Operator’s Manual
Fingertip Pulse Oximeter
Version number of this manual: V4.3 Document No. : J/M70CE-A-008
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.
The mechanical activity of the heart cause arterial pulse, by measuring the pulse
we can get PR value.
The oximeter is standalone, reusable, and not reprocessed. The sensor of the
oximeter is built-in.
Caution
Federal Law Restricts this device to sale by or on the order of a physician.
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 isn’t suitable to monitor patient continuously for long term.
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 do not tremble during measuring.
5. Read corresponding data on the display screen.
6. After turning on the oximeter, each time you press the power switch,
the display screen will change to another direction.
① SpO
2
Plethysmogram（normalized）
② SpO
2
reading
③ Pulse rate reading
④ Indication of battery capacity
⑤ Indication of pulse intensity
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 alarm function; please do not use this product in the
environment where 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 such pointed objects 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, reddening, blistering 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 reference to the electronic pulse simulator the
computation the PR accuracy.
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.
Battery Installations
1. Press the button down on the back panel of oximeter (only for M70A) and push
the battery cover horizontally along the arrow as below.
2. Install the two AAA batteries into battery cabin
in correct polarities.
3. Close the battery cover.
Notes:
Please put or remove batteries in right order,
or it is likely to damage the device 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.
Maintenance
1. Disinfection: use a soft cloth dampened with 70% Isopropanol, lightly wipe the
surfaces of the oximeter.
2. 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.
3. 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.
4. Please do not soak the oximeter in liquid.
5. 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 or 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
Accuracy in the discrete
SpO2 ranges
At 70%~80%, ±2%;At 80%~90%, ±2%;
At 90%~100%, ±2%
Data update period <13 s
PR
Measuring Range 25 bpm ~250 bpm
Resolution 1 bpm
Accuracy ±1% or ± 1 bpm, whichever is greater
Data update period < 13 s
Battery specifications
Type Voltage
two AAA alkaline battery 1.5 Volts DC (per battery)
The oximeter uses two 1.5 V A AA type batteries and a set of new batteries
can be used for more than 18 hours, depending on concrete battery types.
Environmental specifications
Operation
Temperature +5℃～+40℃
Atmospheric Pressure 700hPa～1060hPa
Relative Humidity 15%～85% （non condensing）
Transport and Storage
Temperature -20℃～+55℃
Atmospheric Pressure 500hPa～1060hPa
Relative Humidity 10%～93%（non condensing）
Physical specifications
Weight
about 21g (exclude battery)
about 54g (include battery)
Dimensions
M70:57mm(length) ×36mm(width)×31mm(height)
M70A: 57mm(length) × 39mm(width) ×32mm (height)
Sensors specifications
Wavelength
Pulse oximetry sensors contain LEDs that emit red light at
a wavelength of approximately 660 nm and infrared light at
a wavelength of approximately 905 nm.
The total optical output power of the sensor LEDs is less
than 15 mW.
This information may be useful to clinicians, such as those
performing photodynamic therapy.
Note: Sensor LED light emissions fall within Class 1 level,
according to IEC 60825-1. No special safety precautions
are required.
%100
lobindeoxyhemog bin oxyhemoglo
hemoglobin oxygenated
%SpO
2
Press the button down
⑤
③
②
①
④
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