USER MANUAL
Micromotor for oral surgery
01_26/04/2018
Page 11 of 15
The instructions provided above have been validated by the manufacturer of the medical device as ABLE to prepare a
medical device for re-use.
It is up to the process manager to ensure that repeated processes are actually performed using the equipment,
materials and personnel in the repeated process structure to achieve the desired result.
This generally requires systematic validation and monitoring of the process. Likewise, all deviations from the
process manager from the instructions provided should be appropriately evaluated to judge its effectiveness and
potential unwanted consequences.
Fuses replacement
The control unit is protected by two fuses that are placed in the power supply source.
If you need to replace fuses please follow the following instructions:
•
Disconnect the supply.
•
Remove the fuses-holder cover.
•
Replace the blown fuse with one of the same type (see Technical features).
•
Put on the fuses-holder cover again.
Description of the electro-magnetic fields with renard to the EN 60601-1-2 Directive:
•
The DSI Mini Surgery Motor device must function in the electro-magnetic field specified below. The customer/
user of DSI Mini Surgery Motor must guarantee that it is used in this environment.
•
DSI Mini Surgery Motor can’t be used near or placed on an other device.
•
If you can’t do in a different way, you have to check in normal use conditions the good working of the device
before using.
The essential performance of DSI Mini Surgery Motor is to provide mechanical energy through an electrical
micromotor to a tool (rotating burr) for surgical treatments, by controlling (with specific feedbeck loops) the
rotational speed and the maximum torque, so that the burr rotates, for less than little variations, at the set speed.
EMISSION TEST
CONFORMITY
ELECTROMAGNETIC ENVIRONMENT
Emissions RF – CISPR 11
Group 1
DSI Mini Surgery Motor uses RF energy only for its
internal functioning. So its RF emissions are very low and
probably it doesn’t cause any interference with nearby
electronic devices
Emissions RF – CISPR 11
Class B
DSI Mini Surgery Motor is suitable for using in all the
environments, included domestic ones and those directly
connected to a low voltage electricity network that
supplies domestic buildings
Harmonic emission
Class A
Voltage fluctuation and flicker
Complying
