Model 5300 Series POX Manual - English: Low Resolution
Contents
1. S 17 3 6 Cleaning Iristrll ctionis 1e ences eerte 23 SS 23 Chapter 4 Equipment Specifications esses 25 4 1 Oxygen Saturation And Pulse Rate sse 25 4 2 ACUNCIEEREREEEEPEPEET IE 25 LEOXer II 25 4 4 SONS m sand Mai aaa nana 26 4 5 Power Soufce aunsnnaersannsnnnannnannnennannsnnnnnnnnnsannnnnnnnsnnnnnnnann sammen nenn sann nn 26 4 6 Environmental s2u440H440rsannnnnnnnsannnnnnnnnnannnennnnnsannnnnnnnsannnennnnnsnna nn 26 4 7 Equipment Classification ccccccccssccesssseeeesseeeecseeesssseeesssaeeeseseeeseeeeess 26 Chapter 5 Order Information essent 29 5 1 Product Information aaa isi ERR Ree 29 5 2 Contact Information sssssssseeseeeeeeenenen emen 29 Chapter 6 Mediaid Inc Limited Warranty Information 31 6 1 Applicabilty of Warranty 31 6 2 What Is Covered By This Warranty sssssssssssseeeneerees 31 6 3 What Mediaid Inc Will Do To Correct Problems eeeeee 31 6 4 Owner s Registration sese 32 6 5 Product Information sssssssssseeeeeneneeneneneeenennnn 33 CONPONIM I i oe ents ded ence cece nad een suad vnc cand deed esas A 35 Declaration of Conformity seen eren 35 Contents 1 Principles of Operation Chapter 1 Principles of Operation of the 5300 Series Pulse Ox2. 6 3 What Mediaid Inc Will Do To Correct Problems Should your Mediaid Inc product prove to be defective contact Mediaid Inc for repair at 714 367 2848 Please have your model and serial numbers available when calling Mediaid Inc will then issue a Return Authorization Number 2313 Mediaid Inc Limited Warranty Information RAN Return your instrument securely packaged in its original shipping carton or equivalent packaging and include your Return Authorization Number Mediaid Inc will repair any faulty workmanship and either repair or replace at our 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 Inc and all transportation charges shall be the customer s re sponsibility Mediaid Inc shall not be liable for any damages including but not limited to incidental damages consequential damages or special damages This Warranty does not cover any damage done to the equipment during shipping which shall be the sole responsibility of the transportation company 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 or inconsistent with the User s Manual will void the Warranty 6 4 Owner s Registration To assist Mediaid Inc in serving you ple
3. NOTE There are no user serviceable parts or adjustments inside the instrument Do not attempt to open the instrument case doing so will void the Warranty Always refer to the Warranty for service instructions RE 24 Equipment Specifications Chapter 4 Equipment Specifications 4 1 Oxygen Saturation and Pulse Rate Display Two 3 digit 7 segment LED Displays Resolution SpO 1 Pulse 1BPM Range SpO 0 100 Pulse 32 250 BPM Accuracy SpO 100 70 2 69 60 3 Less than 60 Unspecified Pulse 32 250 BPM 2 4 2 Alarms Model 5340 High SpO 51 100 Low SpO 50 99 High Pulse 31 230 BPM Low Pulse 30 229 BPM 4 3 General Size L x W x H 7 75 in x 4 25 in x 1 50 in 19 7 cm x 10 5 cm x 3 8 cm Weight Model 5305 15 3 oz 473g Model 5340 18 2 oz 516g 25 Equipment Specifications 4 4 Sensors Mediaid Inc opto plethysmographic pulse oximeter sensor with RJ12 connector and extension cable Red Light Wavelength 660 nm 565 pW Infrared Light Wavelength 910 nm 1 8 nW 4 5 Power Source Battery Type Rechargeable Nickel Cadmium NiCad Battery Battery Life 12 Hours of Continuous Operation Power Adaptor Type Radionic SW15100 PL Power Adaptor Input 100 250 V AC 50 60 Hz O 5A Power Adaptor Output 15VDC 1 0A 4 6 Environmental Conditions Acceptable conditions for operating storage and transport Atmospheric Pressure 770 to 282 45 mm Hg 1026 to 377 hPa Rel
4. or on the order of a physician The instrument should not be used in the presence of anesthetics or flammable agents Do not allow any liquid to penetrate the instrument s interior The Model 5300 Series Pulse Oximeters are designed to operate in normal ambient light conditions Do not use near Magnetic Resonance Imaging equipment To avoid potential effects of electromagnetic interference maintain a distance of Principles of Operation at least 15 cm 6 between the oximeter and other devices Also maintain a distance of at least 20 cm 8 between the Mediaid Inc wall adaptor and other devices When used with other equipment such as a defibrillator the accuracy of pulse oximetry readings may be affected In case of abnormal conditions during instrument operation appropriate measures such as powering off instruments should be taken to insure patient safety The user should NOT attempt to modify or repair the instrument This device complies with Electromagnetic Compatibility standards EN55011 and EN60601 1 2 If the user experiences interference problems move the unit away from other electromagnetic emitting equipment Dispose of this device according to hospital and or governmental regulations Keys Indicators Symbols and Markings Chapter 2 Keys Indicators Symbols and Markings Keys Indicators Symbols and Markings A Power On Off Key The unit is powered on with a short depres
