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user manual - SOLIC Medical Equipment

1. M3B Vital Signs Monitor User Manual CO Monitoring Chapter 9 CO Monitoring 9 1 General Information This chapter offers some relevant data concerning CO2 monitoring Monitor provides SideStream and MainStream method for CO monitoring LoFlo CO module is used for SideStream measuring Capnostat 5 CO2 module C5 is used for MainStream measuring y SideStream measurement takes a sample of the respiratory gas with a constant sample flow from the patient s airway and analyzes it with a remote CO sensor You can measure sidestream CO using the monitor s built in CO measurement y MainStream measurement uses a CO sensor attached to an airway adapter to directly insert into the patient s breathing system This method is available using the monitor s built in CO measurement This module can be applied in operation room monitor units etc it can measure the CO partial pressure or concentration of patient Air Way obtain End tidal CO EtCO Fraction of inspired CO FiCO2 Air Way Respiration Rate AwRR and display CO2 concentration waveforms The parameter symbols displayed on the screen are defined as follows EtCO End tidal CO2 FiCO Fraction of inspired CO2 AWRR Air Way Respiration AwRR Resp times min WARNING CO module shall be avoided from crash and vibration 2 The monitor will be damaged if any pipeline from the CO2 module has been disconnected or the air tube the air inlet the air outlet be
2. Transport and Storage 700hPa 1060hPa Power Supply 100V 240V 50Hz 60 Hz Pmax 70VA FUSE T 1 6AL 72 M3B Vital Signs Monitor User Manual Specifications A1 2 3 Display Device 5 7 inch LCD Multicolor LCD resolution 640x480 Messages 1 Power Indicator LED Green 1 Power on Indicator LED Green 1 Alarm Indicator LED Orange Red 1 Charge Indicator LED Yellow 1 Alarm Sound Indicator LED Backlight 1 CO2 Working Status Indicator LED Backlight 3 Indicating modes correspond to alarm mode NURSE CALL Drive mode Relay Electronic lt 1A lt AC125V lt DC110V Isolated voltage 1500V AC Action Normal open A1 2 4 Battery Quantity 1 Type Li battery Power off delay 5 min 15 min After the low battery alarm Voltage 14 8 V DC Capacitance 2 2Ah 4 4Ah optional Working period At 25 C continuous SpO2 measuring automatic NIBP measuring automatic recording per 10min Operating time 2 2Ah 240 min 4 4Ah 480 min Charge time 2 2Ah 150 min 4 4Ah 300 min 73 M3B Vital Signs Monitor User Manual A1 2 5 Recorder Specifications Record Width 48 mm Paper Speed 25 mm s Recording types Current displayed parameter list recording Current displayed alarm list recording Real time 8s waveform recording Recording of all the parameter of current patie
3. User Manual EDAN M3B Vital Signs Monitor Release 1 0 C About this Manual P N 01 54 455380 10 Release Date July 2011 O Copyright EDAN INSTRUMENTS INC 2011 All rights reserved Statement This manual will help you understand the operation and maintenance of the product better It is reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS INC hereinafter called EDAN can not be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modificat
4. function of SpO2 module SpO2 COMM STOP Spo S ed Pi NDS High notify biomedical engineer communication failure or manufacturer s service staff Reconnect the sensor or choose another measured SpO LOW The measured signals position If the problem coming from pulse are too Low remains please notify PERFUSION i weak biomedical engineer or manufacturer s service staff a e Reconnect the sensor with disconnected from the eo Mes eo NO SpO2 SENSOR monitor or the sensor is Low a the monitor is well not connected well to the connected with the cable device 52 M3B Vital Signs Monitor User Manual SpO Monitoring 8 7 Maintenance and Cleaning WARNING 1 Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line Do not subject the sensor to autoclaving Do not immerse the sensor into any liquid 4 Do not use any sensor or cable that may be damaged or deteriorated w N For cleaning E Use a cotton ball or a soft mull moistened with hospital grade ethanol to wipe the surface of the sensor and then dry it with a cloth This cleaning method can also be applied to the luminotron and receiving unit E The cable can be cleaned with 3 hydrogen dioxide 70 isopropanol or other active reagent However connector of the sensor shall not be subjected to such solution To disinfect the SpO sensor please refer to Chapter7 dde
5. 60 TIME ID EtC02 FiCO2 AwRR SPO2 PR 25117123 18 25317322 18 25117121 2 25 17 20 2 25 17 19 2 25 17 18 2 OSIER car I A 17 24 39 Figure 4 8 Parameter Table 2238 M3B Vital Signs Monitor User Manual System Menu ALARM LIST to display alarm trend list ID 1 ADU Y Spo PR BPM A Es TIME ALARM LIST 13315312 1 SpDss 99 13 15 12 1 APNEA CO2 77700 APNEA ar 15 12 43 Figure 4 9 Alarm List E TREND GRAPH select this item to display the trend graph TREND GRAPH 10 09 2010 16 14 58 E 4 68 51 34 1 0 16312317 16 13 37 16 14 57 SPO23 77 AwRR 77 PR EEES FICO23 PARA SPO RESOLVE 15 L RIGHT 200M CURSOR Figure 4 10 Trend Graph 24 M3B Vital Signs Monitor User Manual System Menu Press TREND WAVEFORM to change the trend list or trend graph to waveform display The waveform displays as shown in the following figure ID 1 ADU mmHg EtC02 FiCO2 gt 38 AwRR 14 Sp0 7 PR BPM 99 60 a MA 16203203 Figure 4 11 Waveform Display 4 5 Deleting Data If you press the button when a trend list or an alarm list is displayed onscreen the following menu will pop up DELETE DATA YES NO Figure 4 12 Delete Data DELETE ID Entirely delete the trend and alarm data of the current monitored patient DELETE ALL DATA Entirely delete the trend and alarm data of all the monitored patients Select YES to make the operatio
6. 80 MHz used no closer to any part of the EUS T Radiated RE Ultrasound Scanner including cables IEC EN 3 V m 3 V m than the recommended separation 61000 4 3 distance calculated from the equation 80 MHz to 2 5 GHz applicable to the frequency of the transmitter Recommended separation distance d 22 WP LV 13 5 d JP 80 MHz to 800 MHz Leste gt JP 800 MHz to 2 5 GHz 1 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 metres 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 o 79 M3B Vital Signs Monitor User Manual EMC Information 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 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 a
7. After selecting the alarm time for APNEA alarm having 7 levels which are 10S 15S 20S 255 30S 358 and 405 the CO APNEA information will appear on the screen after the corresponding selected time The alarm level is HIGH m ZERO CAL Perform CO model zero calibration WARNING Connect the CO2 module to the monitor press the CO2 START STOP button then select the ZERO CAL in menu to start the zero calibration See the function details of the items in Chapter9 CO Measuring 27 M3B Vital Signs Monitor User Manual System Menu 4 9 Alarm Setup Press ALARM SETUP in SYSTEM MENU menu to open ALARM SETUP submenu as shown below in which the user may turn on or off alarm or set the upper alarm limit or lower alarm limit If ALM is ON by pressing the SILENCE button on the front panel you can silence the audible alarm or turn off the audio system If the ALM is OFF in this submenu the monitor will not give an alarm when alarm condition is active By configuring ALM REC you may also enable the automatic outputting of the alarm information in case of any physiological alarm For more information please refer to 5 1 3 Alarm Setup ALARM SETUP Figure 4 15 Alarm Setup WARNING If user set ALM to OFF the monitor will not give alarm prompt when alarm condition is active users should use this function cautiously 28 M3B Vital Signs Monitor User Manual System Menu 4 10 Maintenance Select SYSTEM MENU gt MAINTAI
8. Signs Monitor User Manual Alarm NOTE 1 The monitor does not have alarm condition delay or alarm signal generation delay 2 When alarms of different levels occur at the same time the monitor prompts the one of the highest level 3 Ifthe monitor is powered off and then turned on the alarm setup can resume to the setup which is set before the power off 5 1 3 Alarm Setup Setting alarm in the ALARM SETUP menu Select the ALARM SETUP in the SYSTEM MENU to open the submenu as shown below In this menu the user may turn ON or OFF the alarm and set the upper alarm limit and lower alarm limit for each parameter by ALM HI or ALM LO ALARM SETUP Figure 5 3 Alarm Setup Alarm setup of each parameter In the ALARM SETUP menu select the item to set the alarm limit for EtCO FiCO2 AWRR SpO and PR For example Method to set alarm limit for SpO2 ALM Step 1 Set the SpO ALM to ON Step 2 Select the ALM HI higher limit of SpO2 ALM ALM LO lower limit of SpO2 ALM You can use the UP DOWN button and OK button to make the set the value The method for setting the alarm limit of other parameters is the same as SpO2 ALM ALM REC and ALM REC TIME By configuring ALM REC the function of automatically outputting the alarm information in 40 M3B Vital Signs Monitor User Manual Alarm case of any physiological alarm can be enabled or disabled If the item is ON the monitor will automatically print out the alarm information
9. a a A ee ees Ae aio 41 5 5 When am Alarm AAA II AO A E iaa 42 5 6 Testing e e EE 42 Chapter 6 Trend and Recording esssesssecesocesooesoocesscessccesocesoosssocesocessocssocesoosesocesocessocssocesoosssosesso 43 6 1 General Information on RECO ds 43 6 2 Recorder Operations le T ach oe 43 Chapter 7 Maintenance Cleaning ssesssesesocesooesoocesseessecssocescossoocesocesoccesocesoosssosesocsssecesocesocessosesse 45 TA Systemi Check Tia E E E T A 45 EA RA E 45 AA O O aa aaie 46 YA MISC SAA Ron me een oTy NPR 46 Ta Replacement of Pus da 47 7 6 Cleaning Battery and Battery Compartment Covet cooooconoccnococonoconononnnoonncconocnnn cono ccon nono nccnnnos 47 Chapter SSO gt Monitoring ir in a aid 48 8 1 Whats SpOs Monitoring o LEA A a i 48 8 2 Precautions During SpO2 Pulse Monitoring cooocoooccnocconncnonoconononnnconncconocnno cono conocio cono cnncnnnnnons 49 8 3 Monitoring Proced te seuser O O Lcda e 49 8 4 Limitations tor Messe dnd 50 SAS O NDI sich Sate cach e Tatiana tase cutee 50 A O ace hates a a a aE 51 OA A dclncs eau duuctantlS cocked dclcesuitey 53 Chapter 9 COZ MONItOTIME viii daran nacida canica naaa 54 Rata o AA A II A Sanh es eth scence 54 9 2 Preparing for CO2 Monitoring a di cdi lia 55 9 3 COF Setup VICI a ee 59 DS LC SEP das 59 9 32 CO ASUS a 61 9 4 Alarm Information and Propias tddi 64 9 5 Maintenance and Cleaning o 65 Chapter 10 Other FUNCION O dadas 66 1O Nurse A a o 66 10 2 Wireless Not W
10. damage may be caused by incorrect application or prolonged measurement duration using the sensor more than 4 hours Inspect the sensor periodically according to sensor user manual 6 Neonate SpOz sensor can only be used when it requires to less than 20min at a time 7 The sensor complies with the ISO 10993 1 for biocompatibility NOTE 1 Make sure the nail covers the light window 2 The wire should be on the backside of the hand 3 Hand should not be too cold when measuring and the nail polish should be cleaned before measuring or the data accuracy may be affected 4 SpO2waveform is not proportional to the pulse volume 8 3 Monitoring Procedure SpO Plethysmogram Measurement l Switch on the monitor 2 Attach the sensor to the appropriate site of the patient finger 3 Plug the connector of the sensor extension cable into the SpO socket on the SpO module Figure 8 1 Mounting of the Sensor 49 M3B Vital Signs Monitor User Manual SpOz2 Monitoring 8 4 Limitations for Measurement In operation the accuracy of oximetry readings can be affected by High frequency electrical noise including noise created by the host system or noise from external sources such as electrosurgical apparatus which is admitted by the host system Do not use monitor and oximetry sensors during magnetic resonance imaging MRI scanning Induced current could potentially cause burns Intravenous dye Excessive patient movement Outs
