SQA-V and QwikCheck Gold Test Report 61010-1

TEST REPORT
IEC 61010-1
Safety requirements for electrical equipment for measurement, control, and
laboratory use
Part 1: General requirements
Report Number. ............................. : S106490.02

Tested by ....................................... : Vladimir Chernikh
Approved by .................................. : Sima Beloborodov
Date of issue.................................. : 27 July 2011
Total number of pages ................... 108
Testing Laboratory........................: I.T.L (PRODUCT TESTING) Ltd.

Address..........................................: 1 Bat-Sheva St., POB 87, Lod 71100, ISRAEL
Applicant’s name ..........................: Medical Electronic Systems Ltd.

Address..........................................: 20 Alon Hatavor St., Caesaria Industrial Park 38900, Israel
Test specification:
Standard.........................................: IEC 61010-1 (Third Edition): 2010 / EN 61010-1 (Third Edition):
2010
Test procedure ..............................: PM120
Non-standard test N/A
method…………..:
Test Report Form No. ...................: IEC61010_1F
Test Report Form(s) Originator ...: VDE Testing and Certification Institute
Master TRF.....................................: 2011-03
Copyright © 2011 Worldwide System for Conformity Testing and Certification of Electrotechnical
Equipment and Components (IECEE), Geneva, Switzerland. All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting
from the reader's interpretation of the reproduced material due to its placement and context.
If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the
CB Scheme procedure shall be removed.
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory
and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.
Test item description .....................: Sperm Quality Analyzer
Trade Mark .....................................: M.E.S
Manufacturer .................................: Same as Applicant
Model/Type reference ...................: SQA-V, QwikCheck Gold
Ratings ...........................................: 100-240VAC, 50-60Hz, 0.5A
TRF No.: IEC 61010_1F Page 1 of 108 TRF originator: VDE

ITL086 V3.2 07/04/2011
Report No. S106490.02
List of Attachments (including a total number of pages in each attachment - Table 1):
Document Documents included / attached to this report (description) Page

No. Numbers
1 S106491.02 - IEC/EN 61010-2-101 test report 17
Test Report History:

This report may consist of more than one report and is valid only with additional or previous issued
reports:
Ref. No. Item
S106490.01, S106491.01 Original Report
S106490.02, S106491.02 Update report, adding model QwikCheck Gold

ITL086 V3.2 07/04/2011
Tests performed (name of test and test Testing location:

clause):
ITL (Product Testing) Ltd.
1 Bat-Sheva St., POB 87, Lod 71100, ISRAEL
SQA-V:
4.4.2.3 Protective Conductor Abnormal
4.4.2.5 Motor Abnormal
4.4.2.10 Cooling Abnormal
5.1.3 Input Test
5.3 Marking Durability Test
6.3 Permissible Limits For Accessible Parts Test
6.5.2.4 Grounding Continuity Test
6.7.2.1 Clearances and Creepage Distances
6.8.3 Dielectric Strength Test
6.10.3 Capacitance Discharge Test
7.4 Stability Test
8.2.1, 8.2.2 Rigidity Test
9.4 Limited Energy Test
10.1-10.3 Temperature Test
10.5.2 Resistance To Heat Of Non-Metallic
Enclosure
QwikCheck Gold:
4.4.2.10 Cooling Abnormal
6.8.3 Dielectric Strength Test
7.4 Stability Test
8.2.1, 8.2.2 Rigidity Test
10.1-10.3 Temperature Test
10.5.2 Resistance To Heat Of Non-Metallic
Enclosure
Summary of compliance with National Differences

List of countries addressed: CH, DK, SE
Explanation of Codes:
CH=Switzerland, DK=Denmark, SE=Sweden
The product fulfils the requirements of _IEC/EN 61010-1:2010________

ITL086 V3.2 07/04/2011
Copy of marking plate

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

ITL086 V3.2 07/04/2011
Test item particulars:
Type of item ................................................................. : Laboratory
Description of equipment function ............................... : Sperm Quality Analyzer
Connection to MAINS supply......................................... : Detachable cord set
Installation category ..................................................... : II
POLLUTION DEGREE ....................................................... : II
Protection class............................................................ : I
Environmental rating .................................................... : Standard
Equipment mobility....................................................... : Movable
Operating conditions.................................................... : Continuous
Overall size of equipment (W x D x H) ........................ : SQA-V: 32 x 30 x 24 cm
QwikCheck Gold: 32 x 24 x 20 cm
Mass of equipment (kg) ............................................... : SQA-V: 7kg
QwikCheck Gold: 4kg
Marked degree of protection to IEC 60529 ................. : IPX0
Possible test case verdicts:
- Test case does not apply to the test object ............... : N/A
- Test object does meet the requirement ..................... : P (Pass)
- Test object does not meet the requirement ............... : F (Fail)
Testing:
Date of receipt of test item............................................ : SQA-V: 04/04/2011
QwikCheck Gold: 21/07/2011
Date (s) of performance of tests................................... : SQA-V: 07/04/2011 to 29/06/2011
QwikCheck Gold: 25/07/2011 to 26/07/2011
General remarks:
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing testing
laboratory.
"(see ENCLOSURE #)" refers to additional information appended to the report.
"(see Form A.xx)" refers to a table appended to the report.
Throughout this report a comma / point is used as the decimal separator.

General product information:
The EUT is a mains powered sperm quality analyzer unit for laboratory use.
SQA-V mainly includes metal enclosure with front plastic panel, a power entry module with IEC 60320
type appliance inlet, integral line filter, 2-Pole switch and 2-Pole fuseholder, a certified power supply, a
certified printer, a SELV motherboard with lithium battery, a high voltage limited current DC/AC inverter for
the backlight, a camera, SELV PCBs, a DC Zoom motor in SELV, a DC fan.
Unit employs SELV Limited Energy RS-232 and video connections.
QwikCheck Gold is a partial version of SQA-V. QwikCheck Gold does not incorporate printer and DC
Zoom motor. QwikCheck Gold incorporates different enclosure, different type of DC fan and different
plastic of enclosure. Unless specified otherwise testing on model SQA-V represented testing on model
QwikCheck Gold.

ITL086 V3.2 07/04/2011
Table 1: List of Test equipment
ITL Instrument Manufacturer Model Serial CalDue

1040 DVM Fluke 87 60370049 28/02/2012
1147 Digital Oscilloscope Tektronix TDS3012 B015205 24/02/2012
1026 Climatic Chamber Russels RD-16-1 10921274 NCR
1217 Hipot Hipotronics HD-100 380301 07/12/2011
1010 Force Gauge Chatillon DPP 25 17706 26/04/2012
1302 Digital Thermometer Fluke Hydra2635A 7702039 22/02/2012
Leakage Current – 23/02/2012
1135 EN60950 Custom Custom 1085
1335 Caliper Dial 0-150mm Motitoyo 505-646-50 01-051 20/03/2012
1015 Ball for Impact Test Ergonomics ITB15 20/03/2012
1215 Digital Power Analyzer Valhalla Scientific 2110A 33-407 23/02/2012

ITL086 V3.2 07/04/2011
Table 3. List of Critical Components.
manufacturer/ mark(s) of
object/part no. type/model technical data standard
trademark conformity
Power Entry Schurter or CD24.1101.151 Rated: 110/250VAC, 50- EN133200 VDE
Module w/Integral equivalent (former FKSP2- 60Hz, 2A UL1283 UR (E72928)
Appliance Inlet, 55-2/I) Cx: 1x68nF X2
Line Filter, Double CSA C22.2
Pole Switch, Cy: 2x2.2nF No. 8
Double Pole
Fuseholder
Fuse in PEM Schurter or FSF Series Rated: 250V, 1A IEC/EN60127- SEV, VDE
above (2 equivalent P/N 0034.1516 1, -2
Provided, In Line UL248-14
and Neutral) UR (E41599)
CSA C22.2
No. 248.14
Mains Wiring Any Any Rated: 300V, VW-1, UL758 UR
105°C
Switching Power Mean Well RPT-60B Rated Input: 100- IEC60601- TUV
Supply 240VAC, 50/60Hz, 1.4- 1+A1+A2
0.9A EN60601-
Rated Output: 1+A1+A2+A13
+5VDC/4A, UL/CSA
60950-1 UR (E227340)
+12VDC/2A,
-12VDC/0.5A
Max. ambient 50°C
Isolating Sheet Formex or Formex GK-17 Min. thickness: 0.4mm UL746C UR (E121855)
below power equivalent Rated: VTM-0
supply
Printer in SELV, Citizen CBM-920II-40 Rated: 5VDC, 2.5A EN60950:200 TUV SUD
employed only in 6+A11:2009
model SQA-V, not UL/CSA60950 UR
employed in -1
QwikCheck Gold
Lithium Battery on Panasonic or CR-2032 Rated: 3VDC UL1642 UR (MH12210)
Motherboard equivalent Max. abnormal charging
current 10mA
Protection Circuit: IC U10
(DS1307)
Battery Protective Dallas or DS1307 Provides protection UL60950 UR (E99151)
Device U10 equivalent against reverse charging
(Protection current
against reverse
charging current)
DC motor in Hsiang Neng HN-GH12- Rated: 12VDC, 0.26A Evaluated in
SELV (Zoom), 1045Y appliance
employed only in
model SQA-V, not
employed in
QwikCheck Gold

ITL086 V3.2 07/04/2011
manufacturer/ mark(s) of
object/part no. type/model technical data standard
trademark conformity
PCB Any Any Rated: V-0, min. 105°C UR
Wiring Any Any Rated: VW-1, min. 60°C UL758 UR
PVC, TFE, PTFE,
Neoprene or Polyamide
Plastic of Polyram PBB503 Rated: V-0 for min. Evaluated in
Enclosure, thickness 3.0mm appliance
employed only in Thickness in the
model SQA-V, not appliance 3.4mm
employed in
QwikCheck Gold
Plastic of Elastogran Elastolit K Rated: 5VA for min. UL94, UL796 UR (E123445)
Enclosure, 4900/LT/FR thickness 4.0mm
employed only in Thickness in the
model QwikCheck appliance 3.4mm
Gold, not
employed in
SQA-V
Inverter for TDK-Lambda CXA-L10L Rated Input: 12VDC Evaluated in
Backlight Rated Output: 300Vrms appliance
DC Fan, Sunonwealth or KDE1209PTV3 Rated: 12VDC, 1.3W, UL507 UR (E77551)

employed only in equivalent min. 39 CFM EN60950-1 TUV
model SQA-V, not
employed in
QwikCheck Gold
DC Fan, Sunonwealth or KDE1209PTV3 Rated: 12VDC, 1.3W, UL507 UR (E77551)
employed only in equivalent min. 39 CFM EN60950-1 TUV
model QwikCheck
Gold, not
employed in
SQA-V
Alternate DC Fan, Sunonwealth or ME92251V3 Rated: 12VDC, 1.3W, UL507 UR (E77551)
employed only in equivalent min. 39.5 CFM EN60950-1 TUV
model QwikCheck
Gold, not
employed in
SQA-V

ITL086 V3.2 07/04/2011
4.4 Testing in SINGLE FAULT CONDITIONS P
4.4.1 Fault tests (see Form A.1 and A.2) P
4.4.2 Application of SINGLE FAULT CONDITIONS P
4.4.2.1 SINGLE FAULT CONDITIONS not covered by 4.4.2.1 to (see Form A.1 and A.2) —
4.4.2.14
4.4.2.2 PROTECTIVE IMPEDANCE No protective impedance N/A
4.4.2.3 PROTECTIVE CONDUCTOR Protective conductor was P
disconnected. Voltage limits
exceeded permissible limits,
current limits did not exceed
permissible limits for accessible
parts (see Form A.1 and A.2)
4.4.2.4 Equipment or parts for short-term or intermittent No such unit N/A
operation
4.4.2.5 Motors DC motor was locked, see P
Form A.1 and A.2
4.4.2.6 Capacitors No such parts N/A
4.4.2.7 MAINS transformers Part of certified power supply N/A
4.4.2.7.2 Short circuit Part of certified power supply N/A
4.4.2.7.3 Overload Part of certified power supply N/A
4.4.2.8 Outputs Only inherently Limited Energy N/A
signal/data ports provided (RS-
232 and video), test waived
4.4.2.9 Equipment for more than one supply One supply N/A
4.4.2.10 Cooling Blocked vents, disconnected P
fan tests performed (see Form
A.1 and A.2)
4.4.2.11 Heating devices N/A
4.4.2.12 Insulation between circuits and parts N/A
4.4.2.13 Interlocks N/A
4.4.2.14 Voltage selectors N/A
4.4.3 Duration of tests (see Form A.1 and A.2) P
4.4.4 Conformity after application of fault conditions Permissible limits, hi-pot pass P
(see Form A.1; A.2; A.8, A.14)
5 MARKING AND DOCUMENTATION P

5.1.1 General P
Required equipment markings are: —
visible: P
From the exterior; or P
After removing a cover; or No such covers N/A
Opening a door No such doors N/A
After removal from a rack or panel No rack mounted unit N/A

ITL086 V3.2 07/04/2011
Not put on parts which can be removed by an Not put on parts which can be P
operator removed by an operator
Letter symbols (IEC 60027) used V, A, Hz P
Graphic symbols (IEC 61010-1: Table 1) used Not used N/A
5.1.2 Identification —
Equipment is identified by: P
a) Manufacturer’s or supplier’s name or Trademark and manufacturer P
trademark name marked
b) Model number, name or other means Model name marked P
Manufacturing location identified Not required: unit is N/A
manufactured at one location
5.1.3 MAINS supply P
Equipment is marked as follows: P
a) Nature of supply: Marked VAC —
1) a.c. RATED MAINS frequency or range Marked 50-60Hz P
of
frequencies.................................................. :
2) d.c. with symbol 1 N/A
b) RATED supply voltage(s) or range..................... : Marked 100-240VAC P
c) Max. RATED power (W or VA) or input current ... : Marked 0.5A P
The marked value not less than 90 % of the (see Form A.3) P
maximum value
If more than one voltage range: —
Separate values marked; or One range N/A
Values differ by less than 20 % N/A
d) OPERATOR-set for different RATED supply No operator set, voltage is —
voltages: automatically selectable
Indicates the equipment set voltage N/A
Portable equipment indication is visible from the N/A
exterior
Changing the setting changes the indication N/A
e) Accessory MAINS socket-outlets accepting No mains socket outlets N/A
standard MAINS plugs are marked:
With the voltage if it is different from the MAINS No mains socket outlets N/A
supply voltage ................................................... :
For use only with specific equipment No mains socket outlets N/A
If not marked for specific equipment it is marked No mains socket outlets N/A
with:
The maximum rated current or power; or No mains socket outlets N/A
Symbol 14 with full details in the documentation No mains socket outlets N/A
5.1.4 Fuses P
Operator replaceable fuse marking Fuseholder is marked with the P
(see also 5.4.5) ........................................................ : fuse rating 1A 250V

