Satelec ACteon i-Surge+ User manual

User’s Manual
User’s manual • Manuel d’utilisation • Manual de uso
Benutzerhandbuch • Manuale d’uso • Handleiding voor de gebruiker
Manual de utilizacao • Anvandningshandbok • Εγχειρίδιο χρήσης
“I-Surge +”
Implant/Surgery System
Distributed by: SATELEC • A company of ACTEON Group

2
Manufactured by
By Dental • A company of ACTEON Group
Via Vecchia Provinciale Lucchese, 49
51030 SERRAVALLE PISTOIESE
Italy
Distributed by
SATELEC • A company of ACTEON Group
17 av. Gustave Eiffel
BP 30216
33708 MERIGNAC cedex FRANCE
EU Directive 93/42/EEC has been used as a basis
in the design and manufacture of this medical
product. A product with this mark meets the
requirements of the relevant EC directives, i.e.
the applicable standards in Europe.
IEC 60601-1
EN ISO 13485
This equipment is manufactured according to
current regulations and standard (IEC 60601-1)
and according to the EN ISO 13485 quality control
certification system.
Please indicate the product serial number in all requests.

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ENGLISH
CONTENTS
I - INTRODUCTION ........................................................................................................ 7
II –WARNINGS ............................................................................................................. 7
III –DESCRIPTION......................................................................................................... 10
3.1 PHYSICAL DESCRIPTION ............................................................................ 10
3.2 TECHNICAL DESCRIPTION ......................................................................... 10
a. LCD screen/control Keypad .................................................................... 10
b. Control unit back panel ......................................................................... 10
c. Control footswitch ................................................................................ 10
d. Technical characteristics ....................................................................... 11
IV–INSTALLATION / FIRST USE ......................................................................................... 11
4.1 UNPACKAGING THE DEVICE ....................................................................... 11
4.2 RECOMMENDATIONS ................................................................................. 11
4.3 INSTALLATION ......................................................................................... 11
4.4 FIRST USE ............................................................................................... 12
V–IRRIGATION SOLUTION ............................................................................................... 12
VI–IRRIGATION LINE ..................................................................................................... 12
VII–ADJUSTMENTS / SETTINGS / INTERFACE ........................................................................ 12
7.1 START UP ............................................................................................... 12
7.2 SETTINGS ............................................................................................... 13
7.3 TORQUE CALIBRATION ............................................................................. 13
7.4 PROGRAM SETTINGS ADJUSTMENT ............................................................. 13
a. Contra-angle selection .......................................................................... 13
b. Speed adjustment ................................................................................. 13
c. Torque adjustment ............................................................................... 14

4
d. Flow .................................................................................................... 14
e. Reverse ............................................................................................... 14
f. Motor ................................................................................................... 14
g. Pump ................................................................................................... 14
h. Footswitch ........................................................................................... 14
VIII–USING THE DEVICE ................................................................................................. 14
IX –SHUTTING DOWN THE DEVICE..................................................................................... 15
X –ROUTINE MAINTENANCE / STERILIZATION ....................................................................... 16
10.1 IRRIGATION LINE MAINTENANCE .............................................................. 16
10.2 CONTRA-ANGLE MAINTENANCE ................................................................ 17
10.3 ROTARY INSTRUMENT MAINTENANCE ....................................................... 17
10.4 DEVICE MAINTENANCE ............................................................................ 17
10.5 MICRO-MOTOR AND CORD ....................................................................... 17
XI –MONITORING / PREVENTIVE AND CORRECTIVE MAINTENANCE ............................................... 18
11.1 MONITORING ......................................................................................... 18
11.2 PREVENTIVE AND CORRECTIVE MAINTENANCE ........................................... 18
11.3 FUSE REPLACEMENT ............................................................................... 19
11.4 OPERATION FAULTS ............................................................................... 19
XII –ELECTROMAGNETIC COMPATIBILITY ............................................................................. 22
12.1 ELECTROMAGNETIC EMISSIONS ................................................................ 23
12.2 ELECTROMAGNETIC IMMUNITY ................................................................. 24
12.3 RECOMMENDED SEPARATION DISTANCES ................................................... 25
XIII –DISPOSAL AND RECYCLING ....................................................................................... 25
XIV –MANUFACTURER’S LIABILITY..................................................................................... 25
XV –REGULATIONS....................................................................................................... 26
XVI –SYMBOLS ............................................................................................................ 26
I -INLEDNING ............................................................................................................ 30
II –VARNINGAR ........................................................................................................... 30

