Technical Report TüV

Technical Report No.
028-71326415-000
Rev. 0
Dated 2007-10-18
Client: LRE Medical GmbH
Frankfurter Ring 15
D-80807 München
Manufacturer: Dräger Safety AG & Co KGaA
Revalstraße 1
D-23560 Lübeck
Test subject: Product: In vitro diagnostic device

Type: DrugTest 5000
Trademark: Dräger
Test specification: EN 61010-1:2001

EN 61010-2-101:2002
EN 60529/A1:2000
Purpose of examination: Test according to the test specification
Test result: The test subject was found to be in compliance with the mentioned test
specification
This technical report may only be quoted in full. Any use for advertising purposes must be granted in writing. This report is the
result of a single examination of the object in question and is not generally applicable evaluation of the quality of other products in
regular production.
tec_tb_2004_e.dot 01.03.2006
Phone: + 49 49 89 5008-4322 TÜV SÜD Product Service GmbH

Fax: + 49 49 89 5008-4130
File: 028-71326415-000_TR_e.doc Munich Branch
Rep.-No: 028-71326415-000 Project Manager: E-Mail: ralph.fischer@tuev-sued.de Ridlerstraße 65
Revision: 0 Ralph Fischer 80339 Munich
Page 1 of 3 Date: 2007-10-18 Germany
1 Description of the test subject
1.1 Function
The Dräger-DrugTest 5000 Analyzer is a device for proving drugs in oral fluid samples
collected with the Dräger DrugTest 5000 Test-Kit (in-vitro-diagnostics). The
measurement is based upon an optical evaluation of the immunochemical test strips
contained in the Test-Kit. The system is an easy and quick test procedure for proving
amphetamines, benzodiazepines, cannabinoides, cocaine metabolites,
metamphetamines and opiates. Test results are displayed immediately after finishing
the analysis and can be stored in the analyzer, printed with the Dräger Mobile Printer or
transferred to a PC via the integrated USB interface. The system is suited for stationary
as well as for mobile use.
1.2 Technical Data

Model reference: DurgTest 5000
Rated voltage: 12Vdc

Rated power consumption: 50W
Protection class: III

Degree of protection: IP34
2 Order
2.1 Date of Purchase Order

2007-09-03
2.2 Receipt of Test Sample

2007-09-26
2.3 Date of Testing

2007-09-26 to 2007-10-18 (EN 61010-1, EN 61010-2-101)
2007-10-11 (EN 60529)
2.4 Location of Testing

TÜV SÜD Product Service GmbH, Ridlerstr. 65, D-80339 München

Fax: + 49 49 89 5008-4130
3 Test Results
3.1 Positive Test Results
• Electrical safety
• Protection provided by enclosures (IP34)
4 Remark
The user manual has been examined according to the minimum requirements described
in the product standard. The manufacturer is responsible for the accuracy of further
particulars as well as of the composition and layout.
TÜV SÜD Product Service GmbH TÜV SÜD Product Service GmbH
Technical Report checked Engineer
i.A. Dipl.-Ing.(FH) Manfred Schmolke i.A. Ralph Fischer

Industry Electronics Industry Electronics

Fax: + 49 49 89 5008-4130
Page 1 of 44
TEST REPORT
IEC 61010-1
Safety requirements for electrical equipment for measurement, control, and laboratory use
Part 1: General requirements
Report Reference No. .....................: 028-71326415-000
Compiled by (+ signature) ................: Ralph Fischer

......................................................
Approved by (+ signature) ................: Manfred Schmolke

......................................................
Date of issue .....................................: 2007-10-18
CB Testing Laboratory ...................: TÜV SÜD Product Service GmbH
Address.............................................: Ridlerstrasse 65, D-80339 München, Germany
Testing location ................................: CBTL SMT WMT TMP
Address.............................................: Ridlerstrasse 65, D-80339 München, Germany
Applicant’s name ............................: LRE Mediacl GmbH
Address.............................................: Frankfurter Ring 15, D-80807 München
Test specification:
Standard ...........................................: IEC 61010 – 1 : 2001 (Second Edition)
Test procedure .................................: Conformity testing
Non-standard test method ................: N/A
Test Report Form No. .....................: IEC61010_1D
TRF Originator ..................................: UL
Master TRF .......................................: Dated 2004-09
Copyright © 2004 IEC System for Conformity Testing and Certification of Electrical Equipment (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.
Test item description .....................: Laboratoy equipment (drug tester)

Trademark ........................................: Dräger
Model / Type reference.....................: DrugTest 5000
Manufacturer.....................................: Dräger Safety AG & Co KGaA, Revalstr. 1, D-23560 Lübeck
Rating(s) ...........................................: 12VDC, 50W
Test Report IEC 61010-D Rev. 00 / 2004-11

Page 2 of 44
Report Reference No.: 028-71326415-000
2007-10-18
Copy of marking plate:
Summary of Test Results (information/comments):
The equipment complies with EN 61010-1, EN 61010-2-101 and EN 60529.
Attached documents:
No. Decription Pages
1 Photo documentation 9
2 IEC/EN 61010-2-101 Test Report 8
3 IEC/EN 60529/A1 Test Report 17

Page 3 of 44
2007-10-18
Test item particulars:

Type of item tested........................................................ : Laboratory
Description of equipment function ................................ : see intended use
Protection Class of equipment...................................... : III
Pollution degree ............................................................ : 2
Environmental rating .................................................... : standard
Equipment mobility ....................................................... : portable
Connection to mains supply ........................................ : none, supplied by internal battery and/or by external
power supply
Operating conditions .................................................... : continuous
Overall size of the equipment: width; depth; height ..... : 200x250x220mm
Mass of the equipment (kg) ......................................... : 4,5kg
Marked degree of protection to IEC 60529 ................ : not marked but tested according IP34
Accessories and detachable parts included in the
evaluation ...................................................................... : None
Options included ........................................................... : None
Possible test case verdicts:
- test case does not apply to the test object ................. : N
- test object does meet the requirement ....................... : Pass (P)
- test object does not meet the requirement................. : Fail (F)
General remarks:
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.
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 appended table)" refers to a table appended to the report.
Throughout this report, a point (coma) is used as the decimal separator.

List of test equipment must be kept on file and available for review.
Intended use:
The Dräger-DrugTest 5000 Analyzer is a device for proving drugs in oral fluid samples collected with the
Dräger DrugTest 5000 Test-Kit (in-vitro-diagnostics). The measurement is based upon an optical evaluation of
the immunochemical test strips contained in the Test-Kit. The system is an easy and quick test procedure for
proving amphetamines, benzodiazepines, cannabinoides, cocaine metabolites, metamphetamines and
opiates. Test results are displayed immediately after finishing the analysis and can be stored in the analyzer,
printed with the Dräger Mobile Printer or transferred to a PC via the integrated USB interface. The system is
suited for stationar y as as well as for mobile use.

Page 4 of 44
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Clause Requirement − Test Result − Remark Verdict
4.4 Testing in SINGLE FAULT CONDITIONS ⎯

4.4.1 Fault tests.............................................................. : (see TABLE 4.4) P
4.4.2 Specific faults P
4.4.2.1 PROTECTIVE IMPEDANCE N
4.4.2.2 Protective conductor N
4.4.2.3 Equipment or parts for short-term or intermittent N
operation
4.4.2.4 Motors P
4.4.2.5 Capacitors N
4.4.2.6 Mains transformers N
4.4.2.7 Outputs P
4.4.2.8 Equipment for more than one supply N
4.4.2.9 Cooling P
– air holes closed P
– fans stopped N
– coolant stopped N
4.4.2.10 Heating devices P
– timer overridden N
– temperature controller overridden P
– loss of cooling liquid N
– overfilled or empty or both N
4.4.2.11 Insulation between circuits and parts N
4.4.2.12 Interlocks N
5 MARKING AND DOCUMENTATION ⎯
5.1.1 Required marking visible from the exterior; or P
- after removing a cover; or opening a door N
Marking visible after removal from a rack or panel N
Marking not put on parts, which can be removed P
by an OPERATOR
Letter symbols (IEC 60027) used P
Graphic symbols (IEC 61010-1: Table 1) used P
5.1.2 Identification P
5.1.2a) Manufacturer’s or supplier’s name or trademark P

Page 5 of 44
2007-10-18
5.1.2b) Model number, name or other means P

Manufacturing location identified One location N
5.1.3 Mains supply ........................................................ : Supplied by internal battery P
and/or external power supply
5.1.3a) Nature of supply ................................................... : DC P
Use of symbol 1 for d.c. equipment P
5.1.3b) RATED supply voltage(s) or range ......................... : 12V P
5.1.3c) Max. RATED power (W or VA) or input current ..... : 50W P
The measured value not more than 110 % ......... : (see TABLE 5.1.3c) P
If more than one voltage range, separate values N
marked; or
- values differ by less than 20 % N
5.1.3d) Equipment, which the OPERATOR can set for N
different RATED supply voltages
- indicates the equipment set voltage N
- PORTABLE EQUIPMENT indication is visible from N
the exterior
- changing the setting changes the indication N
5.1.3e) Accessory mains socket-outlets accepting N
standard mains plugs marked with voltage if it is
different from the MAINS supply voltage
An outlet for use only with specific equipment, N
marked to identify the equipment, for which it is
intended, or
- the max. RATED current or power marked, or N
- Symbol 14 with full details in the documentation N
5.1.4 OPERATOR replaceable fuse marking (see also N
5.4.5) ..................................................................... :
5.1.5 TERMINALS, connections and operating devices N
Where necessary for safety, indication of purpose USB and PS2 outputs N
of TERMINALS, connectors, controls and indicators indicated; input for external
marked .................................................................. : power supply indicated.
Mismatch cannot lead to
hazards.
If insufficient space, symbol 14 used N
5.1.5.1 TERMINALS N
Mains supply TERMINALS identified N
Other TERMINAL marking ......................................... : N

Page 6 of 44
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5.1.5.1a) FUNCTIONAL EARTH TERMINALS (symbol 5 used) N

5.1.5.1b) PROTECTIVE CONDUCTOR TERMINALS N
Symbol 6 placed close to or on the TERMINAL; or N
- placed on part of appliance inlet N
5.1.5.1c) TERMINALS of measuring and control circuits N
(symbol 7 used)
5.1.5.1d) HAZARDOUS LIVE TERMINALS supplied from the N
interior
Standard MAINS socket outlet; or N
- RATINGS marked; or N
- Symbol 14 used N
5.1.5.1e) ACCESSIBLE FUNCTIONAL EARTH TERMINALS N
Self-evident; or indication (symbol 8 acceptable) N
5.1.5.2 Measuring circuit TERMINALS N
Voltage and current measuring circuit TERMINALS N
not intended for connection to voltages to earth
above 50 V a.c. or 120 V d.c., and clear
indication provided on a measuring instrument ... :
a) Measuring circuit TERMINALS for measurements N
within measurement category I marked with the
RATED voltage or current and with symbol 14 ...... :
b) Measuring circuit TERMINALS for measurements N

within measurement categories II, III and IV
marked with the RATED voltage or current ............ :
Appropriate measurement category marked on N
measuring circuit TERMINALS; (CAT II, CAT III or
CAT IV) ................................................................ :
Voltage and current measuring circuit TERMINALS N
(permanently connected and not ACCESSIBLE) not
marked, and
-the measurement category and the RATED N
maximum WORKING VOLTAGE or RATED
maximum current stated in the equipment
installation instructions
Required markings are adjacent to TERMINALS; or N
- if insufficient space marking on the RATING plate N
or scale plate, or
- TERMINAL is marked with symbol 14 N
5.1.6 Switches and circuit breakers N
If disconnecting device, on or off position marked N

Page 7 of 44
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5.1.7 Equipment protected by DOUBLE INSULATION or N

REINFORCED INSULATION
Protected throughout (symbol 11 used) N

Only partially protected (symbol 11 not used) N
5.1.8 Field-wiring TERMINAL boxes N
If TERMINAL or ENCLOSURE exceeds 60 °C cable (see TABLE 10.5.2) N
temperature RATING marked ................................. :
Marking visible before and during connection, or N
beside TERMINAL
5.2 Warning markings N
Visible when ready for NORMAL USE N
Placed near or on applicable parts N
Symbols and text correct dimensions and color N
If necessary marked with symbol 14 N
Statement to isolate or disconnect N
5.3 Durability of markings P
The required markings remain clear and legible in (see TABLE 5.3) P
NORMAL USE ......................................................... :
5.4 Documentation P
5.4.1 Equipment is accompanied by required P
documentation:
Statement to consult documentation in all cases N
where symbol 14 is used, to find out the nature of
the potential HAZARD and any actions to be taken
5.4.1a) Intended use P
5.4.1b) Technical specification P
5.4.1c) Instructions for use P
5.4.1d) Name and address of manufacturer or supplier P
5.4.1e) Information specified in 5.4.2 to 5.4.5 P
5.4.1f) If marking of TERMINALS required on equipment, N
definition of measurement category

