Nemko ref. no.

:NK-2E-M-055

DESCRIPTION OF EQUIPMENT UNDER TEST:

This equipment is a fetal monitor, Fetal heart rate(FHR), fetal movement(FM), and uterine
activity(UC) extracted automatically by using Doppler Shift Frequency are displayed and
recorded for monitoring up to fetal status.

For description of operating, please refer to User’s Manual supplied by Manufacturer.

NAME AND ADDRESS OF PRODUCTION-SITES (FACTORIES):

See front page.

INFORMATION ABOUT THE STANDARDS / DOCUMENTS CONSIDERED:

EN 60601-1 (1990) + A1 (1993) + A2 (1995) +A13 (1996) + Corrigenda (July 1994).
EMC standard : EN 60601-1-2 (2001)

TESTED ACCORDING TO NATIONAL REQUIREMENTS FOR THE

FOLLOWING COUNTRIES:

LIST OF APPENDIXES / ENCLOSURES TO THE TEST REPORT:

This Part 1 TRF contains 69 pages, numbered from 1 to 69
This TRF contains attachments. Attachment #1: Photos. Page 1 to 5

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SUMMARY OF TESTING
Evaluation of Results
If not explicitly stated otherwise in the standard, the test is passed if the measurement value is equal to or below (above) the
limit line, regardless of the uncertainty of the measurement. If the measurement value is above (below) the limit line, the test
is not passed - ref. IECEE-CTL Guide 001 and Nemko WM L220.
The instrumentation accuracy is within limits agreed (ref. IECEE-CTL/251A and Nemko procedure WM L226) :
The AC/DC adapter is certified by TÜV Rheinland according to EN60601-1.
(refer to “56. list of Critical Component Parts”)
It has double insulation between primary and secondary.
Maximum normal load : Refer to sub-clause 7 (power input)
This equipment was tested with these probes:
• DOP I
• DOP II
• UC Probe
• Event Mark jack

Clause Remarks Information/Comments

Cord set not checked The equipment shall be provided with a cord set
complying with the national regulation of the
countries intended for sale

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LIST OF ATTACHMENTS PROVIDING FURTHER INFORMATION

ON THE EQUIPMENT TESTED AND THE TEST METHODS
The following attachments are added to this TRF or kept in file at the Testing Station
mentioned at the cover page:
Statements on calibrations and measurement uncertainties (where relevant) of the
measurement and test equipment as identified throughout this TRF:
Calibration All instruments used in the tests given in this report are calibrated and
traceable to international standards.
Further information about tractability will be given on request.
Measurement Measurements uncertainties are calculated for all instruments and
uncertainties instruments set-ups given in this report. Calculations are based on the
principles given in the standard EA-4/02 (Dec. 1999), IECEE-
CTL/153/NF (2002-04-19), Nemko WM L226 and actual internal
Nemko procedures. Further information about measurements
uncertainties will be given on request
Document title/identification: Kept in file at Nemko; P31000 ATT. No.: Not attached
List of worksheets which describe measurement procedures or test methods where
practicable:
Document title/identification: Kept in file at Nemko; P31000 ATT. No.: Not attached
List of equipment or units tested and/or accompanying units and accessories (in case not
all individual units can be mentioned on the front-page):
Document title/identification: See summary of testing in this report. ATT. No.: Not attached
Technical design documents of components having basic, supplementary of reinforced
insulation (e.g. transformer specification mentioning the insulation class of the insulation
materials applied - A to H):
Document title/identification: Kept in file at Nemko ATT. No.: Not attached
Description of safety systems (specifying for example safety circuits, redundant circuits,
double circuits, hardware/software safety measures, temperature controls, etc.):
Document title/identification: Kept in file at Nemko ATT. No.: Not attached

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3 GENERAL REQUIREMENTS
3.1 EQUIPMENT when transported, The equipment causes no hazards when used according —
stored, installed, operated in NORMAL the manufacturers instructions.
USE and maintained according to the
instructions of the manufacturer, causes
no SAFETY HAZARD which could
reasonably be fore- seen and which is
not connected with its intended
application in NORMAL CONDITION
and in S.F.C.
3.4 An alternative means of construction is No alternative construction. —
used to that detailed in this standard
and it can be demonstrated that an
equivalent degree of safety is obtained.

5 CLASSIFICATION
5.1 Type of protection against electric Class I equipment
shock.
5.2 Degree of protection against electric Type BF applied part
shock.
5.3 Classification of the equipment against IPX0
ingress of liquids.
5.5 Degree of safety of application in the The equipment is not an AP or APG category
presence of a FLAMMABLE equipment.
ANAESTHETIC MIXTURE WITH
AIR or WITH OXYGEN OR
NITROUS OXIDE
5.6 Mode of operation. Continuous operation.

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INSULATION DIAGRAM
Protection against electric shock - Refer to table on next page. P
Block diagram of system
Drawing

Enclosure connected to PE

L TUV Certified
by EN60601-1
AC/DC
Adapter
A B DOP1
(100-240Vac,
Main board DOP2
50/60Hz, 1.2A, UC Probe
F
N Output: Event Mark jack
+12Vdc, 3.5A)

G D

PLASTIC ENCLOSURE

Comments

TABLE TO INSULATION DIAGRAM ON PREVIOUS PAGE

Area Distance Insulation type Maximum Required distances (mm) Dielectric strength
(Test Refer to Basic/Supplement./ circuit test voltage
20.1 + 20.2)
Double/Reinforced voltage Clearance Creepage Refer to 20.3
Insulation
A A-f Basic 250 V a.c. 1.6 mm 3.0 mm Not applicable
B A-f Basic 12 V d.c. 1.6 mm 3.0 mm Not applicable
D B-a Double/Reinforce 250 V a.c 5.0 mm 8.0 mm 4 000 V a.c.
E A-a1 Basic 250 V a.c. 2.5 mm 4.0 mm 1 500 V a.c.
F A-a1 Basic 250 V a.c. 2.5 mm 4.0 mm 1 500 V a.c.
G A-a2 Double/Reinforce. 250 V a.c. 5.0 mm 8.0 mm 4 000 V a.c.
Comments

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6 IDENTIFICATION, MARKING AND DOCUMENTS

6.1 Marking on the outside Example of marking label:

6.1 a Markings of Mains operated See below P

EQUIPMENT

6.1 b Markings of Internally Powered Not applicable. No Internally Powered EQUIPMENT N

EQUIPMENT
6.1 c Markings of EQUIPMENT supplied N
from a specified power supply
6.1 d Minimum requirements if limited space P
for marking Symbol 14 from DI is included in accompanying
documents.
6.1 e Name and/or trademark of the Bionics P
manufacturer or supplier
6.1 f Model or type reference IFM-500 P
6.1 g Rated supply voltage(s) or voltage 100-240 V P
range(s)
Number of phases Single phase
Type of current ∼
6.1 h Rated frequency or rated frequency 50/60 Hz. P
range(s) in Hz
6.1 j Rated power input (VA, W or A) 0.25-0.15A P
6.1 k Power output of auxiliary mains socket No socket outlet is provided N
outlets
6.1 l Class II symbol Not applicable. N
Symbol for degree of protection with Ordinary equipment. IPX 0. P
respect to harmful ingress of water
according to EN 60529 (IPX0 not
required to be marked)
Symbol for protection against electric P
shock: Type BF . Symbol

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6.1 m Mode of operation (if no marking, Continuous operation. N

suitable for continuous operation)
6.1 n Types and rating of external accessible “T1AL 250V” marked P
fuses
6.1 p Rated output voltage and current or No auxiliary mains socket outlets. N
power, output frequency (where
applicable)
6.1 q Symbol for physiological effect(s): Not applicable. No need for marking. N
6.1 r Anaesthetic-proof symbol: Not of category AP or APG. N
6.1 s High voltage symbol: Not applicable. No parts with a voltage over 1 000 V a.c. N
or over 1 500 V d.c. or 1 500 V peak value.
6.1 t Special cooling requirements No special cooling requirements N
6.1 u) Limited mechanical stability No limited mechanical stability N
6.1 v Protective packing requirement(s). No special measures during transport or storage N
Marking(s) for unpacking safety
hazard(s)
6.1 y Earth terminals: Symbol 9 of table DI, POTENTIAL EQUALIZATION P
TERMINAL is used.
6.1 z Removable protective means No removable protective means N
Durability of markings Tested with a cloth of rack soaked with, in turn, water, P
methylated spirit and isopropyl alcohol.
The sample label withstood the test.

6.2 Marking on the inside

6.2 a Marking clearly legible P
Nominal supply voltage of Not applicable. No permanently installed equipment N
permanently installed equipment
marked inside or outside of equipment
6.2 b Maximum power loading of heating No heating elements or holders for heating lamps N
elements or lamp holders for heating
lamps clearly and indelibly marked
near or in the heater
Heating elements or lamp holders for Not applicable. N
heating lamps not intended to be
changed by operator and which can be
changed only with the use of a tool,
have at least an identifying marking
referring to information stated in the
accompanying documents
6.2 c High voltage parts: No high voltage part N
6.2 d Type of battery and mode of insertion Not applicable. N
(if applicable) marked (see Sub-clause
56.7 b)
Batteries not intended be changed by N
operator and which can be changed
only with use of tool have at least
marking referring to information in
accompanying documents
6.2 e Fuse type and rating or reference stated Not applicable. N

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6.2 f Appliance inlet is used in an according to IEC 60320 N

Protective earth terminal marked
6.2 g Functional earth terminal marked No Functional earth terminal. N

6.2 h Terminals for supply neutral conductor No permanently installed equipment. N

in permanently installed equipment
marked (N)
6.2 j Markings required in Sub-clause 6.2 f, P
h, k and l
6.2 k The supply connections are clearly N
marked adjacent to the terminals or in
accompanying documents (for small
equipment)
6.2 l Statement for suitable wiring materials Not applicable. No temp. over 75°C. P
(at temperatures over 75°C) locates at
or near the point of the supply
connections and is clearly discernible
after connection
6.2 n Capacitors and/or circuit parts are No such a capacitor N
marked as required in Sub-clause 15 c

6.3 Marking of controls and instruments

6.3 a Mains switch clearly identified. ”On” “I/O” marked close to the switch on front side P
and “off” positions marked or
otherwise indicated
6.3 b Adequate indications of different P
positions of controls and other switches
6.3 c Adequate indication of the direction of P
setting devices if change of setting of a
control could cause a safety hazard
6.3 f Functions of operator controls and All control buttons marked. All functions and marking P
indicators identified described in user manual.
6.3 g Numeric indications of parameters are All control buttons marked. All functions and marking P
in SI units according to ISO 1000. described in user manual.
Units outside the International System
as specified

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6.4 Symbols
6.4 a Marking symbols compliance with Complied with appendix D, where applicable P
appendix D, where applicable
6.4 b Symbols for controls and performance P
conform to IEC 60 878, where
applicable
Durability of marking symbols Tested in Clause 6.1. P

