BluePoint MEDICAL AlcoTrue E User manual

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 1

Operating instructions

AlcoTrue

Breathalyser for personal use

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 2

Liability

bluepoint MEDICAL GmbH & Co. KG shall under any circumstances not be liable for

any direct, indirect, special or consequential damages including without limitation

damages for loss of business profits, loss of income, business interruption, loss of

business information, loss of use or other related exposures, however caused, arising

from an incorrect use of the device not conforming to its intended use or/and if the

device is serviced and repaired by personnel not employed or authorized by bluepoint

MEDICAL GmbH & Co. KG.

bluepoint MEDICAL GmbH & Co. KG guarantees that the product delivered has been

thoroughly tested to ensure that it meets its published specifications.

AlcoTrue® is a registered trademark of bluepoint MEDICAL GmbH & Co. KG

Warranty

bluepoint MEDICAL GmbH & Co. KG warrants the products manufactured or distributed

by them to be free from faulty materials and workmanship for a period of 15 months

from date of original shipment to first end user except for wear parts, disposable

products or products which have a stated guarantee longer or shorter than 15 months.

bluepoint MEDICAL GmbH & Co. KG will perform warranty service at its factory.

The obligations for bluepoint MEDICAL GmbH & Co. KG under this guarantee shall be

limited to repair, or at bluepoint MEDICAL GmbH & Co. KG 's option, replacement of

necessary parts or assemblies and shall not include shipping costs or other incidental

damages.

Claims for damages during shipment must be filed promptly with the transportation

company. All correspondence concerning the products must specify both the name of

the product and its serial number as written on the label on the product.

Use of the equipment for other than its intended use, or if it has been repaired by

anyone except bluepoint MEDICAL GmbH & Co. KG or a bluepoint MEDICAL GmbH &

Co. KG authorized service centre, or altered or modified or used without following the

instructions in the user manual, will void this guarantee.

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 3

Contents

1. Safety considerations ......................................................................................... 4

2. Intended use......................................................................................................... 5

3. Device................................................................................................................... 6

3.1 AlcoTrue® E - device components........................................................... 6

3.2 Device label-symbols................................................................................ 6

4. Battery information.............................................................................................. 7

4.1 Charging batteries..................................................................................... 7

4.2 Battery level indications............................................................................. 7

5. Device switch ON/OFF ........................................................................................ 7

6. Carrying out the measurement........................................................................... 9

6.1Before measuring ...................................................................................... 9

6.1.1 Requirements of the person to be tested..................................... 9

6.1.2 Conditions................................................................................... 9

6.1.3 Inserting the mouthpiece........................................................... 10

6.2 Breath test procedure ............................................................................. 10

6.3 Error in delivering the breath sample ...................................................... 11

7. User menu and device settings........................................................................ 11

8. Maintenance, Cleaning, Disinfection ............................................................... 12

9. Disposal of the device....................................................................................... 12

10. Error /cause - solution..................................................................................... 13

11. Technical specifications ................................................................................. 14

12. Order list........................................................................................................... 16

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 4

1. Safety considerations

Strictly follow the instructions for use

Handling the device requires full understanding and strict observation of these operating

instructions.

The device is intended only for the application described herein.

Maintenance

Calibration and maintenance work must be carried out by authorised service personnel

only. Only original parts from bluepoint MEDICAL GmbH & Co. KG may be used for

repairs.

Only the accessories specified in the order list shall be used.

Safety symbols

Important information on a topic or procedure, or conditions that may lead to

damage or malfunction of the device

Indicates potential harmful conditions that may lead to injury

Disposal

Do not dispose in the consumer waste. Electrical and electronic equipment

shall be collected and recycled in accordance with (Directive 2002/96/EC)

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 5

2. Intended use

Intended use

AlcoTrue

E is a mobile breathalyser for personal use with 3x AA alkaline battery.

AlcoTrue

E is intended for quick and accurate determination of alcohol concentration in

a person’s breath.

NOTE: AlcoTrue®E is not an evidential measuring instrument and cannot be used

bindingly to determine if a person after use of alcohol can drive a vehicle or can operate

a machine. Measurements with AlcoTrue®E or similar kind of “ pre-test breathalysers”

are not a evidential proof of for example prior a court suitable. With AlcoTrue®E usage it

can only serve to confirm an initial suspicion.

