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Edan Elite V8 Modular Patient Monitor User Manual

1. Alarm High Limit AWRR 30 30 100 Alarm Low Limit AWRR 8 8 30 Sweep 12 5mm s Amplitude Low C 11 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 EtN20 55 55 55 Alarm Low Limit EtN20 0 0 0 Alarm High Limit FiN2O 53 53 53 Alarm Low Limit FiN20 0 0 0 Alarm High Limit EtO2 90 0 90 0 90 0 Alarm Low Limit EtO2 18 0 18 0 18 0 Alarm High Limit FiO2 88 0 88 0 88 0 Alarm Low Limit F1O 18 0 18 0 18 0 Sweep 12 5mm s Amplitude 2 elite V8 Patient Monitor User Manual D Abbreviation 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 C O Cardiac output CISPR International Special Committee on Radio Interference CMS Central monitoring system CO Carbon dioxide COHb Carboxyhemoglobin CVP C
2. Message Cause Alarm Level Action Taken AG Uncalibrated AG module uncalibrated Low Please calibrate the AG module A l to ch Pl AG Replace Adapter G module needs to change Fi ease replace the adapter adapter l PI k O Out Of Range O is out of range High case make O range resume normal AG TEMP Out Of AG module temperature out Please make the High temperature resume Range of range normal AG Baro Press Out Of AG module baro pressure ans anal Tho Dus High pressure value Range out of pressure resume normal AG AA Td Unreliable AG module can t identify Medium Reduce gas agent the AG agent type A apa Shs aln AG module is calibrating Low rn iet d Progress calibration finishing sae to Please check whether AG Calibration Fail oS module lt saubraugn Medium the module works failure properly gt Please check whether Unable To Calibrate Eo SOUS AMAN De Medium the module works calibrated properly AG Zero In Progress AG module is zeroing Low Please wait zeroing AG Occlusion Tues APIS Hie aie Medium Replace the sampling clogged line AG Init Fail AG module has a failure High An module works improperly AG Data Limit Error AG module has a failure High G module works improperly AG Usa Error AG module has a failure High Aa modules Works improperly AG Cal Fail AG module fails to calibrate High AG module works improperly AG Zref Fail AG module fails to zero High aer module Works i
3. Temperature Working 0 C 40 C Transport and Storage 20 C 55 C Humidity Working 10 90 non condensing Transport and Storage 10 90 non condensing Altitude Working 530hPa 1066hPa Transport and Storage 530hPa 1066hPa V AG module sidestream Temperature Working 5 C 40 C Transport and Storage 20 C 55 C Humidity 160 elite V8 Patient Monitor User Manual Product Specifications Working 10 95 non condensing Transport and Storage 10 95 non condensing Altitude Working 525hPa 1200hPa Transport and Storage 500hPa 1200hPa V AG module mainstream Temperature Working 10 C 40 C Transport and Storage 20 C 55 C Humidity Working 10 95 non condensing Transport and Storage 10 95 non condensing Altitude Working 525hPa 1200hPa Transport and Storage 500hPa 1200hPa A 4 Leakage Current Applied Normal Single Fault Part Condition Condition Earth Leakage Current lt 0 5 mA lt 1 mA Enclosure Leakage Current lt 0 1 mA 0 5 mA CF AC lt 0 01 mA AC 0 05 mA DC lt 0 01 mA DC 0 05 mA Patient Leakage Current BF AC lt 0 1 mA AC lt 0 5 mA DC lt 0 01 mA DC 0 05 mA Patient Leakage Current Mains on CF 0 05 mA Applied Parts BF P CF
4. elite V8 Patient Monitor User Manual Menu 9 mw VGA output External Monitor RS 232 port Nurse call port SD Card port Signal output port Signal output PAM connector The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices Authorised representative in the European community Date of manufacture Manufacturer P N Part Number Intended Use and Safety Guidance elite V8 Patient Monitor User Manual Intended Use and Safety Guidance Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life fa Locked position lt Gas inlet 3 gt Gas outlet evac ISA equipped to measure CO only co 5 ISA equipped to measure multiple gases elite V8 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 them again Open the package ca
5. ST X Low ST measuring value is below the lower alarm limit X stands for I II HI aVR aVL aVF V V1 V2 V3 V4 V5 or V6 User selectable ASYSTOLE No QRS is detected for 4 consecutive seconds User selectable VFIB VTAC Ventricular tachycardia The fibrillation wave lasts for 4 consecutive seconds or the number of continuous Vent beats is larger than the upper limit of cluster Vent beats 25 The RR interval is less than 600ms User selectable VT22 3 the number of cluster PVCs 5 User selectable COUPLET 2 consecutive PVCs User selectable BIGEMINY Vent Bigeminy User selectable TRIGEMINY Vent Trigeminy User selectable RONT A type of single PVC under the condition that HR lt 100 R R 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 User selectable PVC Single PVCs not belonging to the type of above mentioned PVCs User selectable TACHY 5 consecutive QRS complex RR interval is less than 0 5s User selectable BRADY 5 consecutive QRS complex RR interval is longer than 1 5s User selectable MISSED BEATS When HR is less than 100 beats min no heart beat is tested during the period 1 75 times of the average RR interval or When HR is higher than 100beat min no beat is tested within 1 second Use
6. 70 mmHg 2 5 additional error Isoflurane 5 71 100 mmHg 4 additional error Sevoflurane 5 101 150 mmHg 5 additional error Xenon 80 Additional worst case error when compensation Helium 50 for Pg O N20 anesthetic agents or helium is correctly selected for the actual fractional gas Desflurane 15 constituents present Desflurane The presence of desflurane in the exhaled breath at concentrations greater than 5 will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38mmHg Xenon The presence of Xenon in the exhaled breath will negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38mmHg Barometric Pressure on EtCO Measurement Values Quantitative effect Ambient Barometric Operational 0 40 mmHg 1 mmHg additional error 4 70 mmHg 2 5 additional error 71 100 mmHg 4 additional error 101 150 mmHg 5 additional error Additional worst case error when compensation for Pg O N20 anesthetic agents or helium is correctly selected for the actual fractional gas constituents present 174 elite V8 Patient Monitor User Manual Product Specifications A 16 C O Technique Thermodilution Technique Measuring range C O 0 1 L min 20L min TB 23 C 43 C 73 4 F 109 4 F TI Auto 1 C 27 C 30 2 F 80 6 F Manual 0 C 27 C 32 F 80 6 F Reso
7. C3H70H 0 5 vo m D 31j Isopropanol CH3COCH3 1 vol D D D Acetone CH4 Methane 3 vol E a D D CO Carbon 1 vol D D D n monoxide 177 elite V8 Patient Monitor User Manual Product Specifications NO Nitrogen 0 02 vol E E D zn monoxide 07 100 vol 25 3n D Note 1 Negligible interference effect included in the specification Accuracy all conditions above Note 2 Negligible interference with N20 O2 concentrations correctly set effect included in the specification Accuracy all conditions above Note 3 Interference at indicated gas level For example 50 vol Helium typically decreases the CO readings by 6 This means that if measuring on a mixture containing 5 0 vol CO and 50 vol Helium the actual measured CO concentration will typically be 1 0 06 5 0 vol 4 7 vol CO Note 4 According to the EN ISO 21647 standard Note 5 In addition to the EN ISO 21647 standard A 17 2 Mainstream Module Type IRMA AX Displaying the concentration of CO N20 and two anaesthesia agent and indentifying two anaesthesia agent Measurement CO N50 HAL Isoflurane ISO Enflurane ENF Sevoflurane SEV P Desflurane DES awRR MAC arameters Measurement CO N20 anaesthesia agent infra red absorption characteristic Principle Warm up Time Concentrations are reported and the au
8. CAUTION 1 Do not apply tension to the probe cable 2 Do not operate the IRMA probe outside the specified operating temperature environment 118 elite V8 Patient Monitor User Manual Monitoring AG 17 3 Monitoring Steps 17 3 1 Monitoring Steps for ISA Analyzer 17 3 1 1 Performing a Pre use Check Before connecting the Nomoline sampling line to the breathing circuit do the following l 2 de Connect the sampling line to the ISA gas inlet connector LEGI Check that the LEGI shows a steady green light indicating that the system is OK For ISA OR and ISA AX module with O option fitted Check that the O reading on the monitor is correct 21 Breathe into the sampling line and check that valid CO waveforms and values are displayed on the monitor Occlude the sampling line with a fingertip and wait for 10 seconds Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light If applicable Perform a tightness check of the patient circuit with the sampling line attached 17 3 1 2 Leakage Check l Connect a new Nomoline sampling line with male luer lock to the ISA LEGI and check that the LEGI shows a steady green light Connect a short silicon tubing with an inner diameter of 3 32 2 4 mm to the Nomoline male luer Exhale a long breath into the silicon tubing until the CO concentration is greater than 4 5 vol or 34 mmHg Quickly connect the silicon tubing tight
9. Guidance and manufacture s declaration electromagnetic emission 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 Emission test Compliance Electromagnetic environment guidance RF emissions The monitor uses RF energy only for its internal CISPR 11 Gaii 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 purposes Voltage fluctuations flicker emissions Complies IEC EN 61000 3 3 B 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity 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 Immunity test IEC EN 60601 test level Electromagnetic Compliance level environment guidance Electrostatic discharge ESD IEC EN 61000 4 2 6 kV contact E8 kV air Floors should be wood
10. 2 In the CO Setup menu please set the Work Mode to Measure 3 In the CO Setup menu select Zero Calibration 4 If the system briefly displays Zero In Progress the process is successful After the zeroing calibration is finished you can start CO Monitoring If the system displays Breath detected or Zero required zeroing has failed Zero calibration must be performed again 15 3 2 Sidestream CO Module NOTE 1 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 104 elite V8 Patient Monitor User Manual Monitoring CO 2 Disconnect the cannula airway adapter or sample line from the sensor when they are not in use 15 3 2 1 Measurement Steps Plug the sensor cable into the CO input connector on the sidestream CO module Allow the sensor two minutes for warm up 2 Connect the cannula airway adapter or sample line as required to the sensor It will click into place when seated correctly 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 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 b
11. NIBP Non invasive blood pressure O 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 atrial 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 197 P N 01 54 455329 10 EDANUSA 4901 Morena Blvd Suite 505 www edanusa com San Deigo CA 92117 Tel 888 850 4597
12. Resolution 1 PVCs min ST value Range 2 0 mV 2 0 mV Accuracy 0 8 mV 0 8 mV 0 02 mV or 10 whichever is greater Beyond this range not specified Resolution 0 01 mV HR Averaging Method 165 elite V8 Patient Monitor User Manual Product Specifications Method 1 Normally heart rate is computed by excluding the minimum and maximum values from the 12 most recent RR intervals and averaging the residual 10 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 Tachy ADU 120 bpm 300 bpm PED NEO 160 bpm 350 bpm Normal ADU 41 bpm 119 bpm PED NEO 61 bpm 159 bpm Brady ADU 15 bpm 40 bpm PED NEO 15 bpm 60 bpm Range of Ventricular Rhythm Ventricular Tachycardia The interval of 5 consecutive ventricular beats is less than 600 ms Ventricular Rhythm The interval of 5 consecutive ventricular beats ranges from 600 ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular beats is more than 1000 ms Startup time for Tachycardia Ventricular Tachycardia 1 mV 206bpm Ventricular Tachycardia 2 mV 195bpm Gain 1 0 10s Gain 0 5 10s Gain 2 0 10s Gain 1 0 10s Gain 0 5 10s Gain 2 0 10s 166 elite V8 Patient Monitor User Manual Product Specifications Response
13. 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 38 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm level P2 SYS Low P2 SYS measuring value is below lower alarm limit User selectable 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 FiCO High FiCO measuring value is above alarm limits User selectable CO APNEA ee interval no RESP can be detected High AWRR High AwRR measuring value is above upper alarm limit User select
14. module is analyzing the patient signal and SpO Search Pulse searching for the pulse to compute the saturation when sensor is 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 Continual Measuring NIBP module performs continual measuring Stat Measuring NIBP module performs STAT function Please Switch To Maintain Mode NIBP module is in normal mode the user can t start leak test and pressure calibration Please enter User Maintain NIBP Maintain and switch to Maintain Mode to perform leak test or pressure calibration Please Switch To Normal Mode NIBP module is in maintaining mode the user can t start blood pressure measurement Please enter User Maintain NIBP Maintain and switch to Normal Mode to perform blood pressure measurement 52 elite V8 Patient Monitor User Manual Alarm Information Message Cause Place Probe On Measure Place Probe isn t placed on the mea
15. 11 3 Setting PR Volume Six selections are available 0 1 2 3 4 and 5 5 indicates the maximum volume 0 indicates no sound You can change PR Volume in the PR Setup menu 11 4 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 monitor 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 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 NOTE Pulse alarms are only generated when the active alarm source is set to PR a pulse source is set as system pulse and pulse alarms are switched on 88 elite V8 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 Oscillometric devic
16. 12 5 2 Correcting the Measurement 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 6 NIBP Multi Review Window To set the display of NIBP measurements select NIBP Setup gt Review When it is set to On a window for NIBP measurements will be displayed at the waveform area on the main interface and the size of this window varies depending on the numbers of displayed waveforms When it is set to Off the window is unavailable on the screen 12 7 Resetting NIBP When the pressure does not work properly and the system fails to give a message for the problem pick Reset in the User Maintain gt NIBP Maintain menu to activate self test procedure and thus restore the system from abnormal performance 93 elite V8 Patient Monitor User Manual Monitoring NIBP 12 8 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 9 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
17. 3 1 2 Parameter Amplifier Mainframe Users can connect one Parameter Amplifier Mainframe PAM to the monitor via a particular link cable The PAM provides 8 slots for mounting measurement modules The number of modules mounted in the PAM varies with the number of slots needed by different modules Front View Rear View Indicator On when the PAM works normally Off when the PAM is disconnected from the monitor power supply malfunction occurs or the monitor is powered off 2 Contact 3 Handle 4 PAM connector 18 elite V8 Patient Monitor User Manual Basic Operation NOTE To avoid bad contact caused by dust accumulation clean the contacts regularly by wiping them with a cotton swab moistened with alcohol 3 1 3 Measurement Modules Users can use a maximum of 8 measurement modules with the PAM and additional 3 modules in the integrated module slots in the monitor The number of modules mounted in the monitor varies with the number of slots needed by different modules The connector socket on the front of each module is of the same color as the corresponding connector plug on the transducer or patient cable Modules supported by this monitor are 1 V AG module sidestream Anesthetic gas module for sidestream 2 3 4 5 6 7 V CO module mainstream Carbon dioxide module for mainstream V AG module mainstream Anest
18. 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 E If you are using disposable TEMP probes you need to plug the TEMP cable into the connector for TEMP probe on XM module and then connect the probe to the cable With a reusable TEMP probe you can plug the probe directly into the TEMP connector on XM module 96 elite V8 Patient Monitor User Manual Monitoring TEMP B Apply the TEMP probes securely to the patient B Switch on the monitor It takes 5 minutes for the temperature measurement 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 97 elite V8 Patient Monitor User Manual Monitoring IBP Chapter 14 Monitoring IBP 14 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 electrical 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 a maximum of eight channels and displays waveforms and pressure of measured direct blood
19. M 127 18 1 Entering Exiting Freeze SUUS una iia e in te oberen ida 127 1811 Ent ting Breeze Statue eco a e o tl e O 127 184 2 Exiting Freeze Statuss uas t tudine lts 127 18 2 Reviewing Froz n Waveform id A AAA Az ales 128 Chapter 19 Revie W cod BRI Uam Nd D Eds dU Een d EE 129 191 Trend Graph REVIGW ormurinn EE d axe Pda ct be paa o Ea Intp EU ERR S EEEE 129 19 1 1 Selecting Trend Graph of Specific Parameter eret tnnt ore ins 129 1941 2 Setting A oue Ente eni p he mien yai db m didus 129 19 1 3 Scrolling Left and Right the read 130 19 1 4 Switching to the Trend Table sete e os le 130 IAS RE a neto e O c 130 19 2 Trend Table Revia 130 19 2 1 Setting uo e st ES e ro ae oat eism ee dus 130 19 2 2 Scr lling th SCT COM cesse evade nee RE III ENDE A aii Dub cr cutus 130 19 23 Switching to Trend Graph ii eiecit peine eos erasa Teeth epis 130 19 24 REA etta cp do esM 130 jS Ud Tr P r m 131 19 31 Serolling the erstes dls ia 131 EE O E oes emes 131 OAA TIN IRS V O aco eee ed te Eia et n aita tw cn ora oa ea 131 192 T Scrolling the SCre iss oe oe coe Dn naa Haya aate ER n Adds 131 19 4 2 Selecting Alarm Event of Specific Parameter cens eee secre 131 19 43 Setting Time an 131 IO S ATUROVISW lee e 132 LISAS the SCEGOIT aramon teo ee indes e ta dine Tau eut 132 19 5 2 Arrhythmia A Dato Reve Wo aos eese e Pee I HUE ER e Ree as 132 19 6 12 lead Diagnosis RevieW 2 used e cd Aes ees teaches As
20. NIBP CO AG BF Ingress Protection IPXI Disinfection sterilization method Refer to Chapter Care and Cleaning for details Working system Continuous operation 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 EC13 EN12470 4 EN1060 1 EN1060 3 EN1060 4 A 2 Physical Specifications Product Dimension Mix Comments Weight elite V8 425 mm L x 245 mm W x 382 mm H 14 kg Including batteries XM module and recorder without options XM module 188 mm L x 81 5 mm W x 120 mm H 1 kg Without accessories V IBP module 134 mm L x 38 mm W x 102 mm H 0 2 kg Without accessories V C O module 134 mm L x 38 mm W x 102 mm H 0 2 kg Without accessories 158 elite V8 Patient Monitor User Manual Product Specifications Product Dimension nies Comments Weight V CO module 134 mm L x 38 mm W x 102 mm H lt 0 2 kg Without mainstream accessories V CO2 module 134 mm L x 84 mm W x 102 mm H lt 0 65 kg Without sidestream accessories V AG module 134 mm L x 38 mm W x 102 mm H lt 0 2 kg Without mainstream accessories V AG module 134 mm L x 84 mm W x 102 mm H 0 65 kg Without sidestream a
21. please set Alarm Latch to Off When Alarm Latch is set to Off the latch function is invalid 4 5 Disabling Sensor off Alarms To set sensor off alarm please select Menu gt Maintenance gt User Maintain and enter the required password ABC Then select Alarm Setup and set Sensor Off Alm from the pull down list If it is set to On and a sensor off alarm occurs the user can press the Mute key on the front panel to disable the alarm signal Then the alarm indicator stops flashing and the monitor is in temporary mute alarm status If the user presses the Mute key again or the temporary mute time ends the monitor resumes audible alarm And the monitor will display prompt message of sensor off alarm 4 6 Testing Alarms When you switch the monitor on a self test 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 45 s elite V8 Patient Monitor User Manual Chapter 5 Alarm Information 5 1 Physiological Alarm Information Alarm Information Message Cause Alarm level ST X High ST measuring value is above the upper alarm limit X stands for I II HI aVR aVL aVF V V1 V2 V3 V4 V5 or V6 User selectable
22. 45s depend on HR motion disturbance Overpressure protection Dual overpressure protection Adult 297 3mmHg Pediatric 240 3mmHg Neonatal 147 3mmHg PR Measuring range 40 bpm 240bpm 169 elite V8 Patient Monitor User Manual Product Specifications Accuracy 3bpm or 3 5 whichever is greater A 12 SpO Measuring Range 0 100 Alarm Range 0 100 Resolution 1 Accuracy Adult Pediatric 2 70 100 SpO Undefined 0 69 SpO2 Neonate 3 70 100 SpO Undefined 0 69 SpO2 Pulse Rate Measuring Range 25 bpm 300 bpm Alarm Range 30 bpm 300 bpm Resolution 1 bpm Accuracy 2bpm Data update period Is Wave length Red light 660 3 nm Infrared light 905 5 nm Emitted light energy Less than 15 mW Nellcor module Measuring Range Alarm Range Resolution Data update period 1 100 1 100 1 Is 170 Product Specifications elite V8 Patient Monitor User Manual Sensor Type MAX A MAX AL MAX N MAX P MAX I MAX FAST Accuracy 2 70 100 SpO gt OxiCliq A OxiCliq P OxiCiq N Adult OxiCliq N Neonate Accuracy OxiClig I 2 5 70 100 SpO D YS Infant to Adult DS 100A OXI A N OXI P I 3 70 100 SpO D YS including D YSE ear clip D YS including D YSPD spotclip 3 5 70 100 SpO When the sensor is
23. 60 50 30 Alarm High Limit Dia 90 70 60 Alarm Low Limit Dia 50 40 20 Inflation value 160 140 100 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 192 Default Settings elite V8 Patient Monitor User Manual C 9 IBP IBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Unit mmHg Filter 12 5Hz SYS DIA SYS DIA SYS DIA MAP MAP MAP Alarm High Limit ART P1 P2 160 90 110 160 90 110 160 90 110 Alarm Low Limit ART P1 P2 90 50 70 90 50 70 90 50 70 Alarm High Limit PA 35 16 20 35 16 20 35 16 20 Alarm Low Limit PA 10 0 0 10 0 0 10 0 0 MAP MAP MAP Alarm High Limit CVP RAP LAP 10 10 10 ICP Alarm Low Limit CVP RAP LAP 0 0 0 ICP C 10 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 F1CO 4 4 4 193 elite V8 Patient Monitor User Manual Default Settings
24. 99 14 3 1 Selecting a Pressure for Monitoring essssssseseeeeeeeeeeeenrenren nennen 99 14 3 2 Zeroing the Pressure Transducer ic esent treten erroe Feier ove da eren 100 14 3 3 Zeroing a Pressure Measurement eoo eee OOo ER p e ye aede 100 14 3 4 Troubleshooting the Pressure Zeroing Taking Art for Example 100 14 35 TBP Pressure Calibracion aaea deiade dug ded 100 14 3 6 Troubleshooting the Pressure Calibration sse 102 14 4 Changing the IBP Waveform Ruler esses eene enne ener enne 102 Chapter I5 Monitoring CO iio rete HERR PETERS ROI NER GR IERRNNRNI M e I ME NS 103 DS UN O IN 103 15 2 COs Safety Informati n i coena A A t e dete Gans Ep Tee UE RE A d de es 103 15 3 Monitoring Procedures eae Ores nO Na uir ERU a ib eGR 104 15 3 D Zeroing the seisoi ines hisce dd du e 104 18 32 Sidestrsam COs Mod learn 104 15 3 3 Mainstream CO Module 0ococncnnncncncnononanocncncncncncnoncnononononananananananananananananananannnn 106 15 4 Setting CO2 Waveform Sep a Breve nite iu cane Parere eb EE teu ees 108 15 5 Setting CO OrrecnOns i eo ecod e Sata as R ido icu ratae bech d Ga Eius 108 15 6 hangs Apnea NADEL soe on et ta dur em o ee desea cena dear be cq O 108 15 7 Seting CO Wave torn ts ooo os 108 Chapter 16 Monitoring C O M 109 TG Ay CIN Le WIS eate icu faa du c d n M Le a EE 109 T6 2 C Oc Safety Info
25. AC lt 0 01 mA AC 0 05 mA xe DC 0 01 mA DC 0 05 mA Patient Auxiliary Current BF AC lt 0 1 mA AC 0 5 mA DC lt 0 01 mA DC 0 05 mA 161 elite V8 Patient Monitor User Manual A 5 Display Product Specifications Display Messages is configurable Resolution 1280 x 1024 Display screen 17 inch color TFT touch screen A maximum of 12 waveforms One power LED One physiological alarm LED One technical alarm LED One alarm mute LED One charge LED A 6 Battery Number 2 Capacity 4 2 Ah Nominal Voltage 14 8 V DC Operating Time 120 min with 2 new fully charged batteries at 25 C typical configuration continuous SpO measurement and NIBP automatic measurement mode at interval of 15 minutes ECG TEMP module connected recording at interval of 10 minutes brightness set to 1 90 min with 2 new fully charged batteries at 25 C typical configuration continuous SpO measurement and NIBP automatic measurement mode at interval of 15 minutes ECG TEMP module connected sidestream CO and sidestream AG modules connected recording at interval of 10 minutes brightness set to 1 Charge Time 4 2 Ah 350 min Monitor is on or in standby mode A 7 Recorder Record Width 48 mm Paper Speed 12 5mm s 25 mm s 50 mm s Trace 1 2 3 optional Recording types Continuous real time recording 8 second real time recor
26. Alarm Mute The monitor will 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 Alarm pause symbol X 2 The remaining pause time is displayed in text 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 Alarm Mute To mute the alarm please select Menu gt Maintenance gt User Maintain gt Alarm Setup and set Mute to On then press the key on the front panel for more than three seconds 34 elite V8 Patient Monitor User Manual Alarms 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 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
27. Ep UH Nes DURS Mp ecran EE SUUM NE eisses sso sioe Sess 195 XI elite V8 Patient Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1 1 Intended Use This monitor is intended to be used for monitoring storing reviewing recording and generating alarms for multiple physiological parameters including ECG respiration RESP temperature TEMP oxygen saturation of arterial blood SpO pulse rate PR non invasive blood pressure NIBP invasive blood pressure IBP carbon dioxide CO2 cardiac output C O and anesthetic gas AG of adults pediatrics and neonates in hospital environments The arrhythmia detection and ST segment analysis are not intended for neonatal patients This monitor is suitable for use in hospital environments including but not limited to OR PACU ICU and neonate intensive care room 1 2 Safety Guidance WARNING 1 Before using the device the equipment patient cable and electrodes etc should be checked Replacement should be taken if there is any evident defect or signs of aging which may impair the safety or performance 2 Medical technical equipment such as this 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 SHOCK HAZARD The power receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three
28. F and displayed on the 12 lead analysis review interface 19 6 2 Deleting Diagnosis Results The user can delete the analysis results displayed on the current screen by selecting Delete on the interface 19 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 Results option 19 6 4 Recording The monitor can record the 12 lead diagnosis waveforms or results displayed 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 133 elite V8 Patient Monitor User Manual Calculation and Titration Table Chapter 20 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 The monitor can perform drug calculation Hemodynamic calculation is not described in this Instructions for Use To perform one calculation select Menu gt Common Function gt Drug Dose NOTE The drug calculation function acts only as a calculator The patient weights in Drug Calculation menu and in Patient Information menu are independent of each other Therefore changing the Weight in Drug Calculation menu will not change the weight in
29. Freeze Chapter 18 Freeze When monitoring a patient the user may freeze the waveforms and examine them Generally the user can review a frozen waveform of a maximum of 12 minutes The freeze function of this monitor has the following features mM Freeze status can be activated on any operating screen E 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 18 1 Entering Exiting Freeze Status 18 1 1 Entering Freeze Status In the Non Freeze status press the button on the control panel of the monitor to exit the current menu Freeze status is entered and the popup Freeze menu is displayed In Freeze status all waveforms are frozen and will no longer be refreshed 18 1 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 Freeze menu Press the button on the control panel again Execute any operation that may trigger the adjustment of the screen or the display of a new menu After exiting Freeze status the system will clear screen waveforms and resume displaying real time waveforms In the Screen Re
30. If no menu is displayed on the screen pressing it will enter the main menu If there is a menu displayed on the screen pressing it will close that menu 14 Trim Knob Users can rotate the trim knob clockwise or counter clockwise to highlight the desired item and press it to select the item Sits elite V8 Patient Monitor User Manual Basic Operation Side View 1 2 SEE 3 sl 4 7 5 d sq 1 Compartment for optional device supporting WIFI module and hard disk 2 XM module slot 3 XM module snap fix 4 Plug in module slots 5 Contact 6 Battery compartment latch 7 Compartment for recorder NOTE To avoid bad contact caused by dust accumulation clean the contacts regularly by wiping them with a cotton swab moistened with alcohol 14 Basic Operation elite V8 Patient Monitor User Manual Rear View 13 12 11 10 15 elite V8 Patient Monitor User Manual Basic Operation Speaker Equipotential grounding terminal For alarm tones pulse tones and so forth If the monitor is used together with other devices connect this terminal to eliminate potential ground differences between devices Power cable safety latch Used to prevent the power cable from detaching AC power input RS232 interface Extended video interface SD card slot VGA output Connect it to communicate with other devices It connects a secondary display which ext
31. L i 22d disconnected from the ee 60 ey connected monitor T t ble of TEMP shee m iE E be Make sure that the TEMP T2 Sensor Off A Low cable is properly disconnected from the connected monitor TEMPI measuring value is a AD wee Excessive TI High connection and beyond measuring range E patient condition TEMP2 measuring value is a PUE a ipio Excessive T2 High connection and beyond measuring range ES patient condition Stop measuring function of TEMP TEMP Comm Fail TEMP module failure or High module and notify communication failure biomedical engineer or X Manufacturer s service staff YY Sensor Off YY Check the sensor stands for the IBP label IBP sensor falls off Low connection and name reconnect the sensor Stop measuring YY Comm Fail YY is CUNG ni IBP module failure or module and notify stands for the label oye High communication failure biomedical engineer name or X Manufacturer s service staff Stop measuring of C O module or CO Comm Fail C O module failure Or High notify biomedical communication failure engineer or Manufacturer s service staff O TI injecti CO TI No Sensor C O sensor not Los Insert injective connected temperature sensor 46 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken CO TB No Sensor Me cun ATE DOE Low Insert TB sensor connected TEMP Out
32. On Medium Off COUPLET On Medium Off PVC On Medium Off BIGEMINY On Medium Off TRIGEMINY 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 Alarm Switch On 190 elite V8 Patient Monitor User Manual Default Settings 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 1 C 5 SpO2 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 On 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 Auto 191 elite V8 Patient Monitor User Manual C 7 NIBP Default Settings NIBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit SYS 160 120 90 Alarm Low Limit SYS 90 70 40 Alarm High Limit Map 110 90 70 Alarm Low Limit Map
33. Sed etaed diets Quote eis 132 196 1 Scrolling the SOr GIT o einen a ii 133 19 6 2 Deleting Diagnosis Resultsa Eo oce tec rer ete b e De d PUE Ret d pad uide 133 19 6 3 Switching Between Waveforms and Results sse 133 LOG ccv iM E 133 Chapter 20 Calculation and Titration Table 4 eee ee ecce ee eee eee ee eren ee eee sette seen sesta 134 20 1 Drus Calculations soy ende tort eod edat eae d ree ue as di dea dro RS 134 20 1 1 Calculation Procedures id 134 20 ALO Calc lato ade 135 20 2 Titratiot TDS io ibas 135 A A san oases ANE qu PNE passivos ostida ossos sasos RE RR ERE 136 21 1 Pertormance or the ReCordet suae EA oce gast pa dapes 136 ARCE Typene v edem ey ot ee oa um e a i amo o sus 137 21 3 Starting and Stopping RECOM ose rae ere tree distr ente RR eae Eae qu ae due 137 21 4 Recorder Operations and Status Messages sse nennen 138 21 4 1 Record Paper Requirement 25 oan o p E tats e 138 21 42 Proper Oper anon uos ros Sui ac OS 138 ZA AS Paper Qut io Giai Eoo pa aee daa E ERR AVR ada UR RR PUn 138 21 425 Replacing Paper tosta ros 138 21 4 5 Removin Paper Jam ia ee eo Du et satietate bado 139 Chapter 22 Other Func EMPIRE NN ERES QIIHMBRINURIIRSOR NNODOISH It HE 141 22 A A A 141 22 2 Witeless NO A a Batis d Hed a pi Gern 141 Chapter 25 Usimg Battery sa 3 ss cas ese ees havns tinea HR cave cosuaaonns ncaa setae eons ch CORPER wrnsaenieeteaeee 142 23 1 Batt
34. Single Patient SpO sensor patient size gt 30kg 01 57 040197 Pediatrics Single Patient SpO sensor patient size 10kg to 50kg 01 57 040198 Infant Single Patient SpO sensor patient size 3kg to 20kg 01 57 040199 Neonate Single Patient SpO sensor patient size lt 3kg 11 15 30043 Nellcor Reusable Adult SpO Sensor DS 100A OxiMax 11 15 40096 Nellcor Reusable Adult Neonate SpO Sensor OXI A N OxiMax 01 57 471069 10 Nellcor SpO Extension cable Compatible with Nellcor OXI Max SpO2 module and Nellcor sensor 27 2 3 NIBP Accessories Part Number Accessories 11 57 40020 Infant blood pressure cuff 10 19cm CM1201 11 57 40018 Pediatrics blood pressure cuff 18 26cm CM1202 11 57 40029 Adult blood pressure cuff 25 35cm CM1203 01 57 040205 NIBP Cuff Adult 25cm 35cm reusable 01 57 040211 NIBP Cuff Child 18cm 26cm reusable 01 57 040212 11 57 40097 NIBP Cuff Infant 10cm 19cm reusable Neonatal Disposable Cuff 5102 About 6 9cm 11 57 40098 01 57 471157 Neonatal Disposable Cuff 5104 About 9 14cm NIBP Cuff neonatal 1 3 6cm disposable 01 57 471158 NIBP Cuff neonatal 2 4 8cm disposable 01 57 471159 NIBP Cuff neonatal 3 6 11cm disposable 154 elite V8 Patient Monitor User Manual Accessories Part Number Accessories 01 57 471160 NIBP Cuff neonatal 4 7 13cm di
35. WARNING 4 The monitor will be damaged if any pipeline from the CO module is disconnected or the air tube the air inlet the air outlet is plugged by water or other materials 5 The accuracy of the CO 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 6 Follow precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment 7 n 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 8 Do not place the sensor cables or tubing in any manner that may cause entanglement or strangulation 9 Donot 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 NOTE After the low battery alarm appears please do not start the CO measurement or the monitor may turn off for the low capacity of battery 15 3 Monitoring Procedures 15 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
36. adapter adds 6 ml dead space to the patient circuit 5 Do not use the IRMA airway adapter with adults as this may cause excessive flow resistance 6 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 7 Use of high frequency electrosurgical equipment may enhance the risk of being burned therefore a static free or conductive respiratory cannula is not recommended 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 9 Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as this may affect the light transmission of the airway adapter windows 10 The IRMA probe is intended only as an adjunct in patient assessment It must be used in conjunction with other assessment of clinical signs and symptoms 11 Incorrect probe zeroing will result in false gas readings 12 Incorrect agent selection by the user for IRMA AX no automatic agent identification will result in false agent readings 13 Using IRMA AX no automatic identification with gas mixtures containing more than one agent will result in false agent readings 14 Replace the adapter if rainout condensation occurs inside the airway adapter 15 Use only PHASEIN manufactured IRMA airway adapters
37. affected by temperature and barometric pressure NOTE 1 Replace the airway adapter if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexpectedly without a change in patient status 2 To avoid infection use only sterilized disinfected or disposable airway adapters 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 15 3 3 2 Removing Exhaust Gases from the System WARNING Anesthetics when using the mainstream 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 107 elite V8 Patient Monitor User Manual Monitoring CO 15 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 appropriate value from the pop up list The bigger the value is the quicker the speed is 15 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 al
38. alarm function and there will be a symbol ES beside PVCs 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 8 2 3 ARR Relearning Pick this item to start a learning procedure and ECG ARR LEARNING is displayed on the screen The ECG ARR LEARNING will start automatically in the following status Connecting leads Starting ARR learning manually Switching calculation leads 8 8 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 80 elite V8 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 leve
39. be a great deal of interference with the ECG signal 10 For patients with pacemakers the pacing impulse analysis function must be switched ON Otherwise the pacing impulse may be counted as regular QRS complexes which could prevent an asystole event from being detected 11 The electrodes should be made of the same metal materials 12 ECG cables can be damaged when connected to a patient during defibrillation Check cables for functionality before using them again 13 According to AAMI specifications the peak of the synchronized defibrillator discharge should be delivered within 60 ms of the peak of the R wave The signal at the ECG output on the IntelliVue patient monitors is delayed by a maximum of 30 ms Your biomedical engineer should verify that your ECG Defibrillator combination does not exceed the recommended maximum delay of 60 ms 14 Before outputting signals with defibrillator synchronization or ECG check if the output is functioning normally NOTE 1 Interference from a non grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform 2 EC 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 ECG RESP monitoring devices 3 The simultaneous use of cardiac pacemaker and other patient connected
40. 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 100 elite V8 Patient Monitor User Manual Monitoring IBP 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 is listed below l 2 3 4 CA 10 11 1 Close the stopcock that was open to atmospheric pressure for the zero calibration Attach the tubing to the sphygmomanometer Ensure that connection to patient is off Connect the 3 way connector to the 3 way stopcock that is not connected to the patient catheter Open the port of the 3 way stopcock to the sphygmomanometer Select the channel to be calibrated in the menu and select the pressure value to which the IBP is to be adjusted Inflate to make the mercury bar rise to the setup pressure value Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury calibration Press the Start button the device will begin calibrating Wait for the calibrated result You should take corresponding measures based on the prompt information After calibration dis
41. clotting disorders because of the risk of hematoma in the limb fitted with the cuff 89 elite V8 Patient Monitor User Manual Monitoring NIBP WARNING Ensure that the correct setting is selected when performing measurements It may be dangerous for the children to use an over pressure level The equipment is suitable for use in the presence of electrosurgery 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 Before starting a measurement verify that you have selected a setting appropriate for your patient adult child or neonate 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 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 If an alarm occurs or measurement fails please discontinue the measurement 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 Continuous use of the automat
42. 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 24 2 Cleaning WARNING Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line 24 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 methods than the housing Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning Do not allow water or cleaning solution to enter the measurement connectors Wipe around except connector sockets 146 elite V8 Patient Monitor User Manual Care and Cleaning Examples of disinfectants that can be used on the instrument casing are listed below m Tenside m Diluted Ammonia Water lt 3 m Alcohol 24 2 2 Cleaning the Accessories 24 2
43. 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 Technical alarms can t be disabled 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 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 operato
44. gets damp or liquid pours on the monitor please contact the service personnel of EDAN 4 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 every two years You are responsible for any requirements specific to your country 1 3 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC EN60601 1 Type CF ie 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 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 N Symbol for Caution elite V8 Patient Monitor User Manual Intended Use and Safety Guidance Equipotential grounding Ej 4 Consult Instructions For Use C Non ionizing electromagnetic radiation Alternating Current Battery indicator Power Supply switch Serial number Network port USB Universal Serial Bus Connection Audio alarm is off NIBP measurement Trend graph Freeze mM QE we hb gA Record
45. 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 Updating a Patient You should always perform an update before starting monitoring for a new patient When you select Menu Patient Setup Quick Admit or Menu Patient Setup 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 60 elite V8 Patient Monitor User Manual Managing Patients 6 5 Central Monitoring System The monitor can be connected to
46. j k ly i NIBP Leak Test Error Hardware abnormal High MALUM ic dp Me pressure meter mode If the problem still exists contact your service personnel Cuff is too loose or patient Use eee gto NIBP Weak Signal Dd P Low measure blood pulse is too weak pressure ST ee ER Me ere Make sure that the NIBP Excessive oo patient under noise is too large or pulse Low UR Motion monitoring IS rate is not regular E motionless Maybe the patient blood Ma me p erus NIBP Range Exceeded pressure value is beyond the Low ES ER 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 NIBP Pressure Low detect the SYSTOLIC Low has an over high Apply pressure again blood pressure or it is interfered by movement Ni j T Retry twice Check NIBP Pulse Abnormal PN os IT ow for hyperkinesia or waveform 4 arrhythmia ad es Check the patient s Weak use signa Pulse is too low to measure Low condition or the wrapped cuff SAGs elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Temperature cable of TEMP channel may be Make sure that the TEMP TI S Off f
47. one of the two batteries is malfunctioning it is recommended to change both of the two batteries 15 When the monitor is running on battery power do not replace the batteries during monitoring patients or the monitor will be powered off which may result in patient injury 23 2 Battery Power Indicator The indicator labeled Battery on the front panel of the monitor illuminates in green when the monitor 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 23 3 Battery Status on the Main Screen Battery status symbols show the status of each battery detected and the combined battery power remaining also they tell you which battery compartments they are in either 1 or 2 a The battery is in compartment 1 e The battery is in compartment 2 me Remaining battery power 100 r Remaining battery power 75 m Remaining battery power 50 i Remaining battery power 25 1 Batteries are almost depleted and need to recharge immediately Tx No battery is installed 23 4 Checking Battery Performance The performance of rechargeable batteries may deteriorate over time Battery maintenance as recommended here can help to slow down this process 143 elite V8 Patient Monitor User Manual Using Battery 1 Disconnect the patient from the monitor and stop all monitoring and measurement 2 Switch t
48. pressure SYS DIA and MAP Zero key for IBP IBP connector 14 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 98 elite V8 Patient Monitor User Manual Monitoring IBP 2 Calibrate the instrument either whenever a new transducer is used or as frequently as dictated by your Hospital Procedures Policy 14 3 Monitoring Procedures Preparatory steps for IBP measurement 1 Plug the pressure cable into the IBP socket on XM module or V IBP module 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 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
49. 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 Make sure all alarm lamps light up and the alarm sound is heard when turning on the monitor WARNING If any sign of damage is detected or the monitor displays some error messages do not use it on any patient Contact Customer Service Center immediately NOTE 1 Check all the functions of the monitor and make sure that the monitor is in good status 2 If rechargeable batteries are provided charge them after using the 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 21 Recording for details 2 6 Setting Date and Time To set the date and time 1 Select Menu gt System Setup gt Date Time Setup 2 Adjust the date display format based on the user s habit 3 Setthe correct time of year month day hour min and sec from the popup menu and press Exit NOTE 1 f the monitor is not used for a longer period of time its system time may be inaccurate In this case
50. the average Cardiac Output The prompt message on the screen will tell you when to inject C O start key Connector for C O cable 16 2 C O 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 16 3 C O Monitoring Procedures 1 Plug the C O cable into the C O socket on V C O module 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 patient s height and weight 109 elite V8 Patient Monitor User Manual Monitoring C O 3 Pick the CO Measure item in the CO Option menu 4 You can perform more than one measurement as required 5 After the completion of the measurement access the CO Measure window for Review to edit the measured data 1 Monitor 2 Thermodilution Catheter 3 Cardiac Output Cable 4 Injectate Sensor Housing 5 Injectate 6 Delivery System 7 In line injectate Temperature probe C O Sensor Connection WARNING Make sure that the computational constant for the measurement is appropriate to the
