ResMed 61106 Bedienungsanleitung

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

61859r4.book Page 1 Wednesday, April 3, 2013 2:10 PM

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

61859r4.book Page 2 Wednesday, April 3, 2013 2:10 PM

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

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)

61859r4.book Page 3 Wednesday, April 3, 2013 2:10 PM

ENGLISH

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

61859r4.book Page 4 Wednesday, April 3, 2013 2:10 PM

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.

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