PTW Freiburg PTW-UNITEST 47001, PTW-UNITEST 47002, PTW-UNITEST 47003 User Manual
User Manual
PTW-UNITEST
(Electrical Check Device)
Type 47001, Type 47002 and Type 47003
D235.131.0/4 2005-12 Sa
General Information
PTW-UNITEST
(Electrical Check Device)
General Information
− The product bears the CE-mark "CE-0124" in
accordance with the Council Directive
93/42/EEC about Medical Devices and fulfills
the essential requirements of Annex 1 of this
directive.
The product is a class IIb device (MDD).
− The user manual is an integral part of the
product. It should always be kept near the
product. Observance of the manual is a prerequisite for proper product performance and
correct operation.
− Operator safety, specified measuring accuracy
and interference-free operation can be guaranteed only if original products and parts are
used. Furthermore only the accessories listed
in this manual are approved by PTW-Freiburg
and may be used in conjunction with the product, or else accessories whose use has been
expressly permitted by PTW-Freiburg. Safe
operation and proper product performance are
not guaranteed if accessories or consumables
from other manufacturers are used.
− This manual is in conformity with the product
specifications and all applicable safety standards valid at printing date. All rights are reserved for devices, circuits, techniques, software and names referred to in the manual.
− Electromagnetic immunity: The product fully
complies with the electromagnetic immunity
requirements of standard IEC 60601-1-2
`Electromagnetic Compatibility - Medical Electrical Equipment`.
− No part of the technical documentation may be
reproduced without written permission from
PTW-Freiburg.
− PTW-Freiburg works in strict accordance with
a quality management system which is continuously updated according to national and
international standards.
− PTW-Freiburg cannot be held liable for dam-
ages resulting from the use of accessories,
consumables from other manufacturers or
when the user ignores the instructions and information given in this manual.
− The warranty period is 1 (one) year and begins
on the day of delivery.
It is unaffected by repairs covered by the warranty regulations.
− PTW-Freiburg considers itself responsible for
safety, reliability and performance of the product only, if assembly, extension, readjustment,
modification or repair is carried out by
PTW-Freiburg or by persons authorized by
PTW-Freiburg, and if the product is used in
compliance with the technical documentation.
PTW-FREIBURG
Physikalisch-Technische Werkstätten
Dr. Pychlau GmbH
Lörracher Str. 7
79115 FREIBURG
GERMANY
Phone: +49 761 49055-0
Fax: +49 761 49055-70
info@ptw.de
www.ptw.de
2 D235.131.0/4
PTW-UNITEST
(Electrical Check Device)
Contents
Contents
General Information 2
1 Intended Use 4
2 For Your Safety 4
3 Description of the Instrument 7
4 Description of Function 7
5 Measurements with the UNITEST 8
5.1 Hints for the use of the UNITEST 8
5.2 Preparing the measurements 8
5.3 Measurements 8
6 Evaluation of the measuring results 11
6.1 Consistency check of the response in the different measuring ranges 11
6.2 Electrical constancy checks 11
7 Cleaning, Maintenance, Disposal 12
7.1 Cleaning 12
7.2 Preventive Maintenance 12
7.3 Disposal of the Product 12
8 Technical Specifications 13
Literature 14
D235.131.0/4 3
PTW-UNITEST
(Electrical Check Device)
Intended Use
1 Intended Use
UNITEST is an electrical check device for the surveillance of the PTW dosemeters listed in chapter 5. No mains connection or battery is needed to
operate UNITEST; it is simply connected to the
dosemeter instead of an ionization chamber. Using
UNITEST the following checks can be done:
− Check of the consistency of the response in all
doserate and dose measuring ranges.
− Electrical constancy check of the different ampli-
fier ranges and of the internal high voltage supply of the dosemeter.
It must be observed that the connection systems of
UNITEST and dosemeter are compatible. Use of
adapter cables is not permitted.
When the UNITEST is not in use, it should be
stored in a location protected against humidity. The
connector should be protected with a dust protection cap.
2 For Your Safety
The following safety statements are divided into
DANGER, WARNING, CAUTION and NOTE.
Definitions
DANGER
Indicates an imminent hazard. If not avoided,
the hazard will result in death or serious injury.
WARNING
Indicates a hazard. If not avoided, the hazard
can result death or serious injury.
CAUTION
Indicates a potential hazard. If not avoided, the
hazard could result in minor injury or product /
property damage.
NOTE
Provides useful information to assure that you
get the most from your equipment.
4 D235.131.0/4
PTW-UNITEST
(Electrical Check Device)
For Your Safety
Safety Information
DANGER
Explosion Hazard – The product is not suitable
for operation in areas of risk where an explo-
sion hazard may occur. Explosion hazards
may be caused by the use of combustible anaesthetics, skin-cleansing agents and disinfectants.
Furthermore the product is not suitable for application in oxygen-enriched atmospheres.
The atmosphere is considered to be oxygenenriched when more than 25 % of oxygen or nitrous oxide is added to the ambient air.
WARNING
Shock Hazard – Strictly observe the following
warnings. Failure to do so may endanger the
lives of the patient, the user and other persons
involved.
− Before using the product, the operator must
ascertain that it is in correct working order
and operating condition.
− Before putting the device into operation,
visually inspect all connection cables for
signs of damage. Damaged cables and connectors must be replaced immediately.
− Devices on which moisture condensation
has developed as a result of temperature
changes must not be switched on unless
completely dry.
− Liquids must not enter the device. If liquids
have entered the device, it must be thoroughly inspected before being used again.
Exclusion of operation in the patient environment:
Neither the product nor any peripheral device
may be operated within the patient environment
(see Figure 1).
Exclusion of operation as device with patient contact:
The device is not for use in direct contact with
the patient. Neither UNITEST nor any peripheral device may have contact to the patient.
Never touch the patient and open connectors of
the device at the same time.
WARNING
Suffocation Hazard – Dispose of the packaging material, observing the applicable wastecontrol regulations. Keep the packaging material out of children's reach.
Patient Hazard – The product is a medical
electrical device and must only be handled by
persons who are trained in the use of such
equipment and are capable of applying it properly. The operator must be trained in the use of
the device.
Risk of Poisoning – Chemicals required for
application or maintenance of the device, for instance, must under all circumstances be stored,
prepared, and kept at hand in their specific
containers. Failure to observe this instruction
may result in severe consequences for the patient.
CAUTION
Equipment damage - Always observe the ambient conditions as indicated in the `Technical
Specifications`.
NOTE
Please observe the user manuals of all connected devices!
Set up the device so that the operator has a
clear, unobstructed view of the control panel.
D235.131.0/4 5
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