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TESI Comfo Trac (duo)

1. Attention The therapy was interrupted Continue with OK Cause The patient actuated the interruption switch Suggestion 1 Find out why the interruption switch was actuated 2 Confirm the message by touching the Button OK 3 The bench will continue the massage functions if these had been active before the interruption switch was actuated All extension parameters must be reset gbo Medizintechnik AG Version 2 1 24 TESI ComfoTrac duo 6 Maintenance Functionality reliability and safety characteristics of the TESI bench are only guaranteed in case of proper use in accordance with the operating instructions Safety control maintenance work repair work and modifications shall only be carried out by the manufacturer or the service agents authorized by him In case of a failure parts which influence the safety of the device shall only be replaced by original spare parts of the manufacturer The electric installation shall be carried out in accordance with the requirements of VDE IEC The device does not contain any parts which require maintenance work by the user 6 1 Legal provisions and requirements The device is subject to the provisions of the Medical Device Directive The safety controls have to be carried out on the basis of this directive Thereby the operator regulation has to be observed in particular Operators of medical devices in active use are obligated to keep a book of the medical device and document a
2. e Service menu see Service manual The settings are device specific settings see Table 1 These settings should be done during assembly by a medical product adviser or a service technician Once the TESI bench has been switched on and is ready you can start immediately with the standard settings 4 Note You can only start the menu with the Button Menu if no treatment is in progress Settings Setting possibilities Delivery state Language German English Russian Chinese Polish Temperature C Automatic stand by after the end of 10 min 30 min never 10 min treatment within a specific time Table 1 Settings 2 5 2 Modification of the settings Upon switching on the device the settings are preset through the Stand by Switch Touch the Button Menu You are in the menu Touch the Button for settings You are in the submenu settings The submenu provides the above mentioned options Modify the device settings by touching the respective Button To store confirm by touching the Button OK If you do not want to store the modifications of the settings touch the Button Abortion You return to the menu 6 Leave the menu by touching the Button Return You return to the start display a E gbo Medizintechnik AG Version 2 1 12 TESI ComfoTrac duo 3 Description of function 3 1 Acoustic user guidance The following table shows the acoustic signals and their meaning e The interrupt
3. TET Display Environmental conditions Operation Temperature range 10 C 35 C Relative air humidity 30 75 Transport and Temperature 10 C 50 C storage Relative air humidity lt 90 non condensing By request of technical personnel gbo Medizintechnik AG can offer spare part lists check lists and circuit diagrams The mains connector is used for all pin disconnection from the mains power supply gbo Medizintechnik AG reserves the right to modify the design and specification without prior notice gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 29 10 Accessories Article tice numer TESI ComfoTrac 1 Mains supply cable 018 0 0020 Scope of supply 1 Thorax belt 1 Pelvic belt 1 Cervical cushion small 1 User s manual 1 DVD Anlagevideo Setup of the equipment TESI ComfoTrac duo 1 Mains supply cable 018 0 0030 Scope of supply 1 Thorax belt 1 Pelvic belt 1 Cervical carriage 1 Cervical cushion small 1 User s manual 1 DVD Anlagevideo Setup of the equipment 018 0 0002 Pelvic belt small Cervical cushion small cu ou Cervical belt Thorax belt Headphones for hardware revision F and higher Note 1 I Use gbo original accessories only to guarantee the safe function of the unit gbo Medizintechnik AG Version 2 1 30 TESI ComfoTrac duo 11 Index A M Acoustic user guidance 12 massage rollers 15 assembly 9 S B settings 11 Bee
4. 15 15 16 17 17 18 20 Version 2 1 TESI ComfoTrac duo 5 1 5 2 5 3 5 4 6 6 1 6 2 6 3 7 7 1 8 9 10 11 Notes Warnings Errors Other notes MAINTENANCE Legal provisions and requirements Safety controls Cleaning disinfection and care WARNINGS AND SAFETY PRECAUTIONS Contra indications EXPLANATION OF THE SIGNS USED TECHNICAL DATA ACCESSORIES INDEX gbo Medizintechnik AG 20 21 22 23 24 24 24 25 25 26 27 28 29 30 Version 2 1 6 TESI ComfoTrac duo 1 Introduction 1 1 Intended use Device for traction therapy and vibration massage 1 2 Note concerning the operating personnel The device 1s to be operated by healthcare professionals only 1 3 Description of the unit The TESI benches are medical devices for combined physical therapy The following options for treatment are offered thermotherapy paravertebral massage vibration static or intermittent extension The system permits the optional or combined application of these modes While the patient feels very comfortable with the treatment for the therapist it offers high operational comfort for time saving treatment The intermittent TESI bench permits the use of maximal stretching or traction alternating with periods of complete relaxation In the treatment of many painful disturbances of the limbs and the spinal column it is more effective than continuous stat
