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Manual - Cardiac Direct

1. NIBP Non invasive blood pressure Or Oxygen oxyCRG Oxygen cardio respirogram PA Pulmonary artery PAWP Pulmonary artery wedge pressure Ped Pediatric Pleth Plethysmogram PR Pulse rate PVC Premature ventricular complex R Right RA Right arm RAP Right arterial pressure Resp Respiration RHb Reduced hemoglobin RL Right leg RR Respiration Rate Sev Sevoflurane SYS Systolic pressure TB Blood Temperature TD Temperature difference TEMP Temperature USB Universal serial bus 171 P N 01 54 455005 11 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe 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
2. FiCO2 3 mmHg 50 mmHg AwRR 2 rpm 150 rpm Sidestream 0 rpm 150 rpm Mainstream Resolution EtCO ImmHg FiCO ImmHg AwRR rpm EtCO Accuracy 0 1 mmHg 0 mmHg 69 mmHg 153 Patient Monitor User Manual Product Specification 0 25 mmHg 70 mmHg 150 mmHg AwRR Accuracy 1 rpm Suffocation Alarm Delay 10s 15s 20s 25s 30s 35s 40s default value is 20 second Sample Gas Flowrate 50ml min Stability Short Term Drift Drift over 4 hours lt 0 8 mmHg Long Term Drift 120 hour period O2 Compensation Range 0 100 Resolution 1 Default 16 A 16 CO Method Thermodilution Technique Measuring range CO 0 1 L min 20L min TB 23 C 43 C 73 4 F 109 4F TI Auto 1 C 27 C 30 2 F 80 6 F Manual 0 C 27 C 32 F 80 6 F Resolution CO 0 1L min TB TI 0 1 C 0 1 F Alarm range 23 C 43 C 73 4 F 109 4 F Accuracy CO 5 or 0 2 L min TB 0 1 C TI 0 1 C Output parameters CO Hemodynamic Calculation A 17 AG 154 Product Specification Patient Monitor User Manual A 17 1 Phasein Sidestream Module Type ISA AX Analyzer Displaying the concentration of CO N20 and two anaesthesia agent and identifying the anaesthesia agent automatically portable module ISA OR Analyzer Displaying the concentration of CO O2 N2
3. 12 08 078137 Respironics EtCO Module Side stream 1022054 12 08 078166 LoFloTM Module Mounting Bracket Respironics 1027730 11 57 078159 Disposable CO Nasal Cannula Adult Respironics 3468ADU 00 11 57 078140 Disposable CO Nasal Cannula Pediatric Respironics 3468PED 00 11 57 078141 Disposable CO Nasal Cannula Infant Respironics 3468INF 00 11 57 078154 Disposable Sampling Line Kit with Dehumidification Tubing Respironics 3475 00 11 15 040143 Respironics CAPNOSTAT 5 EtCO Main stream Module 1015928 11 59 078155 Disposable Adult Airway Adapter 6063 00 11 59 078156 Disposable Neonatal Infant Pediatric Airway Adapter 6312 00 12 08 078138 Respironics EtCO2 Component Side stream 1024956 11 57 078142 Adult Nasal CO with O Delivery Sampling Cannula 11 57 078143 Pediatric Nasal CO with O2 Delivery Sampling Cannula 11 57 078144 Infant Nasal CO with O2 Delivery Sampling Cannula 136 Patient Monitor User Manual Accessories 11 57 101019 Adult Nasal Oral CO Sampling Cannula 11 57 101020 Pediatric Nasal Oral CO2 Sampling Cannula 11 57 101021 Adult Nasal Oral CO with O2 Delivery Sampling Cannula 01 12 031598 Adult Pediatric Airway Adapter Kit 11 57 078151 Adult Pediatric Airway Adapter Kit with Dehumidification Tubing 11 57 078152 Pediatric Infant Airway Adapter
4. PRESSURE OVER RANGE Make sure that the stopcock is vented to atmosphere If the FAIL problem persists please contact service technician 15 8 IBP Pressure Calibration 1 Mercury calibration should be performed by the biomedical engineering department either whenever a new transducer is used or as frequently as dictated by your Hospital Procedures Policy 2 The purpose of the calibration is to ensure that the system gives you accurate measurements 3 Before starting a mercury calibration a zero procedure must be performed If you need to perform this procedure yourself you will need the following equipment Standard sphygmomanometer 3 way stopcock and Tubing approximately 25 cm long The Calibration Procedure 1 Close the stopcock that was open to atmospheric pressure for the zero calibration 2 Attach the tubing to the sphygmomanometer 3 Ensure that connection to patient is off 4 Connect the 3 way connector to the 3 way stopcock that is not connected to the patient catheter Nn Open the port of the 3 way stopcock to the sphygmomanometer 6 Select the channel to be calibrated in the menu and select the pressure value to which the IBP is to be adjusted 7 Inflate to make the mercury bar rise to the setup pressure value 84 Patient Monitor User Manual Monitoring IBP 8 Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury calibration 9 Pre
5. Pausing to transmit patient data to CMS and other network devices e Pausing to store the currently recorded data and clearing the memory used to store recording and printing data sigs Patient Monitor User Manual Basic Operation Real data the parameter measurement value and real waveform displayed on the screen are from the predefined analog data not the truly monitoring patients data History data the monitor will store the analog real time data in Demo mode including trend data patient information alarm event waveform and setting To exit Demo Mode select Menu gt Common Function gt Demo Mode or press the Demo key on the screen directly WARNING This is for demonstration purposes only You must not change into Demo Mode during monitoring In Demo Mode all stored trend information is deleted from the monitor s memory 3 4 Changing Monitor Settings 3 4 1 Adjusting Screen Brightness To change the screen brightness please 1 Press the Brightness key on the screen directly or 2 Select Menu gt Common Function gt Brightness and select the appropriate setting for the screen brightness 10 is the brightest 1 1s the least bright Your monitor may be configured with lower brightness in standby mode and also for transport to conserve battery power 3 4 2 Changing Date and Time To change the date and time please refer to Section Setting Date and Time WARNING Change to date and time will infl
6. Patient Monitor User Manual Basic Operation M80 Back View 1 SD Card 2 Nurse call port this port is connected to the call system When there is an alarm the monitor outputs nurse call signal to notify the nurse 3 Defibrillator synchronization analog output When the user selects Analog Output the monitor outputs the waveform through the auxillary output port When the user selects Defibrillator the monitor outputs the defibrillator synchronization signal through the auxillary output port 4 VGA output 5 USB interface this port is used to connect the USB device 6 RS232 interface 7 Network interface this port is used to connect to the central monitoring system through the standard network wire 8 Anti theft lock interface 9 Heat emission hole 10 Security lock used to prevent the power supply cord from falling 11 Equipotential grounding terminal when the monitor is used with other equipment the user should connect the monitor to equipment through the lead to eliminate the ground potential difference between different devices 14 Patient Monitor User Manual Basic Operation 12 Speaker 13 Fan 3 1 3 M50 M80 Configuration MS50 M80 configuration is listed as below Function Model Size LxWxH Mente Configuration ECG RESP SpO PR NIBP M50 260 mm L x 140 mm W x 205 mm H Square TEMP Quick TEMP CO ECG
7. 2 Verify probe cables fault detection before the beginning of monitoring phase Unplug the temperature probe cable from the socket and then the screen will display the error message TEMP SENSOR OFF and the audible alarm is activated 3 Take the TEMP probe and cable carefully When they are not in use you should coil up the probe and cable into a loose circle If the wire inside the cable is tensely pulled it may cause mechanical damage to the probe and the cable 4 The calibration of the temperature module is necessary every two years or as frequently as dictated by your Hospital Procedures Policy When you need to calibrate the temperature measurement please contact the manufacturer 5 Patient actions may interfere with accurate oral temperature readings Ingesting hot or cold liquids eating food chewing gum or mints brushing teeth smoking or performing strenuous activity may affect temperature readings for up to 20min after activity has ended 6 Donottake an axillary temperature through patient s clothing Direct probe cover to skin contact is required 7 Biting the sensor tip while taking a temperature may result in damage to the sensor 8 Use disposable TEMP sensor covers recommended by EDAN to limit patient cross contamination The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings 78 Patient Monitor User Manual Monitoring Quick TEMP 14 3 Measuring Procedure 14
8. AG Self Testing AG module is self testing Low sd bis MEE testing finishing t Pl lace the O2 AG Revisde Os Senor O2 sensor needs to be Bi ease replace the O replaced sensor Pl it check AG Check Adapter AG module checks adapter Low poe b cie finishing O Cali Required O2 needs to be calibrated Low Please calibrate O2 35 Patient Monitor User Manual Alarm Information AG Software Error AG module abnormal software High Please replace software revision AG module has hardware Please check whether AG Hardware Error High the hardwares work failure properly Please check whether AG Motor Error AG module motor abnormal High the motor works properly AG Uncalibrated AG module uncalibrated Low ph Gale UR AG module A l to ch Pl l th AG Replace Adapter G module needs to change Hh ease replace the adapter adapter Pl k O Out Of Range O is out of range High FEE resume normal AG TEMP Out Of AG module temperature out dc e M High temperature resume Range of range normal AG Baro Press Out Of AG module baro pressure l ana A High pressure value Range out of pressure resume normal AGAA ld nrelisble AG modle can t identify the Medium Reduce gas agent AG agent type Be ppas eub Hi AG module is calibrating Low ps i Nia Progress calibration finishing T Please check whether AG Calibration Fail s mede fen lyaion Medium th
9. After reconnecting the power supply the user should turn on the monitor for monitoring 16 Keep away from fire immediately when leakage or foul odor is detected 17 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do NOT dispose them together with house hold garbage At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product 18 This equipment is not intended for family usage Patient Monitor User Manual Intended Use and Safety Guidance CAUTION Electromagnetic Interference Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones etc The monitor is designed for continuous operation and is ordinary i e not drip or splash proof Keep the environment clean Avoid vibration Keep it far away from corrosive medicine dust area high temperature and humid environment Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer Do
10. Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light 7 If applicable Perform a tightness check of the patient circuit with the sampling line attached 18 3 1 2 System Setup for Analyzer If your system is using the plug in and measure ISA analyzer please follow the setup instructions below 102 Patient Monitor User Manual Monitoring AG 1 Connect the ISA analyzer interface cable to the monitor 2 Connect a Nomoline sampling line to the ISA analyzer input connector 3 Connect the gas sample exhaust port to a scavenging system or return the gas to the patient circuit 4 Power up the monitor 5 A green LED indicates that the ISA analyzer is ready for use 6 Perform a pre use check as described in section Perform a pre use Check 18 3 1 3 Zeroing The infrared module needs to establish a zero reference level for the CO N5O and anesthetic agent gas measurement This zero calibration is here referred to as zeroing ISA analyzer performs zeroing automatically by switching the gas sampling from the respiratory circuit to ambient air The automatic zeroing is performed every 24 hours and takes less than 3 seconds for ISA CO module and less than 10 seconds for ISA analyzer If the ISA analyzer is fitted with an oxygen sensor the automatic zeroing will also include room air calibration of the oxygen sensor WARNING 1 Since a successful zeroing requires the presence of ambient air 21
11. ECG electrode LL falls off the skin or ECG cables fall off the monitor Low ECG LA Lead Off ECG electrode LA falls off the skin or ECG cables fall off the monitor Low ECG RA Lead Off ECG electrode RA falls off the skin or ECG cables fall off the monitor Low Make sure that all electrodes leads and patient cables are properly connected ECG Signal Exceed ECG measuring value is High beyond measuring range i Check connection patient condition lead and 29 Patient Monitor User Manual Alarm Information The amplitude of ECG Please modify the ECG Signal Overflow l i Low ECG gain signal is too wide Stop measuring function of ECG ECG Comm Fail ECG module failure or josh module and notify communication failure biomedical engineer or manufacturer s service staff Check lead ECG Noise ECG measuring signal is Low connection and greatly interrupted patient condition ECG electrode V1 falls off ECG V1 Lead Off the skin or ECG cables fall Low off ECG electrode V2 falls off ECG V2 Lead Off the skin or ECG cables fall Low off ECG electrode V3 falls off ECG V3 Lead Off skin or ECG cables fall Low Wike Sues alie adi Se electrodes leads and ECG electrode V4 falls off o cables ECG V4 Lead Off the skin or ECG cables fall Low property connected off ECG electrode V5 falls off ECG V5 Lead Off the skin or ECG cables fal
12. FiCO2 High FiCO measuring value is above alarm limits User selectable CO APNEA s E interval no RESP can be detected High AWRR High AwRR measuring value is above upper alarm limit User selectable AWRR Low AwRR measuring value is below lower alarm limit User selectable EtO High EtCO measuring value is above upper alarm limit User selectable FiO Low FiCO measuring value is below lower alarm limit User selectable EtN20 High N20 measuring value is above upper alarm limit User selectable FiN O Low N20 measuring value is below lower alarm limit User selectable EtHAL High EtHAL measuring value is above upper alarm limit User selectable EtHAL Low EtHAL measuring value is below lower alarm limit User selectable FiHAL High FiHAL measuring value is above upper alarm limit User selectable FiHAL Low FiHAL measuring value is below lower alarm limit User selectable EtENF High EtENF measuring value is above upper alarm limit User selectable EtENF Low EtENF measuring value is below lower alarm limit User selectable FiENF High FiENF measuring value is above upper alarm limit User selectable FiENF Low FiENF measuring value is below lower alarm limit User selectable EtISO High EtISO measuring value is above upper alarm limit User selectable EtISO Low EtISO measuring value is below lower alarm limit User selectable FilSO High FilSO measuring value is above upper alarm limit User selectable FilSO Low FiISO measuring value is below lower alarm limit
13. Purple 8 8 1 Electrode Placement for 3 lead Take the American standard for example see the following figure m RA placement directly below the clavicle and near the right shoulder m LA placement directly below the clavicle and near the left shoulder 53 Patient Monitor User Manual Monitoring ECG m LL placement on the left hypogastrium Electrode Placement for 3 lead 8 8 2 Electrode Placement for 5 lead Take the American standard for example see the following figure m RA placement directly below the clavicle and near the right shoulder m LA placement directly below the clavicle and near the left shoulder m RL placement on the right hypogastrium m LL placement on the left hypogastrium m V placement on the chest the position depends on your required lead selection Electrode Placement for 5 lead 54 NOTE To ensure the patient safety all leads must be attached to the patient Patient Monitor User Manual Monitoring ECG For 5 lead attach the V electrode to one of the indicated positions as below VI V2 V3 V4 V5 V6 V3R V6R VE V7 V7R On the 4th intercostal space at the right sterna margin On the 4th intercostal space at the left sterna margin Midway between V2 and V4 electrodes On the 5th intercostal space at the left clavicular line On the left anterior axillary line horizontal with V4 electrode On the left middle axillary line horizontal with
14. RESP SpO PR NIBP TEMP IBP CO CO2 AG 12 lead monitoring M80 370 mm L x 175 mm W x 320 mm H Square 3 2 Operating and Navigating Everything you need to operate the monitor is contained on its screen Almost every element on the screen is interactive Screen elements include measurement numerics waveforms screen keys information fields alarms fields and menus The configurability of the monitor means that often you can access the same element in different ways For example you might be able to access an item through its on screen setup menu via a hard key or via a shortcut key The User Manual always describes how to access items via an on screen menu You may use whichever way you find most convenient 15 Patient Monitor User Manual Basic Operation 17 7 tw 2009 11 12 09 18 32 i C amp i E a A Trend Graph Trend Table Alarm Rec ll NIBP Recall TrendScreen oxyCRG h View Bec Menu 16 15 14 13 12 1110 9 8 1 Department 2 Bed number 3 Patient name 4 Patient type 5 Alarm status area 6 Alarm off 7 Measurement value 8 Menu 9 Scroll right to display more shortcut keys 10 Date and time 11 Networking symbol 12 Battery status symbol 13 AC power supply symbol 16 Patient Monitor User Manual Basic Operation 14 Shortcut key area 15 Scroll left to display more shortcut keys 16 Mute key I7 Parame
15. Review Used to review frozen waveforms REC select this item to record the setting waveform in REC WAVE Exit After this button is pressed the system closes the Frozen menu and exits the Freeze 110 Patient Monitor User Manual Freeze Status NOTE Pressing the Freeze button repeatedly in a short period of time may result in discontinuous waveforms displaying on the screen 19 3 Reviewing Frozen Waveform By moving the waveform you may review a waveform of 120 seconds before it is frozen For a waveform of less than 60 seconds the remaining part is displayed as a straight line Use the rotary snob on the control panel to move the cursor to the Review option in the Frozen menu Press the knob By turning the knob left or right frozen waveforms on the screen will move left or right correspondingly There is an arrow indicating upward on the right side of the last waveform 111 Patient Monitor User Manual Review Chapter 20 Review The monitor provides 120 hour trend data of all parameters storage of 1200 NIBP measurement results and 60 alarm events This chapter gives detailed instruction for review of all data 20 1 Trend Graph Review m The latest 1 hour trend is displayed every 1 or 5 seconds m The latest 120 hour trend is displayed every 1 5 or 10 minutes To review Trend Graph please press the Trend Graph key on the screen or select Menu gt Review gt Trend Graph then the trend graph interface is display
16. User selectable EtSEV High EtSEV measuring value is above upper alarm limit User selectable EtSEV Low EtSEV measuring value is below lower alarm limit User selectable FiSEV High FiSEV measuring value is above upper alarm limit User selectable FiSEV Low FiSEV measuring value is below lower alarm limit User selectable EtDES High EtDES measuring value is above upper alarm limit User selectable EtDES Low EtDES measuring value is below lower alarm limit User selectable FiDES High FiDES measuring value is above upper alarm limit User selectable 28 Patient Monitor User Manual Alarm Information FiDES Low FiDES measuring value is below lower alarm limit User selectable AG FiO Low FiO measurement value is too low High AG APNEA B deed bon interval no RESP can be detected Back TB High TB measuring value is above upper alarm User selectable TB Low TB measuring value is below lower alarm User selectable 5 2 Technical Alarm Information NOTE The ECG alarm information listed in the below table describes the lead names in America For the corresponding lead names in Europe please refer to Section nstalling Electrodes Message Cause Alarm Level Action Taken ECG Lead Off More than one ECG electrode falls off the skin or ECG cables fall off the monitor Low ECG V Lead Off ECG electrode V falls off the skin or ECG cables fall off Low ECG LL Lead Off
17. WARNING This pneumatic test other than being specified in the EN 1060 1 standard is to be used by the user to simply determine whether there are air leaks in the NIBP airway If at the end of the test the system gives the prompt that the NIBP airway has air leaks please contact the manufacturer for repair 12 12 1 Procedure of Leak Test Connect the cuff securely with the socket for NIBP air hole Wrap the cuff around the cylinder of an appropriate size Access User Maintain gt NIBP Maintain Turn the knob to the Leak Test item and press the item Then the prompt of Leak Testing will appear indicating that the system has started performing leak test The system will automatically inflate the pneumatic system to about 180 mmHg After 20 seconds the system will automatically open the deflating valve which marks the completion of a pneumatic measurement Ifthe prompt of Leak Test OK appears it indicates that the airway is in good situation and no air leaks exist However if the alarm information of NIBP Cuff Leak appears it indicates that the airway may have air leaks In this case the user should check for loose connection After confirming secure connections the user should re perform the pneumatic test If the failure prompt still appears please contact the manufacturer for repair Diagram of NIBP Air Leakage Test 76 Patient Monitor User Manual Monitoring TEMP Chapter 13 Monitoring TEMP
18. 2 Stopping tranmitting alarm information to other network devices 3 Alarm Off symbol is displayed on the right side of the parameter name if the parameter alarm is switched to off 4 3 2 Audio Alarm Pause The monitor won t give an audible alarm when there is an alarm during the audio alarm pause and the alarm indicator and screen flash indicating there is an alarm The top of monitor displays the following 1 Audible alarm pause symbol ES 2 The remaining pause time is displayed in txt and the word background is red The user can set the audio alarm pause to 60 s 120 s or 180 s based on the requirement 4 3 3 Mute To mute the alarm please select Menu gt Maintenace gt User Maintain gt Alarm Setup and set Mute to On then press the Mute key on the front panel for more than three seconds 4 3 4 Controlling Alarm Volume The monitor provides five levels of alarm volume 1 2 3 4 and 5 For adjusting the alarm volume please refer to Section Adjusting Alarm Volume 4 3 5 Setting Alarm Limits To change individual measurement alarm limits take HR alarm for example please refer to the following steps 1 Select the HR Parameter area 2 Select HR Setup gt Alarm Setup Then set the alarm limit to the desired value from the popup interface For how to set the alarm limit please refer to the following figure 23 Patient Monitor User Manual Alarms HR Alarm Setup High Upper arrow or lower arrow
19. 5096 for neonates or 2 3 of the upper arm length The inflatable part of the cuff should be long enough to encircle 50 8096 of the limb The wrong size of cuff can cause erroneous readings If the cuff size is in question use a larger cuff Cuff Usage 3 Connect the cuff to the air tubing 4 Check whether the patient mode is appropriately selected Access the Patient Setup menu from Menu and select Patient Info and turn the knob to select the required Patient Type 5 Select a measurement mode in the NIBP Setup menu Refer to section Operation Prompts JR Patient Monitor User Manual Monitoring NIBP for details 6 Press the NIBP button on the front panel to start a measurement 12 6 2 Measurement for M3600 Module Plug the air hose into the connector for blood pressure measurement and connect it by turning it clockwise To demount the air hose you should turn it counterclockwise Switch on the system after verifying the air hose has been well connected Apply the blood pressure cuff to the patient s arm as shown in the following figure Ensure that the cuff is completely deflated Apply the cuff with an appropriate size to the patient and make sure that the symbol o is right over the artery Ensure that the cuff is not wrapped too tightly nor too loosely around the limb In terms of the standard cuff assorted for this monitor you may judge its suitability by inserting two fingers into the wrapped cuf
20. B 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS ses 159 B 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LUN Um SUPPOR ING eL p 160 BA Recommended Separation Distances iiesae sitire etos bar eed exa EY Ld Yo UvS Forke Pep exa perdas nda 162 C Default Sti RET R 163 C 1 Patient Information Default Settings sesesuises oa bre pUXLEY DIO ue dV s d o PR S an eva EXYE I gusce cR a Rude 163 ol A Tam Default SOLUS ssas vex rc eimi ME Lo DR RUM PR FOU P Vi MUSU DES I vU PM MM Ze GV T DNE 163 C3 ECG Default Seting MT CH 163 ee A DT E AE T E A EE EA M 164 CS SPOe E es E E ee a eee 165 COPR eee E E E AAEE E E E E AE 165 Mo TEED eea E E Ea 165 RE Moi A A E A E SET E E 166 CIO k TEMP oee aeee eea aE e SE bcr E e IEEE PUN DS 166 LE I erm e e eE c E E 166 UNTEN a steed acta gloves ea iv Ta a e a aa aa 167 PNE lo eG 168 BY ARC VIAINONS e 169 XII Patient Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1 1 Intended Use The monitor monitors parameters such as ECG 3 lead 5 lead or 12 lead selectable Respiration RESP Functional arterial oxygen saturation SpO2 Invasive or noninvasive blood pressure dual IBP NIBP Temperature dual TEMP Expired CO and Anesthetic g
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22. Kit with Dehumidification Tubing 11 57 078158 Pediatric Mask Mainstream 9960PED 00 11 57 078159 Adult Standard Mask Mainstream 9960S TD 00 11 57 078160 Adult Large Mask Mainstream 9960STD 00 11 57 078161 Band Mainstream 8751 00 11 12 078162 Card Slot Mainstream 6934 00 28 2 8 CO Accessories Part Number Accessories Remark 11 15 40119 In line Injection temperature probe BD 684056 SP4042 11 15 40120 In line Injection temperature probe housing BD 680006 SP5045 11 57 100175 Control Syringe Medex MA387 01 57 471012 Cardiac output main cable Yuanhe 98ME07GB106 28 2 9 AG Accessories Part Number Accessories Remark IRMA Airway Adapter Disposable adult Mainstream 11 57 471042 10 children 25 pcs packape PHASBIN Nomoline with Luer Lock connector L 2m Sidestream 11 57 471043 10 SOmi nin 25 pes package PHASBIN 11 57 471048 AG connection module rack 12 08 208006 Multi gas analyzer IRMA AX CAT NO 200601 12 08 208005 Multi gas analyzer ISA AX CAT NO 800601 12 08 208007 Multi gas analyzer ISA OR CAT NO 800401 28 2 10 Other Accessories Part Number Accessories Remark 11 21 064142 Rechargeable Lithium Ion Battery 14 8V 2 1Ah 137 Patient Monitor User Manual Accessories 11 21 064143 Rechargeable Lithium Ion Battery 14 8V 42Ah 01 57 78035 Recorder paper 12 01 19084 Thermal
23. To change the language please 1 Select Menu gt Maintenance gt User Maintain then type the correct password ABC into the displayed interface 2 Selectthe Language option on the popup interface to open the language list 3 Select the desired language from the list To make the change validate please restart the monitor 3 9 Understanding Screens Your monitor comes with a set of preconfigured screens optimized for common monitoring scenarios such as OR adult or ICU neonatal A screen defines the overall selection size and position of waves numerics and shortcut keys on the monitor screen when you switch on the monitor You can easily switch between different screens during monitoring Screens do NOT affect alarm settings patient category and so forth When you switch from a complex to a less complex screen layout some measurements may not be visible but are still monitored in the background For detailed information please refer to Chapter User Interface 3 10 Calibrating Screens To calibrate the screen please refer to the following steps 1 Select the Touch Calib shortcut key on the screen directly or select Menu gt Maintenance gt User Maintain then input maintenance password ABC then select TouchScr Calibration from the popup interface 20 Patient Monitor User Manual Basic Operation 2 The symbol H appears on the screen 3 Click on the central point of the symbol Hl 4 After successful calibration the
24. Trend Screen 7 6 Viewing Oxygen Screen To view the oxygen screen the user can press the oxyCRG key on the screen or select Menu gt View Setting gt View Selection gt oxyCRG This interface is always used in NICU because the SpO HR and Resp of the neonate are different from those of adults Ag Patient Monitor User Manual User Interface 7 7 Viewing Large Font Screen To open the large font screen please refer to the following steps 1 Select the Large Font key on the screen directly or 2 Select Menu gt View Setting gt View Selection gt Large Font to open this interface To view the large font interface of specific parameter please select the parameter pull down diaglog on the interface the red circle shown in the following figure ICU EX JOECOLE Adult I Manual 119 7664 Rs y E 240 Patient Monitor User Manual Monitoring ECG Chapter 8 Monitoring ECG 8 1 Overview The electrocardiogram ECG measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric This chapter also tells you about arrhythmia monitoring and ST monitoring 8 2 ECG Safety Information WARNING Do not come into contact with the patient table or the monitor during defibrillation Use only the original ECG cable for monitoring When connecting the cables and electrodes make sure no conductive part is in contact with the ground Verify that all ECG electrode
