Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004
4
of
22
1 General information for the operator
1.1 Application
The VacuDAP 2002 dose area product measuring system is used for measuring the radiation dose
the patient is exposed to during an X-ray examination.
The measuring unit must not be used for the primary determination of
characteristics of X-ray equipment (constancy checks).
1.2 Classification
According to the 93/42/EWG Directive on medicinal products, the VacuDAP 2002 dose area product
measuring system is a medicinal product of class 1 with measuring function.
The measuring system is designed for continuous operation.
Protection against the ingress of water: class IPx0.
The system is not designed for use in the vicinity of inflammable
mixtures.
1.3 Electromagnetic compatibility (EMC)
This medicinal product complies with the European IEC 60601-1-2 standard (limit values to
IEC 55011, group 1, class A) and satisfies the EMC protection requirements as specified in the law on
medicinal products.
1.4 Protection against electric shock
At the power supply end, all poles must be disconnectable from the mains, or the external power
supply unit must be completely disconnectable from the mains.
The power supply shall be in compliance with the European standard on medicinal electrical devices
IEC 60601-1-1
(see
2.2, Supply voltage
). The plug-in power pack offered with the VacuDAP 2002
measuring system complies with IEC 60601-1-1 and has the following safety class:
•
safety class
II
system to IEC 601 - 1 HA 3.
The measuring system VacuDAP 2002 works on a safety extra-low voltage.
1.5 Accessories
Any accessory equipment connected to the serial interface shall comply
with the applicable office machine standard IEC 60950 (VDE 0850).
Only original parts or parts complying with the regulations specified by
the manufacturer may be used on the measuring system.
See Chapter 6,
Accessories and options
, for a list of accessory parts offered.