AH-M1 handheld Pulse Oximeter user`s manual
Contents
1. ccecceesseeeseeeeeeeeseeenseeeeens 6 4 5 Alarm Tone Configuration c cesceeeseeeteeeeeeeeeeeens 7 4 5 1 Setting the minimum Alarm Volume 0 7 4 5 2 Changing the Alarm Volume eeeeeeeeeeeeee 7 4 6 Pausing the Alarm Tones cee seceeeeereeeeeneeeeeeeeeee 7 4 7 Shutting off the Alarm Volume cceccecscesseeeeeneees 8 4 8 When an Alarm OCCUIS 0 ccccccsceccceeeesssseeeeeeeesneees 9 Chapter 5 Measuring SpO2 cccssscssssssscesscsscsscsseoeee 1 5 1 Introductions eine aia E 1 5 2 Safety Information sessssessessessesrseresessessesssessresseee 2 5 3 Monitoring Procedure esesseeseeeeeseereereseereereseerrereses 4 SA SpO2 Display viisscetisete ee deneiati a eles 5 5 5 PR Display 04 sabdtenssetbessoostauedennahea cts 5 5 6 SpO2 Alarm Setup cece sees seeeseeseessecseeeneeseeeees 6 5 6 1 Switching SpO2 Alarm On Off eee 6 5 6 2 Setting the Alarm Level cece eeeeteeeeeeeeeee 6 5 6 3 Adjusting the Alarm Limit eceeeenreeees 6 5 6 4 Altering the Desaturation Limit eee 7 5 7 PR Alarin Setups asc ean a 5 7 1 Switching PR Alarm On Off 5 7 2 Setting the Alarm Level 5 7 3 Adjusting the Alarm Limit cece eeeeeeeereeeee Chapter 6 Reviewing scccssscssscsscssssssessssesessesssssseees 1 6 TintroductiOtivs scieschsesiastcadetsad clgcneteteupearostestabeovanaages 1 6 2 Reviewing SCTeCN ccceecc2. scccscsssecscsecssessessesees 1 3 1 Unpacking and Checking cess eseeeeeneeneeenee 1 3 2 Getting Started ec eceeeeceeessecetesseeeteeseesaeeneeenee 2 3 3 Starting the OxiMeter eee cseeeceseeeeeeeceeseeeneeeeeees 3 3 4 General Setups cei aninion OE 3 3 4 1 Beep Volume Setup sr iieininpnnrkrns 3 3 4 2 Key Volume Setup 3 4 3 Adjust the Screen Brightness ceseeeeeeeeeeeee 4 3 4 4 Scan Speed Setup ee eceseescseeseeeseesereeeeeeeees 4 3 5 Date and Time Setup 3 6 Selecting the Work Mode ceecseeseesecteeneeteeeees 5 3 6 1 Continuous Monitoring Mode ccceeesseeeees 6 3 6 2 Spot checking MOode cccceseeeeeeseceneeceteeeeneees 7 3 7 Selecting Patient Type fae ea ITAA EAI 8 3 8 Entering Exiting the Demo Mode eceeeeeeeeees 8 3 9 Changing the Language ee ceeeseeeeeeeetseeeteeees 9 3 10 Checking the Version cccccessccesseeeseeeeteeeeeeeeeeeens 9 3 11 Restoring the Factory Configuration 9 3 12 Shutting off the Oximeter ieee eeeeeeeeeereeeee 10 Chapter 4 Alarm ccccccccscsscsssccsssssscsssssssscssssesssssseseoeee 1 A 1 Alarm Categories os cse ecepevtersenvpeesctelecsotactayettieydestend 1 A Dear evel si2 229 2 822 arto ae hh Si ee hel mah 4 3 Alarm Indicators 4 3 1 Alarm tone 4 3 2 Alarm Lamp 4 3 3 Alarm Message maio nenna a 6 4 3 4 Flashing NUMETiC eseeeseeeeeeeseeeseesrereseserererresrsee 6 4 4 Alarm Status Symbol
3. If you spill liquid onto the equipment or accessories contact your service personnel or Acare 8 2 Annual Safety Checks Note To ensure the ongoing performance and safety of your equipment the device must be checked after 1 year of use Use professional technology engineers to check the device Clean the plug connected to the power cord at least once a year Too much dust on the plug may cause a fire The following safety checks and tests should be performed at least every 12 months by a qualified person with adequate training knowledge and practical experience Handheld pulse oximeter user s manual The data should be recorded in an equipment log If the device is not functioning properly or fails any of the following tests the device must be repaired Inspect the equipment and accessories for mechanical and functional damage Inspect the relevant safety labels for legibility Verify that the device functions properly as described in the instructions for use Test the earth leakage current according to IEC 60601 1 1988 Al 1991 A2 1995 Limit NC 500uA SFC 1000A Test the enclosure leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 100pA SFC 500pA Test the patient leakage current normal operation according IEC 60601 1 1988 A1 1991 A2 1995 Limit type BF for a c 100A for d c 100A _ Test the patient leakage current under single fault condition acco
4. Sensor Off The SpO gt sensor detached the Medium patient or the oximeter Battery Low The battery power is low Medium SpO Low Perf The signal detected is weak Acare Technology Co Ltd Address 6F 6 No 5 Wuquan 1st Rd Xinzhuang Dist New Taipei City 242 Taiwan TEL 886 2 2298 8170 FAX 886 2 2298 8560 Email info acaretech com Website http www acaretech com
5. follow this procedure 1 Disconnect the oximeter from the patient and stop all monitoring and measuring procedures 2 Place the battery in need of optimizing into the battery compartment of the oximeter 3 Place the oximeter in the charger stand and connect it to the AC mains Allow the battery to charge uninterrupted for more than 4 hours Handheld pulse oximeter user s manual Disconnect the oximeter from the AC mains and allow the oximeter to run on the battery until it shuts off Replace the oximeter in the charger stand and connect it to the AC mains Allow the battery to charge uninterrupted for more than 4 hours The optimization of the battery is complete 7 5 Checking the Lithium Ion Battery The performance of a battery may deteriorate over time To check the performance of a battery follow this procedure l Disconnect the oximeter from the patient and stop all monitoring and measuring procedures Place the oximeter in the charger stand and connect it to the AC mains Allow the battery to charge uninterrupted for more than 4 hours Disconnect the oximeter from the AC mains and allow the oximeter to run on the battery until it shuts off Make a note of how long this takes The operating time of a battery directly reflects its performance Handheld pulse oximeter user s manual a Caution The service life of battery depends on the length and frequency of use Lithium Ion batteries can generall
6. All illustrations in this manual serve only as examples They may not necessarily reflect the setup or data displayed on your product Key Bold Italic text is used in this manual to quote the referenced chapter or sections e is used to signify text as it appears on the product screen is used to indicate operational procedures IV Handheld pulse oximeter instruction manual Warning Indicates a potential hazard or unsafe practice that if not avoided will result in death or serious injury e Caution Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage Note Provides application tips or other useful information to ensure that you get the most from your product Contents Chapter 1 General Introduction scsscsssscssseeseoees 1 Lid Intended Us s iiri ene eee 1 1 2 Main Unit cece eee ae ae aA Eas a SRRA 1 2 1 Front View 1 2 2 Rear View 123 Side VieWestvissceseiecneigiy irean RnR tes 1 3 Display ViewSonic ies eE 7 1 3 1 Large Numeric Display Mode s ssseereeeeeeeeees 7 1 3 2 SpO2 Waveform Display Mode ccccceeeeee 9 Chapter 2 Safety cccsccscsccssscssssessssssssssssecssseseesssscssseees 1 2 1 Safety Information eee eeeeeeetecneeeneeneeeees 1 2 2 Explanation of Symbols sseseeeeeeeeeeeeeereeeesesreressrsreee 3 Chapter 3 Basic Operations
