Instruction for use
Hypo/Hyperthermia unit
HICO-VARIOTHERM 550
Page 1: ...Instruction for use Hypo Hyperthermia unit HICO VARIOTHERM 550 ...
Page 2: ...RM 550 HICO VARIOTHERM 550 2 Hirtz Co KG Bonner Str 180 50968 Cologne Germany Tel 49 0 2 21 37 67 8 0 Fax 49 0 2 21 37 67 8 85 e mail info hico de Internet www hico de Doc No 542121 Version 16 03 17 valid from 2017 03 2017 Hirtz Co KG ...
Page 3: ...aste disposal of packaging material 14 4 Commissioning 15 4 1 Safety advice 15 4 2 Setting up 15 4 2 1 Requirements concerning the place of installation 15 4 2 2 Setting up with the unit carrier optional 17 4 2 3 Installation with five castor stand optional 18 4 3 Connecting the HICO VARIOTHERM 550 19 4 3 1 Filling the system 19 4 3 2 Connecting the water pads 20 4 3 3 Electrical connection 21 5 F...
Page 4: ...Operator language 45 6 3 Alarms 46 6 3 1 General information 46 6 3 2 Alarm description during operation 47 7 Cleaning and disinfecting 50 7 1 Safety advice 50 7 2 Unit 51 7 2 1 Water circulation 51 7 2 1 1 General Information for cleaning the water circuit 51 7 2 1 2 Basic cleaning 51 7 2 1 3 Disinfection 51 7 2 1 4 Flushing und refilling 52 7 2 2 Surface 52 7 2 3 Ventilation openings 52 7 3 Wate...
Page 5: ...ts HICO VARIOTHERM 550 5 10 Waste disposal of old unit 62 11 Technical data and accessories 63 11 1 Unit 63 11 2 Accessories 64 11 3 Symbols 66 12 Guidelines and declaration of manufacturer 67 13 Brief instruction 71 ...
Page 6: ...eferred to in the following as unit and provide important information for the commissioning safety proper use and maintenance of the unit All figures and drawings in these operating instructions are for general illustration purposes and are not definitive for the details of their construction The operating instructions must always be available preferably in the vicinity of the unit They must be re...
Page 7: ...rning note of this danger level identifies a possibly dangerous situation Not avoiding this dangerous situation can lead to minor or moderate injuries and damage to property Follow the instructions in this warning note to avoid the risk of injuries to persons or damage to property A note highlights additional information to assist in working with the unit Limitation of liability All technical info...
Page 8: ... if the translation was made by us or ordered by us Only the original German text is binding 1 4Copyright 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 Co KG Subject to changes in contents and ...
Page 9: ...y only be used with HICO units for use in hypo hyperthermia treatment 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 purpose Only use the unit for the purpose it is intended for Observe the procedures described in these operating instructions Use only with original accessories Claims of any type because of damage...
Page 10: ... 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 prote...
Page 11: ...the sides Observe the automatic functional test when switching on Carry out automatic functional test manually at least once a day during continuous operation Medical Electrical Equipment needs special precautions regarding EMC and must be installed and put into operation according to EMC information contained in the accompanying documents Portable and mobile RF communications equipment can affect...
Page 12: ...l cloths gel pads etc adversely affect the heat transfer Operate the unit only with HICO water pads and original accessories Do not operate the unit in an oxygen enriched environment or in the presence of combustible gases In hyperthermia operation do not use or combine the unit together with other heat sources Do not operate the unit in the vicinity of heat sources spotlights direct sunlight radi...
Page 13: ...iately report an incomplete delivery or damage caused by inappropriate packaging or transport to the forwarding agent the insurance company and the supplier 3 2Unpacking To unpack the unit Take the unit out of its box and remove the packaging material Place the unit on a level and horizontal base with sufficient load bearing capacity Condensation in the device can lead to failure After unpacking t...
