Proxomed tergumed 710 Скачать руководство пользователя страница 14 | Manualshive

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3.10

Combination with other products

tergumed

®

710 devices are equipped with smart assist, in which intelligent control can be performed

using medical software. The smart assist was developed and tested in accordance with DIN EN 60601-1.
The currently valid version of the smart assist operating instructions (px tergu) must be consulted when
using the smart assist.

tergumed devices can be combined with medical technology products from the manufacturer Velamed/
Noraxon to perform EMG-based bio-feedback training with electromyographic measurements. The
combination of the products has been tested with regard to its effect and safe use.

3.11

Side effects and residual risks

The devices are developed in such a way that no critical side effects can occur. Occasional side effects,
such as muscle soreness and joint pain, may occur, usually after incorrect ergonomic adjustment or after
too intensive training. 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: [email protected].

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Содержание tergumed 710

Страница 1: ...0123 tergumed 710 tergumed 710 User Manual ...

Страница 2: ...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 ...

Страница 3: ...3 tergumed 710 Cervical Trainer ...

Страница 4: ...ccess is based on a holistic understanding of the needs of our customers and their clients Maximum therapeutic success and personal quality of life improvement for all people are our incentive in the changing healthcare system of the future For the health of your patients and the long lasting use of our products please read carefully this manual with all important information for a safe and correc...

Страница 5: ...t target group 12 3 7 Clinical benefit 12 3 8 Responsible operation 12 3 9 Safety regulations 13 3 10 Combination with other products 14 3 11 Side effects and residual risks 14 3 12 Incident reporting 14 4 Storage transport and installation 15 5 Commissioning 17 6 Training tips 18 7 Device descriptions 20 7 1 tergumed 710 Extension 20 Intended use 20 Settings 20 7 2 tergumed 710 Flexion 24 Intende...

Страница 6: ...ion 32 Intended use 32 Indications 32 Settings 32 7 5 tergumed 710 Cervical Trainer 35 Intended use 35 Settings 35 7 6 General training settings 39 8 Maintenance cleaning servicing disposal 40 9 Accessories 42 10 Technical data 44 11 Warranty 46 ...

Страница 7: ... which the respective setting can be made The setting ranges are approximate values which may show minimal deviations depending on the setting element Rotational adjustment range Top view If the adjustment is made in the horizontal direction the 90 of the coordinate system always points in the direction of the backrest of the training device Rotational adjustment range Front View If the setting is...

Страница 8: ...ions presented in the operating instructions are categorized as follows Safety note Meaning WARNING WARNING Indicates a potentially dangerous situation If the situation is not avoided death or serious injury may result CAUTION CAUTION Indicates a potentially dangerous situation If the situation is not avoided an injury may result ATTENTION ATTENTION Indicates a potentially harmful situation If the...

Страница 9: ...re EN ISO 15223 1 123 CE Mark EU 2017 745 Serial number EN ISO 15223 1 Unique Device Identification EU 2017 745 Medical Device Multi year inspection sticker Next test date marked by perforation EN 62353 Nameplate Identification of the manufacturer address year of manufacture device designation serial number UDI number as well as device specific information EU 2017 745 ...

Страница 10: ...dditionally attached to devices with electr components ISO 15223 1 3 2 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 ...

Страница 11: ...the patient s will be briefed by qualified personnel Training with patients may only be performed under therapeutic supervision The device may only be used by adults 14 years and older unsupervised children must be kept away from the device The application is done in a sitting position The application is made only with intact skin If you feel unwell or have sudden symptoms please stop training imm...

Страница 12: ... unstable anchorage Severe neurological diseases with a tendency to muscle spasms Abdominal wall or inguinal hernia Pregnancy from the 2nd trimester Heart failure and coronary heart disease Patients with high blood pressure may use the device only after consultation with the treating physician 3 6 Patient target group The devices are intended for professional use in health care facilities such as ...

