Pediatric Fingertip Pulse Oximeter
Contents
1. Item 18707 Pediatric Fingertip Pulse Oximeter USER MANUAL Ver4 0C5 drive General Description Oxygen Saturation is a percentage of Oxyhemoglobin HbO2 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 HbO in red a2. When no or low signal is detected the pulse oximeter will power off automatically in 8 seconds See Se eS Intended Use Fingertip pulse oximeter is a portable non invasive device intended for spot checking of oxygen saturation of arterial hemoglobin SpO2 and pulse rate of pediatric patients in hospitals and hospital type facilities 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 Press the switch button one time on front panel to turn the pulse oximeter on 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 BORD oO 6 Press the button again to toggle between six display modes 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 SpO2 PR bpm SpOz PR bpm SpO2 PR bpm un Hd 0dS 198 77 l 2 Holding 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 Front Panel Low power indicator SpO2 PR bpm Power switch SpO2 waveform Pulse Oxlmeter SpO2 Pulse Rate The height of the bar graph indicates
3. infra red emission LED is damaged 2 Check the infra red emission LED on screen Err 6 means the screen is failure Change the screen Error is displayed Err 7 means all the emission LED or reception diode is Check the emission LED and reception diode on screen damaged Symbol Definitions Symbol Type BF applied part N Caution Follow instructions for use Definition Protected against dripping water SpO Oxygen saturation PR bpm Pulse rate BPM q Low power indication Sp02 No SpO Alarm SN Serial No max Ae Storage temperature and relative humidity min RH lt 93 non condensing A Manufacturer s information iw Date of Manufacture Applicable Models 18707 187071 187072 187073 187074 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 Warranty Clause Your Drive brand product is warranted to be free of defects in materials and workmanship for two years from the original purchase date The device was built to exacting standards and carefully inspected prior to shipment This 2 year Limited Liability warranty is an expression of our confidence in the materials and workmanship of our products and our assurance to the consumer of years of dependable service In the event of a defect covered by this warranty we will at our op
4. of the pulse and signal strength The bar should be greater than 30 for a proper reading Product Accessories One lanyard Two AAA batteries One user manual One silicone case One hang bag IRUN Battery Installation 1 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 2 Slide the battery door cover horizontally along the arrow shown as the picture Note 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 3 Please notice that the lanyard which is tied to the oximeter may cause strangulation due to excessive length 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 Extr
5. 3 3 purposes Guidance and Manufacturer s declaration electromagnetic immunity For all EQUIPMENT and SYSTEMS Guidance and Manufacturer s declaration electromagnetic immunity The 18707 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the 18707 Pulse Oximeter should assure that it is used in such an environment Immunity test IEC 60601 test Compliance 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 18707 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the 18707 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
6. 7 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 18707 b Over the frequency range 150 kHz to 80 MHz fields strengths should be less than 3 V m 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 Pulse Oximeter 18707 The Pulse Oximeter 18707 is intended for use in electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Pulse Oximeter 18707 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Pulse Oximeter 18707 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 2 3 VP 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 w
7. atts 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 and Solutions Problems Possible reason po Solution SpO or PR cannot 1 Finger is not inserted correctly 1 Retry by inserting the finger be shown 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 problem exist in the product please go to a hospital timely for exact diagnosis SpO or PR is shown 1 Finger might not be inserted deep enough 1 Retry by inserting the finger unstable 2 Excessive patient movement 2 Remain calm 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 suddenly off signal is detected longer than 8 seconds 2 The battery power is too low to work 1 Normal 2 Replace the batteries Error3 or 1 Err 3 means the red emission LED is damaged 1 Check the red emission LED Error4 is displayed 2 Err 4 means the
8. communications equipment should be used no closer to any part of the Pulse Oximeter 18707 including cables than the RF 80 MHz to l 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 2 P 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz 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 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 gt 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 1870
9. eme moisture may affect oximeter lifetime and may cause damage Dispose of battery properly follow any applicable local battery disposal laws oo Pay 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 oximeter and do not allow any liquid to enter any openings in the device Allow the oximeter to dry thoroughly before reuse 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 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 se
10. mble repair or modify the equipment 17 These materials that contact with the patient s skin contain medical silicone and ABS plastic enclosure are all pass the 1S010993 5 Tests for invitro cytotoxicity and 5010993 10 Tests for irritation and delayed type hypersensitivity Rx only Caution Federal law USA restricts this device to sale by or on the order of a licensed practitioner Contraindication It is not for continuous monitoring 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 10 Fingernail polish or false fingernails 11 Weak pulse quality low perfusion 12 Low hemoglobin COON OO RWDND Product Properties Simple to operate and convenient to carry Small volume light weight and low power consumption OLED display SpO PR and Pulse bar Level 1 10 adjustable brightness 6 display modes 2pcs AAA size alkaline batteries battery low indicator
11. ms 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 half an hour 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 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 It may be unsafe to use accessories detachable parts and materials not described in the instructions for use interconnect this equipment with other equipment not described in the instructions for use disasse
12. nd near infrared zones 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 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 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 SpO measurement Verify that nothing is hindering the pulse measurement before relying on the SpO 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 sympto
13. nsors in comparison to the CO oximeter samples measured over the SpO 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 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 SpO Display range 0 99 Measurement range 70 99 Accuracy 70 99 3 0 69 no definition Resolution 1 3 Pulse Rate Display range Oopm 254bpm Measure range 30bpm 235bpm Accuracy 30bpm 99bpm 2bpm 100bpm 235bpm 2 Resolution 1bpm 4 Probe LED Specifications La Wavelength Radiant Power RED 660 2nm IR 940 10nm 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 600mAnh alkaline batteries could be continuously operated as long as 30 hours 6 Environment Requirements Operation Temperature 5 C 40 C Storage Temperature 20 C 55 C Ambient Humidity lt 80 no condensation in operation lt 93 no condensation in storage Atmosphere
14. pressure 86kPa 106kPa 7 Equipment Response Time As shown in the right figure Response time of slower average is 12 4s Response Time 5 307 Reference 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 against 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 18707 Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of 18707 Pulse Oximeter should assure that it is used in such an environment _Emission test Compliance Electromagnetic Environment guidance _ _ RF emissions CISPR 11 The 18707 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 18707 is suitable for use in all Harmonic emissions Not Applicable establishments including domestic establishments and IEC 61000 3 2 those directly connected to the public low voltage power supply network that supplies buildings used for domestic IEC 61000
15. tion repair or replace the device This warranty does not cover device failure due to owner misuse or negligence or normal wear and tear If you have questions about your Drive device or this warranty please contact an authorized Drive Medical provider Distributed by Drive Medical Design amp Manufacturing 99 Seaview Boulevard Port Washington NY 11050 www drivemedical com lf Local 516 998 4600 Toll Free 877 224 0946
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