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Introduction 
 

1.1 Overview

 

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Description, natural 
course and after-
effects of diseases 

High-frequency therapy is used in musculoskeletal disorders (MSD). These are 
injuries to or pain in the human musculoskeletal system, including the joints, 
ligaments, muscles, nerves, tendons, and structures that support the extremities, 
neck, and back. MSD can develop due to sudden exertion (e.g. lifting a heavy object), 
or by repeating the same movements, including repeated stress. They can also 
develop due to vibrations, the repeated application of force, or improper posture. 
Injuries to or pain in the musculoskeletal system caused by acute traumatic events, 
such as a car accident or a fall, are not considered musculoskeletal diseases, 
however. MSD can affect many different parts of the body, including the upper and 
lower back, the neck, and the shoulders and extremities (arms, legs, feet and hands). 
Examples of MSD are carpal tunnel syndrome, epicondylitis, tendinitis, back pain, 
tension neck syndrome, and hand-arm vibration syndrome. 

 

 

Clinical form, stages, 
and degrees of severity 

Workers remain in the same position over long workdays and often for several years; 
even natural body postures such as standing can lead to MSD such as back pain. 
Rather unnatural postures in particular, such as twisting or strain in the upper body, 
contribute to the development of MSD through their unnatural biomechanical stress. 
There are indications that poor posture contributes above all to MSD of the neck, 
shoulder, and back. Repeated movement is another risk factor for occupational MSD: 
when workers have to make the same movements repeatedly over a long period of 
time, this can wear out joints and muscles involved (for example, typing can lead to 
carpal tunnel syndrome). Even repeated movements at a fast pace of work with little 
recovery time increase the risk of MSD, and workers with no or little control over the 
timing of the movements (such as on assembly lines) are more prone to MSD. Regular 
movements with a high degree of exertion also increase the risk of MSD since the 
muscles tire faster which can lead to injuries and/or pain. In addition, the effects of 
vibrations (such as in the case of truck drivers or construction work) and extremely hot 
or cold temperatures can promote the development of MSD. The vibration exposure is 
also associated with hand-arm vibration syndrome which presents symptoms due to a 
lack of blood circulation of the fingers, such as nerve compression, tingling, or 
numbness. 
 
 

Incidence in the 
general population 

General information 

Musculoskeletal diseases are a growing health problem worldwide and are the second 
most common cause of disability. In the USA, for example, more than 16 million cases 
of strains and sprains were treated in 2004 and the total costs for the treatment of 
MSD are estimated to be more than 125 billion dollars per year. In 2006, approx. 
14.3% of the Canadian population lived with a disability, nearly half of whom suffered 
from MSD. Neck pain is among the most common complaints. Every year, about one 
fifth of adults worldwide report pain in this area. 
 

Workplace 

Most MSD episodes at the workplace concern several parts of the body. MSD are the 
most common complaints of workers in Europe, the USA, and in the Asia-Pacific 
region, and the third most common reason for disability and early retirement in the 
USA. In 2014, the incidence rate of MSD among the working population was 31.9 
newly diagnosed MSD per 10,000 full-time staff. In the same year, the average 
number of sick days due to MSD was 13; in addition, there were 10.4 MSD cases per 
10,000 full-time staff in whom an MSD led to 31 or more days of absence. The MSDs 
are just as widespread in professions with high biomechanical stress such as 
construction and factory work as in occupations with little stress, such as office work. 
The transport and storage industries, with an incidence rate of 89.9 cases per 10,000 

Содержание re

Страница 1: ...Instructions for Use reIModel EN...

Страница 2: ...tal requirements 1 5 4 Display safety and reference symbols 1 3 4 4 5 2 Safety warnings 2 1 Electrical hazards hazards due to radiofrequencies 2 2 Hazards during assembly 2 3 Risk of fire 2 4 Hazards...

