- American Diagnostic Corporation
Contents
1. ADC Diagnostix 2150 Pediatric Fingertip Pulse Oximeter Directions for Use ED 0 rr ES ee a AMERICAN DIAGNOSTIC CORPORATION ADC Fingertip Pediatric Pulse Oximeter Thank you for purchasing an ADC Diagnostix Brand Fingertip Pediatric Pulse Oximeter We re proud of the care and quality that goes into the manufacture of every product that bears our name With proper care and maintenance your Diagnostix Fingertip Pediatric Pulse Oximeter will provide many years of dependable service Device Description and Intended Use This device is intended for medical diagnostic purposes only It is used to indirectly measure the func tional oxygen saturation Sp02 of a pediatric patients blood It is intended for use on fingers with a thick ness of 7 64mm 11 19mm 3 to 44 This is the distance between the fingernail top and the finger pad bottom Functional oxygen saturation refers to the ratio of oxyhemoglobin to all hemoglobin that is capable of carrying oxygen This oximeter is not intended for continuous monitoring The Pulse Oxime ter requires no routine calibration or maintenance other than replacement of batteries Pulse oximetry combines the principles of optical plethysmography and spectrophotometry to deter mine arterial oxygen saturation values Optical plethysmography uses light absorbance technology to reproduce waveforms produced by pulsating blood Spectrophotometry uses various wavele2. ay require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours CAUTION Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing or immersing the sensors in liquid CAUTION The device should not be used on an extremity with a blood pressure cuff arterial catheter or intravascular line CAUTION Do not use this pulse oximeter in situations where alarms are required This device has no alarm Brief Description of Front Panel Low Power Indicator PR Bargraph Pulse Rate Sp0 Power SpO Switch waveform Sp0 5 Pulse Rate The PR Bar graph displays corresponding with the patient s pulse beat The height of the bar graph shows the patient s pulse strength Included Pulse Oximeter Accessories e One 1 lanyard Two 2 AAA batteries One 1 user manual One 1 Safety Bumper One 1 Carry Case 1 1 1 Battery Installation 1 Remove battery compartment top by sliding cover in direction szasa of the arrow until it pops open 2 Insert two AAA batteries into battery compartment being sure to observe the correct polarities Figure 1 3 Replace the battery cover by reversing step 1 L Note Be sure to observe correct battery polarity Failure to do so might i damage the device If device will not be used for an extended period of A a time remove batteries Replace batteries when l
3. e battery on 2 Battery not installed correctly 2 Remove and reinstall battery 3 The monitor may be damaged 3 Contact customer service center Indication is 1 The Oximeter is automatically 1 Normal suddenly off powered off when no signal was de 2 Replace batteries tected after 8 seconds 2 Battery power is too low to operate Err 3 or Err 4 1 Low Power 1 Change batteries 2 Recieving tube being shielded or dam 2 Return to Service Center aged together with broken connector 3 Mechanical Misplace for recieve emission tube 4 Amp Circuit malfunction 1 Low Power 1 Change batteries 2 Return to Service Center 2 Emission tube damaged 3 Current control circuit malfunction Guidance and Manufacturer s Declaration Electromagnetic Emissions Guidance and Manufacturer s declaration electromagnetic emission The Pulse Oximeter 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 an environment Emission Test RF Emissions CISPR11 Electronic Environment Guidance The 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 Compliance Level Group 1 The PULSE OXIMETER is suitable for use in all establish ments including domestic establishments and
4. er Indication Not for Continuous Monitorin sp02 i wal Manufacturer s Information Conforms to EU Standards amp SN serial Number Authorized European Represe natives Information Declaration EMC of this product comply with IEC60601 1 2 standard Measurement Performance in Low Perfusion 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 against Ambient Light Device work normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter tester Warranty American Diagnostic Corporation ADC warrants its products against defects in materials and workmanship under normal use and service as follows 1 Warranty service extends to the original retail purchaser only and commences with the date of delivery 2 Your Pulse Oximeter is warranted for two 2 years from date of purchase all parts What is Covered Replacement of parts and labor What is Not Covered Transportation charges to and from ADC Damages caused by abuse misuse accident or negligence Incidental special or consequential damages Some States do not allow the exclusion or limitation of incidental special or consequential damages So this limitation may not apply to you To Obtain Warranty Service Send item s postage paid to ADC Attn Repair Dept 55 Commerce Dr Hauppauge NY 11788 Please inc
