Operating Instructions HICO VARIOTHERM 550
Contents
1. D Carry out function test During long term operation check the independent protection manually at least once every day For this purpose press the function test key 17 during operation The unit now tests the safety electronics e the alarm sounds e the temperature indicators show DA e the red fault lamp 13 lights up e the display shows FUNCTION TEST After successful testing the display shows the message FUNCTION TEST OK the unit will automatically resume normal operation HICO VARIOTHERM 550 33 AIS A 6 2 8 Operator language HICO VARIOTHERM 550 Control and operation If the function test was not completed successfully the unit is no longer safe to operate In this case gt do not longer use the unit on a patient gt have the unit inspected by the Customer Service The status and error messages in the display 12 can be displayed in the languages German English French Spanish Italian Set the display language as follows Switching the device on Hold the key Alarm off 18 depressed for about 4 sec the language set last appears in the display Keep pressing the arrow key Nominal value higher 19 until the desired language appears in the display About 10 sec after the last input the unit will return to its previous operating status the language displayed last is active 34 LIL A 6 3 Alarms 6 3 1 General Control and operation The unit always emits visual and audib2. Operating Instructions Hypothermia Hyperthermia Unit HICO VARIOTHERM 550 C o124 seit 1945 HIRTZ Operating Instructions HICO VARIOTHERM 550 HIRTZ amp Co KG Bonner Str 180 D 50968 Cologne Phone 49 0 2 21 37 67 8 0 Fax 49 0 2 21 37 678 85 eMail hirtz hico de Internet www hico de Doc No 542121 Version 5 09 09 2009 HIRTZ amp Co KG HICO VARIOTHERM 550 2 IS A HICO VARIOTHERM 550 Table of contents 1 GeNErAL aoa so acces na A 6 1 1 Information regarding these instructions 6 Te ON ANS a ee 7 1 3 Limitation of liability 9 tA COPYN Sennen cn Cnet een Cen oenc ee nee E 9 1 5 Manufacturer address 9 2 Sae rica ae ee eis cee eee eee 10 2 1 INONOSUSR En en ao te Le 10 2 2 Personnel requirements ccccceceeeeeeeeeeeeeeeeeeeeeeneees 11 2 3 General Safety Advice cccccecceeeeeeeeeeeseeeeeneeeneeeeees 12 2 4 Danger SOUICES ccccceeceeeceeeeeeeeneceeeeeseneenesensoneeeeseneees 13 2 4 1 Danger of hypothermia or hyperthermia 13 3 Transport and setup 14 3 1 Scope of delivery and transport inspection 14 3 2 UNPACKING cccseccetcesicesncdenederectvestensesuceedesederedexesecesseemectet 14 3 3 Waste disposal of packaging material 0 15 4 COMMISSIONINQ 2 2 16 4 1 Safety ACVIC
3. Outer visible seal ring damaged Replace the seal ring leaking or missing Coupling valve of unconnected Inner seal ring damaged Customer Service coupling permanently leaking 2 Inner seal ring dirty Plug and release the coupling several times if necessary Customer Service Alarm display message 1 Independent protection Customer Service ALARM TEST DEFECT defective gt CUSTOMER SERVICE 2 Pump electrically defect Alarm display message Connect or disconnect water mat Reset alarm with Alarm key TEMP DIFF gt 1 C during operation Alarm display message every Insufficient cooling power 1 see next line 10 minutes TEMP DIFF gt 1 C Cooling elements or pump 2 Customer Service defective Excessive formation of foam 3 Replace water in tank Bypass interrupted 4 Customer Service Nominal value not reached in Insufficient cooling power The 3 causes affect one another cooling because unfavourably so that at least one 1 ambient temperature too high Cause needs to be rectified and or nominal value to low and or water mat too big 2 water mats Alarm display message Water level too low 1 Fill up water WATER LEVEL Can be reset with Alarm off key for 10 minutes Unit not in horizontal position 2 Place unit horizontally Sensor deviation 3 Customer Service HICO VARIOTHERM 550 48 AIBU A Trouble shooting Fault Possiblecauses Action Alarm
4. display message Various defects 1 Customer Service CHECK UNIT Water tank empty 2 Fill up water gt CUSTOMER SERVICE Sensor breakage short circuit 3 Customer Service T1 Alarm display message Unit too cold lt 9 C Warm up the unit for some CHECK UNIT time at room temperature gt CTEMPERATURE TOO LOW Sensor breakage T2 2 Customer Service Water tank frozen 3 Allow the unit to thaw Check the unit for frost damage does water run out of the unit gt customer service Unit completely without function Mains failure Switch off the unit until the and audible alarm mains supply is up again Mains plug has no contact Check plug on unit and mains socket for correct fit Fuse defective 3 Customer Service Unit defective 4 Customer Service Switch off the unit immediately HICO VARIOTHERM 550 49 LIL A 10 Waste disposal HICO VARIOTHERM 550 Waste disposal of old unit of old unit Old electric and electronic devices very often contain precious materials However they also contain harmful substances which were necessary for their function and safety If disposed of as residual waste or handled incorrectly these can cause harm for human health and damage the environment This device must not be disposed of with normal industrial or domestic waste NOTE gt According to the product reliability acc to 22 of the Kreislaufwirtschafts und Abfallgesetzes R
5. 24 RETZ Function and design Temperature transfer by means of water mats may be considered unsatisfactory if e the patient s body surface exceeds 0 5 m this corresponds with an approx weight of 10 kg or an age higher than 14 months e less than 20 of the water mat contacts the patient e the contact pressure reduces the skin circulation In this case there is an additional risk of bedsore Apart from this the temperature on the patient should normally not exceed 41 C to prevent the risk of burning in case of long term applications With too high temperatures this risk does always exist At a water temperature of more than 41 5 C the HICO VARIOTHERM 550 switches off electronically and mechanically to minimize this risk in case of an equipment fault In case of cooling applications and the related targeted lowering of the patient s temperature therapeutic hypothermia side effects may occur as described below e autonomous reactions among others shivering e electrolyte disturbances e higher diuresis e hyperglycaemia e high blood loss among others due to reduced blood clotting factors e increased rate of wound infection e risk of bedsore Side effects specifically related to water mat systems are not known HICO VARIOTHERM 550 29 LIL A Control and operation 6 Control and operation This chapter contains important information for operation of the unit Please follow these notes to avoid dang