11. it to ON or OFF to turn on or off the Sleep Mode Refer to 4 12 for details 21 M3B Vital Signs Monitor User Manual System Menu KEY VOL Set key volume to HIGH MED LOW or OFF SPHY VOL Set sphygmic volume to HIGH MED LOW or OFF WAVE FORM Set displayed waveforms to UNFILLEDOr FILLED EXIT Select it to return to the previous menu 4 4 Selection Select SELECTION in SYSTEM MENU to access the following submenu in which five selections are available CO TREND TAB SpO TREND TAB ALARM LIST PARAMETER TAB and TREND GRAPH Only one item can be selected to display information in the lower part of the interface SELECTION COs TREND TAB TREND GRAPH SPO2 TREND TAB PARAMETER THE ALARM LIST Figure 4 5 Selection E CO TREND TAB to display CO trend table ID 18 ADU mmHg EtCO2 FiCO2 2 2 0 AwRR 1 4 Sp0D gt 7 PR BPM TIME ID EtCO2 FiCOz AwRR 18313255 18 20 2 14 18113254 18 20 2 14 1813353 2 20 2 14 18113 52 2 20 2 14 18113151 2 20 2 14 18113150 2 20 2 14 18113 49 o aoe a Pa 13 55 22 Figure 4 6 CO Trend Table 22 M3B Vital Signs Monitor User Manual System Menu E SpO TREND TAB to display SpO gt trend table ADU mmHg FiCO2 2 20 Sp0 7 PR BPM A ID ii cc 13 57 15 Figure 4 7 SpO Trend Table E PARAMETER TAB to display parameters trend list of SpO2 and CO in this area ID 1 ADU mmHg FICO2 2 8 Y Sp02 1 PR BPM 99
12. may cause the alarm system to become ineffective The setup for parameter alarms is in their menus In the menu for a specific parameter you can check and set the alarm limit alarm status The setup is isolated from each other 41 M3B Vital Signs Monitor User Manual Alarm When a parameter alarm is off a symbol ES displays near the parameter If the alarms are turned off individually they must be turned on individually For the parameters whose alarm is set to ON the alarm will be triggered when at least one of them exceeds alarm limit The following actions take place 1 Alarm message displays on the screen as described in alarm mode 2 The monitor beeps in its corresponding alarm class and volume 3 Alarm lamp flashes 5 5 When an Alarm Occurs NOTE When an alarm occurs you should always check the patient s condition first The alarm message appears at the top of the screen on the right side It is needed to identify the alarm and act appropriately according to the cause of the alarm 1 Check the patient s condition 2 Identify the cause of the alarm 3 Identify which parameter is alarming or which alarm is happening 4 When cause of alarm has been over check that the alarm is working properly You will find the alarm messages for the individual parameter in their appropriate parameter chapters of this manual 5 6 Testing Alarms When you switch the monitor on a selftest is started You must check that
13. normal working if it has battery for standby Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use recharge or storage Keep it away from the monitor Make sure the monitor is used in the appointed range of voltage so that the effect of power supply can not be noticed Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions thoroughly Do not place battery in the monitor with the and in the wrong way around Do not connect the positive and negative terminals with metal objects and do not put the battery together with metal objects which can result in short circuit Do not heat or throw battery into fire Do not use leave battery close to fire or other places where temperature may be above 60 C Do not immerse throw and wet battery in water seawater Do not destroy the battery do not pierce battery with a sharp object such as a needle do not hit with a hammer step on or throw to cause strong shock do not disassemble or modify the battery Take out the battery before cleaning or delivering Please take out the battery before storing the monitor for more than 1 month 19 M3B Vital Signs Monitor User Manual System Menu Chapter 4 System Menu The monitor features in flexible configurations You can configure various aspects of the monitor including the parameters
14. proportional to CO concentration of patient sample the CO2 concentration will compute from the detecting CO absorption intensity of patient sample The relation between partial pressure and percentage of CO concentration is given below P mmHg Percentage x Pamp Ambient Pressure NOTE a The accuracy of the CO2 measurement will be affected by the following facts The air way was highly obstructed or air leak The leakage of air way connection Quick variation of environment temperature b If the CO2 waveform appears abnormal inspect the CO airway adapters and replace if needed LoFlo CO module setup NOTE You must perform a zero as described in this procedure each time the ambient temperature changes more than 10 C for example during transport Figure 9 1 LoFlo CO2 Module 99s M3B Vital Signs Monitor User Manual CO Monitoring 1 Plug the sensor cable into the monitor s CO input connector Allow two minutes for the sensor warm up 2 Connect the cannula airway adapter or sample line as appropriate to the sensor It will click into place when seated correctly Figure 9 2 Connecting LoFlo Module 3 To zero the sensor Expose the sensor to room air and keep it away from all sources of CO including the ventilator the patient s breath and your own Inthe CO SETUP menu select ZERO CAL The messages indicate state zero started gt zero successful After the zero calibrat
15. the alarm indicator lights and that you hear a single tone This indicates that the visible and audible alarm indicators are functioning correctly For further testing of individual measurement alarms perform the measurement on yourself or use a simulator Adjust alarm limits and check that appropriate alarm behavior is observed 42 M3B Vital Signs Monitor User Manual Trend and Recording Chapter 6 Trend and Recording The monitor provides 72 hour trend data of all parameters EtCO2 FiCO2 AwRR SpO and PR 5 hour CO waveform 5 hour SpO2 waveform and 800 alarm events In SELECTION submenu the user can set the displayed table then the trend table or alarm list which can be printed out via RECORD button 6 1 General Information on Recording A thermal dot matrices recorder with 48mm wide printout paper is used for the monitor Performance of the Recorder E Trend list is printed out at the rate of 25 mm s E English printout Set the displayed content via SELECTION in SYSTEM MENU Refer to 4 4 Selection then print it via RECORD button If you need to print the former data you can shift the displayed table by UP DOWN button and then the former data can be displayed and printed out The real time waveform of 8s can be printed out NOTE 1 You can press the RECORD button on the control panel to stop the current recording process 2 Itis suggested that user should not use the recorder when the low battery displays or t
16. the presence of Hb CO Met Hb or dye dilution chemicals SpO2 Pulse Monitoring WARNING 1 ES Electrosurgery equipment wire and SpO cable must not be tangled up 2 Do not put the sensor on extremities with arterial catheter or venous syringe NOTE Do not perform SpO measuring and blood pressure measuring in a same arm at a time because obstruction of blood flow during blood pressure measuring may adversely affect the reading of SpO value 48 M3B Vital Signs Monitor User Manual SpO Monitoring 8 2 Precautions During SpOz2 Pulse Monitoring WARNING 1 Verify sensor cable fault detection before beginning of monitoring phase Unplug the SpO sensor cable from the socket the screen will display the error message SpO2 SENSOR OFF and the audible alarm is activated 2 Ifthe SpO sensor can not work properly please reconnect the sensor or change a new one 3 Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor 4 Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity rubescence vesicle repressive putrescence and so on lt is especially important to check the sensor placement of neonate and patient of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin More frequent examinations may be required for different patients 5 Tissue
17. the recommended separation distance d in meters 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 Electromagnetic propagation is affected by absorption and reflection from structures objects and people 80 P N 01 54 455380 10 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Trading Corp GmbH Hamburg Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipment Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA Email info edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
18. 32 M3B Vital Signs Monitor User Manual System Menu Select YES to delete all the data UP DOWN select this item then turn the page by pressing the UP or DOWN to browse data SEARCH search data by PATIENT ID DATE and TIME then CONFIRM it The following box displays SEARCH PATIENT 1D 0 o 0 0 DATE 2008 10 3 CONF IRM Figure 4 23 Search RETURN select this item to return to the previous menu Select the single item data in DATA BROWSER menu press OK button to display the following menu DELETE TREND TABLE TREND GRAPH ALARM LIST RETURN Figure 4 24 Menu The user can select to browse TREND TABLE TREND GRAPH or ALARM LIST of SpO or CO For example select TREND TABLE to display the following screen 233 M3B Vital Signs Monitor User Manual System Menu TREND TABLE TIME A BPH 0916357 99 60 0916256 zi 0916355 A 0916354 om ae 0916353 TE a 0916352 ats dia 09116 51 A ses 09116 50 so 09 16 49 E ae 0916348 09 16347 i e 09116 46 gt 5 Figure 4 25 Trend Table User can select DELETE to delete the single item data or select the RETURN to return to the previous menu NOTE 1 Only the trend graph of SpO2 can be reviewed in this menu 2 The data which is being stored can not be browsed in real time Before searching data you should turn off the Data Store function at first 4 12 Sleep Mode Entering Sleep Mode Se
19. 5 1 1 Alarm Level Each alarm either technical or physiological has its own level For alarm of higher level when the alarm condition is active the system will give prompt in various ways Alarms in the monitor are divided into three levels High Medium and Low High level alarm indicates the patient s life is in danger or the monitor has serious problem in technical respect It is the most serious alarm Medium level alarm means serious warning Low level alarm is a general warning Alarms are classified into physiological alarm and technical alarm Physiological alarms refer to those alarms triggered by patient s physiological situation which could be considered dangerous to his or her life Technical alarm refer to system failure which can make certain monitoring process technically impossible or make monitoring result unbelievable Technical alarm is also called System Error Message The monitor has pre set the alarm levels for the parameters Alarm level of the System Error Message technical alarm is pre set in the system The alarm levels for technical alarms general alarms and some physiological alarms are pre set by the system and cannot be changed by the user in most of the cases But you can alter the alarm level for SpOz SENSOR OFF For more information please refer to SpO2 SETUP in 4 10 Maintain 5 1 2 Alarm Modes When alarm occurs the monitor can raise the user s attention in at least three ways which are audio