5. In order to obtain Remove artificial nails and thick nail accurate pulse oximetry en iU En readings an appropriate i eck Tor intravascular dyes which may pulse oximeter and affect pulse oximeter readings Turn off very bright lights such as xenon lamps if they interfere with according to the intended sensor functioning In cases where use All instructions stated such lights are unavoidable cover the within this manual and sensor site with an opaque material y included with each sensor Route sensor cords carefully Avoid applying excessive tension to the should be followed sensor or sensor cable sensor need to be chosen Consider conditions affecting the hemoglobin dissociation curve when interpreting pulse oximeter readings Keep patient movement to a minimum 13 Operating the Model 5300 Series 3 2 Power All of these pulse oximeters can be powered by either a power adaptor or the internal rechargeable NiCad battery Battery operation alone will provide the oximeter with approximately 12 hours of continuous operation To charge the internal NiCad battery connect the Mediaid Inc power adaptor to the POWER CONNECTION located at the bottom of the oximeter Then plug the adaptor into an appropriately rated electrical outlet The green POWER INDICATOR will illuminate Once electric power is applied the battery will charge regardless of the operational state of the oximeter All Mediaid
6. operating on battery power 3 3 2 Continuous Monitoring Pulse Oximetry Model 5340 Choose an appropriate sensor Place the sensor according to the instructions included with each sensor Connect the sensor to the pulse oximeter with the SENSOR CABLE CONNECTION Follow all guidelines to prevent faulty readings and oximeter or sensor complications Power on the unit with the POWER ON OFF KEY Check that all LEDs illuminate during the Power Up Test Monitor the flashing of the VISUAL PULSE INDICATOR Read the patients oxygen saturation and heart rate from the two LED displays Listen to the AUDIBLE OXYGEN SATURATION and PULSE RATE INDICATOR Adjust the tone volume with the INCREMENT and DECREMENT KEYS Set the VISUAL and AUDIBLE ALARMS to the desired level with the INCREMENT DECREMENT KEYS after the OXYGEN SATURATION ALARM or PULSE RATE ALARM KEYS have been selected Read the alarm settings with the HI LO ALARM INDICATORS Silence an alarm with the ALARM OFF KEY Reactivate silenced alarms with WARNING the ALARM OFF KEY Do not silence the audible alarms or decrease their volume if patient safety could be compromised 15 Operating the Model 5300 Series 3 4 Data Transmission Model 5340 Serial and analog data can be communicated through the data port to a peripheral device Analog output of oxygen saturation 0 100 SpO and pulse rate 0 250 BPM are each transmitted on a scale of 0
7. 0 to 1 0 V Serial output of oxygen saturation 0 100 SpO and pulse rate 0 250 BPM are transmitted once per second in a data packet For tests regarding data transmission and the data port please refer to section 3 5 Tests Pin Number 2 Serial Line RX 3 Pulse Rate Analog Output 6 Oxygen Saturation Analog Output 7 Ground Signal Common 8 Serial Line TX 3 4 1 Serial Data Transmission Serial data can be transmitted with a Mediaid Inc Serial Cable Transmission speed is 9600 baud The data field is 8 bits one stop bit no parity The data packet output by the Model 5340 is comprised of four data bytes sent in the following order the Status byte the SpO byte the Pulse Rate byte and the Checksum byte The Status Byte The Status byte contains flags as to the operational state of the unit Bit 7 Not used Bit 6 Pulse is lost having previously been detected Bit 5 Pulse detected normal monitoring begun Bit 4 Error flag indicating that an error is occurring Bit 3 to 0 Number of bytes in the data packet The SpO Byte The SpO byte contains the current oxygen saturation level in SpO and is in 8 bit binary format The Pulse Rate Byte The Pulse Rate byte contains the current pulse rate in BPM and is in 8 bit binary 16 Operating the Model 5300 Series format The Checksum Byte The Checksum byte is the complement to the lower eight bits of the bytewise addition of the Sta
