General Warnings And Cautions - ResMed VPAP III ST-A User Manual

Bilevel adaptive servo ventilator
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Storage and Transport
Temperature
Storage and Transport
Humidity
Atmospheric pressure
range
Additional Information
Additional technical specifications and information can be found
in the device-specific user guide on www.resmed.com on the
Products page under Service & Support.
Electromagnetic Compatibility
Product complies with all applicable electromagnetic compatibility
requirements (EMC) according to IEC60601-1-2, for residential,
commercial and light industry environments. The electromagnetic
compatibility tables for these ResMed devices can be found
on www.resmed.com on the Products page under Service &
Support. Click on the PDF file for your device.
Aircraft Use
Please consult ResMed and the medical services department of
your carrier if you intend to use your device on an aircraft.
The manufacturer reserves the right to change these
specifications without notice.
Symbols that may Appear on the Product
Attention, consult accompanying documents
Follow instructions for use
Type CF equipment
Class II equipment
Drip proof
IPX1
Name and address of manufacturer
Dangerous voltage
Environmental Information This device should be disposed
of separately, not as unsorted municipal waste. To dispose of your
device, you should use appropriate collection, reuse and recycling
systems available in your region. The use of these collection,
reuse and recycling systems is designed to reduce pressure
on natural resources and prevent hazardous substances from
damaging the environment. If you need information on these
disposal systems, please contact your local waste administration.
The crossed-bin symbol invites you to use these disposal
systems. If you require information on collection and disposal of
your ResMed device please contact your ResMed office, local
distributor or go to www.resmed.com/environment.

General Warnings and Cautions

Warnings
Read the entire guide before using the device.
The device is NOT a life support ventilator and may stop
operating with power failure or in the unlikely event of certain
fault conditions.
Advice contained in this guide should not supersede
instructions given by the prescribing physician.
A patient should not connect a device to the data
communication port unless instructed to do so by their health
care provider or physician. Only ResMed products are designed
to be connected to the data communication port. Connecting
other devices could result in injury, or damage to the device.
(Data communication ports are not available on all devices.)
The device should be used with masks (and connectors)
recommended by ResMed, or by a physician or respiratory
therapist. A mask should not be used unless the device is
* Ports may be incorporated into the mask or in connectors that are near the
mask.
-20°C to +60°C
10–95% non-condensing
1013 hPa (sea level) to 700 hPa
(2,591 m) (Bilevel)
1060 hPa (sea level) to 680 hPa
(2,591 m) (ASV)
turned on and operating properly. The vent hole or holes
associated with the mask should never be blocked.
Explanation: The device is intended to be used with special
masks (or connectors) which have vent holes to allow
continuous flow of air out of the mask. When the device is
turned on and functioning properly, new air from the device
flushes the exhaled air out through the mask vent holes.
However, when the device is not operating, insufficient fresh
air will be provided through the mask, and the exhaled air
may be rebreathed. Rebreathing of exhaled air for longer
than several minutes can, in some circumstances, lead to
suffocation. This applies to most models of positive airway
pressure devices.
In the event of power failure or machine malfunction, remove
the mask.
In certain fault conditions, pressures up to 40 cm H
possible.
If oxygen is used with this device, the oxygen flow must be
turned off when the device is not operating. If oxygen has been
left on, turn off the device, then wait 30 minutes before turning
on the device again.
Explanation: When the device is not in operation and the
oxygen flow is left on, oxygen delivered into the air delivery
tubing may accumulate within the device enclosure and create
a risk of fire. This applies to most types of positive airway
pressure devices.
Oxygen supports combustion. Oxygen should not be used
while you are smoking or in the presence of an open flame.
Always ensure airflow is being generated by the device before
the oxygen supply is turned on.
Always turn the oxygen supply off before stopping the airflow
from the device.
Note: At a fixed rate of supplemental oxygen flow, the inhaled
oxygen concentration will vary, depending on where the
oxygen is introduced, the pressure settings, patient breathing
pattern, mask selection, and leak rate.
Do not use the device if there are obvious external defects,
unexplained changes in performance or unusual noises.
Do not open the device case. There are no user serviceable
parts inside. Repairs and internal servicing should only be
performed by an authorised service agent.
Explosion hazard – do not use in the vicinity of flammable
anaesthetics.
The device should not be used with anaesthetised patients.
The device should not be connected to both AC and DC
power sources simultaneously (unless otherwise specified by
ResMed).
In the clinical environment any PC that is used with the device
must be at least 1.5 m away from, or at least 2.5 m above the
patient. It must also comply with IEC 60950 or equivalent.
Cautions
At low pressures, the flow through the exhalation ports of your
mask may not clear all exhaled gas from the tubing. Some
rebreathing may occur.
The air temperature for breathing produced by this device can
be as much as 6ºC higher than the temperature of the room.
Caution should be exercised if the room temperature is warmer
than 32ºC.
Do not remove any attached accessories while power is
connected to your device.
Note: The above are general warnings and cautions. Specific
warnings, cautions, and notes appear with the relevant
instructions in this user guide.
Servicing
The device should be inspected by an authorised ResMed service
*
centre five years from the date of manufacture. Before this, the
device is intended to provide safe and reliable operation if it is
operated and maintained according to the instructions provided
by ResMed. Warranty details are provided with the device at
4
O are
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