Страница 13: ...rtment It must be ensured especially when changing the position of the unit without disassembly that it stands securely on level ground The protective cladding must not be removed The device may only be operated with the protective cladding mounted The warranty becomes void if modifications are made to the device or electronic devices for control and measurement are attached that have not been car...

Страница 14: ...rform EMG based bio feedback training with electromyographic measurements The combination of the products has been tested with regard to its effect and safe use 3 11 Side effects and residual risks The devices are developed in such a way that no critical side effects can occur Occasional side effects such as muscle soreness and joint pain may occur usually after incorrect ergonomic adjustment or a...

Страница 15: ...d the maximum permissible body weight of the user of 200 kg Small unevenness of the floor can be compensated for by means of the adjustable feet that can be attached to the unit Or a level surface must be created by using suitable shim material made of shims or heavy duty plastic The levelling materials should not be susceptible to rust When changing the position without disassembling the training...

Страница 16: ...l make sure that the distance of at least 60 cm starting from the movement dimension to other devices is maintained during installation However the safety clearances may overlap Area until Area until next device Active Training area ...

Страница 17: ... connection Welded joints visual inspection Movement limitation if available as an option Accessories available functional Check for safe stand Make sure that aids accessories cables etc are not within the range of motion ATTENTION Before initial start up the devices should stand at room temperature for at least 24 hours CAUTION Before starting training check the detent pins for tightness Do not p...

Страница 18: ...d shear forces Perform the movement slowly and in a controlled manner The intensity of the load should be selected to be light at the beginning of the training Increase the load gradually to avoid overloading and discomfort The equipment allows for double leg or single leg or double arm or single arm training If mobility is restricted or pain occurs immediately reduce the load and or the extent of...

Страница 19: ...ng with low training intensity before the training of special strength skills such as strength endurance or maximum strength begins with increasing intensity In order to be able to reproduce the training positions made by a therapist trainer during a later possibly independent training all adjustment devices are provided with scales and numbered alphabetically A B C With all devices there is the p...

Страница 20: ...ended use tergumed 710 Extension is intended for muscular stabilization of the trunk erecting back extensor muscles Settings A Seat height 49 cm 61 cm stepless F Start angle E Cushion D Knee pads B Backrest A Seat height C Footrest Knee support Weight tower ...

Страница 21: ...21 Seat inclination 76 104 stepless 7 positions B Height lumbar cushion 14 5 cm stepless C Footrest 85 145 stepless ...

Страница 22: ...22 D Height knee pads 15 cm stepless 7 positions Knee support stepless E Length lever arm 24 cm stepless ...

Страница 23: ...23 F Start position 10 170 ...

Страница 24: ...ergumed 710 Flexion is intended for muscular stabilization of trunk flexing back flexion muscles Settings A Seat height 49 cm 61 cm stepless Weight tower A Seat height B Backrest C Footrest D Knee pads E Chest pad arm F Start angle Knee support ...

Страница 25: ...25 Seat inclination 76 104 stepless 7 positions B Height lumbar cushion 14 5 cm stepless C Footrest 85 145 stepless ...

Страница 26: ...26 D Height knee pad 15 cm stepless 7 positions Knee support stepless E Length lever arm 22 cm stepless ...

Страница 27: ...27 Chest pad 20 cm stepless F Start position 0 180 stepless ...

Страница 28: ...nded use tergumed 710 Rotation is designed for muscular stabilization of trunk rotators Indications Sarcopenia of the trunk muscles Scoliosis A Seat Knee braces Seat cushion D Start angle Cushion arm B Footrest Weight tower C Knee pads ...

Страница 29: ...29 Settings A Seat height 49 cm 61 cm stepless Seat width 32 51 cm stepless B Footrest 85 145 stepless ...

Страница 30: ...30 C Height knee pad 15 cm stepless 7 positions Knee support 75 110 stepless D Start position 55 125 6 à 10 ...

