s
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices
and harmonized standards. In case of modifications and software upgrades, the information contained in this
document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter's features and requirements, the main structure,
functions, specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and
storage, etc. as well as the safety procedures to protect both the user and equipment. Refer to the respective chapters
for details.
Please read the User Manual carefully before using this product. The User Manual which describes the operating
procedures should be followed strictly.Failure to follow the User Manual may cause measuring abnormality,
equipment damage and human injury. The manufacturer is NOT responsible for the safety, reliability and performance
issues or any measuring abnormalities, human injury and equipment damage due to users' negligence of the operation
instructions. The manufacturer’s warranty service does not cover such faults.
We regret to inform you that owing to the forthcoming renovation, the specific products you received may not be
totally in accordance with the description of this User Manual.
This product is a medical device and can be used repeatedly.
WARNING:
Discomfort or pain can occur if the device is used ceaselessly, especially for microcirculation barrier
patients. It is recommended that the sensor should not be applied to the same finger for longer than
2
hours.
For special patients, there should be a more prudent inspection of the placing process. The device
should not be clipped on an edema or tender tissue.
The infrared light emitted from the device, though invisible, is harmful to the eyes. Avoid staring at
it.
The patient cannot use nail enamel or other makeup.
The patient’s fingernails must be clipped short.
Please refer to the related content about clinical restrictions and caution.
This device is not intended for treatment.
1.1 Instructions for Safe Operations
Inspect the main unit and all accessories periodically to ensure that there is no visible damage that may affect
the patient’s safety, and monitor the performance of cables and transducers. It is recommended that the device
should be inspected at least once a week. If there is obvious damage, stop using the device.
Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to
service the device by themselves.
The Oximeter must not be used together with accessories not specified in the User Manual. Only accessories
specified or recommended by the manufacturer can be used with this device.
This product is calibrated before leaving the factory.
1.2 Warning
Explosive hazard—DO NOT use the oximeter in an environment with flammable gas, such as some ignitable
anesthetic agents.
DO NOT use the Oximeter while the patient is measured by MRI and CT.
People who are allergic to rubber cannot use this device.
The disposal of this instrument and its accessories and packaging (including batteries, plastic bags, foams and
paper boxes) should follow local laws and regulations.
Please check the packaging before use to make sure the device and accessories are in complete accordance
with the packaging list or else the device may not work normally.
1.3 Attention
Keep the Oximeter away from dust, vibrations, corrosive substances, explosive materials, high temperatures
and moisture.
Stop operating the Oximeter if it gets wet.
DO NOT use the device immediately after moving it from a cold environment to a warm or humid
environment.
DO NOT operate the keys on the front panel with sharp objects.
High temperature or high pressure steam disinfection of the Oximeter is not permitted. Refer to the User
Manual in the relative chapter for instructions on cleaning and disinfection.
DO NOT immerse the Oximeter in liquid. If it needs cleaning, wipe the surface with medical alcohol using a
soft material. Do not spray any liquid directly onto the device.
When cleaning the device with water, ensure that the temperature of the water is lower than 60 .
Thin or cold fingers will affect the normal measure of the patient's SpO
2
and pulse rate. Be sure to clip a thick
finger such as the thumb or middle finger deeply enough into the probe.
DO NOT use the device on infants or neonatal patients.
This product is only suitable for adults and children above four years old (Weight should be between 15kg-
110kg).
The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.
The update period of data is less than 5 seconds. This is changeable according to different individual pulse
rates.
The waveform is normalized. Please read the measured value when the waveform on-screen is uniform and
steady-going. This measured value is the optimal value and this waveform is the standard one.
If abnormal conditions appear on the screen during the test process, pull out the finger and reinsert it to restore
normal use.
The device has a lifespan of three years after the first electrified use.
The wrist strap attached to the device is made from non-allergenic material. If you are sensitive to the wrist
strap, stop using it. In addition, pay attention to the use of the wrist strap. To avoid harm, DO NOT wear it
around the neck.
The device does not have a low-battery alarm function; it only displays the low battery icon. Change the
battery when the battery energy is low.
The device does not have an alarm function. Do not use the device in situations where alarms are required.
The batteries must be removed if the device is going to be stored for more than one month or else they may
leak.
A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.
The peripheral capillary oxygen saturation (SpO
2
) is the percentage of oxyhemoglobin (HbO
2
) in the total hemoglobin
(Hb) in the blood, or the oxygen concentration in the blood. It is an important bio-parameter for respiration. For the
purpose of measuring the SpO
2
more easily and accurately, our company developed the Pulse Oximeter. The device
can also measure the pulse rate simultaneously.
The Pulse Oximeter features a small size, low power consumption, convenient operation and portability. The patient
only needs to put one of their fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will
show the measured value of Hemoglobin Saturation.
