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OXY-11

Fingertip Oximeter

Operator’s Manual

Shenzhen Creative Industry Co., Ltd.

Summary of Contents for OXY-11

Page 1: ...OXY 11 Fingertip Oximeter Operator s Manual Shenzhen Creative Industry Co Ltd ...

Page 2: ... instructions necessary to operate the product safely and in accordance with its function and intended use Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety This product is reusable medical device The using life is 2 years ...

Page 3: ...traindications Do not use oximeter in a magnetic resonance MR or CT environment 1 2 Warnings Keep the oximeter away from young children Small parts such as the battery door battery and lanyard may trigger choking hazards ...

Page 4: ...g to information provided in the user manual The equipment is NOT intended for neonate and infant Do not use a damaged oximeter which may affect measurement performance Do not place the oximeter on the same hand arm when using a blood pressure cuff or monitor Do not use the oximeter for more than 5 minutes without ...

Page 5: ...asis for making medical decision it is intended only to be used as addtional information that you can give to your licensed health care professional Do not use the oximeter in high frequency environment such as electrosurgical equipment Do not place the oximeter in liquid Follow local disposal and recycling laws for the oximeter and ...

Page 6: ...r clinical limitations and contraindications please carefully review the medical literature The equipment is just a clinical diagnosis of auxiliary equipment The physiological data displayed on the equipment are for reference only and can not be directly used for diagnostic interpretation Not suitable for the users with arrhythmia heart failure ...

Page 7: ...n t use the thumb and tail finger to measure Discomfort or pain may appear if using the equipment ceaselessly especially for microcirculation barrier patients it recommended that the equipment should not be used on the same finger more than 5 minutes The oximeter is designed to measure the percentage of arterial oxygen saturation of functional hemoglobin ...

Page 8: ...he performance of the oximeter Flicking or very bright light Moisture in the oximeter The individual weight less than 20kgs Week pulse quality low perfusion Venous pulsations Low hemoglobin Cardiogreen and other intravascular dyes Carboxyhemoglobin ...

Page 9: ...8 Methemoglobin Dysfunctional hemoglobin Artificial nails or fingernail polish The Finger is too cold Patients with abnormal circulation of finger endings caused by cop ...

Page 10: ... respiration A number of diseases relating to respiratory system may cause the decrease of SpO2 in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body And the corresponding symptoms would appear ...

Page 11: ...therefore prompt information of patients SpO2 is of greats help for the doctor to discover the potential danger and is of great importance in the clinical of medical field 2 1 Principle Principle of the oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law ...

Page 12: ...globin Inspection Technology is adopted in accordance with Capacity Pulse Scanning Recording Technology So that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic ...

Page 13: ...12 circuits and microprocessor Figure 1 Oximeter s schematic illustration ...

Page 14: ...d for measuring the pulse rate and functional oxygen saturation SpO2 through a patient s finger It is applicable for spot checking SpO2 and pulse rate of adult and pediatric patients in homes and medical clinics Warning The oximeter is NOT designed for newborn and infant For ...

Page 15: ...ger thickness should between 8 25 4mm NOTES The probe is the hole in the middle of the equipment to which the finger insert The Probe is the Applied part of the equipment 2 2 2 Features The oximeter is small in volumes light in weight and easy to carry ...

Page 16: ...e three modes power off sleep and measure Automatically turning into sleep mode within 8 seconds after there is no signal Notes Press the operating button to activate oximeter measure mode from sleep mode Power off after removing the batteries ...

Page 17: ...16 2 3 Front View Figure 2 Front view ...

Page 18: ...Functions Display OLED Spo2 parameter measurement Y Pulse rate parameter measurement Y Bar graph display Y Battery display Y Automatically enters sleep mode Y Pulse waveform display Y Four direction display Y ...

Page 19: ...Symbols Symbol Definition SpO2 Pulse Oxygen Saturation PR Pulse Rate BPM Battery positive cathode electrode This item is compliant with Medical Device Directive 93 42 EEC Caution Consult Accompanying Documents ...

Page 20: ...Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Power indication some models have no battery capacity indicator but have low battery indicator Date of Manufacturer Manufacturer ...

Page 21: ...t is protected against harmful effects of dripping water per IEC 60529 Rx Only Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Power indication some models have no battery capacity indicator but have low battery indicator ...

Page 22: ...21 3 Battery Installation A Put the two AAA batteries into battery compartment in correct polarities B Push the battery cover horizontally along the arrow shown as figure 3 Figure 3 Battery installation ...

Page 23: ...ag may be caused to the equiment Please remove the batteries if the oximeter will be stored for mo than 30 days Please remove the batteries if you want to turn off the oximeter Otherwise it is always in power state Battery may leak or explode if used or disposed off improper ...

Page 24: ... markings indicated inside of the battery compartment then reposition the cover B Hold the oximeter with the display facing toward you slide your finger into the opening probe of the device as shown below Figure 4 until the fingertip touches the built in stop guide For best results make sure the finger is centered with in ...

Page 25: ... the oximeter from sleep mode and then measurement interface will appear in 3 seconds D The measurement result will be read directly from the screen E The oximeter will turn into sleep mode automatically within 8 seconds after the finger left the probe ...

Page 26: ...25 4 2 Attention for Operation A Ring finger middle finger and index finger are recommended as suitable monitor position B Excessive or rapid movement may affect measurement ...

Page 27: ...ed after cleaning and disinfection E The measurement comes to the best when the oximeter and the heart are at the same level F The plethysmogram can be used as pulse intensity indicator The displayed parameters G might be unreliable with the discorderly plethysmogram H unreliable with un periodic change ...

Page 28: ...ed parameters will show invalid indicator as if signal quality is very low J The displayed parameters will show invalid indicator as if oximeter fault occur K The maximum continuous test time does not exceed 5 minutes ...

