O2matic HOT 100 Manuel utilisateur
2020.10.29
O2matic HOT end user manual
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Table of Contents
1 Warnings, Cautions and Symbols 4
1.1 Warnings 4
1.2 Cautions 5
1.3 Safety 6
1.4 Disclaimer 6
1.5 Label and Symbols 7
2Installation and Setup 10
2.1 Overview 10
2.2 Installation 13
3Starting Treatment 17
3.1 Connecting your tablet or smartphone to O2matic 20
4Maintenance and Support 21
4.1 Cleaning 21
4.2 Trademark 21
4.3 Support and Contact 22
5Specifications 23
6Troubleshooting 24
D 8.4.1.10
3
O2matic HOT (Healthy Oxygen Therapy) is an intelligent oxygen regulator capable of
measuring and controlling the oxygen supply to the patient based on predefined
threshold ranges prescribed by the medical staff. It regulates and adjusts the oxygen
flow based on trends in the data, and the selected profile. The O2matic HOT device will
adjust the flow of oxygen to the patient based on the saturation in the blood, making
this treatment precise in getting the correct oxygen flow.
On a stable patient O2matic HOT automatically attempts to reduce the oxygen flow,
also defined as “weaning”. This ensures the treatment will be phased out appropriately
and helps the patient recover. This ensures the treatment will be phased out
appropriately and helps the patient recover. It aims to provides the highest standard of
oxygen delivery and can do so in the comforts of your home.
The characteristics of this equipment make it suitable for use at home and hospitals,
where patients are not in critical care and can take care of themselves.
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1 Warnings, Cautions and Symbols
1.1 Warnings
a) Use only pulse oximetry sensors that are approved by O2matic. Contact your
service provider for more information on approved pulse oximetry for use with
the O2matic HOT. Use of any other pulse oximeters increases the risk for
compromising patient safety and will void the warranty.
b) Do not use in an explosive atmosphere or in the presence of flammable
anesthetics or gases.
c) Refer to the applicable sensor instructions for use for additional warnings and
cautions.
d) Regularly check the battery indicator. If lit, see section 5.3 for battery
instructions.
e) O2matic HOT is only to be used with pure oxygen.
f) Only use accessories such as masks, catheters and hoses approved by you
service provider.
g) Do not open the device under any circumstances. Do not use any tools on the
device.
h) Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that
they are operating normally.
i) Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this device could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
j) Portable RF (Radio frequency) communications equipment (including
peripherals such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the O2Matic HOT device, including
Warning
Indicates that you must be extremely careful when executing these
instructions. Not complying with these warnings can cause serious injuries
and even death.
D 8.4.1.10
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cables specified by the manufacturer. Otherwise, this could result in
degradation of the performance of this equipment.
k) Use of any other oximeters than the one provided will void the warranty.
For additional information refer to IEC 60601-1.
1.2 Cautions
a) If O2matic is stored or transported outside operating temperature limits (5-40ⷪ
C) it needs to cooldown/warm up for 1 hour. Keep the device away from direct
sunlight and hot surfaces.
b) Pulse oximetry sensors may have difficulty reading when used on patients with
low perfusions due to reduced blood circulation. In the case of poor perfusion
or low-quality signal then the saturation measurement icon appears lit, and the
sensor should be moved to an alternative site to obtain the best possible signal.
c) The O2matic HOT and the pulse oximetry sensor should only be used by the
patient with the ordination.
d) Avoid using nail polish nails when using pulse oximetry sensor. Nail polish can
cause impaired reading functionality of the pulse oximetry sensor.
e) In compliance with the European Directive on Waste Electrical and Electronic
Equipment (WEEE) 2012/19/EU, do not dispose of this product as unsorted
municipal waste. This device contains WEEE materials. Contact your service
provider regarding take-back or recycling of the O2matic.
f) Extended exposure to the device(s) may cause irritation to the skin, pyrogenicity
or trigger allergies.
g) During treatment the device should always be turned on.
h) To avoid disconnecting please keep the device away from pets, pests and
children.
i) If the device has not been used in a while leave the device on for 30 seconds
before using it.
Caution
Indicates that you must be careful when executing these instructions. Not
complying with these caution directives can cause minor injuries or
equipment damage.
O2matic HOT end user manual
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1.3 Safety
The O2matic HOT has a failsafe rechargeable battery that keeps the device running
upon short power breaks. To shut down the O2matic HOT press and hold for 4
seconds. Upon intended shutdown, or unintended shutdown, such as total loss of
power, the device maintains its last settings.
In case of malfunction it reverts to the defined safe-mode, where the user is informed
by turning on the warning icon and an audible alarm.
In safe-mode the flow of oxygen is reduced to zero. The patient shall change to an
alternative oxygen supply and contact the service provider.
As part of the treatment the patient will be assigned a dedicated tablet which will have
the O2matic HOT app installed. The app will inform the patient of any relevant
notifications and display information from the HOT device. During treatment it is
advised not to turn off the dedicated tablet.
1.4 Disclaimer
O2matic cannot assume responsibility for patient safety, upon:
•Any sign or evidence of opening the O2matic HOT, except by authorized
personnel.
•Use of any unapproved pulse oximeters.
•This IFU has been issued in compliance with requirements set out in Council
Directive 93/42 EC concerning Medical Devices.
•All liability is discontinued if the product is not used as intended and as
described in this IFU.
D 8.4.1.10
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1.5 Label and Symbols
Figure 2: O2matic label found beneath
The labelling on the device are the manufacturers label situated on the bottom and
back of the device. The optimal reading condition of the labelling is at the same reading
distance and angle, as a person would hold and read the cover of a book. In ‘office
lighting’ illumination predominant in hospitals.
O2matic HOT end user manual
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Refer to
instruction
manual/booklet.
Follow
instructions for
use
Direct current:
5 VDC
Manufacturer
0123
CE mark: Made
in compliance
with all
relevant
directives
Do not use if the
package is
damaged
Serial number
Not for general
waste
For use in
oxygen rich
environtment
Alternating
current
Type BF
Applied part
Temperature
limits
On/Off
Class II
equipment
IP22
Protection
against Fingers
or similar
D 8.4.1.10
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objects and
vertically
Dripping water
when tilted at
15°.
For use in
altitudes 0 - 2000
m
O2matic HOT end user manual
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2Installation and Setup
Before using the device, it must be installed as described in the following section. It is
important to read the instructions thoroughly and familiarize oneself with the
information given. It is the service provider’s responsibility to correctly set up the device
and comply with the warranty of any pulse oximetry.
2.1 Overview
Figure 3: Front of O2matic
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