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1. Massage able TESI Relax User Manual gbo Medizintechnik AG Version 2 1 2 TESI Relax The company gbo Medizintechnik AG has taken care in the 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 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 2 1 Date of 1ssue October 10 2013 Part number 018 7 0002 gbo Medizintechnik AG Version 2 1 TESI Relax 3 Notations Times New Roman 1n type size 11 Descriptions and explanations Arial in type size 10 Keys and buttons of the TESI tables Lucida in type size 10 11 Text appears on the display of the TESI tables Warnings and safety precautions Warning Warnings which have to be observed by all means Caution Observe the instructions for use f Note 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 reacts to the smooth touch Touch Smoo
2. Relax 11 Index assembly 10 Note 8 9 12 14 18 20 Basic settings 13 Remote control 15 Chip cards 17 settings 12 Chipkarte 17 Short instructions 8 Compact Flash Card 17 Standby switch 15 Connection and switch on 10 supply voltage 10 Course of treatment 19 Creating chip cards 14 T D Taste OK 15 Tasten 15 Device settings 12 thermotherapy 18 Touch Screen 16 F Transport 10 Fuses 11 U I user guidance 15 User guidance 15 Information sound 15 Vibration 18 Maintenance 23 massage rollers 18 W Warning 24 gbo Medizintechnik AG Version 2 1 TESI Relax 29 Notes in accordance with the EC Directive and Medical Device Directive The TESI Relax is a mains operated system for combined physical therapy of protection class I The device 1s 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 respective graphical symbol 1s placed on the type plate According to the Medical Device Directive the TESI Relax tables are devices of class IIa The manufacturer 1s 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
3. 0 5Hz max 35 C at 23 C ambient temperature Accuracy of position of 2cm stepped bed ici OOOOOOOOOOOOOO Safe working load Table 135 kg Stepped 45 kg bed Support 75 kg 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 depth x width height of the device without with support arm max 80 kg without accessories Color RAL 9002 or special varnish Coat blue Display TFT 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 Relax DT 10 Accessories TESI Relax 1 Mains supply cable 018 0 0010 Scope of supply 1 User s manual 1 Infrared remote control 1 Adjustment card 1 Chip card freely programmable 1 Cervical bolster small 1 Compact flash card 1 Relaxation CD 1 Head phones set Note Use gbo original accessories only to guarantee the safe function of the unit gbo Medizintechnik AG Version 2 1 28 TESI
4. a dry or damp cloth Do not use any agents containing higher portions of alcohol Example for usefull products to be used for cleaning are Mikrobac Tissues by Hartmann Bode or Cleanisept Wipes by Dr Schumacher e If the 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 1s recommended e To clean the remote control use a dry or damp cloth Be careful that no liquid penetrates the housing of the remote control 7 Warnings and safety precautions Warning Do not pierce the heating cover accidentally In case of any visible operational disturbances please contact immediately gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG gbo Medizintechnik AG Version 2 1 TESI Relax 25 8 Explanation of the signs used 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 26 TESI Relax 9 Technical data Supply voltage and supply 100 240V frequency 50 60 Hz Current consumption max 2 3 A at 100 V max 0 95 A at 240 V Vibration freguency 15 35 Hz
5. with OK gbo Medizintechnik AG Version 2 1 TESI Relax 21 5 Behavior in case of failures The following failures will be indicated by the TESI table 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 table 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 Touch the screen with a single finger only Don t slide over the screen Possible reason 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 the Touch Screen will only work properly if it 1s 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 Time credit of chip card expired Please recharge your card for future use Possible reason The time credit of the card is expired Suggestion Recharge time account on the card 5 2 Warnings Warning The stepped bed has been stopped It should only be moved without load Possible reason The stepped bed can only be moved w
6. 61000 4 3 80 MHz to 2 5 GHz 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 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 transmission 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 gbo Medizintechnik AG Version 2 1 32 TESI Relax gbo Medizintechnik AG Version 2 1
7. F THE SIGNS USED TECHNICAL DATA ACCESSORIES INDEX gbo Medizintechnik AG 19 21 21 21 22 22 23 23 23 24 24 25 26 27 28 Version 2 1 6 TESI Relax 1 Introduction 1 1 Intended use Device for 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 Relax tables are medical devices for combined physical therapy The following options for treatment are offered thermotherapy e paravertebral massace e vibration 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 Therapeutic effects of heat e Dilatation of the vascular system reflectorically also in deep tissue layers Also suited for bearers of implants without any restrictions 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 gbo Medizintechnik AG Version 2 1 TESI Relax 7 1 4 Device view of TESI table Touch Screen 5 Slot for Compact Flash Card 1 Slot for Chip Card 2 t IT EE gt 1 EA 34 r switch onnector ains cable Leg rest 9 Optional connector for Loc
