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User Manual | Users Manual | 640.01 KiB | March 07 2014 | |||
1 | Cover Letter(s) | March 07 2014 | ||||||
1 | Cover Letter(s) | March 07 2014 | ||||||
1 | External Photos | March 07 2014 | ||||||
1 | Internal Photos | March 07 2014 | ||||||
1 | ID Label/Location Info | March 07 2014 | ||||||
1 | Test Setup Photos | March 07 2014 | ||||||
1 | Test Report | March 07 2014 |
1 | User Manual | Users Manual | 640.01 KiB | March 07 2014 |
FEEDBACK SENSOR INCL. TOUCH KEY
(MODEL: TT-SENS-14-01) USER MANUAL English translation of original user manual Congratulations!
FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL You've made a great choice by purchasing this feedback sensor incl. touch key. This innovative feedback sensor incl. touch key delivers maximum performance made in Germany. This user manual will help you get to know your feedback sensor incl. touch key better. It takes you safely through the functions and use of your new feedback sensor incl. touch key, and also offers plenty of tips and advice for getting the most out of it. Before using the feedback sensor incl. touch key for the first time, please read and observe chapter 2 Safety and dangers. If you have any further questions or comments, your trained specialized dealer will be happy to help. We hope you will enjoy keeping active with your feedback sensor incl. touch key. 2 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 4 1 USER GUIDANCE . 4 4 1.1 Warnings . 4 4 1.2 Advice . 4 4 1.3 Symbols in the user manual . 5 1.4 Symbols on the product . . 5 6 2 SAFETY AND DANGERS . 6 INTENDED USE . . 7 7 3 7 3.1 Training . 7 3.2 Biocompatibility . 7 7 4 FORSEEABLE MISUSE . . 8 8 4.1 Misuse . 8 8 SCOPE OF DELIVERY AND EQUIPMENT . . 8 5 8 5.1 Scope of delivery . . 8 5.2 Basic equipment . . 8 8 5.3 Removable parts . 9 9 10 OVERVIEW. 10 6 FIRST USE . 11 11 7 11 7.1 Fitting the feedback sensor to the THERA-Trainer balo . 11 7.2 Fitting the feedback sensor to the THERA-Trainer coro . 12 7.3 Fitting the feedback sensor to the BALANCE-Trainer . OPERATION . 8 13 8.1 Charging the battery . . 13 15 8.2 Switching the feedback sensor incl. touch key . 15 8.3 Establishing a connection . 16 8.4 Error state indicators . 9 TROUBLESHOOTING . 14 17 10 CLEANING AND DISINFECTION . 15 18 11 MAINTENANCE AND REPAIRS . . 19 11.1 Maintenance . . 19 11.2 Further use . 16 19 12 TECHNICAL DATA . 17 20 13 DISPOSAL . 17 20 14 NOTES ON THE ELECTROMAGNETIC COMPATIBILITY OF THE FEEDBACKSENSOR INCL. TOUCH KEY . 21 21 14.1 Electromagnetic emissions . 22 14.2 Electromagnetic immunity . 23 14.3 User Information acc. To FCC15.21 . 14.4 Statement for Class B digital device acc.to FCC 15.105 . 23 15 WARRANTY . 20 23 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 3 Note FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 1 USER GUIDANCE The user manual and product are marked with a variety of symbols. These symbols and their functions help you to use the product safely and efficiently. 1.1 Warnings Warning categories Warnings have different signal words depending on the type of danger:
Caution warns about the risk of material damage. Warning warns of physical injury. Danger warns of danger to life. Structure of warnings Type and source of danger!
Action to avoid the danger. Signal Word 1.2 Notes Information on the efficient use of the product. 1.3 Symbols in the user manual Instructions Structure of instructions:
Instruction to do something. Presentation of results if required. Lists Structure of non-numbered lists:
List level 1 List level 2 Structure of numbered lists:
1. 2. List level 1 List level 1 2.1 List level 2 2.2 List level 2 4 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 1.4 Symbols on the product User manual Follow the user manual!
