DIGIPOX 指套式脉搏血氧仪说明书
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1. Fingertip ENE Pulse Oximeter USER MANUAL Ver2 0CF3 ChoiceMMed General Description Oxygen Saturation is a percentage of Oxyhemoglobin HbO capacity compounded with oxygen by all combinative hemoglobin Hb capacity in blood In other words it is consistency of Oxyhemoglobin in blood It is a very important parameter for the Respiratory Circulation System Many respiratory diseases can result in oxygen saturation being lowered in human blood Additionally the following factors can reduce oxygen saturation Automatic regulation of organ dysfunction caused by Anesthesia Intensive Postoperative Trauma injuries caused by some medical examinations That situation might result in light headedness asthenia and vomiting Therefore it is very important to know the oxygen saturation of a patient so that doctors can find problems ina timely manner The fingertip pulse oximeter features low power consumption convenient operation and portability Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display It has been proven in clinical experiments that it also features high precision and repeatability Measurement Principle Principle of the oximeter is as follows A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin RHb and Oxyhemoglobin HbO in glow and near infrared zones2. Operation principle of the instrument Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology so that two beams of different wavelength of lights 660nm glow and 940nm near infrared light can be focused onto a human nail tip through a clamping finger type sensor A measured signal obtained by a photosensitive element will be shown on the oximeter s display through process in electronic circuits and microprocessor Diagram of Operation Principle 1 Red and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube ee Precautions For Use 1 Before use carefully read the manual 2 Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit ESU 3 The fingertip pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO measurement Verify that nothing is hindering the pulse measurement before relying on the SoO2 measurement 4 Do not use the fingertip pulse oximeter in an MRI or CT environment 5 Do not use the fingertip pulse oximeter in situations where alarms are required The device has no alarms It is not for continuous monitoring 6 Do not use the fingertip pulse oximeter in an explosive atmosphere 7 The fingertip pulse oximeter is intended only as an adjunct in patient assessment It must be used in conjunction with other methods of assessing clinical signs and symptoms 8 Check
3. be identified the spring is invalid or the key is unresponsive or unavailable 1 Display Type OLED display 2 SpO Display range 0 99 Measurement range 70 99 Accuracy 70 99 43 0 69 no definition Resolution 1 3 Pulse Rate Display range 0 254BPM Measure range 30 235 BPM Accuracy 30 99bpm 2bpm Resolution 1BPM 100 235bpm 42 4 Probe LED Specifications La Wavelength Radiant Power RED _66022nm IR 940 10nm 5 Power Requirements Two AAA alkaline Batteries Power consumption Less than 40mA Low power indication q Battery Life Two AAA 1 5V 600mAh alkaline batteries could be continuously operated as long as 30 hours 6 Dimension Length 60mm Width 32mm Height 34mm site survey should be less than the compliance level in each frequency range Weight 60g including two AAA batteries Interference may occur in the vicinity of equipment marked with following Note The dimensions of each device may differ slightly from the size that mentioned above symbol Kp 7 Environment Requirements Operation Temperature 5 40 C Storage Temperature 20 55 C Ambient Humidity lt 80 in operation NOTE 1 lt 93 in storage At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection 8 Equipment Response Time structures objects and people Asenown i ane
4. the finger inside of oximeter with a soft cloth dampened with 70 isopropyl alcohol Also clean the being tested finger using alcohol before and after each test Do not pour or spray liquids onto the oximeter and do not allow any liquid to enter any openings in the device Allow the oximeter to dry thoroughly before reuse A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor Clinical testing is used to establish the SpO accuracy The measured arterial hemoglobin saturation value SpO of the sensors is compared to arterial hemoglobin oxygen SaO value determined from blood samples with a laboratory CO oximeter The accuracy of the sensors in comparison to the CO oximeter samples measured over the SpOsz range of 70 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 9919 2005 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one measurement Stop using and contact local service center if one of the following cases occurs An error inthe Possible Problems and solutions is displayed on screen The oximeter cannot be powered on in any case and not the reasons of battery There is acrack on the oximeter or damage on the display resulting readings cannot
5. TONNE figure a Field strengths from fixed transmitters such as base station for radio cellular cordless telephones and land mobile radios Response time of slower average is 12 4s 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 Pulse Oximeter MD300CF3 should be observed to verify normal operation If abnormal performance is observed additional measurements may be necessary such as reorienting of the relocating the Pulse Oximeter MD300CF3 b Over the frequency range 150 kHz to 80 MHz fields strengths should be less than 3 V m Response Time Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMS For all EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the MD300CF3 Pulse Oximeter mii The MD300CF3 Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are a controlled The customer or the user of the MD300CF3 Pulse Oximeter can help prevent electromagnetic interference by 8 Beat maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Avera