7. Information is Warning Explosion hazard Do not use the oximeter in the presence of flammable anesthetics mixed with air oxygen or hydrogen a Do not use the product in the presence of high power appliances such as high voltage cables X ray machines ultrasound equipment or a defibrillator E Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture The device is not designed for use in a sterile field The oximeter should be handled with care so as to avoid it getting knocked or falling Handheld pulse oximeter user s manual wil Warning Do not use this device during defibrillation a When the device is in use ensure that the batteries have sufficient charge remaining otherwise start up abnormalities may occur or the measurement data may be inaccurate HM Patients must not wear nail varnish while using the pulse oximeter as this will lead to unreliable SpO measurements a Measurements and pulse signals can be affected by certain environmental conditions errors in applying the sensor and certain patient conditions See the appropriate sections of this manual for specific safety information 4 The use of accessories sensors and cables other than those specified may result in increased emission low anti disturbance and or may lead to the oximeter producing invalid readings It is advisable to check the oximeter at least once a month Handhe
8. manual screen when the beep volume is off 3 4 2 Key Volume Setup Press the Left button to select the item then adjust the value using the Up or Down button You can select from 0 to 4 3 4 3 Adjust the Screen Brightness Press the Left button to select the item then adjust the value using the Up or Down button You can select from 1 to 5 Selecting the minimum brightness can save power B Caution If the oximeter is used outdoors or if the ambient light is strong set the screen brightness to a higher level 3 4 4 Scan Speed Setup Press the Left button to select the item then adjust its value using the Up or Down button You can select from 12 5mm s to 25mm s Handheld pulse oximeter user s manual 3 5 Date and Time Setup After starting up set the date and time of your oximeter Operations are as follows 1 Select Menu gt System to enter the System menu as shown below Date 09 12 10 Time 11 06 Adu Type Maintenance Load Default Conf Select Return Fig 3 2 System setup window 2 Select the year month and day to the right of Date and set them to the current date at your location 3 Select the hour and minute to the right of Time and set them to the current time at your location 3 6 Selecting the Work Mode The oximeter is designed to operate in two modes continuous monitoring and spot checking The work mode Handheld pulse oximeter user s manual that
9. 1 5V AA alkaline battery Capacity 2000mAh Quantity 3 Run time gt 14 hours With SpO monitored continuously Audio indicators off and backlight brightness set to minimum and using new full power batteries at ambient temperature 25 C Shutdown delay 10 min After the first low battery alarm Handheld pulse oximeter user s manual A 5 Hardware Specifications A 5 1 Display OLED Size diagonal 320x240 pixels A 5 2 Indicating LED Mainframe LED Alarm indicating 1 Yellow Red lamp 1 Orange Battery charging When charged it lights orange indicating lamp When fully charged or not charged it does not light Charger LED 1 Green When connecting to the AC DC adapter it lights AC power green indicating lamp When disconnecting from the AC DC adapter it does not light Handheld pulse oximeter user s manual A 5 3 Audio Indicating Speaker Gives audible alarm button tone and beep tone Supports Pitch Tone and multi level volume Alarm tones meet the requirement of IEC 60601 1 8 Alarm pressure 45 dB to 85 dB Testing place is 1 meter from the tone A 5 4 Buttons Se Functions Power button Up button Down button Left button Right button and Alarm pause button Handheld pulse oximeter user s manual A 5 5 Sensors Pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavel
10. AXCARE Handheld Pulse Oximeter Model AH M1 Instruction Manual Issued Date Jul 12 2011 Ver 1 0 Handheld pulse oximeter instruction manual Product Information Product Model AH M1 Product Name Handheld pulse oximeter Manufacturer Acare Technology Co Ltd After Service Contact Information Address 6F 6 No 5 Wuquan Ist Rd Xinzhuang Dist New Taipei City 242 Taiwan TEL 886 2 2298 8170 FAX 886 2 2298 8560 Email service acaretech com Revision History This manual has a revision number This revision number changes whenever the manual is updated due to software or technical specification change Contents of this manual are subject to change without prior notice Document No P2000040 1 Revision number 1 0 Release time 2011 07 Copyright 2011 Acare Technology Co Ltd All rights reserved Handheld pulse oximeter instruction manual CE mark CE 0434 EC Representative Name MEDIPRO Villapark Business Park Av Quitapesares 8 Building 8 Villaviciosa de Odon Madrid 28670 Spain Statement The manufacturer Acare holds the copyright to this manual and is entitled to treat it as a proprietary file This manual is only to be used for supporting the operation maintenance and service of the AH M1 product and it cannot be resold or republished by any other party This manual contains exclusive information protected by copyright laws and we Acare reserve its co
11. ake sure that the patient s nail faces the light window inside the sensor Handheld pulse oximeter user s manual 5 4 SpO Display Parameter Display h SpO2 100 8 0 Fig 5 1 SpO parameter 1 SpO label 2 High alarm limit of SpO2 3 Low alarm limit of SpO 4 SpO value 5 SpO unit Waveform Display Fig 5 2 SpO2 waveform 5 5 PR Display 1 5 2 120 4 3 10 Fig 5 3 PR parameter 1 PR label 2 High alarm limit of PR 3 Low alarm limit of PR 4 PR value 5 PR unit Handheld pulse oximeter user s manual 5 6 SpO Alarm Setup 5 6 1 Switching On Off SpO Alarm Select Menu Alarm Setup 2 Set the Alarm Jof SpO tol Off Jto shut off SpO alarm When the alarm of SpO is off this sign PAN will be in the visible SpO2 parameter display area 5 6 2 Setting the Alarm Level 1 Select Menu Alarm Setup 2 Set the Alarm of SpO to Med or High 5 6 3 Adjusting the Alarm Limit 1 Select Menu gt Alarm Setup 2 Adjust High If an SpO measurement is higher than the high alarm limit the SpO2 Too High alarm will be triggered 3 Adjust Low If an SpO2 measurement is lower than the low alarm limit the SpO2 Too Low alarm will be triggered Handheld pulse oximeter user s manual 5 6 4 Altering the Desaturation Limit When the oximeter records an SpO value that is lower than the lower saturation limit a high physiological alarm will be trig