6. 6 months Dust deposits inside the unit will reduce the performance of the system Have the dirt inside the unit cleaned out by a Service Engineer Customer Service Medical Engineering Do not open the unit yourself Make sure that the Customer Service or the Medical Engineer complies with the maintenance and safety related inspection intervals Replace the water in the water tank at least every 6 months as follows Disconnect the unit from the mains supply Place a container bucket bowl etc underneath or stand the unit on a water discharge facility e g a sink Unscrew the cap from the water filling socket 5 e g with a coin Tilt the unit backwards and let the water run out of the filling socket Fill the unit with water again as described in chapter 4 3 1 The max filling quantity of the tank is approx 1 litre 44 LIL A 8 1 3 Hose couplings Maintenance and safety related inspection 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 8 2 Safety related inspection HICO VARIOTHERM 550 In order to maintain legal conformity and operational reliability as per Medical Product Directive 93 42 EEC appendix point13 6 d and MPBetreibV 6 1 the unit needs to be subjected to a safety related inspection every 12 months The operator is solely responsible for the p
7. The audible alarm cannot be interrupted with the Alarm off key 18 a Switch off the unit with the mains switch 16 b Leave the unit switched off for 30 minutes c Fill up water until the water level is just below the MAX mark 6 see chapter Filling the system with water d Switch the unit back on Strictly comply with the sequence described above The unit may otherwise be damaged If the unit still emits an alarm take it out of service and have it inspected by a Service Engineer Customer Service Medical Engineering ALARM TEST DEFECT gt CUSTOMER SERVICE The unit triggers this alarm if it has detected a fault during the automatic or manual function test or has found that the independent protection does not respond The display shows ALARM TEST DEFECT and CUSTOMER SERVICE the red fault lamp 13 lights and a signal sounds 3 AIBUA Control and operation The audible alarm cannot be interrupted with the Alarm off key 18 e Switch off the unit with the mains switch 16 e Leave the unit switched off for approx 2 hours e Switch the unit back on If the unit still emits an alarm take it out of service and have it inspected by a Service Engineer Customer Service Medical Engineering UNDERTEMPERATURE CHECK UNIT The unit triggers this alarm if the water tank temperature falls short of the measuring range approx 9 C The display shows UNDERTEMPERATURE and CHECK UNIT The red faul
8. from 36 C to 38 C the heat transfer will double because the temperature difference has doubled from 2 C to 4 C Due to the thermal regulation of the patient this is only approximately true Example for enlarging the contact area In order to enlarge the contact area one can connect two water mats of the same or of different types e g HICO AQUASOFT HICO PU mats in series and place these under and on top of the patient see schematic below With a bigger contact area the increased heat transfer is also achieved with a lower temperature difference The mat temperature i e the nominal temperature value can thus be closer to the patient s temperature Water mats Hose coupling Hose extension 31 AIBUA Control and operation External conditions and mat size influence the desired nominal value e g a lower nominal value of 15 C may probably not be reached when connecting a large or two water mats In this case set a higher nominal value temperature power adaptation Check the water flow in the display 15 6 2 5 Temperature control operation There is a risk that the patient may be overheated or undercooled gt Monitor the patient s temperature when using the unit and the water mat on the patient If the nominal temperature value is set between 35 C and 38 C the unit will start normal operation after switching on and the function test and regulate the water temperature in the circuit t
9. is properly sealed NOTE For initial filling of the unit please follow the procedure described in chapter 6 2 1 Danger caused by water in connection with electricity Water is electrically conductive gt f water has been spilled when filling the unit the unit must first be thoroughly dried and should only be connected to the mains supply and switched on after it has completely dried The use of tap water is also possible depending on the water quality e g water hardness the lifetime of water contacting components in the unit will be reduced approx 10 SANOSIL mixture from Sanosil Farchant gt 11 water 100ml Sanosil solution The usage of a non proportional share of disinfectants can reduce the lifetime of those parts of the unit who will come in touch with water HICO VARIOTHERM 550 19 ET Z Commissioning 4 3 2 Connecting the water mats e The hose bracket 7 supplied with the unit eases the routing of hoses between mat and unit To attach the bracket loosen two knurled screws 8 on the left hand side of the unit and use these to fasten the bracket 7 8 e Push the hose couplings onto the couplings 9 on the unit The couplings are plugged on correctly when the lock on the hose coupling engages in the coupling of the unit so that the connection cannot come loose by itself e You can release the coupling again by pressing the small metal plate on the hose coupling and pulling off the hose N
10. optional equipment HICO VARIOTHERM 550 53 AABT Z Guidelines and declaration of manufacturer 13 Guidelines and declaration of manufacturer Guidelines and declaration of manufacturer electromagnetic emissions Tables for electric medical equipment General information reduced version Table 201 Line 1 Guidelines and declaration of manufacturer electromagnetic emissions The unit or system is intended for operation in an environment as described in the tables and texts of these operating instructions The customer or user of this unit or system should make sure that it is actually operated in this type of environment Interference emission measurements 4 HF emissions Group 1 Acc to CISPR 11 HF emissions Class B Acc to CISPR 11 Emissions of Class A harmonics acc to IEC 61000 3 2 Emissions of Not applicable voltage fluctuations flickering HICO VARIOTHERM 550 54 LIL A Guidelines and declaration of manufacturer Table 202 Interference immunity IEC 60601 test level Conformity level tests Electric static discharge ESD acc to IEC 6 kV contact discharge 6 kV contact discharge 61000 4 2 8 kV air gap discharge 8 kV air gap discharge Quick transient electric disturbances busts Acc to IEC 61000 4 4 2 kV for mains lines 2 kV for mains lines 1 kV for input and 1 KV for input and output lines output lines Surge voltages surges 4 kV normal mode voltage acc to IE
