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Zimmer reLift Instructions For Use Manual

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Instructions for use
reILift
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Summary of Contents for Zimmer reLift

  • Page 1 Instructions for use reILift...

  • Page 2: Table Of Contents

    Contents Page Introduction 1.1 About the manual 1.2 About the device 1.3 Intended use Safety instructions and warnings: 2.1 Device safety 2.2 General precautions and safety measures 2.3 Warnings 2.4. Electrical hazards 2.5 Risk of fire 2.6 Possible side effects 2.7 Contraindications 2.8 Safety symbols Device description...
  • Page 3 These operating instructions form part of the device. They must be kept with the device so that persons authorised to operate the device have access to them at all times. The operating instructions are valid from October 2023 onwards for the product reLift (original device name: Focus Dual).

  • Page 4: Introduction

    The SMAS layer is immediately contracted without damaging the skin surface or surrounding tissue. 1.3 Intended use The reLift consists of two functions, focused ultrasound therapy and the function of fractional RF therapy. The device for reLift focused ultrasound therapy (Focused Ultrasound mode) is suitable for the non-invasive dermatological treatment of ptosis and hyperhidrosis.

  • Page 5: Safety Instructions And Warnings

    The system is well balanced and can be moved, but this should always be done carefully and slowly. Make sure that the reLift device is suitable for the electrical voltage used in your country (110 VAC–240 VAC). Never use the system near explosive or flammable gases, such as flammable anaesthetics, oxidising gases, etc.

  • Page 6: Warnings

    It is forbidden to connect the devices of third parties to the system. The reLift is intended for use indoors and in dry places. Avoid spilling liquids as well as splashes of liquid near the device. Keep ultrasonic gel away from the connection area of the handpiece cartridge.

  • Page 7: Possible Side Effects

    Be careful during use: the device can cause serious burns. § The use of the reLift by children or disabled persons can be dangerous. § 2.7 Contraindications The reLift has not been evaluated for use over the following products.

  • Page 8: Safety Symbols

    Safety instructions and warnings 2.8 Safety symbols Manufacturer Catalogue number (reference number or reorder number) Authorised representative in the European Community Manufacturer's serial number WEEE icon. Should not be disposed of with household waste. Manufacture date See user manual Alternating current Applied part type B Applied part type BF "ON"...
  • Page 9 Safety instructions and warnings Fuse Do not push/press Transport and storage temperature conditions between 5 and 40 degrees C Transport and storage humidity limits between 10 and 90% Limits for atmospheric pressure for transport and storage are between 500 and 1060 hPa Keep the product dry Fragile, handle with care...

  • Page 10: Device Description

    Device description 3.1 Overview The reLift system combines fractional RF microneedling and focused ultrasound therapy in one device. The RF heat energy of the fractional needle acts on the surface of the epidermis, and its controlled impedance-matching technology results in immediate denaturation of fibrosis and effective long-term collagen remodelling.
  • Page 11 Device description Front Item Description Control panel Control panel for operating the device Handpiece holder Connected handpiece Power button On/Off switch Connection between handpiece and main Connection for handpiece body Back side Item Description Power cable connection and On/Off Main power input/power switch switch USB port UI update...
  • Page 12 Device description 3.2.2 RF handpiece Width Depth Height Weight 185.5 mm 41.5 mm 36.5 mm 441 g Item Description Disposable item; is disposed of after each treatment. The RF Microneedling attachment microneedling attachment can be easily removed or placed on the handpiece.
  • Page 13 Device description 3.2.3 Handpiece for focused ultrasound Depth Height Weight Width 231.6 78.1 37.6 mm 474 g Item Description Start button Button for operating the handpiece Cartridge fitting Installing the cartridge During operation, the green light goes out and a blue Operation LED flashing light signals the application of HIFU.

  • Page 14: Components

    Device description ① Main components ② RF handpiece Components ③ Handpiece for focused ultrasound ④ Cartridge SM ⑥ Cartridge SD 7- ⑦ Cartridge SD ⑤ Cartridge DD 7-3.0 4-4.5 7-1.5N (optional) ⑩ Vacuum connection ⑨ Fuse ⑪ AC power cable hose Page 11...
  • Page 15 Device description 3.3.1 RF TIP Number Needle outer Needle (optional) Type no. diameter Depiction isolated needles (mm) FDRK-10PNI16 0.16 FDRK-10PN16 0.16 FDRK-10PNI25 0.25 FDRK-10PN25 0.25 FDRK-25PNI16 0.16 FDRK-25PN16 0.16 FDRK-25PNI25 0.25 FDRK-25PN25 0.25 3.3.2 Cartridge Item SD7-1.5 SD7-1.5N SD7-3.0 SM4-4.5 Frequency 7 MHz 7 MHz...

  • Page 16: Preparation Of The Place Of Use

    50/60 Hz The mains socket must be earthed. § The reLift system should not share the same power line with other devices with a § high current load, such as air conditioners, for example. Ideally, the reLift should be on a separate power line with a separate circuit breaker.

  • Page 17: Storage And Transport Requirements

    Keep the room temperature between 5 and 40°C to optimally store the main § components of the reLift. Keep the cartridges between -5 to 30°C for optimum storage in a closed § container. Keep the system in a place where the humidity is between 10 and 90% and is §...

