User Guide

1.2 Warning
• Explosive hazard—DO NOT use the oximeter in any environment with
inflammable gas such as some ignitable anesthetic agents.
• Anyone allergic to rubber cannot use this device.
• The disposal of the device and its accessories and packaging (including
battery, plastic bags, foams, and paper boxes) should follow local laws and
regulations.
• Check the packing before use to make sure the device and accessories are
totally in accordance with the packing list, or else the device may work
abnormally.
• Only place a human finger inside the device; no other objects should be
placed inside.
• The equipment should not be serviced or maintained while in use.
• No modifications of this equipment are allowed.
• The user is an intended operator.
• The probe of the device is the applied part.
1.3 Attention
• Keep the oximeter away from dust, vibration, corrosive substances, explosive
materials, high temperature, and moisture.
• If the oximeter gets wet, immediately cease operation.
• When the oximeter is moved from a cold environment to a warm or humid
environment, allow time to adjust to new temperature before operating.
• DO NOT operate the front panel with keys or sharp materials.
• High temperature or high pressure steam disinfection of the oximeter is not
permitted. Refer to "Repair and Maintenance" section for cleaning and
disinfection instructions.
• Do not submerge the oximeter in liquid. Do not spray any liquid on the device
directly. Refer to "Repair and Maintenance" section for cleaning and
disinfection instructions.
• Use thick fingers such as thumbs or middle fingers. Fingers that are too thin
or too cold, might not result in an accurate measure of the user’s SpO and
pulse rate. Please clip the thumb or middle finger deeply enough into the
probe.
• Do not use the device on infants or newborns.
• The product is suitable for adults and children above the age of 4 (weight
should be between 15 - 110 kg or 33 - 242 lbs). The product should
only be used on children under the careful supervision of an adult. This
product is not a toy.
• The device may not work for all users. If you are unable to achieve stable
readings, discontinue use.
• The refresh data rate is less than 5 seconds, according to user pulse rate.
• Please read the measured pulse rate value when waveform on screen is
consistent. This is the optimal value.
• If some abnormal conditions appear on the screen during test process,
remove finger from device and reinsert to restore normal use.
• The lanyard attached to the product is made from hypoallergenic material; if
you are sensitive to the lanyard, stop using it. In addition, do not wear it
around the neck to avoid any harm to the user.
• The device does not have a low battery alarm function, it only shows the low
battery indicator. Please change the battery when there is a low battery
indicator.
• The device does not have an alarm function. Do not use the device in
situations where alarms are required.
• Batteries must be removed if the device is going to be stored for more than
one month, or else batteries may leak.
• A flexible circuit connects the two parts of the device. Do not twist or pull on
the connection.
Thank you for purchasing our Puls
e Oximeter. The Pulse Oximeter is a
non-invasive device intended for the spot-check of oxygen saturation of
arterial hemoglobin (SpO ) and the pulse rate of adults in home-use
environments. This device is not intended for continuous monitoring. The
device should be used solely for use with sporting and aviation activities.
This manual describes the Pulse Oximeter's features and requirements, main
structure, functions, specifications, correct methods for transportation,
installation, usage, operation, repair, maintenance, storage, etc. as well as the
safety procedures to protect both the user and equipment. Refer to the
respective sections for details.
Please read the manual very carefully before using this equipment. These
instructions describe the operating procedures to be strictly followed; failure to
follow these instructions can cause measuring abnormalities, equipment
damage, or personal injury. The manufacturer is NOT responsible for the safety,
reliability and performance issues and any monitoring abnormality, personal
injury and equipment damage due to user's negligence of the operation
instructions. The manufacturer’s warranty service does not cover such faults.
This medical device can be used repeatedly. Its usable life is 3 years. In case of
modifications and software upgrades, the information contained in this
document is subject to change without notice.
If you have any questions regarding the use of this product, please call us at
1-855-366-7755.
WARNING!
• You may experience discomfort or pain if using this device for prolonged
periods of time. It is recommended that the device should not be applied
to the same finger for over 2 hours.
• Carefully inspect the placement of the device. The device should not be
clipped on any edema or tender tissue.
• The light (the infrared is invisible) emitted from the device is harmful to
the eyes, so users or anyone repairing the device should not stare at the
light.
• User should not have enamel, other nail polish, or makeup on their nails.
• User should not have nails that are too long.
• Please read the relevant content about the clinical restrictions and
caution.
• This device is not intended for treatment.
1.1 Instructions for Safe Operation
• Check the main unit and all accessories periodically to make sure that there
transducers, and monitor performance. It is recommended to inspect the
device at least once a week. When there is obvious damage, stop using the
oximeter.
• Necessary maintenance must be performed by qualified service engineers
ONLY. Users are not permitted to repair or maintain the device by
themselves.
