Oxygen Saturation Monitor PULSOX™-2 Instruction Manual 9222-1731-14_P-2.indd i 09.8.
Safety Symbols Warnings and precautions noted in this manual are indicated by the following markings, designed to prevent accidents caused by erroneous handling of the equipment. This indicates text consisting of a warning or precaution relating to safety. Please read the text carefully and use the equipment safely. This indicates an action which is prohibited. The prohibited action should never be carried out, under any circumstances. This indicates instructions concerning an action.
SAFETY PRECAUTIONS To ensure correct use of this instrument, read the following points carefully and adhere to them. After you have read this manual, keep it in a safe place where it can be referred to anytime a question arises. WARNING (Failure to adhere to the following points may result in death or serious injury.) Do not use the instrument in places where flammable or combustible gases (anesthetic gas etc.) are present. Doing so may cause a fire.
1. BEFORE OPERATION Safety Notes CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. The PULSOX-2 is a medical instrument, so instructions given by a doctor must be adhered to. The instrument is designed for measurement of the oxygen saturation (SpO2) of arterial blood and the pulse rate. Do not use it for any other purposes, such as warning of sleep apnea and breathing abnormalities.
2. NAMES OF PARTS ■ Main unit Finger holder Battery cover lock Strap eyelet Battery cover Display Thumb rest Battery cover: Battery cover lock: Strap eyelet: Finger holder: Thumb rest: Display: Open or close this cover when replacing the batteries with new ones. It is used to lock the battery cover. Attach the neck strap to this hook. Holds finger when inserted for measurement. A light source is located in the upper side, and a sensor in the lower side.
3. NOTES ON USE • • • • • • • • • • • This instrument should be used in areas with an ambient temperature of 0 to 40°C (32 to 104°F) and a relative humidity of 30 to 95%, with no condensation. This is a precision instrument. To avoid the possibility of it being damaged, the instrument should not be dropped nor should heavy objects be placed on top of it.
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001, Medical Device Directive 93/42/EEC . These limits are designed to provide reasonable protection against harmful interference in a typical medicitl installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
4. OPERATING METHOD Preparations (1) Installing Batteries (Two AAA-size batteries are required.) 1. Push the battery cover, and unlock the battery cover lock. 1 2. Open the battery cover. 3. Insert two AAA-size batteries into the battery chamber. 2 3 4. Close the battery cover and hold it with a finger. 4 6 9222-1731-14_P-2.indd Sec1:6 09.8.
5. Close the battery cover lock until it clicks. • The batteries will last approximately 80 hours. • The battery mark will begin to blink when the battery power is low. 5 Notes on Use • Battery replacement is the Only User Serviceable item. • When replacing the batteries with new ones, do not mix battery types or ages. • If the instrument will not be used for a long period of time, remove the batteries from the battery chamber. Also remove the batteries as soon as possible if they are dead.
Measurements Measurements must be taken with the index finger placed in the finger holder. This instrument must be held tightly. Put the thumb only on the thumb rest. You must not put the thumb on other positions. Don't take the pressure which is unnecessary for the forefinger. Those are important for the accurate measurement. 1. Open the finger holder. 2. Insert the index finger and release the finger holder. • Opening the finger holder will start measurement automatically.
Safety Notes This finger holder is designed only for use on the fingers of adults, so it should not be used on any other body parts. Never secure the finger holder with tape or such like. Doing so may cause hemostasia or dropsy. Notes on Use • • • • Remove nail polish before taking measurements. If no measurement values are displayed, attach the finger holder to a thinner finger to take measurements. It may not be possible to take measurements in case of blood circulation or blood stream problems.
Ending Measurements 1. Open the finger holder and remove the finger. • Measurement will stop automatically, and the display will go off after 10 seconds. Notes on Use • If the instrument will not be used for a long period of time, remove the batteries from the battery chamber. 10 9222-1731-14_P-2.indd Sec1:10 09.8.
How to Read the Measurement Values Pulse level meter: Indicates the pulse level in 8 levels (0 to 10%, full scale if 10% or higher). The pulse level is defined as follows. (For stable measurements, adjust the measuring point of the finger holder or rub or warm the measuring point to improve blood circulation, so that the pulse level meter constantly indicates level 2 or higher.
