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UniqueTemp°

Instruction manual

| PatientWarmingSystem

More than hot air

M e d i c a l W a r m i n g S y s t e m s

Содержание UniqueTemp

Страница 1: ...1 www geratherm com UniqueTemp Instruction manual PatientWarmingSystem More than hot air M e d i c a l W a r m i n g S y s t e m s ...

Страница 2: ...nductor coated textiles Warming with individual blankets Microprocessor controlled Monitoring of the core body temperature with trend graph display Thin cosy warming blankets Noiseless no distribution of germs through air disturbance Simple to use Plug in Switch on Feel the warmth Display and temporary recording of the patient s body temperature Geratherm UniqueTemp has been developed for the prev...

Страница 3: ...ng up the body temperature sensor 19 6 Shutting down 20 6 1 Shutting down individual blankets 20 6 2 Shutting down the Geratherm UniqueTemp 20 7 Message and faults 21 page 8 Preparation and hygiene measures 24 8 1 Cleaning and disinfecting 24 8 2 Checks after processing 25 8 3 Replacement of consumables 25 9 Maintenance 26 9 1 Servicing 26 9 2 Service menu 26 10 Disposal 27 11 Warranty 27 12 Techn...

Страница 4: ...he requirements of Coun cil Directive 93 42 EEC of 14 06 93 on Medical Devices and of the standard DIN EN 60601 1 Medical electrical equipment Part 1 General requirements for safety DIN EN 60601 1 2 Medical electrical equipment Part 1 2 Ge neral requirements for safety Collateral standard Elec tromagnetic compatibility Requirements and Tests DIN EN 12470 4 and DIN EN 60601 2 35 Medical electrical ...

Страница 5: ...ly warming the patient All the blankets can be freely combined The flexibility of the blankets makes it possible to warm the patient even if complicated positioning on the operating table is re quired 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...

Страница 6: ...od thermal conductors such as water gel and other substances are used the body temperature of the patient may fall when the warming equipment is switched off For fastening the control unit only the Geratherm hol ding claw provided shall be used If you do not use the holding claw ensure that the control unit is positioned firmly and securely System components of Geratherm UniqueTemp shall never be ...

Страница 7: ...ient warming system equipotential bonding must be ensured Geratherm UniqueTemp shall only be used under the supervision of the anaesthetist Do not apply adhesive tape to the warming blan kets This will lead to permanent soiling of the sur face Only use dry warming systems on the patient When using the body temperature sensor it is abso lutely necessary to observe the prescribed connecting sequence...

Страница 8: ...ential 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 ...

Страница 9: ...scription 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 2 1 3 4 5 6 ...

Страница 10: ...pe 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 1 3 4 5 8 2 6 7 9 10 11 ...

Страница 11: ...www geratherm com 11 Holding claw for control unit UniqueTemp 2 Leg blankets Torso blanket Arm shoulder blanket ...

Страница 12: ...ndependent safety device have been automatically checked and are operational The control unit will not switch on if the safety device is faulty The functioning of the warming system can be checked by means of the following test After removal of a warming blanket that is in operation the removed blanket should light up on the TFT display and an acoustic alarm should be heard 4 2 Safety features ...

Страница 13: ...es ranging in diame ter from 15 mm to 25 mm The holding claw can be used to attach the control unit at variable heights and angles see Fig 3 Attachment Attach the holding claw to the pole of the IV poles as shown in Fig 3 and fix the position using the adjusting screw Fig 2 B Push the control unit by means of the handle onto the attachment on the holding claw Fig 2 C and secure it using the knurle...

Страница 14: ...it The coloured markings on the plug black anti kink sleeve and on the socket coupling grey anti kink sleeve facilitate connection When connecting the blankets always begin by inserting the plug of one warming blanket into the control unit The plug of the next blanket should then be connected to the coupling of the blanket that is already connected i e the black anti kink sleeve is always in the d...

Страница 15: ...f the control unit When connecting it care must be taken to perform the fol lowing steps in the correct order 1 Insert the sensor plug into the device 2 Connect the sensor to the patient 5 4 Positioning of the blankets Do not lay the patient on top of the Geratherm UniqueTemp warming blankets Put the warming blankets on the patient in such a way that the dark orange side is facing the patient and ...

Страница 16: ...C in all blankets Now the control unit is ready for operation Slider and OK button By touching the OK button on the front of the control unit the heating process in the warming blankets is activated As the tem perature rises the graphical repre sentations of the warming blankets gradually turn orange When the graphical representa tions of the blankets are completely orange the preset tem perature ...

Страница 17: ...eratures for individual blankets After the control unit is switched on and the testing of the safety sys tems has been carried out all the blankets are switched off depicted in blue The warming blankets are switched on by touching the OK button If you would like to set dif ferent temperatures in the various warming blankets press the select button area in the bottom right hand corner of the displa...

Страница 18: ...l system will recognise any changes automati cally and will correct the graphical representation within a few seconds If warming blankets are removed while switched on an 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 Care must be taken that all the blankets still required a...

Страница 19: ... control unit The body temperature can only be measured correctly if the sensor is positioned at the prescribed measuring points In the case of the sensor provided these points are the rectum and the oesophagus The temperature is displayed and recorded automatical ly when the sensor is connected The current body temperature is shown on the TFT dis play in the top right hand corner Touching this di...

Страница 20: ...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 When the control unit is switched off the settings pre set blan ket temperatures and the recorded body temperatures are deleted Warning Before the temperature sensor plug is taken out of the control unit it is very important that the prob...

Страница 21: ...esents 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 trol unit the system can be taken back into operation as described under Point 5 ...