ITL086 V3.2 07/04/2011
5.1.5 TERMINALS, connections and operating devices No such devices affecting N/A
safety
5.1.5.1 General N/A
Where necessary for safety, indication of purpose N/A
of TERMINALS, connectors, controls and indicators
marked
If insufficient space, symbol 14 used N/A
Push-buttons and actuators of emergency stop —
devices and indicators:
used only to indicate a warning of danger or N/A
the need for urgent action N/A
coloured red N/A
coded as specified in IEC 60073 N/A
Supplementary means of coding provided, if N/A
meaning of colour relates (see IEC 60073):
to safety of persons; or N/A
safety of the environment N/A
5.1.5.2 TERMINALS No terminals, appliance inlet P
used
MAINS supply TERMINAL identified N/A
Other TERMINAL marking: N/A
a) FUNCTIONAL EARTH TERMINALS (symbol 5 N/A
used)
b) PROTECTIVE CONDUCTOR TERMINALS: N/A
Symbol 6 is placed close to or on the TERMINAL; N/A
or
Part of appliance inlet No symbol required, appliance P
inlet used
c) TERMINALS of control circuits (symbol 7 N/A
used)
d) HAZARDOUS LIVE TERMINALS supplied from N/A
the interior
Standard MAINS socket outlet; or N/A
RATINGS marked; or N/A
Symbol 14 used N/A
5.1.6 Switches and circuit breakers P
If disconnecting device, off position clearly marked Although mains switch not P
regarded disconnect device, it
is marked with OFF and ON
position
If push-button used as power supply switch: No such switch N/A
Symbol 9 and 15 used for on-position N/A
Symbol 10 and 16 used for off-position N/A
Pair of symbols 9, 15 and 10, 16 close together N/A

ITL086 V3.2 07/04/2011
5.1.7 Equipment protected by DOUBLE INSULATION or N/A
REINFORCED INSULATION
Protected throughout (symbol 11 used) N/A

Only partially protected (symbol 11 not used) Only partially protected N/A
(symbol 11 not used)
5.1.8 Field-wiring TERMINAL boxes No such parts N/A
If TERMINAL or ENCLOSURE exceeds 60 °C: N/A
Cable temperature RATING marked ....................... : N/A
Marking visible before and during connection or N/A
beside TERMINAL
5.2 Warning markings No warning markings provided N/A
or required
Visible when ready for NORMAL USE N/A
Are near or on applicable parts N/A
Symbols and text correct dimensions and colour: —
a) symbols min 2,75 mm and text 1,5 mm high N/A
and contrasting in colour with background
b) symbols and text moulded, stamped or N/A
engraved in material min. 2,0 mm high and
0.5 mm depth or raised if not contrasting in N/A
colour
If necessary marked with symbol 14 N/A
Statement to isolate or disconnect if access by N/A
using a tool to HAZARDOUS LIVE parts is permitted
5.3 Durability of markings Markings are durable and P
legible
The required markings remain clear and legible in (see Form A.4) P
NORMAL USE
5.4 Documentation P
5.4.1 General P
Equipment is accompanied by documentation for P
safety purposes for OPERATOR or RESPONSIBLE BODY
Safety documentation for service personnel Not intended for special N/A
authorized by the manufacturer servicing
Documentation necessary for safe operation is Printed media provided P
provided in printed media or
in electronic media if available at any time Per request P
Documentation includes: —
a) intended use P
b) technical specification P
c) name and address of manufacturer or P
supplier
d) Information specified in 5.4.2 to 5.4.6 P
e) information to mitigate residual RISK No residual risks P
(see also subclause 17)

ITL086 V3.2 07/04/2011
f) accessories for safe operation of the No such accessories N/A
equipment specified
g) guidance provided to check correct function No such hazard N/A
of the equipment, if incorrect reading may
cause a HAZARD from harmful or corrosive
substances of HAZARDOUS live parts
h) instructions for lifting and carrying Deemed not required N/A
Warning statements and a clear explanation of No warning symbols —
warning symbols:
Provided in the documentation; or N/A
Information is marked on the equipment N/A
5.4.2 Equipment ratings P
Documentation includes: —
a) Supply voltage or voltage range .......................: Provided P
Frequency or frequency range....................... : Provided P
Power or current rating .................................. : Provided P
b) Description of all input and output Provided P
connections in accordance to 6.6.1 a)
c) RATING of insulation of external circuits in Deemed not required: external N/A
accordance to 6.6.1 b) circuits are SELV
a) Statement of the range of environmental Provided: Unit is intended for
conditions (see 1.4) indoor use, maximum
recommended operating
ambient 38degC, max. altitude
2000m, max. RH 80% for
temperatures of up to 31degC
decreasing linearly to 50% at
40degC, mains supply
fluctuations ±10%,
Overvoltage Category II,
Pollution Degree II
d) Degree of protection (IEC 60529) IPX0 N/A
e) if impact rating less than 5 J: No impact rating less than 5 J N/A
IK code in accordance to IEC 62262 marked or N/A
symbol 14 of table 1 marked, with N/A
RATED energy level and test method stated N/A
5.4.3 Equipment installation No special installation N/A
instructions deemed required
Documentation includes instructions for: N/A
a) assembly, location and mounting N/A
requirements
b) protective earthing N/A
c) connections to supply N/A
d) permanently connected equipment: N/A
1) Supply wiring requirements N/A
2) If external switch or circuit-breaker, N/A
requirements and location recommendation

ITL086 V3.2 07/04/2011
e) ventilation requirements No special requirements N/A
f) special services (e. g. air, cooling liquid) No special requirements N/A
g) Instructions relating to sound level Unit does not produce sound N/A
5.4.4 Equipment operation P
Instructions for use include: P
a) identification and description of operating P
controls
b) positioning for disconnection Positioning for disconnection P
is self-evident
c) instructions for interconnection P
d) specification of intermittent operation limits N/A
e) explanation of symbols used No symbols N/A
f) replacement of consumable materials Instructions regarding P
replacement of the printer
paper and toner provided
g) cleaning and decontamination Cleaning instructions provided P
(not affecting safety)
h) Listing of any poisonous or injurious gases No such gases N/A
and quantities
i) RISKreduction procedures relating to No flammable liquids N/A
flammable liquids (see 9.5)
j) RISKreduction procedures relating burn from No heated surfaces N/A
surfaces permitted to exceed limits of 10.1
Additional precautions for IEC 60950 conforming No hazard related to moistures N/A
equipment in regard to moistures and liquids and liquids
A statement about protection impairment if used in Provided P
a manner not specified by the manufacturer
5.4.5 Equipment maintenance P
Instructions for RESPONSIBLE BODY include: —
Instructions sufficient in detail permitting safe P
maintenance and inspection and continued safety:
Instruction against the use of detachable MAINS Cord is not part of investigation N/A
supply cord with inadequate rating
Specific battery type of user replaceable batteries Provided P
Any manufacturer specified parts P
Rating and characteristics of fuses Rating of mains fuse provided P
Instructions include following subjects permitting safe No such risks N/A
servicing and continued safety:
a) product specific RISKS may affect service N/A
personnel
b) protective measures for these RISKS N/A
c) verification of the safe state after repair N/A
5.4.6 Integration into systems or effects resulting from No such hazards N/A
special conditions
Aspects described in documentation N/A

ITL086 V3.2 07/04/2011
6 PROTECTION AGAINST ELECTRIC SHOCK P

6.1 General (see Form A.5) P
6.1.1 Requirements —
Protection against electric shock maintained in P
NORMAL CONDITION and SINGLE FAULT CONDITION
ACCESSIBLE parts not HAZARDOUS LIVE P
Voltage, current, charge or energy below the limits in —
NORMAL CONDITION and in SINGLE FAULT CONDITION
between:
ACCESSIBLE parts and earth P
two ACCESSIBLE parts on same piece of the P
equipment within a distance of 1,8 m
Conformity is checked by the determination of 6.2 P
and 6.3 followed by the tests of 6.4 to 6.11
6.1.2 Exceptions No exceptions N/A
Following HAZARDOUS LIVE parts may be accessible to No exceptions N/A
an OPERATOR:
a) parts of lamps and lamp sockets after lamp No exceptions N/A
removal
b) parts to be replaced by operator only by the No exceptions N/A
use of tool and warning marking
Those parts not HAZARDOUS LIVE 10 s after No exceptions N/A
interruption of supply
Capacitance test if charge is received from internal N/A
capacitor
6.2 Determination of accessible parts (see Form A.6) P
6.2.1 General Only plastic parts of enclosure, P
earthed metal enclosure and
SELV circuits are operator
accessible
Unless obviously determination of accessible parts Determination is obvious N/A
as specified in 6.2.2 to 6.2.4
6.2.2 Examination Determination is obvious N/A
- with jointed test finger (as specified B.2) Determination is obvious N/A
- with rigid test finger (as specified B.1) and a force of Determination is obvious N/A
10 N
6.2.4 Openings above parts that are HAZARDOUS LIVE No such openings N/A
- test pin with length of 100 mm and 4 mm in N/A
diameter applied
6.2.4 Openings for pre-set controls No such openings N/A
- test pin with length of 100 mm and 4 mm in No such openings N/A
diameter applied
6.3 Limit values for ACCESSIBLE parts P
6.3.1 Levels in NORMAL CONDITION (see Form A.7) P

ITL086 V3.2 07/04/2011
a) Voltage limits less than 33 V r.m.s. and 46,7 Accessible enclosure voltage P
V peak or 70 V d.c. limits less than 33 V r.m.s. and
46,7 V peak or 70 V d.c.
Inverter output voltage
exceeds 33 V r.m.s. and 46,7
V peak, see Form A.6
for wet locations voltage limits less than 16 V N/A
r.m.s. and 22,6 V peak or 35 V d.c.
Voltages are not HAZARDOUS LIVE the levels of: —
b) Current less than 0,5 mA r.m.s. for Inverter output current is less P
sinusoidal, 0,7 mA peak non sinusoidal or than 0,5 mA r.m.s. for
mixed frequencies or 2 mA d.c. when sinusoidal, 0,7 mA peak non
measured with measuring circuit A.1 or A.2 if sinusoidal or mixed
less than 100 Hz frequencies or 2 mA d.c. when
measured with measuring
circuit A.1, see Form A.6
for wet locations measuring circuit A.4 used N/A
or N/A
c) Levels of capacitive charge or energy less: N/A
1) 45 µC for voltages up to 15 kV peak or d.c. or N/A
line A of Figure 3
2) 350 mJ stored energy for voltages above 15 N/A
kV peak or d.c.
6.3.2 Levels in SINGLE FAULT CONDITION (see Form A.7) P
a) Voltage limits less than 33 V r.m.s. and 46,7 Enclosure voltages exceed 33 N/A
V peak or 70 V d.c. V r.m.s. and 46,7 V peak when
PE conductor is disconnected
for wet locations voltage limits less than 16 V N/A
r.m.s. and 22,6 V peak or 35 V d.c.
Voltages are not HAZARDOUS LIVE the levels of: —
b) Current less than 0,5 mA r.m.s. for Enclosure (earth) leakage P
sinusoidal, 0,7 mA peak non sinusoidal or current does not exceed 0,5
mixed frequencies or 2 mA d.c. when mA r.m.s. for sinusoidal, 0,7
measured with measuring circuit A.1 or A.2 if mA peak non sinusoidal or
less than 100 Hz mixed frequencies or 2 mA d.c.
when measured with
measuring circuit A.1
for wet locations measuring circuit A.4 used N/A
or N/A
c) Levels of capacitive charge or energy less: No stored capacitance N/A
1) 45 µC for voltages up to 15 kV peak or d.c. or N/A
line A of Figure 3
2) 350 mJ stored energy for voltages above 15 N/A
kV peak or d.c.
6.4 Primary means of protection P
6.4.1 ACCESSIBLE parts prevented from being HAZARDOUS P
LIVE by one or more of following means:

ITL086 V3.2 07/04/2011
a) ENCLOSURES or PROTECTIVE BARRIERS (see Plastic enclosure (barrier) P
6.4.2) prevents access to hazardous
parts
b) BASIC INSULATION (see 6.4.3) Basic insulation is provided P
between primary and metal
enclosure
c) Impedance (see 6.4.4) Not used N/A
6.4.2 ENCLOSURES or PROTECTIVE BARRIERS Plastic enclosure (barrier) P
prevents access to hazardous
parts
- meet rigidity requirements of 8.1 P
- meet requirements for BASIC INSULATION, if P
protection is provided by insulation
- meet requirements of 6.7 for CREEPAGE and Plastic enclosure (barrier) P
CLEARANCES between ACCESSIBLE parts and prevents access to hazardous
HAZARDOUS live parts, if protection is provided by parts. Clearances between
limited access primary and external / internal
(coated by conductive material)
surfaces comply with the
requirements for clearances
and creepage distances for
Reinforced Insulation for mains
circuit
6.4.3 BASIC INSULATION Provided between mains and P
metal safety earthed enclosure
(see Form A.13)
- meet CLEARANCE, CREEPAGE DISTANCE and solid P
insulation requirements of 6.7
6.4.4 Impedance Not employed N/A
Impedance used as primary means of protection —
meets all of following requirements:
a) limits current or voltage to level of 6.3.2 N/A
b) RATED for maximum WORKING VOLTAGE and N/A
the amount of power it will dissipate
c) CLEARANCE, CREEPAGE DISTANCE between N/A
terminations of the impedance meet
requirements of BASIC INSULATION of 6.7
6.5 Additional means of protection in case of SINGLE FAULT CONDITION P
6.5.1 ACCESSIBLE parts are prevented from becoming P
HAZARDOUS live by the primary means of protection
and supplemented by one of:
a) PROTECTIVE BONDING (see 6.5.2) Metal parts of enclosure are P
separated from primary by
Basic insulation and bonded to
PE terminal
b) SUPPLEMENTARY INSULATION (see 6.5.3) Part of certified power supply P
(Double or Reinforced
insulation is provided between
primary and SELV)
c) automatic disconnection of the supply (see Not used N/A
6.5.5)

ITL086 V3.2 07/04/2011
d) current- or voltage-limiting device (see 6.5.6) Not used N/A
Alternatively one of the single means of protection is Not used N/A
used:
e) REINFORCED INSULATION (see 6.5.3) Part of certified power supply P
(Double or Reinforced
insulation is provided between
primary and SELV). In addition,
Clearances between primary
and external / internal (coated
by conductive material)
surfaces comply with the
requirements for clearances
and creepage distances for
Reinforced Insulation for mains
circuit
f) PROTECTIVE IMPEDANCE (see 6.5.4) N/A
6.5.2 PROTECTIVE BONDING (see Form A.9, A.10 and A.11) P
6.5.2.1 ACCESSIBLE conductive parts, may become P
HARZARDOUS LIVE in SINGLE FAULT CONDITION:
Bonded to the PROTECTIVE CONDUCTOR TERMINAL; or P

Separated by conductive screen or barrier bonded to N/A
PROTECTIVE CONDUCTOR TERMINAL
6.5.2.2 Integrity of PROTECTIVE BONDING P

a) PROTECTIVE BONDING consists of directly P
connected structural parts or discrete
conductors or both; and withstands thermal
and dynamic stresses
b) Soldered connections: No soldered connections used N/A
for bonding
Independently secured against loosening N/A
Not used for other purposes N/A
c) Screw connections are secured Screw (nut) connections are P
secured by washers
d) PROTECTIVE BONDING not interrupted; or P
exempted as removable part carries MAINS SUPPLY P
INPUT connection
e) Any moveable PROTECTIVE BONDING No moveable connection N/A

connection specifically designed, and meets
6.5.2.4
f) No external metal braid of cables used No external metal braid of P
(not regarded as PROTECTIVE BONDING) cables used
g) IF MAINS SUPPLY PASSES THROUGH: Mains does not pass through N/A
Means provided for passing protective conductor; N/A
Impedance meets 6.5.2.4 N/A
h) Protective conductors bare or insulated, Green yellow color is used for P
if insulated, green/yellow protective bonding
Exceptions: Not applied N/A
1) earthing braids; N/A

ITL086 V3.2 07/04/2011
2) internal protective conductors etc.; N/A
Green/yellow not used for other purposes Green/yellow not used for other P
purposes
TERMINAL suitable for connection of a PROTECTIVE Appliance inlet used P
CONDUCTOR, and meets 6.5.2.3
6.5.2.3 PROTECTIVE CONDUCTOR TERMINAL Earthing pin of IEC 60320 type P

appliance inlet (part of certified
power entry module) used
a) Contact surfaces are metal P
b) Appliance inlet used P
c) For rewirable cords and PERMANENTLY N/A
CONNECTED EQUIPMENT, PROTECTIVE
CONDUCTOR TERMINAL is close to MAINS
supply TERMINALS
d) If no MAINS supply is required, any Mains powered N/A
PROTECTIVE CONDUCTOR TERMINAL:
Is near terminals of circuit for which protective N/A

earthing is necessary
External if other terminals external N/A
e) Equivalent current-carrying capacity to P
MAINS supply TERMINALS
f) If plug-in, makes first and breaks last Provided by IEC 60320 type P
appliance inlet
g) If also used for other bonding purposes, Not used for other bonding N/A
protective conductor: purposes
Applied first; N/A
Secured independently; N/A
Unlikely to be removed by servicing N/A
h) PROTECTIVE CONDUCTOR of measuring No measuring circuit N/A
circuit:
1) Current RATING equivalent to N/A
measuring circuit TERMINAL;
2) PROTECTIVE BONDING: N/A
Not interrupted; or N/A
i) FUNCTIONAL EARTH TERMINALS allow No functional earth terminals N/A
independent connection
j) If a binding screw used for PROTECTIVE Not used N/A
CONDUCTOR TERMINAL:
Suitable size for bond wire N/A

Not smaller than M 4 (No. 6) N/A
At least 3 turns of screw engaged N/A
Passes tightening torque test N/A
k) Contact pressure not capable being reduced Contact pressure not capable P
by deformation of materials being reduced by deformation
of materials

ITL086 V3.2 07/04/2011
6.5.2.4 Impedance of PROTECTIVE BONDING of plug- Impedance of PROTECTIVE P
connected equipment BONDING does not exceed 0.1
Ohm when tested at 25A
applied for 1min. (see Form
A.10)
Impedance between PROTECTIVE CONDUCTOR —
TERMINAL and each ACCESSIBLE part where
PROTECTIVE BONDING is specified, is:
less than 0,1 Ohm; or P

less than 0,2 Ohm if equipment is provided with Detachable cord N/A
non detachable cord
6.5.2.5 Bonding impedance of PERMANENTLY CONNECTED N/A
EQUIPMENT
6.5.2.6 Transformer PROTECTIVE BONDING screen N/A

Transformer provided with screen for protective N/A
bonding:
screen bonding consists of directly connected N/A
structural parts or discrete conductors or both;
and withstands thermal and dynamic stresses
(see 6.5.2.2 a )
screen bonding with soldered connection (see N/A
6.5.2.2 b ) is:
- Independently secured against loosening N/A
- Not used for other purposes N/A
6.5.3 SUPPLEMENTARY and REINFORCED INSULATION SELV and plastic enclosure P
with internal conductive coating
are separated from primary by
Reinforced insulation
(additionally evaluated as part
of certified power supply)
- meet CLEARANCE, CREEPAGE DISTANCE and solid P
insulation requirements of 6.7
6.5.4 PROTECTIVE IMPEDANCE Not used N/A
Limits current or voltage to level of 6.3.1 in NORMAL N/A
and to level of 6.3.2 in SINGLE FAULT CONDITION
CLEARANCE, CREEPAGE DISTANCE between N/A
terminations of the impedance meet requirements of
DOUBLE or REINFORCED INSULATION of 6.7
The protective impedance consists of one or more of —

the following:
a) appropriate single component suitable for N/A
safety and reliability for protection, it is:
1) RATED twice the maximum WORKING VOLTAGE N/A
2) resistor RATED for twice the power dissipation N/A
for maximum WORKING VOLTAGE
b) combination of components N/A
Single electronic device not used as PROTECTIVE N/A
IMPEDANCE

ITL086 V3.2 07/04/2011
6.5.5 Automatic disconnection of the supply Not used N/A
a) RATED to disconnect the load within time N/A
specified in Figure 2
b) RATED for the maximum load conditions of N/A
the equipment
6.5.6 Current- or voltage limiting devices Not used N/A
Device complies with all of: N/A
a) RATED to limit the current or voltage to the N/A
level of 6.3.2
b) RATED for the maximum working voltage; and N/A
RATED for the maximum operational current if N/A
applicable
c) CLEARANCE, CREEPAGE DISTANCE between N/A
terminations of the impedance meet
requirements of SUPPLEMENTARY INSULATION
of 6.7
6.6 Connections to external circuits RS-232 and video (both SELV, P
limited energy) ports provided
6.6.1 Connections do not cause ACCESSIBLE parts of the Unit employs RS-232 and P
following to become HAZARDOUS LIVE in NORMAL video (both SELV, limited
CONDITION or SINGLE FAULT CONDITION: energy) ports, originated from
SELV outputs of the certified
power supply, intended for
interconnection with external
SELV circuits. No electrical
shock hazard can arise
- the external circuits As above P
- the equipment As above P
Protection achieved by separation of circuits; or As above P
short circuit of separation does not cause a HAZARD As above P
Instructions or markings for each terminal include: As above N/A
a) RATED conditions for TERMINAL As above N/A
b) Required RATING of external circuit As above N/A
INSULATION
6.6.2 TERMINALS for external circuits N/A

TERMINALS which receive a charge from an internal No such terminals N/A
capacitor are not HAZARDOUS LIVE after 10 s of
interrupting supply connection
6.6.3 Circuits with terminals which are HAZARDOUS LIVE No such external circuits N/A
These circuits are: N/A
Not connected to ACCESSIBLE conductive parts; or N/A
Connected to ACCESSIBLE conductive parts, but are N/A
not MAINS circuits and have one TERMINAL contact at
earth potential
No ACCESSIBLE conductive parts are HAZARDOUS LIVE N/A
6.6.4 ACCESSIBLE terminals for stranded conductors No such terminals N/A

ITL086 V3.2 07/04/2011
No RISK of accidental contact because: N/A
Located or shielded N/A
Self-evident or marked whether or not connected N/A
to ACCESSIBLE conductive parts
ACCESSIBLE TERMINALS will not work loose N/A
6.7 Insulation requirements (see Form A.5) P
6.7.1 The nature of insulation P
6.7.1.1 Insulation between ACCESSIBLE parts or between Level of insulation, working P
separate circuits consist of CLEARANCES, CREEPAGE voltage, transient overvoltage,
DISTANCES and solid insulation if provided as pollution degree considered
protection against a HAZARD
6.7.1.2 CLEARANCES P
Required CLEARANCES reflecting factors of 6.7.1.1 6.7.1.1 a) to d) and rated P
altitude considered.
Multiplication factor considered
1.00 for altitude up to 2000m
Equipment rated for operating altitude greater than No such case N/A
2000 m correction factor of Table 3 of 61010-1
applied
6.7.1.3 CREEPAGE DISTANCES 6.7.1.1 a) to d) and CTI of the P
insulating material considered
Required CLEARANCES reflecting factors of 6.7.1.1 (see Form A.5) P
CTI material group reflected by requirements P
CTI test performed Material group IIIa assumed for N/A
PCB and IIIb for other materials
6.7.1.4 Solid insulation 6.7.1.1 a) to d) considered P
Required CLEARANCES reflecting factors of 6.7.1.1 (see Form A.5) P
6.7.1.5 Requirements for insulation according to type of (see Form A.5) P
circuit
a) 6.7.2 MAINS circuits of OVERVOLTAGE Applied P
CATEGORY II up to nominal supply voltage of
300 V
b) 6.7.3 Secondary circuits separated from No such case N/A
circuits defined in a) by transformer
c) K.1 MAINS circuits of OVERVOLTAGE CATEGORY No such case N/A
III and IV or OVERVOLTAGE CATEGORY II over
300 V
d) K.2 Secondary circuits separated from No such case N/A
circuits defined in a) by transformer
e) K.3 Circuits having one or more of: No such case N/A
1) maximum TRANSIENT OVERVOLTAGE is limited to No such case N/A
known level below the level of MAINS CIRCUIT
2) maximum TRANSIENT OVERVOLTAGE above the No such case N/A
level of MAINS CIRCUIT
3) WORKING VOLTAGE is the sum of more than one No such case N/A
circuit or a mixed voltage

ITL086 V3.2 07/04/2011
4) WORKING VOLTAGE includes recurring peak Part of certified power supply N/A
voltage, may include non-sinusoidal or non-
periodic waveform
5) WORKING VOLTAGE with a frequency above No such case N/A
30 kHz
6.7.2 Insulation for MAINS CIRCUITS of OVERVOLTAGE P
CATEGORY II with a nominal supply voltage up to
300 V
6.7.2.1 CLEARANCES and CREEPAGE DISTANCES Clearance between primary P
and ground, enclosure
considered, Table 4 was used
(see Form A.13)
Values for MAINS CIRCUITS of table 4 are met P
Coatings to achieve reduction to POLLUTION DEGREE I No coatings N/A
comply with requirements of Annex H
6.7.2.2 Solid insulation P
6.7.2.2.1 Withstands electrical and mechanical stresses in P
normal use and all RATED environmental conditions of
1.4
Equipment passed voltage tests of 6.8.3 with values (see Form A.14) P
of Table 5
Complies as applicable: P
a) ENCLOSURE or PROTECTIVE BARRIER Clause 8 Plastic of enclosure complies P
with the rigidity requirements of
Clause 8
b) moulded and potted parts requirements of Part of certified power supply N/A
6.7.2.2.2
c) inner layers of printed wiring boards Part of certified power supply N/A
requirements of 6.7.2.2.3
d) thin-film insulation requirements of 6.7.2.2.4 Part of certified power supply N/A
6.7.2.2.2 Moulded and potted parts Part of certified power supply N/A
Conductors between same two layers are separated Part of certified power supply N/A
by at least 0,4 mm after moulding is completed
6.7.2.2.3 Inner insulation layers of printed wiring boards Part of certified power supply N/A
Separated by at least 0,4 mm between same two Part of certified power supply N/A
layers
REINFORCED INSULATION have adequate electric Part of certified power supply N/A
strength; one of following methods used:
a) thickness at least 0,4 mm Part of certified power supply N/A
b) insulation is assembled of minimum two Part of certified power supply N/A
separate layers, each RATED for test voltage
of Table 5 for BASIC INSULATION
c) insulation is assembled of minimum two Part of certified power supply N/A
separate layers, where the combination is
rated for test voltage of Table 5 for
REINFORCED INSULATION
6.7.2.2.4 Thin-film insulation Part of certified power supply N/A

ITL086 V3.2 07/04/2011
Conductors between same two layers are separated Part of certified power supply N/A
by applicable CLEARANCES and CREEPAGE DISTANCES
REINFORCED INSULATION have adequate electric Part of certified power supply N/A
a) thickness at least 0,4 mm Part of certified power supply N/A
b) insulation is assembled of min two separate Part of certified power supply N/A
layers, each RATED for test voltage of Table 5
for BASIC INSULATION
c) insulation is assembled of min three Part of certified power supply N/A
separate layers, where the combination of
two layers passed voltage tests of 6.8.3 with
values of Table 5 for REINFORCED INSULATION
6.7.3 Insulation for secondary circuits derived from MAINS No such insulation relied upon N/A
of OVERVOLTAGE CATEGORY II up to 300 V
6.7.3.1 Secondary circuits where separation from MAINS —
CIRCUITS is achieved by a transformer providing:
- REINFORCED INSULATION No such insulation relied upon N/A

- DOUBLE INSULATION No such insulation relied upon N/A
- screen connected to the PROTECTIVE CONDUCTOR No such insulation relied upon N/A
TERMINAL
6.7.3.2 CLEARANCES No such insulation relied upon N/A

a) meet the values of Table 6 for BASIC No such insulation relied upon N/A
INSULATION and SUPPLEMENTARY INSULATION;
or
twice the values of Table 6 for REINFORCED No such insulation relied upon N/A
INSULATION
or No such insulation relied upon N/A

b) pass the voltage tests of 6.8 with values of No such insulation relied upon N/A
Table 6; with following adjustments:
1) values for REINFORCED INSULATION are 1,6 No such insulation relied upon N/A
times the values for BASIC INSULATION
2) if operating altitude is greater than 2000 m No such insulation relied upon N/A
values of CLEARANCES multiplied with factor of
Table 3
3) minimum CLEARANCE is 0,2 mm for POLLUTION No such insulation relied upon N/A
DEGREE 2 and 0,8 mm for POLLUTION DEGREE 3
6.7.3.3 CREEPAGE DISTANCES No such insulation relied upon N/A
Based on WORKING VOLTAGE meets the values of No such insulation relied upon N/A
Table 7 for BASIC and SUPPLEMENTARY INSULATION
Values for REINFORCED INSULATION are twice the No such insulation relied upon N/A
values of BASIC INSULATION
Coatings to achieve reduction to POLLUTION DEGREE I No such insulation relied upon N/A
comply with requirements of Annex H
6.7.3.4 Solid insulation No such insulation relied upon N/A
6.7.3.4.1 Withstands electrical and mechanical stresses in No such insulation relied upon N/A
normal use and all RATED environmental conditions of
1.4

ITL086 V3.2 07/04/2011
a) Equipment passed voltage test of 6.8.3.1 for No such insulation relied upon N/A
5 s with VALUES of Table 6 for BASIC and
SUPPLEMENTARY INSULATION
values for REINFORCED INSULATION are 1,6 times No such insulation relied upon N/A
the values of BASIC INSULATION
b) if WORKING VOLTAGE exceeds 300 V, No such insulation relied upon N/A
equipment passed voltage test of 6.8.3.1 for
1 min with a test voltage of 1,5 times working
voltage for BASIC or SUPPLEMENTARY
INSULATION
value for REINFORCED INSULATION are twice the No such insulation relied upon N/A
WORKING VOLTAGE
Complies as applicable: No such insulation relied upon N/A

1) ENCLOSURE or protective barrier Clause 8 No such insulation relied upon N/A
2) moulded and potted parts requirements of No such insulation relied upon N/A
6.7.3.4.2
3) inner layers of printed wiring boards No such insulation relied upon N/A
requirements of 6.7.3.4.3
4) thin-film insulation requirements of 6.7.3.4.4 No such insulation relied upon N/A
6.7.3.4.2 Moulded and potted parts No such insulation relied upon N/A
Conductors between same two layers are separated No such insulation relied upon N/A
by applicable distances of Table 8
6.7.3.4.3 Inner insulation layers of printed wiring boards No such insulation relied upon N/A
Separated by at least by applicable distances of No such insulation relied upon N/A
Table 8 between same two layers
REINFORCED INSULATION have adequate electric No such insulation relied upon N/A
a) thickness at least applicable distance of No such insulation relied upon N/A
Table 8
b) insulation is assembled of minimum two No such insulation relied upon N/A
separate layers, each RATED for test voltage
of Table 6 for BASIC INSULATION
c) insulation is assembled of min two separate No such insulation relied upon N/A
layers, where the combination is rated for 1,6
times the test voltage of Table 6
6.7.3.4.4 Thin-film insulation No such insulation relied upon N/A
Conductors between same two layers are separated No such insulation relied upon N/A
by applicable CLEARANCES and CREEPAGE DISTANCES
REINFORCED INSULATION have adequate electric No such insulation relied upon N/A
a) thickness at least applicable distance of No such insulation relied upon N/A
Table 8
b) insulation is assembled of min two separate No such insulation relied upon N/A
layers, each RATED for test voltage of Table 6
for BASIC INSULATION

