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AGFA ID Tablet User manual

Getting started with the ID Tablet
2287B EN 20191031 Agfa NV, Septestraat 27, B-2640 Mortsel, Belgium
1 Intended Use
The ID Tablet is a device for the transfer of data from the
NX modality workstation to AGFA CR cassettes. This data
links the image recorded on the cassette to the patient
study selected on the NX modality workstation.
2 Installation
The installation and configuration of the ID Tablet is
performed by the local Agfa service organization and/or
Agfa dealer.
on/off switch
3 Operating controls
The ID Tablet can be switched on (green light illuminated)
and off using the switch on the front side of the ID Tablet.
4 Using the ID Tablet
Insert a cassette in the ID Tablet as shown below.
Inserting CR MD or CR MM
cassette
Inserting CR MD 3.0, CR
MD4.xR, CR HD5.x, CR
HM5.x, CR MM3.0, CR
MM3.xR, CR MD4.xT, CR
MD4.2 Extremities or CR
MM3.xT cassette
In the Examination
window, select the right
thumbnail in the Image
Overview.
Click ID or press F2.
The thumbnail is labelled with the code ‘ID’. The patient
data is written to the cassette.
Make the exposure.
It is advised to identify the cassette before the exposure
to avoid mix-up of exposed, unidentified cassettes.
5 Product complaints
Any health care professional (for example a customer or a
user) who has any complaints or has experienced any
dissatisfaction with the quality, durability, reliability,
safety, effectiveness, or performance of this product must
notify Agfa.
For a patient/user/third party in the European Union and
in countries with identical regulatory regimes (Regulation
2017/745/EU on Medical Devices); if, during the use of
this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its
authorised representative and to your national authority.
Manufacturer address:
Agfa Service Support - local support addresses and phone
numbers are listed on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094
6 Safety precautions
WARNING: Strictly observe all warnings,
cautions, notes and safety markings within
this document and on the product.
WARNING: Safety is only guaranteed when
trained Agfa personnel have installed the ID
Tablet.
WARNING: All Agfa medical products must be
used by Agfa trained and qualified personnel.
WARNING: Although the device is tested
against applicable standards for EMC and
short range devices, there is a residual risk of
interference with other electronic devices.
WARNING: Although all system components
are tested during manufacturing, the ID tablet
may fail to detect /write/ read the data of an
inserted cassette. Try to solve the problem by
restarting the ID Tablet.
CAUTION: Position the Agfa product so that it
is possible to disconnect the mains power
connection if required.
CAUTION: Changes, additions or maintenance
to the Agfa products carried out by persons
Getting started with the ID Tablet
2287B EN 20191031 Agfa NV, Septestraat 27, B-2640 Mortsel, Belgium
without appropriate qualification and training
as well as using unapproved spare parts may
lead to serious risk of injury and damage to
the equipment as well as making the
warranty void.
7 Cleaning and Disinfection
All appropriate policies and procedures should be
followed to avoid contamination of the staff, patients and
the ID Tablet. All existing universal precautions should be
taken to avoid that the ID Tablet comes into contact with
potential contaminations.
To clean the exterior of the ID Tablet
Unplug the ID Tablet from the PC.
Wipe the exterior of the ID Tablet with a clean, soft,
damp cloth. Use a mild soap or detergent if required but
never use ammonia based cleaner.
Plug the ID Tablet back into the PC.
8 Labels
The identification label is located at the back side of the
ID Tablet.
9 Technical specifications
Power supply
5V DC via USB interface
Classification
Class III (IEC60950 /
UL60950)
Operating conditions:
Temp.:
5 to 40°C
RH:
5% to 85%
Weight:
12 kg
Dimensions H x W x D:
115 x 390 x 450 mm
Maximum power
consumption:
200 mA
The equipment is suited for continuous operation.
The ID Tablet is provided with 1 USB 2.0 interface to
connect it to the PC for data transmission and power
supply.
10 System Documentation
For general safety directions, refer to the user
documentation of the Agfa CR system.
11 Environmental Protection
WEEE end user information
(Applicable in the European Union and other European
countries with separate collection system)
This symbol on the product, or in the manual and in the
warranty, and/or on its packaging indicates that this
product shall not be treated as household waste.
For more detailed information about take-back and
recycling of this product, please contact your local Agfa
service organization. By ensuring this product is disposed
of correctly, you will help prevent potential negative
consequences for the environment and human health,
which could otherwise be caused by inappropriate waste
handling of this product. The recycling of materials will
help to conserve natural resources.
12 Compliance
For general safety directions, refer to the user
documentation of the Agfa CR system.
Both the workstation console and the ID Tablet comply
with the following safety standards:
UL 60950 / EN 60950 / EN 62368
CAN/CSA 22.2 NO. 60950-1-07, Third Edition (TÜV- NRTL
c-us)
The equipment bears the CE mark and fully
complies with European Regulation (EU)
2017/745 on medical devices (MDR).and with
the federal code of the United States, bearing on:
Emission and immunity according to EN 60601-1-2, for
emissions the equipment complies with EN 55011 class A
(CISPR 11). This is a Class A product. In a domestic
environment this product may cause radio interference in
which case the user may be required to take adequate
measures.
Emissions according to 47 CFR part 15 subpart B, Class A.
This equipment has been tested and found to comply with
the limits for a Class A digital device, pursuant to part 15
of the FCC rules. These limits are designed to provide
reasonable protection against harmful interference when
the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in
accordance with the Instruction manual, may cause
harmful interference to radio communications. Operation
of this equipment in a residential area is likely to cause
harmful interference in which case the user will be
required to correct the interference at his own expense.
Radio-parameters according to ETS 300330.

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