GERATHERM UniqueResc+ Instruction Manual

Patient warming system

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M e d i c a l W a r m i n g S y s t e m s
Instruction manual
| PatientWarmingSystem
UniqueResc
+
Warmth that saves lives

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Summary of Contents for GERATHERM UniqueResc+

  • Page 1 M e d i c a l W a r m i n g S y s t e m s Instruction manual | PatientWarmingSystem UniqueResc Warmth that saves lives...
  • Page 2 UniqueResc Thank you for choosing a Geratherm Patient Warming System. The benefits of Geratherm UniqueResc are: • Active warming from above • Due to semiconductor-coated textiles respectively car- bon fibres as heating material a consistent and plane heating is ensured • Microprocessor-controlled • Thin, cosy warming blankets by application of modern insulating material • Noiseless, no distribution of germs through air distur- bance • Simple to use: Plug in – forthwith warming • Highly durable and easy to clean as the outer material is made up of welded PU fabrics • Due to special Geratherm line adapter, as an optional feature, it is adaptable to all alternating current net- works from 90 V until 230 V (50Hz/60Hz)
  • Page 3: Table Of Contents

    4.2 Safety features 12.1 Type R130 Starting up and operation 12.2 Type R150 5.1 Assembly and installation 12.3 Geratherm power adapter 12.4 Scope of delivery 5.2 Positioning the blankets 5.3 Starting up 12.5 Symbols used 5.4 Switching off the warming blankets...
  • Page 4: Identification

    1 Identification The Geratherm UniqueResc can be identified as MPG classification: follows: Geratherm UniqueResc has been categorised as a Class IIb device. Manufacturer’s designation: Geratherm UniqueResc meets the requirements of Council Directive 93/42 EEC of 14.06.93 on Medical Devices and of the standard DIN EN 60601-1 (Medi-...
  • Page 5: Purpose

    2 Purpose Geratherm UniqueResc has been developed for the prevention of hypothermia. The warming blankets are light-weight, cosy and warm the patient from above. The use of several blankets per patient is possible. The flexibility of the blankets makes it possible to warm the patient even during complicated rescue operating terms.
  • Page 6: Safety Precautions

    • Geratherm UniqueResc warming blankets must optional Geratherm power adapter. As well the not be cleaned in a washing machine or autoclave! use of suitable batteries is possible. • To ensure safe use, it is necessary to read all the • It should be noted that portable and mobile HF...
  • Page 7 • The temperature setting (only by model type R130) lamps, incubators or hot water bottles)! This could is the responsibility of the physician. be detrimental to the patient’s health. • Do not use Geratherm UniqueResc on patients • Do not place the control unit directly on top of ECG with impaired circulation! The manufacturer is or EEG equipment. Otherwise, faults may arise, e.g.
  • Page 8: Description

    4 Description 4.1 Overview of the components and manual control elements 4.1.1 Type R130 Complete warming blanket example of application...
  • Page 9 control unit Device description and type LED display HEATING (display flashes during heating-up) LED display POWER (display lights up during operating) LED display ERROR (lights up if a fault occurs) Display of the selected set temperature SELECT button for switching-over the set temperature Safety class Do not dispose of in household waste...
  • Page 10: Type R150

    4.1.2 Type R150 Complete warming blanket example of application...
  • Page 11 control unit 1 Device description and type 2 LED display HEATING (display flashes during heating-up) 3 LED display POWER (display lights up duringoperating) 4 LED display ERROR (lights up if a fault occurs) 5 Safety class 6 Do not dispose of in household waste 7 BF type applied part 8 Read operating instructions 9 Serial number of the device...
  • Page 12: Safety Features

    4.2 Safety features Geratherm UniqueResc has an optical and acoustic alarm system, which indicates all faults. The system possesses monitoring installation of hard- ware as well as software. A short tone after the unit is switched on indicates that the alarm system and the independent safety device have been automatically checked and are operational.
  • Page 13: Starting Up And Operation

    5 Starting up and operation 5.1 Assembly and installation 5.2 Positioning the blankets Geratherm UniqueResc warming blankets must be laid on • Do not lay the patient on top of the Geratherm the patient in such a way that they cover as large a propor- UniqueResc warming blankets! tion of the patient‘s body surface as possible. • Put the warming blankets on the patient in such a The range of different warming blankets enables an opti- way that the control unit´s window side is facing mum covering of the most frequently case of operations away the patient.
  • Page 14: Starting Up