• The oximeter cannot be used together with devices not specified in the User
Manual. Only accessories recommended by the manufacturer can be used
with this device.
• This product is calibrated before leaving the factory.
The pulse oxygen saturation is the percentage of HbO
in the total Hb in the
blood, so-called the O concentration in the blood. It is an important
bio-parameter for respiration. For the purpose of measuring the SpO more
easily and accurately, we have developed the Pulse Oximeter. At the same
time, the device can measure the pulse rate simultaneously.
The Pulse Oximeter is portable and features low power consumption for
convenient operation. The user inserts either their middle finger or thumb into
the fingertip sensor, and the screen displays the SpO2 and PRbpm measured
values.
2.1 Features
• Operation of the product is simple and convenient.
• The product is small, lightweight, and convenient to carry.
• Product features low power consumption. Two fully-charged AAA batteries
will continuously operate the product for 20 hours.
• The product will enter standby mode after 5 seconds of inactivity.
• Display direction changes automatically for easier viewing.
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used in measuring pulse oxygen saturation and
pulse rate through a user’s finger. The product is suitable for aviation or
sporting purposes. It can be used before or after physical activity. It is not
recommended to use the device while performing physical activities.
toxicosis which is caused by carbon monoxide; the device is not
recommended to be used under this circumstance.
2.3 Environment Requirements
Storage Environment
a) Temperature: -40˚C to 60˚C, or -40˚F to 140˚F
b) Relative Humidity: ≤95%
c) Atmospheric pressure: 500 hPa to 1060 hPa
Operating Environment
a) Temperature: 10˚C to 40˚C, or 50˚F to 104˚F
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700 hPa to 1060 hPa
Safety
The following symbols may appear on the manual, packaging, or oximeter.
Intended Use
Explanation of Marks or Symbols
Trouble Possible Reason Solution
The SpO
and Pulse
Rate cannot
be displayed
normally
1. The finger is not properly
positioned.
2. The user’s SpO is too
low to be detected.
1. Place the finger properly
and try again.
2. Try again. Contact a
doctor immediately if you
are sure the device is
functioning properly.
The SpO
and Pulse
Rate are not
displayed
stably
1. The finger is not placed
inside deep enough.
2. The finger is shaking or
the user is moving.
1. Place the finger properly
and try again.
2. User should remain
calm.
The device
cannot be
turned on
1. The batteries are drained
or almost drained.
2. The batteries are not
inserted properly.
3. The device is
malfunctioning.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the
retailer.
The display
suddenly
1. The product will enter
standby mode after 5
seconds of inactivity.
2. The batteries are almost
drained.
1. This is normal.
2. Change batteries.
Troubleshooting
PULSE OXIMETER
FOR QUICK & ACCURATE
OXYGEN SATURATION &
PULSE RATE READINGS
Overview
Principle and Caution
Technical Specifications
Battery Installation
Step 1. Pull the small end of the lanyard through the hole on the side
(see Fig. 3).
Step 2. Loop the other end of the lanyard through the first one and then
tighten it.
Lanyard Installation
• Please change the batteries when the low battery indicator is displayed on
the screen.
• Please clean the surface of the device before using. Wipe the device with
medical alcohol and allow to air dry, or dry with a clean, dry cloth.
• Using medical alcohol to disinfect the device after use can prevent cross
contamination for the next user.
• Remove batteries if the device will not be used for over a month.
• The device cannot be transported mixed with toxic, harmful, or corrosive
material.
• Store device at room temperature away from dust, vibration, corrosive
substances, explosive materials, high temperature, and without moisture.
• Users should not attempt to calibrate the device. Only the manufacturer or
appointed agents can calibrate the device.
Repair and Maintenance
3.1 Principle of Measurement
An experience formula of data process is established taking use of Lambert
Beer Law according to Spectrum Absorption Characteristics of Reductive
Hemoglobin (Hb) and Oxyhemoglobin (HbO ) in glow & near-infrared zones.
Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection
Technology is adopted in accordance with Capacity Pulse Scanning &
be focused onto a human fingertip through perspective clamp finger-type
sensor. The measured signal can be obtained by a photosensitive element,
information acquired through which will be shown on screen through treatment
in electronic circuits and microprocessor.
3.2 Caution
1. The finger should be placed properly (see Fig. 4), or else it may cause
inaccurate measurement.
2. The SpO sensor and photoelectric receiving tube should be arranged in a
way with the subject’s arteriole positioned in-between．
3. The SpO sensor should not be used at a location or limb tied with arterial
4. Make sure the optical path is free from any optical obstacles like rubberized
fabric.
fluorescent lamp, dual ruby light, infrared heater, direct sunlight, etc.