Page 29: ...against electric shock Internally powered equipment Degree of protection against electric shock Type BF Applied part non defibrillation proof Operating mode Spot checking The degree of protection against harmful solid foreign objects and ingress of liquid IPX2 ...

Page 30: ...ement Specifications SpO2 declared accuracy Display range 70 to 99 2 digits 0 to 69 Unspecified Resolution 1 Update Period 1s Averaging Time 8s PR declared accuracy Display range 25 to 250 3 digits Resolution 1 bpm ...

Page 31: ...raging Time 8s 5 3 Power Requirements Specification Two 1 5V AAA Operating Voltage DC 2 3 3V 5 4 Environmental Specifications Temperature ºC Operating 41º to 104 ºF 5º to 40 ºC Storage transportation 4º to 140 ºF 20º to 60 ºC ...

Page 32: ...nsing Storage transportation 10 to 95 non condensing Atmosphere Pressure Operating 70 to 106 kpa Storage transportation 50 to 107 4 kpa 5 5 Physical Specifications Width Height Depth About 33x36x58mm Weight About 60 g including the batteries ...

Page 33: ...lay Specifications Display type OLED 0 96 128 64 pixel Display content SpO2 PR battery indicator Pulse rate bar graph pulse waveform 5 7 LED Wavelength Wavelength Radiant Power RED 660 6nm 1 8mW IR 905 10nm 2 0mW ...

Page 34: ...ur equipment and accessories free of dust and dirt and follow these rules A Please clean the equipment before use according to chapter 6 2 Remove the batteries inside the battery cassette if the equipment will not be operated for a long time B Replace the batteries in time when the battery voltage ...

Page 35: ...ntilation anytime The moisture and high light environments will affect its lifetime and even might damage the equipment D It is best to preserve the product in a place where the temperature is between 20 to 60 and the relative humidity is less than 95 E The packed equipment can be transported by ordinary conveyance The equipment can not be ...

Page 36: ...ed mixed with toxic harmful corrosive materials WARNING No modification of this equipment is allowed 6 2 Disposal Dispose of the oximeter in accordance with local environment and waste disposal laws and regulations ...

Page 37: ...d that the oximeter be cleaned and disinfected after use every time or determined by your hospital s policy to avoid long term damage to the oximeter Never use cleaning agents disinfectants other than the recommended The sensor component is not cleaned and disinfected during testing ...

Page 38: ...1 Shut down the oximeter and remove the battery 2 Clean the oximeter with cotton or soft cloth moistened with water 3 After cleaning wipe off the water with a soft cloth 4 Allow the oximeter to air dry 7 2 Disinfection The recommended disinfectants include ethanol ...

Page 39: ... oximeter as instructed above C Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants D After disinfection be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with water E Allow the oximeter to air dry ...

Page 40: ...39 8 Accessories 1 One lanyard 2 Two AAA batteries 3 One user manual 4 One certificate card Note For particular configuration of accessories please refer to the product package list ...

Page 41: ... 9 1 Troubleshooting WARNINGS Necessary maintenance must be performed by qualified service personal ONLY Users are NOT permitted to maintain the equipment by themselves There are NO replaceable components in the equipment ...

Page 42: ...s declaration electromagnetic emission The Fingertip Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the Fingertip Oximeter should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance ...

Page 43: ...nal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Fingertip Oximeter suitable for use in all establishments including domestic establishments Harmonic emissions IEC61000 3 2 N A ...

Page 44: ...ns flicker emissions IEC61000 3 3 N A Guidance and manufacturer s declaration electromagnetic emission The Fingertip Oximeter is intended for use in the electromagnetic environment specified below the customer or the user of the Fingertip Oximeter should assure that it is used in such an environment ...

Page 45: ...lectromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 8 kV contact 15kV air 8 kV contact 15kV air Floors should be wood concrete or ceramic tile if floors are covered with synthetic material the relative humidity should be at least 30 ...

Page 46: ...45 Electrical fast transient burst IEC61000 4 4 2kV for power Supply lines 1 kV for input output lines N A N A Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth N A N A ...

Page 47: ... short interruptions and voltage variations on power supply input lines IEC61000 4 1 1 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s N A N A ...

Page 48: ... field IEC61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level ...

Page 49: ...imeter is intended for use in the electromagnetic environment specified below The customer or the user of The Fingertip Oximeter should assure that it is used in such an electromagnetic environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guidance ...

Page 50: ...z to 80 MHz N A Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Oximeter including cables than the recommended separation distance calculated from the equation applicable to the frequency of ...

Page 51: ...diated RF IEC61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz to 800MHz d 2 3 P 800MHz to 2 5GHz Where P is the maximum output power rating of the ...

Page 52: ... in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be ...

Page 53: ...52 less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol ...

Page 54: ... and people a 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 and electromagnetic site survey should be considered If the measured field strength in...

Page 55: ...o verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating The Fingertip Oximeter b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communication the equipment ...

Page 56: ...ngertip Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Fingertip Oximeter as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter M Meters ...

Page 57: ...56 output power of transmitter W Watts 150kHz to 80MHz d 1 2 P 80MHz to 800MHz d 1 2 P 80MHz to 2 5GHz d 2 3 P 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 ...

Page 58: ...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 ...

Page 59: ...ngbai Road Xili Street Nanshan District 518110 Shenzhen P R China Tel 86 755 2643 3514 Fax 86 755 2643 0930 E mail info creative sz com Website www creative sz com Shanghai International Holding Corp GmbH Europe Add Eiffestrasse 80 20537 Hamburg Germany Tel 49 40 2513175 Fax 49 40 255726 ...

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