6.5 Colours of insulation of conductors

6.5 a Protective earth conductor has P
green/yellow insulation
6.5 b All insulations of internal protective P
earth conductors are green/yellow, at
least at the terminations of the
conductors
6.5 c Only protective earth-, functional Protective earth conductor P
earth-, potential equalisation and inside
earthing conductors (cf. 6.5 b) are
green/yellow
6.5 d Colour of neutral conductor: light blue Light Blue P
according to IEC 60 227 or 245
6.5 e Colours of phase conductors in power Brown, VDE Certified P
supply cord according to IEC 60 227 or
245
6.5 f Additional protective earthing in multi- No Additional protective earthing N
conductor cords are marked
green/yellow at the ends of the
additional conductors

6.6 Identification of medical gas

cylinders and connections
6.6 a Identification of content in accordance Not applicable. Not use of medical gas cylinders N
with ISO/R32
6.6 b Identification of connection point that Not applicable. N
errors are avoided when a replacement
is made

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6.7 Indicator lights and push-buttons

6.7 a Colour red only used for warning of Not used of colour red. P
danger or/and need for urgent action.
The unit used dot-matrix / alphanumeric display
Dot-matrix/alphanumeric displays not
considered to be indicator lights
6.7 b Colours of unilluminated push-buttons. No emergency switch N
Colour red only used in case of
emergency
Location Meaning of indicator lights Illuminated push-button (see IEC 60 Colour
73)
Front of enclosure Operating / LED — Green
(For “Volume”)
Front of enclosure Operating / LED — Green
(For “Record”)
Front of enclosure Operating / LED Green
(For “Alarm”)

6.8 Accompanying documents

6.8.1 Equipment is accompanied at least by
- instructions for use User Manual P
- technical description P
- an address to which the user can refer In both the above mentioned booklets P
All applicable classifications specified In both the above mentioned booklets P
in Clause 5 are included in instructions
for use and technical description
markings in Sub-clause 6.1 included in P
accompanying documents if not
permanently affixed to equipment
Warning statements and explanations Properly described in user manual P
of warning symbols are provided in
accompanying documents
Language of accompanying documents English. Will be in the language required for the market P
where the equipment is intended to be sold.

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6.8.2 Instructions for use

6.8.2 a General information
Necessary information to operate the Included in user manual P
equipment
Explanation of the function of controls, Included in user manual P
displays and signals
Sequence of operation Included in user manual P
Connection and disconnection of Included in user manual P
detachable parts and accessories
Replacement of material which is Included in user manual P
consumed during operation
Indications of recognised accessories, Included in user manual P
detachable parts and materials, if the
use of other parts or materials can
degrade minimum safety
Cleaning, preventive inspection and Included in user manual P
maintenance to be performed including
the frequency of such maintenance
Information about safe performance of Included in user manual P
routine maintenance
Information about preventive Included in user manual P
inspection and maintenance to be
performed by other persons
Meanings of figures, symbols, warning Included in user manual P
statements and abbreviations on
equipment explained in the instructions
for use
Instruction for use states the function Included in user manual P
and intended application of equipment
Instructions for use provide user with Included in user manual N
information regarding potential
electromagnetic or interference and
advice how to avoid such interference
6.8.2 c Signal output and signal input parts
Signal output or signal input parts No SIP/SOP parts N
intended only for connection to
specified equipment stated in
instruction for use
6.8.2 d Cleaning, disinfection and sterilisation
of parts in contact with the patient
Details about cleaning or disinfection Properly described. P
or sterilisation methods that may be
used for equipment parts which come
into contact with the patient during
normal use given in instruction for use

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6.8.2 e Mains operated equipment with

additional power source
A warning statement referring to the This equipment is Alternatively using an internal P
necessity for periodical checking or electrical power source and main supply
replacement of an additional power
source
If Class I equipment a statement saying Included in user manual P
that where the integrity of the external
protective conductor in the installation
or its arrangement is in doubt,
equipment shall be operated from its
internal electrical power source
6.8.2 f Removal of primary batteries (i.e. not
rechargeable batteries):
Instruction for use contains a warning No primary battery N
to remove batteries if equipment is not
likely to be used for some time ,unless
no risk of safety hazard
6.8.2 g Rechargeable batteries:
Instructions to ensure safe use and Not rechargeable batteries N
adequate maintenance
6.8.2 h Equipment with a specified power
supply or battery charger:
Instructions for use identify power Not applicable. N
supplies or battery chargers necessary
to ensure compliance with the
requirements of IEC 601-1
6.8.2 j Instructions for use identify risks The item is properly described. Reference to the user P
associated with disposal of waste, Manual.
residues etc. and of
equipment/accessories at end of their
lives. Further it provides advice on
minimising these risks
6.8.3 Technical description
6.8.3 a General
Technical description provides all data The Technical and Service Manual is well written and P
essential for safe operation including contains all necessary information required.
data in Sub-clause 6.1 and all
characteristics of the equipment
A statement whether particular P
measures or particular conditions are to
be observed for installing equipment
and bringing equipment into use
6.8.3 b Replacement of fuses and other parts :
Required type and rating of fuses No permanently installed equipment N
utilised in the mains supply circuit
external to permanently installed
equipment
Instructions for replacement of Properly described. P
interchangeable and/or detachable parts
which are subject to deterioration
during normal use

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6.8.3 c Circuit diagrams, component part lists,

etc.:
The technical description contains a Included in user manual P
statement that the supplier will make
available on request circuit diagrams,
component part lists, descriptions,
calibration instructions, etc. in order to
assist user in case of necessary
reparations
6.8.3 d Environmental conditions for transport Included in user manual
and storage:
The technical description contains a P
specification of the permissible
environmental conditions for transport
and storage
The above said specification also P
repeated on the outside of the
packaging

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7 POWER INPUT(Continued)
7.1 Steady state current or power input Maximum normal load is followings: P
does not exceed the marked rating by Continuous operation
more than specified 1. Applied parts
(DOPI, DOPII, UC and Event Mark jack)
2. Max. Volume
3. Printer
Equipment: No. 64
50 Hz supply Power input: 100-240VAC, 0.25-0.15A P
Power input Function UNlower = 90V UN = 100V UN = 240V UNupper= 264V
Input current Normal operation (A) 0.24 0.23 0.14 0.13
Standby (A) — — — —
Input power Normal operation (W) 12.0 12.0 13.0 13.0
Input power Standby operation (W) 23.0 23.0 33.0 34.0
Power factor cos ϕ 0.52 0.52 0.39 0.38

60 Hz supply Power input: 100-240VAC, 0.25-015A P

Power input Function UNlower = 90V UN = 100V UN = 240V UNupper=264V
Input current Normal operation (A) 0.22 0.21 0.13 0.13
Standby (A) — — — —
Input power Normal operation (W) 12.0 12.0 13.0 13.0
Input power Standby operation (W) 20.2 21.0 32.0 32.0
Power factor cos ϕ 0.57 0.55 0.40 0.39

10 ENVIRONMENTAL CONDITIONS
10.1 Equipment capable, while packed for Considered OK. P
transport and storage, of being exposed
to environmental conditions as stated
by manufacturer (see 6.8.3 d)
10.2 Operation of equipment according to Considered OK. P
specified environment and power
supply

13 GENERAL
Equipment so designed that risk of Considered OK. P
electric shock obviated as far as
practicable (requirements as given in
section three)

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14 REQUIREMENTS RELATED TO CLASSIFICATION

14.1 Class I equipment
14.1 a Parts with Double Insulation N
Parts with Reinforced Insulation CB Certified adapter used N
Parts with SELV-Voltage CB Certified adapter used N
Parts with Protective Impedance N
14.1 b If the mains part of equipment Not applicable. N
specified for an external d.c. power
source is isolated from accessible
conductive parts by basic insulation
only, a separate protective earth
conductor is provided
14.2 Class II equipment
14.2 a Class II equipment is of one of the Not applicable N
following types:
14.2 b If equipment is fitted with a device for Not applicable. N
changing over from class I to class II
protection, the following requirements
are fulfilled:
The change-over device indicates the Not applicable. N
selected class clearly
A tool for change-over is necessary Not applicable. N
The equipment complies with all Not applicable. N
requirements for the selected class at
any given time
Class II position: Not applicable. N
The device interrupts the connection of
protective earth conductor to
equipment or changes it into functional
earth conductor (compliance with 18.2)
14.2 c Class II equipment provided with Not applicable. N
functional earth connections (cf. Sub-
clause 18 k and l)

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14.4 Class I and II equipment

14.4 a Equipment is provided with an P
additional protection according to the
requirements of Class I or Class II
equipment
14.4 b No safety hazard develop, when a P
connection with the wrong polarity is
made in equipment specified for power
supply from an external d.c. power
source (e.g. for use in ambulances)
14.5 Internally powered equipment
14.5 b Equipment also having means of Not applicable. No external d.c. power source N
connection to supply mains complies
also with requirements for Class I or II
while so connected
14.6 Types B, BF and CF applied parts
14.6 c Applied parts suitable for direct cardiac Type BF N
application are of type CF

15 LIMITATION OF VOLTAGE AND/OR ENERGY

15 b Equipment with mains plug so Certified AC/DC Adaptor N
designed that the voltage 1 sec. after
disconnection does not exceed 60 V
Interference suppression capacitors N
Capacitance between each line and N
protective earth. Measured value
15 c Accessible live parts of capacitors or Not applicable. N
related circuits having a residual
voltage above 60 V does not have a
residual energy above 2 mJ (see 15 c
below)
A non-automatic discharging device is Not applicable N
included and marked

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16 ENCLOSURES AND PROTECTIVE COVERS

16 a Protection against contact with live A tool is needed to open enclosure. No accessible live P
parts. parts.
- and with parts which can become live A tool is needed to open enclosure. No accessible live P
in single fault conditions parts in single fault condition.
Instruction for use instructs operator Not applicable. N
not to touch such parts and the patient
simultaneously
Equipment: Standard test finger : No. 97
Straight test finger : No. 105
Pull force measuring device : No. 52
Test pin : No. 98
Test hook : No. 95
Weight : approximately 4.2kg
Location of opening Test result (finger, pin, hook)
Top-side openings Pass
Rear-side openings Pass
Bottom-side openings Pass
16 b Check of openings in top covers with No holes in enclosure of the unit. P
the vertical suspended test rod
16 c Conductive parts of actuating No handles, knobs, levers for removal N
mechanism of electrical controls after
the removal of handles, knobs, levers
etc. have either resistance to the
protective earth terminal max. 0.2
ohms or the separation from live parts
complies with 17 g
16 d Protection of contact with internal parts No parts exceeding 25V ac, or 60Vdc N
of the equipment with a circuit voltage
exceeding 25 V a.c. or 60 V d.c. which
cannot be disconnected from the supply
by external mains switch or plug
device
16 e Protective enclosures are removable Screw driver is required to remove enclosures P
only with the aid of tool or an
automatic device makes these parts not
live, when the enclosure is opened or
removed
16 f Live parts are inaccessible to the test N
rod through openings for adjustment of
pre-set controls

