Instruction manual
This instruction manual contains important information on the safe, correct
and efcient use of the device. Carefully read this manual and observe all
the notes and information. This instruction manual should be used in con-
junction with the instruction manuals for your other equipment. Make sure
to read those manuals very carefully as well. Always keep all the instruction
manuals at hand.
1. Conformities
1.1 Guidelines and norms
Description Guidelines and norms
DORO Headrest and
Retractor Systems
DIN EN ISO 13485 Medical Devices - QM System
DIN EN ISO 14971 Risk Management
93/42/EEC Medical Device Directive
1.2 CE conformity
DORO Headrest and Retractor Systems conform to the basic requirements
of the applicable guideline and the corresponding norms of the Council of
the European Union.
1.3 FDA Registration
The DORO Headrest and Retractor Systems are registered with the 510(k) Numbers K001808,
K032331, K063494.
Note:
Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order
of a physician.
2. General Safety Information
2.1 Symbols used for safety information
This instruction manual contains the basic information required for the safe use of the device.
The symbols explained below might be used in this instruction manual and/or on the product
labels to point out safety-relevant information:
Danger:
This symbol indicates a danger to the health of the patient. Failure to observe
this information and to follow the appropriate instructions may result in serious
injury to the patient and may even endanger the patient’s life.
Warning:
This symbol indicates a danger of injury to the user of the device.
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DORO
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Instruction Manual
DORO