IGEA BIOSTIM THERAPY User Manual

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Only use the device after reading this manual.

CONTENTS

INTRODUCTION ................................................................................................................ 3

1.1

What is the BIOSTIM and how does it work? ....................................... 3

1.2

Who can use the BIOSTIM? ................................................................. 3

1.3

Intended Use ........................................................................................ 3

1.4

Device performance characteristics ...................................................... 3

1.5

Therapeutic treatments that can be performed with the BIOSTIM ........ 3

1.6

Expected clinical benefits ..................................................................... 4

DEVICE COMPONENTS .................................................................................................... 4

2.1

Generator ............................................................................................. 4

DEVICE PREPARATION ................................................................................................... 5

3.1

Initial battery charge ............................................................................. 5

3.2

Connecting the coil to the generator ..................................................... 6

CLIP ATTACHMENT AND REMOVAL .............................................................................. 7

ADMINISTERING THE TREATMENT ................................................................................ 7

5.1

Coil positioning ..................................................................................... 7

5.2

Recommendations on how to use the coil properly .............................. 8

5.3

Turning on the generator ...................................................................... 9

5.4

Battery monitoring and charging ......................................................... 10

5.5

Battery efficiency ................................................................................ 11

5.6

Device status ...................................................................................... 11

5.7

Treatment times ................................................................................. 13

5.8

Useful Tips ......................................................................................... 13

5.9

Cleaning the device ............................................................................ 14

PROBLEM SOLVING ....................................................................................................... 14

6.1

Error messages .................................................................................. 14

6.2

Anomaly when charging and/or switching on ...................................... 15

SAFETY INSTRUCTIONS ................................................................................................ 16

7.1

Warnings and Recommendations ....................................................... 16

7.2

Maintenance ....................................................................................... 17

7.3

Contraindications and side effects ...................................................... 17

7.4

Electromagnetic Compatibility ............................................................ 18

7.5

Biological safety ................................................................................. 20

MANUFACTURER'S LIABILITY ...................................................................................... 20

DEVICE RETURNS .......................................................................................................... 20

10. TECHNICAL DATA .......................................................................................................... 20

10.1

Table of Emission Levels and Electromagnetic Immunity ................ 22

10.2

Immunity to proximity magnetic fields .............................................. 22

BIOSTIM - User Manual

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Summary of Contents for IGEA BIOSTIM THERAPY