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17 SEPARATION
17 a Separation method of the applied part
from live parts so that allowable
leakage currents are not exceeded
17 a 1 Basic insulation - applied part earthed Not applicable. N
17 a 2 By protectively earthed conductive part Not applicable. N
(e.g. screen)
17 a 3 By separate earthed intermediate circuit Not applicable. N
17 a 4 By double or reinforced insulation DOP I, DOP II, UC Probe and Event Mark jack P

17 a 5 By protective impedances limiting See table 19 P

current to applied part
17 a 6 Other method, e.g. specified in Not applicable. N
particular standard
17 c There is no conductive connection All accessible conductive parts are protectively earthed. P
between applied parts and accessible
conductive parts, which are not
protectively earthed
17 d Supplementary insulation between No such a part N
hand-held flexible shafts and motor
shafts (Class I equipment)
Adequate isolation of accessible metal N
parts from motor shaft
Rated motor voltage N
Test voltage N
Air clearances/creepage distances N
(mm)/(mm)
17 g Separation method of accessible parts Protectively earthed and the applied part has such a low P
other than applied parts from live parts internal impedance to earth that leakage currents do not
so that allowable leakage currents are exceed the allowable values in normal condition and
not exceeded single fault condition.
17 g 1 Basic insulation - accessible part See above 1) and below 4) N
earthed
17 g 2 By protectively earthed conductive part See above 1) and below 4) N
(e.g. screen)
17 g 3 By separate earthed intermediate circuit Unearthed part to mains parts(see insulation diagram) P
17 g 4 By double or reinforced insulation See above 1) and 4) P
17 g 5 By protective impedances limiting See above 1) and 4) P
current to accessible part
Leakage currents measurements, when Protectively earthed and the applied part has such a low P
required internal impedance to earth that leakage currents do not
exceed the allowable values in normal condition and
single fault condition.

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17 h Adequate arrangements used to isolate No defibrillation-proof applied parts N

defibrillation-proof applied parts from
other parts
Impulse voltage tests N
Peak voltage between Y1 and Y2 does N
not exceed 1 V
After recovery time equipment N
continues to perform its intended
function

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18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND

POTENTIAL EQUALIZATION
18 a Sufficiently low impedance to the See 18 f) P
protective earth terminal(18 f and 18 g)
18 b Suitable connection between protective P
earth terminal and protective conductor
in the installation (18 f)
18 e Means for connection of potentially P
equalisation conductor complies with
specified requirements
This connection complies with P
following requirements:
- readily accessible P
- no possibility to accidental P
disconnection in normal use
- conductor is detachable without the P
use of a tool
- power supply cord does not include P
potential equalisation conductor
- connection is marked with symbol P
18 f Impedance of protective earthing P
system: Impedance between any
accessible metal part and:
1) protective earth terminal (PE)
(requirement: R max. 0.1 Ohm),
2) protective earth contact in appliance
inlet (requirement: R max.
0.1 Ohm),
3) protective earth contact in the mains
plug Test equipment: See attached
list. (requirement: R max. 0,2
Ohm),
are tabled below:
Accessible part and its location R (Ohm) measured against (numbers see above)
1 PE 2 inlet 3 plug
Gnd of Inlet - Accessible metal part — 0.02 —
Gnd of Inlet –Probe connector — 0.021 —
Gnd of Inlet – Potential equalization connector — 0.018 —
18 g If the impedance of protective earth Not applicable N
connections other than in 18 f exceeds
0.1 Ohm, the allowable value of the
enclosure leakage current is not
exceeded in single fault condition
18 k Functional earth terminals are not used No functional earth N
to provide protective earthing

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18 l For Class II equipment with isolated Not applicable. Class I equipment. N

internal screens and with a power
supply cord:
- the third conductor is used only as N
functional earth of these screens and is
coloured green/yellow
- insulation of such screens and all N
internal wiring connected to them is
double insulation or reinforced
insulation (see also 20.3)
- marking of functional earth terminal N
is distinguished from protective earth
terminal and is explained in
accompanying documents
Test of insulation (see Clause 20) N

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19 CONTINUOUS LEAKAGE CURRENTS AND PATIENTS

AUXILIARY CURRENTS
19.1 General requirements (tests see 19.4)
19.1 g Equipment with multiple patient P
connections: Patient leakage current
and patient auxiliary current do not
exceed allowable values while one or
more patient connections are
disconnected from the patient or
disconnected from the patient and
earthed
19.2 Single fault conditions (tests see 19.4)
19.3 Allowable values (see 19.4)
19.4 Tests before humidity preconditioning See comment below.
treatment
Equipment: Mains voltage : No. 83
AC-voltage : No. 19
DC-voltage : No.19
MD : 03
Equipment for supply connection normal or reverse: 06
In normal condition In single fault condition
Type of leakage current Allowed value Measured max. Allowed value Measured max.
(µA) value (µA) (µA) value (µA)
Earth leakage current 500 246 1000 453
Enclosure leakage current 100 56.3 500 57.3
Patient leakage current (p.l.c.), a.c. : B, BF: 100 58.7 B, BF: 500 59.3
CF: 10 CF: 50
Patient leakage current (p.l.c.), d.c. : B, BF: 10 0.01 B, BF: 50 0.01
CF: 10 CF: 50
P.l.c. (110 % of the mains voltage on the — — B: 5000 —
signal input part or signal output part) BF, CF: —
P.l.c. (110 % of mains voltage on the — — B: — 45.9
applied part) BF: 5000
CF: 50
Patient auxiliary current, a.c. : B, BF: 100 42.1 B, BF: 500 47.5
CF: 10 CF: 50
Patient auxiliary current, d.c. : B, BF: 10 0.01 B, BF: 50 0.01
CF: 10 CF: 50
Comments
The values listed are the maximum values.

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19.4 Tests after humidity preconditioning See comments below.

treatment
Equipment: Mains voltage : No. 83
AC-voltage : No. 19
DC-voltage : No.19
MD : 03
Equipment for supply connection normal or reverse: 06
In normal condition In single fault condition
Type of leakage current Allowed value Measured max. Allowed value Measured max.
(µA) value (µA) (µA) value (µA)
Earth leakage current 500 249 1000 459
Enclosure leakage current 100 56.7 500 56.8
Patient leakage current (p.l.c.), a.c. : B, BF: 100 58.9 B, BF: 500 59.5
CF: 10 CF: 50
Patient leakage current (p.l.c.), d.c. : B, BF: 10 0.01 B, BF: 50 0.01
CF: 10 CF: 50
P.l.c. (110 % of the mains voltage on the — — B: 5000 —
signal input part or signal output part) BF, CF: —
P.l.c. (110 % of mains voltage on the — — B: — 46.2
applied part) BF: 5000
CF: 50
Patient auxiliary current, a.c. : B, BF: 100 42.4 B, BF: 500 47.8
CF: 10 CF: 50
Patient auxiliary current, d.c. : B, BF: 10 0.01 B, BF: 50 0.01
CF: 10 CF: 50
Comments
The values listed are the maximum values.

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20 DIELECTRIC STRENGTH (at operating temperature)

Overall compliance with Clause 20
Equipment: High voltage supply : No. 61
Equipment Insulation Insulation Reference Test voltage Remarks, observations
under test resistance *) voltage
All A-a1 250 V AC 1 500 V AC No Breakdown
Equipment
A-a2 250 V AC 4 000 V AC No Breakdown
Types

A-e 250 V AC 4 000 V AC No Breakdown

Equipment B-a 250 V AC 4 000 V AC No Breakdown

Types with
No Breakdown,
Applied part B-a ** 5 V DC 500 V AC (DOPI, DOPII, UC and Event
Mark jack)

*) IEC 601-1 does not require to measure this

**) Conducted the test between probe face and patient port

20 DIELECTRIC STRENGTH (after humidity preconditioning

treatment)
Overall compliance with Clause 20
Equipment: Humidity room : No. 72
High voltage supply : No. 61
Equipment Insulation Insulation Reference Test voltage Remarks, observations
under test resistance *) voltage
All A-a1 250 V AC 1 500 V AC No Breakdown
Equipment
A-a2 250 V AC 4 000 V AC No Breakdown
Types

A-e 250 V AC 4 000 V AC No Breakdown

Equipment B-a 250 V AC 4 000 V AC No Breakdown

Types with
No Breakdown,
Applied part B-a ** 5 V DC 500 V AC (DOPI, DOPII, UC and Event
Mark jack)

*) IEC 601-1 does not require to measure this

**) Conducted the test between probe face and patient port

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21 MECHANICAL STRENGTH
21 a Rigidity of enclosure (45 N test force) Tested with 45 N. No damage to enclosure parts. P
21 b Strength of enclosure part and any No damage resulting in a safety hazard. P
component thereon (Impact hammer
test, 0.5 J).
21 c On portable equipment carrying Handle(16.8kg; 1min) P
handles or grips withstand the
requirements of the loading test.
(Test force four times the weight of
equipment)
21.3 No damage to parts of patient support Not applicable. N
and/or immobilisation system after the
loading test (1350 N and 2700 N tests)
The test force for foot rests and chairs Not applicable. N
shall be twice the specified maximum
load or, if not specified, the test force
shall be 2,7 kN. The test force shall be
distributed over an area of 0,1 m2
surface for 1 minute.
21.5 Hand-held equipment or equipment Probes (1m : 3times) P
parts are safe after drop test (dropping
height 1 m)
21.6 a Portable and mobile equipment is able No damage resulting in a safety hazard. P
to withstand rough handling. (Drop height is 5cm)
21.6 b Propel test of mobile equipment Not applicable. N
(performed 20 times). Equipment
complies with requirements of this
standard.

