Dräger DrugTest 5000 Analyzer Instructions for Use 1st Edition May 2007

For Your Safety

Intended Use

Strictly follow the Instructions for Use Strictly observe these instructions when using the Dräger DrugTest® 5000 Analyzer. Any disregard may cause erroneous measuring results and damage the device. The Dräger DrugTest 5000 Analyzer is only to be used for purposes specified herein.

The Dräger-DrugTest 5000 Analyzer is a device for detecting drugs in oral fluid samples collected with the Dräger DrugTest 5000 Test-Kit (In-Vitro Diagnostic Medical Device). The mea-surement 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 detecting 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 well as for mobile use.

Maintenance Maintenance jobs may only be carried out by trained specialists. We recommend commissioning Dräger Safety for servicing the device. Only genuine Dräger parts may be used for maintenance. The Dräger DrugTest 5000 Analyzer does not contain any parts serviceable by the user. Unauthorised opening of the device voids any guarantee claim. We recommend an annual inspection of the device ( see also chapter “Maintenance” on page 8). No use in areas subject to explosion hazards The device is not approved for use in a potentially explosive atmosphere. Connection of electrical devices Do not connect electrical devices not mentioned in this manual before contacting Dräger Safety. Shipping Damages If there are any damages upon receipt of the device, immediately demand a check from the haulier and the local service representative. Dräger Safety is not responsible for damages caused during transport. However, Dräger Safety will be helping with clarifying the incident with the haulier. Dräger Safety AG & Co. KGaA

System Components The following components are provided with the Dräger DrugTest 5000 Analyzer: Quantity 1 1 1

Designation Dräger DrugTest 5000 Analyzer Power supply unit (12 V DC) with line cord Instructions for Use

Additional Accessories For extending the system, Dräger Safety offers additional accessories like printer, keypad, bar code reader, carrying bag, 12 V car cable, separate Test-Kits and transport cases. Refer to the order list (see page 9) for more information.

Switching on the analyzer ● Keep button OK pressed for approx. 3 seconds until an acoustic signal sounds and the start screen is displayed. – After successful completion of the automatic self check the device displays readiness for operation » READY «.

Collecting the oral fluid sample The oral fluid sample is collected using the Dräger DrugTest 5000 Test-Kit (order no.: 83 19 830). For detailed information on the Test-Kit, refer to the Instructions for Use for Dräger DrugTest 5000 Test-Kit, which is enclosed in the Test-Kit units. Wait at least 10 minutes following intake of substances through mouth or nose before collecting a sample. Ensure that the test cassettes and cartridges in the pouch are at ambient temperature (if necessary, wait 15 min. for temperature compensation) . Only open pouches immediately before use, remove test cassette from the pouch. ● Remove the protective cap of the test cassette from oral fluid collector and give the test cassette to the subject – figure 1. ● Instruct the subject to place the oral fluid collector inside the cheeks and and move it carefully from one side of the mouth to the other – figure 2. Do not chew or suck on the oral fluid collector. Observe the collection! ● Once the sample adequacy indicator changes colour to blue, normally after approx. one minute, an adequate sample amount has been collected – figure 3.

Performing the evaluation ●

Carrying through a Drug Test The Dräger DrugTest 5000 Analyzer is immediately usable. There is no assembly or installation required before commissioning.

Preparation Place the Dräger DrugTest 5000 Analyzer onto a plane, solid and horizontal base. Keep all ventilation slots open and clean. ● Make sure that the specific ambient conditions are established: ambient temperature between 5 oC and 40 oC (41 oF and 104 oF); relative humidity between 5 % and 95 %. ● Connect the external keyboard, align printer etc., if required. When using an external power supply, e.g. with insufficient battery charge: ● Connect battery charger. ● ●

______________ ® Dräger DrugTest is a registered trademark of Dräger Safety AG & Co. KGaA.

● ● ●

Take the test cassette from the subject, open the door of the Analyzer and insert the test cassette into the lower compartment, until it engages audibly – figure 4. Insert the cartridge into the upper compartment of the Analyzer, until it engages audibly – figure 5. Close the door of the Analyzer and follow the instructions shown on the screen. Do not move the unit during the test execution! A status bar on the display indicates the progress of the evaluation process. After completed analysis the results are displayed for each substance.

If desired: ● Data of the subject and user can be entered, the test result can be printed and the data can be saved by selecting the menu items in accordance with the notes shown on the screen.

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After finishing the test: ● Open the door of the Analyzer and remove the test cassette with the cartridge attached from the lower compartment of the Analyzer – figure 6. ● Close the door of the Analyzer. – After displaying and, if necessary, printing the test result the current analysis is completed and the unit is ready for carrying out further tests. – Before switching off and transporting the unit remove the used test cassette.

Configuration

Maintenance

The device can be connected to a PC using the integr ated USB interface. This interface can be used by qualified users and the Technical Service of Dräger Safety to set up the device (e.g. for data storage or individual sample allocation). For further information on this topic, please contact Dräger Safety or a service organisation authorised by Dräger Safety.

The Dräger DrugTest 5000 Analyzer is a robust device which requires minimum service.

Switching off the Analyzer ●

Keep button OK pressed. The device switches off after approx. 3 seconds. To load the battery, the power cord can be connected until the device stowed away, for example for a transport.