12. atient ID is flashing will make the patient ID stop flashing and the ID number will remain unchanged The new patient will not be admitted and further measurements will be stored under the current patient ID 3 When the storage of patient measuring data reaches its limit the patient ID will be reset to 1 and new data will Handheld pulse oximeter user s manual replace the information stored under the first patient ID 3 7 Selecting Patient Type To select the patient type 1 Select Menu System gt Type 2 Set Type to Adu Adult Ped Pediatric or Neo Neonate 3 8 Entering Exiting the Demo Mode To enter the demo mode 1 Select Menu gt System Maintenance gt enter the required password 2 Set Screen to Demo and the message Demo Mode will appear in the technical alarm area To exit the demo mode 1 Select Menu System gt Maintenance gt enter the required password 2 Set Screen to Normal B Caution The Demo mode is for demonstration purpose only Do not enter the Demo Mode when a patient is being monitored to avoid mistaking simulated data for the patient s actual data This Handheld pulse oximeter user s manual could result in improper patient monitoring and delayed treatment 3 9 Changing the Language Select Menu System Maintenance enter the required password Select Factory Setup to set Language 3 10 Che
13. ation distance This is calculated from the equation applicable to the frequency of the transmitter d Hg 1 d isip 80 MHz to 800 MHz d Lhe LEi 300 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 12 Handheld pulse oximeter user s manual NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance i
14. cesccesteeesseesteeeeeceeseeeneeenseees 1 6 3 Reviewing Setup cccecescsseesceeseseteeeeeceeseeenseeeeees 2 Chapter 7 Battery cccccsscsssccsssssccssesssssscssscssssssssseoese 1 ToL Introduction ee ia oei A eias 1 7 2 Installing Batteries cece eeeeseneeseeeeetecneeeneeneeenes 3 7 2 1 Opening the Battery Doot ccceeeeceeecesreeeneees 7 2 2 Installing the Alkaline Battery 7 2 3 Installing the Lithium Ion Battery eee 5 7 3 Charging Lithium Jon Battery 6 7 4 Optimizing Battery Performance eee renee 7 7 5 Checking the Lithium Ion Battery cece 8 7 6 Disposing of the Batteries cccceseeeceeseceneeeeneees 9 Chapter 8 Maintenance and Cleaning sscsesssesees 1 8 1 Introduction cece ee eeesscnsceecseeseeseesesseneeeeeeses 8 2 Annual Safety Checks 8 3 Cleaning the Oximeter cccceeeseeeceeeeceneceneeeeneees 4 8 4 Cleaning SpO2 Sensor eeeeeseesseeeeetecseeeneeeeeenee 5 8S Disposal nni rae E Goals E REAN 6 Chapter 9 ACCeSSOrieS eseeeesesosorseseesosseseesorseseesorseseesorseseee 1 Appendix A Product SpecificationS esesessssessossesessosseseee 1 A 1 Safety Specifications seseseeeeeseeeeesseereeresrrrrerese 1 A 2 Physical Specifications eeeeeeseseeeeeeesesesrreresesrrereses 1 A 3 Environmental Specifications s seseeeeeeeeeeeeeereee 2 A 4 Charging Specifications seeeeeeeeeeeereeeeeeererereeere 2 A 4 1 AC DC Adapter Opti
15. cking the Version Select Menu J gt System Maintenance enter the required password Select Factory Setup to check the version of the oximeter 3 11 Restoring the Factory Configuration If you have made changes to the system s configuration and want to restore the original factory settings follow this procedure 1 Select Menu System 2 Select Load Default Conf A pop up window will appear asking you to confirm that you want Handheld pulse oximeter user s manual to return to the original configuration Select OK to restore the factory configuration 3 12 Shutting off the Oximeter To turn off the oximeter follow the steps below 1 Confirm that patient monitoring is complete 2 Disconnect the SpO sensors form the oximeter 3 Press the power button and hold it for 2 seconds to turn off the oximeter gO Caution Under the Spot check mode if the oximeter is not in use and there has been no button operation for more than 5 minutes the oximeter will shut down automatically Handheld pulse oximeter user s manual Chapter 4 Alarm Alarm refers to a prompt that is given by the oximeter through visual audible and other means to alert medical personnel when a vital sign appears abnormal or the oximeter experiences a technical problem Note The oximeter generates all audible and visual alarms through a speaker a visual alarm lamp and the screen 4 1 Alarm Catego
16. different time intervals in this window When SpO or PR values are over the alarm limit that has been set their values will appear in red If the trend data spreads across more than one page you can turn pages by using the Up or Down button Handheld pulse oximeter user s manual 6 3 Reviewing Setup After entering the reviewing window press the left button to enter the Trend Setup window as shown below 30 Sec 5 Delete Selected Delete All Export Trend Select Fig 6 2 Trend Setup In the window you can set Interval Select ID Delete Selected Delete All and Export Trend Interval The time interval between recordings can be adjusted to take regular readings within the range of 2 seconds to 30 minutes Select ID This selects the desired patient ID No The user may change ID Nos to browse the trend data of corresponding patients Delete Selected This deletes the stored trend data of the selected ID No Handheld pulse oximeter user s manual Delete All This deletes all trend data from every stored ID No Export Trend This allows the user to send trend data from a selected ID No to a computer Before this can be done the relevant computer software must be opened and the infrared interfaces of the instrument and the computer must be aligned Handheld pulse oximeter user s manual Chapter 7 Battery 7 1 Introduction The oximeter is designed to operate on three 1 5V alka
17. e time the oximeter will select the highest warning level and give the highest visual and audible alarm indications E When multiple alarms occur at the same time the alarm messages will be displayed in the alarm area in turn Handheld pulse oximeter user s manual 4 3 3 Alarm Message When an alarm occurs the alarm message will be displayed in the alarm area The system uses the following alarm symbols to match the level of physiological alarm messages High level alarms Medium level alarms Low level alarms The system uses the following background colors to indicate different messages and match the alarm level High level alarms red Medium level alarms yellow Low level alarms yellow 4 3 4 Flashing Numeric When a physiological alarm occurs the flashing numeric indicates the parameter that has been breached 4 4 Alarm Status Symbol XX Indicates that the alarm sound is turned off LX Indicates that the alarm sound is paused wR Indicates that individual measurement alarms are turned off Handheld pulse oximeter user s manual 4 5 Alarm Tone Configuration 4 5 1 Setting the minimum Alarm Volume 1 Select Menu System gt Maintenance enter the required password 2 Select Min Al Vol and then select a value between 0 and 4 4 5 2 Changing the Alarm Volume 1 Select Menu gt General Setup 2 Select Alarm Vol and then select a value between X and 4 X is the min