Page 1: Table Of Contents
BIOSTIM - User Manual Only use the device after reading this manual. CONTENTS INTRODUCTION ........................ 3 What is the BIOSTIM and how does it work? ........3 Who can use the BIOSTIM? ..............3 Intended Use ..................3 Device performance characteristics ............3 Therapeutic treatments that can be performed with the BIOSTIM ..
Page 2 BIOSTIM - User Manual 10.3 Immunity to proximity fields from RF wireless communication device 10.4 Dataplate ..................24 11. SYMBOLS ........................26 MI-BIOSTIM-EN Revision 1.6 - April 2024 SW Rev. from 1.7...
Page 3: Introduction
BIOSTIM - User Manual INTRODUCTION 1 . 1 W h a t i s t h e B I O S T I M a n d h o w d o e s i t w o r k ? The BIOSTIM is an electrical osteogenesis stimulator using electromagnetic fields.
Page 4: Expected Clinical Benefits
BIOSTIM - User Manual • Necrosis • Painful prosthetic implantation • Complex and/or risk fractures • Osteoporosis fractures • Revision prostheses • Bone grafts • Healing skin wounds 1 . 6 E x p e c t e d c l i n i c a l b e n e f i t s The expected clinical benefits of using the BIOSIM BB02 pulsed electromagnetic field generator are: •...
Page 5: Device Preparation
A USB socket at the bottom of the generator , covered by a protective cap and reserved for the IGEA technical service. • A removable attachment clip  that the user can use to carry the generator on a belt and perform the treatment on the move.
Page 6: Connecting The Coil To The Generator
BIOSTIM - User Manual IMPORTANT NOTES Only use the supplied power supply unit for charging. The use of other devices may cause damage to the device or the user and the manufacturer will accept no liability for this. ➢ If the device is not used for long periods, the battery may go flat or may not have enough energy left to complete the treatment;...
Page 7: Clip Attachment And Removal
BIOSTIM - User Manual CLIP ATTACHMENT AND REMOVAL If necessary, the generator can be clipped onto the belt using the supplied clip, so that the treatment can also be carried out on the move. To fit the clip, engage one side notch in the slot provided and apply light pressure to the centre of the clip until the second notch is also fully engaged.
Page 8: Recommendations On How To Use The Coil Properly
BIOSTIM - User Manual single coil - positioning examples double coil - positioning examples 5 . 2 R e c o m m e n d a t i o n s o n h o w t o u s e t h e c o i l p r o p e r l y •...
Page 9: Turning On The Generator
BIOSTIM - User Manual • Do not use the coil if the cable connecting it to the generator is visibly damaged. • When using the coil under heavy blankets, the coil surface may become overheard. If this is the case, perform the treatment without covering the coil. •...
Page 10: Battery Monitoring And Charging
BIOSTIM - User Manual PAUSE Below the timer is the button which, when pressed, pauses PLAY the treatment and the button appears on the screen in its Pressing the button again restarts the treatment and the place. remaining treatment time countdown. Each press of the PLAY/PAUSE button is accompanied by a confirmation beep.
Page 11: Battery Efficiency
If the battery does not allow 8 consecutive hours of treatment to be delivered, try charging the battery again. If the problem persists, please contact IGEA support centre. If the battery is no longer efficient, it can be replaced with a new battery. The battery cannot be replaced by the user but must be requested from the service centre, where the user must send the device for replacement.
Page 12 BIOSTIM - User Manual The LED at the top is OFF The display shows the timer indicating the remaining treatment The device is on PAUSE. To time. resume treatment, press the PLAY symbol on the display. Below the timer there is no signal (flat line), and the 'PLAY' symbol is visible (restart treatment).
Page 13: Treatment Times
BIOSTIM - User Manual Generator switched off during battery charging The generator beeps when connected to the external power supply. The device is charging the battery. The display lights up and shows the Charging takes about 4 hours when the image of the battery being charged.
Page 14: Cleaning The Device
IGEA Customer Service for a anomaly. replacement coil. The LED turns YELLOW. 'Coil Absent’ warning The generator vibrates.
Page 15: Anomaly When Charging And/Or Switching On
Should the device become stuck and does not respond to normal commands, perform a RESET as described in the previous paragraph. Technical support for the device is the sole responsibility of the manufacturer IGEA S.p.A. In the event of a fault or in any case in which the device needs to be serviced, the user must contact the IGEA S.p.A.
Page 16: Safety Instructions
BIOSTIM - User Manual SAFETY INSTRUCTIONS 7 . 1 W a r n i n g s a n d R e c o m m e n d a t i o n s For the device to work safely and at its best, the following recommendations must be strictly followed: •...
Page 17: Maintenance
The manufacturer recommends repeating the safe tests on the device to check that safety standards are being continuously maintained, at intervals of no greater than 24 months. By agreement with the customer, IGEA can provide the recommended electrical safety inspection service.
Page 18: Electromagnetic Compatibility
BIOSTIM - User Manual the pelvic bones should be avoided. In any case, always inform the doctor who prescribed the therapy, who will assess on a case by case basis the need to continue/interrupt therapy. • The pacemakers currently in use are not susceptible to the action of electromagnetic fields; however, pacemaker wearers are advised to check the characteristics of their device with their cardiologist and not to undergo therapies involving the application of the coil directly on the chest.
Page 19 BIOSTIM - User Manual If this happens and it is signalled by the BIOSTIM as a fault or interruption in treatment delivery, the device must be switched off and switched on again after a few seconds, using the power button. If the device does not switch off or does not react when the on/off button is pressed, reset the device to restore normal operation following the instructions in paragraph 6.2.
Page 20: Biological Safety
DEVICE RETURNS If the device is to be returned to IGEA, the user is requested to use the original packaging complete with all its parts. The adjacent image shows the correct positioning of the various components to ensure that they are adequately protected.
Page 21 BIOSTIM - User Manual Classification according to MDR 2017/745 EU Class IIa device Rechargeable battery - Type: Lithium-ion polymer battery 11.4VDC / 2800mAh Do not expose the battery to heat sources and do not throw it into fire as there is a danger of explosion! Do not immerse the battery pack in liquids or pour liquids onto it.
Page 22: Table Of Emission Levels And Electromagnetic Immunity
BIOSTIM - User Manual 1 0 . 1 T a b l e E m i s s i o n L e v e l s a n d E l e c t r o m a g n e t i c I m m u n i t y The BIOSTIM BB02, taking into account the risk analysis associated with electromagnetic interference, meets all test levels and complies with the requirements of EN 60601-1-2.
Page 23 BIOSTIM - User Manual Test specifications for device immunity to proximity magnetic fields Test frequency Modulation Immunity test level (A/m) 30 kHz (a) Pulse modulation (b) 134,2 kHz 65 (c) 2,1 kHz Pulse modulation (b) 13,56 MHz 7,5 (c) 50 kHz (a) This test is applicable only to medical equipment and systems intended for use in Home Healthcare Environments.
Page 24 BIOSTIM - User Manual The immunity levels given in the table are met as long as the device is kept at a distance of at least 30 cm from any possible source of RF interference. The BIOSTIM BB02 complies with all test levels with a distance >= 30 cm. 1 0 .
Page 25 BIOSTIM - User Manual use of the manufacturer to facilitate internal product handling, but is not intended to provide information to the user.
Page 26 Separate collection and recycling of batteries: the batteries are subject to a separate collection for recycling. Separate collection: IGEA devices and their applied parts cannot be disposed of as municipal waste but are subject to a separate collection in accordance with the procedures established by the local authorities.

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IGEA BIOSTIM THERAPY User Manual

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