/60 P
(Hz) ..........................................................................:
j) Rated power input (VA, W or A) ...........................: 10A P
k) Power output of auxiliary mains socket-outlets 100-240VAC, 50/60Hz,2A×3 P
l) Class II symbol Class I equipment N
Symbol for degree of protection against ingress of Ordinary equipment N
water provided..........................................................:
Symbol for protection against electric shock...........: Type B applied part P
If equipment has more than one applied part with Only one applied part N
different degrees of protection, the relevant
symbols are clearly marked on such applied parts,
or on or near relevant outlets
Symbol for protection of defibrillation-proof applied No such function N
parts
Symbol 14 from Table DI for defibrillation-proof N
with protection partly in patient cable
m) Mode of operation (if no marking, suitable for Continuous operation P
continuous operation)
n) Types and rating of external accessible fuses . : T10AL/250V P
p) Ratings of external output ..................................: N
q) Symbol for physiological effect(s): N
- attention, consult accompanying documents N
- non-ionizing radiation, or symbols as adopted by N
ISO or IEC 417
r) Anaesthetic-proof symbol: AP or APG.................: Not AP or APG equipment N
s) Dangerous voltage symbol N
t) Special cooling requirements Not used special cool N
u) Limited mechanical stability No such risk N
IEC 60601+ Am. 1 & 2
v) Protective packing requirement(s) Marking on the package P

- Marking(s) for unpacking safety hazard(s) N
- Equipment or accessories supplied sterile, N
marked as sterile
y) Potential equalization terminal Marked on the rear of the P
equipment
- Functional earth terminal N
z) Removable protective means N
Durability of marking test See appended table 6.1b P
6.2 Marking on the inside of equipment or equipment parts P
a) Nominal voltage of permanently installed Non-permanently installed N
equipment equipment
b) Maximum power loading for heating elements or No such heating elements N
holders for heating lamps
c) Dangerous voltage symbol Marked on Inverter P
d) Type of battery and mode of insertion 18.5V, 4000mAh P
- Marking referring to accompanying documents N
used for battery not intended to be changed by the
operator
e) Fuses accessible with a tool identified either by P
type and rating or by a reference to diagram
f) Protective earth terminal Marked on the internal P
terminal of protective earth
g) Functional earth terminal Marked on PCB P
h) Supply neutral conductor in permanently Not permanently install N
installed equipment (N) equipment
j) Markings required in 6.2 f), h), k) ,and l) remain No such marking N
visible after connection and are not affixed to parts
which have to be removed
- Markings comply with IEC 445 N

k) For permanently connected devices the supply Not permanently install N
connections are clearly marked adjacent to the equipment
terminals (or in accompanying documents for small
equipment)
l) Statement for suitable wiring materials at Not exceeding 75°C, see N
temperatures over 75°C attached table
n) Capacitors and/or circuit parts marked as P
required in Sub-clause 15c
6.3 Marking of controls and instruments P
a) Mains switch clearly identified No mains switch N
- ON and OFF positions marked according to N
Symbols 15 and 16 of table D1 or indicated by an
adjacent indicator light
IEC 60601+ Am. 1 & 2
b) Indication of different positions of control All control devices are P

devices and switches indicated
c) Indication of the direction in which the P
magnitude of the function changes, or an indicating
device
f) The functions of operator controls and indicators P
are identified
g) Numeric indications of parameters are in SI P
units except for units listed in Am. 2
6.4 Symbols P
Used symbols comply with Appendix D or IEC 417 Comply with appendix D P
and/or IEC 878 or ISO publications (if applicable)
6.5 Colors of the insulation of conductors P
a) Protective earth conductor has green/yellow P
insulation
b) All insulations of internal protective earth Whole conductors are P
conductors are green/yellow at least at their green/yellow
terminations
c) Only protective or functional earthing, or P
potential equalization conductors are green/yellow
d) Color of neutral conductor ...................................: Blue P
e) Colors of phase conductor(s) .............................: Brown P
- Compliance with IEC 227 and IEC 245 N
f) Additional protective earthing in multi-conductor, Not used such conductor N
cords are marked green/yellow at the ends of the
additional conductors
6.6 Medical gas cylinders and connections P
a) In accordance with ISO ISO/R 32 P
b) Identification of connection point All marked on equipment P
6.7 Indicator lights and push-buttons P
a) Red indicator lights used exclusively to indicate The light is red for the high P
a warning of danger and/or a need for urgent priority alarm
action
- Yellow used to indicate caution or attention Yellow for the medium and P
required low priority alarms
b) Color red used only for push-buttons by which N
a function is interrupted in case of emergency
c) Color green used to indicate ready for action P
6.8 ACCOMPANYING DOCUMENTS P
6.8.1 Equipment accompanied by documents In the whole manual P
containing at least instructions for use, a
technical description and an address to which the
user can refer
IEC 60601+ Am. 1 & 2
Classifications specified in Clause 5 included in Refer to Appendix D.2 of P

both the instructions for use and the technical manual
description
Markings specified in Sub-clause 6.1 included in All marked on equipment N
the accompanying documents if they have not
been permanently affixed to equipment
Warning statements and the explanation of P
warning symbols provided in the accompanying
documents
6.8.2 Instructions for use P
a) General information provided in instructions for P
use
- state the function and intended application of the Refer to the chapter 2 of the P
equipment manual
- include an explanation of: the function of controls, Refer to the chapter 5 of the P
displays and signals manual
- the sequence of operation Refer to the chapter 5 of the P
manual
- the connection and disconnection of detachable Refer to the chapter 3 of the P
parts and accessories manual
- the replacement of material which is consumed No such parts N
during operation
- information regarding potential electromagnetic or Refer to the chapter 1 of the P
other interference and advice regarding avoidance manual
- include: indications of recognized accessories, P
detachable parts and materials, if the use of other
parts or materials can degrade minimum safety
- instructions concerning cleaning, preventive Refer to the chapter 8 of the P
inspection and maintenance to be performed manual
including the frequency of such maintenance
General information provided in instructions: P
- information for the safe performance or routine Refer to the chapter 8 of the P
maintenance manual
- parts on which preventive inspection and Refer to the chapter 8 of the P
maintenance shall be performed by other persons manual
including the periods to be applied
- explanation of figures, symbols, warning All explanation in the manual, P
statements and abbreviations on the equipment Refer to Appendix D.2 of
manual
c) Signal output or signal input parts intended All described in the manual P
only for connection to specified equipment
described
d) Details about acceptable cleaning, disinfection P
or sterilization methods included
e) Warning statement for mains operated Not use additional power N
equipment with additional power source
IEC 60601+ Am. 1 & 2
f) A warning to remove primary batteries if Not used primary batteries N

equipment is not likely to be used for some time
g) Instructions to ensure safe use and adequate Refer to chapter 3 of manual P
maintenance of rechargeable batteries
h) Identification of specified external power Not used external power N
supplies or battery chargers necessary to ensure supplies
compliance with the requirements of IEC 601-1
j) Identification of any risks associated with the No such products N
disposal of waste products, residues, etc.
- Advice in minimizing these risks N
6.8.3 Technical description P
a) All characteristics essential for safe operation Refer all the manual P
provided
b) Required type and rating of fuses utilized in the Mobile equipment N
mains supply circuit external to permanently
installed equipment
- Instructions for replacement of interchangeable No such part N
and/or detachable parts which are subject to
deterioration during normal use
c) Instructions or reference information for repair No operator repairable parts N
of equipment parts designated by the
manufacturer as repairable provided
d) Environmental conditions for transport and Refer to the clause of ambient P
storage specified in accompanying documents conditions
and marked on packaging
7 POWER INPUT P
Power Input Measurements see appended table 7 P
10 ENVIRONMENTAL CONDITIONS P
10.1 Equipment is capable while packed for transport P
or storage of being exposed to the conditions
stated by the manufacturer
10.2.2a Rated voltage not exceeding 250 V for hand-held Mobile equipment N
equipment
Rated voltage not exceeding 250 V d.c. or single- 100-240Vac P
phase a.c. or 500 V polyphase a.c. for equipment
up to 4kVA
Rated voltage not exceeding 500 V for all other N
equipment
Rated input frequency not more than 1kHz 50/60Hz P
10.2.2b Internal replaceable electrical power source 18.5V, 4000mAh P
specified
IEC 60601+ Am. 1 & 2
14 REQUIREMENTS RELATED TO CLASSIFICATION P

