- the device has been used connected to an electrical system that does not comply with current
regulations
- the device has been used in ways other than those specified in this manual
- accessories (tips, handpiece, irrigation lines, etc.) other than those supplied by SATELEC have been
used
- the instructions in this document have not been followed.
Note:
The manufacturer reserves the right to modify the device and/or the user’s manual without
notice.
XVI - REGULATIONS
This medical device is classified as class IIa according to European Directive relevant to Medical Devices
currently in force.
This equipment is manufactured in compliance with the current IEC 60601-1 standard.
This equipment has been designed and manufactured according to an ISO 13485-certified quality
assurance system.
XVII – SYMBOL
1
Transmission fault
2
Toolbox
3
Reduce a value
4
Increase a value
5
Reduce flow rate
6
Increase flow rate
7
Flush/prime
8
Irrigation
9
Light
10
P
IEZOTOME
function
11
N
EWTRON
function
12
Footswitch ON/OFF mode
13
Footswitch progressive mode
14
Storing of settings
15
P
IEZOTOME
program
16
Soft program
17
Medium program
18
High program
Summary of Contents for Satelec Implant Center 2
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