Microlife OXY500 BT User manual

OXY500 BT
Bluetooth®Pulse Oximeter
EN 1
IB OXY 500 BT EN 0122
Revision Date: 2022-01-03
Distributor
Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com
Shenzhen Jumper Medical Equipment Co., Ltd
D Building, No. 71, Xintian Road, Fuyong Street,
Baoan, Shenzhen, Guangdong 518103, China
MedPath GmbH
Mies-van-der-Rohe-Strasse 8
80807 Munich, Germany
0482

Microlife OXY 500 BTGuarantee Card
Name of Purchaser
Serial Number
Date of Purchase
Specialist Dealer
Microlife OXY 500 BT
5
4
3
21
9
10
V2.01.E
Alm setup *
Alm on
Beep off
Demo off
Restore ok
Brightness 4
Exit
V2.01.E
Sounds Setup *
SpO2 Alm Hi 100
SpO2 Alm Lo 94
PR Alm Hi 130
PR Alm Lo 50
+/- +
Exit
6
78
9
10 a) b)
5
4
3
21
9
10
V2.01.E
Alm setup *
Alm on
Beep off
Demo off
Restore ok
Brightness 4
Exit
V2.01.E
Sounds Setup *
SpO2 Alm Hi 100
SpO2 Alm Lo 94
PR Alm Hi 130
PR Alm Lo 50
+/- +
Exit
6
78
9
10 a) b)

1
OXY 500 BT EN
Dear Customer,
This Microlife fingertip pulse oximeter is a portable non-
invasive device intended for spot-checking of the oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate of
adults and pediatric patients. It is suitable for private use (at
home, or on the go) as well as for use in the medical sector
(hospitals, hospital-type facilities). It has been clinically
proven to be of high precision during repeatability.
If you have any questions, problems or want to order spare
parts please contact your local Microlife-Customer Service.
Your dealer or pharmacy will be able to give you the
address of the Microlife dealer in your country. Alterna-
tively, visit the internet at www.microlife.com where you will
find a wealth of invaluable information on our products.
Retain instructions in a safe place for future reference.
Stay healthy – Microlife AG!
Table of Contents
1. Explanation of Symbols
2. Important Safety Instructions
3. General Description
4. Measurement Principles
5. Directions for Use
6. Inserting the batteries 6
7. ON/OFF button 1/ Function button
8. Display Mode
9. Using the Lanyard 7
10. Bluetooth®Function
11. Malfunctions and Actions to take
12. Cleaning and Disinfecting
13. Guarantee
14. Technical Specifications
Bluetooth®Pulse Oximeter EN
1ON/OFF button
2Oxygen saturation (value as percentage)
3Pulse rate (value in beats per minute)
4Pulse bar
5Active Bluetooth®/ Low battery indicator
6Inserting the batteries
7Attaching the lanyard
8Operation principle
9Display modes (6 different)
AT Settings menu
-a Interface 1
-b Interface 2

2
1. Explanation of Symbols
Batteries and electronic devices must be
disposed of in accordance with the locally appli-
cable regulations, not with domestic waste.
Read the instructions carefully before using this
device.
Type BF applied part
2. Important Safety Instructions
Follow instructions for use. This document provides
important product operation and safety information
regarding this device. Please read this document thor-
oughly before using the device and keep for future
reference.
This device may only be used for the purposes
described in these instructions. The manufacturer
cannot be held liable for damage caused by incorrect
application.
Never immerse this device in water or other liquids.
For cleaning please follow the instructions in the
«Cleaning and Disinfecting» section.
Do not use this device if you think it is damaged or
notice anything unusual.
Never open this device.
This device comprises sensitive components and must
be treated with caution. Observe the storage and oper-
ating conditions described in the «Technical Specifica-
tions» section.
Protect it from:
- water and moisture
- extreme temperatures
- impact and dropping
- contamination and dust
- direct sunlight
Manufacturer
Low battery indicator
Serial number
Protected against dripping water
Authorized representative
in the European Community
S N
N
IP22
Oxygen saturation (value as percentage)
Pulse rate (value in beats per minute)
Operating conditions:
5 - 40 °C / 41 - 104 °F
Storage conditions:
-10 - +50 °C / 14 - 122 °F
CE Marking of Conformity
2
% SpO
0482

3
OXY 500 BT EN
- heat and cold
The function of this device may be compromised when
used close to strong electromagnetic fields such as
mobile phones or radio installations and we recom-
mend a distance of at least 1 m (according to 60601-1-
2 table 5). In cases where you suspect this to be
unavoidable, please verify if the device is working prop-
erly before use.
Do not use the device in an MRI or CT environment.
This device is not intended for continuous monitoring.
Do not sterilize this device using autoclaving or
ethylene oxide sterilizing. This device is not intended
for sterilization.
If the device is not going to be used for a prolonged
period the batteries should be removed.
Ensure that children do not use this device unsu-
pervised; some parts are small enough to be
swallowed. Be aware of the risk of strangulation in
case this device is supplied with cables or tubes.
Use of this device is not intended as a substitute
for a consultation with your doctor.
3. General Description
Oxygen saturation indicates the percentage of hemoglobin
in arterial blood that is loaded with oxygen. This is a very
important parameter for the respiratory circulation system.
Many respiratory diseases can result in lower oxygen satu-
ration within human blood.
Following factors can reduce oxygen saturation: Auto-
matic regulation of organ dysfunction caused by anes-
thesia, intensive postoperative trauma, injuries caused by
some medical examinations. These situations may result in
light-headedness, asthenia and vomiting. Therefore, it is
very important to know the oxygen saturation of a patient
so that doctors can detect problems in a timely manner.
4. Measurement Principles
Principle of this fingertip pulse oximeter: A mathemat-
ical formula is established making use of Lambert Beer
Law according to spectrum absorption characteristics of
deoxygenated hemoglobin (Hb) and oxyhemoglobin
(HbO2) in red and near-infrared zones.
Operation principle of this device: Photoelectric oxyhe-
moglobin inspection technology is adopted in accordance
with capacity pulse scanning and recording technology, so
that two beams of different wavelength of lights (660 nm
red and 905 nm near infrared light) can be focused onto a
human nail tip through a clamping finger-type sensor. A
measured signal obtained by a photosensitive element, will
be shown on the display through process in electronic
circuits and microprocessor.
5. Directions for Use
1. Insert the batteries as described in the «Inserting the
batteries 6» section.
2. Insert one finger (nail side up; index or middle finger is
recommended) into the finger opening of the device.
Be sure to fully insert the finger so that the sensors are
completely covered by the finger.
3. Release the device allowing it to clamp down on the
finger.
4. Press the ON/OFF button 1to turn the device on.
5. Do not shake your finger during the test. It is recom-
mended that you do not move your body whilst taking
a reading.
6. Your measurement values will appear on the screen
after a few seconds.
7. Remove your finger from the device.
8. The device will automatically switch off after approx.
10±2 seconds after the finger is removed from the
device.
The height of the bar graph 4is an indication of
the pulse and signal strength. The bar should be
greater than 30 % for a proper reading.