5. Buttons set the roller pressure 5 By touching the Buttons lt gt set the region of the back 6 By touching the Buttons set the speed the massage starts The treatment time does not pass yet see Point 8 7 If required set the vibration by touching the Buttons 8 Touch the Start Button The treatment time passes 9 At the end of the treatment time the triad gong sounds The extension traction if extension has also been selected will get untied The massage rollers go down and stop Vibration stops 10 Remove the straps and belts 11 After the treatment the patient should remain in an upside position sitting with his legs dangling over the side of the bench for about 3 to 5 minutes and remain quiet and relaxed 12 If the bench is not used any longer press the Stand by push button gi Note e The treatment can be stopped at any time by touching the Button Stop e The treatment can be stopped at any time by pressing the Interruption switch e 10 minutes after the end of the treatment the device will automatically activate the stand by mode which means that the stepped bed will move down This setting can be modified see chapter 23 2 gbo Medizintechnik AG Version 2 1 16 TESI ComfoTrac duo 4 3 Extension Warning Before treatment you should explain the function of the emergency stop switch to the patient The emergency stop switch should remain in the patient s hand during the
6. back of the massage Switchboard for Start Stop Switchboard for menu the pause time Ripple form of the traction power during the traction time Basis percentage of the traction power given during the pause time Switchboard for Start Stop Switchboard for menu gbo Medizintechnik AG Version 2 1 14 3 3 Settings Functions Settings Functions Treatment time Temperature Rise of step Traction power lumbar spine cervical spine Traction time Pause time Ripple Form of the traction power during the traction time Basis percentage of the traction power given during the pause time Massage device speed Massage device roller pressure Massage device vibration Massage device region of the back Interruption switch Button Stop Table 3 Settings 4 Note Setting possibilities Confirmation by Therapist Therapist Therapist Therapist Therapist Therapist Therapist Therapist Therapist Therapist Therapist Therapist Patient Therapist TESI ComfoTrac duo Range of values 0 90 10 90 O0 15 cm s 0 100 15 35 Hz e The traction power is limited to 160 N in case of cervical spine extension and to 600 N in case of lumbar spine extension e For the traction time continuous traction is offered automatically When the traction time is changed for the first time the pause time will be set automatically to 1 s e tis possible to set all parameters
7. before and during the treatment e It is possible to switch on and off extension and massage by touching the respective Buttons When a form of treatment is active it is shown by a rose dot in the respective Button e Itis possible to stop the treatment at any time by touching the Button Stop gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 15 4 Therapy 4 1 Thermotherapy For thermotherapy the cover of the middle section of the TESI bench can be heated for the patient When required the thermotherapy can be combined with all other therapies By touching the Button or Button on the Touch Screen the temperature of the cover of the middle section of the TESI bench can be increased up to a maximum heating capacity of 35 C or be reduced 4 2 Massage Through casters which pass the vertebral column with adjustable pressure it is possible to apply a paravertebral roller massage with in depth muscular effect The height of the massage rollers is adjustable If required the massage can be supported by an additional and separately connectable vibration The massage is independent of the thermotherapy and extension treatment and it can be combined with these if required 1 By touching the Buttons set e Temperature if thermotherapy is required e Rise of step 2 Touch the Button of massage The roller pressure will be set on 50 3 By touching the Buttons set the treatment time 4 By touching the
8. the Touch Screen will only work properly if it is touched only by a single finger at a single point If more than one finger or the ball of the thumb are placed on the active surface this will trigger the error message shown above 2 Confirm the message with the Button OK Note The rope of the cervical spine extension is at its limit Please check that there is enough remaining space for its movement Cause The extension rope has been drawn in as far as the end stop It will not be possible to attain the desired force Suggestion 1 Position the carriage to allow sufficient travel distance Move the neck cushions on the carriage right down and then slide the carriage under the head of the patient Hang the extension carriage on the extension bar 2 Confirm the message by touching the Button OK 3 Reset the extension parameters Note The rope of the lumbar spine extension is at its limit Please check that there is enough remaining space for its movement Cause The extension rope was retracted to the end stop It will not be possible to attain the desired force Suggestion 1 Position the patient to allow sufficient travel distance 2 Confirm the message by touching the Button OK 3 Reset the extension parameters Note The stepped bed is at the same height as the traction rope and could not be lowered any more Cause The stepped bed cannot be lowered below the extension bar because othe