25. V4 electrode On the right side of the chest in positions corresponding to those on the left Over the xiphoid position On the 5th intercostal space at the left posterior axillary line of back On the 5th intercostal space at the right posterior axillary line of back V Electrode Placement for 5 lead 8 8 3 Electrode Placement for 12 lead Take the American standard for example The 12 lead electrodes should be placed on extremities and chest The electrodes for extremities should be placed on the skin of legs or arms the electrodes placed on chest should follow the doctor s advice Please see the following figure 55 Patient Monitor User Manual Monitoring ECG Nur Electrode Placement for 12 lead 8 8 4 Recommended ECG Lead Placement for Surgical Patients WARNING When using Electrosurgery ES equipment leads should be placed in a position in equal distance from Electrosurgery electrotome and the ES grounding plate to avoid cautery Electrosurgery equipment wire and ECG cable must not be tangled up Monitoring ECG leads are mainly used for monitoring the patient s vital signs When using the patient monitor with other electrosurgery equipment it is advised to use the counteracting defibrillation ECG lead The placement of the ECG leads will depend on the type of surgery that is being performed For example in an open chest surgery the electrodes may be placed laterally on the chest or on the back In the operating
26. an over pressure level 4 The equipment is suitable for use in the presence of electrosurgery 5 The equipment can provide protective means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT The equipment can protect against the effects of the discharge of a defibrillator 6 Before starting a measurement verify that you have selected a setting appropriate for your patient adult child or neonate 7 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation 8 Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled NOTE 1 It is suggested that the user should not start NIBP measuring when the low battery displays or the monitor may be turned off automatically 2 Ifan alarm occurs or measurement fails please discontinue the measurement 3 If you spill liquid onto the equipment or accessories particularly if there is a chance that it can get inside the tubing or the measurement device contact your service personnel 12 3 Introducing the Oscillometric NIBP Measurement Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure The amplitude suddenly increases as the pulse breaks through the occlusion in the artery As the cuff pressure
27. and ECG HR alarms are switched off If an ECG lead becomes available again the monitor automatically uses HR as alarm source 8 9 2 Smart Lead Off In 5 LEADS 12 LEADS mode if CH1 and CH2 can not be measured because of the lead off or other reasons it can shift to other modes to collect an ECG waveform To change smart lead off setting please select ECG Setup gt Smart Leadoff then a pop up menu is displayed 8 9 3 Setting Beat Volume Beat volume is from HR or PR depending on your HR alarm setting Five selections are available 1 2 3 4 5 5 indicates the maximum volume 1 indicates the minimum volum To change the beat volume first select ECG Setup gt Beat Volume then select an approiate volume from the pop up list 8 9 4 ECG Display It varies with Lead Type When Lead Type is set to 3 Leads Display can be set to Normal and it can display one ECG waveform on the main screen When Lead Type is set to 5 Leads Display can be set to Normal Full Scr and Half Scr Select Normal to display two ECG waveforms on the main screen select Full Ser to display seven 57 Patient Monitor User Manual Monitoring ECG ECG waveforms which occupy the area of seven waveforms on the main screen Select Half Scr to display seven ECG waveforms on the screen occupying the area of four waveforms NOTE If 3 Leads is selected in the ECG Setup menu only Normal can be selected for Display in the sub menu 8 9 5 Setting Pace Statu
28. can identify your patient on recordings reports and networked devices During admission you enter data that the monitor needs for safe and accurate operation For example the patient category setting determines the algorithm the monitor uses to process and calculate some measurements the safety limits that are applied for some measurements and the alarm limit ranges To admit a patient please 1l Selelct the Admission key on the screen or 2 Select Menu gt Patient Setup gt New Patient then a message is displayed to ask the user to confirm to update patient 3 Click on No to cancel this operation click on Yes the Patient Info window is displayed 4 Enter the patient information Serial No Enter the patient s medical record number MRN for example 12345678 Last name Enter the patient s last name family name for example Smith First name Enter the patient s first name for example Joseph Gender Choose Male or Female Type Choose the patient type either Adult Pediat or Neonat BloodType N A A B AB and O Pace Choose On or Off No You must select On if your patient has a pacemaker Date of Birth Enter the patient s date of birth Date of Admission Enter the patient s date of admission Height Enter the patient s height Weight Enter the patient s weight Doctor Enter any extra information about the patient or treatment 5 Select Exit 6 1 1 Patient Category and Paced Status The patient
29. category setting determines the algorithm the monitor uses to process and calculate some measurements the safety limits that are applied for some measurements and the alarm limit ranges The paced setting determines whether the monitor shows pacemaker pulses or not When Pace is set to Off pace pulses are filtered and therefore do not show in the ECG wave 46 Patient Monitor User Manual Managing Patients WARNING 1 Changing the patient category may change the arrhythmia and NIBP alarm limits Always check alarm limits to make sure that they are appropriate for your patient 2 For paced patients you must set Paced to Yes If it is incorrectly set to No the monitor could mistake a pace pulse for a QRS and fail to give an alarm during asystole 6 2 Quick Admit If you do not have the time or information to fully admit a patient Complete the rest of the patient information later To quickly admit a patient please 1 Select Menu gt Patient Setup gt Quick Admit then a message is displayed to ask the user to confirm to update patient 2 Click on No to cancel this operation click on Yes to continue and the Patient Info window is displayed choose Type and Pace and set them to the correct mode 3 Select Exit 6 3 Editing Patient Information To edit the patient information after a patient has been admitted select Menu gt Patient Setup gt Patient Info and make the required changes on the popup interface 6 4 U
30. department or your local distributor 10 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 the wireless communication and make it interrupted 11 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 12 Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment 13 Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment including patient implanted devices Be sure to perform the electromagnetic compatibility test as described in the Wireless LAN System Installation before installation and any time new medical equipment is added to the Wireless LAN coverage area 14 When interfacing with other equipment a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients 15 During monitoring if the power supply is off and there is no battery for standby the monitor will be off
31. desired item Remember when using the knob rotate this button to highlight and press it to select the item 1 10 2 3 9 4 5 6 7 8 M50 Back View 1 Fan 2 Anti theft lock interface 3 Security Lock 4 Power Supply Inlet 5 USB Interface 10 Patient Monitor User Manual Basic Operation 6 VGA Interface 7 Network Interface 8 Defibrillator Synchronization Analog Output 9 SD Card 10 Speaker M50 Side View 1 Sensor interface 2 Recorder door 3 Battery compartment door 3 1 2 M80 Major Parts and Keys The M80 patient monitor has a 15 inch TFT color flat panel display Up to 13 waves can be shown on M80 Screens zits Patient Monitor User Manual Basic Operation 1 EDAN 9 3 45 6 7 8 9 M80 Front View 1 Alarm indicator when an alarm occurs the alarm indicator will light or flash The color of light represents the alarm level 2 Power supply switch when the monitor is connected to the AC power supply press the key to turn the monitor on When the monitor is turned on press the key to turn the monitor off 3 Battery indicator refer to Section Battery Indicator for details 4 Mute Press this button to pause the alarm All the audio alarm will be closed At the same time the message of Temporary Alarm Mute s and the symbol EA will be displayed in the information area
32. 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 g This symbol indicates that the instrument is IEC EN 60601 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 z Symbol for Caution Equipotential grounding system Alternating Current Power Supply switch Serial number Network port USB Universal Serial Bus Connection pe Hl t E e Patient Monitor User Manual Intended Use and Safety Guidance Audio alarm is off NIBP measurement Trend graph Freeze Record Menu VGA output External Monitor RS 232 port Nurse call port SD Card port Patient Monitor User Manual Intended Use and Safety Guidance 5035 5130 Signal output port 1 F CG UL gt gt Signal output The symbol indicates that the device complies with the European E 234 Council Directive 93 42 EEC concerning medical devices N Authorised representative in the European community Date of manufacture Manufacturer P N Part Number ES E Recycle The symbol indicates that the device sho
33. functions or sounds improperly you should open the recorder casing to check for a paper jam Remove the paper jam in the following way m Cut the record paper from the feeding edge m Open the recorder casing m Re insert the paper 121 Patient Monitor User Manual Recording NOTE If the monitor is not installed with a recorder it will indicate RECORDER NOT SETTED after pressing the Record button 122 Patient Monitor User Manual Other Functions Chapter 23 Other Functions 23 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 23 2 Wireless Network The monitor can be equipped with wireless net card and 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 123 Patient Monitor User Manual Using Battery Chapter 24 Using Battery 24 1 Battery Power Indicator The indicator labeled Battery on the front panel of the monitor illuminates in green when the monito
34. into three categories high level alarms medium level alarms and low level alarms 1 High level alarms Indicating that the patient is in a life threatening situation and an emergency treatment is demanded 2 Medium level alarms The patient s vital signs appear abnormally or the device system status is abnormal indicating that prompt operator response is required 3 Low level alarms The patient s vital signs appear abnormal or the device system status appears abnormally indicating that operator awareness is required Alarm Sound The high medium low level alarms are indicated by the system in following different audio ways Alarm level Prompt 22 Patient Monitor User Manual Alarms Mode is DO DO DO DO DO DO DO DO DO DO which High is triggered once every 5 seconds The alarm indicator flashes in red with frequency of 1 4Hz 2 8Hz Mode is DO DO DO which is triggered once every 25 seconds The alarm indicator flashes in yellow with frequency of 0 4Hz 0 8Hz Medium Low Mode is DO which is triggered once every 30 seconds 4 3 Controlling Alarm 4 3 1 Switching the Individual Alarm Off To switch the alarm off please select XX Setup gt Alarm Setup XX stands for parameter name and set the alarm from the popup list If the monitor is in alarm pause status the monitor will perform the following 1 Stopping giving all kinds of current alarm
35. is E aa ES 91 16 7 Changing AnneduA B pne ane pei a a AEE RE ESE EERS 91 Chapter 17 Monitoring CO Nem euss sdsisossen setss 93 INNEN ono oeae E ES 93 17 2 CO Safety Informatio oin uisu bevor r E aa 93 17 3 CO Monitoring PRO Ce QUE CS rsrsr onise peus aei Cyr E bla a a pd EEEE ESE 93 17 4 CO Measurement WiNdOWiirsai esisiini aiara ai ha alan oni pri be od pi iaee aiaia 94 I Ts Measures PRO CCS ics arse ce eee as enisi aroe ird iea aaa EO EKDE EEEE nega 96 176 Editing CO eisen a E T 96 17 7 Blo d Temperature Monitoring aussesu ieu pxun A qd vultu Ret EEEE EAEE NEEE 97 17 8 Setting the Computation Constant esu isa pe re HERE CURE ix RE RR Ph ex hod re Rd PERI IAD AE RRR URN PH ERN EE RG 98 17 9 Recording CO MedSuUfermelifs ei Gun a E ke RR ndun asses 98 17 10 Setting DEP elu c sndbsaniiasancodan tinerendenewinedasnodantinenaierte 98 Chapter 18 Monitoring v C 99 MEI IO e Y Y 99 18 2 Safety HIPOPNVAUION ue conde n e Fac aspu abe FARE US EAI ERR VQ IM Ond tuU td 99 18 2 1 Safety Information for IB A Analyzer uui eokcmi inserenda eben asus us rusa oa ci npa gs za eaa 99 18 2 2 Safety Information for IRMA MOdOULG ierit Fe ripa E ot eRx md dna redibit bius 101 18 3 Monitoring SIC NNNM EUR fuU MAE MM MEME EMI ME 102 18 3 1 Monitoring Steps for ISA Analyzer eec eon ceceta eurer penne e Ihn Ropa Pu FOXX FUHR pni
36. is below lower alarm limit User selectable RAP MAP High RAP MAP measuring value is above upper alarm limit User selectable RAP MAP Low RAP MAP measuring value is below lower alarm limit User selectable P1 SYS High P1 SYS measuring value is above upper alarm limit User selectable P1 SYS Low P1 SYS measuring value is below lower alarm limit User selectable P1 DIA High P1 DIA measuring value is above upper alarm limit User selectable P1 DIA Low P1 DIA measuring value is below lower alarm limit User selectable P1 MAP High P1 MAP measuring value is above upper alarm limit User selectable P1 MAP Low P1 MAP measuring value is below lower alarm limit User selectable P2 SYS High P2 SYS measuring value is above upper alarm limit User selectable P2 SYS Low P2 SYS measuring value is below lower alarm limit User selectable 27 Patient Monitor User Manual Alarm Information P2 DIA High P2 DIA measuring value is above upper alarm limit User selectable P2 DIA Low P2 DIA measuring value is below lower alarm limit User selectable P2 MAP High P2 MAP measuring value is above upper alarm limit User selectable P2 MAP Low P2 MAP measuring value is below lower alarm limit User selectable EtCO High EtCO measuring value is above upper alarm limit User selectable EtCO Low EtCO measuring value is below lower alarm limit User selectable
37. list The bigger the value is the quicker the speed is 16 5 Setting CO Corrections Temperature water vapor in the patient s breath barometric pressure and the proportions of O N50 and Helium in the mixture all influence CO absorption If values seem inaccurately high or low check that the monitor is using the appropriate corrections There are Baro Press O Compens Balance Gas and Anes Agent in the Other Setup menu of the CO2 Setup menu and the user can select the desired item 16 6 Changing CO Alarms This refers to CO specific alarms See the Alarms section for general alarm information To change the alarm please refer to the following steps 1 Select the CO Setup menu 2 Select EtCO Alarm Setup FiCO Alarm Setup or AwRR Alarm Setup to adjust the alarm limit About how to adjust the alarm limit please 16 7 Changing Apnea Alarm This determines the time limit after which the monitor gives an alarm if the patient stops breathing 1 Select the CO Setup menu to open it 9 Patient Monitor User Manual Monitoring CO2 2 Select CO Apnea from the menu 3 Choose the apnea alarm time from the pop up list WARNING Safety and effectiveness of the respiration measurement method in the detection of apnea particularly the apnea of prematurity and apnea of infancy has not been established 92 Patient Monitor User Manual Monitoring CO Chapter 17 Monitoring CO 17 1 Overview The Cardiac Ou
38. make a tabular trend recording of the data in the current trend graph window The report will use the current trend interval settings For the detailed information about recording the trend table please refer to Chapter Recording 20 3 NIBP Review To review the NIBP measurement data select the NIBP Review key on the screen or select 113 Patient Monitor User Manual Review Menu gt Review gt NIBP Review then the NIBP Review window is displayed 20 3 1 Scrolling the Screen All measurement data can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see measurement data that doesn t fit in the current view by selecting and pressing the symbol Wut displayed on the NIBP Review interface 20 3 2 Recording The monitor can record the measurement data in the NIBP review window For the detailed information about recording the NIBP review please refer to Chapter Recording 20 4 Alarm Review The monitor can display up to 10 technical alarm events in the current screen To review the alarm event select the Alarm Review key on the screen or select Menu gt Review gt Alarm Review then the Alarm Review Window is displayed 20 4 1 Scrolling the Screen All alarm events can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see alarm events that don t fit in the current view by select
39. message of Screen Calibration Completed appears on the screen Then select Exit to finish the calibration 21 Patient Monitor User Manual Alarms Chapter 4 Alarms The alarm information here applies to all measurements Measurement specific alarm information is discussed in the sections of individual measurements 4 1 Alarm Category The monitor prodives three types of alarm physiological alarms technical alarms and prompts 4 1 1 Physiological alarms If one or several physiological parameters of the currently monitored patient exceed the predefined alarm limit for example SpO values exceed the alarm limit the monitor will give an alarm and this type of alarm is called physiological alarms About the detailed alarm information please refer to the Section physiological alarm information 4 1 2 Technical Alarms If one or several technical status of the device is in abnormal status such as lead off or low battery and so on the monitor will give an alarm And this type of alarm is called technical alarms About the detailed alarm information please refer to Section technical alarm information 4 1 3 Prompts The monitor can give the character indication of monitoring process or other functions such as ARR Relearning and so on And this character is called prompts About the detailed alarm information please refer to Section Prompts 4 2 Alarm Levels In terms of severity the device s alarm levels can be classified
40. mmHg 165 mmHg Neonatal mode SYS 40 mmHg 135 mmHg DIA 10 mmHg 100 mmHg MAP 20 mmHg 110 mmHg Cuff pressure measuring range 0 mmHg 290 mmHg Pressure resolution ImmHg Maximum mean error S5mmHg 149 Patient Monitor User Manual Product Specification Maximum standard deviation 8mmHg Maximum measuring period Adult Pediatric 120s Neonate 90s Typical measuring period 30s 45s depend on HR motion disturbance Overpressure protection Dual overpressure protection Adult 297 3nmHg Pediatric 240 3mmHg Neonatal 147 3mmHg PR Measuring range 40 bpm 240bpm Resolution 1 bpm Accuracy 3bpm or 3 5 the maximum A 10 2 NIBP from M3600 Module Method Oscillometric Mode Manual Auto Continuous Measuring Interval in AUTO Mode 1 2 3 4 5 10 15 30 60 90 min 2 4 8h PR Range Adult Pediatric mode 40bpm 200bpm Neonatal mode 40 bpm 240bpm PR Accuracy 2 bpm or 2 of the readings Measuring Type SYS DIA MAP Measuring Range Adult Mode SYS 60 mmHg 250 mmHg DIA 40 mmHg 200 mmHg MAP 45 mmHg 235 mmHg Neonatal Mode SYS 40 mmHg 120 mmHg DIA 20 mmHg 90 mmHg MAP 30 mmHg 100 mmHg Alarm Type SYS DIA MAP Cuff Pressure Measuring Range 0 mmHg 300 mmHg Pressure Resolution ImmHg 150 Patient Mo
41. not use autoclave or gas to sterilize the monitor recorder or any accessories The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives Disposable devices are intended forsingle use only They should not be reused as performance could degrade or contamination could occur Remove a battery whose life cycle has expired from the monitor immediately Avoid liquid splash on the device 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 10 To ensure patient safety use only parts and accessories manufactured or recommended by EDAN 11 Federal law restricts this device to sale by or on the order of a physician NOTE 1 2 The monitor can only be used on one patient at a time If the 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 of EDAN This monitor is not a device for treatment purposes The pictures and interfaces in this manual are for reference only Regular preventive maintenance should be carried out annually You are responsible for any requirements specific to your country Patient Monitor User Manual Intended Use and Safety Guidance 1 3 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC EN60601 1 Type CF
42. printer 11 21 64056 Vehicle carried Inverter 12 01 30493 Wall Mount Simple 02 01 30164 Wall Mount 02 01 101043 Basket Only compatible with Wall Mount MS3R 30164 03 28 101952 Rolling Stand MT 207 02 04 101976 Rolling Stand Basket in the bottom 11 18 078191 Flash Disk PNY 2 0 2G USB 11 13 114214 Ground Cable 02 01 109592 Pole clamp 1 set package 02 01 109636 Pole clamp 4 sets package 01 54 113701 M80 Patient Monitor Service Manual 01 54 455198 M50 Patient Monitor Service Manual 138 Patient Monitor User Manual Product Specification A Product Specification A 1 Classification Anti electroshock type Class I equipment and internal powered equipment EMC type Class A Anti electroshock degree ECG RESP TEMP IBP CO Quick Temp CF SpO NIBP CO2 GAS BF Ingress Protection IPXI Disinfection sterilization method Refer to Chapter Care and Cleaning for details Working system Continuous running equipment Compliant with Safety Standards IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN 60601 1 2 2001 A1 ISO 9919 ISO 21647 IEC EN 60601 2 27 IEC EN 60601 2 30 IEC EN 60601 2 34 IEC EN 60601 2 49 ANSI AAMI SP10 IEC EN 60601 2 25 AAMI ANSI ECI3 EN12470 4 EN1060 1 EN1060 3 EN1060 4 A 2 Physical Specifications A 2 1 Size and Weight Product Size Weight M80 370 mm L x 175 mm
43. room artifacts may affect the ECG waveform due to the use of ES Electrosurgery equipment To help reduce this you can place the electrodes on the right and left shoulders the right and left sides near the abdomen and the chest lead on the left side at mid chest Avoid placing the electrodes on the upper arms Otherwise the ECG waveform will be 256 Patient Monitor User Manual Monitoring ECG too small NOTE 1 If an ECG waveform is not accurate while the electrodes are tightly attached try to change the lead 2 Interference from a non grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform 8 9 ECG Menu Setup 8 9 1 Setting Alarm Source To change the alarm source please select ECG Setup gt Alarm Source then a pop up box is displayed HR the monitor considers the HR as HR PR alarm source PR the monitor considers the PR as HR PR alarm source AUTO If the Alarm Source is set to Auto the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical condition The monitor will automatically switch to Pulse as the alarm source 1f a valid ECG lead can no longer be measured and a pulse source is switched on and available The monitor then uses the pulse rate from the measurement currently active as system pulse While Pulse is the alarm source all arrhythmia
44. will be performed automatically at regular intervals whenever the IRMA probe is disconnected from the IRMA airway adapter If the IRMA probe is kept in operation for a long time without disconnected from the airway adapter the IRMA probe will indicate that a new room air calibration is required and a message will appear on the monitor Use the following procedure to perform a room air calibration of the oxygen sensor 1 Disconnect the IRMA probe from the airway adapter 2 Wait until the LED starts blinking with red light 3 Snap the IRMA probe back on the IRMA airway adapter 4 Check that the LED turns green 5 While not connected to the breathing circuit check that the O2 reading on the monitor is 21 18 3 2 5 Cleaning The IRMA probe can be cleaned using a cloth moistened with maximum 70 ethanol or maximum 70 isopropyl alcohol Remove the disposable IRMA airway adapter prior to cleaning the IRMA probe CAUTION 1 The IRMA oxygen sensor cell and IRMA airway adapters are non sterile devices Do not autoclave the devices as this will damage them 107 Patient Monitor User Manual Monitoring AG 2 Never sterilize or immerse the IRMA probe in liquid 18 3 2 6 MAC Calculation The MAC value may be calculated and displayed by using end tidal ET gas concentrations according to the following formula MAC ET AA1 X AA1 ET AA2 X AAz ET N2O 100 X AA HAL 0 75 ENF 1 7 ISO 1 15 SEV 2 05 DES 6 0 18 4 Set
45. 0 and two anaesthesia agent and identifying the anaesthesia agent automatically portable module Measurement CO N20 O2 Halothane HAL Isoflurane ISO Enflurane ENF P Sevoflurane SEV Desflurane DES awRR MAC arameters Measurement CO N20 Anaesthesia Agent infra red absorption characteristic Principle O Paramagnetic method Sampling Flow 50 10 ml min Rate Work Mode Measurement Standby Warm up Time Iso Accuracy Mode 10s 15 to 25 vol Full Accuracy Mode 1min Typical Rise Time CO x 200ms O2 lt 350ms N20 lt 350ms O2 lt 450ms Primary lt 0 15 vol Anaesthesia Agent Threshold Second Anaesthesia 0 2 vol 10 Agent Threshold Agent lt 20 seconds typically lt 10 seconds Identificaiton Time Response Time lt 3 seconds Standard Conditions GAS Range Accuracy CO2 0 to 15 vol 0 2 vol 2 of reading Unspecified N20 0 to 100 vol 2 vol 2 of reading 155 Patient Monitor User Manual Product Specification HAL ENF ISO 0 to 8 vol 0 15 vol 5 of reading 8 to 25 vol Unspecified SEV 0 to 10 vol 0 15 vol 5 of reading 10 to 25 vol Unspecified DES 0 to 22 vol 0 15 vol 5 of reading 22 to 25 vol Unspecified O2 0 to 100 vol 1 vol 2 of reading All Conditions Gas Accuracy CO 0 3kPa 4 of reading N20 2kPa 5 of rea
46. 102 18 3 2 Monitoring Steps for IRM AC GUUG usuras esybba n eee iiia ced Ea Spa up Sea RUNE 104 18 4 Setting idis irea 108 18 Setting Alari NETTE TE TT E T LE 108 18 6 Setting Apnea Alarm Tifenn esi S Yx eina nia e Hip UR DRE Md cule Rb E ATAR EASE AA 108 18 7 Working Status of ISA analyzer Las eises aoeddt p tmp Rae SP Ehe pe PSone d XI RON dI ERI CER tP d SPR Ortes ruine 108 18 8 Working Status of IRMA Module uite pbi D E eI RRL eR MERO Mal bnt HAN EEN US LND BU ML EOD M DE 109 Chapter 19 Freeze T 110 DPM OVEIVI EW PT rr E E 110 19 2 Entering Exiting Freeze SUAS c a5ssedascenicdaccssastesannedsstansiadtarinsateacs en tusenseaseneadaadiademadaesnans 110 19 2 1 Entering 6s ces oy glo 101 See ene MUNDI i DEM er snr NUN 110 19 2 2 Exiting Freeze SAIS auner nr etor een r ERE E E E eS R AEE ETES E ER EERS 110 19 3 R viewing Frozen WOVeFO MH siinsest Der E EEA EEE SA PD dd 111 Chapter 20 REVIEW de 112 20 1 Trend Graph REVicWosrsssoenn s n n E inna Dv bias Phase Pa iE 112 20 1 1 Selecting Trend Graph of Specific Parameter snnsnsesensseseseeesseesesseesseeseeseessee 112 20 1 2 Setting Resolutioniin reenen ioe aiai uad E iaaa E a TASIK E aaRS EESE 112 20 1 3 Scrolling Leftand Right the SOFeefiussdsrdenifQie DU vPE PANIER UD 112 20 1 4 Switching to the Trend Table ences eee esenxteske misdSn nad iSi d Re A Ek tp o a Pa ken ne 113 P
47. 13 1 Overview Body temperature is measured by means of a thermistor probe a semiconductor whose resistance changes with temperature that is inserted in the rectum Two TEMP probes can be used simultaneously to measure two TEMP values and get the temperature difference The standard configuration is axilla sensor for adult 13 2 TEMP Safety Information WARNING 1 Verify probe cables fault detection before the beginning of monitoring phase Unplug the temperature probe cable of the channe1 from the socket and then the screen will display the error message TEMP1 SENSOR OFF and the audible alarm is activated It is the same to the other channel 2 Itis necessary to calibrate the temperature module every two years or as frequently as dictated by your Hospital Procedures Policy When you need to calibrate the temperature measurement please contact the manufacturer 3 Take the TEMP probe and cable carefully When they are not in use you should coil up the probe and cable into a loose circle If the wire inside the cable is tensely pulled it may cause mechanical damage to the probe and the cable NOTE Disposable TEMP probe can only be used once for one patient 13 3 TEMP Monitoring Setup B If you are using disposable TEMP probes you need to plug the TEMP cable into the monitor and then connect the probe to the cable With a reusable TEMP probe you can plug the probe directly into the monitor B Apply the TEMP probes securely to th
48. 2 Inthe CO Setup menu please set the Work Mode to Measure Then select Zero 3 Ifmessage indicates Zeroing and disappears indicating that zeroing is successful After the zeroing calibration is finished the user can start CO Monitoring If the message indicates Breath detected or Zero required indicating zeroing fails The user needs to Zero again 16 3 2 LoFlo CO Module NOTE You must perform a zero calibration as described in this procedure each time the ambient temperature changes more than 10 C for example during transport LoFlo CO module 16 3 2 1 Measurement Steps 1 Plug the sensor cable into the monitor s CO input connector Allow the sensor two minutes for warm up ET Patient Monitor User Manual Monitoring CO2 2 Connect the cannula airway adapter or sample line as appropriate to the sensor It will click into place when seated correctly Connecting LoFlo module 3 To zero the sensor please refer to zeroing the sensor 4 For intubated patients an airway adapter is required Air adapter For non intubated patients Place the nasal cannula onto the patient Place the nasal cannula 88 Patient Monitor User Manual Monitoring CO2 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 cann