51. the calibration 3 11 Disabling the TouchScreen The user can disable touchscreen operation by pressing and holding the Menu shortcut key for 3 seconds A message of Screen Locked and the symbol BS are displayed at the bottom of screen if the touchscreen is disabled To enable the touchscreen operation turn the knob to select the symbol BS and press it NOTE When the touch screen is locked Menu Display Setting Wave Num is unavailable Thus users cannot change the number of displayed waves on the screen 3 12 Using the Bar Code Scanner To enter the barcode setup menu please select Menu Maintenance User Maintain after entering the required password ABC select Other Setup BarCode Setup Then the user can set serial No last Name first Name and so on If Auto Update is set to On the patient information is updated automatically by using a bar code scanner If Auto Update is set to Off the user needs to update the patient information manually 31 elite V8 Patient Monitor User Manual Alarms Chapter 4 Alarms WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area e g an intensive care unit or cardiac operating room 4 1 Alarm Category The monitor provides 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
52. then the trend graph interface is displayed In the trend graph the y axis stands for the measurement value and x axis stands for the time Trend Graph 5 mm hs m y Cursor v Trend Table Record 19 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 19 1 2 Setting Resolution The monitor can support five kinds of resolutions To set an appropriate 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 appropriate resolution among 1 sec 5 sec 1 min 5 min and 10 min 129 elite V8 Patient Monitor User Manual Review 19 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 current view by selecting and pressing the symbol and displayed on the trend graph 19 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 in
53. 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 4 1 2 1 c minimum recommended 1 2mV T Wave amplitude Accuracy of Heart Rate Meter and Response to Irregular Rhythm Complied with ANSI AAMI EC13 2002 Sect 4 1 2 1 e the HR value after 20 seconds of stabilization is displayed as follows Ventricular bigeminy 80bpm 1bpm Slow alternating ventricular bigeminy 60bpm 1bpm Rapid alternating ventricular bigeminy 120bpm 1bpm Bidirectional systoles 91bpm 1bpm Arrhythmia analyses Non Paced Patient Paced Patient ASYSTOLE RonT ASYSTOLE VFIB VTAC PVC TACHY COUPLET TACHY BRADY VT gt 2 BRADY PNC BIGEMINY MISSED BEATS PNP TRIGEMINY IRR VENT VBRADY 167 elite V8 Patient Monitor User Manual Product Specifications Average parameters of heart beat Heart rate bpm Time limit of P wave ms 12 lead ECG Synchronization Analysis PR interval ms QRS interval ms QT QTC ms P QRS T AXIS A 10 RESP Method Impedance between RA LL RA LA Measurement lead Options are lead I and II The default is lead II Respiration excitation waveform Sinusoid 62 8kHz 10 300uA Measuring Sensitivity 200 to 4500 baseline impedance 0 3 Differential input impendence
54. 0 C 32 F T2 50 C 122 F 0 C 32 F TD s0c 90 F O C O F IBP alarm limits are listed as follows unit mmHg Art RAP LAP CVP PA ICP P1 P2 300 55 elite V8 Patient Monitor User Manual CO alarm limits are listed as follows ALM HI ALM LO EtCO 150 mmHg 0 FiCO 50 mmHg 3 AwRR 150 rpm 2 rpm C O alarm limits are listed as follows ALM HI ALM LO TB 43 C 109 4 F 23 C 73 4F AG alarm limits are listed as follows Patient Type ALM HI ALM LO ADU FiCO 25 0 0 0 EtCO 25 0 0 0 FiO 88 0 18 0 EtO 90 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 150 rpm 0 rpm Apnea Time 40s 20s 56 Alarm Information elite V8 Patient Monitor User Manual Patient Type PED FiCO EtCO FiO EtO FiN O EtN20 EtDes FiDes Etlso Filso EtHal FiHal EtSev FiSev EtEnf FiEnf awRR Apnea Time ALM HI 25 0 25 0 88 0 90 0 100 0 100 0 18 0 18 0 5 0 5 0 5 0 5 0 8 0 8 0 5 0 5 0 150 rpm 40s ALM LO 0 0 0 0 18 0 18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 rpm 20s 257 Alarm Information elite V8 Patient Monitor User Manual Patient Type NEO F
55. 11 57 471020 11 59 078155 Reuseable Neonate Infant Airway Adapter 7053 01 Disposable Adult Airway Adapter 6063 00 11 59 078156 11 57 078142 Disposable Neonatal infant pediatric Airway Adapter 6312 00 Adult Nasal CO with O delivery sampling cannula 11 57 078143 Pediatric Nasal CO with O2 delivery sampling cannula 155 Accessories elite V8 Patient Monitor User Manual Part Number Accessories 11 57 078144 Infant Nasal CO with O delivery sampling cannula 11 57 101019 Adult Nasal Oral CO sampling cannula 11 57 101020 Pediatric Nasal Oral CO sampling cannula 11 57 101021 Adult Nasal Oral CO with O delivery sampling cannula 01 12 031598 Adult Pediatric Airway adapter kit 11 57 078140 Disposable CO Nasal Cannula Pediatric Respironics 3468PED 00 11 57 078141 Disposable CO Nasal Cannula Infant Respironics 3468INF 00 11 57 078152 Pediatric Infant Airway adapter kit with dehumidification tubing 11 57 078158 Pediatric mask mainstream 9960PED 00 11 57 078159 Adult standard mask mainstream 9960STD 00 11 57 078160 Adult large mask mainstream 9960S TD 00 11 57 078161 Band mainstream 8751 00 11 12 078162 bayonet socket 27 2 7 C O Accessories Part Number Accessories 01 57 471071 10 Cardiac output cable 11 13 40119 In line Injection tempera
56. 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 lead wires can be cleaned with a warm damp cloth and mild soap or isopropyl alcohol wipes CAUTION 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 24 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 147 elite V8 Patient Monitor User Manual Care and Cleaning Cuffs have been tested to withstand the
57. 3 III 0 02 aVF 0 06 8 7 3 ST Analysis Alarm Setting The user can select ECG Setup ST Analysis 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 22 0 mV 0 2 mV ALM HI should be higher than ALM LO 8 7 4 About ST Measurement Points The ST value for each beat complex 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 In 8 cT ms 108 me 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 7 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 IS
58. 6m reusable 01 57 471171 10 ECG trunk cable 3 lead Defibrillator Proof IEC 2 6m reusable 01 57 471165 10 ECG limb cable 3 lead clip AHA 0 9m reusable 01 57 471025 ECG limb cable 3 lead clip IEC 0 9m reusable 11 57 471056 Adult Disposable Adhesive Electrodes TYCO H99SG 30PCS package CE 11 57 471060 Adult Disposable Adhesive Electrodes TYCO Medi Trace 200 100PCS package FDA 11 57 471057 Children Neonatal Disposable Adhesive Electrodes TYCO H124SG 50PCS package CE 153 elite V8 Patient Monitor User Manual Accessories 27 2 2 SpO Accessories Part Number 02 01 210120 Accessories EDAN SHI Adult Reusable SpO Sensor DB9 Only compatible with EDAN SpO module and EDAN SpO Extension cable 1m finger type patient size gt 40kg 12 01 110492 EDAN SH3 Neonate Warp SpO Sensor DB9 Only compatible with EDAN SpO module and EDAN SpO Extension cable 1m 02 01 210123 EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 Immersion Disinfection Only compatible with EDAN SpOz module and EDAN SpO gt Extension cable 1m finger type patient size gt 50kg 02 01 210121 EDAN SH5 pediatric Silicone Soft tip SpOz Sensor DB9 Only compatible with EDAN SpO module and EDAN SpO Extension cable 1m finger type patient size 10kg to 50kg 01 57 471068 10 EDAN SpO Extension cable 7P 2m TPU 01 57 040196 Adult
59. 9 3 0 2 Adjustitig AT m VOM ue A EN Pea 30 3 0 3 Adjusting Beat VOLUME acs uos o Doa fea PM See eai Ep spend is is 30 3 7 Checking Your Monitor Version uoa ore eer ee Uaec pecu tod e e epe eua que die SY dene Dee 30 3 8 Networked Monitoring A dar rte en 30 3 9 Setting ban Gates ao oie a do 30 S DO Galibiating Sete SIs scusa pages qn nc tut AA RO 30 3 11 Disabling the IO eiSCEeel s den taste lidia 31 CA 31 A RET E E EI I s eias 32 AVATAR Carora tid seam SUE E easet lun M elus 32 4 1 1 Physiological alarms s sent en oes oe O AR UN Set dude 32 4 1 2 Technical Alarms 0 ae a Rent AAA ts ta aa da 32 41 5 Prompts aa tot eer o Leber deduce 32 42 Alam PP cU E NL D Ee NUI cce 32 AS Controlling Alarm yin italia latas 33 ASA Setting Param ter Alarmi ienien tese ee e E E E A R ale uio pas 33 4 3 2 Temporary Alarm MIS eere era iade n roa e a Seite iaaa 34 43 3 A Tarn Mute a od HUC ERU Ea iab e beatis te bin ite sabe Sead ants 34 4 3 4 Controlling Alarm Volume iore tease ir tr Nee oae Mantes Rer tee Rea 35 AAMT SAL CHIT A a e Ree lado cis 35 4 5 Disabling Sensor ob ATIS osea Car m aad Rec mg A 35 4 0 Testing Alarte 35 Chapter 5 Alarm Unitarian aid 36 5 1 Physiological Alarm Information ii AA Ie eerta denda 36 5 2 Technical Alarm Information S ee oce eost ER asin e trm EN Een Mee dite DA 40 NER OMA NEL E ERE 52 5 4 Adjustable Range of Alarm Limits iiie pe Tee teet sii 54 Chapter 6 Managing Patients eer eR DER Reno UFEEESRDNUAS ERR R
60. Active electrode 100nA Reference electrode lt 900nA Input Offset Current x0 1uA Recovery time after 5s Defibrillation Leakage current of patient lt 10uA Scale signal 1mVPP accuracy is 5 System noise 30uVPP Sampling frequency 1000Hz Sampling channel switch lt 80uS time A D precision 24 Bits ESU Protection Incision mode 300W Congelation mode 100W Restore time lt 10s Meets the requirements of ANSI AAMI EC13 2002 Sect 4 1 2 1 a Noise Suppression of Tested according to the test method in EC13 2002 Sect 5 2 9 14 Electrotome it complies with ANSI AAMI EC13 2002 Sect 4 2 9 14 Pace Pulse Pulse indicator Pulse is marked if the requirements of ANSI AAMI EC13 2002 Sect 4 1 4 1 are met Amplitude 2 mV 700 mV Width 0 1 ms 2 ms Ascending time 10 us 100 us 164 elite V8 Patient Monitor User Manual Product Specifications Pulse Rejection Pulse is rejected if the requirements of ANSI AAMI EC13 2002 Sect 4 1 4 1 are met Amplitude 2 mV 700 mV Width 0 1 ms 2 ms Ascending time 10 us 100 us Minimum input slew rate gt 2 5V S lead II Heart Rate HR Calculation Range ADU 15 bpm 300 bpm PED NEO 15 bpm 350 bpm Accuracy 1 or 1 bpm whichever is greater Resolution 1 bpm Sensibility gt 300 uVPP PVC Range ADU 0 300 PVCs min PED NEO 0 350 PVCs min
61. ERSRERNGRSUPE RN ERNENNIER PS ansia UR See pn Ue 59 6 1 Admitting a Patient aite i dios 59 6 1 1 Patient Category and Paced Status eius e ertet celer d se ae E WEE ed 60 ERU qne 60 6 3 Editing Patient Infotematt tis esr E eo Dota maet ed ipe od ind 60 64 Updating a Palit est Drain alas Slat bu a E RA pop bandos sees 60 6 5 Central MOBIUODITPOSVSIGTIT uo t oA e AO Sus 61 Chapter 7 User Interface eue ORE FINIRE TNR O NONIUS ERN Saot EUER 62 Fel Setting Interface Wilton ista EER A DAES a 62 7 2 Selecting Display Para MiS cese see rco seams at QN Da Cm enean e oni iy pee mes iind 62 7 3 Changing Waveform Position sod eut e re taeda erar vet Aisin deed id a ao 62 14 Changing Interface Layos 62 Fe EN EN tea Pot Se do cud E e 62 7 6 Viewing Oxygen Ma ii ii 63 17 1 Viewing Large Pont Screem s eant AAA wind led RECO AAA 63 7 8 Changing Parameter and Waveform Colors sss 64 Fac BUTS iue DU TE O Sila 64 FAO USB ConfigbtatiOD e i ista etate te init agi eps de Haee tein bod iaa iius faga ESES 64 7 11 Default Configuration os onec ase Sepala A idee buena 65 Chapter S Monitora EC G5 ieeeti ur Roi 66 MES aa PR 66 S2 ECG Safety Information oo quo e Mast En hes Ha oda Ea eot atiis quede uM uq eM Rud 66 8 9 BCO DISpIGy eo eee uten Ge tte tene dette Veto a vtl sdiReu NANI 68 8 3 1 Changing the Size of the ECG Wave cccccsscsssscessccsecsssscssccesaceentscscsseasesaceseasens 68 8 3 2 Cha
62. HEMOD menu as the basis for Hemodynamic calculations 16 7 Blood Temperature Monitoring Blood temperature monitoring can function when C O 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 C O measurement When the measurement ends the function will automatically resume 113 elite V8 Patient Monitor User Manual Monitoring C O The current blood temperature is displayed in the C O parameter area Flotation catheters Pulmonary artery Air celle Thermal resistance Right atriume Right ventricle Thermodilution Catheter Site 16 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 16 9 Recording C O Measurements C O measurement can be recorded by the recorder To record the C O measurement please select Record in the CO Measure menu 16 10 Setting INJ TEMP Source To change the INJ Temp Source please 1 Select Inj Temp Source in the CO Settings menu Select Auto or Manual from the list Manual directly displaying the injectate temperature from INJ TEMP e e Auto indicating the system obtains the injectate temperature through
63. IBP Plug the XM module in the XM module slot on the left side of the monitor and it is connected with the monitor as shown below XM module mounted on the left of the monitor 21 elite V8 Patient Monitor User Manual Basic Operation Overview of XM Module KR UU N oO N A tA Setup key press to enter the XM module setup menu Zero key press to enter the zero IBP menu NIBP start stop key press to start or stop NIBP measurement Indicator On when the module works normally Flash when the module is being initialized or malfunctioning Off when the module is unconnected Module name Connectors for transducer sensor Snap fix Connector to the monitor Installing the XM Module Mate the snap fixes on the right side of the module with the slots on the rear of the monitor and push the module forwards until the lever clicks in place then fasten the module with the snap fix on the left side of the monitor 22 elite V8 Patient Monitor User Manual Basic Operation 3 1 5 Configuration The configuration of elite V8 is listed below Size LXWxH Figure Function Configuration g g ECG 3 lead 5 lead 12 lead RESP 425 mm L x 245 mm W x 382mm H Square SpO2 PR NIBP TEMP IBP CO C O AG 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
64. N T QE NENS SEN ERE IN EUER NIRE EEUU 81 9 V OVErVIe Wiss aeq e eo dl ed LUAM IMEEM 81 9 2 RESP Safety Informatio Naninne n ru b eto dute raa M oec 81 9 3 Electrode Placement for Monitoring RESP sse eene 81 9 4 Cardiac Ov Stay code aes eas oe a ah tite ls 82 OV C BESCESDADSIOD cea eth unre petes tate aia beans iden Roig ide cutem tope ua t hilar 82 9 6 Abdominal Bfeathing 4 lt rccssste asstevastuotsnavazaiae aac into te lilas 82 9 7 Selecting RESP Lead a eod dy a esu ute a ideada 82 9 8 Changing Hold PE A d eu roe qute tede a i eod wks 83 9 9 Changing the Size of the Respiration Wave ccccecccesscessceesseceneceeeeeeeeeesseceseecsaeeneeeeeeeensees 83 9 10 Changing the Apnea ie aas ace tecta aces Te oath tans eire Gls tas Sit Gale eue 83 Chapter 10 Monitoring SO etii etse eei etse ovo neo eu ne IO epe eo Eve e oven eo UN REDE VENERARI EE REPRESENT 84 IAN Suo 84 10 72 PISA InfoHTE DE ende oce e e cds dl Eu tat e 84 10 3 Meastitino SG ist dolio 85 LOA Setting SpOo as Pulse SOUlCe AE AAA duod tds 86 MA A AN 87 10 6 Setting Sensitivity A IN 87 Chapter 11 Monitoring PR da 88 TESI VEEVIG WO A Rer dioi E a eate eA A M 88 11 2 Setting PR Sol deas de Re decet pb edes ue Mii ladies 88 TH S Sets PR Volume ss erm d urit tm cedat toS Des ere ae 88 11 4 Selecting the Active Alarm OS 88 Chapter 12 Monitoring NIBP ssivsssssccssessscessevssouceverssesvncssssenssessasvnssessee
65. O CI calculation result 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 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 16 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 C O and CI and 4 in the above figure will be calculated and displayed on the screen The monitor will display C O 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 should take place between two consecutive measurements The length of
66. O Noisy Signal ps Medium patient movement and the waveform is abnormal make sure the cable is well connected 42 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken SpO Interference Light Ambient light around the sensor is too strong Medium Reduce interference of the ambient light and avoid sensor s exposure to strong light NIBP Comm Fail NIBP Loose Cuff NIBP module failure or communication failure Cuff is no properly wrapped or no cuff exists High Low Stop using measuring function of NIBP module and notify biomedical engineer Or manufacturer s service staff Properly wrap the cuff NIBP Pressure Excessive 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 NIBP Signal Saturated Signal amplitude too strong Low Stop the patient from moving NIBP High Init Pressure The initial pressure is too high during measuring High Measure again if failure persists stop measuring function of NIBP module and notify biomedical engineer or manufacturer s service staff 2443 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Leve
67. O 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 78 elite V8 Patient Monitor User Manual Monitoring ECG 8 8 Arr Monitoring 8 8 1 Arrhythmia Analysis The arrhythmia algorithm is used to monitor ECG of neonatal and adult patients in clinics 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 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 in
68. ODD 177 AUS Wireless Ot a a E aan 179 O E AM ME d d MI SUME 181 AO LAOS Outputs eo Tb en erede tie pere e Abas ease ects c boda Ere RE a 181 4 19 72 Defibrillator SytichrontzallOfi s ore eot tn 181 Wael bs Jeo A A E A E T E S 182 A T94 USB Interact aa aa a a ds bee UE ba RIA edo 182 ALIOS VGA ATCT ACE 1 one A Eia 182 A 19 6 DVI Interface a tere A A odd AA tds 182 19 7 RS232 Interface toos irte e a a or iecte bs eta Sateen bae Hd 182 A198 PAM liter faces or Eo tta eub faa sth atten an ae cI teta eed 183 2 19 90 Network Interfaces tp eee ivae b ed me teret ra os 183 B EMC Informatii ices sacs c 184 B 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS eese 184 B 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS sss 184 B 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not EIBBE SUPPOREIBG us ipe tecta ead mv e ML D M oU E La st 186 BA Recommended Separation Distances suas sir lisa 187 C Default SCC cocer eene POS VER eren veces P eun verd essi lu lined ER RUNS Ees bove Pad saors ssis ssas ibs 189 C 1 Patient Information Default Settings us ceras tote aep eee a tig bat ole qu etter uat batig aan 189 C2 Alatm Default Settings assi tectis inst diia lios 189 ES ECG Default comoda 189 CARES A A ii its 190 CAP 191 en A A EU ME 191 CLTEINIBP tii ia 192 IS A a E RN NAE bE Sai 192 A OS 193 CAC tadas 193 CALLAR aa A 194 D ADDFEVIAUOE soci aec oie REM RES CIE FU Mi HD e
69. Of Range TB measuring value is High Please check TB above measuring range sensor CO Lack Param C O measuring needs High Please input patient S parameters height and weight The AA concentration R AA AA Out Of Range exceeds the accuracy range High sauce concentration of gas module Stop measuring of The oxygen sensor of the x f cud he O Sensor Error sidestream gas module has a Medium x MS failure engineer or i Manufacturer s service staff Stop measuring function of AG A le fail i AG Comm Fail G module ailure or High module and notify communication failure biomedical engineer or Manufacturer s service staff Please perform AG Zero Required AG module requires zero Low zeroing i PI it th If AG Self Testing AG module is self testing Low us ee ds testing finishing t A Pl AG Replace Os Sliaor O sensor needs to be High ease replace the O2 replaced sensor Pl it check AG Check Adapter AG module checks adapter Low cu VERE finishing O Cali Required O needs to be calibrated Low Please calibrate O A l ft Pl l AG Software Error G module software High ease replace abnormal software revision Please check whether A le has h AG Hardware Error o ES ae ate High the hardware works failure properly Please check whether AG Motor Error AG module motor abnormal High the motor works properly 47 elite V8 Patient Monitor User Manual Alarm Information
70. The report will use the current trend interval settings For the detailed information about recording the trend table please refer to Chapter Recording 130 elite V8 Patient Monitor User Manual Review 19 3 NIBP Review To review the NIBP measurement data select the NIBP Review key on the screen or select Menu gt Review gt NIBP Review then the NIBP Review window is displayed 19 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 19 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 19 4 Alarm Review The monitor can display up to 8 alarm events in the current screen To review the alarm event select the Alarm Review key on the screen or select Menu Review gt Alarm Review then the Alarm Review Window is displayed 19 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 selecting and pressing the symbol Y and displayed on the Alarm Review interface 19 4 2 Se
71. User Manual EDANUSA elite V8 Patient Monitor Version 1 0 C About this Manual P N 01 54 455329 10 Release Date March 2012 Copyright EDAN INSTRUMENTS INC 2012 All rights reserved Statement This manual will help you understand the operation and maintenance of the product better It is reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS INC hereinafter called EDAN can not be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modif
72. able AWRR Low AwRR measuring value is below lower alarm limit User selectable EtO High EtO2 measuring value is above upper alarm limit User selectable EtO Low EtO2 measuring value is below lower alarm limit User selectable FiO High FiO measuring value is above upper alarm limit User selectable FiO Low FiO measuring value is below lower alarm limit User selectable EtN O High EtN20 measuring value is above upper alarm limit User selectable FiN2O Low FiN2O 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 FilSO measuring value is below lower alarm limit User selectable EtSEV High EtSEV measuring va
73. 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 136 elite V8 Patient Monitor User Manual 21 2 Recording Type Recording The monitor 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 21 3 Starting and Stopping Recording You can start and stop the recording in the following ways Continuous real time recording Auto recording Trend graph recording Press the Record button on the front panel to start the recording and repress it to stop the 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 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 Sele
74. ading the inserted module IBP alias collision The label offered by the IBP module is inconsistent with the label assigned by the monitor DC supply Battery only Only one battery is in use 53 elite V8 Patient Monitor User Manual 5 4 Adjustable Range of Alarm Limits ECG alarm limits are listed as follows unit bpm Patient Type ALM HI ALM LO ADU 300 15 HR 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 ALM HI ALM LO PVCs 10 RESP alarm limits are listed as follows unit rpm Patient Type ALM HI ALM LO ADU 120 6 RESP PED 150 6 NEO 150 6 SpO alarm limits are listed as follows unit ALM HI ALM LO SpO 100 0 PR alarm limits is listed as follows unit bpm ALM HI ALM LO PR 300 30 54 Alarm Information Alarm Information elite V8 Patient Monitor User Manual 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 133 40 DIA 100 10 MAP 110 20 TEMP alarm limits are listed as follows ALM HI ALM LO TI 50 C 122 F
75. age Output Power Supply lt 12VDC 200mA Max Contact Type Normally open or contact optional Interface Type PJ 365 socket 3 5mm audio plug A 19 4 USB Interfaces Number of USB Interfaces Standard 4 optional 4 Drive Mode HOST interface USB1 0 2 0 protocol Power Supply 5VDC 500mA Max Interface Type USB A type port A 19 5 VGA Interface Number of VGA Interface 1 Horizontal Refreshing Rate 63 49KHZ Video Signal 0 7 Vpp 75 Ohm HSYNC VSYNC signal TTL Interface Type DB 15 female receptacle A 19 6 DVI Interface Auto drive is only applicable to DVI display A HDMI to DVI tieline is required Clock Rate 108 0MHZ DVI Video Signal 1280x1024 285HZ 4 3 Interface Type HDMI A type port A 19 7 RS232 Interface Level RS232 Power Supply 13 2V 60mA Max Interface Type DB 9 female receptacle 182 elite V8 Patient Monitor User Manual A 19 8 PAM Interface Only use link cable supplied by EDAN Product Specifications Level RS422 Power Supply lt 24VDC 2A Max Interface Type POWER USB port A 19 9 Network Interface Bandwidth 10MHZ 100MHZ Interface Type Standard RJ 45 network interface 183 elite V8 Patient Monitor User Manual B EMC Information Guidance and Manufacture s Declaration B 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS EMC Information