9. whole treatment 4 Note Your TESI device uses high precision amplifiers for the measurement of the traction force These amplifiers require a heating up phase to reach the best possible performance The extension system can not be used before the heating up phase is elapsed A message will be shown that informs you about the remaining heating up time However the massage function can be used independently from the extension system We recommend switching on the TESI device at least five minutes before the first treatment session Figure 3 Message during heating up phase 1 By touching the Buttons set e Temperature if thermotherapy is required e Rise of step 2 Touch the Button of extension 3 Set the treatment time by touching the Buttons 4 4 Select lumbar spine extension or cervical spine extension by touching the respective Button only in case of ComfoTrac duo 5 Apply the equipment to the patient see also Chapter 4 3 2 6 Set the extension height by touching the Buttons 7 Set the traction power by touching the Buttons the traction time will be set automatically on continuous traction and the extension starts The treatment time will not pass yet see Point 11 8 If required set the traction time and pause time by touching the Buttons 9 If required set the form of the Ripple by touching the Buttons That is the form of the traction power during the tracti
10. age on the unit and that in doing so the extension carriage is positioned at or close to the bottom end of its range of movement 4 Now fasten the cervical spine extension rope to the belt fastener on the tongue of the belt of the extension carriage 5 Continue with the other settings as described in Chapter 4 3 6 Start the extension exercise 4 3 3 How to set up the equipment for lumbar spine extension Adjusting the thorax belt The thorax belt is required for the counterextension exercise and for all extensions of the lower extremities It should be installed on the unit before the patient lies down on the bench We recommend that you release the straps of the thorax belt fixed at the head end of the unit and leave them to hang loosely This will permit the belt to be adjusted for each patient s needs To put on the belt first locate the bottom of the ribs and position the thorax belt so that the bottom end of the ribs is in the middle of the thorax belt between the two wings of the belt To fasten the thorax belt stand sideways to the head end of the unit Take the fastening straps of the belt in your left hand and position the belt so that the bottom end of the ribs is centered under the belt Then place the inner belt wing across the body so that it reaches the opposite shoulder Holding the thorax belt in this position with the left hand take the other wing of the belt in your right hand Pull both ends of the belt upwards and ov
11. al operation You find more EMC comments in the chapter Warnings and Safety Precautions of this manual as well as in the Technical Information on the next two pages gbo Medizintechnik AG Version 2 1 32 TESI ComfoTrac duo In accordance with the EMC regulations for medical products we are obliged by law to provide the following information Guidance and manufacturer s declaration electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The equipment uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Group 1 RF emissions Class B CISPR 11 Harmonic emissions The equipment is suitable for use in all establishments including domestic establishments and those directly connected to the public Class A low voltage power supply network that supplies buildings used for IEC 61000 3 2 Voltage fluctuation flicker emissions IEC 61000 3 3 domestic purposes Note For devices with a power consumption between 75 W and 1000 W only Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the ele
12. ation leather parts use a dry or damp cloth Do not use any agents containing higher portions of alcohol Examples for useful products to be used for cleaning are Mikrobac Tissues by Hartmann Bode or Cleanisept Wipes by Dr Schumacher e Ifthe imitation leather of the heating cover is wet dry it carefully In case you detect any damage or disturbance the heating cover has to be repaired by the manufacturer e For the equipment dry cleaning is recommended 7 Warnings and safety precautions Warning e Do not pierce the heating cover accidentally e Incase of any visible operational disturbances please contact immediately gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG e Please take care that the patient does not hit the support arm or the touch panel when lying down on or getting up from the bench e The lumbar extension device must not be used for cervical extension e The bench must not be left unattended if there is a patient lying on it with extension equipment gbo Medizintechnik AG Version 2 1 26 TESI ComfoTrac duo 7 1 Contra indications Indication dosage and application of an extension are realized in sole responsibility of the user Before applying an extension the harmlessness from a specialist s neurologist s and orthopedists s point of view must be guaranteed An application of the extension system is not recommended in case of e acute inflammato
