ResMed HumidAire 2i User's Manual
Contents
1. 6857 USA ResMed UK Ltd EU Authorized Representative 96 Milton Park Abingdon Oxfordshire OX14 4RY UK ResMed Offices Australia Austria Brazil China Finland France Germany Hong Kong India Japan Malaysia Netherlands New Zealand Norway Singapore Spain Sweden Switzerland UK USA see www resmed com for contact details Patents pending Protected by design registrations AU 147335 CH 128 711 CH 128 712 DE 40202008 DE 40201723 ES 153516 ES 153518 FR 021407 GB 3001820 GB 3001821 JP 1164266 JP 1164267 SE 75598 SE 75715 US D476077 US D477868 Other designs pending HumidAire is a trademark of ResMed Ltd and is registered in the U S Patent and Trademark Office CIDEX is a trademark of Johnson amp Johnson Alconox is a trademark of Alconox Inc Neodisher MediZym is a trademark of Chemische Fabrik Dr Weigert 2008 ResMed Ltd 308236 UEng 2 08 06 Global leaders in sleep and respiratory medicine www resmed com2. Clinical Use Only RESMED HumidAire 2i HEATED HUMIDIFIER Disinfection Guide English Clinical Use Only ResMed HumidAire 2i Disinfection Guide This Disinfection Guide is intended for multipatient use of the HumidAire 2i in a sleep lab clinic or hospital If you use the water chamber as a single user in the home refer to the User Guide for cleaning instructions The following are the recommended and validated procedures for cleaning and disinfection of the water chamber We advise that each healthcare facility consult its own procedures before carrying out the following instructions A WARNINGS and CAUTIONS e ResMed cannot give any assurance that deviations from the procedures listed in this guide and their effect on the performance of the product will be acceptable e When using detergents or disinfectants always follow the manufacturer s instructions Note The HumidAlire 2i is available in both a clear polycarbonate PC version as well as a smoky gray polysulohone UDEL version The following cleaning methods apply only to the clear polycarbonate PC version Clear polycarbonate PC version Smoky gray polysulphone UDEL version ResMed Validated Procedures Table 1 Option 1 Automatic Cleaning and High Level Thermal Disinfection Disassembly Option 1 Automatic Cleaning and High Level Thermal Disinfection Disassemble the humidifier water chamber according to the Disassembling and Reassemblin
3. er moulding to the outer moulding and pushing downwards Clinical Use Only 2 Take the assembled catches and fit them to the water chamber base t 3 Turn the water chamber base upside down Insert the latch s feet into the locking tabs Push firmly and click into place A CAUTION Ensure that you replace the O ring if it is nicked or punctured 5 Push the tub plate into the water chamber with the open side facing down Then firmly press the tub plate down into the water chamber Tub plate 7 Fit the seal onto the rim of the water chamber base Press along the edge to ensure that the seal is fitted properly Seal Rim Lid OE 9 Lock the catches on the side of the water chamber Troubleshooting If the water chamber leaks after being reassembled examine the unit for the following Possible cause Solution Water chamber may be damaged or cracked Replace affected section of water chamber Water chamber seal may be twisted Make sure the seal is seated properly inside the water chamber Side catches are not engaged properly Make sure two side catches are engaged properly Tub plate is incorrectly fitted Ensure tub plate is fitted correctly O ring is punctured or nicked Replace O ring ResMed Ltd Manufacturer 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp US Designated Agent 14040 Danielson Street Poway CA 92064
4. g instructions on page 5 Pre cleaning Rinse all water chamber components 10 times and brush thoroughly with a soft bristle brush in a warm 113 F or 45 C solution of Neodisher MediZym 2 Note Pre cleaning must occur immediately after use Cleaning 1 Support the components in the standard racking of the automatic washerdisinfector so that each will drain water 2 Add the detergent solution and activate the automatic washer disinfector for a standard cycle of cleaning followed by thorough rinsing Drying Not applicable Pre disinfection Not applicable Drying Not applicable Disinfection 1 Activate the automatic washerdisinfector for a standard cycle of thermal disinfection high level 2 Ensure that the machine has thoroughly rinsed each component thermal disinfection Drying Air dry out of direct sunlight Inspection Perform a visual inspection of the water chamber If any visible deterioration is apparent cracking crazing tears etc the water chamber should be discarded and replaced Slight discoloration of the silicone components may occur and is acceptable Reassembly Reassemble the humidifier water chamber according to the Disassembling and Reassembling instructions on page 5 Packaging amp Store in a dry dust free environment away from direct sunlight Storage Storage temperature 4 F to 140 F 20 C to 60 C 1 Cleaning ResMed has tested the deterge
5. immerse the device or power cord in water Always unplug the device before cleaning and be sure that it is dry before plugging back in 1 Turn the main power switch at the back of the device to OFF and unplug the power cord from the power outlet 2 Allow 10 minutes for the tub plate and any excess water to cool 3 Remove the water chamber To do this lift the latch at the bottom of the water chamber and pull the water chamber away from the docking station 4 Discard any excess water by turning the water chamber upside down allowing the water to drain out of the air outlet 5 Disassembling the Water Chamber 1 To open the side catches pull out from the lower edge Side catch Lid Seal Cross member Base Clinical Use Only 6 1 Push down on the tub plate from inside the chamber to remove it from the chamber Tub plate 2 Remove the O ring from the tub plate 3 Turn the water chamber base upside down Firmly pull the latch up and away from the chamber until separated from the base Underside view 4 Disengage the catches from the sides of the water chamber base Then separate the inner and outer moulding of the catch pull back the inner moulding and squeeze The inner moulding will pop out H 7 Reassembling the Water Chamber When all the water chamber parts are clean and dry reassemble the water chamber 1 Reassemble the catches by inserting one side of the inn
6. nents disinfection 2 Thoroughly rinse each component according to the manufacturer s instructions Drying Air dry out of direct sunlight Inspection Perform a visual inspection of the water chamber If any visible deterioration is apparent cracking crazing tears etc the water chamber should be discarded and replaced Slight discoloration of the silicone components may occur and is acceptable Reassembly Reassemble the humidifier water chamber according to the Disassembling and Reassembling instructions on page 5 Packaging amp Store in a dry dust free environment away from direct sunlight Storage Storage temperature 4 F to 140 F 20 C to 60 C 1 Cleaning ResMed has tested the detergent Alconox diluted at 1 using hot water approximately 140 F or 60 C or warm water approximately 120 F or 50 C according to the manufacturer s instructions 2 Disinfection ResMed water chambers have been validated for 20 cycles using solutions of ortho phthalaldehyde 0 55 CIDEX OPA for 12 minutes according to the manufacturer s instructions 3 Rinsing Thoroughly rinse each component in drinking quality water five litres per assembly by immersing it completely for a minimum of one minute in duration Repeat the rinse procedure two additional times using fresh water for a total of three rinses Clinical Use Only Disassembling and Reassembling the HumidAire 2i WARNING A Beware of electrocution Do not
7. nt Neodisher MediZym diluted at 0 5 using warm water approximately 113 F or 45 C according to the manufacturer s instructions 2 Disinfection Due to specific regional requirements ResMed water chambers have been tested for disinfection for 20 cycles using hot water approximately 199 F or 93 C for 10 minutes Table 2 Option 2 Manual Cleaning and High Level Chemical Disinfection Disassembly Option 2 Manual Cleaning and High Level Chemical Disinfection Disassemble the humidifier water chamber according to the Disassembling and Reassembling instructions on page 5 Pre cleaning Rinse all water chamber components 10 times and brush thoroughly with a soft bristle brush in a warm 113 F or 45 C solution of Alconox 1 Note Pre cleaning must occur immediately after use Cleaning 1 Clean all components of the water chamber with a soft bristle brush for one minute while soaking them in the detergent solution Pay particular attention to all crevices and cavities 2 Thoroughly rinse each component according to the manufacturer s instructions Drying Allow the water chamber to air dry out of direct sunlight Pre disinfection Not applicable Drying Not applicable Disinfection 1 Soak the disassembled water chamber components in a commercially available solution of high level ortho phthalaldehyde 0 55 eg CIDEX OPA Take care that no air bubbles are trapped chemical against the compo
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