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PFM Medical HICO-AQUATHERM 660 Instructions For Use Manual
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PFM Medical HICO-AQUATHERM 660 Instructions For Use Manual

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Instructions for Use
HICO-AQUATHERM 660

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Summary of Contents for PFM Medical HICO-AQUATHERM 660

  • Page 1 Instructions for Use HICO-AQUATHERM 660...
  • Page 2 Instructions for Use HICO-AQUATHERM 660 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 Requirements on the installation site / operating location ..16 4.2.2 Mounting on a wall rail (optional) ........... 18 4.2.3 Installation with five-castor stand (optional) ......18 Connecting the HICO-AQUATHERM 660 ........19 4.3.1 Filling the system ..............19 4.3.2 Connecting the water pads ............. 20 4.3.3...
  • Page 4 7.2.1.4. Flushing and refilling............. 50 7.2.2 Surfaces ................50 7.2.3 Ventilation slots ..............50 Water pads, hose extension ............52 Maintenance and safety check............53 Maintenance ................53 8.1.1 Unit ..................54 8.1.2 Water tank ................54 GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 5 Causes of error and troubleshooting ..........58 10 Disposal of an old unit ..............60 11 Technical data, unit, and accessories..........61 11.1 Unit ..................61 11.2 Accessories ................62 12 Guidelines and manufacturer's declaration ........64 13 Quick Start Guide ................68 GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 6 General information 1 General information Please read the information in this manual to become acquainted with the HICO-AQUATHERM 660 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-AQUATHERM 660 (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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • 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 Intended user 2.1.3 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • 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 ► In hyperthermia mode, do not use or combine the unit together with other heat sources. ► 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 13 When used as intended, the lead in the alloys is not released and does not represent any risk to the user. As an additional precaution, we recommend that you wear gloves when changing the HICO-Hose extension and connecting the equipotential bonding bolt. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 14 Transport and setup 3 Transport and setup 3.1 Scope of delivery and transport inspection The scope of delivery of the HICO-AQUATHERM 660 consists of: • HICO-AQUATHERM 660 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 16 (max. height difference approx. 1 m), for example. The five-castor stand (see section 4.2.3) 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 18 (3). • Place the HICO-AQUATHERM 660 on the cylinder (2) of the five-castor stand. • Fasten the unit in place using the star knob (3).
  • 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 water! The use of too much disinfectant can also immediately cause malfunctions, for example due to the excessive formation of foam!³...
  • Page 20 In the heating mode at 39 °C: Reduce the nominal temperature before disconnecting the water pad. Otherwise the water in the unit’s circuit can briefly rise above the upper temperature limit, and the unit may trigger various alarms. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 21 • The power supply at the installation site must meet the requirements for electrical systems in hospitals and medical environments (see VDE 0100- 710 “Low-voltage electrical installations Part 7-710: Requirements for special installations or locations - Medical locations.”). GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 22 20) Release > 38 °C 21) Decrease the nominal temperature value Rear view of the unit: 5a) Water drain outlet with screw 22) Equipotential bonding bolt with colour marking and label 23) Microfuse and power cable socket GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 23 41.5 °C. The result is a maximum surface temperature on the pad that is below 41 °C. The HICO-AQUATHERM 660 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 Germany Finland 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-AQUATHERM 660 is characterised by its safe and easy use, reliability, and compact design. Using its electronic control, the heat 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 27 Indications / contraindications / side effects 5.4.2 Indications In general, the HICO-AQUATHERM 660 can be used in hyperthermia treatment for the following purposes: • Heat supply in case of intraoperative or postoperative hypothermia • Heat supply to stabilize the patient´s temperature (normothermia) •...
  • Page 28 • Autonomous reactions (among others, shivering) • Electrolyte imbalances • Excess urination (diuresis fluctuations) • Hyperglycaemia (glycaemic fluctuations) • Greater blood loss (due to reduced blood-clotting factors) • Changes in the pharmacokinetics • Higher wound infection rates (sepsis) • Risk of decubitus GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 29 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 30 Water pads 6.1.2 • Only connect original HICO hose extensions with HICO water pads or HICO qualified water pads to the HICO-AQUATHERM 660. • 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 31 (e.g. the operating table) and the higher the ratio of the contact area with the patient to the total area of the heating pad, the higher the percentage of the total heat output that is transferred to the patient. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 32 • Check the water level on the indicator (6), especially if you have connected an empty water pad. • After use, switch the unit off using the power switch (16) and disconnect the power cable from the mains supply. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 33 ► The yellow error light (13) 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 34 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 GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 35 With a larger contact area, more heat is transferred, even when the temperature difference is smaller. The pad temperature - i.e. the nominal temperature value - can be set to a value that is closer to the patient’s temperature. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 36 If a nominal temperature is not reached within 30 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”). GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 37 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 38 This leads to the following restrictions: • No restrictions 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 39 °C. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 39 Smallest pad Performance Chart 1 - Ambient Temperature 10 °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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 40 Performance Chart 2 - Ambient Temperature 20 °C 45 °C 40 °C 35 °C 30 °C 25 °C 20 °C 15 °C 10 °C 5 °C °C Largest pad Smallest pad Performance Chart 3 - Ambient Temperature 30 °C GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 41 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 42 ► 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 43 • Keep pressing the “Nominal value higher” (19) 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 44 Display message: WATER LEVEL!? The unit triggers this alarm when the water level drops below the MIN mark on the water level indicator (6) during operation. The display shows Source: IEC 60601-1-8 Table 1 – Alarm condition priorities GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 45 (e.g. 39 °C) cannot be reached in this case. 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 46 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). GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 47 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). GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 48 ► 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 49 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 GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 50 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 51 (Customer Service, Medical Technology). Do not open the unit yourself. 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 52 Check the pad for damage, deformation, and cracks; replace the pad if necessary. 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 53 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 54 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 55 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 56 Any additional costs arising from such measures shall be borne by the customer. 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...
  • Page 57 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 58 Alarm + display message every 10 min.: Strong foam formation in the tank “TEMP.DIFF. > 1°C” Change the water* Bypass interrupted Lack of heat output Customer service* Do not operate unit continuously (> 1h) without a heating pad* GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 59 Unit does not function at all and 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 GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 60 In accordance with the local waste management regulations, the water pad can be disposed of together with domestic waste for incineration. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 61 Technical data, unit, and accessories 11 Technical data, unit, and accessories 11.1 Unit HICO-AQUATHERM 660 Item No. (REF): 590001 (220-230 V) 590020 (110-115 V) 220-230 V, 50/60 Hz Rated voltage: 110-115 V, 50/60 Hz 220-230 V, 530 W Power consumption: 110-115 V, 560 W 220-230 V, approx.
  • Page 62 Technical data, unit, and accessories Subject to technical changes without notice. It is not permitted to make changes to the HICO-Aquatherm 660! ► No modification of this equipment (device and accessories) is allowed. 11.2 Accessories • Only HICO qualified water pads (required accessory) may be used together with the HICO-AQUATHERM 660.
  • Page 63 • 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. GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 64 Guidelines and manufacturer's declaration – electromagnetic interference The HICO-Aquatherm 660 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 65 Guidelines and manufacturer’s declaration – Electromagnetic immunity The HICO-Aquatherm 660 is designed for operation in an electromagnetic environment like the one listed below. The customer or user of the HICO-Aquatherm 660 should ensure that the device is used in such an environment.
  • Page 66 Guidelines and manufacturer’s declaration – Electromagnetic immunity The HICO-Aquatherm 660 is designed for operation in an electromagnetic environment like the one listed below. The customer or user of the HICO-Aquatherm 660 should ensure that the device is used in such an environment.
  • Page 67 If the measured field strength in the location in which the HICO-Aquatherm 660 is used exceeds the compliance level listed above, then the HICO-Aquatherm 660 should be monitored to verify normal operation.
  • Page 68 • 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 power switch (16). GA-592801-EN-05 HICO-AQUATHERM 660...
  • Page 69 ► 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. GA-592801-EN-05 HICO-AQUATHERM 660...