P300i OXYGEN SATURATION MONITOR Instruction Manual

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. When attaching the probe to a patient for use during sleep, care must be taken to avoid the cable from becoming twisted around the neck of the patient, for instance when he/she turns over.

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Foreword

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

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 ... 14 3) Installing the battery ... 15 4) Attaching the PULSOX to the wrist ... 16

Measurement ...17

1) Starting the Measurement (Power ON) ... 17 2) Reading the display ... 19 3) Ending the Measurement (Power OFF) ... 20 About Auto Power-Off function... 20 Regarding the memory function ... 20

External Connection ...21 Trouble Shootings ...23

Error Messages ... 23 Check Points before repairing ... 28 Maintenance and Inspection ... 28 Cleaning ... 28

Specification ...29 Appendix ...31

Calculation Method for Displayed Values ... 31 EMC Guidance ... 32 Measurement Principle ... 34 Relation between Oxygen Saturation and partial Pressure ... 35 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-300i is designed to measure oxygen saturation (SpO2 value) in arterial blood and pulse rate by attaching a probe to a peripheral part of the body, such as a finger, in a non-invasive method. PULSOX-300i is intended for continuous data-collection use such as during a sleep study and not for traditional continuous use. • The compact, lightweight and portable body has a large LCD for easy operation. • The LCD has a backlight function, providing high visibility even in dark areas. • Built-in memory enables storage of up to 300 hours of measured data. • Use of the optional software allows you to set the date/ time and to set the auto-power-off time on the PULSOX300i. In addition, the measured data stored in the memory can be processed, stored collectively or output via a printer using a personal computer.

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

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 14) on this manual and the probeʼs instruction manual.

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Foreword

Package Contents

Foreword

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

Optional accessories Finger Clip Probe SR-5C

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Extension cable EC-300

Spot Check Probe SP-5C

Monitor Probe LM-5C

USB adapter UA-300 Personal Probe SD-5C

Standard accessories Wristband WB-300

AAA-size alkaline battery

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Foreword

Names of Parts Power button

Used to start measurement (Power-ON) or end measurement (Power-OFF).

PULSOX-300Xi

LCD Display

(with the backlight function)

Measurement results and messages are displayed.

Backlight button

Press it to turn ON the backlight of the LCD.

Probe connector

Connect the probe or extension cable EC-300 to this connector.

External output terminal

Connect the optional USB adapter “UA-300” to connect the instrument to a personal computer.

Battery cover

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

Wristband

Used to set the instrument on your wrist. 7

Foreword

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. • A maximum of 300 hours of measurement data can be stored, or the maximum storable number of data files is 399 files. If measurements are continued after the maximum number of storable data has been reached, the new data will overwrite the oldest data. To keep data, be sure to download it before the memory becomes full. • 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 8

• • • • •

When influenced electromagnetically by other electronic devices (e.g. near electrical appliances like TV, medial device) When a mobile telephone is used during measurement 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%.

• Do not immerse the probe, the extension cable or the connecter of PULSOX-300i in disinfectant. Doing so may cause a malfunction. • When using the Extension Cable EC-300, fit and secure cables so they are not too loose or too tight. •

Before connecting to a personal computer, remove the Pulsox from the patient.

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Foreword

•

Foreword

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. • The time/date set to the instrument using the optional software will be reset to the factory setting (Jan. 1, 2000/0:00) if the instrument is left for more than one day without the battery. • The measurement data and the auto power-off time set to the instrument using the optional software will be kept even if the instrument is left without the battery. 10

• 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.

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Foreword

Disposal Method

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.

1

Place the instrument with its rear side up.

2

Pass the angled tip of the hook-and-loop tape of the wrist band outward through band fixture A.

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

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hook-and-loop section

Band fixture A

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

4

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

Preparations

3

Band fixture B

◆ Take care not to twist the band.

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.

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2) Connecting the probe

Preparations

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.

<When using the Extension Cable EC-300>

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

Extension Cable EC-300 (1m)

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3) Installing the battery

2

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

Preparations

1

◆ 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.

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4) Attaching the PULSOX to the Wrist

Preparations

1

Remove the hook-andloop section of the band from the side with no probe connector.

2

Attach PULSOX-300i to the arm by inserting your hand through the Wrist Band.

3

Adjust the fastening position of the hook-andloop tape to adjust the tension of the Band.

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Measurement 1) Starting the Measurement Connect the probe to the PULSOX-300i correctly. Press the Power button for a long time, the Power is ON, the backlight is ON, and all the elements on the display is displayed.

◆ After 30 seconds since the Power is ON, the Backlight is OFF automatically. ◆ Pulse wave mark will also be displayed in the pulse wave saving mode.

3

As shown the right, the setting date for today is displayed.

◆ By default, the date/time has been set to Jan. 1, 2000/0:00, and it is displayed in the order of “ʼ00”, “1 1” and “0-00”. The correct date/time can be set to the instrument using the optional software.

Measurement

1 2

➀Display the Year as A.D.

➁Display the Month and the Day month day ➂Display the Time as 24 hours format hour minute 17

4

Next, it will cause the file number of the next measurement to appear.

◆ The measurement data obtained from power-ON (start of measurement) up to power-OFF (end of measurement) will be stored in one file.

Measurement

5

A file number is given to each set of measurement data (power-ON to power-OFF). (Maximum: 399 files)

And, if the time for AutoPower-Off was set in the instrument, the setting time is displayed.

◆ The time for Auto-Power-Off is set by using the optional software. ◆ If the time for Auto-Power-Off has not been set, this step will be skipped and the measurement display will appear.

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About 10 seconds after the Power is switched ON, measurements will be started and the measurement data at 1-second intervals will be stored in the memory of the PULSOX-300i.

Pulse level meter is started to indicate but the measuring data is not displayed yet.

◆ “---” is displayed until the measuring data is calculated.

<Regarding the measurement data>

The measuring data is calculated and displayed, and the measurement is started.

The measurement data includes the measurement values (SpO2 value, pulse rate, and error message information) and the file information (file number, date and time of start of measurements, and duration of measurement). 18