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PFM Medical HICO-VARIOTHERM 555 Instructions For Use Manual
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PFM Medical HICO-VARIOTHERM 555 Instructions For Use Manual

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Instructions for Use
HICO-VARIOTHERM 555

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Summary of Contents for PFM Medical HICO-VARIOTHERM 555

  • Page 1 Instructions for Use HICO-VARIOTHERM 555...
  • Page 2 Instructions for Use HICO-VARIOTHERM 555 pfm medical hico gmbh Wankelstraße 60 50996 Köln, Germany Tel.: +49 (0) 2 21 / 37 67 8 – 0 Fax: +49 (0) 2 21 / 37 67 8 – 85 Email: hico@pfmmedical.com Internet: www.hico.de...
  • Page 3 4.2.1 Requirements on the installation site / operating location ..16 4.2.2 Setting up with the unit carrier (optional) ........ 18 Connecting the HICO-VARIOTHERM 555 ........19 4.3.1 Filling the system ..............19 4.3.2 Connecting the water pads ............. 20 4.3.3...
  • Page 4 8.1.2 Water tank ................57 8.1.3 Hose connections ..............58 Safety check ................59 8.2.1 Standard configuration for the safety check ......59 Troubleshooting ................61 Safety instructions ..............61 Causes of error and troubleshooting ..........62 HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 5 10 Disposal of an old unit ..............64 11 Technical data and accessories ............65 11.1 Technical data ................65 11.2 Accessories ................66 12 Guidelines and manufacturer's declaration ........69 13 Quick Start Guide ................73 HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 6 General information General information Please read the information in this manual to become acquainted with the HICO-VARIOTHERM 555 as quickly as possible and to be able to utilise its functions to the full extent. 1.1 Information regarding these instructions These instructions for use are a component of the HICO-VARIOTHERM 555 (referred to in the following as the “unit”) and provide important...
  • Page 7 ► Follow the instructions in this caution note to avoid the risk of personal injury and damage to property. A note highlights additional information to assist you when working with the unit. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 8 All rights, also the rights for photo-mechanical reproduction, duplication, and distribution by means of special methods (e.g. data processing, data media, and data networks), even in parts, are reserved by the pfm medical hico gmbh. Technical data and content subject to change without notice. 1.5 Manufacturer’s address pfm medical hico gmbh Wankelstraße 60...
  • Page 9 2.1.3 Intended users Use only by trained staff with appropriate specialist knowledge and training, e.g. anesthetists, anesthesiologists, intensive care and operating room nurses, surgeons and medical technicians. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 10 ► In addition to the instructions for use, all generally valid legal and otherwise binding regulations for the prevention of accidents and protection of the environment as well as general safety and performance requirements must be followed. The owner must instruct his personnel accordingly. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 11 For example 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml Sanosil solution). If you have any questions, please contact the Customer Service department of pfm medical hico gmbh. The use of a disproportionately high amount of disinfectant can reduce the lifetime of parts of the unit that come into contact with water.
  • Page 12 ► Do not operate the unit in the vicinity of heat sources (spotlights, direct sunlight, radiators, radiant heaters, etc.). ► Perform maintenance and conduct safety checks according to these instructions for use. ► There is a risk of poisoning if coolant is swallowed. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 13 Danger of hypothermia or hyperthermia There is a risk of the patient becoming overheated or undercooled. ► The body temperature of the patient must be monitored at all times when using the HICO-Variotherm 555. 2.4.2 Risk of burns HF surgery can cause burns...
  • Page 14 Transport and setup 3 Transport and setup 3.1 Scope of delivery and transport inspection The scope of delivery of the HICO-VARIOTHERM 555 consists of: • HICO-VARIOTHERM 555 unit • Power cable (3 meters) • Hose holder • Instructions for Use •...
  • Page 15 ► If possible, keep the original packaging throughout the unit’s lifetime so that you can repack the unit properly in case of repair. ► If the original packaging is not available anymore, then you can request it from the manufacturer. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 16 (the unit may be position a max. of 1 m higher), for example. • The castor stand available as accessory meets all of these requirements. Make sure that all important parts of the unit (switches, power cable, hose connections, etc.) are easily accessible. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 17 Condensation in the unit can lead to failure of the unit. ► After unpacking, the unit must be acclimatised for at least two hours before commissioning when the actual ambient temperature differs from the specified ambient temperature by more than 8 °C. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 18 ► When assembling the stand, follow the safety instructions in the assembly instructions and instructions for use for the stand! ► If a defect is detected, use only original spare parts as replacements and only allow parts to be replaced by a specialist or customer service. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 19 For example 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml Sanosil solution). If you have any questions, please contact the Customer Service department of pfm medical hico gmbh. The use of a disproportionately high amount of disinfectant can reduce the lifetime of parts of the unit that come into contact with...
