BOSANA Tipstim Instruction Manual Download Page 2

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tipstim

Instruction Manual

TABLE OF CONTENT

IMPORTANT NOTES

Intended use

Medical application areas

SAFETY INSTRUCTIONS AND WARNINGS

Explanation of graphic symbols and product marking

Precautions

MODE OF OPERATION AND CONFIGURATION

Scope of delivery

Optional components

Consumables

Technical description

Overview of signals

Environmental conditions during use

Therapy settings and installation instructions

Preparing a therapy session

Performing a therapy session

Current setting

Interrupting a therapy session

Finishing a therapy session

Cleansing and disinfection

MAINTENANCE, STORAGE, TRANSPORT

Change of batteries

Safety checks

Debugging and repair by untrained users

Debugging and repair by authorized and qualifi ed personnel

Storage and transport

Summary of Contents for Tipstim

Page 1: ...tipstim Instruction Manual 1 INSTRUCTION MANUAL Worldwide exclusive distribution by ...

Page 2: ...nical description 11 Overview of signals 12 Environmental conditions during use 13 Therapy settings and installation instructions 13 Preparing a therapy session 14 Performing a therapy session 15 Current setting 15 Interrupting a therapy session 17 Finishing a therapy session 17 Cleansing and disinfection 17 MAINTENANCE STORAGE TRANSPORT 18 Change of batteries 18 Safety checks 19 Debugging and rep...

Page 3: ... permitted by copyright is inadmissible without previous written permission on the part of Haynl Elektronik GmbH Haynl Elektronik GmbH reserves the right to make improvements and changes without prior notice Some of the pictures and trademarks mentioned in this instruction manual are copyright protected by BOSANA Medizintechnik GmbH Each rendition or utilization outside of the borders permitted by...

Page 4: ...ct of operating the system Please refer to a qualified supplier for assistance Intended use The electrotherapy device tipstim is a class IIa medical device It is intended for sensitive electrical stimulation of the finger tips and for tone regulation in the treatment of spasticity of the upper extremities Medical application areas tipstim is designed to be used for the treatment of patients suffer...

Page 5: ...d result in death or serious injury if not avoided Indicates a possible danger that may result in minor or moderate injury if not avoided Consult instruction manual Manufacturer Year of production Application part Type BF Serial number Reference number ON OFF CE marking and identification number of the notified body involved Caution follow the instructions Protect medical device from moisture Keep...

Page 6: ...tients fitted with a pacemaker Exception explicit permission by a medical specialist Possible risk of danger to patients with cardiac damage tipstim should not be used by patients with cardiac damage Exception explicit permission by a medical specialist Danger to children and untrained users Keep away from Children and untrained users Possible risk of damage to implanted medical products tipstim s...

Page 7: ...n reprocessing this device Possible risk to health heart head genitalia spinal cord neck by electrical stimulation Only use the device as per the instructions at all times Incorrect use of tipstim can lead to possible damage to health Only use the device as per the instructions at all times and always keep this instruction manual with the device Risk of burning the skin by high frequency surgical ...

Page 8: ...ssories consumables are intended for single patient use only Risk by improper use Only use tipstim with accessories provided and in combination with approved medical devices that are compatible with tipstim Risk by electrical shock Do not connect the device or its components accessories directly to mains power supply Deviations in the output parameters Do not operate the device in the vicinity of ...

Page 9: ...o conductive implants Damage to surgical wounds to injured skin and other skin irritations Do not use the device close to fresh surgical wounds or damaged skin Damage to health in case of infectious diseases and fever Do not use the device Danger of injury when operating machinery simultaneously Do not use the device Danger of injury by high electrical currents in case of sensitivity disorders Tal...

Page 10: ...ies 4 pcs 1 instruction manual 1 K4med electrode cable Optional components 4 NiMH rechargeable batteries 2500 mAh 1 external charger PTA USB cable for PC connection and PTA Software Programming instructions for medical experts Consumables You also need tipstim glove to start the therapy and or possibly skin surface electrodes to treat spasticity tipstim glove 4 TENS EMS electrodes 50x50 mm optiona...

