KONICA Oxygen Saturation Monitor PULSOX 2 Instruction Manual

Table of Contents

Oxygen Saturation MonitorPULSOX™-2Instruction Manual

Safety Symbols

Warnings and precautions noted in this manual are indicated by the following markings, designed to prevent accidents caused by erroneous handlingof 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 that 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 that is prohibited.Never disassemble the product or unit.This symbol indicates the type BF applied part.The instrument provides 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.IPX4 This symbol indicates Splash-proof equipment.Authorized StandardsFor North AmericaUL, C_ UL:

WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICALHAZARDS ONLY IN ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2 No.601.1

MEDICAL EQUIPMENT (70SA)For EuropeCE (Medical Device Directive):

This instrument complies with EN60601-1, EN60601-1-2, EN14971, EN13485.

SAFETY PRECAUTIONSTo ensure the 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.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.This device is designed to measure the oxygen saturation level (SpO2) and the pulse rate. It should not be used as a warning device to detect cessation of breathing or irregular breathing during sleep.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. When installing batteries in the instrument, make sure that they are correctly oriented according to the (+) and (–) marks. For a model which uses more than one battery, do not mix new and old batteries, or mix batteries of different types. Failure to adhere to these instructions may cause an explosion of the batteries or leakage of electrolyte, resulting in ﬁre, injury or corrosion.Do not place the instrument on an unstable or sloping surface. Doing so may result in its dropping or overturning, causing injury. Take care not to drop the instrument when carrying it.Do not operate the instrument for long periods of time with a ﬁnger holder at- tached to a patient. Low-temperature burn, redness or rash may result. If you feel pain or itchiness, stop the use of the instrument immediately and consult a doctor. A doctor should also be consulted before using the instrument on infants, those with peripheral blood circulation problems or those with sensitive skins.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 wet batteries. Do not use an instrument if the battery compartment contains water. Doing so may cause explosion or heat generation, resulting in ﬁre or injury.Do not disassemble or modify the instrument. Doing so may cause a ﬁre or electric shock.

BEFORE OPERATION

Safety NotesCAUTION: 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 the 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.

Package ContentsMake sure that all the following items are supplied with the instrument.

PULSOX-2 main unit (×1)
Neck strap NS-M (×1)
AAA-size alkaline battery (×2)

Main FeaturesThis pulse-type oximeter emits light to the user’s ﬁnger to measure the oxygen saturation (% SpO2) of arterial blood and the pulse rate.

Compact, lightweight, and portableThe lightweight, compactness, and portability of the PULSOX-2 allow it to be used for inspection of both outpatients and inpatients. In addition, it is easily transported by both doctors and nurses for house calls or home-care patients.
Battery-operatedThe PULSOX-2 is operated by two AAA-size alkaline batteries.

NAMES OF PARTS

■ Main unit

Battery cover: Open or close this cover when replacing the batteries with new ones.Battery cover lock: It is used to lock the battery cover.Strap eyelet: Attach the neck strap to this hook.Finger holder: Holds ﬁnger when inserted for measurement.A light source is located on the upper side and a sensor on the lower side.Thumb rest: Put the thumb here when you hold this instrument.Display: Displays measured value, pulse level meter, and error messages.

NOTES ON USE

This instrument should be used in areas with an ambient temperature of 0 to 40°C (32 to 104°F) and 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 instrument conforms to the water-seal rating of IPX4 (IEC 60529), which ensures that the instrument will show no adverse damage even if exposed to water splashing from any direction. However, the instrument is not waterproof, so it should never be washed with water or left immersed in water.
When the water remains in the ﬁnger holder, the measurement value is not accurate. Turn the part of the strap eyelet to the bottom, and remove the water.
This instrument should not be used in areas subject to strong vibrations, nor should it be subjected to physical shock. Doing so may cause a breakdown.
The ﬁnger holder is a delicate device and should not be handled roughly nor should objects be placed on top of it.
The accuracy of this instrument, like that of all other dual-wavelength oximeters, can be inﬂuenced by the presence of abnormal hemoglobins such as carboxyhemoglobin (HbCO) and methemoglobin. Tables 1 and 2 below show the errors which may occur due to these hemoglobins. The instrument may also be affected by cardio green or intravascular dyes.<Table 1>

Sa02 H HbCO

1% 5% 10%

50 -0.1 -0.7 -1.5

70 -0.1 -0.7 -1.5

90 -0.2 -0.8 -1.6

100 -0.2 -0.8 -1.7

The measured value is always lower than the actual value.<Table 2>

Sa02 Methemog obin

1% 5% 10%

50 +0.2 +1.3 +3.2

70 -0.6 -2.3 -3.2

90 -1.5 -6.0 -9.6

100 -1.8 -7.5 -12.2

The displayed value is sometimes higher than the actual value if Sa02 is around 50%.
Do not use a mobile telephone when using this instrument. Doing so may result in measurement errors.
This instrument may interfere with the magnetic resonance imaging (MRI) procedure.
The disposal method of AAA batteries varies according to local government regulations.
Dispose of the battery according to the instructions given by local government regulations or ask a specialized waste service company to dispose 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 medical 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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other devices are connected.
Consult the manufacture or ﬁeld service technician for help.

OPERATING METHOD

Preparations(1) Installing Batteries(Two AAA-size batteries are required.)

Push the battery cover, and unlock the battery cover lock.
Open the battery cover.
Insert two AAA-size batteries into the battery chamber.
Close the battery cover and hold it with a ﬁnger.
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

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.

(2) Installing the Neck StrapBy attaching the neck strap to the instrument, the instrument can be hung from the neck.

Pass the neck strap through the strap eyelet as shown in the ﬁgure.

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 accurate measurement.

Open the ﬁnger holder.
Insert the index finger and release the ﬁnger holder.• Opening the finger holder will start measurement automatically.

The ﬁnger should be put in the position shown in the ﬁgure below.

Safety NotesThis 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 bloodstream problems. In this case, remove the ﬁnger holder, rub or warm the ﬁnger to improve blood circulation, then re-attach the ﬁnger holder.
Do not use the instrument in areas where it is exposed to strong right such as direct sunlight.

Notes on Measurements

Check that the pulse level meter changes in synchronization with the pulse rate during measurements. In the following cases, the level meter may not operate properly, hindering the display of correct values. Rapid body movement
The finger Holder is not attached to the patient properly.
Arm or ﬁnger is pressed, causing bad blood circulation.
When using the instrument, take care not to expose the ﬁnger holder to strong light.

Ending Measurements

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.

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 enter constantly indicates level 2 or higher.)

Calculation method for displayed valuesOxygen saturation value (SpO2 ):The value obtained by performing moving average for the last 5 seconds is updated and displayed every second.Pulse rate (P.R.):The value obtained by performing moving average for the last 8 pulse rates is updated and displayed every second.

Back LightThe backlight will light up automatically when the surroundings become dark.When the 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.
When the battery mark is blinking, the backlight isn’t turned on. Please replace the battery.

Error Messages

■ Messages relating to the connection of the ﬁnger holder and attachment to the patient

Error Messages	Cause	Solution
	• Insufficient light for measurement.• Strong light enters the finger holder’s sensor directory.	• 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. If the finger holder is properly attached but this message still appears, the circulation in the area being measured may not be good. If this occurs, warm up the measurement location.
The MeasurementValue andflash alternately	• The pulse is weak and the pulse signals required for the means urement are not obtained. The measurement value is displayed, however, the accuracy of the means urement values can not be guaranteed. Thus, the measured value must be considered as guidance only.	• Attach the finger holder to the body correctly. If this message is displayed when the unit is attached to the patient correctly, the measurement conditions are regarded as blood circulation or other circulatory problems. If this occurs, warm up the measurement locations.• In particular, when the pulse is weak, this error tends to occur. For improved measurement accuracy, if the finger holder is exposed to strong light, wrap it with a piece of black cloth, etc. Also, make sure that the patient rests calmly to avoid the influence of body movement.
The Measurement Value and	• 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 exceeds the upper limit (250 bpm) of the measurement range.	• Measurement cannot be performed when the upper limit of the measurement range is exceeded.

TROUBLESHOOTING

■ Main Unit

Error Messages	Cause	Solution
• Display disappeared in the middle of measurements.• No display appears when the finger holder was opened and the measurement was started.	• Is battery power exhausted?	• Turn the POWER switch OFF and replace the two batteries (AAA-size) with new ones.	P.6
• Are batteries oriented correctly (+ and – marks)?	• Make sure that the batteries are oriented correctly.	P.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.

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. For protection, this instrument should be stored with a drying agent such as silica gel
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 sulfurous atmospheres may affect the instrument.• Do not store the instrument on an inclined surface or on a surface that 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 and finger holders are cleaned and stored safely.
If the PULSOX-2 will not be used for more than two weeks, remove batteries to avoid the possibility of damage due to leakage of electrolyte.