ITL086 V3.2 07/04/2011
c) insulation is assembled of min three No such insulation relied upon N/A
separate layers, where the combination of
two layers passed voltage tests with 1,6 time
values of Table 6:
a.c. test of 6.8.3.1; or No such insulation relied upon N/A
d.c. test of 6.8.3.2 for circuits stressed only by No such insulation relied upon N/A
d.c. voltages
6.8 Procedure for dielectric strength tests (see Form A.5 and A.14) P
6.9 Constructional requirements for protection against P
electric shock
6.9.1 If a failure could cause a HAZARD: P
a) Security of wiring connections P
b) Screws securing removable covers No such screws N/A
c) Accidental loosening P
d) CREEPAGE and CLEARANCES not reduced P
below the values of basic insulation by
loosening
6.9.2 Material not to be used for safety relevant insulation: P
Easily damaged materials not used Certified insulating materials P
used
Non-impregnated hydroscopic materials not used Non-impregnated hydroscopic P
materials not used
6.9.3 Colour coding P
Green-and-yellow insulation shall not be used P
except:
a) protective earth conductors; Cord is not part of investigation N/A
b) protective bonding conductors; P
c) potential equilization conductors; No such conductors N/A
d) functional earth conductors No such conductors N/A
6.10 Connection to MAINS supply source and connections P
between parts of equipment
6.10.1 MAINS supply cords Cord is not part of investigation N/A
RATED for maximum equipment current (see 5.1.3c) N/A
Cable complies with IEC 60227 or IEC 60245 N/A
Heat-resistant if likely to contact hot parts N/A
Temperature RATING (cord and inlet)....................... : N/A
Green/yellow used only for connection to PROTECTIVE N/A
CONDUCTOR TERMINALS
Detachable cords with IEC 60320 MAINS connectors: —

Conform to IEC 60799; or N/A
Have the current RATING of the MAINS connector N/A
6.10.2 Fitting of non-detachable MAINS supply cords No non-detachable cords N/A
6.10.2.1 Cord entry N/A

ITL086 V3.2 07/04/2011
Inlet or bushing smoothly rounded; or N/A
Insulated cord guard protruding >5D N/A
6.10.2.2 Cord anchorage N/A
Protective earth conductor is the last to take the N/A
strain
a) Cord is not clamped by direct pressure from N/A
a screw
b) Knots are not used N/A
c) Cannot push the cord into the equipment to N/A
cause a HAZARD
d) No failure of cord insulation in anchorage N/A
with metal parts
e) Not to be loosened without a tool N/A
f) Cord replacement does not cause a HAZARD N/A
and method of strain relief is clear
Push-pull and or torque test N/A
6.10.3 Plugs and connectors P
MAINS supply plugs, connectors etc., conform with Certified IEC 60320 type P
relevant specifications appliance inlet employed (part
of certified power entry module)
If equipment supplied at voltages below 6.3.2.a) or —
from a sole source:
Plugs of supply cords do not fit MAINS sockets above No cords N/A
rated SUPPLY voltage
MAINS type plugs used only for connection to MAINS Certified IEC 60320 type P
supply appliance inlet employed for
connection to mains (part of
certified power entry module)
Plug pins which receive a charge from an internal Voltage between L and N P
capacitor connections of the inlet
decayed to 0V within 5s after
supply disconnection with
mains switch in ON position.
No test required with mains
switch in OFF position as
capacitance stored in Cx
capacitor of power entry
module is 68nF (mains switch
is located behind X2 capacitor)
(see Form A.7)
Accessory MAINS socket outlets: No such parts —
a) Marking if accepts a standard MAINS plug N/A
(see 5.1.3e)
b) Input has a protective earth conductor if N/A
outlet has EARTH TERMINAL CONTACT
6.11 Disconnection from supply source P

ITL086 V3.2 07/04/2011
6.11.1 Disconnects all current carrying conductors IEC60320 type appliance P
coupler employed for
disconnection from mains.
Appliance coupler disconnects
both L and N
6.11.2 Exceptions No exceptions N/A
6.11.3 Requirements according to type of equipment N/A
6.11.3.1 PERMANENTLY CONNECTED EQUIPMENT and multi- No such equipment N/A
phase equipment:
Employs switch or circuit-breaker N/A
If switch or circuit-breaker is not part of the —
equipment, documentation requires:
a) Switch or circuit-breaker to be included in N/A
building installation
b) Suitable location easily reached N/A
c) Marking as disconnecting for the equipment N/A
6.11.3.2 Single-phase cord-connected equipment P
Equipment is provided with one of the following: P
a) Switch or circuit-breaker Although provided, not N/A
regarded disconnect device
b) Appliance coupler (disconnectable without IEC 60320 type appliance P
tool) coupler regarded disconnect
device
c) Separable plug (without locking device) Not regarded disconnect N/A
device
6.11.4 Disconnecting devices IEC 60320 type appliance P
coupler regarded disconnect
device
Electrically close to the SUPPLY P
6.11.4.1 Switches and circuit-breakers Although provided, not N/A
regarded disconnect device
When used as disconnection device: —
Meets IEC 60947-1 and IEC 60947-3 N/A
Marked to indicate function ..................................... : N/A
Not incorporated in MAINS cord N/A
Does not interrupt PROTECTIVE EARTH CONDUCTOR N/A
6.11.4.2 Appliance couplers and plugs P
Where an appliance coupler or separable plug is IEC 60320 type appliance P
used as the disconnecting device (see 6.11.3.2): coupler regarded disconnect
device
Readily identifiable and easily reached by the P
operator
Single-phase portable equipment cord length not Cord is not part of investigation N/A
more than 3 m
PROTECTIVE EARTH CONDUCTOR connected first and Provided by IEC 60320 type P
disconnected last appliance coupler

ITL086 V3.2 07/04/2011
7 PROTECTION AGAINST MECHANICAL P

HAZARDS
7.1 Equipment does not cause a mechanical HAZARD in P
NORMAL nor in SINGLE FAULT CONDITION
Conformity is checked by 7.2 to 7.7 P

7.2 Sharp edges P
Easily touched parts are smooth and rounded P
Do not cause injury during NORMAL USE and P
Do not cause injury during SINGLE FAULT CONDITION P
7.3 Moving parts Moving parts (fan and zoom P
motor) are suitably guarded
within enclosure and are not
operator accessible
7.3.1 HAZARDS from moving parts limited to a tolerable No such hazards N/A
level with the conditions specified in 7.3.2 and 7.3.5
RISK assessment in accordance with 7.3.3 carried
out
7.3.2 Exceptions No such hazards N/A
Access to HAZARDOUS moving parts permitted under No access permitted N/A
following circumstances:
a) obviously intended to operate on parts or N/A
materials outside of the equipment
inadvertent touching of moving parts minimized N/A
by equipment design (e .g. guards or handles)
b) If operator access is unavoidable outside N/A
normal use following precautions have been
taken:
1) Access requires TOOL N/A
2 ) Statement about training in the instructions N/A
3 ) Warning markings on covers prohibiting N/A
access by untrained operators
or symbol 14 with full details in documentation N/A
7.3.3 RISK assessment for mechanical HAZARDS to body No such hazards N/A
parts
RISK is reduced to a tolerable level by protective N/A
measures as specified in Table 12
Minimum protective measures: —
A. Low level measures N/A
B. Moderate measures N/A
C. Stringent measures N/A
7.3.4 Limitation of force and pressure No such hazards N/A
Following levels are met in normal and single fault N/A
condition:

ITL086 V3.2 07/04/2011
Continuous contact pressure below 50 N / cm² with N/A
force below 150 N
Temporary force below 250 N for an area at least of N/A
3 cm² for a maximum duration of 0,75 s
7.3.5 Gap limitations between moving parts No such hazards N/A
7.3.5.1 Access normally allowed N/A
If levels of 7.3.4 exceeded and body part may be N/A
inserted minimum gap as specified in Table 13
assured in NORMAL and in SINGLE FAULT CONDITION
7.3.5.2 Access normally prevented N/A
Maximum gap as specified in Table 14 assured in N/A
NORMALand in SINGLE FAULT CONDITION
7.4 Stability P
Equipment not secured to building structure is Equipment is stable by design P
physical stable
Stability maintained after opening of drawers etc. by No such parts N/A
automatic means, or
warning marking requires the application of means N/A
Compliance checked by following tests as applicable: —
a) 10° tilt test for other than handheld No overbalance as a result of P
equipment 10° tilt test
b) multi-directional force test for equipment No such case N/A
exceeds height of 1 m and mass of 25 kg
c) downward force test for floor-standing No such case N/A
equipment
d) overload test with 4 times maximum load for No such case N/A
castor or support that supports greatest load
e) castor or support that supports greatest load No such case N/A
removed from equipment
7.5 Provisions for lifting and carrying N/A
7.5.1 Equipment more than 18 kg : —
Has means for lifting or carrying; or Less than 18kg N/A
Directions in documentation N/A
7.5.2 Handles or grips No such parts N/A
Handles or grips withstand four times weight N/A
7.5.3 Lifting devices and supporting parts No such parts N/A
Rated for maximum load; or N/A
tested with four times maximum static load N/A
7.6 Wall mounting No such equipment N/A
Mounting brackets withstand four times weight N/A
7.7 Expelled parts No such parts N/A
Equipment contains or limits the energy N/A
Protection not removable without the aid of a tool N/A

ITL086 V3.2 07/04/2011
8 RESISTANCE TO MECHANICAL STRESSES P

8.1 Equipment does not cause a HAZARD when subjected P
to mechanical stresses in NORMAL USE
Normal protection level is 5 J Considered 5J P
Levels below 5 J but not less than 1 J are acceptable Not for levels below 5J N/A
if all of following criteria are met:
a) lower level justified by RISK assessment of N/A
manufacturer
b) equipment installed in its intended N/A
application is not easily touched
c) only occasional access during NORMAL USE N/A
d) IK code in accordance to IEC 62262 marked N/A
or symbol 14 used with full information in the
documentation
For non-metallic ENCLOSURES rated below 2 °C N/A
ambient temperature value chosen for minimum
rated temperature
Impact energies between IK values, the IK code N/A
marked for nearest lower value
Conformity is checked by performing following tests: —
1) static test of 8.2.1 Performed, no hazard P
2) impact test of 8.2.2 with 5 J except for HAND- Performed, no hazard P
HELD EQUIPMENT
if impact energy not selected to 5 J alternate N/A

method of IEC 62262 used
3) drop test of 8.3.1 or 8.3.2 except for FIXED Drop tests waived based on N/A
and EQUIPMENT with mass over 100 kg engineering judgment: unit
obviously cannot be affected by
this test
Equipment rated with an impact rating of IK 08 that N/A
obviously meets the criteria
After the tests inspection with following results: —
- HAZARDOUS LIVE parts above the limits of 6.3.2 not P
ACCESSIBLE
- insulation pass the voltage tests of 6.8 P

i) no leaks of corrosive and harmful P
substances
ii) ENCLOSURE shows no cracks resulting in a P
HAZARD
iii) CLEARANCES not less than their permitted P

values
iv) insulation of internal wiring remains P
undamaged
v) PROTECTIVE BARRIERS not damaged or P
loosened

ITL086 V3.2 07/04/2011
vi) No moving parts exposed, except permitted P
by 7.3
vii) no damage which could cause spread of fire P
8.2 ENCLOSURE rigidity test P
8.2.1 Static test P
- 30 N with 12 mm rod to each part of ENCLOSURE Applied to enclosure with P
acceptable results
- in case of doubt test conducted at maximum RATED No such doubt N/A
ambient temperature
8.2.2 Impact test Applied to enclosure with P
acceptable results
Impact applied to any part of ENCLOSURE causing a Applied to metal and plastic P
HAZARD if damaged enclosure
Impact energy level and corresponding IK code .... : 5J impact applied P
Non-metallic ENCLOSURES cooled to minimum RATED Not intended for ambient below N/A
ambient temperature if below 2 °C 2 °C
8.3 Drop test Drop tests waived based on N/A
engineering judgment: unit
obviously cannot be affected by
this test
8.3.1 Other than HAND-HELD and DIRECT-PLUG-IN EQUIPMENT N/A
Tests conducted with a drop height or angle of...... : N/A
8.3.2 HAND-HELD and DIRECT-PLUG-IN EQUIPMENT N/A
Non-metallic ENCLOSURES cooled to minimum RATED N/A
ambient temperature if below 2 °C
Drop test conducted with an height of 1 m N/A
9 PROTECTION AGAINST THE SPREAD OF FIRE P

9.1 No spread of fire in NORMAL and SINGLE FAULT P
CONDITION
MAINS supplied equipment meets requirements of 9.6 Overcurrent protection per P

additionally clause 9.6 provided
Conformity is checked by minimum one or a (see Form A.17) P
combination of the following (see Figure 11):
a) Fault test of 4.4; or Not relied upon N/A
b) Application of 9.2 (eliminating or reducing the Not relied upon N/A
sources of ignition); or
c) Application of 9.2 (containment of fire within This method is used P
the equipment)
9.2 Eliminating or reducing the sources of ignition within Not relied upon N/A
the equipment
a) 1) Limited-energy circuit (see 9.4); or Not relied upon N/A
2) BASIC INSULATION provided for parts of Not relied upon N/A
different potential; or
Bridging the insulation does not cause ignition Not relied upon N/A

ITL086 V3.2 07/04/2011
b) Surface temperature of liquids and parts Not relied upon N/A
(see 9.5)
c) No ignition in circuits designed to produce Not relied upon N/A
heat
9.3 Containment of the fire within the equipment, should P
it occur
a) Energizing of the equipment is controlled by Not used N/A
an operator held switch
b) ENCLOSURE is conform with constructional ENCLOSURE is conform with P
requirements of 9.3.1; and constructional requirements of
9.3.1
Requirements of 9.5 are met No flammable liquids N/A
9.3.1 Constructional requirements P
a) Connectors and insulating material have Connectors and insulating P
flammability classification V-2 or better material have flammability
classification V-2 or better
b) Insulated wires and cables are flame Certified wiring rated min. VW- P
retardant (VW-1 or equivalent) 1 used
c) ENCLOSURE meets following requirements: P
1) Bottom and sides in arc of 5 ° (see Figure 13) to P
non-limited circuits (9.4) meets:
i) no openings; or N/A
ii) perforated as specified in Table 16; or Fire enclosure is made of metal P
and plastic flame rated V-0 for
SQA-V and 5VA for
QwikCheck Gold. Bottom of the
enclosure is perforated as
follows: thickness 1.5mm,
circular openings 2mm
diameter, 3mm between the
hole centers
iii) metal screen with a mesh; or N/A
iv) baffles as specified in Figure 12 N/A
2) Material of ENCLOSURE and any baffle or flame Fire enclosure is made of metal P
barrier is made of: and plastic flame rated V-0 for
SQA-V and 5VA for
QwikCheck Gold
Metal (except magnesium); or P
Non-metallic materials have flammability Plastic parts of enclosure are P
classification V-1 or better flame rated V-0 for SQA-V and
5VA for QwikCheck Gold
3) ENCLOSURE and any baffle or flame barrier have ENCLOSURE and any baffle or P
adequate rigidity flame barrier have adequate
rigidity