  • Page 20 In the cooling mode at 5 °C: Raise the nominal temperature slightly before disconnecting the water pad. Otherwise the water in the unit’s circuit can briefly rise above the upper temperature limit or drop below lower temperature limit, and the unit may trigger various alarms. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 21 • The power supply at the installation site must meet the requirements for electrical systems in hospitals and medical environments (see DIN VDE 0100-710 “Low-voltage electrical installations Part 7-710: Requirements for special installations or locations - Medical locations.”). HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 22 14)Decrease the nominal temperature value 15) Handles 16) Water drain outlet 17 ) Nameplate Mains power (power cable socket with fast-acting fuse) 19) Air vents 20) Water drain hose 21) Thread for safety screw (in base plate) HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 23 41.5 °C. The result is a maximum surface temperature on the pad that is below 41 °C. The HICO-VARIOTHERM 555 does not have a function for monitoring the patient’s measured values. ► The core temperature of the patient to be treated must be monitored regularly independent of the application system.
  • Page 24 Design and function 5.3 Symbols Item number Serial number Manufacturer and country of Also involved in the conformity manufacture: assessment procedures: pfm medical hico gmbh SGS Fimko ltd, Wankelstraße 60 Takomotie 8 50996 Köln FI-00380 Helsinki Finland Germany Medical product...
  • Page 25 The transition temperature to be reached on the pad depends on the environmental conditions and the size of the pad. The HICO-VARIOTHERM 555 is characterised by its safe and easy use, reliability, and compact design. Using its electronic control, the temperature transferred to the patient can be adjusted reliably while simultaneously maintaining high operational safety.
  • Page 26 Using the unit can also be hazardous when used for its intended purpose if the desired temperatures cannot be reached due to the ambient conditions. The reliable therapeutic use of the system requires the user to weigh the risks carefully and continuously monitor and care for the patient. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 27 5.4.2 Indications / contraindications / side effects Indications In general, the HICO-VARIOTHERM 555 can be used in hypo/hyperthermia treatment for the following purposes: • Heat supply in case of intraoperative or postoperative hypothermia • Heat supply in case of accidental hypothermia •...
  • Page 28 • Higher wound infection rates (sepsis) • Risk of decubitus In addition, this can cause reversible dilated pupils; for this reason, dilated and unresponsive pupils in an undercooled patient is not necessarily a sign of a serious brain injury. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 29 18 months. The inclusion criteria for newborns is ≥ 36 weeks of pregnancy and an age < 6 hours with acute encephalopathy and peripartum asphyxia. The exclusion criteria is an age > 6 hours and newborns in extremis. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 30 The medical information provided here does not claim to be current or complete since new discoveries are constantly being made in the field of hypo/hyperthermia. The pfm medical hico gmbh is not responsible or liable in any way for negligent or incorrect use and cannot provide any medical recommendations or procedures.
  • Page 31 6.1.2 Water pads • Only connect original HICO hose extensions with HICO water pads or HICO qualified water pads to the HICO-VARIOTHERM 555. • Check the water pads for external damage before connecting. Use only undamaged pads. • Have a collecting basin ready in case a pad should start leaking.
