This document describes the HILOTHERM Chemo Care System (Type HT02-c), a mobile device designed for localized, professional cold treatment, specifically for thermotherapy.
Function Description
The HILOTHERM Chemo Care System provides physical thermotherapy by maintaining a local constant temperature in the range of 5°C to 25°C. This system is used as a prophylactic measure to significantly reduce the risk of chemotherapy-induced polyneuropathy (CIPN), also known as hand-foot syndrome (HFS).
The working principle involves lowering tissue temperature to slow down blood circulation and metabolism, thereby preventing chemotherapeutic agents from penetrating the capillaries of the extremities. This is achieved by delivering the chemotherapeutic agent via sweat glands to the skin surface, where "free radicals" form upon contact with oxygen, damaging tissue cells, especially where the cornea is pronounced (e.g., palms and soles of the feet).
The system consists of a temperature control unit and specialized hand and foot cuffs. The therapy device, along with the cuffs and connecting hoses, forms a closed-circuit system through which a cooling medium flows, maintaining the set temperature constantly. Applications can be carried out for several hours without temperature deviations.
Thermotherapy with "Hilotherm Chemo Care" is used prophylactically before and during chemotherapy to reduce the risk of chemotherapy-induced polyneuropathy. The application should last for half an hour before and during chemotherapy.
Indications for Hilotherapy:
- Chemotherapy-induced polyneuropathy (CIPN).
- Common complications in chemotherapy with cytostatic drugs such as Carboplatin, Capecitabine, 5-FU, Cyclophosphamide, Cytarabine, Docetaxel, Doxorubicin, Oxaliplatin, Paclitaxel, Sorafinide, and Sunitinib, which can lead to hand-foot syndrome.
- Symptoms include numbness on hands and feet with gait insecurity, decreased tactile sensation, loss of depth sensitivity, loss of temperature perception, burning pain, disruption of coordination, and hypersensitivity of the skin.
Contraindications of Hilotherapy:
- All forms of cold application in the presence of Cryoglobulinemia, cold hemagglutination, and histamine release.
- Cold urticaria / cold contact urticaria.
- Diseases from the area of functional circulatory disorders (e.g., M. Raynaud), severe arterial disease, pronounced sensory disturbances, and trophic tissue lesions.
Important Technical Specifications
- Type: HT02-c
- Article No.: 2020 0012
- Nominal Voltage: 230 VAC 50 HZ
- Power Input: max. 320 VA
- Power Consumption: 2.5 A
- Fuse Value: T 2.5 A 250 V
- Protection Class: I
- Degree of Protection for Application Part: B
- Type of Protection: IP 20
- Risk Class (93/42 EWG): IIa (active medical product for therapeutical purposes)
- GMDN Classification: Device: P 42463, Cuffs: P 44604
- Dimensions: 430 mm x 275 mm x 268 mm
- Weight: 10 kg
- Cuff Connections: 2
- Water Tank Capacity: min. 1.25 litres, max. 2.25 litres
- Temperature Range: +5 °C to +25 °C
- Control/Adjustment Tolerance: ±1 °C
- Pressure Pump Nominal Voltage: 15 V
- Operating Pressure: 0.5 bar +0.1
- Heating Unit Nominal Voltage: 230 V
- Power Input (Heating Unit): 220 VA
- Refrigerant: R 134a
- Filling Quantity (Refrigerant): 100 g
- Ambient Conditions (Storage Temperature): min. +0 °C, max. +40 °C
- Ambient Conditions (Storage Humidity): 10 - 70% RH non-condensing
- Ambient Conditions (Operating Temperature): +10 °C to +25 °C
- Ambient Conditions (Operating Humidity): 0 - 80% rel. humidity, non-condensing
- Cuff Material: Thermoplastic Polyurethane (TPU) - latex-free
- Tubing Material: Thermoplastic Polyurethane (TPU)
- Plug-in Nozzle Material: Nickel-plated brass / POM
Usage Features
- Simple Operation: The system is designed for simple handling and ease of operation, allowing operation by nursing staff or patients themselves, though supervision by qualified medical personnel is required.
