MINOLTA Pulsox-2 Instruction and Maintenance Manual
Contents
1. batteries are oriented correctly 17 6 In Case of Malfunction e If a malfunction occurs contact the nearest authorized service facility Never disassemble the unit or attempt to repair it yourself f 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 e When storing the instrument e Do not store the instrument in an area where it will be exposed to water e 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 atmos pheres may affect the instrument e Do not store the instrument on an inclined surface or ona surface which may be subject to vibrations or physical shock Also avoid vibrations or physical shock during transportation e Do not store the instrument in areas where chemicals are stored or where gas may be emitted e To avoid any problems occurring the next time the instrument is used make sure the instrument and finger holders are cleaned and stored safely e If the PULSOX 2 will not be used for more than two weeks remove ba2. 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 instrument conforms to 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 water proof so it should never be washed with water or left immersed in water When the water remains in finger holder the measurement value is not accurate Turn the part of 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 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 cardiogreen or intravascular dyes Difference from the SaQz value to displayed value lt Table 2 gt Measure
3. by pulse oximeters Oxygen Saturation vs Oxygen Partial Pressure Adult hemoglobin pH 7 4 37 C Oxygen Partial Pressure SpO2 20 30 40 50 60 100 110 Torr PaO2 Oxygen Partial Pressure mmHg 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 21 22 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 ofthe Model PULSOX 2 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions The Model PULSOX 2 uses RF energy only for CISPR 11 its internal function Therefore its RF emissions Group 1 are very low and are not likely to cause any interference in nearby electromagnetic equipment RF emissions The Model PULSOX 2 is suitable for use in all CISPR 11 Class B establishments including domestic establishments Harmonic emissions IEC61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC61000 3 3 Not applicable Guidance and manufacture s declaration electromagnetic immunity The Model PULSOX 2 is intended for use in the electromagnetic environment sp
4. part BF Degree of protection against harmful ingress of water Splash ploof equipment IPX4 Not suitability for use in the presence of flammable anaesthetic mixture with air or oxygen or nitrous oxide Mode of operation of Equipment Continuous while in Use IEC60601 1 19 CI I A 20 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 SpOz and the pulse rate SpOz is described by the equation C HbO2 SpO2 C HbO 2 C Hb x 100 SpOz where C Hb Concentration of reduced hemoglobin C HbO2 Concentration of oxyhemoglobin The 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 SpOz2 of the blood Thus this method is free from the effects of skin color muscles bones and veins Spectral Absorption of Hb and HbO2 Red light Infrared light A O oO O Cc oO Fr Q pa O 22 Q lt x 665 700 800 880 900nm Wavelength Relation between Oxygen Saturation and Partial Pressure The relation between oxygen saturation SpO2 and oxygen partial pressure PaOz torr or mmHg is shown in the graph below SpOz is the oxygen saturation as measured
5. ACCORDANCE WITH UL 2601 1 CAN L US CSA C22 2 No 601 1 MEDICAL EQUIPMENT 70SA For Europe CE Medical Device Directive This instrument complies with EN60601 1 EN60601 1 2 0088 EN1441 EN46001 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 N WARNING Failure to adhere to the following points may result in death or serious injury S Do not use the instrument in places where flammable or combustible gases anesthetic gas etc are present Doing so may cause a fire S 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 S 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 A D o 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 MINOLTA When installing batteries in the instrument make sure that they are correctly oriented according to the and marks For a model which use more than one battery do not mix new and old ba
6. Oxygen Saturation Monitor PULSOX 2 INSTRUCTION MANUAL lt Z O gt 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 circum stances 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 type BF applied part 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 POS O amp IPX4 This symbol indicates Splash proof equipment Authorized Standards For North America UL C_ UL 11 7 amp l WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANI CAL HAZARDS ONLY IN
7. an outlet on a circuit different from that to which the other device s are connected e Consult the manufacture or field service technician for help 4 OPERATING METHOD Preparations 1 Installing Batteries Two 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 4 Close the battery cover and hold it with a finger 5 Close the battery cover lock until it clicks e The batteries will last approxi mately 80 hours e The battery mark will begin to blink when the battery power is low Notes on Use e Battery replacement is the Only User Serviceable item e When replacing the batteries with new ones do not mix battery types or ages e 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 Strap By attaching the neck strap to the instrument the instrument can be hung from the neck 1 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 a
8. cond 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 e Once the backlight is lit it will remain lit until measurement stops e When battery mark is blinking backlight isn t turned on Please replace the battery Error Messages mM Messages relating to connection of the finger holder and attachment to the patient Error Messages The Measure ment Value and flash alternately Insufficient light for measurement Strong light enters the finger holder s sensor directory Pulse signal required for measurement is not being received The pulse is weak and the pulse signals required for the meas urement are not ob tained The measure ment value is dis played however the accuracy of the measurement values Cannot be guaran teed Thus the meas ured value must be considered as guid ance only Check that the finger holder is properly attached to the patient Clean the light source and sensor sec tions Take measures to prevent direct entry of strong light to the finger holder 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 me asurement locati
9. d value is always Displayed value is sometimes lower than the actual value higher than the actual value if SaQz is around 50 Do not use a mobile telephone when using this instrument Doing so may result in measurement error This instrument may interfere with magnetic resonance imaging MRI procedure The disposal method of AAA batteries varies according to local government regulation 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 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 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 e Reorient or relocate the receiving device e Increase the separation between the equipment e Connect the equipment into
