Manual. - Omron Healthcare India
Contents
1. Fingertip EMA Pulse Oximeter USER MANUAL Ver1 0C2 General Description Oxygen Saturation is a percentage of Oxyhemoglobin HbOz 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 in a 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 HbOz in red and near infrared zones Op2. other methods of assessing clinical signs and symptoms 8 In order to ensure correct sensor alignment and skin integrity the maximum application time at a single site for our device should be less than 4 fours 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 1 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 13 This equipment is not intended for use during patient transport outside the healthcare facility 14 This equipment should not be used adjacent to or stacked with other equipment 15 Do not disassemble repair or modify the equipment without authority 16 These materials that contact with the patient s skin contain medical silicone and ABS plastic enclosure are all pass the IS010993 5 Tests for invitro cytotoxicity and IS0
3. 10993 10 Tests for irritation and delayed type hypersensitivity _k 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 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 patient is in cardiac arrest or is in shock Fingernail polish or false fingernails Weak pulse quality low perfusion Low hemoglobin OOAN Oa BRAND ak l lt O Product Features Simple to operate and convenient to carry Small volume light weight and low power consumption Dual color OLED displays SpOz PR Pulse bar and waveform Level 1 10 adjustable brightness 6 display modes 2pac AAA size alkaline batteries battery low indicator When no or low signal is detected the pulse oximeter will power off automatically in 8 seconds OoahWND Intended Use Fingertip pulse oximeter is a portable non invasive device intended for spot checking of oxygen saturation of arterial hemoglobin SpOz and pulse rate of adult and pediatric patients in hospitals hospital type facilitie
4. A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve and the PR accuracy The model of functional tester is Index2 FLUKE simulator and the version is 2 1 3 Specifications 1 Display Type OLED display 2 SpO2 Display range 0 99 Measurement range 70 99 Accuracy 70 99 8 0 69 no definition Resolution 1 3 Pulse Rate Display range 0 254BPM Measure range 30 235 BPM Accuracy 30 99bpm 2bpm 100 235bpm 2 Resolution 1BPM 4 Probe LED Specifications ee Wavelength Radiant Power NOTE The information about wavelength range can be especially useful to clinicians 5 Power Requirements Two AAA alkaline Batteries Power consumption Less than 30mA Battery Life Two AAA 1 5V 600mAh alkaline batteries could be continuously operated as long as 30 hours 6 Environment Requirements Operation Temperature 5 40 C Storage Temperature 20 55 C Ambient Humidity lt 80 no condensation in operation lt 93 no condensation in storage Atmosphere pressure 86kPa 106kPa 7 Equipment Response Time As shown in the following figure Response Time S 302 Reference ewe Beat Average 8 Classification According to the type of protection against electric shock INTERNALLY POWERED EQUIPMENT According to the degree of protection against electric shock TYPE BF APPLIED PART According to the degree of protection a
5. TEMS For all EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and Pulse Oximeter MD300C20 The Pulse Oximeter MD300C20 is intended for use in electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Pulse Oximeter MD300C20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Pulse Oximeter MD300C20 as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power of transmitter W 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 2 3 VP poo tem rt ee ooo OY aooo deea OYO aooo sre For transmitters rated at a maximum output power not listed above the recommended separation distanced in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for 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 Possible Problems a
6. creen damaged Symbol Definitions Symbol Definition Type BF applied part Attention consult accompanying documents Protected against dripping water SpOr Oxygen saturation PR bpm Pulse rate BPM a Low power indication X No SpO Alarm SnO gt SN Serial No Storage temperature and relative humidity Manufacturer s information Date of Manufacture ual m 0123 Applicable Models MD300C20 OTC MD300C20 NMR European union approval Authorized representative in the European community Notes 1 The illustrations used in this manual may differ slightly from the appearance of the actual product 2 The specifications are subject to change without prior notice d Beijing Choice Electronic Technology Co Ltd Room 320 WestBuilding 4 No 83 Fuxing Road 100039 Beijing PEOPLE S REPUBLIC OF CHINA Eiffestra 3e 80 20537 Hamburg GERMANY Shanghal Internatlonal Holding Corp GmbH Europe In collaboration with ChoiceMMed ALL RIGHTS RESERVED Issue Date 20 December 2012
7. e oximeter 2 Slide the battery door cover horizontally along the arrow shown as the picture 096 ee Notes Y Ses r 3 lt 4 a a Please remove the batteries if the pulse oximeter will not be used for long periods of time Using the Lanyard r Thread thinner end of the lanyard through the hanging hole 2 Thread thicker end of the lanyard through the threaded end before pulling i tightly X Warnings 1 Keep the oximeter away from young children Small items such as the battery door battery and lanyard are choking hazards il 2 Do not hang the lanyard from the device s electrical wire Maintenance and Storage l 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 OaRWN gt Cleaning the fingertip pulse oximeter Please use medical alcohol to clean the silicone touching 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 oxi
8. e transmitter in watts W 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 site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with following symbol C NOTE 1 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 structures objects and people a Field strengths from fixed transmitters such as base station 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 Pulse Oximeter MD300C20 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 MD300C20 b Over the frequency range 150 kHz to 80 MHz fields strengths should be less than 3 V m 800 MHz to 2 5 GHz Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYS
9. eration 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 red 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 shown on the oximeter s display through electronic circuits and a microprocessor Diagram of Operation Principle 1 Red and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube 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 SpOz measurement Verify that nothing is hindering the pulse measurement before relying on the SoOz 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
10. gainst ingress of water IPX1 According to the mode of operation CONTINUOUS OPERATION Declaration Guidance and Manufacturer s declaration electromagnetic emissions For all EQUIPMENT and SYSTEMS Guidance and Manufacturer s declaration electromagnetic emission The MD300C20 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of MD300C20 Pulse Oximeter should assure that it is used in such an environment Emission test Compliance Electromagnetic Environment guidance _ RF emissions CISPR 11 The MD300C20 Pulse Oximeter 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 electronic equipment The pulse Oximeter MD300C20 is suitable for use in Harmonic emissions Not Applicable all establishments including domestic establishments and oe a those directly connected to the public low voltage power supply network that supplies buildings used for domestic IEC 61000 3 3 purposes Guidance and Manufacturer s declaration electromagnetic immunity For all EQUIPMENT and SYSTEMS Guidance and Manufacturer s declaration electromagnetic immunity The MD300C20 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the MD300C20 Pulse Oximeter should assure that it is used in such an environment Immunity test IEC 60601 test Comp
11. liance Electromagnetic Environment guidance level Level 6kV contact 6kV contact Floors should be wood concrete or ceramic tile If 8kV air 8kV air floor are covered with synthetic material the relative humidity should be at least 30 Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment Electrostatic Discharge ESD IEC 61000 4 2 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Guidance and Manufacturer s declaration electromagnetic immunity For all EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and Manufacturer s declaration electromagnetic immunity The MD300C20 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the MD300C20 Pulse Oximeter should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Environment guidance test test level Level Radiated 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Oximeter MD300C20 including cables than the RF 80 MHz to i j recommended separation distance calculated from the equation applicable to IEC 2 5 GHz the frequency of the transmitter 61000 4 3 Recommended separation distance d 1 2VP 80 MHz to 800 MHz d 2 3 VP Where P is the maximum output power rating of th
12. meter and do not allow any liquid to enter any openings in the device Allow the oximeter to dry thoroughly before reuse The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries 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 in the 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 a crack on the oximeter or damage on the display resulting readings cannot be identified the spring is invalid or the key is unresponsive or unavailable 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 SpOz of the sensors is compared to arterial hemoglobin oxygen SaOz 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 SpOz 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
13. nd Solutions Problems Possible reason Solution SpO2 or PR cannot 1 Finger is not inserted correctly 1 Retry by inserting the finger be shown normally 2 Patient s SpO2 value is too low to be measured 2 There is excessive illumination 3 Try some more times If you can make sure no problem exist in the product please go toa hospital timely for exact diagnosis SpO or PR is shown 1 Finger might not be inserted deep enough 1 Retry by inserting the finger unstably 2 Excessive patient movement 2 Be calmness The oximeter cannot 1 No battery or low power of battery 1 Please replace batteries 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 centre Indication lamps are 1 The product is automatically powered off when no 1 Normal signal is detected longer than 8 seconds 2 Replace the batteries 2 The battery power is too low to work Error3 or 1 Err 3 means the red emission LED is damaged Error4 is displayed 2 Err 4 means the infra red emission LED is damaged suddenly off 1 Check the red emission LED 2 Check the infra red emission LED onscreen Error 6 Err 6 means the screen is failure Change the screen Error is displayed Err 7 means all the emission LED or reception diode is Please contact with local customer service centre ons
14. s and home environments It is not for continuous monitoring Operation Instructions Install two AAA batteries according to the Battery Installation instructions Place one of your fingers into the rubber opening of the pulse oximeter 5 Press the switch button one time on front panel to turn the pulse oximeter on oF Keep your hands still for the reading Do not shake your finger during the test It is recommended that you do not move your body while taking a reading Read the data from the display screen Press the power switch for longer than one second will adjust the brightness of the oximeter There are 10 levels of brightness The default is level four RON O o 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 Front Panel Oxygen Saturation Pulse Rate Power low indicator l pO PR tor i et Pulse Oximeter SpO2 Waveform Power Switch Pulse Oximeter Pulse bar graph The height of the bar graph indicates of the pulse and signal strength The bar should be greater than 30 for a proper reading Product Accessories One lanyard 2 Two AAA batteries 3 One instruction manual Battery Installation 1 Install two AAA batteries into the battery compartment Match the plus and minus r signs in the compartment If the polarities are not matched damage may be caused to S th
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