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Zimmer re Instructions For Use Manual

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Instructions for Use
reIModel
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  • Page 1 Instructions for Use reIModel...

  • Page 2: Table Of Contents

    Contents Page Introduction 1.1 Overview 1.2 Intended use 1.2.1 About the device 1.2.2 Device application specifications 1.3 Applications 1.3.1 Side effects 1.4 System description 1.4.1 Classifications 1.5 Specifications and requirements 1.5.1 Specifications of the high-frequency therapy device 1.5.2 Electrical specifications 1.5.3 Environmental requirements 1.5.4.
  • Page 3 Contents 4.1 Site preparation 4.1.1 About site preparation 4.1.2 Assembly of the main body and handpiece connection 4.1.3 Assembly of the handpiece and tip 4.1.4 Disassembly of the main body and handpiece connection 4.1.5 Disassembly of the handpiece and tip 4.1.6 Switching on/off 4.2 Operation 4.2.1 About operation...
  • Page 4 This also includes the information on the labels on the device. The instructions for use can also be downloaded from our website at www.zimmer-aesthetics.de. We reserve the right to revise this document at any time or change product specifications described. There is no obligation to provide information about the changes to the customer.

  • Page 5: Introduction

    Introduction 1.1 Overview Description, natural High-frequency therapy is used in musculoskeletal disorders (MSD). These are course and after- injuries to or pain in the human musculoskeletal system, including the joints, effects of diseases ligaments, muscles, nerves, tendons, and structures that support the extremities, neck, and back.
  • Page 6 Introduction 1.1 Overview full-time staff, have the highest incidence rate of musculoskeletal diseases. In the health, processing, agriculture, wholesale, retail and leisure industries, the incidence rates are over 35 per 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.

  • Page 7: Intended Use

    Introduction 1.2 Intended use, device specifications 1.2 Intended use The high-frequency therapy device is intended for an effect which offers relief of musculoskeletal pain. 1.2.1 About the device The reModel system was developed in accordance with international safety and performance standards. The staff operating the system must have acquired a basic understanding of the proper operation of the device.

  • Page 8: Applications

    Introduction 1.3 Applications 1.4 System description • The device is intended for use by physicians or medical professionals. • Use the device in a clean treatment room. • Position the device on a flat, straight floor surface. • Frequency of use: Can be used daily. •...

  • Page 9: Specifications And Requirements

    Introduction 1.5 Specifications and requirements Specifications of the Applicator Roll handpiece 1 variant high-frequency therapy Multipolar handpiece 1. large, 2. medium, device 3. small Thermal handpiece 1. large, 2. small Vacuum MAX. 280 mm Hg ± 20% Max. 83 W ± 20%; at 50 Ohm Laser <...
  • Page 10 Introduction 1.5 Specifications and requirements * HF outlet in the case of a nominal load, 50 Ω Veff Watt Veff Watt Handpiece Level Handpiece Level 38.4 29.5 25.6 13.1 41.2 33.9 27.3 14.9 44.2 39.1 29.1 16.9 47.1 44.4 30.8 19.0 50.1 50.2...
  • Page 11 Introduction 1.5 Specifications and requirements Veff Watt Veff Watt Handpiece Level Handpiece Level 15.6 18.4 20.1 Thermal 21.7 - Section 3 23.1 10.7 24.6 12.1 26.2 13.7 27.5 15.1 28.9 16.7 Page 7...

  • Page 12: Electrical Specifications

    Introduction 1.5 Specifications and requirements Electrical specifications 1.5.2 Electrical specifications The customer must have a suitable plug and an appropriate socket. The power outlet must be within two metres from the site intended for the high-frequency therapy device and must be grounded. The safety ground wire of the power system (green strip or green-yellow strip) is an acceptable grounding for the high- frequency therapy device, provided that it is connected only to a ground spike or a special grounding grid.