10. ecified below The customer or the user ofthe Model PULSOX 2 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment Test level level guidance Electromagnetic 6 kV contact 6 kV Floors should be wood concrete or Discharge ESD 8 kV air contact ceramic tile If floors are covered with IEC61000 4 2 8 kV air synthetic material the relative humidity should be at least 30 Electrical fast Transient burst IEC61000 4 4 Not applicable Surge IEC61000 4 5 Voltage dips short Interruptions and Voltage variations on power supply Input lines IEC61000 4 11 Power frequency 50 60Hz magnetic field IEC61000 4 8 Not applicable Not applicable Not applicable 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 IEC 60601 Compliance Electromagnetic environment test level level guidance Conducted RF Not applicable IEC61000 4 6 Radiated RF 3 V m Portable and mobile RF communications IEC61000 4 3 80MHZ to 2 5GHz 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 dis
11. on 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 lo cation 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 influence of body movement 19 E Messages relating to the condition of the main unit Error Messages Cause Solution e Motion artifact Attach the finger holder to the patient The Measure ment Value and D properly If this message still reappears even though the finger holder is attached properly keep the measuring point as I stationary as possible The pulse rate ex Measurement cannot be performed ceeds the upper limit when the upper limit of the measure 250 bpm of the ment range is exceeded measurement range 5 TROUBLESHOOTING E Main Unit Display disap peared in the middle of measurements No display ap pears when the finger holder was opened and the mea surement was started Is battery power ex hausted Are batteries oriented correctly and marks Turn the POWER switch OFF and re place the two batter ies AAA size with new ones Make sure that the
12. re important for the accurate measurement 1 Open the finger holder 2 Insert the index finger and release the finger holder e Opening the finger holder will start measurement automatically The finger should be put on the position shown in the figure below Measurement display A Proper attachment Finger is not sufficiently Finger is inserted too far inserted Measurement cannot be taken O x 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 lt may not be possible to take measurements in case of blood circulation or blood stream 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 light 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 display of correct values e Rapid body movement e Finger Holder is not at
13. should be less than 3V m 23 0 Minolta Co Ltd 3 13 2 Chome Azuchi Machi Chuo Ku Osaka 541 8556 Japan 9222 1731 13 2003 Minolta Co Ltd ADDAPX 1 Printed in Japan
14. tached to the patient properly e Arm or finger is pressed causing bad blood circulation When using the instrument take care not to expose the finger holder to strong light 11 Ending Measurements 1 Open the finger holder and remove the finger e Measurement will stop automatically and the display will go off after 10 seconds Notes on Use e 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 meter constantly indicates level 2 or higher Pulse level Variable transmittance x 100 Constant transmittance Battery indication The battery mark will be gin to blink when the bat tery power level is low For details regarding batteries refer to page 8 Pulse rate P R Oxygen saturation value SpO2 Pulse level meter Calculation method for displayed values Oxygen saturation value SpOz Value obtained by performing moving averaging for the last 5 seconds is updated and displayed every second Pulse rate P R Value obtained by performing moving averaging for the last 8 pulse rates is updated and displayed every se
15. tance d 1 2VP 80MHz to 800MHz d 2 3P 800MHz to 2 5GHz 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones 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 P Over the frequency range 150 kHz to 80MHz field strengths
16. the oxygen S 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 Contents Make sure that all the following items are supplied with the instrument 1 PULSOX 2 main unit x1 2 Neck strap NS M x1 3 AAA size alkaline battery x2 Main Features This pulse type oximeter emits light to the user s finger to measure the oxygen saturation SpO2 of arterial blood and the pulse rate e Compact lightweight and portable The light weight compactness and portability of the PULSOX 2 allows 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 e Battery operated The PULSOX 2 is operated by two AAA size alkaline batteries 2 NAMES OF PARTS E Main unit Finger holder Battery cover lock Battery cover N A Strap eyelet Pepe Thumb rest Battery cover Open or close this cover when replacing the batteries with new ones re cover It is used to lock the battery cover Oc Strap eyelet Attach the neck strap to this hook Finger holder Holds finger when inserted for measurement A light source is located in the upper side and a sensor in the lower side Thumb rest Put the thumb here when you hold this instrument Display Displays measured value pulse level meter and error messages 3
17. tteries or mix batteries of different types Failure to adhere to these instructions may cause 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 attached to a patient Low temperature 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 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 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 1 BEFORE OPERATION 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 Q doctor must be adhered to The instrument is designed for measurement of
18. tteries to avoid the possibility of damage due to leakage of electrolyte 8 Maintenance and inspections e Before using the instrument carefully check that the instrument is operating safely and correctly 9 Cleaning e When cleaning the main unit clean it with a cloth moistened with neutral detergent or water Never clean it by any other methods or with any kind of solvent e 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 10 SPECIFICATIONS PULSOX 2 mM Dual wavelength pulse type oximeter E Functions e Measuring range SpO2 0 to 100 Pulse rate 20 to 250 bpm e Accuracy SpO2 2 SpO2 70 to 100 1 s d Pulse rate 2 bpm m Display Display type Liquid crystal display Oxygen saturation SpOz2 Pulse rate number Pulse level meter Error messages E Operating temperature humidity range 0 to 40 C 32 to 104 F 30 to 95 relative humidity with no condensation E Storage temperature humidity range 10 to 60 C 14 to 140 F 30 to 95 relative humidity with no condensation E Power 2 AAA size batteries 3V 80mW This instrument can use about 80 hours continuously when the use of the AAA alkaline battery mM Dimensions W x H x D 69 x 60 x 28 mm E Weight 579 mM Accessory Standard Accessory Neck strap E Equipment Classification Protection against electric shock Internally powered Type of applied
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