13. cope of the Medical Device Directive You will obtain technical support by the manufacturer dealers or service authorized by the manufacturer The product s duration of life scheduled by the manufacturer is 10 years The TESI benches are electronic devices For their disposal the respective regulations for electronic devices have to be observed On request the manufacturer will provide you with further technical descriptions for all repairable parts of the device such as circuit diagrams spare part lists and adjustment instructions as far as these are of use for the qualified technical staff of the operator Comments on electromagnetic compatibility EMC Medical electrical devices are subject to special precautions concerning the EMC They must be installed and operated according to the EMC advice given in the accompanying documents In particular medical electrical devices may be influenced by portable and mobile RF communication devices The manufacturer guarantees the conformity of the unit with the EMC requirements only when using accessories which are listed in the EC declaration of conformity The usage of other accessories my cause an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity The unit must not be arranged physically close to other devices or stacked with them If such an order is necessary nevertheless the unit must be observed in order to check it for the intention
14. ctromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U for 2 cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for 5s gt 5 dip 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U for 2 cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for 5s gt 5 dip Note U is the a c mains voltage prior to application of the test level gbo Medizintechnik AG Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a t
15. ed inwards into the soft area of tissue of the waist This will prevent the belt fromslipping while the extension unit is being used Moreover this position is also comfortable for the patient and will not give rise to any complaints To fasten the pelvic belt fasten the belt fastener on the pelvic belt to the extension rope on the foot piece 7 Tighten the strap by placing your hand beneath it and pulling upwards Move the stepped bed under the knees of the patient to attain the highest position If a lower position is required the foot piece 7 can be lowered Both positions help to smooth out curvature in the lumbar region gbo Medizintechnik AG Version 2 1 20 TESI ComfoTrac duo 5 Behavior in case of failures The following failures will be indicated by the TESI bench both optically and acoustically Most of them can be remedied by following the instructions on the display As a rule the following applies 1 The TESI bench will not execute any incorrectly entered functions or modifications entered by pressing on the Touch Screen 2 The acoustic error signal will sound 3 An error message will appear on the display 5 1 Notes Note Only touch the screen with one single finger Dont slide over the screen Cause The Touch Screen was touched at several different points or the fingers made a sliding movement across the screen The Touch Screen must not be operated in this way Suggestion 1 Please note that
16. equipment marked with the following Recommended separation distances to portable and mobile RF communication equipment The equipment is intended to be operated in an electromagnetic environment where radiated RF interference is controlled The user can help in avoiding interferences by means of meeting minimum separation distances between portable and mobile RF communication equipment transmitters according to the maximum output power of the communication equipment Rated power of the Separation distance according to the tranmission frequency m transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3VP POD POD p28 1 2 3 8 12 gbo Medizintechnik AG Version 2 1
17. er the rib cage so that the lower inside part of the belt is pressed into the soft area of tissue between the ribs and the hips It is essential that the belt does not slip under the arms and or onto the rib cage To fasten the thorax belt to the bench guide the straps into the eyelets down on the head piece 10 on the bench and tighten the equipment by pulling on the straps underneath the patient gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 19 Adjusting the pelvic belt It is easier to adjust the pelvic belt if the equipment is adjusted on the patient before he lies down on the bench The strap is at the back of the patient between his legs The soft side of the equipment should be facing the patient With the pelvic belt already adjusted and with the corresponding straps hanging freely behind the patient the patient is correctly prepared Even if the pelvic belt had already been adjusted to the patient it should be adjusted to the correct position once again after the patient lies on the bench Stand sideways to the feet end of the bench and take one wing of the pelvic belt in your right hand Then place the belt diagonally across the body towards the opposite leg and press the upper external part of the belt together in the soft area of tissue of the waist E Take the other wing of the pelvic belt in your left hand and cross it over firmly so that the end of the belt is press
