Owner's Manual

Size:480*297mm
Fingertip Pulse oximeter
XM-103
Document No.: JDXM-0304-052 Version: Z
Diagram of Operation Principle
Measurement Principle
General Description
1.Red and infrared-ray emission tube
2.Red and infrared-ray receipt tube
CAUTION:
Federal (U.S.) Law restricts this device to sale by or on the order of a
physician.
Oxygen binds to hemoglobin in red blood cells when moving
through the lungs. It is transported throughout the body as arterial
blood. A pulse oximeter uses two frequencies of light (red and
infrared) to determine the percentage(%)of hemoglobin in the blood
that is saturated with oxygen. The percentage is called blood oxygen
saturation, or SpO2. A pulse oximeter also measures and displays
the pulse rate at the same time it measures the SpO2 level.
The oximeter is for prescription use or prescription home use.
This device conforms to IEC6061-1, IEC60601-1-2, IEC60601-1-
11, ISO 80601-2-61, IEC 62304, 47 FCC part 15C, ANSI C63.27 .
PRINCIPLE of the oximeter is as follows: The pulse oximeter works
by applying a pulsating arteriolar vascular bed. The sensor contains
a dual light source and photo detector. The one wavelength of light
source is 660nm, which is red light the other is 905nm, which is
infrared-red light skin, bone, tissue and venous vessels normally
absorb a constant amount of light over time. The photo detector in
finger sensor collects and converts the light into electronic signal
which is proportional to the light intensity. The arteriolar bed
normally pulsates and absorbs variable amounts of light during
systole and diastole, as blood volume increases and decreases. The
ratio of light absorbed at systole and diastole is translated into an
oxygen saturation measurement. This measurement is referred to as
SpO2.
Safety Notice
1. Before use,carefully read the manual.
2. Do not use the pulse oximeter:
-if you are allergic to rubber products.
-if the device or finger is damp.
-during MRI or CT scan.
-while taking a blood pressure measurement on the arm.
-nail polish, dirty, coating fingers and false nails applied fingers.
-fingers with anatomical changes, edemas, scars or burns.
-Too big finger: the width of finger is over than 20mm and the thickness is
over than 15mm.
-Too small finger: the width of finger is less than 10mm and the thickness is
less than 5mm.
-Minors under 18 years old.
-The environmental light changes strongly.
-near flammable or explosive gas mixtures.
3. Extended use may cause pain for people with circulatory disorders. Do
not use the pulse oximeter for longer than two hours on one finger.
4. Measurements are for your information only - they are no substitute for
a medical examination.
5. Check the pulse oximeter regularly before use to ensure that there is no
visible damage and the batteries are still sufficiently charged. In case of
doubt, do not use the device and contact customer services or
authorized retailer.
6. Do not use any additional parts that are not recommended by the
manufacturer.
7. Any circumstances do not open or repair the device by yourself. Failure
to comply will result in voiding of the warranty. For repairs, please
contact customer services or authorized retailer.
8. Do not look directly inside the housing during the measurement. The red
light and the invisible infrared light in the pulse oximeter are harmful to
your eyes.
9. This device is not intended for use by people (including children) with
restricted physical, sensory or mental skills or a lack of experience or a
lack of knowledge, unless they are supervised by a person who has
responsibility for their safety or they receive instructions from this
person on how to use the device. Children should be supervised around
the device to ensure they do not play with it.
10. If the unit has been stored at temperatures below 0℃ , leave it in a
warm place for about two hours before using it.
11. If the unit has been stored at temperatures above 40℃ , leave it in a
cool place for about two hours before using it.
12. Neither of the displays for the pulse wave and pulse bar allows the
strength of the pulse or circulation to be evaluated at the measurement
site. Rather, they are exclusively used to display the current visual
signal variation at the measurement site and do not enable diagnostics
for the pulse.
13. Operation of the fingertip pulse oximeter may be affected by the use of
an electrosurgical unit (ESU).
14. Follow local ordinances and recycling instructions regarding disposal
or recycling or the device and device components, including batteries.
15.This equipment complies with IEC 60601-1-2:2014 for electromagnetic
compatibility for medical electrical equipment and systems. In
healthcare center or other environment, their radio transmission
equipment and electromagnetic interference may affect the
performance of the oximeter.
16.The oximeter contains radio communication function, it may affect
other electronic medical equipment, so it should not be used close to or
stacked with other equipment.
17. This equipment is not intended for use during patient transport outside
the healthcare facility.
18. When the signal is not stable, the reading may inaccurate. Please do not
reference.
1.Non-observance of the following instructions can lead to
incorrect or failed measurements
-There must not be any nail polish, artificial nails or other cosmetics
on the finger to be measured.
- Ensure that the finger nail on the finger to be measured is short
enough that the fingertip covers the sensor element in the housing.
- Keep your hand, finger and body steady during the measurement.
- In cases of carbon monoxide poisoning, the pulse oximeter will
display a measurement value that is too high.
- To avoid incorrect results, there should not be any strong light
sources( e.g. fluorescent lamps or direct sunlight ) in the immediate
vicinity of the pulse oximeter.
- Protect the pulse oximeter from dust, shocks, moisture, explosive
materials.
- Excessive patient movement.
2.The following situations may cause inaccurate measurements
- Significant levels of dysfunctional hemoglobin (such as carbonyl -
hemoglobin or methemoglobin).
- Venous pulsations.
- Placement of a sensor on an extremity with a blood pressure cuff,
arterial catheter,or intravascular line.
- The patient has hypotension, severe vasoconstriction, severe
anemia, or hypothermia.
- The patient is in cardiac arrest or is in shock.
- Weak pulse quality (low perfusion).
- Low hemoglobin.
Unit Illustration
- 1 x XM103 pulse oximeter
- 1 x Owner ’s Manual
- 1 x Retaining strap
- 1 x Storage Bag
- 2 x 1.5v AAA batteries
Contents
Monitor Unit
Display
The fingertip pulse oximeter is a portable non-invasive, spot-check,
oxygen saturation of arterial hemoglobin and pulse rate of adult at
home, and hospital (including clinical use in internist/surgery,
anesthesia etc).
1.Simple to operate and convenient to carry.
2.Small volume, light weight and low power consumption.
3.Displays SpO2, PR, Pulse bar, and waveform.
4.Level 1-5 adjustable brightness.
5.5 display modes.
6.A low voltage warning will be indicated in visual window when
battery voltage is so low that normal operation of the oximeter
might be influenced.
7.When it shows “Finger out”, the pulse oximeter will power off
automatically in 10 seconds.
8.Beep.
9.When the buzzer and reminder function are turned on, the
numbers on the screen will flash when the reminder occurs, and
the buzzer will beep.
10.Bluetooth function.
Features
Unit Operation
Slide battery cover off as indicate by arrow. Install 2 new AAA
alkaline batteries according to polarity. Close battery Cover.
Battery Installation
Note:
1)Be sure to follow the correct polarity when installing the batteries.
Reversed batteries may cause damage to the device.
2)Use only the size and type of batteries specified.
3)Do not mix different types of batteries together or old batteries
with fresh ones. Always replace batteries as a simultaneous set.
4)Replace the batteries in a timely manner when low voltage lamp is
lighted.
5)If the batteries in the device are depleted or the device will not be
used for a long period of time, remove the batteries to damage or
injury from possible battery leakage.
6)Do not try to recharge batteries not intended to be recharged; they
can overheat and rupture.
7)Do not dispose of batteries in fire, batteries may explode or leak.
8)Keep batteries away from children and pets. Batteries may be
harmful of swallowed. Should a child or pet swallow a battery,
seek medical assistance immediately.
9)Please follow the law of the local government to deal with used
batteries..
System Settings
With power off, press the power button about 5 seconds to actuate
system setting.
Setting available for Tips, Beep, Language, Default, SpO2 Tips Lo
PR Tips Hi, PR Tips Lo and EXIT. Long press to enter the specific
value setting, short press to switch among the setting items.
,
Tips
Tips
Tips
Tips
Settings
Settings
Tips
To Use
CAUTION: Please make sure your finger size is appropriate
(fingertip width is about 10~20 mm, thickness is about 5~15 mm)
CAUTION: This device cannot be used in strong radiation
environment. It can only be used after binding.
CAUTION: This device cannot be used with other medical devices or non-
medical devices.