14.4a Class l and Class II equipment in addition to basic Compliance with class I P
insulation provided with an additional protection equipment
14.4b Equipment supplied from external dc source of Not used external dc source N
reverse polarity results in no safety hazard
14.5b Internally powered equipment complies with Internally powered equipment P
requirements for Class I or Class II equipment complies with requirements for
while connected to supply mains, and with Class I
requirements for internally powered equipment
when not connected
14.6c Applied parts intended for direct cardiac Type B applied part N
application are of type CF
15 LIMITATION OF VOLTAGE AND/OR ENERGY P

15b Voltage measured one sec after disconnection of See appended table 15b P
the mains plug does not exceed 60V
15c For live parts accessible after equipment has N
been de-energized the residual voltage does not
exceed 60 V nor residual energy exceed 2 mJ
Marking provided for manual discharging N
16 ENCLOSURES AND PROTECTIVE COVERS P

16a Equipment enclosed to protect against contact P
with live parts, and with parts which can become
live (finger, pin, hook test)
Insertion or removal of lamps - protection against Not use lamps N
contact with live parts provided
16b Opening in a top cover positioned that No such opening N
accessibility of live parts by a test rod is
prevented
16c Conductive parts accessible after the removal of handles, knobs, levers N
- have a resistance of not more than 0.2 Ω No such parts N
- separated from live parts by one of the means N
described in Sub-clause 17g
16d Parts with voltage exceeding 25V a.c. or 60V d.c. No such live parts N
which cannot be disconnected by external mains
switch or plug protected against contact
16e Removable enclosures protecting against contact with live parts N
- Removal possible only with the aid of a tool No such enclosure N
- Use of automatic device making parts not live N
when the enclosure is opened or removed
- Exception 16e applied to the following parts.......: N

IEC 60601+ Am. 1 & 2
16f Openings for the adjustment of controls using a No such opening N

tool. The tool not able to touch basic insulation or
any live parts
17 SEPARATION P
17a Separation method of the applied part from live parts: P
1) basic insulation: applied part earthed N
2) by protectively earthed conductive part (e.g. N
screen)
3) by separate earthed intermediate circuit limiting N
leakage current to applied part in event of
insulation failure
4) by double or reinforced insulation P
5) by protective impedances limiting current to N
applied part
- Additional leakage current test in single fault N
conditions
17c There is no conductive connection between Not used such connection P
applied parts and accessible conductive parts
which are not protectively earthed
17d Supplementary insulation between hand-held Not used motor N
flexible shafts and motor shafts (Class I)
17g Separation method of accessible parts other than applied parts from live parts: P
1) basic insulation: accessible part earthed P
2) by protectively earthed conductive part (e.g. N
screen)
3) by separate earthed intermediate circuit limiting N
leakage current to enclosure in event of insulation
failure
4) by double or reinforced insulation P
5) by protective impedances limiting current to N
accessible part
- Additional leakage current test in single fault N
conditions
17h Arrangements used to isolate defibrillation-proof applied parts so designed that: N
- no hazardous electrical energies appear during a No such applied part N
discharge of a cardiac defibrillator
- after exposure to the defibrillation voltage, the N
equipment continues to perform its intended
function
IEC 60601+ Am. 1 & 2
18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL P

EQUALIZATION
18a Accessible parts of Class I equipment separated P
from live parts by basic insulation connected to
the protective earth terminal
18b Protective earth terminals suitable for connection P
to the protective earth conductor
18e Potential equalization conductor P
- Readily accessible Readily accessible P
- Accidental disconnection prevented in normal No such risk P
use
- Conductor detachable without the use of a tool P
- Power supply cord does not incorporate a P
potential equalization conductor
- Connection means marked with Symbol 9, P
Table DI
18f For equipment without power supply cord, N
impedance between protective earth terminal and
accessible metal part ≤ 0.1 Ω
- For equipment with an appliance inlet, See appended table 18 P
impedance between protective earth contact and
any accessible metal part ≤ 0.1 Ω
- For equipment with a non-detachable power N
supply cord, impedance between protective earth
pin in mains plug and accessible metal part ≤ 0.2
Ω
18g If the impedance of protective earth connections Not exceeding 0.1Ω N
other than in Cl. 18 f) exceeds 0.1 Ω, the allowable
value of the enclosure leakage current is not
exceeded in single fault condition
18k Functional earth terminal not used to provide N
protective earthing
18l Class II equipment with isolated internal screens N
- insulation of screens and all internal wiring Class I equipment N
connected to them is double insulation or
reinforced insulation
- functional earth terminal clearly marked N
- explanation of functional earth terminal provided N
in the accompanying documents
19 CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY P

CURRENTS
19.1b Leakage currents See appended table 19 P
- earth leakage current P
- enclosure leakage current P
IEC 60601+ Am. 1 & 2
- patient leakage current P

- patient auxiliary current N
20 DIELECTRIC STRENGTH P
Overall compliance with Clause 20 See appended table 20 P
21 MECHANICAL STRENGTH P
21a Sufficient rigidity of an enclosure tested by: See appended table 21 P
force of 45 N
21b Sufficient strength of an enclosure tested by: See appended table 21 P
impact hammer
21c On portable equipment carrying handles or grips Mobile equipment N
withstand the requirements of the loading test
21.3 No damage to parts of patient support and/or Not used such parts N
immobilization system after the loading test
21.5 Hand held equipment or equipment parts are safe N
after drop test
21.6 Portable and mobile equipment is able to See appended table 21 P
withstand rough handling
22 MOVING PARTS N
22.2a Moving parts of a transportable equipment are No moving parts provided N
provided with guards which form an integral part of
the equipment
22.2b Moving parts of a stationary equipment are N
provided with similar guards as above, unless it is
evident that equivalent protection is separately
provided during installation
22.3 Cords (ropes), chains and bands are provided with N
guides to prevent them from running off or from
jumping out of their guiding devices
Guides or other safeguards are removable only N
with a tool
22.4 Dangerous movements of equipment parts, which N
may cause physical injury to the patient, are
possible only by the continuous activation by the
operator
22.6 Parts of equipment subject to mechanical wear N
are accessible for inspection
22.7 Means provided for emergency switching of an N
electrically produced mechanical movement
which could cause a safety hazard
The means for emergency switching is readily N
identifiable and accessible and does not introduce
a further safety hazard
IEC 60601+ Am. 1 & 2
Devices for emergency stopping able to break the N

full load current of the relevant circuit, taking into
account possible stalled motor currents
Means for stopping of movements operate as a N
result of one single action
23 SURFACES, CORNERS AND EDGES P

Rough surfaces, sharp corners and edges which No sharp edges, sharp P
may cause injury or damage avoided or covered corners nor rough surfaces
24 STABILITY IN NORMAL USE P