18. g Before treatment you should explain the function of the emergency stop switch to the patient The emergency stop switch should remain in the patient s hand during the whole treatment Switch on the bench through the main switch at the front of the head piece 10 The device carries out an automatic check of all functions The faultless automatic check ends with an acoustic sign triad gong Please note that the extension system can not be used before the heating up phase which takes 5 minutes A message on the display informs you about the remaining heating up time We recommend to switch on the TESI device at least 5 minutes before the first treatment session However the massage function can be used independently from the extension system Position the patient with the equipment in accordance to the desired treatment Set the following a Temperature b Roller height Select the treatment e Extension e Massage e Extension and Massage Set the treatment time When massage has been selected set the parameters a Roller pressure b Region of the back c Speed the massage starts The treatment time does not pass yet please observe Point 9 d if necessary vibration When extension has been selected set the parameters a Lumbar spine or cervical spine only for TESI ComfoTrac duo b Extension height adjustable only if traction power 0 N c Traction power the traction time is set automat
19. hing on the TESI bench an automatic check of all functions will be carried out gbo Medizintechnik AG Version 2 1 10 TESI ComfoTrac duo Warning To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth It is only allowed to connect CompactFlash cards or chip cards provided by the manufacturer into the card slots of the device 2 2 1 Fuses 1 Unplug the mains plug The device is protected by 2 fuses on the mains side that are located in a pluggable box at the front of the head piece 10 3 With a screw driver the box can be pulled out of the receiver by the small slot 4 Only fuses that correspond to the specifications named in the technical data should be used Warning Risk of fire if unqualified fuses are used 2 3 Placing out of operation In order to disconnect the device just disconnect it from the mains power supply No other measures are to be taken 2 4 Waste removal of the device and accessories This product complies with WEEE Directive 2002 96 EG waste electrical and electronic equipment Separate collection for electrical and electronic equipment The waste removal at the end of the service life will be done by the manufacturer gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 11 2 5 Settings 2 5 1 The menu You can open the menu by touching the Button Menu It provides the following submenus e Settings see Chapter 0
20. i Extension Systems TESI ComfoTrac TESI ComfoTrac duo User Manual gbo Medizintechnik AG Version 2 1 2 TESI ComfoTrac duo The gbo Medizintechnik AG has taken care in preparation of this manual but makes no expressed or implied warranty of any kind and does not assume any responsibility for errors or omissions All rights reserved No part of this manual may be reproduced in any form or by any means electronic mechanical or otherwise without the prior written permission of the gbo Medizintechnik AG gbo Medizintechnik AG gbo Medizintechnik AG Kleiststrasse 6 D 64668 Rimbach Telephone 49 6253 808 0 Telefax 49 6253 808 245 E Mail info gbo med de Internet http www gbo med de Version 24 Date of issue October 10 2013 Part number 018 7 0004 gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 3 Notations Times New Roman in type size 11 Descriptions and explanations Arial in type size 10 keys and buttons of the TESI benches Lucida in type size 10 11 Text appears on the display of the TESI benches Warnings and safety precautions Warning Warnings which have to be observed by all means Caution Observe the instructions for use Note so Information that will facilitate your work Glossary Touch Screen Display equipped with a touch panel The touch panel reacts to the smooth touch of the respective sector Button Sector in the Touch Screen which
21. ic extension Especially designed equipment guarantees best results for the cervical and thoracic extension as well as the extension of the pelvis Additional possibilities for extension are offered for arm shoulder as well as pelvis and foot joints Therapeutic effects of heat e Dilatation of the vascular system reflectorically also in deep tissue layers Also suited without any restriction for carriers of implants e Increase in elasticity and mobility e Pain relief Effects of paravertebral massage and vibration e Increase in circulation and metabolism e Muscle relaxation and increase in elasticity and mobility Therapeutic effects of intermittent extension e Extension and mobilization of muscular and connective tissue structures e Decompression of intervertebral discs and compressed nerves e Dissolution of muscular tensions by intermittent traction and detraction gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 7 1 4 Device view TESI bench Touch Screen 1 Stand by push button and indicator 2 switch mnector ns cable em ne Base 7 Connector for Fastener to exchange the Head piece 10 Operating element massage rollers 9 here TESI ComfoTrac duo left 8a Figure 1 Device view Cushion belts and extension unit represent the applied parts of the bench gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 1 5 Short instructions 10 11 12 13 14 Warnin
22. ically on continuous traction and extension starts The treatment time does not pass yet please observe Point 9 d If necessary traction time duration of pause ripple course of traction power during the duration of traction basis traction power during the duration of pause Press the Button Start and the treatment time passes The treatment time ends with the triad gong The traction devices will loosen The massage rollers will move down and stop Vibration stops Remove the straps and belts After the treatment the patient should remain in an upside position sitting with his legs dangling over the side of the bench for about 3 to 5 minutes and remain quiet and relaxed If the bench is not used any longer press the Stand by push button gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 9 2 Start of operation 2 1 Transport and assembly To place the unit each plane surface is appropriate Please take notice of having enough space around the device to reach the power switch comfortably and possibly be able to pull off the power cable Keep a wall distance of at least 20 cm For fixing the device please use the brakes of the rollers The device should neither be placed in front of radiators or radiant heaters nor should it be covered by pillows or blankets while in operation The device is not made for outdoor operation The TESI benches correspond to the regulations EN 60601 They are devices of protection clas
23. ion switch has been pressed Information sound e In case the limit of power has been reached or in case of a failure Triad gong e At the end of the faultless automatic check when switching on the device e At the end of the treatment time Table 2 Acoustic user guidance 3 2 Operating notes 3 2 1 Interruption switch of the patient Before the start of operation you should explain to the patient how to use the Interruption switch The patient can interrupt the treatment by touching the button at any time All extension powers will get untied automatically the patient remains in a comfortable position tied to the equipment The personnel will be informed by the beep Since the extension gets untied automatically it is not necessary for the personnel to care the patient immediately To start the treatment again touch the Button Start 4 Note The treatment can be interrupted at any time by touching the Button Stop gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 13 3 2 2 Touch Screen EXTENSION J MASSAGE Figure 2 Basic display of the Touch Screen The display shows in case of Extension The display shows in case of Massage the remaining treatment time the temperature the rise of step the extension height the traction power the traction time the remaining treatment time the temperature the rise of step the roller pressure the speed the vibration the region of the
24. ll safety controls they are commited to do as described below Note f The Medical Device Directive is only valid in countries throughout the EU 6 2 Safety controls The device is subject to the Medical Device Directive The safety controls are to be carried out on the basis of this directive at 12 months intervals by a qualified service agency Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is recommended to have the device checked by the manufacturer or by a service agency authorized by him at 12 months intervals The check shall consist of at least the following criteria Safety check of electric parts of the device Check of the device in respect of external integrity Check of all display and operating elements in respect of damages Check of all inscriptions in respect of legibility Check of the power cable Check of all functions of the device The manufacturer keeps a respective check list available gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 23 6 3 Cleaning disinfection and care Warning Before cleaning or disinfection unplug the mains plug out of the socket The device is suited for wiping disinfection Make sure that no liquids soak into the device Under no circumstances the plug or socket must get wet Do not sprinkle the device for cleaning or disinfection The device is not suited for hot sterilisation or sterilisation with gases e To clean the imit
25. on time gbo Medizintechnik AG Version 2 1 10 11 12 13 14 15 TESI ComfoTrac duo 17 If required set the basic value by touching the Buttons That is the percentage of the traction power given during the pause time Touch the Button Start The treatment time passes At the end of the treatment time the triad gong sounds The extension traction gets untied If massage has also been selected the massage rollers go down and stop Vibration stops Remove the straps and belts After the treatment the patient should remain in an upside position sitting with his legs dangling over the side of the bench for about 3 to 5 minutes and remain quiet and relaxed If the bench is not used any longer press the Stand by push button 4 Note The cervical spine extension is only possible with the TESI ComfoTrac duo bench Please note that the extension rope can only be moved when the extension treatment is activated The traction power is limited to 160 N in case of cervical spine extension and to 600 N in case of lumbar spine extension e For the traction time continuous traction is offered automatically When the traction time is changed for the first time the pause time will be set automatically to 1 s e The treatment can be stopped at any time by touching the Button Stop e The treatment can be stopped at any time by pressing the Interruption switch e 10 minutes after the end of the treatment the de