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22 MOVING PARTS
22.2 a Moving parts of transportable Not applicable. N
equipment are provided with guards
which form an integral part of the
equipment
22.2 b Moving parts of stationary equipment Not applicable. N
are 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 Not applicable. N
confined so they cannot run off or jump
out of their guiding devices
Other means used to prevent a safety Not applicable. N
hazard
Mechanical safeguard means are Not applicable. N
removable only with a tool
22.4 Dangerous movements of equipment Not applicable. N
parts, which may cause physical injury
to the patient, are possible only by the
continuous activation of the control
22.6 Parts of equipment subject to Not applicable. N
mechanical wear are accessible for
inspection
22.7 To remove an unexpected safety hazard Not applicable. N
caused by an electrically produced
mechanical movement, there are means
for emergency switching of a relevant
part
The means for emergency switching Not applicable. N
are readily identifiable and accessible
and do not introduce a further safety
hazard
Current breaking capability Not applicable. N
Means for stopping of movements Not applicable. N
operate as a result of one single action

23 SURFACES, CORNERS AND EDGES

There are no rough surfaces, sharp The edges are well rounded. P
corners, flange or frame edges and
burrs which may cause injury or
damage

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24 STABILITY IN NORMAL USE

24.1 Equipment does not overbalance, when Tested. P
tilted through an angle of 10°
24.3 If equipment overbalances when tilted Not applicable. See above N
10°, it does not overbalance when
tilted:
- 5° in any position of normal use, N
excluding transport
- 10° in the condition specified for N
transport
The equipment carries a warning notice N
for transport
24.6 a Equipment or its parts with a mass of Not applicable. N
more than 20 kg:
- is provided with handling devices N
(grips etc.)
- is provided with handling instructions N
for lifting and assembling
24.6 b Portable equipment with a mass of Mass of 4.2kg N
more than 20 kg carrying handle(s)
suitably placed that equipment may be
carried by 2 or more persons

25 EXPELLED PARTS
25.1 Protective means are provided where Not applicable. No expelled parts. N
expelled parts of the equipment could
constitute a safety hazard
25.2 Display vacuum tubes with a face Not applicable. N
dimension of 16 cm or larger are
intrinsically safe with respect to effects
of implosion of tubes and to
mechanical impact, or the enclosure of
the equipment is provided with
adequate protection against implosion
Certificate of the test provided N

26 VIBRATION AND NOISE

No general requirement.

27 PNEUMATIC AND HYDRAULIC POWER

No general requirement.

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28 SUSPENDED MASSES
28.3 Suspension systems with safety Not applicable. N
devices:
Suspension systems include a safety Not applicable. N
device with adequate safety factors to
protect user or patient from hazards
If after activation of a safety device the N
equipment can still be used, the
activation of the device, e.g. a
secondary rope, becomes obvious to
the operator
28.4 Suspension systems of metal without N
safety devices:
The construction of the suspension N
complies with:
28.4 1 The TOTAL LOAD does not exceed No suspension system N
the SAFE WORKING LOAD
28.4 2 Where it is unlikely that supporting See above N
characteristics will be impaired by
wear, corrosion, material fatigue or
ageing, the SAFETY FACTOR of all
supporting parts is not less than 4
28.4 3 Where impairment by wear, corrosion, See above N
material fatigue is expected, the
SAFETY FACTOR is not less than 8
28.4 4 Where metal having a specific See above N
elongation at break of less than 5% is
used in supporting components, the
SAFETY FACTOR is not less than 1.5
times those given in 2) and 3) above
28.4 5 Sheaves, sprockets, band wheels and See above N
guides are so designed that the
SAFETY FACTORS of this Sub-
clause shall be maintained for a
specified minimum life till replacement
of the ropes, chains and bands
28.5 Dynamic loads: No general requirement.

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29 X-RADIATION
29.1 Diagnostic X-ray equipment, see IEC Not applicable. N
601-1-3. Radiotherapy equipment, see
relevant Particular standard
29.2 For equipment not intended to produce Not applicable. N
X-radiation for diagnostic and
therapeutic purposes, ionising radiation
emitted by vacuum tubes excited by
voltages exceeding 5 kV does not
produce an exposure exceeding 130
nC/kg (0.5 mR)

30 ALPHA, BETA, GAMMA, NEUTRON RADIATION AND OTHER

PARTICLE RADIATION
No general requirement.

31 MICROWAVE RADIATION
No general requirement.

32 LIGHT RADIATION (INCLUDING LASERS)

No general requirement.

33 INFRA-RED RADIATION
No general requirement.

34 ULTRAVIOLET RADIATION
No general requirement.

35 ACOUSTICAL ENERGY (INCLUDING ULTRA-SONICS)

No general requirement.

36 ELECTROMAGNETIC COMPATIBILITY
EN 60601-1-2 (2001) Compliance documented by the manufacturer. P

37 - 41 REQUIREMENTS FOR CATEGORY AP AND APG EQUIPMENT

See additional test report form. N

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42 EXCESSIVE TEMPERATURES
Ambient temperature during See tables below.
measurements:
Humidity: 70%
Atmospheric pressure: 1002hpa
Equipment: Humidity : 72
42.1 - 42.2 Determination of the temperature with P
thermocouples:
Equipment: No. 42
Quantity Rated Used in tests Remarks
Supply voltage, V 100-240V AC, 90 V AC / 60Hz Heating
50/60Hz Maximum normal load :
Refer to sub-clause 7(power input)
Supply power, VA — — Calculated temp.
T (°C)

Measuring point Measured Measured Calculated Allowed Remarks

temp. max. temp. temp. max. temp.
∆t (°K) T (°C) T (°C) T (°C)

1. Ambient — 26.5 — —
2. AC inlet 0.4 26.9 40.4 85.0 Added the 40°C
3. Wire between AC inlet and
8.9 35.4 48.9 105.0 Added the 40°C
Mains switch
4. Body of Main switch 1.5 28.0 41.5 85.0 Added the 40°C
5. Body of Motor 26.0 52.5 66.0 110.0 Added the 40°C
6. PCB near U15(main board) 8.7 35.2 33.7 105.0 Added the 25°C
7. PCB near U14(main board) 10.1 36.6 35.1 105.0 Added the 25°C
8. Coil of Transformer
19.0 45.5 59.0 130.0 Added the 40°C
(AC/DC Adapter)
9. Body of enclosure
6.7 33.2 31.7 — Added the 25°C
(AC/DC Adapter)
10. Top enclosure 3.6 30.1 43.6 85.0 Added the 40°C
11. "Record" button 5.4 31.9 45.4 85.0 Added the 40°C
12. Applied part(DOP I) 0.5 27.0 40.5 41.0 Added the 40°C
13. Applied part(DOP II) 0.8 27.3 40.8 41.0 Added the 40°C
14. Applied part(UC) 0.7 27.2 40.7 41.0 Added the 40°C
15. Applied part(event Mark jack) 0.8 27.3 40.8 41.0 Added the 40°C
0 0
Comments According to IEC 601-1 clause 42.1, table Xa and Xb, 40 C or 25 C is added to the temperature rise for
determination of the final temperature T.

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42 EXCESSIVE TEMPERATURES
42.1 - 42.2 Determination of the temperature with P
thermocouples:
Equipment: No. 42
Quantity Rated Used in tests Remarks
Supply voltage, V 100-240V AC, 264 V AC / 50Hz Heating
50/60Hz Maximum normal load :
Refer to sub-clause 7(power input)
Supply power, VA — — Calculated temp.
T (°C)

Output power, VA — —
Measuring point Measured Measured Calculated Allowed Remarks
temp. max. temp. temp. max. temp.
∆t (°K) T (°C) T (°C) T (°C)

1. Ambient — 25.8 — —
2. AC inlet 0.1 25.9 40.1 85.0 Added the 40°C
3. Wire between AC inlet and
9.2 35.0 49.2 105.0 Added the 40°C
Mains switch
4. Body of Main switch 0.1 25.9 40.1 85.0 Added the 40°C
5. Body of Motor 28.4 54.2 68.4 110.0 Added the 40°C
6. PCB near U15(main board) 7.9 33.7 32.9 105.0 Added the 25°C
7. PCB near U14(main board) 9.5 35.3 34.5 105.0 Added the 25°C
8. Coil of Transformer
27.5 53.3 67.5 130.0 Added the 40°C
(AC/DC Adapter)
9. Body of enclosure
7.0 32.8 32.0 - Added the 25°C
(AC/DC Adapter)
10. Top enclosure 3.3 29.1 43.3 85.0 Added the 40°C
11. "Record" button 3.6 29.4 43.6 85.0 Added the 40°C
12. Applied part(DOP I) 0.5 26.3 40.5 41.0 Added the 40°C
13. Applied part(DOP II) 0.7 26.5 40.7 41.0 Added the 40°C
14. Applied part(UC) 0.5 26.3 40.5 41.0 Added the 40°C
15. Applied part(event Mark jack) 0.2 26.0 40.2 41.0 Added the 40°C
Comments According to IEC 60601-1 clause 42.1, table Xa and Xb, 400C or 250C is added to the temperature rise
for determination of the final temperature T.

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42 EXCESSIVE TEMPERATURES
42.1 - 42.2 Determination of the temperature with P
thermocouples:
Equipment: No. 42
Quantity Rated Used in tests Remarks
Supply voltage, V 100-240V AC, 264 V AC / 50Hz Blocked opening
50/60Hz Maximum normal load :
Refer to sub-clause 7(power input)
Supply power, VA — — Calculated temp.
T (°C)

Output power, VA — —
Measuring point Measured Measured Calculated Allowed Remarks
temp. max. temp. temp. max. temp.
∆t (°K) T (°C) T (°C) T (°C)

1. Ambient — 26.5 — —
2. AC inlet 0.4 26.9 40.4 127.0 Added the 40°C
3. Wire between AC inlet and
8.9 35.4 48.9 161.0 Added the 40°C
Mains switch
4. Body of Main switch 1.5 28.0 41.5 127.0 Added the 40°C
5. Body of Motor 26.0 52.5 66.0 169.5 Added the 40°C
6. PCB near U15(main board) 8.7 35.2 33.7 161.0 Added the 25°C
7. PCB near U14(main board) 10.1 36.6 35.1 161.0 Added the 25°C
8. Coil of Transformer
19.0 45.5 59.0 203.5 Added the 40°C
(AC/DC Adapter)
9. Body of enclosure
6.7 33.2 31.7 - Added the 25°C
(AC/DC Adapter)
10. Top enclosure 3.6 30.1 43.6 127.0 Added the 40°C
11. "Record" button 5.4 31.9 45.4 127.0 Added the 40°C
12. Applied part(DOP I) 0.5 27.0 40.5 41.0 Added the 40°C
13. Applied part(DOP II) 0.8 27.3 40.8 41.0 Added the 40°C
14. Applied part(UC) 0.7 27.2 40.7 41.0 Added the 40°C
15. Applied part(event Mark jack) 0.8 27.3 40.8 41.0 Added the 40°C
Comments According to IEC 60601-1 clause 42.1, table Xa and Xb, 400C or 250C is added to the temperature rise
for determination of the final temperature T.

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43 FIRE PREVENTION
43.1 Strength and rigidity of the equipment The equipment is well constructed with regard to avoid P
are sufficient to avoid fire hazards (see fire hazard.
21)
43.2 Oxygen enriched atmospheres: No general requirement.