24.1 Equipment does not overbalance during normal See appended table 24 P
use when tilted through an angle of 10º
24.3 Equipment overbalances when tilted through an angle of 10º N
- does not overbalance when tilted through an N
angle of 5º in any position excluding transport
- carry a warning notice stating that transport N
should only be undertaken in a certain position
- in the position specified for transport does not N
overbalance when tilted to an angle of 10º
24.6a Equipment or its parts with a mass of more than 20 kg is provided with: P
- suitable handling devices (grips etc.), or Handling is provided P
- instructions for lifting and handling during P
assembly
24.6b b) On portable equipment with a mass of more Mobile equipment N
than 20 kg carrying handle(s) is (are) so situated
that equipment may be carried by 2 or more
persons
25 EXPELLED PARTS N
25.1 Protective means are provided where expelled No expelled parts N
parts of the equipment could be a hazard
25.2 Display vacuum tubes with a face dimension LCD used N
exceeding 16 cm are provided with adequate
protection against implosion
28 SUSPENDED MASSES N
28.3 Suspension system with safety device N
Safety device provided where the integrity of a No suspended masses N
suspension depends on parts which may have
hidden defects, or on parts having safety factors
not complying with Sub-clause 28.4
Safety device has safety factors complying with N
Sub-clause 28.4.2
IEC 60601+ Am. 1 & 2
Clear indication to the operator that the safety N

device has been activated after failure of
suspension means
28.4 Suspension systems of metal without safety devices N
1) Total load does not exceed the safe working N
load
2) Safety factors not less than 4 where it is N
unlikely that supporting characteristics will be
impaired
3) Safety factors not less than 8 where N
impairment is expected
4) Safety factors multiplied by 1.5 for metal N
having an elongation at break of less than 5%
5) Sheaves, sprockets, band wheels and guides N
so constructed that the safety factors maintained
till replacement
29 X-RADIATION N
29.2 EQUIPMENT not intended to produce X-radiation No such devices N
produces an exposure ≤ 130 nC/kg (0.5 mR)
36 ELECTROMAGNETIC COMPATIBILITY N
Equipment complies with IEC 601-1-2 Refer to the report of N
IEC60601-1-2
37 COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY APG N

EQUIPMENT
Requirements for category AP and APG Not AP or APG equipment N
equipment (Cl. 37 - 41)
42 EXCESSIVE TEMPERATURES P
42.1 Equipment does not attain temperatures See appended table 42 P
exceeding the values given in Table Xa over the
range of ambient temperatures per Clause 10.2.1
42.2 Equipment does not attain temperatures See appended table 42 P
exceeding the values given in Table Xb at 25ºC
ambient
42.3 Applied parts not intended to supply heat have See appended table 42 P
surface temperatures not exceeding 41ºC
42.5 Guards to prevent contact with hot surfaces P
removable only with a tool
43 FIRE PREVENTION P
Strength and rigidity necessary to avoid a fire See appended table 21 P
hazard
IEC 60601+ Am. 1 & 2
44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS, P

CLEANING, STERILIZATION AND DISINFECTION
44.2 Equipment contain a liquid reservoir: P
- the equipment is electrically safe after 15% Not use liquid reservoir N
overfill steadily over a period of 1 min
- transportable equipment is electrically safe after N
additionally having been tilted through an angle of
15º in the least favorable direction(s) (if necessary
with refilling)
44.3 Electrical properties of the equipment do not N
change in connection of spillage test (200 ml of
water)
44.4 Liquid which might escape in a single fault N
condition does not wet parts which may cause a
safety hazard
44.5 Equipment sufficiently protected against the See appended table 44 P
effects of humidity
44.6 Enclosures designed to give a protection against N
harmful ingress of water classified according to
IEC Publication 529
44.7 Equipment capable of withstanding cleaning, See appended table 44 P
sterilization or disinfection without deterioration of
safety provisions
45 PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE N

45.2 Pressure vessel with pressure volume greater This part evaluation by N
than 200 kPa x l and pressure greater than 50 manufacture
kPa withstand the hydraulic test pressure
45.3 Maximum pressure does not exceed the N
maximum permissible working pressure for
individual parts
45.7 Unless excessive pressure can not occur, N
pressure-relief device provided
45.7a Pressure-relief device connected as close as N
possible to the pressure vessel
45.7b Readily accessible for inspection N
45.7c Not capable of being adjusted or rendered N
inoperative without a tool
45.7d Discharge opening located that the released N
material is not directed towards person
45.7e Discharge opening located that operation will not N
deposit material which may cause a safety
hazard
45.7f Adequate discharge capacity to ensure pressure N
does not exceed the maximum permissible
working pressure
IEC 60601+ Am. 1 & 2
45.7g No shut-off valve between a pressure-relief N

device and the parts intended to be protected
45.7h Minimum number of cycles of operation: 100.000 N
48 BIOCOMPATIBILITY N
Parts of equipment and accessories intended to This part evaluation by N
come into contact with biological tissues, cells or manufacture
body fluids are evaluated in accordance with ISO
10993-1
49 INTERRUPTION OF THE POWER SUPPLY P

49.1 Thermal cut-outs and over-current releases with Not use such part N
automatic resetting not used if they may cause a
safety hazard
49.2 Interruption and restoration of power supply does P
not result in a safety hazard other than
interruption of intended function
49.3 Means are provided for removal of mechanical No mechanical constraints. N
constraints on patient in case of a supply mains
failure
51 PROTECTION AGAINST HAZARDOUS OUTPUT N

51.4 Equipment furnishing both low-intensity and high- N
intensity outputs provided with means minimizing
possibility of a high intensity output being
selected accidentally
52 ABNORMAL OPERATION AND FAULT CONDITIONS P

52.1 Equipment is so designed and manufactured that See appended table 52 P
even in single fault condition no safety hazard as
described under 52.4 exists (see 3.1 and Cl. 13)
The safety of equipment incorporating Evaluation by manufacturer N
programmable electronic systems is checked by
applying IEC 601-1-4
52.5.2 Failure of thermostats presents no safety hazards No such components N
52.5.3 Short-circuiting of either part of double insulation N
presents no safety hazard
52.5.5 Impairment of cooling: See appended table 52.5.5 P
temperatures not exceeding 1.7 times the values
of Clause 42 minus 17.5ºC
52.5.6 Locking of moving parts presents no safety No moving parts N
hazard
52.5.7 Interruption and short-circuiting of motor Not use motor N
capacitors presents no safety hazard
52.5.8 Duration of motors locked rotor test in compliance N
with Cl. 52.5.8
IEC 60601+ Am. 1 & 2
52.5.9 Failure of one component at a time presents no See appended table 52 P

safety hazard
52.5.10 Overload of heating elements presents no safety N
hazard
f) Motors intended to be remotely controlled, Not used motor N
automatically controlled, or liable to be operated
continuously provided with running overload
protection
h) Equipment with three-phase motors can safely N
operate with one phase disconnected
56 COMPONENTS AND GENERAL ASSEMBLY P

List of critical components See appended table 56 P
56.1b Ratings of components not in conflict with the Not conflict P
conditions of use in equipment
Ratings of mains components are identified P
56.1d Components, movements of which could result in P
a safety hazard mounted securely
56.1f Conductors and connectors secured and/or Secured mounted P
insulated to prevent accidental detachment
resulting in a safety hazard
56.3a Connectors provide separation required by P
Sub-clause 17g
Plugs for connection of patient circuit leads can No such risks P
not be connected to other outlets on the same
equipment
Medical gas connections not interchangeable Not use medical gas N
56.3b Accessible metal parts can not become live when No such risk P
detachable interconnection cord between
different parts of equipment is loosened or broken
56.3c Leads with conductive connection to a patient are The gas pipe is not conductive P
constructed such that no conductive connection parts
remote from the patient can contact earth or
hazardous voltages.
56.4 Connections of capacitors P
Not connected between live parts and non- No such connection N
protectively earthed accessible parts
If connected between mains part and protectively See appended table 56 P
earthed metal parts comply with:
IEC Publication 384-14
Enclosure of capacitors connected to mains part P
and providing only basic insulation, is not secured
to non-protectively earthed metal parts
Capacitors or other spark-suppression devices No such device used N
are not connected between contacts of thermal
cut-outs
IEC 60601+ Am. 1 & 2
56.5 Protective devices which cause disconnection By power plug P

from the supply mains by producing a short-
circuit not provided in equipment
56.6 Temperature and overload control devices P
a) Thermal cut-outs which have to be reset by a P
soldering not fitted in equipment
Thermal safety devices provided where P
necessary to prevent operating temperatures
exceeding the limits
Independent non-self-resetting thermal cut-out P
provided where a failure of a thermostat could
constitute a safety hazard
Audible warning provided where the loss of N
function caused by operation of a thermal cut-out
presents a safety hazard
Self-resetting thermal cut-outs and self-resetting N
over-current releases operated 200 times
Non-self resetting over-current releases operated N
10 times
56.6b Thermostats with varying temperature settings Not use such thermostats N
clearly indicated
Operating temperature of thermal cut-outs N
indicated
56.7 Batteries P
a) Battery compartments: P
- adequately ventilated Adequately ventilated P
- accidentally short-circuiting is prevented No such risk P
b) Incorrect polarity of connection prevented By construction P
56.8 Indicators - unless indication provided by other means (from the normal operation P
position), indicator lights are used (color see 6.7):
- to indicate that equipment is energized P
- to indicate the operation of non-luminous No such heater N
heaters if a safety hazard could result
- to indicate when output exists if a safety hazard N
could result
- charging mode indicator provided By LED on the front panel P
56.10 Actuating parts of controls N
56.10b Actuating parts are adequately secured to N
prevent them from working loose during normal
use
Controls are secured to prevent the movement N
relative to scale marking (safety related only)
Detachable indicating devices are prevented from N
incorrect connection without the use of tool
IEC 60601+ Am. 1 & 2
56.10c Stops are provided on rotating controls: N

- to prevent an unexpected change from N
maximum to minimum or vice versa where this
could produce a safety hazard
- to prevent damage to wiring N
56.11 Cord-connected hand-held and foot-operated control devices N
a) Contain voltages not exceeding 25 V a.c. or 60 No such devices N
V d.c. and isolated from the mains part by Cl. 17g
b) Hand-held control devices comply with the N
requirement and test of Sub-clause 21.5
- Foot-operated control devices designed to N
support the weight of an adult human being
c) Devices not change their setting when N
inadvertently placed
d) Foot-operated control devices are at least IPX N
1
- For surgical use, electrical switching parts are N
IPX 8
e) Adequate strain relief at the cord entry N
provided
57 MAINS PARTS, COMPONENTS AND LAYOUT P

57.1 Isolation from supply mains P
a) Equipment provides means to isolate its By the plug P
circuits electrically from the supply mains on all
poles simultaneously
Means for isolation incorporated in equipment or, Such isolated devices are not N
if external, specified in the accompanying external
documents
d) Switches used to comply with Sub-clause Refer to table 56.1 P
57.1a comply with the creepage distances and air
clearances as specified in IEC Publication 328
f) Mains switches not incorporated in a power P
supply cord
h) Appliance couplers and flexible cords with P
mains plugs provide compliance with Sub-clause
57.1a
m) Fuses and semiconductor devices not used as Not used such devices P
isolating devices provided isolating
57.2 Mains connectors and appliance inlets P
e) Auxiliary mains socket-outlets on non- P
permanently installed equipment of a type that
cannot accept a mains plug
IEC 60601+ Am. 1 & 2
g) Unless functional earth needs to be provided, No such terminal used P

Class I appliance inlet is not used in Class II
equipment
57.3 Power supply cords P
a) Not more than one connection to a particular Only one connection to a P
supply mains particular supply mains
If alternative supply allowed, no safety hazards No alternative supply N
when more than one connection is made
simultaneously
The mains plug has only one power supply cord P
Non-permanently connected equipment provided Provided power supply cord P
with power supply cord or appliance inlet
b) Power supply cords sufficiently robust to comply See attended table 56.1 P
with the requirements of IEC 227, designation 53
and IEC 245, designation 53
Polyvinyl chloride insulated power supply cords Not exceeding 75℃, see P
not used for equipment having external metal attended table 42
parts with a temperature exceeding 75°C
c) Nominal cross-sectional area of conductors of 1.0mm² P
power supply cords not less than in Table XV
d) Stranded conductors not soldered if fixed by P
any clamping means
57.4 Connection of power supply cords P
57.4a Cord anchorages N
Equipment provided with power supply cords has Supply by detachable cord N
cord anchorages such that the conductors are
relieved from strain, including twisting
Tying the cord into a knot or tying the ends with N
string not used
Cord anchorages made of insulating material or N
metal insulated from unearthed accessible metal
parts by supplementary insulation
Cord anchorages made of metal provided with an N
insulating lining
Clamping screws do not bear directly on the cord N
insulation
Screws associated with cable replacement are not N
used to secure other components
Conductors of the power supply cord arranged that N
the protective earth conductor is not subject to
strain as long as the phase conductors are in
contact with their terminals
57.4b Power supply cord protected against excessive Supply by detachable cord N
bending
IEC 60601+ Am. 1 & 2
57.4c Adequate space inside equipment to allow the P

supply cable conductors to be introduced and
connected
57.5 Mains terminal devices and wiring of mains part P
Mains connected equipment other than those with Supply by detachable cord N
a detachable supply cord provided with mains
terminals, where connections are made with
screws, nuts or equally effective methods
If a conductor breaks away, barriers are provided P
such that creepage distances and air clearances
cannot be reduced
Screws and nuts which clamp external P
conductors not serve to fix any other component
b) Terminals closely grouped with any protective P
earth terminal
Mains terminal devices accessible only with use of P
a tool
Mains terminal devices located or shielded that, P
should a wire of a stranded conductor escape
when the conductors are fitted, there is no risk of
accidental contact
c) Internal wiring not subjected to stress when the P
means for clamping the conductors are tightened
or loosened
d) Cord terminals not require special preparation P
of the conductor
57.6 Mains fuses and overcurrent releases P
Fuses or over-current releases provided Fuse compliance with P
accordingly for Class I and Class II requirement of Class I
Current rating of mains fuses and over-current P
releases such that they reliably carry the normal
operating current
Protective earth conductor not fused P
Neutral conductor not fused for permanently Not permanently installed N
installed equipment equipment
57.8 Wiring of the mains part P
a) Individual conductor in the mains part with P
insulation not at least electrically equivalent to
that of the individual conductors of flexible supply
cords complying with IEC 227 or 245, treated as
bare conductor
b) Cross-sectional area of conductors up to P
protective device not less than the minimum
required for the power supply cord
Cross-sectional area of other wiring and the sizes 18AWG P
of tracks on printed wiring circuits sufficient to
prevent any fire hazard
IEC 60601+ Am. 1 & 2
57.9 Mains supply transformers P