2.1 Classification:
Class II b(MDD93/42/EEC IX Rule 10)
2.2 Features
Operation of the device is simple and convenient.
The device is small in size and light in weight (total weight is about 50g including batteries) making it
convenient to carry.
The device has low power consumption. The two originally equipped AAA batteries can be operated
continuously for 20 hours.
The device will automatically power off if no signal is received for 5 seconds.
2.3 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through a finger, and
indicate the pulse intensity on a bar-display. The device is suitable for use in the home, hospital (ordinary sickroom),
Oxygen Bar, and social medical organizations.
The device is not suitable for use in continuous supervision of patients.
The problem of overrating will emerge if the patient is suffering from toxicosis caused by carbon
monoxide. The device is not recommended to be used under these circumstances.
2.4 Environment requirements
Storage Environment
a) Temperature :-40
~
+60
b) Relative humidity :
≤
95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature: :10
~
40
b) Relative Humidity :
≤
75%
c) Atmospheric pressure:700hPa~1060hPa
Principle of the Oximeter: Principle of the Oximeter: for the calculation of blood oxygen level the device uses a
formula to process the data according to Lambert Beer Law and Spectrum Absorption Characteristics of Reductive
Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones.
Operation principle of the Oximeter: Photoelectric Oxyhemoglobin Inspection Technology is applied together with
Capacity Pulse Scanning & Recording Technology so that two beams of light of different wavelengths can be focused
onto the human nail tip through a perspective clamp finger sensor. A measured signal is obtained by a photosensitive
element and acquired information will be shown on-screen through treatment in electronic circuits and
microprocessors.
Figure 1. Operating Principle
3.2 Caution
1.
The finger should be placed properly or else it may cause inaccurate measurement (see illustration in Figure 5.)
2.
The SpO
2
sensor should not be used at a location or limb tied with an arterial canal or blood pressure cuff, or
receiving intravenous injection.
3.
Make sure the optical path is free from any optical obstacles like rubberized fabric.
4.
Excessive ambient light may affect the measuring result. This includes fluorescent lamps, dual ruby lights,
infrared heaters, direct sunlight etc.
5.
Strenuous action of the patient or extreme electrosurgical interference may also affect accuracy.
6.
The patient cannot use nail enamel or other makeup.
3.3 Clinical Restrictions
1.
As the measurement is taken on the basis of arteriole pulse, substantial pulsating blood flow of the patient is
required. For a patient with a weak pulse due to shock, low ambient/body temperature, major bleeding, or use
of vascular contracting drugs, the SpO
2
waveform (PLETH) will decrease. In this case, the measurement will be
more sensitive to interference.
2.
For patients with a substantial amount of staining dilution drugs (such as methylene blue, indigo green and acid
indigo blue), carboxyhemoglobin (COHb), methionine (Me+Hb) or thiosalicylic hemoglobin, and some with an
icterus problem, the SpO
2
determination by this monitor may be inaccurate.
3.
Drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for
serious errors of SpO
2
measurements.
4.
As the SpO
2
value serves as a reference value for judgment of anemic anoxia and toxic anoxia, some patients
with serious anemia may also report good SpO
2
measurement.
4.1
Display Format:
Digital tube Display;
SpO
2
Measuring Range:
0% - 100%;
Pulse Rate Measuring Range:
30 bpm - 250 bpm;
Pulse Intensity Display:
columniation display
4.2
Power Requirements:
2
×
1.5V AAA alkaline batteries (or rechargeable batteries),
adaptable range: 2.6V~3.6V.
4.3
Power Consumption:
Lower than 25 mA.
4.4 Resolution:
1% for SpO
2
and 1 bpm for Pulse Rate.
4.5 Measurement Accuracy:
±
2% in stage of 70%-100% SpO
2
, and meaningless when stage being smaller than
70%.
±
2 bpm or
±
2% (select larger) for Pulse Rate.
4.6 Measurement Performance in Weak Filling Condition:
SpO
2
and pulse rate can be shown correctly when
pulse-filling ratio is 0.4%. SpO
2
error is
±
4%, pulse rate error is
±
2 bpm or
±
2% (select larger).
4.7
Resistance to Surrounding Light:
The deviation between the value measured in the condition of man-
made light or indoor natural light and that of darkroom is less than ±1%.
4.8
It is equipped with a function switch. The Oximeter can be powered off in case no finger is in the Oximeter
within 5 seconds.
4.9 Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
One wrist strap;
Two batteries (optional);
One User Manual.
1 Safety
3 Principle and Caution
Instructions to User
2 Overview
4 Technical Specifications
5 Accessories
TORONTEK-H50 Pulse Oximeter