8. TESI Relax 9 7 Note You can handle the table at any time with the Touch Screen as well as with the remote control The activated function will appear in green colour on the display gbo Medizintechnik AG Version 2 1 10 TESI Relax 2 Startof operation 2 1 Transport and assembly To place the unit each plane surface 1s appropriate Please take care 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 not be placed in front of radiators or radiant The device is not made for outdoor operation The TESI Relax corresponds to the regulations of EN 60601 1 It is a device of protection class I Within the scope of the Medical Device Directive MPG the TESI Relax belongs to class IIb 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 c
9. ch Screen If the device is in standby mode the standby push button is shining You can put the table in standby mode by pressing the standby push button The stepped bed will lower down and all functions of the table are switched off By pressing the standby push button again the normal functions of the table will be reactivated 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 2 5 2 3 2 Optical and acoustic user guidance Optical user guidance Optical user guidance is effected on the Touch Screen The setting which is changed at the moment is displayed in green Acoustic user guidance The following table shows the acoustic signals and the relating meaning Information sound e Incaseofa failure Triad gong e At the end of the faultless automatic check when switching on the device e Attheendof the treatment time Table 3 Acoustic user guidance 3 3 Remote control The remote control is an infrared remote control with plastic foil keyboard By the remote control the patient 1s able to change the settings at anytime before and especially during the treatment The cuurrent meaning of the buttons are displayed on the Touch Screen see Figure 2 e By touching the Buttons lt gt setting function can be selected e By touching the Buttons the value of setting function ca
10. ding to the instructions on the Touch Screen Touch the Button in order to create chip cards You are in the submenu create chip cards Touch on the button for the desired card service card adjustment card personal card card with time credit see also Chapter 3 5 In case you want to create a personal card or card with time credit you will be requested to enter the desired time account You can choose between 1 2 5 and 10 hours Confirm your choice with the OK Button Eject the service or adjustment card Insert the card that you want to create in the intended slot at the Touch Screen The card will be programmed Eject the card when you see the information on the display that the programming has been successful If you want to generate further cards insert the service or adjustment card in the intended slot and repeat the above mentioned procedure Otherwise touch the Button Abort You return to the menu Eject the chip card Dependent on the access control the following request appears on the display Please insert your chip card to activate The table is ready for treament Note You can handle the table at any time with the Touch Screen as well as by the remote control The activated function will appear in green colour on the display gbo Medizintechnik AG Version 2 1 TESI Relax 15 3 Description of function 3 1 Standby push button The standby push button is placed on the right side below the Tou
11. ent 1s in progress and the correct chip card 1s inserted You can handle the table at any time with the Touch Screen as well as by the remote control The activated function will appear in green colour on the display 2 5 2 Device settings Several device settings allow the user to customize the user interface and the device s behavior The settings will be automatically restored when the device starts up Settings Setting options Basic settings upon delivery Language German German This language is not activated on English delivery Russian Espanol Italiano Francais Access control Personal cards Personal cards Cards with time credit Unlocked mode free access Standby After 10 min After 10 min After 30 min Never Table 1 Settings gbo Medizintechnik AG Version 2 1 TESI Relax 13 Insert the service card or adjustment card in the intended slot at the Touch Screen You are in the menu Act according to the instructions on the Touch Screen 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 Change the parameters to the desired setting To store confirm by touching the Button OK If you do not want to store the modifications of the settings touch the Button Abort You return to the menu 8 Pull out the chip card Dependent on the access control the following request appears on the di
12. hen 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 The carriage motor 1s blocked and was stopped Possible reason The carriage cannot be moved and was therefore stopped for safety reasons Suggestion 1 Removeall unnecessary 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 gbo Medizintechnik AG Version 2 1 2 TESI Relax Warning The spindle motor is blocked and was stopped Possible reason 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 Possible reason A communication error between the different internal subsystems occurred Suggestion Contact the service center 5 4 Other notes The remote control doesn t work Suggestion 1 Change the batteries 2 Ifthe remote control is still not working please con
