iHealth PO2 Pulse Oximeter Instruction Manual

iHealth PO2 Pulse Oximeter

Instructions to User

Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. The Manual is written for the cUITCD.t Pulse Oximeter. 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, 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 chapten; for details.

Please read the Manual very carefully before using this equipment. These instructions describe the operating procedmes to be followed strictly, failure to follow these instructions can cause measuring abnormality, equipment damage and 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. 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, and can be used repeatedly. Its using life is 3 years.

WARNING:

• The 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 individual patients, there should be more prudent inspecting in the placing proce11. 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, can not stare at the light.
• Testee can not use enamel or other makeup. Testee’s fingernail can not be too long.
• Please peruse the relative content about the clinical restrictions and caution. This device is not intended for treatment.

Safety

Instructions for Safe Operations

• Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect the patient’s safety and monitoring performance. 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 with other devices except certain accessories recommended by the manufacturer.
• This product is calibrated before leaving the factory.

Warning:

• 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.

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 the 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 emerged 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.
• A, to the fingers which are too thin or too cold, it would probably affect the norm.al measure of the patients’ Sp02 and pulse rate, please clip the thick finger such as 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 40 kg to 110 kg).
• 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.
• The waveform is normalized. Please read the measured value when the waveform on screen is equably and steady-going, Here this measured value is optimal value. And the waveform at the moment is the standard one.
• 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.
• The instrument does not have a low-voltage alarm function, it only shows the low-voltage. please change the battery when the battery energy is used out.
• The instrument 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.

Indication for Use

The Fingertip Pulse Oximeter is a non-invasive device intended for the spot- check of oxygen saturation of arterial hemoglobin (SpO:z) and the pulse rate of adult and 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.

Overview

The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the 0 2 concentration in the blood. It is an important bio- parameter for the respiration. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Pulse Oxi:meter. 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

Classification
Class Ila , (MDD93/42/EEC IX Rule IO)

Features

• Operation of the product is simple and convenient.
• The product is small in volume, light in weight (total weight is about S0g 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 20 hours.
• The product will enter standby mode when no signal is in the product within 5 seconds.
• Display direction can be changed automatically, easy to view.

Major Application 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 1upervision 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.

E nvironment Requirements
Storage Environment

1. Temperature: -40 ‘C ~ ~0 ‘C
2. Relative humidity: ‘595%
3.  Atmospheric pressure: 500 hPa ~ l060 hPa

Operating Environment

1. Temperature: lO ‘C ~ 40 ‘C
2. Relative Humidity: 95%
3. Atmospheric pressure: 700 hPa ~ l060 hPa

Principle and Caution

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 (HbO2) in glow & near-infrared zones. The 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 wavelengths 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.

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 SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there between.
3. The Sp()2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving an 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 a 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.

Clinical Restrictions

1. As the measure is taken on the basis of arteriole pulse, the substantial pulsating blood flow of the subject is required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of the vascular contracting drug, the SpO2 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 this salicylic hemoglobin, and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine and but came may also be a major factor blamed for serious error of Sp02 measure.
4. AB the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO2 measurement.

Accessories

• One hanging rope;
• Two batteries(optional)
• One User Manual

Installation

View of the Front Panel

Battery

Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction.
Step 2. Replace the cover.Please take care when you insert the batteries for the improper insertion may damage the device.

Mounting the Hanging Rope

Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the first one and then tighten it.

Operating Guide

1. Insert the two batteries properly to the direction, and then replace the cover.
2. Open the clip as shown in Figure 5.
3. Let the patient’s finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then clip the finger .
4. Press the button once on front panel.
5.  Do not shake the finger and keep the patient at ease during the process. Meanwhile, human body is not recommended in movement status.
6. Get the information directly from screen display.
7. The button has two functions.When the device is in standby mode, pressing the button can exit it; When the device is in operation status, pressing the button long can change brightness of the screen.
8. The device could change display direction according to the handing direction.
   Fingernail and the luminescent tube should be on the same side.

Repairing and Maintenance

• Please change the batteries when the low-voltage is displayed on the screen.
• Please clean the surface of the device before using it. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.
• Using medical alcohol to disinfect the product after use, prevent from cross-infection for next time use.
• Please take out the batteries if the oximeter is not in use for a long time.
• The best storage environment of the device is -40 °C to 60 °C ambient temperature and not higher than 95% relative humidity.
• Users are advised to calibrate the device termly (or according to the calibrating program of the hospital). It also can be performed at the stateappointed agent or just contact us for calibration.

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.

Troubleshooting

Symbols

Technical Specifications

Warranty

The Start by iHealth PO2 has a two-year warranty according to European legislation. If you have any questions regarding the usage of the product, please visit our website
http://www.ihealthlabs.eu or send us a query directly on [email protected]

Appendix

Guidance and manufacture’s declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS

Guidance and manufacture’, declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that not LIFE- SUPPORTING.

Manufacturer information

ANDON HEALTII CO., LTD. No. 3 Jinping Street, YaAnRoad, Nankai District,
Tianjin 300190, China.
iHealthLabs Europe SAS
Rue de Ponthieu, 75008, Paris, France

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