26. p 12 supply voltage 9 F T Fuses 10 thermotherapy 15 Transport 9 H U heating up phase 8 16 user guidance 12 I V Information sound 12 Interruption switch 12 Vibration 15 gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 31 Notes in accordance with the EC Directive and Medical Device Directive The TESI bench is a mains operated Extension System for combined physical therapy of protection class I The device is in accordance with the EC Medical Device Directive 93 42 EEC and therefore carries the CE sign with the registration number of the notified body for medical devices The according graphical symbol is placed on the type plate According to the Medical Device Directive the TESI benches are devices of class Ha The manufacturer is only responsible for the safety operational reliability and functionality of the device if e the device is used in accordance with the instructions for use especially the notes concerning maintenance and cleaning of the device as described in Chapter 6 e the electrical installation of the location where the device will be used corresponds to the respective current requirements of electrical safety e the device is not used in hazardous environments and humid locations e the mountings amplifications readjustments modifications or repair works are carried out only by personnel authorized by the manufacturer e the operator regulation of this EC directive is observed within the s
27. reacts to the smooth touch Touch Smooth touch of the Touch Screen Stand by push button Switch on the right of the Touch Screen puts the device into the Stand by mode In this mode Stand by display lights up Lumbar spine extension Extension of the vertebral column in the lumbar region Cervical spine extension Extension of the vertebral column in the cervical region Firmware Software for a microcontroller in Eprom Flashrom programmed gbo Medizintechnik AG Version 2 1 4 Contents 1 INTRODUCTION 1 1 Intended use 1 2 Note concerning the operating personnel 1 3 Description of the unit 1 4 Device view TESI bench 1 5 Short instructions 2 START OF OPERATION 21 Transport and assembly 2 2 Connection and switch on 2 2 1 Fuses 2 3 Placing out of operation 2 4 Waste removal of the device and accessories 2 5 Settings 2 5 1 The menu 2 5 2 Modification of the settings 3 DESCRIPTION OF FUNCTION 3 1 Acoustic user guidance 3 2 Operating notes 3 2 1 Interruption switch of the patient 3 2 2 Touch Screen 3 3 Settings Functions 4 THERAPY 4 1 Thermotherapy 4 2 Massage 4 3 Extension 4 3 1 The use of the cervical cushion during the extension 4 3 2 How to set up the equipment for cervical spine extension 4 3 3 How to set up the equipment for lumbar spine extension 5 BEHAVIOR IN CASE OF FAILURES gbo Medizintechnik AG TESI ComfoTrac duo 10 10 11 11 11 12 12 12 12 13 14 15
28. rwise the rope would become jammed gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 21 Suggestion 1 First lower the extension height which will enable you to further lower the stepped bed 2 Confirm the message by touching the Button OK 3 The stepped bed can now be lowered further 5 2 Warnings Warning The stepped bed has been stopped It should only be moved without load Cause The stepped bed can only be moved when not under excessive load Suggestion 1 The patient must remove his feet from the stepped bed 2 Touch the Button OK 3 Move the stepped bed into the desired position Warning Height adjustment for lumbar spine extension overloaded Cause The lumbar spine extension height adjuster can only be moved when not under load Suggestion 1 The extension bar must not be moved under load Remove any hindrances or loads 2 Touch the Button OK 3 Move the extension bar to the desired position Warning Height adjustment for cervical spine extension overloaded Cause The cervical spine extension height adjuster can only be moved when not under load Suggestion 1 The extension bar must not be moved under load Remove any hindrances 2 Touch the Button OK 3 Move the extension bar to the desired position Warning A too large meassurement difference was detected on the cervical spine extension unit Cause There is a fault in the measurement of
29. ry processes e open wounds or abscesses in the region of the vertebral column e bacterial bone process osteomyelitis tuberculosis and other inflammatory osteopathies or arthropathies e malign tumors gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 27 8 Explanation of the signs used C 0123 CE Conformity sign Observe the instructions for use Application section with protection class B waste electrical and electronic equipment Separate collection for electrical and electronic equipment X This product complies with WEEE Directive 2002 96 EG gbo Medizintechnik AG Version 2 1 28 TESI ComfoTrac duo 9 Technical data frequency 50 60 Hz max 2 3 A with 100 V max 0 95 with 240 V 15 35 Hz 0 5Hz max 35 C at 23 C ambient temperature max 600 N 10 max 160 N 10 Accuracy of position of extension carriage gallows and stepped bed Operating mode w a Continuous operation I in accordance to IEC 601 1 DIN EN 60601 1 B in accordance to IEC 601 1 DIN EN 60601 1 Safe working load MDD device class IIb in accordance to MDD annex IX 135 kg Stepped 45 kg Support 75k g The handle of the support arm can be used to arm get up Dimensions max 66 175 cm x 200 cm x 94 cm Height x depthx width Height of the device without with support arm max 80 kg without equipment Color RAL 9002 or special varnish Coat blue Display
