Gymna CRYOFLOW ICE-CT User Manual
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Gymna CRYOFLOW ICE-CT User Manual

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CRYOFLOW ICE-CT

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Summary of Contents for Gymna CRYOFLOW ICE-CT

  • Page 1 User Manual CRYOFLOW ICE-CT...
  • Page 2 Your specialist dealer: ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)
  • Page 3 Worldwide distributor GymnaUniphy NV Pasweg 6A, 3740 Bilzen, Belgium Tel +32 (0)89 510 510 Fax +32 (0)89 510 511 www.gymna.com e-mail: info@gymna.com Manufacturer: Uniphy Elektromedizin GmbH & Co. KG Neuendorfstr. 19b, 16761 Hennigsdorf, Germany ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 4: Table Of Contents

    CLEANING THE COOLER ................32 DECOMMISSIONING AND DISPOSAL ............. 34 TECHNICAL SPECIFICATIONS ................ 35 ACCESSORIES ....................36 15.1 Scope of delivery ....................36 15.2 Optional accessories: ..................36 NOTES ON ELECTROMAGNETIC COMPATIBLITY (EMC) ......37 ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 5: Introduction

    Congratulations on the purchase of your new CRYOFLOW ICE-CT! You have opted for the CRYOFLOW ICE-CT, a cold air therapy device with high levels of performance, an attrac- tive and user-friendly design, and of the highest quality. The CRYOFLOW ICE-CT has already proven to be ex- cellent in physiotherapy centres, local practices and clinics.

  • Page 6: Description Of Controls, Displays, Equipment Parts

    20 Handle, pivoting, with IR sensor, for the treatment hose (27) 22 M8x30 star grip on the handle holder 23 Support mounted on the CRYOFLOW ICE-CT for the supporting arm 24 Flange on the device for connecting the treatment hose (26) or (27)
  • Page 7 ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 8: General Information

    Device As a therapy device, the CRYOFLOW ICE-CT is not intended for the mobile or emergent use Careful: Cryotherapy devices should be used exclusively by personnel trained or skilled in the fields of physio- therapy or other similar background, and the treatment must be monitored by this personnel! The device is not intended to drive over obstacles, with the exception of transport to the destination for initial as- sembly.

  • Page 9: Directive For Medical Devices

    Directive for medical devices The CRYOFLOW ICE-CT complies with the requirements outlined in Directive 93/42/EWG on medical devices. The device may only be operated in accordance with the purpose described in these Operating Instructions. We recommend that a safety-related inspection of the device be carried out every 2 years, by an authorised ser- vice (Item 11.3)

  • Page 10: Short Operating Instructions

    After an operating time of 500 hours, a notice will appear on the Display (17) regarding the cleaning of the cooler. The ventilation plate (28) must be unscrewed and then you should proceed as per Item 12. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 11: Commissioning

    Switch on and Switch off Switch on the device using the power switch (3) at the back of the CRYOFLOW ICE-CT. The Display (17) will briefly show the name of the device and its relevant software version. During that time, a device test will be per- formed.

  • Page 12: System Setup

    In the CRYOFLOW ICE-CT you can select the unit for the temperature, either °C or °F. The sound at the end of the treatment is always activated by the CRYOFLOW ICE-CT. Figure 1.: “System setup” ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 13: Treatment

    Operating mode selection After the device initialisation, the CRYOFLOW ICE-CT starts with the Main menu, in which the desired operating mode can be selected. The choices will be determined by whether the device is operated with or without an IR sensor (see Figure 2).

  • Page 14: Timed Operation

    5.4). The output picture will appear again on the Display (17) before the start of the treatment. A new treatment can be started. After stopping the treatment, Figure 2 “Operating mode selection” can be called up again (see Item 6.1) by acti- vating the Main Menu button (13). Figure 3: “Timed operation” ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 15: Continuous Operation

    (9) from the skin surface. At the end of the treatment, Figure 2 “Operating mode selection” can be called up again by activating the Main Menu button (13) (see Item 6.1). Figure 4: “Continuous operation” ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 16: Thermo Feedback

    Use the knob (16), turn it (selection) and press it (activation) to go to the “automatic” operating mode in Figure 5.3 (Item 6.4.1) and to the “manual” operating mode in Figure 5.5 (Item 6.4.2). Figure 5.1: “Thermofeedback” Figure 5.2: “Operating mode” ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 17: Automatic Operation

    After the end of the treatment, or when the treatment is stopped, Figure 2.2 “Operating mode selection” can be called up again by activating the Main Menu button (13) (see Item 6.1). Figure 5.3: “Automatic operation”“ Figure 5.4: “Automatic operation”, START ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 18: Manual Operation

    Main Menu button (13) (see Item 6.1). Figure 5.5: “Manual operation” Careful! Do not point the red LED light towards the eyes! Careful! It is not recommended to remove or insert the IR plug connection when in operation. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 19: Indications

    You can access each programme by using the knob (16), turning it (selection) and pressing it (activation). Activating the Start/Stop button (15) will start the treatment. It is also possible to interrupt the treatment by activating this button. Figure 5.6: “Indications” Figure 5.7: “Treatment suggested for achillodynia - acute” ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 20: Objectives

    3 and 8 cm between Nozzle (9) and skin surface, the optimal is circa 6 cm. The temperature will be shown automatically in the Display (17). In this manner the evolution of the therapy can be followed. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 21: De-Icing

    DE-ICING During the treatment, the CRYOFLOW ICE-CT sucks in the ambient air via a filter mat (2) and cools it down in the heat exchanger to -32 °C. It is well known that the air will lose its moisture. This moisture condensates in the heat exchanger and freezes.

  • Page 22: Draining The Water Tank

    Turn the device off using the power switch (3). Open the valve (4) on the rear panel of the CRYOFLOW ICE-CT and remove the water tank. After draining, clean the tank and replace it so that the drain pipe is located above the tank opening. The left side of the water tank must be positioned in parallel to the plastic housing of the filling level sensor.

  • Page 23: Using Cryotherapy

    3 to 8 cm. 10. The cold is generated in the CRYOFLOW ICE-CT using a special compressor. For an optimum use of the cold air, we recommend to switch on the power switch (3) about 20 to 30 minutes before treatment. The de- vice does into standby mode and the systems are pre-cooled.

  • Page 24: Contraindications

    The information in Items 9.4 and 9.5 do not claim to be complete. For specific cases, and in particular when it comes to contraindications, the treatment physician must always be the one to decide on the use of cryotherapy. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 25: Safety Instructions For The Operation Of The Device

    SAFETY INSTRUCTIONS FOR THE OPERATION OF THE DEVICE The cooling capacity of the CRYOFLOW ICE-CT depends also on the ambient conditions. It uses the ambient air to generate the cold air and to cool its own assembly. Please comply with the following safety instructions: - The device should not be placed near heat sources (heaters, ovens, stoves, saunas, windows with strong sunlight, etc.).
  • Page 26 -Do not move (drive) the unit between treatment rooms and do not use it in emergency medicine. -Drive the device only for the purpose of driving over thresholds, initial setup/delivery transport and using the threshold ramp as a special accessory ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 27: Faults, Service, Guarantee

    FAULTS, SERVICE, GUARANTEE 11.1 Faults Each time the switch on the power supply is turned on, the CRYOFLOW ICE-CT performs an inspection of the software. The device meets the accepted standards for interference resistance and emission of radiation. Faults that may affect the power supply cord (1) can cause indication errors. The device must then be switched off and switched on again at the power supply.

  • Page 28: Service

    You can also contact the service department of the manufacturer directly, as specified in Item 17 of these Operat- ing Instructions. Service and guarantee benefits will be lost if the device is not used in accordance with these Operating Instruc- tions. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 29: Guarantee

    11.3 Guarantee 11.3.1 Guarantee conditions The duration of the guarantee for the CRYOFLOW ICE-CT is based on the relevant national statutory regulations and shall start from the date of purchase (the date on the invoice will count as proof). The guarantee covers all defects in material and build quality.