Страница 31: ...31 Cushion arm inclination 50 stepless ...

Страница 32: ...d 710 Lateral Flexion is designed for muscular stabilization of the lateral trunk Indications Sarcopenia Osteoporosis Nonspecific pain in the lower spine Settings A Seat height 13 cm stepless B C Armpit Pads A Seat Femoral fixation D Start angle Weight tower ...

Страница 33: ...33 B Height cushion arm 0 10 stepless C Width cushion arm 16 cm stepless D Start position 60 120 5 à 10 ...

Страница 34: ...34 E Femoral fixation ...

Страница 35: ...scular stabilization of the cervical extensor flexor or lateral flexor muscles depending on the exercise performed Settings A Seat height 53 cm 66 cm stepless A Seat height D Hip pad right D Hip pad left D Head cushion D Cushion arm height D Cushion arm inclination Seat width Weight tower Seat angle ...

Страница 36: ...36 Seat angle 0 350 4 á 90 Seat width 45 cm 55 cm stepless B Height torso pad stepless ...

Страница 37: ...37 C Width hip pad right 15 cm stepless D Width hip pad left 15 cm stepless E Length lever arm stepless ...

Страница 38: ...38 F Start position stepless Head cushion stepless ...

Страница 39: ...39 7 6 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 ...

Страница 40: ...tervals are observed Component Maintenance interval Testing and maintenance Display daily Only use agents suitable for the display for cleaning and disinfecting Do not apply the agent directly but use a clean microfiber cloth Cushion after training Only use the disinfectants approved by the manufacturer for disinfecting the pads A list of possible disinfectants can be found at https www servicehel...

Страница 41: ...den We will be glad to help you ATTENTION Penetration of liquids into the housing Damage to the training equipment No liquids may get inside the training device during cleaning If tergumed 710 devices are operated with the smart assist accessory the electronic components contained in the smart assist must be disposed of by the operator via a disposal company when the device is decommissioned in ac...

Страница 42: ...n Lateral Flexion Cervical Trainer Additional Platform Item no 10331200 Extension of the floor surface for a wide stance in the training position Available for Extension Flexion Rotation Lateral Flexion Cervical Trainer Electrical Seat Height Adjustment Item no 10351400 Adjustment of the seat height by means of an electric motor already included in the basic unit of the Cervical Trainer Available ...

Страница 43: ... with the smart assist Available for Extension Flexion Rotation Lateral Flexion 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 Available for Extension Flexion Rotation Lateral Flexion Cervical Trainer ...

Страница 44: ...ed 710 Extension 370 kg 180 kg 84 kg 2 000 N 113 x 134 x 163 113 x 168 x 163 tergumed 710 Flexion 370 kg 180 kg 84 kg 1 500 N 113 x 134 x 163 113 x 168 x 163 tergumed 710 Lateral Flexion 370 kg 180 kg 84 kg 3 000 N 126 x 92 x 163 126 x 115 x 163 tergumed 710 Rotation 400 kg 180 kg 84 kg 2 000 N 128 x 148 x 163 130 x 148 x 171 tergumed 710 Cervical Trainer 320 180 kg 18 kg 1 500 N 142 x 83 x 196 14...

Страница 45: ...ort 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 S I Risk classification 93 42 EEC Class I m ...

Страница 46: ...ce but reserves the right to determine the type of service The following procedures are conceivable a Service is performed on site by our service personnel b We will send the requested spare part c We will send a replacement unit The defective parts will be returned to us by the customer within 48 hours Otherwise the calculation of the delivered spare parts will be made If the causes lie outside t...

Страница 47: ...nfo proxomed ch www proxomed ch proxomed is a company certified by TÜV SÜD Product Service GmbH Changes proxomed reserves the right to change products if in our opinion these measures lead to an improvement in quality and function All illustrations in these instructions for use are only approximate for typographical reasons we accept no liability for typographical errors Errors excepted Operating ...

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