Table of Contents
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Table of Contents
Troubleshooting
Related Manuals for Hico Medical Systems HICO-VARIOTHERM 550
Summary of Contents for Hico Medical Systems HICO-VARIOTHERM 550
- Page 1 Instruction for use Hypo/Hyperthermia unit HICO-VARIOTHERM 550...
- Page 2 Instruction for use HICO-VARIOTHERM 550 Hirtz & Co. KG Bonner Str. 180 50968 Cologne, Germany Tel.: +49 (0) 2 21 / 37 67 8 – 0 Fax: +49 (0) 2 21 / 37 67 8 – 85 e-mail: info@hico.de Internet: www.hico.de Doc.
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Page 3: Table Of Contents
4.2.1 Requirements concerning the place of installation ..15 4.2.2 Setting up with the unit carrier (optional) ......17 4.2.3 Installation with five-castor stand (optional)..... 18 4.3 Connecting the HICO-VARIOTHERM 550 ...... 19 4.3.1 Filling the system ............19 4.3.2 Connecting the water pads..........20 4.3.3 Electrical connection ............ - Page 4 8.1 Maintenance ..............55 8.1.1 Unit .................. 56 8.1.2 Water tank ............... 56 8.1.3 Hose couplings ..............56 8.2 Safety related inspection ..........57 9 Troubleshooting ..........59 9.1 Safety information ............59 9.2 Fault causes and troubleshooting ........ 60 HICO-VARIOTHERM 550...
- Page 5 10 Waste disposal of old unit ........62 11 Technical data and accessories ......63 11.1 Unit ................... 63 11.2 Accessories ..............64 11.3 Symbols ................66 12 Guidelines and declaration of manufacturer ..67 13 Brief instruction........... 71 HICO-VARIOTHERM 550...
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Page 6: General Information
General information 1 General information Read the information provided here so that you can quickly become familiar with the HICO-VARIOTHERM 550 and use its functions to their full extent. 1.1 Information regarding these instructions These operating instructions are a component of the HICO-... -
Page 7: Warnings
No claims can be enforced on the basis of information, illustrations and descriptions in these operating instructions. The manufacturer accepts no responsibility for loss in the event HICO-VARIOTHERM 550... -
Page 8: Copyright
Hirtz & Co. KG. Subject to changes in contents and technical modifications. 1.5 Manufacturer adress Hirtz & Co. KG Bonner Str. 180 50968 Cologne Tel.: 02 21 / 3 76 78-0 Fax: 02 21 / 3 76 78-85 e-mail: hirtz@hico.de HICO-VARIOTHERM 550... -
Page 9: Safety
The operating company is the sole bearer of the risk. In these operating instructions the term "water pad" describes all Hirtz accessories, such as water mats, water blankets, Accessories water collars, etc. (see also chapter 11.2 HICO-VARIOTHERM 550... -
Page 10: Personnel Requirements
► All generally valid legal and otherwise binding regulations for the avoidance of accidents and the protection of the environment, as well as general health and safety requirements must be observed in addition to the operating instructions. The operator must instruct his personnel accordingly. HICO-VARIOTHERM 550... -
Page 11: General Safety Information
Alternatively, another long-term germinating preservative can also be used, e.g. Micropur or Certisil. For further information, please contact Hirtz & Co.KG. The use of a disproportionately high amount of disinfectant can reduce the lifetime of unit parts that come into contact with water! HICO-VARIOTHERM 550... -
Page 12: Danger Sources
2.4.1 Danger of hypothermia or hyperthermia There is a risk of the patient may be overheated or undercooled. ► The body temperature of the patient must be monitored when using the unit and the water pad on the patient. HICO-VARIOTHERM 550... -
Page 13: Transport And Setup
Transport and setup 3 Transport and setup 3.1 Scope of delivery and transport inspection The delivery specification of the HICO-VARIOTHERM 550 consists of: • HICO-VARIOTHERM 550 unit • Mains cable • Hose bracket • Operating instructions • Hose extension • Water pads (optional according to order) ►... -
Page 14: Waste Disposal Of Packaging Material
»Green Dot« recycling system. ► If possible, keep the original packaging throughout the unit's lifetime so as to be able to repack the unit properly in case of repair. HICO-VARIOTHERM 550... -
Page 15: Commissioning
• must be at the same level as the water pad, i.e. next to the patient's bed (max. height difference approx. 0.5 m), for example. The carrier or the five-castor stand (see chapter 4.2.2 and 4.2.3) available as accessories meet all of these requirements. HICO-VARIOTHERM 550... - Page 16 Condensation in the device can lead to failure. ► If the temperature differences reach more than 8 °C during installation of the device for the intended operating environment ambient temperature, allow the unit to acclimatise for at least two hours before use. HICO-VARIOTHERM 550...
