Dräger Isolette 8000 plus, Instructions For Use Manual

Page 1: ...Isolette 8000 plus Incubator Supplement to the instructions for use WARNING To properly reprocess the products read and comply with this document Isolette 8000 plus ...

Page 2: ...2 Supplement to the instructions for use Isolette 8000 plus This page has been left blank intentionally ...

Page 3: ...ut this document 4 1 1 Trademarks 4 2 Reprocessing 5 2 1 Safety instructions 5 2 2 Safety information 5 2 3 Information on reprocessing 6 2 4 Classifications for reprocessing 6 2 5 Before reprocessing 7 2 6 Validated reprocessing procedures 13 2 7 Other agents and reprocessing procedures 17 2 8 After reprocessing 19 Index 27 ...

Page 4: ...ademarks owned by Dräger The following web page provides a list of the countries in which the trademarks are registered www draeger com trademarks 1 1 2 Trademarks owned by third party manufacturers Instructions for use Part number Edition Isolette 8000 plus MU25944 4 and higher Trademark Dräger Isolette Softbed Trademark Trademark owner Dismozon BODE Chemie Neodisher mediclean Dr Weigert acryl de...

Page 5: ...d exists when performing cleaning and maintenance procedures in an oxygen enriched environment When performing cleaning and maintenance procedures confirm that the oxygen supply is turned off and that the equipment is disconnected from the oxygen supply Switch off or disconnect oxygen supplies during periods of non use Ensure that oxygen connectors are free from grease and oil Equipment damage Reu...

Page 6: ...se removers or solvents such as acetone 2 3 Information on reprocessing Follow the national infection prevention policies and reprocessing regulations Follow the infection prevention policies and reprocessing regulations of the health care facility e g concerning the reprocessing cycles 2 4 Classifications for reprocessing 2 4 1 Classification of medical devices The classification depends on the i...

Page 7: ...bled Disposable products Dispose of the disposable products 2 5 2 Device specific components The device specific components must be removed from the device and if necessary disassembled Removing the scale and the bed and related components 1 Disconnect the cables from the sensor module 2 Slowly raise the hood A Classification Device specific components Non critical Device surface including control...

Page 8: ...E 10 Remove upper cover F Removing the heater radiator and impeller 1 On devices without the humidification system option remove the heater impeller cover A 2 On devices with the optional humidification system pull the water reservoir partially out and remove the heater impeller cover B and the duct cover C WARNING Risk of death or serious injury The heater can be sufficiently hot to cause burns A...

Page 9: ... or damage to the device Fluid spills or leaks could cause a slip hazard If any fluids spill or leak around the device wipe the area dry CAUTION Risk of injury or damage to the device Liquid in the collection bottle can contain patient fluids Collection bottles and fluids should be handled according to hospital guidelines When using high levels of humidity Dräger recommends using the optional cond...

Page 10: ...t the bottom of the heater well 90 degrees counterclockwise b Pull the hose plug assembly out completely D 5 Discard the collection bottle and hose plug assembly Removing the manifold if installed 1 On devices without the humidification system option remove the manifold from the shell by pulling up on it Set aside 48275 48108 48103 C D ...

Page 11: ...cubator for at least 45 minutes Use caution when emptying or handling the reservoir 2 Pull the latch on top of the water reservoir lid forward and remove the lid A 3 Empty any water remaining in the reservoir NOTICE Risk of damage to the device Sharp tools can cause injury or damage the device Do not use sharp tools to remove the humidifier CAUTION Risk of injury or damage to the device Liquid in ...

Page 12: ...es of the hood to remove them 3 Pull the hose grommets B from each side of the hood to remove them 4 Wipe the retainer rings clean if installed 5 Discard disposable sleeves if installed Removing the air inlet filter 1 Loosen the two thumbscrews A on the air inlet filter cover located under the shell assembly on the rear of the device 2 Remove the air inlet filter cover 3 Remove the air inlet filte...

Page 13: ...n ing followed by disinfection by immersion Machine cleaning with ther mal disin fection Description of the procedure Device surface including con troller screen Yes No No see Surface disinfection with cleaning page 13 Trolley rail and holders Yes No No see Surface disinfection with cleaning page 13 Hood and walls Yes No No see Surface disinfection with cleaning page 13 Gaskets grom mets Yes No No...

Page 14: ...urfaces to be disinfected with surface disinfectant 4 Wait for the surface disinfectant contact time 5 At the end of the contact time moisten a new uncontaminated and lint free cloth with water at least drinking water quality 6 Wipe all surfaces until no remains of the surface disinfectant such as foam residues or streaks are visible 7 Wait until the surfaces are dry 8 Check the surfaces for visib...

Page 15: ...or module 1 When reprocessing the underside of the controller near the on off switch follow surface disinfection recommendations to wipe with a cloth dampened with disinfectant Do not spray cleaning solution directly onto the surface of the device Avoid getting cleaning agent in the openings 2 Clean all surfaces thoroughly including the controller and sensor module 3 Be sure to clean all holes and...

Page 16: ...he device Autoclaving can damage equipment or impact functional integrity Do not steam sterilize parts when disassembling for cleaning 1 Remove any lint build up on the heater radiator and fan impeller 2 Wipe the heater assembly Do not immerse the heater assembly in liquid Reprocessing the air inlet filter chamber and cover WARNING Risk of death or serious injury A dirty air inlet filter could aff...

Page 17: ... 4 Storage and transport After reprocessing there are no special requirements for storage and transport of the product However the following must be observed Store dry and free of dust Avoid recontamination and damage during transport All further information on storage and transport included in the accompanying documents must be observed 2 7 Other agents and reprocessing procedures 2 7 1 Disinfect...

Page 18: ...nvironmental Protection Agency Dispatch Hospital Cleaner Disinfectant Towels with Bleach Chlor Clean Tablets helix Solution ARTG2 2 Australian Register of Therapeutic Goods Actichlor plus Ecolab USA Oxygen releas ing agents Descogen Liquid Antiseptica CE Descogen Liquid r f u Oxygenon Liquid r f u Dismozon plus BODE Chemie CE Oxycide Ecolab USA EPA Perform Schülke Mayr CE SteriMax Wipes Aseptix CE...

Page 19: ...ting device specific components Prerequisites All components have been reprocessed and dried All components have been inspected for breakage or cracks and replaced if necessary Assembling the water reservoir assembly 1 On devices with the humidification system option a Install the humidifier A into the water reservoir assembly Insert it fully into the humidifier chamber and secure it by closing th...

Page 20: ...em option reinstall the manifold Fitting the drain plug 1 On devices without the condensation management system reinstall the drain plug A in the bottom of the heater well Fitting the condensation management system if installed 1 On devices with the condensation management system install a new collection bottle A 48103 49643 48276 A A D E ...

Page 21: ...e hose plug assembly B 3 Turn the plug C at the bottom of the heater well 90 degrees clockwise 4 Install the clamp D on the condensation management hose 5 Connect the condensation management hose E to the collection bottle located underneath the left side of the incubator 48274 48275 B C ...

Page 22: ...NG Risk of death or serious injury Using older software versions can lead to incorrect operation of the humidification system leading to injury The humidification system with the heater impeller cover with duct cover must be used with software version 5 n or higher Fitting the scale and the bed and related components NOTICE Risk of damage to the device The hood contains 4 tabs one at each corner w...

Page 23: ...bator is equipped with a weighing scale perform steps 6 through 9 6 Install the scale E 7 Place the mattress on the bed 8 Reinstall the clamps that hold the scale cable to the incubator 9 Reconnect the scale cable to the sensor module Fitting the iris port sleeves hose grommets and hand port gaskets if installed 1 If equipped with the optional iris ports on the side access panels install the new i...

Page 24: ...er diameter elastic band of a new sleeve over the inner ring of the port housing b Fold back and slip the larger elastic band over the outer ring A of the port housing c To close rotate the outer ring A If properly installed the sleeve opens again when rotation is reversed 48271 48272 48273 A A ...

Page 25: ...gasket so that the 2 tabs on the gasket are on the hinge side of the door opening C and the single tab is on the latch side of the door opening D 4 Ensure that the hand port latch E locks with slight pressure and opens when the latch lever is pressed Fitting the air inlet filter 1 Install the air inlet filter into the air inlet filter chamber located under the shell assembly on the rear of the dev...

Page 26: ...tting patient specific accessories and consumables Fitting the disposable skin probe 1 Plug in the skin temperature probe to the sensor module 2 8 2 2 Checking the operational readiness Prerequisites The device has been assembled and prepared so that it is ready for operation Procedure 1 Check the operational readiness see chapter Getting started in the instructions for use for the main device 481...

Page 27: ...y 20 Controller Reprocessing 15 Cuff 12 D Disassembly 7 Accessories 7 Bed 7 Condensation management 9 Drain plug 9 Heater 8 Impeller 8 Manifold 10 Safety 6 Scale 7 Water reservoir 11 Disinfectant 13 Disinfectants 17 Disinfection 13 Machine 13 Drain plug Assembly 20 Disassembly 9 F Filter 12 Filter chamber Reprocessing 16 Filter cover Reprocessing 16 G Gasket Assembly 23 Gaskets 12 Grommet 12 Assem...

Page 28: ...ated procedures 13 Walls 15 S Safety Cleaning 6 Cracks 5 Disassembly 6 Disposable 5 Explosion 5 Humidity 5 Reprocessing 6 Reusable 5 Scale Assembly 22 Disassembly 7 Sensor module Reprocessing 15 Shell Reprocessing 14 Signs of wear 5 Skin probe Assembly 26 Sleeve 12 Storage 17 Surface disinfectants 18 T Trademarks 4 Transport 17 Trolley Reprocessing 14 V Validated reprocessing procedures 13 W Walls...

Page 29: ...Supplement to the instructions for use Isolette 8000 plus 29 Index ...

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