Manufacturer Date of manufacture Market launch in accordance with Medical Devices Directive 93/42/EEC Serial number Disposal Do not dispose of the product in household waste. Dispose of the product in accordance with local regulations. Type BF medical device IP22 Protection against solid foreign objects with a diameter greater than 12.5 mm. Protection against dripping water when the feedback sensor incl. touch key is tilted up to 15. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 5 6 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL environments. and in proper working order. If the user has a cardiac pacemaker, consult a doctor before the first training session. 2 SAFETY AND DANGERS Observe the user manual. Only use the feedback sensor incl. touch key if it is completely undamaged Do not use the feedback sensor incl. touch key in wet, humid or hot Only have trained dealers carry out any repair work. Make sure that the feedback sensor incl. touch key does not get wet. Only use the feedback sensor with incl. touch key if the charging cable is Only use the USB charger approved by the manufacturer. Only use the USB charger for the feedback sensor with the correct supply In case of damage, malfunctions, etc., of the feedback sensor incl. touch key, contact a trained dealer immediately. voltage. Leave the feedback sensor incl. touch key at room temperature for 1 hour before using it for the first time. undamaged and in proper working order. Only ever use the charging cable supplied by the manufacturer. Disinfect the feedback sensor incl. touch key before every training session. The battery in the feedback sensor incl. touch key may only be replaced by a trained dealer. The feedback sensor incl. touch key may only be opened by a trained dealer and only modified after consultation with the manufacturer. Only ever charge the feedback sensor incl. touch key outside the immediate vicinity of the patient (1.5 metres). Faulty/damaged batteries are not suitable for transport. These must be disposed of in accordance with national regulations. The feedback sensor incl. touch key must not be returned to the manufacturer with a faulty/damaged battery. Ensure that the feedback sensor incl. touch key connected to the THERA-
Trainer software is connected to the correct THERA-trainer. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL Note 3 INTENDED USE The feedback sensor incl. touch key:
is used for wireless transmission of the inclination data to a control and display unit. The biofeedback illustrations of appropriate THERA-Trainer software are controlled on the basis of this inclination data. The feedback sensor incl. touch key is used in conjunction with the appropriate THERA-Trainer software and a control and display unit to mobilise persons with limited mobility using exercises. Observe the indications of the THERA-Trainer and THERA-Trainer software being used. Users Persons who have been instructed by expert staff on how to use the feedback sensor incl. touch key and are thus authorised to operate and exercise with the feedback sensor incl. touch key. The user is entirely responsible for the safe and correct use of the feedback sensor incl. touch key. Expert staff Persons who gained their skills and expertise by means of professional training in the medical or medical-technical sector (e.g. doctors, therapists, specialist dealers) Persons who due to their professional experience and by means of instruction/training by the manufacturer are able to assess safety-relevant regulations and recognise potential risks in their field of work (e.g. assistants). To guarantee safe use of the feedback sensor incl. touch key, train expert staff regularly. 3.1 Training Before the equipment is used for the first time:
Hold training sessions led by trained dealers, doctors or therapists
-
- using this user manual as an aid. Check with doctors or therapists whether unsupervised training is possible with the feedback sensor incl. touch key. Have the assistant trained by trained dealers, doctors or therapists. 3.2 Biocompatibility All components of the feedback sensor incl. touch key the user will touch when using the unit as intended are designed to meet the biocompatibility requirements of the applicable standards. For any questions, contact a trained dealer. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 7 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 4 FORSEEABLE MISUSE The feedback sensor incl. touch key is not used for:
Diagnosis Monitoring Measurement 4.1 Misuse Do not use the feedback sensor incl. touch key in:
explosive substances enriched oxygen combination with other products emitting ionising radiation (e.g. radiation therapy, nuclear medicine, etc.) rooms containing the presence of equipment not approved by the manufacturer. flammable anaesthetics volatile solvents 5 SCOPE OF DELIVERY AND EQUIPMENT The feedback sensor incl. touch key comes with individual options. This user manual describes all options available for the feedback sensor incl. touch key. Depending on the model, the user manual may include options not featured by the feedback sensor incl. touch key. If the feedback sensor incl. touch key features options not described in the user manual, an appendix will be included. 5.1 Scope of delivery The delivery note contains all information about the scope of delivery. 5.2 Basic equipment Basic equipment of the feedback sensor incl. touch key:
5.3 Options Available options:
The feedback sensor incl. touch key can only be used in conjunction with the appropriate THERA-Trainer software, a control and display unit, and a Bluetooth transmitter for the feedback sensor. USB charger for feedback sensor incl. touch key Feedback sensor mounting kit for THERA-Trainer balo Feedback sensor mounting kit for THERA-Trainer coro Feedback sensor mounting kit for BALANCE-Trainer Bluetooth transmitter for feedback sensor Feedback sensor incl. touch key Charging cable User manual for feedback sensor incl. touch key Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 Note 8 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 5.3 Removable parts Name Article no. Charging cable A003-891 USB charger for feedback sensor incl. touch key A003-980 Bluetooth transmitter for feedback sensor incl. touch key A004-020 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 9 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 6 OVERVIEW 1 2 3 4 8 7 6 5
(1) Socket for charging cable
(2) Connection status indicator
(3) Touch key
(4) Activation/charge status indicator
(5) Feedback sensor incl. touch key (applied part type BF)
(6) Sensor mounting (not included in the basic equipment)
(7) Sensor orientation
(8) Sensor detection (here feedback sensor incl. touch key Type A) 10 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 7 FIRST USE To use the feedback sensor incl. touch key for the first time, remove it from Check if delivery is complete. Report any damage to the supplier or carrier without delay. Before using the equipment for the first time, charge the battery for at least 6 its packaging and check for damage caused in transit. hours. 7.1 Fitting the feedback sensor to the THERA-Trainer balo Fit the feedback sensor incl. touch key to a THERA-Trainer balo (or BALANCE-
Trainer with a current table unit) using the feedback sensor mounting kit for the THERA-Trainer balo. To fit it, follow the instructions below:
Mount the sensor holder to the system bracket with two bolts using a suitable tool.
- Fit the sensor holder on the system bracket using the correct orientation
(wider side facing left). Insert two bolts through the holes and secure each one with a nut.
-
Bolt the system bracket to the swivel plate under the table unit of the THERA-Trainer balo (left-hand side) with a suitable tool using two bolts. Clip the feedback sensor incl. touch key into the sensor holder.
- Ensure that the sensor orientation arrows point forwards and upwards. 7.2 Fitting the feedback sensor to the THERA-Trainer coro Fit the feedback sensor incl. touch key to a THERA-Trainer coro using the feedback sensor mounting kit for the THERA-Trainer coro. To fit it, follow the instructions below:
Mount the sensor holder 2 to the system bracket 5 with two bolts 3, using a suitable tool.
- Fit the sensor holder on the system bracket using the correct orientation
(wider side facing left). Insert two bolts through the holes and secure each one with a nut.
-
Mount the sensor holder 5 on the height adjustment clamp 1 on the Thera-
trainer coro (right-hand side) with two bolts 4, using a suitable tool. Clip the feedback sensor incl. touch key into the sensor holder.
- Ensure that the sensor orientation arrows point forwards and upwards. 1 2 3 4 5 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 11 Note 12 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 7.3 Fitting the feedback sensor to the THERA-Trainer The feedback sensor BALANCE-Trainer mounting kit is required for all BALANCE-
Trainers with previous table units. This affects serial numbers up to:- BT 00xxxxxxx
-
-
7001-001-03-xxxxxxxx 7017-002-02-xxxxxxxx Previous table unit for BALANCE-Trainer Mount the sensor holder to the system bracket with two bolts using a suitable Fit the sensor holder on the system bracket using the correct orientation
(wider side facing left). Insert two bolts through the holes and secure each one with a nut. tool.
-
-
Bolt the system bracket under the table unit to the vertical tube of the BALANCE unit (left-hand side) with the half-shell and two bolts, using a suitable tool. Clip the feedback sensor incl. touch key into the sensor holder.
