P300 OXYGEN SATURATION MONITOR Instruction Manual PDF download

OXYGEN SATURATION MONITOR

PULSOX -300 ®

Instruction Manual

This instrument must be used according to the instructions of the doctor.

Safety Symbols Warnings and precautions noted in this manual and the instrument 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. Always follow the instructions carefully. This indicates an action which is prohibited. Never disassemble the product or unit. This symbol indicates that has no alarm function is prescribed in IEC60417-5319. This symbol indicates type BF equipment. The instrument provide a particular degree of protection against electric shock, particularly the leakage current and reliability of the protective earth connection with an F-TYPE APPLIED PART. F-TYPE APPLIED PART indicates applied part isolated from all other parts of the instrument to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1.1 times the highest rated mains voltage is applied between the applied part and earth. This symbol indicates D.C.

Authorized Standards For North America UL, C_ UL:

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1, CAN/CSA C22.2 No.601.1 For Europe CE (Medical Device Directive): This instrument complies with EN60601-1, EN60601-1-2, EN14971, EN13485.

Foreword

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.)

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. Do not use the instrument in places where ﬂammable or combustible gases (anesthetic gas etc.) are present. Doing so may cause a ﬁre. Do not disassemble or modify the instrument and accessories. Doing so may cause a fire or electric shock. The instrument should not be operated if it is damaged, or smoke or odd smells occur. Doing so may result in a ﬁre. In such situations, turn OFF the power immediately, remove the battery, and contact the nearest authorized service facility. Do not put the batteries on a ﬁre, short-circuit them, heat them or disassemble them. Doing so may cause explosion or heat generation, resulting in ﬁre or injury. 1

Foreword

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 KONICA MINOLTA SENSING, INC. When installing batteries in the instrument, make sure that they are correctly oriented according to the mark. If alkali ﬂuid from the battery comes in contact with eyes, skin, or clothing, immediately wash the affected area and see a physician for treatment. Do not use probes other than those specified by KONICA MINOLTA SENSING, INC. Use of alternative probes may cause the probe to overheat, resulting in burns. Do not operate the instrument for long periods of time with a probe attached to a patient. Lowtemperature burn, redness or rash may result. If you feel pain or itchiness, stop use of the instrument immediately and consult a doctor. A doctor should also be consulted before using the instrument on patients with high fever, those with peripheral blood circulation problems or those with sensitive skins.

2

Safety Symbols Safety Precautions ...1 Foreword ...4

Foreword

Contents Safety Notes ... 4 Package Contents ... 5 About Probe ... 5 System Diagrams and Accessories ... 6 Names of Parts ... 7 Notes on Use ... 8 Notes on Storage ... 10 Disposal Method ...11

Preparations ...12

1) Attaching the Wrist Band ... 12 2) Connecting the probe ... 13 3) Installing the battery ... 14

Measurement ...15

1) Starting the Measurement (Power ON) ... 15 2) Reading the display ... 16 3) Ending the Measurement (Power OFF) ... 17 About Auto Power-Off function... 17

Trouble Shootings ...18

Error Messages ... 18 Check Points before repairing ... 22 Maintenance and Inspection ... 22 Cleaning ... 22

Speciﬁcation ...23 Appendix ...25

Calculation Method for Displayed Values ... 25 EMC Guidance ... 26 Measurement Principle ... 28 Relation between Oxygen Saturation and partial Pressure ... 29 3

Foreword

Foreword Safety Notes CAUTION: Federal law restricts this device to sale by or on the order of a physician. The instrument is designed for measurement of the oxygen saturation (SpO 2 ) of arterial blood and the pulse rate. Do not use it for any other purposes, such as warning of sleep apnea and breathing abnormalities.

The Oxygen Saturation Monitor PULSOX-300 is designed to measure oxygen saturation (SpO 2 value) in arterial blood and pulse rate by attaching a probe to an adult ﬁnger, in a non-invasive method. PULSOX-300 is intended for spot check use. • The compact, lightweight and portable body has a large LED display for easy operation.

4

Before using the instrument, make sure that the following items are present. 1) PULSOX-300 main body × 1 2) Wristband WB-300 × 1 3) AAA-size alkaline battery × 1 4) Instruction manuals • PULSOX-300 instruction manual × 1 • Separate manual (Using manual for Probes) × 1 ✻ The probe is optional.

