ResMed 61106 User manual

ENGLISH
The RESMED HOSPITAL NASAL MASK is intended for single patient use for adult patients
(>66 lb/30 kg) prescribed continuous positive airway pressure or bilevel therapy in hospitals
or clinics.
This is a disposable mask. It is intended to be used for the short-term (7 days) treatment of
a single patient only, then discarded.
CAUTION
In the USA, federal law restricts this device to sale by, or on the order of, a physician.
MEDICAL INFORMATION
Note: The mask system does not contain latex, PVC or DEHP materials. If the patient has ANY
reaction to any part of the mask system, discontinue use.
WARNINGS
•This mask should be used only with CPAP or bilevel systems recommended by a
physician or respiratory therapist. A mask should not be used unless the CPAP or bilevel
system is turned on and operating properly.
Explanation of the Warning: CPAP or bilevel systems are intended to be used with
special masks with connectors which have vent holes or separate exhalation devices to
allow continuous flow of air out of the mask. When the CPAP or bilevel device is turned
on and functioning properly, new air from the flow generator flushes the exhaled air out
through the mask exhalation port. However, when the CPAP or bilevel device is not
operating, enough fresh air may not be provided through the mask, and exhaled air may
be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some
circumstances lead to suffocation. This warning applies to most models of CPAP or
bilevel systems.
•The exhaust vent flow is lower at lower mask pressures (see Pressure/Flow curve). If the
mask pressure during expiration is too low, there may not be enough exhaust vent flow
to completely flush the air delivery hose of exhaled air before the start of the next
inspiration.
ResMed Hospital Nasal Mask
USER GUIDE
Rx Only
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ENGLISH
•If oxygen is used with the CPAP or bilevel device, the oxygen flow must be turned off
when the flow generator is not operating.
Explanation of the Warning: When the CPAP or bilevel device is not in operation, and
the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate
within the flow generator enclosure. Oxygen accumulated in the CPAP or bilevel device
enclosure will create a risk of fire. This warning applies to most types of CPAP or bilevel
flow generators.
•Please refrain from smoking while oxygen is in use.
Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will
vary, depending on the pressure settings, patient breathing pattern, mask selection, and leak
rate.
•Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental
condition. If symptoms occur, consult your physician or dentist.
FITTING THE MASK
The RESMED HOSPITAL NASAL MASK is supplied fully assembled.
1Connect one end of the main air tubing to the flow generator and the other end to the
swivel. Turn the flow generator on. See “Technical Specifications” for information on
which flow generator setting to use.
2Place the mask cushion over the patient’s nose and pull the headgear over their head.
3Unfasten and gently tighten the headgear straps to achieve a secure and comfortable fit.
Adjust the top strap first. Then adjust the side straps, making sure that they pass below
the patient’s ears. Do not overtighten the straps.
4The fitted mask should look like this:
5If the patient feels air leaks around the cushion, reposition the mask on the patient’s nose
to achieve a better seal. You may also need to readjust the headgear straps.
REMOVING THE MASK
To remove the RESMED HOSPITAL NASAL MASK, unfasten one of the side headgear straps
and pull the mask and headgear up over the patient’s head.
headgear
top strap
side strap
mask
swivel
elbow
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ENGLISH
DAILY CLEANING OF THE MASK (OR AS REQUIRED)
Disconnect the main air tubing from the swivel.
The RESMED HOSPITAL NASAL MASK is for single patient, multi-use. The mask may be
cleaned using a 70% v/v isopropyl alcohol swab or by wiping with a damp, soapy cloth. If
using a damp cloth, use mild soap or diluted dishwashing detergent. Allow to air dry out of
direct sunlight.
Note: Do not disassemble the mask.
CAUTIONS
•Do not use solutions containing bleach, chlorine, aromatics, moisturizers,
antibacterial agents, or scented oils to clean any part of the system or air tubing.
These solutions may cause damage and reduce the life of the product.
•Do not expose any part of the system or tubing to direct sunlight as it may
deteriorate.
•If any visible deterioration of a component is apparent (cracking, crazing, tears, etc),
the component should be discarded and replaced.
•Check the vent holes for blockage. Ensure the vent holes are cleaned regularly.
TECHNICAL SPECIFICATIONS
PRESSURE / FLOW CURVE
Note: As a result of manufacturing variations, the vent flow may vary from the values listed in
the following table.
FLOW GENERATOR SETTING
Select “Standard” as the mask option, when using the RESMED HOSPITAL NASAL MASK with
ResMed flow generators that have mask setting options. For a full list of compatible devices
for this mask, see the Mask/Device Compatibility List on www.resmed.com on the Products
page under Service & Support. If you do not have internet access, please contact your
ResMed representative.
DEAD SPACE INFORMATION
Explanation: Dead space is the empty volume of the mask up to the swivel.
The dead space of the mask varies according to cushion sizes, but is less than 104 mL.
Pressure
(cm H2O)
Flow
(L/min)
419
828
12 34
16 40
20 45
0
10
20
30
40
50
60
70
80
4 6 8 101214161820
Mask Pressure (cm H20)
Flow Rate (L/min)
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
4 6 8 10 12 14 16 18 20
Pressure (cm H20)
Flow Rate (L/min)
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ENVIRONMENTAL CONDITIONS
Operating Temperature: 41°F (5°C) to 104°F (40°C)
Operating Humidity: 15–95% relative humidity
SYMBOLS
Caution, consult accompanying documents; Batch code; Catalogue number;
European Authorised Representative; Temperature limitation; Humidity
limitation; Does not contain natural rubber latex; Manufacturer; Indicates a
Warning or Caution and alerts you to a possible injury or explains special measures for the
safe and effective use of the device.
REPLACEMENT PARTS
Part No. Item
61106 ResMed Hospital Nasal Mask System–Medium
61107 ResMed Hospital Nasal Mask System–Large
61118 Headgear (10pk.)
LOT
REF
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Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.
See www.resmed.com for other ResMed locations worldwide.
For patent information, see www.resmed.com/ip.
© 2017ResMed Ltd. 61859/5-Eng 2017-10 61859