MNPG66-00 _Manuale pulsossimetro FOX-100 - I
Contents
1. 1 R curve to 2 then user can use this particular calibration curve to measure oximeter 3 Test method used to assess SpO2 accuracy is a Clinical testing Arterial hemoglobin and oxygen saturation levels have to be compared to the levels determined from arterial blood sampling with a CO oximeter DAET abs FOX 100 complies with IEC 60601 1 2 norm pour EM emission Error3 or 1 Discharged battery 1 Replace battery The materials which user can come into contact is no toxicity and no action on tissues Error4 2 Receiving tube being shielded or 2 Clean sensor area with comply with 1S010993 1 ISO 10993 5 and ISO 10993 10 displayed on damaged together with broken alcohol Please contact moo screen SNE manufacturer distributor Technical specifications 3 Internal electronics damaged l 3 Clean sensor area with 1 Display alcohol Please contact LED manufacturer distributor 2 SpO2 Erori 1 Discharged battery 1 Replace battery measurement range 70 99 Toed en 2 Emission tube damaged 2 Clean sensor area with accuracy 80 99 2 70 80 3 lt 69 no definitions 3 Internal electronics damaged alcohol Please contact 3 Pulse rate manufacturer distributor measurement range 30 235 BPM 3 Clean sensor area with accuracy 30 99bpm 2bpm 100 235bpm 2 alcohol Please contact pulse intensity Bar graph indicator manufacturer distributor 4 Power requirements Symb2. Emissions RF Group 1 FOX 100 uses RF energy only for its 1 A C E R S r l SU CISPR 11 internal function Therefore its RF Sede operativa emissions are very low and are not likely 30030 Martellago VE Via S Pertini 24 A to cause any interference in nearby Tel 39 041 5401356 Fax 39 041 5402684 electronic equipment oA a gain naa aa a a Sede legale Emissions RF Class B FOX 100 is suitable for use in all S Marco 2757 30124 Venezia CISPR 11 establishments including domestic Cod Fisc P MA IT 00185480274 establishments and those directly REA VEN 120250 M VE001767 connected to the public low voltage power Cap Soc 110 000 00 i v N a SUPP lee buildings ww w iacer ve it iacer iacer it M D C A lL D V S l 0 N Problem Possible reason Solution SpO2 or Pulse 1 Finger is not introduced correctly 1 Try again by introducing the Rate PR 2 Patient s oxyhemoglobin value is finger l cannot be shown too low to be measured 2 Make more attempts in order normally to make sure about no problem existing in the product In doubt consult your own doctor SpO 2 or PR is 1 Finger might not be introduced 1 Try again by introducing the shown unstably deep enough finger 2 Finger is trembling or patient s 2 Try not to move body Is on the move Finger pulse 1 Check battery indication 1 Please replace batteries oximeter cannot 2 Batteries might be installed 2 Please reinstall batteries be power
3. Pulse rate Pulse rate bar graph flashes in relation with pulse rate shown on display The height of the bar graph shows the patient s pulse strength 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 100 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 Maintenance and Storage 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 20C and 55 and relative humidity less than 93 5 It is recommended keeping the product in a dry environment A wet ambient might damage the product 6 Product subject to WEE regulations Calibration only authorized distributors 1 Functional tester cannot be used to assess oximeter accuracy and calibration Index 2 made by Bioteck company is a functional tester Set Tech to
4. taking use of Lambert 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 MNPG66 00 04 05 11 Fingertip Pulse Oximeter Then measured signal can be obtained by a photosensitive element and it will be shown on oximeter display 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 p
5. User manual 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 FOX 100 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 principles Oximeter principle is as follows an experience formula of data process is established
6. atient Before use carefully read user manual The pulse oximeter has no SpO2 alarms it is not for continuous 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 SoO2 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 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 warnin
7. ed on incorrectly 3 Please contact 3 Finger pue oximeter might be manufacturer distributor damaged Display suddenly 1 The product is automatically 1 Correct working power off powered off when no signal is 2 Replace batteries detected longer than 8 seconds 2 Low power Discharged battery
8. g will be indicated in visual window when battery voltage is so low that normal operation of the oximeter might be influenced The product will automatically be powered off when no signal will be shown in the product for E than 8 seconds e FOX 100 is a portable oximeter non invasive used to measure blood oxygen saturation ie level SpO2 and cardiac pulsation The product is suitable both for home and hospital therapy Moreover FOX 100 is suitable both for adult and pediatric use 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 Installing two batteries AAA size into battery compartment as indicated in paragraph Battery installation 2 Introduce the finger in fingertip pulse oximeter see image below 3 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 corresponding data on the display screen NOTES 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 Power Switch Lower Power Indicator Pulse rate bar graph SpO indicator
9. ol Definitions two alkaline batteries AAA Size power consumption less than 40 mA Symbol lower power indication Device with type BF applied battery life batteries could be continuously operated as long as 30 hours parts 5 Dimensions A Attention refer to user manual length 56 62 mm before application width 32 38 mm Hemoglobin saturation height 34 38 mm Cardiac rate BPM weight 45 60 g batteries excluded 6 Environment requirements Low power indication work temperature 5 40 storage temperature 20 55 a Not ea to monitor patient relative humidity lt 80 in function without condensation Spa COMUNHOUEY lt 93 in storage without condensation 0o O ON OFF 7 Measurement performance in low perfusion condition use the test equipment BIO TEK SN SeiaNo o INDEX Pulse Oximeter tester pulse wave is available without failure when the simulation pulse wave amplitude is at 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 Guide and manufacture s declaration electromagnetic emissions FOX 100 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 C environment 0476 Device in compliance with the 93 42 EEC as amended by 2007 47 EC Emission test Compliance Electromagnetic environment guide
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