49. 3 1 Measurement for Oral Temperature 1 Ensure the oral probe white probe and probe well are installed 2 Remove the probe from the probe well 3 Observe the oral mode indicator on the screen flashing head icon If this icon is not flashing press the Measure Pos button and set it to Oral until the head icon appears 4 Load the probe cover 5 Place the probe tip deep into the patient s sublingual pocket as shown in the following figure Sublingual Pocket Measuring Position in Mouth 6 Do not hand the probe to the patient to place in his or her own mouth 7 Always hold the probe in place maintaining tissue contact until temperature is complete If necessary repeat the measurement procedure shown above NOTE 1 After one measurement the user should put the sensor well to the sensor bracket and then take it out for starting a new measurement 2 To ensure optimal accuracy always confirm that the correct measurement position is selected 14 3 2 Measurements for Rectal Temperatures 1 Ensure that the rectal probe red probe and probe well are installed 2 Remove the red probe from the probe well 3 Observe the Rectal Mode indicator on the display flashing lower body icon 79 Patient Monitor User Manual Monitoring Quick TEMP 4 Load a probe cover Apply lubricant if desired 5 Separate the buttocks and gently insert the probe only 1 5cm 5 8 inch less for infants and children Measuring Position
50. 96 O2 and 096 CO2 in the ISA analyzer ensure that the ISA analyzer is placed in a well ventilated place Avoid breathing near the ISA analyzer before or during the zeroing procedure 2 The sampling line should be replaced every two weeks otherwise it is clogged 18 3 1 4 Cleaning and Maintenance The plug in and measure ISA gas analyzer should be cleaned on a regular basis Use a cloth moistened with max 70 ethanol or isopropyl alcohol to clean the analyzer To prevent cleaning liquids and dust from entering the ISA gas analyzer through its LEGI connector keep the Nomoline sampling line connected while cleaning the analyzer WARNING 1 The Nomoline sampling lines are non sterile devices To avoid damage do not autoclave any parts of the sampling line 2 Never sterilize or immerse the ISA analyzer in liquid 18 3 1 5 MAC Calculation The MAC value may be calculated and displayed by using end tidal Et gas concentrations according to the following formula 103 Patient Monitor User Manual Monitoring AG _ Et AAl Et AA2 Et N20 X AAl X A42 100 X AA HAL 0 75 ENF 1 7 ISO 1 15 SEV 2 05 DES 6 0 Note Altitude patient age and other individual factors are not considereded in the formula above 18 3 2 Monitoring Steps for IRMA Module 1 Plug the IRMA connector into the IRMA input and switch the power on 2 Snap the IRMA sensor head on the top of the IRMA airway adapter It will click in
51. CM1304 01 57 040205 Adult Cuff 25 35cm CM1303 01 57 040211 Pediatric Cuff 18 26cm CM1302 01 57 040212 Infant Cuff 10 19cm CM1301 11 57 40020 Infant Cuff 10 19cm CM1201 11 57 40018 Pediatric Cuff 18 26cm CM1202 11 57 40029 Adult Cuff 25 35cm CM1203 11 57 40074 Large Adult Cuff 33 47cm CM1204 11 57 40097 Neonatal Disposable Cuff 6 9 cm 5102 11 57 40098 Neonatal Disposable Cuff 9 14cm 5104 28 2 4 Temp Accessories 01 57 040185 Skin Temperature Probe 2 252K 0 01 57 040187 Skin Temperature Probe 10KQ 135 Patient Monitor User Manual Accessories 01 57 040184 Rectal Oral Temperature Probe 2 252K 0 01 57 040186 Rectal Oral Temperature Probe C 10K 28 2 5 Quick Temp Accessories Part Number Accessories 02 04 110140 Quick TEMP Oral Axillary Sensor Package 02 04 110139 Quick TEMP Recta Sensor Package 11 57 110159 Probe Covers 25pcs 28 2 6 IBP Accessories Part Number Accessories 01 57 471014 IBP cable BD IBP cable used with 682000 sensor 01 57 471013 Aidehua IBP cable used with PX260 sensor 11 57 40121 Pressure transducer interface cable 01 57 471027 10 IBP cable used with 42584 sensor 01 57 471028 10 IBP cable used with DPT 248 sensor 28 2 7 CO Accessories Part Number Accessories
52. G RESP monitoring devices The simultaneous use of cardiac pacemaker and other patient connected equipment does not cause safety hazard 50 Patient Monitor User Manual Monitoring ECG 4 f the pacemaker signals are beyond the claimed range the heart rate may be calculated incorrectly 5 Inthe default settings of the monitor the ECG waveforms are the first two waveforms from top in the waveform area 6 For measurements in or near the heart we recommend connecting the monitor to the potential equalization system 7 The defibrillator cables should be used in the ECG monitoring that can prevent the cables from being burned by high frequency 8 For protecting environment the used electrodes must be recycled or disposed of properly 8 3 ECG Display The figure below is for reference only IE xd D Q IP 1 mv 1 1 1 mV The symbol indicates lead name of display waveform there are other leads for selection such as I III aVR aVF aVL V If you want to change the lead please refer to section Selecting Calculation Lead The symbol indicates waveform gain there are several options sucn as X0 125 X0 25 X0 5 X1 X2 and Auto If you want to change it please refer to section Changing the size of the ECG Wave The symbol 8 indicates Filter setting there are three options monitoring surgery diagnos If you want to change it please refer to section Changing the ECG Filter Setting 8 3 1 Chang
53. Gas Range Accuracy CO 0 to 10 vol 0 2 vol 2 of reading 10 to 20 vol Unspecified N20 0 to 100 2 vol 2 of reading AX OR AX OR HAL 0 to 5 0 to 8 0 15 vol 5 of reading ISO S5to12 8tol12 Unspecified ENF SEV 0 to 8 0 to 10 0 15 vol 5 of reading 8 to 15 10 to 15 Unspecified DES 0 to 8 0 to 22 0 15 vol 5 of reading 8to25 22 to 25 Unspecified O5 Oto 100 0to 100 1 vol 2 of reading All Conditions GAS Accuracy 157 Patient Monitor User Manual Product Specification CO 0 3 vol 4 of reading N2O 0 3 vol 4 of reading Agents 0 2 vol 10 of reading O5 2 vol 2 of reading Apean Alarm 20s 60s Delay Alarm Providing alarms of EtCOz FiCO EtO2 FiO2 EtN O FiN2O EtAA FiAA awRR A 18 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 Chl 11 America Chl 14 Japan Chl 13 ETSI 158 Patient Monitor User Manual EMC Information B EMC Information Guidance and Manufacture s Declaration B 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The monitor is intended for use in the electromagnetic envi
54. IGEMINY On Medium Off TACHY On Medium Off BRADY On Medium Off MISSEDBEATS On Medium Off IRR On Medium Off PNC On Medium Off PNP On Medium Off VBRADY On Medium Off VENT On Medium Off C 4 RESP RESP Settings ADU PED NEO 164 Patient Monitor User Manual Default Settings Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 30 30 100 Alarm Low Limit 8 8 30 Apnea Time 20s Calculation Type Auto Resp Type II Sweep 12 5mm s Amplitude 2 C 5 SpO SpO Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 100 100 95 Alarm Low Limit 90 90 88 Pitch Tone Off Sweep 12 5mm s C 6 PR PR Settings ADU PED NEO PR Source SpO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100 Pulse Volume 3 Alarm Source HR C 7 NIBP NIBP Settings ADU PED NEO 165 Patient Monitor User Manual Default Settings Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit SY S 160 120 90 Alarm Low Limit SYS 90 70 40 Alarm High Limit Map 110 90 70 Alarm Low Limit Map 60 50 30 Alarm High Limit Dia 90 70 60 Alarm Lo
55. ION The decision to sterilize must be made per your institution s requirements with an awareness of the effect on the integrity of the cable or leadwire 25 2 2 2 Cleaning the Blood Pressure Cuff Wipe cuffs with a solution of mild soap and water If the cover requires more rigorous cleaning remove the air bladder first Allow the cover to thoroughly air dry before use Cuffs have been tested to withstand the following recommended disinfetants cidex sporicidin 128 Patient Monitor User Manual Care and Cleaning microzid isopropyl alcohol 70 ethanol 70 buraton liquid 25 2 2 3 Cleaning the SpO Sensor These reusable sensors should be cleaned and disinfected but never sterilized The validated cleaning agents are listed below m Mild Detergent m Salt Solution 1 25 2 2 4 Other Accessories For cleaning other accessories please contact the manufactures for details 25 3 Disinfection WARNING Do not mix disinfecting solutions such as bleach and ammonia or it may produce hazardous gases 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 Recommended types of disinfecting agents are m Alcohol m Aldehyde CAUTION Do not use EtO gas or formaldehyde to disinfect the monitor 25 4 Sterilization Do not sterilize the monitor or the accessories unless this is necessary ac
56. Lead naming style AHA IEC Display Sensitivity 1 25mm mV x0 125 2 5mm mV x0 25 5mm mV x0 5 10mm mV x1 20mm mV x2 AUTO gain Sweep 12 5mm s 25mm s 50mm s ECG Analog Output Bandwidth 3dB Diagnosis 0 05Hz 150Hz Monitor 0 5Hz 40Hz Surgery 1Hz 20Hz Max transmission delay 500ms in diagnostic mode and with notch off Sensitivity 1V mV 10 PACE t m Without Pace enhancement or pace rejection rejection enhancement Defib Sync Pulse Output impedance 500 Max time delay 35ms High level 3 5 to 5 V providing a maximum of 1 mA output Amplitude current Low level 0 5V receiving a maximum of 5 mA input current Pulse width 100ms 10 Limited current 15 mA rating Rising and falling time lt 1ms 145 Patient Monitor User Manual Product Specification CMRR Common Mode Diagnosis gt 95dB the Notch filter is off Monitor gt 105dB the Notch filter is on Rejection Ratio Surgery gt 105dB the Notch filter is on Notch 50Hz 60Hz Notch filter can be turned on or off manually Differential Input 5MO Impendance Input Signal Range 8mV pp Electrode Offset Potential Tolerance 500mV Auxiliary Current Leads off detection Active electrode lt 100nA Reference electrode lt 900nA Input Offset Current lt O 1pA Recovery time after Se 5s Defibrillation Leak
57. Monitor User Manual Warranty and Service Chapter 27 Warranty and Service Policy 27 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 period begins on the date the products are shipped to distributors The warranty is void in cases of a damage caused by handling 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 components 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 27 2 Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service personnel If the product fails to function properly or if you need assistance service or spare parts contact EDAN s service center A representative will assist yo
58. Monitor reesei eS on dad IN cop Lc IUD abd uM OF MY Dda PAS cH dpi E 7 2 2 1 Installing Wall Mount for the MOBIDE ius rapto UR epe rus YF eta ES e wo S na EE Uy Fon osea cie 7 2 2 Connecting The Power Cable easet Eun aser E bad Va veda PLN dU A eU dE 4 2A Checking Out the NIORBOE uciriseneveciriis prt rtegina b vau INR EErEE OEEO A EEP EEEE NEES sl tu 7 2 5 Checking th GL unde nasi quist s ERR FR RA EIN PH Me np E ma rH cr S n e M EErEE TOERE S 8 2 0 Settine the Date and TIME asserit aer E ENERO ERR ra eee 8 2 7 Handing Over the Monitor ccs incscennaadsansnacsnsannandesaiy tax OUR Ets ER Un rng Rad APRI Gd MEIN REN UURS PU LU 8 Chapter 3 Basic Operation 9 3 1 Introducing M50 M80 SETiES x diicaasccsetengaccuaetacesinapeiaderenniaseiangnataaasasnsanepanadccanbeashenpiasecennceioes 9 3 LM50 Major Parts and KEYS aussehen esne aer EE E Gd prd UE AE 9 3 1 2 M80 Major Parts and Keys issrsserseessesserisieerseersersorosressrsetssrsssessesstee sess orsecs sea essessea 11 3 1 3 M50 M80 Config rati Olisi EE PRI Put E TE A R su 15 2 2 Operating and Navigating s ouseecseet bes ense acum isig T oaa Fede E AOK da a R Er SiE ood 15 ES NEU id os eT 17 3 3 Operating Mode ePaper iE Sepe E E ex PG n eae 18 EXC EIS eno MOJE rerea D A ETE E PR EE T 18 3 4 Changing Monitor Se MAME 55 asics rcccedsampntsaantnsuncsatmouancaasaiensanuanestaaen as aueceua aguas aan 19 3 4 1 Adjusting Screen Brightness s sisvsasase
59. NE cili T ios 113 20 2 Trend Table REVIEW T 113 20 2 1 Setting Reso lUt T MR Tm 113 20 22 Scrolling the ICRC o coucou ue quu a ee e E E DEBA INE uud eV RM Gd 113 202 So Wiens to Trend ouBpliue nasse ttai hne rri rnie E A PM Pre REEF IINE 113 20 24 Recording socis e eDim bU PU incu RUP ef tUe CUM RDUM EEUE 113 20 3 NIBP REVIEW prr M wate 113 20 5 T Scrolling the Seice firs ed Rp bU FH utt UND ort QNOD 114 20 3 2 Recordin icc den todos upper bu Gases adsit Rei uppde a EDU V En AME 114 WA Ala MER EVE desde pete pase prb UMANE UMEN DURUM DM UN MAMANS 114 204 1 Serollino the CECE a ai ssarcusesnaiavus HIrposs dta de oid rrei Eare ETE token vdd eda erae auus 114 20 4 2 Selecting Alarm Event of Specific Parameter iusso etr raise tinis Ped pb bI Ericus 114 20 4 3 Setting Time MACK ersero nerona E a uie Supe gon Dian EE E d taceo uid 114 20S AN ou Pe tM a 114 20 5 TL Scrolling The SOPORE esie ve DRURUEP REN E a DURUM 114 20 0 T2 Iegd Diagnosis eXIGU ac ese eittopi Federn rasa e rne qe un pekqibc e bn UK pes FRU RM NP RR IRR iraia 115 20 6 1 Scrolling the SORORE uso iip terat bxc nn ED PRU dn vp NUR et RRR 115 20 0 2 Deleting Diagnosis Results uuceiooet iter in htl rh tS Rp xK Po ER ReR Fe a n IR iS RR 115 20 6 3 Switching Between Waveforms and Results iet rttet iter retener bacs 115 20 6 4A RECOotdiN E nosiris avi 2e rec dd qve dh lx a ER
60. NIBP Pressure Low detect the SYSTOLIC Low has a over high blood Apply pressure again pressure or it is interfered by movement 33 Patient Monitor User Manual Alarm Information Abnormal oscillometric Retry twice Check NIBP Pulse Abnormal Low for hyperkinesia or waveform f arrhythmia i i Check the patient s DIDF PUNE Pigia Pulse is too low to measure Low condition or the Weak wrapped cuff Pd At gus 2s ino Make sure that the TEMP T1 Sensor Off y Low cable is properly disconnected from the connected monitor T t ble of TEMP Pam us m i be Make sure that the TEMP T2 Sensor Off Low cable is properly disconnected from the connected monitor l heck TEMPI measuring value is one m Excessive TI High connection and beyond measuring range T patient condition heck TEMP2 measuring value is bins dpi Excessive T2 High connection and beyond measuring range t patient condition Stop measuring function of TEMP i l ti TEMP Comm Fail TEMP module failure or High modu e and no ify communication failure biomedical engineer or Manufacturer s service staff YY Sensor Off YY Check the sensor stands for the IBP lable IBP sensor falls off Low connection and name reconnect the sensor Stop measuring YY Comm Fail YY HIDEO ck d IBP module failure or module and notify stands for the lable a High l i communication failure biome
61. O EEe E a S E anitpsusainibiewssaiinacgataiaaha ahiniaesssushs oudcinncsssmbsasasiness 82 13 2 IBP Safety MOT Ai Oerein A E EE E EEEE OEE 82 15 3 Monitoring PEOC CODES arien a E iuet uude omen bom iu 82 15 4 Selecting a Pressure for Monitoring Louie uie REPRE US UMEN DU EIU FERME tai Eia on aS iUa 83 15 5 Zeromg the Pressure Trang BE ecce orn i Me ERR poU e Nn FUR pesa PUCeMBeNcESRpSAR AUDI FUR RETE 83 15 6 7erome a Pressure Measurement snos ice om pu dtr E a ee RUNE 83 15 7 Troubleshooting the Pressure Zeroing Taking Art for Example sss 84 VII 15 8 IBP Pressure CalibratiOna eiti or i oie ero code desee oo eerie etu cond e rae iets voe eee ocn eto eoo Educ 84 15 9 Troubleshooting the Pressure Calibration uoces eae eoines eene into eoi apart eei Ras inaan 85 Ie SELON ER Dr e t c EA 85 Chapter 16 Monitoring C 8 oam 86 1O T OVC VIEW p 86 16 2 Os Satety MIOMA Osise Es EA T E 86 16 3 Monitoring PROCECUTES cx ie cestsnantsnasenstncensndcehaasaadtatencdsaaniantensonaddiaapnlasdaanuasasnenantinesandeees 87 15 eM ZEPRIBP E SEEDS OE desea E E MI aM M MEME 87 163 2 LoFlo COs MOGI c i eai 87 I Xe leen T P 89 16 4 Setting CO2 Waveform Sb Ulo auci itucsnessaxiiu ap upE EIN artt DrosuG d TUw S SRPREUd ubwic SIS 2 Nn S i eva etapa A 91 16 5 Setin CO Corrections ynin ince nadewanbasainseaaabuntainlsouteaaaeameiasiendepieeakaaetsimess 91 16 6 Changing COZ Alarms ener
62. Policy s cssccsssessecssesssscssssssecassessssssescsscsssssessssoesssesescseonsssesesssees 132 ZEW ara oisstoasentet E ta Rafa aded ndn Dunn Edu A 132 21 2 IU duis CNRC c Q 132 Chapter 28 ACCESSORIES R 133 ZO MANGAL ACOGSSOING TT 133 28 2 Optional ACCC SCOTS ircre aE abd Ln Ms FAN Ou MU bU RI M MD d RE ERR 134 252 ECG ACCESSO his sinc sa uct tigate qae d pnulade du VEU Ex I VEHI ETAS 134 28 2 2 Bp S ADOESSOPMES ciunt veicniBa deeds Pu aivad uec E inns U a Cima PIU FIOR UNS 134 28 2 5 NIBP ACCESSONES Lip RUNE IE EN BUE UN Eat aM 135 28 24 Temp JGGeSBOLIGS eode iras a desu cr spia DER Od ETETEA EEE AEEA E abART EEES 135 282 S Q ick Temp AGCOSSODIGS oso ern neni E E EE ERE UU 136 28 205 IBP CG eS OTIS etait dateien ted dtudequmu tane DN E ETE uud iKit 136 28 2 7 CO Accessorles eeeceeeeeseseeesecsceceeseecseseseseseseseseseseseseseseseseseseseseseseseseseseseseseseeees 136 2028 CO ACCS STAGE iiianoe bar Ee ndo puse eioen ei aapa p rece AR Sa Fig 137 282I AG ACCESSOS NNNM a aaee Aaa e ea E a a e oaie Ea E 137 28 2 T0 Other ACCESSO ES asse ar ERES Fe BR i Rez EL aeoeaiei bd Eri Eea eTR eei 137 A Produ t Specificatiot spendin emanates 139 TERIS c IAM E AS 139 A2 Physical Specifications esisiini enerci p emis o a PER E TEELE Ora RETER Fx ERR E 139 Asie and WV CIO yah squid atate Rd E etl E Ca 139 A 3 Environment SOSQIEICBOD uua cea eneiskst inte etum tn ERR n in Rue tdi sn PERS kn
63. Properly wrap the cuff NIBP Excessive Pressure Pressure has exceeded the specified upper safety limit Low Measure again if failure persists stop measuring function of NIBP module and notify biomedical engineer Or manufacturer s service staff NUBE Patient Monitor User Manual Alarm Information Stop the patient from NIBP Signal Sturated Signal amplitude too strong Low moving Measure again if failure persists stop measuring function NIBP Init Pressure The initial pressure is too Hish of NIBP module and High high during measuring notify biomedical engineer Or manufacturer s service staff Measure again if failure persists stop using measuring i functi f NIBP NIBP Invalid Reset The hardware pressure is 7 unction o too high module and notify biomedical engineer or manufacturer s service staff Meus T has Measure again or use NIBP Time Out E Low other measuring exceeded the specified time method Check the NIBP cuff NIBP cuff h NIBP Tube Leak eun er pump nas a Low and pump for leakage leakages The cuff type used isn t Confirm the patient NIBP Cuff Type Error consistent with the patient Low type and change the type cuff Check whether the airway is occluded or Environment atmospheric diem M pe Air Pressure Error pressure abnormal or Low n dd tem pressure abnormal preosyue meer mode EEN l If the problem still exists co
64. SER URL E RxD Y tad VAR pr uE IE 139 AA Eli sepu MNUM NM a UM MEN ME 140 Pu Battery Specification oues eitvdd irabevwadbaaheosu at unensa iorn eq iub d V bead reo ead Ya doo vid asa eaa sad 140 AO RECOLLEN adn dan ONRHRRUN NRI PRU IN DR dU DM a NM E 140 BR UIS dpud qaa etai PR ERE RR BS uud RB a ea ea ea Eoia 141 Pig koc 141 SUN MES ei MI 05900 18 D ROTE TTE OE 141 PL 2 NAGA IV MOTI ORIG esee etiara ebd FU aa rq E Pus FE ebbe postage ttu ER EU deu bei NR ME 145 DO RESP a edant Mud pa nM E DEDE ctun 148 A TONBE x 149 A 10 1 NIBP from V6 Modules sereia eot Leod a reed e senno Ra doadancadeseussbeoss 149 A 10 2 NIBP from M3600 MOQOUIG ipsia p roe evans ba PY EYV RD BER R pA TCU DAR Ro I pa oS ADR 150 PNE DE MMC ce E ENS 151 AJZ TEMP ied 152 A Quick FEMP ss 152 BPs WAPI P oiee aa E E E 153 AIS COn aienea a EEEE 153 9 29 9 MEI E E 154 WWE e rT M 154 PAT A Phaseim SHES USAIN os eiit du RM RU SR E MD DEDE dunt t EREPDA MA RR RU dua d 155 A 172 Phasen Mainsteani ueste pesii avidi vuU tq FE eed Rau Eit n Ug HB ES 156 A18 Wirless NGL WOK 5 sesassntsnctassirsccamiacids oti eR Gn bb Rid kara aln aa d ad Evi 158 lonia dicil m rc 159 B 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS sess 159
65. T2 Selecting Display ParaM t rSssrsosie unrin R Poetas irt AEN Ei 48 7 3 Changing Waveform Position ous evidente MESS NM MIN MM OMA VE E DE M nM RUE 48 7 4 Changing Interface LayoUl audcseedistenmemes rite seisad rep bUM EE quAR D PPbA FUN pbi FP NONEM eua a MEI E 48 T Viewing Trend D EIBEILO Guetta OR m iem a a teft xU admi laicum ifs eU UU nO 48 7 6 Viewing Oxygen SCPC eM a sacesena casas tatis aei suman isst ian oe up RISO Fi Er DER n IN ER a XM ber UE 48 T Mewing Large Pont SUOEGethanncnsesareviscbpedtppM ted eS E RE EIEE E IA usciti ep rU 49 Chanter Monitoring o P Cp 50 NA UU E em 50 8 2 ECG Safety THEOBOLIOTI Suo ip et npeN On poU x URN rU uud E AERA aa 50 SS ECG DISpla T E 51 8 3 1 Cha gimg the size of ine ECG Wave secet bia bt M edidi aedi ta natis 51 8 3 2 Changing the ECG Filter Sete iiciscccsacidancecasneadsannnnapentinad cenesdiaaeneeassannnenticaamdenes 52 84A Using ECG Ala MSi R een od anne 52 8 3 Selecting Calculation Lead oss sect sotestesitobesicerizc veniae ea aE EEEE EEEE EEEE E ETE EERS 52 8 0 Monitoring PEOGOBUUEE sorsien iesea iuh dM R D EE ARE E EEA 52 EOM Preparation Sot PD 22 5 02 Connecting ECG Cables aaeidaisboutbre b ndi rad ewsishins etsi R 53 8 7 seleenmecte TT DEDE VE SnK MM IaN PRENNE 33 8 8 Mie tale Electrodes iae esaeen phia ex dd cad UG RS Duas ri nba Ur pd Mida EE 53 8 81 Electrode Placement for 3 680 esos ipd EP n e a E S 53 8 8 2 Electrode Placement
66. U 300 15 PED 350 15 NEO 350 15 ST analysis alarm limits are listed as follows unit mV ALM HI ALM LO ST 2 0 2 0 PVCs alarm upper limits are listed as follows A1 Patient Monitor User Manual Alarm Information ALM HI ALM LO PVCs 10 RESP alarm limits are listed as follows unit rpm Patient Type ALM HI ALM LO ADU 120 6 PED 150 6 NEO 150 6 PR alarm limits is listed as follows unit bpm ALM HI ALM LO PR 300 30 NIBP alarm limits are listed as follows unit mmHg Patient Type ALM HI ALM LO ADU SYS 270 40 DIA 215 10 MAP 235 20 PED SYS 200 40 DIA 150 10 MAP 165 20 NEO SYS 135 40 DIA 100 10 MAP 110 20 TEMP alarm limits are listed as follows ALM HI ALM LO T1 50 C 122F 0 C 32 F T2 50 C 122 F 0 C 32 F TD 50 C 122 F 0 C 32 TF IBP alarm limits are listed as follows unit mmHg 42 Patient Monitor User Manual Alarm Information PA ICP Pl P2 CO alarm limits are listed as follows ALM HI ALM LO EtCO 150 mmHg 0 FiCO 100 mmHg 0 AwRR 150 rpm 2 rpm Quick Temp alarm limits are listed as follows Patient Type ALM HI ALM LO ADU 42 C 107 6 F 355 059 T PED 42 C 107 6 F 35 5 05 9 FJ AG alarm limits are listed as follows Patient T
67. W x 320 mm H 7 kg M50 260 mm L x 140 mm W x 205 mm H 3 6kg A 3 Environment Specification The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges When the monitor and related products have differing environmental specifications the effective range for the combined products is that range which is common to the specifications for all products Temperature Working 5 C 40 C Transport and Storage 20 C 55 C Humidity Working 25 80 no coagulate Transport and Storage 25 93 no coagulate 139 Patient Monitor User Manual Product Specification Altitude Working 860hPa 1060hPa Transport and Storage 700hPa 1060hPa Power Supply 100V 240V 50Hz 60Hz Pmax 80VA FUSE T 1 6AL A 4 Display Product Display Messages M50 Display screen 8 4 inch colour TFT A maximum of 11 waveforms Resolution 800x600 One power LED One alarm LED One charge LED QRS beep and alarm sound M80 Display screen 15 inch color TFT A maximum of 13 waveforms Resolution 1024 x 768 One power LED One alarm LED One charge LED A 5 Battery Specification M50 2 1Ah Operating Time 180 min At 25 C continuous SpO measuring mode and NIBP automatic measuring mode Charge Time 200 min Monitor is on or in standby mode 4 2A
68. When you repress it or the pause time is over the system will resume the normal monitoring status and the message of Temporary Alarm Mute s and icon will vanish Symbol is shown in the information area Pressing or holding the button again can resume the alarm 5 Start Stop NIBPmeasurement Press this button to inflate the cuff and start blood pressure measurement During the measurement press the button to stop the measurement 6 Trend Key Press this button to enter trend table review interface 7 Freeze Unfreeze In normal mode press this button to freeze all the waveforms on the screen In Freeze mode press this button to restore the waveform refreshing 12 Patient Monitor User Manual Basic Operation 8 Start Stop Recording Press this button to start a real time recording During the recording press this button again to stop recording 9 Menu Press this button to return to the main interface when there is no menu open 10 Rotary Knob hereinafter called knob The user can rotate the knob clockwise or anticlockwise This operation can make the highlighted item shift up down left or right to choose the desired item Remember when using the knob rotate this button to highlight and press it to select the item M80 Side View 1 Sensor port CO rack basement Recorder door BR Ww N Battery compartment door 13
69. able MAP Low MAP measuring value is below lower alarm limit User selectable Art SYS High Art SYS measuring value is above upper alarm limit User selectable Art SYS Low Art SYS measuring value is below lower alarm limit User selectable Art DIA High Art DIA measuring value is above upper alarm limit User selectable Art DIA Low Art DIA measuring value is below lower alarm limit User selectable Art MAP High Art MAP measuring value is above upper alarm limit User selectable Art MAP Low Art MAP measuring value is below lower alarm limit User selectable PA SYS High PA SYS measuring value is above upper alarm limit User selectable PA SYS Low PA SYS measuring value is below lower alarm limit User selectable PA DIA High PA DIA measuring value is above upper alarm limit User selectable PA DIA Low PA DIA measuring value is below lower alarm limit User selectable PA MAP High PA MAP measuring value is above upper alarm limit User selectable PA MAP Low PA MAP measuring value is below lower alarm limit User selectable CVP MAP High CVP MAP measuring value is above upper alarm limit User selectable CVP MAP Low CVP MAP measuring value is below lower alarm limit User selectable ICP MAP High ICP MAP measuring value is above upper alarm limit User selectable ICP MAP Low ICP MAP measuring value is below lower alarm limit User selectable LAP MAP High LAP MAP measuring value is above upper alarm limit User selectable LAP MAP Low LAP MAP measuring value
70. age current of patient 10nA Scale signal 1mVpp accuracy is 5 System noise 30uV pp Incision mode 300W Congelation mode 100W ESU Protection Restore time 10s Meets the requirements of ANSI AAMI EC13 2002 Sect 4 2 9 14 Noise Suppression of Tested according to the test method in EC13 2002 Sect 5 2 9 14 Electrotome it accords with the standard Pace Pulse Pulse indicator PACE pulses meeting the following conditions are marked by the PACE indicator Amplitude 2 mV 700 mV 12 lead Width 0 1 ms 2 ms Ascending time 10 us 100 us Pulse Rejection Pulse is rejected if meets the requirements of ANSI AAMI EC13 2002 Sect 4 1 4 1 and 4 1 4 3 Amplitude 2 mV 700 mV 146 Patient Monitor User Manual Product Specification Width 0 1 ms 2 ms Ascending time 10 us 100 us Heart rate Alarm Range ADU 15 bpm 300 bpm PED NEO 15 bpm 350 bpm Accuracy 1 or 1 bpm the maximum Resolution 1 bpm Sensibility 2300 nu Vp PVC Range ADU 0 300 PVCs min PED NEO 0 350 PVCs min Resolution 1 PVCs min ST value Range 2 0 mV 2 0 mV Accuracy The max of 0 02 mV or 10 0 8 mV 0 8 mV Resolution 0 01 mV HR averaging method Method 1 Normally heart rate is computed by averaging the 12 most recent RR intervals Method 2 If each of three consecutive RR intervals is greater
71. al fast 2 kV for power supply 2kV for power Mains power quality transient burst lines supply lines should be that of a typical commercial or IEC EN 61000 4 4 1 kV for input output 1 kV for input 159 EMC Information Patient Monitor User Manual signal output signal hospital environment Surge IEC EN 61000 4 5 1 kV for line to line 2 kV for line to ground 1 kV for line to line Mains power quality should be that of a typical commercial or voltage variations on power supply input lines IEC EN 61000 4 11 for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 2 kV for line to hospital environment ground Power frequency 3A m 3A m Power frequency 50 60Hz magnetic fields should be at levels characteristic of magnetic field a typical location in a IEC EN 61000 4 8 typical commercial or hospital environment Voltage dips short lt 5 Ur lt 5 Ur Mains power quality interruptions and 29596 dip in Uz 79594 dip in Ur should be that of a typical commercial or hospital environment If the user of the Patient Monitor requires continued operation during power mains interruptions it is recommended that the P
72. al signal which is displayed graphically as pressure versus time on a monitor screen or numerically on digital display The monitor measures direct blood pressure of one selected blood vessel through two channels or four channels and displays waveforms and pressure of measured direct blood pressure SYS DIA and MAP 15 2 IBP Safety Information WARNING 1 The operator should avoid contact with the conductive parts of the appurtenance when it is connected or applied 2 When the monitor is used with HF surgical equipment the transducer and the cables must be avoided from conductive connection to the HF equipment This is to protect against burns to the patient Disposable IBP transducer or domes should not be reused If any kind of liquid other than solution to be infused in pressure line or transducer is splashed on the equipment or its accessories or enters the transducer or the monitor contact the Hospital Service Center immediately NOTE 1 Use only the pressure transducer listed in the IBP Accessories 2 Calibrate the instrument either whenever a new transducer is used or as frequently as dictated by your Hospital Procedures Policy 15 3 Monitoring Procedures Preparatory steps for IBP measurement 1 Plug the pressure cable into the corresponding socket and switch on the monitor 2 Flushing through the system with normal saline solution Ensure that the system is free of air bubbles 3 Connect the patient catheter to