18. en of all the external cables and accessories 2 Insert batteries into the battery compartment Make sure that the battery has sufficient power When using rechargeable batteries for the first time you must charge them first following the instructions given in the Battery chapter Warning If the oximeter is mechanically damaged or if it is not working properly do not use it on a patient for any monitoring procedure Contact your service personnel E To avoid the risk of explosions do not use the oximeter in the presence of flammable anesthetics vapors or liquids Handheld pulse oximeter user s manual 3 3 Starting the oximeter Press the button e to turn on the oximeter The alarm indication lamp should flash and then stop The system should give a beep and enter the main screen After starting the oximeter you can change the settings for more convenient use as shown in section 3 4 3 4 General Setup Press the Left button to enter Menu then select General Setup to enter the general setup menu shown as follows You can set parameters for the following functions Alarm Vol Beep Vol Key Vol Brightness Scan Speed Select Fig 3 1 General setup window 3 4 1 Beep Volume Setup Press the Left button to select the item then adjust its value using the Up or Down button You can select from 0 to 4 A sign i will be shown at the bottom of the monitoring Handheld pulse oximeter user s
19. ength of approximately 905 nm The total optical output power of the sensor LEDs is less Wavelength than 15 mW This information may be useful to clinicians such as those performing photodynamic therapy A 6 Data Storage The changing trends of SpO and PR data will be shown in the oximeter Displaying way Trend tabular Trend interval 2 seconds to 30 minutes Trend parameter PR SpO2 Spot check ID from 1 to 99 300 groups can be stored Trend data for each ID Continuous ID is 0 60000 groups can be stored Handheld pulse oximeter user s manual A 7 Measurement Specifications A 7 1 Digital SpO2 SpO Technic Range Resolution Accuracy Refreshing rate Pitch Tone PR Range Resolution Accuracy Refreshing rate Digital SpO technic 0 100 70 to 100 2 0 to 69 unspecified lt 13 seconds 25 bpm to 250 bpm 2 or 1 bpm whichever is the greater Handheld pulse oximeter user s manual A 7 2 Nellcor SpO2 SpO Range 0 to 100 Resolution 1 70 to 100 2 adult pediatric 70 to 100 3 neonate Accuracy 70 to 100 2 Clow perfusion 0 to 69 unspecified Refreshing rate Pitch Tone PR Range 25 bpm to 250 bpm Resolution 1 bpm Accuracy 3 bpm Refreshing rate Ts A 7 3 Alarm Limit Specifications Alarm limits Range Step SpO high limit low limit 1 to 100 1 SpO low limit Desat to high limit 1 Hand
20. er internal power electric shock device Degree of protection against electric shock Degree of protection against Ordinary equipment without protection hazards of explosion against hazards of explosion Degree of protection against ingress of liquid A 2 Physical Specifications Mainframe weight lt 200g 58 5mm W x 123mm H x28mm D Charger weight lt 100g Charger size 96mm W x66mm H x78mm D Handheld pulse oximeter user s manual AC DC adapter lt 200g weight AC DC adapter size 41 5mm W x90mm H x32mm D A 3 Environmental Specifications Operating 0 C to 40 C Temperature Storage 20 C to 50 C Atmospheric Operating 860hPa to 1060hPa pressure Storage 500hPa to 1060hPa Operating 15 to 85 non condensing Humidity Storage 10 to 93 non condensing A 4 Charging Specifications A 4 1 AC DC Adapter Optional Input 100 240VAC 50 60Hz Output 5V 1 5A A 4 2 Battery Specification Standard Lithium ion rechargeable battery 50mm 46 5 mmx13 5mm Handheld pulse oximeter user s manual Weight Quantity 1 Rated voltage 3 7 VDC Capacity Run time gt 14 hours With SpO2 monitored continuously Audio indicators off and backlight brightness set to minimum and using new full power batteries at ambient temperature 25 C Charge time 3 hours to 90 4 hours to 100 Shutdown delay 10min After the first low battery alarm Optional Type
21. etic propagation is affected by absorption and reflection from structures objects and people Appendix C Factory Defaults This section lists the most important factory default settings These settings can be adjusted and you can load the factory defaults if you need 14 Handheld pulse oximeter user s manual C 1 Alarm Setup Alarm Setup Factory Default Alam Vo Spo Alarm Level PR Alarm Level C 2 System Setup System Setup Factory Default Beep Vol 2 Key Vl brighines Scan Spesd C 3 SpO Setup SpO Setup Adult Pediatric SpO2 High Limit 100 100 90 SpO2 Low Limit 90 90 PR Setup Pediatric Neonate PR Low Limit Handheld pulse oximeter user s manual C 4 Trend Setup Trend Setup Factory Default Handheld pulse oximeter user s manual Appendix D Alarm Message This section lists some important alarm message In the 66399 tables below D 1 Physiological alarm means the alarm level is user adjustable Messages Cause SpO2 Too High A measurement has risen above SpO2 Too Low the high alarm limit or fallen below the low alarm limit SpO2 Desat SpO2 measurement has fallen below the SpO gt desat limit PR Too High A measurement has risen above PR Too Low the high alarm limit or fallen below the low alarm limit No Pulse The pulse signal was too weak to be analyzed Level Handheld pulse oximeter user s manual D 2 Technical alarm
22. gered The desaturation limit may be reset is as follows 1 Select Menu System Maintenance anda pop up window will appear requiring a password 2 Input the password and select OK to enter the maintenance window Select Desat Lim and then set its value through the Up and Down button 5 7 PR Alarm Setup 5 7 1 Switching PR Alarm On Off Select Menu Alarm Setup 2 Set the Alarm of PR to Off to shut off PR alarm When the PR alarm is off this symbol 2 will be in the visible PR parameter display area 5 7 2 Setting the Alarm Level 1 Select Menu Alarm Setup 2 Set the Alarm of PR to Med or High Handheld pulse oximeter user s manual 5 7 3 Adjusting the Alarm Limit 1 Select Menu Alarm Setup 2 Adjust High Ifa PR measurement is higher than the high alarm limit the PR Too High alarm will be triggered 3 Adjust Low Ifa PR measurement is lower than the low alarm limit the PR Too Low alarm will be triggered Handheld pulse oximeter user s manual Chapter 6 Reviewing 6 1 Introduction Select Menu Trend to enter the trend reviewing window You can review previously stored SpO and PR data in this window 6 2 Reviewing Screen Time 11 37 20 11 36 50 11 36 20 11 35 20 Menu Return Fig 6 1 SpO PR reviewing window The above screen shows the SpO PR reviewing window You can review SpO PR values measured at
23. h of these is selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin in the blood An optical receptor measures the changes in the light intensity after the light passes through the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin oxygenated hemoglobin o a SE eee PRO oxyhemoglobin deoxyhemoglobin x100 Handheld pulse oximeter user s manual 5 2 Safety Information wi Warning Only use the SpO sensors specified in this manual Follow the SpO sensor instructions for use and adhere to all warnings and cautions a When a trend toward patient deoxygenation is indicated blood samples should be analyzed by a laboratory co oximeter for a full diagnosis of the patient s condition E Do not use the oximeter and the SpO sensor during magnetic resonance imaging MRI The induced current could cause burns to the patient a Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics of the patient such as irritation reddening blistering or burns Inspect the sensor site every two hours and move the sensor if the skin quality changes For neonates or patients with poor peripheral blood circulation or sensitive skin inspect the sensor site more frequently Handheld pulse oximeter user s manual ul Warning i Check the SpO sensor and its package for any sign of damage before use Do not use the sensor if any damage