Page 8 of 44
2007-10-18
5.4.1g) For equipment CAT I, a warning not to use within N

measurement categories II, III and IV, and a
detailed RATING including the RATED transient
overvoltages
Warning statements and a clear explanation of N
warning symbols marked on the equipment are
provided in the documentation, or
- Durability and legibly marked on the equipment. N
5.4.2 Equipment RATINGS P
5.4.2a) Supply voltage or voltage range .......................... : 12V P
Frequency or frequency range ............................. : DC P
Power or current RATING....................................... : typ. 3A P
5.4.2b) Description of all input and output connections P
5.4.2c) RATING of insulation of external circuits, when N
such circuits are nowhere ACCESSIBLE
5.4.2d) Statement of the range of environmental P
conditions
5.4.2e) Degree of protection (IEC 60529) ........................ : IP34 tested but not indicated N
5.4.3 Equipment installation P
5.4.3a) Assembly, location and mounting requirements P
5.4.3b) Instructions for protective earthing N
5.4.3c) Connections to supply P
5.4.3d) PERMANENTLY CONNECTED EQUIPMENT N
1) Supply wiring requirements N
2) If external switch or circuit-breaker, N
requirements and location recommendation
5.4.3e) Ventilation requirements Hint to keep venting slots open P
and clean
5.4.3f) Special services (e.g. air, cooling liquid) N
5.4.3g) Maximum sound power level N
5.4.3h) Instructions about sound pressure N
5.4.3i) Permanently connected measuring TERMINALS N
Measurement category N
RATED MAXIMUM WORKING VOLTAGE or current N

Page 9 of 44
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5.4.4 Instructions for use contain information for P

equipment operation
5.4.4a) Identification of operating controls P
5.4.4b) Positioning for disconnection N
5.4.4c) Interconnection Part of accessories N
5.4.4d) Specification of intermittent operation limits N
5.4.4e) Explanation of symbols used P
5.4.4f) Replacement of consumable materials N
5.4.4g) Cleaning and decontamination (see 11.2) P
5.4.4h) Listing of any poisonous or injurious gases and N
quantities
5.4.4i) Risk-reduction procedures relating to flammable N
liquids
A statement about protection impairment if used N
in a manner not specified by the manufacturer
5.4.5 Equipment maintenance Maintenance free equipment; P
yearly external maintenance
recommended
Instructions for the RESPONSIBLE BODY concerning N
preventive maintenance and safety inspection are
given in sufficient detail
- replacement of hoses or parts containing N
liquids, etc.
- for replaceable batteries, the specific battery N
type stated
Any manufacturer specified parts N
RATING and characteristics of fuses N
6 PROTECTION AGAINST ELECTRIC SHOCK ⎯
6.1.1 ACCCESSIBLE parts not HAZADOUS LIVE in NORMAL P
CONDITION and SINGLE FAULT CONDITION
6.1.2 Exceptions: Capacitance test............................... : (see TABLE 6.2 and 6.3.1) N

Parts not HAZARDOUS LIVE 10 s after interruption N
of supply
6.2 Determination of ACCESSIBLE parts P
6.2.1 General examination ............................................ : Class III equipment – no part P
of circuits is electrical
hazardous
6.2.2 Openings above parts that are HAZARDOUS LIVE N

Page 10 of 44
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6.2.3 Openings for pre-set controls N

6.3 Permissible limits for ACCESSIBLE parts P
6.3.1 Values in NORMAL CONDITION ................................ : (see TABLE 6.3.1) P
6.3.2 Values in SINGLE FAULT CONDITION ........................ : (see TABLE 6.3.2) P
6.4 Protection in NORMAL CONDITION Class III equipment, no P
hazardous voltages
a) BASIC INSULATION (see annex D) N
b) enclosures or barriers N
c) impedance N
6.5 Protection in SINGLE FAULT CONDITION Class III equipment, no N
hazardous voltages
Additional protection provided by one or more of N
6.5.1 to 6.5.3; or
-automatic disconnection of the supply (6.5.4) N
6.5.1 Protective BONDING N
ACCESSIBLE conductive parts ................................ : N
Separated by DOUBLE INSULATION or REINFORCED N
INSULATION;or
- bonded to the PROTECTIVE CONDUCTOR TERMINAL; N
or
- separated by screen or BARRIER bonded to N
PROTECTIVE CONDUCTOR TERMINAL from parts
which are HAZARDOUS LIVE
6.5.1.1 Integrity of PROTECTIVE BONDING N
6.5.1.1a) PROTECTIVE BONDING consists of directly N
connected structural parts or discrete conductors
or both; and withstands thermal and dynamic
stresses
6.5.1.1b) Soldered connections independently secured N
-not used for other purposes N
Screw connections are secured against N
loosening
6.5.1.1c) PROTECTIVE BONDING not interrupted N
6.5.1.1d) Any moveable connection specifically designed, N
and meets 6.5.1.3
6.5.1.1e) No external metal braid of cables used N
6.5.1.1f) If MAINS supply passes through equipment means N
provided for passing protective conductor

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The impedance to the protective conductor path N

through the equipment meets 6.5.1.3.
6.5.1.1g) Protective conductors bare or insulated, N
if insulated, green/yellow
-green-and-yellow insulation not required for N
earthing braids;
-green-and-yellow insulation not required for N
internal protective conductors etc.;
Green/yellow insulation not used for other N
purposes
6.5.1.1h) TERMINAL suitable, and meets 6.5.1.2 N
6.5.1.2 PROTECTIVE CONDUCTOR TERMINAL N
6.5.1.2a) Contact surfaces are metal N
6.5.1.2b) Appliance inlet used N
6.5.1.2c) For rewireable cords and PERMANENTLY N
CONNECTED EQUIPMENT, PROTECTIVE CONDUCTOR
TERMINAL is close to MAINS supply TERMINALS
6.5.1.2d) If no MAINS supply is required, the PROTECTIVE N

CONDUCTOR TERMINAL is located near to the
TERMINALS of that circuit, for which protective
earthing is necessary
If circuit has external TERMINALS, the PROTECTIVE N
CONDUCTOR TERMINAL is also external.
6.5.1.2e) PROTECTIVE CONDUCTOR TERMINALS for MAINS N

CIRCUITS are at least equivalent in current-
carrying capacity to the MAINS supply TERMINALS . :
6.5.1.2f) If plug-in, makes first and breaks last N
6.5.1.2g) When the PROTECTIVE CONDUCTOR TERMINAL is N
also used for other bonding purposes, the
protective conductor is applied first and secured
independently of other connections
Unlikely to be removed by servicing; or N
- warning marking requires replacement of N
protective conductor
6.5.1.2h) Protective conductor of measuring circuit N
1) The PROTECTIVE CONDUCTOR TERMINAL and N
protective conductor have at least the current
RATING of the measuring TERMINALS
2) PROTECTIVE BONDING is not interrupted by the N

presence of any switching or interrupting device

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Devices used for indirect bonding (see 6.5.1.5) N

are part of the PROTECTIVE BONDING
6.5.1.2i) FUNCTIONAL EARTH TERMINALS allow independent N
connection
6.5.1.2j) When the PROTECTIVE CONDUCTOR TERMINAL is a N
binding screw, the screw is of a suitable size for
the bond wire, but no smaller than M4 (No. 6),
with at least three turns of the screw engaged.
Contact pressure not capable of reduction by N
deformation of materials
Passes tightening torque test............................... : N
6.5.1.3 Impedance of PROTECTIVE BONDING of plug- N
connected equipment........................................... :
6.5.1.4 Bonding impedance of PERMANENTLY CONNECTED N
EQUIPMENT ........................................................... :
6.5.1.5 Indirect bonding for measuring and test N
equipment ........................................................... :
6.5.2 DOUBLE INSULATION and REINFORCED INSULATION N
(see 6.7, 6.8 and 6.9.2)
6.5.3 PROTECTIVE IMPEDANCE ......................................... : N
6.5.3a) HIGH-INTEGRITY single component used (see N
14.6); or
6.5.3b) A combination of components used; or N
6.5.3c) A combination of BASIC INSULATION and current- or N
voltage-limiting device used
Components, wires and connections are RATED N
as required
6.5.4 Automatic disconnection of the supply N
6.5.4a) Automatic disconnection supplied with the N
equipment; or
- specified by installation instruction N
6.5.4b) RATED disconnecting time within limit specified N
6.5.4c) RATED for maximum RATED LOAD N
6.6 Connections to external circuits P
6.6.1a) Connections do not cause ACCESSIBLE parts of Output connections are non- P
the external circuits to become HAZARDOUS LIVE in hazardous voltages
NORMAL CONDITION or SINGLE FAULT CONDITION

Page 13 of 44
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6.6.1b) Connections do not cause ACCESSIBLE parts of Connection to external SELV P

equipment to become HAZARDOUS LIVE in NORMAL only
CONDITION or SINGLE FAULT CONDITION
Protection achieved by separation of circuits N

Short circuit of separation does not cause a N
HAZARD
The manufacturer's instructions or equipment N

markings include the required information for
each external TERMINAL:
1) RATED conditions for TERMINAL N
2) Required RATING of external circuit insulation N
6.6.2 TERMINALS for external circuits N
TERMINALS, which receive a charge from an N
internal capacitor are not HAZARDOUS LIVE ........... :
High voltage TERMINALS energized from the N
interior are not ACCESSIBLE if connected; or
- unmated HAZARDOUS LIVE TERMINALS not N
ACCESSIBLE ; or
- marked with symbol 12 N

6.6.3 Circuits with TERMINALS which are HAZARDOUS LIVE N
Not connected to ACCESSIBLE conductive parts; or N
- connected to ACCESSIBLE conductive parts, but N
are not MAINS CIRCUITS and have one TERMINAL
contact at earth potential
No ACCESSIBLE conductive parts are HAZARDOUS N
LIVE
6.6.4 ACCESSIBLE TERMINALS for stranded conductors N

6.6.4a) ACCESSIBLE TERMINALS are so located or shielded N
that there is no risk of accidental contact
ACCESSIBLE TERMINALS self-evident or marked N
whether or not connected to ACCESSIBLE
conductive parts
6.6.4b) ACCESSIBLE TERMINALS will not work loose N
6.7 CLEARANCES and CREEPAGE DISTANCES ................ : (see TABLE 6 and 6.8) P
6.7.1.2 CTI tests .............................................................. : N
6.8 Dielectric strength tests........................................ : N

Page 14 of 44
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6.9 Constructional requirements for protection P

against electric shock
6.9.1a) The security of wiring connections subjected to P
mechanical stresses does not depend on
soldering
6.9.1b) Screws securing removable covers are captive if N
their length determines a CLEARANCE or CREEPAGE
DISTANCE between ACCESSIBLE conductive parts
and HAZARDOUS LIVE parts
6.9.1c) Accidental loosening or freeing of the wiring, Battery fixed with rubber band; P
screws, etc., does not cause ACCESSIBLE parts to if battery gets free both
become HAZARDOUS LIVE. contacts can reach a
constructional metal part. This
metal part is provided with
plastic insulation.
1) Easily damaged materials not used P
2). Non-impregnated hydroscopic materials not P
used
6.9.2 ENCLOSURES of equipment with DOUBLE N
INSULATION or REINFORCED INSULATION
ENCLOSURE surrounds all metal parts except for N

small metal parts, which are separated
ENCLOSURES or parts made of insulating material N
6.9.2a) Protection for metal ENCLOSURES or parts by an N
insulating coating or BARRIER on the inside; or
6.9.2b) CLEARANCES and CREEPAGE DISTANCES cannot be P
reduced by loosening of parts or wires
6.9.3 Over-range indication is unambiguous N
6.10 Connection to MAINS supply source and N
connections between parts of equipment
6.10.1 MAINS supply cords No mains connection N
6.10.1a) RATED for maximum equipment current (see N
5.1.3c)
Cable complies with IEC 60227 or IEC 60245 N
6.10.1b) Heat-resistant if likely to contact hot parts N
6.10.1c) Temperature RATING of detachable cord and inlet N
rated at least for the highest temperature RATING
for either part (ºC) ................................................ :

