Zimmer Cryo 7 Instructions For Use Manual
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Zimmer Cryo 7 Instructions For Use Manual

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Instructions for Use
Cryo 7
USA

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Summary of Contents for Zimmer Cryo 7

  • Page 1 Instructions for Use Cryo 7...
  • Page 2 Figures Front of the device / Detailed description – defrost container Fig. 1 Front of the Device Cryo 7 Display Shelf plate Ventilation slits Maintenance door of the defrost container Fig. 2 Detailed description – defrost container Button to open the maintenance door of the defrost container...
  • Page 3 Connection port for USB Handle Cryo 7 air filter Ventilation slits Base Castors with locking device Locking lever Connection for power cable Mains switch Air outlet with magnetic connection and treatment tube connection Connection port for Cryo 7 therapy hose spring arm...
  • Page 4 Fig. 4 Detailed description Air outlet with magnetic connection / Connection port for Cryo 7 therapy hose spring arm / Locking lever Air outlet with magnetic connection and treatment tube connection Connection port for Cryo 7 therapy hose spring arm Locking lever “The angle of the lever can be adjusted by pulling the locking lever and...
  • Page 5 Figures Accessories Fig. 5 Accessories Cryo 7 Therapy Hose 2.5m Cryo 7 Therapy Hose Spring Arm Cryo 7 Air filter...
  • Page 6 Screens / Display Fig. 6 Display views Currently selected screen Touchscreen buttons (press / swipe) Navigation bar buttons Toolbar buttons Fig. 7 Navigation bar/ Opens the device status hub Toolbar Opens the therapy hose pre-cooling menu (Only with Pro Therapy Hose) Function description Opens the defrost menu Switches to the Memory area to save Favourites...
  • Page 7 Explanation of symbols Symbol Description In the United States of America, federal law restricts this device to sale by or on the order of a physician. Medical device This symbol indicates “Caution” with regard to possible material damage. This symbol indicates “Danger” with regard to possible risks to people. Follow instructions for use.
  • Page 8 Explanation of symbols Symbol Description On (power supply) Disposal of electrical and electronic devices as well as used disposable and rechargeable batteries. Products which are marked with the adjacent symbol may not be discarded with household waste. Do not stack Protect from moisture Transport upright Fragile...

  • Page 9: Table Of Contents

    Explanation of symbols Page Intended use 1.1 Indications / Contraindications 1.2 Side effects / Residual risks Application information and warnings Cryo 7 performance features System set-up Software Operation instructions 6.1 Configuration 6.2 Performing the treatment 6.3 Displays and buttons – start screen...
  • Page 10 If the instructions for use have become illegible, damaged, or are not accessible for the user for other reasons, a replacement is to be requested from the manufacturer for the safe use of Cryo 7 and made available to the user.

  • Page 11: Intended Use

    Intended use 1.1 Indications / Contraindications Indications Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. Contraindications • Hypersensitivity to cold • Areas of impaired sensation •...

  • Page 12: Side Effects / Residual Risks

    Intended use 1.2 Side effects / Residual risks Side effects Transient skin irritation due to the cold, especially in sensitive patients. Intended purpose Cold air therapy devices are intended to minimize pain and thermal injury during laser and dermatological treatments and for the temporary topical anesthetic relief for injections.

  • Page 13: Application Information And Warnings

    Application information and warnings Do not place the device in the vicinity of heat sources (heater, hot medicinal mud products, sauna, etc.) and leave a distance of at least 50 cm between the device and a wall (to enable the supply of cool air). If used in combination with a laser device, the laser ventilation system should not impair the cooling of the cold air therapy device.
  • Page 14 During the application of cold to the face, the eyes and mucous membranes must be protected in general. Do not switch Cryo 7 on and then immediately switch it off. Doing so could damage Cryo 7. If the user identifies a potential safety problem or operating anomaly during use, the treatment must be immediately discontinued and the manufacturer must be contacted.
  • Page 15 Objects must be placed in the centre of the shelf plate. Observe the maximum load! Do not place any liquids on the shelf plate. Pushing Cryo 7 at the sides labelled with corresponding warnings is not permitted. Do not lean on the device.