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III –BESKRIVNING......................................................................................................... 32
3.1 FYSISK BESKRIVNING ................................................................................ 32
3.2 TEKNISK BESKRIVNING ............................................................................. 33
a. LCD-skärm/tangentbord ........................................................................ 33
b. Kontrollenhetens bakre panel ................................................................ 33
c. Fotpedal .............................................................................................. 33
d. Tekniska egenskaper ............................................................................. 34
IV–INSTALLATION/FÖRSTA ANVÄNDNINGSTILLFÄLLET ............................................................. 34
4.1 UPPACKNING AV ENHETEN ........................................................................ 34
4.2 REKOMMENDATIONER ............................................................................... 34
4.3 INSTALLATION ......................................................................................... 34
4.4 FÖRSTA ANVÄNDNINGSTILLFÄLLET ............................................................ 35
V–IRRIGATIONSLÖSNING ................................................................................................ 35
VI–IRRIGATIONSSLANG .................................................................................................. 35
VII–JUSTERINGAR/INSTÄLLNINGAR/GRÄNSSNITT ................................................................... 35
7.1 START .................................................................................................... 35
7.2 INSTÄLLNINGAR ...................................................................................... 36
7.3 KALIBRERING AV VRIDMOMENT .................................................................. 36
7.4 JUSTERING AV PROGRAMINSTÄLNINGAR ..................................................... 36
a. Val av vinkelstycke ............................................................................... 36
b. Justering av hastighet ........................................................................... 36
c. Justering av vridmoment ....................................................................... 37
d. Flöde ................................................................................................... 37
e. Motsatt ................................................................................................ 37
f. Motor ................................................................................................... 37
g. Pump ................................................................................................... 37
h. Fotpedal .............................................................................................. 37

6
VIII–ANVÄNDA ENHETEN ................................................................................................ 37
IX –STÄNGA AV ENHETEN............................................................................................... 38
X –RUTINMÄSSIGT UNDERHÅLL/STERILISERING ..................................................................... 39
10.1 UNDERHÅLLNING AV IRRIGATIONSSLANG .................................................. 40
10.2 UNDERHÅLL AV VINKELSTYCKE ................................................................ 40
10.3 UNDERHÅLL AV DET ROTERANDE INSTRUMENTET ....................................... 40
10.4 UNDERHÅLL AV ENHETEN ....................................................................... 40
10.5 MIKROMOTOR OCH SLADD ....................................................................... 40
XI –ÖVERVAKNING/FÖREBYGGANDE OCH KORRIGERANDE UNDERHÅLL ......................................... 41
11.1 ÖVERVAKNING ....................................................................................... 41
11.2 FÖREBYGGANDE OCH KORRIGERANDE UNDERHÅLL .................................... 41
11.3 BYTE AV SÄKRING .................................................................................. 42
11.4 OPERATIONSFEL .................................................................................... 42
XII –ELEKTROMAGNETISK KOMPATIBILITET .......................................................................... 46
12.1 ELEKTROMAGNETISK EMISSION ................................................................ 46
12.2 ELEKTROMAGNETISK IMMUNITET ............................................................. 47
12.3 REKOMMENDERADE SEPARATIONSAVSTÅND ............................................... 48
XIII –AVFALLSHANTERING OCH ÅTERVINNING ....................................................................... 48
XIV –TILLVERKARENS ANSVAR.......................................................................................... 49
XV –BESTÄMMELSER ..................................................................................................... 49
XVI –SYMBOLER .......................................................................................................... 49
I - INTRODUCTION ....................................................................................................... 11
II –WARNINGS ............................................................................................................ 11
III –DESCRIPTION......................................................................................................... 14
3.1 PHYSICAL DESCRIPTION ............................................................................ 14
3.2 TECHNICAL DESCRIPTION ......................................................................... 14
a. LCD screen/control Keypad .................................................................... 14

7
b. Control unit back panel ......................................................................... 14
c. Control footswitch ................................................................................ 14
d. Technical characteristics ....................................................................... 15
IV–INSTALLATION / FIRST USE ......................................................................................... 15
4.1 UNPACKAGING THE DEVICE ....................................................................... 15
4.2 RECOMMENDATIONS ................................................................................. 15
4.3 INSTALLATION ......................................................................................... 15
4.4 FIRST USE ............................................................................................... 16
V–IRRIGATION SOLUTION ............................................................................................... 16
VI–IRRIGATION LINE ..................................................................................................... 16
VII–ADJUSTMENTS / SETTINGS / INTERFACE ........................................................................ 16
7.1 START UP ............................................................................................... 16
7.2 SETTINGS ............................................................................................... 17
7.3 TORQUE CALIBRATION ............................................................................. 17
7.4 PROGRAM SETTINGS ADJUSTMENT ............................................................. 17
a. Contra-angle selection .......................................................................... 17
b. Speed adjustment ................................................................................. 17
c. Torque adjustment ............................................................................... 18
d. Flow .................................................................................................... 18
e. Reverse ............................................................................................... 18
f. Motor ................................................................................................... 18
g. Pump ................................................................................................... 18
h. Footswitch ........................................................................................... 18
VIII–USING THE DEVICE ................................................................................................. 18
IX –SHUTTING DOWN THE DEVICE..................................................................................... 19
X –ROUTINE MAINTENANCE / STERILIZATION ....................................................................... 20
10.1 IRRIGATION LINE MAINTENANCE .............................................................. 20