5. facilitate reading by the observer Horizontal modes display the pulse wave form along with SPO2 and pulse rate while vertical modes display a pulse rate bar graph along with the SPO2 and pulse rate readings To alter the display mode After the unit is powered on each brief press of the power switch will cycle through to the next display mode in the sequence shown Note The default setting is display mode 1 Display Mode Cycle Normal Horizontal Normal Horizontal Normal Horizontal Wave Display Wire Display 3rd click Default Setting 2nd click O 44 46 oD iX Handstand Horizontal Normal Vertical Handstand Vertical 4th click Sth click 6th click Changing the Display Brightness 10 adjustable brightness settings To change the brightness setting After the unit is powered on depress and hold the power switch for 2 seconds the brightness will then change by degrees There are 10 levels of brightness Note The default setting is level 4 Lanyard Attachment 1 Thread thinner end of the lanyard through the hanging hole at either side of the device 2 Thread thicker end of the lanyard through the threaded end before pulling it tightly Note Unclasping the lanyard connector will facilitate thread ing thicker end through threaded loop Lanyard Holes Care and Maintenance e Replace the batteries promptly when low voltage indicator appears e Clean surface of the fingertip and oxime
6. iscon tinued immediately could lead to patient injury illness or death WARNING Before use carefully read the manual WARNING Do not use the pulse oximeter in an MRI or CT environment WARNING The operation of Pulse Oximeter may be affected by the use of an electrosurgical unit ESU WARNING Federal law restricts this device to sale by or on the order of a physician or licensed healthcare practitioner WARNING 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 WARNING Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries WARNING This product may contain a chemical known to the state of California to cause cancer birth defects or other reproductive harm CAUTION Do not use the pulse oximeter in an explosive atmosphere CAUTION Sp02 and pulse rate data is displayed for informational purposes only and does not con stitute a diagnosis or medical advice of any kind Only a qualified healthcare professional should in terpret the data obtained on this device CAUTION Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the patient CAUTION The pulse oximeter is not for continuous monitoring CAUTION Prolonged use or the patient s condition m
7. lude your name and address phone no proof of purchase and a brief note explaining the problem Implied Warranty Any implied warranty shall be limited in duration to the terms of this war ranty and in no case beyond the original selling price except where prohibited by law This war ranty gives you specific legal rights and you may have other rights which vary from state to state La 42 SSS SSS SS SS OSS AMERICAN DIAGNOSTIC CORPORATION i ADC Inspected in the U S A Sealed tel 631 273 9600 1 Hare ao aT Hauppauge NY 11788 El 09 l 2 3 I 0UU 292 ie fax 631 273 9659 www adctoday com ADC UK Ltd email PEPA com Unit 6 P014 1TH l l United Kingdom IB p n 93 2150 00 rev 4 english
8. ngths of light to perform quantitative measurements about light absorption Photoelectric Oxyhemoglobin In spection Technology is combined with Capacity Pulse Scanning and Recording Technology so that two beams of different wavelengths of light 660nm glow and 940nm near infrared light can be fo cused onto the human nail tip through a finger tip sensor These two LED s are chosen because the light absorption varies with the oxygen concentration of hemoglobin in these frequencies The pulse amplitudes of the red and near infrared signals are detected using photoelectric sensors and run through a microprocessor which converts the readings to numerical values Contraindications e The patient suffers from significant levels of dysfunctional hemoglobins such as carbonxy he moglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue have been injected into the patient Used in the presence of high ambient light ie direct sunlight Shield the sensor area with a surgical towel if necessary There is excessive patient movement The patient experiences venous pulsations The patient has hypotension severe vasoconstriction severe anemia or hypothermia The patient is in cardiac arrest or is in shock Patients have fingernail polish or false fingernails as they may cause inaccurate Sp02 readings General Warnings A warning statement in this manual identifies a condition or practice which if not corrected or d
9. ow battery symbol ap Figure 1 pears on display Always replace BOTH batteries at the same time Operating Instructions 1 Be sure to insert two AAA batteries before attempting to operate 2 Clean inside surface of oximeter and patients finger with 70 isopropyl alcohol before use 3 Squeeze the end opposite the power switch between the thumb and forefinger in order to open the device there is a textured surface on the battery cover side to facilitate grip Fig 2 4 Insert patient s finger nail side up into the device be sure to fully insert the patient s finger so that the sensors are completely covered by the finger Index or middle finger is recommended 5 Release the device allowing it to clamp down on the patient s finger 6 Press the power switch on the front top panel to activate 7 Have patient keep still for optimal accuracy 8 Depending upon environmental and patient conditions the device will begin to display readings in about 4 seconds 9 Note readings on the display 10 Remove the patients finger from the de vice by squeezing between forefinger and OTN thumb as indicated in Figure 2 _ Or 11 The display will indicate finger out i 12 The unit will power off approximately 8 _ seconds after the patient s finger is removed from Figure 2 the device Changing Oximeter Display Mode There are six different display modes The display modes alter the orientation of the display to
10. ter with 70 isopropyl alcohol before it is used in di agnosis of patients Remove the batteries if unit will not be operated for extended period of time It is best to store this product in a place where ambient temperature is 20 C 55 C 4 F 131 F and humidity is lt 93 It is recommended that the product should be kept in a dry environment at all times Please follow local ordinances when disposing of batteries Cleaning the Pulse Oximeter Clean the rubber touching the finger inside of the Oximeter with a soft dampened cloth with 70 isopropyl alcohol and clean the test finger using alcohol before and after each test Note Do not pour or spray any liquids onto the Oximeter and do not allow any liquids to enter any openings in the device Allow the Oximeter to dry thoroughly before reusing Troubleshooting Possible Problems Possible Reason Solution p02 or pulse rate do not dis 1 Finger is not inserted correctly 1 Retry inserting the finger play normally 2 Patient Sp02 value is too lowto 2 There is excessive illumination be measured 3 Measure more times If you determine the product is working correctly see your healthcare provider for an exact diagnosis Sp02 or pulse rate is shown 1 Finger might not be inserted 1 Retry inserting the finger unstably deep enough 2 Sit calmly and retry 2 Excessive patient movement The monitor cannot be powered 11 No battery or low battery power 1 Replac
11. those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF Emissions CISPR11 Class B Technical Specifications Display Type OLED Display Power consumption Less than 40mA SP02 display range 70 100 Low power indication PR Display Range 30 235 BPM Battery Life 2 AAA 1 5V 600mAh PR Display Mode Bargraph alkaline batteries could be Data Update Time lt 15s continuously operated as LED Wavelengths long as 30 hours Red 660nm Dimension Infrared 940nm Length l A 50mm Measurement range Width 1 28mm SP02 70 100 100 3 s lt 70 Height 1 28mm no definition Weight 2 1 702 35 509 Pulse Rate 30 235 BPM 2 bpm during Including 2 AAA batteries the pulse rate range of 30 99 Environment bpm and 2 during the pulse Operation Temperature 41 F 104 F 5 C 40 C fate range of 100 235 bpm Storage Temperature 4 F 131 F 20 C 55 C Accuracy 2 onthe stage of 80 100 Relative Humidty 15 80 in operation 3 on the stage of 70 79 10 80 in storage Accuracy 2 BPM or 2 larger Pulse Intensity Bargraph Indicator Finger Range 3 44 7 64mm 11 19mm Power Requirements Two AAA alkaline Batteries Minimum Weight 33lbs 15kg Symbol Definitions t Important Warning Caution amp Latex Free Equipment type is BF Hemoglobin Saturation SpO d Heart Rate BPM BPM D Low Pow
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