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Page 17: Setting Up With The Unit Carrier (Optional)
(K2B0045). • There are two elongated holes in the base of the stand; place the HICO-VARIOTHERM 550 on the base of the stand in such a way that the elongated holes and the thread in the base of the unit are aligned with one another. -
Page 18: Installation With Five-Castor Stand (Optional)
4.2.3 Installation with five-castor stand (optional) The five-castor stand available as an accessory makes the HICO-VARIOTHERM 550, designed as a stationary unit, mobile. Install the unit together with the stand as follows: • Assemble the five-castor stand as described in its operating instructions. -
Page 19: Connecting The Hico-Variotherm 550
Commissioning 4.3 Connecting the HICO-VARIOTHERM 550 Danger caused by water in connection with electricity. ► Only connect the unit to the mains supply after it has been filled. 4.3.1 Filling the system • Unscrew the cap from the water filling socket (5), e.g. with a coin. -
Page 20: Connecting The Water Pads
In cooling operation at 15 °C: Increase the nominal temperature before decoupling the water pad. The water in the unit circuit may otherwise briefly go above the upper or lower limit temperature and the unit may trigger various alarms. HICO-VARIOTHERM 550... -
Page 21: Electrical Connection
• Power supply at the installation site must meet the requirements for electrical systems in hospitals and medical environments (see VDE 0100 Part 710:2012-10 "Low-voltage electrical installations Part 7-710: Requirements for special installations or locations - Medical locations."). HICO-VARIOTHERM 550... -
Page 22: Function And Design
15) Water flow display 16) Mains switch 17) Functional test 18) Audio paused 19) Nominal value higher 20) Release <35 °C / >38 °C 21) Nominal value lower Rearview (section) of the unit with microfuse and connector plug HICO-VARIOTHERM 550... -
Page 23: Safety Installations
• whether its own functional safe and emits alarms in case of malfunctions (see chapter 6.3). The HICO-VARIOTHERM 550 application system has no monitoring function for measuring of the patient. ► Monitoring core temperature of the patient to be treated must be carried out regularly independently of the application system. -
Page 24: Type Plate
Function and design 5.3 Type plate The type plate with the connection and performance data is located on the rear side of the unit: HICO-VARIOTHERM 550... -
Page 25: Function
Reaching the transition temperature of the pads is dependent on the environmental conditions and the size of the pad. The HICO-VARIOTHERM 550 is characterised by its simple and safe use, reliability and compact design. Through its electronic control, the temperature transfer to the patient can be accurately adjusted whilst at the same time maintaining high operational safety. - Page 26 (see chapter 6.2.8 Schematic performance descriptions), may also lead to restrictions in the intended use. Operating the HICO-VARIOTHERM 550 is simple and intuitive, incorrect use is almost ruled out. Danger caused by overestimation and underestimation of...
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Page 27: Indications / Side Effects / Contraindications
(pad size, ambient temperature etc.) ► individual and unpredictable patient reactions. The reliable therapeutic use of the system requires the user to carry out a careful risk assessment and continuous monitoring and care of the patient. HICO-VARIOTHERM 550... - Page 28 • change to the pharmacokinetics, • increased rate of wound infection (sepsis), • risk of decubitus In addition, this can cause reversible dilated pupils; dilated fixed pupils in an undercooled patient, therefore, must not be a sign of a serious brain injury. HICO-VARIOTHERM 550...
- Page 29 • persistent state of shock / cardiopulmonary instability • pregnancy • coma of different origin • body temperature below 30 °C during the recording • time interval when starting resuscitation and cardiac arrest above 15 minutes • application distal of arterial cross-clamping HICO-VARIOTHERM 550...
- Page 30 Hirtz & Co. KG has no responsibility or liability for negligence or false applications and also cannot specify any medical recommendations and procedures. The user must independently weigh up what is used and how this is carried out. HICO-VARIOTHERM 550...
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Page 31: Control And Operation
6.1.2 Water pads • Only connect original HICO hose extensions with HICO water pads to the HICO-VARIOTHERM 550. • Check the water pads for external damage before connecting. Use only undamaged pads. • Prepare a collecting basin in case a pad should start leaking. - Page 32 ► The use of a thin fleece as an intermediate layer is recommended. Direct skin contact with the pad, which is made of plastic, can lead to skin damage and increases the risk of bedsore. ► Pay attention to crease-free installation of the fleece. HICO-VARIOTHERM 550...
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Page 33: Operation
(20) if it is. • Check the water level on the indicator (6), especially if you have connected an unfilled water pad. • After use, switch the unit off using the pressure switch (16) and disconnect the plug from the mains. HICO-VARIOTHERM 550... -
Page 34: Function Test
► the automatic functional test automatically switches the unit off because it has detected a defect in the independent protection device. ► one or more displays are defective. In these cases, have the unit checked by HICO customer service. HICO-VARIOTHERM 550... -
Page 35: Setting The Temperature
In this case, set a lower or higher nominal value so the unit can safely regulate the temperature. Check the water flow on the display (15)! cf. Scott S.M., Thermal blankets injury in the operating room, Arch. Surg. 34, Page 181, 1967 HICO-VARIOTHERM 550... - 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 approximately true. HICO-VARIOTHERM 550...
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Page 37: Temperature Control Operation
60 mins after switching on the system, an alarm message (TEMP.DIFF >1 °C) see chapter 6.3.2 Alarm descriptions during operation…; In this case, adjust the nominal value to the actual value displayed. Check the water flow in the display (15)! HICO-VARIOTHERM 550... -
Page 38: Handling Water Pads
After commissioning the unit, observe the nominal and actual temperature differences and in this case set a lower or higher nominal value after approx. 45-40 min after operation, corresponding to the actual value on the unit. HICO-VARIOTHERM 550... - Page 39 1 °C. ► The thicker the intermediate layers are between patient and water pad (bed sheets, surgical cloths, gel pads etc.), the worse the heat transfer. HICO-VARIOTHERM 550...
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Page 40: Schematic Performance Description
23 °C is expected for the vest. The details of the performance descriptions are approximate values. In accordance with the requirements of DIN EN 80601-2-35:2009 August 2010, the system is limited to 40 °C temperature attainment. HICO-VARIOTHERM 550... - Page 41 Performance chart 1 The temperature data are reference values from the schematic performance descriptions of the laboratory investigations. They do not claim the accuracy in the practical use of the system. HICO-VARIOTHERM 550...
- Page 42 Performance chart 2 Ambient temperature 30 °C 45 °C 40 °C 35 °C 30 °C 25 °C 20 °C 15 °C 10 °C 5 °C °C largest pad smallest pad head wrap vest Performance chart 3 HICO-VARIOTHERM 550...
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Page 43: Obligations During Operation
Hirtz & Co. KG has no responsibility or liability for negligence or false applications and also cannot specify any medical recommendations and procedures. The user must independently weigh up what is used and how this is carried out. HICO-VARIOTHERM 550... - Page 44 ► do not use the unit on a patient. ► have the unit inspected by Customer Service. Checking the temperature control operation During long-term operation, check the nominal and actual values of the temperature display regularly; see chapter 6.2.5 and 6.3.2. HICO-VARIOTHERM 550...