73. and detect the changes of heart rate and ventricular rhythm and also save arrhythmia events and generate alarming information Arrhythmia algorithm can monitor paced and non paced patients Qualified personnel can use arrhythmia analysis to evaluate patient s condition such as heart rate PVCs frequency rhythm and ectopic beat and decide the treatment Besides detecting change of ECG arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia The monitor can support up to 16 different arrhythmia analyses ARR Types Occurring Condition ASYSTOLE No QRS is detected for 4 seconds Ventricular tachycardia The fibrillation wave lasts for 4 consecutive seconds or the number of continuous Vent beats is VFIB VTAC larger than the upper limit of cluster Vent beats 75 The RR interval is less than 600ms VT gt 2 3 lt the number of cluster PVCs lt 5 60 Patient Monitor User Manual Monitoring ECG COUPLET 2 consecutive PVCs BIGEMINY Vent Bigeminy TRIGEMINY Vent Trigeminy A type of single PVC under the condition that HR lt 100 R R RONT interval is less than 1 3 the average interval followed by a compensating pause of 1 25X the average R R interval the next R wave advances onto the previous T wave Single PVCs not belonging to the type of above mentioned PVC PVCs TACHY 5 consecutive QRS complex RR interval is less than 0 5s BRADY 5 cons
74. art a learning procedure and ECG ARR LEARNING is displayed on the screen The ECG ARR LEARNING will start automatically in the following status Changing lead type Connectiong leads Updating the patients Starting ARR learning manually After the ARR analysis is switched on The module is set to on Calibration mode is changed to nomoral measurement mode Exiting the Demo mode Exiting the standby mode 8 11 2 4 ARR Alarm The users can switch on or off all arrhythmia alarms by selecting ECG Setup gt ARR Analysis gt ARR Alarm And some arrhythmia alarms can be individually switched on or off They are ASYSTOLE VFIB VTAC R ON T VT gt 2 COUPLET PVC BIGEMINY TRIGEMINY TACHY BRADY MISSED BEATS IRR PNC PNP VBRADY and VENT To switch individual alarm on or off select ECG Setup gt ARR Analysis gt ARR Alarm The user can set the individual ARR alarm from the popup interface 62 Patient Monitor User Manual Monitoring RESP Chapter 9 Monitoring RESP 9 1 Overview The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes The change of impedance between the two electrodes due to the thoracic movement produces a respiratory waveform on the screen 9 2 RESP Safety Information WARNING 1 If you do not set the detection level for the respiration correctly in manual detection mode it may not be possible for the monitor to detect apnea If you set the detection leve
75. as AG The 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 during patient transport inside a healthcare facility 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 WARNING 1 Before use the equipment patient cable and electrodes etc should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance 2 Medical technical equipment such as these monitor monitoring system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly 3 EXPLOSION HAZARD Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur 4 SHOCK HAZARD The power receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three prong plug from the monitor to fit a two slot outlet 5 Extreme care must be exercised when applying medical electrical equipment Many parts of the human machine circuit are conductive such as the patient connectors electrodes transducers It is very important that these conductive parts do not come into c
76. at surrounding a limb dampens the oscillations coming from the artery Patients on an edematous extremity 12 5 Measurement Methods There are three methods of measuring NIBP Manual measurement on demand Auto continually repeated measurements between 1 and 480 minute adjustable interval Sequence the measurement will run consecutively in five minutes then the monitor enters manual mode es Patient Monitor User Manual Monitoring NIBP WARNING Prolonged non invasive blood pressure measurements in Auto mode may be associated with purport ischemia and neuropathy in the limb wearing the cuff When monitoring a patient examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the blood pressure measurements 12 6 Measurement Procedures 12 6 1 Measurement for V6 Module 1 Plug in the air hose and switch on the monitor 2 Apply the blood pressure cuff to the patient s arm or leg and follow the instructions below Ensure that the cuff is completely deflated Apply the appropriate size cuff to the patient About the cuff size selection please refer to Section MBP accessories and make sure that the symbol is over the artery Ensure that the cuff is not wrapped too tightly around the limb Excessive tightness may cause discoloration and eventual ischemia of the extremity NOTE The width of the cuff should be either 4096 of the limb circumference
77. atient Monitor be powered from an uninterruptible power supply or a battery NOTE Uristhe a c mains voltage prior to application of the test level B 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity environment The Patient Monitor is intended for use in the electromagnetic environment specified below The customer or the user of Patient Monitor should assure that it is used in such an Immunity IEC EN 60601 test Compliance Electromagnetic environment 160 Patient Monitor User Manual EMC Information test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Patient Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vins 3 Vins 39 d WP IEC EN 150 kHz to 80 MHz L 61000 4 6 s d JP 80 MHz to 800 MHz EA Radiated RF 3 V m 3 V m 2 61000 4 3 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 t
78. bular trend recording of the data in the current trend graph window The report will use the current trend interval settings For the detailed information about recording the trend graph please refer to Chapter Recording 20 2 Trend Table Review To review the trend table please press the Trend Table key on the screen or select Menu gt Review gt Trend Table then the trend table is displayed NOTE The CO module and GAS module can not be measured at the same time so their trend graph can not be displayed at the same time 20 2 1 Setting Resolution The monitor can support seven kinds of interval To set an apprioate resolution please select Menu gt Review gt Trend Table and an interface is displayed Choose Resolution on the interface to open the list and select an apprioate interval among 1 sec 5 sec 1 min 5 min 10 min 30 min and 60 min 20 2 2 Scrolling the Screen All trend tables can t be displayed on the current screen due to the screen limitation The user can scroll left right up and down the screen manually to see measurement trend tables that do not fit in the current view by selecting and pressing the symbol 4 gt gt F ust displayed on the trend graph 20 2 3 Switching to Trend Graph The user can switch to the trend graph on the Trend Table interface To do so please select Menu gt Review gt Trend Graph and select the Trend Graph option from the popup interface 20 2 4 Recording The monitor can
79. calculation the user can open the Titration on the Drug Dose interface The user can change the following items in the titration table Basic Step Dose Type The data in the trend table will vary with the changes above And the user can perform the following Scroll up and down the screen by selecting and pressing the symbol F and displayed on the trend graph Record the data displayed in the current window by selecting Record 117 Patient Monitor User Manual Recording Chapter 22 Recording 22 1 General Information A thermal dot matrix recorder is used for the monitor and can support many recording types and output patient information measurement data review data waveform and so forth 3 4 1 Recording indicator 2 Recording key press this key to start or stop recording task 3 Paper outlet 4 Recorder Door 22 2 Performance of the Recorder M Waveform record is printed at the rate of 25 mm s or 50 mm s B 48mm wide printout paper WI It can record up to three waveforms WB User selectable real time recording time and waveform Auto recording interval is set by the user and the waveform is in accordance with the real time recording NOTE It is suggested that the user should not use the recorder when the low battery displays or the monitor may be turned off automatically 118 Patient Monitor User Manual 22 3 Recording Type Recording The mon
80. cesvaccansensavedeseacestessndentnsnks Gineonidendainiasthuanantesnioans 19 312 Changing Date and TIME sesiis esea E E E EA E iuit 19 2 0 Adj sting Vol m opis rni Dx c me dues eM MR AEAEE TERE ATE E EEEO EEEE E 19 S I Adj stine Key VOoLUDWleusaqus ventprse dera p ups d Es mea egi dap EA 19 3 5 2 Adj sting A latm VolUM Seesen asese dpud ni vid nE EAEE Pe pst ponas samet b Vosa E 19 2 9 3 Adj sting Be t V OWNING syror ecenin aE A Ea Ea E REESE 20 3 6 Checking Your Monitor VOrBIOD aussen senses e E EE ars 20 3 7 TV CL WTC GEOINT AIID esd se cess Ceateneasannsdanseccanaanncatnnceisiaiessad beans daaestantinaasadsstaisactneonatiaeoneie 20 20 Seting Language Lc RN dM M ene eRe ere er OMM ME DNE 20 3 0 Linderstamding SCLC C115 a ste aate n e bat geb adn E RETER MI aH e p EIN rcs eR RR DIN ES 20 3 10 Calibrating SOIOGPIS ui aegeui ossi pen aiea E pan d Mee densa E REE RER EEE 20 Chapter d Alaris scistesscsensenoissericonnieniwanninnunsiaiaennianiannnanen EKDE OEN ES TECEN 22 29S BEC d POP eere E EE a was EEEE E nue E EE 22 41 1 Physiological alarms soseste TOES 22 4 1 2 Technical AlarniS onsite RE RSEN Ms ena tease pam EM ERa MU i iE EUM 22 LN Neuro c RUN 22 AZ Alam BUE eet apa usted ta oct eave em eE E ae osm awn ev suse iceman 22 4 3 Controlling DORT sissies e E E EE A E E NR 23 4 3 1 Switching the Individual Alarm OR eset rrnbecde sila terietebat vei Meere sen been san 23 23 2 Audio Alarm PAUSE isinen S DU dan eoi Y d A urat pu A nite p
81. cording to your hospital regulation Clean and disinfect the accessories before sterilizing using Ethylene Oxide Eto gas sterilization only Don t autoclave WARNING Please sterilize and disinfect the accessories timely to prevent the cross infection between patients 129 Patient Monitor User Manual Maintenance Chapter 26 Maintenance WARNING 1 Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 2 If you discover a problem with any of the equipment contact your service personnel Philips or your authorized supplier 26 1 Inspecting The overall check of the monitor including the safety check should be performed only by qualified personnel every 6 12 months and each time after fix up The following items should be checked Ifthe environment condition and power supply meet requirement If the power supply cord has damage and insulativity meets requirement If the device and accessories have damage Specified accessories e e e Ifthe alarm system can work properly Ifthe recorder can work properly and the paper meets the requirement Battery performance fall monitoring functions are in good conditions Ifthe grounding resistance and leakage current meet requirement If any damage or abnormality is found pl
82. d Pace Pulse 2149 Patient Monitor User Manual Product Specification Pulse indicator PACE pulses meeting the following conditions are marked by the PACE indicator Amplitude 2 mV 700 mV Width 0 1 ms 2 ms Ascending time 10 us 100 us Pulse Rejection Pulse is rejected if meets the requirements of ANSI AAMI EC13 2002 Sect 4 1 4 1 and 4 1 4 3 Amplitude 2 mV 700 mV Width 0 1 ms 2 ms Ascending time 10 us 100 us Heart rate Range ADU 15 bpm 300 bpm PED NEO 15 bpm 350 bpm Accuracy 1 or 1 bpm the maximum Resolution 1 bpm Sensibility 2300 n Vpp PVC Range ADU 0 300 PVCs min PED NEO 0 350 PVCs min Resolution 1 PVCs min ST value Range 2 0 mV 2 0 mV Accuracy The max of 0 02 mV or 10 0 8 mV 0 8 mV Resolution 0 01 mV HR averaging method Method 1 Normally heart rate is computed by averaging the 12 most recent RR intervals Method 2 If each of three consecutive RR intervals is greater than 1200ms then the four most recent RR intervals are averaged to compute the HR Range of Sinus and SV Rhythm Brady ADU 120 bpm 300 bpm PED NEO 160 bpm 350 bpm 143 Patient Monitor User Manual Product Specification Normal ADU 40 bpm 120 bpm PED NEO 60 bpm 160 bpm Tachy ADU 15 bpm 40 bpm PED NEO 15 bpm 60 bpm Range of Ventricular Rhythm Ventricular Tachycardia The inte
83. d by using unapproved substances or methods EDAN makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection Consult your hospital s Infection Control Officer or Epidemiologist for control infection 25 1 General Points Keep your monitor cables and accessories free of dust and dirt To prevent the device from damage please follow the procedure Always dilute according to the manufacturer s instructions or use lowest possible concentration Do not immerse any part of the equipment or any accessories in liquid Do not pour liquid onto the system Never use bleach Do not allow liquid to enter the case Never use abrasive material such as steel wool or silver polish CAUTION If you spill liquid on the equipment battery or accessories or they are accidentally immersed in liquid contact your service personnel or EDAN service engineer 25 2 Cleaning WARNING Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line 25 2 1 Cleaning the Monitor Regular cleaning of the monitor shell and the screen are 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 met
84. d on the current screen To do so press Record on the interface For the detailed information about recording the diagnosis waveforms or results please refer to Chapter Recording 115 Patient Monitor User Manual Calculation and Titration Table Chapter 21 Calculation and Titration Table The monitor provides calculation function and titration table Calculations are patient data that are not directly measured but calculated by the monitor when you provide it with the appropriate information The monitor can perform the following calculations drug calculation and hemodynamic calculation To perform one calculation please select Menu gt Common Function gt Drug Dose NOTE This drug calculation function acts only as a calculator That means the patient weight in Drug Calculation menu and in Patient Information menu is independent from each other Therefore if the Weight in Drug Calculation changes it will not change the Patient Information In this way we can say the Drug Calculation menu is independent from other menus in the system Any change of it will not affect other information about the patient being currently monitored 21 1 Drug Calculation 21 1 1 Calculation Procedures 1 The drug calculation window is displayed by selecting Menu gt Common Function gt Drug Dose 2 Select the right pull down box of the Drug option and select the required drug name among the 15 drugs which are listed as follows And the drug
85. dapters shall not be reused Used disposable airway adapters shall be disposed of in accordance with local regulations for medical wastes 4 Use only PHASEIN manufactured oxygen sensor cells Depleted oxygen sensors shall be disposed of in accordance with local regulations for batteries 5 Do not use the IRMA Adult Pediatric adapter with infants as the adapter adds 6 ml dead space to the patient circuit 6 Do not use the IRMA airway adapter with adults as this may cause excessive flow resistance 7 Measurements can be affected by mobile and RF communications equipment It should be assured that the IRMA probe is used in the electromagnetic environment specified in this manual 8 Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this may allow patient secretions to block the adapter windows and result in incorrect operation 7a Wi 9 To keep secretions and moisture from pooling on the windows or oxygen sensor port always position the IRMA probe in a vertical position with the LED pointing upwards 10 Do not use the IRMA airway adapter with metered dose inhalsers or nebulized medications as this may affect the light transmission of the airway adapter windows 11 Do not try to open the oxygen sensor assembly The oxygen sensor is a disposable 101 Patient Monitor User Manual Monitoring AG product and contains a caustic electrolyte and lead 12 The IRMA probe is intended only as an adjunct i
86. decreases further the pulsations increase 70 Patient Monitor User Manual Monitoring NIBP in amplitude reach a maximum which approximates to the mean pressure and then diminish WARNING Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation Do not measure NIBP on patients with sickle cell disease or any condition where skin damage has occurred or is expected Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled 12 4 Measurement Limitations Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm or if the patient is on a heart lung machine The measurement may be inaccurate or impossible in the following situations A regular arterial pressure pulse is hard to detect Patients with cardiac arrhythmias Patients with excessive and continuous movement such as shivering or convulsions Patients with rapid blood pressure changes Patients with severe shock or hypothermia that reduces blood flow to the peripheries Patients with obesity where a thick layer of f
87. dical engineer name or Manufacturer s service staff The O2 concentration Red co CO Out Of Range excceds the accuracy range High ae i concentration of gas module 34 Patient Monitor User Manual Alarm Information Stop measuring of CO module or notify le fail Y A CO Comm Fail a mody M i lbs High biomedical engineer communication failure or X Manufacturer s service staff Insert injectat CO TI No Sensor CO TI sensor not connected Low d b temperature sensor TB CO TB No Sensor in M Low Insert TB sensor connected TB i i TEMP Out Of Range measuring value is Hisl Please check TB above measuring range sensor Hemod Lack Param HEMOD calculation needs Hil Please input patient S parameters height and weight CO Lack Param CO measuring needs Hick Please input patient S parameters height and weight The AA concentration R AA AA Out Of Range exceeds the accuracy range High ome concentration of gas module Stop measuring of A l The oxygen sensor of the e So be O Sensor Error sidestream gas module has a Medium 7 failure engineer or Manufacturer s service staff Stop measuring function of GAS A le fail l ti AG Comm Fail GAS modu e failure or Bosh modu e and no ify communication failure biomedical engineer or Manufacturer s service staff Please perform AG Zero Required AG module requires zero Low zeroing Pl it th
88. ding Agents 0 2kPa 10 of reading O2 2kPa 2 of reading Resolution CO ImmHg awRR Irpm Delay Time 3s Apean Alarm Delay 20s 60s Alarm Providing alarms of EtCO FiCO EtO FiO EtN O Fi N20 EtAA FiAA awRR A 17 2 Phasein Mainstream Module Type IRMA OR Displaying the concentration of CO2 O2 N20 and one anaesthesia agent and no anaesthesia agent identification IRMA AX Displaying the concentration of CO2 N2O and two anaesthesia agent and indentifying two anaesthesia agent Measurement CO N20 O2 HAL Isoflurane ISO Enflurane ENF P Sevoflurane SEV Desflurane DES awRR MAC arameters Measurement CO N20 anaesthesia agent infra red absorption characteristic Principle O2 oxygen battery Warm up Time The automatic agent indentification is running within 10 seconds Full accuracy within 1 min 156 Patient Monitor User Manual Product Specification IRMA AX OR HAL measurement Full accuracy within 3 minutes Resolution CO ImmHg awRR Irpm Delay Time 3s Update Time 1 second Rise Time CO x 90ms O2 x 300ms N20 x 300ms HAL ISO ENF SEV DES lt 300ms Primary Agent 0 15 vol Threshold Secondary Agent 0 2 vol 10 of total agent concentration Threshold Agent lt 20 seconds Identificaiton Time Response Time lt 1 second Standard Conditions
89. e 20 6 12 lead Diagnosis Review Select Menu gt Review gt Analysis Review to open the 12 lead analysis review interface If there is no analysis result the prompt of No Analysis Result is displayed on the interface Diagnosis Review Analysis time 2010 02 25 16 41 48 1 1 HR 60bmp P QRS T axis 54 44 49 PR Intervel 176ms RV5 SV1 1 09 0 55mv QRS Intervel 72ms RV5 SV1 1 64mv QT QTC 339 339ms Diag Code Diag Result 800 Sinus Rhythm 861 Supraventricular Tachycardia 863 Ventricular Tachycardia Right Ventricular Hypertrophy Pulmonary 309 Disease UEMG 2 y Delete Record O ee 20 6 1 Scrolling the Screen All analysis results or waveforms can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see the analysis results or waveforms that do not fit in the current view by selecting and pressing the symbol W and t displayed on the 12 lead analysis review interface 20 6 2 Deleting Diagnosis Results The user can delete the analysis results displayed on the current screen by selecting Delete on the interface 20 6 3 Switching Between Waveforms and Results The user can review the analysis waveforms on the analysis result interface by selecting the Wave option and review the analysis results on the analysis waveform interface by selecting the Wave option 20 6 4 Recording The monitor can record the 12 lead diagnosis waveforms or results displaye
90. e IEC Standard 01 57 471001 11 3 Lead Clip Connector ECG Cable IEC Standard 01 57 471002 11 3 Lead Clip Connector ECG Cable IEC Defibrillation 01 57 471003 11 5 Lead Clip Connector ECG Cable IEC Standard 01 57 471004 11 5 Lead Clip Connector ECG Cable AHA Standard 01 57 040190 11 5 Lead Snap Connector ECG Cable IEC Standard 01 57 101027 11 5 Lead Snap Connector ECG Cable AHA Defibrillation 01 57 040182 11 5 Lead Snap Connector ECG Cable AHA Standard 01 57 109100 11 10 Lead ECG Trunk Cable AHA Defibrillation 01 57 109101 10 Lead Snap ECG Limb Wires AHA 01 57 471029 10 3 Lead Snap Connector ECG Cable AHA Standard 01 57 471006 3 Lead Snap Connector ECG Cable IEC Standard 01 57 040206 5 Lead ECG Trunk Cable IEC Defibrillation 01 57 040207 5 Lead Snap ECG Limb Wires IEC 01 57 040208 5 Lead Clip ECG Limb Wires IEC 01 57 471022 5 Lead ECG Trunk Cable AHA Defibrillation 01 57 471023 5 Lead Snap ECG Limb Wires AHA 01 57 471024 3 Lead ECG Trunk Cable IEC Defibrillation 01 57 471025 3 Lead Clip ECG Limb Wires IEC 01 57 471009 5 Lead Snap Connector ECG Cable IEC 01 57 040202 11 10 Lead ECG Trunk Cable IEC Defibrillation 01 57 040203 10 Lead Snap ECG Limb Wires IEC 28 2 2 SpO Accessories 12 01 109069 EDAN SHI Adult Reusable SpO2 Sensor L
91. e If your monitor has been ordered preconfigured to your requirements the settings at delivery will be different from those listed here C 1 Patient Information Default Settings Patient Information Settings Patient Type Adult Pace Off C 2 Alarm Default Settings Alarm Settings Pause Time 120s Mute On Alarm Twinkle Font Flash Sensor Off Alarm On Alarm Latch Unlatch C 3 ECG Default Settings ECG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100 Pace Off Lead Type 5 Leads Display Normal Filter Monitor Smart Lead Off Off Heart Volume 2 ST Analysis ADU PED NEO ST Analysis Off 163 Patient Monitor User Manual Default Settings ST X Alarm Switch Off Alarm Level Medium Alarm Record Off Alarm High Limit 0 2 ST X Alarm Low Limit 0 2 X stands for I II IIT aVR aVL aVF V V1 V2 V3 V4 V5 or V6 ARR Analysis ARR Analysis Off PVCs Alarm Level Medium PVCs Alarm Switch Off PVCs Alarm Record Off ARR Alarm Settings Alarm Switch Alarm Level Alarm Record ASYSTOLE On High Off VFIB VTAC On High Off RONT On Medium Off VT gt 2 On Medium Off COUPLET On Medium Off PVC On Medium Off BIGEMINY On Medium Off TR
92. e Rate Measuring Range 20bpm 300bpm Resolution Ibpm Accuracy X 3bpm 20bpm 250bpm A 12 TEMP Channel 2 Measuring and Alarm Range 0 C 50 CQG2 F 122 F Sensor type YSI B series and CF FI Resolution 0 1 C 0 1 F Accuracy Without sensor 0 1 C or 20 2 F Refresh Time Every 1s 2s A 13 Quick TEMP Measuring Range 25 C 45 C 7T F 113 F Operating Temp 10 C 40 C 50 F 104 F Sensor Type Oral Axillary sensor Rectal sensor Alarm Range 35 5 C 42 C 95 9 F 107 6F Resolution 0 1 C 0 1 E Accuracy 0 1 C 25 C 45 C or 152 Patient Monitor User Manual Product Specification 0 2 F 77F 113F Response time lt 60s Update time ls 2s A 14 IBP Dynamical Pressure Measuring 50 mmHg 300 mmHg Range Resolution 2 or 1 mmHg the larger Pressure Sensor Sensitivity 5 uV V mmHg Impedance 3009 30009 Frequency Response d c 12 5 Hz d c 40 Hz Zero Range 200 mmHg Accuracy 1 mmHg Measuring and Alarm Range Art 0 mmHg 300 mmHg PA 6 mmHg 120mmHg CVP RAP LAP ICP 10 mmHg 40 mmHg P1 P2 50 mmHg 300mmHg A 15 CO Method Infra red Absorption Technique Unit mmHg 96 Kpa Measuring and Alarm Range EtCO 0 mmHg 150 mmHg
93. e module works failure properly Please check whether Unable To Calibrate E M E Medium the module works calibrated properly AG Zero In Progress AG module is zeroing Low Please wait zeroing Th li li i Replace th li AG Occlusion e sampling line is Medium eplace the sampling clogged line AG Init Fail AG module has a failure High ie oe vere improperly AG dul k AG Data Limit Error AG module has a failure High ee ee improperly 2 364 Alarm Information Patient Monitor User Manual AG Usa Error AG module has a failure High ee indu S improperly AG Cal Fail AG module fails to calibrate High a peau Woka improperly AG Zref Fail AG module fails to zero High n d improperly AG Change Oxygen Replace oxygen sensor of Please wait changing Low ing Sensor AG module finishing AG No Oxygen The oxygen sensor falls off _ Connect the sensor High Sensor from the AG module again A le detects mi idi AG Med Areik G module detects mixture Medium Close the subsidiary gas agent gas agent CO Occlude Water trap of SideStream is Dom Make sure the gas occluded exhaust works well CO Sensor Faulty Stop measuring functi CO module failure High ne di bo module notify CO Sensor Over i biomedical engineer Temp le fai CO Comm Fail eh communication failure CO Ram Error CO module failure High Stop using CO alarm function and notify CO Rom Error CO
94. e patient B Switch on the monitor It takes 2 min 3 min for the body temperature to stabilize 13 4 Calculating Temp Difference The monitor can calculate and display the difference between two temperature values by subtracting the second value from the first The difference is labeled TD qu Patient Monitor User Manual Monitoring Quick TEMP Chapter 14 Monitoring Quick TEMP 14 1 Overview Quick temperature measurement is to establish thermal balance between probe and human body When the probe is placed on the measurement site until a steady reading is available after approximately three minutes for oral and rectal measurements and five minutes for axillary measurements And the measurement temperature is the monitoring temperature The temperature curve in this process has a certain discipline The approximatively actual temperature curve can be simulated by temperature data sampled earlier The temperature at thermal balance is calculated through the specific algorithm based on the curve The monitor can only measure temperature of adult and pediatric patients If the user measures temperature of neonatal patient the monitor will not display data The Oral Axillary sensor and Rectal sensor are of standard configuration 14 2 Quick TEMP Safety Information WARNING 1 Toensure optimal accuracy always confirm that the correct mode and alarm limit are selected Changing the measure position may lead to the change of alarm limit
95. ease don t use the monitor and contact local Customer Service Center 26 2 Maintenance Task and Test Schedule The following tasks are for EDAN qualified service professionals only Contact an EDAN qualified service provider if your monitor needs a safety or performance test Clean and disinfect equipment to decontaminate it before testing or maintaining it Maintenance and Test Schedule Frequency Safety checks Selected tests on At least once every two years or as needed after any the basis of IEC60601 1 repairs where the power supply is removed or replaced or if the monitor has been dropped Check ECG synchronization of the At least once every two years or as needed monitor and defibrillator 130 Patient Monitor User Manual Maintenance NIBP Leakage Inspection At least once every two years or as specified by local laws NIBP Pressure Calibration At least once every two years or as specified by local laws NIBP Calibration At least once every two years or as specified by local laws CO Calibration and Performance Test At least once every two years or if you suspect the measurement values are incorrect AG Calibration At least once every two years or if you suspect the measurement values are incorrect AG Preventive Maintenance At least once every two years or if you suspect the measurement values are incorrect 131 Patient
96. ected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements Interference can be caused by High levels of ambient light or strobe lights or flashing lights such as fire alarm lamps Hint cover application site with opaque material Electromagnetic interference SRT Patient Monitor User Manual Monitoring SpOs Excessive patient movement and vibration 10 5 Understanding SpO Alarms This refers to SpO specific alarms See the Alarms section for general alarm information SpO offers high and low limit alarms and the users can adjust them 10 6 Adjusting Alarm Limits In SpO Setup menu select Alarm Setup Set the SpO High Alarm Limit to an apprioate value from the popup interface Set the SpO Low Alarm Limit to an apprioate value from the popup interface WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia If this is a consideration do NOT set the high alarm limit to 10096 which is equivalent to switching the alarm off 10 7 Setting SpO as Pulse Source 1 Inthe PR Setup menu select PR Source 2 Select SpO from the pop up list 10 8 Setting Pitch Tone If tone modulation is on the PR sound lowers when the SpO level drops In SpO2 Setup menu select pitch tone to toggle between On and Off 10 9 Setting Sensitivity The different sensitivity indicates differ