Page 15 of 44
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6.10.1d) Green/yellow used only for connection to N

PROTECTIVE CONDUCTOR TERMINALS
Detachable cords with IEC 60320 MAINS N

connectors comply with IEC 60799; or
- have the current RATING of the MAINS connector N
6.10.2 Fitting of non-detachable MAINS supply cords N
Non-detachable cord protected against abrasion N
and sharp bends at the point where the cord
enters the equipment
6.10.2a) Inlet or bushing smoothly rounded; or N
6.10.2b) Insulated cord guard protruding = 5D N
The protective earth conductor is the last to take N
the strain
Cord anchorages N
6.10.2a) Cord is not clamped by direct pressure from a N
screw
6.10.2b) Knots are not used N
6.10.2c) c) Cannot push the cord into the equipment to N
cause a hazard
6.10.2d) No failure of cord insulation in anchorage with N
metal parts
6.10.2e) A compression bushing not used unless it has N
provision for clamping all types and sizes of
MAINS supply cords
- suitable for connection to the TERMINALS N

provided, or the bushing has been designed to
terminate a screened MAINS supply cord
6.10.2f) Cord replacement does not cause a HAZARD and N
method of strain relief is clear
Push-pull test ....................................................... : N
6.10.3 Plugs and connectors N
6.10.3a) MAINS supply plugs, connectors etc., conform N
with relevant specifications
6.10.3b) If equipment supplied at voltages below 6.3.2.a) N
or from a sole source, plugs of supply cords do
not fit MAINS sockets above RATED supply voltage
MAINS-type plugs used only for connection to N
MAINS supply
6.10.3c) Plug pins which receive a charge from an internal N

capacitor .............................................................. :

Page 16 of 44
2007-10-18
6.10.3d) Accessory MAINS socket outlets N

1) Marking if accepts a standard MAINS plug N
(see 5.1.3e)
2) Input has a protective earth conductor if outlet N
has earth TERMINAL contact
6.11 Disconnection from supply source P
6.11.1 Disconnection of all current carrying conductors; N
except for
6.11.1.1a) Equipment supplied by low energy source; or N
6.11.1.1b) Equipment connected to impedance protected N
supply; or
6.11.1.1c) Equipment constitutes an impedance protected Input of external power supply P
load is limited by polyswitch SI1 on
mainboard.
6.11.2 Requirements according to type of equipment N
6.11.2.1 PERMANENTLY CONNECTED EQUIPMENT and multi- N
phase equipment employs switch or circuit-
breaker
Documentation provided in case the switch or N
circuit-breaker is not part of the equipment
6.11.2.1a) Switch or circuit-breaker to be included in building N
installation
6.11.2.1b) Location N
6.11.2.1c) Marking N
6.11.2.2 Single-phase cord-connected equipment N
6.11.2.2a) Provided with switch or circuit-breaker; or N
6.11.2.2b) With appliance coupler (disconnectable without N
TOOL);or
6.11.2.2c) With separable plug (without locking device) N
6.11.2.3 HAZARDS arising from function N
Emergency switch N
Emergency switch less then 1 m from the moving N
part
6.11.3 Disconnecting devices are electrically close to the N
supply
6.11.3.1 Switches and circuit-breakers used as N
disconnection device
Meet IEC 60947-1 and IEC 60947-3 N

Page 17 of 44
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Marked to indicate function N

Not incorporated in MAINS cord N
Do not interrupt protective earth conductor N
Other contacts, if any, meet separation N
requirements of 6.6 and 6.7
6.11.3.2 Appliance couplers and separable plug used as N
the disconnecting device
Readily identifiable and easily reached by the N
OPERATOR
Single-phase PORTABLE EQUIPMENT cord length is N

not more than 3 m
Protective earth conductor connected first and N
disconnected last
7 PROTECTION AGAINST MECHANICAL HAZARDS ⎯
7.1 Conformity is checked by 7.2 to 7.6 P
7.2 Moving parts not able to crush, etc. see Attachment 1 P
(see also 6.11.2.3)
7.2a) If OPERATOR access permitted, then access N
requires TOOL
7.2b) Statement about training is provided N
7.2c) Warning markings or symbol 14 N
7.3 Stability P
Marking of non-automatic means N
7.3a) 10° tilt test P
7.3b) Multi-directional force test N
7.3c) Downward force test N
7.4 Provisions for lifting and carrying P
Handles or grips withstand four times weight P
Equipment more than18 kg has means for lifting N
or carrying; or
- directions provided in documentation N
7.5 Mounting brackets withstand four times weight N
7.6 Equipment contains or limits the energy of N
expelled parts
Protection not removable without the aid of a N
TOOL

Page 18 of 44
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8 MECHANICAL RESISTANCE TO SHOCK AND IMPACT ⎯

Voltage tests after the tests of 8.1 to 8.2 ............. : N
8a) HAZARDOUS LIVE parts not accessible N
8b) ENCLOSURE shows no cracks (hazard) P
8c) CLEARANCES not less than their permitted values N
8d) BARRIERS not damaged or loosened N
8e) No moving parts exposed, except permitted by P
7.2
8f) No damage which could cause spread of fire P
9 PROTECTION AGAINST THE SPREAD OF FIRE ⎯
Conformity for each source of HAZARD or area of (see TABLE 9) P
the equipment checked by one of the following ... :
9a) Fault test of 4.4; or (see TABLE 4.4) P
9b) Application of 9.1 (eliminating or reducing the P
sources of ignition); or
9c) Application of 9.2 (containment of fire within the P
equipment)
9.1 Eliminating or reducing the sources of ignition P
within the equipment
9.1a) 1) Limited-energy circuit (see 9.3); or P
2) Insulation between parts at different potential N
meets the requirements for BASIC INSULATION; or
- bridging the insulation does not cause ignition N
9.1b) Surface temperature of liquids and parts (see N
9.4.a)
9.1c) No ignition in circuits designed to produce heat N
9.2 Containment of the fire within the equipment P
9.2a) Energizing of the equipment is controlled by an N
OPERATOR held switch
9.2b) Enclosure is conform with constructional P

requirements of 9.2.1; and
Requirements of 9.4b) or c) are met N
9.2.1 Constructional requirements P
9.2.1a) Insulated wires have flammability classification (see TABLE 9.2.1) P
FV1 or better ........................................................ :
Connectors and insulating material have (see TABLE 9.2.1) P
flammability classification FV2 or better .............. :

Page 19 of 44
2007-10-18
9.2.1b) 1) The bottom of the enclosure has no openings P

or to extend as specified in Fig. 7
Constructed with baffles as specified in Fig. 6; or N
- perforated as specified in Table 12; or N
- metal screen with a mesh N
2) Sides have no openings as specified in figure P
7
3) Material of ENCLOSURE and any baffle or flame N
barrier is made of metal (except magnesium); or
Non metallic materials have flammability (see TABLE 9.2.1) P
classification FV1 or better...................................
4) ENCLOSURE and any baffle or flame barrier P
have adequate rigidity
9.3 Limited-energy circuit P
Fuse or a non adjustable electromechanical P
device used as overcurrent protective device
9.3a) Potential not more than 30 r.m.s. and 42.4 V P
peak, or 60 V dc ................................................... : 12Vdc
9.3b) 1) Current inherently limited or by impedance; or N
2) By overcurrent protective device; or P
3) A regulating network limits also in SINGLE FAULT N
CONDITION
9.3c) Separated by at least BASIC INSULATION P

9.4 Equipment containing or using flammable liquids N
Flammable liquids contained in or specified for N
use with equipment do not cause spread of fire
Risk is reduced to a tolerable level ....................... : N
9.4a) The temperature of surface or parts in contact N
with flammable liquids is 25 °C below fire point
9.4b) The quantity of liquid is limited N
9.4c) Flames are contained within the equipment N
Detailed instructions for risk-reduction provided N
9.5 Overcurrent protection No mains connection N
Devices not in the protective conductor N
Fuses or single-pole circuit-breakers not fitted N
in neutral (multi-phase)

Page 20 of 44
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9.5.1 PERMANENTLY CONNECTED EQUIPMENT N

Overcurrent device fitted within the equipment; or N
- specified in manufacturer’s instructions N
9.5.2 Other equipment N
Protection within the equipment N
10 EQUIPMENT TEMPERATURE LIMITS AND RESISTANCE TO HEAT ⎯
10.1 Surface temperature limits for protection against P
burns
Easily touched surfaces within the limits ............. : (see TABLE 10) P
Heated surfaces necessary for functional reasons N
exceeding specified values are recognizable as
such by appearance or function; or
- are marked with symbol 13 N
Guards are not removable without TOOL N
10.2 Temperatures of windings N
Resistance method used ..................................... : N
Thermocouple method used ................................ : N
Limits not exceeded in NORMAL CONDITION N
Limits not exceeded in SINGLE FAULT CONDITION N
10.3 Other temperature measurements ....................... : (see TABLE 10) P
10.3a) Value of 60 °C of field-wiring TERMINAL box not N
exceeded
10.3b) Surface of flammable liquids and parts in contact N
with this liquids
10.3c) Surface of non-metallic ENCLOSURES P
10.3d) Parts made of insulating material supporting parts N
connected to MAINS supply
10.3e) TERMINALS carrying a current more than 0.5 A P
10.4 Temperature test .................................................. : (see TABLE 10) P
10.5 Resistance to heat P
10.5.1 Integrity of CLEARANCE and CREEPAGE DISTANCES .. : N

Page 21 of 44
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10.5.2 Non-metallic ENCLOSURES ................................... : (see TABLE 10.5.2) P

No HAZARDOUS LIVE parts ACCESSIBLE after the N
treatment
Tests of 8.1 and 8.2 ............................................. : (see TABLE 8) P
In case of doubt, tests of 6.8 (without humidity (see TABLE 6.8) N
preconditioning) ................................................... :
10.5.3 Insulating material P
10.5.3a) Parts supporting parts connected to MAINS supply N
10.5.3b) TERMINALS carrying a current more than 0.5 A P
Examination of material data; or P
1) Ball pressure test; or N
2) Vicat softening test of ISO 306 N
11 PROTECTION AGAINST HAZARDS FROM FLUIDS ⎯
11.2 Cleaning .............................................................. : (see TABLE 11) P
11.3 Spillage ............................................................... : N
11.4 Overflow .............................................................. : N
11.5 Battery electrolyte leakage presents no hazard P
11.6 Specially protected equipment ............................. : (see Attachment 3) P
11.7 Fluid pressure and leakage N
11.7.1 Maximum pressure of any part does not exceed N
PRATED
11.7.2 Leakage and rupture at high pressure ................. : N
Test to IEC 60335 (refrigeration only) N
11.7.3 Leakage from low-pressure parts ........................ : N
11.7.4 Overpressure safety device does not operate in N
NORMAL USE; and
- meets ISO 4126-1; and N

11.7.4a) Connected as close as possible to parts intended N
to be protected
11.7.4b) Easy access for inspection, maintenance and N
repair
11.7.4c) Adjustment only with TOOL N
11.7.4d) No discharge towards person N
11.7.4e) No HAZARD from deposit of discharged material N
11.7.4f) Adequate discharge capacity N

Page 22 of 44
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11.7.4g) No shut-off valve between overpressure safety N

device and protected parts
12 PROTECTION AGAINST RADIATION, INCLUDING LASER SOURCES, AND ⎯
AGAINST SONIC AND ULTRASONIC PRESSURE
12.1 Equipment provides protection N
12.2 Equipment producing ionizing radiation N
12.2.1 Ionizing radiation ................................................. : N
12.2.2 Accelerated electrons N
12.3 Ultra-violet (UV) radiation..................................... : N
No unintentional and HAZARDOUS escape of UV N
radiation
12.4 Micro-wave radiation N
2
Power density does not exceed 10 W/m ............. : N
12.5 Sonic and ultrasonic pressure N
12.5.1 Sound level ......................................................... : N
12.5.2 Ultrasonic pressure ............................................. : N
12.6 Laser sources (IEC 60825-1) Class 1 IrDA transceiver P
13 PROTECTION AGAINST LIBERATED GASES, EXPLOSION AND IMPLOSION ⎯
13.1 Poisonous and injurious gases N
Attached data/test reports demonstrate N
conformity
13.2 Explosion and implosion P
13.2.1 Components liable to explode provided with N
pressure release device; or
- with apparatus incorporates OPERATOR N
protection (see also 7.6)
Pressure release device discharge without N
danger
Cannot be obstructed N
13.2.2 Batteries and battery charging P
If explosion or fire hazard could occur protection SI2 P
incorporated in the equipment; or
- instructions specify batteries with built-in N
protection
No HAZARD in case of wrong battery type used; or Internal battery – not intended N
to be changed
- warning by marking and within instructions N