76. an 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 T1 High Measuring value of T1 channel is above upper alarm User selectable limit i h l is below 1 l TI Low Measuring value of T1 channel is below lower alarm DEM limit T2 High Measuring value of T2 channel is above upper alarm User selectable limit T Low Measuring value of T2 channel is below lower alarm Uschi limit TD High Measuring value of TD channel is above upper alarm scietis 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 37 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm level 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 selectable 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 be
77. ansducer or tubing Every time you reconnect the transducer cable to the monitor If you think the monitor s pressure readings are not correct When using a pressure module the zero information is stored in the module 14 3 3 Zeroing a Pressure Measurement The zeroing procedure is listed as below 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 14 3 4 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 PRESSURE OVER RANGE Make sure that the stopcock is vented to atmosphere If the FAIL problem persists please contact service technician PULSATILE PRESSURE Make sure that the transducer is vented to air not connected ZERO FAIL to a patient and try again 14 3 5 IBP Pressure Calibration 1 Mercury calibration should be performed
78. anterior axillary line horizontal with V4 electrode On the left middle axillary line horizontal with V4 electrode On the right side of the chest in positions corresponding to those on the left Over the xiphoid position On the Sth intercostal space at the left posterior axillary line of back On the 5th intercostal space at the right posterior axillary line of back 707 elite V8 Patient Monitor User Manual Monitoring ECG V Electrode Placement for 5 lead 8 5 4 3 Electrode Placement for 12 lead Take the American standard for example the 12 lead electrodes should be placed as follows The limb electrodes are placed in the same position as the 3 lead placement RL placement on the right hypogastrium V1 V2 V3 V4 V5 V6 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 V4 electrode zs elite V8 Patient Monitor User Manual Monitoring ECG Angle of Lewis V1 V6 Electrode Placement for 12 lead 8 5 4 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 avo
79. apan 2 412 GHz 2 472 GHz ETSI Working frequency segment Chl 11 America Chl 14 Japan Chl 13 ETSI 180 elite V8 Patient Monitor User Manual A 19 Interfaces A 19 1 Analog Output Product Specifications Bandwidth 3dB frequency 10Hz reference Diagnosis 0 05Hz 100Hz Monitor 0 5Hz 40Hz Surgery 1Hz 20Hz Maximum Transmission Delay 500ms Diagnosis Mode Sensitivity 1 V 1mV 10 PACE Rejection Enhancement Not applicable Waveform Display Consistent with the calculation leads Compliant with Standard and Directive Complies with the requirements in terms of short circuit protection and leakage current in EN60601 1 Output Impedance 500 Interface Type PJ 365 socket 3 5mm audio plug A 19 2 Defibrillator Synchronization Output Impedance 500 Maximum Time Delay 35mS R wave peak to leading edge of pulse Waveform Rectangular wave Amplitude High level 3 5V 5V providing a maximum of 1mA output current Low level 0 5V receiving a maximum of 5mA input current Minimum Required R wave 0 3mV Amplitude Pulse Width 100mS 10 Limited Current 15mA rating Rising and Falling Time lt ImS Interface Type BNC SR 2P connector 181 elite V8 Patient Monitor User Manual Product Specifications A 19 3 Nurse Call Drive Mode Volt
80. apter before proceeding with the Zeroing Procedure The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress 17 3 2 4 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 airway adapters are non sterile devices Do not autoclave the devices as this will damage them 2 Never sterilize or immerse the IRMA probe in liquid 17 3 2 5 Maintenance Gas readings should be verified at regular intervals with a reference instrument or by conducting the gas check The suggested interval is once every year 17 3 2 6 MAC Calculation The MAC value is calculated and displayed by using end tidal ET gas concentrations according to the following formula MAC ET AA1 X AA1 ET AA2 X AA2 ET N20 100 X AA HAL 0 75 ENF 1 7 ISO 1 15 SEV 2 05 DES 6 0 17 4 Setting Work Mode There are two woke modes Measure and Standby To change the work mode please refer to the following steps 1 Select the CO AG O2 N20 AA HAL ENF ISO SEV DES Setup menu 124 elite V8 Patient Monitor User Manual Monitoring AG 2 Select Work Mode on the interface and select Measure or Standby from the pull down list 17 5 Setting Apnea Alarm Time This determines the time limit after which the monitor gives an alarm if the patient stops b
81. as analyzer is intended only as an adjunct in patient assessment It must be used in conjunction with other assessments of clinical signs and symptoms 19 Replace the sampling line if the sampling line input connector starts flashing red or a Sample line clogged message is displayed on the host 20 No modification of this equipment is allowed without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe operation 21 ISA analyzers are not designed for MRI environments 22 During MRI scanning the monitor must be placed outside the MRI suite 23 Use of high frequency electrosurgical equipment in the vicinity of the monitor may produce interference and cause incorrect measurements 24 Use of high frequency electrosurgical equipment may enhance the risk of being burned therefore a static free or conductive respiratory cannula is not recommended 25 Do not use external ambient cooling of the ISA device 116 elite V8 Patient Monitor User Manual Monitoring AG WARNING 26 Do not apply negative pressure to remove condensed water from the Nomoline Family sampling line 27 Too strong positive or negative pressure in the patient circuit might affect the sample flow 28 Strong scavenging suction pressure might affect the sample flow 29 Exhaust gases should be returned to the patient circuit or a scavenging system 30 Due to the risk of patien
82. assemble the blood pressure tubing and the attached 3 way valve T e Nant 0 Boe Hydrargyrum pressure meter 2 3 way connector 3 3 way stopcock 4 Pressure transducer 5 Pressure transducer interface cable 6 Monitor IBP Calibration 101 elite V8 Patient Monitor User Manual Monitoring IBP 14 3 6 Troubleshooting the Pressure Calibration The status line lists the probable reasons of an unsuccessful calibration Message Corrective Action Sensor Off Fail Unable to calibrate in Demo Mode Make sure that sensor is not off then start the calibration Contact service technician if necessary Make sure that the monitor is not in DEMO mode Contact service technician if necessary Pressure out of normal range fail Make sure that you have selected transducer value in IBP CAL and 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 14 4 Changing the IBP Waveform Ruler The top middle and bottom rulers are available for each channel of IBP waveform Users can adjust the top middle or bottom rulers manually 1 Open the menu Wave Setup of IBP by clicking on the IBP waveform area 2 Selecta suitable ruler from the options TopRuler MidRul
83. b and access the alarm review interface to get more information On the alarm review interface you can Right or left shift the waveform to review the complete 8 scecond waveform Select Record and output the arrhythmia waveform by the recorder Select another name from the pull down list of Rename for the arrhythmia event to change its name Select Delete to remove a specific arrhythmia event Select Alarm List or Exit to get back to the arrhythmia review interface NOTE 1 If there are more than 200 arrhythmia events the monitor will only keep the recent ones 2 The name of arrhythmia event will be shown on the alarm status area 19 6 12 lead Diagnosis Review Select Menu gt Review gt Analysis Review to open the 12 lead analysis review interface 132 elite V8 Patient Monitor User Manual Review Diagnosis Review Analysis Time 2007 03 08 00 15 59 1 1 HR 80bpm P QRS T Axis 52 44 529 PR Interval 166ms RV5 SV1 Amp 0 73 0 08mv QRS Duration 80ms RV5 SV1 Amp 0 81mv QT QTC Interval 338 390ms Diag Code Diag Result 800 Sinus Rhythm v Wave 2 y Delete Record IA 19 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
84. catheter used NOTE The blood temperature alarm will not function during C O measurement It will resume automatically when the measurement is over 110 elite V8 Patient Monitor User Manual Monitoring C O 16 4 C O Measurement Window Select the CO Option menu to enter the CO Measure window and start C O measurement If C O transducer is not connected the monitor will display No Sensor on the screen NOTE Before a C O measurement is initiated check the accuracy of patient setup The calculation of C O is related to the patient height and weight therefore incorrect input will lead to error in calculation CO Measure CO 2 50 l min 3 CI 1 4 mnm BSA 1 804 m4 6 TB 36 8 TI 0 0 C 5 Measure Time 00 26 31 9 C O Measure Window Measurement curve Prompt message area Cardiac Output Cardiac Index Body Surface Area Blood Temperature Injectate Temperature Q e e e e e Start time of the measurement Function keys 111 elite V8 Patient Monitor User Manual Monitoring C O 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 C
85. ccessories V SpO module 134 mm L x 38 mm W x 102 mm H 0 2 kg Without accessories PAM 503 mm L x 170 mm W x 148 mm H 2 5 kg Without accessories A 3 Environmental Specifications 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 Main unit PAM XM module V SpO module V IBP module V C O module Recorder Temperature Working 0 C 40 C Transport and Storage 20 C 55 C Humidity Working 15 95 non condensing Transport and Storage 15 95 non condensing Altitude Working 860hPa 1060hPa 159 elite V8 Patient Monitor User Manual Product Specifications Transport and Storage Power Supply 700hPa 1060hPa 100V 240V 50Hz 60Hz 1 8A 0 75A Pmax 180VA FUSE T3 15AH250VP V CO module sidestream Temperature Working 5 C 35 C Transport and Storage 20 C 55 C Humidity Working 10 90 non condensing Transport and Storage 10 90 non condensing Altitude Working 530hPa 1066hPa Transport and Storage 530hPa 1066hPa V CO module mainstream
86. concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 6 kV contact E8 kV air 184 elite V8 Patient Monitor User Manual EMC Information Electrical fast transient burst IEC EN 61000 4 4 2 kV for power supply lines 1 kV for input output signal 2kV for power supply lines 1 kV for input output signal Mains power quality should be that of a typical commercial or hospital environment Surge 1 kV for line to line 1 kV for line to Mains power quality i houl that of IEC EN 61000 4 5 2 kV for line to ground Hng 2 an bubo T a ie 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 295 dip in Ur 295 dip in Uz should be that of a 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 295 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 295 dip in Uz for 5 sec typical commercial or hospital environment If the user o
87. ct Record on the diagnosis review interface to start the recording To stop the recording press the Record button on the front panel C O measurements recording Select Record on the CO Measure 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 recorder 137 elite V8 Patient Monitor User Manual Recording Malfunction stops the recorder from running properly NOTE You can press the FI button on the front panel to stop the currently recording process 21 4 Recorder Operations and Status Messages 21 4 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 print head may be damaged 21 4 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 21 4 3 Paper Out When the Recorder Out OF Paper alarm is displayed the recorder cannot start Please insert record paper properly 21 4 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 i
88. d the volume percentage of CO N20 O and anesthetic agents depend on the amount of water vapor in the measured gas The O measurement will be calibrated to show 20 8 vol at actual ambient temperature and humidity level instead of showing actual partial pressure 20 8 vol O corresponds to the actual O concentration in room air with 0 7 vol H20 concentration at 1013 hPa this equals for example 25 C and 23 RH The measurement of CO N20 and anesthetic agents e g all gases measured by the IR bench will always show the actual partial pressure at the current humidity level In the alveoli of the patient the breathing gas 1s saturated with water vapor at body temperature BTPS When the breathing gas flows through the sampling line the gas temperature will adapt to ambient before reaching the gas analyzer As the NOMO section removes all condensed water no water will reach the ISA gas analyzer The relative humidity of the sampled gas will be about 95 If CO values at BTPS are required the following equation can be used EtCO2 BTPS EtCO2 1 where EtCO EtCO value sent from ISA vol Pamb Ambient pressure sent from ISA kPa 3 8 Typical partial pressure of water vapor condensed between patient circuit and ISA kPa EtCO2 BTPS EtCO gas concentration at BTPS vol O is assumed to be room air calibrated at a humidity level of 0 7 vol H20 126 elite V8 Patient Monitor User Manual
89. ded 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 149 elite V8 Patient Monitor User Manual Maintenance Maintenance and Test Schedule NIBP Leakage Inspection Frequency 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 If you suspect the measurement values are incorrect and need to calibrate please contact the manufacturer 150 elite V8 Patient Monitor User Manual Warranty and Service Chapter 26 Warranty and Service 26 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty is void in cases of a damage caused by mishandling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e re
90. ding Parameter alarm recording Trend recording Titration table recording Frozen waveform recording 162 elite V8 Patient Monitor User Manual Product Specifications A 8 Review Trend Review Short 1 hr at 1 second resolution Long 150 hrs at 1 min resolution Review 1200 sets of NIBP measurement data A 9 ECG Lead Mode 3 Lead I IL III 5 Lead I II III aVR aVL aVF V 12 Lead I II HI aVR aVL aVF V1 V2 V3 V4 V5 V6 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 40mm mV x4 AUTO gain Sweep 6 25mm s 12 5mm s 25mm s 50mm s Bandwidth 3dB Diagnosis 0 05Hz 150Hz Monitor 0 5Hz 40Hz Surgery 1Hz 20Hz CMRR Common Mode Diagnosis gt 95dB the Notch filter is off Rejection Ratio Monitor gt 105dB the Notch filter is on Surgery gt 105dB the Notch filter is on Notch In diagnosis monitor and surgery modes 50Hz 60Hz Notch filter can be turned on or off manually Differential Input gt 5MQ Impedance Input Signal Range 8mV PP Accuracy of Input Signal The total error and frequency response comply with Reproduction ANSI AAMI EC13 2002 Sect 4 2 9 8 Electrode Offset Potential 500mV Tolerance 163 elite V8 Patient Monitor User Manual Product Specifications Auxiliary Current Leads off detection
91. ding to good clinical practice or when an occlusion message appears Occlusion occurs when the sample flow is too low This is indicated by a flashing red LEGI together with a message on the monitor 17 3 1 8 MAC Calculation The MAC value is calculated and displayed by using end tidal Et gas concentrations according to the following formula Et AAL Et AA2 Et N20 X AA X AA2 100 MAC 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 considered in the formula above 17 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 into place when properly seated J g fr a p p p P lt ya 5 Ji Fad as e i AM y KC T AR u W E END ESF RAY T 4 QW V X A P d E A LI Ys LKA Px 5 ANN SS Y Y I e DN Pin M Sy Fa A Y A N f E d EN Jl d Y A 4 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 121 Monitoring AG elite V8 Patient Monitor User Manual Z y A JK N Y O FI 9 YY Connect the IRMA airway adapter 15mm female connector to the patient s endotracheal tube P d j A 4 oen c N Dy EP j Es N M NDA N k
92. directly or refer to Section Setting Beat Volume 3 7 Checking Your Monitor Version To check the monitor version please select Menu gt Common Function gt About to check the monitor software revision 3 8 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 9 Setting Languages To change the language please 1 Select Menu gt Maintenance gt User Maintain then type the correct password ABC into the displayed interface 2 Select the Language option on the popup interface to open the language list 3 Select the desired language from the list To make the change valid please restart the monitor 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 30 elite V8 Patient Monitor User Manual Basic Operation 2 The symbol T appears on the screen 3 Click on the central point of the symbol 4 After successful calibration the message of Screen Calibration Completed appears on the screen Then select Exit to finish
93. e Cause Alarm Level Action Taken Check if the adapter The cannula is off or CO Check Adapter Low is well connected or disconnected use another adapter The concentration of anesthetic exceeds the Reduce AA AA Out Range High accuracy range of gas concentration module Stop measuring of AG module and The oxygen sensor of the notif biomedical f edica O Sensor Error sidestream gas module has a Medium y failure engineer or l Manufacturer s service staff The TEMP value is beyond an me ia a ick e sensor bracket Temp exceed limit the range of 25 C Med take it out and 45 C 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 Put the sensor into the sensor bracket Ambient temp too The Sensor temperature is L measure again after OW high higher than 40 C the ambient temperature reaches normal value Put the sensor into the sensor bracket The Sensor temperature is measure again after Ambient temp too low Low p lower than 10 C the ambient temperature reaches normal value 50 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Probe data error Offline NTC resistance gt R 0 C Short NTC resistance lt R 100 C Medium Put the sensor into the sensor bracket take it out and measure again If the p
94. e Family sampling lines in accordance with local regulations for biohazardous waste otherwise it may cause environmental contamination Use only airway T adapters with the sampling point in the center of the adapter Do only use sample lines intended for anesthetic agents if N2O and or anesthetic agents are being used 10 Do not use T adapter with infants as this adds 7 ml dead space to the patient circuit 11 Do not use adult pediatric type sampling line configurations with infants as this may add dead space to the patient circuit 12 Do not use infant type sampling line configurations with adults as this may cause excessive flow resistance 13 Do not use the ISA analyzer with metered dose inhalers or nebulized medications as this may clog the bacteria filter 14 Check that the gas sample flow is not too high for the present patient category 15 Since a successful zeroing requires the presence of ambient air 21 Os and 0 CO ensure that the ISA is placed in a well ventilated place Avoid breathing near the ISA sidestream gas analyzer before or during the zeroing procedure 16 The Nomoline sampling line and its interfaces are non sterile devices To avoid damage do not autoclave any part of the sampling line 17 Measurements can be affected by mobile and portable RF communications equipment Make sure that the ISA sidestream gas analyzer is used in the electromagnetic environment specified in this manual 18 ISA sidestream g
95. e modules with plug and play convenience The monitor stores data in trend and event Users can see tabular as well as graphical trends and document them on a recorder 11 elite V8 Patient Monitor User Manual Basic Operation 3 1 1 Main Unit Front View 1 Alarm mute indicator When the audible alarm is mute the indicator is in red 2 Physiological alarm When a physiological alarm occurs the indicator indicator lights on or flashes with different frequencies and colors reflecting the alarm level 12 elite V8 Patient Monitor User Manual Basic Operation 3 Technical alarm When a technical alarm occurs the indicator indicator lights on or flashes with different frequencies and colors reflecting the alarm level 4 Display 17 inch TFT screen with resolution of 1280x1024 5 Power supply switch Press it to turn the monitor on when the monitor is connected to the AC power supply or press the key to turn the monitor off when the monitor is on 6 Battery indicator Refer to the section Battery Indicator for details 7 AC power indicator 8 Mute Press it to suspend the output of all audible alarm signals 9 Start stop NIBP Press it to start or stop blood pressure measurement measurement 10 Trend Press it to review the trend table 11 Freeze unfreeze Press it to freeze or unfreeze waveforms 12 Start stop recording Press it to start or stop recording 13 Menu
96. e selections are available 0 1 2 3 4 5 5 indicates the maximum volume 0 indicates the minimum volume To change the beat volume select ECG Setup gt Beat Volume then select an appropriate volume from the pop up list 8 6 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 75 elite V8 Patient Monitor User Manual Monitoring ECG 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 Scr to display seven 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 6 5 Setting Pace Status 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 On or Off When Pace is set to On 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
97. e tire b iu EE D ues 152 21 3 Opuotndl ANC CESSOT OS ient eade mte suene es DEUS obtu ee 153 A A A dn Mab e essa etae ess 133 ZOCO ESOS Ss 154 E A enano trii feed nort d teet ein e i mco e Rast 154 21 2 4 TEMP PCC SE OLIES detenta ife see atu bm er diis E etos Fa cn A 155 2152 S BO ACCESOS Gur do Beds aaa eae Ane ue ri b eed ue did dob eus 155 21 20 COZ ICES OL ICS a Getestet E Eu Ete Nee t dE 155 2S A ao a S uad ER enu A cuo AR a 156 212 A AGCOSSODIOS c rid aaa 156 2129 Other SCCOBSOPIGS datae e e untur A esteso eta esu CDI uat cd 157 AA TT T T T 158 A LCOlassificatioi a isti avete A doa Lavua Ea atas RAN aanita 158 Ac Physical Specifications cast Seeded meia Mab poA IA 158 A 3 Environmental Specifications idc eere did end eur ie Xa in earth tous ada 159 AA Le k ge CUrtent iiu ies ved be b a 161 AS Display iso estet eot ms ont oue e de o Lud ette 162 15 0 Baltery us seca od wan a db ate ERROR ASNO MEE e RUM HERR PEN EGER Dx UEM ear iud 162 P WU qM Cd 162 PRISER VM Wes Sede ote t end to o en mte Ut etu Ceca Rar 163 PROS Ts Cas est Tcr 163 PMO TE SP E 168 BALNIB PAN cidit duda uem tn SORA A RO ede ie uude 169 A do tutes IA O LA Let LAE CA Le 170 AUS TENIP ii A anfu uo Datus SL rae eap ot aun dan C Usus 171 A tdi uidet ttn Ate S Lc A aic dtu EE 172 AOL Otto Eos aat t ed 172 A16 OV eT TT LC 175 ATTA Gode n ar a ad Mass tier D aa Cei ie raved E te Suara ie in etd 175 PPA Sid stream o eeu od ibt de coat Vd 175 AA72 Mainstream ear