  • Page 32 Direct skin contact with the pad, which is made of plastic, can lead to skin damage and increases the risk of decubitus. ► Make sure there are no creases in the fleece after placement. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 33 • Check the water level on the indicator (2), especially if you have connected an empty water pad or want to connect a second water pad. • After use, switch the unit off using the power switch (8) and disconnect it from the mains supply. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 34 ► The yellow error light (5) is continuously lit or does not light up at all (functional test). ► The unit does not respond when you press a key. In these cases, have the unit to be checked by HICO Customer Service. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 35 In this case, set the temperature to a lower or higher value until the unit can reliably regulate the temperature. Cf. Scott S.M., Thermal blankets injury in the operating room, Arch. Surg. 34, page 181, 1967 HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 36 36 °C to 38 °C, then the heat transfer will double because the temperature difference is doubled from 2 °C to 4 °C. Due to the thermoregulation of the patient, this is only an approximation. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 37 If a nominal temperature is not reached within 60 minutes after switching on the system due to external conditions and the size of the pad, then an alarm message (TEMP.DIFF >1 °C) will appear (see section 6.3.2 “Alarm descriptions during operation”). HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 38 After starting the unit, monitor the nominal and actual temperature differences and, after approx. 45-40 min of operation, set the temperature on the unit to a lower or higher nominal value that approximately corresponds to the actual value. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 39 1 °C. ► The thicker the intermediate layers between patient and water pad are (bed sheets, surgical drapes, gel pads, etc.), the poorer the heat transfer. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 40 2 large pads are connected and the ambient temperature is below 15 °C. The values shown the performance charts are approximate values. In accordance with the requirements of IEC 60601-2-35, the temperature of the system is limited to 40°C. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 41 Pad combinations Performance Chart 1 – Ambient Temperature 26 °C The temperatures shown are reference values from the schematic performance charts of the laboratory analyses. They do not claim to be completely accurate when actually using the system. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 42 Performance Chart 2 – Ambient Temperature 10 °C rreichbare Übergangstemperaturen bei Umgebungstemperatur 40° Reachable transition temperature for an ambient temperature of 40 °C max. reachable temp. min. reachable temp. Pad combinations Mattenkombinationen Performance Chart 3 - Ambient Temperature 40 °C HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 43 The medical information provided here does not claim to be current or complete since new discoveries are constantly being made in the field of hypo/hyperthermia. The pfm medical hico gmbh is not responsible or liable in any way for negligent or incorrect use and cannot provide any medical recommendations or procedures.
  • Page 44 ► Do not use the unit on a patient. ► Have the unit inspected by Customer Service. Checking the temperature control mode During long-term operation, check the nominal temperature setting and actual temperature values shown in the display regularly; see section 6.2.5 and 6.3.2. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 45 • Keep pressing the “Nominal value higher” (12) arrow key until the desired language appears in the display. • About 10 seconds after the last input, the unit will return to its previous operating status, and the last language displayed is the active language. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 46 Before pressing the “Mute audio” key (11) or the power switch (8) to suppress the alarm or take the unit out of service, please read the error message in the display! Source: IEC 60601-1-8 Table 1 – Alarm condition priorities HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 47 Change the temperature setting until the unit is able to regulate the temperature reliably. ► After switching on the unit and changing the temperature setting, this alarm function is suppressed for a defined period of time. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 48 4.2.1 “Requirements on the installation site / operating location”!) If the unit still emits an alarm, take it out of service and have it inspected by a service technician (Customer Service / Medical Technology). HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 49 The alarm automatically turns off when the mains power supply returns. The last temperature setting is stored in the unit. When power is restored, the temperature setting stored must be checked by the user and confirmed before the unit returns to normal operation (see section 6.2 “Operation”). HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 50 HALT” can also be displayed. The source of these error messages may be a software malfunction. • Switch off the unit using the power switch (16) and have it inspected by a service technician (Customer Service / Medical Technology). HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 51 ► Use only disinfectants based on aldehydes, ammonium compounds, or alcohols that do not affect ABS plastics, PVC, or PU on all surfaces and parts. ► Do not use any disinfectants based on phenol derivatives because these will shorten the lifespan of plastic materials. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 52 After the exposure time has expired, disconnect the unit from the mains power supply and completely empty the unit and all accessories. German Association for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from the mhp-Verlag, Wiesbaden HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 53 For example 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml Sanosil solution). If you have any questions, please contact the Customer Service department of pfm medical hico gmbh. The use of a disproportionately high amount of disinfectant can reduce the lifetime of parts of the unit that come into contact with water.
  • Page 54 (e.g. due to MRSA). Do not apply any cleaning and decontamination methods other than the ones recommended by pfm medical hico gmbh. Before introducing new methods, have them checked together with pfm medical hico gmbh.
  • Page 55 Check the pad and the hose extension for damage, deformation, or cracks and replace any damaged accessories. Do not apply any cleaning and decontamination methods other than the ones recommended by pfm medical hico gmbh. Before introducing new methods, have them checked together with pfm medical hico gmbh.
  • Page 56 Please follow these instructions to avoid damage to the unit caused by inadequate maintenance and to ensure trouble-free operation. 8.1 Maintenance We recommend closing a maintenance contract with the pfm medical hico gmbh. By closing a maintenance contract, you fulfil the following requirements: •...