11. temperature and possibly trigger the alarm TEMP DIFF gt 1 C depending on the time behaviour HICO VARIOTHERM 550 2 LIL A 6 2 Operation Control and operation 6 2 1 Switching on for initial commissioning Switch on the unit with the push button 16 in switched off condition the push button is flush with the front panel Run the unit for about two minutes to remove any air from the circuit in the unit Check the water level in the indicator 6 if necessary switch off the unit disconnect it from the mains supply and fill up with water Connect a water mat to the unit mat and unit should be at the same level Reconnect the unit to the mains supply switch it on and run it for another two minutes to force all air out of the water mat Check the water level in the indicator 6 again if necessary switch off the unit disconnect it from the mains supply and fill up with water 6 2 2 Switching on in normal operation HICO VARIOTHERM 550 Switch on the unit with the push button 16 in switched off condition the push button is flush with the front panel Check the water level in the water level indicator 6 especially if you connected an empty water mat 28 AIBUA Control and operation 6 2 3 Function test After switching on the device performs a function test During this test watch whether all indicating elements behave as described below e a short audible alarm indicates that the unit is prepared
12. the unit see page 22 views of unit HICO VARIOTHERM 550 21 ABTT A Function and design 5 Function and design This chapter contains important information about the design and function of the unit 5 1 Views of the unit control and display elements 4 Thread for locking screw in bottom plate 5 Water filling socket with screw cap 6 Water level indicator 9 Hose couplings 10 Handles 17 11 Temperature display for 18 water mat 12 Display for status and error messages 13 Fault lamp 14 Temperature display for nominal value 15 Water flow display 16 Mains switch 17 Function test 18 Alarm off 19 Nominal value higher 20 Release lt 35 C gt 38 C 21 Nominal value lower Rear view detail of the unit with miniature fuse and unit socket HICO VARIOTHERM 550 22 RETZ Function and design 5 2 Safety installations 5 2 1 Sensors During operation the HICO VARIOTHERM 550 monitors e the water level in the unit e whether the water temperature in the circuit corresponds with the set nominal value e whether mains voltage is applied e whether the function is safe and emits alarms in case of malfunction see chapter 6 3 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 REF 540001 SN 08 0642 r 2008 230 V 50 60 Hz 320W IPX1 Alil E RE C 0124 JE amp Co KG 50968 K ln veurscnian
13. when connecting two water mats because the specified nominal value e g 15 C can in this case not be achieved Keep increasing the nominal value until the unit is able to regulate the temperature reliably gt After switching on the unit and after changing the nominal temperature this alarm function is suppressed over a specified period of time WATER LEVEL The unit triggers this alarm if the water level drops below the MIN mark in the water level indicator 6 during operation The display shows WATER LEVEL the red fault lamp 13 lights and a signal sounds e Press the Alarm off key 18 to interrupt the audible alarm for 10 minutes e Immediately fill up water until the water level is just below the MAX mark 6 see chapter Filling the system with water If no water is added the alarm LACK OF WATER an alarm with high priority see below will be triggered gt Incase of a too low water level a sufficient water circulation can no longer be assured gt A too low water level can cause damage to components of the unit and thus total failure of the unit 36 LIL A Control and operation 6 3 3 Alarms with high priority HICO VARIOTHERM 550 LACK OF WATER The unit triggers this alarm if the operational reliability is endangered because of a too low water level The display shows LACK OF WATER the red fault lamp 13 lights and a signal sounds the unit switches heating and pump off
14. 14 Brief instructions e Connect the unit to the mains supply e Connect the water mat to the unit e Check the water level on the unit e Switch on the unit by the mains switch 0 I and watch the automatic function test 538 C e If the nominal temperature value is gt 38 C or lt 35 C when lt 35 switching on an alarm will be emitted Acknowledge and start by pressing the release key e Set the temperature with the arrow keys e For temperatures higher than 38 C press arrow key and lt 30 6 release key together e For temperatures below 35 C press arrow key and release lt 30 key together e Depending on the application place the water mat under or over the patient e Monitor the body temperature of the patient e Watch the water level and the water flow on the unit A e In case of continuous operation perform a manual function Vv test once every day by pressing the Function test key e Audible alarms of low priority can be interrupted with the Alarm key e Alarms with high priority cannot be interrupted Switch off the unit with the mains switch 16 A hoad HICO VARIOTHERM 550 57 LIL A HICO VARIOTHERM 550 Brief instructions NOTE In case of an alarm with high priority the unit will switch off all functions Take the unit out of service and submit it to a Service Engineer for inspection and to re establish the operational reliability There is a risk that the patient may be overhe
15. 6 2 7 Obligations during operation 33 6 2 8 Operator language ccccccecceeeceeeceeeseeeaeeeeeeeeeeseeees 34 6 3 PAGING a ea ee nee de ce 35 CS Se EEE 35 6 3 2 Alarms with low priority cccccceceseeceeeeeeeeeeeeeneees 39 6 3 3 Alarms with high priority 37 6 3 4 Power failure alarm 39 7 Cleaning and disinfection 40 7 4 Safety AN ce eee teen ete eee 40 f2 C0 LUI O1 EST LAPS ecco cccnececnectesecesccebensseaciewnssenteaseesoees 41 PL AIG E E auenqatnenes E N 41 22 VENUAUONSIOIS ne es 41 149 Waler INAS sn senene nn men sense ss mme mse sc ecsse 42 8 Maintenance and safety related inspection 43 8 1 Maintenance cccccccceeeeeeeeeeeeeseeeeeeseeseesenesenseneseesenees 43 8 1 1 Equipment ss 44 OLL NOR en en ee 44 oi eo FOSO COLIS eee eee mene eee ee 45 8 2 Safety related inspection 45 9 Trouble shooting 47 9 1 Safety AOVICR 5 ee 2e ci cs sie 47 9 2 Fault causes and rectification 48 4 IS A HICO VARIOTHERM 550 Table of contents 10 Waste disposal of old unit 50 11 Warranty oasis sews ence ee eee eee cee ei iniaa 51 12 Technical data and accessories 52 12 1 Technical Data cccccccccecceccencenccsccencencencencesneenseneees 52 12 2 ACCeESSOrieS a ae 53 13 Guidelines and declaration of manufacturer 54 14 Brief INStrUCTIONS cccccccceccecceceec
16. C 61000 4 5 1 kV normal mode voltage 2 kV common mode voltage 2 kV common mode voltage fluctuations in the supply Magnetic field in supply frequency 50 60 Hz acc to IEC 61000 4 8 60 dip in UT for 25 periods lt 5 UT gt 95 dip in UT for5s HICO VARIOTHERM 550 60 dip in UT for 25 periods lt 5 UT gt 95 dip in UT for5s Voltage dips short term lt 5 UT lt 5 UT interruptions and gt 95 dip in UT gt 95 dip in UT voltage acc to IEC for 2 period for 72 period eens 40 U 40 U 60 dip in UT 60 dip in UT for 5 periods for 5 periods 70 UT 70 UT 99 ABT ZZ Guidelines and declaration of manufacturer Table 204 NON life supporting systems Interference immunity tests Interference immunity tests tests IEC 60601 test level 60601 IEC 60601 test level level Conformity level Conformity level Conducted HF disturbances acc to 3 Veg 3 V IEC 61000 4 6 150 kHz to 80 MHz Radiated HF disturbances acc to 3 Vef 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz Radiated HF disturbances acc to 10 V m 10 V m EN 60601 2 35 Table 206 Electrical clearance to wireless telecommunication facilities Electric clearance depending on transmission frequency m Nominal power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d P exp0 5 3 5 V 1 d P exp0 5 3 5 E1 d P exp0 5 7 E1 HICO VARIOTHERM 550 56 RETZ Brief instructions
17. E 2 2 1 nnne 16 4 2 Setting D eee nee eee ree eee eee 16 4 2 1 Requirements concerning the place of installation 16 4 2 2 Setting up with five castor stand optional 18 4 3 Connecting the HICO VARIOTHERM 550 19 4 3 1 Filling the system with water ccccccceccseeeeeeeeeees 19 4 3 2 Connecting the water mats ccccccceecceeeeeeeeeeeees 20 A 3 3 IeCIFrICAl CONMCCUON tcsccccssrscccodvrdaeadnnacsncdenceenedeninteadans 21 5 Function and design 22 5 1 Views of the unit control and display elements 22 5 2 Safety installations 23 SLT DNOS ee ea etes ee een 23 933 Type pilale soiit 23 A FUNGUO oio EE A E EEn 24 DA Basie DIODES a nn oo 24 5 4 2 Indications contraindications side effects 24 3 IS A HICO VARIOTHERM 550 Table of contents 6 Control and operation 26 6 1 Before switching on M 26 6 1 1 Inspections on the unit 26 C NE ere eee 26 62 ODOFATION 2eme see caane ess one ce ac cnne cc ascemecsenses 28 6 2 1 Switching on for initial commissioning 28 6 2 2 Switching on in normal operation 28 029 FUNCHOMAISSE res ea a ann nn en E 29 6 2 4 Setting the temperature cc ccccceceeceeeeeeeeeeeees 30 6 2 5 Temperature control operation 32 6 2 6 Note on handling water mats ccccccceeeseeeeeeeeees 33
18. OTE gt The hoses of the water mat can not be mixed up by mistake when plugging on the couplings of the unit because it does not matter which way the water flows through the water mat gt Water mats can also be decoupled while the unit is switched on Water dripping out of the coupling is in this case quite normal and does not indicate a leakage or defect In heating operation Reduce the nominal temperature before you disconnect the water mat Otherwise the water in the circuit of the unit will temporarily heat up above nominal temperature and possibly trigger the alarm TEMP DIFF gt 1 C depending on the time behaviour HICO VARIOTHERM 550 20 RETZ Commissioning 4 3 3 Electrical connection 1 Danger caused by electric current Defective cables and or plugs can cause life threatening electric shock gt Check the condition of unit cable and plug before connecting Please observe the following notes when connecting the unit electrically to ensure safe and fault free operation e Before connecting the unit compare the electric data voltage and frequency on the type plate with the data of your mains supply These data must match to prevent the unit from being damaged Please ask your electrics expert for advice if in doubt e The electric socket must be protected by a 16 A circuit breaker e Use the cable supplied with the unit to connect the unit to the mains supply The unit socket is on the back side of
19. a disinfectant follow the instructions of the manufacturer Only use the mat again after the disinfectant has evaporated completely Check the mat for damage deformation or cracks if necessary replace the mat 42 LIL A Maintenance and safety related inspection 8 Maintenance and safety related inspection 8 1 Maintenance HICO VARIOTHERM 550 This chapter contains important information for maintenance of the unit Please follow these instructions to avoid damage caused by inadequate maintenance of the unit and to assure trouble free operation We recommend the conclusion of a maintenance contract with HIRTZ amp Co KG By concluding a maintenance contract you fulfil the requirements e of the BetrSichV BGV A2 VBG 4 new BGV A3 e the Medical Product Directive 93 42 EEC e the MPBetreibV all of which request regular technical inspection of the units Furthermore maintenance by our experts ensures maximum operational reliability and longevity of the unit Do not apply any other cleaning and decontamination methods than the ones recommended by HIRTZ amp Co KG Before introducing new methods check these together with HIRTZ amp Co KG Only this makes sure that the unit will not be damaged by this method 43 LIL A 8 1 1 Equipment 8 1 2 Water tank HICO VARIOTHERM 550 Maintenance and safety related inspection Check the ventilation slots on both sides of the unit for dirt at the latest after
20. arising from this must be borne by the customer Questions concerning service maintenance or safety related inspection should be directly addressed to HIRTZ amp Co KG Bonner Str 180 D 50968 Cologne Phone 02 21 3 76 78 0 Fax 02 21 3 76 78 85 E mail hirtz hico de 46 LIL A Trouble shooting 9 Trouble shooting 9 1 Safety Advice HICO VARIOTHERM 550 This chapter contains important information for fault localisation and trouble shooting Please follow these notes to avoid dangers and damages gt Repairs on electric devices must only be carried out by skilled professionals which may have been trained by the manufacturer gt Inappropriate repairs can cause considerable dangers for the user and damage to the unit NOTE Opening of the unit by unauthorized persons will lead to the loss of any warranty claims 47 AIBU A Trouble shooting 9 2 Fault causes and rectification No or insufficient water circulation 1 Hoses or mat buckled 1 ensure correct routing or positioning 2 Couplings not locked properly 2 Plug couplings firmly together Device positioned too far Position unit at same height or below the water mat above Excessive formation of foam 4 Replace water High weight of patient 5 Place unit higher than water mat Pump worn defective Customer Service Couplings are stiff Seal rings dry and brittle Grease seal rings with Vaseline silicone grease Coupling connection permanently
21. ate gt Temperatures above 38 C supply the patient with heat at a higher rate gt Places of the body which are subjected to increased pressure may suffer under pressure necrosis and or burns even at temperatures below 41 C This applies for long term applications and risk patients in particular NOTE The lower temperature that can be controlled by the unit depends on type and size of the water mat A nominal value of 15 C may even not be achieved with large water mats and or ambient temperatures above 25 C see Scott S M Thermal blankets injury in the operating room Arch Surg 34 page 181 1967 HICO VARIOTHERM 550 30 LIL A HICO VARIOTHERM 550 Control and operation The heat transfer heat supply or heat withdrawal between patient and water mat will only take place if the temperature of the water mat is higher or lower than the skin temperature of the patient at the contact area The measure of heat transfer is directly proportionate e to the temperature difference between skin temperature and water mat temperature e to the size of the contact area Intermediate layers impair the heat transfer e g surgical cloths or gel mats Example for temperature difference The heat transfer from mat to patient doubles when the temperature difference between water mat and patient is doubled If the patient s skin has a temperature of 34 C at the contact area and the water mat temperature is raised
22. ated or undercooled gt Monitor the patient s temperature when using the unit and the water mat on the patient Do not start the unit if gt the display has failed gt individual segments of the temperature display have failed temperature can no longer be read reliably gt the red fault lamp 13 lights permanently or not at all function test gt the signal sounds permanently or not at all function test M the unit does not respond to key operation gt the unit does not respond as described in the chapter 6 2 3 Function test when switching on or when running a function test 58 RETZ Brief instructions Notes HICO VARIOTHERM 550 59
23. ce temperature of lt 41 C Measuring range approx 9 50 C Measuring deviation 1 lt 0 1 C display water temperature Measuring deviation 2 lt 0 5 C display contact surface temperature Correction value 0 5 C water temp temp display Sensor element 2 x NTC 5K Pump capacity max 5 5 l min max 0 21 bar Heat output approx 750 W max at 27 C Cooling power approx 500 W max at 27 C Warm up time approx 5 10 min 20 37 C Cool down time approx 5 10 min 20 15 C Class type of protection Type of protection IP IP X1 drip proof Risk class 93 42 EEC Wb Ambient temperature Relative air humidity Storage temperature Air pressure 1013 hPa 10 permissible height difference HICO VARIOTHERM 550 52 ABT ZZ Technical data and accessories Dimensions WxHxD Noise emission Test basis Medical Product Directive 93 42 EEC IEC 601 1 IEC 601 1 2 IEC 601 2 35 UMDNS Code The right for technical modifications remains reserved The degree of electric protection in the application part corresponds with TYPE BF 12 2 Accessories Only original HICO water mats may be used in connection with the HICO VARIOTHERM 550 necessary accessories The required information about HICO water mats can be found in the corresponding brochures and price lists Hose extension approx 3 m necessary accessories Five castor stand incl stand plate height approx 68 cm
24. cecsecseesceeseaees 57 LIL A 1 General General Please read the information in this manual to become acquainted with the HICO VARIOTHERM 550 as quickly as possible to be able to utilize its functions to the full extent 1 1 Information regarding these instructions HICO VARIOTHERM 550 These operating instructions are part of the HICO VARIOTHERM 550 hereafter referred to as unit and contains important notes concerning commissioning safety intended use as well as care and maintenance of the unit All illustrations and drawings in these operating instructions serve the purpose of general understanding and are not relevant with respect to design details These operating instructions must be available at all times preferably near the unit They must be read by any person involved in the e commissioning e operation e cleaning e Maintenance e Trouble shooting of the unit LIL A 1 2 Warnings HICO VARIOTHERM 550 General The following warning notes are used in these operating instructions ADANGER A warning note of this danger level identifies an imminent dangerous situation Not avoiding this dangerous situation will cause severe injury or even death gt Follow the instructions given in this warning note to avoid the danger of death or severe injury to persons A warning note of this danger level identifies a possibly dangerous situation Not avoiding this dangerous situation can lead to
25. d HICO VARIOTHERM 550 23 RETZ Function and design 5 4 Function 5 4 1 Basic principles The hypothermia hyperthermia unit HICO VARIOTHERM 550 serves the purpose of cooling or warming patients by means of water mats The unit was developed under due consideration of the latest safety and application related knowledge about water mat systems The temperature conductance between patient and water mat is solely achieved by surface contact Thanks to its high heat capacity and heat conductivity water is an ideal transmission medium for this type of application The water is cooled or heated in a water tank inside the unit by means of thermo electrical elements and continuously pumped through the water mat by a centrifugal pump The HICO VARIOTHERM 550 is characterised by simple and safe use reliability and compact design Its electronic control enables exactly controlled temperature transmission to the patient while ensuring high operational reliability The risk of local temperature accumulation is ruled out Operation of the HICO VARIOTHERM 550 is simple and intuitive incorrect use Is almost ruled out 5 4 2 Indications contraindications side effects The HICO VARIOTHERM 550 is used for e Heat supply in case of intraoperative or postoperative hypothermia e Heat supply or heat withdrawal to stabilize the patient s temperature normothermia e Heat withdrawal in case of malignant hyperthermia HICO VARIOTHERM 550
26. e alarm for at least 10 minute without mains supply The audible alarm cannot be interrupted with the Alarm off key 18 e Switch off the unit with the mains switch 16 NOTE The alarm automatically goes out when the power supply returns 39 AIS A Cleaning and disinfection 7 Cleaning and disinfection 7 1 Safety Advice HICO VARIOTHERM 550 This chapter contains important information about the cleaning and disinfection of the unit Please follow these instructions to avoid damage caused by incorrect cleaning of the unit and to assure trouble free operation Observe the following safety notes before starting to clean the unit gt Pull out the mains plug before starting cleaning and disinfecting the unit gt Prevent fluids from entering into the unit gt Let the unit dry completely before switching it on again Sensitive surfaces The surfaces of unit and mats can be destroyed by using wrong cleaning agents and disinfectants gt Use only disinfectants based on aldehydes ammonium components or alcohols which will not affect ABS plastics as well as PVC and PU for all surfaces and parts gt If possible do not use any phenol derivative based disinfectants because these will shorten the lifetime of plastic materials 40 LIL A 7 2 Equipment 7 2 1 Finish 7 2 2 Ventilation slots Cleaning and disinfection If possible use decalcified water Only wipe the unit with a damp cloth For clea
27. ecycling Economy and Waste Management Act and the Elektro und Elektronikgesetzes Electrics and Electronics Act 2 section 1 cipher 8 the unit must be handed over to a corresponding communal collecting point or returned to the manufacturer NOTE gt In accordance with waste management regulations of the user the water mat can be disposed off for incineration together with domestic waste 50 LIL A 11 Warranty HICO VARIOTHERM 550 Warranty The HICO VARIOTHERM 550 has been developed according to latest knowledge and is manufactured and tested by HIRTZ amp Co KG in strict compliance with highest technical standards However should any defects occur during the period of 24 months starting with the date of purchasing by the end user we guarantee free of charge replacement or free of charge repair of defects caused by material design or production faults Under the following conditions among others warranty becomes null and void a Damage caused by improper transport b C d e Damage caused by environmental effects Damage caused by improper handling Use of impermissible accessories sr ES N ee Opening of unit by unauthorized persons 51 ABT ZZ Technical data and accessories 12 Technical data and accessories 12 1 Technical Data HICO VARIOTHERM 550 Power consumption Nominal value range Safety shut down 42 1 42 5 C independent safety shut down This results in a max mat surfa