57.9.1 Overheating P
External to the transformer protective devices P
connected in such a way that failure of any
component cannot render the protective devices
inoperative
57.9.1a Short-circuit of secondary windings not caused See appended table 57.9.1a P
excessive temperature
57.9.1b Overload of secondary windings not caused See appended table 57.9.1b P
excessive temperature
57.9.2 The dielectric strength of the electrical insulation N
of a mains supply transformer such that it passes
tests
57.9.4 Construction P
a) Separation of primary and secondary windings P
- separate bobbins or formers N
- one bobbin with insulating partition P
- one bobbin with concentric windings and having N
copper screen with a thickness of not less than
0.13 mm
- concentrically wound on one bobbin with N
windings separated by double insulation
c) Means provided to prevent displacement of By margin of the bobbin P
end turns
d) Insulated overlap of not less than 3 mm if a 4mm P
protective earthed screen has only one turn
e) Insulation between the primary and secondary in transformers with double P
insulation
- 1 insulation layer with thickness of at least 1 mm N
- at least 2 insulation layers with a total thickness P
of at least 0.3 mm
- three layers provided that each combination of N
two layers can withstand the dielectric strength
test for reinforced insulation
g) Exit of the wires of toroidal transformers Not toroidal transformers N
provided with double sleeving complying with
requirements for double insulation and having total
thickness at least 0.3 mm extending at least 20
mm outside the winding
57.10 Creepage distances and air clearances P
a) Values: compliance with at least the values of See table for insulation P
Table XVI diagram
Creepage distances for slot insulation of motors at N
least 50% of the specified values
IEC 60601+ Am. 1 & 2
b) Minimum creepage distances and air N

clearances in the mains part between parts of
opposite polarity not required if short-circuting
does not produce a safety hazard
c) Creepage distances or clearances of at least 4 N
mm are maintained between defibrillation-proof
applied parts and other parts
58 PROTECTIVE EARTHING - TERMINALS AND CONNECTIONS P

58.1 Clamping means of the protective earth terminal P
Not be able to loosen without the aid of a tool Clamping by screw P
Screws for internal earth connections are covered P
or protected against loosening from outside
58.7 Earth pin of the appliance inlet regarded as the Earth pin of the appliance inlet P
protective earth terminal regarded as the protective
earth terminal
58.8 The protective earth terminal not used for the P
mechanical connection or the fixing of any
component not related to earthing
58.9 Where the protective earth connections are made P
via a plug or socket device the protective earth
connection is made before and interrupted after
the supply connections during connection and
interrupting
59 CONSTRUCTION AND LAYOUT P

59.1 Internal wiring P
a) Cables and wiring protected against contact No moving parts N
with a moving part
Wiring having basic insulation only protected by P
additional fixed sleeving
Components are not likely to be damaged in the P
normal assembly or replacement of covers
b) Movable leads are not bent around a radius of N
less than five times the outer diameter of the lead
c) Insulating sleeving adequately secured P
If the sheath of a flexible cable or cord is used as P
supplementary insulation it complies with
requirements of IEC 227 and IEC 245 and
dielectric test
Conductors subjected to temperatures exceeding Not exceeding 70℃, refer to N
70°C have an insulation of heat-resistant material the temperature data
d) Aluminum wires of less than 16 mm2 cross- Not use aluminum wires N
section not used
f) Connecting cords between equipment parts P
considered as belonging to the equipment
IEC 60601+ Am. 1 & 2
59.2 Insulation P
b) Mechanical strength and resistance to heat Refer to the clause 42 P
and fires retained by all types of insulation
c) Insulation not likely to be impaired by P
deposition of dirt or by dust resulting from wear of
parts
Parts of rubber resistant to ageing N
59.3 Excessive current and voltage protection P
Internal electrical power source provided with No internal electrical power N
device for protection against fire hazard source used
Fuse elements replaceable without opening the Fuse holed in the power inlet P
enclosure fully enclosed in a fuseholder
Protective devices between an isolated applied No such devices N
part and the body of the equipment do not operate
below 500 V r.m.s.
59.4 Oil containers N
Oil containers adequately sealed Not used oil containers N
Container allow for the expansion of the oil N
Oil containers in mobile equipment sealed to N
prevent the loss of oil during transport
Partially sealed oil-filled equipment or equipment N
parts provided with means for checking the oil
level
6.1 TABLE: marking durability P

Marking tested Remarks
Rating label with distilled water Clearly legible & durable
Rating label with methylated spirit Clearly legible & durable
Rating label with isopropyl alcohol Clearly legible & durable
7 TABLE: power input P

Operating condition Voltage Frequency Current Power Remarks
(V) (Hz) (A) (VA)
Max. load 90 50 1.68 152.5
100 50 1.56 157.0
240 50 0.765 185.4
264 50 0.723 191.5
90 60 1.69 153.5
100 60 1.57 157.8
240 60 0.76 182.7
264 60 0.72 190.5
Supplementary information: The rated of the input is 10 A(The auxiliary output is 3X2A)
15b TABLE: residual voltage in attachment plug P

Voltage measured Measurements [ V ] Remarks
between:
1 2 3 4 5 6 7 8 9 10
supply pins (pin 1 & pin 2) 8 10 10 6 8 10 10 10 8 10 Pass
line pin 1 and enclosure 16 12 14 12 14 12 14 16 14 14 Pass
line pin 2 and enclosure 12 14 16 12 14 14 14 12 14 14 Pass
pin 1 and earth pin
pin 2 and earth pin
The capacity between L and N is 1.449uF, L and N to ground is 5940pF
15c TABLE: residual voltage or energy in capacitors N

Residual Time after Capacitance Residual
Capacitor and its location voltage disconnectio value energy Remarks
(V) n (s) (µF) (mJ)
17h1 TABLE: defibrillation-proof applied parts N

Test Accessible part of Applied part with test Test Measured Remarks
Condition: measurement: voltage voltage voltage
Fig. 50 or 51 polarity between
Y1 and Y2
(mV)
17h2 TABLE: defibrillation-proof recovery time N
Applied part Test Recovery time

voltage from Measured Remarks
with test voltage
polarity accompanying recovery
documents (s) time (s)
18 TABLE: protective earthing P

Test Measured Resistanc
Test location current voltage e (ohms) Remarks
(A) (V)
Earth pin of inlet to bottom 25 -- 0.068 1 minute
19 TABLE: leakage current P

