LIVIN Med FO0920A User manual

Fingertip Pulse Oximeter
User Manual
Model: FO0920A
Version: V2.0
Revised Date: November 1st, 2021

Dear Customer,
Thank you for choosing the LIVIN Med Fingertip
Pulse Oximeter.Please read this Manual carefully
before use. Failure to follow these instructions may
cause inaccurate measurement or damage to the
device.
This Manual is published in English, and we have the
ultimate right to explain it. No part of this Manual
may be photocopied, reproduced, or translated into
another language without written consent from us.
We reserve the right to amend it at any time without
prior notice.

Notes
•
The contents contained in this Manual are subject
to change without notice.
•
Information furnished by our company is believed
to be accurate and reliable. However, no
responsibility is assumed by us for its use or any
infringement of patents or other rights of third
parties that may result from its use.
Instructions for Safe Operation
•
Check the device to make sure that there is no
visible damage that may affect user’s safety or

measurement performance with regard to
sensors and clips. It is recommended that the
device be inspected before each use. If there is
obvious damage, please stop using this device.
•
Special attention shall be paid when the device is
used at an ambient temperature above
98.6°F/37°C as burns may occur due to over-
heating of the sensor.
•
Necessary maintenance must be performed only
by qualified service technicians.
•
The oximeter shall not be used with devices and
accessories not specified in this Manual.

Cautions
•
Explosive hazard—DO NOT use the Oximeter in
environment with inflammable gas such as some
ignitable anesthetic agents.
•
DO NOT use the Oximeter while the patient is
under MRI or CT scanning. This device is NOT
MRI Compatible.
Warnings
•
Discomfort or pain may appear if using the
Oximeter continuously on the same location for a
long time, especially for patient with poor

microcirculation. It is recommended that the
Oximeter should not be applied to the same
location for longer than 2 hours. If any abnormal
condition is found, please change the position of
Oximeter.
•
DO NOT clip this device on edema or tender
tissue.
•
The light (the infrared light is invisible) emitted
from the device is harmful to the eyes. Do not
stare at the light.
•
The Oximeter is not a treatment device.

•Local laws and Regulations must be followed
when disposing of the device.
Attention
•
Keep the Oximeter away from dust, vibration,
corrosive substances, explosive materials, high
temperature, and moisture.
•
The device should be kept out of the reach of
children.
•
If the Oximeter gets wet, please stop using it and
do not resume operation until it is dry and
checked for correct operation. When it is carried

from a cold environment to a warm and humid
environment, please do not use it immediately.
Allow at least 15 minutes for Oximeter to reach
ambient temperature.
•
DO NOT operate the button on the front panel
with sharp materials or sharp point.
•
DO NOT use high temperature or high pressure
steam disinfection on the Oximeter. Refer to
Chapter 6 for instructions regarding cleaning and
disinfection.
•
The equipment is IP22 with protection against
harmful solid foreign objects and ingress of liquid,

which means that the equipment is protected
against solid foreign objects of 12.5mm and
greater and against vertically falling water drops
when enclosure tilted up to 15°.
•
Please pay attention to the effects of lint, dust,
light (including sunlight), etc.
Declaration of Conformity
The manufacturer hereby declares that this device
complies with the following standards:
IEC 60601
-1: 2012 Medical electrical equipment -
Part 1: General requirements for basic safety and

essential performance;
BS/EN/ISO 9919: 2009 or the equivalent;
ISO 80601
-2-61: 2017 Medical electrical equipment
-
Part 2-61: Particular requirements for basic safety
and essential performance of pulse oximeter
equipment.
And it also follows the provisions of the council
directive MDD 93/42/EEC.

Table of Contents
1. OVERVIEW
.......................................................... 1
1.1 APPEARANCE.................................................... 1
1.2 NAME AND MODEL ........................................... 3
1.3 INTENDED USE.................................................. 3
1.4 FEATURES AND CONFIGURATION ......................... 4
2. BATTERY INSTALLATION
................................... 9
3
. OPERATION ..................................................... 10
4. TECHNICAL SPECIFICATIONS
......................... 19
5. PACKING LIST
.................................................. 25
6. REPAIR AND MAINTENANCE
.......................... 26
6.1 MAINTENANCE ............................................... 26

6.2
C
LEANING AND
D
ISINFECTING
I
NSTRUCTIONS
…...29
7. TROUBLESHOOTING
....................................... 30
8. KEY SYMBOLS
.................................................. 31
9. FREQUENTLY ASKED QUESTIONS
.................. 33
APPENDIX I RESULT DESCRIPTION
..................... 38
APPENDIX II EMC
................................................. 40
THE EQUIPMENT MEETS THE REQUIREMENTS OF
IEC 60601
-1-2:2014.............................................. 40

1
1. Overview
1.1
Appearance
Figure 1 Front View
Plastic Cushions
Display Key
Display Screen

2
Figure 2 Rear View
Nameplate
Battery Cover

3
1.2 Name andModel
Name: LIVIN Med Fingertip Pulse Oximeter
Model: FO0920A
1.3 IntendedUse
This Fingertip Pulse Oximeter is for Over-the-
Counter ("OTC") purchase and is intended for
measuringSpO2and pulse rate of adult and
pediatric users through his/her finger.
This oximeter is for sports or aviation use only
and not for medical use.

4
1.4 Features and Configuration
Display Type
OLED
SpO2, PR, PI
√
Plethysmogram
√
Auto On/Off
√
Pulse Bar Graph
√
PR and PI Shifts
√
Over-limits Indication
√
Over-limits Indication
Sound
√
Indication Sound
Mute
Manual
Four-direction Display
√

5
Settings Menu
√
Over-limits Setting
√
Pulse Beep
√
Measuring Mode
Continuous,
Spot check
Record List
√
Function Description:
•
Indication Sound Mute
With the over
-limits indication function and pulse
beep function, when beep is on and over
-limits
indication sound is activated, the Display
Key will

6
work as the Mute key, and a short-time press will
mute the over
-limits indication sound and pulse
beep for 90 seconds.
•
Measuring Mode
§ Spot Check Mode: measurement starts
automatically when finger is inserted into the
finger clip properly, and the measuring time
lasts 30 seconds with a counting-down
indication. The SpO2and PR readings will
freeze at the end of the 30 seconds, and the
analysis for the pulse rhythm will be
displayed on the screen as well. Once the
finger is out, the display will turn off, and the

7
device will turn off automatically.
§ Continuous Mode: measurement starts
automatically when finger is inserted into the
device, and SpO2and PR readings will be
displayed until the finger is removed from
the device. Once the finger is out, the device
will turn off automatically.
•
Record List
§ A single group of stable readings will be
recorded in the record list each time before
the device turns off under both the spot-
check and continuous mode. However, if the