    In case of using the Geratherm power adapter it will be ready for use approx. two seconds after connecting to • At the same time, a short tone signal announces the the AC voltage (showed by a green LED).
  • Page 15: Switching Off The Warming Blankets

    5.4 Switching off the warming blankets The switching off of the warming blanket is achieved by disconnecting it from the voltage source. • Note: The heating phase of the warming blanket from 20 °C to 37 °C is approx. 5 minutes. When executing R130 and the power supply is inter- rupted, the temperature is re-set independently from the eventually preselected temperature to 41 °C.
  • Page 16: Shutting Down

    6 Shutting down 6.1 Shutting down between the 6.2 Long-termed shutting down of operations the Geratherm UniqueResc See chapter: Prior to storing UniqueResc no maintenance is re- 5.4 Switching off the warming blankets quired. The system may only be deposited dryly. If ring connectors are often used, it is recommended to lightly grease (Vaseline) the contacts of the ring con- nectors to avoid oxidation.
  • Page 17: Messages And Faults

    7 Messages and faults The control unit is equipped with a program which re- cognizes errors autonomically and displays them by the red ERROR LED. The type of disorder of devices with infrared module can be read-out additionally with an infrared adapter by the service technician.
  • Page 18: Preparation And Hygiene Measures

    Upon re- quest, Geratherm will be pleased to provide samples storing respectively before stowing into the of the materials for such tests. A suitable product is, transportation containers.
  • Page 19: Checks After Processing

    8.2 Checks after processing 8.3 Replacement of consumables Check the warming blankets and connecting cables re- There are no consumables! gularly for any damage. Any damage to the surface coating due to long-term intensive use or strong mechanical forces necessitates replacement by the manufacturer. Damaged blankets shall not be used again.
  • Page 20: Maintenance

    The device must be disposed of in accordance with the pliance with EN60601-1 and MPBetreibV (in Germany WEEE Recycling Directive, not as household waste. only) using the Geratherm Service Manual of Rescue Warming Systems UniqueResc and the checks for Disposal does not entail any particular hazards.
  • Page 21 11 Warranty Geratherm Medical AG provides a 24-month warranty on the warming blankets. The warranty does not include the remedying of damage arising as a result of • accidents, disasters, improper use or other external influences, • use of parts that do not belong to the product, • maintenance work that is not carried out by Geratherm Medical itself or by an authorised person.
  • Page 22: 12 Technical Data

    12 Technical data 12.1 Type R130 12.2 Type R150 Art.No.: 8001110615 Art.No.: 8001110616 Nominal voltage: 12V to 28 V DC Nominal voltage: 12V to 28 V DC Power: max. 100 VA Power: max. 100 VA Fuse: 16A M delayed action (6x25)mm in the car plug Fuse: 16A M delayed action (6x25)mm in the car plug Default temperatures: 37,0 °C / 41,0 °C Default temperature: 41,0 °C...
  • Page 23: Geratherm Power Adapter

    12.3 Geratherm power adapter 12.4 Scope of delivery Art.No.: 8001110940 • UniqueResc R130 Nominal voltage: 100V to 240V AC Art.-Nr.: 8001110615 Frequency: 50/60 Hz Warming blanket (50cm x 86cm) with Power: 150W instruction manual Fuse: 1,6A Dimensions: 7 cm x 11 cm x 19 cm • UniqueResc...
  • Page 24: 12.5 Symbols Used

    12.5 Symbols used SN Serial number of the warming blanket CE mark (confirms the conformity of the medical product with Directive 93/42 EEC). The identification number 0118 stands for the Thuringian State Office for Measurement and Calibration. Pay attention to operating instructions BF type device IPX2 Device is splash-proof in a 15°...
  • Page 25: Annex

    Advice on electromagnetic compatibility - Emission tic compatibility (EMC) and must be installed and In the following the Geratherm UniqueResc is des- operated in compliance with the EMC information signated as a device or system.
  • Page 26 Notes and statement of manufacturer – Electromagnetic emissions The device or system is suitable for use in the electromagnetic environment described below. The purchaser and/or user of the device or system must ensure that it is used in an electromagnetic environment that conforms to the following description. Emission test Compatibility Notes on the electromagnetic environment HF emissions CISPR 11 Group 1 The device or system uses HF energy only for its internal functioning. Therefore its HF emissions are very low, and it is unlikely that they will affect electro- nic instruments located nearby. HF emissions CISPR 11 Class B The device or system is suitable for use in all facilities, including households and facilities that are Overtone emissions IEC 61000-3-2 Class A directly connected to the public low-voltage electri- Voltage fluctuations / Flicker emissions IEC 61000-3-3 Compatible city supply network that supplies buildings used for residential purposes. a4) Warning regarding installation The device or system should not be used next to other devices or be stacked with other devices and a warning shall be given that if use next to or stacking with other devices is unavoidable, the device or system shall not be used for the purpose of verifying normal operation in the configuration in which it is being used. a5) Compatibility level The device meets the insensitivity test level required under IEC 60601. a6) Advice on electromagnetic compatibility – insensitivity...
  • Page 27 Voltage reductions, < 5 % UT for 0.5 of a cycle < 5 % UT for 0.5 of a cycle The quality of the line current should cor- short interruptions and (> 95 % reduction of UT) (> 95 % reduction of UT) respond to that of a typical commercial voltage fluctuations in and/or hospital environment.If the user 40 % UT for 5 cycles 40 % UT for 5 cycles electricity supply lines of a device or system requires continued (60 % reduction of UT) (60 % reduction of UT) IEC 61000-4-11 operation during power supply interrup- tions, it is recommended that the device 70 % UT for 25 cycles 70 % UT for 25 cycles or system be supplied via an uninterrup- (30 % reduction of UT) (30 % reduction of UT) tible power supply or by battery. < 5 % UT for 5 seconds < 5 % UT for 5 seconds (> 95 % reduction of UT) (> 95 % reduction of UT) Electrical frequency 3A/m 3A/m The power frequency magnetic field (50/60 Hz) magnetic should be measured at the intended field IEC 61000-4-8 installation location to ensure that it is sufficiently low. NOTE: Geratherm UniqueResc is the network AC voltage prior to application of the test level.
  • Page 28 Notes and statement of manufacturer – Electromagnetic insensitivity The device or system is suitable for use in the electromagnetic environment described below. The purchaser and/or user of the device or system must ensure that it is used in an electromagnetic environment that conforms to the following description. Insensitivity test IEC 60601 – Test level Compatibility level Notes on the electromagnetic environment Portable and mobile HF communication equipment should not be used closer to any part of the device system, including cables, than the recommended distance calcu- lated using the correct equation for the frequency of the transmitter. Recommended distance: Conducted HFIEC 3 V effective value 3 V effective value d= [3.5/3]√P = 1.17 √P 61000-4-6 150 kHz to 80 MHz Radiated HF IEC 3V/m 10 V/m d = [3.5/10]√P = 0.35√P 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 800 MHz d = [7.0/10]√P = 0.70√P 800 MHz to 2.5 GHz Where P is the maximum rated output of the transmitter in (W) according to the manufacturer of the transmitter and d is the recommended distance in metres (m) . The field strengths of fixed HF transmitters measured in an electromagnetic location check should be lower than the compatibility level in each frequency range.
  • Page 29 Notes and statement of manufacturer – Electromagnetic insensitivity a) The field strengths of transmitters such as base stations for mobile phones (mobile or cordless phones) and mobile non-public radio equipment, amateur radio transmitters, SW and VHF radio transmissions and television broadcasts cannot be precisely pre- dicted in theory. In order to evaluate the electromagnetic environment around fixed HF transmitters, an electromagnetic location check should be considered. If the field strength measured at the location where the device or system is used exceeds the aforesaid HF compatibility level, the device or system should be observed in order to verify normal operation. If abnormal operation is observed, further measures may be necessary, such as realigning the device or system or transferring it to a different location. b) Above the frequency range from 150 kHz to 80 MHz the field strengths should be lower than 3 V/m.
  • Page 30 Recommended distances between portable and mobile HF communication equipment and the device or system The device or system is suitable for use in the electromagnetic environment described. The purchaser and/or user of the device or system can avoid electromagnetic interference by adhering to the minimum distance between portable and mobile HF communication equipment (transmitters) depending on the output of the communication equipment, as follows: Maximum rated out- Distance / m put of the transmitter in Watt 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1,17√P d = 0,35√P d = 0,70√P 0,01 0,12 0,04 0,07 0,37 0,11 0,22 1,17 0,35 0,70 3,70 1,11 2,21 11,70 3,50 7,00...
  • Page 31 Manufacturer: The manufacturer reserves the right to make technical modifications in keeping with technical advances.
  • Page 32 Geratherm Medical AG Fahrenheitstrasse 1 98716 Geschwenda Germany Phone +49 (0) 36 205 / 98-0 Fax +49 (0) 36 205 / 98-116 E-Mail info@geratherm.com www.geratherm.com...

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