97. ecutive QRS complex RR interval is longer than 1 5s When HR is less than 100 beats min no heart beat is tested MISSED during the period 1 75 times of the average RR interval or BEATS When HR is higher than 100beat min no beat is tested within 1 second The patient has irregular heart rate check patient s condition IRR electrodes cables and leads After the pacemaker is paced QRS complex can not be PNC detected during 300ms After the QRS complex no pace is detected during 1 75 times PNP l of RR interval VBRADY The patient has irregular HR and his average HR is less than 60bpm Check his condition electrodes cables and leads The patient has irregular heart rate check patient s condition VENT electrodes cables and leads 8 11 2 ARR Analysis Menu 8 11 2 1 Switching ARR Analysis On and Off To switch ARR Analysis on or off in the ECG Setup menu select ARR Analysis to toggle between On and Off from the popup interface 8 11 2 2 PVCs Alarm Select On in the menu to enable prompt message when an alarm occurs select Off to disable the alarm function and there will be a symbol beside PVCs Splis Patient Monitor User Manual Monitoring ECG WARNING When the PVCs Alarm is set to OFF the monitor won t give an alarm prompt even if an alarm occurs In order to avoid endangering the patient s life the user should use this function cautiously 8 11 2 3 ARR Relearning Pick this item to st
98. ed In the trend graph the y axis stands for the measurement value and x axis stands for the time Trend Graph lt Page b Resolution 1s v Cursor Trend Table Record Exit 20 1 1 Selecting Trend Graph of Specific Parameter The monitor can review trend graph of different parameters To change the existing trend graph please select Menu gt Review gt Trend Graph and select a required parameter name from the popup list as shown in red text in the above figure 20 1 2 Setting Resolution The monitor can support five kinds of resolutions To set an apprioate resolution please select Menu gt Review gt Trend Graph and an interface is displayed Choose Resolution on the interface to open the list and select an apprioate resolution among 1 sec 5 sec 1 min 5 min and 10 min 20 1 3 Scrolling Left and Right the Screen All trend graphs can t be displayed on the current screen due to the screen limitation The user can scroll left and right the screen manually to see measurement trends that do not fit in the 112 Patient Monitor User Manual Review current view by selecting and pressing the symbol amp and ad displayed on the trend graph 20 1 4 Switching to the Trend Table The user can switch to the trend table interface on the Trend Graph interface To do so please select Menu gt Review gt Trend Graph and select the Trend Table option from the popup interface 20 1 5 Record The monitor can make a ta
99. eless N tWOTkK HL a E EES a 123 Titer 2d NEN M 124 24 1 Battery Power Indicator o ooeccirenivexevtc Er tux I REMO iR onte tp Ut tm TEER EE iea ER PANE 124 24 2 Battery Status om the Main SOEBBI eiae Rd abf ed era on eee 124 24 3 Checking Battery Performance au scsoeuese teint mbi e ERPIA rk ort ER XR e Reo pP UN EU eR PURER TI SEN UR IE 124 24 4 Replacing the BIB ases MEME MEE 125 24 5 Recycling the BSEBgbyuseseeetuisin oasis pei eri p denti saxi btevu esa pes deua Esa dtu P Yo FETE odes aad 126 24 6 M int ining the Batte ys meii dieat deba gaudia EE E E AEA UII du MG 126 Chapter 25 are and Cleaning oisi i verba erkFevee isi ERR Vo VN vv pem RENE EEL ki VF e SEE Fr ERE oe sorsra ssassn 127 25 1 General PONES pneter don Kr pcd Du ava nanan D ad du Ped RIO usi a PM ai bM 127 252 8 6100010 ee ee ee Roe cee Ee ee IN et ce cere ere UR MEE 127 25 2 1 Cleaning the Monitor eH 127 25 22 Cleaning the ACCESSOrIES ceci crop dp E RUD GU EUN EE ER 128 Eo WME CHOI cc aac feta E istud e Re ajesd ot udis Dist Mike Sut seo ne acento 129 25 4 Steril abl Ole 2 ied oec deer eoe ea eoo eoe ose ae dac oe deest eve sis ooa oos eis E oed es ope eee ava be deese oce ue ida 129 Chanter 20 Maintenante asecisserisnnientnnionnicwetemnm an CU ERE QE MEE CF PREIS asis 130 PIENE D TQ ea naan E ae EE 130 26 2 Maintenance Task and Test See OG ragiosscashsaunscaauecsacsajasesaianeiatisianeastsSeesarasuans bU NR pM 130 Chapter 27 Warranty and Service
100. eline from the CO module is disconnected or the air tube the air inlet the air outlet is plugged by water or other materials The accuracy of the CO2 measurement will be affected by the following reasons the airway was highly obstructed the leakage of air way connection or quick variation of environment temperature Follow precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment 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 Do not place the sensor cables or tubing in any manner that may cause entanglement or strangulation 10 Do not store the CO Module at temperatures less than 40 F 40 C or greater than 158 F 70 C Do not operate the CO Module at temperatures less than 32 F 0 C or greater than 104 F 40 C 86 Patient Monitor User Manual Monitoring CO2 NOTE After the low battery alarm appears please do not start the CO2 measurement or the monitor may turn off for the low capacity of battery 16 3 Monitoring Procedures 16 3 1 Zeroing the sensor You must perform zeroing following the steps when using the new airway adapter 1 Expose the sensor to room air and keep it away from all sources of CO including the ventilator the patient s breath and the operator s
101. emo 12 01 109079 EDAN SHI Adult Reusable SpO2 Sensor DB9 01 13 110513 EDAN SpO2 Extension cable 01 13 210001 EDAN SpO2 Extension Cable DB9 to Lemo 2m TPU 12 01 110492 DAN SH3 Neonate Warp SpO2 Sensor DB9 134 Patient Monitor User Manual Accessories 12 01 110515 EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 02 01 110531 EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 Immersion Disinfection 12 01 110521 EDAN SHS Pediatric Silicone Soft tip SpO Sensor DB9 01 57 040196 Adult Disposable SpO Sensor 01 57 040197 Pediatric Disposable SpO Sensor 01 57 040198 Infant Disposable SpO Sensor 01 57 040199 Neonatal Disposable SpO Sensor NELLCOR Nellcor Reusable Adult SpO2 Sensor DS 100A OxiMax Weak 11 15 30043 Perfusion Resistance 11 15 40096 Nellcor Reusable Adult Neonate SpO Sensor OXI A N OxiMax 11 13 30131 11 Nellcor SpO Extension Cable Compatible with Nellcor OXI Max SpO Module and Nellcor Sensor 28 2 3 NIBP Accessories 01 57 471005 NIBP Tube 3m with Connector 01 59 36104 NIBP Tube 3m with Connector 01 59 036118 NIBP Tube 3m with Connector 01 59 36036 NIBP Tube 3m with Connector 01 57 471021 Connecting Tube for Neonatal Cuff Only Compatible with Neonatal Disposable and NIBP Tube 01 57 040210 Large Adult Cuff 33 47cm
102. ent refresh frequency High indicates the refresh frequency of SpOz value is the most frequent To change the sensitivity please follow the steps 1 Select the SpO Setup menu 2 Select Sensitivity on the interface and select the desired sensitivity from the popup list 68 Patient Monitor User Manual Monitoring PR Chapter 11 Monitoring PR 11 1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute bpm You can display a pulse from any measured SpO signal or any arterial pressure 11 2 Setting PR Source The monitor provides PR sources options but currently only SpO is supported If the parameter as PR source is switched off the monitor will switch based on priority If all parameters producing SpO are switched off the PR parameter will be switched off 11 3 Setting PR Volume Five selections are available 1 2 3 4 and 5 5 indicates the maximum volume 1 indicates no sound You can change PR Volume in the PR Setup menu 11 4 Using Pulse Alarms You can change pulse rate alarm limits in the PR Setup menu by selecting PR Alarm Limit Pulse alarms are only generated when the active alarm source is set to Pulse a pulse source is set as system pulse and pulse alarms are switched on 11 5 Selecting the Active Alarm Source In most cases the HR and Pulse numerics are identical In order to avoid simultaneous alarms on HR and Pulse the mo
103. entral monitoring system CO Carbon dioxide COHb Carboxyhemoglobin CVP Central venous pressure DC Direct current Des Desflurane Dia Diastolic ECG Electrocardiogram EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnetic interference Enf Enflurane ESU Electrosurgical unit Et End tidal EtCO End tidal carbon dioxide EtN O End tidal nitrous dioxide 169 Abbreviation Patient Monitor User Manual Eto Ethylene oxide EtO End tidal oxygen FCC Federal Communication Commission FDA Food and Drug Administration Fi Fraction of inspired FiCO Fraction of inspired carbon oxygen FiN20 Fraction of inspired nitrous oxide FiO2 Fraction of inspired oxygen Hal Halothane Hb Hemoglobin Hb CO Carbon mono xide hemoglobin HR Heart rate IBP Invasive blood pressure ICP Intracranial pressure ICU Intensive care unit ID Identification IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers Iso Isoflurane LA Left arm LAP Left atrial pressure LCD Liquid crystal display LED Light emitting diode LL Left leg MAP Mean arterial pressure MDD Medical Device Directive MetHb Methemoglobin MRI Magnetic resonance imaging N A Not applied N2 Nitrogen N20 Nitrous oxide Neo Neonate 170 Abbreviation Patient Monitor User Manual
104. er Malfunction stops the recorder from running properly NOTE You can press the Record button on the front panel to stop the currently recording 119 Patient Monitor User Manual Recording process 22 5 Recorder Operations and Status Messages 22 5 1 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 printhead may be damaged 22 5 2 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 m Do not operate the recorder without record paper 22 5 3 Paper Out When the Recorder Out OF Paper alarm is displayed the recorder cannot start Please insert record paper properly 22 5 4 Replacing Paper 1 Pull outwards the upper arc part of the recorder casing to release the casing shown in the following figure 2 Insert a new roll of paper into the paper cassette printing side facing upwards 120 Patient Monitor User Manual Recording 3 Ensure proper position and tidy margin 4 Pull about 2cm of the paper out and close the recorder casing NOTE Be careful when inserting papers Avoid damaging the thermo sensitive print head Unless when inserting papers or shooting troubles do not leave the recorder catch open 22 5 5 Removing Paper Jam When the recorder
105. ero the transducer in accordance with your hospital policy at least once per day You must perform a zero When you use a new transducer or tubing Every time you reconnect the transducer cable to the monitor Ifyou think the monitor s pressure readings are not correct When using a pressure module the zero information is stored in the module 15 6 Zeroing a Pressure Measurement WARNING Invasive pressure alarms and pulse alarms if derived from invasive pressure are temporarily suppressed until 30 seconds after the transducer finishes zeroing The zeroing procedure is listed as below 83 Patient Monitor User Manual Monitoring IBP 1 Turn off the stopcock to the patient 2 Vent the transducer to atmospheric pressure to compensate for the static and atmospheric pressure exerted on the transducer 3 Inthe setup menu for the pressure select Zero 4 When you see the message Zero Ok please close the stopcock to atmospheric pressure and open the stopcock to the patient 15 7 Troubleshooting the Pressure Zeroing Taking Art for Example The status message lists the probable cause of an unsuccessful calibration Message Corrective Action Art ZERO FAIL Make sure that the transducer is not attached to the patient Art SENSOR OFF FAIL Make sure that transducer is not off and then proceed zeroing IN DEMO FAIL Make sure that the monitor is not in DEMO mode Contact service technician if necessary
106. es eodein e pud er Eea s voa NEL ead Spa E RES UMORE 61 Chapter 9 Monitoring RESP a ivevevna cniin p b ate ela VA ER dp RR OD VERON REEF iE 63 MEE an Sit pM EET ER 63 9 2 RESP Safety TOT IMATION e oai que on d n Fe E ear dant sum For p FE RIEN II Sd ES 63 9 3 Resp lea areca aS E iR CH ae ce ea ee 63 9 4 Electrode Placement for Monitoring Resp ener 63 9 5 Cardiac ed ceu MEME MEUM 64 9 G Chest EXPAN Deyrnas nr ie ear n ea ea eA Fudpi apis bas es AEREE ETENE EE EEn eu Mud copen di 64 9 7 Abdominal Breathing sissies eira E AEAEE EEE REE E DEES 64 NUI AH og REP E A AE ROET AATE 64 FDC ims i Hold TyPerenssnn n e E E Id PIS R Vidal Nd 64 9 10 Changing the Size of the Respiration Wave esten Mm urbes uat e Mp IM En MEDIE 65 9 11 Usina EPA TETTE R E EA E AEEA TEENE 65 9 12 Changing the Apnea TIM e ese oe mre Harm DAR e Rr Hep DR D ES E 65 Chapter 10 Monitoring SpO 66 ADA NOV caro MF T M 66 10 2 SpOz Safety Tof OPA AE Ossi scx sexe tegosa iea vn n e i an Edo v vM peu dio eva ob NEN ATES 66 103 Dye ASU MN dero E NETTE 67 10 4 Meas rem nt PTOCOGUEG ie cba pho ra Pai Eu IS RUN RR rU dg x RR D Un xa no 67 10 5 Understanding SpOs AOI pannua i Rp at tate Fina aa Pc Eme tua SUL ATE beni 68 10 6 Adj usting Alarmi TO 8e opaca iater ib pnm dados SA omtelun aser a A UU Re ntl uten Lu bo E 68 10 7 S tting SpCls ae Pulse SOUPE ceiien esaiar eaa iea FUHR UDIN E RU EERTE 68 10 8 Setting Pitch TONG csete
107. esult Cancel Cancel the processing measurement or cancel the result after measurement Record Print out the curve Y axis Change the scale Y temperature value Three modes are available 0 0 5 C 0 1 C 0 2 0 C Adjust the scale by the temperature differences A smaller scale results in a larger curve 95 Monitoring CO Patient Monitor User Manual Monitoring CO X axis Change the Scale X time value Two modes are available 0 30s 0 60s If you start measurement in the 0 30s mode it will be switched to 0 60s mode automatically if the measurement can not finish within 30 seconds After the switch no further adjustment can be made to the Scale X Review Enter the Review window Exit Press the item to exit CO Measure 17 5 Measurement Process Measurement should be taken when the message Ready for new measurement appears on the screen Press the Start button and then start injection The thermodilution curve current blood temperature and the injectate temperature are displayed during the measurement Curve drawing will stop automatically when the measurement finishes and the the CO and C I 8 and in the above figure will be calculated and displayed on the screen The monitor will display CO in the parameter area and the start measurement time in the above figure To ensure the accuracy of the measurement it is suggested that a reasonable interval shou
108. f C Applying Cuff Arrows symbols are marked at the inner side of the cuff between the two lines as below The write lines as markers can be found at the edge outside the cuff If the end of the cuff is not able to be attached within this marked range please select another cuff with a suitable size 2 Patient Monitor User Manual Monitoring NIBP NOTE 1 Please make sure the cuff is well connected A leak of air may cause measurement error 2 Please select the cuff with the suitable size An unsuitable cuff may cause incorrect measurements 3 Do not disinfect the cuff with radiation or gas or the cuff will be deteriorated 4 Avoid incursion of liquid into the cuff If this happens please desiccate the cuff completely Size of reusable cuffs for adults children Size of disposable cuff for neonates 3 Patient Type Limb Perimeter Cuff Width Hose Adult No 1 12cm 18 cm 7 cm Adult No 2 17 cm 23 cm 9 cm 3 5m Adult No 3 23 cm 33 cm 12 cm Adult No 4 3 cm 40 cm 14 cm Size No Limb Perimeter Cuff Width Hose 1 3 5 cm 6 0 cm 2 5 cm 2 5 0 cm 7 5 cm 3 0cm 3 5m 3 7 5 cm 10 5 cm 4 0cm 4 8 5 cm 13 0 cm 5 0cm Connect the air hose with the cuff by turning it clockwise To demount the air hose you should turn it widdershins Check whether the patient mode is appropriately selected Access PATIENT SETUP menu f
109. f the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe operation 19 ISA analyzers are not designed for MRI environments 20 During MRI scanning the monitor must be placed outside the MRI suite 21 Use of high frequency electrosurgical equipment in the vicinity of the monitor may produce interference and cause incorrect measurements 22 Do not use external ambient cooling of the ISA device 23 Do not apply negative pressure to the Nomoline to remove condensed water 24 Too strong positive or negative pressure in the patient circuit might affect the sample flow 25 Exhaust gases should be returned to the patient circuit or a scavenging system 26 Always use a bacteria filter on the evac side if sampled gas is intended to be re breathed 27 Do not place the ISA analyzer in any position that might cause it to fall on the patient CAUTION 1 ThelSA analyzers should be securely mounted in order to avoid the risk of damage to the ISA 2 Do notapply tension to the ISA analyzer cable 3 Do not operate the ISA analyzer outside the specified operating temperature environment 100 Patient Monitor User Manual Monitoring AG 18 2 2 Safety Information for IRMA Module WARNING 1 The IRMA probe is intended for use by authorized and trained medical personnel only 2 The IRMA probe must not be used with flammable anesthetic agents 3 Disposable IRMA airway a
110. for 2 160 aeos dann ties iioc adit t x aids md UR Idi ritsisiek 54 8 8 3 Electrode Placement for cia rp H 55 8 8 4 Recommended ECG Lead Placement for Surgical Patients sususe 56 8 9 ECG IE c NM one iA E a A EEE E 57 8 9 1 Setting Alarm OWES usd vac n a e ips ETE ER fna oup eer EN gon rcd CUM COR E iS aT 8 92 Smart Load OR associe PR rox mds ure PS PR a ipea uad uv sU rM EM 57 6 9 3 Setung B at VOTUNBE oos costs aU E E ESS 57 nori gu dis CN E E EA E E EEE E 57 80 53 Setting Pace Stat S odo dem as iucunda E T ae qu FU ees 58 8 9 6 ECG Cali brati OUsisessedisineeni eerd ere oan aaen uu tu aufs dad etm iisdiiid 58 8 9 7 ECG Waveform Settings ssrin eM ERN D E E MM DNE 58 OR 12 Leads ECG T EEEE OESS 58 S T0 S T Segment Monitoring sassis one sisesreon eri a p RS unu aE Geo RE E e dedit ua EE teda 59 8 101 Settmp ST ANAYS Seo E EE ONENE Duo E ANTEN 59 8 10 2 ST oii HR 59 8 10 3 ST Analysis Alarm Setting accade at ib RR RICE EN ERR Han UM asai HA UR MI DNE 59 8 10 4 About ST Measurement Points ss ssssseeeeseeseeseseeseesesressrstrsesstserstssessesseseesesseseese 59 8 10 5 Adjusting ST and ISO Measurement POIDS era patere enn taie Ry Ra xh 60 SUL AGE MOnitoring es etis ter kae tr prr ceiien hori e anm ER Up OU R aaaea ae Enea Eaei 60 8 111 Aihythmia Analysis oed ositinio rt pax neg dup FR cba E Poza pas ua d rco ka Ti 60 8 11 2 ARR Pata SG MICH n soccer caret ir
111. fter the ambient temperature reaches normal value 38 Patient Monitor User Manual Alarm Information Probe data error Offline NTC resistance gt R 0 C Short NTC resistance lt R 100 CC Med Put the sensor into the sensor bracket take it out and measure again If the problem persists stop using measuring function of TEMP module and notify biomedical engineer Or manufacturer s service staff Probe heater error Single failure Med Put the sensor into the sensor bracket take it out and measure again If the problem persists stop using measuring function of TEMP module or notify biomedical engineer or manufacturer s service staff Probe temp too high The original temperature of sensor gt 33 C amp lt 40 C Low Put the sensor into the sensor bracket measure again after the sensor temperature reaches normal value Temp Sensor Off After the sensor temperature reaches Predict value it descends to the value lower than Predict value Med Reconnect the sensor and make sure that the cable is properly connected Battery Low Battery Low High Please change the battery or charging Recorder Out Of Paper Recorder Out Of Paper Low Please install the paper Recorder Not Setted The user presses the RECORD button when the monitor is not installed with a recorder Low Notify the manufacturer s service s
112. gh baseline In the operating room the Filter reduces artifacts and interference from electro surgical units Under normal measurement conditions selecting Surgery may suppress the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the monitor Diagnos Use when diagnostic quality is required The unfiltered ECG wave is displayed so that changes such as R wave notching or discrete elevation or depression of the ST segments are visible 8 4 Using ECG Alarms ECG alarms can be switched on and off and the changes to high and low alarm limits are just like other measurement alarms which are described in the Alarms section Special alarm features applying only to ECG are described here 8 5 Selecting Calculation Lead On the Normal interface the users can select either 3 LEADS or 5 LEADS for this item Normal QRS complex should be B The normal QRS should be either completely above or below the baseline and it should not be biphasic For paced patients the QRS complexes should be at least twice the height of pace pulses B The QRS should be tall and narrow B The P waves and the T waves should be less than 0 2 mV 8 6 Monitoring Procedure 8 6 1 Preparation The skin is a poor conductor of electricity therefore preparation of the patient s skin is important to facilitate good electrode contact to skin m Select sites with intact skin without impairment of any kind m Shave hair from site
113. h Operating Time 420 min At 25 C continuous SpO measuring mode and NIBP automatic measuring mode Charge Time 380 min Monitor is on or in standby mode M80 4 2Ah Operating Time 120 min At 25 C continuous SpO measuring mode and NIBP automatic measuring mode Charge Time 320 min Monitor is on or in standby mode A 6 Recorder Record Width 48 mm Paper Speed 25 mm s 50 mm s Trace Up to 3 140 Patient Monitor User Manual Product Specification Recording types 8 second real time recording Auto 8 second recording Parameter alarm recording Trend recording Drug calculation and titration table recording Frozen waveform recording A 7 Review Trend Review Short 1 hrs 1 Second Resolution Long 96 hrs 1 min Resolution Review 500 sets NIBP measurement data 50 sets 12 lead ECG diagnosis results A 8 ECG A 8 1 3 5 lead Monitoring Lead Mode 3 Lead I II III 5 Lead I II HI aVR aVL aVF V Waveform 3 Lead 1 channel waveform 5 Lead 2 channel waveform max seven waveforms Lead naming style AHA IEC Display Sensitivity 1 25mm mV x0 125 2 5mm mV x0 25 5mm mV x0 5 10mm mV x1 20mm mV x2 AUTO gain Sweep 12 5mm s 25mm s 50mm s ECG Analog Output Bandwidth 3dB Diagnosis 0 05Hz 150Hz Monitor 0 5Hz 40Hz Surgery 1Hz 20Hz Max transmission delay 500ms in diagnostic mode and with notch off Se
114. han the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C 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 E Field strengths from fixed transmitters 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 such as base stations for radio 161 Patient Monitor User Manual EMC Information the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Patient Monitor is used exceeds the applicable RF compliance level above the Patient Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Patient Monitor gt Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m B 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the monitor The monitor is intended for use in an electromagnetic envir
115. he Large Font interface Directly select this item on the screen to enter the module switch interface Directly select this item on the screen to change the key volume Directly select this item on the screen to adjust the screen brightness Directly select this item on the screen to calibrate the touch screen Directly select this item on the screen to zero the IBP sensor Directly select this item on the screen to enter the alarm setup interface 55 E a 1 e DI Q all Directly select this item on the screen to change the beat volume Directly select this item on the screen to mute the alarm m Directly select this item on the screen to enter the menu 3 2 1 3 Hardkeys A hardkey is a physical key on a monitoring device such as the recording key on the front panel 3 2 1 4 Pop up keys Pop up keys are task related graphical keys that appear automatically on the screen when required For example the confirmation pop up key appears only when you need to confirm a change 3 3 Operating Mode 3 3 1 Demo Mode To change the operating mode into the demo mode please refer to the following procedure 1 Select the Demo key on the screen directly or 2 Select Menu Common Function then choose Demo Mode from the popup interface and input password 3045 After entering Demo Mode the monitor will perform the followings Storing no data of new patient Pausing to give all types of alarm
116. he monitor is working for it can cause instability of the system If you do it inadvertently please turn off the module in menu immediately The module enters STANDBY mode if you reconnect it to monitor which it is powered on If the readings are inaccurate you should do calibration 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 90 Patient Monitor User Manual Monitoring CO2 status 2 To avoid infection use only sterilized disinfected or disposable airway adapters 3 Inspect the airway adapters prior to use Do not use it if airway adapter appears damaged or broken Observe airway adapter color coding for patient population 4 Periodically check the flow sensor and tubing for excessive moisture or secretion buildup 16 3 3 2 Removing Exhaust Gases from the System WARNING Anesthetics when using the sidestream CO measurement on patients who are receiving or have recently received anesthetics connect the outlet to a scavenging system to avoid exposing medical staff to anesthetics Use an exhaust tube to remove the sample gas to a scavenging system Attach it to the mainstream sensor at the outlet connector 16 4 Setting CO Waveform Setup Select the CO waveform area to open the CO waveform menu Set Mode to Curve or Filled as your desire Set Sweep to an apprioate value from the pop up
117. hermodilution Catheter 3 Cardiac Output Cable 4 Injectate Sensor Housing 5 Injectate 6 Delivery System 7 In line injectate Temperature probe CO Sensor Connection WARNING Make sure that the computational constant for the measurement is appropriate to the catheter used NOTE The blood temperature alarm will not function during CO measurement It will resume automatically when the measurement is over 17 4 CO Measurement Window Select the CO Settings menu to enter the CO Measure window and start CO measurement If CO transducer is not connected the monitor will display No Sensor on the screen 94 Patient Monitor User Manual C O Measure C O 2 40 l min 3 CI 1 4 l min m BSA 1 652 m 2 TB 36 79 C TIO Measure Time 16 21 04 0 Ready for new measuremX axis 60 sec WY axis v Start Review Exit CO Measure Window Measurement curve Prompt message area Cardiac Output Cardiac Index Body Surface Area Blood Temperature 9 0 0 S 6 3 Injectate Temperature Start time of the measurement Funciton keys The functional keys on the CO measure window are explained in the following table Start Start a measurement Stop If the blood temperature cannot resume in a considerably long time the measurement could not stop automatically Use this button to stop the measurement and display the CO CI calculation r
118. hods 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 Examples of disinfectants that can be used on the instrument casing are listed below 127 Patient Monitor User Manual Care and Cleaning m Tenside m Diluted Ammonia Water lt 3 m Alcohol 25 2 2 Cleaning the Accessories 25 2 2 1 Cleaning the ECG Cables and Lead Wires NOTE 1 Use only recommended cleaning substances and disinfectants listed in this document Others may cause damage not covered by warranty reduce product lifetime or cause safety hazards 2 Keep the cable and lead wires free of dust and dirt 3 Never immerse or soak the ECG cable 4 Inspect the cables after cleaning CAUTION Do not allow a cleaning or disinfecting agent to leave residues on any equipment surface After allowing the appropriate time for the agent to work as indicated by the manufacturer wipe off residues with a cloth dampened with water Clean with a lint free cloth moistened with warm water 40 C 104 F and substances listed below Never use strong solvents such as acetone or trichloroethylene Approved Cleaning Substances m Mild Soaps m Tenside as active cleaning agent Cables and leadwires can be cleaned with a warm damp cloth and mild soap or isopropyl alcohol wipes CAUT
119. if Limb is not at Heart Level To correct the measurement if the limb is not at heart level to the displayed value Add 0 75mmHg 0 10kPa for each centimeter Deduct 0 75mmHg 0 10kPa for each higher or centimeter lower or Add 1 9mmHg 0 25kPa for each inch higher Deduct 1 9mmHg 0 25kPa for each inch lower 12 9 NIBP Alarm When NIBP Alarm is set to On the physiology alarm occurs if any measurement value of Systolic pressure Mean pressure Diastolic pressure exceeds alarm limit The users can adjust the alarm limit by accessing NIBP Setup gt Sys Alarm Map Alarm Dia Alarm 12 10 Resetting NIBP When the pressure does not work properly and the system fails to give a message for the problem pick Reset in the NIBP Setup menu to activate self test procedure and thus restore the system from abnormal performance 75 Patient Monitor User Manual Monitoring NIBP 12 11 Calibrating NIBP NIBP is not user calibrated Cuff pressure transducers must be verified and calibrated if necessary at least once every two years by a qualified service professional See the Service Manual for details 12 12 Leak Test This item is used for leak test Turn the knob to pick the Leak Test item in the User Maintain gt NIBP Maintain menu to start the air leakage test When the item is selected it will change into Stop If this item is selected again the system will stop air leakage test And the item returns to Leak Test