Страница 3: ...off 4 2 Operation 4 2 1 About operation 4 2 2 Instructions for use 4 2 3 System start up 4 2 4 Screen 4 2 5 Main device 4 2 6 Handpiece 4 3 Error messages 4 3 1 Handpiece error 4 3 2 Tip error 4 3 3 P...

Страница 4: ...the person appointed to operate the device a replacement is to be requested from the manufacturer for the safe use of the reModel device and made available to the user This also includes the informat...

Страница 5: ...s with no or little control over the timing of the movements such as on assembly lines are more prone to MSD Regular movements with a high degree of exertion also increase the risk of MSD since the mu...

Страница 6: ...er 10 000 full time staff For example a national survey of US nurses revealed that 38 suffered an MSD in the previous year primarily injuries to the lower back In workers the neck and back are affecte...

Страница 7: ...s in the high frequency low level laser and vacuum modes must be adjusted via the LCD display of the device This device consists of the main body handpiece 1 handpiece 2 handpiece 3 and power cable Sp...

Страница 8: ...quency therapy with the reModel device is indicated in a variety of indications for example in painful diseases of the musculoskeletal system or in chronic inflammation Source pschyrembel de keyword h...

Страница 9: ...xDxH mm 414 523 1230 mm Weight Approx 60 kg HF outlet Watt Handpiece Load Level 10 50 200 500 1000 Roll 5 101 1 50 2 30 0 14 2 6 1 10 166 5 82 9 49 5 23 3 9 9 Multipolar large 5 16 4 21 3 18 9 9 9 5 5...

Страница 10: ...82 9 10 42 1 35 4 Handpiece Level Veff Watt Handpiece Level Veff Watt Multipolar medium 1 19 3 7 4 Multipolar small 1 15 3 4 7 2 21 7 9 4 2 16 5 5 4 3 24 11 5 3 17 6 6 2 4 25 9 13 4 4 18 9 7 1 5 27 9...

Страница 11: ...ifications and requirements 1 Page 7 Handpiece Level Veff Watt Handpiece Level Veff Watt Thermal Section 3 1 15 6 4 9 2 17 5 8 3 18 4 6 8 4 20 1 8 1 5 21 7 9 4 6 23 1 10 7 7 24 6 12 1 8 26 2 13 7 9 27...

Страница 12: ...ated branch circuit is recommended The operation of the device at a power line that does not meet the specification can damage the system and invalidate the warranty Environmental requirements 1 5 3 E...

Страница 13: ...number Authorised representative established in the European Community Serial number Follow the disposal procedures in this manual Date of manufacture See user manual Alternating current Applied part...

Страница 14: ...Introduction 1 5 Specifications and requirements 1 Page 10 Humidity limitation...

Страница 15: ...hazards due to radiofrequencies Pull the plug out of the socket immediately after each use Do not place or store the device such that it could fall over or get into a tub or sink Do not allow the devi...

Страница 16: ...not be used or should be kept at a safe distance from the device Hazards due to laser radiation 2 4 Hazards due to laser radiation Visible laser radiation Avoid contact of direct or scatter radiation...

Страница 17: ...ting the device ensure that no solvent residues remain on the device before you start the therapy Ensure that patients do not come into contact with solvents Before treatment with the device ensure th...

Страница 18: ...case of doubt qualified advice should be sought Caution during start up 2 8 Caution during start up Check the power cable Do not use the device in places with water or fire Ensure that the device loc...

Страница 19: ...f the reModel device is 10 years depending on the vacuum pump Reuse The reModel device must be cleaned and prepared after each treatment Please contact the manufacturer or your distributor if there is...

Страница 20: ...handpiece When the vacuum is switched on air is aspirated through the solenoid valves through underpressure in the handpiece o High frequency section the HF circuit board generates a pulse with 2 MHz...

Страница 21: ...age 17 Main body Handpiece 1 roll application parts Handpiece 2 multipolar APPLICATION PARTS Handpiece 3 rubbing tip application parts Operating manual Fuse 2 x T5AH 250V Mains cable 16A 250V Security...