24. held pulse oximeter user s manual el eo PR high limit low limit 1 to 250 1 PR low limit 20 to high limit 1 Handheld pulse oximeter user s manual Appendix B EMC Guidance and manufacturer s declaration electromagnetic emission The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should make certain that they are in such an environment when operating it Emissions test Electromagnetic environment guidance The device only uses RF energy for its internal Radio frequency function Therefore its RF emissions are very RF emissions low and are not likely to cause any CISPR 11 interference in nearby electronic equipment Radio frequency RF emissions CISPR 11 The device is suitable for use in all Harmonic establishments including domestic emissions establishments and those directly connected to IEC 61000 3 2 the public low voltage power supply network Voltage that supplies buildings used for domestic fluctuations flicker purposes emissions IEC 61000 3 3 10 Handheld pulse oximeter user s manual Guidance and Declaration Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below The customer or the user of the device should make certain that they are in such an environment when operating it Immunity test TEC 60601 Compliance Electromagnetic environmen
25. imum volume The value of X depends on the setting of the minimum alarm volume 4 6 Pausing the Alarm Tones Press the alarm pause button X to keep the alarm paused for 120 seconds An alarm paused symbol will indicate that the alarm is paused and the pause time will be displayed in the alarm status area When the audible alarm is paused the alarm lamp remains lit and the alarm message remains displayed The remaining alarm pause time is displayed in the alarm status area Handheld pulse oximeter user s manual The symbol ZA is displayed in the alarm status area Pressing the 2 key will restart the audible alarm The audible alarm automatically starts again once the alarm pause period expires 4 7 Shutting off the Alarm Volume Set the Min Al Vol and Alarm Vol to 0 to shut off the alarm volume This symbol 2X will show in the alarm status area The alarm lamp and alarm messages remain active even when the alarm volume is off The audible alarm is reactivated automatically when The factory configuration is selected The alarm volume is set to a nonzero value When a factory configuration is selected the alarm volume of the oximeter may be lower than the minimum alarm volume In this case the alarm volume is automatically adjusted according to the minimum alarm volume Handheld pulse oximeter user s manual wl Warning When the alarm sound is switched off the oximeter will give n
26. is currently selected will be displayed in the technical alarm area You can choose the oximeter s work mode through the following steps 1 Select System Maintenance at which point a window will pop up and ask for your password Input the password and select OK to enter the maintenance window shown as follows Normal Continuous FactorySetup Alarm Maintenance Select Fig 3 3 Maintenance window 2 Select Work Mode and then set the oximeter s work mode to Continuous or Spot Check 3 6 1 Continuous Monitoring Mode The continuous monitoring mode is intended for long term monitoring of a patient This mode is normally selected when the patient is in hospital or under transport The Handheld pulse oximeter user s manual default patient ID given by the system is 0 When the oximeter s memory reaches full capacity the oldest stored data will be deleted 3 6 2 Spot checking Mode Spot checking mode is intended for short term on site measurement This mode is normally selected to check up on the condition of a patient by doctors making rounds of a ward The patient ID will automatically increase from 1 to 99 with each patient Details are as follows Apply the SpO sensor to the patient After valid SpO2 signals are detected 1 The patient ID flashes and after 8 seconds will automat ically increase by 1 number to admit a new patient 2 Pressing the Left hand button when the current p
27. is detected When discarding a disposable or broken SpO probe please observe all local state and federal regulations relating to the disposal of this products or similar products Caution In cases where it is necessary to add a clip to fix the fingertip sensor clip the cable and not the sensor itself Please note that the sensor cable should not be pulled with force Note The pleth wave is not equal to the intensity of PR signal The oximeter does not provide an automatic self check alarm signal the operator should use an SpO2 simulator or use the oximeter on themselves to check the oximeter is working correctly Handheld pulse oximeter user s manual 5 3 Monitoring Procedure 1 Selecting the SpO2 Sensor Depending on the patient category weight and application site you can select a different SpO2 sensor as required 2 Connecting the SpO Sensor Plug the SpO sensor cable into the SpO connector on the oximeter 3 Applying the SpO Sensor to the patient Clean the application site removing barriers such as colored nail polish and apply the sensor to the patient Warning H Do not use the SpO sensor on a limb where a NIBP cuff has been applied This may result in inaccurate SpO readings during cuff inflation H Do not attempt to monitor SpO levels on a finger that has been painted with nail polish as this may result in unreliable measurements E When attaching a finger sensor to a patient m
28. lay a number between and 99 PR parameter area Current pulse rate PR value and its high and low alarm limits are displayed in this area Physiological alarm area Current physiological alarm information is displayed in this area SpO parameter area Current SpO value and its high and low alarm limits are displayed in this area Technical alarm and prompt information area Current technical alarm and prompt information is shown in this area Alarm status area Alarm status symbols and alarm pause time are displayed in this area Pleth bar Pulse intensity is indicated by the number of stacked blocks visible System time Current time is shown in the area Shift Directly after startup Shift shown here is the function controlled by the right hand button Press the right hand button to shift between different display modes 11 Battery symbol This symbol indicates the remaining quantity of electrical charge in the batteries 1 3 2 SpO Waveform Display Mode SpO2 Fig 1 5 SpO waveform display mode 1 SpO waveform area The waveform shown in this area illustrates the current SpO volume curve of the patient being monitored 2 SpO gt parameter area Current SpO value and its upper and lower alarm limits are displayed in this area 3 PR parameter area Current PR value and its upper and lower alarm limits are displayed in this area Handheld pulse oximeter user s manual Chapter 2 Safety 2 1 Safety