Menu The menu can be reached via the » Menu « item when the device is ready for measurement. Detailed information is included in the technical handbook Dräger DrugTest System *). The user navigates through the menu via three buttons with their respective functions displayed on the screen (Softkey). – If no buttons are pressed within 120 seconds the display will automatically return to the measurement mode.

Navigation in the menu Graphical symbols (icons) simplify the navigation through the menu levels: Return to the next higher menu level Closed folder: This item contains further functions or sub-menus Open folder The functions and sub-menus shown here are contained in this item. Function If activated, functions can be executed in a single step or several steps. Selection activated Press the » OK « key for functions which can be selected and activated.

*) The technical handbook can be downloaded for free from the Dräger homepage (www.draeger.com).

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Fault – Cause – Remedy The following table describes possible faults and system messages. If you encounter problems other than the ones listed in the table while using the device or if your problem cannot be solved by following the listed remedies, please contact the Dräger Safety Service department or a service organisation authorised by Dräger Safety (see section “Problem Solution and Repair” in chapter “Maintenance” on page 8). Faults

Cause

No screen display within 10 seconds after powering up the device

Battery totally dis- Connect battery charged and no charger and external power external power supply estabsupply. lished

Remedy

Audio alarm and displayed message » Close door «

The door has been opened in the analysis process

Close the door.

Audio alarm and displayed message » Remove Test Cassette «

A Test Cassette is in the device during the automatic self check

Open the door, remove the Test Cassette, close the door.

Smoke / pungent smell

Incorrect battery charger used

Use battery charger supplied. Should the problem persist: Contat Dräger Safety

Maintenance We recommend to let the device get ser viced regularly every 12 months. The maintenance should be carried out by the Dräger Safety Service department or a service organisation authorized by Dräger Safety. We recommend to enter a service contract.

Problem Solution and Repair If you should encounter any problem which cannot be solved with the suggestions given in table “Fault – Cause – Remedy” on page 8, please inform the Dräger Safety Service department or a service organisation authorised by Dräger Safety.

Cleaning If necessary, you can clean the outside of the device with a soft cloth moistened with a mild soap solution or a commercially available laboratory cleaning agent. ● Do not dip the device into liquids and do not let any liquid get into the terminals! – The inside of the device does not require cleaning when used as intended. ●

Battery maintenance The unit is equipped with an integrated lead storage battery.The unit consumes a small standby current even if switched off, which can discharge a fully charged battery in approx. 6 months. The capability of the batter y is retained at an optimum and for the long term if prolonged periods of low charge are avoided. To to so the following measures are required: – If the unit indicates a low battery charge, connect the battery charger and completely charge the battery as soon as possible. – Prior to prolonged storage of the unit (several weeks) charge the battery completely. Before the next use another complete charge is recommended. – For long-term storage of the unit (several months) charge the battery completely every six months or keep the battery charger connected throughout the duration of storage. – During storage at temperatures below –10 oC also keep the battery charger connected throughout the duration of storage.

Disposal of Electric and Electronic Devices From August 2005, regulations apply to the whole of the EU for the disposal of electrical and electronic devices; these regulations are set in the EU Directive 2002/96/EG and in national laws relating to this device. Special collection and recycling possibilities have been established for private households. However, since the instrument has not been registered for use in private households, it cannot be disposed of as special household waste. For disposal, it can be sent back to your national Dräger Safety Sales organisation; if you have any questions requiring disposal, then please contact this location.

Order list Designation and description

Part no.

Dräger DrugTest 5000 Analyzer including battery charger, mains cable and instructions for use

83 19 900

Compact keypad (PS/2, dimensions approx. 28.2 x 13.2 x 2.4 cm): "QWERTZ" – German keyboard layout

83 15 095

"QWERTY" – English keyboard layout

83 15 497

"AZERTY" – French keyboard layout

83 15 142

Dräger Mobile Printer

83 19 310

Paper for Dräger Mobile Printer (5 rolls)

83 19 002

Technical Data

Carrying bag Dräger DrugTest 5000 Analyzer

83 19 960

Supply voltage

12 V DC (11 to 15 V DC)

Transport case

83 19 925

Current consumption

typically 3 A

Power supply unit 12 V with primary adapter for EU, UK, USA, AUS

83 15 675

Dimensions (W x H x D)

200 mm x 250 mm x 220 mm 4.5 kg

Car charging cable 12 V Power cable from car cigarette lighter sockets to Dräger DrugTest 5000 Analyzer

83 12 166

Weight Temperature

operation:

USB connection cable for communication with a PC

AG 02 661

Bar code scanner

AG 02 491

Dräger DrugTest 5000 Test-Kit Package containing 20 pcs.

83 19 830

Dräger DrugTest5000 training test kit Package containing 20 pieces

83 19 970

Dräger DCD 5000 Device for collecting oral fluid samples

83 19 910

Operating manual Dräger DrugTest 5000 Analyzer

90 23 949

Instructions for Use Dräger DrugTest 5000 Test-Kit

90 23 951

storage / transport:

5 oC to 40 oC (41 oF to 104 oF) –20 oC to 60 oC (–4 oF to 140 oF)

Moisture range

5 to 95 % rel. hum., non-condensing

Interfaces

optical IRDA (printer), PS/2 (for external keyboard or scanner), USB Slave (for communication with a PC

Duration of one meas- depending on the type of test, urement 5 to 10 minutes Storage capacity

500 data sets with test results

Technical handbook Dräger DrugTest System

www.draeger.com

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