13. k for service access 11 Head rest 13 support arm left 10a Figure 1 Device view gbo Medizintechnik AG Version 2 1 8 TESI Relax 1 5 Short instructions 1 Switch on the table through the main switch at the front of the head piece 13 The device carries out an automatic check of all functions The faultless automatic check ends with an acoustic sign triad gong 2 Please act upon the instructions shown on the Touch Screen The instructions depend on the accounting mode of the table You can choose between free access unlocked mode in this mode you don t need a chip card to use the table and card with time credit or personal card for details see Chapter settings In the following the instructions for the a locked mode are described 3 On the Touch Screen you find the request Please insert your chip card to activate 4 The patient inserts his chip card into the slot to unlock the table 5 The patient positions himself on the table according to the intended treatment 6 On the Touch Screen you find the request Load settings of last treatment from chip card e By touching the YES Button on the Touch Screen or the OK Button on the remote control the treatment of the stored settings will be started e By touching the NO Button on the Touch Screen the request to adjust the height of the stepped bed 3 will appear After adjusting the height press the OK Button and the treatment will be
14. learance distance of 2 3 m 1s sufficient e Do not pierce the heated cover e In case of any visible operational disturbances please contact gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG immediately 2 2 Connection and switch on The TESI Relax 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 Relax is switched on by the mains switch at the front of the head piece 13 By this arrangement an erroneous or unintended disconnection of the device during normal operations shall be avoided After switching on the TESI Relax an automatic check of all functions will be carried out gbo Medizintechnik AG Version 2 1 TESI Relax 11 Warning To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth It 1s 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 On
15. ly fuses that correspond to the specifications named in the technical data should be used Warning Risk of fire if ungualified 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 12 TESI Relax 2 5 Settings 2 5 1 The menu You can open the menu by using the adjustment card or a service card The adjustment card is included in the delivery of the table When inserting the respective card the menu will be opened It provides the following submenus e Basic settings see Chapter 2 5 3 e Device settings see Chapter 2 5 2 e Create chip cards see Chapter 2 5 4 e Service menu see Service manual 1t can only be activated by a service card The settings are device specific settings see Table 1 and Table 2 These settings should be done during installation by a medical product adviser or a service technician Once the TESI table has been switched on and is ready you can start the threapy immediately using the customized settings 4 Note You can only start the menu if no treatm
16. medical devicse and document all safety controls 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 24 TESI Relax 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 imitation leather parts use
17. n be changed e By touching the Button OK you confirm your choice If you want to change the batteries 1 Open the remote control by unscrewing the cross head screw on the backside of the remote control Open the cover plate carefully Please pay attention to the connecting cables between the cover plate and the backside of the remote control 3 Remove the holding clamp for the batteries by dismantling the screw Replace the old batteries with two new micro batteries 5 Fix the holding clamp D gbo Medizintechnik AG Version 2 1 16 TESI Relax 6 Lock the housing of the remote control on the bakcside with the cross head screw 3 4 Touch Screen TESI Relax has a high resolution colour graphic display 640 x 480 pixels In front of this display there is a touch panel This whole unit is therefore called Touch Screen Following settings are shown on the Touch Screen Pressure of the rolls Height of stepped bed cm Time of treatment min Volume of audio signal Table 4 Possible variations of the settings Current settings can be changed by using User guidance for the the remote control remote control Button used when operating MASSAGE the Touch Screen 0 Pressure 100 S e ecte d O crs Speed 15 cms l d e EG Change selected item using up and pa down keys off Vibration 35 Hz Change settings with and nae REIN 13 re Dconcesion CH vibration Area n gt S
18. of the treatment will be stored at the end of the treatment to make it possible to use them for the next treatment gbo Medizintechnik AG Version 2 1 20 TESI Relax At the end of the treatment the following request appears Question Do you want to activate with another treatment e By touching the Button YES on the Touch Screen or pressing Button OK on the remote control treatment will be started with the current settings again e By touching the Button No on the Touch Screen or pressing Button Button NO will be activated pressing the Button OK Continue with point 9 9 You will find the instruction to remove the chip card After removing the chip card TESI Relax will be deactivated 10 After the treatment the patient should remain in an upright position with his legs dangling over the side of the table for about 3 to 5 minutes and remain quiet and relaxed 4 Note e You can handle the table at any time with the Touch Screen as well as by the remote control The activated function will appear in green colour on the display e While adjusting parameters for Vibration you have the possibility to select the desired effectiveness Dicongestion 19 Hz Warming up phase 23 Hz Build up of muscles 25 Hz Muscle extension 26 Hz Pain relief 29 Hz e While adjusting parameters for Volume you have the possibility to select the function of play back Play Next track Last track Stop Continue
