PULOX PO-200A Manual

Key of Symbols

Symbol	Description
	Type BF applied part
	Refer to instruction manual/booklet
%SpO2	Pulse oxygen saturation (%)
bpm	Pulse rate (bpm)
PI	Perfusion Index (%)
	Low battery
	No finger inserted An indicator of signal inadequacy
	Battery anode/Battery cathode
	Date of manufacture
	UK Authorised Representative
	Menu/Power button
	Sound prompt on
	Pulse sound on
	Serial number
	WEEE (2002/96/EC)
	UKCA marking
IP22	International Protection
	Manufacturer
	European authorised representative
	Swiss authorised representative
	This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community.

Overview

The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, in other words the O2 concentration in blood. It is an important bioparameter for respiration. A number of diseases relating to the respiratory system may cause a decrease of SpO2 in the blood. Serious symptoms might bring danger to person's life. Therefore, prompt information of patients' SpO2 is of great help for the doctor to discover the potential danger, and is of great importance in the clinical medical field.
The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for patients to put one of his fingers into a probe for diagnosis, and a display screen will directly show the measured value of pulse oxygen saturation.

Classification
Class IIb, (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 and convenient for carrying.
3. Low power consumption
4. The product will automatically be powered off when there is no signal for 5 seconds.

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 excercises) and more.
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 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

The 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 device 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 a human nail tip 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.

1. The finger should be placed properly (see the attached illustration of this manual, Figure 4), or else it may cause inaccurate measurement.
2. The SpO2 probe and photoelectric receiving tube should be arranged in a way with the subject's arteriole in a position there between
3. The SpO2 probe 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 lamps, 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 measurements are 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: TFT 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 in the Oximeter within 5 seconds.
9. Optical Sensor
   Red light (wavelength is 660nm, 6.65mW)
   Infrared (wavelength is 880nm, 6.75mW)
10. Adjustable alarm range
    SpO2: 0%~100%
    Pulse Rate: 0bpm~254bpm

Accessories

Hanging rope, pouch, silicone protector, batteries (optional), user manual

Installation

View of the front panel

Battery

1. Refer to Figure 3 and insert the two AAA size batteries properly in the right direction.
   
2. Replace the cover.

Please take care when you insert the batteries for the improper insertion may damage the device.

Mounting the Hanging Rope

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

Operating Guide

1. Measurement
   1. Insert the two batteries properly in the correct direction and then replace the cover.
   2. Open the clip as shown in Figure 4.
      
   3. Put the patient's finger 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 button has three functions. When the device is off, press the button to turn it on. When the device is on, press the button shortly to enter the menu. In the state of alarm, press the button long to pause the alarm for 60s.
2. Change display direction:
   The display direction of the screen changes automatically.
3. Pause sound prompt
   1. Sound prompt includes over-limit prompt or finger out prompt.
   2. In sound prompt "ON" state, when the sound prompt occurs, short press the button to pause the sound prompt, and it will resume automatically after about 60s.
   3. If you want to turn off the sound prompt permanently, please set it in menu.
4. Menu operation
   1. Main menu
      
      Pulse: When you enter the main menu, „Pulse" is already selected. Press the button for a few seconds to turn on the pulse sound. Long press again to switch off the pulse sound. Press the button long to turn the pulse sound on. Long press again to switch off the pulse sound.
      Alarm: Press the button briefly to select „Alarm". Press the button for a few seconds to turn on the alarm prompt on. Long press again to switch off the alarm prompt.
      Alarm Set: Press the button briefly to select„Alarm Set". Press the button for a few seconds to go into the sound prompt menu. For details on setting the limit values, see c. Set limit values.
      Exit: Short press the button to select "Exit", then long press the button to exit the main menu and return to the measurement interface. b.
   2. Sound prompt menu
      
      Pulse Alarm: Press the button briefly to select „Pulse Alarm". Press the button for a few seconds to go to the Pulse limit value settings, see c. Set limit values for details.
      SpO₂ Alarm: Press the button briefly to select „ SpO₂ Alarm". Press the button for a few seconds to go to the SpO2 limit value settings, see c. Set limit values for details.
      Exit: Briefly press the button to select "Exit", then long press the button to exit the alarm menu and return to the main menu.
   3. Set limit values
      
      Dir: When you enter the limit value settings, „Dir" is already selected. Long press the button to switch between up (increase the value) and down (decrease the value).
      High: Briefly press the button to select "High". Long press the button to set the upper limit prompt of pulse or SpO_2. Make sure that the direction in which you want to change the value is correctly set to up or down. Lower limit can not exceed the upper limit.
      Low: Briefly press the button to select "Low". Long press the button to set the lower limit prompt of pulse or SpO_2. Make sure that the direction in which you want to change the value is correctly set to up or down. Lower limit can not exceed the upper limit.
      Exit: Briefly press the button to select "Exit", then long press the button to exit and return to the alarm menu.

Cleaning, Transportation and Storage

• Please change the batteries when the low-voltage is being 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 on air or clean it with 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

Function Specification

• 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 special patients, there should be a more prudent inspection in the placing process. The device can not be clipped on the edema and tender tissue.
• The light (infrared is invisible) emitted from the device is harmful to the eyes, so the user and maintenance personel 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 diagnosis.

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. In case of 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 accessory appointed or recommended by manufacture can be used with this device.
• This product is calibrated before leaving factory.

• 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 is being 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 have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol on soft tissue. 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' SpO2 and pulse rate, please clip a thicker 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 15kg and 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.
• 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 an estimated lifespan of three years from the first electrified use.
• The hanging rope attached to the device 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 on the purpose of avoiding harm to the patient
• This device includes a alarmfunction, users can check this according to chapter "Operating Guide".
• The device has the function of limits alarming, when the measured data is beyond the highest or lowest limit, the device would start alarming automatically on the premise of the alarming function is on.
• The device has the function of alarming, this function can either be paused, or closed (default setting) for good. This function could be turned on through menu operation if you need. Please check the chapter "Operating Guide" as a reference.
• 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.
• 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 (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). This device is not intended for continuous monitoring.

Novidion GmbH
Fuggerstr. 30
51149 Cologne
Germany
Tel.: +49 (0) 2203/9885 200
Fax: +49 (0) 2203/9885 206
www.pulox.de
Mail: info@novidion.de