Operating Instructions HICO AQUATHERM 660
Contents
1. 30 6 2 5 Temperature control operation 32 6 2 6 Note on handling water mats 33 6 2 7 Obligations during operation 33 6029 Operator lanquad 34 ee tetera ae eee den de 35 A 35 6 3 2 Alarms with low priority 35 6 3 3 Alarms with high priority 37 6 3 4 Power failure alarm 39 7 Cleaning and disinfection 40 7 4 40 Ll 41 PRIS ne 41 7 2 2 Ventilation slots 41 7 3 Water ARS a ne a es ed tee 42 8 Maintenance and safety related inspection 43 8 1 43 OL Cars 44 NN MER dp Wm 44 8 1 3 Hose COUPINOS santana 45 8 2 Safety related inspection 45 9 Trouble shooting 47 9 1 Safety Advice 47 9 2 Fault causes and rectification 48 4 idle A HICO AQUATHERM 660 Table of contents 10 Waste disposal of old unit 50 11 Warranty 51 12 Technical data and accessories 52 12 1 Technical Data creer en nnn nnn 52 12 2 ACCOSSOTIOS a ae 53 13 Guidelines and declaration of manufacturer 54 14 Brief instructions2. Do not start the unit if the display has failed gt individual segments of the temperature display have failed temperature can no longer be read reliably the red fault lamp 13 lights permanently or not at all function test gt the signal sounds permanently or not at all function test v the unit does not respond to key operation the unit does not respond as described in the chapter 6 2 3 Function test when switching on or when running a function test 98 RETZ Brief instructions Notes HICO AQUATHERM 660 99
3. 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 AQUATHERM 660 owitch 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 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 00 0 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 the automatic function test of the unit automatically switches off th
4. Only switch on the unit after the disinfectant has evaporated completely Check the ventilation slots on the rear side 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 AQUATHERM 660 41 Alles A 7 3 Water mats HICO AQUATHERM 660 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 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 Alles A Maintenance and safety related inspection 8 Maintenance and safety related inspection 8 1 Maintenance HICO AQUATHERM 660 This chapter con
5. 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 oide effects specifically related to water mat systems are not known 25 Alles A Control and operation 6 Control and operation This chapter contains important information for operation of the unit Please follow these notes to avoid dangers 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 1 litres Top up water if 6 1 2 Water mat HICO AQUATHERM 660 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 AQUATHERM 660 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 Alles A 6 1 3 Heat emission HICO AQUATHERM 660 Control and operation Water mats can be connected and disconnected with the unit sw
6. of hoses between mat and unit To attach the bracket loosen two knurled screws 8 on the right hand side of the unit and use these to fasten the bracket 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 NOTE 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 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 20 ez 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 electrical
7. esee 57 Alles A 1 General General Please read the information in this manual to become acquainted with the HICO AQUATHERM 660 as quickly as possible to be able to utilize its functions to the full extent 1 4 Information regarding these instructions HICO AQUATHERM 660 These operating instructions are part of the HICO AQUATHERM 660 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 Alles A 1 2 Warnings HICO AQUATHERM 660 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 severe inju
8. 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 AQUATHERM 660 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 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 AIBUA Control and operation gt Connecting or disconnecting a water mat during operation can cause an alarm triggering temperature difference gt The alarm can be triggered in heating operation at low room temperatures and or when connecting two or several water mats because the specified nominal value e g 39 C can in this case not be achieved Reduce the number size of mats until the unit is able to control the temperature reliably Patient temperature 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 th