120. igurations with infants as this may add dead space to the patient circuit 9 Do not use infant type sampling line configurations with adults as this may cause excessive flow resistance 10 Do not use the ISA analyzer with metered dose inhalers or nebulized medications as this may clog the bacteria filter 11 Check that the gas sample flow is not too high for the present patient category 12 Since a successful zeroing requires the presence of ambient air 21 O2 and 0 CO2 in the gas analyzer ensure that the ISA is placed in a well ventilated place Avoild breathing near the ISA sidestream gas analyzer before or during the zeroing procedure 13 The Nomoline sampling line and its interfaces are non sterile devices To avoid damage do not autoclave any part of the sampling line 99 Patient Monitor User Manual Monitoring AG WARNING 14 Never sterilze or immerse the ISA analyzer in liquid 15 Measurements can be affected by mobile and RF communications equipment Make sure that the ISA analyzer is used in the electromagnetic environment specified in this manual 16 ISA analyzer is intended only as an adjunct in patient assessment It must be used in conjunction with other assessments of clinical signs and symptoms 17 Replace the sampling line if the sampling line input connector starts flashing red or a Nomoline occulsion message is displayed on the host 18 No modification of this equipment is allowed without authorization o
121. in Rectal WARNING Incorrect insertion can cause bowel perforation 14 3 3 Measurements for Axillary Temperatures 1 Ensure that the white probe and probe well are installed 2 Remove the probe from the probe well 3 Press Quick TEMP Setup gt Measure Pos and select the Axillary mode 4 Observe the axillary mode indicator on the display flashing axillary icon 5 Load a probe cover 6 Adjust clothing to visualize the axilla 7 Avoid folds in the axilla and place the probe tip vertically as high as you can as shown 8 Place the arm at the patient s side Hold in this position without movement of the arm or probe during the measurement cycle Measuring Position in Axillary NOTE 1 Do not take an axilliary temperature through the patient s clothing Direct contact between the patient s skin and the probe is required 2 To obtain accurate rectal temperature use the white temperature probe 80 Patient Monitor User Manual Monitoring Quick TEMP 14 4 Changing Temp Unit To change Temp Unit please Select the Quick Temp Setup menu to open it and select Unit on the interface Select the appropriate unit from the popup list 81 Patient Monitor User Manual Monitoring IBP Chapter 15 Monitoring IBP 15 1 Overview IBP is measured by means of a catheter inserted directly into the circulatory system A pressure transducer connected to the catheter converts the mechanical force exerted by the blood into an electric
122. in the window QD Six curves of the six measurements and CO value 2 Average value of CO 3 Average value of CI Function button in the edit window Values of selected measurements can be averaged and stored in the CO item in the HEMOD menu as the basis for Hemodynamic calculations 17 7 Blood Temperature Monitoring Blood temperature monitoring can function when CO measurement is not taken The blood temperature is measured by the thermistor situated in the distal end of the flotation catheter in the pulmonary artery The blood temperature alarm function will not work during the CO measurement When the measurement ends the function will automatically resume The current blood temperature is displayed in the CO parameter area 97 Patient Monitor User Manual Monitoring CO Flotation catheter Thermal resistance Right atrium Right ventricle Thermodilution Catheter Site 17 8 Setting the Computation Constant The computation constant is associated with catheter and injectate volume When the catheter is changed please adjust Constant in the CO Settings menu based on product description provided by the manufacturer 17 9 Recording CO Measurements CO measurement can be recorded by the recorder To record the CO measurement please select Record in the CO Measure menu 17 10 Setting INJ TEMPSource To change the INJ Temp Source please 1 Select Inj Temp Source in the CO Setti
123. ing and pressing the symbol F and displayed on the Alarm Review interface 20 4 2 Selecting Alarm Event of Specific Parameter The monitor can review alarm event of the specific parameters To view the alarm event of the specific paramenter please select Menu gt Review gt Alarm Event and choose Event Type to select the required parameter name from the popup list 20 4 3 Setting Time Index The user can set end time of alarm review by selecting the Time Index option displayed on the alarm review interface If the user selects Current Time on the popup interface the alarm events occurring before the current time are displayed on the alarm event review interface If the user selects User Define he can define the review time by setting time box displayed on the interface The alarm events occuring before the User Define option are displayed on the alarm event review interface 20 5 Arr Review Select ECG Setup gt Arr Analysis gt Arr Review or Menu gt Review gt Arr Review to open the Arr review interface The interface displays the latest arrhythmia events 20 5 1 Scrolling the Screen All arrhythmia events can t be displayed on the current screen due to the screen limitation The user can scroll up and down the screen manually to see the other arrhythmia events that do not fit dies Patient Monitor User Manual Review in the current view by selecting and pressing the symbol F ust displayed on the Arrhythmia Review interfac
124. ing the Size of the ECG Wave If any of the displayed ECG waveform is too small or clipped you can change the size of it on the screen First select ECG Wave Setup gt ECG Gain then select an apprioate factor from the pop up box to adjust the ECG waveform X0 125 to make strength of ECG signal waveform of ImV become 1 25mm X0 25 to make strength of ECG signal waveform of 1mV become 2 5mm X0 5 to make strength of ECG signal waveform of ImV become 5mm XI to make strength of ECG signal waveform of ImV become 10mm X2 to make strength of ECG signal waveform of ImV become 20mm Auto let the monitor choose the optimal adjustment factor for all the ECG waves 5 Patient Monitor User Manual Monitoring ECG 8 3 2 Changing the ECG Filter Settings The ECG filter setting defines how ECG waves are smoothed An abbreviation indicating the filter type is shown underneath the lead label on the monitor display Filter settings do not affect ST measurement To change the filter setting in the ECG Setup menu select Filter and then select the appropriate setting Monitor Use this mode under normal measurement conditions Surgery The filter reduces interference to the signal It should be used if the signal is distorted by high frequency or low frequency interference High frequency interference usually results in large amplitude spikes making the ECG signal look irregular Low frequency interference usually leads to a wandering or rou
125. it is set to the Manual mode you can adjust the broken lines in RESP area by the Hold High and Hold Low items 64 Patient Monitor User Manual Monitoring RESP 9 10 Changing the Size of the Respiration Wave Select the Resp waveform area to open the Resp waveform menu Select AMP then choose an apprioate value The value is bigger the waveform amplitude is Select Sweep select an apprioate setting from the pop up list 9 11 Using Resp Alarms Resp alarms can be switched on and off and the high and low alarm limits can be changed just like other measurement alarms as described in the Alarms chapter 9 12 Changing the Apnea Time The apnea alarm is a high priority red alarm used to detect apneas The apnea alarm delay time defines the time period between the point where the monitor cannot detect any respiration activity and the indication of the apnea alarm 1 Inthe Resp Setup menu select Apnea Alarm 2 Select the appropriate setting from the popup list 65 Patient Monitor User Manual Monitoring SpOs Chapter 10 Monitoring SpO 10 1 Overview SpO is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO measuring unit SpO Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood If for example 9796 of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen then the b
126. itor provides several types of stripe recording Time recording Alarm recording Arrhythmia review recording NIBP review recording Alarm review recording 12 lead analysis recording Continuous real time recording Trend graph trend table recording Drug calculation titration recording Hemodynamic Calculation result recording 22 4 Starting and Stopping Recording You can start and stop the recording in the following ways Continuous real time recording Press the Record button on the front panel to start the recording and repress it to stop the recording Auto recording Record three waveforms selected in Recorder Setup menu according to the setup time interval in Recorder Setup menu It will automatically stop in 8 seconds Trend graph recording Enter the Menu gt Review gt Trend Graph menu and press the Record button to start recording Trend table recording Enter the Menu gt Review gt Trend Table menu and press the Record button to start recording NIBP review recording Enter the Menu gt Review gt NIBP Review menu then press the Record button to start recording 12 lead diagnosis recording Select Record on the diagnosis review interface to start the recording To stop the recording press the Record button on the front panel The recorder will stop recording in the following situations The recording task is finished No paper in the record
127. l Low off ECG electrode V6 falls off ECG V6 Lead Off the skin or ECG cables fall Low off Stop measuring function of RESP RESP Comm Fail RESP module failure or High module and notify communication failure biomedical engineer or the manufacturer s service staff 30 Patient Monitor User Manual Alarm Information SpO Sensor Off SpO2 sensor may be disconnected from the patient or the monitor Low Make sure the sensor is well connected to the patient s finger or other parts SpO No Sensor SpO2 sensor was not connected well or connected to the monitor or the connection is loose Low Make sure the monitor and sensor is well connected reconnect the sensor SpO Comm Fail SpO module failure or communication failure High Stop using measuring function of SpO module and notify biomedical engineer Or manufacturer s service staff SpO Low Perfusion The pulse signal is too weak or the perfusion of the measurement site is too low Low Reconnect the SpO sensor and change the measurement site If problem exists please notify biomedical engineer Or manufacturer s service staff NIBP Comm Fail NIBP module failure or communication failure High Stop using measuring function of NIBP module and notify biomedical engineer Or manufacturer s service staff NIBP Loose Cuff Cuff is no properly wrapped or no cuff exists Low
128. l too low the monitor is more likely to detect cardiac activity and to falsely interpret cardiac activity as respiratory activity in the case of apnea 2 The respiration measurement does not recognize obstructive and mixed apneas it only indicates an alarm when a pre adjusted time has elapsed since the last detected breath 3 If operating under conditions according to the EMC Standard EN 60601 1 2 Radiated Immunity 3V m field strengths above 1V m may cause erroneous measurements at various frequencies Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit NOTE The RESP monitoring is not recommended to be used on patients who are very active as this can cause false alarms 9 3 Resp Display Resp 30 8 9 4 Electrode Placement for Monitoring Resp Correct patient skin preparation techniques for electrode placement are important for Resp measurement you will find this information in the chapter on ECG The Resp signal is always measured between two of the ECG electrodes There are two standard ECG leads for selection I lead RA and LA and II lead RA and LL 63 Patient Monitor User Manual Monitoring RESP Electrodes Placement for 5 lead 9 5 Cardiac Overlay Cardiac activity that affects the Resp waveform is called cardiac overlay It happens when the Resp electrodes pick up impedance changes caused by the rhythmic blood f
129. ld take place between two consecutive measurements The length of the interval can be set in the CO Setup menu Time unit second The interval time counter is displayed on the screen The next measurement can not be performed until the time reduces to zero and a message Ready for new measurement appears NOTE 1 It is strongly recommended that the user must push the injector within four seconds after pressing the Start button 2 Itis strongly recommended that you wait at least 1 minute or longer depending on the patient s clinical condition before starting the next measurement Repeat this procedure until you have completed the measurements you want You can perform a maximum of six measurement editing If you perform additional measurements the earliest measurement each time will be deleted If any of the curves in the editing window is not selected for calculation excluded from the averaging calculations the place will be taken by the new measurement 17 6 Editing CO Pick the Review button on the CO Measure menu to access the Review as shown below 96 Patient Monitor User Manual Monitoring CO C O Review l ahha MC O 2 40 l min MC O 2 42 l min MC O 2 40 l min Measure Time 16 1tMeasure Time 16 1 Measure Time 16 17 NIME MC O 2 40 l min MC O 2 41 l min Measure Time 16 1 Measure Time 16 4 Average C O 2 41 l min CI 1 4 1 min m2 Sr a Window For CO Edit Contents displayed
130. limit by accessing Art Setup gt SYS Alarm MAP Alarm DIA Alarm 85 Patient Monitor User Manual Monitoring CO2 Chapter 16 Monitoring CO 16 1 Overview The monitor provides the SideStream and MainStream methods for CO2 monitoring LoFlo CO module is used for SideStream measuring and Capnostat 5 CO module C5 is used for mainStream measuring The principle of CO measurement is primarily based on the fact that CO2 molecule can absorb 4 3um infrared ray Absorption intensity is proportional to CO concentration of patient sample the CO concentration will compute according to the detecting CO absorption intensity of patient sample 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 MainStream measurement uses a CO sensor attached to an airway adapter directly inserted into the patient s breathing system 16 2 CO Safety Information WARNING CO module shall be avoided from crash and vibration Do not use the device in the environment with flammable anesthetic gas The device should be used by trained and qualified medical personnel authorized by EDAN Nitrous oxide elevated levels of oxygen helium xenon halogenated hydrocarbons and barometric pressure can influence the CO measurement The monitor will be damaged if any pip
131. lood has a SpO 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 SpO2 PLETH parameter can also provide a pulse rate signal and a plethysmogram wave 10 2 SpO Safety Information WARNING 1 If the SpO sensor can not work properly please reconnect the sensor or change a new one 2 Do not use the sterile supplied SpO sensors if the packaging or the sensor is damaged and return them to the vendor 3 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 It 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 4 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor more than 4 hours Inspect the sensor periodically according to the sensor user manual 5 Neonate SpO sensor can only be used when required no more than 20 min at a time 6 Use only EDAN permitted sensors and extension cables with the oximeter Other sensors or extension cables may cause improper monitor performance and or minor per
132. low Correct electrode placement can help to reduce cardiac overlay avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes This is particularly important for neonates 9 6 Chest Expansion Some patients especially neonates expand their chests laterally In these cases it is best to place the two respiratory electrodes in the right midaxillary and left lateral chest areas at the patient s maximum point of breathing movement to optimize the respiratory wave 9 7 Abdominal Breathing Some patients with restricted chest movement breathe mainly abdominally In these cases you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave NOTE Place the red and green electrodes diagonally to optimize the respiration waveform Avoid the liver area and the ventricles of the heart in the line between the RESP electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow This is particularly important for neonates 9 8 Selecting Resp Lead To change Resp lead in the Resp Setup menu select Resp Lead to pick up the apprioate lead from the pop up list 9 9 Changing Hold Type To change the calculation mode in the Resp Setup menu set Hold Type to Manual or Auto When it is set to the AUTO mode Hold High and Hold Low are unavailable and the monitor can calculate the respiration rate automatically When
133. module failure High biomedical engineer or Manufacturer s service staff CO Zero Required Zero calibration failure Low GO Cheek Adapter The cannula is off or You disconnected 37 Patient Monitor User Manual Alarm Information The O2 concentration Reduce CO CO Out Range excceds the accuracy range High f concentration of gas module The AA concentration piede P AA Out Range exceeds the accuracy range High concentration of gas module Stop measuring of The oxygen sensor of the GAR module and O Sensor Error sidestream gas module has a Medium s T eee failure engineer or Manufacturer s service staff Stop measuring function of TEMP QuickTemp Comm TEMP module failure or ee module and notify Fail communication failure biomedical engineer Or manufacturer s service staff Put the sensor into o The TEMP value is beyond the sensor bracket Temp EROE Lt the range of 25 C 45 C Med take it out and measure again TEMP sensor is not Connect the sensor No Temp Sensor connected to the TEMP Low and the monitor well module and measure again Ambient temp too The Sensor temperature is Low Put the sensor into high higher than 40 C the sensor bracket measure again after the ambient temperature reaches normal value Ambient temp too low The Sensor temperature is Low Put the sensor into lower than 10 C the sensor bracket measure again a
134. n patient assessment It must be used in conjunction with other assessment of clinical signs and symptoms 13 Incorrect probe zeroing will result in false gas readings 14 Incorrect agent selection by the user for IRMA AX OR no automatic agent identification will result in false agent readings 15 Using IRMA AX no automatic identification with gas mixtures containing more than one agent will result in false agent readings 16 Replace the adapter if rainout condensation occurs inside the airway adapter 17 Use only PHASEIN manufactured IRMA airway adapters CAUTION 1 Do not apply tension to the probe cable 2 Do not operate the IRMA probe outside the specified operating temperature environment 3 Do not leave depleted oxygen sensors mounted in the IRMA probe even if the probe is not in use 18 3 Monitoring Steps 18 3 1 Monitoring Steps for ISA Analyzer 18 3 1 1 Performing a Pre use Check Before connecting the Nomoline sampling line to the breathing circuit do the following 1 Connect the sampling line to the ISA gas inlet connector LEGI 2 Check that the LEGI shows a steady green light indicating that the system is OK 3 For ISA OR and ISA AX module with O2 option fitted Check that the O2 reading on the monitor is correct 2196 4 Breathe into the sampling line and check that valid CO2 waveforms and values are displayed on the monitor 5 Occlude the sampling line with a fingertip and wait for 10 seconds 6
135. name of Drug A Drug B Drug C Drug D and Drug E can be defined by the user Drug A Drug B Drug C Drug D and Drug E AMINOPHYLLINE DOBUTAMINE DOPAMINE EPINEPHRINE HEPARIN ISUPREL LIDOCAINE NIPRIDE NITROGLYCERIN PITOCIN 3 After that the system will give a group of default value which can t be treated as the calcaultion results The user must enter the correct parameter value based on the doctor s instruction 4 Enter the patient s weight 116 Patient Monitor User Manual Calculation and Titration Table 5 Enter the correct parameter value 6 Confirm whether the calculation result is correct 21 1 2 Calculation Unit Each drug has the fixed unit or unit series to calculate Among the same unit series the unit binary varies with the entered parameter value The calcution units of the drugs are listed as follows Drug Unit DRUG A DRUG B DRUG C AMINOPHYLLINE g mg mcg DOBUTAMINE DOPAMINE EPINEPHRINE ISUPREL LIDOCAINE NIPRIDE NITROGLYCERIN DRUG D PITOCIN HEPARIN Ku mu DRUG E mEq When the user defines some drug the operator should select Drug A Drug B Drug C Drug D and Drug E based on the unit series NOTE 1 The drug calculation is displayed as invalid value before the user edits the drug name and patient weight and the user can t enter any value 2 Drip Rate and Drop Size are invalid in the neonatal mode 21 2 Titration Table After completing the drug
136. nclude the following Sweep ofthe waveform Parameters needing to be monitored Change to some settings may have the risk so only the authorized person can change them After changing the settings please notify the operator 7 2 Selecting Display Parameters The user can select the display parameters based on the monitoring and measurenment requirements To select the parameter please 1 Select Menu gt System Setup gt Module Switch 2 Select the required parameters from the popup interface 3 Press Exit to exit the menu and the screen will adjust the parameters automatically 7 3 Changing Waveform Position The user can exchange the waveform positions of parameter A and parameter B please refer to the following steps to do so 1 Select waveform A and open the setup menu of waveform A 2 Select Change from the popup menu and select the desired lable name of waveform B from the pull down list 7 4 Changing Interface Layout To change the interface layout please refer to the following steps 1 Select Menu gt View Setting 2 Select one interface from the popup menu 3 The user can implement one kind of function screen based on the requirements If the user selects the Large Font option there is no function screen to be selected 7 5 Viewing Trend Screen To view the short trend screen the user can press the Trend Screen key on the screen directly or select Menu gt View Setting gt View Selection gt
137. ngs menu 2 Select Auto or Manual from the list Manual directly displaying the injectate temperature from INJ TEMP e Auto indicating the system obtains the injectate temperature through sampling 98 Patient Monitor User Manual Monitoring AG Chapter 18 Monitoring AG 18 1 Overview The monitor uses ISA sidestreasm gas analyzer hereinafter called ISA analyzer and IRMA mainstream molude hereinafter called IRMA module to monitor the anesthetic gas which can be used to measure the gases of adult pediatric and neonatal patients during anesthesia recovery and respiratory care And the anesthetic gas includes Halothane HAL Isoflurane ISO Enflurane ENF Sevoflurane SEV Desflurane DES CO and N20 18 2 Safety Information 18 2 1 Safety Information for ISA Analyzer WARNING 1 The ISA analyzer is intended for use by authorized and trained medical personnel only Use only Nomoline sampling lines manufactured by PHASEIN The ISA analyzer must not be used with flammable anesthetic agents Carefully route the sampling line to reduce the risk of patient entanglement or strangulation 5 Do notre use disposable sampling line 6 Do not lift the monitor by the sampling line as it could disconnect from the monitor causing the monitor to fall on the patient 7 Used disposable sampling lines shall be disposed of in accordance with local regulations for medical waste 8 Do not use adult pediatric type sampling line conf
138. nitor User Manual Product Specification Measuring Accuracy Maximum Mean Error 5mmHg Maximum Standard Deviation 8mmHg Maximum measuring period Adult Pediatric 160s Neonate 80s Overpressure protection Dual overpressure protection Adult 297 3nmHg Neonatal 150x3mmHg A 11 SpO gt Measuring Range 0 100 Alarm Range 0 100 Resolution 1 Accuracy Adult including Pediatric 2 70 100 SpO2 Undefined 0 69 SpO Neonate 3 709610096 SpO Undefined 0 69 SpO Pulse Rate Measuring Range 25bpm 300bpm Alarm Range 30bpm 300bpm Resolution Ibpm Accuracy 2bpm Data update period Is Nellcor module Saturation Measuring Range 1 100 Alarm Range 1 100 Resolution 1 Accuracy Sensor Type Accuracy MAX A MAX AL MAX N MAX P 2 70 100 SpO2 151 Patient Monitor User Manual Product Specification MAX I MAX FAST OxiCliq A OxiCliq P OxiCliq N Adult OxiCliq N Neonate OxiClig I 2 5 70 100 SpO2 D YS Infant to Adult DS 100A OXI A N 3 70 100 SpO2 OXI P I D YS including D YSE ear clip D YS 3 5 70 100 SpO2 C including D YSPD spotclip When the sensor is used to neotate as recommendation the specified accuracy range of the neotate is always higher 1 than adult Puls
139. nitor uses either ECG or Pulse as its active alarm source To change the alarm source select Alarm Source in the ECG Pulse Alarms menu then select HR ifyou want HR to be the alarm source for HR Pulse PR If you select Pulse as the active alarm source the monitor will prompt you to confirm your choice Be aware that if you select Pulse as the alarm source all arrhythmia and ECG HR alarms are switched off AUTO If the Alarm Source is set to Auto the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without an technical alarm condition The monitor will automatically switch to Pulse as the alarm source 69 Patient Monitor User Manual Monitoring NIBP Chapter 12 Monitoring NIBP 12 1 Overview This monitor uses the oscillometric method for measuring NIBP It can be used for adult pediatric and neonatal patients 12 2 NIBP Safety Information WARNING 1 Do not measure NIBP on patients with sickle cell disease or any condition where skin damage has occurred or is expected 2 Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff 3 Ensure that the correct setting is selected when performing measurements It may be dangerous for the children to use
140. nsiabowhssadsetaisiesonnevsatndennsadubtantiebanssdaepea saaanesantaweenis lambs le tiet ien i boda 75 12 10 Resetting NIBP P 75 12 11 Calibrating NIBP PT ep 76 12 12 Leak TEST cia rE EE ima pan adde ER adag Eva ai UE apr DD Ca Spit 76 12 12 Procedure ot Leak T6680 sese pbi ues px I RM Max MED RN MM 76 Chapter 13 Monitoring TEMD sd ioi ieeta orit ela RR YE DIVER DERE UERTU VIS HUM NERO ORE iede oikeen 77 IEEE dodo Pe M HM MO 71 13 2 TEMP Safety Informations dic cestonascsnassrareatiieadeengn 2T niies din na readin a di iia 77 13 3 TEMP IN Oia ST SUD cpi sapien bumrv bud be Ud RIDE Unter aaa aso TI 13 4 Calcolatmp Temp DIPIGEBIOE serssinonsiisr ni Ero iae inia Eee Ero EER ENEN EEE Or ed rota oan 7T Chapter 14 Monitoring Quick TEMP ssssiscsssessssssenssscscesssesessedssesosssssonventsescsasccssesascseuscsescuscsecssiestes 78 INE ILI E 78 142 Quick TEMP Safety IDEST vecbessn it pa pid bam obit ec R E Piu ndn ie rim Po RE 78 14 3 Measuring Procedure oov nmn Rui blu M PURA AM ane NUM T bU E 79 14 3 1 Measurement for Oral Ternperdtute een eel axerit rna e era Fn art rr tad ea Rd FER oi O 79 14 3 2 Measurements tor Rectal Iemperatubesussecasesexem breui tnim exea adnan 79 14 3 3 Measurements for Axillary Temperatures sse 80 144 Changing Temp UDIs e E E tne de 81 Chapter 15 Monitoring IBP ee 82 TSL Riuciur MUT
141. nsitivity 1V mV 10 PACE rejection enhancement Without Pace enhancement or pace rejection Defib Sync Pulse sj l Patient Monitor User Manual Product Specification Output impedance 500 Max time delay 35ms High level 3 5 to 5 V providing a maximum of 1 mA output current Amplitude Low level 0 5V receiving a maximum of 5 mA input current Pulse width 100ms 10 Limited current 15 mA rating Rising and falling time lt 1ms Diagnosis gt 95dB the Notch filter is off MRR M uae poumon ius Monitor gt 105dB the Notch filter is on Rejection Ratio Surgery gt 105dB the Notch filter is on Notch 50Hz 60Hz Notch filter can be turned on or off manually Differential Input Impendance 25MO Input Signal Range 8mV pp Electrode Offset Potential 4500mV Tolerance Auxiliary Current Leads off detection Active electrode lt 100nA Reference electrode lt 900nA Input Offset Current lt 0 1pA Recovery time after ae 5s Defibrillation Leakage current of patient lt I0uA Scale signal 1mV pp accuracy is 5 System noise lt 30uUVpp Incision mode 300W Congelation mode 100W ESU Protection Restore time lt 10s Meets the requirements of ANSI AAMI EC13 2002 Sect 4 2 9 14 Noise Suppression of Tested according to the test method in ECI3 2002 Electrotome Sect 5 2 9 14 it accords with the standar
142. ntact your service personnel NIBP Self Test Error Sensor or other hardware feb Contact your service errors personnel 32 Patient Monitor User Manual Alarm Information NIBP cuff or pump has a Check the NIBP cuff NIBP Pneumatic Leak Low and pump for leakage leakages Contact your service NIBP System Failure Hardware abnormal High personnel NIBP cuff isn t NIBP Cuff Leak Cuff pump or airway has a Low properly connected leakage or there is a leak in the airway Check whether the airway is occluded or pressure sensor k ly 1 NIBP Leak Test Error Hardware abnormal High dt e pressure meter mode If the problem still exists contact your service personnel Cuff is too 1 nf Use other method to NIBP Weak Signal ie x rev e Eure e measure blood pulse is too weak pressure m Make sure that the NIBP Excessive 9 Mog patient under noise is too large or pulse Low Ds Motion monitoring IS rate is not regular l motionless Maybe the patient blood eid ie p dd NIBP Range Exceeded pressure value is beyond the Low uc b aed is beyond the measurement range measurement range Check the The cuff pressure can t reach connections and the NIBP Air Leak the set value within 60sec Low wrapped cuff to see and 20sec in Neo mode whether they are all prepared well Inflate again and retry thrice Check The module isn t able to whether the patient
143. nu gt System Setup gt Date Time Setup 2 Adjust the date display format based on the user s habit 3 Set the correct time of Year Month Day Hour Min and Sec from the popup menu and press Exit 2 7 Handing Over the Monitor If you are handing over the monitor to the end users directly after configuration make sure that it is in the monitoring mode The users must be adequately trained to use the monitor before monitoring a patient To achieve this they should have access to and read the following documentation delivered with the monitor User Manual this book for full operating instructions Quick Reference Card for quick reminders during use Patient Monitor User Manual Basic Operation Chapter 3 Basic Operation This manual is for clinical professionals using the M50 and M80 patient monitors Unless otherwise specified the information here is valid for all the above products This user manual describes all features and options Your monitor may not have all of them they are not all available in all geographies Your monitor is highly configurable What you see on the screen how the menus appear and so forth depends on the way it has been tailored for your hospital and may not be exactly as shown here 3 1 Introducing M50 M80 Series The M50 M80 series patient monitors offers a monitoring solution optimized for the surgical cardiac medical and neonatal care environments The monitor stores data in t
144. omplex is the vertical difference between the ISO point and the ST point as shown in the diagram below The isoelectric ISO point provides the baseline and the ST point is at the midpoint of the ST segment The J point is where the QRS complex changes its slope as it is a fixed distance away from the ST point it can be useful to help you position the ST point correctly 59 Patient Monitor User Manual Monitoring ECG BD 5 oT ms 16 m DEF POINT The ST and ISO measurement points need to be adjusted when you start monitoring and if the patient s heart rate or ECG morphology changes significantly Always ensure that ST measurement points are appropriate for your patient Abnormal QRS complex is not considered in ST segment analysis 8 10 5 Adjusting ST and ISO Measurement Points Depending on your monitor s configuration the ST point can be positioned too These two points can be adjusted by turning the knob When adjusting ST measurement point the system will show the ST Measurement Point Window The system displays the QRS complex template in the window It is adjustable for the highlight bar in the window You may select ISO or ST switch the knob left or right to move the cursor line When the cursor is at the required position you may select the base point or the measurement point 8 11 Arr Monitoring 8 11 1 Arrhythmia Analysis The arrhythmia algorithm is used to monitor ECG of neonatal and adult patients in clinics
145. on please refer to the following table Indication Status Steady green light System OK Blinking green light Zeroing in progress Steady blue light Anesthetic agent present Steady red light Sensor error Blinking red light Check adapter 18 9 N2O and O2 Compensations The following models need O2 compensation IRMA AX IRMA CO2 ISA AX ISA CO2 The following models need N2O compensation details please refer to the following table IRMA CO2 and ISA CO2 For the compensation O2 Range SetO2 Range 0 30 vol 21 30 70 vol 50 70 100 vol 85 N20 Range Set N2O Range 0 30 vol 0 30 70 vol 50 109 Patient Monitor User Manual Freeze Chapter 19 Freeze 19 1 Overview When monitoring a patient you may freeze the waveforms of interest so as to view them carefully Generally you can review a frozen waveform of a maximum of 120 seconds The freeze function of this monitor has the following features M6 Freeze status can be activated on any operating screen B Once entering the Freeze status the system exits all other operating menus Besides the system freezes all waveforms in the Waveform area of the Basic Screen and also freezes Full Lead ECG waveforms and extra waveforms on the Full Lead ECG interface if any Nevertheless the Parameter area refreshes normally E The frozen waveforms can be reviewed and recorded 19 2 Entering Exiting F
146. on the monitor is correct 21 See the following section on how to perform air calibration Always verify gas readings and waveforms on the monitor before connecting the airway adapter to the patient circuit Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA airway adapter 106 Patient Monitor User Manual Monitoring AG 18 3 2 3 Zeroing WARNING Incorrect probe zeroing will result in false gas readings In order to secure high precision of the IRMA probe measurements the following zeroing recommendations should be followed Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe without connecting the airway adapter to the patient circuit and then using the host instrument to transmit a zero reference command to the IRMA probe Special care should be taken to avoid breathing near the airway adapter before or during the zeroing procedure The presence of ambient air 21 O2 and 0 CO2 in the IRMA airway adapter is of crucial importance for a successful zeroing If a ZERO REQ alarm should appear directly after a zeroing procedure the procedure has to be repeated Always perform a pre use check after zeroing the probe Allow 30 seconds for warm up of the IRMA AX probes after power on and after changing the IRMA airway adapter before proceeding with the zeroing procedure 18 3 2 4 Room Air Calibration of Oxygen Sensor Room air calibration of the oxygen sensor
147. onment in which radiated RF disturbances are controlled The customer or the user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the monitor as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of 1591317 to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d ED d EI d A V E E 0 01 0 12 0 12 0 23 0 1 0 36 0 37 0 74 1 1 16 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 162 Patient Monitor User Manual Default Settings C Default Settings This appendix documents the most important default settings of your monitor as it is delivered from the factory Not
148. ontact with other grounded conductive parts when connected to the isolated patient input of the device Such contact would bridge the patient s isolation and cancel the protection provided by the isolated input In particular there must be no contact of the neutralelectrode and ground 6 Magnetic and electrical fields are capable of interfering with the proper performance of the device For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation 7 Route all cables away from patient s throat to avoid possible strangulation Patient Monitor User Manual Intended Use and Safety Guidance WARNING 8 Devices connecting with monitor should be equipotential 9 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard IEC EN 60601 1 1 Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system standard IEC EN60601 1 1 If in doubt consult our technical service
149. oring The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions This information can be displayed in the form of ST numerics and snippets on the monitor ST segment monitoring function is shut off by default You can switch it to On when necessary When using the ST analysis function the ST analysis results will be displayed on the right of the main screen please refer to the following figure NOTE The ST algorithm has been tested for accuracy of the ST segment data The significance of the ST segment changes need to be determined by a clinician 8 10 1 Setting ST Analysis To change ST analysis please select ECG Setup gt ST Analysis then select On or Off from the pop up list 8 10 2 ST Display Your monitor screen may be configured to look slightly different from the illustrations ST I 008 aVR 009 V 0 04 II 0 10 aVL 0 03 III 0 02 aVF 0 06 NOTE 1 ST Analysis only can be used only in Adu mode 2 When setting ST Analysis to on the monitor should be in Diagnos mode 3 ECG monitoring should be in Diagnos mode 8 10 3 ST Analysis Alarm Setting The user can select ECG Setup gt ST Analysis gt Alarm Setup to set the upper alarm limit and lower alarm limit ALM HI can be set to 0 2 mV 2 0 mV and ALM LO can be set to 2 0 mV 0 2 mV ALM HI should be higher than ALM LO 8 10 4 About ST Measurement Points The ST value for each beat c
150. pdating a Patient You should always perform an update before starting monitoring for a new patient When you select Menu gt Patient Setup gt Quick Admit or Menu gt Patient Setup gt New Patient a message of Press Yes to create new patient profile by clearing all current patient data is displayed Ifthe user selects Yes the monitor will update the patient information If the user selects No the monitor won t update the patient information and returns to patient setup interface NOTE Discharging patient will clear the history data in the monitor associated with the patient 6 5 Central Monitoring System The monitor can be connected to the central monitoring system Through the network 1 The monitor sends patient information real time monitoring or measurement data alarm limit alarm level alarm message and all kinds of settings to the central monitoring system 2 The real time monitoring information is displayed on the central monitoring system as the same to the monitor and the central monitoring system can perform some bilateral control For example changing patient information receiving patient discharging patient and so forth For detailed information please refer to CMS MFM Central Monitoring System User Manual zd s Patient Monitor User Manual User Interface Chapter 7 User Interface 7 1 Setting Interface Style The user can set the interface based on the requirement and the set options i
151. po User Manual EDAN M50 M80 Patient Monitor Release 1 1 with Software Revision 1 2 C About this Manual P N 01 54 455005 11 Release Date Oct 2010 Copyright EDAN INSTRUMENTS INC 2009 2010 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 ex
152. r is battery powered and illuminates in yellow when battery is being charged The indicator is not illuminated when the monitor is not powered or when AC power is applied 24 2 Battery Status on the Main Screen Battery status shows the status of each battery detected and the combined battery power remaining with an estimate of the monitoring time this represents There is a sign E in the lower left corner of screen to show the charging status and the yellow part is the electric energy of battery When the monitor is not equipped with battery the When the monitor is powered by the battery the monitor will switch off automatically if there is battery status will be shown as the sign which means no battery no electric energy in the battery When there isn t enough electric energy a sign Lil is displayed on the screen 24 3 Checking Battery Performance The performance of rechargeable batteries may deteriorate over time Battery maintenance as recommended here can help to slow down this process 1 Disconnect the patient from the monitor and stop all monitoring and measurement 2 Switch the monitor power on and charge the battery for more than 6 hours continuously 3 Disconnect monitor from mains power and let the monitor run until there is no battery power left and the monitor shuts off 4 The running time of the battery reflects the battery performance If the running time is obviously less than the specified time in the
153. ra ERERER RE A 68 10 9 SNS SSIS HIV ICY serere E E Er EERE OEA EA EEE 68 Chapter 11 Monitoring PR vssssesscsssessscassssisecsssesnissvcnssscsvaesnessssessaessussascesssosuissbensscnsvacsnutssdectanssusssecave 69 INNEN GIVI m ren 69 E Nes cM Hiero tt T 69 11 3 Setting PR Vol m os iosisesssciacen set resin uu quii uad bus ERE DIU cb iotus Aen Pru E cz Cu T E EE E DRM LEA 69 14 4 Using Polsce Alarm S isi necrcabemus bids Potter E FOU C S 69 11 5 Selecting the Active Alarm SOURCES o iain tR Un IG p URB RUN tUm EN M UpD M MEDIUM MI SQUE Un 69 Chapter 12 Monitoring NIBP sssrini FE RUMP PAK VERI EDU KO RRTR VIVA URP UD RO DUET FRAU 70 c3 suco a N 70 12 2 NIBP Safety EGPOFEHADRORLu sexes enin po xS PRORA HRGIDUA Tk XR NES RQU EUN KHU EATER IM DERE PATRI NUM UU RM do 70 12 3 Introducing the Oscillometric NIBP M asuretustit coser pet Rescue rus EH eR PR HER RU PNE 70 12 4 Meas rement Limitations oen cp RA ai rie a uc a aaea TA 12 5 AUS ae eo a Mi clim T 71 T1205 Measurement Procedures siseses ae Ea a MEAM UM M EUnUME T2 12 6 1 Measurement Tor V6 MIOQUIO eaim tei tds titan x Ode bdpin EDI FERA I mr UM e EUN E p 126 2 Measurement for M3600 Module ditior ven ttesb ente ute orders nex eee 73 12 7 Ope ration Prompts NT c iie 75 12 8 Correcting the Measurement if Limb is not at Heart Level sssssesesssseessssseessseseesesses 75 12 9 NIBP Alare 5 ssatizce
154. rb din 23 43O MUE rS 23 4 3 4 Controlling Alarm Vol m 5 insassx sted ciataaaiesanbavannteasyaunXeiadshuntaaitameinsisadepieiuveatsineds 23 433 Seting Alarm LIMIS i a EE 23 4A Latehing Alarm S NT eenaa enan nae ER E A RE DOS 24 4 5 Testing Alarm sr cases cep E E E E R 24 ChapterS Alarm Information m 25 5 1 Physiological Alarm nForce poi xr pA UE RUM PR aes aaenae eee 25 5 2 Technical Alarm Dt Or AO su sveu rin bord is Vg P FH ERU For EPA Pao Ta rbv taped set oid piana pide cid 29 ame A PrOMDIS ME 40 5 4 Adjustable Range of Alarm Litas uei ees ese ebur peto estan oue Yen sera pax Eia areae Eos vain a uuei n 41 Chapter o Manasing PAUGHES susce inks tiri ct PERLKK V VER ATA DN meinen 46 SN Admiting NRI TETTE TOT E NEUE PEE 46 6 1 1 Patient Category and Paced Status oues pe ebbe Rind re RR FORE FOAU PNE NU FELIS ed FER edu D 46 6 2 COUT AGI adio qan bd ERI pip UR eee nS Si UD ea ER ordi a rb ante 47 6 3 Editing Patient InfoLtmalIDEL su caer ness u uti SeEx In Een Ian lu dno ne REM En RO in tinta pa ERR tac pU INED RS 47 6 4 Updating a PODES eto RODEO MR EM ME RM MM EI D MUN 47 6 5 Central Monitoring Syste spuert ae soqub vuota debili es piv sua Pu dtu oa a uv orb vd sse Mod ES 47 Chapter 7 User InferTAGe ise oen iste bored Ua s teda Pe bos e RE pu OPE sacs beU ER e vV OE p eV VE ee FQ Vn YU PEE Ve 1lY e dL Ure eU EVE bb Eb ed va 48 TA Setting Interface Stylesin cuban da pue ado does dou pida de un DAS aa Sae EE 48
155. reeze Status 19 2 1 Entering Freeze Status In the Non Freeze status press the FREEZE button on the control panel of the monitor to let the system exit the Menu being currently displayed if available then enter the Freeze status and display the popup FROZEN menu In the Freeze status all other waveforms are frozen In other words the system will no longer refresh all other waveforms 19 2 2 Exiting Freeze Status In the Freeze status executing any of the following operations will command the system to exit the Freeze status Select the Exit option in from the Frozen menu Press the Freeze button on the control panel again Press the non immediate to execute button for example once a button is pressed a menu will pop up for you to further select an option on the front panel and system buttons of Menu and Main Execute any operation that may trigger the adjustment of the screen or the display of a new menu After exiting the Freeze status the system will discharge the Freeze status clear screen waveforms and resume display real time waveforms In the Screen Refresh mode the system will sweep the waveforms from left to right in the Waveform Area Press the Freeze button on the control panel and the Frozen menu will appear on the bottom part of the screen At the same time the system enters the Freeze status BH REC WAVE it can be set to any waveform of 8s such as IBP1 CO2 PLETH etc It can also be set to OFF
156. rend and event You can see tabular trends vital signs and document them on a local 3 1 1 M50 Major Parts and Keys The M50 patient monitor has an 8 4 inch TFT color flat panel display Up to 11 waves can be shown on M50 screens eG t EDAN 10 3 4 5 67 8 9 M50 Front View 1 Alarm indicator The color and flash frequency vary with alarm level 2 Switch When the monitor is connected to the AC power press it to start the monitor Then by pressing and holding it Patient Monitor User Manual Basic Operation you can shut off the monitor 3 Battery indicator refer to Section Battery Indicator for details 4 Mute Press and hold it to enter alarm silence status and the alarm sound stops Press it only and the alarm sound pauses 5 Start stop NIBP measurement Press it to start inflating the cuff and performing NIBP measurement Then press it again to stop measurement and deflate the cuff 6 Trend Press it to enter trend review interface 7 Freeze In normal mode press it to enter frozen status Press it again to unfreeze the system 8 Record Press it to start realtime recording Press it again to stop recording 9 Menu Press the item to open the menu 10 Rotary Knob hereinafter called knob The user can rotate the knob clockwise or anticlockwise This operation can make the highlighted item shift up down left or right to choose the
157. rom SYSTEM MENU and pick PAT TYPE item and turn the knob to select the required patient type Select a measurement mode in the NIBP SETUP menu Refer to the following paragraphs Operation Prompts for details Press the NIBP button on the front panel to start a measurement and press it again to finish the NIBP measurement e Patient Monitor User Manual Monitoring NIBP 12 7 Operation Prompts 1 Manual Measuring Access the NIBP Setup menu and set the Measure Mode item to Manual Measuring Then press the NIBP button on the front panel to start a manual measurement During the idle period of measurement process press the NIBP button on the front panel at any time to start a manual measurement Then press the N button on the front panel to stop manual measurement and the system continues to execute auto measurement program according to the selected time interval 2 Automatical Measurement Access the NIBP Setup menu and set the Measure Mode item to Auto Measuring then press the NIBP button on the front panel to start the automatical measurement according to the selected time interval 3 Continuous measurement Access the NIBP Setup menu and pick the Continual item to start a continuous measurement The continuous measurement will last 5 minutes 4 Stopping continuous measurement During continuous measurement press the Start button on the front panel at any time to stop continuous measurement 12 8 Correcting the Measurement
158. ronment specified below The customer or the user of the monitor should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions The monitor uses RF energy only for its internal CISPR 11 Groug 1 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission The monitor is suitable for use in all CISPR 11 Class A establishments other than domestic establishments and those directly connected to Harmonic emissions Class A the public low voltage power supply network IEC EN 61000 3 2 that supplies buildings used for domestic urposes Voltage fluctuations ia flicker emissions Complies IEC EN 61000 3 3 B 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunit g The monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Electromagnetic Immunity test IEC EN 60601 test level Compliance level environment guidance Electrostatic t6 kV contact 6 kV contact Floors should be wood i ic tile discharge ESD 48 kV air 48 kV air csi Or iia pa IEC EN 61000 4 2 oor are covere wi synthetic material the relative humidity should be at least 3096 Electric
159. rval of 5 consecutive ventricular wave is less than 600 ms Ventricular Rhythm The interval of consecutive ventricular wave ranges from 600 ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular wave is more than 1000 ms Startup time for Tachycardia Ventricular Tachycardia Gain 1 0 5s 1 mV 206bpm Gain 0 5 15 s Gain 2 0 4s Ventricular Tachycardia Gain 1 0 3s 2 mV 195bpm Gain 0 5 6s Gain 2 0 3s Response time of Heart Rate Meter to Change in HR HR range 80 bpm 120 bpm Range 7s 8s average is 7 5s HR range 80bpm 40bpm Range 7s 8s average is 7 5s Tall T wave Rejection Exceeds ANSI AAMI EC13 2002 Sect 3 1 2 1 minimum recommended 1 2mV T Wave amplitude C Accuracy of Heart Rate Meter and Response to Irregular Rhythm According with ANSI AAMI EC13 2002 Sect 4 1 2 1 e The HR value displays after a stable period of 20s Ventricular bigeminy 80bpm Slow alternating ventricular bigeminy 60bpm Rapid alternating ventricular bigeminy 120bpm Bidirectional systoles 90bpm 144 Product Specification Patient Monitor User Manual A 8 2 12 lead Monitoring 3 Lead I II III Lead Mode 5 Leads I II III aVR aVL aVF V 12 Lead I IL IIL aVR aVL aVF V1 V2 V3 V4 V5 V6 Waveform 3 Lead 1 channel waveform 5 Lead 2 channel waveform max seven waveforms 12 Lead 2 channel waveform max 13 waveforms
160. s It is important to set the paced status correctly when you start monitoring ECG To change the paced status in the ECG Setup menu select Pace to toggle between Yes or No When Pace is set to Yes Pace Pulse Rejection is switched on This means that pacemaker pulses are not counted as extra QRS complexes Paced symbol is displayed as on the main screen NOTE 1 When monitoring a patient with a pacemaker set Pace to On If monitoring a patient without a pacemaker set Pace to Off 2 If Pace is set to On the system will not perform some types of ARR analysis WARNING Some pace pulses can be difficult to reject When this happens the pulses are counted as a QRS complex and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias Keep pacemaker patients under close observation 8 9 6 ECG Calibration This item is used to calibrate ECG waveform When you select this item from ECG Setup menu again the ECG waveform calibration ends NOTE The device can t be monitored during ECG calibration 8 9 7 ECG Waveform Settings To change this speed select ECG Wave Setup gt Sweep then select an appropriate setting from the pop up list The bigger the value is the wider the waveform is 8 9 8 12 Leads ECG When the monitor is installed with 12 lead it can provide 3 lead 5 lead and 12 lead ECG monitoring functions 58 Patient Monitor User Manual Monitoring ECG 8 10 ST Segment Monit
161. s if necessary m Wash sites thoroughly with soap and water Never use ether or pure alcohol because this increases skin impedance 52 Patient Monitor User Manual Monitoring ECG m Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease 8 6 2 Connecting ECG Cables 1 Attach clip or snap to electrodes prior to placement 2 Put the electrodes on the patient Before attaching apply some conductive jelly on the electrodes if the electrodes are not electrolyte self supplied 3 Connect the electrode lead to the patient s cable 8 7 Selecting Lead Type To change the lead type please 1 Select the ECG parameter area open the ECG Setup menu 2 Set Lead Type to 3 Leads 5 Leads or 12 Leads based on the lead used 8 8 Installing Electrodes NOTE The following table gives the corresponding lead names used in Europe and America respectively Lead names are represented by R L F N C C1 C6 in Europe whose corresponding lead names in America are RA LA LL RL V V1 V6 AHA American Standard IEC Europe Standard Electrode Labels Color Electrode Labels Color RA White R Red LA Black L Yellow LI Red F Green RL Green N Black V Brown C White VI Brown Red CT White Red V2 Brown Yellow C2 White Yellow V3 Brown Green C3 White Green V4 Brown Blue C4 White Brown V5 Brown Orange C5 White Black V6 Brown Purple C6 White
162. s including neutral electrodes are securely attached to the patient but not the conductive part or ground Check every day whether there is skin irritation resulted from the ECG electrodes If yes replace electrodes every 24 hours or change their sites Place the electrode carefully and ensure a good contact Check if the lead connection is correct before monitoring If you unplug the ECG cable from the socket the screen will display the error message ECG LEAD OFF and the audible alarm is activated When using the monitor with the defibrillator or other high frequency equipment please use counteracting defibrillation ECG lead to avoid cautery When using Electrosurgery ES equipment do not place an electrode near the grounding plate of the Electrosurgery device otherwise there will be a great deal of interference with the ECG signal For patients with pacemakers the pacing impulse analysis function must be switched ON Otherwise the pacing impulse may be counted as normal QRS complex which results in failure of ECG LOST error detection NOTE 1 Interference from a non grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform IEC EN60601 1 2 protection against radiation is 3v m specifies that the electrical field density exceeding 1v m may cause measurement error in various frequencies It is accordingly suggested that do not use equipment generating electrical radiation near EC
163. se only Edan approved accessories Using non edan approved accessories may compromise device functionality and system performance and cause a potential hazard 3 Do not use a sterilized accessory if its packaging is damaged The following cables may not all be available in all countries Please check availability with your local Edan supplier 28 1 Standard Accessories The standard accessories are listed in the below table Part Number Accessories 12 01 109069 EDAN SHI Adult Reusable SpO2 Sensor Lemo 11 57 40029 Adult Cuff 25 35cm CM1203 01 59 036104 NIBP Tube with Connector CM1203 01 57 040187 Skin Temperature Probe C10KO 01 57 040190 11 5 lead snap connector ECG cable IEC standard 11 57 471010 ECG monitoring Cable With 5 lead Wires AHA Standard 11 57 040159 Adult Disposable Adhesive Electrodes 11 57 040193 Adult Pediatric Disposable Adhesive Electrodes 11 13 01950 Power cable 01 13 36014 Power Cable IEC Standard 220V 11 13 36015 Power Cable AHA Standard 11 21 064142 Rechargeable Lithium Ion Battery 14 8V 2 1Ah 11 21 064143 Rechargeable Lithium Ion Battery 14 8V 4 2Ah 11 13 114214 SE 1 Ground Cable 01 54 455005 User Manual 133 Patient Monitor User Manual 28 2 Optional Accessories 28 2 1 ECG Accessories The following table lists the optional configuration for the monitor Accessories 01 57 041091 11 3 Lead Snap Connector ECG Cabl
164. sonal injury NOTE 1 Make sure the nail covers the light window The wire should be on the backside of the hand 2 SpO waveform is not proportional to the pulse volume 3 Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line 66 Patient Monitor User Manual Monitoring SpOs 4 Don t use the functional tester to access the SpO accuracy The function of SpO measurement does not require calibration The materials with which the patient or any other person can come into contact conform with the standard of SO10993 10 3 Measuring SpO 1 Select the correct patient category setting adult pediatric and neonatal as this is used to optimize the calculation of the SpO and pulse numerics 2 During measurement ensure that the application site has a pulsatile flow ideally with a good circulation perfusion has not changed in its thickness causing an improper fit of the sensor 10 4 Measurement Procedure 1 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 SpO2 module Mounting of the Sensor WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment If the skin quality changes move the sensor to another site Change the application site at least every four hours NOTE Inj
165. specification please change the battery or contact the service personnel WARNING 1 Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions thoroughly 2 Do not connect the positive and negative terminals with metal objects and do not put the battery together with metal object which can result in short circuit 3 Do notunplug the battery when monitoring 4 Do not heat or throw battery into a fire 124 Patient Monitor User Manual Using Battery WARNING 5 Do not use leave battery close to fire or other places where temperature may be above 60 C Do not immerse throw or 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 or drop to cause strong shock Do not disassemble or modify the battery 8 Use the battery only in the monitor Do not connect battery directly to an electric outlet or cigarette lighter charger 9 Do not solder the leading wire and the battery terminal directly 10 If liquid leaking from the battery gets into your eyes do not rub your eyes Wash them well with clean water and go to see a doctor immediately If liquid leaks of the battery splash onto your skin or clothes wash well with fresh water immediately 11 Keep away from fire immediately when leakage or foul odor is detected 12 Stop using the ba