Type of leakage current and test condition Supply Supply Measured Remarks
(including single faults) voltage frequency max.
Limitation
value
(V) (Hz)
(uA)
(uA)1)
Figure 16, Earth Leakage
ER, NC, S1 = 1, S5 = N 264 60 392/394 500
ER, NC, S1 = 1, S5 = R 264 60 392/394 500
ER, SFC (Neutral Open), S1 = 0, S5 = N 264 60 627/630 1000
ER, SFC (Neutral Open), S1 = 0, S5 = R 264 60 632/644 1000
Figure 18, Enclosure Leakage
EN, NC, S1 = 1, S5 = N, S7 = 1, S9 = N 264 60 0/0 500
EN, NC, S1 = 1, S5 = R, S7 = 1, S9 = N 264 60 0/0 500
EN, NC, S1 = 1, S5 = N, S7 = 1, S9 = R 264 60 0/0 500
EN, NC, S1 = 1, S5 = R, S7 = 1, S9 = R 264 60 0/0 500
EN, SFC, S1 = 0, S5 = N, S7 = 1, S9 = N 264 60 1/2 1000
EN, SFC, S1 = 0, S5 = R, S7 = 1, S9 = N 264 60 1/2 1000
EN, SFC, S1 = 0, S5 = N, S7 = 1, S9 = R 264 60 1/2 1000
EN, SFC, S1 = 0, S5 = R, S7 = 1, S9 = R 264 60 1/2 1000
EN, SFC (Ground Open), S1 = 1, S5 = N, S7 = 0, 1000
264 60 2/4
S9 = N
EN, SFC (Ground Open), S1 = 1, S5 = R, S7 = 0, 1000
264 60 2/4
S9 = N
EN, SFC (Ground Open), S1 = 1, S5 = N, S7 = 0, 1000
264 60 2/4
S9 = R
EN, SFC (Ground Open), S1 = 1, S5 = R, S7 = 0, 1000
264 60 2/4
S9 = R
Figure 20, Patient Leakage
P, NC, S1 = 1, S5 = N, S7 = 1, S13 = 1 264 60 1/2 100
P, NC, S1 = 1, S5 = R, S7 = 1, S13 = 1 264 60 1/2 100
P, SFC, S1 = 0, S5 = N, S7 = 1, S13 = 1 264 60 2/2 500
P, SFC, S1 = 0, S5 = R, S7 = 1, S13 = 1 264 60 2/2 500
P, SFC (Ground Open), S1 = 1, S5 = N, S7 = 0, 500
264 60 2/3
S13 = 1
P, SFC (Ground Open), S1 = 1, S5 = R, S7 = 0, 500
264 60 2/3
S13 = 1
P, SFC (Ground Open), S1 = 1, S5 = N, S7 = 0, 500
264 60 2/3
S13 = 0
P, SFC (Ground Open), S1 = 1, S5 = R, S7 = 0, 500
264 60 2/3
S13 = 0
(Record at least maximum measured value for each test required by Clause 19 and the specific conditions of
the test circuit and equipment).
Abbreviations used:
ER – Earth leakage current A – After humidity conditioning
EN – Enclosure leakage current B – Before humidity conditioning
P - Patient leakage current 1 – Switch closed or set to normal polarity
PM – Patient leakage current with mains on the applied parts 0 – Switch open or set to reversed polarity
PA -Patient auxiliary current NC - Normal condition
Fig. 15 – refers to Fig. 15 in IEC601-1 SFC – Single fault condition
MD – Measuring device
Supplementary information: 1)Before/After Humidity (µA)
20 TABLE: dielectric strength P

Insulation under test Insulation type: (OP-operational / Referenc Test
(area from insulation BI-basic / SI-supplementary / e voltage voltage Remarks
diagram) DI-double / RI-reinforced) (V) (V)
Before humidity
B BI (A-a1) 240 1500 No breakdown
C BI (B-d) 240 1500 No breakdown
D1 BI(A-b) 240 1500 No breakdown
D2 SI (A-c) 240 2500 No breakdown
D RI/DI (A-e) 240 4000 No breakdown
E RI/DI (B-a) 240 4000 No breakdown
F BI (B-d) 240 1500 No breakdown
G RI/DI (A-a2) 240 4000 No breakdown
After humidity
B BI (A-a1) 240 1500 No breakdown
C BI (B-d) 240 1500 No breakdown
D1 BI(A-b) 240 1500 No breakdown
D2 SI (A-c) 240 2500 No breakdown
D RI/DI (A-e) 240 4000 No breakdown
E RI/DI (B-a) 240 4000 No breakdown
F BI (B-d) 240 1500 No breakdown
G RI/DI (A-a2) 240 4000 No breakdown
21 TABLE: mechanical strength P

Part under test Test (impact, drop, force, handle, rough Remarks
handling, mobile)
Enclosure (Top, Side and near Force test 21a 45 N, No cracking or live parts
opening) that became accessible
Enclosure (Top, Side and near Impact 21b 0.5J, No cracking or live parts
opening) that became accessible
Unit 21.6 b) Mobile 0.4m/s, maintained
24 TABLE: - stability P
Part under test Test condition Remarks
Unit The equipment was placed in a position of Remained stable
normal use on a plane inclined 10° from the
horizontal.
29 TABLE: X - radiation N
Part under test Test condition Measured Remarks
radiation (mR)
42 TABLE: normal temperature P

Supply voltage: 264Vac/60Hz Test Condition: Max. load (in charging)
Ambient temperature: See below
Measuring location Measured Remarks
temperature
(limitation ºC)
(adjust to 40 )
[ºC]
1. Power input cord 25.1 39.8 85
2. Power switch 26.5 41.2 80
3. Touch panel 32.5 47.2 60
4. Internal primary wiring 30.8 45.5 85
5. Battery 31.3 46.0 60
6. PCB nearly Q1(FA116) 41.4 56.1 130
7. X-cap(FA116) 30.1 44.8 105
8. Y-cap(FA116) 41.7 56.4 105
9. L1(FA116) 33.0 47.7 105
10. Photocoupler(FA116) 39.4 53.1 85
11. Transformer core(FA116) 56.4 71.1 105
12. Transformer wiring(FA116) 58.3 73.0 105
13. Ambient 25.3 40.0 ---
14. PCB nearly Q1(FA95B) 34.0 48.7 130
15. X-cap(FA95B) 33.6 48.3 105
16. Y-cap(FA95B) 34.2 48.9 105
17. L1(FA95B) 33.6 48.3 105
18. Transformer core(FA95B) 34.5 49.2 130
19. Transformer wiring(FA95B) 35.1 49.8 130
20. Enclosure 29.0 43.7 75
COR - indicates measurements taken using change-of-resistance method
44 TABLE: overflow, spillage, leakage, humidity, ingress of liquids, cleaning, P

sterilization, desinfection
Test type and condition Part under test Remarks
Humidity (25ºC, 95%, 48 hrs) Complete Unit No breakdown.
Cleaning Complete Unit No breakdown.
45 TABLE: hydrostatic pressure and pressure-relief device cycling test N

Test type and condition Part under test Test Remarks
pressure
52 TABLE: abnormal operation P

Test type, condition and clause reference Observed results Remarks
Impairment of cooling((Fan and opening Refer to table 52.5.5a) and 52.5.5b) No safety hazards
block))
Short DB1 (+,-)(FA116) Fuse open No safety hazards
Short C12(FA116) Fuse open No safety hazards
Short MBR1(FA116) System shutdown, no output No safety hazards
Short R26(FA116) System shutdown, no output No safety hazards
Short Q2 (g-d) (FA116) System shutdown, no output No safety hazards
Short Q2 (g-s) (FA116) System shutdown, Fuse open No safety hazards
Short Q2 (d-s) (FA116) System shutdown, Fuse open, R26 No safety hazards
damaged
Short U7B(FA116) System shutdown, no output No safety hazards
Short L7(FA116) Thermal fuse open, and the No safety hazards
temperature of transformer is102.5℃
Short L8(FA116) Thermal fuse open, and the No safety hazards
temperature of transformer is106.4℃
Short Q4 (1-7) Battery final temperature is 45℃ No safety hazards
Short DB1(FA95B) Fuse open No safety hazards
Short C6(FA95B) Fuse open No safety hazards
Short MBR1(FA95B) System shutdown, no output No safety hazards
Short R12(FA95B) System shutdown, no output No safety hazards
Short Q2 (g-d) (FA95B) System shutdown, no output No safety hazards
Short Q2 (g-s) (FA95B) System shutdown, Fuse open No safety hazards
Short Q2 (d-s) (FA95B) System shutdown, Fuse open, R12 No safety hazards
damaged
Short U1-1(FA95B) System shutdown, no output No safety hazards
52.5.5a) TABLE: Impairment of cooling P

Supply voltage: 264Vac/60Hz Test Condition: Opening blocked and Max. load
temperature
(limitation ºC)
(adjust to 40 )
[ºC]
2. Power switch 26.0 41.2 118.5
3. Touch panel 31.9 47.1 84.5
5. Battery 34.3 49.5 84.5
6. PCB nearly Q1(FA116) 44.4 59.6 203.5
7. X-cap(FA116) 33.9 49.1 161
8. Y-cap(FA116) 47.1 62.3 161
9. L1(FA116) 36.6 51.8 161
10. Photocoupler(FA116) 43.3 58.5 127
13. Ambient 24.8 40.0 --
14. PCB nearly Q1(FA95B) 37.6 52.8 203.5
15. X-cap(FA95B) 37.3 45.5 161
16. Y-cap(FA95B) 38.8 54.0 161
17. L1(FA95B) 37.3 52.5 161
18. Transformer core(FA95B) 39.2 54.4 182.5
19. Transformer wiring(FA95B) 39.7 54.9 182.5
20. Enclosure 25.7 40.9 100
52.5.5b TABLE: Impairment of cooling P