Foreword

Package Contents

About Probe

The following probe types can be used with this instrument. • Finger Clip Probe SR-5C • Spot Check Probe SP-5C • Monitor Probe LM-5C • Personal Probe SD-5C ◆ As shown in the table below, the measuring point varies with the probe used, so select the one that is suitable for your purpose. Probe type SR-5C SP-5C LM-5C SD-5C

Patient

Allowed measuring point Adult

Finger (hand)

◆ For the usage method, please refer to “Connecting the probe” (page 13) on this manual and the probeʼs instruction manual.

5

Foreword

System Diagrams and Accessories The instrument consists of the following items. Standard accessories Optional accessories

Optional accessories Finger Clip Probe SR-5C

Extension cable EC-300

Spot Check Probe SP-5C

�� Monitor Probe LM-5C

Personal Probe SD-5C

Standard accessories

Wristband WB-300

AAA-size alkaline battery

6

Foreword

Names of Parts Power button

Used to start/end measurement.

PULSOX-300

Display (LED)

Measurement results and messages are displayed.

Probe connector

Connect the probe to this connector.

Battery cover

The cover can be opened by turning it approximately 90 degrees.

Wristband

Used to set the instrument on your wrist. 7

Foreword 8

Notes on Use • This instrument should be used under the following operating conditions. • Temperature of 0 to 40°C (32 to 104°F), relative humidity of 30 to 85%, with no condensation. • Atmospheric pressure of 700 to 1060 hPa (altitude of –400 to 3000m). • 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. • Do not expose this instrument to rain and water. • This instrument has no alarm function. Do not use this instrument if an alarm function is necessary. • This instrument is designed for use on adults. When using the instrument on infants or babies, please note that the designed measurement accuracy cannot be guaranteed. • Do not use the instrument on a point where there is excessive vibration. In addition, to avoid excessive impact on the instrument, it should be handled gently. Failure to observe this may cause breakdown. • Accurate measurement data may not be obtained in the following cases. • When body movement is excessive • When the probe is not attached properly • When blood circulation at the measuring point is poor (due to pressure on arm/finger, peripheral circulatory insufficiency) • When ambient light (e.g. panel light, ﬂuorescent light, infrared heat lamp, direct sunlight) is too strong • When inﬂuenced electromagnetically by other electronic devices (e.g. near electrical appliances like TV, medial device) • When a mobile telephone is used during measurement

•

• •

Foreword

•

When influenced by abnormal hemoglobin like carbon monoxide hemoglobin (HbCO) and methemoglobin When pigments such as cardiogreen, intravascular dyes and indocyanine greenare present in the blood When ﬁnger nails are polished

Tables 1 and 2 below show the errors which may occur due to these hemoglobins. Difference from the SaO2 value to displayed value <Table 1> <Table 2> HbCO Methemoglobin SaO2 SaO2 1% 5% 10% 1% 5% 10% -0.1 -0.7 -1.5 +0.2 +1.3 +3.2 50 50 70 70 -0.1 -0.7 -1.5 -0.6 -2.3 -3.2 90 90 -0.2 -0.8 -1.6 -1.5 -6.0 -9.6 100 -0.2 -0.8 -1.7 100 -1.8 -7.5 -12.2 Displayed value is sometimes Measured value is always lower than the actual value. higher than the actual value if SaO2 is around 50%.

9

Foreword 10

Notes on Storage • This instrument should be stored under the following storage conditions. • Temperature of –10 to 60°C (14 to 140°F), relative humidity of 10 to 95%, with no condensation. • Atmospheric pressure of 700 to 1060 hPa (altitude of –400 to 3000m). • When storing the instrument: • Do not store the instrument in an area where it will be exposed to water. • Do not store the instrument in an area where direct sunlight, pressure, temperature, humidity, ventilation, sunlight, dust, strong magnetic ﬁelds, and/or saline or sulphurous atmospheres may affect the instrument. • Do not store the instrument on an inclined surface or on a surface which may be subject to vibrations or physical shock. (Also avoid vibrations or physical shock during transportation.) • Do not store the instrument in areas where chemicals are stored or where gas may be emitted. • To avoid any problems occurring the next time the instrument is used, make sure the instrument, cords, probes and other accessories are cleaned and stored safely. • If the instrument will not be used for more than 2 weeks, remove the batteries from the battery to avoid the possibility of damage due to leakage of electrolyte.

