Ackermann
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SHAVER SYSTEM
4
EN 60601-1-6
Medical electrical equipment -- Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
5
EN ISO 62366
Medical devices -- Application of usability engineering to medical devices
6
EN ISO 62304
Medical device software - Software life cycle processes
7
EN ISO 17664
Sterilization of medical devices -- Information to be
provided by the manufacturer for the processing of
resterilizable medical devices
8
EN 10993-1
Biological evaluation of medical devices -- Part 1:
Evaluation and testing within a risk management process
9
EN 10993-18
Biological evaluation of medical devices -- Part 18: Chemical characterization of
materials
10
EN 15223-1
Medical devices -- Symbols to be used with medical device labels, labelling and
information to be supplied -- Part 1: General requirements
11
EN 980
Symbols for use in the labelling of medical devices
12
EN 1041
Information supplied by the manufacturer of medical devices
3. DESCRIPTION Of COMPONENTS
3.1. fRONT PANEl DESCRIPTION
1. Display window
: displays operating parameters in digital form.
2. “hANDPIECE 1” socket
: socket for the Handpiece 1.
3. “hANDPIECE 2” socket
: socket for the Handpiece 2.
4. “fOOTSWITCh” socket
: socket for the Footswitch.
5. “STANDBY” button
: switches the device from a “STANDBY” state of energy saving / sleep to a working state and vice
versa.
6. “DIRECTION (REv)” button
: function key to switch the shaver blade in the Handpiece to anti-clockwise rotation. If
buttons (6) and (7) are pressed at the same time, the device will be working in the oscillation mode.
7. “DIRECTION (fWD)” button
: function key to switch the shaver blade in the Handpiece to clockwise rotation. If buttons (6)
and (7) are pressed at the same time, the device will be working in the oscillation mode.
8. “SPEED DOWN” button
: stepwise reduction of the speed to the lower level of rotational speed.