Page 23 of 44
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Equipment with means to charge rechargeable N

batteries provided with warning against the
charging of non-rechargeable batteries; and
Type of rechargeable battery indicated; or N
- Symbol 14 used N
Battery compartment design ................................ : N
Single component failure (see TABLE 13.2.2) P
Polarity reversal test N
13.2.3 Implosion of cathode ray tubes N
If max. face dimensions more than 160 mm, then N
intrinsically protected and correctly mounted; or
- ENCLOSURE provides protection N
If non-intrinsically protected, screen not N
removable without TOOL
If glass screen, not in contact with surface of tube N
13.2.4 Equipment RATED for high pressure (See 11.7) N
14 COMPONENTS ⎯
14.1 Where safety is involved, components meet P
relevant requirements
14.2 Motors P
14.2.1 Motor temperatures P
Motor does not present a HAZARD when stopped P
or prevented form starting; or
- protected by overtemperature or thermal N
protection device conform with 14.3
14.2.2 Series excitation motors N
Connected direct to device, if overspeeding N
causes a HAZARD
14.3 Overtemperature protection devices N
Devices operating in a SINGLE FAULT CONDITION .. : N
14.3a) Reliable function is ensured N
14.3b) RATED to interrupt maximum current and voltage N
14.3c) Does not operate in NORMAL USE N
14.4 Fuse holders; no access to HAZARDOUS LIVE parts N
14.5 Mains voltage selecting devices; accidental N
change not possible

Page 24 of 44
2007-10-18
14.6 HIGH INTEGRITY components N

Used in applicable positions ............................... : N
Conforms with IEC publications N
Single electronic device not used N
14.7 Mains transformers tested outside equipment ..... : N
14.8 Printed circuit boards P
Data shows conformity with FV-1 of IEC 60707 or P
better; or
- test shows conformity with FV-1 of IEC 60707 or N
better; or
- thin film flexible PCB with limited-energy circuit N
used
14.9 Circuits or components used as transient N
overvoltage limiting devices
After test, no sign of overload or degradation N
15 PROTECTION BY INTERLOCKS ⎯
15.1 Interlocks are designed to remove a hazard N
before OPERATOR exposed
15.2 Prevention of reactivation N
15.3 Reliability N
Single fault unlikely to occur; or N
- cannot cause a HAZARD N
16 TEST AND MEASUREMENT EQUIPMENT ⎯
16.1 Current measuring circuits ................................... : N
16.2 Multifunction meters and similar equipment ........ : N
No HAZARD from RATED input voltage N
combinations
No HAZARD from settings of functions N
No HAZARD from settings of range controls N
ANNEX F ROUTINE TESTS ⎯
Manufacturer’s declaration No routine tests specified for N
Class III equipment

Page 25 of 44
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4.4 TABLE: Testing in single FAULT CONDITION P

Test subclause/ Fault Fault description Test duration
component No. (h:min:s) Results
4.4.2.4 Travers motor blocked ~1s Equipment stops motor function
4.4.2.4 Carriage motor blocked ~30s Equipment tries to finish the
program step, then system error
detected
4.4.2.7 USB connector shorted 1h Supplied by limited energy circuit
4.4.2.7 PS2 connector shorted 1h Supplied by limited energy circuit
4.4.2.9 Vent openings closed 1h Vent openings and fan nit for
cooling of equipment, no special
warming occurred
4.4.2.10 Temperature controller 2h Accessible part of peltier
overridden (of Peltier reaches 83°C at 24°C ambient.
element) Other components show higher
temperatures as in normal use,
all<42°C at 24°C ambient
4.4.2.11 Insulation at keypad foil 1h Supplied by limited energy circuit
shorted
Supplementary information:
5.1.3c) TABLE: Mains supply P

Marked rating (V) ................... : 12V —
Phase ....................................... : none —
Frequency (Hz) ...................... : DC —
Current (A) ............................. : typ. 3A (value in manual) —
Power (W) .............................. : 50W —
Power (VA) ............................. : --- —
Test Voltage Frequency Current Power in Power in Comments
No. (V) (Hz) (A) (W) (VA)
12V DC 0,25A standby mode
12V DC 2,20A max. peak input during
use
12V DC 0,78 input during battery
charging – 0,78A at
beginning and 0,30 after
45min of charging
Note: Measurements are only required for marked ratings.

Page 26 of 44
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5.3 TABLE: Durability of markings P

Marking location Marking method (see NOTE)
Identification (5.1.2) Inked label fixed with adhesive
Mains supply (5.1.3) N
Fuses (5.1.4) N
TERMINALS and operating devices (5.1.5.1) Inked label fixed with adhesive (connector indications)
Printed foil (operating devices)
Measuring circuit TERMINALS (5.1.5.2) N
Switches and circuit breakers (5.1.6) N
DOUBLE/REINFORCED equipment (5.1.7) N
Field wiring TERMINAL boxes (5.1.8) N
Warning marking (5.2) N
Battery charging (13.2.2) N
NOTE – Where applicable include print method, label material, ink or paint type, fixing method, adhesive
and surface to which marking is fixed.
Method Test agent Remains Label loose Curled edges Comments
legible Yes/No Yes/No
Yes/No
Inked label Isopropanol Yes No No
Printed foil Isopropanol Yes No No
6.2 TABLE: determination of ACCESSIBLE parts P
Item Description Determination method Exception under 6.1.2

(NOTE 1) (NOTE 2)
Connectors USB, PS2 visual
NOTE 1 – The determination methods are: visual; rigid test finger; jointed test finger; pin 3 mm diameter; pin 4 mm diameter.
NOTE 2 – Capacitor test may be required (see TABLE 6.3.1).

Page 27 of 44
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6.3.1 TABLE: Values in NORMAL CONDITION P

Voltage Current Capacitance 10 s test
Item (mA)
r.m.s../peak/d.c.
(TABLE 6.2)
Comments
(V)
Test r.m.s. μC μC
circuit or peak or V or
A1/A2/A3 or d.c. mJ mJ
All 12Vdc DMM Max. available voltage in
equipment
6.3.2 TABLE: Values in SINGLE FAULT CONDITION P

Item Subclause/ Voltage Transient Current; (mA)
(TABLE
Fault No. r.m.s../ Capacitance
6.2) (TABLE 4.4) peak/d.c (μF) Comments
.
Test circuit r.m.s.
(V) (s) A1/A2/A3 or peak
or d.c.
All All 12Vdc DMM Max. available
voltage in
equipment
Transient voltages must be below the limits given from Figure 1 and the capacitance below the limits from
figure 2 of IEC 61010-1.
6.5.1.1 TABLE: Cross-sectional area of bonding conductors N

Conductor location Cross-sectional area Comments
(mm2)

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6.5.1.2 TABLE: Tightening torque test N

Conductor location Size of Screw Tightening torque Comments
(Nm)
6.5.1.3 TABLE: Bonding impedance of plug connected equipment N

Test Voltage attained Calculated resistance Comments
ACCESSIBLE part under test current after 1 min (maximum allowed 0.1 Ω)
(A) (V) (Ω)
6.5.1.4 TABLE: Bonding impedance of PERMANENTLY CONNECTED EQUIPMENT N

Test Voltage attained after 1 min Comments
ACCESSIBLE part under test current (maximum 10 V)
(A) (V)
6.5.1.5a) TABLE: Indirect bonding for test and measuring equipment N

Voltage limiting device
Voltage Time for voltage to drop to Comments
ACCESSIBLE part under test attained (V) allowable levels (s)

Page 29 of 44
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6.5.1.5b) TABLE: Indirect bonding for test and measuring equipment N

Voltage-sensitive tripping device
ACCESSIBLE part under test Voltage Time for device to trip Comments
applied (V) (s)
6.5.3 TABLE: PROTECTIVE IMPEDANCE N

A HIGH INTEGRITY single component
Component Location Comments
A combination of components
A combination of BASIC INSULATION and a current or voltage limiting device


Page 30 of 44
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6.7 TABLE: Protection against electric shock / CLEARANCES and CREEPAGE DISTANCES P
Pollution degree ..................................................... : 2 —
Measurement category .......................................... : N —
Required CLEARANCES and CREEPAGE DISTANCES
Location or Insulation Max working CREEPAGE DISTANCE CLEARANCE
description type voltage (NOTE 4) (NOTE 4) Comments
and circuit
type
(NOTE 1) (NOTE 2) (NOTE 3) PWB CTI Other CTI mm
(mm) (mm)
1) BI 12Vdc 0,04 IIIa N N 0,01mm
1) Basic insulation between unlimited 12Vdc and limited energy circuits according 9.3
Clearance according 6.7.3.2 with D1=0,010, D2=0,010, F=1, Uw=12Vdc, Ut=0V, Um=12Vdc
NOTE 1 – Type of circuit: M= MAINS, D= circuits derived from MAINS, OR MS= Measuring circuits
NOTE 2 – Type of insulation: BI = BASIC INSULATION; DI = DOUBLE INSULATION; PI = PROTECTIVE IMPEDANCE; RI = REINFORCED
INSULATION; SI = SUPPLEMENTARY INSULATION
NOTE 3 – Types of voltage: Peak impulse test voltage (pulse); r.m.s.; d.c.; peak
NOTE 4 – For equipment having multiple Pollution Degree and/or Measurement Category ratings, applicable rating(s) should be
shown under "Comments"
Measured CLEARANCES and CREEPAGE DISTANCES

Location CREEPAGE CLEARANCE Comments
(mm) (mm)
Basic insulation between unlimited 12Vdc >0,04 >0,01 Not measured, located on
and limited energy circuits mainboard only – factoring
process provides required
distances.

Page 31 of 44
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6.8 TABLE: Dielectric strength tests N

Test site altitude (m) ......................................... : 570m —
Test voltage correction factor (See 6.8.4.1)...... : --- —
Test voltage
Location Working voltage r.m.s../peak/d.c. Result /Comments
(V) (V)
6.10.2 TABLE: Cord anchorage N

Location Mass Pull Result Torque Result Comment
(kg) (N) (Nm)
Indicate under Comments: B = Before Humidity Conditioning
A = After Humidity Conditioning (no recovery time)
8 TABLE: Mechanical resistance to shock and impact P

Location Rigidity Drop Description of Damage
Static Dynamic Corner Face Hand-held/ Reduction Dielectric Exposure of
(30 N) (5 J) Plug-in in Spacings Breakdown Parts
Door P P P P N P N None
Fan air P P P P N P N None
opening
Enclosure P P P P N P N None
rear
NOTE: See also TABLE 10.5.2

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9 TABLE: Protection against the spread of fire P

Source of HAZARD or area of the Protection
Item equipment considered (circuit, Method Protection details Comment
component, liquid etc.) (9a, 9b or 9c)
Enclosure All circuits are defined as not 9c Fire enclosure
energy limited provided with V-0
material except
display foil
Display foil Display foil does not fulfil 9a SFC shows that
constructional requirements there is no fire
hazard
9.2.1 TABLE: Constructional requirements N

Material tested ................................................... : —
Generic name .................................................... : —
Material manufacturer ........................................ : —
Type ................................................................... : —
Color .................................................................. : —
Conditioning details ........................................... : —
Sample 1 Sample 2 Sample 3
Thickness of specimen (mm)
Duration of flaming after first Application (s)
Duration of flaming plus glowing
After second application (s)
Specimen burns to holding clamp (Yes/No)
Cotton ignited (Yes/No)
Sample result (Pass/Fail)
Supplementary information: Recognized material used

Page 33 of 44
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9.3 TABLE: Limited-energy circuit P

9.3 a) 9.3 b) Current and power limitation
Item or
Location Comments
Maximum potential Maximum Maximum Overload

in circuit voltage available available protection after
r.m.s./d.c.; (V) current; (A) power; (VA) 120 s; (A)
Circuits / 12Vdc 3,6A 43,2VA Time to trip at These voltages are
voltages VCC, 10A < 1s created on mainboard
VDDup, VLCD and limited with SI3
on mainboard (SMD185F):
IH=1,8A, IT=3,6A,
Vmax=33V, Imax=40A
Components supplied by VCC, VDDup and VLCD are display and keypad
Outputs supplied by VCC: PS2 and USB
Typical Time-to-Trip Curves at 20°C:

Page 34 of 44
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9.4 TABLE: Requirements for equipment containing or using flammable liquids N

Flammable liquids
Type of liquid Result
b) quantity c) Containment
10 TABLE: Temperature Measurements (Thermocouple method) P

Frequency (Hz) .................................................... : DC —
Voltage (V) ........................................................... : 12V —
Test room ambient temperature (ta) (°C) ............. : 23°C —
Test duration ( h min) ......................................... : 2h —
Part / Location tm tc tmax Comments
°C °C °C
Battery 27 44 info rated for 40°C ambient, battery was
charged during test
Battery connector X16 31 48 85
Carriage motor 79 96 info rated for 50°C ambient
Traverse motor 25 42 info rated for 50°C ambient
Relay (Rel1) 28 45 70
Heat sink 26 43 info
Fan 28 45 70
Enclosure (inside) 25 42 info for test according 10.5.2
Enclosure 28 45 70 accessible peltier element
Ambient 23 40 ---
Where: tm = measured temperature
tc = tm corrected (tm–ta+ 40 °C or max. RATED ambient)
tmax = maximum permitted temperature

Page 35 of 44
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10.2 TABLE: Temperature of windings (Resistance method) N

Frequency (Hz) .................................................... : —
Voltage (V) ........................................................... : —
Test room ambient temperature (ta1/ta2) (°C) ....... : —
Test duration ( h min) ......................................... : —
*
Part / Designation Rcold Rwarm Current tr tc tmax Comments
(Ω) (Ω) (A) (K) (°C) (°C)
tc = tr corrected (tc= tr - { ta2 - ta1} + [40 °C or max RATED ambient])
10.5.1 TABLE: Integrity of CLEARANCES and CREEPAGE DISTANCES N

Ambient temperature (°C)......................................... : —
Measured after mechanical tests
Location Result/Comments
CREEPAGE CLEARANCE
(mm) (mm)
Supplementary information: No changes is creepage and clearance distances after use in 40°C ambient
expected.

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10.5.2 TABLE: Resistance to heat of non-metallic enclosures P

Test method used .................................................: Complete equipment —
Temperature during tests .......................................: 70°C —
Treated samples were subjected to mechanical —
resistance to shock and impact tests (see Table 8) P
...............................................................................:
Treated samples were subjected to dielectric —
strength tests (see Table 6.8) ................................: N
Non operative treatment ........................................: 7h P
- Empty ENCLOSURE ................................................: N
Operative treatment ...............................................: N
Description Material Comments
Enclosure Bayblend FR 2000, see table No deformation of enclosure after testing
14.1
10.5.3a) TABLE: Insulating Materials – Ball pressure test N

Allowed impression diameter (mm) ....................... : 2 mm ⎯
Part Test temperature Impression diameter
(°C) (mm)
10.5.3b) TABLE: Insulating Materials - Vicat softening test (ISO 306) N

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

Page 37 of 44
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11 TABLE: Protection against hazards from fluids P

Location Cleaning Spillage Overflow IEC 60529 Working Test
(see form A.5) (11.2) (11.3) (11.4) (11.6) voltage voltage Result / Comments
(V) (V)
Enclosure P N N P* 12Vdc N *see Attachment 3
NOTE – Use r.m.s., d.c. or peak to indicate the used test voltage.
11.7.2 TABLE: Leakage and rupture at high pressure N

Maximum permissible Test Leakage Burst
Part working pressure pressure Comments
(Mpa) (Mpa) YES / NO YES / NO
11.7.3 TABLE: Leakage from low-pressure parts N

Test Leakage
Part pressure Comments
(Mpa) YES / NO
12.2.1 TABLE: Ionizing radiation N

Measured values
Locations tested (µSv/h) Result / Comments

Page 38 of 44
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12.5.1 TABLE: Sound level N

Locations tested: at operator’s normal Measured values Calculated maximum sound
position and at bystanders’ positions dBA pressure level
12.5.2 Ultrasonic pressure N

Locations tested Measured values Comments
dB kHz
At OPERATOR’S normal position
At 1 m from the ENCLOSURE
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.

Page 39 of 44
2007-10-18
13.2.2 TABLE: Batteries P

Battery load and charging circuit diagram ........... : see below —
Battery type .......................................................... : rechargeable lead-acid —
Battery manufacturer/model/catalogue No. ......... : see table 14.1 —
Battery ratings ...................................................... : see table 14.1 —
Reverse polarity instalment test ........................... : battery if fix connected inside —
equipment – no
Single component failures Results
Component
Open circuit Short circuit
FE8 No battery charge/discharge; Empty battery:
no hazard max. charging voltage is
12Vdc of external power
supply. Battery rated for
higher charging voltages.
Full battery:
SI2 opens short circuit
discharge current

Page 40 of 44
2007-10-18
14.1 TABLE: Components P

object/part No. manufacturer/ type/model technical data standard mark(s) of
trademark conformity1)
Enclosure --- Mechanical and fire enclosure - overall ---
200x250x220mm, min. 3mm thick. Consists of several
parts secured together by screws. Provided with outer
rubber material which is not part of fire enclosure.
Provided with side openings at fan are (area ∅60mm
with grids 2,4mm x max. 12,2; crosspiece 1,5mm)
Enclosure Bayer Material Bayblend min thickness UL94 UR
material Science FR2000 >1,5mm rated V-0
Internal wiring various various 18AWG, VW-1 UL1007 UR
(Battery to
mainboard)
Internal wiring various various 23AWG, VW-1 UL1007 UR
(Motors)
PolySwitch SI1 Tyco Rychem RGEF500 IH=5,0A, IT=8,5A, IEC 60730-1 UR, TUV
on mainboard Vmax=16V,
Imax=100A
PolySwitch SI2 Tyco Rychem RGEF800 IH=8,0A, IT=13,6A, IEC 60730-1 UR, TUV
on mainboard Vmax=16V,
Imax=100A
PolySwitch SI3 Tyco Raychem SMD185F IH=1,8A, IT=3,6A, IEC 60730-1 UR, TUV
on mainboard Vmax=33V, Imax=40A
Relay Schrack RY210012 Coil: 12Vdc UR, VDE

(Rel1, Rel2) Contact: 205V, 10A
Internal battery Kung Long WP2.9-12T 12Vdc, 2,9Ah UL1989 UR
Batteries
alternate Geyer LEAD-LINE 2.9- 12Vdc, 2,9Ah UL1989 UR
electronics 12
(Dynamis)
Blower fan Minebea BG0702-B045- 12Vdc, 3W, 0,33A, UL507 VDE, CSA, UR
000 9,50 CFM
DC Motor KINGO RS-380SA- 12Vdc EN 61010-1 tested within
(Traverse motor) 20150R equipment
DC Motor Stepping Motor PM2515 12Vdc, 50°C,7,6°, EN 61010-1 tested within
(Carriage motor) 10Ω equipment
Peltier element Eureca TEC2L-23-23- 9,2V, 7A EN 61010-1 tested within
32/73 equipment
IrDA Agilent HSDL-3612 LED Class 1 eye EN 61010-1 tested within
safe equipment

Page 41 of 44
2007-10-18
Display Emerging ET035007DM6 3,3V, 250mA, LED EN 60950 supplied with

Display based back light limited energy
Technologies
Corp.
Printed wiring various various rated V-1 or better UL94 UR
boards
Connectors (all located on mainboard, connectors in unlimited energy circuits only):
X6 Kycon KLDX-0202-xC 24Vdc, 3,5A or UL1977 CSA
(Power supply) 20Vdc max., 5A
85°C, V-0
other internal various various reated V-2 or better UL94 NRTL
connectors UL1977
1
) an asterisk indicates a mark which assures the agreed level of surveillance
14.3 TABLE: Overtemperature protection devices - Reliability test N
Component Type Result Comments

(note)
NOTE: NSR = non-self-resetting (10 times); NR = non-resetting (1 time); SR = self-resetting (200 times)

Page 42 of 44
2007-10-18
14.7.1 TABLE - short-circuit tests (for mains transformers) N

Type ........................................................................ : ⎯
Manufacturer ........................................................... : ⎯
Tested ..................................................................... : ⎯
Temperature protection class of the lowest RATED ⎯
winding (class or maximum RATED temperature) :
Winding identification .............................................. : ⎯
Type of protector for winding .................................. : ⎯
Elapsed time ........................................................... : ⎯
Current, primary (A) ................................................ : ⎯
Current, secondary (A) ........................................... : ⎯
Winding temperature, primary (°C) ........................ : ⎯
Winding temperature, secondary (°C) ................... : ⎯
Tissue paper/cheesecloth test
Voltage test, primary to secondary (V) ................... :
Voltage test, primary to core (V) ............................ :
Voltage test, secondary to secondary (V) .............. :
Voltage test, secondary to core (V) ........................ :

Page 43 of 44
2007-10-18
14.7.2 TABLE - overload tests (for mains transformers) N

Type ........................................................................ : ⎯
Manufacturer ........................................................... : ⎯
Tested ..................................................................... : ⎯
Temperature protection class of the lowest RATED ⎯
winding (class or maximum RATED temperature) :
Winding identification .............................................. : ⎯
Type of protector for winding .................................. : ⎯
Elapsed time ........................................................... : ⎯
Current, primary (A) ................................................ : ⎯
Current, secondary (A) ........................................... : ⎯
Winding temperature, primary (°C) ........................ : ⎯
Winding temperature, secondary (°C) ................... : ⎯
Tissue paper/cheesecloth test
Voltage test, primary to secondary (V) ................... :
Voltage test, primary to core (V) ............................ :
Voltage test, secondary to secondary (V) .............. :
Voltage test, secondary to core (V) ........................ :
16.1a) TABLE: Current measuring circuits - Current transformers N

Type/Model RATED current Test current Interrupt Result / Comments
(A) (A) Yes / No
NOTE - These tests are performed with all types and models of current transformers without internal
protection, and which are specified by the manufacturer for use with the equipment

Page 44 of 44
2007-10-18
16.1b) TABLE: Current measuring circuits - Range changing switches N

Type / Model Switch maximum rated Cycling test Comments
current (A) Result
16.2 TABLE: Multifunctional meters and similar equipment N

Operating conditions .......................... : —
Maximum RATED voltage applied (V) . : —
Measurement category ...................... : —
Test source limit (KVA) ...................... : —
Function Range Comments

Photo Documentation for Project No. 028-71326415-000 /
Attachment 1
of 15.10.2007
Client: LRE Medical GmbH

Device: Drug tester
Type: DrugTest 5000 Trademark: Dräger
Figure 1: Overview of equipment ................................................................................................ 2

Figure 2: Rear side view of equipment ........................................................................................ 3
Figure 3: Bottom of equipment .................................................................................................... 4
Figure 4: Open equipment, right side .......................................................................................... 5
Figure 5: Open equipment, left side ............................................................................................ 6
Figure 6: Open equipment, rear side ........................................................................................... 7
Figure 7: Front view with open door ............................................................................................ 8
Figure 8: Detail – Motor stop ....................................................................................................... 9
tec_bilddokumentation_e.dot 01.03.2006
Phone: + 49 89 5008-4322 TÜV SÜD Product Service GmbH

Fax: + 49 89 5008-4130
Niederlassung München
File: 028-71326415-000_TRF_A1_e.doc Project Manager: E-Mail: ralph.fischer@tuev-sued.de Ridlerstraße 65
Rep-No.: 028-71326415-000 / Attachment 1 Ralph Fischer 80339 München
Page 1 of 9 Date: 15.10.2007 Deutschland
Figure 1: Overview of equipment

Fax: + 49 89 5008-4130
Figure 2: Rear side view of equipment

Fax: + 49 89 5008-4130
Figure 3: Bottom of equipment

Fax: + 49 89 5008-4130
Figure 4: Open equipment, right side
Traverse motor shown.


Fax: + 49 89 5008-4130
SI2
SI3
SI1
Figure 5: Open equipment, left side


Fax: + 49 89 5008-4130
Figure 6: Open equipment, rear side
Carriage motor shown under battery.