Calibration

AlcoTrue®E is provided with a standard calibration by bluepoint MEDICAL GmbH & Co.

The periods of calibration validity are 1000 measurements or 12 months, after

calibration period expires the device will require re-calibration. Using of AlcoTrue®E

with an expired device calibration has a risk of obtaining erroneous results.

The device can either be re-calibrated by bluepoint MEDICAL GmbH & Co. KG or an

authorised service partner.

The calibration overdue is displayed after device “Self test” procedure with <CAL>

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 6

3. Device

3.1 AlcoTrue® E – device components

Front view Side view Rear view

No.

Description

No.

Description

Display

Device inlet

Device outlet

“ON/OFF/Confirm” button Device label

Background light Battery compartment lid

3.2 Device label-symbols

Consult user manual for

detailed operating instructions! Serial number

CE certified to 89/336/EWG Product number

Manufacturer

Observe disposal regulations!

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 7

4. Battery information

4.1 Insert/exchange batteries

Insert batteries before use or exchange batteries if the battery symbol on the display

indicates .

•Press onto the lock of the battery compartment and remove cover

•Insert batteries in battery case. Observe correct polarity and correct position

when inserting the batteries!

•Close battery cover.

Use only 3 x 1.5V Type Alkaline (Mignon, LR6, AA). Never mix batteries of

different brands and different discharge levels. Always replace all

batteries at once. Remove the batteries if the device is to be stored or not

used for a long period of time.

4.2 Battery level indications

Battery full 75% battery capacity

50% battery capacity 25% battery low 25%

Battery empty

5. Device switch ON/OFF

Afterwards a self test of the internal functions and

components is automatically performed.

Switch ON

Keep button pressed for 2 seconds, device turns

on accompanied with an acoustic tone (beep).

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 8

Software-Version Number of measurements self test

till new calibration is required

Automatic switch off

AlcoTrue

E switches off automatically approx. 3 minutes after the last

use.

Switch OFF

Keep button pressed, countdown is displayed.

Device switches off after 3 seconds.

After self-test is completed, the unit is ready for test

(Ready).

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 9

6. Carrying out the measurement

6.1 Before measuring

6.1.1 Requirements of the person to be tested

•A waiting period of at least 20 minutes shall be observed if the person to be

tested has consumed alcohol within the last 20 minutes.

Aromatic drinks (e.g. fruit juice), mouth sprays and mouthwashes containing

alcohol, medicines may interfere with the measurement. Rinsing the mouth with

non-alcoholic drinks or water does not reduce the waiting period.

•Prior to measuring the person to be tested must breathe normally and calmly.

Fast inhaling and exhaling through the mouth should be avoided.

•Tobacco smoke in the expiration air might short the service life time of the

alcohol sensor. It must be ensured that the test person has not been smoking

before performing the measurement. A waiting period of at least 5 minutes after

smoking must be observed.

•A required minimum breath volume must be provided by the person to be tested.

The breath flow must be evenly and without interruption.

6.1.2 Conditions

•

A new mouthpiece must be used for every person to be tested.

Risk of contamination!

•Using high grade-alcohol shortly before the measurement will

reduce the sensor service life, e.g. mouthwashes containing

alcohol.

•The blood alcohol concentration can continue to rise for up to

2h after the cessation of drinking. It should be care taken if a

caution result or a result close to the designated blood alcohol

concentration is indicated.

•It can take 10h or more for the blood alcohol level to return to

zero after a high blood alcohol level has been reached. In such

case a further test should be carried out later in the day or the

following morning.

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 10

6.1.3 Inserting the mouthpiece

6.2. Breath test procedure

After switching on the AlcoTrue ® E and successful self-test, the device is ready for test.

the person to be tested must blow evenly through the mouthpiece without interruption.

A sufficient flow is indicated by a beep tone.

During sampling, the follow display is showing.

Alcohol breat test is successful when breathing volume and blowing time are reached,

beep tone stops.

Press button for a new measurement.

Insert a new mouthpiece into inlet of AlcoTrue

E. Use the hygienic

packaging as a hygienic protection.

nsure that the mouthpiece

packaging is not damaged.

•

Wait until device self test is complete and READY

displayed.

•Insert mouthpiece into device inlet

•Proceed with the test

•

Wait until analysing complete.

Analysing time depends on the measured

concentration.

•

Test result is displayed.

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