20. ANE AGENT 00 BALAN GAS ROOM AIR APNEA ALM 205 Figure 9 8 CO Setup Menu Now we introduce the functions of each item in CO SETUP submenu WAVE SCALE Adjust full scale size of CO2 waveform display area with LOW or HIGH selectable The default value is LOW a BARO PRESS set the barometric pressure value For gaining accurate readings you should set this barometric pressure correctly 59 M3B Vital Signs Monitor User Manual CO Monitoring e __Baronielt e Pressure Barometric Pressure a O a pp 154 A5 2286 T8 3048 3I 4572 mr 6096 704 762 fC pp m9 T 10668 665 12192 652 J 13716 640 1524 676 4 616 188 OH 1981 2 sao 21336 5er 26 sro 24384 _ 5600 2508 589 21832 539 J 8048 32004 509 33528 499 3505 2 490 36576 480 J 8810 390624 462 anses 454 4672 445 4419 6 437 J 4572 ara 420 48768 4 5092 0 51206 40 Table 9 1 O COMPENS to adjust the O compensating concentration as per the selection of the user Input the proper Oz compensating value according to the O concentration of the inhaled gas m ANE AGENT to adjust the anesthetic compensating concentration as per the selection of the user The concentration ranges from 0 20 Input the proper concentration value 60 M3B Vital Signs Monitor User Manual CO Monitoring ac
21. Dehumidification 1 lpi bl ae isposable ds Tubing Respironics 3475 00 p 01 13 36014 Power cable EUR standard 220V 1 Reusable 01 13 036106 Medical grade power cable USA standard 1 Reusable 21 21 064168 Rechargeable Lithium Ion Battery TWSLB 009 14 8V i Reusable 2 2 Ah 11 13 114214 Grounded cable 1 Reusable Optional accessories Reusable Part No Accessories Qty or Disposable EDAN SpO 12 01 109069 EDAN SH1 Adult Reusable SpO Sensor Lemo 1 Reusable 67 M3B Vital Signs Monitor User Manual Accessories and Ordering Information 12 01 109079 EDAN SH1 Adult Reusable SpO Sensor DB9 Reusable 01 13 210001 EDAN SpO Extension cable DB9 to Lemo 2m TPU Reusable 12 01 110492 EDAN SH3 Neonate Warp SpO Sensor DB9 Reusable 12 01 110515 EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 Reusable EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 02 01 110531 ve f Reusable Immersion Disinfection EDAN SH5 pediatric Silicone Soft tip SpOz Sensor 12 01 110521 Reusable DB9 CO 12 08 078137 Respironics EtCO2 module Side stream 1022054 Reusable rd LoFloTM Module Mounting Bracket Respironics Reusabl As 1027730 pdas d i Disposable CO Nasal Cannula Adult Respironics Di bl 57 078139 3468ADU 00 Isposable i i Disposable CO Nasal Cannula Pediatric Respironics Di bl 57 078140 3468PED 00 Isposable i i Disposable CO Nasal Cannula Infa
22. Jayeq eAowel o 38 lt 32 D E 205 S og 5 0 Bo 28 ag go 2 52 lt gt Fuse box Figure 3 8 Bottom Panel 3 5 Built in Rechargeable Battery The monitor is equipped with a built in rechargeable battery When switching on AC power supply the battery will be recharged automatically until full electric energy There is a sign F or in the lower right corner of screen When the monitor is working with AC mains power and it has no battery or the battery has full electric energy it displays qF When the monitor is working with AC mains power and the battery is being recharged this icon flashes of ama When the monitor is working with battery it displays cara If the monitor is off you can see charging status from the charger indicator Battery status light is yellow when charging off when full The battery is 90 to 100 charged after 300min of charging Replace Battery During monitoring state or communication state when the electric energy of battery is low the icon for indicating battery state will display and flash When the lifespan of battery is over or foul odor and leakage has been detected please contact the manufacturer or local distributor for replacement of battery 18 M3B Vital Signs Monitor User Manual Introduction O 00 10 11 12 13 WARNING Do not unplug the battery when monitoring The unexpected power supply off can not impact the monitor
23. N to open ENTER MAINTAIN PASSWORD dialog box as shown below in which you can enter password and then customize maintenance settings Factory maintenance function is only available for the service engineers of EDAN or representative authorized by EDAN ENTER MAINTAIN PASSWORD 9 0 0 CONFIRM sfefolof_conrimm_ alo ao corm EXIT Figure 4 16 Enter Maintain Password User Maintain Input the password 9 9 8 1 in the USER KEY box and press OK button the USER MAINTAIN menu will pop up in which you can set the following items USER MAINTAIN EXIT Figure 4 17 User Maintain 29 M3B Vital Signs Monitor User Manual System Menu BED No set the bedside number to a value between 1 and 64 LANGUAGE set the displayed language NOTE Users should restart the monitor after changing the language NURSE CALL turn on or off the nurse call When the parameter alarm condition is active the monitor gives 3s nurse call alarm prompt if the audio alarm or the audio system is off the monitor can also give the nurse call alarm in abnormal condition Normally open relay contacts between pin7 and pin8 of RJ45 connector Contacts closed when any alarm is audible SERVER IP The default server IP is 202 114 4 119 it can be changed by the user according to the IP of PC installed with MFM CMS of EDAN SERVER PORT set server port PRES UNIT Set the pressure unit to mmHg kPa or SpO SETUP Access SpO SETUP and
24. NT 0 20 Default 0 0 BALAN GAS ROOM AIR N2O HELIUM Default ROOM AIR APNEA ALM Selections are 10s to 40s Default 20s 63 M3B Vital Signs Monitor User Manual CO Monitoring 9 4 Alarm Information and Prompt Tables below describe the possible physiological alarms technical alarms and prompt messages occurring during CO measurement Physiological alarms Message Cause Alarm Level In specific time interval no RESP can be CO APNEA High E detected using CO module E CO TOO HIGH EtCO2 measuring value is above upper Medium alarm limit CO TOO LOW EtCOz measuring value is below lower Medium alarm limit FiCO TOO HIGH FICO measuring value is above alarm Medium limits AWRR TOO HIGH AWRR measuring value is above upper Medium alarm limit A l AWRR TOO LOW WRR measuring value is below lower Medium alarm limit Technical alarms Message Cause Alarm Level Remedy CO ROM ERR CO module failure High CO COMM CO module failure Stop using measuring function or communication High of CO module notify STOP E A failure biomedical engineer or Manufacturer s service staff CO INT RAM ERR CO module failure High Check if the adapter is well connected or High occluded CO ADAPTER OCCULED Well connect the adapter again check if the adapter is occluded 64 M3B Vital Signs Monitor User Manual CO Monitoring Stop using measur
25. a and parameters are displayed 12 M3B Vital Signs Monitor User Manual Introduction SpO SpO Unit PR Pulse Rate unit BPM CO EtCO unit mmHg kPa or FiCO unit mmHg kPa or AwRR Unit times minute Waveform Area Trend Table Alarm List It can display SpO2 and CO waveform Trend graph Trend tab or Alarm list You can select it in SELECTION of SYSTEM MENU Alarm Indicator and Alarm Status Under normal status the alarm indicator does not light When an alarm is generated the alarm indicator lights or flashes The color of light represents the alarm level Refer to Chapter 5 Alarm for details Refer to the relevant content of parameters for alarm information and prompt Charge Indicator and Charge Status To indicate the status of charging when the battery is being charged the light turns to yellow after the charge is finished the light will be off 13 M3B Vital Signs Monitor User Manual Introduction 3 3 Button Functions zes off Figure 3 5 Buttons All the operations to the monitor can be finished by several buttons They are O ON OFF When the monitor is off press this button to switch on the monitor When the monitor is on press this button and hold for 2s to switch off the monitor press this button for less than 1s the monitor will enter the sleep mode SILENCE Press this button for less than 2s to silence the audib
26. able for the service engineers of EDAN or representative authorized by EDAN 4 11 Data Storing The monitor can support the USB storage for the Data Store function Enter the menu by SYSTEM MENU gt DATA STORE to set the data storing function You can set the storing interval browse data search data and delete all the data or single item data DATA STORE INTERWAL 15 MANAGEMENT BROWSE Figure 4 20 Data Store 31 M3B Vital Signs Monitor User Manual System Menu E ON OFF set the Data Store function to ON or OFF WARNING 1 If you set this item to ON after restarting the montor this item will resume OFF automatically 2 If you want to stop the data storing function you should set this item to OFF before unplugging the USB disk 3 Do not unplug the USB storage when storing data If the damaged data caused by unpluging the USB storage during data storing can not be deleted on the monitor the user can delete them on the PC E INTERVAL set the storing interval by this item it can be set to 18 5S 10S 30S IMIN or 5MIN MANAGEMENT select BROWSE to browse data stored before DATA BROWSER 0001 20081009 16 43150 0001 20081009 16 48102 0001 20081009 16 55134 0012 20081009 16 435 10 DELETE ALL UP DOWM SEARCH RETURM Figure 4 21 Data Browser DELETE ALL select this item to delete all the data stored before The following dialog box displays DELETE ALL RECORDS Figure 4 22 Data Browser
27. aler or the manufacturer for recycling or proper disposal 7 Keep the environment clean Avoid vibration Keep it far from corrosive medicine dust area high temperature and humid environment 8 Avoid liquid splash and excessive temperature The temperature must be kept between 5 C and 40 C while working And it should be kept between 20 C and 55 C during transportation and storage 9 Before use the equipment patient cable and sensor should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance 10 Ifthe monitor gets damp put it in dry circumstance to dry it until it can work normally If liquid pours on the monitor please contact the service personnel authorized by EDAN 11 Setting alarm limits to extreme values can render the alarm system useless 12 A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area NOTE 1 Position the device in a location where the operator can easily see the screen and access the operating controls 2 This equipment is not intended for family usage 3 If the device is discolored or damaged then discontinue the use of the device 4 The equipment can protect against the effects of the discharge of a defibrillator sis M3B Vital Signs Monitor User Manual Intended Use and Safety Guidance 5 The monitor can only be used on one patient at a time 6 The equipme
28. con EtCOz FICO 2 3800 SpD gt 9 PR BPM 100 0 Alarm indication Medium alarm ID 1 ADU Zing eel EtCO FICO 2 38 e Y spd PR BPM Alarm indication 5p2 COMM STOP EA 10 45 52 High alarm Figure 5 1 Alarm Displays on Screen with Waveform 38 Alarm M3B Vital Signs Monitor User Manual Alarm The physiological alarms are displayed in alarm list as follows Alarm indication Alarm icon Y Spd PR BPM A E TIME ALARM LIST 314542 1 SpDs 99 13115 12 1 APNEA CO2 C02 APNEA ne 15312343 Figure 5 2 Alarm Displays on Screen with Alarm List Lamp light The high medium low level alarms are indicated by the system in following different visual ways Alarm Level Visual Prompt High Alarm indicator flashes in red with high frequency Medium Alarm indicator flashes in orange with low frequency Low Alarm indicator lights on in orange Alarm Sound The high medium low level alarms are indicated by the system in following different audio ways Alarm Level Audio Prompt Mode is beep beep beep beep beep beep beep beep beep beep High ar E which is triggered once every 5 seconds Medium Mode is beep beep beep which is triggered once every 20 seconds Low Mode is beep which is triggered once every 25 seconds The sound pressure range for audible alarm signals is from 45 dB to 85 dB 39 M3B Vital
