O2matic HOT 100 User manual

2020.10.29

O2matic HOT end user manual
2
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.

O2matic HOT end user manual
4
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
5
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
6
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
7
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
8
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
9
objects and
vertically
Dripping water
when tilted at
15°.
For use in
altitudes 0 - 2000
m

O2matic HOT end user manual
10
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

D 8.4.1.10
11
1. FLOW INDICATOR
Shows the amount of oxygen currently being delivered. If the amount of
oxygen the device is delivering is different from the expected amount, the
device will light up two values. One value is blinking which refers to the
expected amount of oxygen. The other will light up statically, which
indicates how much oxygen is currently being delivered.
Upon start up, two values are lit for 3 seconds, indicating the flow
limitations for current device configuration.
2. OXYGEN SOURCE ERROR
Check oxygen source.
3. NOTIFICATIONS
Check your App for more information.
4. BATTERY LEVEL
Green blinking: Charging
Green: Battery status good
Yellow: Battery status low. Connect to power source when possible
Red: Battery status critical. Connect to power source immediately
Red blinking: Battery fail. Contact service provider
Function of the device is not affected by the device being connected to
power or not.
5. NO STABLE POWER SOURCE
Connect to stable power source when possible.
6. SATURATION MEASUREMENT
Constant lid: Put pulse oximeter on finger. Treatment will start.
Blinking: Signal is lost, reconnect be adjusting your finger.
Off: Session finished. Take pulse oximeter off finger.
7. OXYGEN OUTPUT
Connect your oxygen mask here.
8. ON/OFF BUTTON
The button will light up when the device is turned on.

O2matic HOT end user manual
12
9. ERROR
Stop using the device and contact your service provider.
10. BLUETOOTH
When connected to the app this symbol will light up.
Figure 4: Back of O2matic
11. POWER SUPPLY
Here is where the power supply should be connected. By connecting the
other end to a power source, the device will recharge its batteries and
avoid running out of power. Connect the device to a power source and do
not turn off the device while it is charging.

D 8.4.1.10
13
12. OXYGEN IN
Connect your oxygen source to this socket to ensure the device
can receive and regulate the oxygen flow.
2.2 Installation
To install O2matic HOT:
a) Place the O2matic HOT near yourself at a flat surface, such as a table.
b) Connect the AC power adapter to the wall outlet and to the O2matic HOT
device power plug.
Warning
Only use the AC power adaptor provided by O2matic. Any other power
supply may interfere with the proper operation of the device.
c) Connect the oxygen hose to your source of oxygen like a concentrator or an
oxygen cylinder. Then connect oxygen hose to the oxygen inlet of the O2matic
HOT.
d) Connect the oxygen output to your oxygen mask or nasal cannula and put on
the mask.
e) Turn on the O2matic HOT by pressing and holding down for 4 seconds.
The O2matic HOT device should now be turned on.
Warning
The nasal catheter needs to be placed in the correct position during
treatment. Contact your service provider if you are in doubt.

O2matic HOT end user manual
14
Warning
All cables connected to the HOT device should be positioned safely to best
prevent tripping and/or strangulation. Keep any unnecessary cables away
from the device.

D 8.4.1.10
15

O2matic HOT end user manual
16
Figure 5: Oxygen mask and nasal catheter appliance
Warning
O2matic HOT is only to be used with pure oxygen.
Afterwards the device should be ready to start the treatment within 5 seconds. If you
are having trouble installing or using the device, please contact your service provider
for further assistance.

D 8.4.1.10
17
3Starting Treatment
This section explains how to get started with using the device and connecting it to your
smartphone or tablet.
Turn on the O2matic HOT by pressing for more than 4 seconds. The green
light on the on/off button indicates that the O2matic HOT device is turned on.
The O2matic HOT will already have been customized to you by the responsible medical
service providers.
It is not always possible or needed to have continuous measurement of oxygen
saturation. O2matic HOT has an intelligent algorithm that only needs a few daily
measurements of oxygen saturation. The number and the length of measurements can
vary from time to time. If oxygen source is a concentrator make sure its set to the
maximum flow.
Warning
Only the patient should be connected to the pulse oximeter. By not
complying with this the patient could risk receiving the wrong treatment.
Warning
The patient should only use one pulse oximeter at a time.
Caution
The HOT spends the first five minutes after turning on measuring exclusively.
If the signal during this period is interrupted for more than one minute, the
process must be repeated from the beginning.

O2matic HOT end user manual
18
Figure 6: Pulse oximetry demonstration
When a new measurement is required, the oxygen measurement icon lights up
on the display. Once it lights up, if the user does not start the measurement within one
hour, then an acoustic notification will be played. However, it is always possible to do a
new measurement even if the oxygen measurement icon has not been turned on. To
begin the measurement session, simply put the pulse oximeter on a finger and follow
the instructions on the tablet or until the measurement icon is no longer lid.
It is recommended to do a new measurement before sleeping and when the activity
level changes.
If the O2matic HOT device has been turned off, then a new measurement is required.
Figure 7: O2matic treatment cycle

D 8.4.1.10
19
No one else but the patient shall use the pulse oximetry sensor that is paired with
O2matic HOT.
Pulse oximetry sensors may have reading troubles when used on patients with low
perfusions due to reduced blood circulation. In the case of low perfusion or low-quality
signal the sensor should be moved to an alternative site to obtain the best possible
signal or you may be asked to do a new measurement within one hour.
Avoid using nail polish and of acrylic nails when using pulse oximetry sensor. For more
information regarding the pulse oximetry contact service provider.
Warning
If the O2matic device is dropped down from above 30 cm, then the device shall be
checked by installer.
NOTE: It may take up to 10 seconds before there is a clear signal from the pulse
oximetry sensor.
NOTE: Nail polish can cause impaired reading functionality of the pulse oximetry
sensor.
Warning
Never smoke during treatment. This can inflict serious injuries.
Warning
Never use any flammable products on the patient as this can cause serious injuries.
Warning
O2matic HOT device shall be functional in altitude range 0 to 2.000 meter

O2matic HOT end user manual
20
If the patient feels ill or uncomfortable, the patient shall always contact their service
provider.
To properly shut down the O2matic press for more than 5 sec. The light in the
on/off button turns off, when the device is turned down.
3.1 Connecting your tablet or smartphone to
O2matic
The O2matic HOT is designed to be as simple as possible and for maximum safety. The
device can be used stand-alone without any apps.
If you are interested in additional information and trends, you can always connect your
Android smartphone or tablet to the O2matic HOT. It requires that your device has as a
minimum Bluetooth® 4.2 and is using Android O2matic BYOD App.
Start by downloading the app from Google play:
https://play.google.com/store/apps
Search for “O2matic BYOD” and install the app on your device. Then follow the
instructions on the app.