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Legal notice

 

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Page 37   

 

 

High-frequency therapy device 

 
This document is the property of Zimmer MedizinSysteme. 
It contains confidential information and may not be reproduced. 
The instructions for use may be used only in connection with the use of the reModel 
device. This document is to be returned promptly to Zimmer MedizinSysteme upon 
request. 

 

 

 

Before using the device, please check local regulations. If local legislation is infringed, 
use cannot be permitted. 

 

 

Manufacturer 

 

EUNSUNG GLOBAL CORP. 
120, Gieopdosi-ro, Wonju-si, Gangwon-do, South Korea  
Email: [email protected] Website: www.esglobal.co.kr 
 

Importer 

 

Zimmer MedizinSysteme GmbH 
Junkersstraße 9 
89231 Neu-Ulm 
Germany 
Tel. +49 731 / 9761-0 
Fax +49 731 / 9761-118 
[email protected] 

www.zimmer.de

 

 

 

 

reModel* 

*Registered product name “Powershape2” 

 

 

The device bears the CE mark 

 

in accordance with the EC directive on medical devices 93/42/EEC and meets the 
essential requirements of appendix I of this directive. 
 
The device is classified in class IIa according to appendix IX of the directive. 

 

 

 

Authorised representative established in the European Community: 
KTR Europe GmbH 
Mergenthalerallee 77, 65760 Eschborn, Germany 
Tel.: +49(0)6196 887170, Fax: +49(0)6196 8871728, Email: [email protected] 

 

 

 

If the device is defective or not operational, please contact the service team 
immediately. Do not attempt to repair the device yourself. Changes or disassembly are 
not permitted. 

 

 

Copyright 

Copyright© 2018 Eunsung Global Corp. All rights reserved. 

Eunsung Global reserves the right to make changes to its products or specifications to improve the performance, 
reliability, or manufacturability. The information provided by Eunsung Global is considered to be correct and reliable. 
However, Eunsung Global does not assume any responsibility for its use. No license is granted through implication or 
otherwise under any patents or patent rights of Eunsung Global. 
No part of this document may be reproduced or transferred in any form or in any way, electronically or mechanically, 
for any purpose without the express written consent of Eunsung Global. 
The manufacturer reserves the right to change data without prior notice. Unless expressly agreed on in a written 
agreement from Eunsung Global, you do not receive any licence for patents, trademarks, copyrights, or other rights to 
intellectual property with the provision of this document. The manufacturer reserves the right to change specifications 
without prior notice. 

 

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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