19. ollow the instructions on the Touch Screen 2 On the Touch Screen you find the request Please insert your chip card to activate 3 Insert the chip card into the slot The table will be unlocked 4 The patient positions himself on the table according to the intended treatment 5 a Incase of current settings stored on the Touch Screen you will find the request Load settings of the last treatment from chip card e By touching the Button YES on the Touch Screen or by pressing the Button OK on the remote control the treatment of the stored settings will be started Continue with point 6 e By touching the Button NO on the Touch Screen or by pressing the Button gt Button NO will be activated pressing the Button OK Continue with point 5 b b Alternatively If you use a new personal card or card with time credit you will find the request Please change height of stepped bed using the keys and Proceed with OK Change height of stepped bed accordingly and confirm with OK Treatment will start with basic settings 6 If the patient wants some changes in the settings he can adjust them at any time during the treatment by the remote control Optionally the settings can be changed on the Touch Screen by touching the respective buttons 7 The treatment time ends with the triad gong The massage rollers will move down and stop Vibration Stops 8 If a personal chip card is used current settings
20. ood 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 typical 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 Relax 31 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 said 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 Recommended separation distance Conducted RF 3 Vims IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m IEC
21. pine area Height Temperature Treatment time Volume PIENO CC HNOE CC int mm selected height of selected treatment time left selected volume of audio stepped bed temperature signal Figure 2 Display shown during the treatment gbo Medizintechnik AG Version 2 1 TESI Relax 17 3 5 Chip cards There are four types of chip cards 1 Service card This authorized card 1s meant for e Using the service menu Creating chip cards including service cards see Chapter 2 5 4 Changing device settings see Chapter 2 5 2 Changing basic settings see Chapter 2 5 3 2 Adjustment card This authorized card 1s meant for e Creating chip cards see Chapter 2 5 4 e Changing device settings see Chapter 2 5 2 e Changing basic settings see Chapter 2 5 3 3 Personal card With this chip card the patient can use the TESI Relax for pre paid time of treatment The treatment settings used last are stored on the card and will be applicable for the next treatment 4 Card with time credit With this chip card the patient can use the TESI Relax for pre paid time of treatment However no treatment settings can be stored on this card 3 6 Head phones The head phones included in the scope of delivery are used for audio playback Please note that there 1s also a volume control regulator at the earphones You can set the volume at the head phones to maximum and adjust it comfortably on the Touch Screen or by remote con
22. ressure will be set on 50 3 Touch the Buttons to set the treatment time 4 Touch the Buttons to set the roller pressure 5 Touch the Buttons lt gt to set the region of the back 6 Touch the Buttons to 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 massage rollers go down and stop Vibration stops 10 After the treatment the patient should remain in an upright position with his legs dangling over the side of the table for about 3 to 5 minutes and remain quiet and relaxed 11 If the table is not used any longer press the Standby 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 standby mode consequently the stepped bed will move down This setting can be modified see Chapter 2 3 2 gbo Medizintechnik AG Version 2 1 TESI Relax 19 4 3 Course of treatment In general the course of treatment 1s as follows MASSAGE User guidance and hints for remote control Patient has to follow the instructions Figure 3 Basic display of Touch Screens 1 F
23. se directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 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 said 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 5 s 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 3 4 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 5 s gt 5 dip Note U is the a c mains voltage prior to application of the test level gbo Medizintechnik AG Floors should be w
24. splay Please insert your chip card to activate The table is ready for treament V eee ee 2 5 3 Basic settings The following therapy settings can be customized and will be automatically restored when the device starts up Compression of the rolls Temperature C 15 35 Volume of audio signal 0 15 Table 2 Basic settings 1 Insertthe service card or adjustment card see Chapter 3 5 in the intended slot at the Touch Screen 2 Youarein the menu Act according to the instructions on the Touch Screen 3 Touch the Button for basic settings 4 Youarein the submenu basic settings The submenu provides the above mentioned options 5 Modify the device settings by touching the respective Button 6 Change the parameters to the desired setting 7 To store confirm by touching the Button OK If you do not want to store the modifications of the settings touch the Button Abort You return to the menu 8 Eject the chip card Dependent on the access control the following request appears on the display Please insert your chip card to activate The table is ready for treament gbo Medizintechnik AG Version 2 1 14 2 5 4 TESI Relax Creating chip cards For the creation of chip cards please act according to the instructions on the Touch Screen ar ci 10 Insert the service card or adjustment card see Chapter 3 5 in the intended slot at the Touch Screen You are in the menu Act accor
25. started with the basic settings If you use the remote control Press the button to activate NO Press OK The request to adjust the height of the stepped bed 3 will appear Adjust the height according to the instructions on the Touch Screen and press OK The treatment will be started with the basic settings 7 Note If you use newly created personal cards or cards with time credit this request does not appear You will only find the request to adjust the height of the stepped bed 3 Adjust the height according to the instructions on the Touch Screen and press OK The treatment will be started with the basic settings 7 If the patient wants to change the settings he can adjust them with the remote control Or if desired the settings can be changed on the Touch Screen by touching the respective buttons 8 The treatment time ends with the triad gong The massage rollers move down and stop Vibration stops 9 After the treatment the patient should remain in an upright position with his legs dangling over the side of the table for about 3 to 5 minutes and remain quiet and relaxed 10 If the table is not used any longer press the Standby push button If the table is not used for 10 minutes it switches automatically in standby mode this may be customized at the settings menu By pressing the Standby push button again or by touching the Touch Screen the table will be activated again gbo Medizintechnik AG Version 2 1
26. tact the service center gbo Medizintechnik AG Version 2 1 TESI Relax 23 6 Maintenance Functionality reliability and safety characteristics of the TESI Relax table 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 Simple maintenance e g lubrication of the rollers will be carried out by the user in accordance to the instructions The middle part of the patient cover can be removed by the user In case of intended use the removable middle section of the patient cover must be placed and locked with the fastener All other service works shall be carried out by service agents authorized by the manufacturer The device does not contain any parts which require maintenance work by the user 0 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 maintain a book of the
27. th touch of the Touch Screen Standby push button Switch to the right of the Touch Screen puts the device into the Standby mode In this mode Stand by display lights up 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 14 Device view of TESI table 1 5 Short instructions 2 START OF OPERATION 2 1 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 Device settings 2 5 3 Basic settings 2 5 4 Creating chip cards 3 DESCRIPTION OF FUNCTION 3 1 Standby push button 3 2 Optical and acoustic user guidance 3 3 Remote control 34 Touch Screen 3 5 Chip cards 3 6 Head phones 3 7 Compact Flash Card 4 THERAPY 4 1 Thermotherapy 4 2 Massage gbo Medizintechnik AG TESI Relax 10 10 10 11 11 11 12 12 12 13 14 15 15 15 15 16 17 17 17 18 18 18 Version 2 1 TESI Relax 4 3 9 5 1 32 5 3 5 4 6 6 1 6 2 6 3 10 11 Course of treatment BEHAVIOR IN CASE OF FAILURES Notes Warnings Errors Other notes MAINTENANCE Legal provisions and reguirements Safety controls Cleaning disinfection and care WARNINGS AND SAFETY PRECAUTIONS EXPLANATION O
28. 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 framework of the Medical Device Directive You will obtain technical support by the manufacturer dealers or service authorized by the manufacturer The product s life time anticipated by the manufacturer is 10 years The TESI Relax tables are electronic devices For their disposal the respective regulations for electronic devices have to be observed On request the manufacturer will provide 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 conformi
29. trol 3 7 Compact Flash Card The Compact Flash Card has stored about 1 hour of music In order to play this music insert the Compact Flash Card in the intended slot at the Touch Screen Activate the settings for volume control and choose from the menu playback Confirm your choice by touching the Button OK Adjust the volume according to your desire Now you can listen to the music through the head phones gbo Medizintechnik AG Version 2 1 18 TESI Relax 4 Therapy 4 1 Thermotherapy For thermotherapy the cover of the middle section of the TESI Relax table can be heated If 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 Relax table can either be increased up to a maximum heating capacity of 35 C or reduced 4 2 Massage Through casters which pass the vertebral column with adjustable pressure it 1s 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 but can be combined with them if required 1 By touching the Buttons you set e Temperature if thermotherapy is required e Raise of step 2 Touch the Button for massage The roller p
30. ty The usage of other accessories may cause an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity The unit must not be placed close to other devices or stacked If such an arrangement cannot be avoided the unit must be observed for the intentional 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 30 TESI Relax 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 said 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 The equipment is suitable for use in all establishments including CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuation flicker emissions IEC 61000 3 3 Note For devices with a power consumption between 75 W and 1000 W only domestic establishments and tho

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