29. cording to the anesthetic gas concentration of the inhaled gas m BALAN GAS to balance the gas compensating operations Select the different compensating types for balancing gas The compensate types are ROOM AIR N20 and HELIUM m APNEA ALM After selecting the alarm time for APNEA alarm having 7 levels which are 10S 15S 20S 25S 30S 35S and 40S the CO APNEA information will appear on the screen after the corresponding selected time The alarm level is HIGH m ZERO CAL used to perform CO model zero calibration When a dramatic change in CO measurement or the accuracy of reading is suspected by the clinician the zero calibration should be operated First the CO2 module should be taken off from the patient then press the CO START STOP button select ZERO CAL item then the system will automatically inhale clean CO gt free room air to the air inlet of CO2 module beside the monitor and start zero calibration NOTE 1 The standard barometric pressure is 760mmHg O2 concentration is about 16 The BARO PRESS should be set according to local altitude refer to table 9 1 for details 2 If the ANE AGENT O COMPENS BALAN GAS are set incorrectly the measure readings will be seriously remote the reality leads to wrong diagnosis 3 The ZERO CAL needs about 20 seconds During this period you d better not do other operation such as respiration measuring Or the zero calibration will be fail and you should do calibration opera
30. e for patient movement On the LCD display screen SpO2 waveform CO2 waveform and all the monitoring parameters can be displayed clearly The monitor is a user friendly device with operations conducted by a few buttons on the front panel Refer to 3 3 Button Functions for details EDAN 0 05 a j i A Figure 3 1 M3B Vital Signs Monitor The monitor can monitor SpO Arterial oxygen saturation SpO Pulse Rate PR SpO2 PLETH Plethysmogram CO End Tidal CO EtCO Fraction of inspired CO FiCO Air Way Respiration Rate AwRR The monitor provides extensive functions as visual and audible alarm net connection nurse call recording and storage for trend data SpO2 CO2 measurements review net connection nurse call alarm events and so on Recording and mobile storage are optional functions for monitor M3B Vital Signs Monitor User Manual Introduction 3 2 Screen Display The monitor is equipped with LCD The patient parameters waveforms alarm messages bed number time monitor status and other data can be reflected from the screen The screen is divided into three areas 1 Information area D 2 Parameter area 2 3 Waveform Trend table Alarm list area O lt mmHg FICS 2 E Aur 1 4 Y sp0 0 PRCBPN 99 SpO2 COMM STOP Ea 10 45 52 Figure 3 2 Main Display with Waveform 10 M3B Vital Signs Monitor User Manual Introduction mmHg FICO2 38 nn Y sp0 i
31. e monitor is intended to be used only under regular supervision of clinical personnel It is applicable to adult pediatric and neonatal usage in a hospital environment and intra hospital moves The monitor is equipped with alarms that indicate system faults such as loose or defective electrodes physiologic parameters that have exceeded the limits set by the operator or both 1 2 Safety Guidance 1 2 1 Environment Follow the instructions below to ensure a completely safe electrical installation The environment where the monitor will be used should be reasonably free from vibration dust corrosive or explosive gases extremes of temperature humidity and so on For a cabinet mounted installation allow sufficient room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open The monitor operates within specifications at ambient temperatures between 5 C and 40 C Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits Allow at least 2 inches Scms clearance around the instrument for proper air circulation 1 2 2 Power Source Requirements Refer to Appendix 1 2 3 Grounding the Monitor To protect the patient and hospital personnel the cabinet of the monitor must be grounded Accordingly the monitor is equipped with a detachable 3 wire cable which grounds the instrument to the power line ground protect
32. e wireless communication and make it interrupted Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment including patient implanted devices Please disinfect timely to prevent cross infection between patients M3B Vital Signs Monitor User Manual Intended Use and Safety Guidance 26 27 WARNING During monitoring if the power supply is off and there is no battery for standby the monitor will be off and only the patient information and alarm settings can be saved After reconnecting the power supply the user should turn on the monitor for monitoring CO module shall be avoided from crash and vibration CAUTION 1 Federal law restricts this device to sale by or on the order of a physician 2 Electromagnetic Interference Ensure that the environment in which the monitor is installed is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones etc 3 The device is designed for continuous operation and is ordinary i e not drip or splash proof 4 Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer 5 Remove a battery whose life cycle has expired from the monitor immediately 6 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the de
33. en plugged by water or other materials 3 The accuracy of the measurement of the CO will be affected by the following reasons the air way was highly obstructed or air leak the leakage of air way connection or quick variation of environment temperature 4 Follow precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment 5 Do not place the sensor cables or tubing in any manner that may cause entanglement or strangulation 6 Do not store the CO Module at temperatures less than 40 F 40 C or greater than 158 F 70 C 7 Do not operate the CO2 Module at temperatures less than 32 F 0 C or greater than 104 F 40 C 8 In the presence of electromagnetic devices i e electrocautery patient monitoring may be interrupted due to electromagnetic interference Electromagnetic fields up to 20V m will not adversely affect module performance 54 M3B Vital Signs Monitor User Manual CO Monitoring NOTE 1 Do not use the device in the environment with flammable anesthetic gas 2 Device is to be used by trained and qualified medical personnel authorized by EDAN 3 Nitrous oxide elevated levels of oxygen helium xenon halogenated hydrocarbons and barometric pressure can influence the CO2 measurement 9 2 Preparing for CO2 Monitoring Principle of COz measurement is primarily based on the fact that CO2 molecule can absorb 4 3 um infrared ray Absorption intensity is
34. er on LOGO information will be displayed on the screen WARNING Do not use it on any patient if any sign of damage is detected or the monitor displays some error messages Contact biomedical engineer in the hospital or Customer Service Center immediately M3B Vital Signs Monitor User Manual Installation of Monitor NOTE 1 Check all the functions of the monitor and make sure that the monitor is in good status 2 If rechargeable batteries are provided charge them after using the monitor every time to ensure the electric power is enough 3 The interval between double presses of ON OFF button should be more than 1 second 4 After continuous 168 hour runtime please restart the monitor to ensure the monitor s steady performance and long lifespan 2 4 Connecting Sensor to Patient Connect all the necessary patient sensors between the monitor and the patient NOTE For information on correct connection refer to related chapters 2 5 Checking the Recorder If your monitor is equipped with a recorder open the recorder door to check if paper is properly installed in the slot If no paper present refer to Chapter 6 Trend and Recording for details M3B Vital Signs Monitor User Manual Introduction Chapter 3 Introduction 3 1 General Information The monitor integrates the function of parameter measurement modules display recording and output to compose a compact portable device Its built in replaceable battery provides convenienc
35. eriod Suffocation alarm delay 10 15 20 25 30 35 40s 20s by default 75 M3B Vital Signs Monitor User Manual Specifications A1 2 9 Wirless Network Compliant with Standard and IEEE802 11b g R amp TTE Directive 99 5 EEC Directive Frequency Range 2 412 GHz 2 462 GHz America 2 412 GHz 2 484 GHz Japan 2 412 GHz 2 472 GHz ETSI Working frequency segment Ch1 11 America Ch1 14 Japan Ch1 13 ETSI 76 M3B Vital Signs Monitor User Manual EMC Information Appendix I EMC Information Guidance and Manufacture s Declaration A2 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The M3B is intended for use in the electromagnetic environment specified below The customer or the user of the M3B should assure that it is used in such and environment Emission test Compliance Electromagnetic environment guidance The M3B uses RF energy only for its internal function RF emissions Group 1 Therefore its RF emissions are very low and are not CISPR 11 p likely to cause any interference in nearby electronic equipment RF emissions Class A CISPR 11 Hamonic emissions The M3B is suitable for use in all establishments other Class A than domestic and those directly connected to the IEC EN 61000 3 2 public low voltage power supply network that supplies building used for dome
36. from the monitor to fit a two slot outlet 7 When the monitor and electrosurgical device are used together the user physician or nurse should guarantee the safety of patient M3B Vital Signs Monitor User Manual Intended Use and Safety Guidance 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 WARNING If liquid is inadvertently splashed on the equipment or its accessories or may enter the conduit or inside the monitor contact local Customer Service Center Do not attempt to connect or disconnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN60950 for data processing equipment and IEC EN60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN60601 1 1 Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor The simultaneous use of cardiac pacemaker and other patient connected equipment may cause safety hazard The equipment can provide protec
37. fter the measuring value returns to the normal one the information disappears a AWR ALM LO to adjust the lower alarm limit of AwRR If the measuring value is smaller than the lower alarm limit of AwRR AWRR TOO LOW appears in the Information area After the measuring value returns to the normal one the information disappears The default value for each items are as follows CO ALM HI when EtCO value exceeds this limit there will be alarm for exceeding the upper limit Default Adult 50 mmHg Pediatric 50 mmHg Neonatal 45 mmHg CO ALM LO when EtCO value is smaller than the lower limit there will be alarm for exceeding lower limit Default Adult 15 mmHg Pediatric 20 mmHg Neonatal 30 mmHg 62 M3B Vital Signs Monitor User Manual CO Monitoring AWRR ALM HI when parameter value exceeds this limit there will be alarm for exceeding upper limit Default Adult 30 rpm Pediatric 30 rpm Neonatal 100 rpm AWRR ALM LO when parameter value is smaller than the limit there will be alarm for exceeding lower limit Default Adult 8 rpm Pediatric 8 rpm Neonatal 30 rpm FiCOz ALM HI when parameter value exceeds this limit there will be alarm for exceeding upper limit Default Adult 4 mmHg Pediatric 4 mmHg Neonatal 4 mmHg WAVE SCALE LOW HIGH Default LOW WAVEFORM FILLED UNFILLED Default UNFILLED BARO PRESS 400 850mmHg Default 760mmHg O COMPENS 0 100 Default 16 ANE AGE