4
The device must be able to measure the pulse
properly to obtain an accurate SpO2measure-
ment. Verify that nothing is hindering the pulse
measurement before relying on the SpO2
measurement.
The maximum application time at a single site
should be less than 30 minutes, in order to
ensure correct sensor alignment and skin integ-
rity.
Inaccurate measurements may occur if:
The patient suffers from significant levels of dysfunc-
tional hemoglobin (such as carboxyhemoglobin or
methemoglobin).
Intravascular dyes such as indocyanine green or meth-
ylene blue have been injected into the patient.
Used in the presence of high ambient light (e.g. direct
sunlight). Shield the sensor area with a surgical towel if
necessary.
There is excessive patient movement.
The patient experiences venous pulsations.
The patient has hypotension, severe vasoconstriction,
severe anemia, or hypothermia.
The patient is in cardiac arrest or is in shock.
Fingernail polish or false fingernails are applied.
6. Inserting the batteries 6
After you have unpacked your device, first insert the
batteries. The battery compartment is on the bottom of the
device. Remove the battery cover by sliding it in the direc-
tion shown. Insert the batteries (2 x 1.5 V, size AAA),
thereby observing the indicated polarity.
Replace the batteries when the low power indi-
cator 5appears on the display.
Always replace both batteries at the same time.
7. ON/OFF button 1 / Function button
Press and release the ON/OFF button 1to turn on, hold
the button for about one second. The device shows the
settings menu AT. Press or hold the ON/OFF button to
perform corresponding operations. Hold it to set an item, or
press it to switch an option or switch the display mode.
Press means no more than 0.5 seconds, while hold means
more than 0.5 seconds.
Alert Sound Setting
Hold ON/OFF button 1while the device is switched
on.Settings menu (interface 1) is displayed AT-a. Move «*»
to the corresponding option, and hold the function button to
set Alm to on and set Beep to off. When Alm is set to on
and the measured values of the blood oxygen saturation
and pulse rate go beyond the upper limit or lower limit, the
device gives off an alert sound. When Beep is set to on, a
tick will be heard along with pulse beats during pulse rate
measurement. While the «*» symbol stays on the Restore
option, hold the functional button to restore default settings.
Brightness Setting
Press ON/OFF button 1to select the Brightness option
and then hold the ON/OFF button to set the brightness to a
value ranging from 1 to 5. The greater the value, the
greater the brightness of the screen.
Alert Range Setting
On settings menu (interface 2) AT-b, press the ON/OFF
button 1to switch between options. On this interface, you
can set the upper limit and lower limit of SpO2 Alm and PR
Alm. While the «*» symbol stays on the +/- option, hold the
functional button to set the option to + or -.
In + mode, select the corresponding option and hold the
ON/OFF button to increase the upper or lower limit; in -
mode, hold the ON/OFF button to decrease the upper or
lower limit. Move «*» to the Exit option, and hold the ON/
OFF button to return to the monitoring interface.

5
OXY 500 BT EN
8. Display Mode
When the device is switched on, shortly press the ON/OFF
button 1to switch to another display mode to select your
desired display mode 9. There are 6 different display
modes. The default setting is mode 1.
9. Using the Lanyard 7
1. Thread the thinner end of the lanyard through the
hanging hole at the rear end of the device.
2. Thread the thicker end of the lanyard through the
threaded end before pulling it tightly.
10. Bluetooth
®
Function
This device can be used in conjunction with a smartphone
running the «Microlife Connected Health+» App. The
measurement results will be automatically transferred via
Bluetooth®.
Downloading the «Microlife Connected Health+» App
Download «Microlife Connected Health+» App for free from
Google Play™ (Android) or App Store (iOS) and install it on
your smartphone.
How the Bluetooth®Function works
The Bluetooth®function on your device will automatically
turn on and will be ready to connect with the «Microlife
Connected Health+» App after the device is switched on.
Your device will automatically upload the data once it is
connected to the smartphone.
11. Malfunctions and Actions to take
12. Cleaning and Disinfecting
Use an alcohol swab or cotton tissue moistened with
alcohol (70% Isopropyl) to clean the silicone that touches
the finger inside of the device. Also clean the finger being
Descrip-
tion
Symptom/Possible
causes
Solutions
SpO2or
pulse rate
do not
display
normally.
1. Finger is not
inserted
correctly.
2. Patient SpO2
value is too low to
be measured.
3. There is exces-
sive illumination.
1. Retry inserting the
finger.
2. & 3. Measure more
times. If you deter-
mine the product is
working correctly,
consult your doctor.
SpO2or
pulse rate
is shown
unstable.
1. Finger might not
be inserted deep
enough.
2. Excessivepatient
movement.
1. Retry inserting the
finger.
2. Sit calmly and retry.
The
device
cannot be
powered
on.
1. No batteries or
low battery
power.
2. Batteries are not
installed
correctly.
3. The device may
be damaged.
1. Replace the
batteries.
2. Remove and rein-
stall the batteries.
3. Contact your local
Microlife-Customer
Service.
The
display
suddenly
switches
off.
1. The device is
automatically
powered off,
when no signal
was detected
after 10±2
seconds.
2. The battery
power is too low
to operate.
1. Normal.
2. Replace the
batteries.
Descrip-
tion
Symptom/Possible
causes
Solutions

