PULOX PO-200 Solo Manual

Instructions to User

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, 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.

This product is medical device, which can be used repeatedly. Its using life is 3 years.

• 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 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.

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 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 device.
• 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.

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 functional tester for the device's related information.

Attention

• 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 immerse the oximeter in liquid. When it needs cleaning, please wipe its surface with disinfectant solution using a soft cloth. Do not spray any liquid directly onto the device.
• 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' SpO2 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 15 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.
• Please read the measured value when the waveform on screen is equably and steady-going. 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 instrument does not have 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 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 spotcheck of oxygen saturation of arterial hemoglobin (SpO2) 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 O2 concentration in the blood. It is an important bioparameter for the respiration. For the purpose of measuring the SpO2 more easily and accurately, our 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.

Classification

Class II b, (MDD93/42/EEC IX Rule 10)

Features

1. Operation of the product is simple and convenient.
2. The product is small in volume, light in weight (total weight is about 50 g including batteries) and convenient in carrying.
3. Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for 20 hours.
4. The product will enter standby mode when no signal is in the product within 5 seconds.
5. Display direction can be changed automatically, easy to view.

Major Applications and Scope of Application

The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger. The product is suitable for being used in family, hospital, oxygen bar, community healthcare, physical care in sports (It can be used before or after doing sports and it is not recommended to use the device during the process of having sport) and etc.

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.

Environment Requirements

Storage Environment

1. Temperature: -40°C ~+60°C
2. Relative humidity: ≤95%
3. Atmospheric pressure: 500hPa~1060hPa

Operating Environment

1. Temperature: 10°C ~40°C
2. Relative Humidity: ≤75%
3. Atmospheric pressure: 700hPa~1060hPa

Principle

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. Operation principle of the device 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.

Figure 1

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 SpO2 sensor should not be used at a location or limb tied with arterial canal or 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.

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 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 thiosalicylic hemoglobin, and some with icterus problem, the SpO2 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 SpO2 measure.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO2 measurement.

Technical Specifications

1. Display Format: OLED Display
   SpO2 Measuring range: 0 ~100 %
   Pulse Measuring range: 30bpm ~250bpm
   Perfusion Index Measuring Range: 0% ~ 20%
   Pulse Wave Display: columniation display and the waveform display
2. Power Requirements: 2 ×1.5V AAA alkaline battery (or using the rechargeable battery instead), adaptable range: 2.6V~3.6V.
3. Power Consumption: Smaller than 30mA
4. Resolution: SpO2: 1%, Pulse: 1bpm, Perfusion Index: 0.1%.
5. Measurement Accuracy: ±2% in stage of 70%-100% SpO2, and meaningless when stage being 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: SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is ±4%, pulse rate error is ±2 bpm or ±2% (select larger).
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%.
8. It is equipped with a function switch. The Oximeter can be powered off in case no finger is the Oximeter within 5 seconds.
9. Optical Sensor
   Red light (wavelength is 660nm, 6.65mW)
   Infrared (wavelength is 880nm, 6.75mW)

Accessories

2x batteries AAA (optional), user manual

Installation

View of the front panel

Fig. 2 Front view

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.

Fig. 3 Batteries installation

Operating Guide

1. Insert the two batteries properly to the direction, and then replace the cover.
2. Open the clip as shown in Figure 4.
   
   Figure 4 Finger Position
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 switch 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 device could change display direction according to the handing direction.
   Fingernails and the luminescent tube should be on the same side.

Cleaning, Transportation and Storage

• Please change the batteries when the low-voltage displayed on the screen.
• Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.
• Using the 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 -40ºC to 60ºC ambient temperature and not higher than 95% relative humidity.

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

Key of Symbols

Symbol	Description	Symbol	Description
	Type BF applied part		WEEE (2002/96/EC)
	Refer to instruction manual/booklet	IP22	International Protection
%SpO2	Pulse oxygen saturation (%)		This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community.
bpm	Pulse rate (bpm)		Manufacturer
PI	Perfusion Index (%)		Date of manufacture
	The battery voltage indication is deficient (change the battery in time avoiding the inexact measure)		Storage and Transport Temperature limitation
	No finger inserted An indicator of signal inadequacy		Storage andTransport Humidity limitation
	Battery anode / Battery cathode		Storage and Transport Atmospheric pressure limitation
	Change brightness of the screen. Exit standby mode.		This side UP
	Serial number		Fragile, handle with care
	recovery		Keep dry

Function Specification

Tel.: +49 (0) 2203 / 9885 200
Fax: +49 (0) 2203 / 9885 206

Mail: info@novidion.de

www.pulox.de

Documents / Resources

References

• http://www.pulox.de

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