Page 11: ...umables accessories are for single patient use only ON OFF button Selection buttons and channel 1 Connecting socket to PC OLED display Selection buttons and channel 2 OK button Connecting socket to electrode cable inscriptions product marking battery compart ment opened batteries 4 x AA battery compart ment lid removed ...

Page 12: ... two beeps indicate button locking repeated signals indicate current flow interrupted or substantially decreased display is blinking repeated acoustic signal after 30 seconds Optical signals and pictograms automatic current setting activated key symbol indicates current locking activated current intensity in steps of 0 5 mA remaining treatment time manual current setting activated training phase i...

Page 13: ...ed for a new one Please confirm this message by pressing the OK button You should prepare to change tipstim glove for a new one now Please change the Glove Only 2 sessions remaining Danger to the operator user in case of defect Medical device may only be operated at an ambient temperature between 5 C and 35 C Medical device to be protected from moisture Medical device to be protected from strong s...

Page 14: ...now show following message Please confirm by pressing the OK button The message will no longer appear and the integrated counter starts at zero again Preparing a therapy session Please choose a quiet place for the therapy session You should be sitting comfortably or lying down Please make sure the device is secured and protected from falling down When preparing the therapy session the device must ...

Page 15: ...therwise the therapy session starts with the current setting Current setting Program 1 Therapy with tipstim glove Switch on the device by pushing the ON OFF button You will enter the menu current setting Set the current by pressing the selection buttons and until you feel a clear electrical tingling sensation A precise determination of the current intensity to be chosen is not pos sible since ever...

Page 16: ...OFF button You will enter the menu current setting By pressing the selection buttons and of channel 1 you can choose the intensity for the left channel By pressing the selection buttons and of channel 2 you can choose the intensity for the right channel The intensity chosen is shown in the display If no further operation is done for 8 seconds the current intensity setting will be locked This state...

Page 17: ... place all components back in their original packaging Cleansing and disinfection Taking care of the self adhesive surface electrodes optional extra In case the self adhesive reusable electrodes no longer stick moisten the sticky side with some water drops Before placing the electrodes wash the skin with soap and water or with an alcohol wipe Cleansing of the device Light soiling can easily be rem...

Page 18: ...atteries in the correct position with proper polarity 3 Close the battery compartment You may also use rechargeable batteries These can be charged with an external charger To replace rechargeable batteries please follow the instructions above To check the state of charge of the rechargeable batteries Switch off the device Press the button of the right channel and keep it pressed Now press the ON O...

Page 19: ...ble is not connected correctly to the socket at the head end of the device Check the seating of the plug at the device s socket error cause solution Insufficient skin contact Replace tipstim glove by a new one Replace surface electrodes Accessories are damaged Replace accessories Current intensity settings locked Unlocking by pressing button Device cannot be switched on Rechargeable batteries are ...

Page 20: ...een 5 C and 35 C Medical device to be protected from moisture Medical device to be protected from strong sunlight and strong heat sources Medical device not to be used in dusty environment Medical device only to be operated at a relative humidity of 30 75 Medical device only to be operated at a relative pressure between 700 1060 hPa Storage and transport ...

Page 21: ...e disposal of goods under Green Laws Do not disassemble the device under any circumstances tipstim is not to be disposed of with normal household waste Only dispose using a repu table recycling company or return the device to the supplier With proper operation and care tipstim has a life cycle of 10 years and K4med electrode cable of 3 years This shall not preclude that within these periods repair...

Page 22: ...e manufac turer of the tipstim medical device is not responsible for any failure of the OLED display Connections Three pole socket at the head of the device allows connection of the electrode cable to the device Four pole socket for connecting the device to a PC via a USB connecting cable tested with 5000V optically decoupled Mode of operation Electrical stimulation Setting options for timer Curre...

