O2matic OMC PC-100 User manual

2022.6.09

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Table of contents
1Introduction, General Warnings and Cautions. 3
1.1 Intended purpose 3
1.2 Contraindications 3
1.3 Warnings 4
1.4 Cautions 5
1.5 Symbols 6
1.6 Essential performance 7
1.7 Operators and safety 7
1.8 Button functionality 8
2Installation and Setup 9
2.1 Overview 9
2.2 Installation 11
2.3 Setting up the device 13
2.4 Importing settings 19
2.5 Changing codes and resetting 21
3Starting Treatment 23
3.1 Assign a new patient to device 25
4Treatment and Operation 33
4.1 Treatment modes 33
4.2 Patient assessment 35
4.3 Critical profiles 40
4.4 Walking tests 43
4.5 Shutdown 52
5Warnings and Alarms 53
5.1 Alarm level indicators 53
5.2 Alarm zones 53
5.3 Possible alarm events 58
5.4 Alarm priorities 58
6Electromagnetic Emissions and Immunities 59
6.1 Emissions compliance class and group 59
6.2 Immunity test levels 59
7Maintenance 62
7.1 Cleaning 62
7.2 Exporting data 63
7.3 Changing battery 65
8Service and Support 66
8.1 Warranty 66
8.2 Service 66
8.3 Training 66
8.4 Support and Contact 67
9Specifications 68
Appendix A –Detailed Specifications 69
Appendix B –Exported File Contents 71

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Appendix C –Accessories 72
1Introduction, General Warnings and Cautions.
The O2matic PRO 100 is a medical device with the ability to assist medical
staff in hospitals and respiratory clinics with oxygen supplementation to
secure a stable oxygenation of the blood. The O2matic PRO 100 device will
do this by continuously adjusting the flow of oxygen to the patient based on
the actual oxygen saturation in the blood, which is measured by standard
pulse oximetry.
The O2matic PRO 100 device is suitable for use in hospitals except near
active HF surgical equipment and the RF shielded room of a medical
electrical system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
NOTE: The emissions characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
To avoid adverse events to the patient due to electromagnetic disturbances,
the patient shall be assessed by medical staff at regular intervals,
determined based on the condition of the patient.
1.1 Intended purpose
O2matic PRO 100 is an electro/mechanical medical device, intended for
oxygen therapy optimization at all hospital departments and units that
administer oxygen therapy. O2matic PRO 100 is for short term continuous
use at hospital for not more than 30 days. The regulation of oxygen is
managed by a software algorithm.
1.2 Contraindications
a) Do not use in an explosive atmosphere or in the presence of
flammable anesthetics or gases.
b) Do not use on multiple patients simultaneously

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c) O2matic PRO 100 must not be used with devices which delivers a
fixed fraction of oxygen (FiO2) regardless of oxygen flow, such as
the Venturi masks, as O2matic PRO 100 would not be able to
increase FiO2in response to a low SpO2with such systems
Do not use this unit on a patient:
d) Less than 18 years old
e) In the O2matic mode with suspected CO poisoning
f) That is not spontaneously breathing
g) Who is incapable to keep airways free of secretions
h) For whom the SpO2-signal is not stable
1.3 Warnings
a) Use only Nonin Purelight pulse oxymetri sensors, as other sensors
might not meet the same accuracy criteria required by the O2matic
PRO 100.
b) Refer to the applicable sensor instructions for use for additional
warnings and cautions.
c) Regularly check the battery indicator. If lit, See section 7.3 for
battery instructions.
d) O2matic PRO 100 is only to be used with pure oxygen.
e) Use of this equipment adjacent to or stacked with other equipment
should be voided 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.
f) 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
Warning
Indicates that you must be extremely careful when
executing these instructions. Not complying with
these warnings can cause serious injuries and even
death.