9. not use water mats as electric insulation mats in combination with HF surgery gt Intermediate layers between patient and water mat sheets surgical cloths gel mats etc adversely affect the heat transfer gt Operate the unit only with HICO water mats and original accessories gt Do not operate the unit in the presence of combustible gases gt in hyperthermia mode do not use or combine the unit with other heat sources gt Do not operate the unit in the vicinity of heat sources spotlights direct insolation radiators radiant heaters etc gt Perform maintenance and safety related inspections by following these operating instructions 2 4 Danger sources 2 4 1 Danger of overheating There is a risk that the patient may be overheated gt Monitor the patient s temperature when using the unit and the water mat on the patient HICO AQUATHERM 660 13 Alles A Transport and setup 3 Transport and setup 3 1 Scope of delivery and transport inspection The scope of delivery of the HICO AQUATHERM 660 consists 3 2 Unpacking HICO AQUATHERM 660 of HICO AQUATHERM 660 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 packaging or transport to the forwarding agent the insurance company and
10. 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 AQUATHERM 660 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 Gr ner 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 Alles 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 The weight of the unit is approx 9 kg Transport unpack and 4 2 Setting up set up the unit with two persons 4 2 1 Requirements concerning the place of installation For safe and fault free operation of
11. unit immediately HICO AQUATHERM 660 Water level too low Unit not in horizontal position Sensor deviation Water tank empty Insufficient heat emission Ambient temperature too high Shorting sensor T2 Various defects Water tank empty Sensor breakage short circuit T1 Unit too cold x 9 C Sensor breakage T2 Mains failure Mains plug has no contact Fuse defective Unit defective 1 Fill up water Place the unit horizontally Customer Service Fill up water Do not operate unit continually gt 1 h without heating mat Allow to cool down and observe max ambient temperature Customer Service Customer Service Fill up water Customer Service Warm up the unit for some time at room temperature Customer Service Switch off the unit until the mains supply is up again Check plug on unit and mains socket for correct fit Customer Service Customer Service 49 FILES T ez Waste disposal of old unit 10 Waste disposal 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 SR industrial or domestic waste NOTE gt According to the product reliability acc to S 22 of the Kreislaufwi
12. 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 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 5 approx 10 96 20 SANOSIL from Sanosil Farchant HICO AQUATHERM 660 12 I ez Safety gt During operation check the water flow and the water level on the unit regularly gt Operate the unit only with an appropriate water level gt Strictly comply with the ambient temperature range 10 30 and storage temperature range 10 40 C gt Apply appropriate measures to position the patient on or under the water mat if necessary gt Do
13. 96 Alles A 14 Brief instructions HICO AQUATHERM 660 Brief instructions Connect the unit to the mains supply Connect the water mat to the unit Check the water level on the unit Switch on the unit by the mains switch 0 1 and watch the automatic function test If the nominal temperature value is gt 38 C or 35 C when switching on an alarm will be emitted Acknowledge and start by pressing the release key oet the temperature with the arrow keys For temperatures higher than 38 C press arrow key and release key together Depending on the application place the water mat under or over the patient Monitor the body temperature of the patient Watch the water level and the water flow on the unit In case of continuous operation perform a manual function test once every day by pressing the Function test key Audible alarms of low priority can be interrupted with the Alarm key Alarms with high priority cannot be interrupted Switch off the unit with the mains switch 16 57 Alles A HICO AQUATHERM 660 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 overheated or undercooled gt Monitor the patient s temperature when using the unit and the water mat on the patient
14. E COOLING NOT POSSIBLE see Scott S M Thermal blankets injury in the operating room Arch Surg 34 page 181 1967 HICO AQUATHERM 660 30 AIBUA Control and operation The heat transfer heat supply between patient and water mat will only take place if the temperature of the water mat is higher 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 from 36 to 38 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 AQUASOF T HICO PU mats in parallel and place these over or under the patient series connection of max 2x2 SMALL mats or collars is possible see schematic below in illustration 1x2 With a bigger c
15. HICO AQUATHERM 660 93 WT ez 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 AQUATHERM 660 o4 ilie A Table 202 Guidelines and declaration of manufacturer Interference immunity tests IEC 60601 test level Conformity level Electric static discharge ESD acc to IEC 61000 4 2 Quick transient electric disturbances busts Acc to IEC 61000 4 4 Surge voltages surges acc to IEC 61000 4 5 Voltage dips short term interruptions and fluctuations in the supply voltage acc to IEC 61000 4 11 Magnetic field in supply frequency 50 60 Hz acc to IEC 61000 4 8 HICO AQUATHERM 660 6 kV contact discharge 9 kV air gap discharge 2 kV