98. ed NOTE Transducers and sensors have a limited shelf life Refer to the package labeling The following cables may not all be available in all countries Please check availability with your local Edan supplier 27 1 Standard Accessories 152 elite V8 Patient Monitor User Manual Accessories 27 2 Optional Accessories The following table lists the optional configuration for the monitor 27 2 1 ECG Accessories Part Number Accessories 01 57 471072 10 ECG trunk cable 10 lead Defibrillator Proof AHA 2 6m reusable 01 57 471168 10 ECG trunk cable 10 lead Defibrillator Proof IEC 2 6m reusable 01 57 109101 ECG limb wires 10 lead snap AHA 0 9m reusable 01 57 040203 01 57 471169 10 ECG limb wires 10 lead snap IEC 0 9m reusable ECG limb wires 10 lead clip AHA 0 9m reusable 01 57 471163 10 ECG limb wires 10 lead clip IEC 0 9m reusable 01 57 471067 10 ECG trunk cable 5 lead Defibrillator Proof AHA 2 6m reusable 01 57 471167 10 ECG trunk cable 5 lead Defibrillator Proof IEC 2 6m reusable 01 57 471023 ECG limb wires 5 lead snap AHA 0 9m reusable 01 57 040207 ECG limb wires 5 lead snap IEC 0 9m reusable 01 57 040208 ECG limb wires 5 lead clip IEC 0 9m reusable 01 57 471170 10 ECG limb cable 5 lead clip AHA reusable 01 57 471164 10 ECG trunk cable 3 lead Defibrillator Proof AHA 2
99. efore removing the sensor 105 elite V8 Patient Monitor User Manual Monitoring CO 2 Always disconnect the cannula airway adapter or sample line from the sensor when the sensor is not in use 15 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 15 3 3 Mainstream CO Module NOTE You must perform a zero calibration as described in this procedure each time you use a new airway adapter 15 3 3 1 Measurement Steps 1 Attach the sensor connector to the CO connector on the mainstream CO module 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 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 106 elite V8 Patient Monitor User Manual Monitoring CO Connecting Airway Adapter WARNING 1 Noroutine user calibration required 2 Accuracy is
100. egative terminals with metal objects and do not put the batteries together with metal objects which can result in short circuits Do not unplug the batteries when monitoring Do not heat or throw the batteries into a fire Do not use leave the batteries close to fire or other places where temperature may be above 60 C 7 Do not immerse throw or wet the batteries in water seawater 8 Do not destroy the batteries do not pierce the batteries 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 batteries 9 Use the batteries only in the monitor Do not solder the leading wire and the battery terminal directly 10 If liquid leaking from the batteries 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 batteries 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 batteries 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 142 elite V8 Patient Monitor User Manual Using Battery WARNING 14 Use the batteries with similar performance which can extend the service life of the batteries If
101. elect the appropriate setting from the popup list 83 elite V8 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 97 of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen then the blood 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 SpO PLETH parameter can also provide a pulse rate signal and a plethysmogram wave SpO socket 10 2 SpO Safety Information WARNING 1 If the SpOs sensor can not work properly please reconnect the sensor or change a new one 2 Do not use the sterile supplied SpO2 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 acc
102. ends the display capability of your monitor Used to mount an SD memory card It enables the VGA video output NOTE If incomplete display occurs on the screen of an external display connecting to the monitor via the VGA output adjust it with the button for automatic screen adapting of the external display or refer to its user manual Nurse call port analog output If users select it as nurse call it connects the monitor to the hospital s nurse call system Alarms indications are alerted through the nurse call system if configured to do so If users select it as analog output the monitor outputs the waveform through the port NOTE The function of nurse call analog output is only available when the XM module is inserted in the monitor 16 elite V8 Patient Monitor User Manual Basic Operation 10 Defibrillator synchronization The monitor outputs the defibrillator synchronization signal through the port NOTE The function of defibrillator synchronization is only available when the XM module is inserted in the monitor 11 USB interfaces They support USB1 0 2 0 output 12 Network interface It connects the monitor to the central monitoring system via standard network cable 13 PAM connector It connects the Parameter Amplifier Mainframe to the monitor 14 Heat sink 15 Anti thief lock sigs elite V8 Patient Monitor User Manual Basic Operation
103. entral 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 EtN20 End tidal nitrous oxide 195 elite V8 Patient Monitor User Manual Abbreviation Abbr English Full Name Description 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 dioxide FiN O 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 196 elite V8 Patient Monitor User Manual Abbreviation Abbr English Full Name Description Neo Neonate
104. equipment may cause safety hazard 4 f the pacemaker signals are beyond the claimed range the heart rate may be calculated incorrectly 5 In the 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 For protecting environment the used electrodes must be recycled or disposed of properly 67 elite V8 Patient Monitor User Manual Monitoring ECG 8 3 ECG Display The figure below is for reference only II X1 Di c Q li r The symbol D indicates lead name of display waveform there are several options such as I IL III aVR aVF aVL V If you want to change the lead please refer to section Selecting Calculation Lead The symbol 2 indicates waveform gain there are several options such as X0 125 X0 25 X0 5 X1 X2 X4 and Auto If you want to change it please refer to section Changing the size of the ECG Wave The symbol 3 indicates Filter setting there are three options Monitor Surgery and Diagnos If you want to change it please refer to section Changing the ECG Filter Setting 8 3 1 Changing 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 appropriate factor from the pop up box to adjus
105. er and BotRuler 102 elite V8 Patient Monitor User Manual Monitoring CO2 Chapter 15 Monitoring CO 15 1 Overview The monitor provides the SideStream and MainStream methods for CO monitoring The principle of CO measurement is primarily based on the fact that CO 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 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 Identifying CO Modules From left to right are sidestream CO module and mainstream CO module Gas inlet Connector for CO transducer Gas outlet 15 2 CO Safety Information WARNING 1 Do not use the device in the environment with flammable anesthetic gas 2 The device should be used by trained and qualified medical personnel authorized by EDAN 3 Nitrous oxide elevated levels of oxygen helium xenon halogenated hydrocarbons and barometric pressure can influence the CO measurement 103 elite V8 Patient Monitor User Manual Monitoring CO
106. er 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 Inappropriate disposals of waste may contaminate the environment 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 21 The packaging is to be disposed of according to local or hospital s regulations otherwise it may cause environmental contamination Place the packaging at the place which is inaccessible to children 22 After defibrillation the screen display recovers within 10 seconds if the correct electrodes are used and applied based on the manufacturers instructions 23 Clinical decision making based on the output of the device is left to the discretion of the provider 24 This equipment is not intended for family usage CAUTION 1 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 2 Keep the environment clean Avoid vibration Keep it far away from corrosive medicine dust area high temperature and humid environment 3 Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer Do not use autoclave or gas to sterilize the monitor reco
107. eric This chapter also tells you about arrhythmia monitoring and ST monitoring ECG connector 8 2 ECG Safety Information WARNING Do not come into contact with the patient table or the monitor during defibrillation 2 Only use the ECG leads supplied by the manufacturer when using the monitor for ECG monitoring 3 When connecting the cables and electrodes make sure no conductive part is in contact with the ground Verify that all ECG electrodes including neutral electrodes are securely attached to the patient but not the conductive part or ground 4 Check every day whether there is skin irritation resulted from the ECG electrodes If yes replace electrodes every 24 hours or change their sites 5 Place the electrode carefully and ensure a good contact 6 Checkifthe 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 7 When using the monitor with the defibrillator or other high frequency equipment please use defibrillator proof ECG lead to avoid burn 8 In order to avoid being burnt please keep the electrodes far away from the radio knife while using electrosurgical equipment 66 elite V8 Patient Monitor User Manual Monitoring ECG WARNING 9 When using Electrosurgery ES equipment do not place an electrode near the grounding plate of the Electrosurgery device otherwise there will
108. ery Safety Inforgiatloto cue pee etus tale datus RM DER diit aue 142 23 2 Battery Power Indicator is e eerte deae A aute oppo Ns dete oe dedu tes 143 23 3 Battery Status on the Main Sri aia 143 23 4 Checking Battery Performance Sasso e o deum ua 143 23 5 Replacing the Battista dd bt 144 230 Recycling tha Datteryooes di tel Put phenol aba 144 23 7 M imtaining the Wat et Ysa aer dei or e b atari deiode ai nia i 145 Chapter 24 Care and Cleaning gasses csi eene HERD eens ctedeeuh NER EEESN PARERE cass cabanavaseebcxvosavacousenacavsterceess 146 24 1 General A O tdem tum dud eu d nice 146 24 A ONET a T EEEE d o ut d M UL da eu Cn tide dut 146 24 2 Cleaning the MOnitOr is 146 24 22 Cleaning the JXecessOLTeB ovo edades initio eni tete bbs i eddatid 147 LAS Dismfecti n ee oe ob o rado e O O ce 148 24 PAS SUCT NIZATION seb Fei nope mtt on maed i cea mu ms ale nre hdd et MV e Dd 148 Chapter 25 Maintenatric indias 149 23 EU T NER IT 149 25 2 Maintenance Task and Test Schedule oocncncnnncncncococononocononacanonananananacaconanaroranananananannns 149 Chapter 26 Warranty and Service ierit pert EP SEN RETE EIE ne pe aen ve ae Ups inve ei ao pe S PEU REN qe EE PN IE OU 151 VON Ici ARP 151 26 2 Contact IICA A A A A ee sens A REO eed un 151 Chapter 27 ACCCSSOPIOS quoi Gb dS CERO IP EUREN alce aora Iaido LINO Ear aer DANA EK ERRARE ERO 152 21 I Standard ACCESSOMES i uc uii oa el eo ai ive i ede
109. es 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 decreases further the pulsations increase in amplitude reach a maximum which approximates to the mean pressure and then diminish In adult and pediatric mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers ANSI AAMI SP10 1992 in relation to mean error and standard deviation when compared to auscultatory measurements in a representative patient population For the auscultatory reference the fifth Korotkoff sound was used to determine the diastolic pressure In neonatal mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers ANSI AAMI SP10 1992 in relation to mean error and standard deviation when compared to intra arterial measurements in a representative patient population NIBP start stop key Connector for NIBP cuff 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 judgment to decide whether to perform frequent unattended blood pressure measurements on patients with severe blood
110. etup gt HR Alarm Setup and then set the Switch to On or Off from the drop down list Alarm Off symbol ES is displayed on the parameter area if the parameter alarm is switched to off WARNING When the 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 Setting Alarm Record Click on the ECG area on the screen select ECG Setup gt Alarm Setup gt HR Alarm Setup and then set the Record to On or Off from the drop down list 2 33 elite V8 Patient Monitor User Manual Alarms Setting Alarm Level Click on the ECG area on the screen select ECG Setup gt Alarm Setup gt HR Alarm Setup and then set the Level to High Mid or Low from the drop down list Setting Alarm Limits WARNING 1 Prior to monitoring make sure that the alarm limit settings are appropriate for your patient 2 Setting alarm limits to extreme values may cause the alarm system to become ineffective Click on the ECG area on the screen select ECG Setup gt Alarm Setup gt HR Alarm Setup and set the alarm limits on this interface as follows HR Alarm Setup Upper arrow or High o lower arrow to 30 Switch lon Y Alarm Limit increase or decrease the alarm Record loff v Level Mid v limit Setting value of high alarm limit Setting value of Low low alarm limit 1 L q Alarm Limit e 4 3 2 Temporary
111. ey 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 122 elite V8 Patient Monitor User Manual Monitoring AG 17 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 17 3 2 2 Performing a Pre use Check Prior to connecting the IRMA airway adapter to the breathing circuit 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 17 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 zeroin
112. f the Patient Monitor requires continued operation during power mains interruptions it is recommended that the Patient Monitor be powered from an uninterruptible power supply or a battery NOTE Uris the a c mains voltage prior to application of the test level 185 elite V8 Patient Monitor User Manual B 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING EMC Information Guidance and manufacture s declaration electromagnetic immunity 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 environment Immunity IEC EN 60601 test Compliance Electromagnetic environment 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 Vims 3 Vims 3 5 d gt WP IEC EN 150 kHz to 80 MHz V 61000 4 6 d VP 80 MHz to 800 MHz Ld Radiated RF 3 V m 3 V m 2 61000 4 3 L 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 fro
113. following recommended disinfectants cidex sporicidin microzid isopropyl alcohol 70 ethanol 70 buraton liquid 24 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 24 2 2 4 Other Accessories For cleaning other accessories please contact the manufactures for details 24 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 24 4 Sterilization Do not sterilize the monitor or the accessories unless this is necessary according 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 148 elite V8 Patient Monitor User Manual Maintenance Chapter 25 Maintenance WARNING 1 Failure on the part of the responsible individual hospital or institution employing the use of
114. fresh mode the system will sweep the waveforms from left to right in the Waveform Area Press the button on the control panel and the Freeze menu will appear on the bottom part of the screen At the same time the system freezes the waveforms NOTE Pressing the button repeatedly over a short period of time may result in discontinuous waveforms on the screen 127 elite V8 Patient Monitor User Manual Freeze 18 2 Reviewing Frozen Waveform By moving the waveform you may review a waveform of 12 minutes before it is frozen For a waveform of less than 12 minutes 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 Freeze 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 128 elite V8 Patient Monitor User Manual Review Chapter 19 Review The monitor provides 150 hour trend data of all parameters storage of 1200 NIBP measurement results and 200 alarm events This chapter gives detailed instruction for review of all data 19 1 Trend Graph Review m The latest 1 hour trend is displayed every 1 or 5 seconds m The latest 150 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
115. g 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 O and 0 CO in the IRMA airway adapter is of crucial importance for a successful zeroing If a Zero Required alarm should appear directly after a zeroing procedure the procedure has to be repeated 123 elite V8 Patient Monitor User Manual Monitoring AG Always perform a pre use check after zeroing the probe Zeroing for IRMA CO probes Zeroing needs to be performed ONLY when an offset in gas values is observed or when an unspecified accuracy message is displayed Allow 10 seconds for warm up of the IRMA CO probe after power on and after changing the IRMA airway adapter before proceeding with the Zeroing Procedure The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress Zeroing for IRMA AX probes Zeroing should be performed every time the IRMA airway adapter is replaced or whenever an offset in gas values or an unspecified gas accuracy message is displayed Allow 30 seconds for warm up of the IRMA AX probes after power on and after changing the IRMA airway ad
116. gt 2 5MQ Waveform bandwidth 0 2Hz 2 5Hz 3dB Baseline Impedance Range 2000 25009 no leads cables resistance 22000 45000 leads cables 1KQ resistance 0 1 Q 3 5 lead monitoring 0 2 Q 12 lead monitoring Noise Maximum dynamic range Baseline impedance 500 Variable impedance 3 No clipping RR Measuring Range Adult 0 rpm 120rpm Neo Ped 0 rpm 150rpm Resolution 1 rpm Accuracy 2 rpm Gain Selection x0 25 x0 5 x1 x2 x3 x4 x5 Apnea Alarm Time Setup 10s 15s 20s 25s 30s 35s 40s 168 elite V8 Patient Monitor User Manual Product Specifications A 11 NIBP Technique Oscillometry 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 SYS DIA MAP Measuring Range 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 mmHg 165 mmHg Neonatal mode Alarm Type SYS 40 mmHg 135 mmHg DIA 10 mmHg 100 mmHg MAP 20 mmHg 110 mmHg SYS DIA MAP Cuff pressure measuring range 0 mmHg 300 mmHg Pressure resolution ImmHg Maximum mean error 5mmHg Maximum standard deviation 8mmHg Maximum measuring period Adult Pediatric 120s Neonate 90s Typical measuring period 30s
117. he 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 specification please change the battery or contact the service personnel 23 5 Replacing the Battery To install or replace the battery please follow the procedure Battery door 1 To open the battery door press the battery compartment latch and pull the battery door leftwards according to indication beside the button 2 Remove the battery from the compartment 3 Insert a new battery into the battery compartment 4 Close the battery door NOTE The markers which respectively indicate compartment 1 and compartment 2 on the battery door are corresponding to the symbols and Y on the main screen 23 6 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 144 elite V8 Patient Monitor User Manual Using Battery WARNING Do not disassemble batteries put them into fire or cause them to short circuit They may ignite explode or leak causing personal injury 23 7 Maintaining the Battery To prolong the life of the batteries there is current limitation for using batteries T
118. herefore the monitor which runs on battery power may not be powered on under following circumstances 1 Only one battery is installed 2 One of the two installed batteries is damaged or large capacity difference between the two installed batteries exists 3 Batteries in the monitor are almost empty If above mentioned circumstances are detected recharge the batteries or use another two batteries with similar capacity Batteries should be conditioned regularly to maintain their useful life Remove the batteries from the monitor if they are not used for a longer period of time And recharge the batteries at a minimum of every 6 months when they are stored Discharge the battery completely once every month 145 elite V8 Patient Monitor User Manual Care and Cleaning Chapter 24 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 caused 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 24 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
119. hetic gas module for mainstream V C O module Cardiac output module V IBP module Invasive blood pressure module V CO module sidestream Carbon dioxide module for sidestream V SpO module Functional arterial oxygen saturation module 19 elite V8 Patient Monitor User Manual Basic Operation Example Module The structure of each plug in module is similar the module name is located at the bottom part hard keys are in the upper part measurement connectors are in the lower part Take the V IBP module for example Setup key press to enter setup menu of the measurement module 2 Indicator On when the module works normally Flash when the module is being initialized or malfunctioning Off when the module is unconnected 3 Connectors for transducer sensor 4 Second module specific key such as the zero key for IBP 5 Module name Plugging Unplugging Modules Users can plug and unplug modules during monitoring To plug a module insert the module until the lever on the module clicks into place Tounplug a module press the lever upwards and pull the module out NOTE Make sure the indicator on the module is on after the module is plugged in the monitor Otherwise re plug the module until the indicator is on 20 elite V8 Patient Monitor User Manual Basic Operation 3 1 4 XM Module The XM module is integrated with functions of multiple measurement modules of ECG RESP SpO TEMP IBP and N
120. his menu displays the measurement modules which have been mounted in the XM module slot three slot module rack and PAM from top to bottom Beside each measurement connector is the measurement label The color in which a measurement connector appears matches the status of the measurement parameter amp Colored indicates the module is activated Grey indicates the module is deactivated e Colored with a appearing indicates a module conflict 26 elite V8 Patient Monitor User Manual Basic Operation For IBP connectors with a circle slash symbol appearing indicates an IBP module conflict Colored with an X appearing indicates a module error 3 3 2 Activating Deactivating a Parameter Measurement For different measurement parameters approaches to parameter activation deactivation may vary a little Take the parameters ECG and NIBP in XM module for example To activate deactivate the ECG measurement select the ECG connector in the XM module on the MeasureSet menu and set the ECG measurement to on or off on the pop up submenu To activate deactivated the NIBP measurement select the NIBP connector in the XM module on the MeasureSet menu and the NIBP measurement will directly be activated deactivated 3 3 3 Resolving Module Conflicts This monitor supports a maximum of eight channels of IBP measurement Both the XM module and each V IBP module provide two channels of IBP measurement A maxi
121. iCO EtCO FiO EtO FiN O EtN20 EtDes FiDes Etlso Filso EtHal FiHal EtSev FiSev EtEnf FiEnf awRR Apnea Time ALM HI 25 0 25 0 88 0 90 0 100 0 100 0 18 0 18 0 5 0 5 0 5 0 5 0 8 0 8 0 5 0 5 0 150 rpm 40 s ALM LO 0 0 0 0 18 0 18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 rpm 20s 58 Alarm Information elite V8 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 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 1 Select 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
122. ic measuring mode for short intervals may lead to the discomfort of patient 12 3 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 fat surrounding a limb dampens the oscillations coming from the artery Patients on an edematous extremity 90 elite V8 Patient Monitor User Manual Monitoring NIBP 12 4 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 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 ob
123. ications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure II Table of Contents Chapter 1 Intended Use and Safety Guidance 4 eee ee eee eee eese eene eese en etna tn aeta seta sno 1 a O Dacos ode css uet deme tendu aw mn utu sentis IE Mrs 1 L2 Safety UI e xou re neos A We A ah Aedes An ee AA 1 1 3 Explanation of Symbols on the Monitor aii oasis en tr eto ere Dec ree REED 4 Chapter 2 rns Calla tint eC 8 2 T Inittal TASS Ct Otc O 8 2 2 Mounting the MOIITOTC S s c ose co bci epa a 8 2 5 Connecting the Power Cable ocio AAA AAA 8 24 Checking thus Monitor ssl estia Pages tot be tat a tab 9 DS HCC A AA 9 2 6 Sett
124. id 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 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 too small WARNING 1 When using electrosurgical ES equipment never place ECG electrodes near to the grounding plate of the ES device as this can cause a lot of interference on the ECG signal 2 ECG cables can be damaged when connected to a patient during defibrillation or using other high frequency equipment Check cables for functionality before using them again It is recommended to use the ECG cables which are defibrillator proof 74 elite V8 Patient Monitor User Manual Monitoring ECG NOTE 1 If an ECG waveform is not accurate while the electrodes are tightly attached try to change the
125. ing Date MITIN uei e err e o hoa edu do b dede uda dob eibi nde 9 2 7 Handing Over the Monitor sc uisi pto tete Pe ea aint ae d dec a M weds 9 Chapter 3 Basic Opetati fk eee aia quie Ne PUT QUA SEP ae pin 11 Dd OV ELVIS A RiGee 11 ILL Man Unit E 12 3 1 2 Parameter Amplifier Mainframe spaces stent ess cates Sues Saas eeu eese aa 18 21 5 Measurement Mod iia 19 3 LAXM Mod le RR DR RENS 2 Sv OMS UA aod e Ao Sack e e eee Sese S tb este odes 23 3 2 Operating and NavIBating ui e c deae to pie ad aeta bea Nae iPad vere 23 3 21 Deme IN CYS entendre dee a crate d te leder ees vt ER e NAA 24 33 Setting Parameters a SO Na ce aee adsit aS sa tes 26 3 3 1 Accessing the Parameter Men s noe SENA 26 3 3 2 Activating Deactivating a Parameter Measurement sss 27 3 3 3 Resolving Module Conflicts pta epos cues ee i e uta A edd 27 3 3 4 Resolving IBP Label Conflicts eere nett rei eher Li ut ur rtt etr t edendo 27 34 Operating Mode aiu eate pre ue beta vasto Hie due i boca asta eccle Pili 28 Bd SL Demo MOIS osos a oe rane er Ln LM tt d 28 SAD Standby Mode i o tn re eate E FR NER Dea PR Ep HE UIN PO ds oa Ei 29 3 9 Changing Monitor A A RS 29 3 5 1 Adjusting Screen Brightness e e dese tede ei Fem ait eR Med 29 3 5 2 Changing Date and Titae usi oes aee Rd 29 3 6 Adjusting Vole ues o o dea ied em e oda quac ha dl se dto d bd RS 29 3 6 1 Adjustmp Key Vol fHle oi eoe iet isis d eaten tena de db a 2
126. ite V8 Patient Monitor User Manual Monitoring ECG 8 5 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 4 Plug the patient cable into the ECG connector on XM module CAUTION To protect the monitor from damage during defibrillation for accurate ECG information and to protect against noise and other interference use only ECG electrodes and cables specified by EDAN 8 5 3 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 5 4 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 LL Red F Green RL Green N Black V Brown C White VI Brown Red Cl White Red V2 Brown Yellow C2 White Yellow V3 Brown Green C3 White Green 70 elite V8 Patient Monitor User Manual Monito
127. l Action Taken Measure again if failure persists stop using measuring i i f NIBP NIBP Invalid Reset The hardware pressure is i ow function o too high module and notify biomedical engineer or manufacturer s service staff Measurin ies has Measure again or use NIBP Time Out E E A Low other measuring exceeded the specified time method Check the NIBP cuff NIBP cuff h NIBP Tube Leak SMS DESSEN MOOR T 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 ARE A E P w Air Pressure Error pressure abnormal or Low propery system pressure abnormal preccunsaneter medi y l If the problem still exists contact your service personnel ther h tact i NIBP Self Test Error Sensor or other hardware High Contact your service errors personnel Check the NIBP cuff a NIBP cuff h NIBP Pneumatic Leak xb ar ER and pump for leakage leakages Contact your service NIBP System Failure Hardware abnormal High personnel NIBP cuff isn t i l t NIBP Cuff Leak Cuff pump or airway has a US properly connected leakage 44 or there is a leak in the airway elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Check whether the airway is occluded or pressure sensor
128. l for the respiration correctly in manual detection mode it may not be possible for the monitor to detect apnea If you set the detection level 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 4 Cardiogenic artifact in impedance respiration monitoring may make it difficult to detect breaths or may otherwise be counted as breaths In some instances the breath rate may also correspond to the heart rate making it difficult to determine if the signal is due to breathing or the cardiac cycle Do not rely on RESP monitoring as the sole method for detecting cessation of breathing Follow hospital guidelines and best clinical practices for apnea detection including monitoring additional parameters that indicate the patient s oxygenation status such as etCO and SpO NOTE The RESP monitoring is not recommended to be used on patients who are very active as thi
129. l 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 15 6 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 2 Select Apnea Alm 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 15 7 Setting CO Waveform Open the menu CO Wave Setup by clicking on the CO waveform area Choose Mode and set it to Curve or Filled from the pop up list Choose Sweep and select a suitable setting from the pop up list The bigger the value is the wider the waveform will be 108 elite V8 Patient Monitor User Manual Monitoring C O Chapter 16 Monitoring C O 16 1 Overview The Cardiac Output C O 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
130. lead 2 Interference from a non grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform 8 6 ECG Menu Setup 8 6 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 if 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 and ECG HR alarms are switched off If an ECG lead becomes available again the monitor automatically uses HR as alarm source 8 6 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 6 3 Setting Beat Volume Beat volume is from HR or PR depending on your HR alarm setting Fiv
131. lecting Alarm Event of Specific Parameter The monitor can review alarm event of the specific parameters To view the alarm event of the specific parameter please select Menu gt Review gt Alarm Event and choose Event Type to select the required parameter name from the popup list 19 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 occurring before the User Define option are displayed on the alarm event review interface 131 elite V8 Patient Monitor User Manual Review 19 5 Arr Review Select ECG Setup gt Arr Analysis Arr Review or Menu gt Review gt Arr Review to open the Arr review interface The interface displays the latest arrhythmia events 19 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 in the current view by selecting and pressing the symbol Y ust displayed on the Arrhythmia Review interface 19 5 2 Arrhythmia Alarm Review You may select an alarm event by the kno
132. ll Low off ECG electrode V5 falls off Make sure that all ECG V5 Lead Off the skin or ECG cables fall Low electrodes leads and off patient cables are 4 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken ECG electrode V6 falls off properly comnected ECG V6 Lead Off the skin or ECG cables fall Low off Stop measuring function of RESP RESP dule fail l le tif RESP Comm Fail E n i E High modu ki au T ae communication failure biomedical engineer or the manufacturer s service staff Make sure the sensor PDO ao Bay nep is well connected to SpO Sensor Off disconnected from the Low NASA s the patient s finger or patient or the monitor other parts SpO2 sensor was not Make sure the SOK NG S nior connected well E SET monitor and sensor is connected to the monitor or well connected the connection is loose reconnect the sensor Stop using measuring function of SpO Sy Comm Fall SpO module failure Or High module and notify communication failure biomedical engineer or manufacturer s service staff Reconnect the SpO sensor and change The pulse signal is too the measurement site E weak or the perfusion of Do If problem exists the measurement site is too please notify low biomedical engineer Or manufacturer s service staff E heck th iti There is interference with der E ana SpO measurement signals a las Sp
133. llowing 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 as follows Storing no data of new patient Pausing to give all types of alarms Pausing to transmit patient data to CMS and other network devices Pausing to store the currently recorded data and clearing the memory used to store recording and printing data 28 elite V8 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 true data of the patient being monitored 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 to exit WARNING Demo Mode 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 2 Standby Mode Standby mode can be used when you want to temporarily interrupt monitoring To enter standby mode please press the shortcut key O on the screen directly To resume monitoring select anything on the screen or press any key 3 5 Changing Monitor Settings 3 5 1 Adjusti
134. lls off properly connected ECG V Lead Off the skin or ECG cables fall Low off ECG electrode LL falls off Make sure that all ECG LL Lead Off the skin or ECG cables fall Low electrodes leads and off the monitor patient cables are 40 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken ECG electrode LA falls off properly connected ECG LA Lead Off the skin or ECG cables fall Low off the monitor ECG electrode RA falls off ECG RA Lead Off the skin or ECG cables fall Low off the monitor Check lead E i l i A ECG Signal Exceed nu ao ROOM High connection and beyond measuring range T patient condition ECO Sianal Overflow The amplitude of ECG Low Please modify the signal is too wide ECG gain Stop measuring function of ECG ECG Comm Fail ECG module failure or High module and notify communication failure biomedical engineer or manufacturer s service staff f Check lead ECG Noise ron AASR sepat g Low connection and greatly interrupted ES 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 skin or ECG cables fall Low Make uve chat Al M electrodes leads and ECG electrode V3 falls off E Mid ECG V3 Lead Off the skin or ECG cables fall Low POBRE aa cea off ECG electrode V4 falls off ECG V4 Lead Off the skin or ECG cables fa
135. low 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 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
136. lue 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 39 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm level 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 FiDES Low FiDES measuring value is below lower alarm limit User selectable AG FiO Low FiO measurement value is too low High AG APNEA Hn a specific time interval no RESP can be detected High using AG module 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 Europe please refer to the section America For the corresponding lead names in Installing Electrodes Message Cause Alarm Level Action Taken More than one ECG electrode falls off the skin or BOO ele HCG cables Hill off the monitor Make sure that all electrodes leads and patient cables are ECG electrode V fa
137. lution C O 0 1L min TB TI 0 1 C 0 1 F Alarm Range 23 C 43 C 73 4 F 109 4 F Accuracy C O 5 or 0 2 L min TB 0 1 C TI 0 1 C Output parameters C O Hemodynamic Calculation NOTE At least 90 of the C O data should reside inside the bounded region and the lower 95 confidence interval should not exceed 85 A 17 AG A 17 1 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 O N20 and two anaesthesia agent and identifying the anaesthesia agent automatically portable module 175 elite V8 Patient Monitor User Manual 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 ml min Rate Work Mode Measurement Standby Warm up Time lt 20s Typical Rise Time CO x 200ms O2 lt 350ms N20 lt 350ms O 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 Identification Time Response Time lt 3 seconds Standard Conditions GAS Range Accurac
138. ly to the exhaust port Wait 1 minute until the CO concentration has stabilized Note the value Wait 1 minute and check that the CO concentration has not decreased more than 0 4 vol or 3 mmHg If it has decreased more there is a major leakage in the ISA unit or in the Nomoline Do not operate the ISA if there is a major leakage in the unit 17 3 1 3 System Setup for Analyzer If your system is using the plug in and measure ISA analyzer please follow the setup instructions below 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 4 circuit Power up the monitor 119 elite V8 Patient Monitor User Manual Monitoring AG 5 Agreen 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 17 3 1 4 Zeroing The infrared module needs to establish a zero reference level for the CO N20 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 ox
139. m fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range 186 elite V8 Patient Monitor User Manual EMC Information Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters 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 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 communicatio
140. 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 24 elite V8 Patient Monitor User Manual 12 Perform a 12 lead analysis Exit from 12 lead analysis Access the 12 lead review Perform 12 lead record Admit a patient Review the trend graph Review the trend table Review the alarm event Access the NIBP review Access the ARR review Switch to the trend screen E Bet Eh 83 p 4 amp 3 2 1 3 Hardkeys Basic Operation Switch to the standard screen Switch to the OxyCRG screen Switch to the large font screen Set the module switch Change the key volume Adjust the screen brightness Calibrate the touch screen Zero the IBP sensor Alarm setup Change the beat volume Enter standby mode Select this item by the trim knob to enable the touch screen operation A hardkey is a physical key on a monitoring device such as the recording key on the front panel Refer to the illustration in 3 1 1 Main Unit for more information elite V8 Patient Monitor User Manual Basic Operation 3 3 Setting Parameters 3 3 1 Accessing the Parameter Menu ekl Select MessureSell on the bottom of the screen to enter the MeasureSet menu as shown below The display on your monitor may be configured to look slightly different depending on the modules mounted MeasureSet Module Switch T
141. 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 3 4 5 2 Ns sa dee Li du O ECG ha Off I NIBP Time 2011 08 30 17 02 56 HMM tm orn 2011 08 30 17 03 9 10 11 12 13 14 15 16 17 18 223 5 elite V8 Patient Monitor User Manual Basic Operation 1 Department 10 Measurement setup key 2 Bed number 11 Scroll left to display more shortcut keys 3 Patient name 12 Shortcut key area 4 Patient type 13 Symbol for AC power supply 5 Alarm status area 14 Symbol for battery status 6 Symbol for alarm off 15 Symbol for networking 7 Measurement value 16 Scroll right to display more shortcut keys 8 Parameter waveform 17 Date and time 9 Mute key 18 Menu key 3 2 1 Using 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 ES To mute the audible alarm JE To display the measuring setup interface MeasureSel a To display the main setup menu 3 2 1 2 Shortcut Keys A shortcut key is a configurable graphical key located at the bottom of the
142. mproperly AG Change Oxygen Replace oxygen sensor of Eos Please wait changing Sensor AG module finishing 48 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken AG No Oxygen The oxygen sensor falls off Connect the sensor High Sensor from the AG module again A le detects mixt l idi AG Mixed Aena G module detects mixture Medium Close the subsidiary gas agent gas agent CO Occlude Water trap of sidestream is lus Make sure the gas occluded exhaust works well The CO concentration CO Out Of Range exceeds the accuracy range High Reduce co concentration of gas module CO Sensor Faulty Stop measuring l functi f CO module failure High Ru LE CO module notify CO Sensor Over i biomedical engineer Temp CO Comm Fail CO module failure Or Bist Check if the water communication failure tray has been fixed CO Ram Error CO module failure High Stop using CO alarm function and notify biomedical engineer or Manufacturer s CO Rom Error CO module failure High service staff Disconnect the sampling cannula or adapter from the airway initiate the CO Zero Required Zero calibration failure Low zeroing before making sure that no expired air is inside the sampling cannula and adapter 49 elite V8 Patient Monitor User Manual Alarm Information Messag
143. mum of four V IBP modules can be used simultaneously if the XM module is not used while three if the XM module is used If eight channels of IBP measurement are loaded another IBP module s plugging in will trigger an IBP module the corresponding IBP connector will be changed into on the MeasureSet menu as an indication To remove the IBP conflict unplug the conflicting module and re plug it while less than eight channels of IBP are loaded For other modules only one of the same type is available at a time another one inserted will be in the conflicting status For example if a CO module module A is loaded then another CO module module B is inserted a symbol in red will appear on the corresponding connector on the MeasureSet menu to indicate a module conflict To use module B directly select the connector of module B on the MeasureSet menu and module A is consequently switched to be in conflicting status 3 3 4 Resolving IBP Label Conflicts Each label must be unique and can only be assigned once The measurement labels are stored in the measurement modules If you try to use two measurement modules that have identical labels this causes a label conflict in the monitor For example an IBP module module A has already been loaded and the label Art is used for module A Then another IBP module module B is inserted and the label Art is also used for 207 elite V8 Patient Monitor User Manual Basic Operation module B I
144. n or high signal attenuation Venous pulsation Placement of the sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line 10 4 Setting SpO as Pulse Source 1 In the PR Setup menu select PR Source 2 Select SpO from the pop up list 86 elite V8 Patient Monitor User Manual Monitoring SpO 10 5 Setting Pitch Tone If tone modulation is on the PR sound lowers when the SpO level drops In the SpO Setup menu select pitch tone to toggle between On and Off 10 6 Setting Sensitivity The different sensitivity indicates different refresh frequency High indicates the refresh frequency of SpO 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 87 elite V8 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 gt are switched off the PR parameter will be switched off
145. n 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 20 2 Titration Table After completing the drug 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 Y and displayed on the trend graph Record the data displayed in the current window by selecting Record 135 elite V8 Patient Monitor User Manual Recording Chapter 21 Recording 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 1 Recording indicator Recording key press this key to start or stop recording task Paper outlet A2 vC N Recorder Door 21 1 Performance of the Recorder Waveform record is printed at the rate of 12 5mm s 25 mm s or 50 mm s 48mm wide printout paper It can record up to three waveforms User selectable real time recording time and waveform Auto recording interval is set by the user and the waveform is in
146. n this case a label conflict will be triggered A prompt indicating IBP label conflict will appear on the left of the screen Additionally at the corresponding measurements area two labels flicker to indicate a label conflict The label inside the brackets is the conflicting one while the label outside the brackets is the default one assigned by the system Via comparing the labels displayed on the MeasureSet menu with the label outside the brackets you may identify the model with a label conflict and accordingly decide on the module to work The IBP module with a label conflict will not provide any measurement data besides the functions of setup zeroing and calibrating are unavailable To resolve the label conflict you have to change the conflicting label into a non conflicting one Three resolutions are available Resolution 1 1 Select the IBP channel with a label conflict on the screen and open the Options menu 2 Choose another label among the options from the Alias pull down list to resolve the label conflict Resolution 2 Deactivate the parameter with label A which works properly or unplug the corresponding module 2 Theconflicting label A will consequently turn to be available Resolution 3 1 Choose another label for label A which works properly 2 Theconflicting label A will consequently turn to be available 3 4 Operating Mode 3 4 1 Demo Mode To change the operating mode into the demo mode please refer to the fo
147. ncessevessssunsovecesesvecssereneeeevounes 89 T2 TOSS VIC Ws RO t a 89 12 2 NIBP Safety Information a ese baeo tr ccn d ward a a raa ba Ma PURUS 89 12 3 Measuremert IX mit aEOTIS AS AAA ARE 90 12 4 Measurement Methods o eon e ce a eise a a o t e Seu het eee 9 12 5 Measurement Procedutes o qoc tu el te oret He Geb er adecuada co rte diea ie ga 9 12 5 Operation Prompts cess cene eot eee d Ca opta dar a erc den Rs 92 12 5 2 Correcting the Measurement if Limb is not at Heart Level sssss 93 12 6 NIBP Multi Review WI diria eau e Er rrt to eid euo iie ten RE RN RUE e REUS 93 12 Resetting NIBP ud ne enc adea ecd aguda tea ree a eite von D enr e ovid 93 12 8 Calibratine NIBP oe dete estet etude uten d NR cate eat onan M Net 94 1o Dd Celle TOP de ate a bri e aate tt ba eue ed 94 12 10 Setting Inflation Mode urere ere tie AAA ae eet d Bene 95 Chapter 15 Monitoring TEMP oerte reser ege eum oe ua one ve SR eter Fee SEN Pune e OS NN rEPO UN DERE ERR EE EL e ERU 96 PS ANS SU 96 13 2 TEMP Safety InfotmatiOf ut e n e Pid Ee eror ato breed i iau taxa 96 133 TEMP Monitoring Sep sesto o pida cus 96 13 4 Calculating Temp DTSC iore diia 97 Chapter 14 Monitoring IBP ii ii 98 iEn d nuo C aaah 98 142 IBP Safety Ion AO desee atout entis a odas E on d 98 14 3 Monitoring LOCO ee o e or aee Rua e cine Mn eds epe eed
148. ng combines close personal surveillance with correct operation of monitoring equipment 15 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 16 When interfacing with other equipment a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients 17 If multiple instruments are connected to a patient the sum of the leakage currents must not exceed the limits or it may result in shock hazard 18 During monitoring if the power supply is off and there is no battery for standby the monitor will be off and only the patient information and alarm settings can be saved After reconnecting the power supply the user should turn on the monitor for monitoring elite V8 Patient Monitor User Manual Intended Use and Safety Guidance WARNING 19 Keep away from fire immediately when leakage or foul odor is detected 20 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 togeth
149. ng Screen Brightness To change the screen brightness please 1 Press the Brightness key on the screen directly or 2 Select Menu Common Function Brightness and select the appropriate setting for the screen brightness 10 is the brightest 1 is the least bright Your monitor may be configured with lower brightness in standby mode and also for transport to conserve battery power 3 5 2 Changing Date and Time To change the date and time please refer to Section Setting Date and Time WARNING A change in date and time will influence the storage of trend data 3 6 Adjusting Volume 3 6 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 29 elite V8 Patient Monitor User Manual Basic Operation 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 6 2 Adjusting Alarm Volume To change the alarm volume please 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 6 3 Adjusting Beat Volume To change the beat volume please press the Beat Volume key on the screen
150. nging the ECG Filter idos dei cal 68 8 4 Selecting Calculation Lead nessa iii lts 69 8 5 Monitoring PROCS oa AAA A cara nte Au ad 69 A A aee aa d ta 69 8 52 Connecting ECG Cables aaa 70 8 5 3 Selecting Lead AAA tert recen ne eer Ades ladle t a eee eda 70 8 5 4 Installing Bleetrodesu i ote e ep i YR e c tva t Qe iii 70 BO ECG Menu Sete o oie b etd a eu diesque babeat dela uud ue waned e et P pua 75 8 01 Setting Alarm SOUECG sie ipa ded er aa er ea a a aai 75 8 0 2 Smart Lead Offenen acies caes esta at e ase bad aetna dae Merete 75 8 0 3 Setung Beat Volutne a ae di ret eder is cte edet a t Ear moi eius 75 8 6 4 ECG Display isein un dotar a ds Mayes RHA es 75 8 6 3 Setting Pace SEatusaa A E E 76 8 0 6 ECG Caldos 76 8 6 7 ECO WaysformMm SEDES ri 76 A A ds bed nat ee e telae tat uu tel i Mein 71 8 7 SI Segment Monitoring A Ces E 77 BS Serine ST ANALYSIS is Joi A e adde tu terea diea i e E ed qd 71 8 7 2 O dote eir ier e etat es e MEM ud a e aes TT 8 7 3 ST AnalysisAl rm SEDIT AAA Du elena 78 8 7 4 About ST Measurement Points aseo teresa essi e o M uen ee ERN ANS VATER nod 78 8 7 5 Adjusting ST and ISO Measurement Points essere 78 S OX TE MORITOFIDE oes sce pet dte na d vnr edet A OR e pP 79 8 8 1 Arrhythmia Ad ree Lee de aite d dede as tec peine Ln aR a 79 S OP ARR An lysis MODUS a a le a cete CLE D EE LL Ded 80 Chapter 9 Monitoring RESP 6 iscctiscssccciessncisiscacececeatecscaseccecasansss qe Y eoe NU VIE
151. ns equipment and the monitor The monitor is intended for use in an electromagnetic environment 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 1505 to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d E d EI d BH 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 33 187 elite V8 Patient Monitor User Manual EMC Information 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 188 elite V8 Patient Monito
152. nto the paper cassette printing side facing upwards 138 elite V8 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 21 4 5 Removing Paper Jam When the recorder 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 139 elite V8 Patient Monitor User Manual Recording NOTE 1 If the monitor is not installed with a recorder it will indicate RECORDER SETUP NEEDED after pressing the Record button 2 Do not touch the thermo sensitive print head when performing continuous recording 140 elite V8 Patient Monitor User Manual Other Functions Chapter 22 Other Functions 22 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 22 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 f
153. nufacturer for repair Diagram of NIBP Air Leakage Test 94 elite V8 Patient Monitor User Manual Monitoring NIBP 12 10 Setting Inflation Mode To change the inflation mode you can 1 Select NIBP Setup gt Inflation Mode 2 Choose Manual or AUTO from the pull down list If Manual is chosen the preset value by users will be adopted as the inflation value when measuring blood pressure If AUTO is chosen the default value will be adopted as the inflation value when measuring blood pressure 95 elite V8 Patient Monitor User Manual Monitoring TEMP Chapter 13 Monitoring TEMP 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 Connector for TEMP probe 1 Connector for TEMP probe 2 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 TEMP T1 Sensor Off and the audible alarm is activated It is the same to the other channel 2 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
154. ont screen please refer to the following steps 1 Select the Large Font key on the screen directly or 2 Select Menu gt Display Setting gt View Selection gt Large Font to open this interface To view the large font interface of a specific parameter please select the parameter from the pull down list on the interface the red circle shown in the following figure 99 120 7487 rm ern 2011 08 30 17 03 N ER Bl s ARR Review Standard TrendScreen OxyCRG um Adult 7 SO y Spog 4 Mute MeasureSet Admission Trend Graph Trend Table AlarmReview NIBP Review 63 elite V8 Patient Monitor User Manual User Interface 7 8 Changing Parameter and Waveform Colors The user can set the display colors of parameter and waveform as desire To change the display color please select Menu Maintenance User Maintain enter the required password ABC Then select Color Select to make color changes on parameter and color NOTE To make the color changes effective please restart the monitor after changing the colors 7 9 User Configuration Users can save the current monitor s configuration delete the saved user configuration and rename it To save the user configuration 1 Select Menu gt Maintenance gt User Maintain enter the required password ABC and then select User Configure 2 Click on Save enter a file name for the configuration and confirm it A message will dis
155. or 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 3 Before using the function of nurse call check if it is functioning normally 141 elite V8 Patient Monitor User Manual Using Battery Chapter 23 Using Battery This monitor can run on battery power which ensures its uninterrupted operation even when AC power supply is interrupted The batteries recharge whenever the monitor is connected to the AC power source During monitoring if the AC power is interrupted the monitor will take power from the internal batteries If the monitor is powered by batteries the monitor will switch off automatically before the batteries are completely depleted 23 1 Battery Safety Information WARNING 1 Before using the rechargeable lithium ion batteries hereinafter called batteries be sure to read the user manual and safety precautions thoroughly 2 The service life of the batteries depends on the service frequency and time The service life of the batteries is about three years if the batteries are well maintained and stored The service life of the batteries may shorten if they are used inappropriately 3 Do not connect the positive and n
156. ording to changes of the skin More frequent examinations may be required for different patients 84 elite V8 Patient Monitor User Manual Monitoring SpO WARNING 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 Neonate SpO sensor can only be used when required no more than 20 min at a time Use only EDAN permitted sensors and extension cables with the oximeter Other sensors or extension cables may cause improper monitor performance and or minor personal injury 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 NOTE 1 Make sure the nail covers the light window The wire should be on the backside of the hand SpO waveform is not proportional to the pulse volume Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line Don t use the functional tester to access the SpO accuracy The device is calibrated to display functional oxygen saturation The materials with which the patient or any other person can come into contact conform with the standard of 1SO10993 10 3 Measuring SpO l Select the correct patient category setting adult pediatric and neonatal as this is
157. placement 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 26 2 Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn 151 elite V8 Patient Monitor User Manual Accessories Chapter 27 Accessories You can order accessories from EDAN supplies at www edan com cn or consult your local Edan representative for details WARNING 1 Never reuse disposable transducers sensors accessories and their casing that are intended for single use or only use them on a single patient Reuse may compromise device functionality and system performance and cause a potential hazard 2 Use only EDAN approved accessories Using non EDAN approved accessories may compromise device functionality and system performance and cause a potential hazard It is not recommended to use accessories supplied by EDAN with patient monitors by other manufacturers 3 Do not use a sterilized accessory if its casing is damag
158. play after the operation To delete the user configuration 1 Select Menu gt Maintenance gt User Maintain enter the required password ABC and then select User Configure 2 Select the configuration file needed to delete from the list click on Delete and confirm the operation A message will display after the operation To rename the user configuration 1 Select Menu gt Maintenance gt User Maintain enter the required password ABC and then select User Configure 2 Select a configuration file needed to rename from the list and click on Rename 3 Enter a name for the configuration file and confirm it 7 10 USB Configuration When installing several monitors with identical user configuration it is not necessary to set each device separately An USB drive can be used to transfer the configuration from monitor to monitor To export the current monitor s configuration 1 Connect USB device to the monitor s USB port 2 Select Menu Maintenance User Maintain enter the required password ABC and then select USB Configure 3 Select Export to export configuration A status message will display after the operation To import the configuration on the USB drive to the monitor 64 elite V8 Patient Monitor User Manual User Interface Connect the USB drive to the monitor s USB port Select Menu Maintenance User Maintain enter the required password ABC and then select USB Configure Select Import and
159. prong plug from the monitor to fit a two slot outlet 4 EXPLOSION HAZARD Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur 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 contact 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 neutral electrode 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 elite V8 Patient Monitor User Manual Intended Use and Safety Guidance MARN 7 Route all cables away from patient s throat to avoid possible strangulation 8 Devices connecting with monitor should be equipotential 9 If the earth protection system is not stable use the batteries for power supply 10 Two batteries must be used when the monitor uses inte
160. r User Manual C Default Settings This appendix documents the most important default settings of your monitor as it is delivered from the factory Default Settings Note 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 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 Alarm Low Limit 50 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 189 elite V8 Patient Monitor User Manual Default Settings Alarm Switch Off Alarm Level Medium Alarm Record Off Alarm High Limit ST X 0 2 Alarm Low Limit ST X 0 2 X stands for I IL III aVR aVL aVF V V1 V2 V3 V4 V5 or V6 ARR Analysis ARR Analysis On 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 RON T On Medium Off VT gt 2
161. r awareness is required 2303 elite V8 Patient Monitor User Manual Alarms Alarm Sound The high medium low level alarms are indicated by the system in following different audio ways Alarm level Prompt 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 Medi jen eor alarm indicator flashes in yellow with frequency of 0 4Hz 0 8Hz Low Mode is DO which is triggered once every 30 seconds The sound pressure range for audible alarm signals is from 45 dB to 85 dB WARNING 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 patient danger Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment 4 3 Controlling Alarm 4 3 1 Setting Parameter Alarm Alarm switch alarm record and alarm level settings are available on the respective menu for each parameter alarm setup And for most parameters the methods to access their alarm setup menus are similar Take HR for example methods to set parameter alarm will be introduced below Setting Alarm Switch Click on the ECG area on the screen select ECG Setup gt Alarm S
162. r selectable IRR IRREGULAR RHYTHM The patient has irregular heart rate check patient s condition electrodes cables and leads User selectable 36 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm level PACE NOT CAPTURE After the pacemaker is PNC paced QRS complex can not be detected during User selectable 300ms PNP PACER NOT PACED After the QRS complex no U Reb pace is detected during 1 75 times of RR interval Pearce 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 RR measuring value is above upper alarm limit User selectable RR Low RR 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 SpO2 High SpO measuring value is above upper alarm limit User selectable SpO2 Low SpO measuring value is below lower alarm limit User selectable SpO No Pulse The signal of the measurement site is too weak so the High monitor c
163. rder or any accessories The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives 6 Disposable devices are intended for single use only They should not be reused as performance could degrade or contamination could occur 7 Remove a battery whose life cycle has expired from the monitor immediately 8 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 elite V8 Patient Monitor User Manual Intended Use and Safety Guidance CAUTION 9 To ensure patient safety use only parts and accessories manufactured or recommended by EDAN 10 Before connecting the monitor to the AC power make sure the voltage and the power frequency are consistent with the requirements indicated on the device label or in this user manual 11 Protect the device against mechanical damage resulting from gravitation collision powerful vibration and so on 12 A drafty environment for monitor installation is required and do not block up the ventilation grille at the back of the device 13 Federal law restricts this device to sale by or on the order of a physician NOTE 1 Position the device in a location where the operator can easily see the screen and access the operating controls 2 The monitor can only be used on one patient at a time If the monitor
164. re 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 12 5 1 Operation Prompts l Manual Measuring Access the NIBP Setup menu and set the Measure Mode item to Manual Then press the ey button on the front panel to start a manual measurement During the idle period of measurement process press the e button on the front panel at any time to start a manual measurement Then press the a button on the front panel to stop manual measurement and the system continues to execute auto measurement program according to the selected time interval Ze Automatical Measurement 92 elite V8 Patient Monitor User Manual Monitoring NIBP Access the NIBP Setup menu and set the Measure Mode item to Auto then press the e 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 a button on the front panel at any time to stop continuous measurement
165. reathing 1 Select the CO AG Setup gt Apnea Alarm 2 Choose the apnea alarm time from the pull down list 17 6 Working Status of ISA analyzer Working 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 Blinking red light Check sampling line 17 7 Working Status of IRMA Module The working status of the IRMA module can be transmitted by the IRMA probe 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 Blinking red light Check adapter 17 8 N20 and O2 Compensations The following models need O2 compensation IRMA AX IRMA COs ISA AX ISA CO The following models need N20 compensation IRMA CO and ISA CO For the compensation details please refer to the following table 125 elite V8 Patient Monitor User Manual Monitoring AG O Range Set O Range 0 30 vol 21 30 70 vol 50 70 100 vol 85 N20 Range Set N20 Range 0 30 vol 0 30 70 vol 50 17 9 Effects of Humidity The partial pressure an
166. refully 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 Place the monitor on a flat level surface hang it on the bed rail or mount it on a wall For detailed information about how to install the wall mount for the monitor please refer to the Wall Mounting Bracket Assembly Instruction WARNING 1 The wall mounting bracket can be fixed only on a concrete wall 2 The safe load of the top splint is 20kg Overweight may cause the device to rupture and even fall over 2 3 Connecting the Power Cable Before connecting the power cable check if the fuse is well installed inside the connector Refer to the illustration Rear View in the section 3 1 7 and locate AC power input The specification of the fuse is T3 15AH250V 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 1 8A 0 75A 2 Apply the power line provided with the monitor Plug the power line to inlet interface of the monitor Connect the other end of the power line to a grounded 3 phase power output NOTE 1 Connect the power cable to the socket specialized for hospital use 2 Onlyuse the power cable supplied by EDAN elite V8 Patient Monitor User Manual Installation 2 4 Checking
167. reset the system time after powering on the monitor 2 If the system time cannot be saved and resumes the default value after restart contact the service department of EDAN to replace the button cell of the main board 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 elite V8 Patient Monitor User Manual Installation 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 10 elite V8 Patient Monitor User Manual Basic Operation Chapter 3 Basic Operation This user manual is based on the maximum configuration and therefore your monitor may not have all of the functions and options described in the manual Also illustrations in this manual serve as examples only and do not necessarily reflect the setup on your monitor The content displayed on you monitor depends on the way it has been tailored for your hospital 3 1 Overview The elite V8 patient monitor offers a monitoring solution optimized for the surgical cardiac medical and intensive care environments Combining patient surveillance and data management it allows multi measurement monitoring by linking separat
168. ring ECG AHA American Standard IEC Europe Standard v4 BrownBlue C4 White Brown V5 Brown Orange C5 White Black V6 Brown Purple C6 White Purple 8 5 4 1 Electrode Placement for 3 lead Take the American standard for example see the following figure RA placement directly below the clavicle and near the right shoulder LA placement directly below the clavicle and near the left shoulder LL placement on the left hypogastrium Electrode Placement for 3 lead 8 5 4 2 Electrode Placement for 5 lead Take the American standard for example see the following figure RA placement directly below the clavicle and near the right shoulder LA placement directly below the clavicle and near the left shoulder RL placement on the right hypogastrium LL placement on the left hypogastrium V placement on the chest the position depends on your required lead selection 2s NOTE To ensure the patient safety all leads must be attached to the patient elite V8 Patient Monitor User Manual Monitoring ECG Electrode Placement for 5 lead For 5 lead attach the V electrode to one of the indicated positions as below V1 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
169. rmation soe us E uet e 109 16 3 CC Monitorme Procedures es sese odd IAE expe ed uw needa Rivas 109 16 4 C O Measurement WindoW 4 ee ores hades ree tices RE EN e e evan ase ger pto ea 111 16 5 Measurement Process 4 oque ge tita AS a aas 112 A A ecu slat oe fede ea o ae wan a ean E ans UR ae wi Ned tq kes 113 16 7 Blood Temperature Monitoring uoo esci eco in 113 16 8 Setting the Computation Constant cus qi a ete ete Co et e Dub RS tU dns 114 16 9 Recording C O Measurements is oar dues decia tus bh brit io Paneg I4 Fav ek4 baena 114 16 10 S tting INJ TEMP Sordos 114 Chapter 17 Monitoring AG noc INEO EIN BUT 115 INA Bd Uu NET 115 RASO TR ERE D UU IL 115 17 2 1 Safety Information for ISA Analyzer ee eeceescesecseeeneeeeeeeceesecaecaeeeaeeeeeeaeeneenss 115 17 2 2 Safety Information for IRMA Module sese 117 VII 17 3 Monitoring Steps s esae cepe la dhe Saale tice at ed Gt Sees ates oe ale ER pe TEE IR EY NE 119 17 3 1 Monitoring Steps Tor ISA Analyzet nre ii 119 17 3 2 Monitoring Steps for IRMA Module 4 eee ee eeeeee eiie etes tnnt enata 121 174 Setting Work Mods visto atlas 124 17 5 Set Apnea Alarm dd adios 125 17 6 Working Status of ISA analyzer i A rote eis 125 17 7 Working Status of IRMA Module essere enne nennen 125 17 8 N20 and Os Compensations uns eene qut eter Venice tam eu een b ems is 125 O ENL a b gir c
170. rnal power supply 11 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 department or your local distributor 12 The monitor is equipped with a wireless AP via network interface to receive RF electromagnetic energy Therefore any other equipment complying with CISPR radiation requirements may also interfere with the wireless communication and make it interrupted 13 Only use patient cable and other accessories supplied by EDAN Or else the performance and electric shock protection can not be guaranteed and the patient may be injured Prior to use check if the casing of a disposable or sterilized accessory is intact Do not use it if its casing is damaged 14 Do notrely 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 monitori
171. roblem persists stop using measuring function of TEMP module and notify biomedical engineer Or manufacturer s service staff Probe heater error Single failure Medium 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 Medium 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 251 elite V8 Patient Monitor User Manual Alarm Information Message Cause Alarm Level Action Taken Recorder setup needed The user presses the Notify the RECORD button when the monitor is not installed with a recorder manufacturer s service staff to install and set the recorder Low 5 3 Prompts Message Cause BCG An amid The QRS template building required for Arr Analysis is in process SpO
172. rom the pull down list of Lead Type and also set Display to 12 Leads In 12 lead display mode 12 ECG waveforms and one rhythm lead waveform will be shown at the waveform area on the screen The rhythm lead is for ECG calculation before entering 12 lead display mode Also in this mode the filter mode is set to Diagnos and can not be changed 8 7 ST Segment Monitoring 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 1 ST segment analysis is intended for adults only 2 When ST Analysis is On the monitor should be in Diagnos mode 3 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 7 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 7 2 ST Display Your monitor screen may be configured to look slightly different from the illustrations e elite V8 Patient Monitor User Manual Monitoring ECG ST 1 008 aVR 009 v 0 04 II 0 10 aVL 0 0
173. s can cause false alarms 9 3 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 81 elite V8 Patient Monitor User Manual Monitoring RESP Electrodes Placement for 5 lead 9 4 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 flow 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 5 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 6 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
174. 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 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 59 elite V8 Patient Monitor User Manual Managing Patients 6 1 1 Patient Category and Paced Status 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 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 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 On If it is incorrectly set to Off the monitor could mistake a pace pulse for a QRS and fail to
175. sampling 114 elite V8 Patient Monitor User Manual Monitoring AG Chapter 17 Monitoring AG 17 1 Overview The monitor uses ISA sidestreasm gas analyzer hereinafter called ISA analyzer and IRMA mainstream module 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 Identifying AG Module From left to right are sidestream AG module and mainstream AG module Gas inlet Gas outlet Connector 17 2 Safety Information 17 2 1 Safety Information for ISA Analyzer WARNING 1 The ISA sidestream gas analyzer is intended for use by authorized healthcare professionals only Use only Nomoline sampling lines manufactured by PHASEIN 3 The ISA analyzer must not be used with flammable anesthetic agents 4 Carefully route the sampling line to reduce the risk of patient entanglement or strangulation 5 Do not re use disposable single patient use Nomoline Family sampling lines due to the risk of cross contamination 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 115 for AG transducer elite V8 Patient Monitor User Manual Monitoring AG WARNING 7 Dispose Nomolin
176. select a configuration file needed to import from the list confirm the operation A status message will display after the operation Besides users can delete configuration files from the USB device via the monitor 1 Connect USB device to the monitor s USB port 2 Select Menu Maintenance User Maintain enter the required password ABC and then select USB Configure 3 Select Delete and select a configuration file needed to delete from the list confirm the operation NOTE 1 The U disk only supports two kinds of format FAT and FAT 32 2 The exported configuration files are saved into the folder named USERCONFIG and the user can t modify files the in the folder Up to three configuration files can be saved and recognized 4 To make monitors using the same user configuration display identically the display setting in each monitor should be the same 7 11 Default Configuration To set default configuration select Menu Default Users can choose a factory configuration adult pediatric or neonate based on the patient category Also users can choose a user configuration saved in the monitor For more information about user configuration refer to 7 9 User Configuration and 7 10 USB Configuration 65 elite V8 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 num
177. seline 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 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 EH 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 The QRS should be tall and narrow The P waves and the T waves should be less than 0 2 mV 8 5 Monitoring Procedure 8 5 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 WI Select sites with intact skin without impairment of any kind W Shave hair from sites if necessary B Wash sites thoroughly with soap and water Never use ether or pure alcohol because this increases skin impedance E Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease 69 el
178. served stop the blood pressure measurements 12 5 Measurement Procedures 1 Connect the air hose to the connector on XM module 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 NIBP 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 40 of the limb circumference 50 for neonates or 2 3 of the upper arm length The inflatable part of the cuff should be long enough to encircle 50 80 of the limb The wrong size of cuff can cause erroneous readings If the cuff size is in question use another cuff with suitable size to avoid errors 91 elite V8 Patient Monitor User Manual Monitoring NIBP 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 Turn the knob to select the required patient Type in the Patient Info menu 5 Select a measurement mode in the NIBP Setup menu Refer to section Operation Prompts for details 6 Press the a button on the front panel to start a measurement NOTE 1 Please make su
179. 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 6 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 6 7 ECG Waveform Settings To change the 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 76 elite V8 Patient Monitor User Manual Monitoring ECG 8 6 8 12 Leads ECG 8 6 8 1 Activating 12 Lead ECG Monitoring Select Menu gt Maintenance gt User Maintain gt Other SetUp gt 12 Leads Activate in order to get the SN number which is supposed to be supplied to EDAN for a corresponding password Enter the password on the above mentioned interface and restart the monitor and the 12 lead ECG monitoring function will be activated NOTE If the 12 lead ECG monitoring fails to be activated users can reenter the password and try to activate this function again 8 6 8 2 Monitoring Procedure 1 Select and place the 12 lead electrodes as introduced in the above mentioned section 2 Select 12 Leads f
180. sposable 01 57 471161 NIBP Cuff neonatal 5 8 15cm disposable 01 57 471077 10 NIBP Tube 3m with connector 01 59 473006 10 NIBP Tube for Neonatal Cuff Only compatible with Neonatal Disposable cuff 27 2 4 Temp Accessories Part Number Accessories 01 15 040226 10 2 pin adult skin temperature probe 2 252K 25 C 01 15 040227 10 2 pin adult intracavitary temperature probe 2 252K 25 C 01 15 040225 10 2 pin adult skin temperature probe 10K 25 C 01 15 040228 10 2 pin adult intracavitary temperature probe 10K 25 C 27 2 5 IBP Accessories Part Number Accessories 01 57 471070 10 Pressure transducer interface cable BD 11 57 40121 Disposable pressure transducer kit BD DT 4812 01 57 471172 10 Pressure transducer interface cable EDWARD 01 57 471173 10 Pressure transducer interface cable HOSPIRA 01 57 471166 10 Pressure transducer interface cable UTAH 27 2 6 CO2 Accessories Part Number 01 57 471085 10 Accessories CO Module Extension cable 11 57 078139 Disposable CO Nasal Cannula Adult Respironics 3468ADU 00 11 57 078151 Adult Pediatric Airway adapter kit with dehumidification tubing 11 57 078154 Disposable Sampling Line Kit Respironics 3475 00 with Dehumidification Tubing 11 57 471019 Reuseable Adult Pediatric Airway Adapter 7007 01
181. surement site 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 CO Measurement Fail C O measuring needs parameters CO measure need param Measurement is unavailable due to absence of setting patient height and weight Please enter Menu gt Patient Setup gt Patient Info and input the patient height and weight No Sensor CO measurement fail No Sensor C O measurement fail Measuring The C O module is performing measuring Ready for new measurement C O module is ready for new measurement Invalid CO result C O measurement result is invalid CO Measurement Complete C O Measurement is completed CO Measurement Abort C O 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 No module detected No module is mounted in the monitor No module activated No module is activated Loading module The system is lo
182. t 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 label 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 Display 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 Display Setting gt View Selection gt TrendScreen 62 elite V8 Patient Monitor User Manual User Interface 7 6 Viewing Oxygen Screen To view the oxygen screen the user can press the oxyCRG key on the screen or select Menu gt Display Setting View Selection oxyCRG This interface is always used in NICU because the SpO2 HR and Resp of the neonate are different from those of adults 7 7 Viewing Large Font Screen To open the large f
183. t cross infection always use a bacteria filter on the exhaust port side if sampled gas is intended to be re breathed 31 Do not place the ISA gas analyzer in any position that might cause it to fall on the patient 32 Do not sterilize or immerse Nomoline Family sampling lines in liquid 33 Do not operate the ISA sidestream gas analyzer if the enclosure is damaged CAUTION 1 The ISA analyzers should be securely mounted in order to avoid the risk of damage to the ISA 2 Do not apply tension to the ISA analyzer cable 3 Do not operate the ISA analyzer outside the specified operating temperature environment 4 The sidestream AG module configured with ISA OR analyzer is fragile and should be handled with care 5 After plugging the module into the monitor remember to connect the sampling line to the module to prevent dust ingress which may result in performance degradation 17 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 adapters shall not be reused Used disposable airway adapters shall be disposed of in accordance with local regulations for medical wastes otherwise it may cause environmental contamination 117 elite V8 Patient Monitor User Manual Monitoring AG WARNING 4 Do not use the IRMA Adult Pediatric adapter with infants as the
184. t the ECG waveform X0 125 to make strength of ECG signal waveform of 1mV 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 1mV become 5mm X1 to make strength of ECG signal waveform of 1mV become 10mm X2 to make strength of ECG signal waveform of 1mV become 20mm X4 to make strength of ECG signal waveform of ImV become 40mm Auto let the monitor choose the optimal adjustment factor for all the ECG waves NOTE The effect of ECG wave gain is subject to the size of the wave area Whichever wave gain is chosen the ECG wave has to be displayed within the wave area 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 68 elite V8 Patient Monitor User Manual Monitoring ECG 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 rough ba
185. terface 19 1 5 Record The monitor can 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 graph please refer to Chapter Recording 19 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 19 2 1 Setting Resolution The monitor can support seven kinds of interval To set an appropriate 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 appropriate interval among 1 sec 5 sec 1 min 5 min 10 min 30 min and 60 min 19 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 Y Y and displayed on the trend graph 19 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 Table and select the Trend Graph option from the popup interface 19 2 4 Recording The monitor can make a tabular trend recording of the data in the current trend graph window
186. terval 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 consecutive 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 A detected during 300ms 79 elite V8 Patient Monitor User Manual Monitoring ECG ARR Types Occurring Condition After the QRS complex no pace is detected during 1 75 times PNP 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 8 2 ARR Analysis Menu 8 8 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 8 2 2 PVCs Alarm Select On in the menu to enable prompt message when an alarm occurs select Off to disable the
187. 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 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 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 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 ma
188. the Patient Information menu 20 1 Drug Calculation 20 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 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 The system generates values that can t be treated the calculation results The user must enter the correct parameter value based on the doctor s instruction 4 Enter the patient s weight 5 Enter the correct parameter value 6 Confirm whether the calculation result is correct 134 elite V8 Patient Monitor User Manual Calculation and Titration Table 20 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 calculation 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 Unit DRUG E mEq When defining a drug select Drug A Drug B Drug C Drug D and Drug E based o
189. the central monitoring system Through the network 1 The monitor sends patient information real time monitoring or measurement data 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 MFM CMS Central Monitoring System User Manual and CMS Central Monitoring System User Manual And the monitor supports HL 7 protocol NOTE Use wired instead of wireless networking when connecting the monitor to central monitoring system in the operating room because the ESU will interfere with a wireless network which may cause networking failure 61 elite V8 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 include 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 measurement requirements To select the parameter please 1 Select Menu g
190. the interval can be set in the C O 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 112 elite V8 Patient Monitor User Manual Monitoring C O 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 16 6 Editing C O Pick the Review button on the CO Measure menu to access the Review as shown below CO Result Review CO 2 50 l min CO 2 50 l min Measure Time 00 26 31 Measure Time 00 27 07 Window For C O Edit Contents displayed in the window D Six curves of the six measurements and C O value 2 Average value of C O 3 Average value of CI Values of selected measurements can be averaged and stored in the C O item in the
191. 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 7 Selecting RESP Lead To change RESP lead in the Resp Setup menu select Resp Lead to pick up the appropriate lead from the pop up list 82 elite V8 Patient Monitor User Manual Monitoring RESP 9 8 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 it is set to the Manual mode you can adjust the broken lines in RESP area by the Hold High and Hold Low items 9 9 Changing the Size of the Respiration Wave Select the RESP waveform area to open the Resp Wave Setup menu Select AMP then choose an appropriate value The value is bigger the waveform amplitude is higher Select Sweep select an appropriate setting from the pop up list 9 10 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 In the Resp Setup menu select Apnea Alm 2 S
192. this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 2 f you discover a problem with any of the equipment contact your service personnel or your authorized supplier 25 1 Inspecting The overall check of the monitor including the safety check should be performed only by qualified personnel every 24 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 please don t use the monitor and contact local Customer Service Center 25 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 nee
193. tion mmHg Kpa 0 mmHg 150 mmHg 3 mmHg 50 mmHg 0 rpm 150 rpm Mainstream 2 rpm 150 rpm Sidestream 172 Product Specifications elite V8 Patient Monitor User Manual Product Specifications EtCO Accuracy 2 mmHg 0 to 40 mmHg 5 of reading 41 to 70 mmHg 8 of reading 71 to 100 mmHg 10 of reading 101 to 150 mmHg AwRR Accuracy tlrpm Sample Gas Flowrate 50 10 ml min O Compensation Range 0 100 Resolution 196 Default 16 Stability Short Term Drift Drift over 4 hours lt 0 8 mmHg Long Term Drift 120 hours Initialization time Response time Calibration Barometric compensation pressure Alarm Type Apnea Alarm Delay It displays the value within 15s and meets the requirement for measurement accuracy within 2min Mainstream It displays the value within 20s and meets the requirement for measurement accuracy within 2min Sidestream 60ms Mainstream 3s Sidestream Not required User setup EtCO FiCO AwRR 10s 15s 20s 25s 30s 35s 40s default value is 20s 173 elite V8 Patient Monitor User Manual Product Specifications Interfering Gas and Vapor Effects on EtCO2 Measurement Values Gas or vapor Gas level 96 Quantitative effect Comments Nitrous oxide 60 Dry and Saturated Gas Halothane 4 0 40 mmHg 1 mmHg additional error Enflurane 5 4
194. tomatic agent indentification is running within 10 seconds Full accuracy within 20 seconds Response Time Rise Time CO x 90ms N20 x 300ms HAL ISO ENF SEV DES x 300ms Primary Agent 0 15 vol Threshold Secondary Agent 0 2 vol 10 of total agent concentration Threshold Agent 20 seconds typically 10 seconds Identificaiton Time second 178 elite V8 Patient Monitor User Manual Product Specifications Standard Conditions Gas Range Accuracy CO 0 10 vol 0 2 vol 2 of reading 10 15vol 0 3 vol 2 of reading 15 25 vol Unspecified N O 0 to 100 vol 2 vol 2 of reading HAL 0 to 8 vol 0 15 vol 5 of reading ISO 8 to 25 vol Unspecified ENF 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 All Conditions GAS Accuracy CO 0 3 vol 4 of reading N20 2 vol 4 of reading Agents 0 2 vol 10 of reading Apnea Alarm 20s 40s Delay Alarm Providing alarms of EtCO FiCO EtO FiO EtN O FIN2O EtAA FiAA awRR Interfering gas and vapour effects Gas or vapour Gas level CO Agents N20 IRMA CO IRMA AX N20 60 vol bs oo E sU HAL 4 vol D A 2 u ENF ISO SEV 5 vol 8 of e 9 reading DES 15
195. ture probe BD 684056 SP4042 11 57 40120 In line Injection temperature probe housing BD 680006 SP5045 11 57 100175 Control Syringe Medex MA387 27 2 8 AG Accessories Part Number Accessories 01 57 471086 10 GAS module extension cable 11 57 471043 10 Nomoline with Luer Lock connector 25pieces box CAT NO 108210 11 57 471042 10 IRMA Airway Adapter Adult Pediatric 25pieces box CAT NO 106220 01 57 471189 Nomoline Adapter 01 57 471190 Nomoline Airway Adapter Set 01 57 471191 Nomo Extension 01 57 471192 T adapter 156 elite V8 Patient Monitor User Manual Accessories 27 2 9 Other Accessories Part Number Accessories 22 08 208017 XM module 22 08 208020 V CO module sidestream 22 08 208021 V CO module mainstream 22 08 208022 V AG module sidestream 22 08 208023 V AG module mainstream 22 08 208029 V C O module 22 08 208030 Parameter amplifier mainframe 22 08 208031 V IBP module 22 08 208036 V SpO module Nellcor 01 57 78035 Recording paper 02 01 101207 ASUS wireless AP WL 330g EAP 157 elite V8 Patient Monitor User Manual Product Specifications A Product Specifications A 1 Classification Anti electroshock type Class I equipment and internal powered equipment EMC type Group I Class A Anti electroshock degree ECG RESP TEMP IBP C O CF SpO
196. used on neonates as recommended the specified accuracy range increases by 1 compared with that used on adults Pulse Rate Measuring Range 20bpm 300bpm Resolution bpm Accuracy 3bpm 20bpm 250bpm Sensor Wave length approximately 660 and 900nm Emitted light energy 15mW A 13 TEMP Channel TR Sensor type YSE IOKandYSI 2 252K Technique Thermal resistance Position Skin oral cavity rectum Measuring Range 0 C 50 C 32 F 122 F Resolution 0 1 C 0 1 F Accuracy Without sensor 0 1 C or 0 2 F Refresh Time Every 1s 2s 171 elite V8 Patient Monitor User Manual A 14 IBP Technique Direct invasive measurement Pressure measuring range 50 to 300 mmHg Resolution mmHg Accuracy without sensor 2 or 1 mmHg whichever is greater Pressure sensor Sensitivity 5 uV V mmHg Impedance 300 to 3000 Q Frequency response d c to 12 5 or 40 Hz Zero Range 200 mmHg Accuracy 1 mmHg Measuring range Art 0 mmHg to 300 mmHg PA 6 to 120mmHg CVP RAP LAP ICP 10 to 40 mmHg P1 P2 50 to 300 mmHg Volume displacement of MSI 4 5 x 107 in 100 mmHg A 15 CO Applicable Patient Type Adult pediatric and neonatal patients Technique Infra red Absorption Technique Unit Measuring Range EtCO FiCO gt AwRR Resolu
197. used to optimize the calculation of the SpO and pulse numerics 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 Measurement Procedure Switch on the monitor Attach the sensor to the appropriate site of the patient finger Plug the connector of the sensor extension cable into the SpO socket on XM module or V SpO module 85 elite V8 Patient Monitor User Manual Monitoring SpO 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 Injected 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 High frequency electrical noise including electro surgical apparatus and defibrillators Intravascular dye injections Significant concentrations of dysfunctional hemoglobin such as carboxyhemoglobin and methemoglobin Excessive patient movement and vibration Improper sensor application Low perfusio
198. vol 12 of y E a reading Xe Xenon 80 vol 10 of D D reading 179 elite V8 Patient Monitor User Manual Product Specifications He Helium 50 vol 6 of D sy reading Metered dose Not for use with metered dose inhaler propellants inhaler propellants C HsOH Ethanol 0 3 vol 3 D D D 4 C H OH 0 5 vol s D D D Isopropanol 2 CH COCH 1 vol E D D D Acetone CH 4 Methane 3 vol 1 D D D CO Carbon 1 vol 7 D D D monoxide 07 100 vol 192 182 m 1 above Note 1 Negligible interference effect included in the specification Accuracy all conditions Note 2 For probes not measuring N20 and or O the concentrations shall be set from monitor IRMA CO measures neither N20 nor O2 IRMA AX does not measure O Note 3 Interference at indicated gas level For example 50 vol Helium typically decreases the CO readings by 6 This means that if measuring on a mixture containing 5 0 vol CO and 50 vol Helium the measured CO concentration will typically be 1 0 06 5 0 vol 4 7 vol CO Note 4 According to the EN ISO 21647 standard Note 5 In addition to the EN ISO 21647 standard A 18 Wireless Network Compliant with Standard and Directive IEEE802 11b g R amp TTE Directive 99 5 EEC Frequency Range 2 412 GHz 2 462 GHz America 2 412 GHz 2 484 GHz J
199. with the patient s heart approximately mid axillary line 5 For the label name selection please refer to Selecting a Pressure for Monitoring 6 To zero 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 14 3 1 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 label 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 99 elite V8 Patient Monitor User Manual Monitoring IBP 14 3 2 Zeroing the Pressure Transducer To avoid inaccurate pressure readings the monitor requires a valid zero Zero the transducer in accordance with your hospital policy at least once per day You must perform a zero When you use a new tr
200. y CO2 0 to 15 vol 0 2 vol 2 of reading 15 to 25 vol Unspecified N20 0 to 100 vol 2 vol 2 of reading 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 O 0 to 100 vol 1 vol 2 of reading All Conditions 176 Product Specifications elite V8 Patient Monitor User Manual Product Specifications Gas Accuracy CO 0 3kPa 4 of reading N20 2kPa 5 of reading Agents 0 2kPa 10 of reading O 2kPa 2 of reading Apnea Alarm Delay 20s 40s Alarm Providing alarms of EtCOz FiCO EtO FiO EtN20 FiN2O EtAA FIAA awRR Mechanical Meets the shock and vibration requirements of SS EN ISO 21647 2004 Robustness clause 21 101 Interfering gas and vapor effects Gas or Vapour Gas Level CO Agents N20 ISA CO ISA AX N309 60vol my 1 HAL 4 vol SY D D D ENF ISO SEV 5 vol 8 of n 5 reading gt DES 15 vol 12 of D ED D reading gt Xe Xenon 80 vol 10 of D D reading He Helium 50 vol 6 of D y reading Metered Dose Not for use with metered dose inhaler propellants Inhaler Propellants C HsOH Ethanol 0 3 vol D E D 4
201. ygen sensor the automatic zeroing will also include room air calibration of the oxygen sensor WARNING Since a successful zeroing requires the presence of ambient air 21 Oz and 0 CO ensure that the ISA analyzer is placed in a well ventilated place Avoid breathing near the ISA analyzer before or during the zeroing procedure 17 3 1 5 Cleaning The ISA sidestream gas analyzers and Nomoline Adapter can be cleaned using a cloth moistened not wet with max 70 ethanol or isopropyl alcohol To prevent cleaning liquids and dust from entering the ISA gas analyzer through its LEGI connector keep the Nomoline Family sampling line connected while cleaning the analyzer CAUTION Never sterilize or immerse the ISA sidestream gas analyzer in liquid 17 3 1 6 Maintenance Once every year or whenever gas readings are questionable perform a leakage check according to section 17 3 1 2 and verify gas readings with a reference instrument or with calibration gas WARNING The Nomoline sampling lines are non sterile devices To avoid damage do not autoclave any parts of the sampling line 17 3 1 7 Replacement of Consumables The Nomoline and Nomoline Airway Adapter Set are single patient use products The Nomoline Adapter is a multiple patient use product The T adapter and Nomo Extension are single patient use products 120 elite V8 Patient Monitor User Manual Monitoring AG All consumables mentioned above should be replaced accor

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