-
Ensure that the sensor orientation arrows point forwards and upwards. To fit the feedback sensor incl. touch key to a BALANCE-Trainer with a current table unit (such as the THERA-Trainer balo), follow the instructions in Chapter 7.1 Fitting the feedback sensor to the THERA-Trainer balo. The feedback sensor incl. touch key is now ready for operation. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 8 OPERATION 8.1 Charging the battery Caution V Incorrect use will result in damage!
Handle batteries with care. Do not open the batteries. Protect batteries from extreme heat or fire. Always have the battery replaced by a trained dealer. The feedback sensor incl. touch key is fitted with a maintenance-free rechargeable lithium-ion 3.6 V/680 mAh battery. Only use USB chargers recommended by the manufacturer. Standard USB charger for feedback sensor incl. touch key:
Available from the manufacturer as an option. Is not a medical-device USB charger for the feedback sensor.
-
- Do not use within 1.5 metres of the immediate vicinity of the patient. Use a commercially-available USB charger (with CE marking).
- 5 V (d.c.)/0.5 A
- USB connection
- Do not use within 1.5 metres of the immediate vicinity of the patient. The feedback sensor incl. touch key is supplied with a charging cable as standard. This can be used to charge the battery from a USB interface (computer, control and display unit, etc.) without a feedback sensor USB charger. The service life of the battery depends on its charging/discharging cycles and storage temperature. Possible energy performance of batteries:
Approx. 1,000 partial discharges The feedback sensor incl. touch key is fitted with over-discharge protection for the battery. When the battery is discharged:
When the remaining charge (based on the capacity still available) is under 30%, the activation/charge status LED will flash green-red. When the remaining charge (based on the capacity still available) is under 15%, the activation/charge status LED will flash red. If the battery is fully discharged, the activation/charge status LED will be off. USB charger Charging cable Operating period Charging requiremen ts Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 13 Operating period Note Charging process Note Note Storage Replacing the battery Disposal Warranty FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL An operating period of approx. 10 hours per charging cycle can be obtained depending on the conditions of use. The battery capacity will decline over time. The manufacture recommends having the battery replaced by a trained dealer after 2 to 3 years, depending on the number of charging cycles. Caution Faulty charging cable connection due to cable being plugged in incorrectly!
Make sure that the charging cable plug is correctly Observe position of plug. Only use a charging cable approved by the manufacturer. positioned in the charging socket when it is connected. Charging the battery:
Remove the feedback sensor incl. touch key from the sensor holder. Switch off the feedback sensor incl. touch key before charging (see Chapter 8.2). Ensure that the feedback sensor incl. touch key is switched off while charging. Plug the charging cable into the charging socket in the feedback sensor incl. OR touch key. Insert the USB plug of the charging cable into a USB interface. Insert the USB plug of the charging cable in the USB interface of the USB charger for the feedback sensor. Insert the plug of the USB charger for the feedback sensor into the socket. The USB charger for the feedback sensor available optionally from the manufacturer is not a medical-device USB charger. Charging must take place outside a 1.5-metre radius of the immediate vicinity of the patient. Charging process begins. The LED of the charge/activation status indicator shows the status of the charging process. LED flashes green:
Battery charging. LED lights green:
Battery is fully charged. During the charging phase of the battery, the feedback sensor incl. touch key is inoperable and cannot therefore be used for training. Batteries are leak-proof if handled and stored correctly. Store the battery in a cool place if not used for an extended period. Have batteries replaced exclusively by a trained dealer. To have batteries replaced, contact a trained dealer. When batteries are replaced by a trained dealer, dispose of them in accordance with national regulations. The battery warranty is subject to legal regulations:
24 months
- 6 months full warranty
- 18 months with reversal of burden of proof 14 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 8.2 Switching the feedback sensor incl. touch key on/off To switch the feedback sensor incl. touch key on:
Press the touch key until the activation/charge status indicator shows a The battery must be charged. status. The LED of the charge/activation status indicator lights up green. The feedback sensor incl. touch key is trying to establish a connection with the control and display unit. The LED of the connection status indicator flashes green while the connection with the control and display unit is being established. When the LED of the connection status indicator lights up with a steady green, a connection has been established. If a connection cannot be established, the LED of the connection status indicator flashes red. To switch the feedback incl. touch key off:
Press the touch key until the activation/charge status indicator no longer shows a status. The LED of the charge/activation status indicator will go out. When the feedback sensor incl. touch key is switched off, the LED of the activation/charge indicator flashes every few seconds to indicate the remaining charge of the battery. If the remaining charge is more than 30%:
LED flashes green. If the remaining charge is under 30%:
LED flashes green-red. If the remaining charge is under 15%:
LED flashes red. 8.3 Establishing a connection After the feedback sensor incl. touch key has been switched on, a wireless connection is established between the feedback sensor incl. touch key and the control and display unit. In order for a wireless connection to be established, a Bluetooth transmitter for the feedback sensor must be plugged in to the control and display unit. Only use the Bluetooth transmitter approved by the manufacturer (item no. A004-020). If a different Bluetooth transmitter is used, no wireless connection can be established. Switching on Switching off Remaining charge display Note The LED of the connection status indicator indicates the following statuses:
LED flashes green (slowly):
A connection is being established between the feedback sensor incl. touch key and the control and display unit. This can take several seconds. LED lights green:
A connection exists between the feedback sensor incl. touch key and the control and display unit. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 15 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL control and display unit. LED flashes red:
No connection exists between the feedback sensor incl. touch key and the Check whether the feedback sensor incl. touch key is too far away from the control and display unit.
- The wireless connection has a range of about 5 metres. Check whether the control and display unit is switched on. Check whether a Bluetooth transmitter for the feedback sensor is plugged in Check whether the correct Bluetooth transmitter for feedback sensor is Check whether the feedback sensor incl. touch key is already registered with the control and display unit.
- If no registration exists, follow the user manual for the relevant THERA-
Trainer software. plugged in (article no. A004-020). to the control and display unit. LED flashes green (quickly):
The feedback sensor incl. touch key is being registered with the control and display unit.
- See the user manual for the relevant THERA-Trainer software 8.4 Error state indicators The feedback sensor incl. touch key can display the following error states:
LED of the connection status indicator flashes red:
No connection exists between the feedback sensor incl. touch key and the control and display unit.
- see Chapter 8.3 Establishing a connection LED of the activation/charge status indicator flashes alternately green and red:
The remaining battery charge is under 30%. Charge the battery.
- see the Chapter Charging the battery LED of the activation/charge status indicator flashes red:
The remaining battery charge is under 15%. Charge the battery.
- see the Chapter Charging the battery Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 16 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 9 TROUBLESHOOTING If a system fault occurs in the feedback sensor incl. touch key, all the LEDs flash simultaneously. The error code is shown on the control and display unit. Observe the user manual for the relevant THERA-Trainer software. The software version of the feedback sensor incl. touch key is required for troubleshooting. This is shown as follows:
Press the touch key 2 until this lights up once. 1 2 3
- The software version is displayed. The activation indicator 1 lights up successively to indicate the first figure.
- e.g. 3 times The touch key lights up once.
- This means that second figure will now be shown. The activation/charge indicator 3 lights up successively to indicate the second figure.
- e.g. 5 times The touch key lights up once again.
- The software version display process has finished. The software version in this example was therefore 3.5. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 17 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 10 CLEANING AND DISINFECTION Danger Danger to life due to electric shock!
Always switch off the feedback sensor incl. touch key before cleaning and disinfecting. The charging process must always have finished and the feedback sensor incl. touch key must always be disconnected from the mains before cleaning and disinfecting. Make sure that no cleaning agent or disinfectant gets into the feedback sensor incl. touch key. If any cleaning agent or disinfectant gets into the feedback sensor incl. touch key, contact a trained dealer immediately. Risk of infection due to contaminated accessories/options!
Wear gloves for cleaning and disinfection. Warning Caution or caustic, or contain solvents. Material damage due to incorrect cleaning or disinfection!
