ResMed ApneaLink Plus Patient Instructions For Use

ApneaLink™ Plus
Patient Instructions
English
Intended Use Intended Use
The ApneaLink TM Plus device is indicated for use by Health Care
Professionals (HCP), where it may aid in the diagnosis of sleep
disordered breathing for adult patients. ApneaLink Plus records
the following data: patient respiratory nasal airfl ow, snoring, blood
oxygen saturation, pulse and respiratory effort during sleep. The
device uses these recordings to produce a report for the HCP
that may aid in the diagnosis or for further clinical investigation.
Caution: In the USA, federal law restricts this device to sale by
or on the order of a physician.
Important Notes Important Notes
• Read these entire instructions before using the ApneaLink
Plus unit.
• ApneaLink Plus and the accessories are to be used for the
specifi ed intended use only.
• Do not use the system if there are any defects noted.
• The nasal pressure cannula is single use only. Only use
the original nasal pressure cannula supplies in the original,
unopened pack.
• The recorder's pressure sensors are highly sensitive. For this
reason, you should never blow directly into the connections
for the nasal pressure cannula or the effort sensor. You
should always screw on the ventilated protective caps
supplied when the unit is not in use. Do not use any other
caps.
• Use only the specifi ed types of battery or rechargeable
battery (2 NiMH rechargeable batteries: Mignon/AA/1.2 V/at
least 2100 mAh or 2 batteries: LR 6/Mignon/AA/1.5 V).
• Wear ApneaLink Plus and the effort sensor over pajamas or
nightshirts with long sleeves, in order to avoid any discomfort
from the belt.
• When using consumables and accessories, please read the
manufacturer's information supplied with the products.
• Apply the nasal pressure cannula, the fi nger pulse sensor,
the effort sensor and the belt correctly to avoid the unlikely
risk of strangulation.
• Blood fl ow must not be impeded during the recording
process. The chest belt and fi nger sensors should be applied
snug and comfortable, but not too tight.
ResMed Germany (Manufacturer) Fraunhoferstr. 16 82152 Martinsried Germany ResMed Ltd (Manufacturer for Canada) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp (US Designated Agent) 14040
Danielson Street Poway CA 92064-6857 USA ResMed Offi ces Australia, Austria, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK, USA (see
www.resmed.com for contact details). Patents and designs pending. ApneaLink is a trademark of MAP Medizin-Technologie GmbH © 2009 ResMed
• Excessive ambient light and excessive motion may degrade
pulse oximeter performance or affect the accuracy of the
measurement.
• The oximeter sensor may not work on cold extremities due
to reduced circulation. Warm or rub the fi nger to increase
circulation, or reposition the sensor.
• Do not stretch the adhesive tape when attaching the fi nger
pulse sensor.
• Nail polish or false nails should be removed before using
the fi nger sensor.
• The nasal pressure cannula and the disposable fi nger pulse
sensor supplied are intended for single use only and must
be disposed of after use. The effort sensor is intended for
multiple use.
• The Health Care Practitioner (HCP) is responsible for
cleaning and care of ApneaLink Plus. Do not attempt to
clean the unit.
• Pulse oximetry measurement is optional.
• Keep all parts away from children.
• Risk of explosion. Never use the recorder in the vicinity of
fl ammable gases (e.g. anesthetics).
Contraindications Contraindications
Depending on your skin condition or general state of health, you
may experience sensitivity to the self-adhesive fi nger sensor.
Discontinue use if you experience a reaction to the adhesive
material.
Directions for Use Directions for Use
Note: Refer to the drawings on the next page.
Thread the belt through the brackets of the ApneaLink Plus and
®
the effort sensor. Fix the Velcro fastener at the belt and move
the recorder in a comfortable position [see Fig. 1].
The easiest way to put on the device is while standing in front
of a mirror. Fix the ApneaLink Plus on to your chest using the
supplied belt [see Fig. 2].
Fit the nasal pressure cannula so that the two small open tubes
point towards the nostrils. When doing this, ensure that the
ends point towards the face, and are not bent upwards. Fit the
loop around the ears and then back to the front again, without
pulling it over your head. Pull the loop tight so that the fi t is
comfortable but securely fi tted [see Fig. 3].
Attach the fi nger pulse sensor to the left ring fi nger. The
symbolised fi nger on the adhesive strip shows in which position
the adhesive strip has to be placed on the fi nger nail. Then
press the pulse oximeter into the clip-on holder [see Fig. 4].
Attach the clip on the holder to the belt. Insert the end of the
pulse oximeter cable into the recorder. Remove and save the
protective cap from the nasal pressure cannula connection. Fit
the effort sensor tube and the end of the the nasal pressure
cannula to the connections of the recorder by turning it
clockwise [see Fig. 5].
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Global leaders in sleep and respiratory medicine
Start the recording in bed by pressing and holding the START/
STOP button, until the small light above the button turns green.
The ApneaLink Plus is recording when the green light is on [see
Fig. 6 and 7].
To stop the recording press the START/STOP button until the
small light goes out (~1.5 seconds) [see Fig. 8].
Remove the nasal pressure cannula and fi nger pulse sensor.
Unfasten the chest belt with the ApneaLink Plus recorder and
connected components. Discard the nasal pressure cannula.
With the saved protective cap, carefully screw the recorder unit
connection. Detach the pulse oximeter from the recorder unit.
Detach the fi nger pulse sensor from the pulse oximeter. Return or
dispose of the fi nger pulse sensor as instructed by your HCP .
Return the ApneaLink Plus together with protective cap, belt,
fi nger pulse sensor, oximeter, clip fastener and effort sensor back
to your HCP .
Cleaning the ApneaLink Plus Cleaning the ApneaLink Plus
Caution:
• Never use abrasive agents, alcohol, chlorine-containing
substances, acetone, or other solvents to clean the recorder.
• Do not immerse the recorder, the pulse oximeter, the fi nger
pulse sensor or the effort sensor in fl uids, and ensure that
no fl uids penetrate into the products.
• Do not attempt to disinfect or sterilize the recorder, since
this could cause unseen damage to the inside of the unit.
Cleaning instructions:
• Switch off the recorder.
• Remove and dispose of the nasal pressure cannula.
• Remove the respiratory effort sensor.
• Screw the ventilated cap onto the nasal pressure cannula
connection.
• Detach the pulse oximeter from the recorder.
• Detach the fi nger pulse sensor from the pulse oximeter.
Note: Dispose of the single-use fi nger pulse sensor. If you
are using other approved fi nger pulse sensors, follow the
manufacturer's cleaning instructions.
• Press the protective cover for the USB cable in the housing
opening.
• Clean the following parts with a damp cloth and a mild liquid
soap: recorder and pulse oximeter housing, pulse oximeter
cable, clip fastener, respiratory effort sensor.
• Leave the cleaned parts to dry.
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