CAUTION: When placing your fingers, ensure your fingers can
completely cover the LED transparent window in the finger clamp
compartment.
1. As shown in the figure, squeeze the clip of the pulse oximeter, fully
insert your finger into the finger clip compartment, and then loosen
the clip
2.Press the power button one time on front panel to turn the pulse
oximeter on.
3.Keep your hands still for the reading. Do not shake your finger
during the test. It is recommended that you do not move your body
while taking a reading.
4. Read the data from the display screen.
5.To select your desired display brightness, press and hold the power
button during operaion untill the brightness level changes.
6.To choose among the various display formats, press the power
button briefly during operation.
7.If you remove the oximeter from your finger, it will shut off after
about 10 seconds.
8.Using Bluetooth communication
a)Download and install the"JOYTECH Healthcare" app from your
smartphone’s app store. Recommended App Store: recommend
"Google store" for Android users, and recommend "App store" for
IOS users.
b)Open the App on your phone. If requested, you should enable
Bluetooth on your phone. You can enable Bluetooth under the
Settings menu on your smart phone.
c)Create a new user account on the APP or use existed user name and
password to login.
d) Attention： First, turn on the oximeter and then click "not
connected" on the APP. When the APP scans the Bluetooth of the
oximeter, the icon and the name of the oximeter will be displayed
on the APP. At this time, click "Pair this device" on the APP, when
"connected" is displayed on the APP, the connection is successful.
Note: To realize the connection between the designated mobile
phone and the designated oximeter, it is necessary to ensure that all
oximeters except the designated oximeter are turned off.
e)When your oximeter is connected successfully to your smart phone,
The data transfer will begin automatically. The APP will display the
received data from oximeter immediately without delay.Note: The
monitor requires a smart device with: Android 5.0 or later, IOS9.0
or later.
9. APP Introduction
As shown in the figure, this is an app icon.
The APP interface can display blood oxygen value, pulse rate value,
pulse waveform and historical data curve, historical data is sotred
in the APP,When the user pulls out the finger from the oximeter,
the APP will record the data once， The "Home" page of the APP
can display Last 3 historical data，and the "Curve" page of the APP
can display a graph with all of historical data of any date in the past.
The oimeter can only send the data to APP, mutual control is not
supported. When the Bluetooth connection is succcessful between
the oximeter and the APP , the APP cannot actively disconnect.The
Bluetooth connection can only be disconnected when the oximeter
is turned off or the Bluetooth of the mobile phone is turned off.
Only when the original oximeter is disconnected, the APP can be
paired with the new oximeter
Cleaning and Maintenance
Troubleshooting Guide
Model
XM-103
Display OLED display
SpO2
Display Range
0%~99%
Measurement Range
70%~100%
Accuracy
70%~100% ±2%
0%~69% no definition
Resolution
1%
Pulse Rate
Display Range
0~240bpm
Measurement Range
30~240bpm
Connection
failure/ Data is
not being
transmitted
If there are no causes of data
transmission interference
found near the oximeter,
move the oximeter with 16ft.
(5m) of the smart device ang
try again
Problem
cause
Solution
Monitor do not
display
Measurements
are erratic
Measurements
can not be
shown
normally
Reinsert the batteries.
If after reinserting the
batteries correctly There
are still no measurement
values displayed, contact
customer service
Observe the Important
Guidelines
Keep your finger, hand
and body still during the
measurement
Seek medical attention
There is excessive
illumination; Or, Try some
more times. If you can
make sure no problem
exist in the product,
please go to a hospital
timely for exact diagnosis.
Retry by inserting
the finger
Replace the batteriesBatteries are epletedd
Batteries not inserted
correctly
Insufficient circulation
in the measurement finger
Finger,hand or body is
moving
Cardiac arrhythmia
Patient’s SpO2 value is
too low to be measured
Finger is not inserted
correctly
The oximeter might not be
porperly placed within the
smart device’s tranmission
range and is too far from
the smart device
Try to pair the devices
once again
Check the application
then try sending the data
again
The oximeter did not
pair successfully to the
smart device
The application on the
smart device is not ready
1.Please use medical alcohol to clean the silicone touching the
finger inside of oximeter with a soft cloth dampened with 70%
isopropyl alcohol. Also clean the being tested finger using alcohol
before and after each test.
