Instruction Manual 98 77
Contents
1. declaration electronmagnetic emissions for all Equipmnet and Systems Guidance and manufacture s declaration electromagnetic emission The Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer of the user of the Pulse Oximeter should assure that it is used in such an environment Electromagnetic Emission P ssion test environment guldance Compliance The Pulse Oximeter uses RF energy only for its internal function Therefore it s RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Group 1 The Pulse Oximeter is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings use for domestic purposes RF emission CISPR 11 17 Symbol Definitions The equipment type is BF Refer to user manual before application No SpOz alarm Hemoglobin saturation Heart rate BPM Low power indication Serial No Attached inside of the unit Notes Please remove the battery when product will not be in used for period of time FERNO bySpiracle Technology USA wae Mfg For Spiracle Technology 16520 Harbor Blvd D Fountain Valley CA 92708 U S A Ph 714 418 1091 Fax 714 418 1095 www spiracle com email info spiracle com EC R2. EP EUROPEAN CONTACT Ferno Washington Italia s r l via Benedetto Zallone n 26 40066 Pieve di Cento Bo Italy P 39 051 6860028 F 39 051 6861508 Revision July 2013 CE
3. Instruction Manual Finger type Pulse Oximeter No 710565 1 General Description Hemoglobin Saturation is a percentage of the amount of oxygen combined with hemoglobin in proportion to the amount of oxygen the hemoglobin is capable of carrying It is expressed as a percentage of a ratio content capacity In other words it is the existence of oxygen in the blood which is known as Oxyhemoglobin It is a very important physiological parameter for Respiratory circulation system Many respiratory diseases can result in hemoglobin saturation being lowered in human blood Moreover the following factors can also lead to problems in oxygen supply potentially causing human hemoglobin saturation to be reduced Automatic Organic Regulation Malfunction caused by Anesthesia Intensive Postoperative Trauma injuries resulting from medical examinations etc or in the situation of illnesses such as light headedness asthenia vomiting etc might happen to the patients and possibly endanger the patient s life Therefore it is very important to know the patient s hemoglobin saturation The Finger type Pulse Oxime ter features a large display low power consumption convenient operation all in a compact portable unit The patient simply puts one finger into the photoelectric sensor for diagnosis and the display screen will directly show the measured value of hemoglobin Saturation 2 Measurement principle Principle of the Oximeter i
4. eter before it is used in diagnosis for patients 3 Remove the batteries inside the battery cassette if the Oximeter will not be operated for an extended period of time 4 It is best to store the product in a place where ambient temperatures are 10 to 40 C 14 to 104 F and humidity is 10 to 80 5 It is recommended that the product be kept in a dry environment for storage A wet and excessive humid environment might affect the units performance damage the product or effect its useful life 6 Please follow the local laws and protocols for proper disposable of used batteries 12 Calibrating the pulse oximeter 1 The functional tester cannot be used to assess the accuracy of the oximeter 2 Index 2 that is made by Bioteck company is a function tester Set Tech to 1 R curve to 2 then user can use this particular calibration curve to measure the oximeter 3 The test methods used to establish the SpO2 accracy is clinical testing The oximeter used to measure the arterial hemoglobin oxygen saturatin levels and these levels are to be compared to the levels determined from arterial blood sampling with a CO oximeter 13 Declaration EMC of this product comply with IEC60601 1 1 2 standards The materials which the user comes in contact with are not toxic and no adverse effects on tissues The unit complies with ISO10993 1 5 10 14 Detailed descriptions of product functions 1 Display Type OLED display 2 SPO2 Mea
5. ethod If ue too problem owito A continues follow Measure local protocols for patient assessment and treatment P 1 Finger might 1 Retry by SPEAR PRs not be plugged inserting the unstably deep enough finger until fully 2 Finger is engaged trembling or patient s body 2 Ty not to is in movement OV status The Oximeter 1 Low ordead 1 Replace can not be batteries Batteries powered on 2 Batteries 2 Remove and might be reinstall the installed batteries incorrectly 3 Contact your 3 The Oximeter local service might be center damaged Display screen 1 The product 1 Normal is suddenly off is automatically powered off 2 Replace the when no signal batteries is detected longer than 8 seconds 2 Power level of batteries is inadequate Error3 or 1 Low power i Cnange Error4 2 Receiving ane displayed on tube being 2 Contact your screen shielded or local service damaged center together with broken 3 Contact your connector local service 3 Mechanical center misplace for _ Saale ese 4 Contact your cea local service 4 Amp circuit center malfunction NOTIFIED BODY DET NORSKE VERITAS 0434 Error 1 Low power 1 Change displayed on an batteries screen 2 Emission tube damaged 2 Contact your local service 3 Current center control circuit malfunction 3 Contact your local service center 16 Guidance and manufacture s
6. ger using alcohol before an after each test The rubber inside os the Oximeter belongs medical rubber which has no toxin and no harmful to the skin of human being When the patients finger is inserted into the Oximeter the fingernail surface must be facing upward SPO2 PR Bar graph PR Power Switch wae Low power indicator SPO2 waveform The heart rate bar graph display corresponds with pulse rate 8 Product Accessories 1 One hang lace 2 Two AAA batteries 3 One Instruction manual 9 Battery Installation Remove batter cover Install two 2 AAA batteries into the battery cassette with the proper polarity alignment Replace cover horizontally along the arrow shown as below Notes Battery polarities must be correctly installed Otherwise damage to the device may occur Install or remove batteries with care and in the right position so as to not damage the device Batteries should be removed from the Oximeter if the unit will not be used for an extended period of time battery corrosion may occur 10 Hang Lace Installations 1 Thread thinner end of the hang lace through the eyelet on end of the unit 2 Thread thicker end of the lace through the loop of the thread that was just inserted in eyelet Pull thicker thread firm Do not over tighten 11 Maintenance and Storage 1 Replace the batteries when the low voltage lamp is displayed on the screen 2 Clean surface of the finger type Oxim
7. gns and symptoms Unit is designed for temporary checking not permanent attachment 8 Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the patient 9 Do not use adhesive tape to apply or secure the unit ROM OQ 10 The pulse oximeter has no SpO2 alarms it is not for continuous monitoring as indicated by the symbol 11 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 12 Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing or immersing the sensors in liquid may cause inaccurate readings 13 Significant levels of dysfunctional hemoglobin s such as carbonxy hemoglobin or methemoglobin 14 Intravascular dyes such as indocyanine green or methylene blue 15 SpO2 measurements may be adversely affected in the presence of high ambient light or direct sunlight Shield the sensor area from the light source example shield with a towel 16 Excessive patient movement 17 High frequency electrosurgical and electromagnetic interference and defibrillators 18 Venous pulsations 19 Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line 20 The patient has hypotension severe vasoconstriction severe a
8. nemia or hypothermia 21 The patient is in cardiac arrest or is in shock 22 Fingernail polish or false fingernails may cause inaccurate SpO2 readings Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries 4 Product Properties 1 Operation of the product is simple and convenient 2 The product is small in volume light in weight total weight is about 50g including batteries and can be conveniently carried 3 Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for approximately 30 hours 4 Low voltage warning will be indicated in the visual window when battery voltage is so low that normal operation of the oximeter might be influenced 5 The product will automatically be powered off when no signal is detected for longer than 8 seconds 5 Product Operation Scope The finger type Oximeter can be used to measure human Hemoglobin Saturation and heart rate through a finger The product is suitable for use in family hospital including clinical use in internist surgery anesthesia pediatrics intensive care etc With medical direction the unit can be used in sports medicine The unit can be used before or after sports Operation in sport procedure is not recommended etc The product is not suitable to monitor patient continuously during play or activity 6 Operation Instruction
9. s 1 Remove batter cover Install two AAA batteries into the battery cassette Replace cover 2 Patients finger to be monitored should be clean Use medical alcohol to clean the test finger Medical alcohol can be used to wipe down the rubber pads inside the clamp zone Clean the unit before and after each use 3 Nip squeeze the clamp as shown in the diagram 4 Plug one patient finger into the rubber hole of the Oximeter It is best to fully engage the finger into the unit before releasing the clamp 5 Press the switch button once on front panel 6 Hold the patient s finger steady while the unit is taking its reading Body movement is not recommended during operation 7 Read correspondent data from display screen 8 There are six 6 display modes After turn 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 bpr 98 77 FERNO2 2 SpO2 PR bpr 98 77 FERNO2 98 77 FERNO2 Gada yg wzods LL 961 FERNO2 PRbpm SpO2 N S S FERNO2 wzods wdayd co ol FERNO2 When you press the power switch for a long time more than on second the brightness of the oximeter will be changed by degrees there are 10 levels on brightness the default level is level four Declaration Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter and clean the test fin
10. s as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin R Hb and Oxyhemoglobin O2 Hb in glow and near infrared zones The operation principle of the instrument is 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 glow and 940nm near infrared light can be focused onto a human nail tip through perspective clamp finger type sensor The measured signal is obtained by a photosensitive element The information acquired will be shown on two groups of LEDs through a process in the electronic circuits and microprocessor Diagram of Operation Principle 1 Red and Infrared ray Emission Red and Infrared ray Receipt ine Precautions for use Device to be used on or by the order of a physician Before use carefully read the manual Follow all local protocols and care provider standards Do not use the pulse oximeter in an MRI or CT environment 5 Do not use the pulse oximeter in situations where alarms are required The device has no alarms 6 Explosion hazard Do not use the pulse oximeter in an explosive atmosphere 7 The pulse oximeter is intended only as an adjunct in patient assessment It must be used in conjunction with other methods of assessing clinical si
11. surement range 0 100 Accuracy 2 on the range of 70 100 lt 70 no definition 3 Pulse Rate Measure range 30 to 235 BPM Beats Per Minute Accuracy 2 BPM Power Requirements Two AAA 1 5V Alkaline Batteries Power consumption less than 40mA Low power indication Battery Life Two AAA 1 5V 600mAh alkaline batteries can be continuously operated for approximately 30 hours Dimension Length 58mm 2 28 inches Width 32mm 1 25 inches Height 34mm 1 33 inches Weight 50g 1 7 oz including two AAA batteries Environment Requirements Operation Temperature 5 to 40 C 41 to 104 F Storage Temperature 10 to 40 C 14 to 104 F Ambient Humidity 15 to 80 in operation 10 to 80 in storage Declaration EMC of this product complies with IEC60601 1 1 2 standard Measurement Performance in Weak Filling Condition required the test equipment BIO TEK INDEX Pulse Oximeter tester the pulse wave is available without failure when the simulation pulse wave amplitude is at 6 Interference Resistance Capacity aginst Ambient Light Device work normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter tester 15 Possible Problems and Resolutions Possible Problems reason Solution SpO2 or PR 1 Fingerisnot 1 Retry by can not be plugged in inserting the displayed correctly finger until fully normally UAR engaged a F i bin 2 Repeat test Oxyhemoglobin m
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