6. ck aai The oximeter can not 1 No battery or low power of battery 1 Please replace batteries _ e et ail eal NR fe be powered on 2 Batteries might be installed incorrectly 2 Please reinstall the batteries 3 The oximeter might be damaged 3 Please contact with local customer service Guidance and Manufacturer s declaration electromagnetic immunity For all EQUIPMENT and SYSTEMS centre Guidance and Manufacturer s declaration electromagnetic immunity Indication lamps are 1 The product is automatically powered off when no 1 Normal The MD300CF3 Pulse Oximeter is intended for use in the electromagnetic environment specified below suddenly off signal is detected longer than 8 seconds 2 Replace the batteries The customer or the user of the MD300CF3 Pulse Oximeter should assure that it is used in such an environment 2 The battery power is too low to work Compliance l Error3 or 1 Low power 1 Change batteries Immunity test IEC 60601 test level Level Electromagnetic Environment guidance Error4 is displayed 2 Receiving tube being shielded or damaged together 2 Please contact local customer service center with broken connector 3 Please contact local customer service center on screen Electrostatic Discharge kV contact 6KV contact lors should be wood concrete or ae e If 3 Mechanical Misplace for receive emission tube 4 Please contact local customer service center ESD IEC 61000 4 2 8KV air 8KV air
7. er Notes Install the batteries with the correct polarity Incorrect placement may cause damage to the bracket Please remove the batteries if the pulse oximeter will not be used for long periods of time Using the Lanyard 1 Thread thinner end of the lanyard through the hanging hole 2 Thread thicker end of the lanyard through the threaded end before pulling it tightly Warnings 1 Keep the oximeter away from young children Small items such as the battery door battery and lanyard are choking hazards 2 Do not hang the lanyard from the device s electrical wire ae Jer eae a Lanyard hole Product Accessories iis One lanyard 2 Two AAA batteries 3 One user manual Operation Instructions Install two AAA batteries according to the Battery Installation instructions Open the clamp as illustrated in the picture below Fully insert one fingertip into the silicone hole of the oximeter before releasing the clamp aiee Press the switch button once on front panel Keep your finger still during measurement Read corresponding data from display screen Press the button again to toggle between six display modes NOORA ON After turning on the Oximeter each time you press the power switch the Oximeter will switch to another display mode There are 6 display modes shown as follows p02 PR bpm 97 74 p02 PR bpm p02 PR bpm 97 74 2 Holding the power switch for longer than one
8. gat Sa epee teas material the relative 4 Amp circuit malfunctions 2 Error6 Err 6 means the screen is failure Change the screen 4 2kV for power suppl Mains power quality should be that of a typical ee eer ae ae Sat Electrostatic transient me di at eo sivironment ii Error7 is displayed Err 7 means all the emission LED or reception dioxide is Check the emission LED and reception dioxide burst IEC 61000 4 4 1kV for input output on screen damaged lines Surge IEC 61000 4 5 1 kV differential mode NIA Mains power quality should be that of a typical Symbol Definitions 2 kV common mode commercial or hospital environment lt 5 UT gt 95 dip in Mains power quality should be that of a typical S aia or mbol Definition Definition Definition Voltage dips short UT for 0 5 cycle commercial or hospital environment If the user of y interruptions and 40 60 aip in the MD300CF3 Pulse Oximeter requires continued Manufacturer s voltage variations on 70 a i operation during power mains interruptions it is Type BF applied part Low power indication ci l power supply input UT for 25 cycles recommended that the MD300CF3 Pulse Oximeter ete lines IEC 61000 4 11 lt 5 UT gt 95 dip in r from an uninterruptible power supply or SN Serdahii paea anaE Fane i Power frequency Power frequency magnetic fields should be at levels 50 60 Hz magnetic 3A m 3A m characteristics of a typical location in a typical Oxygen saturation Pu
9. ge MD300CF3 Pulse Oximeter as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 9 Interference Resistance Capacity against Ambient Light transmitter W ds e3 VP Fi 35 P Device works normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter tester V1 ara 10 Classification According to the type of protection against electric shock INTERNALLY POW ERED EQUIPMENT According to the degree of protection against electric shock TYPE BF APPLIED PART According to the method s of sterilization or disinfection recommended by the manufacturer Equipment with method s of sterilization or disinfection recommended by the manufacturer According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can According to the degree of protection against ingress of water IPX1 be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of According to the mode of operation CONTINUOUS OPERATION the transmitter in watts W according to the tran
10. lse rate BPM No SpO Alarm field IEC 61000 4 8 commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level TN T eee ae Attention consult Guidance and Manufacturer s declaration electromagnetic immunity o approval i accompanying For EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING and relative humidity documents Guidance and Manufacturer s declaration electromagnetic immunity if Authorized The MD300CF3 Pulse Oximeter is intended for use in the electromagnetic environment specified below EC JREP representative in the The customer or the user of the MD300CF3 Pulse Oximeter should assure that it is used in such an environment European community Immunity IEC 60601 Compliance f teat test l vel bevel Electromagnetic Environment guidance Applicable Models Portable and mobile RF communications equipment should be used no closer to any part of the MD300CF3 Pulse Oximeter including cables than the MD300CF3 MD300CF31 MD300CF32 MD300CF33 MD300CF34 MD300CF35 MD300CF36 MD300CF37 recommended separation distance calculated from the equation applicable to MD300CF38 MD300CF39 MD300CF30 MD300CF3A MD300CF3B MD300CF3C MD300CF3D MD300CF3E the Mequeney At the Monster MD300CF3F MD300CF3G MD300CF3H Conducted 3 Vrms Recommended separation distance RF IEC 150 kHzto E 61000 4 6 80 MHz d F WP Noje The illustrations used in this Mapyal may differ slightly from the appeara