ITL086 V3.2 07/04/2011
9.4 Limited-energy circuit Unit outputs to other equipment P
(signal data ports RS-232 and
Video) were evaluated as
inherently limited signal data
energy sources not associated
with power transfer (see Form
A.19)
a) Potential not more than 30 r.m.s. and 42.4 Maximum 7VDC at RS-232 P
V peak, or 60 V dc
b) Current limited by one of following means: P
1) Inherently or by impedance (see Inherently limited signal data P
Table 17); or energy sources not associated
with power transfer (RS-232
and video signal outputs)
Maximum available current
12mA at 7VDC at pin 3 of RS-
232
2) Over current protective device (see Not used N/A
Table 18); or
3) A regulating network limits also in Not used N/A
SINGLE FAULT CONDITION (see Table
17)
c) Is separated by at least BASIC INSULATION Not used N/A
Fuse or a nonadjustable electromechanical device is Not used N/A
used
9.5 Requirements for equipment containing or using No flammable liquids N/A
flammable liquids
Flammable liquids contained in or specified for use No flammable liquids N/A
with equipment do not cause spread of fire
RISK is reduced to a tolerable level : No flammable liquids N/A
a) The temperature of surface or parts in No flammable liquids N/A
contact with flammable liquids is 25 °C
below fire point
b) The quantity of liquid is limited No flammable liquids N/A
c) Flames are contained within the equipment No flammable liquids N/A
Detailed instructions for RISK-reduction provided No flammable liquids N/A
9.6 Overcurrent protection Overcurrent protection in mains P
provided as part of the
equipment
9.6.1 MAINS supplied equipment protected Unit is protected by fuses rated P
1A in Line and Neutral
conductors, installed in power
entry module
BASIC INSULATION between MAINS parts of opposite Part of certified power entry N/A
polarity provided module and certified power
supply
Devices not in the protective conductor No fuses in the protective P
conductor
Fuses or single-pole circuit-breakers not fitted in Single phase N/A
neutral (multi-phase)

ITL086 V3.2 07/04/2011
9.6.2 PERMANENTLY CONNECTED EQUIPMENT No such equipment N/A
Overcurrent device: N/A
Fitted within the equipment; or N/A
Specified in manufacturer's instructions N/A
9.6.3 Other equipment P
Protection within the equipment Protection provided within the P
equipment
10 EQUIPMENT TEMPERATURE LIMITS AND P

RESISTANCE TO HEAT
10.1 Surface temperature limits for protection against P
burns
Easily touched surfaces within the limits in NORMAL (see Form A.21A) P
and in SINGLE FAULT CONDITION:
- at an specified ambient temperature of 40 °C P
- for equipment rated above 40 °C ambient N/A
temperature limits not exceeded raised by the
difference to 40 °C
Heated surfaces necessary for functional reasons No such surfaces N/A
exceeding specified values:
Are recognizable as such by appearance or N/A
function; or
Are marked with symbol 13 N/A
Guards are not removable without tool N/A
10.2 Temperatures of windings P
Limits not exceeded in: (see Form A.21A) P
NORMAL CONDITION P
SINGLE FAULT CONDITION P
10.3 Other temperature measurements P
Following measurements conducted if applicable: (see Form A.21A) P
a) Value of 60 °C of field-wiring terminal box No such parts N/A
not exceeded
b) Surface of flammable liquids and parts in No such parts N/A
contact with this liquids
c) Surface of non-metallic ENCLOSURES (see Form A.21A) P
d) Parts made of insulating material supporting (see Form A.21A) P
parts connected to MAINS supply
e) Terminals carrying a current more than 0,5 (see Form A.21A) P
A
10.4 Conduct of temperature test P
10.4.1 Tests conducted under reference test conditions and (see Form A.21A) P
manufacturer’s instructions
10.4.2 Temperature measurement of heating equipment No such equipment N/A
Tests conducted in test corner N/A

ITL086 V3.2 07/04/2011
10.4.3 Equipment intended for installation in a cabinet or No such equipment N/A
wall
Equipment built in as specified in installation N/A
instructions
10.5 Resistance to heat P
10.5.1 Integrity of CLEARANCE and CREEPAGE DISTANCES P
10.5.2 Non-metallic ENCLOSURES Unit was subjected to non- P
operative treatment at 70degC
for 7 hours with acceptable
results, there was no
deformation (see Form A.22)
Within 10 min after treatment: —
Equipment subjected to suitable stresses of 8.2 and Unit passed tests of 8.2 with P
8.3 complying with criteria of 8.1 acceptable results. Tests of 8.3
waived based on engineering
judgment
10.5.3 Insulating material P
a) Parts supporting parts connected to MAINS Certified components used P
supply within ratings employed
b) TERMINALS carrying a current more than 0.5 Certified components used P
A within ratings employed
Examination of material data; or Data was examined P
in case of doubt: Test waived based on N/A
engineering judgment
1) Ball pressure test; or Test waived based on N/A
2) Vicat softening test of ISO 306 Test waived based on N/A
11 PROTECTION AGAINST HAZARDS FROM P

FLUIDS
11.1 Protection to OPERATORS and surrounding area P
provided by EQUIPMENT
All fluids specified by manufacturer considered Certified lithium battery P
employed. No other fluids
11.2 Cleaning N/A
11.3 Spillage No such liquids. Battery is P
located so that electrolyte
leakage cannot affect safety
critical insulation
11.4 Overflow No such liquids N/A
11.5 Battery electrolyte P
Battery electrolyte leakage presents no HAZARD Battery is located so that P
electrolyte leakage cannot
affect safety critical insulation
11.6 Specially protected equipment IPX0 N/A
11.7 Fluid pressure and leakage No fluids under pressure N/A

ITL086 V3.2 07/04/2011
11.7.1 Maximum pressure ............................................... : N/A
Maximum pressure of any part does not exceed N/A
PRATED
11.7.2 Leakage and rupture at high pressure N/A
Fluid containing parts subjected to hydraulic test if: N/A
a) product of pressure and volume > 200 kPal; N/A
and
b) pressure > 50 kPa N/A
Parts of refrigerating systems meets pressure-related N/A
requirements of IEC 60335-24 or IEC 60335-24
11.7.3 Leakage from low-pressure parts N/A
11.7.4 Overpressure safety device N/A
Does not operate in NORMAL USE N/A
a) Connected as close as possible to parts N/A
intended to be protected
b) Easy access for inspection, maintenance N/A
and repair
c) Adjustment only with TOOL N/A
d) No discharge towards person N/A
e) No HAZARD from deposit of discharged N/A
material
f) Adequate discharge capacity N/A
No shut-off valve between overpressure safety N/A
device and protected parts
12 PROTECTION AGAINST RADIATION, INCLUDING No radiation, lasers or N/A

LASER SOURCES, AND AGAINST SONIC AND considerable sound pressure
ULTRASONIC PRESSURE produced
12.1 Equipment provides protection N/A
12.2 Equipment producing ionizing radiation N/A
12.2.1 Ionizing radiation N/A
12.2.1.1 Equipment meets the following requirements: N/A
a) if intended to emit radiation meets N/A
requirements of 12.2.1.2; or
tested, classified and marked in accordance to N/A
IEC 60405
b) if only emits stray radiation meets N/A
requirements of 12.2.1.3
12.2.1.2 Equipment intended to emit radiation N/A
Effective dose rate of radiation measured .............. : N/A
If dose rate exceeds 5 µSv/h marked with the N/A
following:
a) Symbol 17 (ISO 361) N/A
b) Abbreviations of the radionuclides .................. : N/A

ITL086 V3.2 07/04/2011
c) With maximum dose at 1 m; or ....................... : N/A
with dose rate value between 1 µSv/h and 5 N/A
µSv/h in m........................................................... :
12.2.1.3 Equipment not intended to emit radiation N/A
Limit for unintended stray radiation of 1 µSv/h at any N/A
easily reached point kept ........................................ :
12.2.2 Accelerated electrons N/A
Compartments opened only by the use of a TOOL N/A
12.3 Ultraviolet (UV) radiation N/A
No unintentional HAZARDOUS escape of UV radiation: —
- checked by inspection; and N/A
- evaluation of RISK assessment documentation N/A
12.4 Micro-wave radiation N/A
2
Power density does not exceed 10 W/m ............. : N/A
12.5 Sonic and ultrasonic pressure N/A
12.5.1 Sound level N/A
No HAZARDOUS sound emission N/A
Maximum sound pressure level measured and N/A
calculated for maximum sound power level as
specified in ISO 3746 or ISO 9614-1
Instruction describes measures for protection N/A
12.5.2 Ultrasonic pressure N/A
Equipment not intended to emit ultrasound does not N/A
exceed limit of 110 dB between 20 kHz and 100 kHz
Equipment intended to emit ultrasound: N/A
Outside useful beam does not exceed limit of 110 dB N/A
between 20 kHz and 100 kHz
If inside useful beam above values exceeded: N/A
Marked with Symbol 14 of Table 1 N/A
and following information in the documentation: N/A
a) dimensions of useful beam N/A
b) area where ultrasonic pressure exceed 110 N/A
dB
c) maximum sound pressure inside beam area N/A
12.6 Laser sources N/A
Equipment meets requirements of IEC 60825-1 N/A
13 PROTECTION AGAINST LIBERATED GASES, P

EXPLOSION AND IMPLOSION
13.1 Poisonous and injurious gases No such gases N/A
No poisonous or injurious gases or substances N/A
liberated in NORMAL CONDITION

ITL086 V3.2 07/04/2011
Attached data/test reports demonstrate conformity N/A
13.2 Explosion and implosion P
13.2.1 Components No components liable to N/A
explode
Components liable to explode: —
Pressure release device provided; or N/A
Apparatus incorporates operator N/A
protection (see also 7.7)
Pressure release device: —
Discharge without danger N/A
Cannot be obstructed N/A
13.2.2 Batteries and battery charging Certified non-rechargeable P
lithium battery employed. (see
Form A.28)
If explosion or fire HAZARD could occur: —
Protection incorporated in the equipment; or Battery is protected against p

reverse charging current by
certified IC U10 (DS1307).
Battery was tested for short
circuit as part of certification
per UL 1642
Instructions specify batteries with built-in protection N/A
In case of wrong type of battery used: —
No HAZARD; or N/A
Warning by marking and within instructions Suitable instructions are P
provided in manual
Equipment with means to charge rechargeable No means to charge —
batteries: rechargeable batteries
Warning against the charging of non-rechargeable N/A
batteries; and
Type of rechargeable battery indicated; or N/A
Symbol 14 used N/A
Battery compartment design N/A
Single component failure N/A
Polarity reversal test N/A
13.2.3 Implosion of cathode ray tubes No CRT N/A
If maximum face dimensions > 160 mm ................. : —
Intrinsically protected and correctly mounted; or N/A
ENCLOSURE provides protection: N/A
If non-intrinsically protected: —
Screen not removable without TOOL N/A
If glass screen, not in contact with surface of tube N/A
14 COMPONENTS AND SUBASSEMBLIES P

ITL086 V3.2 07/04/2011
14.1 Where safety is involved, components and (see Table 3) P
subassemblies meet relevant requirements
14.2 Motors P
14.2.1 Motor temperatures Unit employs certified DC fan P
and non-certified DC motor
Does not present a HAZARD when stopped or Non-certified DC motor was P
prevented form starting; or tested for locked rotor with
acceptable results (see Form
A.1 and A.2)
Protected by over-temperature or thermal protection No such device N/A
device conform with 14.3
14.2.2 Series excitation motors No such motors N/A
Connected direct to device, if over-speeding causes N/A
a HAZARD
14.3 Overtemperature protection devices No such devices N/A
Devices operating in a SINGLE FAULT CONDITION N/A
a) Reliable function is ensured N/A
b) RATED to interrupt maximum current and N/A
voltage
c) Does not operate in NORMAL USE N/A
If self-resetting device used to prevent a HAZARD, N/A
protected part requires intervention before restarting
14.4 Fuse holders P
No access to HAZARDOUS LIVE parts Operator has no access to live P
parts during mains fuse
replacement
14.5 MAINS voltage selecting devices No such devices, voltage is N/A
automatically selectable
Accidental change not possible N/A
14.6 MAINS transformers tested outside equipment Part of certified power supply N/A
14.7 Printed circuit boards Certified PCB flame rated V-0 P
used
Data shows conformity with V-1 of IEC 60695-11-10 P
or better; or
Test shows conformity with V-1 of IEC 60695-11-10 N/A
or better
Not applicable for printed wiring boards with limited- No such parts N/A
energy circuits (9.4)
14.8 Circuits or components used as transient No such parts N/A
overvoltage limiting devices
Test conducted between each pair of MAINS SUPPLY N/A
TERMINALS
No HAZARD resulting from rupture or overheating of N/A

the component:
- no bridging of safety relevant insulation N/A
- no heat to other parts above the self-ignition points N/A

ITL086 V3.2 07/04/2011
15 PROTECTION BY INTERLOCKS No interlocks N/A

15.1 Interlocks are designed to remove a HAZARD N/A
before OPERATOR exposed
15.2 Prevention of reactivation N/A
15.3 Reliability N/A
Single fault unlikely to occur; or N/A
Cannot cause a HAZARD N/A
16 HAZARDS RESULTING FROM APPLICATION N/A

16.1 REASONABLY FORESEEABLE MISUSE No such hazards N/A
No HAZARDS arising from settings not intended and No such settings that can N/A
not described in the instructions present a hazard
Other cases of REASONABLY FORESEEABLE MISUSE No such hazards N/A
addressed by RISK assessment
16.2 Ergonomic aspects No such hazards N/A
Factors giving rise to a HAZARD the RISK assessment N/A
is reflecting those aspects:
a) limitation of body dimensions N/A
b) displays and indicators N/A
c) accessibility and conventions of controls N/A
d) arrangement of TERMINALS N/A
17 RISK assessment N/A

RISK assessment conducted, if HAZARD might arise All hazards deemed fully N/A
and not covered by Clauses 6 to 16 addressed by Clauses 6 to 16
TOLERABLE RISK achieved by iterative documented N/A
process covering the following:
a) RISK analysis N/A
Identifies HAZARDS and estimates RISK N/A
b) RISK evaluation N/A
Plan to judge acceptability of resulting RISK level N/A
based on the estimated severity and likelihood of
a RISK
c) RISK reduction N/A
Initial RISK reduced by counter measures; N/A
Repeated RISK evaluation without new RISKS N/A
introduced
RISKS remaining after RISK assessment addressed in N/A
instructions to RESPONSIBLE BODY:
Information contained how to mitigate these RISKS N/A
Following principles in methods of RISK reduction N/A
applied by manufacturer in given order:

ITL086 V3.2 07/04/2011
1) RISKS eliminated or reduced as far as possible N/A
2) Protective measures taken for RISKS that cannot N/A
be eliminated
3) User information about residual RISK due to any N/A
defect of the protective measures
Indication of particular training is required N/A
Specification of the need for personal protective N/A
equipment
Conformity checked by evaluation of the RISK N/A
assessment documentation
ANNEX F ROUTINE TESTS Manufacturer performs P
Dielectric Strength test mains
to GND, 2121VDC and GND
continuity test
Manufacturer ´s declaration Provided P