Never use cleaning agents that are aggressive, abrasive Only use mild and environmentally friendly cleaning Only use disinfectants that conform to country-specific Observe manufacturer safety instructions for cleaning agents and disinfectants. agents and disinfectants. regulations. Clean/disinfect the feedback sensor incl. touch key as follows:
Check electronic components for damage. Switch the feedback sensor incl. touch key off. Stop the charging process and disconnect the feedback sensor incl. touch key from the mains. If any damage is found, do not clean contact a trained dealer. Make sure that the room is sufficiently ventilated during cleaning or disinfection. Clean the surface of the feedback sensor incl. touch key with a soft, damp cloth. When cleaning surfaces of the feedback sensor incl. touch key, only use Clean foils and stickers with care. Let the feedback sensor incl. touch key dry properly. Switch on the feedback sensor incl. touch key. disinfectants approved under national regulations. 18 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 11 MAINTENANCE AND REPAIRS maintenance and servicing work. Danger Danger to life due to electric shock!
Switch off the feedback sensor incl. touch key before all Stop the charging process before all maintenance and servicing work and disconnect the USB plug from the USB interface. Only allow trained dealers to carry out this work. 11.1 Maintenance The feedback sensor incl. touch key does not require maintenance. The manufacture recommends having the battery in the feedback sensor replaced by a trained dealer after 2 to 3 years, depending on the number of charging cycles. 11.2 Reuse The feedback sensor incl. touch key is suitable for reuse by a different customer. Before the feedback sensor incl. touch key is reused:
Clean and disinfect thoroughly (see Chapter 10 Cleaning and disinfection). Perform a visual functional check/perform a functional check. Check if all accessories and options are complete (see delivery note). Note Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 19 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 12 TECHNICAL DATA Feedback sensor incl. touch key Dimensions:
Weight:
Protection category:
Mains connection of USB charger for feedback sensor USB charger voltage for feedback sensor USB charger current for feedback sensor incl. touch key Lithium-ion battery Nominal battery energy Ambient conditions for use Ambient conditions for transport/delivery L x W x H 7.5 cm x 5.5 cm x 2.5 cm 80 g IP22
(only if the feedback sensor incl. touch key is attached to the sensor holder) 100-240 V~, 50/60 Hz 5 V 0.5 A 3.6 V/680 mAh 2.65 Wh 5 C to 40 C 15% to 93% Rh 700 to 1,060 hPa
-25 C to 70 C 15% to 93% Rh 700 to 1,060 hPa Materials used:
Plastic (POM, PA6, ABS, PE), rubber, rechargeable lithium-
Operational life:
Feedback sensor incl. touch key ion battery 7 years
(not including the battery) 13 DISPOSAL To dispose of the feedback sensor incl. touch key:
Observe country-specific regulations and specifications. Dispose of metal parts as scrap metal. Dispose of plastic parts as prescribed, depending on the type of material. Dispose of electric and electronic components as electronic scrap. Dispose of lithium-ion batteries in accordance with national rules and regulations.
- Do not dispose of lithium ion batteries unless the positive and negative terminals have been taped up. 20 Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 14 NOTES ON ELECTROMAGNETIC COMPATIBILITY OF THE FEEDBACK SENSOR INCL. TOUCH KEY 14.1 Electromagnetic emissions Connection Housing Electromagnetic emissions/frequency range (MHz) Radiation 30..230 Radiation 230..1000 Wired interference 0.15 0.5 AC mains power supply*
Wired interference 0.5
.. 5 Wired interference 5 .. 30 Distortion due to harmonics Voltage fluctuations and flicker Limit 30 dB(uV/m) quasi-peak value at 10 m distance 37 dB(uV/m) quasi-peak value at 10 m distance 66 dB(uV) to 56 dB(uV) quasi-peak value 56 dB(uV) to 46 dB(uV) mean value The limit values decrease linearly with the logarithm of the frequency. 56 dB(uV) quasi-peak value 46 dB(uV) mean value 60 dB(uV) quasi-peak value 50 dB(uV) mean value Not tested. As defined in EN 61000-3-3. Underlying standard CISPR 11 CISPR 11 EN 61000-
3-2 EN 61000-
3-2
* Observance of the limit values and requirements depends largely on the characteristics of the external power supply. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 21 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 14.2 Electromagnetic immunity Connection Test Housing Electrostatic discharge ESD Emitted electromagnetic fields Mains-frequency magnetic field Voltage drop/short-term voltage drop AC mains power supply*
