GERATHERM UniqueTemp Instruction Manual

GERATHERM UniqueTemp 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
UniqueTemp°
More than hot air
1

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Summary of Contents for GERATHERM UniqueTemp

  • 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 UniqueTemp° More than hot air...
  • Page 2 Plug in – Switch on – Feel the warmth • Display and temporary recording of the patient’s body temperature Geratherm UniqueTemp° has been developed for the Before using the Patient Warming System, please prevention of hypothermia in the operating theatre. It is read through the operating instructions carefully!
  • Page 3: Table Of Contents

    5.10 Starting up the body temperature sensor 12.9 Holding claw 12.10 Mains cable Shutting down Shutting down individual blankets 12.11 Body temperature sensor 6.2 Shutting down the Geratherm UniqueTemp° 12.12 Scope of delivery Message and faults 12.13 Symbols used Annex...
  • Page 4: Identification

    0118 label. The serial number of the control unit is to be found on the back of the casing, on the commercial invoice and in the attached documentation. MPG classification: Geratherm UniqueTemp° has been categorised as a Class IIb device.
  • Page 5: Purpose

    After being placed over the patient, Geratherm Unique Temp° can be covered over with surgery drapes. Geratherm UniqueTemp° is suitable for use with adult pa- tients of all sizes. The blankets should not be used for children. Geratherm UniqueTemp° shall only be operated under the supervision...
  • Page 6: Safety Precautions

    • To ensure safe use, it is necessary to read all the way ding claw provided shall be used! If you do not use the through the operating instructions. holding claw, ensure that the control unit is positioned • Like all medical devices, Geratherm Patient Warming firmly and securely! Systems require special care with regard to EMC. The • System components of Geratherm UniqueTemp° shall never be connected to or operated with equipment safety precautions described in these operating instruc- tions (e.g.
  • Page 7 • Before each use, check the surface of the warming • Geratherm UniqueTemp° shall only be used under the supervision of the anaesthetist. blankets for any visible damage! Discontinue use of any damaged blankets immediately! • Do not apply adhesive tape to the warming blan- • Put the Geratherm UniqueTemp° warming blankets com-...
  • Page 8 potential hazard can be reduced by selecting a tempera- ture measuring point, which is located far away from the expected course of the HF current flow to earthing. • The use of adapter cables for the temperature sensor is prohibited.
  • Page 9: Description

    4 Description 4.1 Overview of individual components and of manual control elements Control unit: front 1 Housing 2 Handle 3 TFT display 4 Slider (sensitive slide control) 5 OK button (to confirm input) 6 Infrared interface...
  • Page 10 Control unit: back 1 Blanket connector socket 1 2 BF type applied part 3 Blanket connector socket 2 4 Equipotential bonding pin 5 Temperature sensor socket 6 Serial number of the device 7 Mains cable socket 8 Power switch 9 Read operating instructions 10 Safety class 11 Do not dispose of in household waste 10 11...
  • Page 11 2 Leg blankets Torso blanket Arm/shoulder blanket Holding claw for control unit UniqueTemp°...
  • Page 12: Safety Features

    4.2 Safety features Geratherm UniqueTemp° has an optical and acoustic alarm system, which indicates all faults. 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. The control unit will not switch on if the safety device is faulty.
  • Page 13: Starting Up And Operation

    5 Starting up and operation 5.1 Assembly and installation Prior to starting up, Geratherm UniqueTemp° must be as- sembled in such a way that it is safe to operate. Attachment Attach holding claw to the pole of Assembly variants The holding claw (Fig.
  • Page 14: Connecting The Blankets

    5.2 Connecting the blankets Up to 4 warming blankets can be used simultaneously. When several blankets are used together, they must first be connected to each other and then connected to one of the two sockets (marked A and B) on the back of the control unit.
  • Page 15: Connecting The Temperature Sensor

    • Do not lay the patient on top of the Geratherm patient’s body surface as possible. UniqueTemp° warming blankets! Using the different blankets in combination makes it possible • Put the warming blankets on the patient in such a way...
  • Page 16: Starting Up

    5.5. Starting up with all the warming blankets currently connected (in blue), and the preset starting temperature of 36°C in all blankets. After connecting the control unit Now the control unit is ready for operation. to the power supply and attaching the required warming blankets, the Slider and “OK”...
  • Page 17: Switching Off The Warming Blankets

    5.6 Switching off the warming 5.7 Preselection of temperatures for blankets individual blankets After the control unit is switched on Using the slider, the blanket temperature on the control unit and the testing of the safety sys- is set at less than 30.0°C. Then the blankets on the display tems has been carried out, all the appear in blue and lines appear instead of the number indi- blankets are switched off (depicted...
  • Page 18: Switching Off Individual Warming Blankets

    5.8 Switching off individual warming If warming blankets are removed while switched on, an blankets acoustic signal will be heard and a failure message will appear for a short time. The warming blankets are activa- ted and the temperatures are set as described in Point 5.5. In the “select”...
  • Page 19: Starting Up The Body Temperature Sensor

    5.10 Starting up the body temperature sensor • Warning! Only sensors that correspond to the MET 400 basic setpoint series shall be used! • The control unit is not designed for operation with sen- sors of the MET 700 basic setpoint series. • The use of adapter cables is prohibited. •...
  • Page 20: Shutting Down

    6.2 Shutting down the Geratherm UniqueTemp° In order to shut down Geratherm UniqueTemp°, it is neces- sary to switch off the control unit at the power switch. A brief confirmation tone will be heard. All the indicator lamps will go out and the illuminated TFT display will go dark.
  • Page 21: Message And Faults

    7 Messages and faults Fault symbol The control unit has a program that automatically recog- nises faults and presents them on the display along with an alarm sound. A red hazard-warning triangle and the blanket affected appear alternately on the display. Fault in a warming blanket Fault in the control unit After removing or replacing the defective blanket or con-...
  • Page 22 Possibly prohibited mixed use of Please use only blanket types that belong to Blankets will not switch on UniqueTemp° blankets together with the UniqueTemp° system. components of a different system Control unit does no longer Safety shutdown was activated by a...
  • Page 23 Explanations failure messages Message Meaning Error 0102 Watchdog failure message Error 0103 Flash fault Error 0105 Blanket overheating Error 0106 Temperature display between regulating sensor and safety sensor differs by more than 5 °C Error 0107 Initial test of the heating power stage failed Error 0108 Heating power stage test during runtime failed Error 0109...
  • Page 24: 8 Preparation And Hygiene Measures

    Upon request, Geratherm will be pleased to provide samples of the ma- If you wish to use other cleaning agents or procedures, you terials for such tests. A suitable product is, for example, must consult the manufacturer first.
  • Page 25: 8.2 Checks After Processing

    8.2 Checks after processing Check the warming blankets and connecting cables regu- larly 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. 8.3 Replacement of consumables There are no consumables!
  • Page 26: 9 Maintenance

    If temperature sensors are used, these should be subjected to technical inspection every 2 years (legally required in Germany). • Warning! Alterations to the UniqueTemp° are not per- mitted without the consent of the manufacturer.
  • Page 27: Disposal

    10 Disposal 11 Warranty The device must be disposed of in accordance with the Geratherm Medical AG provides a 24-month warranty on WEEE Recycling Directive, not as household waste. the control unit and on the warming blankets. The warran- ty does not include the remedying of damage arising as a result of Disposal does not entail any particular hazards.
  • Page 28: 12 Technical Data

    12 Technical data 12.1 Control unit Art. No.: 8001140800 Rated voltage: 90 bis 230 V AC +/- 10% Frequency: 50 / 60 Hz Power: max. 400 VA Fuse: 6,3 A delayed action 5x20 mm Safety class: I Degree of protection: IPX2 Protection against splashing water Range of settings of control unit: 30 °C to 42 °C in 0.1 K steps Connection for body temperature probe: Probe of the MET 400 basic setpoint series with 6.3 mm mono jack plug Output voltage: max.
  • Page 29: Arm/Shoulder Blanket

    12.2 Arm/shoulder blanket Art. No.: 8001140202 Dimensions (L x W): 175 cm x 32 cm Operating voltage: max. 35.5 V DC Connecting cable length: 70 cm each for ingoing and outgoing leads 12.3 Torso blanket Art. No.: 8001140301 Dimensions ( Lx W): 92 cm x 45 cm Operating voltage: max.
  • Page 30: Connecting Cable

    12.5 Connecting cable 12.9 Holding claw Art. No.: 8001140803 Art. No.: 8001140900 Length: 150 cm 12.6 Reusable cover for 12.10 Mains cable arm/shoulder blanket Art. No.: 8001120801 Art. No.: 8001140203 Length: 250 cm Conductor cross-section: 3 x 1,00 mm² 12.7 Reusable cover for leg blankets 12.11 Body temperature sensor Art.
  • Page 31: Scope Of Delivery

    Art. No.: 8001140303 Art. No.: 8001140800 with connecting cable • Leg blanket right • Holding claw Art. No.: 8001140408 (specially produced for Geratherm UniqueTemp° Patient Warming Systems) • Leg blanket left Art. No.: 8001140900 Art. No.: 8001140409 • Mains cable • Reusable cover for leg blanket right...
  • Page 32: Symbols Used

    12.13 Symbols used A Connector socket 1 for warming blankets B Connector socket 2 for warming blankets Pay attention to operating instructions Equipotential To equalise the potential of simultaneously used parts. BF type device IPX2 Device is splash-proof Connecting socket for body temperature sensor, MET 400 basic setpoint series Device must not be disposed of as household waste...
  • Page 33: Annex

    Advice on electromagnetic compatibility - Emission The operating instructions must contain the following: 1.) A declaration that medical electrical devices require special pre- In the following EUT Geratherm DWS (UniqueTemp°) is designated cautions as regards electromagnetic compatibility (EMC) and must as a device or system.
  • Page 34 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...
  • Page 35 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. Emission test IEC 60601 –...
  • Page 36 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 –...
  • Page 37 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 predicted in theory.
  • Page 38 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 communica- tion equipment (transmitters) depending on the output of the communication equipment, as follows: Maximum rated Distance / m...
  • Page 39 Manufacturer: The manufacturer reserves the right to make technical modifications in keeping with technical advances.
  • Page 40 Geratherm Medical AG Fahrenheitstrasse 1 98716 Geschwenda Germany Phone +49 (0) 36 205 / 98-0 +49 (0) 36 205 / 98-116 E-Mail: info@geratherm.com www.geratherm.com...

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