  • Page 16: Cryo 7 Performance Features

    Cryo 7 performance features What is new? The use of the latest technology to provide cold air. Space-saving thanks to a slim housing type in a new design. Ergonomic operation. High-resolution display with touch operation. All keys, menus and sub-menus, as well as buttons can be activated directly on the touch screen with finger pressure.

  • Page 17: System Set-Up

    After transport/assembly or repair, Cryo 7 must be placed in and kept in an upright position for at least 30 minutes before being switched on. If Cryo 7 is switched on before the 30 minutes have elapsed, the compressor can become damaged.
  • Page 18 The Cryo 7 therapy hose spring arm holds the Cryo 7 therapy hose and assists the user by supporting the weight of the Cryo 7 therapy hose. Assembly of the Place the Cryo 7 therapy hose in the guide of the Cryo 7 therapy hose spring therapy hose spring arm.
  • Page 19 System set-up Start-up Switch on the device using the power switch (18). After it is switched on, Cryo 7 performs a one-time initial set-up. You are guided through a brief menu with the following questions: 1. Language selection 2. Support Location 3.

  • Page 20: Software

    IT safety measures Cryo 7 is controlled via special device software. and information The Cryo 7 device software is protected by special software protection measures against copying. Only USB sticks may be inserted in the USB port. It is prohibited to draw operating voltage for small devices or connect devices with an external power supply.

  • Page 21: Operation Instructions

    Operation instructions 6.1 Configuration Note Device-specific parameters and default settings are pre-set in the factory and can be changed only by factory support. Basic user settings, such as fan levels and therapy time, are not affected by this. User parameters in the configuration can be changed and individually stored at any time.
  • Page 22 “standby” energy-saving mode. The Cryo 7 cooling phase restarts by touching anywhere on the touch screen. If using the Cryo 7 Pro Therapy Hose, exit standby mode by pressing both handpiece buttons at the same time. If the cooling phase is completed, Cryo 7 automatically switches to the therapy screen.

  • Page 23: Performing The Treatment

    Operation instructions 6.2 Performing the treatment Switch device on Cryo 7 performs a “precooling” cooling phase after it has been switched on. If the cooling phase is completed, Cryo 7 automatically switches to the therapy screen. Patient preparation For standard procedures in your medical practice, we additionally recommend that the patient remove metal objects in the therapy area, if possible.

  • Page 24: Displays And Buttons - Start Screen

    Operation instructions 6.3 Displays and buttons – start screen Description of the display elements and buttons (1) Arrow buttons By tapping the arrow button, the fan level and therapy time values decrease or increase in single increments. (2) Preset Activating the “Preset” button restores the respective factory settings or the individual settings in the configuration menu.
  • Page 25 Operation instructions 6.3 Displays and buttons – start screen Favourites The entries changed and saved in the start screen are filed in Favourites through the save procedure. Favourites list In the Favourites list, these can be: 1. Select for use. To do this, the desired entry is selected directly in the corresponding line.

  • Page 26: Technical Information

    Technical information Mains voltage* 100V – 120V / 50-60Hz (10A) Mains fuse 16 A Protection class IP protection class IP20 Type of applied part n.a. (no applied part) Dimensions H 1060 mm x W 500 mm x D 560 mm Weight 60 kg (without accessories) Environmental...

  • Page 27: Cleaning / Disinfection

    To filter coarse dust particles from room air, there is a Cryo 7 air filter located at the back of Cryo 7. If the icon to change the Cryo 7 air filter appears in the status bar, the Cryo 7 air filter along with the frame must be changed.

  • Page 28: Manufacturer / Distributor

    Manufacturer / Distributor Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm Germany Distributor Zimmer MedizinSystems 3 Goodyear, Suite B Irvine, CA 92618 Page 18...

  • Page 29: Scope Of Delivery And Accessories

    ** Individual power cable available. Please get in touch with your contact partner. Subject to changes Note: The device may be operated only with original parts from Zimmer MedizinSysteme GmbH. Otherwise the function and safety of the patient, user and third parties cannot be guaranteed. Orders Contact your responsible contact person on site.

  • Page 30: Device Combinations

    In the case of a combination, observe the instructions for use of the combined device. If Cryo 7 is connected to an IT network (for example, to an aesthetic medical laser), previously unidentified risks to patients, operators, or third parties may arise.

  • Page 31: Safety / Maintenance / Service

    Safety / Maintenance / Service 12.1 Safety Safety and Cryo 7 was developed and manufactured in compliance with the safety maintenance regulations of ES60601-1. Zimmer MedizinSysteme GmbH is responsible for the safety and reliability of the device only if 1. the device is operated using a proper power outlet with a protective contact.

  • Page 32: Service

    While the defrosting process is running, no screen entries or therapy is possible. The defrost can be ended at any time. It is possible to have Cryo 7 automatically switch to standby mode after the defrost is complete. After the end of the defrosting process, the defrost container must be emptied Capacity of the The defrost container has a capacity of approx.
  • Page 33 At the end, a summary appears on the screen. You should photograph or write down the summary of the data at the end of Run S01. Caution! Run S01 lasts about 90 minutes. Afterwards, Cryo 7 restarts. Performing S02 Activating the “Start” button under the “Run S02” display field starts the “Run S02”...
  • Page 34 Cryo 7 configuration. Cryo 7 Air filter An icon in the status bar indicates that the Cryo 7 air filter needs to be replaced. We recommend keeping a replacement Cryo 7 air filter on hand in your medical practice (see air filter information in this chapter).
  • Page 35 Safety / Maintenance / Service 12.2 Service Export log Cryo 7 provides data for error analysis. These data can be saved on a USB stick. Creating the export Insert the USB stick in the port provided on the back of Cryo 7 (10).

  • Page 36: Functional Test

    • Wait until the device is ready for use. • This is the case when the device switches to the start screen. • Start Cryo 7 using the start button. Select the various fan levels one after the other and check the strength of the air stream and the cold air output.

  • Page 37: Function Failure Error Message / Troubleshooting Disposal

    Reduced cold air Reduced cold air output / reduction in cold air output output / reduction in Icing of Cryo 7 may be the cause of a significant reduction in cold air output cold air output and a weak air stream.
  • Page 38 Please refer to national regulations for disposal. Contact your distributor if necessary. Cryo 7 must not be disposed of in household waste under any circumstances. Packaging materials must be kept out of the reach of children since there is a...

  • Page 39: Manufacturer's Emc Declaration

    The tested frequencies are listed in Table 4. Cryo 7 does not contain any components which can age during the life of the device and which can lead to worsening of the electromagnetic compatibility. No third-party maintenance is required during the service life of the device, but the user must replace the air filter and empty the defrost container on his own.
  • Page 40 Guidelines and manufacturer’s declaration – Electromagnetic emissions The Cryo 7 device is intended to be used in the electromagnetic environment as indicated below. The customer or user of the Cryo 7 device must ensure that it is used in such an environment.
  • Page 41 Guidelines and manufacturer’s declaration – Electromagnetic immunity The Cryo 7 device is intended to be used in the electromagnetic environment as indicated below. The customer or user of the Cryo 7 device must ensure that it is used in such an environment.
  • Page 42 Guidelines and manufacturer’s declaration – Electromagnetic immunity The Cryo 7 device is intended to be used in the electromagnetic environment as indicated below. The customer or user of the Cryo 7 device must ensure that it is used in such an environment.
  • Page 43 Manufacturer’s EMC declaration Table 4 Electromagnetic immunity to HF radio equipment Test Maximum Test level Band Distance frequency Service Modulation energy immunity (MHz) (MHz) (V/m) 380 – 390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460, FRS 460 ±...
  • Page 44 Cryo 7 Instructions for Use Distributor: Zimmer MedizinSystems 3 Goodyear, Suite B Irvine, CA 92618 Tel: (800)-327-3576 Fax: (949)-727-2154 www.zimmerusa.com info@zimmerusa.com...

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