44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF

LIQUIDS, CLEANING, STERILIZATION, DISINFECTION AND
COMPATIBILITY
44.2 Overflow
Equipment containing a liquid Not applicable. No use of liquid containers or liquids in N
reservoir: normal operation
- The equipment is electrically safe N
after 15% overfill steadily over a
period of 1 min
- Transportable equipment is N
electrically safe after additionally
having been tilted through 15° in least
favourable direction(s) (if necessary
with refilling)
No signs of wetting of uninsulated live N
parts
Dielectric strength test (if deemed N
necessary)
44.3 Spillage
Safety of the equipment does not P
change in consequence of spillage test
performed by the method mentioned in
the standard (200 ml of water for
approximately 15 s from a height of
max. 5 cm)
44.4 Leakage
Safety of the equipment does not Not applicable. No use of liquid containers or liquids in N
change in consequence of leakage test normal operation
performed by the method mentioned in
the standard (drops of water).
Equipment shall be so constructed that
liquid which might escape in a single
fault condition does not cause a safety
hazard(see also Sub-clause *52.4.1)
44.5 Humidity
Checked by the pre-conditioning 32°C, 93%, 48hr P
treatment and tests (see 4.10)

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44.6 Ingress of liquids

Equipment checked by relevant tests of Not applicable. N
IEC 60 529
Equipment withstands dielectric N
strength test in Clause 20.
Water, if entered equipment, has no N
harmful effect, in particular there is no
trace of water on insulation for which
creepage distances are specified
44.7 Cleaning, sterilisation and
disinfection
Equipment/equipment parts capable of See Sub-clause 6.8.2 d. P
withstanding cleaning, sterilisation or
disinfection likely to be encountered in
normal use or specified by the
manufacturer
Test with saturated steam at 134 Cleaning instructions given in user manual. N
degrees C+-4 for 20 cycles, each of 20
min duration
Method specified by the manufacturer See Sub-clause 6.8.2 d. P
in instructions for use
Safety of the equipment not impaired N
by the test. No appreciable signs of
deterioration. Dielectric strength test
specified in Clause 20. withstood.
44.8 Compatibility with substances used No general requirement
with the equipment:

45 PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE

45.2 Pressure vessel with a pressure volume Not applicable. No pressure vessel. N
greater than 200 kPa x l, and pressure
greater than 50 kPa, withstands the
hydraulic test pressure.
Hydraulic test pressure: (The test N
pressure shall be maximum permissible
working pressure multiplied by a factor
obtained from Fig. 38).
45.3 The maximum pressure to which a part N
can be subjected in normal condition
and single fault condition does not
exceed the maximum permissible
working pressure for the part
The used maximum pressure is the N
highest of the following:
45.3 a Rated maximum supply pressure from N
an external source
45.3 b Pressure setting of a pressure relief N
device provided as part of the assembly

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45.3 c Maximum pressure that can be N

developed by an air compressor that is
part of the assembly, unless the
pressure is limited by a pressure-relief
device
45.7 Equipment incorporates pressure-relief N
device(s) where excessive pressure
could occur
If yes, it complies with all the N
following requirements:
45.7 a Connected as close as possible to the N
pressure vessel or parts of system it is
intended to protect
45.7 b Readily accessible for inspection, N
maintenance and repair
45.7 c Not capable of being adjusted or N
rendered inoperative without a tool
45.7 d Its discharge opening located and N
directed so, that released materials is
not directed towards any person
45.7 e Operation of device does not deposit N
material on parts causing possible
safety hazard
45.7 f Ensures that the pressure does not N
exceed the maximum permissible
working pressure by more than 10%, if
a failure occurs in the control of the
supply pressure
45.7 g No shut-off valve between the N
pressure-relief device and the parts it is
intended to protect
45.7 h Minimum number of cycles of N
operation is 100 000, except for
bursting disks

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46 HUMAN ERRORS
No general requirement.

47 ELECTROSTATIC DISCHARGES
No general requirement.

48 BIOCOMPATIBILITY
Equipment parts and accessories According to the information provided by the P
intended to come into contact with manufacturer the equipment is considered to comply
biological tissues, cells or body fluids with the requirements.
assessed and documented as given in
ISO 10993-1.
Inspection of information provided by
manufacturer.

49 INTERRUPTION OF POWER SUPPLY

49.1 If automatically resetting thermal cut- Not applicable. N
outs and overcurrent releases are used,
they give a safe condition by such
resetting
49.2 Interruption and restoration of the No hazard in case of interruption of power supply P
power supply do not result in hazards
49.3 Means are provided for removal of N
mechanical constrains on patients in
case of a supply mains failure

50 MARKING OF CONTROLS AND INSTRUMENTS

50.1 See Sub-clause 6.3.

51 PROTECTION AGAINST HAZARDOUS OUTPUT

51.1 Intentional exceeding of safety limits. No general requirement (cf. Appendix A, Sub-clause A2)
51.2 Indication of parameters relevant to No general requirement (cf. Appendix A, Sub-clause A2)
safety.
51.3 Reliability of components. See Sub-clause 3.6 f.
51.4 Equipment providing both low- and The intended purpose of this equipment is not treatment N
high-intensity outputs. Minimised
possibility of high intensity output
being selected accidentally
51.5 Incorrect output. No general requirement

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52 ABNORMAL OPERATION AND FAULT CONDITIONS

52.1 Equipment shall be so designed and P
manufactured that even in single fault
condition no safety hazard as described
under Sub-clause 52.4 exists (see 3.1
and 13)
52.1 Safety of equipment incorporating Manufacturer risk analysis was reviewed P
programmable electronic systems
(PES) conforms to the rules of future
IEC 601-1-4
52.5.1 Overloading of mains supply Not applicable N
transformers
52.5.2 Failure of thermostats Not applicable. N
52.5.3 Short-circuiting one part of a double Not applicable. N
insulation
52.5.4 Interruption of the protective earth See Sub-clause 19.4 P
conductor (tests as described in Sub-
clause 19.4)
52.5.5 Impairment of cooling. Temperatures Blocked openings, See clause 42 P
do not exceed 1.7 times values of
Clause 42, Tables Xa and Xb, minus
17.5 degrees C.
52.5.6 Locking of moving parts (see also See the table of clause 52.5.9. P
52.5.8)
52.5.7 Interruption and short-circuiting of Not applicable. N
motor capacitors (see also 52.5.8)
52.5.8 Additional tests for motor operated See clause 52.5.6 P
equipment:
52.5.9 Failure of components (refer to Table P
in Clause 56)
X1 and X2 capacitors between parts of No capacitor
opposite polarity in the mains part and
complying with IEC 60 384-14
exempted from this requirement
52.5.10 Overload
52.5.10 a Equipment with heating elements: No heating elements N
52.5.10 a 1 Thermostatically controlled equipment N
(see 52.5.10.c and d)
52.5.10 a 2 Equipment with heating elements N
with short-time rating (see 52.5.10 c
and e)
52.5.10 a 3 Other equipment with heating elements N
(see 52.5.10 c)
52.5.10 b Equipment having motors, which are a Not applicable. N
part of equipment (see 52.5.5 - 52.5.8
and 52.5.10 f - 52.5.10 h)

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52.5.10 b 1 Mention circuit/component concerned N

(e.g. regulator, capacitor, wiring, etc.)
and mention the fault condition (e.g.
disconnected, short-circuited, etc.).
Mention creepage-distances separately
if applicable (refer to the text of 52.5
above 52.5.1 in the 601-1 standard)
52.5.10 b 2 Mention for example safety hazards N
according to 3.1 and 13 and 52.4

52.5.9 FAULT CONDITION TESTS P

Rated Voltage(V) 100-240V AC

Fuse Rating 1A

No Comp. Fault Test Test Fuse No Fuse Mains power/temperatures/results

No voltage time current
(V) (A)

1 Ventilation Blocked 264 1 hr Fuse in 0.13 Normal operated.

opening 45min Inlet Temperaturer stabilized.
See table of 42
No hazard.

2 Printer Locked 264 30 min Fuse in 0.14 Temperature stabilized at 50.2 ° C

motor Inlet with ambient 24.2 ° C.
No hazard

F No = Fault Number, S-c = Short-circuit, Dis = Disconnection

53 ENVIRONMENTAL TESTS
See Sub-clause 4.10 and Clause 10.

54 CONSTRUCTIONAL REQUIREMENTS - GENERAL

See Clause 55 to 59.

55 ENCLOSURES AND COVERS

See Clause 16, 21 and 24.

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56 COMPONENTS AND GENERAL ASSEMBLY - LIST OF CRITICAL

COMPONENT PARTS
Part No Component/ Manufacturer Type / Model Ratings / Complies Approved
Object Technical Data with the by
following
standard

AC/DC Ault Inc. MW160 Input: EN 60601- TÜV Rhl.

Adaptor 100-240 Vac, 1
1.2A, 50/60 Hz
Output:
12 Vdc, 3.5 A

Appliance Jackson Electronics JR-101 10A, 250V IEC 60320 VDE

Inlet Inc. Corp

Fuse in AC ORISEL Co., Ltd. 50T 1A, 250Vac EN60127-1 VDE

inlet

Mains SUNG JIN IND. CO SJS-51 7/10A, 250Vac IEC 60320 SEMKO
Connector

Mains Cord Hwajin KDK Co. Ltd H05VV-F 3G x 0.75mm² - SEMKO

Main switch ITT Industries Rudolf Serie NE18 6A, 250Vac EN61058-1 VDE
Schadow GmbH

DC Motor Nippon Pulse PF42-48B1G DC24V EN60601-1 Tested in

appl.

PCB Various Various V-1 or better - UL

Enclosure LG chemical AF-302 V-0 - UL

Applied part

DOP probe Bionics Co., Ltd. Bionics-probe(D) Max. 5V EN 60601- Tested in

1 appl.

UC probe Bionics Co., Ltd. Bionics-probe(U) Max. 5V EN 60601- Tested in

1 appl.

Event Mark Bionics Co., Ltd. Bionics-probe(U) Max. 5V EN 60601- Tested in

jack 1 appl.

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56.1 General Marking of components (refer to Table in Clause 56).

56.1 b Component markings are according The components are used according to their ratings. All P
with conditions of use components in the mains part and applied part are
marked or otherwise identified regarding their ratings.
56.1 d Fixing of components. The movement of components is prevented. P
56.1 f Fixing of wiring. Conductors and connectors are adequately secured and P
insulated. Accidental detachment does not result in a
safety hazard.
56.3 Connections - general
56.3 a Incorrect interconnection of accessible No such a connector N
connectors is prevented where a hazard
may be caused
Accessible parts are separated from P
live parts (see 17 g)
Plugs for connection of patient circuit P
cannot be connected to other outlets
Medical gas connections are not Not applicable. N
interchangeable (see Sub-clause 6.6
and ISO R407)
56.3 b Accessible conductive parts are Prevented P
prevented from becoming live when
connection between different part of
the equipment is broken
56.3 c Connectors having conductive DOPI, DOPII, UC, and Event Mark jack P
connection to patient are constructed so
that no conductive connection of the
connector remote from patient can
contact earth or hazardous voltages
Test with flat conductive surface Not possible by construction P
Test with straight unjointed test finger No single-pole connectors N
Test if able to be plugged into a mains N
socket
56.4 Connections of capacitors
Capacitors not connected between live CB certified AC/DC Adapter used N
parts and non- protectively earthed
accessible conductive parts
Capacitors between the mains part and No capacitors N
earthed accessible parts, comply with
IEC 60384-14 or equivalent
The enclosure of capacitors are not No capacitors. N
secured directly to non-protectively
earthed accessible metal parts
Capacitors or other spark-suppression Not applicable. N
devices are not connected between
contacts of thermal cut-outs

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56.5 Protective devices

Protective devices which operate by CB Certified AC/DC Adapter used N
producing a short circuit which results
in operation of an overcurrent
protection device in supply mains
system not used (see also 59.3)
56.6 Temperature and overload control
devices
56.6 a Thermal cut-outs which require No such thermal cut-outs used N
soldering to reset are not used
Thermal safety devices are provided to N
prevent temperature limits being
exceeded
An independent non-self resetting Not applicable. N
thermal cut-out is provided where the
failure of a thermostat may cause a
hazard
The operating temperature of the above Not applicable. N
thermal cut-out is between the upper
limit of the first thermostat and the safe
limit for the function
There is an audible alarm where loss of Not applicable. N
function could present a safety hazard
Test of thermal cut-outs and Not applicable. N
overcurrent releases
Heated liquid containers are protected Not applicable. N
against dangerous overheating when
container is empty
56.6 b Means provided for varying the Not applicable. N
temperature setting of thermostats, the
temperature setting is clearly indicated
The operating temperature of thermal Not applicable. N
cut-outs is clearly indicated
56.7 Batteries
56.7 a 1 Adequately ventilation Not applicable. N
56.7 a 2 Accidental short-circuiting is prevented N
(Note! Lithium batteries)
56.7 b Incorrect polarity of connection N
prevented (Note! Lithium batteries)
1) Establish whether there is a
possibility of making an incorrect
battery connection.
2) Where such a possibility exists,
establishing the effect of an incorrect
battery connection.
Type of battery is clearly marked (see N
also 6.2 d)
56.7 c Battery state. No general requirement. N

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56.8 Indicators
Unless indication is otherwise apparent Colors, see Sub-clause 6.7. P
to the operator from normal operating
position , indicator lights are provided:
- to indicate that equipment is See Sub-clause 6.3 a. P
energised
- to indicate the operation of non- Not applicable. N
luminous heaters
- to indicate when output exists if a Not applicable. N
safety hazard could result
Charging mode is visibly indicated to See Sub-clause 6.7. P
the operator
56.10 Actuating parts of controls
56.10 a Accessible parts of electrical controls N
comply with requirements in Sub-
clause 16 c
56.10 b Fixing, prevention of maladjustments: N
Actuating parts are adequately secured N
to prevent them working loose during
normal use
Controls are secured to prevent N
movement relative to scale marking
Detachable indicating devices are N
prevented from incorrect connection
without the use of a tool
56.10 c Stops of adequate mechanical strength N
are provided on rotating or movable
parts of controls, where necessary to
prevent an unexpected change from
maximum to minimum, or vice-versa,
of the controlled parameter where this
could produce a safety hazard
Manual torque test N
Axial pull test N
56.11 Cord connected hand-held and foot-
operated control devices
56.11 a Voltages on cord connected control Measured voltage of probes : Max. 5 V P
devices do not exceed 25 V a.c. or 60
V d.c. or peak value
Circuits isolated from mains part (see P
17 g)
56.11 b Hand-held control devices: No safety P
hazard as a result of the free fall test
(Sub-clause 21.5)
Foot-operated control devices able to See above N
support the weight of an adult human
being. Test with an actuating force of
1350 N over an area of 625 mm2. No
damage to the device resulting in a
safety hazard.

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56.11 c Hand-held and foot-operated control N

devices do not change their control
setting when inadvertently placed in
abnormal position
56.11 d IP-classification of foot-operated N
control device at least IPX1
Electrical switching parts specified for N
use in operating rooms at least IPX8
56.11 e Provided with adequate means of N
anchoring as for power supply cords
(see test of 57.4).

57 MAINS PARTS, COMPONENTS AND LAY-OUT

57.1 Isolation from supply mains
57.1 a Means of isolation: Approved AC inlet P
The equipment has means for simultaneous See above P
disconnection of all supply poles
Means for disconnection incorporated in See above P
equipment
External means for disconnection are N
specified in accompanying documents
57.1 d Switches for mains disconnection comply VDE Certified by IEC61058-1 P
with creepage distance and air clearances
(IEC 60328 , replaced by IEC 60 61058-1)
57.1 f Mains switches are not incorporated in power P
supply cord or flexible leads
57.1 g The directions of movement of actuators of “I/O” marked P
mains switches comply with IEC 60447
57.1 h Suitable plug device used to isolate the non- N
permanently installed equipment from the
supply mains
57.1 m Fuses and semiconductor devices are not used N
as isolating devices
57.2 Mains connectors , appliance inlets and the
like
57.2 e Auxiliary mains sockets outlets: No Auxiliary mains sockets outlets N
- cannot accept a mains plug (does not apply N
to emergency trolleys)
Number of socket-outlets on emergency N
trolleys are limited to maximum 4.
- and they are properly marked N

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57.3 Power supply cords

57.3 a Equipment not provided with more than one One connection to supply mains P
connection to supply mains
Alternative connections to a different supply Not applicable. N
system do not cause safety hazards when
more than one connection is made
simultaneously

Mains plug not fitted with more than one One power supply cord P
power supply cord
Equipment not intended to be permanently Appliance inlet. P
connected to fixed wiring is provided with
either a power supply cord or an appliance
inlet
57.3 b Power supply cords not less robust than P
ordinary flexible cord, designation 53 of IEC
60245 or IEC 60227
PVC insulated power supply cords not used P
for equipment having external metal parts
exceeding 75°C , unless cord rated for the
temperature measured
57.3 c Cross-sectional area of power supply cords 3 x 0.75 mm² P
(see Table XV)
57.3 d Stranded conductors fixed by any clamping Detachable power cord set used. N
means or screws are not soldered

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57.4 Connection of Power Supply Cords

57.4 a Cords anchorages: Probes P
The equipment or its mains connectors P
incorporate a cable anchoring device to
relieve strain on conductors and prevent
abrasion of covering (no knots etc.)
The construction and materials of the cord P
anchorages are made of insulating material or
insulated from unearthed accessible metal
parts by supplementary insulation,
or having an insulating lining complying with P
the requirements for basic insulation fixed to
the cord anchorage if an insulation fault on
power supply cord could make accessible
parts live
Clamping screws do not bear directly on the P
cord insulation
Screws associated with cable replacement are P
not used to fix other components
Conductors so arranged that if the cord Not applicable N
anchorage fails no strain on protective earth
conductor occurs as long as phase conductors
are in contact with their terminals
Pull test 25 times At 30N for probes P
Torque test for 1 min With 0.1Nm for probes P
After the tests, the cord sheath has not been P
longitudinally displaced by more than 2 mm
and the conductor ends have not moved over
a distance of more than 1 mm from their
normally connected position
Creepage distances and air clearances are not P
reduced below the values specified in Sub-
clause 57.10.
Not possible to push the cord into equipment P
to such an extent that the cord, or internal
parts of the equipment, could be damaged
57.4 b For other than stationary equipment, the Probes P
power supply cord is adequately protected
against excessive bending by means of a cord
guard of insulating material
Alternatively shaped opening for the power P
supply cord
Bending test: Overall diameter: 5.0 mm for probes P
Overall diameter: 3.0 mm for probe
(Event mark jack)
Flexing test (if guards fail the dimensional N
test) (see IEC 60335-1 AM 6:1988, Sub-
clause 25.10)
Results of flexing test: N
Percent of broken conductor strands: N

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57.4 c There is sufficient space inside the equipment N

to allow the supply cable conductors to be
introduced and connected
Any covers can be fitted without risk of —
damage to the conductors or their insulation
It is possible to check that conductors are N
correctly connected before the cover is fitted
57.5 Mains Terminal Devices and wiring of
mains part
57.5 a Mains connected equipment other than those Appliance inlet used P
with a detachable supply cord is provided
with mains terminals, where connections are
made with screws, nuts , soldering ,
clamping , crimping of conductors or equally
effective methods
Reliance not placed upon terminals alone to Not applicable. N
maintain conductors in position, unless
barriers are provided
Terminals of components used for external Not applicable. N
conductors comply with specified
requirements and are properly marked (see
6.2 h, j and k)
Screws and nuts which clamp external N
conductors are not used to fix any other
component (other than internal conductors
unlikely to be displaced)
Barriers provided N
57.5 b Terminals including any protective earth Not applicable. N
terminal are closely grouped to allow easy
connection
Protective earth conductor, see 58 Not applicable. N
Marking of mains terminals, see 6.2 Not applicable. N
Mains terminal devices are inaccessible Not applicable. N
without the use of a tool
Mains terminal devices are so located or No accidental contact possible P
shielded that there is no risk of accidental
contact between live parts and accessible
conductive parts
- and for class II equipment between live N
parts and conductive parts separated from
accessible parts by supplementary insulation
only
Single strand of wire (8 mm). Test result: N
57.5 c Tightening or loosening of clamping means N
of conductors does not subject internal wiring
to stress
- does not reduce creepage distances and air N
clearances below allowable values
Cross-sectional area of the conductor used in N
the fastening and loosening test:

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57.5 d Effective connection to mains terminals does N

not require special preparation of cables
Conductors are not damaged or displaced N
when tightening or loosening of clamping
screws or nuts
57.5 e Fixing of wiring See Sub-clause 56.1 f. N
57.6 Mains Fuses and Over-current Releases
List of fuses and over-current releases: See 2 fuses provided in each line P
table at the beginning of Clause 56 in this
TRF
There are fuses or over-current releases in P
each supply lead for class I equipment and
class II equipment having a functional earth
according to Sub-clause 18.1
There is at least one mains fuse for other Class I equipment N
single phase class II equipment
A protective earth conductor is not fused P
No fuse is fitted in neutral conductor of Portable equipment N
permanently installed equipment
57.8 Wiring of Mains Part
57.8 a The insulation of an individual conductor is P
at least equivalent to that required by IEC
60227 or IEC 60245 (otherwise the conductor
is considered bare)
- dielectric strength test of 2000 V for 1 min All wiring of mains part P
57.8 b The cross-sectional area of internal wiring No wiring because 2 mains fuses are employed in N
between the mains terminal and protective the applied inlet.
devices is not less than minimum required for
the power supply cord. Measured area:
(see Sub-clause 57.3 c)
The cross-sectional area of other wiring in the P
mains part and sizes of tracks on printed
wiring circuits are sufficient to prevent any
fire hazard in case of possible fault currents
In case of doubt concerning adequacy of P
incorporated overcurrent protection
connecting test performed. No safety hazard
arises
57.9 Mains supply transformers (refer to table
below)
57.9.1 Insulation of mains supply transformers Not applicable. Approved adapter used N
protected against overheating in event of
short-circuit or overload (see 57.9.1 a and b)
External protective devices connected such N
that failure of components cannot render the
protective devices inoperative

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57.9.1 a Short-circuit test(s) at 90 to 110 percent of Not applicable N

rated supply voltage / voltage range
57.9.1 b Overload
Tests under the conditions specified in Clause Not applicable N
42 until steady thermal conditions are
obtained. Results: See table below.
Loading of a section or winding of the N
transformer:
57.9.2 Dielectric strength of electrical insulation
between turns and layers
Insulation between turns and layers, test N
performed according to 57.9.2:
Voltage used in test:
Frequency used in test:
57.9.4 Construction
57.9.4 a One of the following methods is used to Not applicable. N
separate primary from secondary and patient
connected windings:
57.9.4 c Means are provided to prevent displacement Not applicable. N
of end turns
57.9.4 d An earthed screen has a minimum overlap of Not applicable. No earthed screen used. N
3 mm and a width at least equal to the axial
length of the primary winding
57.9.4 e The insulation between the primary and Not applicable N
secondary winding in reinforced or double
insulated transformers consists of:
number of insulation layer(s): N
total thickness N
combination of two layers withstands N
dielectric strength test for reinforced
insulation
57.9.4 f The creepage distances between the primary N
and secondary windings comply with
requirements for reinforced insulation, with
specified allowances
mm at location: N
57.9.4 g For toroidal transformers:
the exit of wires from internal windings is Not applicable N
provided with double sleeving complying
with requirements for double insulation
its total thickness is at least 0.3 mm extending N
at least 20 mm outside the winding. Measured
thickness:

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57.10 Creepage distances and air clearance

57.10 a Values (refer to table )
Creepage distances and air clearances comply P
at least with the values of Table XVI
Creepage distances for slot insulation of Not applicable N
motors are at least 50% of the values in the
table with a minimum of 2 mm at 250 V
Creepage distances and air clearances No defibrillation proof applied parts N
between defibrillation proof applied parts and
other parts are not less than 4 mm
Insulation Ref. Air clearance (mm) Creepage distance (mm) Notes
voltage
between (V) Required Measured Required Measured
Equivalent to Basic A -f 250 1.6 >1.6 3.0 >3,0 Before
insulation between fuse
parts of opposite
polarity
Equivalent to Basic A -f 12 0.4 2.6 0.8 2.6 DC Input
insulation between
parts of opposite
polarity
Basic or A – a1 250 2.5 4.0 4.0 4.0 AC/DC
supplementary Adapter
insulation
Basic or A – a1 250 2.5 5.0 4.0 5.0 AC inlet
supplementary
insulation
Double insulation or A – a2 250 5.0 >5.0 8.0 >8.0 AC/DC
reinforced insulation Adapter
Double insulation or A-e 250 5.0 5.0 8.0 10.0 AC/DC
reinforced insulation Adapter
Double insulation or B-a 250 5.0 5.0 8.0 10.0 Probe
reinforced insulation
Comments
57.10 b Statements , test specifications etc. observed
57.10 d Statements regarding measurement of
creepage distances and clearances observed

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58 PROTECTIVE EARTHING -TERMINALS AND CONNECTIONS

58.1 Clamping means of the protective earth Detachable power supply cord used N
terminal for fixed supply conductors or
power supply cords comply with
requirements of Sub-clause 57.5 c:
Not possible to loosen the clamping Not applicable. N
means without use of a tool
Screws for internal protective earth Not applicable. N
connections are covered or protected
against loosening from outside
58.2 Internal protective earthing connections P
by means of screw, soldering,
crimping, wrapping, welding or a
reliable pressure contact
58.3 Not used (see 57.5 b)
58.7 Where an appliance inlet is used for the P
supply connection, its earth pin is
regarded as the protective earth
terminal
58.8 The protective earth terminal is not P
used for connection between different
parts or fixing of any component not
related to protective or functional
earthing
58.9 Where the protective earth connections Connected together with appliance inlets of equipment P
are made via a plug or socket device and integral part of AC/DC adaptor
the protective earth connection is made
before and interrupted after the supply
connections during connection and
interrupting

59 CONSTRUCTION AND LAYOUT

59.1 Internal wiring
Fixing of wiring in the applied part and P
the mains part, see Sub-clause 56.1 f
59.1 a Internal cables and wiring:
- are protected against contact with The wiring is adequately protected against sharp edges, P
moving parts and friction with sharp moving parts and etc.
corners and edges
- are protected by additional fixed Not applicable. N
sleeving or similar means , if there is
movement relative to metal parts where
it is in direct contact with metal parts
- and wiring , cord forms or P
components are not likely to be
damaged by opening or assembling the
equipment or opening or closing of
inspection doors

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59.1 b The bending radius of cables and cable Not applicable. N

forms is at least 5 times the outer
diameter of the lead
59.1 c Insulation:
- insulating sleeving is adequately Tubings for AC inlet terminals P
secured. It can only be removed by
breaking or cutting or is secured at both
ends
Sheath of a flexible cord used as Not applicable. N
supplementary insulation inside
equipment is not subject to undue
mechanical or thermal stresses and its
insulation properties are at least as
specified in IEC 60227 or IEC 60245
- insulated conductors, which are Not applicable. N
subject to temperatures greater than
70°C, have an insulation of heat-
resistant material
Dielectric strength test of insulation of Not applicable. N
2000 V for 1 min
59.1 d Aluminium wires below 16 mm² cross- No aluminium wires N
section are not used
59.1 e Separation of circuits (see Clause 17)
59.1 f Connecting cords between equipment Not applicable. N
parts (e.g. parts of an x-ray or patient
monitoring installation or a data-
processing installation or
combinations) are considered
belonging to equipment and subject to
requirements of this standard
59.2 Insulation
59.2 b Insulation characteristics, mechanical Test of enclosure parts: Temperature of ball 75 °C. P
strength and resistance to heat and fire Enclosure 1.3 mm
is retained. Result of the ball-pressure
test:
59.2 c Insulation is not likely to be impaired P
by deposition of dirt or dust resulting
from wear of parts within the
equipment such that creepage distances
and clearances are reduced below
specified values
Ceramic materials and the like Not applicable. N
specified in this sub-clause are not used
as supplementary or reinforced
insulation
Rubber materials used as N
supplementary insulation in class II
equipment are resistant to ageing
(oxygen test) and arranged and
dimensioned adequately
Creepage distances are not reduced N
below values specified in 57.10 despite
any cracks in such insulation

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Insulating materials in which heating N

elements are embedded are not used as
reinforced insulation
59.3 Excessive current and voltage
protection
See Sub-clause 57.6. An internal Not applicable. N
electrical power source in equipment is
provided with an appropriately rated
device to protect against fire hazards.
Protective means used. Inspection of
design data
Fuse elements replaceable without There were fuse inside of Inlet P
opening the enclosure are fully
enclosed in a fuseholder and fuse
replacement does not cause safety
hazard. Test with standard test finger.
Live parts of fuseholders are shielded There were fuse inside of Inlet P
to prevent electric shock when
replacing fuses (if replaceable without
the use of a tool)
Protective devices between an F-type No such a protective device N
applied part and the enclosure do not
operate below 500 V r.m.s.
59.4 Oil containers
Oil containers in portable equipment Not applicable. N
are adequately sealed to prevent oil
loss in any position and the oil
container design allows for the
expansion of oil
Oil containers in mobile equipment are N
sealed to prevent loss of oil during
transport
An oil level indicator is provided on N
partially sealed oil-filled equipment or
parts. Inspection of equipment and
technical description , and by manual
test

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19.4 f APPENDIX 1
Fig. 16 in Measurement of the earth leakage P
IEC 60601-1 current

L(N)
T1 S5 P1

R?eau P3
Mains V 5
N(L) P1
S1

S10 P1
FE

MD PE

S12 P1

(Measuring supply circuit with one side of the supply mains at approximately earth potential (fig. 10)).
Switch positions NC (S1 = 1) SFC (S1 = 0) Additional SFC*
(see Clause 17.a)* (S1 = 1)
Measured (µA) Measured (µA) Measured (µA)
1 2
S5 S12 Before After Before1 After2 Before1 After2
1 1 246 249 450 456 — —
1 0 245 248 451 457 — —
0 1 238 242 452 458 — —
0 0 239 242 453 459 — —
1)Insulation-enclosed
2)Metal enclosed
3)Combination of Insulation- and metal-enclosed
and 2 = Before and after humidity preconditioning treatment.
Note: NC = Normal Conditions 1 = Switch Closed * = describe additional SFC according to
SFC = Single Fault Condition 0 = Switch Open Sub-clause 17 a in notes above

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19.4 g APPENDIX 2
Fig. 18 in Measurement of the enclosure FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 leakage current

L(N)
T2 S9

R?eau
Mains
V V2
N(L)
P1

L(N) 1
T1 S5 P1

R?eau P3
Mains V V1 5
N(L) MD2
P1
S1

S10 P1
FE

S7 P1
PE

MD1
P1
S12

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 S12 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 1 56.2 56.7 55.3 56.0 56.5 56.8 — —
1 0 55.5 56.7 54.7 56.0 55.4 56.8 — —
0 1 56.4 56.7 55.2 56.0 57.3 56.8 — —
0 0 56.3 56.7 54.6 56.0 56.5 56.8 — —
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional SFC
equipment SFC = Single Fault Condition 0 = Switch Open according to Sub-clause 17 a in
notes above

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19.4 h APPENDIX 3
Fig. 20 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current (For UC)

1
L(N)
T1 S5 P1 P3

R?eau
Mains V 5
N(L) P1
S1

S10 P1
FE

S7 P1
PE

6
P1
MD

S13

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 S13 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 1 55.7 55.8 54.5 55.1 55.1 55.6 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 0 55.7 55.8 54.5 55.1 55.1 55.6 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 1 54.3 55.1 54.5 55.1 55.6 55.8 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 0 54.3 55.1 54.5 55.1 55.6 55.8 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1
and 2 = Before and after humidity preconditioning treatment.
Comments :
Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional SFC
equipment SFC = Single Fault Condition 0 = Switch Open according to Sub-clause 17 a in
notes above ** = AC / DC

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19.4 h APPENDIX 3
Fig. 20 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current (For DOP I)

1
L(N)
T1 S5 P1 P3

R?eau
Mains V 5
N(L) P1
S1

S10 P1
FE

S7 P1
PE

6
P1
MD

S13

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 S13 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 1 55.9 56.0 56.1 56.3 56.3 56.5 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 0 55.9 56.0 56.1 56.3 56.3 56.5 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 1 56.3 56.0 56.0 56.3 56.5 56.7 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 0 56.3 56.0 56.0 56.3 56.5 56.7 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1
and 2 = Before and after humidity preconditioning treatment.
Comments :
Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional SFC
equipment SFC = Single Fault Condition 0 = Switch Open according to Sub-clause 17 a in
notes above ** = AC / DC