16. LRU 4 Operating Instructions Hyperthermia unit HICO AQUATHERM 660 o124 seit 1945 METZ Operating Instructions HICO AQUATHERM 660 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 67 8 85 eMail hirtz hico de Internet www hico de Doc No 592121 Version 6 09 09 O 2009 HIRTZ amp Co KG HICO AQUATHERM 660 2 idle A HICO AQUATHERM 660 Table of contents A EEE acces na A 6 1 4 Information regarding these instructions 6 2 om 7 1 3 Limitation of liability 9 14 9 1 5 Manufacturer 9 is 10 2 1 intended us AA A 10 2 2 Personnel requirements 11 2 3 General Safety Advice 12 2 4 Danger 13 2 4 1 Danger of overheating 13 3 Transport and setup 14 3 1 Scope of delivery and transport inspection 14 ovi iudi 14 3 3 Waste disposal of packaging material 15 4 COMMISSIONING sectio ceo 16 4 1 Safety AdVICO 16 AA Pt 16 4 2 1 Requirements concer
17. UATHERM 660 22 TT ez Function and design 5 2 Safety installations 5 2 1 Sensors During operation the HICO AQUATHERM 660 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 AQUATHERM 660 REF 590001 SN 09 0948 2009 230V 50Hz 530W IPX1 AN A IUE C 0124 JL amp Co KG 50968 HICO AQUATHERM 660 23 TT ez Function and design 5 4 Function 5 4 1 Basic principles The hyperthermia unit HICO AQUATHERM 660 serves the purpose of 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 heat 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 heated in a water tank inside the unit by means of heating elements and continuously pumped through the water mat by a centrifugal pump The HICO AQUATHERM 660 is characterised by simple and safe use reliability and compact design Its electronic control enable
18. ater 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 do not lose the sealing ring for the cap Unscrew the cap from the drain socket 5a e g with a coin do not lose the sealing ring for the cap Tilt the unit backwards and let the water run out through the drain socket Close the drain socket again Fill the unit with water again as described in chapter 4 3 1 The max filling quantity of the tank is approx 1 4 litre 44 Alles 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 AQUATHERM 660 In order to maintain legal conformity and operational reliability as per Medical Product Directive 93 42 EEC appendix point13 6 d and MPBetreibV S 6 1 the unit needs to be subjected to a safety related inspection every 12 months The operator is solely responsible for the performance 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 pers
19. e that is lower than the actual temperature 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 32 AIBUA Control and operation 6 2 6 Note on handling water mats NOTE 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 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 x Carry out function test A WW v 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 HB H e the red fault lamp 13 lights up e the display shows FUNCTION TEST After successful testing the display
20. e 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 AQUATHERM 660 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 35 to 39 C The temperature display 14 shows the set nominal value e For nominal temperature values above 38 C press the arrow key 19 and the release key 20 at the same time gt At temperatures below 35 C the patient increasingly loses heat 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 temperature that can be controlled by the unit depends on type and size of the water mat NOTE The unit does not regulate the temperature actively to a nominal temperature value that is lower than the actual temperature The water mat is passively cooled by ambient temperature or by the body temperature of the patient The display shows the message TEMP DIFF gt 1 C ACTIV
21. e 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 in case 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 HICO AQUATHERM 660 36 Alles A Control and operation 6 3 3 Alarms with high priority HICO AQUATHERM 660 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 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 otrictly comply with the sequence described above The unit may
22. endent safety shut down This results in a max mat surface temperature of 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 2x NTC 5K Pump capacity max 19 l min max 0 34 bar 10 W Heat output approx 500 W max at 27 C Warm up time approx 5 10 min 20 37 C Class type of protection Type of protection IP IP X1 drip proof Risk class 93 42 EEC Mb Ambient temperature Relative air humidity Storage temperature Air pressure 1013 hPa 10 permissible height difference HICO AQUATHERM 660 92 Ide ez Technical data and accessories Dimensions WxHxD Noise emission Test basis Medical Product Directive 93 A2 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 AQUATHERM 660 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 clamping bracket height approx 68 cm optional equipment
23. for mains lines 1 kV for input and output lines 1 kV normal mode voltage 2 kV common mode voltage lt 5 UT gt 95 dip in UT for Y period 40 9o U 60 dip in UT for 5 periods 70 UT 60 dip in UT for 25 periods lt 5 UT gt 95 for5s 3 A m 6 kV contact discharge 8 kV air gap discharge 2 kV for mains lines 1 KV for input and output lines 1 kV normal mode voltage 2 kV common mode voltage lt 5 UT gt 95 dip in UT for Y period 40 U 60 dip in UT for 5 periods 70 UT 60 dip in UT for 25 periods lt 5 UT gt 95 dip in UT for5s A m 99 Ide ez Guidelines and declaration of manufacturer Table 204 NON life supporting systems Interference immunity tests Interference immunity tests tests 60601 test level 60601 60601 test level level Conformity level Conformity level Conducted HF disturbances acc to 3 Veg 3V IEC 61000 4 6 150 kHz to 80 MHz Radiated HF disturbances acc to 3 Ver 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 NE Electric clearance depending on transmission frequency Nominal power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter d P exp0 5 3 5 V 1 d P exp0 5 3 5 E1 d P exp0 5 7 E1 HICO AQUATHERM 660
24. itched on or off NOTE Disconnecting water mats with the unit switched on 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 1 C depending on the time behaviour Information During operation the display shows the heat emitted heat emission by the unit to the heating mat i e the heating power in Watt W which is emitted to the environment air contact area to the operating table etc and to the patient The proportion of the indicated heat emission to the patient in percent depends on the type and size of the heating mat and is always lower than 100 The better the heating mat e g HICO AQUASOFT is thermally insulated towards the base e g operating table and the higher the proportion of the patient s contact area is to the total area of the heating mat the higher the heat proportion for the patient 27 Alles A 6 2 Operation Control and operation 6 2 1 Switching on for initial commissioning owitch 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
25. ly 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 he 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 the unit see page 22 views of unit HICO AQUATHERM 660 21 FILES T ez 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 10 4 Thread for clamping bracket in side of housing bottom plate rear side 5 Water filling socket with SCrew cap 6 Water level indicator 17 9 Hose couplings 10 Handles 11 Temperature display for 14 water mat 12 Display for status and 21 error messages 13 Fault lamp 14 Temperature display for nominal value 15 15 Water flow display 16 Mains switch 17 Function test 18 Alarm off 19 Nominal value higher 20 Release gt 38 C dj u 21 Nominal value lower 16 Rear view detail of unit 5 5a Water drain socket with screw 1 E ir Ei ura au ie t nra w merami Miniature fuse and unit socket HICO AQ
26. mping bracket to fix the unit to the rail HICO AQUATHERM 660 17 tlle A Commissioning 4 2 3 Setting up with five castor stand optional The five castor stand which is optionally available as an accessory makes the stationary HICO AQUATHERM 660 mobile oet up the unit together with the five castor stand as follows Assemble the five castor stand as described in the assembly instructions Fasten the clamping bracket 1 which is optionally available for the five castor stand with both screws 3 in the required position to the underside of the unit Slide the HICO AQUATHERM 660 over the vertical tube 2 of the five castor stand Fix the unit with the star knob screw 4 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 AQUATHERM 660 2 it is necessary that during the assembly of the five foot rack e all 5 punches of the metallic disc lock into the wholes of the five foot extension e 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 FILES I ez Commissioning 4 3 Connecting the HICO AQUATHERM 660 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 6 5 e U
27. ner 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 46 Alles A Trouble shooting 9 Trouble shooting 9 1 Safety Advice HICO AQUATHERM 660 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 Alles A 9 2 Fault causes and rectification No or insufficient water circulation Couplings are stiff Coupling connection permanently leaking Coupling valve of unconnected coupling permanently leaking Heat emission value not indicated Display message HEAT EMISSION 0 W or HEAT UP PHASE Alarm display message ALARM TEST DEFECT gt CUSTOMER SERVICE Alarm display message one time TEMP DIFF gt 1 Alarm display message every 10 minutes TEMP DIFF gt 1 HICO AQUATHERM 660 Possible causes Hoses or mat buckled Couplings not locked properly Unit positioned too far below the water mat Excessive formation of foam High weight of patient Pump worn defective Seal rings dry and brittle Oute
28. ning the place of installation 16 4 2 2 Fixation on wall rail optional 17 4 2 3 Setting up with five castor stand optional 18 4 3 Connecting the HICO AQUATHERM 660 19 4 3 1 Filling the system with water 19 4 3 2 Connecting the water mats 20 4 3 3 Electrical connection 21 9 Function and design 22 5 1 Views of the unit control and display elements 22 5 2 Safety installations 23 A oro 23 OS I VDO ANS iia 23 A PU CHO 24 5 4 1 Basic principles 24 5 4 2 Indications contraindications side effects 24 3 idle A HICO AQUATHERM 660 Table of contents 6 Control and operation 26 6 1 Before switching on eere M 26 6 1 1 Inspections on the unit 26 D 1 2 eee 26 6 1 3 Heat emission 27 MESI Cu TER m 28 6 2 1 Switching on for initial commissioning 29 6 2 2 Switching on in normal operation 20 PAS FUNCUON essa orante 29 6 2 4 Setting the temperature
29. nscrew 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 e Fill the unit tank with distilled water to which a germicidal agent has been added e After filling turn the screw cap hand tight back onto the water filling socket until it is properly sealed NOTE _ PS 91 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 If 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 1l 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 AQUATHERM 660 19 idle A 4 3 2 Connecting the water mats B HICO AQUATHERM 660 E Commissioning e The hose bracket 7 supplied with the unit eases the routing
30. o 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 AQUATHERM 660 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 I ez 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 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 intended for gt Follow the procedures described in these operating instructions Claims of any type because of damages resul
31. on 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 Alles A HICO AQUATHERM 660 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 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 Bon
32. ontact 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 coupling Hose extension HICO AQUATHERM 660 31 A Control and operation NOTE When connecting too large or too many water mats a nominal value of 39 may probably not be reached In this case set a lower nominal value Check the water flow in the display 15 6 2 5 Temperature control operation HICO AQUATHERM 660 There is a risk that the patient may be overheated or unintentionally 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 the unit will start normal operation after switching on and the function test and regulate the water temperature in the circuit to the set value If the set nominal value is higher than 38 C the unit will emit an audible alarm and the message NOMINAL VALUE gt 38 C RELEASE KEY will appear in the display 12 Check whether the nominal value is correct before pressing the release key 20 The unit starts temperature control operation and the display 12 shows HEATING ACTIVE if the nominal temperature value is higher than the actual temperature value The unit does not regulate the temperature actively to a nominal temperature valu
33. ontains 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 Alles 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 cleaning 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
34. 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 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 gt CUSTOMER SERVICE the red fault lamp 13 lights and a signal sounds 37 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 fault lamp 13 lights and a signal sounds The temperature indicator shows 7 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 other
35. r visible seal ring damaged or missing Inner seal ring damaged Inner seal ring dirty Temperature difference nominal actual independent protection defective Pump electrically defect Comnect or disconnect water mat during operation Heating cartridge or pump defective Excessive formation of foam in tank Bypass interrupted Insufficient heat emission Trouble shooting Possible action ensure correct routing or positioning Couplings too tightly plugged together Position unit at same height or above Replace water Position the unit above the water mat Customer Service Grease seal ring with Vaseline silicone grease or similar Replace the seal ring Customer Service Plug and release the coupling several times if necessary Customer Service Heat is only emitted at equal temperature Customer Service Customer Service Reset alarm with Alarm off key Customer Service Replace water Customer Service Do not operate unit continually gt 1 h without heating mat 48 Alles A Trouble shooting Alarm display message IWATER LEVEL Can be reset with Alarm off key for 10 minutes Alarm display message LACK OF WATER Cannot be reset with the Alarm off key Alarm display message CHECK UNIT CUSTOMER SERVICE Alarm display message CHECK UNIT UNDERTEMPERATURE Unit completely without function and audible alarm Switch off the