6. Strenuous action of the subject or extreme electrosurgical interference may
7. User should not have enamel, other nail polish, or makeup on their nails.
3.3 Clinical Restrictions
1. As the measure is taken on the basis of arteriole pulse, substantial pulsating
blood flow of subject is required. For a subject with weak pulse due to shock,
low ambient/body temperature, major bleeding, or use of vascular
contracting drug, the SpO waveform (PLETH) will decrease. In this case,
the measurement will be more sensitive to interference.
2. For those with a substantial amount of staining dilution drug (such as
methylene blue, indigo green, and acid indigo blue), carbon monoxide
hemoglobin (COHb), methionine (Me+Hb) or thiosalicylic hemoglobin, or
some with an icterus problem, the SpO determination by this monitor may
be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine, and butacaine may
also be a major factor blamed for serious error of SpO measure.
4. As the SpO value serves as a reference value for judgement of anemic
anoxia and toxic anoxia, some users with serious anemia may also report
good SpO measurement.
1. Display Format: TFT
SpO
Measuring Range: 0% ~ 100%
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm
Pulse Wave Display: Columniation display and the waveform display.
2. Power Requirements: 2×1.5 V AAA alkaline battery (or use a
rechargeable battery instead); adaptable range: 2.6 V - 3.6 V.
3. Power Consumption: Smaller than 30 mA.
4. Increments: 1% for SpO and 1 bpm for Pulse Rate.
5. Measurement Accuracy: ±2% in stage of 70% - 100% SpO , and
meaningless when stage is smaller than 70%, ±2 bpm during the pulse
rate range of 30 - 99 bpm, and ±2% during the pulse rate range of 100 ~ 250
bpm.
6. Measurement Performance in Weak Filling Condition: SpO and pulse
rate can be shown correctly when pulse-filling ratio is 0.4%. SpO error is
±4%, pulse rate error is ±2 bpm during the pulse rate range of 30 ~ 99 bpm,
and ±2% during the pulse rate range of 100 ~ 250 bpm.
7. Resistance to surrounding light: The deviation between the value
measured in the condition of man-made light or indoor natural light and
darkroom is less than ±1%.
8. It is equipped with a function switch: The product will enter standby mode
when no signal is in the product within 5 seconds.
9. Optical Sensor
Red light (wavelength is 660 nm, 6.65 mW)
Infrared (wavelength is 880 nm, 6.75 mW)
Fig. 2
Fig. 3
Step 2. Insert two AAA size batteries with correct polarity (see Fig. 2).
Step 3. Replace the cover by aligning the arrows on the side and sliding the
cover back into place.
Please take care when you insert the batteries; improper insertion may
damage the device.
Unit
Description
97
84
%SpO
2
PRbpm
SpO Display
Pulse Rate Waveform
Low Battery
Indicator
Pulse Rate
Bar Graph
Button
Pulse Rate Display
1. Insert two AAA batteries with correct polarity, and then replace the cover
(see Fig. 2).
2. Open the clip and insert the user’s finger so that it’s resting on the rubber
cushions of the clip (make sure the finger is in the correct position), and
then clip the onto finger (see Fig. 4).
3. Press the button on the front panel once.
4. Do not shake the finger and keep the user at ease during the process.
User should remain stationary during measurement.
5. Screen will display the user's measurements.
6. The button has two functions.
a. When the device is in standby mode, press the button to exit it.
b. When the device is in operation status, press and hold the button
to change the screen brightness.
7. The device should change display direction automatically.
Fingernails and the luminescent tube should be on the same side.
Operation Guide
Fig. 4
High-pressure sterilization cannot be used on the device.
Do not immerse the device in liquid.
It is recommended that the device should be kept in a dry environment;
humidity may reduce the useful life of the device, or even damage it.
Symbol Description
Type BF
Refer to instruction manual/booklet
The pulse oxygen saturation (%)
Pulse rate (beats per minute)
Full battery
%SpO
2
PRbpm
Low battery indicator (change the batteries in time to avoid
inaccurate measurement)
1. No finger inserted
2. An indicator of signal inadequacy
1. Exit standby mode
2. Change brightness of the screen
Battery positive electrode
Battery negative electrode
Serial number
Alarm inhibit
International protection
CE Mark: Conforms to essential requirements of the
Medical Device Directive 93/42/EEC.
Manufacturer
Manufacture date
WEEE (2002/96/EC)
SN
Storage and transport temperature limitation
Storage and transport humidity limitation
Storage and transport atmospheric pressure limitation
+60˚C
-40˚C
0%
95%
500 hPa
1060 hPa
Glow & Infrared-ray
Emission Tube
Glow & Infrared-ray
Receipt Tube
Fig. 1