Operating Manual for the Handi+ Oxygen Analyzer
Contents
1. R218P12 MANUAL amp TIONS FOR USE R218M12 Rev D Maxtec Inc TEL 800 748 5355 6526 South Cottonwood Street FAX 801 270 5590 Salt Lake City Utah 84107 www maxtecinc com USA Authorized Representative ual MN 0123 6436 AM Amstenrade The Netherlands e CLASSIFICATION Classification pae ne Class Il medical device Protection against electric shock 22 2222 Internally powered equipment Protection against water cidcid IPX1 Mode of Operation hr roe ehhh 1 bee Basar Anm d DU UE Continuous Sterilization karrdren niria ani R pU Rer ee See section 6 0 Flammable anesthetic mixture 222222220 Not suitable for use in presence of a flammable anesthetic mixture Product Disposal Instructions The sensor batteries and circuit board are not suitable for regular trash disposal E Return sensor to Maxtec for proper disposal or dispose according to local guidelines Follow local guidelines for disposal of other components WARRANTY Maxtec Inc warrants the Handi to be free from defects of workmanship or materials for a period of two 2 years from the date of shipment from Maxtec under normal operating conditions and provided that the Handi is properly operated and maintained in accordance with Maxtec s operating instructions Should Handi fail prematurely the replacement Handi is warranted for the remainder of the original analyzer warranty per2. The Handi oxygen sensor has been validated at pressures up to 2 atmospheres absolute Calibration or operation above this pressure is beyond the intended use 866 4 Maxtec www maxtecinc com 5 4 4 Humidity Effect Humidity has no effect on the performance of the Handi other than diluting the gas as long as there is no condensation Depending on the humidity the gas may be diluted by as much as 4 which proportionally reduces the oxygen concentration The device responds to the actual oxygen concentration rather than the dry concentration Environments where condensation may occur are to be avoided since condensate may obstruct passage of gas to the sensing surface resulting in erroneous readings and slower response time For this reason the following is recommended Avoid usage in environments greater than 9596 relative humidity When used in a breathing circuit place the sensor upstream of the humidifier 5 0 CALIBRATION ERRORS AND ERROR CODES The Handi analyzers have a self test feature built into the software to detect faulty calibrations oxygen sensor failures and low operating voltage These are listed below and include possible actions to take if an error code occurs E02 No sensor attached Open unit and disconnect and reconnect sensor Unit should perform an auto calibration and should read 20 9 If not contact Customer Service for possible sensor replacement E03 No valid calibration data availa
3. CAL button on the Handi The calibration gas value on the analyzer display should read 20 9 or 100 depending on the gas stream used 2 4 Direct Flow Calibration Configuration B 1 Attach the Barbed Adapter to the Handi 2 Connect the clear sampling tube to the Barbed Adapter 3 Attach the other end of the clear sampling tube to a source of oxygen with a known oxygen concentration value and initiate flow of the calibration gas to the unit at a rate of 1 10 liters per minute 2 liters per minute is recommended 4 Allow the oxygen to saturate the sensor Although a stable value is usually observed within 30 seconds allow at least 2 minutes to ensure 866 4 Maxtec www maxtecinc com 3 complete saturation of the sensor with the calibration gas 5 If the Handi is not already turned on do so now by pressing the analyzer ON button 6 Press the CAL button on the Handi The calibration gas value on the analyzer display should read 20 9 or 100 depending on the gas stream used Configuration A Configuration B Flow Diverter M Barbed Adapter Clear Tubing T Adaptor N To gas HA 3 0 OPERATING THE HANDI To Check the Oxygen Concentration of a Sample Gas 1 Maintain the Handi in an upright position such that you can read the product label 2 Place the Handi in the sample gas stream IMPORTANT When usin
4. Pressure Effect a A AA A AA 4 4 Humidity Electra eae bd 5 0 CALIBRATION ERRORS AND ERROR CODES 0 00000 6 0 CLEANING AND MAINTENANCE 00000000000 ees T SPECIFICATIONS 2 sci ee eee Rex Rute Rp FEES Re an he Ber 7 1 Analyzer Specifications iit ene rem en aes 7 2 Effect of Interferent Gases and Vapors 0 0 00 eee eee eee 8 0 HANDI SPARE PARTS AND ACCESSORIES esses 8 1 Standard Replacement Parts and Accessories 0 000000 e eee 9 0 FREQUENTLY ASKED QUESTIONS 0 00 00 0 0 nes 866 4 Maxtec www maxtecinc com 1 0 INTRODUCTION 1 1 Component Identification TOP VIEW LCD CALIBRATION DISPLAY e de OVER RANGE o maxtec LCD Display A 3 digit display provides a direct readout of oxygen concentration in the range of 0 100 The display is blank when the Handi enters its Sleep power off mode The Handi will automatically enter the Sleep mode after approximately 1 3 minutes from the last time the ON button was pressed ON OFF Button Use this button to turn the Handi on and off When the Handi is in the Sleep power off mode the LCD display is blank The analyzer turns off after 1 3 minutes if no buttons are pressed Calibration Button Press the calibration CAL button to adjust the calibration value to reflect the known oxygen concentration To simplify operation the Handi Analyzer automatically determines the calib
5. ane Isoflurane Enflurane Sevoflurane and Desflurane and found to have acceptably low interference the device in entirety including electronics is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Only the threaded sensor face flow diverter and T adapter may be allowed to contact such a gas mixture This device does not contain automatic barometric pressure compensation Do not use near any type of flame or flammable explosive substances vapors or atmosphere Not for use in an MRI environment Improper use of this device can cause inaccurate oxygen readings which can lead to improper treatment hypoxia or hyperoxia Follow the procedures outlined in this user manual CAUTION Indicates a potentially hazardous situation if not avoided could result in minor or moderate injury and property damage The Maxtec MAX 250 oxygen sensor is a sealed device containing a weak acid electrolyte lead Pb and lead acetate Lead and lead acetate are hazardous waste constituents and should be disposed of properly or returned to Maxtec for proper disposal or recovery The Handi is not intended for steam ethylene oxide or radiation sterilization Do not autoclave or expose the sensor to high temperatures Do not immerse the Handi oxygen analyzer in any cleaning solution The flow diverter provided with the Handi is for use with flowing gases only Do no
6. are systems Its lightweight compact size extended battery life and auto off feature makes this oxygen analyzer ideal for portable oxygen analysis by qualified heath care professionals 2 0 CALIBRATING THE Handi 2 1 Before You Begin Contains lead 1 3 Description A protective film covering the threaded sensor face must be removed and the sensor allowed to breath for at least 30 minutes Next the Handi Oxygen Analyzer should be calibrated Thereafter Maxtec recommends calibration on a weekly basis However more frequent calibration will not adversely affect product performance 2 2 Calibrating the Handi Oxygen Analyzer Calibration of the instrument is necessary if the temperature of the gas stream changes by more than 3 degrees Celsius Changes in elevation result in calibration error of approximately 196 of reading per 250 feet In general calibration of the instrument should be performed when the geographic elevation at which the product is being used changes by more than 500 feet 2 866 4 Maxtec www maxtecinc com In addition calibration is recommended if the user is unclear when the last calibration procedure was performed or if the measurement value displayed is in question Calibrate the Handi to an oxygen source which has a traceable certificate and or USP certification of either 20 996 oxygen as found in room air or 10096 oxygen It is recommended that the oxygen source be documented a
7. ble Make sure unit has reached thermal equilibrium Press and hold the Calibration Button for three seconds to manually force a new calibration E04 Battery below minimum operating voltage Contact Customer Service for possible battery replacement CAL Err St O2 Sensor reading not stable Wait for displayed oxygen reading to stabilize when calibrating the device at 10096 oxygen Wait for unit to reach thermal equilibrium Please note that this can take up to one half hour if the device is stored in temperatures outside the specified operating temperature range CAL Err lo Sensor voltage too low Press and hold the Calibration Button for three seconds to manually force a new calibration If unit repeats this error more than three times contact Customer Service for possible sensor replacement CAL Err hi Sensor voltage too high Press and hold the Calibration Button for three seconds to manually force a new calibration If unit repeats this error more than three times contact Customer Service for possible sensor replacement 866 4 Maxtec www maxtecinc com CAL Err Bat Battery voltage too low to recalibrate Contact Customer Service for possible battery replacement 6 0 CLEANING AND MAINTENANCE When cleaning or disinfecting the Handi take appropriate care to prevent any solution from entering the analyzer The Handi surface may be cleaned using a cloth moistened with 65 isopropyl alcohol water solution or germicidal wi
8. g a standard T adapter make sure that the sensor is mounted in the adapter with the flow diverter pointing down Make sure that there is a tight fit between the flow diverter and the T adapter 3 Start the flow of the sample gas to the sensor 4 Allow the oxygen sensor to remain in the flow of the sample gas until stable 5 If the Handi is not already turned on do so now by pressing the analyzer ON button 6 Read the value displayed on the LCD Note If the Handi is used to measure the oxygen concentration with equipment using a heated or humidified gas stream it is recommended that the Handi be placed upstream of the heater and or humidifier For more information refer to Factors Influencing Calibration and Performance on page 5 of this manual 4 866 4 Maxtec www maxtecinc com For hospital and home care a new calibration is required when The measured O2 percentage in 100 Oo is below 97 0 Oz The measured O2 percentage in 100 Oo is above 103 0 O2 For ID testing or optimum accuracy a new calibration is required when The measured O2 percentage in 100 Oo is below 99 0 Oz The measured O2 percentage in 100 Oo is above 101 0 O2 4 0 FACTORS INFLUENCING ACCURATE READINGS 4 1 Elevation Changes Changes in elevation result in a reading error of approximately 1 of reading per 250 feet A change in altitude greater than 500 ft will require sensor recalibration This dev
9. ice does not automatically compensate for changes in barometric pressure or altitude If the device is moved to a location of a different altitude it must be recalibrated before use see section 2 2 4 2 Temperature Effects The Handi will hold calibration and read correctly within 3 when in thermal equilibrium within the operating temperature range The device must be thermally stable when calibrated and allowed to thermally stabilize after experiencing temperature changes before readings are accurate For these reasons the following is recommended When used in a breathing circuit place the sensor upstream of the heater For best results perform the calibration procedure at a temperature close to the temperature where analysis will occur Allow adequate time for the sensor to equilibrate to a new ambient temperature 4 3 Pressure Effect Readings from the Handi are proportional to the partial pressure of oxygen The partial pressure is equal to the concentration times the absolute pressure Thus the readings are proportional to the concentration if the pressure is held constant Flow rate of sample gas can affect pressure at the sensor in that back pressure at the sensing point may change For these reasons the following is recommended Calibrate the Handi at the same pressure as the sample gas If sample gases flow through tubing use the same apparatus and flow rates when calibrating as when measuring
10. iod Based on Maxtec s product evaluation Maxtec s sole obligation under the foregoing warranty is limited to making replacements repairs or issuing credit for equipment found to be defective This warranty extends only to the buyer purchasing the equipment directly from Maxtec Inc or through Maxtec s designated distributors and or agents as new equipment Routine maintenance items are excluded from this warranty Maxtec Inc shall not be liable to the purchaser or other persons for incidental or consequential damages or equipment that has been subject to abuse misuse misapplication alteration negligence or accident THESE WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE 866 4 Maxtec www maxtecinc com WARNINGS N Indicates a potentially hazardous situation if not avoided could result in death or serious injury Before use all individuals who will be using this product must become thoroughly familiar with the information contained in this Operation Manual Strict adherence to the operating instructions is necessary for safe and effective product performance This product will perform only as designed and only if installed and operated in accordance with the manufacturer s operating instructions Although the sensor of this device has been tested with various anesthesia gases including nitrous oxide Haloth
11. lectronics rated general purpose not for use in hazardous areas or for use with flammable gases Sensor Type xao her Re pete amets Maxtec MAX 250 series galvanic fuel cell Weight s eise ee turo Se sax na E ME is Approx 60 grams 866 4 Maxtec www maxtecinc com 7 2 45 in no j Handit N o e OVER RANGE i 0 20 in 7 2 Effect of Interferent Gases and Vapors Nitrous Oxide Halothane Isoflurance Enflurane Sevoflurane Desflurane Carbon Dioxide Helium 8 0 HANDI SPARE PARTS AND ACCESSORIES 8 1 Standard Replacement Parts and Accessories Part Number Item R218M12 Operation Manual Handi R218M 12 001 Operation Manual Handi International RP16P02 T Adapter R110P10 Flow Diverter Fitting R207P17 Barbed Adapter R100P92 002 Clear Tubing R213P92 Lanyard RP16P10 MaxConnect T Adapter R218P09 Handi Cover 8 866 4 Maxtec www maxtecinc com 9 0 Frequently Asked Questions 1 After calibrate to 20 9 the display changes as much as 1 This is within the normal Handi operating tolerance of 1 when temperature and pressure are constant have calibrated to 99 9 but when check my oxygen delivery equipment the Handi reads 0 4 or greater Over Range Indicator It is recommended that you conduct the calibration procedure again to get another reading The most likely cause is that the Handi has received a false calibrati
12. on value Make sure that the calibration gas is connected to the Handi at 2 liters per minute for a minimum of 2 minutes prior to proceeding with calibration This 2 minute equilibration time is necessary to insure that the sensor is completely saturated with the calibration gas I have found the reading to drift greater than 3 from a know source value What is the possible cause The sensor may be at or near its useful life Replace your Handi Sensor life is dependent on the oxygen concentration exposure For example a sensor which is used to check flow meters once a week for 8 hours will outlast one which is used to analyze oxygen blender performance 24 hours per day 5 days a week 866 4 Maxtec www maxtecinc com
13. pe The Handi may be disinfected using standard topical disinfectants The Handi is not intended for steam ethylene oxide or radiation sterilization Store the Handi in a temperature similar to its ambient environment of daily use 7 0 SPECIFICATIONS 7 1 Analyzer Specifications Measurement Range 2222222 eese 0 0 99 9 oxygen gas Res lution Displays ans a re 0 1 The three digit LCD indicates values between 0 0 99 9 oxygen Over range indicated by one decimal point on display located after the first digit Accuracy and Linearity 1 of full scale at constant temperature R H and pressure when calibrated at full scale Total Accuracy 3 actual oxygen level over full operating temp range Response Time 222222220 15 seconds for 9096 step change at 25 C Warm up Time None required Operating Temperature 2222222 15 C 40 C 59 F 104 F Storage Temperature sts ern 15 C 50 C 5 F 122 F Atmospheric Pressure llle 800 1013 mBars Humidity uris s xe rr one mere x Yo RD Ee 0 95 non condensing Environmental General purpose housing equivalent to NEMA 1 The Handi is not waterproof Warranty sese Twelve months in normal operating conditions Power Requirements 2 222222 seen nenn Powered by one internal non replaceable Lithium battery CR2450 Power on push button automatically shuts off after 80 seconds time out E
14. ration gas being used as room air 20 996 or high grade 100 Flow Diverter The flow diverter is designed to fit industry standard 15 mm I D T adapters Over Range Indicator The appearance of a decimal point after the first digit means that the Handi is reading in excess of 99 9 Example sese opi E CERO e sa een QUE Ruido Bog 0 0 0 100 De Seite ao di 0 0 1 101 SE 0 0 2 102 Pese If the display reads gt 0 0 3 the Handi should be re calibrated 866 4 Maxtec www maxtecinc com 1 1 2 Symbol Guide The following symbols and safety labels are found on the the Handi Attention consult accompanying documents On off Button M Meets ETL standards y Calibration Button Do not throw away Follow local guidelines for disposal sn Serial Number Lot code Batch code ul Manufacturer Rxonly For use by prescription only Catalog Number Contains acid X Authorized Representative in the European Community The Maxtec Handi oxygen analyzer is designed to monitor oxygen concentration in the patient breathing environment Itis one of a full line of oxygen analyzers by Maxtec The Handi oxygen analyzer utilizes the Maxtec MAX 250 oxygen sensor and is engineered for fast response maximum reliability and stable performance The Handi is designed primarily for spot checking of oxygen levels delivered by medical oxygen delivery equipment and respiratory c
15. t a pressure and flow similar to your clinical application Note Before beginning calibration the Handi must be in thermal equilibrium You may also need to be aware of other factors which affect device calibration values For more information refer to Factors Influencing Calibration and Performance on page 5 of this manual Note We recommend use of medical grade oxygen at 10096 when calibrating the Handi 2 3 In Line Calibration Configuration A 1 Put the Handi in an upright position such that you can read the product label 2 Connect a sample supply hose to a standard T piece The Maxtec T is precision tapered to insure a tight connection with O rings of the MAX 250 oxygen sensor diverter 3 Insert the Handi in the center position of the T piece 4 Attach an open ended reservoir to the end of the T piece Then start the calibration flow of oxygen at 1 10 liters per minute Note Six to 10 inches of corrugated tubing works well as a reservoir Note A calibration oxygen flow to the Handi of 2 liters per minute is recommended to minimize the possibility of obtaining a false calibration value 5 Allow the oxygen to saturate the sensor Although a stable value is usually observed within 30 seconds allow at least 2 minutes to ensure that the sensor is completely saturated with the calibration gas 6 Ifthe Handi is not already turned on do so now by pressing the analyzer ON button 7 Press the
16. t use the diverter when performing static sampling e g in incubators oxygen tents oxygen hoods Do not attempt any repairs or procedures which are not described in this Operation Manual Maxtec cannot warrant this product from damage resulting from misuse unauthorized repair or improper maintenance of this product The Federal USA law restricts this device to sale by or on the order of a physician There are no internal user serviceable parts Never install the sensor in a location that will expose the sensor to patient s exhaled breath or secretions I 866 4 Maxtec www maxtecinc com TABLE OF CONTENTS Classification zur ose EY EUER dba es EGG ea Veet oe een Warranty ini d Reed s pp E parer el Bust D eno Rad ae vns WAMINOS LET TIO INTRODBDUGTIGN terr era I MEE EE ne eR 1 1 Component Identification llle 1 2 Symbol GUIAS vu xxr se ee rd rie due Gx dade et dtr pers 1 3 Description 2x caged beatae oca ra rok Rx Re ce Rude bead 2 0 CALIBRATING THE HANDI ooo 2 1 Before you beglni used Rea kuret een 2 2 Calibrating the HANDI Oxygen Analyzer esses 2 3 In Line Calibration Configuration A llis 2 4 Direct Flow Calibration Configuration B 0 0 cee eee 3 0 OPERATING THE HANDI E 0 n 4 0 FACTORS INFLUENCING ACCURATE READINGS 2 222 222 4 1 Elevation Changes 24 404400 nass se nis 4 2 Temperature Effects rhii giier a ara lE eare oead 4 3
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