6
tested using alcohol before and after each test. Allow the
device to dry thoroughly before use.
Never use abrasive cleaning agents, thinners or
benzene for cleaning and never immerse the
device in water or other cleaning liquids.
13. Guarantee
This device is covered by a 2 year guarantee from the date
of purchase. During this guarantee period, at our discre-
tion, Microlife will repair or replace the defective product
free of charge.
Opening or altering the device invalidates the guarantee.
The following items are excluded from the guarantee:
Transport costs and risks of transport.
Damage caused by incorrect application or non-
compliance with the instructions for use.
Damage caused by leaking batteries.
Damage caused by accident or misuse.
Packaging/storage material and instructions for use.
Regular checks and maintenance (calibration).
Accessories and wearing parts: Battery.
Should guarantee service be required, please contact the
dealer from where the product was purchased, or your local
Microlife service. You may contact your local Microlife
service through our website:
www.microlife.com/support
Compensation is limited to the value of the product. The
guarantee will be granted if the complete product is
returned with the original invoice. Repair or replacement
within guarantee does not prolong or renew the guarantee
period. The legal claims and rights of consumers are not
limited by this guarantee.
14. Technical Specifications
Type: Fingertip Pulse Oximeter OXY 500 BT
Display: OLED display
Display range: Oxygen saturation: 35 - 100 %
Pulse rate: 25 - 250 bpm
Resolution: Oxygen saturation: 1 %
Pulse rate: 1 bpm
Measurement
precision:
Oxygen saturation:
±2 % (70 - 100 %)
No requirement: (≤69 %)
Pulse rate: ± 2 bpm
Alert range:
Oxygen saturation: Upper limit: 50 - 100 %
Lower limit: 50 - 100 %
Pulse rate: Upper limit: 25 - 250 bpm
Lower limit: 25 - 250 bpm
Alert error: Oxygen saturation: ± 1 % of the
preset value
Pulse rate: the greater of ± 10% of the
preset value and ± 5 bpm
PI (Perfusion Index)
Weak PI Min. 0.2 %

7
OXY 500 BT EN
Technical alterations reserved.
The Bluetooth®word mark and logos are registered trade-
marks owned by Bluetooth SIG, Inc. and any use of such
marks by Microlife Corp. is under license. Other trade-
marks and trade names are those of their respective
owners.
Operating condi-
tions:
5 - 40 °C / 41 - 104 °F
15 - 80 % relative maximum humidity
Storage conditions: -10 - +50 °C / 14 - 122 °F
10-93 % relative maximum humidity
Automatic switch-
off:
Automatically shut down in
10±2 seconds, when no or low signal
is detected.
Communication:
Bluetooth®Low Energy 4.0
Compatibility: iOS: iOS 10.0 or newer
Android: Android OS 5 or newer
Battery: 2 x 1.5 V alkaline batteries; size AAA
Battery lifetime: approx. 30 hours (using new
batteries)
Weight: 42.5 g (including batteries)
Dimensions: 62 x 37 x 32 mm
IP Class: IP22
Reference to
standards:
EN ISO10993-1/-5/-10;
IEC 60601-1; EN 60601-1-2;
ISO 80601-2-61; EN 62304;
EN 60601-1-6
Expected service
life:
5 years (when used 15 times/day; 20
minutes for each measurement)

8