8. Inc pulse oximeters were designed to be used with the power adaptor provided by Mediaid Inc at the time of purchase The use of any other adaptor may damage the oximeter and will void the Mediaid Inc Warranty Refer to the product number of the power adaptor when reordering a new adaptor Include the serial number of the unit as this allows Mediaid Inc to determine the adaptor needed Also avoid excess tension on the adaptor cable for safe and continuous operation 3 3 Measuring and Displaying Pulse Oximetry 3 3 1 Spot Check Pulse Oximetry Model 5305 WARNING Choose an appropriate pulse oximeter Patient movement light and sensor according to the source or any other intended use interfering events that Place the sensor according to the f th 30 instructions included with each occur tor more than sensor seconds are indicated by Connect the sensor to the pulse a blinking display During CONNECTION i oximeter readings can be adversely affected Follow all guidelines to prevent faulty 14 Operating the Model 5300 Series readings and oximeter or sensor complications NOTE Power on the unit with the POWER The unit powers off ON OFF KEY automatically when a Check that all LEDs illuminate during pulse search is the Power Up test Monitor the flashing of the VISUAL PULSE INDICATOR Read patient s oxygen saturation level and pulse rate from the two LED displays unsuccessful while
9. and internal circuitry set up values As with normal monitoring initiate the test with a sensor applied to a subject The instrument will perform normal set up and monitoring functions and will periodically display single digit set up numbers zero for thin tissue one for medium tissue or two for thick tissue This test can only be exited by powering off the instrument 18 Operating the Model 5300 Series 3 5 2 Model 5340 3 5 2 1 Power Up Test A short depression of the POWER ON OFF KEY initiates a one second Display and Indicators Test All LEDs need to be illuminated for proper LED functioning 3 5 2 2 Internal Confidence Tests A long depression approximately three seconds of the POWER ON OFF KEY will power on the instrument test the Display and Indicators Power Condition and EEPROM and then display the units Software Version Number The instrument will revert to the normal power on sequence upon release of the POWER ON OFF KEY 3 5 2 3 Diagnostic Tests Diagnostic tests on the Model 5340 can be run automatically or be initiated manually They are initiated by first holding down the ALARM ON OFF KEY and then powering on the unit Upon initialization the characters tSt will appear in the left display window and the numeral in the right display window Any test may be selected via the INCREMENT or DECREMENT KEYS The selected test will be represented by a numeral in the right display window Upon selection the sequence is in
10. 20 INTERNAL MEMORY TEST Test 9 Upon initiation this test checks each location of the oximeters memory If all locations test to be functional the numeral 128 will be displayed SET UP TEST Test 10 This test alternately displays SpO pulse rate and internal circuitry set up values As with normal monitoring initiate the test with a sensor applied to a subject The instrument will perform normal set up and monitoring functions and will periodically display single digit set up numbers zero for thin tissue one for medium tissue or two for thick tissue This test can only be exited by powering off the instrument 22 Operating the Model 5300 Series 3 6 Cleaning Instructions All Mediaid Inc Model 5300 Series pulse oximeters can be wiped clean with isopropyl alcohol or glutaralde hyde Avoid caustic or abrasive cleaners that will mar the enclosure or keypad Use extra care when cleaning the red display window to avoid scratching the finish Do not clean the instrument while it is in operation 3 7 Troubleshooting Error Code Possible Causes Err 5 Improper sensor application area of sensor application too opaque sensor problem Err 135 Ambient light too bright direct light onto sensor Err 1 11 13 16 17 18 Internal failure of pulse oximeter bAt LO Low battery condition Err 20 Internal EEPROM failure Chirping Tone Model 5340 Data transmission failure
11. ED display window The VISUAL PULSE INDICATOR simultaneously flashes with the patient s pulse It will typically begin to flash a few seconds before numerical values for oxygen saturation and pulse rate are shown E Low Battery Indicator The LOW BATTERY INDICATOR will illuminate when the battery is near depletion prompting the user to suspend operation of the unit and change or recharge the battery using the method described in Section 3 2 Power The Pulse oximeter will Keys Indicators Symbols and Markings automatically power off shortly after low battery indication The acronym bAt LO will be displayed if power on is attempted during a low battery condition F Sensor Cable Connection LAL All Mediaid Inc pulse oximetry sensors with RJ12 connectors are compatible with the Model 5300 Series To connect a sensor to the pulse oximeter align the plug with the jack on the oximeter and insert it gently until an audible click is heard indicating that the plug tab is latched in place To remove squeeze the locking tab on the plug and slide the plug out of the jack Always route cords in such a way as to prevent accidental tripping and subsequent damage to the oximeter G Power Connection For electric power plug the adaptor into the pulse oximeter s POWER CONNECTION and then plug the other end of the adaptor into a standard electrical outlet All Mediaid Inc pulse oximeters were designed to be used with the adapto
12. Model 5300 Series Pulse Oximeter User s Manual Model 5305 amp Model 5340 MEDIAID 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 Model 5300 Series Pulse Oximeters User s Manual Model 5305 amp Model 5340 0197 EU Authorized Representative MDD 93 42 EEC Mayer Engineering amp Consulting Support GmbH Anna Schieber Weg2 D 73728 Esslingen Germany F 9615 Rev 0 Table Of Contents Contents Chapter 1 Principles of Operation of the 5300 Series Pulse OXIMeteTS omnia 1 1 1 Intended USES nani anna Ata 1 1 2 Principal Fealures innatas 1 1 3 Modes Of Monitor secos ce etn te creditor eed etes 2 1 4 Caution iiie dete tede tee iere nte iced fece de te iode fed rie deis 2 Chapter 2 Keys Indicators Symbols and Markings 5 2 1 Keys and Indicators sssssssssssssssssssseseeeeeeee nennen nennen 5 2 2 Additional Features essent 9 2 3 Symbols and Markings esseeenenenenenenenrem ener 10 Chapter 3 Operating the Model 5300 Series 13 3 1 Receiving Accurate Readings sene 13 DL PO P E EEEPEERES 14 3 3 Measuring and Displaying Pulse Oximetry eeee 14 3 4 Data Transmission nern 16 30 TES S
13. Operating the Model 5300 Series 3 5 1 2 Internal Confidence Tests A long depression approximately three seconds of the POWER ON OFF KEY will power on the instrument test the Display and Indicators Power Condition and then display the unit s Software Version Number 3 5 1 3 Self Diagnostic Tests A prolonged 10 second depression of the POWER ON OFF KEY is required at power on to initiate the self diagnostic test mode While pressing the POWER ON OFF KEY the unit cycles through the Internal Confidence Tests blanks the display for approximately five seconds and displays the acronym tSt an acronym for test The POWER ON OFF KEY needs to be released at this time to initiate automatic testing of Sensor Reference Voltage and Set Up SENSOR TEST Test 1 This test verifies the functionality of the sensor the oximeter s LED driver circuit and the oximeter s light detection circuit This occurs by the emission of sensor light at a preset frequency and level and the monitoring of the received signal from the sensor detector REFERENCE VOLTAGE TEST Test 2 lt takes 10 seconds to determine Pass or Fail verifying the units internal reference voltage A failure is indicated by a display of Err2 and a pass is indicated by the next test being performed If a failure is indicated refer to the Mediaid Inc Warranty for servicing instructions SET UP TEST Test 3 This test alternately displays SpO pulse rate
14. Y will switch the display between the high and low alarm settings as shown by the HI LO ALARM INDICATORS These alarm settings can be adjusted with the INCREMENT and DECREMENT KEYS The alarm settings will be retained in memory until reset by the user Exception When the low saturation alarm is set below 80 it will return to 80 at the next power up The saturation alarm factory settings are High 100 and Low 85 The high saturation alarm can be disabled by setting it at 100 The unit reverts to normal monitoring after a five second period of key inactivity M Pulse Rate Alarm Key Model 5340 Short depressions of the PULSE RATE ALARM KEY will switch the display between the high and low alarm settings as shown by the HI LO ALARM INDICATORS These alarm settings can be adjusted with the INCREMENT and DECREMENT KEYS The alarm settings will be retained in memory until reset by the user The pulse rate alarm factory settings are High 140 BPM and Low 50 BPM The unit reverts to normal monitoring after a five second period of key inactivity Keys Indicators Symbols and Markings N Indrement amp Decrement Keys Model 5340 A gt The pulse tone volumes can be adjusted using the INCREMENT and DECREMENT KEYS There are three levels of audible pulse tone volume and off The pulse tone volume can be increased with the INCREMENT KEY and decreased or silenced with the DECREMENT KEY Alarm settings are also adjusted with these k
15. a Way Suite H Cerritos CA 90703 USA Telephone 714 367 2848 Fax 714 367 2852 Email info mediaidinc com 29 30 Mediaid Inc Limited Warranty Information Chapter 6 Mediaid Inc Limited Warranty Information 6 1 Applicability of Warranty aes This product is This Warranty covers only the Mediaid manufactured and sold by Inc pulse oximeter Model 5300 Series Mediaid Inc under the warranties set forth below and accessories as indicated It is not extended to other products or components that the customer uses in conjunction with Mediaid Inc 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 any other than an authorized Mediaid Inc service technician Opening of the sealed enclosure or altering the serial number will void the Warranty Use of equipment contrary to or inconsistent with the User s Manual will also void the Warranty 6 2 What Is Covered By This Warranty Mediaid Inc warrants that the Mediaid Inc product enclosed with this Warranty will conform to the manufacturer s specifications and shall be free from defects in workmanship and materials for a period of five 5 years from the date of original purchase Items excluded from this five year term are power adaptor sensor extension cable sensors and other accessories
16. acter sent to the pulse oximeter the Model 5340 responds with the binary inverse character The test is ended by the host sending the oximeter a lower case g character REFERENCE VOLTAGE TEST Test 7 lt takes 10 seconds to determine Pass or Fail verifying the units internal reference voltage A failure is indicated by a display of Err7 and a pass is indicated by the next test being performed The display is blank while this test is run If a failure is indicated refer to the Mediaid Inc Warranty for servicing instructions 21 Operating the Model 5300 Series ANALOG OUTPUT TEST Test 8 The use of a voltmeter is required to perform this test First connect one lead to pin 6 saturation analog output and the common output lead to pin 7 ground signal common Once initiated each depression of the ALARM OFF KEY tests the three saturation values which are displayed in the left window in ascending order Observe the meter display to confirm a proper operation as listed below Then connect the first lead to pin 3 pulse rate analog output to test the three pulse rate values as they are displayed in the right window Pin Number 2 Serial Line RX 3 Pulse Rate Analog Output 6 Oxygen Saturation Analog Output 7 Ground Signal Common 8 Serial Line TX Sp0 Pin 6 BPM Pin3 0 0 000V 0 001 0 0 000V 0 001 50 0 500V 0 010 125 0 500V 0 010 100 1 000V 0 020 250 1 000V 0 0
17. ase complete the Warranty Registration Card that is included and return it to Mediaid Inc 17517 Fabrica Way Suite H Cerritos CA 90703 USA NOTE There are no warranties expressed or implied which extend beyond the warranties set forth above Mediaid Inc makes no warranty of 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 Mediaid Inc Will Not Be liable to the user for incidental or consequential damage or loss arising out of the user s inablilty to use this product 32 Mediaid Inc Limited Warranty Information 6 5 Product Information To better assist customers Mediaid Inc recommends all users to write down all pertinent product and warranty information Product Number Serial Number Software Version Number Warranty Expiration Date 33 34 Delcaration of Conformity Conformity Declaration of Conformity Appication of European Union Council Directive 93 42 ECC Manufacturer Mediaid Inc Address 17517 Fabrica Way Suite H Cerritos CA 90703 USA Product Description Sphygmo Oxymeter Type Model Mediaid Palco 5305 Classification lla Type Model Mediaid Palco 5340 Classification IIb Certification of Quality System European Authorized Certificate Number HD 60006298 0001 Representative Issued by TUV Rhienland Mayer Engineering amp Consult
18. ative Humidity 5 to 95 Noncondensing Operating Temperature 0 to 40 C 32 to 104 F Storage Temperature 30 to 65 C 22 to 149 F 4 7 Equipment Classification The Mediaid Inc Model 5300 Series pulse oximeters are designed in accordance with CAN CSA C22 2 No 601 1 EN 60601 1 and UL 2601 1 The oximeters are classified by IEC 601 1 as follows Type of protection against electric shock CLASS AND INTERNALLY POWERED TYPE BF APPLIED PARTS Degree of protection against harmful ingress of water 26 Equipment Specifications IPX 0 ACCORDING TO IEC 529 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 Mode of operation Continuous Operation 27 28 Order Information Chapter 5 Order Information 5 1 Product Information Part Number Description POX010 5305 Model 5305 Hand Held Pulse Oximeter w Rechargeable Battery POX010 5340 Model 5340 Hand Held Pulse Oximeter w Alarms Rechargeable Battery Serial and Analog Output 5 2 Contact Information For information on any other Mediaid Inc products visit the Mediaid Inc home page on the web at www mediaidinc com or contact Mediaid Inc at Customer Service 17517 Fabrica Way Suite H Cerritos CA 90703 USA Returns Department 17517 Fabric
19. eys O Visual Hi Lo Alarm Indicators HI LO Model 5340 Located beneath the OXYGEN SATURATION ALARM and PULSE RATE ALARM KEYS these indicators illuminate when the patient s oxygen saturation or pulse rate reaches the preset high or low alarm settings In order to set alarms the appropriate indicator must be illuminated 2 2 Additional Features Audible Oxygen Saturatio Indicator Model 5340 A varying pitch of the audible tone signals a change in the SpO level a falling pitch indicates a decreasing SpO level Audible Pulse Rate Indicator Model 5340 A beeping audible tone signals the heart beat Audible Alarm Indicator Model 5340 The alarm tone is a fixed pitch and the volume cannot be adjusted Alarm conditions are generated only when a pulse has been detected Alarm tones are automatically silenced when the alarm condition goes away HIGH PRIORITY alarm tones sound continuously at the highest frequency and highest volume HIGH PRIORITY alarms are caused by conditions such as low and high oxygen saturation and pulse rate no pulse excessive ambient light and other error conditions MEDIUM PRIORITY alarm tones sound for 0 75 seconds every five Keys Indicators Symbols and Markings seconds at the highest frequency and highest volume MEDIUM PRIORITY alarms are cause by measuring problems such as disconnected sensor too thin or thick tissue or a faulty sensor LOW PRIORITY alarm tones sound for one second every 10
20. imeters 1 1 Intended Uses The Model 5305 is intended for spot NOTE checks Before using the pulse The Model 5340 is intended for Oximeter the user should continuous monitoring become thoroughly familiar with the information in this manual 1 2 Principle Features and with all information Models 5305 and 5340 included with the sensor The Mediaid Inc Model 5300 Series pulse oximeters are portable lightweight instruments designed to WARNING monitor arterial oxygen saturation Do not use the pulse a a ER oximeter as an infant Both models have two bright Light apnea alarm Emitting Diode LED displays that give a constant read out of oxygen saturation in SpO and heart rate in beats per minute BPM Each machine has a front panel LOW BATTERY INDICATOR that alerts the user to a low battery condition Both models perform a functional test at power on and diagnostics tests can be initiated All MEDIAID INC pulse oximetry sensors with RJ12 connectors are compatible with the Model 5300 Series Both pulse oximeters can be powered either by standard electric power or an internal rechargeable Nickel Cadmium NiCad battery Model 5340 The Model 5340 allows for data transmission through the DATA PORT when Serial or Analog Cable is plugged in at power up while heart rate and Principles of Operation SpO are displayed on the OXYGEN SATURATION and PULSE RATE DISPLAYS The Model 5340 has vis
21. ing Product Safety GmbH Support GmbH Date 31 October 2003 Anna schieber Weg 2 D 73728 Esslingen Germany We herewith declare that the above mentioned procuct complies with the applicable requirements of EC Directive 93 42 EEC The CE mark will be affixed on the above mentioned device based on Directive 93 42 EEC Annex Il Vez l 3lo2 Mahesh C Patel Date 35 36
22. itiated by the depression of the ALARM ON OFF KEY The test sequence will run and stop automatically It must be noted that NOTE for a number of these tests visual and or audio inspection is required Write down the While in this test mode either a instrument s software single test or a batch containing all version number in the of the tests sequentially may be run Once testing is complete the only space provided in section way to exit the assurance test mode 6 5 Product Information of operation is by powering off the so Mediaid Inc can better instrument assist you in the future GLOBAL TEST Test 0 This test automatically initiates all of the diagnostic tests which will run automatically and in order until either an error is detected or all test sequences are completed 19 Operating the Model 5300 Series DISPLAY AND INDICATOR TEST Test 1 The instrument s LED displays and indicators are tested by this sequence Upon initialization of this test the LED display segments and discrete LED indicators will be illuminated one at a time The user should observe proper operation of all LED segments and indicators Careful visual inspection is required for this test AUDIBLE ANNUNCIATION TEST Test 2 Both the variable pitch audible pulse tone and audible alarms are annunciated by the Model 5340 s 8 pitch 3 volume level audible annunciation system This test when initiated sequentially sounds all of
23. r provided by Mediaid Inc at the time of purchase H Power Indicator The green LED located on the bottom of the oximeter adjacent to the POWER CONNECTION will illuminate when electric power is connected I Data Port Model 5340 gt The DATA PORT is used for serial and analog output To eliminate risk of shock do not touch the DATA PORT 8 pin connector and the patient simultaneously The DATA PORT should be used only for connection to equipment that complies with CSA IEC UL601 1 Refer to section 3 4 for information on data transmission J Alarm Off Key Model 5340 CR A short depression of the ALARM OFF KEY silences the alarm for a period of 60 seconds A long three second depression of the ALARM OFF KEY will completely disable the audible alarm Keys Indicators Symbols and Markings The LED display will show AL OFF the ALARM OFF INDICATOR will begin to flash and the oximeter will revert to normal monitoring Silenced alarms can be reactivated by a short depression of the ALARM OFF KEY Disabled alarms are reactivated by a long depression of the ALARM OFF KEY K Alarm Off Indicator NOTE Model 5340 indi The ALARM OFF INDICATOR will Visual alarm indicators illuminate and remain on constantly cannot be deactivated when audible alarms are silenced and will flash when audible alarms are disabled L Oxygen Saturation Alarm Key S Model 5340 A Short depressions of the OXYGEN SATURATION ALARM KE
24. seconds at the lowest frequency and highest volume LOW PRIORITY alarms are caused by excessive patient movement or patient arrhythmia 2 3 Symbols amp Markings Symbol Definition SpO2 Oxygen Saturation Display BPM Pulse Rate Display CO Power On Off Key Alarm Off KEY Oxygen Saturation Alarm KEY amp Pulse Rate Alarm KEY Increment Key Decrement Key 10 Keys Indicators Symbols and Markings o Data Port AS Sensor Cable Connection Power Connection zu El y Low Battery Indicator Attention Consult Accompanying Documents Q Non anesthetic Proof HI LO Type BF Applied Part HI LO Alarm Indicator 11 12 Operating the Model 5300 Series Chapter 3 3 1 Receiving Accurate Readings To prevent faulty readings and sensor complications Do not apply the sensor to anything but a well perfused extremity INTZNSINTINIe Do not place the sensor on extremities To ensure personal safety and proper operation of with blood pressure cuffs or with arterial or venous catheters Avoid extremity positions that may the oximeter the user compress venous return should adhere to all Keep sensors at heart level whenever directions information possible and cautions stipulated Fit sensors comfortably without constricting or compressing digits within this document Make sure elastic tape used to secure sensor does not restrict circulation NOTE Trim long fingernails if necessary
25. sion of the POWER ON OFF KEY A one second display and indicator test is performed automatically and all Light Emitting Diodes LEDs are illuminated Carefully observe the OXYGEN SATURATION and PULSE RATE DISPLAYS at the top of the oximeter for proper operation of all segments of the display a nonfunctioning segment will result in an incomplete numeral and possible erroneous reading A long depression of the POWER ON OFF KEY will initiate Internal Confidence and Self Diagnostics tests see section 3 5 Tests B Pulse Rate Display Whenever the pulse oximeter receives at least three pulses during a 30 second period the right three digit LED display shows the patient s heart rate in beats per minute Any blinking display signals that pulse rate monitoring may be adversely affected and indicates the continuous presence 30 seconds or more of significant patient movement or light source interference C Oxygen Saturation Display Whenever the pulse oximeter receives at least three pulses during a 30 second period the left LED display shows the patient s SpO levels The display is updated with every normal pulse A blinking display signals that SpO monitoring may be adversely affected and indicates the continuous presence 30 seconds or more of significant patient movement or light source interference D Visual Pulse Indicator As soon as a pulse is found the heartbeat is indicated by the small green LED beneath the L
26. the eight pitches frequencies and three volume levels Carefully listen for tone pitch and volume changes AUDIBLE VISUAL ALARM TEST Test 3 This sequence tests the instrument s alarm functions The alarm tone and the four HI LO ALARM INDICATORS are simultaneously activated for a period of approximately five seconds Audible and visual observation is required CONTROL KEY TEST Test 4 This test checks the functionality of the front panel control keys excluding the POWER ON OFF KEY Once initiated the operator must press the control keys one at a time in the following order ALARM OFF OXYGEN SATURATION ALARM INCREMENT DECREMENT and PULSE RATE ALARM Do NOT press the POWER ON OFF KEY at this time as it will power the unit off An internal software routine waits for a signal to be received from each of the keys A unique number indicating the internal memory address for each key will be displayed Observe the changing values to ensure proper reception of each key s signal 20 Operating the Model 5300 Series SENSOR TEST Test 5 This test verifies the functionality of the sensor the oximeter s LED driver circuit and the oximeter s light detection circuit This occurs by the emission of sensor light at a preset frequency and level and the monitoring of the received signal from the sensor detector SERIAL COMMUNICATIONS PORT TEST Test 6 This test requires a serial connection with a host system For every char
27. tus SpO and Rate bytes plus one 3 4 2 Analog Data Transmission Analog data can be transmitted from the Model 5340 to an analog data receiving device with a Mediaid Inc Analog Cable Analog outputs are as follows 0 Scale 0 000V Nois Refer to the manufacturer of the monitoring device 50 Scale 0 500V 100 Scale 1 000V for additional information 3 5 Tests on data receiving devices Each model can perform a variety of tests which are described below If an error is detected during any given sequence the test sequence will be terminated and the characters Err an acronym for error will appear in the left display window The numeral representing the test during which the error occurred will appear in the right display window The instrument must be powered off before testing or monitoring can continue If there is a low battery condition at power up the unit will show bAt LO and the oximeter will power off prohibiting test functions NOTE Some tests require audible visual and or operator supervision and or the connection of an external device such as a sensor or voltmeter The absence of required peripheral devices will result in an error message Please read each of the test descriptions carefully 3 5 1 Model 5305 3 5 1 1 Power Up Test A short depression of the POWER ON OFF KEY initiates a one second Display and Indicators Test All LEDs need to be illuminated for proper LED functioning 17
28. ual and audible alarms for oxygen saturation and pulse rate monitoring The Model 5340 has an audible tone that sounds with each pulse and varies with oxygen saturation falling in pitch with reduced saturation and rising as saturation increases 1 3 Modes of Monitoring Models 5305 and 5340 Both models in the Mediaid Inc 5300 Series are designed to measure the oxygen saturation SpO of functional hemoglobin A normal steady display indicates the pulse oximeter has received at least three normal intelligible pulses during the last 30 second period The display will be updated each time a normal pulse has been received A blinking display indicates the continuous presence 30 seconds or more of significant patient movement or light source interference In this mode no normal pulses are being received and the last reliable values for SpO and heart rate are displayed Monitoring of SpO may be adversely affected Model 5340 A blinking display with a one second warning tone every 10 seconds indicates the continuous presence 60 seconds or more of significant patient movement or light source interference In this mode no normal pulses are being received and SpO monitoring may be adversely affected 1 4 Cautions Before using the equipment the operator should be thoroughly familiar with the information in the User s Manual and all accompanying documents Federal U S A law restricts this device to use by
Download Pdf Manuals
Related Search