Страница 22: ...temperature setting Put blanket completely on the body or switch off the blanket and open completely Remove objects from the blanket 4 Blankets will not switch on Possibly prohibited mixed use of UniqueTemp blankets together with components of a different system Please use only blanket types that belong to the UniqueTemp system 5 Control unit does no longer work and indicates a fault Safety shutdo...

Страница 23: ... 0107 Initial test of the heating power stage failed 6 Error 0108 Heating power stage test during runtime failed 7 Error 0109 Voltage error 5 V range in blanket electronics 8 Error 0110 Power supply fault 9 Error Blanket has been removed If a fault occurs that is neither listed on this table nor indicated in a self explanatory way on the display please contact our customer service department If yo...

Страница 24: ...ed on a test area Upon request Geratherm will be pleased to provide samples of the ma terials for such tests A suitable product is for example Incidur Spray manufactured by Ecolab GmbH P O Box 130406 D 40554 Düsseldorf Warning Insufficiently disinfected blankets constitute an infection hazard Warming blankets Do not clean or sterilise the warming blankets in a washing machine or autoclave Reusable...

Страница 25: ...d 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 ...

Страница 26: ... or an authorised person every 24 months Checking the calibration of the systems is only required after the replacement of assembly modules and as part of the safety related checks The Service Manual can be ob tained free of charge from the manufacturer upon request If temperature sensors are used these should be subjected to technical inspection every 2 years legally required in Germany Warning A...

Страница 27: ...arranty Geratherm Medical AG provides a 24 month warranty on the control unit and on the warming blankets The warran ty does not include the remedying of damage arising as a result of accidents disasters improper use or other external in fluences 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 ...

Страница 28: ...ody temperature probe Probe of the MET 400 basic setpoint series with 6 3 mm mono jack plug Output voltage max 35 5 V DC Dimensions H x W x D H x B x T 23 2 cm x 11 cm x 14 7 cm Weight 4 0 kg Classification under Directive 93 42 EEC II b Operating environment Temperature 10 C to 40 C Humidity 30 to 75 Air pressure 700 hPa to 1060 hPa Transport and storage Temperature 30 C 48h to 60 C 168h Humidity...

Страница 29: ... leads 12 3 Torso blanket Art No 8001140301 Dimensions Lx W 92 cm x 45 cm Operating voltage max 35 5 V DC Connecting cable length 70 cm each for ingoing and outgoing leads 12 4 Leg blankets Art No 8001140408 right leg blanket Art No 8001140409 left leg blanket Dimensions L x W 92 cm x 45 cm Operating voltage max 35 5 V DC Connecting cable length 70 cm each for ingoing and outgoing leads ...

Страница 30: ...1140410 right Art No 8001140411 left 12 8 Reusable cover for torso blanket Art No 8001140303 12 9 Holding claw Art No 8001140900 12 10 Mains cable Art No 8001120801 Length 250 cm Conductor cross section 3 x 1 00 mm 12 11 Body temperature sensor Art No 8001140802 Length 310 cm The parts listed under Point 12 to can be ordered from your dealer or from the manufacturer citing the Art No ...

Страница 31: ...e combination being purchased Arm shoulder blanket Art No 8001140202 Reusable cover for Arm shoulder blanket Art No 8001140203 Torso blanket Art No 8001140301 Reusable cover for torso blanket Art No 8001140303 Leg blanket right Art No 8001140408 Leg blanket left Art No 8001140409 Reusable cover for leg blanket right Art No 8001140410 Reusable cover for leg blanket left Art No 8001140411 Connecting...

Страница 32: ...t series Connection point for protective earthing conductors of the individual components of the control unit SN Serial number of the control unit 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 s...

Страница 33: ...ecial pre cautions as regards electromagnetic compatibility EMC and must be installed and operated in compliance with the EMC information included in the accompanying documentation 2 A statement that portable and mobile HF communication equip ment may affect the function of medical electrical devices 6 8 3 201 Technical description a1 Cables maximum lengths of cables and accessories A list of all ...

Страница 34: ...s B The device or system is suitable for use in all facilities including households and facilities that are directly connected to the public low voltage electri city supply network that supplies buildings used for residential purposes Overtone emissions IEC 61000 3 2 Class A Voltage fluctuations Flicker emissions IEC 61000 3 3 Compatible a4 Warning regarding installation The device or system shoul...

Страница 35: ...ode 1 kV Differential mode 2 kV Common mode The quality of the line current should cor respond to that of a typical commercial and or hospital environment Voltage reductions short interruptions and voltage fluctuations in electricity supply lines IEC 61000 4 11 5 UT for 0 5 of a cycle 95 reduction of UT 40 UT for 5 cycles 60 reduction of UT 70 UT for 25 cycles 30 reduction of UT 5 UT for 5 seconds...

Страница 36: ... Recommended distance Conducted HFIEC 61000 4 6 3 V effective value150 kHz to 80 MHz 3 V effective value d 3 5 3 P 1 17 P Radiated HF IEC 61000 4 3 3V m 80 MHz to 2 5 GHz 10 V m d 3 5 10 P 0 35 P 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 met...

Страница 37: ...ate 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 obser ved further measures may be necessary such as ...

Страница 38: ... Watt Distance m 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 1 0 37 0 11 0 22 1 1 17 0 35 0 70 10 3 70 1 11 2 21 100 11 70 3 50 7 00 For transmitters the rated output of which is not listed above the distance can be estimated using the equation in the corresponding column with P representing the maximum rated output of the transmitter in ...

Страница 39: ...www geratherm com 39 Manufacturer The manufacturer reserves the right to make technical modifications in keeping with technical advances ...

Страница 40: ...40 www geratherm com 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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