ITL086 V3.2 07/04/2011
4.4.2 TABLE: Summary of SINGLE FAULT CONDITIONS Form A.1 P
Subclause Title Does not Carried Comments

apply out
4.4.2.1 SINGLE FAULT CONDITIONS not covered by X No such faults considered
4.4.2.2 to 4.4.2.14
4.4.2.2 PROTECTIVE IMPEDANCE X Not employed
4.4.2.3 PROTECTIVE CONDUCTOR X See Form A.2 and A.8
4.4.2.4 Equipment or parts for short-term or X Continuous operation
intermittent operation
4.4.2.5 Motors X
– stopped while fully energized X Applied to non-certified DC
motor, see Form A.2
– prevented from starting X Applied to non-certified DC
motor, see Form A.2
– one phase interrupted (multi-phase) X No such motors
4.4.2.6 Capacitors X No motors with capacitors
4.4.2.7 MAINS transformers X Part of certified power supply
Attach drawing of MAINS transformers
showing all protective devices
(see Forms A.30 and A.31)
4.4.2.8 Outputs X Limited energy signal/data
outputs employed
4.4.2.9 Equipment for more than one supply X Unit for one supply
4.4.2.10 Cooling X
– air holes closed X Tested, see Form A.2 and
A.21A
– fans stopped X Tested, see Form A.2 and
A.21A
– coolant stopped X
– loss of cooling liquid X
4.4.2.11 Heating devices X No heating devices
– timer overridden
– temperature controller overridden
4.4.2.12 Insulation between circuits and parts X Part of certified power supply
4.4.2.13 Interlocks X No such parts
4.4.2.14 Voltage selectors X No such parts
List below all SINGLE FAULT CONDITIONS not covered by 4.4.2.2 to 4.4.2.14:
Supplementary information:
(see Form A.2 for details of tests)

ITL086 V3.2 07/04/2011
TESTED BY: DATE: TEST EQUIPMENT LIST ITEM:

ITL086 V3.2 07/04/2011
IEC 61010-1
Clause Requirement — Test Result — Remark Verdict
4.4 TABLE: Testing in SINGLE FAULT CONDITION – Results Form A.2 P

Test Fault Fault description Td 4.4.3 How was test terminated Meets
subclause No. (NOTE) Comments 4.4.4
SQA-V
4.4.2.3 1 Protective earthing conductor disconnected --- Accessible voltage on metal enclosure exceeded permitted P
limits. However, touch current does not exceed permitted
limits, see Form A.8
4.4.2.5 2 Non-certified DC motor locked 4h No fire or other hazard. Locked rotor current 155mA initial, P
further reduced to 126mA. Motor body 45.3degC in ambient
24.6degC
4.4.2.10 3 Ventilation openings blocked 1h 30m No fire or other hazard. See Form A.21A for temperatures. Hi- P
Pot pass
4.4.2.10 4 Fan disconnected 1h 05m No fire or other hazard. See Form A.21A for temperatures. Hi- P
Pot pass
QwikCheck Gold
4.4.2.10 5 Ventilation openings blocked 1h 35m No fire or other hazard. See Form A.21A for temperatures. Hi-
Pot pass
4.4.2.10 6 Fan disconnected 2h 15m No fire or other hazard. See Form A.21A for temperatures. Hi-
Pot pass
NOTE Td = Test duration in hh:mm:ss

Record dielectric strength test on Form A.14 and temperature tests on Form A.21.
Record in the comments column for each test whether carried out during or after SINGLE FAULT CONDITION.

ITL086 V3.2 07/04/2011
TESTED BY: Vladimir Chernikh DATE: 26/07/2011 TEST EQUIPMENT LIST ITEM

ITL086 V3.2 07/04/2011
IEC 61010-1
5.1.3c) TABLE: MAINS supply Form A.3 P

Marked rating.........................: 100-240VAC V —
Phase ....................................: 1 —
Frequency .............................: 50/60Hz Hz —
Current ..................................: 0.5A A —
Power ...................................: W —
Power ...................................: VA —
Test Voltage Frequency Current Power in Power in Comments

No. V Hz A W VA
1 264 50 0.155 16.5 Application running
Note – Measurements are only required for marked ratings.

TESTED BY: V. Koytih DATE: 23/06/11 TEST EQUIPMENT LIST ITEM: 1215

ITL086 V3.2 07/04/2011
IEC 61010-1
5.3 TABLE: Durability of markings Form A.4

Marking method (see NOTE) Agent
1) Adhesive label A Water
2) Ink printed B Isopropyl alcohol 70%
3) Laser marked C (specify agent)
4) Filmcoated (plastic foil control panel) D (specify agent)
5) Imprinted on plastic (moulded in) E (specify agent)
NOTE – Where applicable include print method, label material, ink or paint type,
fixing method, adhesive and surface to which marking is fixed.
Marking location Marking method (see above)

Identification (5.1.2) 1, 2
MAINS supply (5.1.3) 1
Fuses (5.1.4) 1
terminals and operating devices (5.1.5.2)
Switches and circuit breakers (5.1.6)
Double/reinforced equipment (5.1.7)
Field wiring Terminal boxes (5.1.8)
Warning marking (5.2)
Battery charging (13.2.2)
Method Test agent Remains legible Label loose Curled edges Comments
Verdict Verdict Verdict
1, 2 A, B P P P
TESTED BY: V.Chernikh DATE: 05/04/11 TEST EQUIPMENT LIST ITEM:

ITL086 V3.2 07/04/2011
IEC 61010-1
6 TABLE: Protection against electric shock - Block diagram of system Form A.5 P
Pollution degree .....: II Overvoltage category ...................: II

Location or Insulation Maximum CREEPAGE Distance CLEARANCE Test Comments
type working (NOTE 3) (NOTE 3) voltage
description (NOTE 1) voltage PWB CTI Other CTI mm (NOTE 2)
(NOTE 2) mm mm V
Primary – Basic 240VAC Part of Part of 3.0 IIIb 1.5 2121VDC
GND certifie certifie
d d
power power
supply supply
Primary- Reinforced 240VAC Part of Part of Part of Part of Part of Part of Part of
SELV certifie certifie certifie certifie certified certified certified
d d d d power power power
power power power power supply supply supply
supply supply supply supply
Primary- Reinforced 240VAC --- --- --- --- 3.0 4242VDC
plastic
enclosure
NOTE 1 – Type of insulation: NOTE 2 - Types of voltage NOTE 3 - INSTALLATION CATEGORIES

BI = BASIC INSULATION Peak impulse test voltage (pulse) (OVERVOLTAGE CATEGORIES)
DI = DOUBLE INSULATION r.m.s. or POLLUTION DEGREES which differ from
PI = PROTECTIVE IMPEDANCE d.c. these should be shown under "Comments".
RI = Reinforced INSULATION peak
SI = Supplementary INSULATION
Supplementary Information:

ITL086 V3.2 07/04/2011
IEC 61010-1
6.2 TABLE: List of ACCESSIBLE parts Form A.6

6.1.2 Exceptions —
6.2 Determination of ACCESSIBLE parts —
Item Description Determination method Exception under 6.1.2
(NOTE 5) (NOTE 4)
1 Plug pins 5s after supply Visual
disconnection (L-N)
2 Metal enclosure Visual
3 RS-232 Visual
4 Video Visual
5 Inverter output – normal load condition Visual
(not accessible)
6 Inverter output – output connector Visual
disconnected (open circuit voltage)
NOTE 1 – Test fingers and pins are to be applied without force unless a force is specified (see 6.2.2)
NOTE 2 – Special consideration should be given to inadequate insulation and high voltage parts (see 6.2)
NOTE 3 – Parts are considered to be ACCESSIBLE if they could be touched in the absence of any covering which is not considered
to provide suitable insulation (see 6.4).
NOTE 4 – Capacitor test may be required (see Form A.7).
NOTE 5 – The determination methods are:
V = visual; R = rigid test finger; J = jointed test finger; P3 = pin 3 mm diameter; P4 = pin 4 mm diameter.
TESTED BY: V.Chernikh DATE: 05/04/2011 TEST EQUIPMENT LIST ITEM: 1147, 1135

ITL086 V3.2 07/04/2011
IEC 61010-1
6 TABLE: Values in NORMAL CONDITION Form A.7 P

6.1.2 Exceptions 11.2 Cleaning and decontamination —
6.3.1 Values in NORMAL CONDITION (see NOTE 1) 11.3 Spillage —
6.6.2 Terminals for external circuit 11.4 Overflow —
6.10.3 Plugs and connections —
Item Voltage Current Capacitance 10 s / 5 s test (NOTE) Comments
(see V V V Test mA mA mA
Form A.6) r.m.s. peak d.c. circuit r.m.s. peak d.c. µC mJ V µC mJ
+/A2/A3
1, main 0 0 0 Voltage between L and N decayed
switch on to 0V within 5s after power
disconnection (also 0V within 1s)
1, main --- --- --- Test not required: stored
switch off capacitance 68nF (X-capacitor in
line filter)
2 (metal --- --- 0
enclosure)
3, pin 1 --- --- 0
3, pin 2 --- --- 1VDC
3, pin 3 --- --- 7VDC
3, pin 4 --- --- 0
3, pin 5 --- --- 0
3, pin 6 --- --- 0
3, pin 7 --- --- 0
3, pin 8 --- --- 0
3, pin 9 --- --- 0
4 (video --- --- 2.9

ITL086 V3.2 07/04/2011
IEC 61010-1
6 TABLE: Values in NORMAL CONDITION Form A.7 P

6.1.2 Exceptions 11.2 Cleaning and decontamination —
6.3.1 Values in NORMAL CONDITION (see NOTE 1) 11.3 Spillage —
6.6.2 Terminals for external circuit 11.4 Overflow —
6.10.3 Plugs and connections —
Item Voltage Current Capacitance 10 s / 5 s test (NOTE) Comments
(see V V V Test mA mA mA
Form A.6) r.m.s. peak d.c. circuit r.m.s. peak d.c. µC mJ V µC mJ
+/A2/A3
output)
5 (inverter 390 630 --- A1 0.14 0.36 --- --- --- Frequency 36.5kHz
output,
under
normal
load)
6 (inverter 603 910 --- A1 0.14 0.36 --- --- --- Frequency 40kHz
output,
under open
circuit
condition)
NOTE – A 10 s test is specified in 6.1.2 a) b). A 5 s test is specified in 6.10.3. The capacitance level versus voltage below the limits given from figure 3 of IEC 61010-1.

ITL086 V3.2 07/04/2011
TESTED BY: V.Chernikh DATE: 10/04/2011 TEST EQUIPMENT LIST ITEM 1147, 1135

ITL086 V3.2 07/04/2011
IEC 61010-1
6.3.2 TABLE: Values in SINGLE FAULT CONDITION Form A.8

Item Subclause Voltage Transient Current Capacitance
and (see NOTE)
(see fault No. V V V Test mA mA mA µF Comments
Form A.6) (see Form A.2) r.m.s. peak d.c. V s circuit r.m.s. peak d.c. (see NOTE)
A1/A2/A3
2 1 (protective 134 194 --- A1 0.3 0.57 ---
conductor
disconnected)
1-6 2-6 Same as in normal condition
NOTE – Transient voltages must be below the limits given from Figure 2 and the capacitance below the limits from figure 3 of IEC 61010-1.
TESTED BY: V.Chernikh DATE: 10/04/2011 TEST EQUIPMENT LIST ITEM 1147, 1135

ITL086 V3.2 07/04/2011
IEC 61010-1
6.5.2.2 TABLE: Cross-sectional area of bonding conductors Form A.9 P

CONDUCTOR LOCATION CROSS-SECTIONAL AREA VERDICT
mm²
PEM to chassis 18 AWG, 0.75mm2 P
6.5.2.3 TABLE: Tighting torque test N/A

Conductor location Size of screw Tighting Verdict
torque
Nm

ITL086 V3.2 07/04/2011
IEC 61010-1
6.5.2.4 TABLE: Bonding impedance of plug connected equipment Form A.10 P

Test Voltage attained Calculated resistance Verdict
ACCESSIBLE part under test current after 1 min (Maximum 0,1 or 0,2 Ω)
A V (NOTE 2) Ω (NOTE 1)
Metal chassis to inlet GND pin 25 0.41 VDC 0.0164 P
Test Voltage attained Calculated resistance Verdict
ACCESSIBLE part under test current after 2 min (Maximum 0,1 or 0,2 Ω)
A V (NOTE 2) Ω (NOTE 1)
Metal chassis to inlet GND pin 40 0.70 0.0175 P
NOTE 1 – For none-detachable power cord the impedance between protective conductor plug pin of MAINS cord and each
ACCESSIBLE part shall not exceed 0,2 Ohm.
6.5.2.5 TABLE: Bonding impedance of permanently connected equipment N/A

Test Voltage attained after 1 min Verdict
ACCESSIBLE part under test current (maximum 10 V)
A V
TESTED BY: V.Chernikh DATE: 10/04/2011 TEST EQUIPMENT LIST ITEM: 1040

ITL086 V3.2 07/04/2011
IEC 61010-1
6.5.2.6 TABLE: Transformer PROTECIVE BONDING screen Form A.11 N/A

Test current Voltage attained Calculated resistance Verdict
ACCESSIBLE part under test (see NOTE) after 1 min (maximum 0,1 Ω)
A (maximum 10 V) Ω
V
NOTE – Test current must be twice the value of the overcurrent protection means of the winding. Test is specified in 6.5.2.6 a) or b).

ITL086 V3.2 07/04/2011
IEC 61010-1
6.5.4 TABLE: protective impedance Form A.12 N/A

A single component
Component Location Measured Calculated Rated Verdict Comments
Working Current Power Working Power
voltage dissipation voltage dissipation
V A W V W
A combination of components
Component Location Comments
NOTE – A PROTECTIVE IMPEDANCE shall not be a single electronic device that employs electron conduction in a vacuum, gas or semiconductor.
6.5.6 TABLE: Current- or voltage-limiting device N/A

Component Location Measured Rated Verdict Comments
Working Current Working Current
voltage voltage
V A V A
TESTED BY: DATE: TEST EQUIPMENT LIST ITEM

ITL086 V3.2 07/04/2011
IEC 61010-1
6.7 TABLE: CLEARANCES and CREEPAGE distances Form A.13

6.4.2 ENCLOSURES and protective barriers 8 Mechanical resistance to shock and impact —
6.4.4 Impedance 9.6.1 Overcurrent protection basic insulation between MAINS parts —
6.5.4 Protective impedance 10.5.1 Integrity of CLEARANCES and CREEPAGE distances —
6.5.6 Current- or voltage-limiting device —
Location Measured Verdict Mechanical tests (note) Test at Measured after Verdict Comments
(initial – 6.7) max. test
(if required)
(see Form CREEPAGE CLEARANCE Applied Rigidity Drop RATED CREEPAGE CLEARANCE
A.5) DISTANCE force (8.2) (8.3) ambient DISTANCE
mm mm N Static Impact Normal Hand-held/ (10.5.1) mm mm
(8.2.1) (8.2.2) (8.3.1) Plug-in
Primary at Part of 9 P 30N P P N/A N/A N/A Part of 9 P
power certified certifie
supply to power d
GND supply power
(enclosure) supply
Primary to Part of Min. 54 P 30N P P N/A N/A N/A Part of Min. 54 P
conductive certified certifie
coating/pla power d
stic supply power
enclosure supply
NOTE – Refer to Form A.14 for dielectric strength tests following the above tests.

ITL086 V3.2 07/04/2011
TESTED BY: V.Chernikh DATE: 26/07/2011 TEST EQUIPMENT LIST ITEM 1335

ITL086 V3.2 07/04/2011
IEC 61010-1
6.8 TABLE: Dielectric strength tests Form A.14 P

4.4.4.1 b) Conformity after application of SINGLE FAULT CONDITIONS1 N/A
6.4 Primary means of protection 2
P
6.6 Connections to external circuits N/A
6.7. Insulation requirements2 (see Annex K) P
6.10.2 Fitting of non-detachable MAINS supply cords 1
N/A
9.2 a) 2) Eliminating or reducing the sources of ignition within the equipment N/A
9.4 c) Limited-energy circuit N/A
9.6.1 Overcurrent protection basic insulation between MAINS - parts N/A
1 2
Record the fault, test or treatment applied before the dielectric strength test. Humidity preconditioning required.
Test site altitude ....................................................... : 55m —
Test voltage correction factor (see Table 10) .......... : —
Location or Clause or Humidity Working Test voltage Comments Verdict
references from sub-clause voltage r.m.s./peak/d.cV
Forms A.2 and A.5 Yes/No V
Primary to GND 6.4, 6.6 No 240 2121VDC P
Primary to 6.5.2 No 240 4242VDC Y-capacitors were P
conductve disconnected in order not
coating/plastic to overstress basic
enclosure insulation
Supplementary information: Reinforced insulation between primary and SELV was evaluated as part of certified
power supply
TESTED BY: V.Chernikh DATE: 29/06/2011 TEST EQUIPMENT LIST ITEM: 1217

ITL086 V3.2 07/04/2011
IEC 61010-1
6.10.2 TABLE: Cord anchorage Form A.15 N/A

Location Mass Pull Verdict Torque Verdict Comment
kg N Nm
Dielectric strength test for 1 min. (6.8.3.1)............. : V r.m.s.


ITL086 V3.2 07/04/2011
IEC 61010-1
7. TABLE: Protection against mechanical HAZARDS Form A.16 N/A

7.3.4 Limitation of force and pressure —
7.3.5 Gap limitations between moving parts —
Clause 7.3.4 Clause 7.3.5.1 Clause 7.3.5.2
Continuous Temporary Minimum gaps (mm) Maximum gaps (mm)
Part / Location Contact présure max. 250 N / Torso Head Leg Foot Toes Arm Hand Finger Head Foot Finger Verdict Comments
max. 50 N /cm² 3 cm² @ 500 300 180 120 50 120 100 25 120 35 4
@ max. 150 N max. 0,75 s

ITL086 V3.2 07/04/2011
IEC 61010-1
9 TABLE: Protection against the spread of fire Form A.17 P

Source of HAZARD or area of the equipment Protection
Item considered (circuit, component, liquid etc.) Method Protection details Verdict
(9a, 9b or 9c)
Any internal component 9c Components are located within compliant fire enclosure, internal P
components are rated V-2 or better and mounted on PCB rated V-0,
insulated wiring is rated min. VW-1
TESTED BY: V.Chernikh DATE: 26/07/2011 TEST EQUIPMENT LIST ITEM

ITL086 V3.2 07/04/2011
IEC 61010-1
9.3.2 TABLE: Constructional requirements Form A.18 N/A

14.7 Printed circuit boards
Material tested ............................................................ : —

Generic name ............................................................. : —
Material manufacturer................................................. : —
Type ............................................................................ : —
Colour ......................................................................... : —
Conditioning details .................................................... : —
Sample 1 Sample 2 Sample 3

Thickness of specimen mm
Duration of flaming after first Application s
Duration of flaming plus glowing s
After second application
Specimen burns to holding clamp Yes/No
Cotton ignited Yes/No
Sample result Pass/Fail

ITL086 V3.2 07/04/2011
IEC 61010-1
9.4 TABLE: Limited-energy circuit Form A.19 P

Item 9.4 a) 9.4 b) Current and power limitation 9.4 c) Decision
or Maximum potential in Maximum Maximum Overload Circuit
Location circuit voltage available available protection separation Yes/No Comments
r.m.s./d.c. current power after 120 s
(see Form A.17) V A VA A
RS-232, pin 1 0 --- ---
RS-232, pin 2 1VDC 0 ---
RS-232, pin 3 7VDC 12mA 0.084
RS-232, pin 4 0 --- ---
RS-232, pin 5 0 --- ---
RS-232, pin 6 0 --- ---
RS-232, pin 7 0 --- ---
RS-232, pin 8 0 --- ---
RS-232, pin 9 0 --- ---
Video 2.9VDC 0 ---

ITL086 V3.2 07/04/2011
IEC 61010-1
9.5 TABLE: Requirements for equipment containing or using flammable liquids Form A.20 N/A
Type of liquid 9.5 Flammable liquids Verdict
b) Quantity c) Containment

ITL086 V3.2 07/04/2011
IEC 61010-1
10. TABLE : Temperature Measurements Form A.21A P

10.1 Surface temperature limits - NORMAL CONDITION – SQA-V P
10.2 Temperature of windings- NORMAL CONDITION – SQA-V P
10.3 Other temperature measurements – SQA-V P
Operating conditions: Normal condition, application running
Frequency ............... : 60 Hz Test room ambient temperature (ta) 25.4 °C

.................................:
Voltage.................... : 90 V Test duration ...........: 1 h 30 min
Part / Location tm tc tmax Verdict Comments
°C °C °C
P.S.: X-Capacitor C1 body near 45.5 85 P
LF1 30.9
P.S.: LF1 coil (120°C) 46.1 120- P Max. permitted temperature
10=110 was reduced by 10°C due to
31.5 thermocouple method
P.S.: C5 body near BD1 32.4 47.0 85 P
P.S.: HS1 body 36.2 50.8 130 P
P.S.: T1 coil (Class B) 50.3 130- P Max. permitted temperature
P.S.: T1 core 37.5 52.1 130 P
P.S.: L100 coil 45.7 105- P Max. permitted temperature
P.S.: C4 body near BD1 28.0 24.6 125 P
Line filter 25.8 40.4 85 P
Lithium battery body 26.2 40.8 --- P
Inverter transformer winding 48.4 105- P Max. permitted temperature
Enclosure metal 25.4 40.0 70 P
Enclosure plastic 25.7 40.3 80 P
NOTE 1 - tm = measured temperature
tc = tm corrected (tm–ta+ 40 °C or max. RATED ambient)
tmax = maximum permitted temperature
NOTE 2 - see also 14.1 with reference to component operating conditions
NOTE 3 - Record values for NORMAL CONDITION and / or SINGLE FAULT CONDITION in this Form use additional form if necessary
NOTE 4 - see Form A.21B for details of winding temperature measurements

ITL086 V3.2 07/04/2011
IEC 61010-1


.................................:
°C °C °C

ITL086 V3.2 07/04/2011

10.1 Surface temperature limits - NORMAL CONDITION – QWIKCHECK GOLD P
10.2 Temperature of windings- NORMAL CONDITION – QWIKCHECK GOLD P
10.3 Other temperature measurements – QWIKCHECK P
GOLD

.................................:
°C °C °C
LF1 27.9
P.S.: C5 body near BD1 29.3 46.0 85 P
P.S.: HS1 body 30.8 47.5 130 P
P.S.: T1 core 30.8 47.5 130 P
TESTED BY: V. Chernikh DATE: 26/07/11 TEST EQUIPMENT LIST ITEM: 1302

ITL086 V3.2 07/04/2011
IEC 61010-1

Frequency ............... : 50 Hz Test room ambient temperature (ta)

25.2 °C
.................................:
°C °C °C
33.9
LF1
33.7 10=110 was reduced by 10°C due to
thermocouple method
P.S.: C5 body near BD1 37.0 51.8 85 P
P.S.: HS1 body 53.2 68.0 130 P
thermocouple method
P.S.: T1 core 46.6 61.4 130 P
thermocouple method
thermocouple method
P.S.: C4 body near BD1 28.7 43.5 125 P
Line filter 25.6 40.4 85 P
Surge Protector 26.2 41.0 --- P
thermocouple method

ITL086 V3.2 07/04/2011
IEC 61010-1


25.2 °C
.................................:
°C °C °C

ITL086 V3.2 07/04/2011

10.1 Surface temperature limits - NORMAL CONDITION – QWIKCHECK GOLD P
10.2 Temperature of windings- NORMAL CONDITION – QWIKCHECK GOLD P
10.3 Other temperature measurements – QWIKCHECK P
GOLD

.................................:
Voltage.................... : 264 V Test duration ...........: 1 h --- min
°C °C °C
LF1 32.6
P.S.: C5 body near BD1 35.8 52.3 85 P
P.S.: HS1 body 45.9 62.4 130 P
P.S.: T1 core 37.8 54.3 130 P

ITL086 V3.2 07/04/2011
IEC 61010-1

10.1 Surface temperature limits – SINGLE FAULT CONDITION – BLOCKED VENTS – SQA-V P
10.2 Temperature of windings- SINGLE FAULT CONDITION – BLOCKED VENTS – SQA-V P
10.3 Other temperature measurements - SINGLE FAULT P
CONDITION – BLOCKED VENTS– SQA-V
Operating conditions: Blocked vents

25.7 °C
.................................:
°C °C °C
P.S.: C1 body near LF1 33.0 47.3 P
P.S.: LF1 coil 49.7 175- P Max. permitted temperature
thermocouple method
P.S.: C1 body near BD1 39.9 54.2 P
P.S.: HS1 body 52.9 67.2 P
P.S.: T1 coil 56.7 175- P Max. permitted temperature
thermocouple method
P.S.: T1 core 46.0 60.3 P
thermocouple method
thermocouple method
Line filter 30.3 44.6 P
Surge Protection 31.6 45.9 P
Lithium battery body 31.4 45.7 P
thermocouple method

ITL086 V3.2 07/04/2011
IEC 61010-1

10.1 Surface temperature limits – SINGLE FAULT CONDITION – BLOCKED VENTS – SQA-V P
10.2 Temperature of windings- SINGLE FAULT CONDITION – BLOCKED VENTS – SQA-V P
CONDITION – BLOCKED VENTS– SQA-V

25.7 °C
.................................:
°C °C °C

ITL086 V3.2 07/04/2011

10.1 Surface temperature limits – SINGLE FAULT CONDITION – BLOCKED VENTS – P
QWIKCHECK GOLD
10.2 Temperature of windings- SINGLE FAULT CONDITION – BLOCKED VENTS – QWIKCHECK P
GOLD
CONDITION – BLOCKED VENTS– QWIKCHECK GOLD

23.4 °C
.................................:
°C °C °C
P.S.: HS1 body 42.3 58.9 P
P.S.: T1 core 34.8 51.4 P

ITL086 V3.2 07/04/2011
IEC 61010-1

10.1 Surface temperature limits – SINGLE FAULT CONDITION – SQA-V P
10.2 Temperature of windings- SINGLE FAULT CONDITION – SQA-V P
10.3 Other temperature measurements – SINGLE FAULT P
CONDITION – SQA-V
Operating conditions: Fan disconnected

25.4 °C
.................................:
°C °C °C
thermocouple method
P.S.: HS1 body 64.9 79.5 P
thermocouple method
P.S.: T1 core 56.9 71.5 P
thermocouple method
thermocouple method
Line filter 29.3 43.9 P
Surge Protection 33.1 47.7 P
thermocouple method

ITL086 V3.2 07/04/2011
IEC 61010-1

10.1 Surface temperature limits – SINGLE FAULT CONDITION – SQA-V P
10.2 Temperature of windings- SINGLE FAULT CONDITION – SQA-V P
10.3 Other temperature measurements – SINGLE FAULT P
CONDITION – SQA-V
Operating conditions: Fan disconnected

25.4 °C
.................................:
°C °C °C

ITL086 V3.2 07/04/2011

10.1 Surface temperature limits – SINGLE FAULT CONDITION – DISCONNECTED FAN – P
QWIKCHECK GOLD
10.2 Temperature of windings- SINGLE FAULT CONDITION – DISCONNECTED FAN – P
QWIKCHECK GOLD
CONDITION – DISCONNECTED FAN– QWIKCHECK GOLD
Operating conditions: DISCONNECTED FAN

23.1 °C
.................................:
°C °C °C
P.S.: HS1 body 49.6 66.5 P
P.S.: T1 core 41.2 58.1 P

ITL086 V3.2 07/04/2011
IEC 61010-1
10.2 TABLE: Temperature of windings Form A.21B N/A

Resistance method Temperature Measurements
4.4.2.7 MAINS transformers
14.2.1 Motor temperatures
Operating conditions ... :
Frequency..................: Hz Test room ambient temperature (ta1/ta2) / °C (initial / final)

.................................:
Voltage ......................: V Test duration............: h min
Part / Designation Rcold Rwarm Current tr tc tmax Verdict Comments
Ω Ω A K °C °C
NOTE 1- Rcold = initial resistance Rwarm = final resistance

tr = temperature rise tc = tr corrected (tc= tr - { ta2 - ta1} + [40 °C or max RATED ambient])
NOTE 2 - Indicate insulation class (IEC 60085) under comments (optional)

ITL086 V3.2 07/04/2011
IEC 61010-1
10.5.2 TABLE: Resistance to heat of non-metallic ENCLOSURES Form A.22 P

Test method used....................................................: —
Non operative treatment..........................................: [ X ] P
Empty ENCLOSURE ...................................................: [ ] N/A
Operative treatment.................................................: [ ] N/A
Temperature during tests ........................................: 70degC —
ENCLOSURE samples tested were............................: —
Description Material Comments Verdict
Front panel PBB503 by Polyram There was no effect P
Front panel Elastolit K 4900 There was no effect P
Dielectric strength test (6.8)…………………………: V r.m.s./peak/d.c.

NOTE – Within 10 minutes of the end of treatment suitable tests in acc. to 8.2 and 8.3 must be conducted and pass criteria of 8.1.
TESTED BY: V.Chernikh DATE: 25/07/2011 TEST EQUIPMENT LIST ITEM: 1026, 1302

ITL086 V3.2 07/04/2011
IEC 61010-1
10.5.3 TABLE: Insulating Materials Form A.23 N/A

10.5.3 1) Ballpressure test
Max. allowed impression diameter..........................: 2 mm —
Part Test temperature Impression Diameter Verdict
°C (mm)
10.5.3 2) Vicat softening test (ISO 306) N/A

Part Vicat softening temperature Thickness of sample Verdict
°C (mm)

ITL086 V3.2 07/04/2011
IEC 61010-1
8 TABLE: Mechanical resistance to shock and impact Form A.24 P

11 Protection against HAZARDS from fluids N/A
Voltage tests can be carried out once after performing the tests of clause 8 and clause 11. However, if voltage tests are carried out separately after each set of tests, two forms can be used.
Clause 8 tests Clause 11 tests
Location Static Impact Normal Handheld Cleaning Spillage Overflow IEC Working Test Verdict Comments
(see form A.5) (8.2.1) (8.2.2) (8.3.1) Plug-in (11.2) (11.3) (11.4) 60529 voltage voltage
30 N (11.6) V V
Front panel P P N/A N/A N/A N/A N/A N/A N/A N/A P
(plastic)
NOTE – Use r.m.s., d.c. or peak to indicate the used test voltage.