28. erformance of this safety related inspection Based on the MPBetreibV 6 4 1 3 this safety related inspection must only be performed by HIRTZ amp Co KG or a qualified person The safety related inspection covers at least the following points e Inspection of the device and application components for external damage wear aging and legibility of displays and inscriptions e Measurement of the PE resistance and the earth leakage current acc to the testing facility and manufacturer s data e Inspection of all functions by following the operating instructions e Inspection of all safety functions acc to manufacturer s data e Inspection of all sensors acc to manufacturer s data for this purpose HIRTZ amp Co KG provides a Service Manual for authorized persons 45 AIS A HICO VARIOTHERM 550 Maintenance and safety related inspection In order to maintain conformity with statutory safety regulations we recommend to conclude a Safety Related Inspection Contract with HIRTZ amp Co KG We will in this case carry out the annual safety related inspections NOTE For heavily soiled units or accessories returned to us for maintenance or repair with which there is a suspicion of contamination by contact we reserve the right to reject such units or components for safety reasons or after consultation to subject these to additional treatment before performing a technical revision or damage analysis Any additional costs
29. ers and damages 6 1 Before switching on 6 1 1 Inspections on the unit Examine the unit for any external damage Check the water level before and after switching on the unit connecting the water mat The water level must be between the two marks on the water level indicator 6 preferably just below the maximum mark The filling difference between both marks is approx 0 5 litres Top up water if 6 1 2 Water mat HICO VARIOTHERM 550 the water level is below the minimum mark you would like to connect an empty water mat and the water level is below the maximum mark Only connect original HICO water mats to the HICO VARIOTHERM 550 Check the water mats for external damage before connecting Use only undamaged mats Prepare a collecting basin in case a mat should start leaking 26 MENU AZ Control and operation Water mats can be connected and disconnected with the unit switched on or off NOTE Disconnecting water mats with the unit switched on gt in heating operation Reduce the nominal temperature before you disconnect the water mat Otherwise the water in the circuit of the unit will temporarily heat up above nominal temperature and possibly trigger the alarm TEMP DIFF gt 1 C depending on the time behaviour gt in cooling operation Increase the nominal temperature before you disconnect the water mat Otherwise the water in the circuit of the unit will temporarily cool down below nominal
30. for a possible power failure alarm The unit now checks its self sufficient protection and e shows the result in the display 12 e the temperature displays 11 and 14 show no 0 e the fault lamp 13 lights up e the audible alarm is on This test take a few seconds If the function tests were not completed successfully the unit is no longer safe to operate Do not operate the unit if gt the unit does not emit the short signal for power failure alarm after switching on gt the automatic function test of the unit automatically switches off the unit because a defect in the independent protection was found gt one or several displays are defective In cases like these have the unit checked by the HICO Customer Service HICO VARIOTHERM 550 29 AIBUA Control and operation 6 2 4 Setting the temperature e Set the nominal value for the water temperature i e the temperature on the contact area between water mat and patient with the two arrow keys 19 and 21 The temperature can be set in steps of 0 1 C from 15 to 39 C The temperature display 14 shows the set nominal value 4 e For nominal temperature values above 38 C press the arrow lt 30 C key 19 and the release key 20 at the same time e For nominal temperature values below 35 C press the arrow lt 35t key 21 and the release key 20 at the same time gt Temperatures below 35 C withdraw heat from the patient at a higher r
31. ging or transport to the forwarding agent the insurance company and the supplier To unpack the device e Take the unit out of its box and remove the packaging material Stand the unit on a level and horizontal base with sufficient load bearing capacity 14 AIS A Transport and setup 3 3 Waste disposal of packaging material HICO VARIOTHERM 550 The packaging material protects the unit against transport damage The packaging material has been chosen under environmental and waste disposal related aspects and is therefore recyclable Returning packaging material to the material circulation system saves raw materials and reduces the amount of waste Return packaging material that is no longer needed to the collecting locations for the recycling system Gruner Punkt in Germany NOTE gt If possible keep the original packaging over the warranty period to be able to pack the unit again properly in case of a warranty claim 15 AIS A 4 Commissioning Commissioning This chapter contains important information for commissioning the unit Please follow these notes to avoid dangers and damages 4 1 Safety Advice Personal injuries and material damage may occur when commissioning the unit Please comply with the following safety notes to avoid dangers gt The weight of the unit is approx 17 kg Transport unpack 4 2 Setting up and set up the unit with two persons 4 2 1 Requirements concern
32. gt Before start up check the proper condition of the unit mains cable housing couplings etc and the water mats Lay out hoses and water mats without creases and buckling Do not touch hoses and water mats with pointed or sharp objects The system is not able to work correctly with perforated mats Fill the unit tank with distilled water to which a germicidal agent has been added Operate the unit only after the tank has been closed with the SCrew Cap Stand the unit horizontally inclination of the support area lt 3 Height difference between unit and water mat lt 1 m Do not cover the unit there are ventilation slots on bottom and rear side the sides have ventilation slots and fan air inlet openings Observe the automatic function test when switching on In continuous operation perform the automatic function test manually at least once every day The use of tap water is also possible depending on the water quality e g water hardness the lifetime of water contacting components in the unit will be reduced approx 10 20 SANOSIL from Sanosil Farchant HICO VARIOTHERM 550 12 LIL A 2 4 Danger sources Safety During operation check the water flow and the water level on the unit regularly Operate the unit only with an appropriate water level Strictly comply with the ambient temperature range 10 0 C and storage temperature range 10 40 C Apply appropriate measures to