29. ld pulse oximeter user s manual p Caution In order to obtain accurate results the oximeter should be used in a quiet and comfortable environment 2 2 Explanation of Symbols Symbol Note Type BF applied part defibrillation protected Attention Consult accompanying documents this manual Direct Current DC Degree of protection against ingress of liquid Alarm volume off Alarm volume pause parameter alarm off Handheld pulse oximeter user s manual Symbol Note Beep volume off Date of manufacture Manufacturer Symbol for the marking of electrical and electronics devices according to Directive 2002 96 EC Handheld pulse oximeter user s manual Chapter 3 Basic Operations 3 1 Unpacking and Checking Open the package Take out the oximeter and its accessories The following parts are provided in the package Parts Standard Optional Quantity SpO probes DB9 plugs User s manual tisma Lithium battery AC DC adapter Battery charger stand Clip with lanyard QuickStart CDROM J J K v Protective cover v of J J J Check list Alkaline battery Handheld pulse oximeter user s manual 3 2 Getting Started 1 Before using the oximeter to take measurements for the first time carry out the following checks on the oximeter and all connected modules Check for any mechanical damage Check for correct connection betwe
30. line AA batteries or one piece Li ION rechargeable battery Under normal circumstances no special battery maintenance is necessary When alkaline batteries or the Li ION battery are used the battery icon indicates the battery status as follows 1 Indicates that the power of the battery is full 2 Indicates that the power of the battery has 3 grids left 3 4 full 3 E Indicates that the power of the battery has 2 grids left half full 4 i Indicates that the power of the battery has 1 grid left 1 4 full 5 Indicates that the battery is almost depleted The battery power supply can only last for a certain period of time If the voltage of batteries is too low a Battery Handheld pulse oximeter user s manual Low alarm will be triggered If alkaline AA batteries are used please change them at timely intervals If the Li ION rechargeable battery is used please insert the oximeter to the battery charger and connect the charger to a commercial power supply to charge the battery The oximeter will switch off automatically 10 minutes after the first Battery Low alarm is given Caution Remove the batteries prior to shipping or if the oximeter is not likely to be used for an extended period of time Qi Warning Use only batteries specified in this manual m Keep the batteries out of the reach of children E When the oximeter is not in use for a long time the batteries should be re
31. moved Dispose of used batteries in accordance with local ordinances and regulations Handheld pulse oximeter user s manual 7 2 Installing Batteries The battery compartment is at the back of the device follow the steps below to install or change the batteries 7 2 1 Opening the Battery Door 1 Turn the oximeter off first 2 Use a screw driver to remove the screw that secures the battery door to the oximeter screw Fig 7 1 Loose the screw 3 Press the battery door pushing it downwards to remove the battery door Handheld pulse oximeter user s manual Fig 7 2 Push the battery door 7 2 2 Installing the Alkaline Battery 1 Insert the AA alkaline batteries into the battery compartment aligning the on each battery with the shown inside the battery compartment 2 Close the battery door and push it upwards 3 Use a screw driver to tighten the screw that secures the battery door to the pulse oximeter a Caution Check the batteries periodically for corrosion Replace batteries if corrosion is present otherwise damage to the oximeter may occur Handheld pulse oximeter user s manual D Caution Do not run the pulse oximeter using alkaline batteries of different types or capacities at the same time 7 2 3 Installing the Lithium Ion Battery 1 Insert the lithium ion battery in the battery compartment following shown as follows Press the battery in Fig 7 3 Install the Li bat
32. n hospitals ordinary departments in clinics nursing hospitals and community medical institutions It may also be used in the home 1 2 Main Unit 1 2 1 Front View 1 a 7 3 i d mmm 9 _7 8 Fig 1 1 Front view of the oximeter 1 Alarm indication lamp When an alarm occurs this lamp will light up as defined below High level alarm the lamp quickly flashes red Medium level alarm the lamp slowly flashes yel low Low level alarm the lamp lights yellow without flashing Display screen Left button Press this button to Enter the main menu under the monitoring screen Select the highlighted menu item under the menu screen Right button Press this button to Switch the screen display between large numeric mode and SpO waveform mode under the monitoring screen Exit current menu under the menu screen Alarm pause button Pressing this button Will not work when the alarm volume is off Can pause the alarm for 120 seconds when the alarm volume is on Changes the alarm message to prompt message when Sensor off alarm is activated Note the alarm can not be permanently switched off Power button After the batteries are installed Press this button to turn on the oximeter Press and hold it for 2 seconds to turn the oximeter off Up button Press this button to Raise the volume of the heart beat displayed Move the cursor upwards o
33. n be classified into two categories of severity medium level alarms and low level alarms e Caution The technical alarms cannot be changed by the user 4 3 Alarm Indicators When an alarm occurs the oximeter will indicate it through the following signals Alarm tone The speaker on the rear panel of the oximeter will sound the alarm in different tones according to the severity of the alarm Alarm lamp The alarm lamp on the front of the oximeter will flash a different color and speed according to the severity of the alarm Handheld pulse oximeter user s manual Alarm message Alarm messages are displayed on the front screen Flashing numeric The monitored parameter that has been breached to cause the alarm to sound will flash D Caution Alarm lamp alarm tone and alarm messages will vary according to the level of severity of the alarm 4 3 1 Alarm tone The different level alarms are indicated by the system in the following audio tones Alarm f level Audible prompt High Low DO Handheld pulse oximeter user s manual 4 3 2 Alarm Lamp When an alarm occurs the severity is indicated on the alarm lamp in the following visual ways Alarm level Visual prompt High Alarm lamp flashes in red at 2 Hz Medium Alarm lamp flashes in yellow at 0 5 Hz Low Alarm lamp is yellow but does not flash ga Caution E When multiple alarms of different levels occur at the sam
