BluePoint MEDICAL AlcoTrue E User manual

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 1
Operating instructions
AlcoTrue
®
E
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.
KG
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
Menu
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!
5
6
7
8
4
3
2
1
2
4
5
1
8
7
3
6

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.
E
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.

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 11
6.3 Error in delivering the breath sample
Press button and repeat the measurement.
7. User menu and device settings
Press the button for 3 seconds until following display will be shown.
The display flashes Cal. To scroll through the indicated unit press on the button. To
select a unit press the button.
With the button you can turn on / off the backlight. Continuously usage of the
backlight will reduce battery lifetime.
Blow failure
This error appears when the person abruptly cease to
exhale or if during the blowing process the respiratory
flow drops below the required level before the required
volume is reached.
selected unit ‰

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 12
8. Maintenance
Cleaning and disinfection
•Keep Mouthpiece port during the cleaning / disinfection closed.
•Use a soft cloth dampened with a commercial, nonabrasive cleaner to clean the
device.
•
Use a soft cloth dampened with solution of 70% alcohol in water to disinfecting
the device. Lightly wipe the housing surface of the device and then allow to dry in
air for at least 30 minutes before turn on device. Otherwise this will short the
service life time of the alcohol sensor.
Do not submerge the device in liquids. Keep the battery compartment
closed while cleaning. Battery compartments must remain dry to ensure
proper function of AlcoTrue®E.
Calibration
•The period of calibration validity is 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.
•Calibration must be carried out by authorised personnel or bluepoint® MEDICAL
GmbH & Co. KG service.
9. Disposal of the device
Do not open batteries by force and do not expose to fire, danger of
explosion!
The device should not be disposed with domestic waste. Please ask a
suitable contractor to dispose of the instrument and alcohol sensor.
The local environmental agency can supply further information.
Empty batteries must be disposed in accordance to the relevant
national waste disposal regulations (EU 91/157/EEC).

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 13
10. Error / cause - solution
Error message Cause Solution
None sufficient blow volume
or breath flow interruption.
Repeat the test. The breath
flow must be evenly
and without
interruption.
Low battery Replace the battery
Ambient temperature is
higher than 50℃
Turn off device. Bring device
within specified operating
conditions. Turn on device.
Ambient temperature is lower
than 5℃
Turn off device. Bring device
within specified operating
conditions. Turn on device.
pressure sensor error
Start device again. If the fault
occurs again during the self
test, runtime or when
performing a measurement
please contact service.
Alcohol sensor error due high
gradient alcohol into device
inlet.
Turn OFF device and wait for
at least 5 min. Start device
again. If the fault occurs again
during the self test, runtime or
when performing a
measurement please contact
service.
Calibration overdue device has to be calibrated

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 14
11. Technical specifications
•Device name/model/type AlcoTrue E – breathalyser for personal use
•Manufacturer bluepoint MEDICAL GmbH&Co.KG
•Sensor Type Electrochemical sensor
•Sampling system Standard sampling system by bluepoint®
•Measurement mode Active breath test
•Measurement range
Breath alcohol concentration 0.00 to 1,08 mg/L
(BrAC) 0 to 108 µg/100mL
(Ethanol mass per breath volume at 34°C and
1013 hPa.)
Blood alcohol concentration 0.00 to 2,50‰
(BAC) 0.000 to 0.250 %
0.00 to 2,50g/L
0 to 250 mg/100mL
(Ethanol mass per blood volume resp. mass at 20°C
and 1013 hPa)
This data is given using a conversion factor of 2300:1 between blood and breath -
alcohol concentrations.
•Ambient Conditions
For operation 5°C to 50°C
20 to 98% r.H. (none condensed)
600 to 1400 hPa
For storage -20°C to 60°C
20 to 98% r.H. (none condensed)
600 to 1400 hPa
•Sample conditions
Minimal acceptable flow > 12 L/min
Minimal volume > 1.1L

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 15
•Measurement accuracy
Reproducibility with an ethanol standard
0 to 0.50 mg/L BrAC ≤0,024 mg/L
0 to 1,00 ‰ BAC ≤0,05 ‰
•Ready for operation
After switching on ca. 6 s
After completing a measurement in range (BrAC):
Typ.
0,00 mg/L ≤2s
0,50 mg/L ≤15s
After completing a measurement in range (BAC):
Typ.
0,00‰ ≤2s
1,00‰ ≤15s
•Mouthpiece type
Typ „S“ from bluepoint Medical GmbH & Co. KG
•Calibration interval 1000 measurements or 12 months
•Calibration type Wet gas
Permissible calibration range for unit of measuring value:
mg/L 0.24 to 0.71 mg/L
‰ 0.50 to 1.50 ‰
mg/100mL 50 to 150 mg/100mL
Standard calibration value:
mg/L 0.435 mg/L
‰ 1.00 ‰
mg/100mL 100 mg/100mL
The use of these standard calibration values corresponds to a conversion factor
of 2300:1 between blood and breath alcohol concentration values.

AlcoTrue® E - Operating instructions | bluepoint® MEDICAL GmbH & Co. KG 2014 16
•Units
Default: mg/L BrAC
Available units: µg/100mL BrAC
‰ BAC
mg/100mL BAC
% BAC
g/L BAC
•Language English
•Dimensions 132 mm x 63mm x 26mm
•Weight approx. 187 g inclusive 3 x 1.5V Alkaline batteries
•Electrical supply
- Internal batteries 3 x 1.5V Type Alkaline
(Mignon, LR6, AA)
Typ. ≥2000 measurements at room temperature
•Display 1,8“ black/white LCD with LED background light
•Data memory --
•CE-marking /Standards EN 61326-1:2006, designed acc EN16280
12. Order list
AlcoTrue® E Reference number
5040112005
- AlcoTrue®E device
- 10 individually packed mouthpieces (S-Type)
- 3 x AA Alkaline batteries (LR6, MN1500)
- Instruction for use
Accessories AlcoTrue® E Reference number
Mouthpiece(S-Typ), 25 hygienic pieces, individually packed 4040121001

6040112007-EN
| Rev 2.0
AlcoTrue® E – Operating instructions
Version: 2.0 (English)
The information in this document is
subject to alterations without notice.
.
Copyright © 2014 bluepoint®MEDICAL GmbH & Co. KG. All Rights Reserved.
No part of this document may be photocopied, reproduced or translate to another
language without prior written consent of bluepoint®MEDICAL GmbH & Co. KG.
bluepoint® MEDICAL GmbH & Co. KG.
An der Trave 15
23923 Selmsdorf
Germany
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
www.bluepoint-medical.com