- Temperature Setting: Adjustable from +5°C to +25°C.
- Continuous Duty: The device is designed for continuous operation.
- Display: Shows set values and current operating conditions.
- Malfunction Indication: Visual and acoustic alarms, with malfunction codes displayed.
- Cuff Connections: Cuffs are connected via grommets on couplings, secured by an audible click.
- Filling: The tank should only be filled with demineralized water. The fill level indicator shows between "min" and "max" markings.
- De-airing: The system includes a de-airing set to remove air from the circuit.
- Stopping Operation: A "Stop" button is available to halt operation. The device can be switched off via the main switch on the rear. For longer periods of disuse, it should be disconnected from the power supply.
- Electromagnetic Compatibility (EMC): Designed to be installed and commissioned according to EMC directions. Portable and mobile radio communication devices may interfere, so the system should not be operated next to or on top of other appliances unless closely observed.
Maintenance Features
- Lifecycle: With proper use and maintenance, the device can reach a lifecycle of 10 years or more.
- Water Filter and Water Exchange: Replace the water filter and exchange water at least every 6 months. This involves removing the grating, filter, vent plug, and draining the water, then refilling with distilled water and a preserving agent (e.g., Ebotec MG).
- Heat Exchanger Cleaning: Clean the heat exchanger at least every 6 months or if contamination is visible. This involves removing the ventilation grille and carefully dusting off the cooling plates.
- Plug-in Connections Greasing: Grease the plug-in connections (tips of nozzles on cuffs and tubes) with Vaseline at least every 6 months to ensure easy plugging and complete engagement of O-rings.
- Technical Service (Visual Inspection): Conducted at least once every 2 years, checking for completeness and legibility of operating instructions, type plate, markings, secure components, intact casing, functional plug-in connections, switches, buttons, correct master fuse, undamaged mains plug and power cord, clean device and accessories, and clean venting slots/heat exchanger. Water filter and distilled water should be exchanged.
- Technical Service (Functional Test): Conducted at least once every 2 years, testing the cooling unit, heating unit, pressure pump, and water level sensor.
- Safety Related Inspections: Carried out during production and if repair work is done on electrical systems. The operator is responsible for determining the scope and interval, but no later than every 2 years.
- Cleaning and Disinfection:
- Machine Surface: Clean and disinfect with standard detergents and surface disinfectants approved for clinical use, ensuring no fluids enter the device through venting slots.
- Cuffs: Manual cleaning and disinfection of non-single-use cuffs should be performed after treatment using approved cleaning and surface disinfectants. Wiping disinfection is recommended for smooth surfaces, and wipe or spray disinfection for fabric-like surfaces. Cuffs and insulation are made of polyurethane, compatible with various disinfectants. At least 10 conditioning cycles can be performed on multiple collars.
- Machine Cleaning (Non-critical medical devices): Can be cleaned, disinfected, rinsed, and dried in a washer-disinfector with a validated chemical or chemical-thermal process at max. 55°C.
- Basic Device: The ABS plastic surface can be treated with wiping disinfection. Disinfection of the cooling circuit is not necessary if maintenance requirements and regular water changes are observed.
- Checkup (Cuffs): After cleaning and disinfecting, visually inspect cuffs for damage (foil, tubing, plug-in nozzles). Damaged cuffs must be discarded. Check for residual dirt and repeat cleaning if necessary. Before applying to a patient, attach the cuff to the device and fill it to check for leaks.
- Sterilization: Cuffs cannot be sterilized.
- Disposal: The device must not be disposed of with commercial waste or regular garbage. It should be disposed of at a communal collecting point or returned to the manufacturer, in accordance with product responsibility regulations. The appliance contains refrigerant R134a and the compressor unit contains oil.
- Storage: Store dry and horizontal at 5°C to 40°C, 10-70% RH, and air pressure of 700-1060 hPa. If stored below 0°C, the water in the cooling circuit must be completely drained to prevent freezing damage.
- Transport: Empty the device completely before transport. Do not tilt the device during transport. If tilted, let it stand for 24 hours to regain full capacity. Transport should only be via a logistics company on a pallet to prevent damage.
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