Maintenance and inspections

Before using the instrument, carefully check that the instrument is operating safely and correctly.

Cleaning

When cleaning the main unit, clean it with a cloth moistened with neutral detergent or water. Never clean it by any other method or with any kind of solvent.
When cleaning a ﬁnger holder, clean it using a soft cloth moistened with ethyl alcohol or cationic soap, and wipe it off using a dry soft cloth or dry it naturally.

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.)Pulse rate: ±2 bpm■ DisplayDisplay type: Liquid crystal displayOxygen saturation (SpO2 )Pulse rate numberPulse level meterError messages■ Operating temperature/humidity range0 to 40°C (32 to 104°F); 30 to 95% relative humidity with no condensation■ Storage temperature/humidity range–10 to 60°C (14 to 140°F); 30 to 95% relative humidity with no condensation■ Power2 AAA-size batteries 3V 80mW(This instrument can use about 80 hours continuously when the use of the AAA alkaline battery.)■ Dimensions (W × H × D)69 × 60 × 28 mm■ Weight57 g■ AccessoryStandard Accessory: Neckstrap■ Equipment Classiﬁcation

Protection against electric shock: Internally powered
Type of applied part: BF
Degree of protection against harmful ingress of water: Splashploof equipment (IPX4)
Not suitable for use in the presence of ﬂammable anesthetic mixture with air or oxygen or nitrous oxide.
Mode of operation of Equipment: Continuous while in Use (IEC 60601-1)

REFERENCE

Measurement PrincipleOxygen Saturation Monitor PULSOX-2 is a photometric instrument that non-invasively and continuously measures the oxyhemoglobin saturation ofarterial blood (SpO2) and the pulse rate. SpO2 is described by the equation:

whereC (Hb): Concentration of reduced hemoglobinC (HbO2): Concentration of oxyhemoglobinThe light-absorption characteristics of reduced hemoglobin (Hb) are very different from those of oxyhemoglobin. The PULSOX-2 measures the changes in the absorption of red and infrared lights passing through the tissue to determine the SpO2 of the blood. Thus, this method is free from the effects of skin color, muscles, bones, and veins.Spectral Absorption of Hb and HbO2

Relation between Oxygen Saturation and Partial PressureThe 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

The curve of the above graph may shift to the right or left according to the pH of the blood or the body temperature. (Shift to right: acidosis, high body temperature; shift to left: alkalosis, low body temperature)

EMC Declaration

Guidance and manufactureʼs 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	Electromagnetic environment – guidance
RF emissionsCISPR 11	Group 1	The Model PULSOX-2 uses RF energy only for its internal function. Therefore its RF emissions are very low and are not likely to cause any interference in nearby electromagnetic equipment.
RF emissionsCISPR 11	Class B	The Model PULSOX-2 is suitable for use in all establishments, including domestic establishments.
Harmonic emissionsIEC61000-3-2	Not applicable
Voltage ﬂuctuations/ ﬂicker emissionsIEC61000-3-3	Not applicable

Guidance and manufactureʼs 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	IEC 60601Test level	Compliancelevel	Electromagnetic environment guidance
ElectromagneticDischarge (ESD)IEC61000-4-2	6 kV contact8 kV air	6 kV contact8 kV	Floors should be wood, concrete or ceramic tile, if ﬂlors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fastTransient/burstIEC61000-4-4	Not applicable
SurgeIEC61000-4-5	Not applicable
Voltage dips, short Interruptions, and Voltage variations on power supply Input lines IEC61000-4-11	Not applicable
Power frequency (50/60Hz) magnetic ﬁeld IEC61000-4-8	Not applicable

Guidance and manufactureʼs 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	IEC 60601 Test level	Compliance level	Electromagnetic environment guidance
Conducted RF IEC61000-4-6	Not applicable
Radiated RFIEC61000-4-3	3 V/m80MHz to 2.5GHz	3 V/m	Portable and mobile RF communications equipment should be used no closer to any part of the PULSOX-2, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strength from ﬁxed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aﬀected by absorption and reﬂection from structures, objects, and people.
a Field strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephone and land mobile radios, amateur radio, AM, and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the PULSOX-2 is used exceeds the applicable RF compliance level above, the PULSOX-2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PULSOX-2.b Over the frequency range 150kHz to 80MHz, ﬁeld strengths should be less than 3V/m.