2.Do not pour or spray liquids onto the oximeter, and do not allow
any liquid to enter any openings in the device allow the oximeter
to dry thoroughly before reuse.
3.The fingertip pulse oximeter requires no routine calibration or
maintenance other than replacement of batteries.
4.The use life of the device is 3 years when it is used for 10
measurements every day and 15 minutes per one measurement.
Stop using and contact local service center if one of the following
cases occurs:
● An error in the Possible Problems and solutions is displayed on
screen.
●The oximeter cannot be powered on in any case and not the reasons
of battery.
●There is a crack on the oximeter or damage on the display resulting
readings cannot be identified; the spring is invalid or the key is
unresponsive or unavailable.
5.Cleaning and Disinfecting
Cleaning procedures:
a)Place the oximeter on a clean table and wipe the entire surface and
upper and lower finger pads for 3 times by a clean soft cloth dipped
in 70% isopropanol;
b) Wait for 1 minute to fully dry the oximeter.
Disinfection procedures:
a) Dip a clean soft cloth in 70% isopropanol, and clip it by the finger
pads for at least 3 minute;
b) Take out the soft cloth, wait for 1 minute to fully dry the oximeter.
CAUTION: Never use EtO or formaldehyde for disinfection.
6.The devise is provided as non-sterile, please clean and disinfect it
according to the instructions before each use.
Storage Environment
Humidity
15%~93%RH
Pressure
700hPa~1060hPa
Ingress RatingProtection
IP22
Classification
Internal Powered Equipment Type BF
Bluetooth communication
Frequency range
2.4GHz(2400~2483.5MHz)
Modulation
GFSK
Approx.3.2mW
Approx.2.4mW
Probe LED Specifications
Wavelength
Power Consumption
RED
Approx. 660nm
IR
905nmApprox.
The Date UPDATE period
Less than 12s
BT Version
5.0 BT Signal mode
Supply voltage
1.8V - 3.6V
Transmit output power
Rx sensitivity
97dBm @ 1Mbps mode
3dBm @ room temperature
Current consumption
2uA @Sleep Mode
0.7uA @OFF Mode
5mA @TX mode(0dBm)
5mA @RX mode(0dBm)
Approx.50g
<60mA
Approx.60mm*32mm*31.4mm
Accuracy
30~100bpm,
100~240bpm,±2%
±2bpm;
Resolution
1bpm
Power supply
2x1.5vAAA batteries
Power Consumption
Weight
Dimensions
Temperature
-20℃~55℃
Operating Environment
Temperature
5℃ ℃~40
Humidity
15%~93%RH
Pressure
700hPa~1060hPa
Note:
The functional tester cannot be used to assess the accuracy of the
oximeter. The test methods used to establish the SpO2 accuracy is clinical
testing. The oximeter used to measure the arterial haemoglobin oxygen
saturation levels and these levels are to be compared to the levels
determined from arterial blood sampling with a CO-oximeter.
1.ISO 80601-2-61, medical electrical equipment - part 2-61: particular
requirements for the basic safety and essential performance of pulse
oximeter equipment.
2.AAMI/ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and
a2:2010/(r)2012 (consolidated text) medical electrical equipment -- part
1: general requirements for basic safety and essential performance.
3.AAMI/ANSI/IEC 60601-1-2, medical electrical equipment -- part 1-2:
general requirements for basic safety and essential performance --
collateral standard: electromagnetic disturbances -- requirements and
tests (General II (ES/EMC)).
4.IEC 60601-1-11, medical electrical equipment -- part 1-11: general
requirements for basic safety and essential performance - collateral
standard: requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment.
Correct disposal of this product.
(Waste electrical & electronic equipment)
This marking shown on the product indicates that it should not be
disposed with other household waste at the end of its life. To prevent
potential harm to the environment or to human health, please separate this
product from other types of wastes and recycle it responsibly. When
disposing this type of product, contact the retailer where product was
purchased or contact your local government office for details regarding
how this item can be disposed in an environmentally safe recycling center.
Business users should contact their supplier and check the terms and
conditions of the purchasing agreement. This product should not be mixed
with other commercial wastes for disposal. This product is free of
hazardous materials.