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Page 45: Operator Language
• Keep pressing the arrow key "Nominal value higher" (19), until the desired language appears in the display. • About 10 seconds after the last input the unit will return to its previous operating status, the language displayed last is active. HICO-VARIOTHERM 550... -
Page 46: Alarms
Before pressing the "Audio paused" key (18) or the mains switch (16) to suppress the alarm or take the unit out of service, please read the error message in the display! Source: DIN EN 60601-1-8:2008-02 Tabelle 1 – Alarmbedingungs-Prioritäten HICO-VARIOTHERM 550... -
Page 47: Alarm Description During Operation
15 °C or 39 °C) can in this case not be achieved. Change the nominal value until the unit is able to regulate the temperature reliably. ► After switching on the unit and after changing the nominal temperature this alarm function is suppressed over a specified period of time. HICO-VARIOTHERM 550... - Page 48 (Observe chapter 4.2.1 Requirements for installation and operating site!) If the unit still emits an alarm take it out of service and have it inspected by a Service engineer (Customer service / Medical engineering). HICO-VARIOTHERM 550...
- Page 49 The alarm automatically goes out when the power supply returns. The temperature set last is stored in the unit. With restoration of the power supply, the temperature stored must be controlled by the user and approved before the device returns to normal operation (see chapter 6.2 Operation). HICO-VARIOTHERM 550...
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Page 50: Cleaning And Disinfecting
ABS plastics as well as PVC and PU for all surfaces and parts. ► If possible, do not use any phenol derivative based disinfectants, because these will shorten the lifetime of plastic materials. HICO-VARIOTHERM 550... -
Page 51: Unit
Switch off the unit and observe the predefined exposure time of the manufacturer of the disinfectant. Afterwards disconnect the unit from the power supply and empty the unit and all accessories entirely. Verband für Angewandte Hygiene, list available at mhp-Verlag, Wiesbaden HICO-VARIOTHERM 550... -
Page 52: Flushing Und Refilling
Hirtz & Co.KG. The use of a disproportionately high amount of disinfectant can reduce the lifetime of unit parts that come into contact with water! Verband für Angewandte Hygiene, list available at mhp-Verlag, Wiesbaden HICO-VARIOTHERM 550... - Page 53 Do not apply any other cleaning or decontamination processes other than the ones recommended by Hirtz & Co. KG. Before introducing new methods, check these together with Hirtz & Co. KG. Only this makes sure that the unit will not be damaged by this method. HICO-VARIOTHERM 550...
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Page 54: Water Pads, Hose Extension
Hirtz & Co. KG. Before introducing new methods, check these together with Hirtz & Co. KG. Only this makes sure that the unit will not be damaged by this method. Verband für Angewandte Hygiene, list available at mhp-Verlag, Wiesbaden HICO-VARIOTHERM 550... -
Page 55: Maintenance And Safety Related Inspection
With proper and regular maintenance, the unit has a product lifetime of about 10 years. When handled properly, the water pads and hose extensions results in a life span of these necessary accessories from the natural aging and use wear. HICO-VARIOTHERM 550... -
Page 56: Unit
4.3.1. The max. filling capacity of the unit tank is approx.1 litre. 8.1.3 Hose couplings The seal rings (O-rings) on all couplings are subject of aging and become dry and brittle. You should therefore cover the rings with a thin film of silicone paste or vaseline every 6 months. HICO-VARIOTHERM 550... -
Page 57: Safety Related Inspection
• Inspection of all functions by following the operating instructions • Inspection of all safety functions according to manufacturer's data • Inspection of all sensors according to manufacturer's data (for this purpose Hirtz & Co. KG provides a Service Manual for authorised persons). HICO-VARIOTHERM 550... - Page 58 Questions concerning service, maintenance or safety related inspection should be directly addressed to: Hirtz & Co. KG Bonner Str. 180 50968 Cologne Phone: 02 21 / 3 76 78-0 Fax: 02 21 / 3 76 78-85 e-mail: hirtz@hico.de HICO-VARIOTHERM 550...
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Page 59: Troubleshooting
Opening of the unit by unauthorised persons will lead to the loss of any warranty claims. ► Repairs to the unit may only be carried out by Hirtz & Co. KG or by experts trained and/or authorised by Hirtz & Co. KG. HICO-VARIOTHERM 550... -
Page 60: Fault Causes And Troubleshooting
Alarm + Display message: 1. Water level too low 1. Refill water “WATER LEVEL!?“ 2. Unit is not horizontal 2. Position unit horizontally Can be acknowledged for 10 3. Sensor deviation 3. Customer service* mins. using the "Alarm OFF" button HICO-VARIOTHERM 550... - Page 61 1. Switch off unit until power acoustic alarm returns 2. Mains connector no contact 2. Check connector on unit and in socket for correct fit 3. Customer service* 3. Fuse defective 4. Customer service* 4. Unit defective Switch off the unit immediately HICO-VARIOTHERM 550...
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Page 62: Waste Disposal Of Old Unit
1, cipher 8, the unit must be handed over to a corresponding communal collecting point or returned to the manufacturer. ► In accordance with waste management regulations of the user the water pad can be disposed of for incineration, together with domestic waste. HICO-VARIOTHERM 550... -
Page 63: Technical Data And Accessories
Technical data and accessories 11 Technical data and accessories 11.1 Unit HICO-VARIOTHERM 550 540001 (220 V/230 V) / 540021 Article No. (REF): (115 V) 230 VAC 50/60 Hz / 115 VAC Rated voltage: 50/60 Hz / 220 VAC 60 Hz... -
Page 64: Accessories
• Hose extension, approx. 3 m (required accessory) REF:550022 • Thermo hose extension, approx. 2 m (optional accessory) REF: 660022 • Together with the HICO-VARIOTHERM 550, only original HICO water pads made of PU may be used (required accessory); among others, available sizes and their empty weight:... - Page 65 ► Hirtz & Co. KG is only responsible for the safety and function of the unit carrier if the installation and operating instructions are followed in every respect, and only used specifically for this equipment and accessories provided by Hirtz & Co. KG. HICO-VARIOTHERM 550...
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Page 66: Symbols
Extreme caution! (e.g. do not operate the unit in the presence of combustible gases) Full instruction manual / operating instructions Observe / follow instruction manual Waste disposal Year of manufacture Manufacturer Also involved in the conformity assessment procedures: DEKRA Certification GmbH, Handwerkstraße 15 70565 Stuttgart HICO-VARIOTHERM 550... -
Page 67: Guidelines And Declaration Of Manufacturer
Guidance and manufacturer declaration – Electromagnetic emission The HICO-Variotherm 550 is designed for operation in the electromagnetic environment listed below. The customer or user of the HICO-Variotherm 550 should ensure that the device be used in such an environment. Emission test... - Page 68 Guidance and manufacturer declaration – Electromagnetic immunity The HICO-Variotherm 550 is designed for operation in the electromagnetic environment listed below. The customer or user of the HICO-Variotherm 550 should ensure that the device is used in such an environment. Emission tests...
- Page 69 Guidance and manufacturer declaration – Electromagnetic immunity The HICO-Variotherm 550 is designed for operation in the electromagnetic environment listed below. The customer or user of the HICO-Variotherm 550 should ensure that the device is used in such an environment. Emission tests...
- Page 70 Recommended safety distance between portable and mobile RF telecommunication devices and the HICO-Variotherm 550 The HICO-Variotherm 550 is designed for operation in an electromagnetic environment, in which the RF disturbances are controlled. The customer or the user of the HICO-Variotherm 550 can help to...
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Page 71: Brief Instruction
• Acoustic warnings of medium priority (“WATER LEVEL!?” and “TEMP.DIFF >1 °C”) can be interrupted using the "Audio paused" key. • All other acoustic alarms of medium priority cannot be interrupted. Switch off the unit at the mains (16). HICO-VARIOTHERM 550... - Page 72 ► the signal tone continues to sound or does not sound at all (functional test), ► the unit does not respond to key operation, ► the unit does not respond as described in chapter 6.2.3 "Functional test" when switching on or when running a function test. HICO-VARIOTHERM 550...
- Page 73 Brief instruction Notes HICO-VARIOTHERM 550...
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