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Oxygen Saturation Monitor PULSOX ™ -2 INSTRUCTION MANUAL.
For North America UL, C_ UL: WITH RESPECT T O ELECTRIC SHOCK, FIRE AND MECHANI- CAL HAZARDS ONL Y IN ACCORDANCE WITH UL 2601-1, CAN/ CSA C22.2 No.601.1 MEDICAL EQUIPMENT ( 70SA ) For Europe CE (Medical Device Directive): This instrument complies with EN60601-1, EN60601-1-2, EN1441, EN46001.
1 SAFETY PRECAUTIONS T o 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. W ARNING (Failure to adhere to the following points may result in death or serious injury .
2 CAUTION (Failure to adhere to the following points may result in injury or damage to the instrument or other property .) Do not use batteries other than those specified by MINOL T A. When installing batteries in the instrument, make sure that they are correctly oriented according to the (+) and (–) marks.
4 1. BEFORE OPERA TION Safety Notes CAUTION: 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 (SpO 2 ) of arterial blood and the pulse rate.
5 2. NAMES OF P ARTS ■ Main unit Battery cover: Open or close this cover when replacing the batteries with new ones. Battery cover: It is used to lock the battery cover . lock Strap eyelet: Attach the neck strap to this hook. Finger holder: Holds finger when inserted for measurement.
6 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.
7 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.
8 4. OPERA TING METHOD Preparations (1) Installing Batteries (T wo AAA-size batteries are required.) 1. Push the battery cover , and unlock the battery cover lock. 2. Open the battery cover . 3. Insert two AAA-size batteries into the battery chamber .
9 5. Close the battery cover lock until it clicks. • The batteries will last approxi- mately 80 hours. • The battery mark will begin to blink when the battery power is low . 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.
10 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. Y ou must not put the thumb on other positions. Don't take the pressure which is unnecessary for the forefinger .
11 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.
12 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 .
13 How to Read the Measurement V alues 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.
14 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 . • Once the backlight is lit, it will remain lit until measurement stops.
15 Error Messages ■ Messages relating to connection of the finger holder and attachment to the patient.
16 ■ Messages relating to the condition of the main unit.
17 5. TROUBLESHOOTING ■ Main Unit.
18 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 .
19 10. SPECIFICA TIONS PULSOX-2 ■ Dual-wavelength pulse-type oximeter ■ Functions: • Measuring range: SpO 2 : 0 to 100% Pulse rate: 20 to 250 bpm • Accuracy: SpO 2 ± 2% (SpO 2 :70 to 100%, 1 s.
20 1 1. REFERENCE Measurement Principle Oxygen Saturation Monitor PULSOX-2 is a photometric instrument that non-invasively and continuously measures the oxyhemoglobin saturation of arterial blood (SpO 2 ) and the pulse rate.
21 Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation (SpO 2 , %) and oxygen partial pressure (PaO 2 , torr or mmHg) is shown in the graph below . SpO 2 is the oxygen saturation as measured by pulse oximeters.
22 EMC Declaration.
23.
9222-1731-13 Minolta Co.,Ltd. 3-13, 2-Chome, Azuchi-Machi,Chuo-Ku, Osaka 541-8556, Japan 2003 Minolta Co., Ltd. ADDAPX ( 1 ) Printed in Japan.
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