34. ntally gets wet rinse them with distilled or deionized water and dry them in an environment with a temperature between 40 C and 80 C for at least one hour 8 4 Cleaning SpO Sensor 1 The casing of the sensor and light tube can be cleaned with a swab or a non velvet soft cloth dipped in medical alcohol The sensor cable can be cleaned or sterilized with hydrogen peroxide 3 or isopropyl alcohol 70 Never put the oximeter in a high pressure container and never put the sensor directly in liquid Handheld pulse oximeter user s manual Warning Do not reuse or disinfect disposable SpO gt sensors 8 5 Disposal Dispose of the oximeter in accordance with local environment and waste disposal laws and regulations For the disposal of SpO2 sensors follow local regulations regarding the disposal of hospital waste Handheld pulse oximeter user s manual Chapter 9 Accessories Nellcor SpO sensor Type Patient Category ASDNR A1 Adult finger patient size gt 30kg Pediatric foot hand Disposable ASDNR RZ patient size 10 50kg Adult finger or neonatal foot hand ASDNR N3 patient size gt 40 kg or lt 3 kg ASANR D3 Adult Reusable ASYNR D3 Adult neonatal ASPNR D3 Pediatric neonatal Handheld pulse oximeter user s manual Appendix A Product Specifications A 1 Safety Specifications SFDA classification CE classification Type of protection against IL with external pow
35. o audible alarm tones even if a new alarm occurs Any decision to switch off the alarm sound should be made with extreme caution W Users should not rely exclusively on the audible alarm system for patient monitoring Adjusting the alarm volume to a low level may result in a hazard to the patient Always keep the patient under close surveillance 4 8 When an Alarm Occurs Note When an alarm occurs always check the patient s condition first Check which alarm message has appeared on the screen This is necessary to identify the alarm and the appropriate action to be taken 1 Check the patient s condition Handheld pulse oximeter user s manual 2 Identify which parameters have set off the alarm and identify the alarm category 3 Identify the cause of the alarm 4 Silence the alarm if necessary 5 When the cause of the alarm has been identified and addressed check that the alarm system is working properly Alarm messages for individual parameters can be found in Appendix D Alarm message Handheld pulse oximeter user s manual Chapter 5 Measuring SpO2 5 1 Introduction The measurement of oxygen saturation of arterial blood also known as peripheral oxygen saturation usually shortened to SpO relies on the principles of light spectra and volume tracing An LED in the oximeter emits light rays through the body wherever the probe is used e g through the finger at two different specific wavelengths Eac
36. onal ccceeeeseeeeeesees 2 A 4 2 Battery Specification eeceeeseeseeeeeeeeeeeeeee 2 A 5 Hardware Specifications cecseessseseseeereeneeeenee 4 ASU DiS Planei nno ht op A 5 2 Indicating LED A 5 3 Audio Indicating A 5 4 Buttons A 5 5 Sensors ALO Data St ra fesis ii ai ees A 7 Measurement Specifications A 7 1 Digital SpO2 eee ACT 2 NellCor SpO2 irira ae tiaotens A 7 3 Alarm limit specifications ce eeeseeeeereeeee 8 Appendix B EMC ssssssesesesesoesessssoosessosoosessosoosesoosoosesooe 10 Appendix C Factory Defaults ssscssscsscsrecssssseoees 15 C 1 Alarm Setup sesessseeseessssssesseesrerserseresessessssssessees 15 C 2 System Setup C3 SpO2 Setups esner heehee 16 C 4 Trend Setup cceccseccesccenecesneeeeeeseeeeeseeeneeenaeees 16 Appendix D Alarm Message sscssssssssscssecrsssseoees 17 D 1 Physiological alarm esses eeceteetecneeeeeeeeeeee 17 D 2 Technical alarim cccccccesscceessececssseeceeseeeeeeseeeens 18 Chapter 1 General Introduction 1 1 Intended Use The AH M1 handheld pulse oximeter is intended for continuously monitoring or spot checking peripheral oxygen saturation SpO and pulse rate PR for adult pediatric or neonatal patients This device can be used in institutions or units with health care capability This includes outpatient departments emergency rooms and departments of internal medicine i
37. pyright No parts of this manual shall be photocopied Xeroxed or translated into other languages without written approval from the manufacturer The contents of this manual are subject to amendment without notification II Handheld pulse oximeter instruction manual Manufacturer s Responsibility The manufacturer will be responsible for the safety reliability and performance of the instrument under the following circumstances only All installation expansion readjustment renovation or repairs of the instrument are conducted by personnel certified by the manufacturer The storage conditions operating conditions and electrical status of the instrument conform to the product specification The instrument is used in accordance with the user manual About this manual This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use Observance of this manual is a prerequisite for proper product performance and correct operation of the product and ensures patient and operator safety Tl Handheld pulse oximeter instruction manual This manual is based on the maximum potential configuration of the product and therefore some contents may not apply to your device If you have any questions please contact us This manual is an integral part of the product It should always be kept close to the equipment so that it can be referred to when needed
38. r increase the value of a selected menu item under the menu screen Down button Press this button to Lower the volume of the heart beat displayed Move the cursor downwards or decrease the value of a selected menu item Battery charging indicating lamp Lights orange when the battery is being charged Will show no light when the battery is fully charged or not being charged 1 2 2 Rear View Fig 1 2 Rear view of the oximeter 1 Speaker 2 Battery door 1 2 3 Side View Topside Downside Leftside 3 e Fig 1 3 Side view of the oximeter 1 SpO probe connector 2 Cord hold 3 Power supply connector Used to connect the charger stand 4 Infrared port A port through which a personal computer can communicate with the product to export data in real time 1 3 Display Views This device features an automatic display rotation gravity activated which allows vertical and horizontal positioning of the screen to maximize space utilization and visibility 1 3 1 Large Numeric Display Mode 6 7 SpO2 1 5 8 4 3 2 9 1 10 11 Fig 1 4 Big numerics display mode 1 Menu Directly after startup Menu shown here is the function controlled by the left hand button When appropriate press the left button to enter Menu Patient ID No When Continuous is selected for work mode the patient ID is set at 0 at all times when Spot Check is selected the ID will disp
