M70C
Operator’s Manual Fingertip Pulse Oximeter
Version number of this manual: V1.0 Document No. : J/M70-O-346-001
General Description
The measurement of oxygen saturation of arterial blood (also known as pulse
oxygen saturation, usually shortened as SpO
2
) adopts the principles of light
spectra and volume tracing. The LED emits lights with two specific wavelengths,
which are selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin.
The optical receptor measures the changes in the light intensity after the light
passes the capillary network and estimates the ratio of oxygenated hemoglobin
and the total hemoglobin.
Method for evaluating SpO2 accuracy: The SpO2 accuracy of pulse oximeter is
measured by comparing SpO2 readings of the pulse oximeter to values of SaO2
determined with a CO-OXIMETER.The healthy volunteers who consent to induced
hypoxia and arterial blood sampling as part of the experimental procedure (see
ISO80601-2-61 Annex EE.2)
Caution
Please read the user manual carefully prior to operating.
Intended Use
The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen
saturation (SpO2) and pulse rate of adult, pediatric and adolescent patients in
hospital, hospital type facilities as well as in the home care environment.
The oximeter is not suitable to monitor patient continuously for long term
Battery Installations
1.
Push the battery cover.
2.
Install two AAA batteries into battery cabin in correct
polarities, as shown on the right.
3.
Close the battery cover.
Notes:
For battery installation, see picture to the right.
Put or remove batteries in right order, or it may
damage the bracket.
Battery polarities must be correctly installed. Otherwise, damage might be
caused to device.
Please remove the battery if the oximeter will not be used for long time.
Operation Instructions
1.
Install two AAA batteries into battery cassette before closing its cover.
2.
Nip the oximeter, then insert one of fingers into the
rubber hole of the oximeter before releasing the
oximeter, and your nail surface must be upward.
3.
Press the function button once on front panel.
4.
Your finger and body should not tremble during measuring.
5.
Read corresponding data on the display screen.
6.
After turning the oximeter on, each time you press the power switch, the
display screen will change to another direction. There are two display modes. If you
long press the power switch, you can adjust the brightness of screen from 1 to 5.
①
SpO
2
Plethysmogram
②
SpO
2
reading
③
Pulse rate reading
④
Indication of battery capacity
⑤
Indication of pulse intensity
⑥
Indication of screen brightness
⑦
Display modes
Precautions for Use
The patient is the operator when the device is used at home.
Patients can maintain and use all functions of the device safely according to this
user′s manual.
Keep this product out of reach of children to avoid injury to children.
Explosion hazard. Do not use the oximeter in the presence of flammable
anesthetics mixture with air, oxygen, or hydrogen.
When the oximeter is in use, there should not be any great power appliances as
high voltage cables, X-ray machine, ultrasound equipment and electrizer in use
nearby.
Keep the oximeter away from lint, dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
This oximeter does not have an alarm function; please do not use this product in
the environment where an alarm is required.
The oximeter should be handled with care so as to avoid shocks and falls.
When the oximeter is in use, it must be ensured the batteries have sufficient
capacity; otherwise, there might be such phenomena as starting-up
abnormalities or inaccurate measurement data, etc.
Please do not use pointed objects such as pen point or nails for pressing
operation, otherwise it might cause permanent damage to the surface of the
keyboard.
Do not make any clinical judgments based solely on the oximeter. The oximeter
is intended only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms, as well as doctor’s diagnoses.
To ensure accurate performance and prevent device failure, do not expose the
oximeter to extreme moisture, such as direct exposure to rain. Such exposure
may cause inaccurate performance or device failure.
Do not conduct SpO
2
measurement on the finger smeared with nail polish,
otherwise this will lead to unreliable measurement results.
Please do not open the enclosure. The enclosure shall only be opened by the
authorized person.
In order to have more accurate measurements of SpO
2
and PR, the oximeter
should be used in quiet and comfortable environment.
Follow local ordinances and recycling instructions regarding disposal or
recycling of the device and device components, including batteries.
Prolonged continuous monitoring may increase the risk of unexpected changes
in skin characteristics, such as irritation, redness, blisters or burns. Inspect the
sensor site every two hours and move the sensor if the skin quality changes.
Pulse oximeter simulator can not be used to access the accuracy of the pulse
oximeter.
The expected service life of the device is five years.
For assistance with installation, use or maintenance, contact the manufacturer
or manufacturer's representative.
To validate the PR accuracy, we refer to the electronic pulse simulator.
When used at room temperature from the lowest or highest storage temperature
environment, the product can be used directly without needing to be placed for
a period of time to achieve its expected function.
Download and Install APP Software
1.
Software download methods
:
IOS device users, login to your
App Store
account and search for LifeSmart
Health.
Android device users, login to your
Google Play
account and search
LifeSmart.
QR Code for download:
Android system IOS system
2.
Download the
Free LifeSmart App
Note: App software only applied for the oximeter with Bluetooth.
Maintenance
1.
Using a soft cloth dampened with either a commercial nonabrasive cleaner, or
a solution of 70% alcohol in water, lightly wipe the surfaces of the oximeter.
2.
The most commonly used hospital cleaning agent and non-corrosive
detergents can be used for cleaning the oximeter, but please be careful that
most detergents must be diluted before use; Please use them according to the
directions of the manufacturers of the detergents.
3.
Avoid using alcohol-based, amido or acetone-based detergents
4.
The casing of the oximeter should be kept from the contamination of filth and
dirt, and it can be wiped with non-velvet soft cloth. When cleaning, do not spill
the liquid onto the instrument. Ensure no liquid is allowed to enter the inside of
the oximeter.
5.
It is forbidden to use such grinding materials as wire brush or metal polishing
agent, because these materials may cause damage to the panels of the
oximeter.
6.
Please do not soak the oximeter in liquid.
7.
Under normal circumstances, it is unnecessary for the oximeter to have
special maintenance, and cautions must be exercised on the following points
during the use of the oximeter:
Please use the oximeter in the environment according to the requirements of
the performance criteria.
Avoid exposure to direct sunlight.
Avoid excessive radioactive infrared rays or ultraviolet rays.
Avoid contacts with organic solutions, dusts or corrosive gases.
Product Specifications
Measurement specifications
SpO
2
Measuring Range
0~100%
Resolution
1%
Accuracy
At 70~100%, ±2%
;
At 0~69%, unspecified
Data update period
<13 s
%
100
lobin
deoxyhemog
bin
oxyhemoglo
hemoglobin
oxygenated
%
SpO
2
⑦
④
②
⑤
③
①
⑥