Supply voltage: 264Vac/60Hz Test Condition: Fan blocked and Max. load
temperature
(limitation ºC)
(adjust to 40 )
[ºC]
2. Power switch 27.1 42.3 118.5
3. Touch panel 32.4 57.6 84.5
5. Battery 32.8 48.0 84.5
6. PCB nearly Q1(FA116) 46.5 58.7 203.5
7. X-cap(FA116) 34.1 49.3 161
8. Y-cap(FA116) 48.2 63.4 161
9. L1(FA116) 39.7 54.9 161
10. Photocoupler(FA116) 45.2 60.4 127
13. Ambient 24.8 40.0 --
14. PCB nearly Q1(FA95B) 38.2 53.4 203.5
15. X-cap(FA95B) 37.9 53.1 161
16. Y-cap(FA95B) 39.8 55.0 161
17. L1(FA95B) 38.6 53.8 161
18. Transformer core(FA95B) 42.1 57.3 182.5
19. Transformer wiring(FA95B) 43.2 58.4 182.5
20. Enclosure 26.9 42.1 100
56.1 TABLE: lists of critical component parts P

Object/part No Manufacturer/ Type/model Technical data Standard Mark(s) of
trademark conformity1)
Filter HIGH &LOW 10SS3A-2S-Q 115/250V 10A UL1283 UL:E179761
CORP co.,Ltd. 50/60Hz 9u40℃
Plug, Connector of Rong Feng E-08 16A,250V DIN 49 440 VDE:40008508
Power Cord Industrial Co.,
Ltd.
Cable of power cord Shenzhen H05VV-F 3G 10A,300/500V IEC60227 VDE:40006070
tongyuan 1.0mm²
industrial
co.,ltd./I-SHENG
Power input inlet with Openwise
OP520 10A, 250V UL512 UL:E161798
fuse holder industrial ltd
WATLTER
Fuse of Input ELECTRONICC SCC，SCP+ 10A, 250V UL248 UL:E56092
O., LTD.
XC
ELECTRONICS UL UL:E249609
Fuse of Output 5F-NN# 2A, 250V
(SHENZHEN) VDE VDE:40009609
CORP LTD
Shenzhen 1015 18AWG 105°600V UL 758 UL:E214500
Internal primary wire
biteca
Arcolectric H1550AH 16A, 250V UL1054 UL:E45221
Switches
switches
Fastprint circuit 700D-M-
Main board V-0, 130℃ UL94 UL:E204460
tech co., ltd 02001-A
Fastprint Circuit B-700D-S-

Gas Control Board V-0, 130℃ UL94 UL:E204460
Tech CO., Ltd 03102-B
Shenzhen King
Gas Parameter Brother PCB B-700D-S-
V-0, 130℃ UL94 UL:E225430
Board Technology 03202-C
Limited
Shenzhen King
Flowmeter Control Brother PCB B-700D-S-
V-0, 130℃ UL94V-0 UL:E225430
Board Technology 04002-B
Limited
Shenzhen King
Flowmeter Brother PCB B-700D-S-
V-0, 130℃ UL94V-0 UL:E225430
Parameter Board Technology 04102-A
Limited
Shenzhen King
Display Control Brother PCB B-700D-S-
V-0, 130℃ UL94V-0 UL:E225430
Board Technology 05202-1.0
Limited
Shenzhen King
Oxygen Insulate Brother PCB B-700D-S-
V-0, 130℃ UL94V-0 UL:E225430
board Technology 07002-2.0
Limited
Shenzhen King
High Pressure Brother PCB B-700D-S-
V-0, 130℃ UL94V-0 UL:E225430
Sensor Board Technology 09002-2.0
Limited
Shenzhen King
Brother PCB B-700D-S-
Back Light Board V-0, 130℃ UL94V-0 UL:E225430
Technology 10002-2.0
Limited
Shenzhen King
Brother PCB B-700D-S-
Top Light Board V-0, 130℃ UL94V-0 UL:E225430
Technology 11002-A
Limited
PEEP Valve Shenzhen King
Interface and Brother PCB B-700D-S-
V-0, 130℃ UL94V-0 UL:E225430
Encoder Interface Technology 13002-1.0
Board Limited
Shenzhen King
Plug Box Inside Brother PCB B-700-S-
V-0, 130℃ UL94V-0 UL:E225430
Bottom Board Technology 17002-3.0
Limited
Shenzhen King
Plug Box Outside Brother PCB B-700-S-
V-0, 130℃ UL94V-0 UL:E225430
Bottom Board Technology 18002-2.0
Limited
Shenzhen King
Oxygen Plug Box Brother PCB B-700-S-
V-0, 130℃ UL94V-0 UL:E225430
Lamp Board Technology 19002-1.0
Limited
Shenzhen
Ghaik
LCD Screen M20-P-00117 G150XG03 UL UL:E204356
Technology Co.
Ltd.
Groovy
Technology GP-150F-5H- CS-2006-
Touch Screen M20-P-00042 CE
Corporation NB04B 1092D
Company
Lithium Battery cell Sanyo energy (u UR18650FJ 12V, 3800mAh UL1642 UL: MH12383
s a) corp
Thermal Yangzhou TB02 AC250V VDE & UL
Baozhu Electric DC24V, 100℃ VDE:40016121
Appliance Co. UL:E305764
Ltd.
Power Heat- Shenzhen woer
Suppl shrinkable heat-shrinkable RSFR-H 600V, 125℃ UL224 UL: E203950
y tubing material co ltd
FA116 Foshan Ji Hui
Thermal Electrical
BW9700 125℃ EN60730-1 VDE:40019595
protector Appliance Co.,
Ltd.
JOINT FORCE
METAL
Thermal link T2A 130℃ UL60691 UL: E142267
RESEARCH &
CO LTD
Dain electronics
X-Cap MPX 0.47uF, 275Vac UL1414 UL:E147776
co ltd
Guangdong
south hongming
electronic
Y-Cap F 250V, 2200pF UL1414 UL: E154899
science &
technology co
ltd
SMT Cosmo
P181 5kVac UL1577 UL: E169586
photocoupler electronics corp
Photocoupler Cosmo PC817 5kVac UL1577 UL: E169586
electronics corp
Shenzhen belta
Inductance electronics co B83 130℃ UL1446 UL: E233265
ltd
Fuse Hollyland co ltd 30N T4A/250Vac UL248 UL: E156471
Zhejiang jinda
Connector electronics co VH3.96-5Pin 5A, 250V, V-0 UL1977 UL: E237523
ltd
Harbour
PCB industrial HL-C1 V-0, 130℃ UL94 UL: E117875
laminate ltd
Transformer
Various TP4A 15.5X45mm Various Various
core
Transformer Chang chun
MP-185JL V-0, 150℃ UL94 UL: E59481
bobbin plastics co ltd
Shen zhen city

Transformer
chengwei MW75-C 130℃ UL1446 UL: E227475
wiring
industry co ltd
Jingjiang yahua
Transformer
pressure
insulation CT 130℃ UL510 UL: E165111
sensitive glue co
type
ltd
Jingjiang yahua
Transformer pressure
WF 130℃ UL510 UL: E165111
margin type sensitive glue co
ltd
Transformer
Chemtech co ltd MW75 130℃ UL1446 UL: E258329
varnish
JOINT FORCE
Power
METAL
Supply Thermal link T2A 130℃ UL60691 UL: E142267
RESEARCH &
FA95B
CO LTD
CHANG CHUN
Transformer
PLASTICS CO MP-185JL V-0, 150℃ UL94 UL: E59481
bobbin
LTD
Transformer
Various TP4A 15.5X45mm Various Various
core
Shen zhen city
Transformer
chengwei MW75-C 130℃ UL1446 UL: E227475
wiring
industry co ltd
Jingjiang yahua
Transformer
pressure
insulation CT 130℃ UL510 UL: E165111
sensitive glue co
type
ltd
Jingjiang yahua
Transformer pressure
WF 130℃ UL510 UL: E165111
margin type sensitive glue co
ltd
Transformer
Chemtech co ltd MW75 130℃ UL1446 UL: E258329
varnish
HSUAN TAI
X-Cap ELECTRONICS MCY 0.47uF, 275Vac UL1414 UL:E199069
CO LTD
HSUAN TAI
Y-Cap ELECTRONICS CY 250V, 2200pF UL1414 UL: E199069
CO LTD
BOLUO WEI ER
GAO
PCB W-2 V-0, 130℃ UL94 UL: E310226
ELECTRONICS
CO LTD
1
) an asterisk indicates a mark which assures the agreed level of surveillance
56.10 TABLE: actuating parts and controls N

Part under test Torque applied Remarks
56.11b TABLE: foot operated control devices-loading N

Part under test Observed results Remarks
57.4 TABLE: cord anchorages N

Cord under test Mass of Pull Torque Remarks Verdict
equipmen
t
57.4b TABLE: cord bending N

Cord under test Test mass Measured Remarks
curvature
57.9.1a TABLE: transformer short circuit P

Winding Protection Measured temperatures (ºC) Test Remarks
under test duration
Primary Secondary Ambient
FA116: Fuse 26.8 27.1 25.5 1s System shut down, no safety hazards
T (14-15)
FA95B: Fuse 26.9 27.3 25.5 1s System shut down, no safety hazard
T24V
57.9.1b TABLE: overload P

Winding Protection Measured temperatures (ºC) Test Test current Remarks
under test Primary Secondary Ambient duration or thermal
cutout temp.
FA116: Fuse 102 129.1 26.5 2hrs 10A System shut down, no
T(12V) safety hazards
FA116: Fuse 87.7 76.7 26.6 1hr 6.2A System shut down, no
T (5V) safety hazards
FA116: Fuse 67.6 70.1 26.5 2hrs 0.8A System shut down, no
T (-12V) safety hazards
FA95B: Thermal 113.2 112.9 26.3 2hs 4A System shut down, no
T24V Fuse safety hazards
57.9.2 TABLE: transformer dielectric strength N
Transformer under Test voltage Test voltage Test Remarks

test applied to frequency
Supplementary information: Refer to table 20

TABLE: additional tests P

Clause Test type and condition Remarks and observed results Verdict
49 Interruption power supply test System shutdown, no safety hazards Pass
59.2 Ball pressure test, 75℃ Enclosure impression is 0.1mm Pass
. Page 44 of 50 Report No.TRS09070042
SUMMARY OF CONTENTS:
The equipment has been tested according to standard IEC 60601-1 (1988) +A1 (1991) +A2 (1995)
All applicable tests according to the above specified standard(s) have been carried out.
This test report comprises 44 pages and the following Attachments:
Attachment # Description Pages

1 Attachment file 1 photo of the dut 6
Note:
Attachments may include Schematics, Components information, Component test Reports, Particular
Standard test Reports, Standard test Reports, Information from accompanying documents and similar.
ATTACHMENT FILE 1 photo of the DUT
Photo 1
[ √ ] complete
[ ] internal
[ ] component
[ ] PCB
Photo 2
[ √ ] complete
[ ] internal
[ ] component
[ ] PCB
Photo 3
[ ] complete
[ √ ] internal
[ ] component
[ ] PCB
Photo 4
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
Power supply box

Photo 5
[ ] complete
[ ] internal
[ √ ] component
[ ] PCB
FA116
Photo 6
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
FA116
Photo 7
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
FA95B
Photo 8
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
FA95B
Photo 9
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
Battery
Photo 10
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
Screen
Photo 10
[ ] complete
[ ] internal
[√ ] component
[ ] PCB
Fans

Boaray 7005. IEC60601IEC60601-1

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Boaray 7005. IEC60601IEC60601-1

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TEST REPORT

Compiled by (+ signature) ........... Ivy.chen ...................................................

Reviewed by (+ signature)........... Terry.zhang ...................................................

Approved by (+ signature) ........... Kathy.Guo ...................................................

Model/type reference................... Boaray 600, Boaray 700

Copy of marking plate

Possible test case verdicts:

Table: to insulation diagram P

INSULATION DIAGRAM CONVENTIONS

5) Blocks containing the letter “Z” indicate protective impedance.

6 IDENTIFICATION, MARKING AND DOCUMENTS P

v) Protective packing requirement(s) Marking on the package P

- Markings comply with IEC 445 N

b) Indication of different positions of control All control devices are P

Classifications specified in Clause 5 included in Refer to Appendix D.2 of P

f) A warning to remove primary batteries if Not used primary batteries N

14 REQUIREMENTS RELATED TO CLASSIFICATION P

15 LIMITATION OF VOLTAGE AND/OR ENERGY P

16 ENCLOSURES AND PROTECTIVE COVERS P

- Exception 16e applied to the following parts.......: N

16f Openings for the adjustment of controls using a No such opening N

18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL P

19 CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY P

- patient leakage current P

Devices for emergency stopping able to break the N

23 SURFACES, CORNERS AND EDGES P

24 STABILITY IN NORMAL USE P

Clear indication to the operator that the safety N

37 COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY APG N

44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS, P

45 PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE N

45.7g No shut-off valve between a pressure-relief N

49 INTERRUPTION OF THE POWER SUPPLY P

51 PROTECTION AGAINST HAZARDOUS OUTPUT N

52 ABNORMAL OPERATION AND FAULT CONDITIONS P

52.5.9 Failure of one component at a time presents no See appended table 52 P

56 COMPONENTS AND GENERAL ASSEMBLY P

56.5 Protective devices which cause disconnection By power plug P

56.10c Stops are provided on rotating controls: N

57 MAINS PARTS, COMPONENTS AND LAYOUT P

g) Unless functional earth needs to be provided, No such terminal used P

57.4c Adequate space inside equipment to allow the P

57.9 Mains supply transformers P

b) Minimum creepage distances and air N

58 PROTECTIVE EARTHING - TERMINALS AND CONNECTIONS P

59 CONSTRUCTION AND LAYOUT P

6.1 TABLE: marking durability P

7 TABLE: power input P

15b TABLE: residual voltage in attachment plug P

15c TABLE: residual voltage or energy in capacitors N

17h1 TABLE: defibrillation-proof applied parts N

17h2 TABLE: defibrillation-proof recovery time N

Applied part Test Recovery time

18 TABLE: protective earthing P

19 TABLE: leakage current P

20 TABLE: dielectric strength P

21 TABLE: mechanical strength P

Unit 21.6 b) Mobile 0.4m/s, maintained

42 TABLE: normal temperature P

44 TABLE: overflow, spillage, leakage, humidity, ingress of liquids, cleaning, P

45 TABLE: hydrostatic pressure and pressure-relief device cycling test N

52 TABLE: abnormal operation P

52.5.5a) TABLE: Impairment of cooling P

52.5.5b TABLE: Impairment of cooling P