Page 14: ...ly and disposal related factors and are therefore recyclable Feeding the packaging back into the material cycle saves raw materials and decreases generated waste Dispose of packaging materials that are no longer required at the collection points for the Green Dot recycling system If possible keep the original packaging throughout the unit s lifetime so as to be able to repack the unit properly in ...
Page 15: ...e in such case is required Is it necessary to observe the device to guarantee the intended use 4 2Setting up 4 2 1Requirements concerning the place of installation For safe and fault free operation of the unit the set up place must have sufficient load bearing capacity weight of unit approx 17 kg must be level must be horizontal inclination 3 must provide 20 cm space to either side of the unit and...
Page 16: ... the place of installation should meet the following enviromental conditions ambient temperature 20 C 3 C relative air humidity 50 20 air pressure 700 hPa to 1060 hPa Performance limitations in the attainable pad transition temperatures under extreme environmental conditions and selected pad see chapter 6 2 8 Schematic performance diagrams may also lead to restrictions in the intended use Condensa...
Page 17: ...ase of the stand is screwed to the unit using a knurled screw Personal and material damage may occur when installing and using the stand with the unit To assemble the stand observe the safety notes in the assembly and operating instructions on the stand The stand only serves to carry HICO systems Do not use any aggressive detergents the stand is not suitable for use in washing systems The stand sh...
Page 18: ...stand assembly For the safe functioning and stable condition of the system it must be ensured that when assembling the five castor stand the holding rod 2 in the centre section and all 5 stabilisers with castors are safely mounted in accordance with the instructions and safety information on the five castor stand The five castor stand only serves to carry HICO systems Do not use any aggressive det...
Page 19: ... with water For initial filling of the unit please follow the Danger caused by water in connection with electricity Water is electrically conductive 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 out 2 Depending on the quality of the water e g calcareousness among...
Page 20: ...ion will no longer come loose by itself You can loosen the coupling again by pushing the metal plate on the hose coupling and pulling the coupling out The coupling connections of the hose extension cannot be confused when connecting them to the couplings of the unit since it makes no difference in what direction the water flows through the water pad Water pads can also be decoupled when the unit i...
Page 21: ...lectric data voltage and frequency on the type plate with the data of your mains power supply This data must match to prevent the unit from being damaged Please ask your electrics expert for advice if in doubt The electric socket must be protected by a 16 A circuit breaker Use the cable supplied with the unit to connect the unit to the mains supply The unit socket is located on the rear side of th...
Page 22: ...r neck with screw cap 6 Water level indicator 9 Hose couplings 10 Unit handles 11 Temperature display for water pad 12 Display for status and fault messages 13 Fault lamp 14 Temperature display for nominal value 15 Water flow display 16 Mains switch 17 Functional test 18 Audio paused 19 Nominal value higher 20 Release 35 C 38 C 21 Nominal value lower Rearview section of the unit with microfuse and...
Page 23: ...tions see chapter 6 3 The HICO VARIOTHERM 550 application system has no monitoring function for measuring of the patient Monitoring core temperature of the patient to be treated must be carried out regularly independently of the application system The temperature settings of the transition temperatures on the pad must be manually entered in the system by the user and the individual course of thera...
Page 24: ...Function and design HICO VARIOTHERM 550 24 5 3Type plate The type plate with the connection and performance data is located on the rear side of the unit ...
Page 25: ...lectrical elements and continuously pumped through the water pad by a centrifugal pump Reaching the transition temperature of the pads is dependent on the environmental conditions and the size of the pad The HICO VARIOTHERM 550 is characterised by its simple and safe use reliability and compact design Through its electronic control the temperature transfer to the patient can be accurately adjusted...
Page 26: ...treme environmental conditions and selected pad see chapter 6 2 8 Schematic performance descriptions may also lead to restrictions in the intended use Operating the HICO VARIOTHERM 550 is simple and intuitive incorrect use is almost ruled out Danger caused by overestimation and underestimation of the performance of the system Dangers may arise from the unit if it is put to unintended use and if de...