Underlying standard EN 61000-4-2 Technical standard EN 60601-1-2 EN 61000-4-3 EN 61000-4-8 EN 61000-4-11 Fast transients Surge voltage EN 61000-4-4 EN 61000-4-5 Test specification/inte nsity Contact 6 kV Intensity 3 air 8 kV intensity 3 3 V/m 10 V/m (device may go out, no critical status may occur) 3 A/m 0.5 period test voltage level <5%
Ut 5 periods test voltage level 40%
Ut 25 periods test voltage level 70%
Ut Voltage interruption <5%
duration 5 s 2 kV Conductor to earth 0.8, 1 kV and 2 kV Conductor to conductor 0.5 and 1 kV 3V intensity 2 Assessment criterion A A A A C A A A A A A A A A Wired HF signals Fast transients Surge voltage Wired HF signals Fast transients Wired HF signals DC supply connection Input/output, signal/control lines (call nurse, PC interface) EN 61000-4-6 EN 61000-4-4 EN 61000-4-5 EN 61000-4-6 2 kV No requirements 3V intensity 2 EN 61000-4-4 EN 61000-4-6 1 kV on lines longer than 3 m 3V 22
* Observance of the limit values and requirements depends largely on the characteristics of the external power supply. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 FEEDBACK SENSOR INCL. TOUCH KEY USER MANUAL 14.3 User Information acc. To FCC15.21 Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 14.4 Statement for Class B digital device acc.to FCC 15.105 Note This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-
-
-
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio / TV technician for help.
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15 WARRANTY In accordance with legal regulations, the manufacturer grants a manufacturer's warranty for the feedback sensor incl. touch key if it is handled with due care. This is based on the delivery date. The manufacturer grants a manufacturer's warranty of 6 months (as of the date of delivery) for the battery if it is handled with due care. Within this period of time, the manufacturer will replace free of charge any faulty parts of the feedback sensor incl. touch key or repair free of charge the feedback sensor incl. touch key in the factory or an authorised workshop. The following are excluded from the manufacturer's guarantee:
Wear parts Opened devices Devices repaired by persons other than trained dealers. Third-party installations and attachments Any damage due to incorrect use. Art. No. A003-928_Rev 01 Last revision: Calendar week 23/2014 23 MANUFACTURER:
THERA-Trainer A trademark of medica Medizintechnik GmbH Blumenweg 8 88454 Hochdorf Germany Tel:
Fax:
+49 7355-93 14-0
+49 7355-93 14-15 Email:
info@thera-trainer.de Internet: www.thera-trainer.de Article no. A003-928_Rev 01 Last revision: Calendar week 23/2014 See www.thera-trainer.de for declarations of conformity
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2014-07-03 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2014-07-03
|
||||
1 | Applicant's complete, legal business name |
medica Medizintechnik GmbH
|
||||
1 | FCC Registration Number (FRN) |
0023358799
|
||||
1 | Physical Address |
Blumenweg 8
|
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1 |
Hochdorf, N/A 88454
|
|||||
1 |
Germany
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
h******@acbcert.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ABUS
|
||||
1 | Equipment Product Code |
TTSENS1401
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D**** N********
|
||||
1 | Title |
Head of Customer Service and Quality Management
|
||||
1 | Telephone Number |
+49 7********
|
||||
1 | Fax Number |
+49 7********
|
||||
1 |
d******@thera-trainer.de
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
CSA Group Bayern GmbH
|
||||
1 | Physical Address |
Germany
|
||||
1 |
T******@csagroup.org
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Balance Trainer | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power Output listed is e.i.r.p. This device is certified for mobile and portable applications. Co-location with other transmitters may be done in accordance with FCC multi-transmitter product procedures. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
CSA Group Bayern GmbH
|
||||
1 | Name |
F****** S******
|
||||
1 | Telephone Number |
49-94********
|
||||
1 | Fax Number |
49-94********
|
||||
1 |
f******@csagroup.org
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0002000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC