Beruflich Dokumente
Kultur Dokumente
028-71326415-000
Rev. 0
Dated 2007-10-18
Frankfurter Ring 15
D-80807 München
Revalstraße 1
D-23560 Lübeck
EN 60529/A1:2000
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
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.
2 Order
• 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
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
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
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.
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
Supplementary information:
Supplementary information:
Supplementary information:
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).
Supplementary information:
Supplementary information:
Transient voltages must be below the limits given from Figure 1 and the capacitance below the limits from
figure 2 of IEC 61010-1.
Supplementary information:
Supplementary information:
Supplementary information:
Supplementary information:
Supplementary information:
Supplementary information:
A combination of components
Component Location Comments
Supplementary information:
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
Supplementary information:
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"
Supplementary information:
Supplementary information:
Supplementary information:
Indicate under Comments: B = Before Humidity Conditioning
A = After Humidity Conditioning (no recovery time)
Supplementary information:
NOTE: See also TABLE 10.5.2
Supplementary information:
Supplementary information:
Components supplied by VCC, VDDup and VLCD are display and keypad
Outputs supplied by VCC: PS2 and USB
Supplementary information:
Supplementary information:
Where: tm = measured temperature
tc = tm corrected (tm–ta+ 40 °C or max. RATED ambient)
tmax = maximum permitted temperature
Supplementary information:
tc = tr corrected (tc= tr - { ta2 - ta1} + [40 °C or max RATED ambient])
Supplementary information: No changes is creepage and clearance distances after use in 40°C ambient
expected.
Supplementary information:
Supplementary information:
Supplementary information:
Supplementary information:
NOTE – Use r.m.s., d.c. or peak to indicate the used test voltage.
Supplementary information:
Supplementary information:
Supplementary information:
Supplementary information:
Supplementary information:
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.
Supplementary information:
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
1
) an asterisk indicates a mark which assures the agreed level of surveillance
Supplementary information:
NOTE: NSR = non-self-resetting (10 times); NR = non-resetting (1 time); SR = self-resetting (200 times)
Supplementary information:
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
Supplementary information:
Supplementary information:
SI3
SI1
(2)
‘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.
tec_bilddokumentation_e.dot 01.03.2006
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.
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.
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.
NOTE – Record surface temperatures of flammable liquids and parts in contact with them in Form A.20A
Supplementary information:
(see Form A.2 of TRF IEC/EN 61010-1for details of tests)
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
General remarks:
"(see remark #)" refers to a remark appended to the report.
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 testing laboratory.
Summary of testing:
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);
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.
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: