Model 100 POX Manual - English: Low Resolution
Contents
1. Type of protection against electric shock Internally powered Type BF applied parts Degree of protection against harmful ingress of water Ordinary equipment Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide 21 22 Mediaid Inc Limited Warranty Chapter 6 Mediaid Inc Limited Applicability of Warranty This warranty covers only the Mediaid Model 100 pulse oximeter and accessories as indicated It is not extended to other products or components that the customer uses in conjunction with Mediaid products This warranty shall not apply if the manufacturer determines that the product has been damaged due to abuse misuse misapplication accident negligence tampering or as a result of service or modification by anyone other than an authorized Mediaid service technician Opening of the sealed enclosure or altering of the serial number voids the Mediaid Warranty Use of equipment contrary to or inconsistent with the User s Manual will also void the warranty NOTE This product is sold by Mediaid Inc referred to as Mediaid under the warranties set forth herein Warranty Coverage Mediaid warrants that the Model 100 enclosed with this warranty will conform to the manufacturers specifications and shall2. Do not attempt to modify or repair the instrument doing so voids the warranty Dispose of this device according to governmental regulations Adhere to all cautions stipulations and instructions included with the Integral Finger Sensor the Cable Adapter and all Mediaid sensors used with the Cable Adapter Environmental Cautions Do not use the instrument in the presence of flammable agents or flammable anesthetics Do not immerse in liquid and do not allow any liquid to penetrate the instruments interior Operate the pulse oximeter in normal light conditions Principles of Operation Avoid bright light or glare on the sensing area to ensure correct reading of the displays and indicators Keep the pulse oximeter away from MRI Magnetic Resonance Imaging equipment Move the pulse oximeter away from other electromagnetic emitting equipment if you experience interference problems This device complies with electromagnetic compatibility standard EN 60601 1 2 Keep away from equipment that emits x ray alpha particles beta particles neutron particles or microwave emissions Battery Cautions Use only 1 5 volt AA sized alkaline batteries Duracell Ultra batteries are recommended Never use manganese batteries lithium batteries or any other type of battery not specifically recommended Use of such batteries may damage the pulse oximeter Never dispose of batteries into fire short circuit the terminals or attempt
3. Integral Finger Sensor Product Number POX050 750 1S Serial Number Warranty Expiration Date Cable Adapter Product Number POX055 200 1S Serial Number Warranty Expiration Date 26
4. Service Information sssssssssssseseeeee 25 Prod ct Information ice err rr Rn ERREUR ERR AREE E E an aE aE E 26 Contents 2 Principles of Operation Chapter 1 Principles of Operation Intended Uses The Mediaid Model 100 pulse WARNING oximeter is intended to non Before using the Model 100 invasively measure arterial oxygen become thoroughly familiar saturation and pulse rate in hospitals physicians offices emergency medical facilities or at home The Model 100 is not intended for continuous patient monitoring with the information in this manual Principles of Pulse Oximetry The Mediaid Model 100 pulse oximeter is designed to measure the percentage of functional oxygenated hemoglobin to total hemoglobin Non invasive arterial oxygen saturation measurement is obtained by directing red and infrared light through a pulsating vascular bed The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform The non pulsatile signal is removed electronically for the purpose of calculation Therefore skin bone and other non pulsating substances do not interfere with the measurement of arterial oxygen saturation Intrinsic Calibration The light absorption by hemoglobin is wavelength
5. be free from defects in workmanship and materials for a period of two years from the date of purchase Batteries and accessories are excluded from this warranty The Integral Finger Sensor and the Cable Adapter are warranted according to information on their respective instruction sheets This warranty does not cover any damage done to the equipment during shipping which shall be the sole responsibility of the transportation company There are no warranties expressed or implied which extend beyond the warranties set forth herein Mediaid makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof This warranty gives you specific legal rights You may have other legal rights which vary from state to state or sad a Mediaid Inc Limited Warranty country to country Mediaid will not be liable to the user for incidental or consequential damage or loss arising out of the user s inability to use this product Mediaid Problem Correction Plan Should the Mediaid product prove to be defective contact Mediaid by telephone at 1 714 367 2848 info mediaidinc com Have the product and serial numbers available when calling Mediaid will then issue a Return Authorization Number RAN Return the instrument securely packaged in its original shipping carton or equivalent packaging and include the RAN Mediaid will repair any faulty workmanship and will either repair or replace at our
6. dependent Mediaid red and infrared LED wavelengths are tightly controlled by testing in production In addition the LED intensity recorded at the detector is automatically adjusted for amplitude this allows Mediaid pulse oximetry sensors to be used interchangeably without calibration Principles of Operation Principle Features The Mediaid Model 100 pulse WARNING oximeter is a portable lightweight Do not use the Model 100 for pocket sized instrument that continuous patient monitoring monitors functional arterial oxygen saturation and pulse rate non invasively The principal features of the Model 100 are as follows Gives an alternating readout of SpO percentage SpO and pulse rate in beats per minute BPM on a 3 digit 7 segment LED light emitting diode display Can be used with either the Integral Finger Sensor or any Mediaid pulse oximetry sensor that has a CompuShield Connector that attaches to the Cable Adapter Increases the longevity and functionality of the pulse oximeter with the removable and replaceable sensor modules Performs approximately 1200 spot checks on a single 1 5 volt AA sized alkaline battery when using a Duracell Ultra battery which is recommended Cautions General Cautions US federal law restricts this device to sale by or on the order of a physician Become thoroughly familiar with the information in this User s Manual and all accompanying documents before using the Model 100
7. option any defective part with new or refurbished parts For non warranty repairs the customer will be charged the current repair rate at the time of receipt by Mediaid All transportation charges shall be the customer s responsibility Always read the user s manual carefully The information included in the User s Manual will assist the user in preventing equipment misuse and ensuring patient safety Operation of the equipment in a manner contrary to or inconsistent with the User s Manual voids the warranty Owner s Registration To assist Mediaid in better serving the user please complete the included Warranty Registration Card and return it to Mediaid Inc 17517 Fabrica Way Suite H Cerritos CA 90703 USA 24 User Information Chapter 7 User Information Contact Customer Service Information For information on other Mediaid Inc products visit the Mediaid Inc home page on the web at www mediaidinc com or contact us at Customer Service 17517 Fabrica Way Suite H Cerritos CA 90703 USA Returns Department 17517 Fabrica Way Suite H Cerritos CA 90703 USA Phone 714 367 2848 Fax 714 367 2852 Email info mediaidinc com 25 User Information Product Information To better assist customers Mediaid recommends that all users write down all pertinent product and warranty information in the spaces provided below Model 100 Product Number POX010 100 Serial Number Warranty Expiration Date
8. the Model 100 B Battery Compartment The Battery Compartment holds a single 1 5 volt AA sized alkaline battery that provides operating power for the Model 100 C Belt Clip The removable Belt Clip provides a convenient method of carrying the Model 100 D Belt Clip Retaining Screw The Belt Clip Retaining Screw attaches the Belt Clip to the Model 100 A Oxygen Saturation Display The Oxygen Saturation Display shows the oxygen saturation values B Oxygen Saturation Indicator The Oxygen Saturation Indicator lights whenever an oxygen saturation value is displayed C Low Battery Indicator The Low Battery Indicator lights up whenever the remaining operation time is less than 30 minutes The Pulse Rate Indicator lights up when a pulse rate value is displayed Features Indicators and Symbols Pulse Oximeter Top View A Module Connector The Module Connector connects the Integral Finger Sensor or the Cable Adapter module to the pulse oximeter B Insertion Guides The Insertion Guides align with the Insertion Tabs on the Integral Finger Sensor or the Cable Adapter to ensure proper attachment Integral Finger Sensor Front Top View A Sensor Top Lever The Sensor Top Lever is pressed to open B ay the sensor so that a finger can be inserted Pressing the Sensor Top Lever when the Integral Finger Sensor is attached powers on the Model 100 B Finger Insertion Area The Finger Insertion Area is the loc
9. the pulse oximeter tests the sensor availability internal functions and the battery The LED Display shows three dashes during the power on tests which last 1 2 seconds 14 Operating the Model 100 When the pulse oximeter has successfully passed the power on tests it begins measuring oxygen saturation and pulse rate data If the battery is low the Low Battery Indicator will light An error code will show if any other malfunction occurs See Troubleshooting in Chapter 4 for error code interpretation Powering Off the Model 100 To power off the pulse oximeter complete one of the following WARNING steps To ensure personal safety and If the Integral Finger Sensor is proper operation of the pulse attached remove the finger oximeter adhere to all directions warnings cautions and policies stated within this manual as well as those included with each accessory from the sensor Ifthe Cable Adapter is attached either press the On Off key or disconnect the sensor from the Cable Adapter If the pulse oximeter cannot detect oxygen saturation or pulse rate or if the finger is positioned incorrectly it will power off automatically Measuring Oxygen Saturation and Pulse Rate The Model 100 displays pulse oximetry data whenever a sensor is attached to a patient and the monitoring site has sufficient perfusion Pulse oximetry data can be viewed on the LED Display as follows Oxygen saturatio
10. to disassemble heat or recharge the batteries Doing so may damage the batteries and cause a fire injury or environmental contamination Liquid leaking from the battery can cause skin burns or damage the pulse oximeter If a battery leaks inside the instrument return the pulse oximeter for servicing Remove the battery during shipment or if the Model 100 is to be idle for several weeks Preventing Device Complications and Faulty Readings To prevent device complications or faulty readings Trim the patients long fingernails and remove artificial nails and thick nail polish Insert the patient s finger completely into the Integral Finger Sensor When using the Integral Finger Sensor both the pulse oximeter and the patient s hand should rest on the same flat surface Fit the sensor comfortably without constricting or compressing the application site when using a sensor that is attached to the Cable Adapter Donotapply the sensor to anything but a well perfused extremity Do not apply the sensor on extremities that have blood pressure cuffs or arterial or venous catheters Principles of Operation Avoid extremity positions that could compromise venous return Keep sensors at heart level whenever possible Check for intravascular dyes which may affect pulse oximeter readings Turn off very bright lights such as surgical bilirubin fluorescent or infrared heating if they interfere with sensor functioning In cas
11. Model 100 Pulse Oximeter MU User s Manual Enan MEDIAID INC 17517 Fabrica Way Cerritos California 90703 USA Tel 714 367 2848 Fax 714 367 2852 Web www mediaidinc com Email info mediaidinc com POX010 100 Contents Contents Chapter 1 Principles of Operation esee 1 Intended Uses entier te t het thea tbe ipe dt dentia 1 Principles of Pulse Oximetry sesesessseessseeeeeennee nennen nnns 1 INtriNSIC Calibra tion cms 1 Principal Feat res eicere reir tora penetra pete eai ges REEERE A 2 Cautions sce Seco n 2 Preventing Device Complications and Faulty Readings 3 Chapter 2 Features Indicators and Symbols 5 Model 100 Front View 2 a iaa 5 Model 100 Back View ssssessseeeenenenenneneen emere nnne enne ens 6 LED Display RIED IRIURE ERRAT coa 6 Pulse Oximeter Top View ssessssssssssseseeeeeenee nennen entente nnns tnn tns 7 Integral Finger Sensor Front Top View eese 7 Cable Adapter Front Top View sssssssssssesseeeeeeeneneee nennen 8 Cable Adapter and Integral Finger Sensor Bottom View sss 8 we 9 Chapter 3 Operating the Model 100 eseseesssss 11 Replacing the Battery cosillas 11 Attachi
12. The pulse oximeter will Remove the battery and not power off contact Mediaid Inc Technical Support 3 The battery needs to be Replace the battery If replaced replacing it does not clear the code contact Mediaid Inc Technical Support 7 8 The Cable Adapter the Replace the Integral sensor attached to the Finger Sensor or the Cable Adapter or the sensor attached to The Integral Finger Sensor is Cable Adapter with a malfunctioning functioning sensor If replacing the sensor does not clear the code try replacing the Cable Adapter If the error code persists contact Mediaid Inc Technical Support 11 The pulse oximeter Remove then reattach cannot detect the sensor either because of a sensor malfuntion or the sensor is not properly attached the Cable Adapter and the sensor connected to the Cable Adapter or the Integral Finger Sensor If reattaching does not clear the error code contact Mediaid Inc Technical Support 4 6 9 10 12 13 14 15 An internal failure has occurred Contact Mediaid Inc Technical Support If any other error codes appear contact Mediaid Technical Support 18 Equipment Specification Chapter 5 Equipment Specifications General Specifications Dimensions Size 4 73 x 1 82 x 0 96 in 12 x 4 67 x 2 46 cm Weight 4 1 0z 113 g w Cable Adapter 3 9 oz 111 g w Integral Finger Sensor weight includes battery Display Type 3 digit 7 segment LED display Display R
13. ate SpO2 Every 7 5 seconds BPM Every 2 5 seconds Resolution SpO2 196 Pulse 1 BPM Range SpO2 20 to 100 Pulse 25to 250 BPM Accuracy SpO2 100 to 7096 12 69 to 60 13 lt 60 unspecified Pulse 25to 200 BPM 2 BPM or 2 gt 200 BPM 13 Response Time SpO2 8 seconds for 80 of patients Pulse 8 seconds for 80 of patients 49 Equipment Specification Sensors The Integral Finger Sensor or any Mediaid pulse oximeter sensor with the CompuShield Connector for use with the Cable Adapter is compatible with the Model 100 Red LED Wavelength 660 2nm Energy 60 uW IR LED Wavelength 910 10nm Energy 150 uW Power Source Battery Type One 1 5 volt AA sized alkaline battery Duracell Ultra recommended Battery Life Approximately 1200 Spot Checks using Duracell Ultra NOTE Battery life varies with usage conditions and battery brand Environmental Conditions Operating Temperature 0 to 40 C 32 to 104 F Storage Transport Temperature 40 to 70 C 40 to 158 F Operational Relative Humidity 30 to 75 Storage Transport Relative Humidity 10 to 100 including condensation 20 Equipment Specification Operational Atmospheric Pressure 700 to 1060 hPa Storage Transport Atmospheric Pressure 500 to 1060 hPa Equipment Classification The Mediaid Model 100 Pulse Oximeter is classified according to CAN CSA C22 2 No 601 1 IEC 601 1 Part 1 Section 1 Subclause 5 as follows
14. ation for insertion of a finger or a thumb into the sensor C Insertion Tabs The Insertion Tabs align with the Insertion Guides on the pulse oximeter to ensure proper attachment Features Indicators and Symbols Cable Adapter Front Top View A A Cable Adapter On Off Key B a The Cable Adapter On Off key C powers on the pulse oximeter when the Cable Adapter is attached B CompuShield Connector The CompuShield Connector connects an appropriate Mediaid sensor to the Cable Adapter C Insertion Tabs The Insertion Tabs align with the Insertion Guides on the pulse oximeter to ensure proper attachment Cable Adapter and Integral Finger Sensor Bottom View A Spring Clip The Spring Clip secures either the Integral Finger Sensor or the Cable Adapter to the pulse oximeter B Module Release The Module Release mechanism allows for removal of either the Integral Finger Sensor or the Cable Adapter from the pulse oximeter C Insertion Tabs The Insertion Tabs align with the Insertion Guides on the pulse oximeter to ensure proper attachment D Rear Connector The Rear Connector electrically connects Integral Finger Sensor or the Cable Adapter to the pulse oximeter Symbols Symbols AA ies 40 RX O nly Features Indicators and Symbols Definition Cable Adapter On Off Oxygen Saturation Pulse Rate Indicator Low Battery Indicator Battery Polarity Symbol Attent
15. d on the Cable Adapter or pulling upward on the attached sensor connector Figure 4 Slide the Cable Adapter out of the pulse oximeter 13 Operating the Model 100 Removing the Belt Clip To remove the Belt Clip from the Model 100 complete the following steps Use a 1 Jeweler s small Phillips screwdriver to remove the Belt Clip Retaining Screw Remove the Belt Clip from the pulse oximeter Attaching the Belt Clip If the Belt Clip has been removed from the pulse oximeter complete the following steps to replace it Place the flat part of the 0 Ali C ES LIIS Belt Clip Belt Clip Retaining Screw Belt Clip on the back of the pulse oximeter lining up the screw holes on the Belt Clip and the pulse oximeter Retaining Screw Place the Belt Clip Retaining Screw into the hole in the Belt Clip Use a 1 Jeweler s small Phillips screwdriver to tighten the Belt Clip Powering On the Model 100 To power on the Model 100 complete one of the following two WARNING steps To ensure personal safety and If the Integral Finger Sensor is attached press the Sensor Top Lever until the Model 100 powers on If the Cable Adapter is attached press the Cable Adapter On Off key proper operation of the pulse oximeter adhere to all directions warnings cautions and policies stated within this manual as well as those included with each accessory After power on
16. es where such lights are unavoidable cover the sensor site with an opaque material Route sensor cords carefully Avoid applying excessive tension to the sensor or sensor cable Consider conditions affecting the hemoglobin dissociation curve when interpreting pulse oximeter readings such as intravascular dyes Keep patient movement to a minimum When not in use do not wind the sensor cord around the oximeter Features Indicators and Symbols Chapter 2 Features Indicators and Model 100 Front View A Module Release The Module Release mechanism allows for removal of the Integral Finger Sensor or the Cable Adapter module from the Model 100 B Module Connector The Module Connector connects the Integral Finger Sensor or the Cable Adapter module to the Model 100 C LED Display The LED Display alternates between showing the pulse rate and the oxygen saturation values The LED Display also shows error code numbers and functions MEDIAID D Visual Pulse Indicator E PALCO The Visual Pulse Indicator is an orange LED that flashes with every pulse detected by the Model 100 Features Indicators and Symbols Model 100 Back View Taraa pe marat ie e Ali C D Pulse Rate Display The Pulse Rate Display shows the pulse rate values E Pulse Rate Indicator A Module Release The Module Release mechanism allows for removal of either the Integral Finger Sensor or the Cable Adapter module from
17. ion Consult accompanying documents Not anesthetic proof Type BF equipment Date of manufacture US federal law restricts this device to sale by or on the order of a physician 10 Operating the Model 100 Chapter 3 Replacing the Battery The Model 100 is powered by a CAUTION single 1 5 volt AA sized alkaline battery that will operate Always adhere to all of the the instrument for approximately 1200 spot checks when using a Duracell Ultra battery To replace the battery complete the following steps 1 Gently press down on the Battery Compartment door and push it out of the pulse oximeter 2 Insert the battery Follow the correct polarity indicated by the Battery Polarity symbol located on the inside of the compartment 3 Insert the tabs on the Battery Compartment Door into the Battery Compartment and gently slide the door into place cautions listed in Battery Cautions in Chapter 1 Battery Compartment 11 Operating the Model 100 Attaching the Integral Finger Sensor or the Cable Adapter To attach either the Integral Finger Sensor or the Cable Adapter to the Model 100 complete the following steps CAUTION To obtain accurate oximetry readings choose an lt gt appropriate Mediaid pulse oximeter and sensor according to the intended use Follow all instructions stated within this manual as well as those included with each sensor FIGURE 1 The Integral Finger Senso
18. n values display for 7 5 seconds Pulse rate values display for 2 5 seconds To measure pulse oximetry data complete the following steps 1 Apply the sensor to the patient Either insert the patients finger into the Integral Finger Sensor or apply the sensor that is attached to the Cable Adapter 2 If the Cable Adapter is attached press the Cable Adapter On Off key to power on the Model 100 The LED Display shows three dashes for 1 2 seconds while the Model 100 performs the power on tests The Pulse Indicator begins to blink signalling that the Model 100 is measuring a site with sufficient perfusion 3 If the Pulse Indicator does not blink adjust the sensor position 15 Operating the Model 100 After the power on tests the following information shows on the Model 100 With each pulse detected by the pulse oximeter the Vistual Pulse Indicator flashes SpO2 values show on the LED Display when the Oxygen Saturation Indicator lights Pulse rate values show on the LED Display when the Pulse Rate Indicator lights The following conditions apply when the Model 100 cannot detect pulse rate or oxygen saturation values If the Model 100 cannot detect a pulse rate but can detect oxygen saturation values three dashes will show on the LED Display each time the Pulse Rate Indicator lights If the Model 100 cannot detect oxygen saturation values but can detect a pulse rate three dashes will
19. ng the Integral Finger Sensor or the Cable Adapter 12 Removing the Integral Finger Sensor 13 Removing the Cable Adapter cc cccsceeeseeeeeeeeeeeseaeeeeeeeeaeeeeaeeseaeeeeeeeeeeeeeaeeee 13 Removing the Belt Clip essent nnne 14 Attaching the Belt Clip sssssssssssssseseeseeeee enne 14 Powering On the Model 100 esseseeeeeeeeenneeeene enne 14 Powering Off the Model 100 sssssseeeneeeennen emen rennen 15 Measuring Oxygen Saturation and Pulse Rate sseseee 15 Chapter 4 Maintaining the Model 100 eee 17 Cleaning the Model 100 sessssseeeeeeenneeneen nennen rennen 17 Troubleshooting et erret ie 17 Chapter 5 Equipment Specifications esses 19 General Specifications x decedente rte eo eite br ec breeze tds 19 Environmental Conditions 1 1 AAN 20 Equipment Classification sssessssssssseeeeeeenne enne 21 Contents 1 Contents Chapter 6 Mediaid Inc Limited Warranty eeeeee 23 Applicability of Warranty ciirsa 23 Warranty COVerage chistosa 23 Mediaid Problem Correction Plan sssssssssssesseseeeeeeennee ennt 24 Owner s Registration essen nene eene 24 Chapter 7 User References oerte trend 25 Contact Customer
20. r or the Cable Adapter can be left connected to the pulse oximeter FIGURE 2 1 Set the Integral Finger Sensor or the Cable Adapter module into the pulse oximeter pointing the Rear Connector of the module toward the Module Connector of the pulse oximeter Figure 1 The arrow on the bottom of the module will point toward the LED Display of the pulse oximeter 2 Slide the Integral Finger Sensor or the Cable Adapter module completely into the pulse oximeter Figure 2 The Insertion Tabs at the end of the module will fit into the Insertion Guides on the pulse oximeter 12 Operating the Model 100 Removing the Integral Finger Sensor FIGURE 3 To remove the Integral Finger Sensor from the Model 100 complete the following steps 1 Locate the Module Release mechanism at the back of the instrument just above the label 2 Push the pointed end of a paper clip into the Module Release mechanism while simultaneously pushing gently upward on the Sensor Top Lever Figure 3 until the Integral Finger Sensor is released Slide the Integral Finger Sensor out of the pulse oximeter Removing the Cable Adapter FIGURE 4 E To remove the Cable Adapter from the pulse oximeter complete the following steps 1 Locate the Module Release mechanism at the back of the pulse oximeter just above the label 2 Push the pointed end of a paper clip into the Module Release mechanism while simultaneously pushing upwar
21. show on the LED Display each time the Oxygen Saturation Indicator lights If the Model 100 can detect neither a pulse rate nor oxygen saturation values it will power off automatically 16 Maintaining the Model 100 Chapter 4 Cleaning the Model 100 The Mediaid Model 100 Pulse There are no user serviceable Oximeter the Integral Finger parts or adjustments inside the Sensor and the Cable Adapter Model 100 Do not attempt to can be wiped clean with a soft open the instrument case any cloth lightly dampened with attempt to open the instrument isopropyl alcohol a glutaraldehyde voids the Mediaid warranty solution or soap and water Do not Refer to the information in immerse in liquid or allow any Mediaid Problem Correction liquid to penetrate the interior of Plan in Chapter 6 for service the pulse oximeter Avoid caustic information or abrasive cleaners that will mar the case or the sensors Use extra care in cleaning the LED Display window to avoid scratching the finish Troubleshooting Whenever an error occurs the pulse oximeter displays the letters Err error for 2 seconds and then displays the error code for 2 seconds Error messages cycle three times then the pulse oximeter powers off Table 1 explains the error code messages and gives possible solutions to the problems described in the messages 17 Maintaining the Model 100 Table 1 Error Code Description Solution 2
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