  • Page 13: Display, Safety And Reference Symbols

    Introduction 1.5 Specifications and requirements Safety and reference 1.5.4. Display, safety and reference symbols symbols Manufacturer Importer Model name or reference 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 type BF...
  • Page 14 Introduction 1.5 Specifications and requirements Humidity limitation Page 10...

  • Page 15: Safety (Warnings!)

    Safety (warnings!) 2.1 Electrical hazards (hazards due to radiofrequencies) WARNING! Please read this manual carefully before use to ensure that you are familiar with the features and functions. This manual contains important information on assembly, safety notices, and on the use and care of your device. Please be sure to read all safety information and operation instructions before use.

  • Page 16: Hazards During Assembly

    Safety 2.2 Hazards during assembly, 2.3 Risk of fire, 2.4 Hazards due to laser radiation Hazards during 2.2 Hazards during assembly • Do not expose this device to direct sunlight. Assemble the device in well assembly ventilated interior rooms. • Place the device only on a flat, straight surface. •...

  • Page 17: Hazards Induced By Cleaning

    Safety 2.5 Cleaning-induced hazards 2.6 Compliance with regulations Hazards induced by 2.5 Hazards induced by cleaning • cleaning Neither the main body nor the handpiece may be immersed in liquid. Please switch off the AC power switch before cleaning the device. •...

  • Page 18: Contraindications

    Safety 2.7 Contraindications, 2.8 Caution during start-up, 2.9 Caution during operation, 2.10 Caution after use Contraindications 2.7 Contraindications Please do not use the device • on children, infants, and pregnant women • in the case of diseases such as cardiovascular diseases, liver diseases, kidney diseases, cancer, diabetes •...

  • Page 19: Description

    Description 3.1 Structure Structure LCD monitor Handpieces Handpiece holder Drawer Air filter Service life of the The service life of the reModel device is 10 years (depending on the vacuum pump). device Reuse The reModel device must be cleaned and prepared after each treatment. Please contact the manufacturer or your distributor if there is a problem.

  • Page 20: Operating Principle

    Description 3.2 Operating principle Operating principle 3.2 Operating principle The reModel high-frequency therapy device is equipped with three different technologies: with a high-frequency function, with a low-level laser, and with the function for vacuum massage. The handpiece for high-frequency and laser treatment comprises three different sizes for different parts of the body and is primarily used to relieve musculoskeletal pain.

  • Page 21: Components

    Description 3.3 Components 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 key Connection cleaning brush Page 17...

  • Page 22: Device Accessories

    Description 3.4. Device accessories Model/product Part Description Figure designation Roll handpiece Roll Motorised roll handpiece which uses bipolar radiofrequency, low-level laser, and vacuum in one treatment. It emits energy to the treatment site. The stimulation through mechanical force (suction), high frequency, and laser (5 mW) improves the local circulation and the metabolism and thus relieves pain in the treatment area.

  • Page 23: Use

    4.1.1 About site preparation 1. The device preparation should be performed only by authorised maintenance staff from Zimmer MedizinSysteme. 2. When preparing the reModel site, the operator should take the spatial, electrical, environmental, storage, and transport requirements of the system into account.

  • Page 24: Switching On/Off

    4.1 Site preparation Assembly of the 4.1.3 Assembly of the handpiece handpiece 1. Multipolar handpiece • Handpiece 2 (multipolar) is available in three different sizes. The three attachments can be easily changed. • Small black marks which you align with each other are printed on the outer part of the neck of the cable and inside the head.
  • Page 25 4.1 Site preparation 1. To switch the main device on, connect the mains cable 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.

  • Page 26: Operation

    4.2. Operation About 4.2.1 About operation operation Below you will learn how the device is started and operated, including possible maintenance and precautionary measures for each operating step. Before using the system, ensure that the following preconditions are met. • Are the device and handpieces clean and disinfected? •...