38. ful After the zero calibration is finished user can start CO2 Monitoring 5 Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y section Figure 9 7 Connecting Airway Adapter NOTE 1 Replace the airway adapter if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexpectedly without a change in patient status To avoid infection use only sterilized disinfected or disposable airway adapters 3 Inspect the airway adapters prior to use Do not use if airway adapter appears to N 58 da A M3B Vital Signs Monitor User Manual CO Monitoring have been damaged or broken Observe airway adapter color coding for patient population The CO sensor should be compared against calibration gas every 12 months Accuracy is affected by temperature and barometric pressure Periodically check the flow sensor and tubing for excessive moisture or secretion buildup It is forbidden to insert or draw out the module when the monitor is working for it can cause instability of the system If you do it unconsciously please turn off the module in menu immediately The module enters STANDBY mode if you reconnect it to monitor which is powered on If the readings are inaccurate you should do calibration 9 3 CO Setup Menu 9 3 1 CO Setup Select CO SETUP in SYSTEM MENU as shown below C02 SETUP WAVE SCALE EARO PRESS G mmHg 02 COMPENS 16
39. he monitor may be turned off automatically 6 2 Recorder Operations Record Paper Requirement Only standard thermosensitive record paper can be used otherwise the recorder may not function the recording quality may be poor and the thermosensitive print head may be damaged Proper Operation m When the recorder is working the record paper goes out steadily Do not pull the paper outward with force otherwise the recorder may be damaged Do not operate the recorder without record paper Paper Out When RECORDER OUT OF PAPER alarm is displayed the recorder can not start Please insert record paper properly 43 M3B Vital Signs Monitor User Manual Trend and Recording Inserting Paper m Pull outwards the upper arc part of the recorder casing to release the casing m Inserta new roll of paper into the paper cassette printing side facing upwards m Ensure proper position and tidy margin m Pull about 2cm of the paper out and then close the recorder casing NOTE Be careful when inserting paper Avoid damaging the thermo sensitive print head Unless when inserting paper or shooting troubles do not leave the recorder catch open Removing Paper Jam When the recorder functions or sounds improperly you should open the recorder casing to check for a paper jam Removing the paper jam in the following way Cut the record paper from the feeding edge m Open the recorder casing m Re insert the paper 44 M3B Vi
40. ide ray radiation Improper sensor application Sensor temperature maintain between 28 C and 42 C for best operation Placement of the sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line Significant concentration of dysfunctional hemoglobin such as carboxyhemoglobin and methemoglobin Low SpO Circular perfusion is not well for test part It is recommended to use SpO sensors described in chapter Accessories and Ordering Information The dissipation power is less than 50uW when the sensor temperature is higher than 41 C you should shorten the measuring time 8 5 Alarm Setup Menu Enter SYSTEM MENU gt ALARM SETUP In the menu the alarm for SpO2 or PR can be turned ON or OFF and the alarm limits can be adjusted Select ON to enable alarm during SpO monitoring select OFF to disable the alarm function and a PAN will be displayed on the screen beside the corresponding parameter ALARM SETUP Figure 8 2 Alarm Setup 50 M3B Vital Signs Monitor User Manual SpO Monitoring WARNING In order to avoid endangering the patient s life the user should use this function cautiously Default SpO alarm limits Max Upper Limit Min Lower Limit Step ADU 100 90 1 PED 100 90 1 NEO 95 88 1 Default PR alarm limits Max Upper Limit Min Lower Limit Step ADU 120 50 1 PED 160 75 1 NEO 200 100 1 SpO7 PR alarm range Pa
41. ing function CO SENSOR a of CO module notify le fail M FAULT Or modue riire o biomedical engineer or Manufacturer s service staff ZERO The module need to REQUIRED be zero calibrated now Zero the CO2 module Check if the adapter CHECK ida ie Well connect the adapter again ADAPTER check if the adapter is occluded occluded Prompt message Message Cause Alarm Level Turn from measuring mode to standby mode CO STANDBY STATUS A gt making the module in energy saving status CO SENSOR TEMP HIGH The temperature of CO sensor is too high No alarm CO SENSOR TEMP LOW The temperature of CO sensor is too low CO WARM UP The CO module is at warm up state 9 5 Maintenance and Cleaning NOTE 1 Before cleaning the module it should be disconnected from the monitor 2 Do not immerse the module into liquid or the module will be damaged For cleaning CO module 1 Use a cloth dampened with isopropyl alcohol 70 a 10 aqueous solution of sodium hypochlorite bleach disinfectant spray cleaner such as mild soap 2 Wipe down with a clean water dampened cloth to rinse and dry before use Make certain that the sensor windows are clean and dry before reuse The disposable airway adapter cannula or other disposable accessories can not be cleaned or disinfected 65 M3B Vital Signs Monitor User Manual Other Functions Chapter 10 Other Functi
42. ing the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line CAUTION Please pay special attention to the following items 1 Most cleaning agents must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the monitor 2 Do not use the grinding material such as steel wool etc Do not let the cleaning agent enter into the chassis of the system 4 Do not leave the cleaning agents at any part of the equipment oO 45 M3B Vital Signs Monitor User Manual Maintenance Cleaning The monitor cables and accessories must be kept dust free Regular cleaning of the monitor shell and the screen is strongly recommended Use only non caustic detergents such as soap and warm water 40 C 104 F maximum to clean the monitor shell Do not use strong solvents such as acetone or trichloroethylene Take extra care when cleaning the screen of the monitor because it is more sensitive to rough cleaning methods than the housing Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning Do not allow water or cleaning solution to enter the measurement connectors Wipe around except connector sockets Recommended cleaning agents are Tenside dishwasher detergents Edisonite Schnellreiniger Alconox Ammonias Dilution of Ammonia lt 3 Window cleaner Alcohol Ethanol 70 Isopropanol 70 Window cleaner Sodium Hypochlo
43. ion is finished user can start CO monitoring 4 For intubated patients requiring an airway adapter Figure 9 3 Air Adapter For non intubated patients place the nasal cannula onto the patient 56 M3B Vital Signs Monitor User Manual CO Monitoring Figure 9 4 Place the Nasal Cannula NOTE 1 Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit In reverse always remove the airway adapter from the breathing circuit before removing the sensor 2 Always disconnect the cannula airway adapter or sample line from the sensor when not in use C5 CO Module NOTE You must perform a zero calibration as described in this procedure each time you use a new airway adapter Figure 9 5 C5 CO Module 1 Attach the sensor connector to the CO connector on the monitor 2 Wait 2 minutes allowing the sensor to reach its operating temperature and a stable thermal condition 3 Choose the appropriate airway adapter and connect it to the sensor head The airway adapter clicks into place when seated correctly sola M3B Vital Signs Monitor User Manual CO Monitoring Figure 9 6 Connecting Sensor 4 To zero the sensor Expose the sensor to room air and keep it away from all sources of CO including the ventilator the patient s breath and your own Inthe CO SETUP menu select ZERO CAL The messages indicate state zero started gt zero success
44. ions or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure II Table of Contents Chapter 1 Intended Use and Safety Guidance cssccsssscssssccssssccssssccssssccssseccsscscssssscssssssossees 1 LA sd 1 1 2 Safety Guidance nean tea e nara E eee a ee hada oon het 1 E o 1 1 2 2 Power Source Requirements sac sciussc ican es certain teehee ah eee oes etna 1 1 2 3 Gro nding the Moni eo 1 1 2 4 Equipotentia OTOMANO 2 A ON 2 126 Safety PREC AUUIONS ccs sass ed eraann n a a E E a AE REA EAA E a AANA 2 1 2 7 Explanation of Symbols on the Monitot ooooooconocccocccononconncconoconn cono nono nccnocnnn crac cconncinns 5 Chapte
45. ive earth when plugged into an appropriate 3 wire receptacle If a 3 wire receptacle is not available consult the hospital electrician Connect the grounding wire to the equipotential grounding terminal on the mains system If it is not evident from the instrument specifications whether a particular instrument combination is hazardous or not for example due to summation of leakage currents the user should consult the manufacturers concerned or an expert in the field to ensure that the necessary safety of all instruments concerned will not be impaired by the proposed combination M3B Vital Signs Monitor User Manual Intended Use and Safety Guidance 1 2 4 Equipotential Grounding Protection class 1 instruments are already included in the protective grounding protective earth system of the room by way of grounding contacts in the power plug For internal examinations on the heart or the brain the monitor must have a separate connection to the equipotential grounding system One end of the equipotential grounding cable potential equalization conductor is connected to the equipotential grounding terminal on the instrument rear panel and the other end to one point of the equipotential grounding system The equipotential grounding system assumes the safety function of the protective grounding conductor if ever there is a break in the protective grounding system Examinations in or on the heart or brain should only be carried out in medically used r
46. land 3XM9 CAN CSA C22 2 No 601 1 M3B Vital Signs Monitor User Manual Installation of Monitor Chapter 2 Installation of Monitor NOTE To ensure that the monitor works properly please read Chapter 1 Intended Use and Safety Guidance and follow the steps before using the monitor 2 1 Opening the Package and Checking Open the package and take out the monitor and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list EH Check for any mechanical damage E Check all the cables modules and accessories If there is any problem contact the manufacturer or local representative immediately 2 2 Connecting the Power Cable Connection procedure of the AC power line NH Make sure the AC power supply complies with following specification 100V 240V 50Hz 60Hz E Apply the power line provided with the monitor Plug the power line to input interface of the monitor Connect the other end of the power line to a grounded 3 phase power output NOTE Connect the power line to the jack special for hospital usage E Connect to the ground line if necessary Refer to Chapter 1 2 Safety Guidance for details NOTE When the battery configuration is provided after the device is transported or stored the battery must be charged Switch on AC power supply can charge the battery no matter if the monitor is powered on 2 3 Powering on the Monitor Pow
