CONTEC MEDICAL SYSTEMS OXY-2 User Manual

Zdravplus.sk
Sv. Jakuba 20, 085 01 Bardejov, Slovakia
info@zdravplus.sk
OXY-2 FINGER OXIMETER
User manual
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter.
The Manual describes, in accordance with the Pulse Oximeter's features and
requirements, 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 and any monitoring abnormality, human injury and equipment damage due to
users' negligence of the operation instructions. The manufacturer's warranty service
does not cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be
totally in accordance with the description of this User Manual. We would sincerely
regret for that.
This product is medical device, which can be used repeatedly.
WARNING:
 Uncomfortable or painful feeling may appear if using the device ceaselessly,
especially for the microcirculation barrier patients. It is recommended that the sensor
should not be applied to the same finger for over 2 hours.
 For the special patients, there should be a more prudent inspecting in the placing
process. The device can not be clipped on the edema and tender tissue.
 The light (the infrared is invisible) emitted from the device is harmful to the eyes,
so the user and the maintenance man should not stare at the light.
 Testee can not use enamel or other makeup.
 Testee's fingernail can not be too long.
 Please refer to the correlative literature about the clinical restrictions and caution.
 This device is not intended for treatment.
Caution: Federal law restricts this device to sale by or on the order of a physician
The User Manual is published by our company. All rights reserved.
1 Safety
1.1 Instructions for Safe Operations
• Check the main unit and all accessories periodically to make sure that there is no
visible damage that may affect patient's safety and monitoring performance about
cables and transducers. It is recommended that the device should be inspected
once a week at least. When there is obvious damage, stop using the monitor.
• Necessary maintenance must be performed by qualified service engineers ONLY.
Users are not permitted to maintain it by themselves.
• The oximeter cannot be used together with devices not specified in User's Manual.
Only the accessory that appointed or recommendatory by manufacture can be used
with this device.
• This product is calibrated before leaving factory.
1.2 Warnings
• Explosive hazard—DO NOT use the oximeter in environment with inflammable gas
such as some ignitable anesthetic agents.
• DO NOT use the oximeter while the testee measured by MRI and CT.
• The person who is allergic to rubber can not use this device.
• The disposal of scrap instrument and its accessories and packings(including battery,
plastic bags, foams and paper boxes) should follow the local laws and regulations.
• Please 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 have the possibility
of working abnormally.
• Please don't measure this device with function test paper for the device's related
information.
1.3 Attentions
 Keep the oximeter away from dust, vibration, corrosive substances, explosive
materials, high temperature and moisture.
 If the oximeter gets wet, please stop operating it.
 When it is carried from cold environment to warm or humid environment, please do
not use it immediately.
 DO NOT operate keys on front panel with sharp materials.
 High temperature or high pressure steam disinfection of the oximeter is not
permitted. Refer to User Manual in the relative chapter for instructions of cleaning
and disinfection.
 Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its
surface with medical alcohol by soft material. Do not spray any liquid on the device
directly.
 When cleaning the device with water, the temperature should be lower than 60°C.
 As to the fingers which are too thin or too cold, it would probably affect the normal
measure of the patients' SpO and pulse rate, please clip the thick finger such as
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thumb and middle finger deeply enough into the probe.
 Do not use the device on infant or neonatal patients.
 The product is suitable for children above four years old and adults(Weight should be
between 15kg to 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, which is changeable according to
different individual pulse rate.
 If some abnormal conditions appear on the screen during test process, pull out the
finger and reinsert to restore normal use.
 The device has normal useful life for three years since the first electrified use.
 The hanging rope attached the product is made from Non- allergy material,
if particular group are sensitive to the hanging rope, stop using it. In addition,
pay attention to the use of the hanging rope , do not wear it around the neck
avoiding cause harm to the patient.
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 The instrument dose not have low-voltage alarm function, it only shows the
low-voltage, please change the battery when the battery energy is used out.
 When the parameter is particularly, The instrument dose not have 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.
1.4 Indication for Use
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check
of oxygen saturation of arterial hemoglobin (SpO
pediatric patients in home and hospital environments (including clinical use in internist/
surgery, anesthesia, intensive care ect.). This device is not intended for continuous
monitoring.
2 Overview
The pulse oxygen saturation is the percentage of HbO
so-called the O2 concentration in the blood. It is an important bio-parameter for the
respiration. For the purpose of measuring the SpO
company developed the Pulse Oximeter.
At the same time, the device can measure the pulse rate simultaneously.
The Pulse Oximeter features in small volume, low power consumption, convenient
operation and being portable. It is only necessary for patient to put one of his fingers
into a fingertip photoelectric sensor for diagnosis, and a display screen will directly
show measured value of Hemoglobin Saturation.
2.1 Features
• Operation of the product is simple and convenient.
• The product is small in volume, light in weight (total weight is about 50g including
batteries) and convenient in carrying.
• Power consumption of the product is low and the two originally equipped AAA
batteries can be operated continuously for 24 hours.
• The product will automatically be powered off when no signal is in the product within
5 seconds.
• Low-battery indicator as battery icon flash manner.
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse
rate through finger, and indicate the pulse intensity by the bar-display. The product is
suitable for use in family, hospital (Ordinary sickroom ), Oxygen Bar, social medical
organizations and also the measure of saturation oxygen and pulse rate.
The product is not suitable for use in continuous supervision for patients.
The problem of overrating would emerge when the patient is suffering
from toxicosis which 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~+60°C
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature: 10°C~40°C
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700hPa~1060hPa

3 Principle and Caution

3.1 Principle of Measurement
Principle of the Oximeter is as follows: 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
& near-infrared zones. Operation principle of the instrument is: Photoelectric
Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse
Scanning & Recording Technology, so that two beams of different wavelength of lights
can be focused onto human nail tip through perspective clamp finger-type sensor.
Then 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.
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
Figure 1. Operating Principle
3.2 Caution
1. The finger should be placed properly (see the attached illustration of this manual,
Figure 5), or else it may cause inaccurate measurement.
2. The SpO sensor and photoelectric receiving tube should be arranged in a way with
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the subject's arteriole in a position there between.
3. The SpO sensor should not be used at a location or limb tied with arterial canal or
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blood pressure cuff or receiving intravenous injection.
4. Make sure the optical path is free from any optical obstacles like rubberized fabric.
5. Excessive ambient light may affect the measuring result. It includes fluorescent lamp,
dual ruby light, infrared heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electrosurgical interference may also
affect the accuracy.
7. Testee can not use enamel or other makeup.
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), or carbon monoxide hemoglobin (COHb),
or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem,
the SpO determination by this monitor may be inaccurate.
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3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be
a major factor blamed for serious error of SpO
4. As the SpO value serves as a reference value for judgement of anemic anoxia
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and toxic anoxia, some patients with serious anemia may also report good SpO
measurement.
) and the pulse rate of adult and
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in the total Hb in the blood,
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more easily and accurately, our
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) in glow
2
2
measure.
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