ResMed H5i User manual

1
CLINICAL USE ONLY
H5i™ disinfection guide
heated humidifier
This disinfection guide is intended for multipatient use of the H5i in a sleep lab, clinic or hospital. If you are using the H5i
as a single user in the home, refer to the Welcome Guide for cleaning instructions.
This guide describes ResMed’s recommended and validated procedures for cleaning and disinfection of the humidifier.
However, the steps for disinfection vary regionally. As a result, each healthcare facility should consult its own procedures
before carrying out those within this guide.
Parts suitable for disinfection
Part High level thermal or chemical disinfection
H5i cleanable water tub (including tub lid, plate and base) ü
Air outlet ü
Validated disinfection procedures
In the procedures below, only one disinfection process needs to be performed.
Procedures
Disassembly Disassemble the H5i according to the instructions below.
Cleaning Clean all components with a soft bristle brush for one minute while soaking them in the1.
detergent1solution. Pay particular attention to all crevices and cavities.
Thoroughly rinse each component according to the manufacturer’s instructions.
2.
Disinfection and
drying
High level thermal
Soak the disassembled components in a hot water bath at pasteurising temperature
1. 2. Take care
that no air bubbles are trapped against the components.
Air dry out of direct sunlight.
2.
High level chemical
Soak the disassembled components in a commercially available solution of a chemical1.
sterilant3. Take care that no air bubbles are trapped against the components.
Thoroughly rinse
2. 4each component according to the manufacturer’s instructions.
Air dry out of direct sunlight.
3.
Inspection Perform a visual inspection of all components. If any visible deterioration is apparent (cracking,
crazing, tears etc), the water tub should be discarded and replaced. Slight discolouration of the
silicone components may occur and is acceptable.
Reassembly Reassemble the H5i according to the instructions below.
Packaging and
storage
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature: -20°C to 60°C (-4°F to 140°F).
1 Cleaning: ResMed has tested the following detergents according to the manufacturer’s instructions:
Alconox Tergazyme (diluted at 1%) using hot water (approximately 60°C or 140°F) or warm water (approximately 50°C or 122°F)•
Aniosyme DDI (diluted at 0.5%) using room temperature water (approximately 20°C or 68°F)•
Neodisher MediZym (diluted at 2.0%) using warm water (approximately 45°C or 113°F)•
2High level thermal disinfection: Due to specific regional requirements, ResMed water tubs have been tested for disinfection for 100 cycles using hot
water (approximately 93°C or 199°F) for 10 minutes.
3High level chemical disinfection: ResMed cleanable water tubs have been validated for 100 cycles according to the manufacturer’s instructions using
solutions of:
Ortho-phthalaldehyde 0.55% CIDEX OPA for 12 minutes•
Anioxyde 1000 for 30 minutes•
Sekusept aktiv 2.0% for 30 minutes•
4 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.

2
CLINICAL USE ONLY
Disassembling the H5i
Slide the latch.1.
Lift open the flip lid.2.
Remove the water tub.3.
Discard any excess water from the water tub.4.
Unclip all four side latches.5.
Pull apart the tub lid, plate and base.6.
Remove the maximum water level mark from the plate by pinching and pushing out the locks.7.
Locate the air outlet on the back of your H5i.8.
Remove the outlet clip by pulling apart the clip ends and sliding it off.9.
Remove the air outlet by pushing it through to the inside of the H5i.10.

3
CLINICAL USE ONLY
Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Distributed by: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK
See www.resmed.com for other ResMed locations worldwide.
H5i: Protected by AU 2002233025, CN ZL02804936.5, HK 1065483, NZ 527088, US 6935337. Other patents pending. Designs pending.
CIDEX is a trademark of Johnson & Johnson. Alconox is a trademark of Alconox Inc. Neodisher MediZym is a trademark of Chemische Fabrik Dr Weigert. Aniosyme and Anioxyde are trademarks of
Laboratoires Anios.
© 20010 ResMed Ltd. 368143-Eng/2 10 01
Global leaders in sleep and respiratory medicine www.resmed.com
Reassembling the H5i
When all the parts are clean and dry, reassemble the H5i as follows:
Reinsert the air outlet ensuring that the straight side is facing up.
1.
Place the outlet clip back onto the air outlet. Ensure that the outlet clip goes past the ridge on the air outlet.2.
Reinsert the maximum water level mark into the plate ensuring that it clicks into place.3.
Place the plate back onto the base ensuring that the maximum water level mark faces up.4.
Place the tub lid back onto the plate/base ensuring that the centre holes are aligned.5.
Clip all four side latches.6.
Fill the water tub and return the water tub to the H5i.7.
Close the flip lid ensuring that it clicks into place.8.
GENERAL WARNINGS AND CAUTIONS
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.
When using detergents, disinfectants or sterilisation agents, always follow the manufacturer’s instructions.•
Beware of electrocution. Do not 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.