Maquet HU 35 Instructions For Use Manual Download | Manualshive

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REVISED INSTRUCTIONS FOR USE
CLEANING, DESCALING, DISINFECTION

HEATER UNIT
HU 35

11/11/2016

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Summary of Contents for HU 35

Page 1: ...REVISED INSTRUCTIONS FOR USE CLEANING DESCALING DISINFECTION HEATER UNIT HU 35 ...

Page 2: ...Maquet Cardiopulmonary GmbH Subject to technical changes Owing to our policy of continuous product development the illustrations and technical data contained in this document may differ slightly from the current version of the device Manufacturer Maquet Cardiopulmonary GmbH Kehler Straße 31 76437 Rastatt GERMANY Phone 49 7222 932 0 Fax 49 7222 932 1888 info cp maquet com www maquet com ...

Page 3: ...oi 50 3 Détartrage et désinfection du circuit d eau 52 Italiano 1 Informazioni generali 69 2 Pulizia e disinfezione delle superfici dell apparecchio dopo ogni uso 71 3 Decalcificazione e disinfezione del circuito dell acqua 73 Español 1 Aspectos generales 90 2 Limpieza de superficies y desinfección del aparato después de cada uso 92 3 Descalcificación y desinfección del circuito de agua 94 Portugu...

Page 4: ...göring och desinficering av apparaten efter varje användning 218 3 Avkalkning och desinficering av vattencirkulationen 220 Norsk 1 Generelt 237 2 Overflaterengjøring og desinfeksjon av apparatet etter hver gangs bruk 239 3 Avkalkning og desinfeksjon av vannkretsløpet 241 Pусский 1 Общие сведения 256 2 Очистка поверхностей и дезинфекция аппарата после каждого применения 258 3 Удаление накипи из вод...

Page 5: ... HU 35 Table of Contents 5 Revised Instructions for Use Cleaning Descaling Disinfection 1 0 XX 01 Copyright Maquet Cardiopulmonary GmbH 2 每次使用设备后进行表面清洁和消毒 321 3 水路的除垢和消毒 323 ...

Page 6: ...caling and Disinfection shall apply until further notice for all instructions for the Heater Unit HU 35 1 1 2 Symbols References References to other pages in these Instructions for Use begin with the arrow sign Action and reaction The operator s actions are identified with numbered paragraphs 1 while the symbol identifies the reaction triggered in the system Example 1 Switch the light switch on Th...

Page 7: ...an result in death or serious injury CAUTION Identifies a possible risk which can result in injury NOTICE Identifies a possible risk to property which can result in equipment damage and or data loss Structure of the other information Information concerning events without personal injury or equipment damage is indicated as follows NOTE Additional support and other helpful information EN ...

Page 8: ...e hand washing and using disposable gloves WARNING For surface cleaning of the HU 35 housing use a damp cloth WARNING For surface cleaning of the HU 35 use disinfectants based on aldehydes amonium components or alcohol only Avoid the use of phenol derivates WARNING Switch the HU 35 off and unplug the HU 35 from the external power supply before surface cleaning WARNING Do not use chemical solvents ...

Page 9: ... water or a suitable cleaning solution for sensitive medical devices 2 Clean the device and cables after each use to remove soiling and residual blood Surface disinfection Disinfect the surfaces after each use You can use the following disinfectants n Tosylchloramide sodium Chloramine T n Alcohol ethanol isopropyl 70 by vol n Bacillol Bode Chemie n Buraton 10F Schülke Mayr n Buraton rapid Schülke ...

Page 10: ...d for descaling disinfection n Sterile inline filter with a pore size of 0 2 µm n Personal protective clothing as specified on the safety data sheet for the descaling disinfection agent Chemical resistant gloves made of nitrile or butyl rubber Dust mask for P2 respiratory protection Protective goggles Laboratory coat The following equipment is additionally required n Canister chemical resistant fo...

Page 11: ...explicitly not allowed WARNING Thoroughly follow the manufacturer s safety instructions for the disinfectant descaling agent during the disinfection descaling of the HU 35 WARNING Check the water level in the HU 35 water tank If the water level is too low fill up the tank to the maximum mark of the water level display WARNING Provide adequate ventilation for the disinfection process Avoid generati...

Page 12: ...ed or sharp objects WARNING The disinfectant descaling agent must only be used pre and postoperatively never intraoperatively WARNING During the disinfection descaling procedure of the HU 35 the heat exchanger must be replaced by a cleaning connector The disinfectant descaling agent could damage or contaminate the heat exchanger WARNING Perform the descaling process every 6 months with a concentra...

Page 13: ...monitoring shall be used to determine the appropriate disinfection concentration required for each HU 35 WARNING The re commissioning of the device shall only be performed by accompanied regular hygienic monitoring WARNING Use a sterile inline filter with 0 2 μm porosity for filling the HU 35 with water WARNING The HU 35 tank shall be filled with soft sterile filtered water Do not use deionized wa...

Page 14: ... Revised Instructions for Use Cleaning Descaling Disinfection 1 0 XX 01 Copyright Maquet Cardiopulmonary GmbH WARNING If the Hansen connectors at the tubes are not connected to any heat exchanger the couplings shall be connected using the cleaning connector EN ...

Page 15: ...Disconnect the device from the power supply 3 Disconnect the heat exchanger connected to the water circuit 4 Disconnect the water tubes from the HU 35 5 Empty the water tubes through the Hansen couplings over an outflow 6 Put a container under the HU 35 or place the HU 35 over an outflow or other means of drainage 7 Unscrew the filler neck cap 3 e g using a coin 1 2 3 4 7 5 6 8 8 Unscrew the cap o...

Page 16: ...e a powder funnel to put 30 g of citric acid into a chemical resistant 10 liter canister with watertight lid Add 1 5 liters of sterile filtered warm water approx 35 C Close the canister check that it is leak tight and dissolve the citric acid by shaking Or When connecting hoses measuring 2 x 3 m to the HU 35 Use a powder funnel to put 34 g of citric acid into a chemical resistant 10 liter canister...

Page 17: ...of the disinfection descaling agent solutions Descaling of the HU 35 is now complete The HU 35 is now empty 3 1 3 Rinsing the HU 35 1 Disconnect the cleaning connector and disinfect it and the Hansen couplings 2 Connect the open hose ends to the cleaning connector supplied 3 Fill the HU 35 with sterile filtered water up to the maximum mark on the water level indicator 4 Connect the device to the p...

Page 18: ...ection of the water circuit HU 35 Revised Instructions for Use Cleaning Descaling Disinfection 1 0 XX 01 Copyright Maquet Cardiopulmonary GmbH 14 Close the cap on the filler neck e g using a coin The HU 35 has now been rinsed EN ...

Page 19: ...water volume of the HU 35 Special highly effective disinfection and biofilm removal with 5 Chloramine T are described under High Level Disinfection and Biofilm Removal Process for HU 35 page 23 3 2 1 Emptying the HU 35 1 Switch the device off 2 Disconnect the device from the power supply 3 Disconnect the heat exchanger connected to the water circuit 4 Disconnect the water tubes from the HU 35 5 Em...

Page 20: ...descaling agent 1 Connect the open hose ends to the cleaning connector supplied 2 Create a Chloramine T solution When connecting hoses measuring 2 x 1 5 m to the HU 35 Use a powder funnel to put 30 g of Chloramine T into a chemical resistant 10 liter canister with watertight lid Add 1 5 liters of sterile filtered warm water approx 35 C Close the canister check that it is leak tight and dissolve th...

Page 21: ...e filler neck 3 e g using a coin Fill the device with the remaining Chloramine T solution up to the maximum mark on the water level indicator Close the cap on the filler neck 3 e g using a coin Switch on the device 9 Set the setpoint temperature to 38 C 10 Run the HU 35 for 90 minutes 11 Switch off the device 12 Disconnect the device from the mains 13 Empty the HU 35 NOTE Use a suitable drain for ...

Page 22: ...g a coin 6 Switch on the device 7 Set the setpoint temperature to 37 C 8 Run the HU 35 for 3 minutes 9 Switch off the device 10 Disconnect the device from the mains 11 Empty the HU 35 NOTE Use a suitable drain for disposing of the disinfection descaling agent solutions 12 Repeat the rinsed steps outlined above twice so that the HU 35 is rinsed a total of three times 13 Fill the HU 35 with sterile ...

Page 23: ...35 n High Level Disinfection of the HU 35 n Rinsing the HU 35 3 3 1 Emptying the HU 35 1 Switch the device off 2 Disconnect the device from the power supply 3 Disconnect the heat exchanger connected to the water circuit 4 Disconnect the water tubes from the HU 35 5 Empty the water tubes through the Hansen couplings over an outflow 6 Put a container under the HU 35 or place the HU 35 over an outflo...

Page 24: ...suring 2 x 1 5 m to the HU 35 Use a powder funnel to put 75 g of Chloramine T into a chemical resistant 10 liter canister with watertight lid Add 1 5 liters of sterile filtered warm water approx 35 C Close the canister check that it is leak tight and dissolve the Chloramine T by shaking Or When connecting hoses measuring 2 x 3 m to the HU 35 Use a powder funnel to put 85 g of Chloramine T into a c...

Page 25: ...e T to work for 24 hours in the water system 14 Connect the device to the power supply 15 Switch on the device 16 Run the HU 35 for 5 minutes 17 Switch off the device 18 Disconnect the device from the mains 19 Empty the HU 35 NOTE Use a suitable drain for disposing of the disinfection descaling agent solutions Highly effective disinfection of the HU 35 is now complete The HU 35 is now empty 3 3 3 ...

Page 26: ... NOTE Use a suitable drain for disposing of the disinfection descaling agent solutions 12 Repeat the rinsed steps outlined above twice so that the HU 35 is rinsed a total of three times 13 Fill the HU 35 with sterile filtered water up to the maximum mark on the water level indicator 14 Close the cap on the filler neck e g using a coin The HU 35 has now been rinsed EN ...

Page 27: ...onstruction changes GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences We operate under the three brands of ArjoHuntleigh GETINGE and MAQUET ArjoHuntleigh focuses on patient mobility and wound management solutions GETINGE provides solutions for infection control within healthcare and cont...

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