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ABPM with custo screen 300 and custo diagnostic | GEB 0154 – DK 1055 | Version 002 – 05.06.2013 | custo med GmbH
02
Safety instructions
02.1
General
Strict compliance with the safety instructions protects against personal injury
and property damage during device operation. This Operating Manual is de-
signed to accompany the product and should be kept ready to hand close to
the device. As either the operator or user of this device you should have read
and understood this Operating Manual, in particular the safety instructions.
Laws and regulations applicable to the product
This system is designed in accordance with Medical Device Directive 93/42/EEC,
Class II a, and meets the requirements of protection class I or II (depending on
the power supply unit used; the recorder is a device with an internal power
supply), type BF according to DIN EN 60601-1.
Other devices which are part of the system must meet the requirements of
the Standard for Information Technology Equipment (DIN EN 60950) and the
Standard for Electrical Medical Devices (DIN EN 60601-1).
The electrical installations in the rooms in which the system is used must meet
the requirements of the applicable safety standards.
For users outside the Federal Republic of Germany, the respective national
accident prevention measures, regulations and requirements apply.
Summary of Contents for custo screen 300
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