47. le alarm then the icon ES appears and a message SILENCE XXX S shows in the information area Repress 1t or wait until the pause time is over and the audible alarm resumes to the normal monitoring status You can set the duration for silencing the audible alarm to 60s 120s or 180s For more information please refer to 4 10 Maintain Press this button for more than 2s to turn off the audio system including audible alarm key volume and pulse tone 14 M3B Vital Signs Monitor User Manual Introduction Then the icon X displays in the information area Pressing the button again can resume the audio system CO START STOP O ESE Press to start the CO measuring During the measuring ES process press the button to stop measuring a TREND WAVEFORM ae Press this button to switch between waveform trend table and pe A d graph displ iw trend graph display RECORD n Press to print out the currently displayed trend graph trend San table or alarm list MENU o gt Press to call up the SYSTEM MENU Refer to Chapter mea SYSTEM MENU for details 4 Use the UP DOWN button to select items in menu and O vw decrease or increase the items Confirm the selection by OK OK button Cv DOWN The icons on the front panel CHARGE Indicator The LED besides this icon indicates the charging status When the battery is being recharged the LED is bright POWER Indicator The LED be
48. lect SYSTEM MENU gt SYSTEM SETUP gt STANDBY and configure the item to ON Then you will see the following dialoge box after pressing the switch for less than 1s ENTER SLEEP MODE Figure 4 26 Enter Sleep Mode Select YES to enter the Sleep mode 34 M3B Vital Signs Monitor User Manual System Menu NOTE When the SYSTEM SETUP gt STANDBY is OFF or the monitor is in DEMO mode or there is any inputting signal pressing the ON OFF button can not make the monitor enter the sleep mode Quitting Sleep Mode In the sleep mode if a new signal occurs or you press any button on the front panel the monitor will enter the working mode NOTE 1 If the following situation occurs monitor will return to normal monitoring mode automatically the monitor receives physiological signal of SpOz and lasts for 5s if the monitor is powered by battery when the battery electric energy is low it will enter normal monitoring mode and indicates low battery alarm 2 In DEMO mode the monitor can not enter Sleep mode 35 M3B Vital Signs Monitor User Manual Alarm Chapter 5 Alarm This chapter gives general information about the alarm and measures to be taken accordingly Alarm setup is provided in respective parameter setup sections WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area e g an intensive care unit or cardiac operating room 5 1 Alarm Modes
49. mbine with oxygen then the blood has an SpO2 oxygen saturation of 97 The SpO numeric on the monitor will read 97 The SpO numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin The SpOy PLETH parameter can also provide a pulse rate signal and a plethysmogram wave How the SpO2 PLETH Parameter Works m Arterial oxygen saturation is measured by a method called pulse oximetry It is a continuous non invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin It measures how much light sent from light sources on one side of the sensor is transmitted through patient tissue such as a finger or an ear to a receiver on the other side m The amount of light transmitted depends on many factors most of which are constant However one of these factors the blood flow in the arteries varies with time because it is pulsating By measuring the light absorption during a pulsation it is possible to derive the oxygen saturation of the arterial blood Detecting the pulsation gives a PLETH waveform and pulse rate signal m The SpO gt value and the PLETH waveform can be displayed on the main interface m The sensor contains LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm The power of the sensor LED is less than 15mW WARNING Pulse oximetry can overestimate the SpOz value in
50. n effective select NO to cancel the operation 25 M3B Vital Signs Monitor User Manual System Menu 4 6 Version Select VERSION in SYSTEM MENU to see the version of the monitor or the module details 4 7 Time Setup Select TIME SETUP in SYSTEM MENU menu to access the submenu of TIME SETUP as shown below System time is in format of Y M D M D Y D M Y users can set the year month day hour minute and second Pick the item you want to modify and confirm it using OK Select EXIT item to save the setup and return to the previous menu If you want to exit the menu without saving it press the MENU button on front panel TIME SETUP FORMATE YEAR 2008 HOUR MONTH 2 MINUTE 14 29 SECOND 38 Figure 4 13 Time Setup 26 M3B Vital Signs Monitor User Manual System Menu 4 8 CO Setup Select CO2 SETUP in SYSTEM MENU menu to open the following menu C02 SETUP WAVE SCALE EARO PRESS G mmHg 02 COMPENS 16 ANE AGENT 00 BALAN GAS ROOM AIR APNEA ALM 205 ZERO CAL Figure 4 14 CO Setup E WAVE SCALE Adjust full scale size of CO waveform display area with LOW or HIGH selectable The default value is LOW E BARO PRESS Set the barometric pressure value O COMPENS Adjust the O2 compensating concentration as per the selection of the user E ANE AGENT Adjust the anesthetic compensating concentration as per the selection of the user E BALAN GAS Balance the gas compensating operations E APNEA ALM
51. n electromagnetic site survey should be considered If the measured field strength in the location in which the EUS TUltrasound Scanner is used exceeds the applicable RF compliance level above the EUS T Ultrasound Scanner should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the EUS TUltrasound Scanner gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A2 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the M3B Vital Signs Monitor The M3B is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the M3B can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the M3B 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 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of 35 35 7 transmitter W gep d 2 WP d WP V E 1 E 1 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 2 1 2 2 3 10 3 7 3 7 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above
52. nia as hazardous gases may result CAUTION 1 Disinfect the product as determined by your hospital s policy to avoid long term damage to the product 2 Follow the manufacturer s instruction to dilute the solution or adopt the lowest effective concentration Do not let liquid enter the monitor No part of this monitor can be subjected to immersion in liquid Do not pour liquid onto the monitor during sterilization Use a moistened cloth to wipe up any agent remained on the monitor Do not use gas such as EtO or formaldehyde to disinfect the monitor NO 00 7 5 Replacement of Fuse Unscrew the fuse cap anticlockwise replace the fuse protector tube and screw down the fuse cap clockwise Fuse size D5x20 Rated value T1 6AL 250V NOTE Switch off the power of the monitor before examining the fuse 7 6 Cleaning Battery and Battery Compartment Cover Use only non caustic detergents such as soap and warm water 40 C 104 F maximum to clean the battery Do not use strong solvent to clean battery and do not dip the battery in liquid 47 M3B Vital Signs Monitor User Manual SpO Monitoring Chapter 8 SpO Monitoring 8 1 What is SpO2 Monitoring The monitor uses oximetry to measure functional oxygen saturation in the blood SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood If for example 97 hemoglobin molecules in the red blood cells of the arterial blood co
53. nt Respironics Di bl PNO 3468INF 00 oe ido Disposable Sampling Line Kit with Dehumidification Dj bl ec isposable Do Tubing Respironics 3475 00 aeoo Respironics CAPNOSTAT 5 EtCO Main stream R bl a dd Module 1015928 EAS 11 59 078155 Disposable Adult Airway Adapter 6063 00 Disposable Disposable Neonatal infant pediatric Airway Adapter D l 11 59 078156 6312 00 isposable 12 08 078138 Side stream CO Component Side stream 1024956 Reusable 11 57 078142 Adult Nasal CO with O delivery sampling cannula Disposable 11 57 078143 Pediatric Nasal CO with O delivery sampling cannula Disposable 68 M3B Vital Signs Monitor User Manual Accessories and Ordering Information 11 57 078144 Infant Nasal CO with O delivery sampling cannula Disposable 11 57 101019 Adult Nasal Oral CO sampling cannula Disposable 11 57 101020 Pediatric Nasal Oral CO sampling cannula Disposable et jaa nee Oral CO with O delivery sampling Digpowble 01 12 031598 Adult Pediatric Airway adapter kit Disposable i157 09815 AP Edag Airway adapter kit with Disposable dehumidification tubing ras po ran Away adapter kit with Disposable dehumidification tubing 11 57 078158 Pediatric mask mainstream 9960PED 00 Disposable 11 57 078159 Adult standard mask mainstream 9960STD 00 Disposable 11 57 078160 Adult large mask mainstream 9960STD 00 Disposable 11 57 078161 Band mainst
54. nt ID A1 2 6 Review Trend List Recall 72 hours 1 Min Resolution Alarm List Recall 800 groups Measuring Range 0 100 Alarm Range 0 100 Resolution 1 Accuracy Adult including Pediatric 2 70 100 SpO Undefined 0 69 SpO Neonate 3 70 100 SpO Undefined 0 69 SpO Pulse Rate Measuring range 25 bpm 300 bpm Alarm Range 30 bpm 300bpm Resolution 1 bpm Accuracy 2bpm Data update period ls Wave length Red light 66043 nm 74 M3B Vital Signs Monitor User Manual Specifications Infrared light 90545 nm Emitted light energy Less than 15 mW A1 2 8 CO Applicable patient type Adult pediatric and neonatal patients Method Infra red Absorption Technique Unit mmHg kPa EtCO 0 150 mmHg C O measuring range FiCO 3 50 AwRR 2 150 Main stream EtCO 1 mmHg Resolution FiCO ImmHg AwkRR Irpm 2mmHg 0 40 mmHg Reading 5 41 mmHg 70 mmHg EtCO Accuracy Reading 8 71 mmHg 100 mmHg Reading 10 101 mmHg 150 mmHg AwRR 1 rpm Sample gas flow rate 50ml min O compensation Range 0 100 Resolution 1 Default 16 Stability Short term drift Drift over 4 hours shall not exceed 0 8 mmHg maximum Long term drift Accuracy specification will be maintained over a 120 hours p
55. nt is calibrated to display functional oxygen saturation 7 The pictures and interfaces in this manual are for reference only 1 2 7 Explanation of Symbols on the Monitor This symbol indicates that the instrument is IEC EN60601 1 Type BF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock and is suitable for use during defibrillation gt Caution Consult Instructions for Use Equipotentiality Stand by It designates that the switch or switch position which one part of the monitor has been switched on while the monitor is at the status of stand by Serial number The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices k Pa 4 Authorised representative in the European community Date of manufacture Manufacturer Econ q e lt p M3B Vital Signs Monitor User Manual Intended Use and Safety Guidance P N Part Number amp Recycle The symbol indicates that the device should be sent to the ps special agencies according to local regulations for separate collection after its useful life Federal US law restricts this device to sale by or on the neomy order of a physician ASSIA s CANS With respect to electrical shock fire and mechanical cus hazards only in accordance with UL 60601
56. o ii 66 Chapter 11 Accessories and Ordering Information o moooomm 67 Chapter 12 Warranty and SOr vices iecasencisiaceisycccesaadevccecssvacchedscesvuesgudeos sdacaccasseasevendsdecaeaseatsvendsveees 71 A E 71 12 2 Contact Information A E E E 71 Appendix ES pericias 72 BUT Classifications A an au hoc TEE CEE 12 ALD PEC CAOS 12 AT ASize and WEI A A A A AAA A E ER aeons 12 PAD 2D EOI a da a 12 AS Display A A A A dk A A AOS 73 AT 24 Battery RN 73 PVD SRECA ETa a a Nk on aaah tan ce taal Flan an ae 74 PV DAG A 74 A Sa saat caters ge Pa i ala a e e do 74 A O cee et rete ee Re re oS ee eRe eI a Prey ae a Nee eRe ear 75 A WATE SS NETWOTK pace Feasts cake Se tra anne Soa cand a al od eh E sate lag a Ns 76 Appendix TL EMC Information sssossesesescsocsossesescscsocsoscesesceccocscsoesescsesocscsoesesesesossescssesesesossesosssssse 77 A2 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS sossen TE A2 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS ssion 77 A2 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not EIFE SSURPORTING nnana a e Pag teal ds 79 AD 4 Recommended Separation Distances a dai 80 M3B Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1 1 Intended Use The M3B Vital Signs Monitor hereinafter called monitor is intended to be used for non invasive continuous monitoring of SpO2 oxygen saturation of the blood and CO Th