30. s I Within the scope of the Medical Device Directive MDD the TESI benches belong to class Ha please observe also Chapter 7 Warnings and safety precautions Please check all components to be in external integrity before use Warning e The unit is not designed to be operated in places with the inherent risk of explosions If it is used in dangerous areas of anesthesia departments the possibility of an explosion cannot be excluded e If the patient and or the patient cable is directly exposed to a radiator of a medical device for high frequency heat therapy damage of the device or danger to the patient cannot be excluded As a rule a clearance distance of 2 3 mis sufficient e Do not pierce the heated cover e In case of any visible operational disturbances please contact immediately gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG 2 2 Connection and switch on The TESI bench has been set to be connected to supply voltages of 100 240 V Irrespective of the adjusted mains voltage the device is appropriate for power frequencies of 50 to 60 Hz Connect the device with the mains cable to a socket with protective ground The protective ground must work correctly The TESI bench is switched on by the mains switch at the front of the head piece 10 By this arrangement an erroneous or unintended disconnection of the device during normal operations shall be avoided After switc
31. the traction power What to do Contact the Service Center Warning A too large meassurement difference was detected on the lumbar spine extension unit Cause There is a fault in the measurement of the traction power What to do Contact the Service Center gbo Medizintechnik AG Version 2 1 22 TESI ComfoTrac duo Warning The carriage motor is blocked and was stopped Cause The carriage cannot be moved and was therefore stopped for safety reasons Suggestion 1 Remove all unintended loads from the cover 2 Confirm the message by touching the Button OK and try again to move the carriage by touching the Touch Screen 3 If the message appears again contact the Service Center Warning The spindle motor is blocked and was stopped Cause The contact pressure adjuster for the carriage cannot be moved and has therefore been stopped for safety reasons Suggestion 1 Remove all unnecessary loads from the cover 2 Confirm the message by touching the Button OK and try to move the carriage again by touching the Touch Screen 3 If the message appears again contact the Service Center 5 3 Errors There are two possible error messages Error CAN No ACK and Error CAN Timeout Cause communication error between the different internal subsystems occured Suggestion Contact the service center gbo Medizintechnik AG Version 2 1 TESI ComfoTrac duo 23 5 4 Other notes
32. vice will automatically activate the stand by mode which means that the stepped bed will move down This setting can be modified see chapter 2 32 4 3 1 The use of the cervical cushion during the extension When the cervical padding is used during the extension please check the diffraction angle because it changes the position a lot during the treatment In most cases the cervical cushion is not used except in cases of excessive contortion of the superior dorsal region 4 3 2 How to set up the equipment for cervical spine extension tr 1 2 6 Note e The cervical spine extension can only be carried out with the TESI ComfoTrac duo bench e The cervical cushion will not normally be required for cervical spine extension Please refer also to Chapter 4 3 1 Move the cervical spine extension bar from its home position as far upwards as possible so that the cervical spine extension unit can be fully and easily suspended approx 10 cm should be sufficient Position the patient on the bench gbo Medizintechnik AG Version 2 1 18 TESI ComfoTrac duo 3 Set the basic position of the cervical spine extension unit when the patient s head 1s resting on the cover of the extension unit and is held firmly by the extension clamps The spacing of the clamps can be adjusted Be sure that the horizontal basic position is set by the basic position is not set by moving the moving the unit as shown in this illustration extension carri
33. ypical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the equipment requires continued operation during power mains interruptions it is recommended that the equipment be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Version 2 1 TESI ComfoTrac duo 33 Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF FN IEC 61000 4 6 150 kHz to 80 MHz Radiated REF IEC 61000 4 3 for 80 MHz to 800 MHz d 2 3VP for 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters m Interference may occur in the vicinity of

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