Страница 22: ...ieces MULTI L Vacuum aided handpiece provides superficial and deep warmth through focused radiofrequency in the skin The alternating current with 2 MHz allows intracellular ions to fluctuate from posi...

Страница 23: ...Then turn the connector to the right until it snaps into place Both are printed on the jack and at the edge of the connector Then turn the plug to the right until it snaps into place 2 The multipolar...

Страница 24: ...ndpiece is available in two different sizes Grasp the body of the handpiece and align the grooves corresponding to the applicator head of the handpiece Press lightly until it clicks into place Disconn...

Страница 25: ...e to the connection port located at the lower area of the back of the device and press the switch to ON as shown below I 2 Changing the fuse a Switch off the power switch b Unscrew the fuse cover and...

Страница 26: ...mation to each patient prior to the application At the first treatment we strongly recommend that you start with the preset value A treatment with excessively high energy or excessively strong suction...

Страница 27: ...by touching the corresponding function button on the touch screen The screen shows the system status by displaying the treatment modes If necessary it also displays an informative error message No Des...

Страница 28: ...e medium handpiece automatically emit the low level laser when the laser output is switched on No Description 1 Screen transition Selection of the handpiece treatment mode 2 Pulses 4 pulses Continuous...

Страница 29: ...de 2 High frequency level 1 10 standard level 5 3 Select treatment area 4 Time display standard 15 min 5 Sound setting device information 6 Standby Ready Main device 4 2 5 Main device 1 When the syste...

Страница 30: ...value for the high frequency energy from 10 levels Preset value 5 4 If you want to use the laser press the function button once then the window lights up If you do not want to use the laser press the...

Страница 31: ...e starts working If you want to stop the treatment simply press the button once again and then operation stops During combined treatment energy transfer and vacuum you can change the direction of the...

Страница 32: ...n The small handpiece 2 does not emit any laser radiation 3 Thermal handpiece Select the appropriate handpiece 3 and the small blue LED on the handpiece in the area marked below lights up In ready mod...

Страница 33: ...d error 1 Connect the applicators of handpiece 3 If the applicator tip is correctly connected the program switches to the control screen with touch operation 2 Replace the handpiece head of handpiece...

Страница 34: ...ceramic electrodes first with a damp cloth and then with a soft dry cloth 4 Device and screen Clean the outside of the system and LCD main display with a soft cloth A mild cleaning agent can be used b...

Страница 35: ...to repair the device yourself A change or disassembly is not permitted Cleaning procedure 5 3 Cleaning procedure Please note that you may start cleaning and maintenance of the device only after the d...

Страница 36: ...Labelling and packaging 6 1 Labelling data 6 2 Packaging label 6 Page 32 Labelling label Material Silver label Size 8 x 6 cm Rear cover Device label...

Страница 37: ...Labelling and packaging 6 1 Labelling data 6 2 Packaging label 6 Page 33 Packaging label Device label...

Страница 38: ...act our technical customer service department for help or advice Please contact our technical customer service if you have any questions Please contact our technical customer service if you have any q...

Страница 39: ...or provided by the manufacturer of this device can lead to increased electromagnetic emissions or decreased electromagnetic immunity of this device and to faulty operation WARNING Portable HF communi...

Страница 40: ...1 kHz Immunity to approximation fields of RF wireless Communication equipment IEC 61000 4 3 Table 9 in IEC 60601 1 2 2014 Rapid electrical transients burst immunity IEC 61000 4 4 2 kV 100 kHz For alte...

Страница 41: ...alerallee 77 65760 Eschborn Germany Tel 49 0 6196 887170 Fax 49 0 6196 8871728 Email jooyell ktreurope de If the device is defective or not operational please contact the service team immediately Do n...

Страница 42: ...I Manufacturer Eunsung Koera I Original trade name PowerShape 2 reIModel Instructions for Use Distribution Zimmer MedizinSysteme GmbH Junkersstra e 9 89231 Neu Ulm Germany Tel 49 7 31 97 61 291 Fax 49...

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