Fax: + 49 89 5008-4130
Figure 7: Front view with open door

Fax: + 49 89 5008-4130
(1)
(2)
Figure 8: Detail – Motor stop
‘Stop’ (1) prevents crushing or cutting caused by endless traverse motor movement in single
fault condition. Space between (2) and moving part is approx. 14mm.

Fax: + 49 89 5008-4130
Page 1 of 8
TEST REPORT
IEC 61010-2-101 / EN 61010-2-101
Safety requirements for electrical equipment for measurement, control, and
laboratory use
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Report Reference No. .................... : 028-71326415-000 / Attachment 2
Compiled by (+ signature) ................ : Ralph Fischer
......................................................
Approved by (+ signature) ................ : Manfred Schmolke
......................................................
Date of issue .................................... : 2007-10-18
CB Testing Laboratory................... : TÜV Product Service GmbH
Address ............................................ : Ridlerstr. 65, D-80339 München, Germany
Testing location ................................ : CBTL SMT TMP
Address ............................................ : Ridlerstr. 65, D-80339 München, Germany
Applicant’s name............................ : LRE Medical GmbH
Address ............................................ : Frankfurter Ring 15, D-80807 München
Test specification:
Standard ........................................... : IEC 61010-2-101: 2002 (ed.1) for use with IEC 61010-1: 2001 (ed.2)
EN 61010-2-101: 2002 (ed.1) for use with IEC 61010-1: 2001 (ed.2)
Test procedure ................................. : Conformity testing
Non-standard test method ................ : N/A
Test Report Form No...................... : IECEN61010_2_101A
TRF Originator.................................. : VDE
Master TRF ...................................... : Dated February 2004
Copyright © 2004 IEC System for Conformity Testing and Certification of Electrical Equipment
(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.
Test item description ..................... : Laboratoy equipment (drug tester)

Trade Mark ....................................... : Dräger
Manufacturer .................................... : DrugTest 5000
Model/Type reference ...................... : Dräger Safety AG & Co KGaA, Revalstr. 1, D-23560 Lübeck
Ratings ............................................. : 12VDC, 50W
Test Report IEC/EN 61010-2-101A Rev. 00 / 2004-08

Page 2 of 8
Report Reference No.: 028-71326415-000 / Attachment 2
2007-10-18
Copy of marking plate
Summary of testing
The presented equipment is a drug tester and intended for non medical and non self test use for
examination of in general healthy persons. Therefore the probes and the equipment were defined as non-
potential infectious. Nevertheless the using organisation shall consider protective rules.

Page 3 of 8
2007-10-18

Type of item tested ........................................................ : Laboratory
Description of equipment function ............................... : see intended use
Installation/overvoltage category ................................. : III
Pollution degree ........................................................... : II
Environmental rating .................................................... : 2
Equipment mobility ....................................................... : standard
Connection to mains supply ......................................... : portable
Operating conditions .................................................... : none, supplied by internal battery and/or by external
power supply
Overall size of the equipment (W x D x H) .................. : continuous
Mass of the equipment (kg) ......................................... : 200x250x220mm
Marked degree of protection to IEC 60529 ................. : 4,5kg
Accessories and detachable parts included ............. : None
Other options included ................................................ : None
- test case does not apply to the test object ................. : N/A
- test object does meet the requirement ....................... : Pass (P)
- test object does not meet the requirement ................. : Fail (F)
General remarks:
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.
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.
Throughout this report, a point (coma) is used as the decimal separator.
List of test equipment must be kept on file and available for review.
This Test Report is intended for the investigations of laboratory equipment for in vitro diagnostic (IVD) use and shall not be used
without the CB Test Report covering the evaluation of the product according to IEC 61010-1, Part 1, General Requirements.
This Test Report includes the assessment of group differences to complete the assessment according to the last valid edition the
relevant EN standards. Those requirements / differences are included at the end of the test case section (main body).
Intended use:
The Dräger-DrugTest 5000 Analyzer is a device for proving drugs in oral fluid samples collected with the
Dräger DrugTest 5000 Test-Kit (in-vitro-diagnostics). The measurement is based upon an optical evaluation of
the immunochemical test strips contained in the Test-Kit. The system is an easy and quick test procedure for
proving amphetamines, benzodiazepines, cannabinoides, cocaine metabolites, methamphetamines and
opiates. Test results are displayed immediately after finishing the analysis and can be stored in the analyzer,
printed with the Dräger Mobile Printer or transferred to a PC via the integrated USB interface. The system is
suited for stationary as well as for mobile use.

Page 4 of 8
2007-10-18
Clause Requirement + Test Result - Remark Verdict
5. MARKING AND DOCUMENTATION ⎯
5.1.1 General P
Additional symbols cannot be confused with the P
international ones
5.1.2 Identification ⎯
Equipment is identified by: ⎯
5.1.2a) Manufacturer’s name or trademark and address P
5.1.2b) Model number, name or other means P
5.1.2c) The name and address of the authorized N
representative of the manufacturer
The equipment or packaging or the instructions for P
use include:
1) The serial-number or the batch code preceded Provided on type plate P
by ”LOT” symbol 102 of table 1
2 i) Indication that the equipment is IVD medical Provided on type plate P
equipment
2 ii) Indication that the equipment is self-test IVD N
medical equipment
2 iii) Identification of detachable components Part of test cassettes N
2 iv) Expiry date of consumable parts Part of test cassettes N
5.1.101 Transport and storage ⎯
Packaging labelled to indicate special conditions for N
transport or storage
5.2 Warning markings ⎯
Potentially infectious equipment marked with Part of test cassettes N
symbol 101 of table 1
Equipment that can be hazardous due to the use of N
chemical substances marked with the appropriate
symbol; or
with Symbol 14 of Table 1 (if none is available) N
Containers or bags for biohazardous waste material N
which can be removed from the equipment during
NORMAL USE marked with symbol 101 of table 1
5.3 Durability of markings ⎯
The required markings resist the effects of P
temperature and rubbing, and of solvent and
reagents likely to be encountered in NORMAL USE
Resistant also against agents specified by P
manufacturer for cleaning and decontamination
procedure

Page 5 of 8
2007-10-18
5.4 Documentation ⎯
5.4.1 General ⎯
Information about any RISKS not reduced to a P
TOLERABLE RISK level
Information included in documentation on: ⎯
Training; or N
Protective devices; or N
Personal protective equipment to reduce RISKS to N
a TOLERABLE RISK level specified:
5.4.3 Equipment transportation, installation and assembly ⎯
instructions
Documentation for the RESPONSIBLE BODY ⎯
includes:
5.4.3.a) Instructions for transportation after delivery to the N
RESPONSIBLE BODY
5.4.3.b) Floor loading requirements N
5.4.3.c) Individual weights of principal heavy subassemblies N
5.4.3.d) Location and mounting instructions N
5.4.3.e) Assembly instructions N
5.4.3.f) Instructions for protective earthing N
5.4.3.g) The sound data required by 12.5.1 N
5.4.3.h) Instructions relating to the handling, containment N
and exhaust of hazardous substances
5.4.3.i) Any drainage systems required N
5.4.3.j) Protective measures relating to hazardous radiation N
5.4.3.k) Connections to the supply P
5.4.3.l) PERMANENTLY CONNECTED EQUIPMENT only: ⎯
1) Mains supply requirements and details of N
connections
2) If external switch or circuit-breaker, N
requirements and location recommendation
5.4.3.m) Special services including pressure limits N
5.4.4 Equipment operation ⎯
Instructions for use include: ⎯
5.4.4a) Details of operating controls P
5.4.4b) Positioning for disconnection N
5.4.4c) Interconnection P

Page 6 of 8
2007-10-18
5.4.4d) Specification of intermittent operation limits N
5.4.4e) Explanation of symbols used P
5.4.4.f) Any actions to be taken by an OPERATOR in case P
of a malfunction
5.4.4.g) Cleaning and decontamination (see 11.2) incl. P
materials
5.4.4.h) Disposal of waste N
5.4.4.i) Hazardous substances, use, need for training, or N
personal protection measures
5.4.4.j) Infectiouse substances, need to use protective N
gloves or other protective means
5.4.4.k) Hazardous vapours, instructions for protection of N
the mouth, nose or eyes
5.4.4.l) Hazardous radiation, instructions and requirements N
for protective devices
5.4.4.m) A statement about protection impairment if used in N
a manner not specified by the manufacturer
5.4.4.101 Self-test IVD medical equipment ⎯
Instructions for use for self-test equipment comply N
with annex BB
5.4.101 Removal of equipment from use for repair or ⎯
disposal
Instructions for the RESPONSIBLE BODY for ⎯
eliminating or reducing HAZARDS includes:
Removal from use P
Transportation or disposal N
Requirements for minimizing biohazards N
Permissible environmental conditions for transport ⎯
and storage specified:
In documentation; and N
On outside of packaging N
8 MECHANICAL RESISTANCE TO SHOCK AND IMPACT ⎯
Records of tests performed by the manufacturer P
show conformity (Guidance ASTM D4169 of ISTA)
11 PROTECTION AGAINST HAZARDS FROM FLUIDS ⎯
11.3 Spillage N

Page 7 of 8
2007-10-18
Potentially aggressive substances (such as N
corrosive, toxic or flammable liquids) taken into
account
Potentially aggressive substances compatible with N
contacted parts of the equipment
13 PROTECTION AGAINST LIBERATED GASES AND SUBSTANCES, EXPLOSION ⎯
AND IMPLOSION
13.1 Poisonous and injurious gases and substances ⎯
Attached data/test reports demonstrate conformity N
(in NC and SFC)
Dangerous amounts of poisonous or injurious N
gases or substances not liberated in NORMAL
CONDITION or in SINGLE FAULT CONDITION
If potentially hazardous substances are liberated: ⎯
OPERATOR not be wetted nor able to inhale N
quantities likely to be hazardous
Protective covers or similar means of protection N
14 COMPONENTS ⎯
14.3 Overtemperature protection devices ⎯
14.3 c) Does not operate in NORMAL USE ⎯
Not self-resetting in self-test IVD equipment N
Annex AA RISK MANAGEMENT ⎯
EN ISO 14971 applied P
Conformity demonstrated (see documents attached) P
GROUP DEVIATIONS OF EN 61010-2-101: 2002 ⎯

5.4.4 Equipment operation ⎯
Instructions for IVD medical equipment for P
commercial use comply with EN 591
Instructions for self-test IVD medical equipment use N
comply with EN 592
5.4.4.101 Self-test IVD medical equipment Clause deleted ⎯

Page 8 of 8
2007-10-18
4.4.2 TABLE: Summary of SINGLE FAULT CONDITIONS Form A.1 ⎯
Subclause Title Does not Carried Comments

apply out
4.4.2.101 Incorrect voltage selection x
List below all SINGLE FAULT CONDITIONS not covered by 4.4.2.1 to 4.4.2.101:
13.1 Poisonous and injurious gases and x
substances
NOTE – Record surface temperatures of flammable liquids and parts in contact with them in Form A.20A
(see Form A.2 of TRF IEC/EN 61010-1for details of tests)

Page 1 of 17
TEST REPORT
IEC/EN 60529
Degrees of protection provided by enclosures (IP Code)
Report reference No. ......................... : 028-71326415-000 / Attachment 3
Date of issue ...................................... : 2007-10-18
Testing laboratory .............................. : TÜV SÜD Product Service GmbH
Address .............................................. : Ridlerstr. 65, D-80339 München
Testing location .................................. : as above
Applicant ............................................. : LRE Medical GmbH
Address .............................................. : Frankfurter Ring 15, D-80807 München
Standard ............................................. : IEC 60529:1989+A1:1999 / EN 60529:1991+A1:2000
Test Report Form No. ........................ : TUV_IECEN 60529A / Rev. 1
TRF originated by............................... : TÜV Product Service GmbH
Master TRF ........................................ : PS_INFO\
Copyright blank test report................. : This test report is based on the contents of the standard. It was
prepared by TÜV Product Service GmbH.
Test procedure .................................. : Conformity testing
Procedure deviation ........................... : None
Non-standard test method ................. : None
National deviations ............................. : None
Number of pages (Report) ................. : 17
Number of pages (Attachments) ....... : None
Compiled by .... : Approved by..... :

(+ signature) Ralph Fischer (+ signature) Manfred Schmolke
Test Report TUV_IECEN 60529A Rev. 01 / 2005-11

Page 2 of 17
Type of test object .............................. : Laboratory equipment (drug tester)

Trademark .......................................... : Dräger
Model and/or type reference .............. : DrugTest 5000
Rating(s) ............................................. : 12Vdc, 50W
Manufacturer ...................................... : Dräger Safety AG & Co KGaA
Address .............................................. : Revalstr. 1, D-23560 Lübeck
Sub-contractors/ tests (clause) .......... : None
Address .............................................. : None
Date of receipt of test item ................. : 2007-09-26
Date(s) of performance of test ........... : 2007-10-11
Degree of protection .................................................... : IP34
see main test report for further details

- test case does not apply to the test object ................. : N(.A.)
- test object does meet the requirement ....................... : P(ass)
- test object does not meet the requirement................. : F(ail)
Attachments:
None
General remarks:
"(see remark #)" refers to a remark appended to the report.
Throughout this report a comma is used as the decimal separator.
This report shall not be reproduced except in full without the written approval of the testing laboratory.