39. rding to IEC 60601 1 1988 A1 1991 A2 1995 Limit type BF for a c 5mA for d c 5mA Handheld pulse oximeter user s manual Test the patient leakage current Mains voltage on applied part According IEC 60601 1 1988 A1 1991 A2 1995 Limit type BF for a c 5mA Warning Do not attempt to service the device yourself take it to an authorized representative or manufacturer 8 3 Cleaning the Oximeter 1 Common detergent and non corrosive disinfectant used in hospitals can be used to clean the oximeter be aware that many kinds of detergents must be diluted prior to utilization Use cleaning fluids according to the instruction of the detergent manufacturer Avoid the use of alcohols amino or acetonyl detergents when cleaning the oximeter The oximeter case and screen must be kept free of dust It can be wiped with a lint free soft cloth or a sponge soaked in detergent While cleaning the oximeter be careful not to spill liquid onto the instrument and do not Handheld pulse oximeter user s manual allow any liquid to spill inside the oximeter When wiping the side panel of the oximeter be especially careful to keep liquid away from the cable and the outlet Do not use abrasive materials such as wire brushes or metal brighteners when cleaning the oximeter as they will damage the panel and the oximeter screen Do not submerge the oximeter in liquid If the cable or plug accide
40. ries The oximeter s alarms fall into three categories 1 Physiological alarms Physiological alarms are triggered when a monitored parameter moves outside of set alarm limits or by an abnormal patient condition Physiological alarm messages are displayed in the physiological alarm area 2 Technical alarms Handheld pulse oximeter user s manual Technical alarms are triggered by a device malfunction or a patient data distortion due to system problems or improper operation of the oximeter Technical alarm messages are displayed in the technical alarm area 3 Prompt messages Prompt messages are not alarm messages The pulse oximeter will sometimes show messages updating the user on the system status separate from the physiological and technical alarm messages Prompt messages are displayed in the technical alarm area 4 2 Alarm Levels 1 The oximeter s physiological alarms fall into three categories of increasing severity low level alarms medium level alarms and high level alarms High level alarms Indicate that the patient is in a life threatening situation and emergency treatment is required Medium level alarms Indicate that the patient s vital signs appear abnormal and immediate treatment is required Handheld pulse oximeter user s manual E Low level alarms Indicate that the patient s vital signs appear abnormal and immediate treatment may be required 2 The oximeter s technical alarms ca
41. s observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SL F SL Series Anti decubitus Mattress The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 80 MHz to 800 800 MHz to 2 5 GHz output power of MHz MHz 13 Handheld pulse oximeter user s manual transmitter W For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagn
42. t test level level guidance Electrostatic Floors should be wood concrete discharge ESD or ceramic tile If floors are IEC 61000 4 2 6 kV 46 kV covered with synthetic material contact contact the relative humidity should be at least 30 48 kV air 48 kV air Electrical fast transient burst EFT N A TEC 61000 4 4 Surge IEC N A 61000 4 5 Voltage dips short interruptions and voltage NA variations on power supply input lines IEC 61000 4 11 Power frequency Power frequency magnetic The 50 60 Hz power frequency of magnetic magnetic field 3 A m fields should be at levels IEC 61000 4 8 characteristic of a typical location in a typical commercial or hospital environment Note Ur is the AC mains voltage prior to application of the test level Guidance and Declaration electromagnetic Immunity 11 Handheld pulse oximeter user s manual The device is suitable for use in the electromagnetic environment specified below The customer or the user of device should make certain that they are in such an environment when operating it TEC 60601 test level Compliance level Radiated RF 3 V m Immunity test Conducted RF IEC 61000 4 6 IEC 61000 4 3 80 MHz to 2 5 GHz Electromagnetic environment guidance Portable and mobile RF communications equipment should not be used closer to any part of the device including cables than the recommended separ
43. tery 2 Close the battery door and push it upwards 3 Tighten the screw that secures the battery door to the pulse oximeter Warning Disconnect the oximeter from the patient and stop all monitoring before charging the battery Handheld pulse oximeter user s manual 7 3 Charging Lithium Ion Battery Only Lithium Ion rechargeable battery can be recharged by the charger stand with this pulse oximeter Handheld oximeter Charger stand 4 AC DC adapter Fig 7 4 Charging device To charge the Lithium Ion battery 1 Place the oximeter in the charger stand 2 Connect the AC DC adapter and plug the adapter into the AC mains 3 The indicating lamp on the battery charger and the indicating lamp on the oximeter will light up to show that the battery is charging Handheld pulse oximeter user s manual 4 When the indicating lamp on the oximeter turns off the battery is fully charged 7 4 Optimizing Battery Performance A batteries need to be run through at least two optimizing cycles when they are put into use for the first time A battery optimizing cycle is one complete uninterrupted charge of the battery followed by a complete uninterrupted discharge of the battery A battery should be conditioned with this method regularly to maintain its useful life Condition a battery once when it has been used or stored for two months or when its run time becomes noticeably shorter To optimize a battery
44. y be charged and discharged 300 times The operating time of a battery depends on the configuration and operation of the pulse oximeter 7 6 Disposing of the Batteries Batteries that are damaged or depleted should be replaced and discarded properly Dispose of used batteries according to local regulations Warning Do not disassemble batteries dispose of them in fire or cause them to short circuit They may leak ignite or explode causing personal injury Handheld pulse oximeter user s manual Chapter 8 Maintenance and Cleaning 8 1 Introduction Keep your equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules 1 When cleaning the oximeter always dilute cleaning products according the manufacturer s instructions and use the lowest possible concentration 2 Do not immerse any part of the equipment in the liquid 3 Do not pour liquid on to the equipment or the accessories 4 Do not allow liquid to enter the case 5 Never use abrasive materials such as steel wool or silver polish or erosive cleaners such as acetone or acetone based cleaners to clean the oximeter Warning Be sure to shut down the system and disconnect all power cables from the outlets before cleaning the equipment Handheld pulse oximeter user s manual Warning For optimal performance product service should be performed only by qualified service personnel e Caution
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