Page 23: ... 500 Ohms at 27Hz Effect current 5 0 mA at 1000 Ohms Pulse width 200µs Frequency adjustable 2 Hz to 50 Hz Max Amplitude on 500 Ohms 25 V Max amplitude on open output 180 V Max energy of a single pulse on a 2 5 mJ at 2 Hz and 500µs load impedance of 500 Ohms pulse width Pulse pattern ...

Page 24: ...ide the stimulation phase A gentle reduction in swelling of the current pulse Electrode alarm function automatic limitation and adjustment of current in case skin contact of electrodes is too small Increase of current intensity not possible without previous reduction of intensity intensity locking after 8 seconds without operation Protection class II IP 20 Program 1 Program 2 Stimulation time s 2 ...

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Page 28: ...xpert s instructions The warranty does not apply in the event of accidents misuse and interventions and changes performed by non authorized personnel Should you experience any problem with the medical device or its components please refer to the manufacturer or your local dealer Your local dealer Worldwide exclusive distribution by Kappusstiege 13 D 46282 Dorsten Germany Tel 49 23 62 9 99 62 0 Tel...

Page 29: ...soon as the menu heading code appears on the screen release the OK button Enter the access code via the selection buttons und The correct entry has to be confirmed by pressing the OK button The access code is available from your local dealer If the entry was incorrect switch off the device and start again The menu is divided into the following 3 main areas 1 Settings 2 Extras 3 Statistics All entr...

Page 30: ...city To change parameters of program no 1 Choose menu heading PROGRAM 1 and confirm your selection by pressing the OK button Choose menu heading WORK REST and confirm your selection by pressing the OK button For each program WORK TIME and REST TIME can be adjusted By pressing the selection buttons and you may change WORK TIME and REST TIME in seconds sec Confirm your selection by pressing the OK b...

Page 31: ...ssion DURATION in minutes min Confirm your selection by pressing the OK button If you want to change the parameters for program 2 choose menu heading PROGRAM 2 and proceed as described above for program 1 In the heading SETTINGS add on options are available An auto repeat heading AUTOREPEAT to fix the current output for immediate therapy session a heading to activate the limitation of the general ...

Page 32: ... determined once at the beginning of the therapy session The current intensity selected in the first session after activating AUTOREPEAT is retained for the following therapy sessions Thereafter when switching on the device you have to keep the ON OFF button pressed for at least 3 seconds to activate the preset value Otherwise the current intensity has to be regulated manually Choose menu heading ...

Page 33: ...uttons and you may change the maximum current out put LIMIT DEF in milliampere mA Confirm your selection by pressing the OK button Factory default settings 15 mA Extras In the menu heading EXTRAS you can adjust the contrast CONTRAST of the OLED display and you can switch the acoustic signals SOUND on or off Choose menu heading EXTRAS and confirm your selection by pressing the OK button Choose menu...

Page 34: ...should not be changed unless absolutely necessary Higher contrast settings may lead to premature ageing or a complete loss of the OLED display The menu heading SOUND serves to switch the acoustic signals on or off Choose menu heading SOUND and confirm your selection by pressing the OK button By pressing the selection buttons and you may activate ON or disable OFF the acoustic signals SOUND Confirm...

Page 35: ...ys the following information Total no of therapy sessions no of sessions Average treatment time avg time in minutes min Average current intensity channel 1 avg chn 1 in miliamperes mA Average current intensity channel 2 avg chn 2 in milliamperes mA Statistical values can be reset via the optionally available PTA software or via a RESET function Please contact the manufacturer or your local dealer ...

Page 36: ...ution by Kappusstiege 13 D 46282 Dorsten Germany Tel 49 23 62 9 99 62 0 Tel 49 23 62 9 99 62 22 www bosana de sales bosana de Manufacturer Haynl Elektronik GmbH Magdeburger Str 117a D 39218 Schönebeck Germany www haynl com info haynl com 0123 ...

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