166. ss the Start button the device will begin calibrating 10 Wait for the calibrated result You should take corresponding measures based on the prompt information 11 After calibration disassemble the blood pressure tubing and the attached 3 way valve i S E Buen 1 Hydrargyrum pressure meter 2 3 way connector 3 3 way stopcock 4 Pressure transducer 5 Pressure transducer interface cable 6 Monitor IBP Calibration 15 9 Troubleshooting the Pressure Calibration The status line lists the probable reasons of an unsuccessful calibration Message Corrective Action Art SENSOR OFF FAIL Make sure that sensor is not off then start the calibration Contact service technician if necessary IN DEMO FAIL Make sure that the monitor is not in DEMO mode Contact service technician if necessary PRESSURE OVER RANGE FAIL Make sure that you have selected transducer value in IBP CAL then start the calibration Contact service technician if necessary Pulsate Pressure Calibration Fail Make sure that pressure value shown by hydrargyrum pressure meter is changeless Contact service technician if necessary 15 10 IBP Alarm When IBP alarm is set to On the physiology alarm occurs if any measurement value of Systolic pressure Mean pressure or Diastolic pressure exceeds alarm limit Users can adjust the alarm
167. t AWRR 30 30 100 Alarm Low Limit AWRR 8 8 30 167 Patient Monitor User Manual Default Settings Sweep 12 5mm s Amplitude Low C 12 AG AG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Measure Apnea Time 20s Unit O Compensate OFF Anes Agent HAL Alarm High Limit EtAA 8 0 8 0 8 0 Alarm Low Limit EtAA 0 0 0 0 0 0 Alarm High Limit FiAA 6 0 6 0 6 0 Alarm Low Limit FiAA 0 0 0 0 0 0 Alarm High Limit EtN O 55 23 55 Alarm Low Limit EtN20 0 0 0 Alarm High Limit FiN O 53 23 33 Alarm Low Limit FIN O 0 0 0 Alarm High Limit EtO 90 0 90 0 90 0 Alarm Low Limit EtO 18 0 18 0 18 0 Alarm High Limit FiO2 88 0 88 0 88 0 Alarm Low Limit FiO2 18 0 18 0 18 0 Sweep 12 5mm s Amplitude 2 168 Patient Monitor User Manual D Abbreviations Abbreviation Abbr English Full Name Description AC Alternating current Adu Adult AG Anaesthesia gas Art Arterial aVF Left foot augmented lead aVL Left arm augmented lead aVR Right arm augmented lead awRR Airway respiration rate BP Blood pressure BTPS Body temperature and pressure saturated CI Cardiac index CO Cardiac output CISPR International Special Committee on Radio Interference CMS C
168. t is tested during the period 1 75 times of the average RR MISSED BEATS interval or User selectable When HR is higher than 100beat min no beat is tested within 1 second IRREGULAR RHYTHM The patient has irregular IRR heart rate check patient s condition electrodes cables User selectable and leads 25 Patient Monitor User Manual Alarm Information PACE NOT CAPTURE After the pacemaker is paced DNE QRS complex can not be detected during 300ms Rea pean PNP PACER NOT PACED After the QRS complex no U lectabl pace is detected during 1 75 times of RR interval LUE VENTRICULAR BRADYCARDIA The patient has VBRADY irregular HR and his average HR is less than 60bpm User selectable Check his condition electrodes cables and leads VENTRICULAR RHYTHM The patient has irregular VENT heart rate check patient s condition electrodes cables User selectable and leads RESP APNEA RESP can not be measured within specific time High interval RR High RESP measuring value is above upper alarm limit User selectable RR Low RESP measuring value is below lower alarm limit User selectable HR High HR measuring value is above the upper alarm limit User selectable HR Low HR measuring value is below the lower alarm limit User selectable SpO High SpO measuring value is above upper alarm limit User selectable SpO Low SpO measuring value is belo
169. taff to install and set the recorder 39 Patient Monitor User Manual Alarm Information 5 3 Prompts Message Cause SpO module is analyzing the patient Peaca te Gee connected with patient Manual Measuring In manual measuring mode Continual Measuring In continuous measuring mode Auto Measuring In automatic measuring mode Measure Abort Measurement over Calibrating During calibrating Calibrate Abort Calibration over Leak Testing During pneumatic test Leak Test Ok NIBP module has passed leak test Leak Test Abort Pneumatic test over Resetting NIBP module in resetting Please Start NIBP module is in idle status Done NIBP measurement successfully done NIBP module performs continual Continual Measuring measuring Stat Measuring NIBP module performs STAT function NIBP module is in normal mode the user can t start leak test and pressure calibration Please Switch To Maintain Mode Please enter User Maintain gt NIBP Maintain and switch to Maintain Mode to perform leak tset or pressure calibration NIBP module is in maintain mode the user can t start blood pressure measurement Please Switch To Normal Mode Please enter User Maintain gt NIBP Maintain and switch to Normal Mode to perform blood pressure measurement Quick TEMP Is Warming Up Quick TEMP Is Warming Up Place Probe On Measure Place Probe isn t placed on the measurement si
170. te 40 Patient Monitor User Manual Alarm Information CO Standby Turn from measuring mode to standby mode making the module in energy saving status CO Sensor Warm Up The CO module is in warm up state Excessive CO Temp TB measuring value is beyond measuring range Excessive Temp Measurement Fail CO CO measuring needs parameters CO measure need param HEMOD calculation needs parameters Dynamics Insufficient factors for Hemod HEMO Dynamics calculation needs parameters No Sensor CO measurement fail No Sensor CO measurement fail Measuring The CO module is performing measuring Ready for new measurement CO module is ready for new measurement Invalid CO result CO measurement result is invalid CO Measurement Complete CO Measurement is completed CO Measurement Abort CO Measurement is aborted Warm up over The monitor displays this message after taking the sensor out of the bracket and warm up is over Measure over After the Predict measuring is over the data and message display on the interface Measure time out No measuring result after the module entering Predict state for 30s AG Standby AG module is operating in the standby status 5 4 Adjustable Range of Alarm Limits ECG alarm limits are listed as follows unit bpm Patient Type ALM HI ALM LO HR AD
171. tensions re adjustments modifications 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 I 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 c eere eee eee eese eee esee eene eren netta seen na see 1 BB roS NT PP ba eae 1 DEMIR NS gate tim fa ON Pd aaa cars ora es ese os pa a eee 1 1 3 Explanation of Symbols on the Monitor 5 csssassscdcccsnasesnnen sadistanssdsansnancendestdstenssad adinactaansnantiats 4 Chapter 2 UistallatiG LP 7 2 minal TERRI C LACM oce PEpPER Pd E a ERNURKRITAN EIN E det nde Dip ER Und PE REDE ia PIDE de Rie tru HAE J 2 2 Nous the
172. ter waveform 3 2 1 Using Keys The monitor has four different types of keys 3 2 1 1 Permanent Keys A permanent key is a graphical key that remains on the screen all the time to give you fast access to functions Menu enter the main setup menu E3 Mute key close the audio alarm to switch off the alarm 3 2 1 2 Shortcut Keys A shortcut key is a configurable graphical key located at the bottom of the main screen It gives you fast access to functions The selection of shortcut keys available on your monitor depends on your monitor configuration and on the options purchased Directly select this item on the screen to quickly admit a patient Directly select this item on the screen to enter trend graph review interface Directly select this item on the screen to enter trend table review interface Directly select this item on the screen to enter the alarm event review interface Directly select this item on the screen to enter the NIBP review interface Directly select this item on the screen to enter the ARR review interface Directly select this item on the screen to enter the TrendScreen interface E e C 4 m R Directly select this item on the screen to enter the standard interface Directly select this item on the screen to enter the OxyCRG interface T Re NETS Patient Monitor User Manual Basic Operation Directly select this item on the screen to enter t
173. than 1200ms then the four most recent RR intervals are averaged to compute the HR Range of Sinus and SV Rhythm Brady ADU 120 bpm 300 bpm PED NEO 160 bpm 350 bpm Normal ADU 40 bpm 120 bpm PED NEO 60 bpm 160 bpm Tachy ADU 15 bpm 40 bpm PED NEO 15 bpm 60 bpm Range of Ventricular Rhythm Ventricular Tachycardia The interval of 5 consecutive ventricular wave is less than 600 ms Ventricular Rhythm The interval of consecutive ventricular wave ranges from 600 147 Patient Monitor User Manual Product Specification ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular wave is more than 1000 ms Startup time for Tachycardia Ventricular Tachycardia Gain 1 0 5s 1 mV 206bpm Gain 0 5 15 s Gain 2 0 4 s Ventricular Tachycardia Gain 1 0 3s 2 mV 195bpm Gain 0 5 6 s Gain 2 0 3s Response time of Heart Rate Meter to Change in HR HR range 80 bpm 120 bpm Range 7s 8s average is 7 5s HR range 80bpm 40bpm Range 7s 8s average is 7 5s Tall T wave Rejection Exceeds ANSI AAMI EC13 2002 Sect 3 1 2 1 C minimum recommended 1 2mV T Wave amplitude Accuracy of Heart Rate Meter and Response to Irregular Rhythm According with ANSI AAMI EC13 2002 Sect 4 1 2 1 e The HR value displays after a stable period of 20s Ventricular bigeminy 80bpm Slow alternating ventricular bigeminy 60bpm Rapid alternating ven
174. the pressure line making sure that there is no air present in the catheter or pressure line 4 Position the transducer so that it is at the same level with the patient s heart approximately mid axillary line 5 Forthe label name selection please refer to Selecting a Pressure for Monitoring 82 Patient Monitor User Manual Monitoring IBP 6 Tozero the transducer please refer to Zeroing the Pressure Transducer WARNING If there are air bubbles in the pressure line or the transducer you should flush the system with the solution to be infused 15 4 Selecting a Pressure for Monitoring Tell the monitor which pressure you want to monitor by selecting its pressure label The label is a unique identifier for each type of pressure When you choose a label the monitor uses that label s stored settings for example color wave scale and alarm settings The label also determines which algorithm is used to process the pressure signal so an incorrect label can lead to incorrect pressure values To select the lable please refer to the following table Label Description ART Arterial blood pressure PA Pulmonary artery pressure CVP Central venous pressure ICP Intracranial pressure LAP Left atrial pressure RAP Right atrial pressure P1 P2 Alternative non specific pressure labels 15 5 Zeroing the Pressure Transducer To avoid inaccurate pressure readings the monitor requires a valid zero Z
175. ting Work Mode There are two woke modes Measure and Standby To change the work mode please refer to the following steps 1 Select the AG Setup menu 2 Select Work Mode on the interface and select Measure or Standby from the popup list 18 5 Setting Alarms Here we take CO2 alarm for example This refers to CO specific alarms See the Alarms Chapter for general alarm information To change the alarm please refer to the following steps 1 Select the CO Setup menu 2 Select EtCO Alarm High Limit or EtCO Alarm Low Limit to adjust the alarm limit 18 6 Setting Apnea Alarm Time This determines the time limit after which the monitor gives an alarm if the patient stops breathing 1 Select the AG Setup menu to open it 2 Select Apnea Alarm from the menu 3 Choose the apnea alarm time from the pop up list 18 7 Working Status of ISA analyzer Woking status of the ISA analyzer can be indicated by the indicator For the detailed information please refer to the following table Indication Status Steady green light System OK Blinking green light Zeroing in progress Steady blue light Anesthetic agent present Steady red light Sensor error 108 Patient Monitor User Manual Monitoring AG Blinking red light Check sampling line 18 8 Working Status of IRMA Module The working status of the IRMA module can be transmitted by the IRMA probe For the detailed informati
176. tion Message Cause Alarm level ECG Too Weak Can not detect the signal in designated time period High ST measuring value is above the upper alarm limit X ST X High stands for I II III aVR aVL aVF V V1 V2 V3 User selectable V4 V5 or V6 ST measuring value is below the lower alarm limit X ST X Low stands for I II III aVR aVL aVF V V1 V2 V3 User selectable V4 V5 or V6 ASYSTOLE No QRS is detected for 4 consecutive seconds User selectable Ventricular tachycardia The fibrillation wave lasts for 4 ti th f ti VFIB VTAC consecutive seconds or the number of continuous selectable Vent beats is larger than the upper limit of cluster Vent beats gt 5 The RR interval is less than 600ms VT gt 2 3 lt the number of cluster PVCs lt 5 User selectable COUPLET 2 consecutive PVCs User selectable BIGEMINY Vent Bigeminy User selectable TRIGEMINY Vent Trigeminy User selectable A type of single PVC under the condition that HR lt 100 R R interval is less than 1 3 the average RONT interval followed by a compensating pause of 1 25X User selectable the average R R interval the next R wave advances onto the previous T wave PVC Single PVCs not belonging to the type of above Useieselsctable mentioned PVCs TACHY m QRS complex RR interval is less than lacer BRADY oo QRS complex RR interval is longer than User selectable When HR is less than 100 beats min no heart bea
177. to increase or Switch On M decrease the alarm Level Mid v Setting value of dii high alarm limit 50 v Setting value of Low low alarm limit 1 4 4 Latching Alarms To set the alarm latch function please select Menu gt Maintenance gt User Maintain gt Alarm Setup and set Alarm Latch from the pull down list If it is set to On when an alarm occurs the monitor will display the alarm message of the parameter in the alarm status area If the parameter resumes to normal the alarm information of this parameter still displays in the alarm display area and the alarm time is also displayed If many parameters appear to be latching alarms the alarm messages are displayed in the physiological alarm message area in turn To deselect the alarm latch please set Alarm Latch to Off When Alarm Latch is set to Off the latch function is invalid 4 5 Testing Alarms When you switch the monitor on a selftest is started You must check that 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 24 Alarm Limit Alarm Limit Patient Monitor User Manual Chapter 5 Alarm Information 5 1 Physiological Alarm Information Alarm Informa
178. to place when properly seated 3 A green LED indicates that the IRMA probe is ready for use 4 Connect IRMA airway adapter 15mm male connector to the breathing circuit Y piece 104 Patient Monitor User Manual Monitoring AG 7 5 Connect the IRMA airway adapter 15mm female connector to the patient s endotracheal tube Alternatively connect an HME Heat Moisture Exchanger between the patient s endotracheal tube and the IPMA probe Placing an HME in front of the IRMA probe protects the airway adapter from secretions and effects of water vapor and eliminates the need of changing the adapter It allows free positioning of the IRMA probe as well 6 Unless the IRMA probe is protected with an HME always position the IRMA probe with the status LED pointing upwards 105 Patient Monitor User Manual Monitoring AG 18 3 2 1 Placement of IRMA Probe When connecting IRMA probe to an infant patient circuit it is important to avoid a direct contact between the IRMA probe and the infant s body If for whatever the reason the IRMA probe is in direct contact with any parts of the infant s body an insulation material shall be placed between the IRMA probe and the body WARNING The IRMA probe is not intended to be in long term skin contact 18 3 2 2 Performing a Pre use Check Prior to connecting the IRMA airway adapter to the breathing circuit verify the O2 calibration by checking that the O reading
179. tput CO measurement is performed by using Thermodilution method The monitor can determine blood temperature measure cardiac output and perform hemodynamic calculations You can have iced injecta using either the flow through system or individual syringes of injecta You can perform up to 6 measurements before editing the average Cardiac Output The prompt message on the screen will tell you when to inject 17 2 CO Safety Information WARNING 1 Make sure that appurtenance applied is in conformity with relevant Medical Device Safety Requirements 2 Appurtenance should be avoided from contact with conductive metal body when being connected or applied NOTE To replace the catheter thermistor please enter the catheter computation coefficient into the Constant item according to the instruction 17 3 CO Monitoring Procedures 1 Plug the CO interface cable into the CO socket and turn on the monitor 2 Attach the injectate probe connector and catheter thermistor connector to the appropriate parts of the cardiac output interface cable And open the patient information window to confirm the patinet s height and weight 4 Pick the CO Measure item in the CO Option menu 5 You can perform more than one measurement as required 6 After the completion of the measurement access the CO Measure window for Review to edit the measured data 93 Patient Monitor User Manual Monitoring CO o 1600000 amp 1 Monitor 2 T
180. tricular bigeminy 120bpm Bidirectional systoles 90bpm 12 lead ECG synchronization analysis 208 kinds of diagnosis results Average parameters of heart beat Heart rate bpm Time limit of P wave ms PR interval ms QRS interval ms QT QTC ms P QRS T AXIS A 9 RESP Method Impedance between RA LL RA LA Base line Impedance Range 200 2500Q no leads cables resistance 148 Patient Monitor User Manual Product Specification 22009 4500 leads cables 1KQ resistance Measuring Sensitivity 0 3Q baseline impedance is 1KQ Max dynamic range 500Q resistance 3Q variable resistance no clipping Waveform bandwidth 0 2Hz 2 5Hz 3dB RR Measuring and Alarm Range Adult 6 rpm 120rpm Neo Ped 6 rpm 150rpm Resolution 1 rpm Accuracy 2 rpm Gain Selection x0 25 x0 5 x1 x2 x3 x4 x5 A 10 NIBP A 10 1 NIBP from V6 Module Method Oscillometric Mode Manual Auto Continuous Measuring interval in AUTO Mode 1 2 3 4 5 10 15 30 60 90 120 240 480 min Continuous 5min interval is 5s Measuring type Systolic Pressure Diastolic Pressure MAP Pressure Alarm type SYS DIA MAP Measuring and Alarm Rang Adult mode SYS 40 mmHg 270 mmHg DIA 10 mmHg 215 mmHg MAP 20 mmHg 235 mmHg Pediatric mode SYS 40 mmHg 200 mmHg DIA 10 mmHg 150 mmHg MAP 20
181. ttery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor 13 Do not use a battery with serious scar or deformation 24 4 Replacing the Battery To install or replace the battery please follow the procedure Battery Door 1 Pull the battery door downwards to open it accoding to indication on it Pull the metal retainer until the battery can be removed Insert the new battery into the battery compartment B i gd Pull the metal retainer downward to fix the battery and close the battery door 125 Patient Monitor User Manual Using Battery 24 5 Recycling the Battery When the battery no longer holds a charge it should be replaced Remove the old battery from the monitor and recycle it properly NOTE To prolong the life of rechargeable battery it is recommended to charge it at least once every month and it must be done after the electric energy runs out 24 6 Maintaining the Battery Batteries should be conditioned regularly to maintain their useful life Discharge the battery completely once every month And remove the battery from the monitor when the monitor isn t used for a long time 126 Patient Monitor User Manual Care and Cleaning Chapter 25 Care and Cleaning Use only the EDAN approved substances and methods listed in this chapter to clean or disinfect your equipment Warranty does not cover damage cause
182. u troubleshooting the problem and will make every effort to solve it over the phone or Email avoiding potential unnecessary returns In case a return can not be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA form that includes the appropriate return address and instructions An RMA form must be obtained prior to any return Freight policy Under warranty the service claimer is responsible for freight amp insurance charges when a return is shipped to EDAN for service including custom charges EDAN is responsible for freight insurance amp custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for any freight insurance amp custom charges for product 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 132 Patient Monitor User Manual Accessories Chapter 28 Accessories You can order accessories from EDAN supplies at www edan com or consult your local Edan representative for details WARNING 1 Never reuse disposable transducers sensors accessories and so forth that are intended for single use or single patient use only Reuse may compromise device functionality and system performance and cause a potential hazard 2 U
183. uence the storage of trend data 3 5 Adjusting Volume 3 5 1 Adjusting Key Volume The key volume is the volume you hear when you select any field on the monitor screen or when you turn the knob To adjust the key volume please 1 Select the Key Volume key on the screen directly or 2 Select Menu gt System Setup gt Key Volume then select the appropriate setting for the key volume Five is the loudest and Zero is the quietest 3 5 2 Adjusting Alarm Volume To change the alarm volume please 19 Patient Monitor User Manual Basic Operation 1 Press the Alarm Volume key on the screen directly or 2 Select Menu gt Alarm Setup gt Alarm Volume and select the desired setting from the popup interface For detailed information please refer to Section Controlling Alarm Volume 3 5 3 Adjusting Beat Volume To change the beat volume please press the Beat Volume key on the screen directly or refer to Section Setting Beat Volume 3 6 Checking Your Monitor Version To check the monitor version please select Menu gt Common Function gt About to check the monitor software revision 3 7 Networked Monitoring Your monitor can be connected to the wired network and the wireless network If the monitor is networked a network symbol is displayed on the screen NOTE Be aware that some network based functions may be limited for monitors on wireless networks in comparison to those on wired networks 3 8 Setting Languages
184. ula airway adapter or sample line from the sensor when the sensor is not in use 16 3 2 2 Removing Exhaust Gases from the System WARNING Anesthetics When using the sidestream CO measurement on patients who are receiving or have recently received anesthetics connect the outlet to a scavenging system to avoid exposing medical staff to anesthetics Use an exhaust tube to remove the sample gas to a scavenging system Attach it to the sidestream sensor at the outlet connector 16 3 3 C5 CO Module NOTE You must perform a zero calibration as described in this procedure each time you use a new airway adapter C5 CO module 16 3 3 1 Measurement Steps 1 Attach the sensor connector to the CO connector on the monitor 2 Wait two 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 89 Patient Monitor User Manual Monitoring CO2 Connecting Sensor 4 To zero the sensor please refer to zeroing the sensor 5 Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y section Connecting Airway Adapter WARNING 1 The CO sensor should be contrasted with calibration gas every 12 months Accuracy is affected by temperature and barometric pressure It is forbidden to insert or draw out the module when t
185. uld be sent to the special agencies according to local regulations for separate collection after its useful life Patient Monitor User Manual Installation Chapter 2 Installation NOTE 1 The monitor settings must be specified by the authorized hospital personnel 2 To ensure that the monitor works properly please read the user manual and follow the steps before using the monitor 2 1 Initial Inspection Before unpacking check the packaging and ensure that there are no signs of mishandling or damage If the shipping cartons are damaged contact the carrier for compensation and package it again Open the package carefully and remove the monitor and accessories Check that the contents are complete and that the correct options and accessories have been delivered If you have any question please contact your local supplier 2 2 Mounting the Monitor If all situations are normal please place the monitor on a flat level surface hung on the bed rail or mounted on a wall About how to install the wall mount for the monitor please refer to the following content 2 2 1 Installing Wall Mount for the Monitor For how to install wall mount for the monitor please refer to Wall Mounting Bracket Assembly Instruction 2 3 Connecting the Power Cable Connection procedure of the AC power line is listed below 1 Make sure the AC power supply complies with the following specifications 100V 240V 50Hz 60Hz 2 Apply the po
186. w Limit Dia 50 40 20 Unit mmHg Interval Manual C 8 TEMP TEMP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit T1 39 0 39 0 39 0 Alarm Low Limit T1 36 0 36 0 36 0 Alarm High Limit T2 39 0 39 0 39 0 Alarm Low Limit T2 36 0 36 0 36 0 Alarm High Limit TD 2 0 2 0 2 0 Unit C 9 Quick TEMP Quick TEMP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit T1 39 0 39 0 Alarm Low Limit T1 36 0 36 0 Unit C C 10 IBP 166 Patient Monitor User Manual Default Settings IBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Unit mmHg Filter 12 5 Hz SYS DIA MAP SYS DIA MAP SYS DIA MAP Alarm High Limit ART 160 90 110 120 70 90 90 60 70 P1 P2 Alarm Low Limit ART 90 50 70 70 40 50 55 20 35 P1 P2 Alarm High Limit PA 35 16 20 60 4 26 60 4 26 Alarm Low Limit PA 10 0 0 24 4 12 24 4 12 MAP MAP MAP Alarm High Limit CVP 10 4 4 RAP LAP ICP Alarm Low Limit CVP 0 0 0 RAP LAP ICP C 11 CO CO2 Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Standby Unit mmHg Apnea Time 20s O Compensate 16 Anes Agent 0 Alarm High Limit EtCO2 50 50 45 Alarm Low Limit EtCO 15 20 30 Alarm High Limit FiCO2 4 4 4 Alarm High Limi
187. w lower alarm limit User selectable SpO No Pulse The signal er the measurement site is too weak so the High monitor can t detect the pulse signal PR High PR measuring value is above upper alarm limit User selectable PR Low PR measuring value is below lower alarm limit User selectable TI High Measuring value of T1 channel is above upper alarm Usersdectibi limit TI Low Measuring value of T1 channel is below lower alarm incus limit T2 High Measuring value of T2 channel is above upper alarm EN E limit T2 Low Measuring value of T2 channel is below lower alarm oada limit TD High Measuring value of TD channel is above upper alarm Useiessicetibds limit i lue of TD ch l is below 1 l TD Low Measuring value o channel is below lower alarm Dersen limit TEMP High Measuring value of TEMP is above upper alarm limit User selectable TEMP Low Measuring value of TEMP is below lower alarm limit User selectable SYS High SYS measuring value is above upper alarm limit User selectable 226 Patient Monitor User Manual Alarm Information SYS Low SYS measuring value is below lower alarm limit User selectable DIA High DIA measuring value is above upper alarm limit User selectable DIA Low DIA measuring value is below lower alarm limit User selectable MAP High MAP measuring value is above upper alarm limit User select
188. wer 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 2 4 Checking Out the Monitor Make sure there is no damage on the measurement accessories and cables Then turn on the monitor check whether the monitor can start normally The machine LOGO is displayed on the screen after turning on the machine Patient Monitor User Manual Installation WARNING If any sign of damage is detected or the monitor displays some error messages do not use it on any patient Contact biomedical engineer in the hospital or Customer Service Center immediately NOTE 1 Check all the functions of the monitor and make sure that the monitor is in good status 2 lfrechargeable batteries are provided charge them after using the device every time to ensure the electric power is enough 3 The interval between double pressing of POWER switch should be longer than 1 minute 4 After continuous 360 hour runtime please restart the monitor to ensure the monitor s steady performance and long lifespan 2 5 Checking the Recorder If your monitor is equipped with a recorder open the recorder s door to check if paper is properly installed in the slot If no paper exists refer to Chapter Recording for details 2 6 Setting the Date and Time To set the date and time 1 Select Me
189. ype ALM HI ALM LO ADU F1CO 99 0 0 0 EtCO 99 0 0 0 FiO 100 0 18 0 EtO 100 0 18 0 FiN2O 100 0 0 0 EtN O 100 0 0 0 EtDes 18 0 0 FiDes 18 0 0 EtIso 5 0 0 Filso 5 0 0 EtHal 5 0 0 FiHal 5 0 0 EtSev 8 0 0 FiSev 8 0 0 EtEnf 5 0 0 FiEnf 5 0 0 awRR 100 rpm 0 rpm 43 Patient Monitor User Manual Alarm Information Apean Time 40s 20s PED FiCO 99 0 0 0 EtCO 99 0 0 0 FiO 100 0 18 0 EtO 100 0 18 0 FiN2O 100 0 0 0 EtN O 100 0 0 0 EtDes 18 0 0 FiDes 18 0 0 EtIso 5 0 0 Filso 5 0 0 EtHal 5 0 0 FiHal 5 0 0 EtSev 8 0 0 FiSev 8 0 0 EtEnf 5 0 0 FiEnf 5 0 0 awRR 100 rpm 0 rpm Apean Time 40s 20s NEO FiCO 99 0 0 0 EtCO 99 0 0 0 FiO 100 0 18 0 EtO 100 0 18 0 FiN2O 100 0 0 0 EtN O 100 0 0 0 EtDes 18 0 0 FiDes 18 0 0 EtIso 5 0 0 Filso 5 0 0 EtHal 5 0 0 FiHal 5 0 0 EtSev 8 0 0 A4 Patient Monitor User Manual Alarm Information FiSev EtEnf FiEnf awRR Apean Time 8 0 5 0 5 0 100 rpm 40s 0 0 0 0 rpm 20s 45 Patient Monitor User Manual Managing Patients Chapter 6 Managing Patients 6 1 Admitting a Patient The monitor displays physiological data and stores it in the trends as soon as a patient is connected This allows you monitor a patient who is not yet admitted It is however important to admit patients properly so that you

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