  • Page 18: Installation

    Installation 5.1 About installation The reLift is intended for installation in a practice or clinic and requires minimal on-site preparation. The installation of the system can be carried out by the clinic staff according to the following instructions: Unpack the system and place the components in their intended locations.

  • Page 19: Connecting The Rf Multi-Needle

    Installation 5.4 Connecting the Connect the vacuum hose to the handpiece. RF multi-needle Connect the other side of the hose to the RF multi-needle attachment. To connect the RF multi-needle attachment, press the attachment onto the handpiece. To disconnect the RF multi-needle attachment, press the two buttons on the opposite sides of the attachment and carefully pull out the RF multi-needle attachment.

  • Page 20: Connecting The Cartridges

    Installation 5.5 Connecting the Slide the cartridge into the handpiece to connect it (see illustration below). cartridges When the cartridge is fully and correctly inserted, an acoustic signal will sound. The control unit automatically detects this and displays the graphical user interface, updated to Standby mode, on the screen.

  • Page 21: Operating Instructions

    Operating instructions 6.1 About these This section of the manual explains how to start and operate the system, including the operating instructions possible caution and warnings at each stage of treatment. Before using the system, make sure that the following conditions are met: Are the main body, handpiece, needle and cartridges clean and disinfected? §...
  • Page 22 Operating instructions 6.3.2 Switching on the As soon as the system boots up, boot and load screens appear one after the reLift other. Once the charging process is completed, the system will display the start screen. Lightly touch the start screen to switch between the left (RF handpiece) and right (focused ultrasound handpiece) handpiece menu for the selected handpiece.
  • Page 23 Operating instructions 6.3.4 Focused The following figure shows an example of the user interface when the DD 7-3.0 Ultrasound mode cartridge is active. In the table below, each parameter to be set is described. Description Description Handpiece button Info button Select the left handpiece (RF) or the right handpiece (focused ultrasound).
  • Page 24 Device & software information Information about software and device version 6.3.6 Switching off the Stop operating the device. reLift Press the system "Off" button on the top of the device to switch off the device. Press the main power switch (on the back) to the OFF position.

  • Page 25: Maintenance

    Maintenance 7.1 About maintenance This chapter contains maintenance instructions for the reLift system. Routine maintenance can be carried out by specially trained personnel unless otherwise stated. All maintenance work not mentioned in this chapter may only be carried out by persons authorised by Zimmer MedizinSysteme GmbH or Zimmer MedizinSysteme GmbH.

  • Page 26: Error Messages

    Zimmer MedizinSysteme the control unit. GmbH representative. Switch the device off and AD number has a contact your local Zimmer system error. MedizinSysteme GmbH representative. Switch the device off and allow it to cool down for a The device while.
  • Page 27 Slide the cartridge out and then slide it back in. If the The sensor in the problem persists, please cartridge is contact your local Zimmer defective. MedizinSysteme GmbH representative. Switch the device off and The cartridge contact your local Zimmer...

  • Page 28: Troubleshooting

    Display and the power malfunction cable is correctly plugged into the socket. Please contact your local Zimmer MedizinSysteme GmbH representative. The RF or focused Malfunction of the Replace the ultrasound emission is needle or cartridge...

  • Page 29: Electromagnetic Compatibility (Emc)

    Electromagnetic compatibility (EMC) This device is suitable for use in practices and clinics as well as comparable medical institutions. All medical, electronic devices must follow the requirements of the following standard: IEC 60601-1-2. The precautions, compliance with the information on the EMC Directive contained in this manual, and inspection of all medical devices in simultaneous operation are necessary to ensure the electromagnetic compatibility and coexistence of all other medical devices before a treatment procedure.
  • Page 30 Electromagnetic compatibility (EMC) The device is intended for an electromagnetic environment as specified below. The user of the device should ensure that it is used in such an environment. IEC 60601 test Specifications for Protection test Conformity level electromagnetic environment Floors should be made of wood, concrete, or ceramic Electrostatic discharge...
  • Page 31 Electromagnetic compatibility (EMC) Manufacturer's instructions and declaration – Electromagnetic protection The device is intended for an electromagnetic environment as specified below. The customer or user of the device should ensure that it is used in such an environment. Protection test IEC 60601 test level Conformity Instructions for electromagnetic...

  • Page 32: Guarantee

    Damage caused by products or components that have been modified without § the written permission of Zimmer MedizinSysteme GmbH in order to change the functionality or performance. A device without a serial number.

  • Page 33: Specifications

    Service Guarantee Agreement. Please contact your local Zimmer MedizinSysteme GmbH representative before attempting to remedy this system in any way other than as described in this manual. Before returning goods, please obtain the approval of Zimmer § MedizinSysteme GmbH. Failure to follow the detailed instructions will void the guarantee. Please also §...

  • Page 34: Legal Notice

    Legal notice Manufacturer EUNSUNG GLOBAL CORP. Member of the Zimmer Group 120, Gieopdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Korea Manufactured for: Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm Germany Tel. +49 731 / 9761-0 Fax +49 731 / 9761-299 info@zimmer.de www.zimmer.de The notified body is MIT (MIT International Testing S.r.l.). The number of this body is 0068.
  • Page 35 Instructions for use Distributor: Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Deutschland Tel. 07 31. 97 61-0 Fax 07 31. 97 61-118 info@zimmer.de www.zimmer-aesthetics.com Export: Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de...

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