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Related Manuals for HILOTHERM ChemoCare-CIPN
Summary of Contents for HILOTHERM ChemoCare-CIPN
- Page 1 Instructions for use HILOTHERM HT02 ChemoCare-CIPN ChemoCare-CIPN Instructions for use HILOTHERM GmbH Wittumweg 38 0123 D-88260 Argenbühl Iron Resin Phone +49 / 75 66 / 9 11 99 - 1 - HT02 ChemoCare CIPN englisch 2022-02-10 cs...
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Page 2: Table Of Contents
Instructions for use HILOTHERM HT02 ChemoCare-CIPN Table of contents 1.General description9.Cuffs 1.1 Purpose 9.1 Variants and material properties 1.2 Usages of application 9.2 Warning notes 1.3 Indications and contraindications 9.3 Product use 1.4 Requirements for operators 9.4 Risk classification 1.5 Device description 9.5 Application description... -
Page 3: Purpose
1. General description 1.1 Purpose HILOTHERAPIE using the Hilotherm ChemoCare System is a form of physical thermotherapy that uses a constant temperature in the range of 5°C to 25°C locally. Applications lasting several hours can be carried out without temperature deviations. Used prophylactically, HILOTHERAPY with significantly reduces the risk of chemotherapy-induced polyneuropathy (CIPN) –... -
Page 4: Requirements For Operators
DisplayThe display (item 03) shows the set values and the operating status. The following describes the use of a cooling unit of the ChemoCare system. The two cooling units of the HILOTHERM ChemoCare System are identical and can therefore be operated in the same way. -
Page 5: Safety Instructions
Instructions for use HILOTHERM HT02 ChemoCare-CIPN 2. Safety instructions 2.1 General safety instructions • Before commissioning, the user must check the correct condition of the device and user part. • The therapy facility always consists of the Hilotherapy device, connecting tube and cuff(s). -
Page 6: Commissioning
Instructions for use HILOTHERM HT02 ChemoCare-CIPN At higher temperatures, the guaranteed cooling capacity cannot be provided. If the device has been exposed to temperatures that are far outside the specified temperature range, it should be waited before commissioning until the device has reached room temperature. - Page 7 Instructions for use HILOTHERM HT02 ChemoCare-CIPN associated return from the cuffs. • During initial commissioning and after water change, ventilate the pump system, see 3.3. • Plug in the power plug. • Turn on the device at the main switch on the back of the device. When switched on, the device checks itself.
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Page 8: Connecting The Cuffs
Instructions for use HILOTHERM HT02 ChemoCare-CIPN 3.6 Connecting the cuffs and hose attachment • Cuff and connection hose are connected (audible snapping of the locking grommets into the couplings). • The hose is plugged into the couplings with the locking grommets (Fig. 1). -
Page 9: Cleaning And Disinfection
Instructions for use HILOTHERM HT02 ChemoCare-CIPN Diagnosis " indicator appears If an error occurs, the "E . Only the current error is displayed. The display can only be deleted when the error has been resolved. For troubleshooting and troubleshooting measures, see item 7.4. -
Page 10: Grease Plug Connections
Instructions for use HILOTHERM HT02 ChemoCare-CIPN The heat exchanger is located behind the ventilation grille on the right side of the unit. • Remove the three Phillips screws in the floor under the ventilation grille. Caution: The screws with hexagon socket must not be loosened! •... -
Page 11: Liability
Instructions for use HILOTHERM HT02 ChemoCare-CIPN 5.6 Liability HILOTHERM GmbH (as the manufacturer) is only liable for the effects on the safety, reliability and functionality of this device if: • Assembly, extensions, new hires, modifications or repairs are carried out by authorized persons of the manufacturer. -
Page 12: Characters
Instructions for use HILOTHERM HT02 ChemoCare-CIPN Dimensions 430 mm x 275 mm x 268 mm Weight 10 kg Cuff connections Capacity water tank min.1.25 liters, max. 2.25 liters Temperature range + 5°C to + 25 °C Control/setting tolerance ± 1°C... - Page 13 EC Council Directive 93/42/EEC on medical devices of 14 June 1993 Medical Devices Act MPG of 02 August 1994 DIN EN 60601-1 DIN EN 60601-1-2 DIN EN ISO 10993-1 HILOTHERM GmbH reserves the right to change specifications without notice. 7.4 Faults and troubleshooting Error Possible cause Measures 1.
- Page 14 A successfully performed reset can be recognized by the fact that the operating hours on the start display are set to "0h". 8. Accessories and spare parts All spare parts and accessories are available from HILOTHERM GmbH or an authorized dealer. Accessories Only original HILOTHERM accessories may be used.
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Page 15: Variants And Material Properties
Instructions for use HILOTHERM HT02 ChemoCare-CIPN 9. Cuffs 9.1 Variants and material properties For the Hilotherm ChemoCare System, the following cuffs are to be used for thermotherapeutic application in anatomically adapted form: • Hand cuff • Foot cuff slippers Material properties: TPU (thermoplastic polyurethane) –... -
Page 16: Application Description
Instructions for use HILOTHERM HT02 ChemoCare-CIPN • the application on the patient. The cuffs are intended only for contact with intact skin. Pathologically altered skin areas (e.B. abrasions, infectious wounds) or surgical wounds must be provided with a wound dressing before treatment. -
Page 17: Control And Testing
Instructions for use HILOTHERM HT02 ChemoCare-CIPN A hygiene and disinfection plan with corresponding process descriptions and work instructions as part of the quality management must be drawn up by the operator in order to be able to document a comprehensible and validated treatment process. - Page 18 Guidelines and manufacturer's declaration - Electromagnetic emissions The Hilotherm Chemocare is designed to operate in an electromagnetic environment as specified below . The customer or user of The Hilotherm Chemocare should ensure that it operates in such an environment. Emission measurements...
- Page 19 Instructions for use HILOTHERM HT02 ChemoCare-CIPN interruptions and (>95% drop in typical business or hospital fluctuations of the for 1/2period environment. If the user of the supply voltage Hilotherm Chemocare according to IEC requests continued function 61000-4-11 (60% drop in...
- Page 20 Guidelines and Manufacturer's Statement - Electromagnetic immunity for ME equipment or ME systems that are not life-sustaining. The Hilotherm Chemocare is designed to operate in the electromagnetic environment specified below. The client or user of the Hilotherapy system should ensure that it is used in such an environment.
- Page 21 The Hilotherm Chemocare is designed to operate in an electromagnetic environment where RF disturbances are controlled. The customer or user of the Hilotherm Chemocare can help to avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the Hilotherm Chemocare, depending on the output power of the communication device, as specified below.
- Page 22 Instructions for use HILOTHERM HT02 ChemoCare-CIPN - 22 - HT02 ChemoCare CIPN englisch 2022-02-10 cs...
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