Back Light The backlight will light up automatically when the surroundings become dark. When backlight isn’t turned by the bright surroundings, cover the backlight sensor window with finger. Backlight sensor window • Once the backlight is lit, it will remain lit until measurement stops. • When battery mark is blinking, backlight isn’t turned on. Please replace the battery. 12 9222-1731-14_P-2.indd Sec1:12 09.8.
Error Messages ■ Messages relating to connection of the finger holder and attachment to the patient Cause Error Messages • Check that the finger holder is properly attached to the patient. Clean the light-source and sensor sections. Take measures to prevent direct entry of strong light to the finger holder. • Pulse signal required • for measurement is not being received. Check that the finger holder is properly attached to the patient.
■ Messages relating to the condition of the main unit Error Messages Cause Solution • Motion artifact • Attach the finger holder to the patient properly. If this message still reappears even though the finger holder is attached properly, keep the measuring point as stationary as possible. • The pulse rate ex- • ceeds the upper limit (250 bpm) of the measurement range. Measurement cannot be performed when the upper limit of the measurement range is exceeded.
5. TROUBLESHOOTING ■ Main Unit Error Messages • • Display disap- • peared in the middle of measurements. No display appears when the • finger holder was opened and the measurement was started. Cause Solution • Turn the POWER switch OFF and replace the two batteries (AAA-size) with new ones. P.5 Are batteries oriented • correctly (+ and marks)? Make sure that the batteries are oriented correctly. P.5 Is battery power exhausted? 15 9222-1731-14_P-2.indd Sec1:15 09.8.
6. In Case of Malfunction • If a malfunction occurs, contact the nearest authorized service facility. Never disassemble the unit or attempt to repair it yourself. 7. Maintenance and Storage • • This instrument should be stored at temperatures of between –10 and 60 °C (14 and 140°F) at 30 to 95% relative humidity. Do not store this instrument in areas subject to high temperatures or high humidity, and do not subject this instrument to sudden temperature changes which may result in condensation.
10. SPECIFICATIONS PULSOX-2 ■ Dual-wavelength pulse-type oximeter ■ Functions: • Measuring range: SpO2: 0 to 100% Pulse rate: 20 to 250 bpm • Accuracy: SpO2 ±2% (SpO2:70 to 100%, 1 S.D.
11. REFERENCE Measurement Principle Oxygen Saturation Monitor PULSOX-2 is a photometric instrument that non-invasively and continuously measures the oxyhemoglobin saturation of arterial blood (SpO2) and the pulse rate. SpO2 is described by the equation: SpO2 = where C (Hb): C (HbO2): C (HbO2) C (HbO2) + C (Hb) × 100 (% SpO2) Concentration of reduced hemoglobin Concentration of oxyhemoglobin The light-absorption characteristics of reduced hemoglobin (Hb) are very different from those of oxyhemoglobin.
Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation (SpO2, %) and oxygen partial pressure (PaO2, Torr or mmHg) is shown in the graph below. SpO2 is the oxygen saturation as measured by pulse oximeters. Oxygen Saturation vs. Oxygen Partial Pressure Oxygen Partial Pressure SpO2 % 100 90 85 80 70 60 50 40 Adult hemoglobin 30 pH=7.
EMC Declaration Guidance and manufacture s declaration - electromagnetic emissions The Model PULSOX-2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PULSOX-2 should assure that it is used in such an environment. Emissions test Compliance CISPR 11 Electriomagnetic environment - guidance The Model PULSOX-2 uses RF energy only for its RF emissions Group 1 internal function.
Guidance and manufacture s declaration - electromagnetic immunity The Model PULSOX-2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PULSOX-2 should assure that it is used in such an environment. Immunity test Conducted RF IEC 60601 Test level Compliance level Electromagnetic environment guidance Not applicable IEC61000-4-6 Radiated RF 3 V/m Portable and mobile RF communications IEC61000-4-3 80MHz to 2.
3-91, Daisen-nishimachi, Sakai-ku, Sakai-shi, Osaka 590-8551, Japan 9222-1731-16 © 2002-2013 KONICA MINOLTA, INC.