Page 27: ...protection for patients after cardiac arrest Neuroprotection for cerebral trauma stroke and in neurosurgery Myocardial protection after myocardial infarction Induced hypothermia in asphyctic newborn infants Hypoxic ischaemic encephalopathy HIE in newborn infants Danger caused by overestimation and underestimation of the performance of the system Dangers may arise from the unit if it is put to unin...
Page 28: ...mperatures there is always a risk of burning In cooling applications and the related targeted lowering of the patient s temperature therapeutic hypothermia there is a also possibility of burn risk freezer burn in the same way as with warming applications and side effects may occur such as autonomous reactions among others shivering electrolyte disturbance higher diuresis diuresis fluctuations hype...
Page 29: ...a ischaemia moderate hypothermia of 33 34 C within the first 6 hours for a period of 48 72 hours causes a significant improvement in the neurological outcome between the age of 12 18 months The inclusion criteria for newborns is 36 weeks of pregnancy and in ages 6 hours with acute encephalopathy and peripartum asphyxia results The exclusion criteria is in ages 6 hours and newborns in extremis Cont...
Page 30: ...r is of the utmost importance The therapeutic moderate mild to moderate hypothermia requires the user to carry out a careful risk assessment and continuous monitoring and care of the patient with regards to side effects the prophylaxis of pressure induced lesions and the efficiency of the system Due to the excellent heat conductivity of water the patient may cool down when the unit is switched off...
Page 31: ...cator 6 preferably just below the maximum mark The filling difference between both marks is approx 0 5 litre Top up sterile filtered tap water to which a germicidal agent has been added if the water level is below the minimum mark you want to connect an empty water pad and the water level is below the maximum mark 6 1 2Water pads Only connect original HICO hose extensions with HICO water pads to t...
Page 32: ... disconnect the water pad The sterile filtered tap water in the circuit of the unit can otherwise temporarily exceed the high or low temperature limit and possibly trigger various alarms Intermediate layers between the patient and water pad sheets surgical cloths gel pads etc adversely affect the heat transfer The use of a thin fleece as an intermediate layer is recommended Direct skin contact wit...
Page 33: ...e unit the pad and the 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 pad Check the water level on the indicator 6 again if necessary switch off the unit disconnect it from the mains supply and refill sterile filtered tap water to which a germicidal agent has been added 6 2 2Switching on in n...
Page 34: ...the display 12 the temperature displays 11 and 14 shows the fault lamp 13 lights up the audible alarm is on This test takes a few seconds If the functional tests did not complete successfully the unit is no longer fail safe Do not operate unit if the unit does not issue the short signal tone for the power failure alarm when switching on the automatic functional test automatically switches the unit...
Page 35: ...eratures above 38 C supply the patient with heat at a higher rate Places of the body which are subjected to increased pressure may suffer under pressure necrosis and or burns even at temperatures below 40 C This applies for long term applications and risk patients in particular5 For the indication and safe operation application the chapters 4 2 1 5 4 2 6 2 8 and 6 2 9 are to be observed External c...
Page 36: ...water pad temperature to the size of the contact area Intermediate layers impair heat transfer e g surgical cloths or gel pads Example of temperature difference The heat transfer from the pad to the patient doubles if the temperature difference between the water pad and the patient is doubled If the patient s skin has a temperature of 34 C at the contact area and the water pad temperature is raise...
Page 37: ...MINAL VALUE 35 38 C RELEASE KEY appear in the display 12 Check whether the nominal value is correct and do not pressing the 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 pad in contact with the patient in normal operation Due to the excellent heat conductivity of water the patient may cool dow...
Page 38: ...nd over the patient It is also possible if necessary to use smaller pads and blankets as a wrap It is important to ensure a crease and buckle free routing of the pad and the hoses so that the water flow is not affected or caused by the pads not unnecessary pressure points on the patient Pay attention to the largest possible surface contact with the patient given the particular pad size The use of ...
Page 39: ...on and 6 1 2 Water pads For a trouble free and stable operation the temperature difference between the nominal and actual value displayed on the unit should not be greater than 1 C The thicker the intermediate layers are between patient and water pad bed sheets surgical cloths gel pads etc the worse the heat transfer ...
Page 40: ...formance descriptions represent according to standards established in the laboratory schematic limit value observations extreme conditions with respect to ambient temperatures applied parts and setting possibilities This leads to the following restrictions At an ambient temperature of 30 C only a minimum temperature of 22 C is expected for the smallest pad At an ambient temperature of 30 C only a ...
Page 41: ...pters 4 2 1 Requirements concerning the place of installation 5 4 1 Basic principles 5 4 2 Indications side effects contraindications 6 2 5 Temperature control operation 6 2 7 Usage of water pads 6 2 8 Schematic performance descriptions 6 2 9 Obligations during operation 6 3 2 2 Alarms Display message TEMP DIFF 1 C Performance chart 1 7 The temperature data are reference values from the schematic ...
Page 42: ...rt 2 Performance chart 3 C 5 C 10 C 15 C 20 C 25 C 30 C 35 C 40 C 45 C largest pad smallest pad head wrap vest Ambient temperature 20 C Max Min C 5 C 10 C 15 C 20 C 25 C 30 C 35 C 40 C 45 C largest pad smallest pad head wrap vest Ambient temperature 30 C Max Min ...
Page 43: ...uous monitoring and care of the patient with regards to side effects the prophylaxis of pressure induced lesions by heat or cold For low risk application of hypo hyperthermia an external continuous monitoring of the body core temperature e g by taking a measurement in the urinary bladder is of the utmost importance since uncontrolled hypo hyperthermia is associated with increased patient mortality...
Page 44: ... the function test key 17 during operation The unit now tests the safety electronics the alarm sounds the temperature indicators show the yellow fault lamp 13 lights up the display shows FUNCTIONAL TEST After successful testing the display shows the message FUNCTION TEST OK the unit will automatically resume normal operation If the function test was not completed successfully the unit is no longer...
Page 45: ...olish Set the display language as follows Switch on device on Hold the key Audio paused 18 depressed for about 4 seconds 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 seconds after the last input the unit will return to its previous operating status the language displayed last is active ...
Page 46: ...ter than the immediate named time period delayed If for reasons described in chapter 6 3 2 a system alarm message is given these can be cancelled as follows depending on the expected result Pressing the Audio paused key 18 interrupts the audible alarm for 10 minutes The error message can be read in the display 12 The flashing fault lamp 5 stays on as long as the alarm condition is present The alar...
Page 47: ...t and thus lead to total failure of the unit 6 3 2 2 Display message TEMP DIFF 1 C Should the water pad 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 1 C the yellow fault lamp 13 flashes and a pulse signal tone sounds Press the Audio paused key 18 to interrupt the audible alarm for 10 minutes Chan...
Page 48: ...iggers this alarm if the water tank temperature falls below the measuring range approx 9 C The display shows UNDERTEMPERATURE and CHECK UNIT The yellow fault lamp 13 flashes and a pulsating signal tone sounds The temperature display shows The audible alarm cannot be interrupted using the Audio paused key 18 Switch off the unit with the mains switch 16 Take the unit to a warmer environment and wait...
Page 49: ...6 3 2 6 Mains failure alarm The unit triggers this alarm if the power supply fails during operation The yellow fault lamp 13 lights up and a permanent signal sounds All other displays are without function The power accumulator in the unit receives the alarm for at least 10 minutes without mains supply The alarm cannot be interrupted with the Audio paused key 18 Switch off the unit with the mains s...
Page 50: ...t Pull out the mains plug before starting cleaning and disinfecting the unit Prevent fluids from entering into the unit Let the unit dry completely before switching it on again Sensitive surfaces The surfaces of the unit and the pads can be destroyed by using wrong cleaning agents and disinfectants Use only disinfectants based on aldehydes ammonium components or alcohols which will not affect ABS ...
Page 51: ... to 35 C Turn on the unit and leave it on for 30 minutes Disconnect the unit from the power supply and remove the connected accessories Empty the unit and all accessories entirely 7 2 1 3 Disinfection For disinfection any VAH11 listed disinfectant which is free of phenolic derivatives can be used Suitable are e g Terralin protect Gigasept FF Gigasept AF Mikrozid AF or Sanosil S003 Observe the dosa...
Page 52: ... 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 according to VAH list e g with S M Mikrozid 14 AF When using a disinfectant follow the instructions of the manufacturer Only switch on the unit after the disinfectant has evaporated completely Check ve...
Page 53: ...n the inside of the unit removed by a service technician customer service medical engineering Do not open the unit yourself Do not apply any other cleaning or decontamination processes other than the ones recommended by Hirtz Co KG Before introducing new methods check these together with Hirtz Co KG Only this makes sure that the unit will not be damaged by this method ...
Page 54: ...7 e g with S M Mikrozid AF When using a disinfectant follow the instructions of the manufacturer Only use the pad and the hose extension again after the disinfectant has evaporated completely Check the pad and the hose extension for damage deformation or cracks replace damaged accessories Do not apply any other cleaning or decontamination processes other than the ones recommended by Hirtz Co KG Be...
Page 55: ... with authorised companies By concluding a maintenance contract you fulfil the requirements of BetrSichV BGV A2 VBG 4 new BGV A3 of medical device directive 93 42 EEC of 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 With proper and regular maintenance the unit has a ...
Page 56: ... mains Support container bucket baisin etc or place the unit onto a draining device e g rinsing tank Unscrew the cap of the water filler neck 5 e g with a coin Take the water drain hose and place it on one of the front hose couplings 9 Tilt the unit forwards and drain the water through the water drain hose until it is emptied completely Remove the water drain hose from the front hose coupling and ...
Page 57: ...ted inspection must only be performed by Hirtz Co KG or a qualified person The safety related inspection covers at least the following points Inspection of the device and application components for external damage wear aging and legibility of displays and inscriptions Measurement of the PE resistance and the earth leakage current according to the testing facility and manufacturer s data Inspection...
Page 58: ...MRSA the system must pre disinfected and packaged for transport with an appropriate disinfectant in accordance with the decontamination requirements and material compatibility Otherwise we reserve the right to reject such units or components for safety reasons or to subject these to additional treatment chemo thermal before performing a technical revision or damage analysis Any additional costs ar...
Page 59: ...on Repairs on electric devices must only be carried out by skilled professionals which may have been trained by the manufacturer Inappropriate repairs can cause considerable dangers for the user and damage to the unit Opening of the unit by unauthorised persons will lead to the loss of any warranty claims Repairs to the unit may only be carried out by Hirtz Co KG or by experts trained and or autho...
Page 60: ...coupling several times if necessary customer service Alarm Display message ALARM TEST DEFECTIVE CUSTOMER SERVICE 1 Independent protection device defective 2 Pump defective electrically Customer service Alarm Display message TEMP DIFF 1 C Coupling or decoupling of the water pad during operation Acknowledge alarm with Alarm OFF button Alarm Display message every 10 mins TEMP DIFF 1 C 1 Cooling power...
Page 61: ...PERATURE 1 Unit too cold 9 C 2 Sensor break T2 3 Water tank frozen 1 Heat up unit at room temperature for a while 2 Customer service 3 Defrost unit Examine unit for frost damage Is water flowing out of the unit Customer service Entire device not functioning acoustic alarm 1 Mains failure 2 Mains connector no contact 3 Fuse defective 4 Unit defective 1 Switch off unit until power returns 2 Check co...
Page 62: ...ironment This device must not be disposed of with normal industrial or domestic waste According to the product reliability according to 22 of the Kreislaufwirtschafts und Abfallgesetzes Recycling 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 retu...
Page 63: ...15 C Fuse rating 2x T 3 15 A L 250 V 220 V 230 V 2x T 5 A L 250 V 115 V Class type of protection I BF defibrillation protected Type of protection IP IP X1 drip proof Power supply Must correspond with VDE 0100 Part 710 2012 10 Electrical safety in medical environments Risk class 93 42 EEC II b Ambient temperature 10 30 C hyperthermia operation 10 23 C hypothermia operation Relative air humidity app...
Page 64: ...than water pad 50 x 170 cm 0 91 kg REF 550046 HICO Polyurethan water pad 50 x 92 cm 0 54 kg REF 550047 HICO Polyurethan water pad 50 x 30 cm 0 24 kg REF 550044 HICO Polyurethan water pad 35 x 170 cm 0 67 kg REF 550048 HICO Polyurethan water pad 35 x 92 cm 0 44 kg REF 550049 HICO Polyurethan water pad 70 x 60 cm 0 52 kg REF 550025 HICO Polyurethan water pad 70 x 120 cm 0 90 kg REF 550026 Various PU...
Page 65: ...see chapter 4 2 2 optional accessory For the unit carrier observe the associated instructions for use Excerpt of the safety information on the unit carrier Assembly handling and use require careful attention to these safety instructions The unit must be screwed to the insert panels with the 2 knurled screws included To move forward the brake rollers must be released Driving over obstacles soft flo...
Page 66: ...ponds with type BF defibrillation protected Extreme caution e g do not operate the unit in the presence of combustible gases Full instruction manual operating instructions Observe follow instruction manual Waste disposal Year of manufacture Manufacturer Also involved in the conformity assessment procedures DEKRA Certification GmbH Handwerkstraße 15 70565 Stuttgart ...
Page 67: ...that the device be used in such an environment Emission test Agreement Electromagnetic environment guidance RF emissions according to CISPR 11 Group 1 The HICO Variotherm 550 uses RF energy exclusively for its internal function Therefore its RF emission is very small It is unlikely that nearby electronic devices will be disturbed RF emissions according to CISPR 11 Class B The HICO Variotherm 550 i...
Page 68: ...vironment Surge voltage Surges according to IEC 61000 4 5 1 kV differential mode voltage 2 kV common mode voltage 1kV differential mode voltage 2 kV common mode voltage The quality of the power supply should correspond to that of a typical commercial or hospital environment Voltage dips short interruptions and variations of the power supply according to IEC 61000 4 11 5 UT 95 dip in UT for cycles ...
Page 69: ...eters m The field strength from a stationary radio transmitter according to an onsite survey a is less than the compliance level b for all frequency ranges In the environment of equipment marked with the following symbol interferences are possible NOTE 1 At 80 MHz and 800 MHz the higher the frequency range applies NOTE 2 These guidelines may not apply in all situations The propagation of electroma...
Page 70: ... device as indicated below Output power of the transmitter W Safety distance depend on the transmitted frequency m 150 kHz to 80 MHz d 1 2 𝑃𝑃 80 MHz to 800 MHz d 1 2 𝑃𝑃 800 MHz to 2 5 GHz d 2 3 𝑃𝑃 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters whose maximum output power rating is not listed in the table above the distance can be determined by calc...
Page 71: ... temperatures higher than 38 C press the arrow key and release key together For temperatures below 35 C press arrow key and release key together Depending on the application place the water pad under or over the patient Monitor the body temperature of the patient Monitor the water level and water flow on the unit In case of continuous operation perform a manual function test once every day by pres...
Page 72: ...perature when using the unit and the water pad on the patient Do not start the unit if the display has failed individual segments of the temperature display have failed temperature can no longer be read safely the yellow fault lamp 13 lights permanently or not at all functional test the signal tone continues to sound or does not sound at all functional test the unit does not respond to key operati...
Page 73: ...Brief instruction HICO VARIOTHERM 550 73 Notes ...