11. nce of the actual product Radiated 3 V m 3 5 BailangyuanB1127 1128 Fuxing R A36 mr oa 100039 Beiji RF IEC 80 MHz to d E P PEOPLE S REPUBLIC OF CHINA 61000 4 3 2 5 GHz l 80 MHz to 800 MHz a EiffestraBe 80 20537 LEC REP Hamburg GERMANY C Shanghai International E VP Holding Corp GmbH Europe 0123 800 MHz to 2 5 GHz i ALL RIGHTS RESERVED Where P is the maximum output power rating of the transmitter in watts W issue Dat 28 June 2011 according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic
12. of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line The patient has hypotension severe vasoconstriction severe anemia or hypothermia The patientis in cardiac arrest or is in shock 10 Fingernail polish or false fingernails 11 Weak pulse quality low perfusion 12 Low hemoglobin OAOANOAaARAWAN Product Properties Operation of the product is simple and convenient The product is small in volume light in weight and convenient to carry Power consumption of the product is low and the two AAA batteries can be operated continuously for 30 hours A low voltage warning will be indicated when battery voltage is low and normal operation of the oximeter might be influenced The product will automatically power off when there is no signal for longer than 8 seconds O AOUN Intended Use The fingertip pulse oximeter is a portable non invasive device intended for spot checking of arterial hemoglobin oxygen saturation SpO and pulse rate of adult and pediatric patient at home and hospital including clinical use in internist surgery anesthesia and intensive care units It is not for continuous monitoring Battery Installation 1 Lift the battery door cover 2 Install two AAA batteries into the battery compartment Match the plus and minus signs in the compartment If the polarities are not matched damage may be caused to the oximeter 3 Close the battery door cov
13. second will adjust the brightness of the oximeter There are 10 levels of brightness The default level is level four 8 PR tone modulation function 9 Warning indication Indication range SpO lt 90 PR Rate lt 60 bom or gt 100bpm Indication mode Audible and Visible Indication silence When the audio indication occurs the indication sound can pause for 30 seconds by pressing Power button and there is only the visual indication By pressing the power button again the audio indication will resume NOTE This function is only valuable for audio indication but not for pulse rate sound Front Panel Sp02 PR bpm Low power indicator SpO2 waveform Bar graph SpO2 Pulse rate Patient pulse quality signals are indicated by bar graph The bar is graded as 10 levels if the strength is level 2 to 3 the pulse signal is inadequate Maintenance and Storage Replace the batteries in a timely manner when low voltage lamp is lighted Clean surface of the fingertip oximeter before it is used in diagnosis for patients Remove the batteries if the oximeter is not operated for a long time It is best to store the product in 20 C 55 C and lt 93 humidity Keep in a dry place Extreme moisture may affect oximeter lifetime and may cause damage Dispose of battery properly follow any applicable local battery disposal laws D o rey gt Cleaning the fingertip pulse oximeter Please use medical alcohol to clean the silicone touching
14. smitter manufacturer z NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Declaration NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection Guidance and Manufacturer s declaration electromagnetic emissions For all EQUIPMENT and SYSTEMS from structures objects and people Guidance and Manufacturer s declaration electromagnetic emission z The MD300CF3 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or Possible Problems and Solutions the user of MD300CF3 Pulse Oximeter should assure that it is used in such an environment a Emissiontest Compliance Electromagnetic Environment guidance Reuse Roae i ie SpO or PRcannot 1 Finger is not inserted correctly Retry by inserting the finger RF emissions CISPR 11 Miia tay carta Pe eae ce a a Rasen normally 2 Patient s SpO value is too low to be measured 2 There is excessive illumination 3 Try some more times If you can make sure no and are not likely to cause any interference in nearby problem is existing in the product please go electronic equipment to a hospital timely for exact diagnosis RF emissions CISPR 11 ClasB SpO or PR is shown 1 Finger might not be inserted deep enough Retry by inserting the finger Fe Harmoricemissions 1EC6100032 NA SC 2 Excessive patent moveren Be calmness 1 2 fli
15. the pulse oximeter sensor application site every 4 hours to determine the positioning of the sensor and circulation and skin sensitivity of the patient 9 Do not sterilize the device using autoclaving ethylene oxide sterilizing or immersing the device in liquid The device is not intended for sterilization 10 Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries 11 This equipment complies with IEC 60601 1 2 2007 for electromagnetic compatibility for medical electrical equipment and or systems However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare and other environments it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device 12 Portable and mobile RF communications equipment can affect medical electrical equipment Rx only Caution Federal law restricts this device to sale by or on the order of a physician Inaccurate measurements may be caused by Significant levels of dysfunctional hemoglobin such as carbonyl hemoglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue High ambient light Shield the sensor area if necessary Excessive patient movement High frequency electrosurgical interference and defibrillators Venous pulsations Placement
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