Proxomed tergumed 710 User Manual
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Proxomed tergumed 710 User Manual

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Summary of Contents for Proxomed tergumed 710

  • Page 1 ® tergumed User Manual 0123 tergumed ®...
  • Page 2 In this user manual you will find information on the following products: tergumed® 710 Extension tergumed® 710 Flexion tergumed® 710 Rotation tergumed® 710 Lateral Flexion...
  • Page 3 tergumed® 710 Cervical Trainer...

  • Page 4: Foreword

    Dear Customer, We would like to thank you for your confidence that you have chosen products of proxomed Medizintechnik GmbH with your purchase and that you share and support our vision of a healthy society. We are pleased that our devices are in therapeutic use with you and support many patients in their rehabilitation.

  • Page 5: Table Of Contents

    Table of contents Foreword ............................ 4 Legend ............................7 General symbolism................................7 Safety instructions .................................8 Safety instructions ........................9 Marking on the device ..............................9 Applied symbols for transport..........................10 Liability notice ................................11 Intended use ................................. 11 Indications and contraindications ........................12 Patient target group ..............................
  • Page 6 Settings ................................. 29 tergumed® 710 Lateral Flexion ..........................32 Intended use ............................... 32 Indications ................................32 Settings ................................. 32 tergumed® 710 Cervical Trainer .......................... 35 Intended use ............................... 35 Settings ................................. 35 General training settings ............................39 Maintenance, cleaning, servicing, disposal ................40 Accessories ..........................

  • Page 7: Legend

    Legend These operating instructions are part of the product and must be kept safe and accessible throughout the entire service life. In the event of a change of ownership, the operating instructions must be handed over to the new owner. If supplements to these operating instructions are supplied, they must be added to the document.

  • Page 8: Safety Instructions

    Setting levels Indicates the number of steps and the distances in the • respective setting range. The setting ranges are approximate values which may show minimal deviations depending on the setting element. Safety instructions The safety instructions presented in the operating instructions are categorized as follows: Safety note Meaning WARNING...

  • Page 9: Safety Instructions

    Safety instructions Marking on the device Figure Description Reference Observe operating instructions EN ISO 15223-1 Manufacturer, name, address, year EN ISO 15223-1 manufacture CE Mark EU 2017/ 745 Serial number EN ISO 15223-1 Unique Device Identification EU 2017/ 745 Medical Device Multi-year inspection sticker EN 62353 Next test date...

  • Page 10: Applied Symbols For Transport

    Follow instructions ISO 15223-1 Is additionally attached to devices with electr. components Applied symbols for transport Figure Description Reference TOP - top here DO NOT stack Protect from moisture Temperature range ISO 15223-1 Humidity ISO 15223-1...

  • Page 11: Liability Notice

    Liability notice The device has been built according to the current state of the art and recognized safety regulations. Nevertheless, inadmissible misuse may result in hazards to persons and the device. No design or development changes may be made to the device. The installation of additional components or the removal of components is not permitted The device may only be used if it is in perfect technical condition and in the intended use described.

  • Page 12: Indications And Contraindications

    Indications and contraindications The devices are indicated and may be used for the conditions listed below: Spinal syndromes with significant symptomatology • Proven ligamentous prolapse (including postoperative) and significant protrusion outside the • acute stage Proven degenerative changes • Proven spondylolyses and spondylolistheses •...

  • Page 13: Safety Regulations

    Defective parts of the device must be replaced immediately - in this case, it is advisable to stop using the device until repairs have been made. Use only original accessories, otherwise no liability will be accepted. The device may only be opened by proxomed service or authorized personnel. Do not reach with your hands between the moving bearings/rollers.

  • Page 14: Combination With Other Products

    These symptoms should subside spontaneously after a few days. 3.12 Incident reporting Please report any clinical events that occurred in and immediately after the use of the device directly to the manufacturer at the address: vigilance@proxomed.com.

  • Page 15: Storage, Transport And Installation

    The devices are usually delivered completely assembled. In rare cases, it may be necessary to ship the units partially disassembled for transport reasons. In these cases, please contact the service service@proxomed.com ● Only in dry rooms free from seawater air (>65% humidity).
  • Page 16 In general, make sure that the distance of at least 60 cm (starting from Movement ● the movement dimension) to other devices is maintained during dimension installation. However, the safety clearances may overlap. Area until next device Active Training area Area until...

  • Page 17: Commissioning

    Commissioning Before each start-up, check that the training device is in perfect technical condition.  Locking bolt on function, the locking button must engage automatically.  Protective cladding - present or damaged.  Screw connections - check for tight connection. ...

  • Page 18: Training Tips

    Training tips The device must be adjusted to the ergonomic conditions of the user before the first training. The adjustment of the training device for the user is the responsibility of the qualified personnel. CAUTION Improper or excessive training can lead to health problems To prevent injuries and make training more effective, a general and special warm-up program •...
  • Page 19 Different training methods are used. If training is done according to the repetition method, • several series of exercises are performed with appropriate breaks. The load intensity is based on the load capacity of the individual indications, the rehabilitation • phase and the treatment goal.

  • Page 20: Device Descriptions

    Device descriptions tergumed® 710 Extension Weight tower E - Cushion B - Backrest F - Start angle D - Knee pads Knee support A - Seat height C - Footrest Intended use tergumed ® 710 Extension is intended for muscular stabilization of the trunk erecting (back extensor) muscles.
  • Page 21 Seat inclination 76° - 104° stepless (7 positions) – Height lumbar cushion 14,5 cm stepless - Footrest 85° - 145° stepless...
  • Page 22 - Height knee pads 15 cm stepless (7 positions) Knee support stepless - Length lever arm 24 cm stepless...
  • Page 23 - Start position 10° - 170°...

  • Page 24: Tergumed® 710 Flexion

    tergumed® 710 Flexion Weight tower E - Chest pad arm F - Start angle D - Knee pads B - Backrest Knee support A - Seat height C- Footrest Intended use tergumed 710 Flexion is intended for muscular stabilization of trunk flexing (back flexion) muscles. ®...
  • Page 25 Seat inclination 76° - 104° stepless (7 positions) - Height lumbar cushion 14,5 cm stepless - Footrest 85° - 145° stepless...
  • Page 26 - Height knee pad 15 cm stepless (7 positions) Knee support stepless - Length lever arm 22 cm stepless...
  • Page 27 Chest pad 20 cm stepless - Start position 0° - 180° stepless...

  • Page 28: Tergumed ® 710 Rotation

    tergumed ® 710 Rotation Cushion arm Weight tower Seat cushion Knee braces A - Seat C- Knee pads D - Start angle B - Footrest Intended use tergumed 710 Rotation is designed for muscular stabilization of trunk rotators. ® Indications Sarcopenia of the trunk muscles •...

  • Page 29: Settings

    Settings - Seat height 49 cm - 61 cm stepless Seat width 32 - 51 cm stepless - Footrest 85° - 145° stepless...
  • Page 30 - Height knee pad 15 cm stepless (7 positions) Knee support 75° - 110° stepless - Start position 55° - 125° 6 à 10 °...
  • Page 31 Cushion arm inclination 50° stepless...

  • Page 32: Tergumed® 710 Lateral Flexion

    tergumed® 710 Lateral Flexion Weight tower D - Start angle B/C - Armpit Pads A - Seat Femoral fixation Intended use tergumed ® 710 Lateral Flexion is designed for muscular stabilization of the lateral trunk. Indications Sarcopenia • Osteoporosis • Nonspecific pain in the lower spine •...
  • Page 33 - Height cushion arm 0 - 10° stepless - Width cushion arm 16 cm stepless - Start position 60° - 120° 5 à 10°...
  • Page 34 - Femoral fixation...

  • Page 35: Tergumed® 710 Cervical Trainer

    tergumed® 710 Cervical Trainer D - Cushion arm height D - Head cushion D - Hip pad right D - Hip pad left A - Seat height Weight tower Seat angle Seat width D – Cushion arm inclination Intended use tergumed ®...
  • Page 36 Seat angle 0 - 350° 4 á 90° Seat width 45 cm - 55 cm stepless - Height torso pad stepless...
  • Page 37 - Width hip pad right 15 cm stepless - Width hip pad left 15 cm stepless - Length lever arm stepless...
  • Page 38 - Start position stepless Head cushion stepless...

  • Page 39: General Training Settings

    General training settings Weight settings 5kg Main weights max. 80 kg max. 20 weights à 5 kg Additional weights 4 kg 4 weights à 1 kg Isometry...

  • Page 40: Maintenance, Cleaning, Servicing, Disposal

    Maintenance, cleaning, servicing, disposal CAUTION The devices are subject to an annual safety and functional test (maintenance) in accordance with §7 of the Medical Devices Operator Ordinance "Maintenance of Medical Devices". With the optional "smart assist ISO" accessory, a metrological test (MTP) is performed at 2-year intervals in accordance with the manufacturer's specifications.
  • Page 41 The authorized service will help you quickly and competently. You will find the "Repair order/ malfunction report" form in the enclosed medical device booklet. Create an error message and send it by mail (service@proxomed.com) or use our servicehelper form (see Chap. Fehler! Verweisquelle konnte nicht gefunden werden. Fehler! Verweisquelle konnte nicht gefunden werden.).

  • Page 42: Accessories

    Accessories Clip for Crutches/Rack for Drinking Bottle Item no. 10611000 The holder can be used as a holder for crutches or drinking bottle holder, depending on use. Attach magnetic holder to load-bearing metal cladding. Extension Flexion Rotation Lateral Flexion Available for: Cervical Trainer Additional Platform Item no.
  • Page 43 Rotation Lateral Flexion Available for: Cervical Trainer Pneumatic Seat Inclination for T710 Ext./Flex. Item no. 10353000, 10331100 Adjustment of seat inclination at tergumed 710 Extension and Flexion in a range of plus/minus 8 degrees. Extension Flexion Rotation Lateral Flexion Available for:...

  • Page 44: Technical Data

    10 Technical data Movement Isometric Device Patient Training Adjustable size dimension weight weight weight load Depth x width x Depth x width x maximum maximum maximum maximum height in cm height in cm tergumed ® 710 Extension 370 kg 180 kg 84 kg 2.000 N 113 x 134 x 163...
  • Page 45 Ambient conditions operation Temperature +5° to +45° Celsius Humidity <65% Transport and storage Temperature -20° to +45° Celsius Humidity <65% Requirements Medical Device Directive 93/ 42/ EEC Product life 7 years as medical device Stationary training equipment EN ISO 20957-1, ISO 20957-2 Use class according to ISO 20957-1 Risk classification 93/ 42/ EEC...

  • Page 46: Warranty

    It is the customer's responsibility to ensure the functionality of the device by replacing the wear parts at an early stage if the intervals for safety checks specified by proxomed are not adhered to or if no maintenance contract has been concluded with proxomed.
  • Page 47 All illustrations in these instructions for use are only approximate for typographical reasons; we accept no liability for typographical errors. Errors excepted. Operating Instructions tergumed 710, Version 03, 2022-06-03...

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