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electromagnetic immunity of this equipment and result in improper
operation.
g) Portable RF 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 PRO device,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
h) O2matic PRO 100 shall never be used as a substitute for personal
and qualified observations by medical and nursing staff, as O2matic
PRO 100 only monitors oxygenation of the blood and pulse rate, and
other parameters and patient condition can deteriorate if personal
observation is inadequate.
For additional information refer to IEC 60601-1
1.4 Cautions
a. Do not place O2matic PRO 100 in a corner, as it can be difficult to
connect and disconnect accessories.
b. The accuracy of the SpO2measurement may be affected if the total
sensor length (including extension cables) is greater than 3 meters.
c. Pulse oximetry sensors may have reading troubles when used on
patients with cold extremities due to reduced blood circulation. For
more information please contact your local distributor.
d. Follow local or national recycling instructions regarding disposal of
device and accessories.
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 distributor regarding take-back or recycling of
the O2matic PRO 100.
Caution
Indicates that you must be careful when executing
these instructions. Not complying with these caution
directives can cause minor injuries or equipment
damage.

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1.5 Symbols
Refer to
instruction
manual/booklet.
Follow
instructions for
use
Direct
current: 12
VDC
Manufacturer
0123
CE mark:
Made in
compliance
with all
relevant
directives
Manufacturing
date
Serial
number
Do not use if
the package is
damaged
Bell can be
temporarily
cancelled
Not for general
waste
For use in
oxygen rich
environtm-
ent
Alternating
current
Type BF
Applied part
Storage
Temperature
limits
Standby

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“ON”
“OFF”
Class II
equipment
IPX0
Ingress
protection
from dust
and water
Equipment shall
only be used
with
rechargeable
battery.
WARNING
1.6 Essential performance
The essential performance of the O2matic PRO 100 device is to measure
pulse and SpO2, to maintain or adjust oxygen flow to the patient in response
to changes to measured values according to the user defined target values
and range thresholds. If the measured values are outside the user specified
limits, the O2matic PRO 100 device shall trigger the relevant alarms.
1.7 Operators and safety
O2matic PRO 100 should only be used by medical staff, with basic
experience in the use of pulse oximeters and treatment of patients in need
of oxygen therapy. It is recommended that each hospital appoints
administrators responsible for setting up the device metadata, i.e. standard
profiles and alarm delays. These should normally be physicians.
The O2matic PRO 100 has a failsafe rechargeable battery that keeps the
device running upon short power breaks. The device has two power related
buttons, Main power and Standby, for the purpose of distinguishing
between a power break and a proper shutdown. Once the device has been
turned on, a proper shut down is needed for the device not to trigger any
alarms. To shut down O2matic PRO 100 press and hold (A) for 3
seconds.

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Note: The Main power switch, on the back, can be used to isolate the
device from the supply mains.
1.8 Button functionality
When navigating through settings and information screens in the O2matic
PRO 100, only the four navigation buttons on the front of the O2matic PRO
100 are used. They are used to move the marker up and down inside a
menu but also to select, enter, undo or go back a level as well as to
increase or decrease values. This is possible due to the dynamic
functionality that is built in, so that the function descriptions on the screen
change, based on the marker position. Navigation buttons are physically lid,
when active and having a function in the active screen.
If the device is not interacted with it will eventually display the pause
screen. To disable or change the time before the pause screen is showed or
which information is shown on it, choose “Admin” followed by “Settings” and
finally “Pause Screen”.

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2Installation and Setup
Before starting any patient treatment, the O2matic PRO 100 must be
installed and setup accordingly as described in the following.
2.1 Overview
Figure 1: O2matic PRO 100 from the front
Front Buttons
A: Standby
E: Battery indicator
B: Home
F: (Manual / Automatic) Mode
C: Power warning
G: Mute (alarms)
D: Navigation
A
B
C
D
E
F
G
Handle

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Figure 2: O2matic PRO 100 from behind
Back & Bottom Buttons
H: Pulse oximeter
connection
L: Power switch
I: USB connection hatch
M: Power connection
J: Oxygen output
connection
N: Oxygen input connection
K: Slider
O: Battery / ventilation hatch
Figure 3: Bottom of O2matic PRO 100
K
O
K
L
M
J
I
H
N

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2.2 Installation
O2matic PRO 100 must be installed near the patient, either on a rail
or other fittings matching the standard slide on the back of the
O2matic PRO 100. To install O2matic PRO 100:
a) Slide your regions corresponding power plug into the AC adapter.
f. Connect the AC power to the wall outlet and to the O2matic PRO 100
device power supply. For safety reasons, the connector is a screw-lock
mechanism.
Warning
Only use the AC power adaptor provided by O2matic.
Any other power supply may interfere with the proper
operation of the device.
g. Connect the oxygen hose to the source of oxygen in the wall or an
oxygen cylinder. Then connect oxygen hose to the oxygen inlet of the
O2matic PRO 100.
Warning
O2matic PRO 100 is only to be used with pure oxygen.
h. Flick power switch (L) to “l”on the back of The O2matic PRO 100.
i. Turn on The O2matic PRO 100 by pressing (A) for 2 seconds.
The O2matic PRO 100 should now be on and the Home Screen
appears.

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Figure 4: User interface O2matic PRO 100 (Home Screen)
The O2matic PRO 100 device will by default always provide
treatment. Therefore, the device “expects” input signal from the
pulse oximeter sensor, worn by the patient, and will start an alarm
immediately if there is no signal. To mute the alarm, press the Mute
button (G), and the alarm will be muted for 2 minutes. The light in
the button is lid to indicate that it is muted.
Note: Audible alarms are disabled in menus. O2matic PRO 100
returns back to home screen after 1 minute of inactivity.
Note: If above steps have been followed correctly and there is no
visible home screen, see the Service and Support section.
Note: O2matic PRO 100 goes in to pause screen mode after 30
mins. Press any button to get back to the home screen.

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2.3 Setting up the device
All setup functionality in The O2matic PRO 100 are gathered in the
Admin Menu. From the Home Screen press to enter the
Admin Menu shown below.

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Figure 5: O2matic PRO 100 Admin menu
Setting up a new profile:

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1. From the home screen select Admin and select Profiles
2. Move to New Profile and select Create.
3. Enter the profile name by using the and buttons.
When finished, press the left arrow twice to save the name.
4. Navigate to the desired parameters and adjust them as needed.
5. Return to home screen by pressing (B).

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Figure 6: O2matic PRO 100 Profile settings
Warning
Setting up profile limits to extreme values can render
warnings and alarms meaningless.
NOTE: The O2matic PRO 100 has built in input validation, to protect
against unintended user input. See appendix A for a list of input
ranges.
Editing an existing profile:
1. From the home screen select Admin and choose Profiles.
2. Move to the desired profile and press Select.
3. Navigate to the desired parameters and adjust them as needed.
4. Save the adjustment.
Return to home screen by pressing (B).

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Figures 7 and 8: O2matic PRO 100 Edit Profile menu (COPD_NORM)
NOTE: A profile have a parameter named flow response, which can
be used to dampen or quicken the flow response rate. If a patient is
very unstable and responds very quickly or slowly to changes in flow
rate, this parameter can be adjusted to increase comfort for the
patient. See appendix A for further info.
The O2matic PRO 100 has built in alarms and warnings that indicate
the patient’s health status. Warnings are issued when the patient’s
SpO2moves slightly outside desired level without being critical.
2.4 Importing settings
If you have multiple O2matic PRO 100 devices and you want a
specific set of settings on all the devices this can be done easily by
importing the same settings file to all the devices. This minimizes
the risk of inconsistency between devices.

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NOTE: The O2matic PRO 100 device complies with the EU directive
95/46/EC from and GDPR from 2018 (General Data Protection
Regulation) hence, all access to data logs and settings are protected
by physical as well as software related barriers. To gain access to
the USB flash on the device you must have the relevant physical
tools, and the administrator pin code. For more information about
the physical tool, visit www.o2matic.com
Warning
The exported files should only be edited by an
administrator that have extensive knowledge of the
device. Ignoring this can result in dangerous situations
for the patient.
To import settings or profiles:
a. Remove the screws of the USB hatch.
b. Connect your device to a computer/laptop via a USB 1.0 –2.0
cable with Type A to Type B connectors.
c. Enter the device’s USB pin code on the device to unlock the USB
port.
d. Check device connections on your computer. It should be
showing up like any other USB device
e. Enter the USB drive
You will see the following files: