Table Of Contents; Introduction; And How Does It Work; W Intended Ho Can Use The Use - IGEA I-ONE User Manual

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IGEA
IGEA
CONTENTS
CONTENTS
CONTENTS
1.
INTRODUCTION .............................................................................................................................................................. 2
1. INTRODUCTION .................................................................................................................................................................3
1.

INTRODUCTION .............................................................................................................................................................. 2

1.1
W

I-ONE

HAT IS THE

AND HOW DOES IT WORK

1.1 WHAT IS THE I-ONE AND HOW DOES IT WORK? ................................................................................................................................................ 3
1.2
1.1

I-ONE

I-ONE? ....................................................................................................................................................... 2

1.2 WHO CAN USE THE I-ONE? ................................................................................................................................................................................... 3
HAT IS THE
1.2
1.3
......................................................................................................................................................................... 2
I-ONE? ....................................................................................................................................................... 2
1.3 INTENDED USE ...................................................................................................................................................................................................... 3
1.3
I
U
......................................................................................................................................................................... 2
1.4
D
1.4 DEVICE PERFORMANCE CHARACTERISTICS ....................................................................................................................................................... 3
NTENDED
SE
1.4
1.5
1.5 TREATMENTS THAT CAN BE CARRIED OUT WITH I-ONE THERAPY ................................................................................................................... 3
1.5
1.6
1.6 EXPECTED CLINICAL BENEFITS ............................................................................................................................................................................ 4
1.6
2. I-ONE DEVICE COMPONENTS ............................................................................................................................................4
2.
I-ONE DEVICE COMPONENTS .......................................................................................................................................... 3
2.
I-ONE DEVICE COMPONENTS .......................................................................................................................................... 3
2.1
............................................................................................................................................................................ 3
2.1 GENERATOR ........................................................................................................................................................................................................... 4
2.1
G
............................................................................................................................................................................ 3
ENERATOR
3. DEVICE PREPARATION .......................................................................................................................................................5
3.
DEVICE PREPARATION .................................................................................................................................................... 4
3.
DEVICE PREPARATION .................................................................................................................................................... 4
3.1
3.1 INITIAL BATTERY CHARGE .................................................................................................................................................................................... 5
3.2 CONNECTING THE COIL TO THE GENERATOR ..................................................................................................................................................... 6
3.2
3.1
3.2
4. CLIP ATTACHMENT AND REMOVAL ...................................................................................................................................6
4.
CLIP ATTACHMENT AND REMOVAL ................................................................................................................................ 5
4.
CLIP ATTACHMENT AND REMOVAL ................................................................................................................................ 5
5. ADMINISTERING THE TREATMENT ....................................................................................................................................7
5.
ADMINISTERING THE TREATMENT .................................................................................................................................. 6
5.
ADMINISTERING THE TREATMENT .................................................................................................................................. 6
5.1
.................................................................................................................................................................... 6
5.1 COIL POSITIONING ................................................................................................................................................................................................ 7
5.1
5.2
5.2 TURNING ON THE GENERATOR ............................................................................................................................................................................ 7
.................................................................................................................................................................... 6
5.3 BATTERY MONITORING AND CHARGING ............................................................................................................................................................ 9
5.2
5.3
5.4 STATUS INDICATION OF THE DEVICE ................................................................................................................................................................... 9
5.3
5.4
5.5 BATTERY EFFICIENCY........................................................................................................................................................................................... 11
5.4
5.5
............................................................................................................................................................... 10
5.6 TREATMENT TIMES ............................................................................................................................................................................................. 11
5.6
5.5
................................................................................................................................................................. 10
............................................................................................................................................................... 10
5.7 USEFUL TIPS ......................................................................................................................................................................................................... 11
5.6
5.7
U
T
......................................................................................................................................................................... 10
................................................................................................................................................................. 10
REATMENT TIMES
SEFUL
5.8 CLEANING THE DEVICE ....................................................................................................................................................................................... 12
5.8
5.7
......................................................................................................................................................................... 10
............................................................................................................................................................. 11
5.8
............................................................................................................................................................. 11
6. PROBLEM SOLVING .......................................................................................................................................................... 12
6.
PROBLEM SOLVING ...................................................................................................................................................... 11
6.
PROBLEM SOLVING ...................................................................................................................................................... 11
6.1 ERROR MESSAGES ............................................................................................................................................................................................... 12
6.1
.................................................................................................................................................................. 11
6.2 ANOMALIES OR BLOCKED DEVICE ..................................................................................................................................................................... 13
6.1
.................................................................................................................................................................. 11
6.2
6.2.1 The device will not switch on and will not charge ............................................................................................................................................. 13
6.2
6.2.1
A
The device will not switch on and will not charge....................................................................................................... 12
6.2.2 Blocked device during normal operation ........................................................................................................................................................... 13
6.2.2
6.2.1
Blocked device during normal operation. ................................................................................................................... 12
The device will not switch on and will not charge....................................................................................................... 12
6.2.3 Technical Support .............................................................................................................................................................................................. 13
6.2.2
6.2.3
Blocked device during normal operation. ................................................................................................................... 12
Technical Support ....................................................................................................................................................... 12
6.2.3
Technical Support ....................................................................................................................................................... 12
7. SAFETY INSTRUCTIONS .................................................................................................................................................... 13
7.
SAFETY INSTRUCTIONS ................................................................................................................................................. 12
7.
SAFETY INSTRUCTIONS ................................................................................................................................................. 12
7.1 WARNINGS AND RECOMMENDATIONS ............................................................................................................................................................ 13
7.1
7.2 MAINTENANCE .................................................................................................................................................................................................... 14
7.1
7.2
...................................................................................................................................................................... 13
7.3 CONTRAINDICATIONS AND SIDE EFFECTS ........................................................................................................................................................ 14
7.2
7.3
...................................................................................................................................................................... 13
7.4 ELECTROMAGNETIC COMPATIBILITY ................................................................................................................................................................ 15
7.4
7.3
E
C
C
LECTROMAGNETIC
ONTRAINDICATIONS AND SIDE EFFECTS
OMPATIBILITY
7.5 BIOLOGICAL SAFETY ........................................................................................................................................................................................... 15
7.5
7.4
................................................................................................................................................................ 14
7.5
B
................................................................................................................................................................ 14
IOLOGICAL SAFETY
8. MANUFACTURER'S LIABILITY .......................................................................................................................................... 15
8.
MANUFACTURER'S LIABILITY ........................................................................................................................................ 14
8.
MANUFACTURER'S LIABILITY ........................................................................................................................................ 14
9. DEVICE RETURNS ............................................................................................................................................................. 16
9.
DEVICE RETURNS .......................................................................................................................................................... 15
9.
DEVICE RETURNS .......................................................................................................................................................... 15
10. TECHNICAL DATA ........................................................................................................................................................... 16
10.
TECHNICAL DATA .......................................................................................................................................................... 15
10.
TECHNICAL DATA .......................................................................................................................................................... 15
10.1 TABLE 1 - ELECTROMAGNETIC EMISSIONS ..................................................................................................................................................... 17
10.1
T
1 - E
ABLE
LECTROMAGNETIC
10.2 TABLE 2 - ELECTROMAGNETIC IMMUNITY ..................................................................................................................................................... 17
10.2
10.1
T
T
2 - E
10.3 IMMUNITY TO PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATION DEVICES ............................................................................... 18
10.2
10.3
10.4 INFORMATION PLATE ........................................................................................................................................................................................................................ 20
10.4
10.3
........................................................................................................................................................... 19
10.4
I
........................................................................................................................................................... 19
11. SYMBOLS ........................................................................................................................................................................ 21
NFORMATION PLATE
11.
SYMBOLS ...................................................................................................................................................................... 20
11.
SYMBOLS ...................................................................................................................................................................... 20
MI-IONE-EN Revision 1.4 - June 2023
MI-IONE-EN Revision 1.4 - June 2023
SW Rev. from 1.6
SW Rev. from 1.6
2
Page 1
Page 1
Only use the device after reading this manual.
Only use the device after reading this manual.
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I-ONE T
HERAPY
...................................................................................................................................................... 3
I-ONE T
HERAPY
...................................................................................................................................................... 3
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E
................................................................................................................................ 16
MISSIONS
................................................................................................................................ 16
................................................................................................................................ 16
................................................................................................................................ 16
....................................................................................................... 2
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............................................................................. 17
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I-ONE - User Manual
I-ONE - User Manual

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