57. once any physiological alarm happens If the item is OFF the monitor will not automatically output the alarm information Additionally if ALM REC is set to ON you can also adjust the recording time of the alarm waveform to be outputted by setting ALM REC TIME Available options are 8s 16s and 32s 5 2 Alarm Cause Alarm occurs when 1 Physiological alarm is evoked 2 Alarm for error of the system technical alarm is evoked E A Conditions that activate the parameter alarms The measurement value exceeds the alarm limit and the alarm is set to ON Alarms will not activate if the alarm is set to OFF E B Conditions that activate the system alarms technical alarm Upon the system error the monitor prompts alarm immediately 5 3 Silence The user can press Silence button on front panel to stop audio alarm or turn off the audio system Alarm silenced icon EX Press the SILENCE button on the front panel for less than 2s and the audible alarm is mute The alarm silenced icon displays Pressing SILENCE button again can resume the audible alarm Audio system off icon X Press the Silence button for more than 2s the audio system is turned off including the audio alarm key volume and the pulse tone Then press Silence button again can resume the audio system 5 4 Parameter Alarm WARNING 1 Prior to monitoring make sure that the alarm limit settings are appropriate for your patient 2 Setting alarm limits to extreme values
58. onment Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 NOTE UT is the a c lt 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for cycles lt 5 UT 295 dip in UT for 5 sec 23 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the EUS TUltrasound Scanner requires continued operation during power mains interruptions it is recommended that the EUS T Ultrasound Scanner be powered from an uninterruptible power supply or a battery mains voltage prior to application of the test level 78 M3B Vital Signs Monitor User Manual EMC Information A2 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The M3B is intended for use in the electromagnetic environment specified below The customer or the user of M3B should assure that it is used in such an environment IEC EN 60601 Compliance Electromagnetic environment Immunity test test level level guidance Conducted RF Portable and mobile RF IEC EN 3 Vrms 3Vrms communications equipment should be 61000 4 6 150 kHz to
59. ons 10 1 Nurse Call The monitor provides dedicated nurse call port which is connected to nurse call system through the nurse call cable to perform the nurse call function 10 2 Wireless Network The monitor can constructs wireless network through AP Access Point Our company arranges the qualified engineers to install and set the wireless network for the user and test the corresponding performance For details please refer to Patient Monitor Wireless Network Installation Guide NOTE 1 Be aware that some network based functions may be limited for monitors on wireless networks in comparison with those on wired networks 2 The obstacle may interfere with data transmission and even cause data loss 66 M3B Vital Signs Monitor User Manual Accessories and Ordering Information Chapter 11 Accessories and Ordering Information WARNING The specification of accessories recommended is listed below Using other accessories may damage the monitor The following accessories are recommended when using this monitor Standard accessories Reusable Part No Accessories Qty or Disposable 12 01 109069 EDAN SH1 Adult Reusable SpO Sensor Lemo 1 Reusable eee Disposable CO Nasal Cannula Adult Respironics 1 lpi bl isposable a 3468ADU 00 P Meri Adult Pediatric Airway adapter kit with i lpi bl isposa Samaka dehumidification tubing iia ET Disposable Sampling Line Kit with
60. ooms incorporating an equipotential grounding system Check each time before use that the instrument is in perfect working order The cable connecting the patient to the instrument must be free of electrolyte WARNING If the protective grounding protective earth system is doubtful the monitor must be supplied by internal power only 1 2 5 Condensation Make sure that during operation the instrument is free of condensation Condensation can form when equipment is moved from one building to another thus being exposed to moisture and differences in temperature 1 2 6 Safety Precautions WARNING and CAUTION messages must be observed To avoid the possibility of injury observe the following precautions during the operation of the instrument WARNING 1 This monitor is not a device for treatment purpose 2 The monitor is provided for the use of qualified physicians or personnel professionally trained And they should be familiar with the contents of this user manual before operation 3 Only qualified service engineers can install this equipment And only service engineers authorized by EDAN can open the shell 4 EXPLOSION HAZARD Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur 5 Always keep the battery away from fire 6 SHOCK HAZARD the power receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three prong plug
61. prompt visual prompt and description Audio and visual prompt is given by LCD display device the speaker on the display device and the alarm indicator Physiological alarm Technical Alarm or description is displayed in Information area at the bottom of the screen 36 M3B Vital Signs Monitor User Manual Alarm NOTE The concrete presentation of each alarm prompt is related to the alarm level Screen Display When the measured parameter exceeds its alarm limits and triggers a physiological alarm the monitor will give alarm prompt on the screen indicating the occurrence of alarm The description will display in Information area such as NS TOO HIGH and A displays beside the parameter to indicate the low medium level alarm Technical alarm will not prompts signal Alarm Level Visual Prompt High ee displays in Parameter area 2 displays beside the parameter Physiological alarm only Medium 1 ras displays in Parameter area 2 displays beside the parameter Physiological alarm only Low 1 A displays in Parameter area 2 displays beside the parameter Physiological alarm only The waveform screens with alarm are displayed as follows lt Q mmHg Alarm icon EtCOs FICO A 38 ha PR BPM SpDo 7 Alarm indication PO SENSOR OFF 11 05 12 Low alarm 37 M3B Vital Signs Monitor User Manual ID 1 ADU mmHg Alarm i
62. r 2 Installation of Monitor seessoeesooesoosesoesssecesocesooesoocesoeessecesocesoosssosesoecssocesocssoosssoessseesssee 7 2 1 Opening the Package and Checkout dol 7 2 2 Connecting the Power Cable ssar raniti ria so a E A AA EA ANEETA 7 2 3 Powering on the Monitor oergeande di io 7 2 4 Connecting Sensor to Patent sti ii talon 8 2 9 CACA Recorder miner e a e a as 8 Chapter 3 Introductio A iness sese iae esteses esisi oos csokso siniese ovino essesi ase 9 3 General Informationen A a a a bodeaen each sees 9 BEPA O E NAE E E E E A A E ae athaeectere 10 Sp ABU PUNCH OTIS eea a Scat Bet a Gomes ic a a a a a a 14 Bi A ONE E RNA E AE E E E E 16 3 5 Built in Rechargeable BAS A IN A AA IS 18 Chapter 4 System Men iris 20 BPM NA tie Aa ee eae ae hee aA 20 4 2 Default SE GU E Peat pate Sh Scere EAS 21 A 3 System SQUID A A a tases A A Rea ats A A oe CR 21 E A AO 22 4 5 DEMO AD A A a RR A E AE 25 ASG AO nana a A a A Neg A AZ aa a EA 26 A AA EE EEEE T AA 26 A 27 RN 28 A O 29 4l Data SCOT agile his etal et salsa a catalan Danek Iai cecal attains Saad Sees Pais Gas elath od taut Pal 31 412 Sleep O a 34 Chapter AIM A Gan sean aau apo eee aw a ee 36 Sil UAT MAN WI OCC Suc ais seine ia teat acces a let aah mle Go nats ahs ait alee ees a la tal orients 36 Dia WNIT A ON EA 36 DMD Aa Mode nit la dena ea ceded Di aan 36 MATAS UA A A A AAA EA IES 40 52 Alarm CO A A Ae a aes a 41 5 3 Silents ie la tonnin TO 41 54 Parameter AMA A a a a
63. rameter Max Upper Limit Min Lower Limit Step SpO2 100 0 1 PR 300 30 1 8 6 Alarm Description SpO Alarm Message Tables below describe the possible physiological alarms technical alarms occurring during SpO measurement When there is no SpO2 or PR input it prompts weak signal Physiological alarm Message Cause Alarm Level SpO measuring value is above upper SpO2 TOO HIGH ape Medium alarm limit SpO TOO LOW SpO measuring value is below lower Medium alarm limit 51 M3B Vital Signs Monitor User Manual SpO Monitoring PR TOO HIGH ER measuring value is above upper alarm Medium limit PR i lue is below 1 l PR TOO LOW R measuring value is below lower alarm Medium limit Sphygmic signal from the measured NO PULSE position is too weak the monitor does not High detect any sphygmic signal Technical alarms Al Message Cause T What to do Level l Mak th i The SpO2 sensor may be High Low R N ad sana SpO2 SENSOR OFF disconnected from the Configured P finger or another patient by the user A ds appropriate position If no pulse information is displayed after 30s passes check whether the sensor SpOz sensor may be is connected with the SEARCH PULSE disconnected from the Low patient s finger If patient or the monitor necessary attach the sensor to another position which might provide better signal Stop using measuring
64. ream 8751 00 Reusable 11 12 078162 Card Slot Mainstream 6934 00 Reusable OTHERS 01 57 78035 Printing paper Disposable 12 01 109480 Trolley Reusable 02 01 109481 Wall hanger Reusable 02 01 109592 Pole Clamp 1 piece Reusable 02 01 109636 Pole Clamp 4 pieces Reusable 01 13 36014 Power cable EUR standard 220V Reusable 01 13 036106 Medical grade power cable USA standard Reusable 21 21 064167 proce Lithium Ion Battery TWSLB 008 14 8V Reusable 11 13 114214 Grounded cable Reusable 69 M3B Vital Signs Monitor User Manual Accessories and Ordering Information 02 01 101207 ASUS wireless AP WL 330g EAP 1 Reusable 11 18 078191 Flash Disk PNY 2 0 2G USB 1 Reusable 70 M3B Vital Signs Monitor User Manual Warranty and Service Chapter 12 Warranty and Service 12 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty is void in cases of a damage caused by mishandling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materials componen
65. rite 1 10 To clean the SpO sensor please refer to the instruction delivered with the accessory NOTE 1 The diluted sodium hypochlorite from 500ppm 1 100 diluted bleaching agent to 5000ppm 1 10 bleaching agents is very effective The concentration of the diluted sodium hypochlorite depends on how many organisms blood mucus on the surface of the chassis to be cleaned 2 The monitor and sensor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth 3 This company has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details 7 3 Sterilization Do not sterilize the monitor or the accessories unless this is necessary according to your hospital regulation 7 4 Disinfection To avoid extended damage to the equipment disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule Disinfection facilities should be cleaned first Use a soft cloth saturated with disinfectant to disinfect the monitor the reusable CO sensor and SpO sensor Recommended types of disinfecting agents are 46 M3B Vital Signs Monitor User Manual Maintenance Cleaning m Alcohol Alcohol Ethanol up to 70 1 and 2 Propanol up to 70 m Aldehyde Glutaraldehyde up to 3 6 WARNING Please do not mix disinfecting solutions such as bleach and ammo