Page 3 of 17
Summary of testing:
The equipment complies with protection class IP34.
Copy of marking plate:

Page 4 of 17
10 Marking N
The requirements for marking shall be specified N
in the relevant product Standard.
Where appropriate, such a Standard should N
also specify the method of marking which is to
be used when
- one part of an enclosure has a different N
degree of protection to that of another part of
the same enclosure;
- the mounting position has an influence on the N
degree of protection;
- the maximum Immersion depth and time are N
indicated.
11 General requirements for tests P
11.1 Atmospheric conditions for water or dust tests P
Unless otherwise specified in the relevant product
Standard, the tests should be carried out under
the Standard atmospheric conditions described in
IEC 60068-1.
The recommended atmospheric conditions during P
the tests are as follows:
Temperature range: 1 5 ° C to 3 5 ° C P
Relative humidity: 25 % to 75 % P
Air pressure: 86 kPa to 106 kPa P
(860 mbar to 1 060 mbar).
11.2 Test samples P
The tests specified in this Standard are type tests.
Unless otherwise specified in a relevant product P
Standard, the test samples for each test shall be in
a clean and new condition, with all parts in place
and mounted in the manner stated by the
manufacturer.
If it is impracticable to test the complete N
equipment, representative parts or smaller
equipment having the same full-scale design
details shall be tested.
The relevant product Standard shall specify details P
such as:
- the number of samples to be tested; One sample tested P
- conditions for mounting, assembling and Portable equipment P
positioning of the samples, for example by the
use of an artificial surface (ceiling, floor or wall);

Page 5 of 17
NOTE This also applies to equipment N

intended to be united with other relevant
equipment, for example, components which
can be used either alone or in an assembly;
- the pre-conditioning, if any, which is to be used; N
- whether to be tested energized or not; not energized N
- whether to be tested with its parts in motion or N
not.
In the absence of such specification, the N
manufacturer's instructions shall apply.
11.3 Application of test requirements and N
Interpretation of test results
The application of the general requirements for
tests and the acceptance conditions for
equipment containing drain-holes or Ventilation
openings is the responsibility of the relevant
technical committee.
In the absence of such specification the P
requirement of this Standard shall apply.
The Interpretation of test results is the N
responsibility of the relevant technical
committee. In the absence of a specification the
acceptance conditions of this Standard shall at
least apply.
11.4 Combination of test conditions for the first P
characteristic numeral
Designation with a first characteristic numeral
implies that all test conditions are met for this
numeral:
Table 5 - Test conditions for degrees of P
protection indicated by the first characteristic
numeral
11.5 Empty enclosures N
If the enclosure is tested without equipment
inside, detailed requirements shall be indicated
by the enclosure manufacturer in his
instructions for the arrangement and spacing of
hazardous parts or parts which might be
affected by the penetration of foreign objects
or water.
The manufacturer of the final assembly shall N
ensure that after the electrical equipment is
enclosed the enclosure meets the declared
degree of protection of the final product.
12 Tests for protection against access to hazardous parts indicated by the P
first characteristic numeral

Page 6 of 17
12.1 Access probes P

Access probes to test the protection of persons
against access to hazardous parts are given in
table 6.
12.2 Test conditions P
The access probe is pushed against or (in case of
the test for first characteristic numeral 2) inserted
through any openings of the enclosure with the
force specified in table 6.
For tests on low-voltage equipment, a low-voltage N
supply (of not less than 40 V and not more than 50
V) in series with a suitable lamp should be
connected between the probe and the hazardous
parts inside the enclosure. Hazardous live parts
covered only with varnish or paint, or protected by
oxidation or by a similar process, are covered by
a metal foil electrically connected to those parts
which are normally live in operation.
The signal-circuit method should also be applied N
to the hazardous moving parts of high-voltage
equipment.
Internal moving parts may be operated slowly, N
where this is possible.
Table 6 - Access probes for the tests for P
protection of persons against access to
hazardous parts
12.3 Acceptance conditions P
The protection is satisfactory if adequate
clearance is kept between the access probe
and hazardous parts.
For the test of first characteristic numeral 1, N
the access probe 50 mm diameter shall not
completely pass through the opening.
For the test of first characteristic numeral 2, the N
jointed test finger may penetrate to its 80 mm
length, but the stop face (0 50 mm x 20 mm)
shall not pass through the opening. Starting
from the straight position, both joints of the test
finger shall be successively bent through an
angle of up to 90° with respect to the axis of the
adjoining section of the finger and shall be
placed in every possible position.
See annex A for further clarification. P
Adequate clearance means: P
12.3.1 For low-voltage equipment (rated voltages not P
exceeding 1 000 V a.c. and 1 500 V d.c.)

Page 7 of 17
The access probe shall not touch hazardous No hazardous live parts N
live parts.
If adequate clearance is verified by a signal N
circuit between the probe and hazardous parts,
the lamp shall not light.
NOTE The attention of relevant technical N
committees is drawn to the fact that in some
types of electrical equipment the maximum
voltage produced internally (r.m.s. value or d.c.
value of the working voltage) is higher than the
rated voltage of the equipment. This maximum
voltage should be considered when the
dielectric test voltage and the adequate
clearance are determined.
12.3.2 For high-voltage equipment (rated voltages N
exceeding 1 000 V a.c.
and 1 500 V d.c.)
When the access probe is placed in the most N
unfavourable position(s), the equipment shall be
capable of withstanding the dielectric tests as
specified in the relevant product standard
applicable to the equipment.
Verification may be made either by dielectric N
test or by inspection of the specified clearance
dimension in air which would ensure that the
tests would be satisfactory under the most
unfavourable electric field configuration (see
IEC 60071-2).
In the case where an enclosure includes N
sections at different voltage levels the
appropriate acceptance conditions for adequate
clearance shall be applied for each section.
NOTE The attention of relevant technical N
committees is drawn to the fact that in some
types of electrical equipment the maximum
voltage produced internally (r.m.s. value or d.c.
value of the working voltage) is higher than the
rated voltage of the equipment. This maximum
voltage should be considered when the
dielectric test voltage and the adequate
clearance are determined.
12.3.3 For equipment with hazardous mechanical The internal fan is accessible P
parts: with test probe, but the
The access probe shall not touch hazardous accessible parts are not
mechanical parts. hazardous moving.
If adequate clearance is verified by a signal N
circuit between the probe and hazardous parts,
the lamp shall not light.

Page 8 of 17
13 Tests for protection against solid foreign objects indicated by the first P
characteristic numeral
13.1 Test means P
Test means and the main test conditions are
given in table 7.
Table 7 - Test means for the tests for P
protection against solid foreign objects
13.2 Test conditions for first characteristic P
numerals 1, 2, 3, 4
The object probe is pushed against any
openings of the enclosure with the force
specified in table 7.
13.3 Acceptance conditions for first characteristic P
numerals 1, 2, 3, 4
The protection is satisfactory if the full
diameter of the probe specified in table 7
does not pass through any opening.
NOTE For the first characteristic numerals 3 and 4 N
the probes specified in table 7 are intended to
simulate foreign objects which may be spherical.
Where an enclosure has an indirect or tortuous
entry path and there is any doubt about ingress of
a spherical object capable of motion, it may be
necessary to examine drawings or to provide
special access for the object probe to be applied
with the specified force to the opening(s) where
ingress has to be checked.
13.4 Dust test for first characteristic numerals 5 and N
6
The test is made using a dust chamber
incorporating the basic principles shown in
figure 2 whereby the powder circulation pump
may be replaced by other means suitable to
maintain the talcum powder in suspension in a
closed test chamber. The talcum powder used
shall be able to pass through a square-meshed
sieve the nominal wire diameter of which is 50
(Am and the nominal width of a gap between
wires 75 (Am. The amount of talcum powder to
be used is 2 kg per cubic metre of the test
chamber volume. It shall not have been used
for more than 20 tests.
NOTE Health and safety regulations should be N
observed in selecting the type of talcum powder
and its use.
Enclosures are of necessity in one of two N
categories:

Page 9 of 17
Category 1: Enclosures where the normal N

working cycle of the equipment causes
reductions in air pressure within the
enclosure below that of the surrounding air,
for example, due to thermal cycling effects.
Category 2: Enclosures where no pressure N
difference relative to the surrounding air is
present.
Category 1 enclosures: N
The enclosure under test is supported inside
the test chamber and the pressure inside the
enclosure is maintained below the surrounding
atmospheric pressure by a vacuum pump. The
suction connection shall be made to a hole
specially provided for this test. If not otherwise
specified in the relevant product standard, this
hole shall be in the vicinity of the vulnerable
parts.
If it is impracticable to make a special hole, the N
suction connection shall be made to the cable
inlet hole. If there are other holes (for example,
more cable inlet holes or drain-holes) these
shall be treated as intended for normal use on
site.
The object of the test is to draw into the N
enclosure, by means of depression, a
volume of air 80 times the volume of the
sample enclosure tested without exceeding the
extraction rate of 60 volumes per hour. In no
event shall the depression exceed 2 kPa (20
mbar) on the manometer shown in figure 2.
If an extraction rate of 40 to 60 volumes per N
hour is obtained the duration of the test is 2 h.
If, with a maximum depression of 2 kPa (20 N
mbar), the extraction rate is less than 40
volumes per hour, the test is continued until 80
volumes have been drawn through, or a period
of 8 h has elapsed.
Category 2 enclosures: N
The enclosure under test is supported in its
normal operating position inside the test
chamber, but is not connected to a vacuum
pump. Any drain-hole normally open shall be
left open for the duration of the test. The test
shall be continued for a period of 8 h.
Category 1 and category 2 enclosures: N
If it is impracticable to test the complete
enclosure in the test chamber, one of the
following procedures shall be applied:

Page 10 of 17
- testing of individually enclosed sections of the N

enclosure;
- testing of representative parts of the N
enclosure, comprising components such as
doors, ventilation openings, joints, shaft seals,
etc., in position during test;
- testing of a smaller enclosure having the N
same full-scale design details.
In the last two cases, the volume of air to be N
drawn through the enclosure under test shall be
the same as for the whole enclosure in full
scale.
13.5 Special conditions for first characteristic N
numeral 5
13.5.1 Test conditions for first characteristic N
numeral 5
The enclosure shall be deemed category 1
unless the relevant product standard for the
equipment specifies that the enclosure is
category 2.
13.5.2 Acceptance conditions for first N
characteristic numeral 5
The protection is satisfactory if, on inspection,
talcum powder has not accumulated in a
quantity or location such that, as with any other
kind of dust, it could interfere with the correct
operation of the equipment or impair safety.
Except for special cases to be clearly specified
in the relevant product standard, no dust shall
deposit where it could lead to tracking along the
creepage distances.
13.6 Special conditions for first characteristic N
numeral 6
13.6.1 Test conditions for first characteristic N
numeral 6
The enclosure shall be deemed category 1,
whether reductions in pressure below the
atmospheric pressure are present or not.
13.6.2 Acceptance conditions for first N
characteristic numeral 6
The protection is satisfactory if no deposit of
dust is observable inside the enclosure at the
end of the test.
14 Tests for protection against water indicated by the second characteristic P
numeral

Page 11 of 17
14.1 Test means P

The test means and the main test conditions
are given in table 8.
Table 8 - Test means and main test P
conditions for the tests for protection
against water
14.2 Test conditions P
Test means and main test conditions are given
in table 8. Details concerning compliance of
degrees of protection - in particular for
second characteristic numerals 5/6 (water jets)
and numerals 7/8 (immersion) - are given in
clause 6.
The tests are conducted with fresh water. P
During the tests for IPXI to IPX6 the water N
temperature should not differ by more than 5
K from the temperature of the specimen
under test. If the water temperature is more
than 5 K below the temperature of the
specimen a pressure balance shall be provided
for the enclosure. For IPX7 details of the water
temperature are given in 14.2.7.
During the test, the moisture contained inside P
the enclosure may partly condense. The dew
which may thus deposit shall not be mistaken
for an ingress of water.
For the purpose of the tests, the surface area P
of the enclosure is calculated with a tolerance
of 10%.
Adequate safety precautions should be taken N
when testing the equipment in the energized
condition.
14.2.1 Test for second characteristic numeral 1 N
with the drip box
The test is made with a device which produces N
a uniform flow of water drops over the whole
area of the enclosure.
An example of such a device is shown in figure N
3 a).
The turntable on which the enclosure is placed N
has a rotation speed of 1 r/min and the
eccentricity (distance between turntable axis
and specimen axis) is approximately 100 mm.