• When disposing of the used battery, insulate the polarity terminals with insulating tape etc. If the terminals of the battery come into contact with metal objects, heat generation, explosion or ﬁre may result. • Make sure that the battery is either disposed of or recycled correctly in accordance with local laws and regulations.

Foreword

Disposal Method

11

Preparations Preparations

Before starting measurements using this instrument, follow the procedure given below to ensure that measurements are stable.

1) Attaching the Wrist Band

Attach the Wrist Band WB-300 (supplied as a standard accessory) to the instrument. Since the WB-300 is made of elastic material, it allows for ﬂexibility and comfort of ﬁtting on the wrist.

Procedure

1 2

Place the instrument with its rear side up. Pass the angled tip of the hook-and-loop tape of the wristband outward through band ﬁxture A.

◆ When doing so, make sure that the Velcro tape section faces upward.

3

12

Fold up the inserted hook-and-loop section, and stick it firmly to the band.

Band ﬁxture A

4

Pass the other end of the band outward through band ﬁxture B.

Band ﬁxture B

◆ Take care not to twist the band.

Preparations

5

Fold back and secure the band with the hookand-loop tape section.

◆ When attaching the instrument to an arm, adjust the band length and fitting at this hookand-loop tape section.

2) Connecting the probe Connect the probeʼs connector plug into the Probe Connector on the instrument. ◆ Make sure that probeʼs connector plug is oriented correctly. ◆ Do not connect it in with excessive force. Doing so may damage the connector. ◆ Do not touch the connector terminals by hand. Contact failure may occur.

*Connecting the extension cable EC-300 between the PULSOX-300 and the probe extends the probe cable to a total length of 1m.

Extension Cable EC-300 (1m)

13

3) Installing the battery Procedure Preparations

1

2

Turn the battery cover clockwise approximately 90 degrees to open the cover.

◆ When turning the c o v e r, k e e p t h e f l a t part of your finger on the coverʼs catch. This facilitates opening the cover with minimum force.

Insert the battery into the battery compartment according to the polarity mark ( )shown on the rear of the instrument. ◆ This instrument requires one AAA-size battery.

3

Turn the battery cover counter-clockwise approximately 90 degrees to close it. ◆ Introduction of a new mechanism locks the cover automatically when it is closed.

14

Measurement 1) Starting the Measurement

1 2

Attach the probe to a ﬁnger of an adult patient. Press the Power button.

PULSOX-300

Measurement

● The Power is ON, all the elements on the display are displayed for about 2 seconds, and then the display changes to the measurement display. ◆ Until the measurement value has been calculated and displayed, "---" will be displayed as the values of the oxygen saturation (SpO2) and the pulse rate.

all the elements on the display are displayed for about 2 seconds

the measurement value is displayed and then the measurement is started 15

2) Reading the display When the instrument is turned ON, all the elements of the LED will light up. The pulse level, pulse rate and SpO 2 value are displayed during measurement.

Battery indicate

Measurement

Flashing when battery is nearly empty.

Pulse Level Meter

Indicate the pulse level.

✻ For stable measurement, make sure that the pulse level meter lights up two or more segments by adjusting the measuring point or rubbing or warming it up to improve blood circulation.

16

Pulse rate (P.R.)

If an error occurs, an error message mainly a b o u t P. R . w i l l b e displayed.

Oxygen saturation (SpO2) value If an error occurs, an error message mainly about SpO2 will be displayed.

3) Ending the Measurement Press the Power button, the measurement is finished and the Power is off.

PULSOX-300

The instrument has an auto power-off function that operates independently. If no probe is connected to the PULSOX ("C" blinks) or no probe is attached to the patient ("L" blinks) continuously for more than 2 minutes, the Power is automatically switched off.

Measurement

About Auto Power-Off function

17

Trouble Shootings Error Messages

The instrument display error messages when the error occurs. Check and correspond to them correctly. ��

Check Points

��

18

��