  • Page 27: Screen

    4.2. Operation Screen 4.2.4 Screen 1. Roll handpiece screen The screen for “handpiece 1” shows the necessary operating elements and • displays for the operation and control of the system when the module is active and handpiece 1 is properly connected to the device. •...
  • Page 28 4.2. Operation 2. Multipolar handpiece screen • The basic parameter settings for the multipolar handpiece work in the same way as for the roll handpiece, except for the laser parameters which can additionally be selected for the multipolar handpiece. • Both the large and the medium handpiece automatically emit the low-level laser when the laser output is switched on.

  • Page 29: Main Device

    4.2. Operation 3. Thermal handpiece When one of the two thermal handpieces is connected, the parameter settings shown below become visible for the user. Only the high-frequency level can be adjusted for the thermal handpieces. Description Screen transition Selection of the handpiece/treatment mode High-frequency level (1-10) (standard level: 5) Select treatment area Time display (standard: 15 min)
  • Page 30 4.2. Operation 4. Select the desired module and the appropriate handpiece: • Roll handpiece • Multipolar handpiece • Thermal handpiece Once the selected module is selected, the program settings screen for the respective treatment appears. 5. Use of the roll handpiece (example) 1.
  • Page 31 4.2. Operation Roll handpiece 4.2.6 Roll handpiece 1. Roll handpiece • You can press the ON/OFF button on the roll handpiece. In ready mode, press the button on the top of the head and then the device starts working. If you want to stop the treatment, simply press the button once again and then operation stops.
  • Page 32 4.2. Operation 2. Multipolar handpiece • Select the suitable handpiece 2. In ready or start mode, the small blue LED starts to light up, as shown below. Since handpiece 2 does not have an ON/OFF button, start and stop the treatment directly from the LCD screen. •...

  • Page 33: Error Messages

    4.3 Error messages Handpiece error 4.3.1 Handpiece error 1. The handpiece is not correctly connected and the applicator heads are not correctly mounted. Handpiece head error 4.3.2 Handpiece head 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.

  • Page 34: Maintenance

    Maintenance 5.1 Cleaning Cleaning The handpiece and the tips directly touch the skin of the person being treated. Therefore, it is necessary to clean and disinfect it after each use. For cleaning and disinfection, first use a soft, damp cloth, followed by a dry cloth. •...

  • Page 35: Technical Customer Service

    Maintenance 5.2. Technical customer service, 5.3 Cleaning procedure, 5.4 Environmental requirements Technical customer 5.2 Technical customer service service Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm Germany Tel. +49 731 / 9761-0 Fax +49 731 / 9761-118 info@zimmer.de www.zimmer.de If the device is defective or not operational, please contact the service team immediately.

  • Page 36: Labelling And Packaging

    Labelling and packaging 6.1 Labelling data, 6.2 Packaging label Labelling/label Device label Material: Silver label Size: 8 x 6 cm Rear cover Page 32...
  • Page 37 Labelling and packaging 6.1 Labelling data, 6.2 Packaging label Packaging label Device label Page 33...

  • Page 38: Disposal

    Disposal Disposal If necessary, please contact 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 questions about disposal and for any other questions. Page 34...
  • Page 39 Electromagnetic compatibility (EMC) table This device is suitable for use in a “medical environment”. This device meets the requirements of IEC 60601-1-2. Precautionary measures, compliance with the EMC guideline information contained in this manual, and the review of all medical devices in simultaneous operation are necessary in order to ensure the electromagnetic compatibility and coexistence of all other medical devices in the immediate vicinity prior to a treatment procedure.
  • Page 40 Electromagnetic compatibility (EMC) table Basic EMC standard or test Phenomenon Test level/requirement method Electromagnetic emissions Mains connection CISPR 11 Group 1, class A Interference voltage Radiation interference CISPR 11 Group 1, class A Harmonic current emission IEC 61000-3-2 Not applicable Change in voltage, IEC 61000-3-3 Not applicable...
  • Page 41 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.
  • Page 42 Instructions for Use Distribution: Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de www.zimmer-aesthetics.com...

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