Page 12 of 17
The enclosure under test is placed in its N

normal operating position under the drip box,
the base of which is larger than that of the
enclosure. Except for enclosures designed for
wall or ceiling mounting, the support for the
enclosure under test should be smaller than the
base of the enclosure.
An enclosure normally fixed to a wall or N
ceiling is fixed in its normal position of use to
a wooden board having dimensions which are
equal to those of that surface of the enclosure
which is in contact with the wall or ceiling when
the enclosure is mounted as in normal use.
The duration of test is 10 min. N
NOTE When the base of the drip box is N
smaller than that of the enclosure under test,
the latter may be divided into several sections,
the area of each section being large enough to
be covered by the dripping water. The test is
continued until the whole area of the enclosure
has been sprinkled for the specified time.
with the drip box
The dripping device is the same as specified in N
14.2.1 adjusted to provide the water flow rate
specified in table 8.
The table on which the enclosure is placed N
does not turn as in the case of the test for the
second characteristic numeral 1.
The enclosure is tested for 2,5 min in each of N
four fixed positions of tilt.
These positions are 15° on either side of the N
vertical in two mutually perpendicular planes
(see figure 3b)).
The total duration of the test is 10 min. N
with oscillating tube or spray nozzle
The test is made using one of the two test N
devices described in figure 4 and in figure 5 in
accordance with the relevant product standard.
a) Conditions when using the test device as in N
figure 4 (oscillating tube):
The total flow rate is adjusted as specified in N
table 9 and is measured with a flow meter.

Page 13 of 17
The oscillating tube is provided with spray N

holes over an arc of 60° either side of the
centre point. The support is not perforated.
The enclosure to be tested is placed at the N
centre point of the semicircle. The tube is
caused to oscillate through an angle of 120°,
60° on either side of the vertical, the time for
one complete oscillation (2 x 120°) being about
4 s and the test duration being 5 min.
The enclosure is then turned through an N
horizontal angle of 90° and the test is continued
for a further 5 min.
The maximum acceptable radius of the N
oscillating tube is 1 600 mm.
If for certain types of apparatus it is not N
possible to wet all parts of the enclosure
under test, the support of the enclosure may be
moved up or down. The hand-held test device
as in figure 5 (spray nozzle) should be used as
a preference in such cases.
b) Conditions when using the test device as in N
figure 5 (spray nozzle):
The counterbalanced shield is in place for this N
test.
The water pressure is adjusted to give the N
specified delivery rate. The pressure to achieve
this delivery rate will be in the range of 50
kPa to 150 kPa. It should be kept constant
during the test.
The test duration is 1 min/m2 of the calculated N
surface area of the enclosure (excluding any
mounting surface), with a minimum duration of
5 min.
14.2.4 Test for second characteristic numeral 4 P
with oscillating tube or spray nozzle
The test is made using one of the two test
devices described in figure 4 and in figure 5
in accordance with the relevant product
standard.
a) Conditions when using the test device P
as in figure 4 (oscillating tube):
The oscillating tube has spray holes over the P
whole 180" of the semicircle. The total flow rate
is adjusted as specified in table 9 and is
measured with a flow meter.

Page 14 of 17
The tube is caused to oscillate through an P

angle of almost 360°, 180° on either side of the
vertical, the time for one complete oscillation (2
x 360°) being about 12s.
The duration of the test is 10 min. P
If not specified otherwise in the relevant P
product standard, the support for the enclosure
under test is perforated so as to avoid acting as
a baffle and the enclosure is sprayed from every
direction by oscillating the tube to the limit of its
travel in each direction.
b) Conditions when using the test device N
as in figure 5 (spray nozzle):
The counterbalanced shield is removed from N
the spray nozzle and the enclosure is
sprayed from all practicable directions.
The rate of water flow and the spraying time per N
unit area are as specified in 14.2.3.
Table 9 - Total water flow rate qv under IPX3 P
and IPX4 test conditions -Mean flow rate per
hole qv| = 0,07 l/min
with the 6,3 mm nozzle
The test is made by spraying the enclosure
from all practicable directions with a stream of
water from a standard test nozzle as shown in
figure 6.
The conditions to be observed are as follows: N
- internal diameter of the nozzle: 6,3 mm; N
- delivery rate: 12,5 l/min ± 5 %; N
- water pressure: to be adjusted to achieve the N
specified delivery rate;
- core of the substantial stream: circle of N
approximately 40 mm diameter at 2,5 m
distance from nozzle;
- test duration per square metre of enclosure N
surface area likely to be sprayed: 1 min;
- minimum test duration: 3 min; N
- distance from nozzle to enclosure surface: N
between 2,5 m and 3 m.

Page 15 of 17

with the 12,5 mm nozzle
The test is made by spraying the enclosure
from all practicable directions with a stream of
water from a standard test nozzle as shown in
figure 6.
The conditions to be observed are as follows: N
- internal diameter of the nozzle: 12,5 mm; N
- delivery rate: 100 l/min ± 5 %; N
- water pressure: to be adjusted to achieve the N
specified delivery rate;
- core of the substantial stream: circle of N
approximately 120 mm diameter at 2,5 m
distance from nozzle;
- test duration per square metre of enclosure N
surface area likely to be sprayed: 1 min;
- minimum test duration: 3 min; N
- distance from nozzle to enclosure surface: N
between 2,5 m and 3 m.
14.2.7 Test for second characteristic numeral 7: N
temporary immersion between 0,15 m and 1
m
The test is made by completely immersing the
enclosure in water in its service position as
specified by the manufacturer so that the
following conditions are satisfied:
a) the lowest point of enclosures with a height N
less than 850 mm is located 1 000 mm below
the surface of the water;
b) the highest point of enclosures with a height N
equal to or greater than 850 mm is located
150 mm below the surface of the water;
c) the duration of the test is 30 min; N
d) the water temperature does not differ N
from that of the equipment by more than 5
K. However, a modified requirement may be
specified in the relevant product standard if the
tests are to be made when the equipment is
energized and/or its parts in motion.

Page 16 of 17
14.2.8 Test for second characteristic numeral 8: N

continuous immersion subject to agreement
Unless there is a relevant product standard,
the test conditions are subject to agreement
between manufacturer and user, but they
shall be more severe than those prescribed
in 14.2.7 and they shall take account of the
condition that the enclosure will be continuously
immersed in actual use.
14.3 Acceptance conditions P
After testing in accordance with the
appropriate requirements of 14.2.1 to 14.2.8
the enclosure shall be inspected for ingress of
water.
It is the responsibility of the relevant technical P
committee to specify the amount of water which
may be allowed to enter the enclosure and the
details of a dielectric strength test, if any.
In general, if any water has entered, it shall not: P
- be sufficient to interfere with the correct Amount of water get through P
operation of the equipment or impair safety; the air grid of the fan into the
equipment. Water was
detected in the bottom (-tub) of
the equipment without
influence to electrical parts.
- deposit on insulation parts where it could lead N
to tracking along the creepage distances;
- reach live parts or windings not designed to N
operate when wet;
- accumulate near the cable end or enter the N
cable if any.
If the enclosure is provided with drain-holes, it N
should be proved by inspection that any water
which enters does not accumulate and that it
drains away without doing any harm to the
equipment.
For enclosures without drain-holes, the P
relevant product standard shall specify the
acceptance conditions if water can accumulate
to reach live parts.
15 Tests for protection against access to hazardous parts indicated by the N
additional letter
15.1 Access probes N
Access probes to verify the protection of
persons against access to hazardous parts are
given in table 6.

Page 17 of 17
15.2 Test conditions N

The access probe is pushed against any
openings of the enclosure with the force
specified in table 6. If it partly or fully
penetrates, it is placed in every possible
position, but in no case shall the stop face fully
penetrate through the opening.
Internal barriers are considered part of the N
enclosure as defined in 3.1.
For tests on low-voltage equipment, a low- N
voltage supply (of not less than 40 V and not
more than 50 V) in series with a suitable lamp
should be connected between the probe and
the hazardous parts inside the enclosure.
Hazardous live parts covered only with varnish
or paint, or protected by oxidation or by a
similar process, are covered by a metal foil
electrically connected to those parts which are
normally live in operation.
The signal-circuit method should also be N
applied to the hazardous moving parts of
high-voltage equipment.
Internal moving parts may be operated slowly, N
where this is possible.
15.3 Acceptance conditions N
The protection is satisfactory if adequate
clearance is kept between the access probe
and hazardous parts.
In the case of the test for the additional letter N
B, the jointed test finger may penetrate to its
80 mm length, but the stop face (0 50 mm x 20
mm) shall not pass through the opening.
Starting from the straight position, both joints
of the test finger shall be successively bent
through an angle of up to 90° with respect to the
axis of the adjoining section of the finger and
shall be placed in every possible position.
In case of the tests for the additional letters C N
and D, the access probe may penetrate to its
full length, but the stop face shall not fully
penetrate through the opening. See annex A for
further clarification.
Conditions for verification of adequate N
clearance are identical with those given in
12.3.1, 12.3.2 and 12.3.3.

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Technical Report TüV

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Technical Report No.

Client: LRE Medical GmbH

Manufacturer: Dräger Safety AG & Co KGaA

Test subject: Product: In vitro diagnostic device

Test specification: EN 61010-1:2001

Purpose of examination: Test according to the test specification

Phone: + 49 49 89 5008-4322 TÜV SÜD Product Service GmbH

1.2 Technical Data

Rated voltage: 12Vdc

Protection class: III

2.1 Date of Purchase Order

2.2 Receipt of Test Sample

2.3 Date of Testing

2.4 Location of Testing

Phone: + 49 49 89 5008-4322 TÜV SÜD Product Service GmbH

3.1 Positive Test Results

Technical Report checked Engineer

i.A. Dipl.-Ing.(FH) Manfred Schmolke i.A. Ralph Fischer

Phone: + 49 49 89 5008-4322 TÜV SÜD Product Service GmbH

Compiled by (+ signature) ................: Ralph Fischer

Approved by (+ signature) ................: Manfred Schmolke

Test item description .....................: Laboratoy equipment (drug tester)

Test Report IEC 61010-D Rev. 00 / 2004-11

Copy of marking plate:

Summary of Test Results (information/comments):

The equipment complies with EN 61010-1, EN 61010-2-101 and EN 60529.

Test Report IEC 61010-D Rev. 00 / 2004-11

Test item particulars:

Throughout this report, a point (coma) is used as the decimal separator.

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

4.4 Testing in SINGLE FAULT CONDITIONS ⎯

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

5.1.2b) Model number, name or other means P

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

5.1.5.1a) FUNCTIONAL EARTH TERMINALS (symbol 5 used) N

b) Measuring circuit TERMINALS for measurements N

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

5.1.7 Equipment protected by DOUBLE INSULATION or N

Protected throughout (symbol 11 used) N

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

5.4.1g) For equipment CAT I, a warning not to use within N

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

5.4.4 Instructions for use contain information for P

6.1.2 Exceptions: Capacitance test............................... : (see TABLE 6.2 and 6.3.1) N

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

6.2.3 Openings for pre-set controls N

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

The impedance to the protective conductor path N

6.5.1.2d) If no MAINS supply is required, the PROTECTIVE N

6.5.1.2e) PROTECTIVE CONDUCTOR TERMINALS for MAINS N

2) PROTECTIVE BONDING is not interrupted by the N

Test Report IEC 61010-D Rev. 00 / 2004-11

Clause Requirement − Test Result − Remark Verdict

Devices used for indirect bonding (see 6.5.1.5) N

Test Report IEC 61010-D Rev. 00 / 2004-11