Page 57 of 69
Nemko ref. no.:NK-2E-M-054

19.4 h APPENDIX 3
Fig. 20 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current (For DOP II)

1
L(N)
T1 S5 P1 P3

R?eau
Mains V 5
N(L) P1
S1

S10 P1
FE

S7 P1
PE

6
P1
MD

S13

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 S13 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 1 56.4 56.6 58.7 58.9 59.3 59.5 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 0 56.4 56.6 58.7 58.9 59.3 59.5 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 1 58.7 58.9 58.8 59.0 58.8 59.0 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 0 58.7 58.9 58.8 59.0 58.8 59.0 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1
and 2 = Before and after humidity preconditioning treatment.
Comments :
Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional SFC
equipment SFC = Single Fault Condition 0 = Switch Open according to Sub-clause 17 a in
notes above ** = AC / DC

Page 58 of 69
Nemko ref. no.:NK-2E-M-054

19.4 h APPENDIX 3
Fig. 20 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current (For Event Mark jack)

1
L(N)
T1 S5 P1 P3

R?eau
Mains V 5
N(L) P1
S1

S10 P1
FE

S7 P1
PE

6
P1
MD

S13

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 S13 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 1 56.3 56.5 56.1 56.3 55.4 55.6 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 0 56.3 56.5 56.1 56.3 55.4 55.6 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 1 56.2 56.4 56.1 56.3 55.2 55.4 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 0 56.2 56.4 56.1 56.3 55.2 55.4 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1
and 2 = Before and after humidity preconditioning treatment.
Comments :
Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional SFC
equipment SFC = Single Fault Condition 0 = Switch Open according to Sub-clause 17 a in
notes above ** = AC / DC

Page 59 of 69
Nemko ref. no.:NK-2E-M-054

19.4 h2 APPENDIX 4
Fig. 21 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current with mains voltage on the f- (For UC)
type isolated (floating) applied part

1 6
L(N)
T1 S5 P1

R?eau P3
Mains V V1 5
N(L) P1
S1

3
S10 P1
FE

S7 P1 3
PE

P1

L(N) MD
T2 S9 R

R?eau
Mains V V2
N(L)

S13

Switch position Measured µA

1
S5 S9 S13 Before After2

1 1 1 45.7 46.0
1 1 0 45.7 46.0
1 0 1 45.4 45.7
1 0 0 45.4 45.7
0 1 1 45.7 46.0
0 1 0 45.7 46.0
0 0 1 45.4 45.7
0 0 0 45.4 45.7
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II equipment NC = Normal Conditions 1 = Switch Closed
SFC = Single Fault Condition 0 = Switch Open

Page 60 of 69
Nemko ref. no.:NK-2E-M-054

19.4 h2 APPENDIX 4
Fig. 21 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current with mains voltage on the f- (For DOP I)
type isolated (floating) applied part

1 6
L(N)
T1 S5 P1

R?eau P3
Mains V V1 5
N(L) P1
S1

3
S10 P1
FE

S7 P1 3
PE

P1

L(N) MD
T2 S9 R

R?eau
Mains V V2
N(L)

S13

Switch position Measured µA

1
S5 S9 S13 Before After2

1 1 1 45.0 45.3
1 1 0 45.0 45.3
1 0 1 45.9 46.2
1 0 0 45.9 46.2
0 1 1 45.1 45.4
0 1 0 45.1 45.4
0 0 1 45.8 46.1
0 0 0 45.9 46.1
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II equipment NC = Normal Conditions 1 = Switch Closed
SFC = Single Fault Condition 0 = Switch Open

Page 61 of 69
Nemko ref. no.:NK-2E-M-054

19.4 h2 APPENDIX 4
Fig. 21 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current with mains voltage on the f- (For DOP II)
type isolated (floating) applied part

1 6
L(N)
T1 S5 P1

R?eau P3
Mains V V1 5
N(L) P1
S1

3
S10 P1
FE

S7 P1 3
PE

P1

L(N) MD
T2 S9 R

R?eau
Mains V V2
N(L)

S13

Switch position Measured µA

1
S5 S9 S13 Before After2

1 1 1 36.8 37.1
1 1 0 36.8 37.1
1 0 1 37.4 37.7
1 0 0 36.7 37.0
0 1 1 37.5 37.8
0 1 0 37.4 37.7
0 0 1 37.3 37.6
0 0 0 37.3 37.6
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II equipment NC = Normal Conditions 1 = Switch Closed
SFC = Single Fault Condition 0 = Switch Open

Page 62 of 69
Nemko ref. no.:NK-2E-M-054

19.4 h2 APPENDIX 4
Fig. 21 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT P
IEC 60601-1 current with mains voltage on the f- (For Event Mark jack)
type isolated (floating) applied part

1 6
L(N)
T1 S5 P1

R?eau P3
Mains V V1 5
N(L) P1
S1

3
S10 P1
FE

S7 P1 3
PE

P1

L(N) MD
T2 S9 R

R?eau
Mains V V2
N(L)

S13

Switch position Measured µA

1
S5 S9 S13 Before After2

1 1 1 36.4 36.7
1 1 0 36.4 36.7
1 0 1 36.7 37.0
1 0 0 36.7 37.0
0 1 1 36.4 36.7
0 1 0 36.4 36.7
0 0 1 36.7 37.0
0 0 0 36.7 37.0
1 2
and = Before and after humidity preconditioning treatment.
Note: S7 not used for Class II equipment NC = Normal Conditions 1 = Switch Closed
SFC = Single Fault Condition 0 = Switch Open

Page 63 of 69
Nemko ref. no.:NK-2E-M-054

19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient auxiliary FOR MAINS OPERATED EQUIPMENT P
IEC 601-1 current (Probe: Event Mark jack and DOP II)

1
L(N)
T1 P3
S5 P1

R?eau
Mains V 5 MD
N(L) P1
S1

S10 P1
FE

S7 P1
PE

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 34.6 34.9 35.8 36.1 38.2 38.5 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 35.1 35.4 35.5 35.8 38.0 38.3 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 and 2 = Before and after humidity preconditioning treatment.

Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional
equipment SFC = Single Fault 0 = Switch Open SFC according to Sub-
Condition clause 17 a in notes above

Page 64 of 69
Nemko ref. no.:NK-2E-M-054

19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient auxiliary FOR MAINS OPERATED EQUIPMENT P
IEC 601-1 current (Probe: Event Mark jack and UC)

1
L(N)
T1 P3
S5 P1

R?eau
Mains V 5 MD
N(L) P1
S1

S10 P1
FE

S7 P1
PE

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 42.1 42.4 40.6 40.9 47.5 47.8 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 41.1 41.4 40.5 40.8 47.3 47.6 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 and 2 = Before and after humidity preconditioning treatment.

Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional
equipment SFC = Single Fault 0 = Switch Open SFC according to Sub-
Condition clause 17 a in notes above

Page 65 of 69
Nemko ref. no.:NK-2E-M-054

19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient auxiliary FOR MAINS OPERATED EQUIPMENT P
IEC 601-1 current (Probe: Event Mark jack and DOP I)

1
L(N)
T1 P3
S5 P1

R?eau
Mains V 5 MD
N(L) P1
S1

S10 P1
FE

S7 P1
PE

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 36.8 37.1 35.2 35.5 36.4 36.7 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 36.7 37.0 36.8 37.1 37.0 37.3 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 and 2 = Before and after humidity preconditioning treatment.

Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional
equipment SFC = Single Fault 0 = Switch Open SFC according to Sub-
Condition clause 17 a in notes above

Page 66 of 69
Nemko ref. no.:NK-2E-M-054

19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient auxiliary FOR MAINS OPERATED EQUIPMENT P
IEC 601-1 current (Probe: UC and DOP I)

1
L(N)
T1 P3
S5 P1

R?eau
Mains V 5 MD
N(L) P1
S1

S10 P1
FE

S7 P1
PE

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 31.9 32.2 32.0 32.3 34.8 35.1 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 31.5 31.7 32.1 32.3 34.6 34.9 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 and 2 = Before and after humidity preconditioning treatment.

Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional
equipment SFC = Single Fault 0 = Switch Open SFC according to Sub-
Condition clause 17 a in notes above

Page 67 of 69
Nemko ref. no.:NK-2E-M-054

19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient auxiliary FOR MAINS OPERATED EQUIPMENT P
IEC 601-1 current (Probe: UC and DOP II)

1
L(N)
T1 P3
S5 P1

R?eau
Mains V 5 MD
N(L) P1
S1

S10 P1
FE

S7 P1
PE

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 31.5 31.7 32.2 32.5 34.2 34.5 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 31.8 32.1 32.1 32.4 34.3 34.6 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 and 2 = Before and after humidity preconditioning treatment.

Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional
equipment SFC = Single Fault 0 = Switch Open SFC according to Sub-
Condition clause 17 a in notes above

Page 68 of 69
Nemko ref. no.:NK-2E-M-054

19.4 j APPENDIX 6
Fig. 26 in Measurement of the patient auxiliary FOR MAINS OPERATED EQUIPMENT P
IEC 601-1 current (Probe: DOP I and DOP II)

1
L(N)
T1 P3
S5 P1

R?eau
Mains V 5 MD
N(L) P1
S1

S10 P1
FE

S7 P1
PE

Switch position NC SFC SFC Additional SFC*

S1 = 1, S7 = 1 S1 = 0, S7 = 1 S1 = 1, S7 = 0 S1 = 1, S7 = 1
Measured (µA) Measured (µA) Measured (µA) Measured (µA)
S5 Before1 After2 Before1 After2 Before1 After2 Before1 After2
1 28.3 28.6 28.5 28.7 30.6 30.9 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
0 28.1 28.4 28.2 28.5 30.8 31.0 — —
/0.01 /0.01 /0.01 /0.01 /0.01 /0.01
1 and 2 = Before and after humidity preconditioning treatment.

Note: S7 not used for Class II NC = Normal Conditions 1 = Switch Closed * = describe additional
equipment SFC = Single Fault 0 = Switch Open SFC according to Sub-
Condition clause 17 a in notes above

Page 69 of 69
Attachment no. #1.
Photos Nemko ref. no.: NK-2E-M-054

Page 1 of 5
Attachment no. #1.
Photos Nemko ref. no.: NK-2E-M-054

Page 2 of 5
Attachment no. #1.
Photos Nemko ref. no.: NK-2E-M-054

Page 3 of 5
Attachment no. #1.
Photos Nemko ref. no.: NK-2E-M-054

Page 4 of 5
Attachment no. #1.
Photos Nemko ref. no.: NK-2E-M-054

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