33. ing the place of installation For safe and fault free operation of the unit the set up place HICO VARIOTHERM 550 must have sufficient load bearing capacity weight of unit approx 17 kg must be level must be horizontal inclination lt 3 must provide 20 cm space to either side of the unit must ensure sufficient ventilation of the device e g in a rack trolley also upwards must be at the same level as the water mat i e with the bed of the patient the unit may only be max 1 m higher 16 IBI A Commissioning The optionally available five castor stand meets these prerequisites NOTE gt Ifthe unit is not horizontal the display in the front of the unit will indicate the water level incorrectly gt Ifthe unit is far below the level of the water mat the water circulation may be interrupted with heavy patients Furthermore water may flow back into the unit and cause overflowing of the water tank when the water filling socket is opened with the unit switched off HICO VARIOTHERM 550 17 LIL A Commissioning 4 2 2 Setting up with five castor stand optional The five castor stand which is optionally available as an accessory makes the stationary HICO VARIOTHERM 550 mobile Set up the unit together with the five castor stand as follows Assemble the five castor stand as described in the assembly instructions Slide the stand plate 1 over the vertical tube 2 of the five castor stand F
34. ix the plate with the star knob screw 3 The stand plate is equipped with a locking screw 4 place the HICO VARIOTHERM 550 on the plate so that screw and thread in the bottom of the unit are in line Turn the locking screw into the bottom of the unit to secure the unit Personal injuries and material damage may occur when commissioning the unit gt To guarantee a safe function and for a stable fixed stay bar HICO VARIOTHERM 550 2 it is necessary that during the assembly of the five foot rack all 5 punches of the metallic disc lock into the wholes of the five foot extension the screw must be tighten strong by min 9Newton m These 2 phases must be checked direct after the assembly of the five foot rack and regularly during the running time 18 IBI A Commissioning 4 3 Connecting the HICO VARIOTHERM 550 Danger caused by water in connection with electricity gt Only connect the unit to the mains supply after it has been filled 4 3 1 Filling the system with water e Unscrew the cap from the water filling socket 5 e g with a coin Take care not to lose the sealing ring of the cap e Watch the water level indicator while filling 6 After filling the water level should be slightly below the MAX mark OS 88 5 Fill the unit tank with distilled water to which a germicidal agent has been added After filling turn the screw cap hand tight back onto the water filling socket until it
35. le alarms The operator is instantaneously informed about any malfunction which in turn enhances the operational reliability of the system The display 12 shows the fault condition that has caused the alarm except power failure alarm In case of alarms with low priority see below pressing the key Alarm off 18 will stop the audible alarm for 10 minutes The error message in the display 12 is erased the fault lamp 13 stays on as long as the alarm condition is present In case of alarms with high priority chapter 6 3 3 the unit switches off all functions The audible alarm cannot be interrupted Switch off the unit by the mains switch 16 take it out of service and if necessary have it inspected by a Service Engineer Customer Service Medical Engineering 6 3 2 Alarms with low priority HICO VARIOTHERM 550 TEMP DIFF gt 1 C Should the water mat temperature deviate from the set nominal temperature by more than 1 C during operation the unit will trigger this alarm The display shows TEMP DIFF gt 1 C the red fault lamp 13 lights and a signal sounds e Press the Alarm off key 18 to interrupt the audible alarm for 10 minutes 35 AIS A HICO VARIOTHERM 550 Control and operation NOTE gt Connecting or disconnecting a water mat during operation can cause an alarm triggering temperature difference gt The alarm can be triggered in cooling operation at high room temperatures and or
36. ning use only warm water max 50 C with a mild commercial dish washer liquid Wipe off again with clear water and wipe the unit dry with a cloth To disinfect the surface of the unit we recommend a wiping or area disinfection acc to RKI or DGHM list e g Mikrozid from S amp M or Sanosil from Sanosil When using a disinfectant follow the instructions of the manufacturer Only switch on the unit after the disinfectant has evaporated completely Check the ventilation slots on both sides of the unit regularly for dirt but at the latest after 6 months Remove external dirt as far as this is possible Dust deposits inside the unit will reduce the performance of the system Have the dirt inside the unit cleaned out by a Service Engineer Customer Service Medical Engineering Do not open the unit yourself Robert Koch Institut Deutsche Gesellschaft f r Hygiene und Mikrobiologie Lists available from mhp Verlag Wiesbaden HICO VARIOTHERM 550 41 LIL A 7 3 Water mats HICO VARIOTHERM 550 Cleaning and disinfection If possible use decalcified water Only wipe the mat with a damp cloth For cleaning use only warm water max 50 C with a mild commercial dish washer liquid Wipe off again with clear water and wipe the mat dry with a cloth To disinfect the surface of the unit we recommend a area wiping or spraying disinfection acc to RKI or DGHM list e g Mikrozid from S amp M or Sanosil from Sanosil When using
37. ns are made to the best of knowledge We will not assume liability for translation mistakes even if the translation was made by us or ordered by us Only the original German text is binding This documentation is protected by copyright law All rights also the rights for photo mechanical reproduction copying and distribution by means of special methods e g data processing data carrier and data networks even in parts remain reserved by HIRTZ amp Co KG Subject to changes in contents and technical modifications 1 5 Manufacturer address HICO VARIOTHERM 550 HIRTZ amp Co KG Bonner Str 180 D 50968 Cologne Phone 49 0 2 21 3 76 78 0 Fax 49 0 2 21 3 76 78 85 E mail hirtz hico de AIBU A Safety 2 Safety This chapter contains important safety notes for work with this unit This unit complies with the specified safety regulations However improper use can lead to personal injury or material damage 2 1 Intended use This unit is solely intended for the cooling or heating of water mats used to cool or warm a patient Any other use exceeding the use described above is considered as unintended use Danger due to improper utilisation Dangers may arise from the unit if it is put to unintended use and or if it is used for any other purposes gt Only use the unit for the purpose is is intended for gt Follow the procedures described in these operating instructions Claims of any type because
38. o the set value If the set value is higher than 38 C or less than 35 C the unit will emit an audible alarm and the message NOMINAL VALUE lt 35 gt 38 C RELEASE KEY will appear in the display 12 gt 38 E Check whether the nominal value is correct before pressing the lt 35 L release key 20 The unit starts temperature control operation and the display 12 shows the reading HEATING ACTIVE or COOLING ACTIVE Only leave the water mat in contact with the patient in normal operation Due to the excellent heat conductivity of water the patient may cool down when the unit is switched off or the water mat is disconnected from the unit HICO VARIOTHERM 550 32 AIBUA Control and operation 6 2 6 Note on handling water mats NOTE gt When disconnecting water mats from the switched off unit the mat should be lower than the unit This prevents backflow and the mats stay sufficiently filled with water for the next use gt Water mats connected to the unit should never be stored at a higher level than the unit e g not on top of the unit The water will in such cases flow from the mat back into the unit and flow over 6 2 7 Obligations during operation Check the water flow During operation check the water flow through unit and mat at regular intervals The sight glass of the water flow indicator 15 features an impeller wheel With optimal water flow the individual blades of the impeller are not visible
39. of damages resulting from unintended use are excluded The operating company is the sole bearer of the risk In these operating instructions the term water mat describes all HIRTZ accessories such as water mats water blankets water collars etc HICO VARIOTHERM 550 10 AIS A Safety 2 2 Personnel requirements HICO VARIOTHERM 550 NOTE gt Work on with the unit must only be carried out by persons who are authorized for this work because of their education and qualification Apart from this these persons must also be entrusted with this work by the operator Allow personnel to be trained instructed directed or undergoing general training to only work on or with the unit under the supervision of an experienced person Persons who are under the influence of drugs alcohol or medication that affects their responsiveness may under no circumstances carry out work on or with the unit Dangers may arise from the unit if it is improperly used by untrained personnel 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 11 LIL A Safety 2 3 General Safety Advice NOTE For safe handling of the unit you should comply with the following general safety notes gt gt
40. position the patient on or under the water mat if necessary Do not use water mats as electric insulation mats in combination with HF surgery Intermediate layers between patient and water mat sheets surgical cloths gel mats etc adversely affect the heat transfer Operate the unit only with HICO water mats and original accessories Do not operate the unit in the presence of combustible gases In hyperthermia hypothermia mode do not use or combine the unit with other heat sources Do not operate the unit in the vicinity of heat sources spotlights direct insolation radiators radiant heaters etc Perform maintenance and safety related inspections by following these operating instructions 2 4 1 Danger of hypothermia or hyperthermia HICO VARIOTHERM 550 There is a risk that the patient may be overheated or undercooled gt Monitor the patient s temperature when using the unit and the water mat on the patient 13 LIL A Transport and setup 3 Transport and setup 3 1 Scope of delivery and transport inspection The scope of delivery of the HICO VARIOTHERM 550 consists 3 2 Unpacking HICO VARIOTHERM 550 of HICO VARIOTHERM 550 unit Power cable Hose bracket Operating Instructions Hose extension Water mats optional as ordered NOTE gt Check the delivery for completeness and visible damage gt Immediately report an incomplete delivery or damage caused by inappropriate packa
41. severe injuries gt Follow the instructions in this warning note to avoid the risk of injuries to persons A warning note of this danger level identifies a possibly dangerous situation Not avoiding this dangerous situation can lead to minor or moderate injuries gt Follow the instructions in this warning note to avoid the risk of injuries to persons LIL A HICO VARIOTHERM 550 General A warning note of this danger level identifies the possibility of material damage Not avoiding this situation can lead to material damage gt Follow the instructions in this warning note to avoid the risk of material damage NOTE A note highlights additional information to assist in working with the unit LIL A General 1 3 Limitation of liability 1 4 Copyright All technical information data and notes on installation operation and care contained in this manual were up to date at the date of printing and have been entered to the best of our knowledge under due consideration of our previous experience and knowledge 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 of e failure to comply with the operating instructions e unintended use e unprofessional repairs e technical modifications e use of non approved spare parts e Unauthorized conversions and changes Translatio
42. t lamp 13 lights and a signal sounds The temperature indicator shows 77 7 The audible alarm cannot be interrupted with the Alarm off key 18 e Switch off the unit with the mains switch 16 e Take the unit to a warmer environment and wait for about 2 hours e Switch the unit back on gt Store the unit only in the permissible temperature range the unit may otherwise be damaged 10 40 C gt Operate the unit only in the permissible temperature range the unit may otherwise not operate reliably and may be damaged 10 30 C 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 38 LIL A Control and operation CHECK UNIT gt CUSTOMER SERVICE The unit triggers this alarm in case of various defects The display shows CHECK UNIT and CUSTOMER SERVICE the red fault lamp 13 lights and a signal sounds The audible alarm cannot be interrupted with the Alarm off key 18 e Switch off the unit with the mains switch 16 Take the unit out of service and have it inspected by a Service Engineer Customer Service Medical Engineering 6 3 4 Power failure alarm HICO VARIOTHERM 550 The unit triggers this alarm if the power supply fails during operation The red fault lamp 13 lights and a signal sounds All other displays are without function The power accumulator in the unit receives th
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