ITL086 V3.2 07/04/2011
IEC 61010-1
11.7.2 TABLE: Leakage and rupture at high pressure Form A.25 N/A
Maximum
Part permissible Test Leakage Deformation Burst Comments
working pressure
pressure
Mpa MPa Yes / No Yes / No Yes / No
NOTE – see also Annex G with requirements for USA and Canada.
11.7.3 Leakage from low-pressure parts N/A

Test Leakage
Part pressure Comments
Mpa Yes / No

ITL086 V3.2 07/04/2011
IEC 61010-1
12.2.1 TABLE: Ionizing radiation Form A 26 N/A

12.2.1.2 Equipment intended to emit radiation N/A
Measured values Verdict
Locations tested µSv/h Comments
12.2.1.3 Equipment not intended to emit radiation N/A

Max. allowed effective dose rate at 100 mm………: 1 µSv/h —
Measured values Verdict
Locations tested µSv/h Comments

ITL086 V3.2 07/04/2011
IEC 61010-1
12.5.1 TABLE: Sound level Form A.27 N/A

Locations tested Measured values Calculated maximum sound
dBA pressure level
At operator’s normal position
and at bystanders’ positions
a)
b)
c)
d)
e)
f)
12.5.2 Ultrasonic pressure N/A

Locations tested Measured values Comments
dB kHz
At operator’s normal position
At 1 m from the ENCLOSURE
a)
b)
c)
d)
e)
NOTE – No limit is specified at present, but a limit of 110 dB above the reference pressure value of 20 µPa is under consideration for
applicable frequencies between 20 kHz and 100 kHz.

ITL086 V3.2 07/04/2011
IEC 61010-1
13.2.2 TABLE: Batteries Form A.28 P

Battery load and charging circuit diagram:
Battery type ............................................................: See Table 3 —

Battery manufacturer/model/catalogue No. ...........: See Table 3 —
Battery ratings ........................................................: See Table 3 —
Reverse polarity instalment test No possibility to install battery P
in reverse polarity
Single component failures Verdict
Component Open circuit Short circuit

ITL086 V3.2 07/04/2011
IEC 61010-1
14.3 TABLE: Overtemperature protection devices Form A.29 N/A

Reliability test
Component Type Verdict Comments
(NOTE)
NOTE:
NSR = non-self-resetting (10 times)
NR = non-resetting (1 time)
SR = self-resetting (200 times)

ITL086 V3.2 07/04/2011
IEC 61010-1
4.4.2.7 TABLE: MAINS transformer Form A.30 N/A

4.4.2.7.2 Short circuit
14.6 MAINS transformers tested outside equipment
Type ..............................: —
Manufacturer .................: —
Test in equipment
Test on bench
Test repeated inside equipment (see 14.6)
Optional – Insulation class (IEC 60085) of the lowest rated winding : —
Winding identification
Type of Protector for winding (Note 1)
Elapsed time
Current, A primary
secondary
Winding temperature, °C primary
(see Note 2) secondary
Tissue paper / cheesecloth OK ?
(Pass / Fail)
Voltage tests (see Note 3)
Primary to secondary ______ V ____
Primary to core ______ V ____
Secondary to secondary ______ V ____
Secondary to core ______ V ____
Verdict
Note 1: Primary fuse - PF / ( ) A
Secondary fuse - SF / ( ) A
Overtemperature protection - OP / ( ) °C
Impedance protection -Z
Note 2: Indicate method of measurement TC = with thermocouple
R = resistance method
If resistance method is used, record resistance in cold and warm condition in FormA.20B!
Note 3: Record the voltage applied and the type of voltage (r.m.s. / d.c. / peak) and for
results use NB = no breakdown or B = breakdown

ITL086 V3.2 07/04/2011
IEC 61010-1
4.4.2.7 TABLE: MAINS transformer Form A.31 N/A

4.4.2.7.3 Overload tests (for MAINS transformers)
14.6 MAINS transformers tested outside equipment
Type ................................ : —
Manufacturer................... : —
Test in equipment
Test on bench
Test repeated inside equipment (see 14.6)
Optional – Insulation class (IEC 60085) of the lowest rated winding : —
Winding identification
Type of Protector for winding (Note 1)
Elapsed time
Current, A primary
secondary
Winding temperature, °C primary
(see Note 2) secondary
Tissue paper / cheesecloth OK ?
(Pass / Fail)
Voltage tests (see Note 3)
Primary to secondary ______ V ____
Primary to core ______ V ____
Secondary to secondary ______ V ____
Secondary to core ______ V ____
Verdict
Note 1: Primary fuse - PF / ( ) A
Secondary fuse - SF / ( ) A
Overtemperature protection - OP / ( ) °C
Impedance protection -Z
Note 2: Indicate method of measurement TC = with thermocouple
R = resistance method
If resistance method is used, record resistance in cold and warm condition in FormA.20B!
Note 3: Record the voltage applied and the type of voltage (r.m.s. / d.c. / peak) and for
results use NB = no breakdown or B = breakdown

ITL086 V3.2 07/04/2011
IEC 61010-1
14.8 TABLE: Transient overvoltage limiting devices Form A.32 N/A

Component / Designation Overvoltage MAINS voltage Test voltage tm tc tmax Rupture Circuit breaker Verdict Comments
Category V rms V °C °C °C Yes / No tripped
Test room ambient temperature ….: °C

NOTE - tm = measured temperature
Conformity is checked by applying 5 positive and 5 negative impulses with the applicable impulse withstand voltage, spaced up to 1 min apart, from a hybrid impulse generator (see IEC 61180-1).

ITL086 V3.2 07/04/2011
Appendix of tables to be used as needed

ITL086 V3.2 07/04/2011
IEC 61010-1
Clause Requirement – Test Result — Remark Verdict
Annex H TABLE: Qualification of conformal coating Addition to Form A.xx N/A

for
protection against pollution
Technical properties
Manufacturer ................................................. : —
Type............................................................... : —
Meet requirements of ANSI / UL 746E.......... : [yes / no]
Manufacturer declaration of coating material : [yes / no]
Operating temperature of coating ................. : [ ] °C
Comparative tracking index (CTI) ................. : [ ]
Insulation resistance...................................... : [ ] Ω
Dielectric strength.......................................... : [ ] V
UV resistance (if required)............................. : [yes / no]
Flammability rating ........................................ :
Preparation of the test specimens [yes / no]
Item Test conditioning Parameter Td Samples Verdic Comments
t
h 1 2 3 4 5 6
1 Scratch resistance
Visual inspection
2 Cold 24
3 Dry heat 48
4 Rapid temp.
change
5 Damp heat 24
6 Adhesion of 5N
coading
Visual inspection
7 Humidity 48
8 Insulation >= 100 Ω
resistance
Visual inspection
NOTE Td = Test duration time


ITL086 V3.2 07/04/2011
IEC 61010-1
Clause Requirement – Test Result — Remark Verdict
6.7.2.2.2 TABLE: Reliability of potted components Addition to Form A.14 N/A
Temperature Cycling Test
Manufacturer................................................ :
Type ............................................................. :
Construction................................................. :
Potting compound........................................ :
CREEPAGE distances measured................... :
CLEARANCES measured................................ :
Thickness through insulation ....................... :
Adhesive test Pass/Fail ............................... :
Test temperature T °C ................................. :
Cycles at U= AC 500 V Leakage current (500 V)
mA
Number of cycles Date 68 h / 1h/ 2h/ 1h/
125 °C 25 °C 0 °C 25 °C
1. Cycle from to
2. Cycle from to
3. Cycle from to
4. Cycle from to
5. Cycle from to
6. Cycle from to
7. Cycle from to
8. Cycle from to
9. Cycle from to
10. Cycle from to
After Cycling Test :
Humidity conditioning 48 h
Requirements for dielectric strength (s. insulation diagram) Test voltage V r.m.s Verdict
Basic insulation ______ V r.m.s.
Additional insulation ______ V r.m.s.
Reinforced insulation ______ V r.m.s.

ITL086 V3.2 07/04/2011
IEC 61010-1
6. TABLE: WORKING VOLTAGE of Switch Mode Power Supply Addition to Form A.5 N/A
Location / Measuring track Insulation RMS voltage Peak voltage Required Measured Required Measured Verdict Comments
(Form A.5) V V cl cl cp cp
mm mm mm mm
Input supply voltage…….: V Hz


ITL086 V3.2 07/04/2011

ITL086 V3.2 07/04/2011
IEC 61010-1
x.x.x TABLE: Addition to Form A.xx N/A
NOTE –

ITL086 V3.2 07/04/2011
IEC 61010-1
x.x.x TABLE: Addition to Form A.xx N/A

ITL086 V3.2 07/04/2011
National Differences
National Differences for Switzerland (CH) P

1 Switzerland (Ordinance on environmentally No hazardous substances used P
hazardous substances SR 814.081, Annex 1.7,
Mercury - Annex 1.7 of SR 814.81 applies for
mercury.)
Switches containing mercury such as
thermostats, relays and level controllers are not
allowed.
Ordinance on chemical hazardous risk reduction
SR 814.81, Annex 2.15 Batteries
Annex 2.15 of SR 814.81 applies for batteries
containing cadmium and mercury.
Note. Ordinance relating to environmentally
hazardous substances, SR814.013 is no longer
in force and superseded by SR814.81 of
2009/02/01 (ChemRRV)
5.1.3 Supply cords of portable electrical appliances No cord evaluated as part of the N/A
having a RATED CURRENT not exceeding 10 A equipment
shall be provided with a plug complying with IEC
60884-1 (3.ed) + am1, SEV 1011 or and one of
the following dimension sheets:
- SEV 6533-2:2009 Plug type 11, L + N, 250V

10A
- SEV 6534-2:2009 Plug type 12, L + N + PE,
250V 10A
- SEV 6532-2:2009 Plug type 15, 3L + N + PE,
250/400V 10A
Supply cords of portable electrical appliances
having a rated current
not exceeding 16 A shall be provided with a plug
complying with IEC 60884-1(3.ed.) + am1,
SEV 1011 and one of the following dimension
sheets:
- SEV 5933-2:2009 Plug type 21 L + N, 250 V,
16A
- SEV 5934-2:2009 Plug type 23 L + N + PE, 250
V, 16A
- SEV 5932-2:2009 Plug type 25 3L + N + PE,
250/400V 16A
NOTE 16 A plugs are not often used in Swiss

domestic installation system.
See TRF template regulatory requirements

Switzerland on IECEE Website R.R. TRF
templates.

ITL086 V3.2 07/04/2011
Appendix 1. Photographs.
Photograph 1.
SQA-V front view.
ITL086 V3.2 07/04/2011
Photograph 2.
SQA-V rear view.
ITL086 V3.2 07/04/2011
Photograph 3.
SQA-V internal rear view (bottom perforating plates not shown).
ITL086 V3.2 07/04/2011
Photograph 4.
SQA-V internal front view (bottom perforating plates not shown).
ITL086 V3.2 07/04/2011
Photograph 5.
QwikCheck Gold front view.
ITL086 V3.2 07/04/2011
Photograph 6.
QwikCheck Gold rear view.
ITL086 V3.2 07/04/2011
Photograph 7.
QwikCheck Gold internal rear view (bottom perforating plates not shown).
Note: surge protector shown on photo is not installed in final version.
ITL086 V3.2 07/04/2011
Photograph 8.
QwikCheck Gold internal front view
ITL086 V3.2 07/04/2011
Bottom of Enclosure Drawing:
End of Test Report.
ITL086 V3.2 07/04/2011

SQA-V and QwikCheck Gold Test Report 61010-1

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TEST REPORT

Report Number. ............................. : S106490.02

Testing Laboratory........................: I.T.L (PRODUCT TESTING) Ltd.

Applicant’s name ..........................: Medical Electronic Systems Ltd.

TRF No.: IEC 61010_1F Page 1 of 108 TRF originator: VDE

Document Documents included / attached to this report (description) Page

Test Report History:

TRF No.: IEC 61010_1F Page 2 of 108 TRF originator: VDE

Tests performed (name of test and test Testing location:

Summary of compliance with National Differences

The product fulfils the requirements of _IEC/EN 61010-1:2010________

TRF No.: IEC 61010_1F Page 3 of 108 TRF originator: VDE

Copy of marking plate

TRF No.: IEC 61010_1F Page 4 of 108 TRF originator: VDE

Throughout this report a comma / point is used as the decimal separator.

Unit employs SELV Limited Energy RS-232 and video connections.

TRF No.: IEC 61010_1F Page 5 of 108 TRF originator: VDE

Table 1: List of Test equipment

ITL Instrument Manufacturer Model Serial CalDue

TRF No.: IEC 61010_1F Page 6 of 108 TRF originator: VDE

Table 3. List of Critical Components.

TRF No.: IEC 61010_1F Page 7 of 108 TRF originator: VDE

DC Fan, Sunonwealth or KDE1209PTV3 Rated: 12VDC, 1.3W, UL507 UR (E77551)

TRF No.: IEC 61010_1F Page 8 of 108 TRF originator: VDE

5 MARKING AND DOCUMENTATION P

TRF No.: IEC 61010_1F Page 9 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 10 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 11 of 108 TRF originator: VDE

Protected throughout (symbol 11 used) N/A

TRF No.: IEC 61010_1F Page 12 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 13 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 14 of 108 TRF originator: VDE

6 PROTECTION AGAINST ELECTRIC SHOCK P

TRF No.: IEC 61010_1F Page 15 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 16 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 17 of 108 TRF originator: VDE

Bonded to the PROTECTIVE CONDUCTOR TERMINAL; or P

6.5.2.2 Integrity of PROTECTIVE BONDING P

e) Any moveable PROTECTIVE BONDING No moveable connection N/A

TRF No.: IEC 61010_1F Page 18 of 108 TRF originator: VDE

6.5.2.3 PROTECTIVE CONDUCTOR TERMINAL Earthing pin of IEC 60320 type P

Is near terminals of circuit for which protective N/A

Suitable size for bond wire N/A

TRF No.: IEC 61010_1F Page 19 of 108 TRF originator: VDE

less than 0,1 Ohm; or P

6.5.2.6 Transformer PROTECTIVE BONDING screen N/A

The protective impedance consists of one or more of —

TRF No.: IEC 61010_1F Page 20 of 108 TRF originator: VDE

6.6.2 TERMINALS for external circuits N/A

TRF No.: IEC 61010_1F Page 21 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 22 of 108 TRF originator: VDE

6.7.2.2.4 Thin-film insulation Part of certified power supply N/A

TRF No.: IEC 61010_1F Page 23 of 108 TRF originator: VDE

- REINFORCED INSULATION No such insulation relied upon N/A

6.7.3.2 CLEARANCES No such insulation relied upon N/A

or No such insulation relied upon N/A

TRF No.: IEC 61010_1F Page 24 of 108 TRF originator: VDE

Complies as applicable: No such insulation relied upon N/A

TRF No.: IEC 61010_1F Page 25 of 108 TRF originator: VDE

Detachable cords with IEC 60320 MAINS connectors: —

TRF No.: IEC 61010_1F Page 26 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 27 of 108 TRF originator: VDE

TRF No.: IEC 61010_1F Page 28 of 108 TRF originator: VDE