  • Page 57 • Refill the unit with sterile filtered tap water to which a disinfectant has been added as described in section 4.3.1. The max. filling capacity of the unit tank is approx. 1.5 - 2 litres. Drain hose in the holder Drain hose when connected HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 58 The seal rings (O-rings) on all hose connections are subject to aging and can become dry and brittle as a result. You should therefore coat the seal rings with a thin film of silicone paste or petroleum jelly every 6 months. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 59 According to the MPBetreibV (section 6(4)(1+3)), this safety check may only be performed by pfm medical hico gmbh or a qualified person. The safety check covers the following points at a minimum: •...
  • Page 60 Maintenance and safety check Questions regarding service, maintenance, or safety checks should be addressed directly to: pfm medical hico gmbh Wankelstraße 60 50996 Köln, Germany Tel.: +49 (0)2 21 / 3 76 78-0 Fax: +49 (0)2 21 / 3 76 78-85 Email: hico@pfmmedical.com...
  • Page 61 Opening the unit by unauthorised persons will void all rights to any guarantee and warranty claims. ► Repairs to the unit may only be performed by the pfm medical hico gmbh or by experts trained and/or authorised by the pfm medical hico gmbh.
  • Page 62 The 3 causes indicated have an adverse cooling mutual affect on each other, which Ambient temperature too high means at least one cause must be and/or eliminated. temperature setting too low and/or water pad too large (2 water pads) HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 63 Switch off unit until power returns acoustic alarm Check the connector on unit and in Mains connector does not make the socket for correct fit contact Customer service* Customer service* Fuse defective Unit defective * Switch off the unit immediately HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 64 In accordance with the local waste management regulations, the water pad can be disposed of together with domestic waste for incineration. HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 65 Technical data and accessories 11 Technical data and accessories 11.1 Technical data HICO-VARIOTHERM 555 Item No. (REF): 600001 (220-230 V) 600021 (110-115 V) ~220-230 V, 50/60 Hz Rated voltage: ~110-115 V, 50/60 Hz Power consumption: 220-230 V, 440 W 110-115 V, 440 W Current consumption: 220-230 V, approx.
  • Page 66 4042301Z1204AAVT Basic UDI-DI: Subject to technical changes without notice. It is not permitted to make changes to the HICO-Variotherm 555! ► No modification of this equipment (device and accessories) is allowed. 11.2 Accessories Only original HICO qualified water pads and the corresponding hose extensions (required accessories) may be used together with the HICO- VARIOTHERM 555.
  • Page 67 • Female/male drain hose coupling (optional accessories; use only to drain the HICO PU pads) REF 550077 / 550078 • Female/male drain hose coupling SP (optional accessories; use only to drain the HICO PU pads SP) REF 550177 / 550178 HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 68 ► Assembly, handling, and use require you to follow these safety instructions carefully. ► To ensure the stability of the HICO-VARIOTHERM 555, the panel must not be inserted in the top position. Use the middle position! ► The unit must be screwed to the insert panels using the 2 knurled thumb screws included! ►...
  • Page 69 Guidelines and manufacturer's declaration – electromagnetic interference The HICO-Variotherm 555 is designed for operation in the electromagnetic environments listed in the tables and text of these instructions for use. The customer or user of the unit or system should ensure that the unit is used in an appropriate environment.
  • Page 70 Guidelines and manufacturer’s declaration – Electromagnetic immunity The HICO-Variotherm 555 is designed for operation in an electromagnetic environment like the one listed below. The customer or user of the HICO-Variotherm 555 should ensure that the device is used in such an environment.
  • Page 71 Guidelines and manufacturer’s declaration – Electromagnetic immunity The HICO-Variotherm 555 is designed for operation in an electromagnetic environment like the one listed below. The customer or user of the HICO-Variotherm 555 should ensure that the device is used in such an environment.
  • Page 72 If the measured field strength in the location in which the HICO-Variotherm 555 is used exceeds the compliance level listed above, then the HICO-Variotherm 555 should be monitored to verify normal operation.
  • Page 73 • Acoustic alarms of medium priority (“WATER LEVEL!?” and “TEMP.DIFF > 1°C”) can be interrupted for 10 minutes using the “Mute audio” key. • All other acoustic alarms of medium priority cannot be interrupted. Switch off the unit using the mains switch (8). HICO-VARIOTHERM 555 GA-602801-EN-05...
  • Page 74 ► The alarm signal tone continues to sound or does not sound at all (functional test). ► The unit does not respond when you press a key. ► The unit does not respond as described in section 6.2.3 “Functional test” when switching on the unit or during a function test. HICO-VARIOTHERM 555 GA-602801-EN-05...