FOX-300 User manual (MNPG48-01) - I
Contents
1. TEGH MEDICAL DIVISION General Description Hemoglobin Saturation is blood oxyhemoglobin HbO2 percentage that is the total hemoglobin quantity able to combine with oxygen Hb in blood In other words it is the Oxyhemoglobin consistency in blood It is a very important ecological parameter for respiratory circulation system Many respiratory diseases can result in hemoglobin saturation decreasing in human blood Moreover the following factors can also lead to problems in oxygen supply so that human hemoglobin saturation might be reduced automatic organic regulation malfunction caused by anesthesia intensive postoperative trauma hurts resulted by some medical examination and etc In these situation illnesses such as dizziness asthenia vomit might happen to patients and even endanger the patient s life Therefore it is very important to know hemoglobin saturation of patient timely in clinical medical aspects So that doctors can find problems in time The fingertip pulse oximeter features in small volume low power consumption easy operation and being portable It is only necessary for patient to put one of his fingers into the fingertip photoelectric sensor and a display screen will directly show measured value of hemoglobin saturation Clinical experiments evidenced its high accuracy and repeatability Measurement principle Oximeter principle is as follows an experience formula of data process is established taking use of Lam2. brightness the default level is level four Cleaning Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter and clean the test finger using alcohol before and after each test When your finger is plugged into the Oximeter your nail surface must be upward as shown here below Front panel description Low power indicator Pulse rate bar graph indicator SPO2 Waveform Pulse Rate Pulse rate bar graph flashes in relation with pulse rate shown on display Accessories 1 One hang lace 2 Two batteries AAA Size 3 User manual Battery installation 1 Push the battery cover horizontally along the arrow shown as below 2 Insert two batteries AAA size according to correct polarity indicated in the battery compartment 3 Close battery cover of battery compartment Notes battery polarities must be correctly respected in order to avoid device damages Please remove the battery if FOX 300 will not be used for long time Hang lace installation 1 Thread hang lace end through the hanging hole 2 Close hang lace around itself ET al lake laversmrs late ey OLEC 1 Replace the batteries timely when low voltage lamp is lighted 2 Clean fingertip oximeter surface before each test 3 Remove batteries from battery compartment if the device will not be operated for a long time 4 Preserve product in a place where ambient temperature is between 20 C and 55 C and relative hum
3. Error3 or 1 Discharged battery 1 Replace battery Error4 2 Receiving tube being shielded or 2 Clean sensor area with Technical specifications displayed on geinaded Teatar with broken alcohol Please contact 1 Display screen a i manufacturer distributor Internal electronics damaged OLED Display 3 Clean sensor area with 2 SpO2 alcohol Please contact manufacturer distributor measurement range 70 99 accuracy 80 99 3 70 80 3 lt 69 no definitions pe ee 1 Discharged battery 1 Replace battery 3 Pulse rate R 2 Emission tube damaged 2 Clean sensor area with measurement range 30 235 BPM 3 Internal electronics damaged alcohol Please contact accuracy 30 99bpm 2bpm 100 235bpm 2 manufacturer distributor pulse intensity Bar graph indicator 3 Clean sensor area with two alkaline batteries AAA Size Men UISGIUeHe SiO Mor power consumption less than 30 mA Symbol Definitions low power indication N battery life batteries could be continuously operated as long as 30 hours Definition 5 Dim nsi n Device with type BF applied ts length 58 mm p l l Attention refer to user manual width 32 mm before application height 37 mm Hemoglobin saturation weight 33 g batteries excluded 6 Environment requirements Cardiac rate BPM work temperature 5 40 C ee storage temperature 20 55 C Low power indication relative humidity lt 80 in function without cond
4. SO Tel 39 041 5401356 Fax 39 041 5402684 Problem Possible reason Solution i eeaeee SpOz or Pulse 1 Finger is not introduced correctly 1 Try again by introducing the eee Rate PR at finger Marco 2757 30124 Venezia 2 Patient s oxyhemoglobin value is Cod Fisc P VA IT 00185480274 cannot be shown too low to be measured 2 Make more attempts in order REA VEN 120250 M VE001767 normally to make sure about no problem Cap Soc 110 000 00 iv MEDI C AL DIVI S 0 N existing in the product ww w iacer ve it iacer iacer it In doubt consult your own doctor
5. bert Beer Law according to spectrum absorption characteristics of reductive hemoglobin RHb and oxyhemoglobin O2 Hb in glow and near infrared zones Operation principle of the instrument is photoelectric oxyhemoglobin inspection technology adopted in accordance with capacity pulse scanning and recording technology so that two lights beams of different wavelength 660nm glow and 940nm near infrared light can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element and it will be shown on oximeter display User manual MNPG48 01 25 03 13 Fingertip Pulse Oximeter Diagram of Operation Principle 1 Red and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube Precautions for use 1 Do not use the pulse oximeter in an MRI or CT environment 2 Do not use the pulse oximeter in situations where alarms are required The device has no alarms 3 Explosion hazard do not use the pulse oximeter in an explosive atmosphere The 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 5 Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the patient Before use carefully read user manual The pulse oximeter has no SpO2 alarms it is not for continu
6. ensation lt 93 in storage without condensation Not sutao e to monitor patient 7 Measurement performance in low perfusion condition use the test equipment BIO TEK Sorunvouey INDEX Pulse Oximeter tester pulse wave is available without failure when the Serial No simulation pulse wave amplitude is at 0 6 8 Interference resistance capacity against ambient light device works normally with Month Year of production mixed noise produced by BIO TEK INDEX Pulse Oximeter tester Directive WEE EMC Table Guide and manufacture s declaration electromagnetic emissions FOX 300 is intended for use in the electromagnetic environment specified below The customer or the user of the Pulse Oximeter should assure that it is used in such SP l l environment 0476 Device in compliance with the 93 42 EEC as amended by 2007 47 EC Emission test Compliance Electromagnetic environment guide Emissions RF Group 1 FOX 300 uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Emissions RF Class B FOX 300 is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes LACER Srl POSSIBLE PROBLEMS AND SOLUTIONS Sede operativa 30030 Martellago VE Via S Pertini 24 A
7. he oximeter might be influenced The product will automatically be powered off when no signal will be shown in the product for longer than 8 seconds FOX 300 is a portable oximeter non invasive used to measure blood oxygen saturation level SpO2 and cardiac pulsation The product is suitable both for home therapy and hospital first aids or dentists The product is not suitable to monitor patient continuously The device doesn t need any calibration or maintenance with the exception of batteries change Operating instructions 1 Installing two batteries AAA size into battery compartment as indicated in paragraph Battery installation Introduce the finger in fingertip pulse oximeter See image below w N Press the switch button once on front panel 4 Avoid finger movements when oximeter is working Your body is not recommended in moving status 5 Read correspondent datum from display screen choosing your favorite display modes following image ATTENTION After turn on the oximeter each time you press the power switch the oximeter will switch to another display mode 6 display modes SpOe PR tem SpO s PR iom SpO2 PR bpm 97 74 97 74 1 TA Ei ttl 3 uda Yd 2QUS PR bpm SpO2 zQdS wdd Yd NI O CO N i 86 X Orr 4 5 6 Brightness regulation When you press the power switch for a long time more than one second the brightness of the oximeter will be changed by degrees There are 10 levels on
8. idity less than 93 5 It is recommended keeping the product in a dry environment A wet ambient might SpO gt 2 or PR is iL Fine mini not be introduced 1 Try again by introducing the damage the product shown unstably deep enoug finger 6 Product subject to WEE regulations 2 Finger is trembling or patient s 2 Try not to move body Is on the move authorized distributors Finger pulse 1 Check battery indication 1 Please replace batteries 1 Functional tester cannot be used to assess oximeter accuracy and calibration oximeter cannot 2 Batteries might be installed 2 Please reinstall batteries 2 Index 2 made by Bioteck company is a functional tester Set Tech to 1 R curve to 2 then 2o Bevel Sie Gl AEON 3 Please contact _ user can use this particular calibration curve to measure oximeter ee pulse oximeter might be manufacturer distributor 3 Test method used to assess SpO2 accuracy is a clinical testing Arterial hemoglobin and AT saat o have to be compared to the levels determined from arterial Display suddenly 1 The product is automatically 1 Correct working ood sampling with a CO oximeter power off powered off when no signal is 2 Replace batteries detected longer than 8 seconds 7 i FOX 300 complies with IEC 60601 1 2 norm pour EM emission 2 Low power Discharged battery The materials which user can come into contact is no toxicity and no action on tissues comply with IS010993 1 ISO 10993 5 and ISO 10993 10
9. ous monitoring as indicated by the symbol 8 Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours 9 Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing immersing the sensor in liquid significant levels of dysfunctional hemoglobin such as carbonxy hemoglobin or methemoglobin intravascular dyes such as indocyanine green or methylene blue 10 SP02 measurements may be adversely affected in the presence of high ambient light protect sensor area from direct sunlight excessive patient movement venous pulsations placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line patients with hypotension severe vasoconstriction severe anemia or hypothermia in the presence of cardiac arrest or shock 11 Fingernail polish or false fingernails may cause inaccurate SpO2 readings ois Product subject to WEEE regulations concerning separate waste collection General features Medical device features in small volume and low power consumption and it is used to measure human hemoglobin saturation and cardiac rate It s equipped with 2 batteries AAA size that can be operate continuously for 30 hours Low voltage warning will be indicated in visual window when battery voltage is so low that normal operation of t
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