  • Page 30: Handling The Treatment Hose/Ir Cablefaults

    Do not rotate the handle > 360°! Figure 8.2.2: Cable on the handle If the cable twists around the hose, the handle must always be turned back. Figure 8.3:1 Cable on the device Do not turn the hose > 360°! ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 31: Handling The Supporting Arm

    If the cable twists directly around the device, the complete hose must always be turned back. 11.5 Handling the supporting arm Figure 9.1: Supporting arm Figure 9.2: Handle slot on the supporting arm Figure 9.3: Axial adjustment of the supporting arm ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 32: Relocating The Device

    11.6 Relocating the device The CRYOFLOW ICE-CT is fitted with 4 double rollers, to enable the easy positioning of the device at the place of treatment. Since the device is not earmarked for mobile use, no pushing into another treatment room can be done and it should not run over obstacles in the room (such as cable or similar).

  • Page 33: Maintenance And Cleaning

    Caution: Careful to the clamping points on the filter slot and to the bottle holder! The state of the cooler affects the functionality of the CRYOFLOW ICE-CT. Inside the device, a ventilator sucks in ambient air and blows it through the cooler and the round ventilation slots of the front wall to the outside. The environment will then be instrumental in how long it will take for the cooler to get dirty.
  • Page 34 Caution! If during the performance, a smell of ether occurs due to the potentially leaking coolant, make sure fresh air is brought in, switch the device off and lead people out of the treatment room! ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 35: Decommissioning And Disposal

    Please comply with the appropriate national regulations when disposing of packaging. For the disposal of the cleaning products and disinfectants, please comply with the relevant instructions on the packaging or on the manufacturers‘ material data sheets included with the products! ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 36: Technical Specifications

     500 hPa to 1060 hPa atmospheric pressure  +10 °C to +40 °C ambient temperature Operating conditions  5 % to 90 % relative humidity, non-condensing  500 hPa to 1060 hPa atmospheric pressure ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 37: Accessories

    - Threshold ramp (for the purpose of haulage/line-up in the treatment room) Item number 333.210 We are constantly striving to keep our products at the cutting edge of technology. As a result, we reserve the right to make changes. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

  • Page 38: Notes On Electromagnetic Compatiblity (Emc)

    Guidelines and manufacturer’s declaration – Electromagnetic Interferences The CRYOFLOW ICE-CT is intended for use in an electromagnetic environment specified below. The customer or user of the CRYOFLOW ICE-CT must ensure that it is used in such an environment. Interference measurements Compliance...
  • Page 39 Radiated HF disturbances d = 1.17 in accordance with IEC 80 MHz to 2,5 GHz 80 MHz to 2.5 GHz for 80 MHz to 800 MHz 61000-4-3 d = 2.33 for 800 MHz to 2.5 GHz ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)
  • Page 40 NOTE 1 At 80 Hz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply to all cases. The propagation of electromagnetic quantities will be impacted by the ab- sorptions and reflections of the building, objects and people.. ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)
  • Page 41 SERVICE ADDRESS Gymna Uniphy NV Pasweg 6A B-3740 Bilzen, Belgium Tel: +32(0) 89-510 510 FAX: +32(0) 89-510 511 www.gymna.com Email: info@gymna.com ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)
  • Page 42 (1. Code number 2 = protected against solid IP 21 foreign bodies with a diameter of 12.5 mm; Protected against access with a finger) (2. Code number 1 = protect against vertical falling drops) Safety signs “Do not push” “ON” “OFF” ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)
  • Page 43 Warning label on the outer cardboard box of the packaging for: a) This side up b) Caution, fragile c) Protect from humidity d) Keep dry ELCR007-AUM001-V10 Operating instructions CRYOFLOW ICE-CT (2014-11-03)

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