8
10.2 CONTRA-ANGLE MAINTENANCE ................................................................ 21
10.3 ROTARY INSTRUMENT MAINTENANCE ....................................................... 21
10.4 DEVICE MAINTENANCE ............................................................................ 21
10.5 MICRO-MOTOR AND CORD ....................................................................... 21
XI –MONITORING / PREVENTIVE AND CORRECTIVE MAINTENANCE ............................................... 22
11.1 MONITORING ......................................................................................... 22
11.2 PREVENTIVE AND CORRECTIVE MAINTENANCE ........................................... 22
11.3 FUSE REPLACEMENT ............................................................................... 23
11.4 OPERATION FAULTS ............................................................................... 23
XII –ELECTROMAGNETIC COMPATIBILITY ............................................................................. 26
12.1 ELECTROMAGNETIC EMISSIONS ................................................................ 27
12.2 ELECTROMAGNETIC IMMUNITY ................................................................. 28
12.3 RECOMMENDED SEPARATION DISTANCES ................................................... 29
XIII –DISPOSAL AND RECYCLING ....................................................................................... 29
XIV –MANUFACTURER’S LIABILITY..................................................................................... 29
XV –REGULATIONS....................................................................................................... 30
XVI –SYMBOLS ............................................................................................................ 30
I -INLEDNING ............................................................................................................ 34
II –VARNINGAR ........................................................................................................... 34
III –BESKRIVNING......................................................................................................... 36
3.1 FYSISK BESKRIVNING ................................................................................ 36
3.2 TEKNISK BESKRIVNING ............................................................................. 37
a. LCD-skärm/tangentbord ........................................................................ 37
b. Kontrollenhetens bakre panel ................................................................ 37
c. Fotpedal .............................................................................................. 37
d. Tekniska egenskaper ............................................................................. 38
IV–INSTALLATION/FÖRSTA ANVÄNDNINGSTILLFÄLLET ............................................................. 38
4.1 UPPACKNING AV ENHETEN ........................................................................ 38

9
4.2 REKOMMENDATIONER ............................................................................... 38
4.3 INSTALLATION ......................................................................................... 38
4.4 FÖRSTA ANVÄNDNINGSTILLFÄLLET ............................................................ 39
V–IRRIGATIONSLÖSNING ................................................................................................ 39
VI–IRRIGATIONSSLANG .................................................................................................. 39
VII–JUSTERINGAR/INSTÄLLNINGAR/GRÄNSSNITT ................................................................... 39
7.1 START .................................................................................................... 39
7.2 INSTÄLLNINGAR ...................................................................................... 40
7.3 KALIBRERING AV VRIDMOMENT .................................................................. 40
7.4 JUSTERING AV PROGRAMINSTÄLNINGAR ..................................................... 40
a. Val av vinkelstycke ............................................................................... 40
b. Justering av hastighet ........................................................................... 40
c. Justering av vridmoment ....................................................................... 41
d. Flöde ................................................................................................... 41
e. Motsatt ................................................................................................ 41
f. Motor ................................................................................................... 41
g. Pump ................................................................................................... 41
h. Fotpedal .............................................................................................. 41
VIII–ANVÄNDA ENHETEN ................................................................................................ 41
IX –STÄNGA AV ENHETEN............................................................................................... 42
X –RUTINMÄSSIGT UNDERHÅLL/STERILISERING ..................................................................... 43
10.1 UNDERHÅLLNING AV IRRIGATIONSSLANG .................................................. 44
10.2 UNDERHÅLL AV VINKELSTYCKE ................................................................ 44
10.3 UNDERHÅLL AV DET ROTERANDE INSTRUMENTET ....................................... 44
10.4 UNDERHÅLL AV ENHETEN ....................................................................... 44
10.5 MIKROMOTOR OCH SLADD ....................................................................... 44
XI –ÖVERVAKNING/FÖREBYGGANDE OCH KORRIGERANDE UNDERHÅLL ......................................... 45

10
11.1 ÖVERVAKNING ....................................................................................... 45
11.2 FÖREBYGGANDE OCH KORRIGERANDE UNDERHÅLL .................................... 45
11.3 BYTE AV SÄKRING .................................................................................. 46
11.4 OPERATIONSFEL .................................................................................... 46
XII –ELEKTROMAGNETISK KOMPATIBILITET .......................................................................... 50
12.1 ELEKTROMAGNETISK EMISSION ................................................................ 50
12.2 ELEKTROMAGNETISK IMMUNITET ............................................................. 51
12.3 REKOMMENDERADE SEPARATIONSAVSTÅND ............................................... 52
XIII –AVFALLSHANTERING OCH ÅTERVINNING ....................................................................... 52
XIV –TILLVERKARENS ANSVAR.......................................................................................... 53
XV –BESTÄMMELSER ..................................................................................................... 53
XVI –SYMBOLER .......................................................................................................... 53