36. ries 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 Alles A HICO AQUATHERM 660 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 Alles 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 Translations are made t
37. rtschafts und Abfallgesetzes Recycling Economy and Waste Management Act and the Elektro und Elektronikgesetzes Electrics and Electronics Act S 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 HICO AQUATHERM 660 90 Alles A 11 Warranty HICO AQUATHERM 660 Warranty The HICO AQUATHERM 660 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 gt Opening of unit by unauthorized persons 51 Ide ez Technical data and accessories 12 Technical data and accessories 12 1 Technical Data HICO AQUATHERM 660 Power consumption Nominal value range Safety shut down 42 1 42 5 C indep
38. s exactly controlled heat transmission to the patient while ensuring high operational reliability The risk of local temperature accumulation is ruled out Operation of the HICO AQUATHERM 660 is simple and intuitive incorrect use is almost ruled out 5 4 2 Indications contraindications side effects The HICO AQUATHERM 660 is used for e Heat supply in case of intraoperative or postoperative hypothermia e Heat supply to stabilize the patient s temperature normothermia HICO AQUATHERM 660 24 Alles A HICO AQUATHERM 660 Function and design Temperature transfer by means of water mats may be considered unsatisfactory if e the patient s body surface exceeds 0 5 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 to prevent the risk of burning in case of long term applications With too high temperatures this risk is always apparent At a water temperature of more than 41 5 C the HICO AQUATHERM 660 switches off electronically and mechanically to minimize this risk in case of an equipment fault In case of a heat loss and the related unintentional lowering of the patient s temperature hypothermia side effects may occur as described below
39. shows the message FUNCTION TEST OK the unit will automatically resume normal operation HICO AQUATHERM 660 33 Alles A 6 2 8 Operator language HICO AQUATHERM 660 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 owitching 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 Alles A 6 3 Alarms 6 3 1 General Control and operation The unit always emits visual and audible 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
40. tains 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 ofthe 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 Alles A 8 1 1 Equipment 8 1 2 Water tank HICO AQUATHERM 660 Maintenance and safety related inspection Check the ventilation slots on underside and rear side of the unit for dirt at the latest after 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 w
41. the unit the set up place HICO AQUATHERM 660 must have sufficient load bearing capacity weight of unit approx 9 kg must be level must be horizontal inclination lt 3 96 provide min 20 cm clearance behind the back 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 FEST ez Commissioning The optionally available five castor stand see under 4 2 3 meets these prerequisites NOTE Ifthe unit is not horizontal the display in the front of the unit will indicate the water level incorrectly If the 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 4 2 2 Fixation on wall rail optional The unit can also be fixed to the wall rails 5 x 20 mm which are commonly used in hospitals For this purpose fix the clamping holder 1 which is available as an accessory preferably on the rear wall or on the left side of the unit with two screws 3 To do so e loosen the optionally available clamping bracket 1 on the rear side of the unit turn it to the required position and fix it again Use the star handle screw 4 on the cla
42. ting 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 AQUATHERM 660 10 Alles A Safety 2 2 Personnel requirements HICO AQUATHERM 660 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 Alles A Safety 2 3 General Safety Advice NOTE For safe handling of the unit you should comply with the following general safety notes Before start
43. wise 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 AQUATHERM 660 38 Alles A Control and operation CHECK UNIT CUSTOMER SERVICE The unit triggers this alarm in case of various defects The display shows CHECK UNIT 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 AQUATHERM 660 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 the 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 Alles A Cleaning and disinfection 7 Cleaning and disinfection 7 1 Safety Advice HICO AQUATHERM 660 This chapter c
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