66. sides this icon indicates the power status O When the monitor connects to the mains power supply the nos LED is bright 15 M3B Vital Signs Monitor User Manual Introduction 3 4 Interfaces For the convenience of operator interfaces of different function are in different sites of the monitor There is a USB port on rear panel for Data storing function Left side of the monitor At the left side of the monitor there is the recorder s paper inlet cover a a a Y A E G Figure 3 6 Front Panel and Left Panel Sensor port on the front panel Connectors for cables and sensors are as shown in Figure 3 6 1 SpO sensor connector 2 2 CO sensor connector 3 WARNING Only connect the device to EDAN supplied or recommended accessories 16 M3B Vital Signs Monitor User Manual Introduction Figure 3 7 Rear Panel of M3B Sockets on the rear panel are shown in Figure 3 7 Equipotential grounding terminal for connection with the hospital s grounding system 2 Power supply socket 100V 240V 50Hz 60Hz USB connecting port for USB storage 4 Network Interface Standard RJ45 Socket for connecting to MFM CMS of EDAN Bottom panel There are battery compartment and fuse box at the bottom panel 17 M3B Vital Signs Monitor User Manual Introduction gt Battery compartment cover e Bes0j s Jo s emje ebewep Jeyeq piore oL Burddiys eJojeq
67. stic oses Voltage fluctuations PTEE R flicker emissions Complies IEC EN 61000 3 3 A2 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The M3B is intended for use in the electromagnetic environment specified below The customer or the user of M3B should assure that it is used in such an environment IEC EN 60601 Electromagnetic Immunity test Compliance level A environment guidance test level Floors should be wood Electrostatic k k concrete or ceramic tile If 6 kV contact 6 kV contact f discharge ESD floor are covered with IEC EN 61000 4 2 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 es i M3B Vital Signs Monitor User Manual EMC Information Electrical fast transient burst IEC EN 61000 4 4 2 kV for power supply lines 2V for supply lines power Mains power quality should be that of a typical commercial or hospital environment Surge TEC EN 61000 4 5 Power frequency 50 60Hz magnetic field IEC EN 61000 4 8 1 kV differential mode 2 kV mode common 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital envir
68. tal Signs Monitor User Manual Maintenance Cleaning Chapter 7 Maintenance Cleaning 7 1 System Check Before using the monitor do the following m Check if there is any mechanical damage m Check if all the outer cables inserted modules and accessories are in good condition m Check all the functions of the monitor to make sure that the monitor is in good condition If you find any damage on the monitor stop using the monitor on patient and contact the biomedical engineer of the hospital or EDAN immediately The overall check of the monitor including the safety check should be performed only by qualified personnel once every 6 to 12 months and each time after fixing up All the checks that need you to open the monitor should be performed by qualified customer service technician The safety and maintenance check can be conducted by persons from this company You can obtain the material about the customer service contract from the local company s office WARNING 1 If the hospital or agency that is responding to using the monitor does not follow a satisfactory maintenance schedule the monitor may become invalid and the human health may be endangered 2 Replace batteries according to the instruction of our service engineer NOTE To prolong the life of rechargeable battery charging it once every month at least is recommended and it must be done after the electric energy runs out 7 2 General Cleaning WARNING Before clean
69. tion again 9 3 2 CO Alarm Setup Select ALARM SETUP in SYSTEM MENU to display the menu as shown below ALARM SETUP Figure 9 9 Alarm Setup 61 M3B Vital Signs Monitor User Manual CO Monitoring The items to be set in the menu include a EtCO ALM FiCO ALM AWRR ALM Select ON to enable and store alarm prompt when CO parameters have alarms Select OFF to disable alarm and display RX beside CO The default is ON WARNING In order to avoid endangering the patient s life the user should use this function cautiously a EtCO ALM HI to adjust the upper alarm limit of EtCO If the measuring value is larger than CO upper alarm limit CO2 TOO HIGH appears in the Information area After the measuring value returns to the normal one the information disappears sEtCO ALM LO to adjust the lower alarm limit of EtCO2 If the measuring value is smaller than CO lower alarm limit CO2 TOO LOW appears in the Information area After the measuring value returns to the normal one the information disappears a FiCO ALM HI to adjust the upper alarm limit of FICO If the measuring value is larger than FiCO gt upper alarm limit FICO TOO HIGH appears in the Information area After the measuring value returns to the normal one the information disappears a AWR ALM HI to adjust the upper alarm limit of AwRR If the measuring value is larger than the upper alarm limit of AWRR AWRR TOO HIGH appears in the Information area A
70. tive means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT Do not unplug the USB storage during storing data If the damaged data caused by unpluging the USB storage during data storing can not be deleted on the monitor the user can delete it on the PC Do not solder the leading wire and the battery terminal directly If liquid leaking from the battery gets into your eyes onto your skin or clothes do not rub your eyes Wash them well with clean water and go to see a doctor immediately Only patient cable and other accessories supplied by EDAN can be used Or else the performance and electric shock protection can not be guaranteed and the patient may be injuried Do not use a battery with serious scar or deformation Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor Do not sterilize the monitor recorder or any accessories Do not touch the patient bed or instrument during defibrillation Please set the alarm according to the individual status of patient to avoid delaying treatment Ensure there will be alarm audio prompt when alarming Devices connecting with monitor should be equipotential The monitor is equipped with a wireless AP via network interface to receive RF electromagnetic energy Therefore any other equipment complies with CISPR radiation requirements may also interfere with th
71. to be monitored audio signal volume and output content Press the MENU button on the front panel to call uy SYSTEM MENU You can perform the following operations in this menu SIS TEM MENU PATIENT SETUP MAINTAIN DEFAULT TIME SETUP SYSTEM SETUP COz SETUP SELECTION ALARM SETUP VERSION DATA STORE Figure 4 1 System Memu 4 1 Patient Setup Pick PATIENT SETUP in SYSTEM MENU to open the following menu PATIENT SETUP Figure 4 2 Patient Setup You can set the following patient information E PAT ID Patient ID 1 1000 E PAT TYPE Patient type ADU PED or NEO Press the UP DOWN button to select the items then press the OK button to confirm Pick EXIT to return to the previous menu 20 M3B Vital Signs Monitor User Manual System Menu 4 2 Default Setup NOTE Select any item in this submenu to cancel the current setup and use the selected default setup DEFAULT SAVE CBE AS USER CONFIG CONF RM Figure 4 3 Default Menu E FAC DEF CONFIG factory default configuration USER DEF CONFIG user defined default configuration E SAVE CURRENT AS USER CONFIG Save the current setup as user default configuration CONFIRM Confirm your choice exit this submenu and return to the previous menu 4 3 System Setup SYSTEM SETUP HIGH OFF MED MED Exel Figure 4 4 System Setup E ALARM VOL Set alarm volume for high medium or low level HIGH MED or LOW are selectable E STANDBY Set
72. ts or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 12 2 Contact Information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn auf is M3B Vital Signs Monitor User Manual Specifications Appendix I Specifications A1 1 Classification Anti electroshock type Class equipment and internal powered equipment EMC type Class A Anti electroshock degree SpO2 CO2 BF Ingress Protection IPX1 Disinfection sterilizing method Refer to Chapter 7 Chapter 9 for details Working system Continuous operation equipment no more than 7 days Compliant with Safety Standards IEC60601 1 1988 A1 A2 EN60601 1 1990 A 1 A2 IEC EN 60601 1 2 2001 A1 ISO 9919 ISO 21647 A1 2 Specifications A1 2 1 Size and Weight Size 173 5 L x 241 H x 189 D mm Weight 3 kg A1 2 2 Environment Temperature Working 5 C 40 C Transport and Storage 20 C 55 C Humidity Working 25 80 no coagulate Transport and Storage Altitude 25 93 no coagulate Working 860hPa 1060hPa
73. x PR BPM 99 TIME ID EtCO2 FIC02 AwRR SP0 PR 2517 23 18 25147322 18 25117321 2 25117120 2 2517219 2 25147118 2 2517 17 Tar Oo OAR 17 24 33 Figure 3 3 Main Display with List The display on the screen can be changed to a trend graph as follows TREND GRAPH Y 10 09 2010 16 14 58 68 51 34 17 0 16 12 17 16 13 37 16 14 57 SPO23 7 AwRR 77 PR Som Els FiCO2 PARA SPO RESOLVE 1S ID 1 L RIGHT ZOOM CURSOR REC Figure 3 4 Display Trend Graph M3B Vital Signs Monitor User Manual Introduction The icons on the interface and their meanings are as follows Battery status indicator Connected to mains power supply Network connection Network connection off Medium Low alarm icon High alarm Audio system off Alarm silenced Parameter alarm off B D Bl alae a g Patient type ADU PED Patient type PED NEO Patient type NEO Heart beat ID Current patient ID 10 45 52 Current time Information Area O The Information areas are to display operating status of the monitor and condition of the patient including the following data Patient ID Signs indicating the net connection status Signs indicating the battery or mains power supply status Current time Signs indicating the sensor off or alarm off Parameter Area Parameter area is on the right of Waveform are
74. you can see the menu as follows Sp02 SETUP EXIT Figure 4 18 SpO Setup SpO ALARM LEV You can configure the alarm level for SpO2 SENSOR OFF to HIGH or LOW SENSITIVITY The SpO reading is the average of data collected within a specific time You can set Sensitivity to HIGH MED or LOW via the menu The higher the sensitivity is the quicker the pulse oximeter responds to the changes in the patient s oxygen saturation level Contrarily the lower the sensitivity is the slower the pulse oximeter responds to the changes in the patient s oxygen saturation level but the measurement accuracy will be improved When a critical patient is monitored selecting high sensitivity will help to understand the patient s state COLOR SELECT set the displaying color of waveforms 30 M3B Vital Signs Monitor User Manual System Menu COLOR SELECT CONF RM Figure 4 19 Select Color ALARM SETUP ALARM NUTE Set the duration of silencing the audible alarm to 60s 120s or 180s ALARM SILENCE You can set this item to ON or OFF If the item is ON you can turn off the audio system by pressing the SILENCE button on the front panel for more than 2s In this case all sounds including the alarm sound key sound and sphygmic sound coming from the monitor will be mute If the item is OFF the function mentioned above is unavailable EXIT exit the menu Factory Maintain Factory maintenance function is only avail

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