Bluetooth
012 3
Follow instruction
for use
Authorized
representative
in the European
community
Manufacturer’s
information
The Bluetooth® Smart
word mark and logos are
registered trademarks
owned by Bluetooth SIG,
Inc. and any use of such
marks by JOYTECH
Healthcare Co.,Ltd.
Conformity to
WEEE Directive
European union
approval
Date of
Manufacture
MR unsafe
Prescription use
!
SpO
2
%
PR
bpm
Symbol
IP22
SN
Symbol
Definition Definition
Type BF
applied part.
Attention
Oxygen saturation
Low power
indication
Serial No.
Storage
temperature
and relative
humidity
Alarm inhibit
Pulse rate (BPM)
Protected against
dripping water.
(Note: This device
does not provide any
alarm function)
Icon Explanation
FCC Information
Caution: Changes or modifications to this unit not expressly
approved by the party responsible for compliance could void the user
authority to operate the equipment. This device complies with Part
15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including
interference that may cause undesired operation.
*Note:The device has been evaluated to meet general RF exposure
requirement.The device can be used in portable exposure condition
without restriction.
This equipment has been tested and found to comply with the limits
for a Class B digital device,pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses, and can radiate radiofrequency energy. If this
equipment does cause harmful interference to radio or television
reception,which can be determined by turning the equipment off and
on, the user is encouraged to try and correct the interference by one
or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the distance between the equipment and the receiver.
- Connect the equipment to an outlet on a circuit different from that
to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
Warranty
Contact Information
JOYTECH Healthcare Co., Ltd.
No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou City, 311100 Zhejiang, China
Please contact us on:
Email: [e-mail]
Telephone: [phone]
Fax: [phone]
The Fingertip Pulse oximeter is guaranteed for 2-year from the date
of purchase. If the Fingertip Pulse oximeter does not function
properly due to defective components or poor workmanship, we will
repair or replace it freely. The warranty does not cover damages to
your Fingertip Pulse oximeter due to improper handling. Please
contact local retailer for details.
Items
Descriptions
Clinical SpO2 accuracy (Arms) (70-80%)
± 2%
Clinical SpO2 accuracy (Arms) (80-90%)
± 2%
Clinical SpO2 accuracy (Arms) (90-100%)
± 2%
Sterile
Non-sterile
Default settings
None
Reuse
Disinfect for repeated use
1.Instructions for the frequency of inspection of the application site for
skin integrity：
Before each finger is inserted into the oximeter probe, the integrity of the
skin should be visually
checked to ensure that the skin is free from injury and other conditions.
2.Instructions for the frequency of sensor relocation：
There is no need to replace the blood oxygen sensor within the service
life of the product.
3.Use during exercise and weak perfusion:
(1) DO NOT move your finger, arm and body during the measurement.
Movement, including talking, coughing, or sneezing, during
measurement, can affect the accuracy of the measurement results.
(2) The reading should NOT be considered reliable and accurate in the
condition of low perfusion during measurement.
The sensor with specific monitor has been validated and tested for
compliance with EN ISO 60601-2-61:2011 and FDA Guidance--
Pulse Oximeters - Premarket Notification Submissions
[510(k)s].
In the clinical recruitment, the data is obtained from a controlled,
induced hypoxia study in healthy adult volunteers. A total of 12
subjects including 6 females and 6 males were recruited from
the healthy adult volunteers aged from 21 to 40 without smoker.
In the clinical evaluation, 288 paired data of the 12 adults were
validated for XM-103
Fig.1: Linear regression fit (X axis is SaO2, Y axis is the difference of SpO2-SaO2)
Fig. 2: Linear regression fit (X axis is SaO2, Y axis is SpO2 for the subject device)
a) When the Oximeter is placed on the patient‟s finger or simulated finger,
the SpO2 values and PR values can be displayed normally.
b) Measurement accuracies:
* Clinical accuracy of SpO2 (Arms): in the range of 70%-100%, ± 2%;
* Clinical accuracy of pulse rate (Arms): in the range of 30~100bpm, ±2bpm;
100~240bpm,±2%.
Statement of Essential performance
Probe Accuracy of Oximeter
Power Button
Finger Opening
Slot for retaining strap