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Safety

1-5

1.3 Reference Literature

Medical Device Directive 93/42/EEC

IEC 60601-1:1988+A1:1991+A2:1995 or
EN 60601-1:1990+A1:1993+A2:1995+A13:1996,
Medical Electrical Equipment, Part 1: General Requirements for Safety

EN60601-1-1 or IEC60601-1-1, Medical Electrical Equipment- Part 1-1: General
Requirements for Safety - Collateral Standard: Safety Requirements for Medical
Electrical Systems

IEC60601-1-4, Medical Electrical Equipment- Part 1-4: General Requirements for
Safety - Collateral Standard: Programmable Electrical Medical Systems

IEC60601-2-49 Medical Electrical Equipment-Part 2-49: Particular Requirements for
the Safety of Multifunction Patient Monitoring Equipment

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Summary of Contents for BeneView T8

Page 1: ...BeneView T8 Patient Monitor Operation Manual...

Page 2: ......

Page 3: ...2 Electromagnetic Compatibility Medical Electrical Equipment Revision History This manual has a revision number This revision number changes whenever the manual is updated due to software or technical...

Page 4: ...of this manual as confidential information Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden Release amendment repr...

Page 5: ...rict observance of this manual Warranty This warranty is exclusive and is in lieu of all other warranties expressed or implied including warranties of merchantability or fitness for any particular pur...

Page 6: ...ason for return 2 Freight policy The customer is responsible for freight charges when this product is shipped to Mindray for service including any relevant customs fees or other freight related charge...

Page 7: ...egral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical professionals who are...

Page 8: ...2 FOR YOUR NOTES...

Page 9: ...2 2 3 Bottom View 2 4 2 2 4 Rear View 2 5 2 3 Satellite Module Rack 2 7 2 4 Modules 2 8 2 4 1 Plug In Modules 2 8 2 4 2 Multi Parameter Module 2 9 2 5 Display Screen 2 10 2 6 QuickKeys 2 12 3 Basic O...

Page 10: ...3 4 4 Discharging a Patient 4 3 4 5 Connecting to a Central Monitoring System 4 4 5 User Screens 5 1 5 1 Tailoring Your Screens 5 1 5 1 1 Setting the Waveform Sweep Mode 5 1 5 1 2 Changing the Wave L...

Page 11: ...g the Patient and Placing the Electrodes 7 3 7 3 2 Choosing AHA or IEC Lead Placement 7 4 7 3 3 ECG Lead Placements 7 4 7 3 4 Checking Paced Status 7 7 7 4 Understanding the ECG Display 7 8 7 5 Changi...

Page 12: ...SpO2 Settings 8 4 8 5 1 Accessing SpO2 Menus 8 4 8 5 2 Adjusting the Desat Alarm Limit 8 4 8 5 3 Setting SpO2 Sensitivity 8 4 8 5 4 Monitoring SpO2 and NIBP Simultaneously 8 5 8 5 5 Sat Seconds Alarm...

Page 13: ...11 5 1 Changing a Pressure for Monitoring 11 4 11 5 2 Defining Pressure Labels 11 4 11 5 3 Choosing the Pressure Alarm Source 11 4 11 5 4 Setting the Pressure Unit 11 5 11 5 5 Setting Up the IBP Wave...

Page 14: ...0 13 7 2 For Mainstream CO2 Modules 13 10 13 8 Calibrating the Sensor 13 11 13 9 Oridion Information 13 11 14 Monitoring AG 14 1 14 1 Introduction 14 1 14 2 Identifying AG Modules 14 1 14 3 Understand...

Page 15: ...k 16 5 16 6 Cyclic Impedance Check 16 6 16 7 BIS Sensor Check Window 16 7 16 8 Choosing the BIS Smoothing Rate 16 8 16 9 Setting up the EEG Wave 16 8 17 Monitoring RM 17 1 17 1 Introduction 17 1 17 2...

Page 16: ...20 7 20 4 1 Performing Calculations 20 7 20 4 2 Entered Parameters 20 8 20 4 3 Calculated Parameters 20 8 20 5 Hemodynamic Calculations 20 9 20 5 1 Performing Calculations 20 9 20 5 2 Entered Paramete...

Page 17: ...24 Care and Cleaning 24 1 24 1 General Points 24 1 24 2 Cleaning 24 2 24 3 Disinfecting 24 2 25 Maintenance 25 1 25 1 Safety Checks 25 1 25 2 Service Tasks 25 2 25 3 Checking Monitor and Module Inform...

Page 18: ...C Factory Defaults C 1 C 1 Patient Demographics C 1 C 2 Alarm Setup C 1 C 3 Screen Setup C 1 C 4 ECG Setup C 2 C 5 Resp Setup C 3 C 6 SpO2 Setup C 4 C 7 NIBP Setup C 5 C 8 Temp Setup C 5 C 9 IBP Setup...

Page 19: ...a potential hazard or unsafe practice that if not avoided could result in death or serious injury CAUTION z Indicates a potential hazard or unsafe practice that if not avoided could result in minor p...

Page 20: ...by our company only z When using the equipment with electrosurgical units ESU make sure the patient is safe z Do not come into contact with patients during defibrillation Otherwise serious injury or d...

Page 21: ...possible source of interference as they may emit higher levels of electromagnetic radiation z Before connecting the equipment to the power line check that the voltage and frequency ratings of the pow...

Page 22: ...potential grounding Video output USB connector Network connector CIS connector Auxiliary output connector Defibrillator connector Zero key Check sensor Calibrate key Measure standby Serial number Gas...

Page 23: ...C60601 1 1 Medical Electrical Equipment Part 1 1 General Requirements for Safety Collateral Standard Safety Requirements for Medical Electrical Systems IEC60601 1 4 Medical Electrical Equipment Part 1...

Page 24: ...Safety 1 6 FOR YOUR NOTES...

Page 25: ...r use on adult patients who meet the following requirements height 122 to 229 cm weight 30 to 159 kg 12 lead ECG and BIS monitoring are not intended for neonatal patients This monitor is to be used in...

Page 26: ...urs this lamp will flash as defined below High level alarms the lamp quickly flashes red Medium level alarms the lamp slowly flashes yellow Low level alarms the lamp turns yellow without flashing 2 Te...

Page 27: ...r no AC source is connected Flash when the patient monitor operates on battery power 7 Press to silence all system sounds 8 Press to pause restore or clear alarms 9 Press to freeze or unfreeze wavefor...

Page 28: ...View 1 Integral Module Racks 2 Compartment for CF storage card slot 3 Recorder 4 Filter 5 Contact WARNING z Do not touch the filters and contacts when the patient monitor is on 2 2 3 Bottom View Batte...

Page 29: ...The Basics 2 5 2 2 4 Rear View Ventilation 1 10 4 3 5 2 9 8 6 7...

Page 30: ...6 CIS Connector It is a standard RJ45 connector that connects the patient monitor to the hospital s clinical information system CIS The CIS feature is available in China only 7 USB Connectors They co...

Page 31: ...e above there is an indicator telling the status of the SMR On when the SMR works normally Off when the SMR disconnects from the patient monitor there is a problem with the power or the patient monito...

Page 32: ...ia gas module The functions of the O2 and BIS modules can be incorporated into it ICG module Impedance cardiography module BIS module Bispectral index module RM module Respiration mechanics module 2 4...

Page 33: ...ors on the lower part Other measurement modules look similar to the MPM 1 Module name 2 Setup key press to enter the MPM Setup menu 3 Zero key press to enter the Zero IBP menu 4 NIBP start stop key pr...

Page 34: ...ows the patient information such as department bed number patient name patient category and paced status indicates that no patient is admitted or the patient information is incomplete indicates that t...

Page 35: ...t this area and the physiological alarm list will be displayed 6 Waveform Area This area shows measurement waveforms The waveform name is displayed at the left upper corner of the waveform Select this...

Page 36: ...urable graphical key located at the bottom of the main screen They give you fast access to functions Their availability and the order in which they appear on your screen depend on how you patient moni...

Page 37: ...er setup menu for the Big Numerics screen Have a split screen view of another patient s conditions You can also select your desired QuickKeys to display on the screen 1 Select Main Menu Maintenance Us...

Page 38: ...yCRG trends Have a split screen view of minitrends Enter the user maintenance menu Enter the analog output setup menu Change key volume Default configurations Enter the full screen 7 lead ECG screen S...

Page 39: ...ty standards for medical electrical equipment The system configuration must meet the requirements of the IEC 60601 1 1 medical electrical systems standard Any personnel who connect devices to the equi...

Page 40: ...ny mechanical damage Contact us in case of any problem NOTE z Save the packing case and packaging material as they can be used if the equipment must be reshipped WARNING z When disposing of the packag...

Page 41: ...and behind shall be left for convenient operation maintenance and repair Moreover to maintain good ventilation the patient monitor shall be at least 2 inches 5cm away from around the cabinet When the...

Page 42: ...physiological alarm lamps respectively flash blue and red once simultaneously and the system gives a beep as well 4 The monitor shows the product name and then enters the main screen WARNING z Do not...

Page 43: ...save or clear the patient monitoring data as required 4 Press and hold the power on off switch for above 2 seconds The patient monitor shuts down and you can unplug the power cable If the patient mon...

Page 44: ...connected to any USB connector other than that dedicated one When you are using a mice By default the left mice button is the primary button and the right one the secondary button Clicking the primar...

Page 45: ...nation with the on screen keyboard The patient monitor supports two external keyboards One is for controlling the secondary display and must be connected to a dedicated USB connector and the other for...

Page 46: ...ain menu Other menus are similar to the main menu and contain the following parts 1 Heading gives a sum up for the current menu 2 Main body displays options buttons prompt messages etc The menu button...

Page 47: ...button flips out To remove the CF storage card take the stick and use it to press the button until the CF storage card flips out To browse the data saved in the CF storage card follow this procedure 1...

Page 48: ...tion site you need to setup the patient monitor as follows 1 Select Main Menu Maintenance User Maintenance enter the required password 2 In the User Maintenance menu select in turn Monitor Name Depart...

Page 49: ...gle between On and Off 3 9 5 Setting the Date and Time 1 Select Main Menu System Time 2 Set the date and time 3 Select Date Format and toggle between yyyy mm dd mm dd yyyy and dd mm yyyy 4 Select Time...

Page 50: ...imum volume QRS Volume The QRS tone is derived from either the HR or PR depending on which is currently selected as the alarm source in ECG Setup or PR Setup When monitoring SpO2 there is a variable p...

Page 51: ...can modify the factory default values from the factory default configuration and then save the modified configuration as a user default configuration The patient monitor can save multiple user default...

Page 52: ...want to apply and then select Ok 3 Select Yes from the popup menu 4 Make sure the configuration is appropriate Change some values if necessary 3 10 4 Deleting a User Default Configuration You can del...

Page 53: ...ient the new patient s data will be saved into the data of the previous patient The monitor makes no distinction between the old and the new patient data 3 If Discharge Patient button appears dimmed d...

Page 54: ...segment analysis 4 2 Quick Admitting a Patient Use Quick Admit only if you do not have the time or information to fully admit a patient Complete the rest of the patient demographic details later Other...

Page 55: ...Setup 2 Select Patient Demographics and then make the required changes 3 Select Ok 4 4 Discharging a Patient To discharge a patient 1 Select the Patient Setup QuickKey or Main Menu Patient Setup 2 Se...

Page 56: ...can be transferred to the CMS All patient information measurement data and settings can be displayed simultaneously on the patient monitor and CMS For some functions such as editing patient informati...

Page 57: ...e Waveform Sweep Mode 1 Select Main Menu Screen Setup 2 Select Sweep Mode and toggle between Refresh and Scroll Refresh The waveforms keep stationary with real time refreshing from left to right by a...

Page 58: ...e g wave A on the monitor where you want a new wave to appear This calls up a popup menu 2 Select Change Wave and then select a wave e g wave B you want The wave A is substituted by the wave B If the...

Page 59: ...e waveforms as shown in the figure below To have a split screen view of minitrends you can Select Minitrends QuickKey or Select Screen Layout QuickKey Minitrends Ok or Select Main Menu Screen Setup Sc...

Page 60: ...nitrend Setup menu select Minitrend Length and then choose 1 h 2 h 4 h or 8 h 3 Select the button 5 2 3 Changing a Parameter for Viewing In each field you can change a parameter to view its minitrends...

Page 61: ...he lower part of the waveform area and shows HR trend SpO2 trend and RR trend or Resp wave At the bottom there are three controls Trend length list box In the trend length list box you can select 1 mi...

Page 62: ...r Patient window by Selecting Other Patients QuickKey or Selecting Screen Layout QuickKey Other Patients Ok or Selecting Main Menu Screen Setup Screen Layout Other Patients Ok 2 Select Setup in the Vi...

Page 63: ...nt monitor is giving high level physiological alarms Yellow indicates the patient monitor is giving medium or low level physiological alarms Blue indicates the patient monitor is giving technical alar...

Page 64: ...out QuickKey or Main Menu Screen Setup Screen Layout 2 Select Big Numerics or Factory Default Big Numerics Ok You can select your desired parameters to display in this screen select the Para Setup Qui...

Page 65: ...arm messages are displayed in the physiological alarm area 2 Technical alarms Technical alarms also called system status alarms are triggered by a device malfunction or a patient data distortion due t...

Page 66: ...2 Medium level alarms Indicate that your patient s vital signs appear abnormal and an immediate treatment is required 3 Low level alarms Indicate that you patient s vital signs appear abnormal and an...

Page 67: ...low Low level alarms the lamp turns yellow without flashing 6 3 2 Alarm Message When an alarm occurs an alarm message will appear in the technical or physiological alarm area For physiological alarms...

Page 68: ...triple double triple double beep Medium level alarms triple beep Low level alarms single beep 6 3 5 Alarm Status Symbols Apart from the aforementioned alarm indicators the patient monitor still uses...

Page 69: ...larm Sounds 1 Select Main Menu Maintenance User Maintenance enter the required password 2 Select Alarm Setup to enter the Alarm Setup menu 3 Select High Alarm Interval s Med Alarm Interval s and Low A...

Page 70: ...orms and parameters Off The alarm off symbol is displayed in the measurement parameter window 6 5 2 Setting the Alarm Level 1 Select the parameter window for your desired measurement to enter its setu...

Page 71: ...surement select Alm Rec and toggle between On and Off or 2 Select Main Menu Alarm Setup Alarm Recordings In the Alarm Recordings menu select your desired measurement and toggle between On and Off Addi...

Page 72: ...tenance enter the required password 2 Select Alarm Setup Alarm Pause Time and then select the appropriate setting from the popup list 6 7 Silencing the System You can silence all system sounds by pres...

Page 73: ...ent monitor restores the normal status the patient monitor can give alarm indications correctly when these alarms are triggered again For some other technical alarms all their alarm indications are cl...

Page 74: ...Alarms 6 10 FOR YOUR NOTES...

Page 75: ...includes 3 5 and 12 lead ECG monitoring and ECG analysis includes 12 lead ECG analysis only This section also tells you about ST monitoring and arrhythmia monitoring Impedance respiration is measured...

Page 76: ...ication site to ensure skin quality If the skin quality changes replace the electrodes or change the application site z Use defibrillator proof ECG cables during defibrillation When monitoring the pat...

Page 77: ...cedure Shave hair from skin at chosen sites Gently rub skin surface at sites to remove dead skin cells Thoroughly cleanse the site with a mild soap and water solution We do not recommend using ether o...

Page 78: ...plied for your hospital 7 3 3 ECG Lead Placements 3 Leadwire Electrode Placement Following is an electrode configuration when using 3 leadwires RA placement directly below the clavicle and near the ri...

Page 79: ...nt on the fifth intercostal space at the left midclavicular line V5 placement on the left anterior axillary line horizontal with the V4 electrode position V6 placement on the left midaxillary line hor...

Page 80: ...ateral chest or back To reduce artifacts and interference from electrosurgical units the limb electrodes can be placed close to the shoulders and lower abdomen and the chest electrodes on the left sid...

Page 81: ...tion area or Main Menu Patient Setup Patient Demographics or the ECG parameter window and then select Paced from the popup menu and toggle between Yes and No Warning z For paced patients you must set...

Page 82: ...lay may be configured to look slightly different 1 Lead label of the displayed wave 2 ECG gain 3 ECG filter label 4 Notch filter status 1 Current heart rate alarm limits 2 Current heart rate 3 Heart b...

Page 83: ...te from the ECG measurements as the alarm source whenever a valid heart rate is available If the heart rate becomes unavailable for example the ECG module is turned off or becomes disconnected the pat...

Page 84: ...its Under normal measurement conditions select Surgery may suppress the QRS complexes too much and then interfere with ECG analysis WARNING z The Monitor or Surgery filter may cause ECG waveform disto...

Page 85: ...ed the system test and can be safely used jointly z Before defibrillation make sure that Defib Sync is set to On and the Filter is set to Diagnostic z After defibrillation is finished set Defib Sync t...

Page 86: ...a lead as the HR lead in Normal screen select the wave corresponding to the HR parameter to enter its lead menu In the lead menu select HR Source and then select the lead you want The selected lead s...

Page 87: ...segment depression Measurement unit of the ST segment mV Measurement range of the ST segment 2 0 mV to 2 0 mV 7 6 1 Switching ST On and Off To switch ST monitoring on or off 1 In the ECG Setup menu s...

Page 88: ...ent s heart rate or ECG morphology changes significantly To adjust the ST measurement points 1 In the ST Analysis menu select Adjust ST Points to open the Adjust ST Points window 2 Select ISO or ST th...

Page 89: ...in the Alarms section In the Arrh Analysis menu you can change alarm settings for all arrhythmia events You can also select Arrh Alarm Setup from the Arrh Analysis menu and then change alarm settings...

Page 90: ...n arrhythmia event for viewing The event list displays a few events only You can have more event selections by selecting or You can select or beside Scroll to navigate through the arrhythmia waveforms...

Page 91: ...Lead Set 12 Lead and select ECG Display 12 Lead The ECG numerics are displayed above the ECG wave There are totally 12 ECG waves and 1 rhythm wave displayed on the screen Before entering the 12 lead...

Page 92: ...Cannot analyze will be displayed In the 12 lead ECG analysis window Select Freeze All ECG waves except the rhythm wave are frozen and the Freeze button changes to Unfreeze If you want to browse the fr...

Page 93: ...G analysis results for viewing This window displays a set of 12 lead ECG analysis results only You can view other sets of 12 lead ECG analysis results by selecting or beside the Delete button Select o...

Page 94: ...acement is very important Some patients due to their clinical condition expand their chests laterally causing a negative intrathoracic pressure In these cases it is better to place the two respiration...

Page 95: ...toggle between I and II 7 9 4 Changing the Apnea Alarm Delay The apnea alarm is a high level alarm used to detect apneas You can set the apnea alarm delay time after which the patient monitor alarms i...

Page 96: ...or beside them Once set the detection level will not adapt automatically to different respiration depths It is important to remember that if the depth of breathing changes you may need to change the d...

Page 97: ...r in the probe The SpO2 module processes the electrical signal and displays a waveform and digital values for SpO2 and pulse rate It provides four measurements 1 Pleth waveform Pleth visual indication...

Page 98: ...uld potentially cause burns The sensor may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements z Interference can be caused by high level of ambient light electr...

Page 99: ...le Masimo SET Nellcor SpO2 module Nellcor 8 4 Applying the Sensor 1 Select an appropriate sensor according to the module type patient category and weight 2 Remove colored nail polish from the applicat...

Page 100: ...not alarm if other physiological alarms occur 8 5 3 Setting SpO2 Sensitivity To set the SpO2 measurement sensitivity for MPM SpO2 module select Sensitivity in the SpO2 Setup menu and toggle between Hi...

Page 101: ...limit is violated Such frequent alarm can be distracting Nellcor s Sat Seconds alarm management technique is used to reduce these nuisance alarms With Sat Seconds alarm management high and low alarm l...

Page 102: ...remaining steady for a period of several seconds Often the patient SpO2 may fluctuate above and below an alarm limit re entering the non alarm range several times During such fluctuation the monitor i...

Page 103: ...he alarm source Auto If the Alm Source is set to Auto the monitor will use the heart rate from the ECG measurement as the alarm source whenever a valid heart rate is available If the ECG signal is too...

Page 104: ...ce fall within the scope of one or more of the patents relating to this device 8 7 Nellcor Information Nellcor Patents This device is covered under one or more the following U S Patents 4 802 486 4 86...

Page 105: ...o these pressures as long as the arterial pressure curve is normal Since the monitor cannot hear the blood pressure it measures cuff pressure oscillation amplitudes Oscillations are caused by blood pr...

Page 106: ...terial catheter in place This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation z If you doubt the NIBP readings determines the patient s vital...

Page 107: ...e marked on the cuff The width of the cuff should be 40 50 for neonates of the limb circumference or 2 3 of the upper arm s length The inflatable part of the cuff should be long enough to encircle at...

Page 108: ...manual mode 3 Start a measurement manually Then monitor will then automatically repeat NIBP measurements at the set time interval WARNING z Continuous non invasive blood pressure measurements may cau...

Page 109: ...shows numerics only as below 1 Time of last measurement 2 Time remaining to next measurement 3 Measurement mode 4 Unit of pressure mmHg or kPa 5 Prompt message area shows NIBP related prompt messages...

Page 110: ...ean alarms are given when the systolic or mean pressure violates the alarm limits Mean Dia alarms are given when the mean or diastolic pressure violates the alarm limits Sys Dia alarms are given when...

Page 111: ...cture or the hardkey on the monitor s front or the on screen QuickKey to deflate the cuff The cuff deflates automatically after a set time if you do not deflate it During measurement the NIBP display...

Page 112: ...ak is displayed it indicates that the NIBP airway may have leakages Check the tubing and connections for leakages If you ensure that the tubing and connections are all correct perform a leakage test a...

Page 113: ...eter and displayed values should be no greater than 3 mmHg 5 Raise the pressure in the metal vessel to 50 mmHg with the balloon pump Repeat step 3 and 4 6 Raise the pressure in the metal vessel to 200...

Page 114: ...Monitoring NIBP 9 10 FOR YOUR NOTES...

Page 115: ...e probe detection program works correctly before monitoring Plug out the temperature probe cable from the T1 or T2 connector and the monitor can display the message T1 Sensor Off or T2 Sensor Off and...

Page 116: ...re cable to the temperature connector 4 Attach the probe to the patient correctly 5 Check that the alarm settings are appropriate for this patient 10 4 Understanding the Temp Display The Temp Monitori...

Page 117: ...or each pressure 1 Connector for IBP cable 2 Zero key 11 2 Safety WARNING z Use only pressure transducers specified in this manual Never reuse disposable pressure transducers z Make sure that the appl...

Page 118: ...usion solution again Air bubble may lead to wrong pressure reading 4 Connect the pressure line to the patient catheter 5 Position the transducer so that it is level with the heart approximately at the...

Page 119: ...below shows the waveform and numerics for the Art pressure For different pressures this display may be slightly different 1 Waveform 2 Systolic pressure 3 Diastolic pressure 4 Mean pressure 5 Pressure...

Page 120: ...l blood pressure P1 to P8 Non specific pressure label Custom labels User defined pressure labels 11 5 2 Defining Pressure Labels You can define up to 8 IBP labels Your defined labels cannot be identic...

Page 121: ...g the Pressure Unit In the setup menu for the pressure select Unit and toggle between mmHg cmH2O and kPa 11 5 5 Setting Up the IBP Wave In the waveform menu for the pressure you can Select Sweep and t...

Page 122: ...and open the stopcock to the patient NOTE z Your hospital policy may recommend that the ICP transducer is zeroed less frequently than other transducers 11 7 Making the Pressure Calibration A calibrati...

Page 123: ...4 Inflate using the balloon pump until the mercury in the manometer reaches to the preset calibration pressure value 5 Adjust the preset calibration value until it equals to the reading on the manomet...

Page 124: ...Monitoring IBP 11 8 FOR YOUR NOTES...

Page 125: ...change in blood temperature is measured with a thermistor at the distal end of the catheter in the pulmonary artery The temperature change is displayed as a curve in the C O split screen and the monit...

Page 126: ...te solution volume of injectate solution patient s baseline blood temperature patient s inspiratory expiratory cycle placement of catheter with relation to proximity of lung field the catheter itself...

Page 127: ...the monitor 2 Interconnect the C O module catheter and syringe as shown below Make sure that The module is securely inserted The PA catheter is in place in the patient The C O cable is properly connec...

Page 128: ...w catheter is used the computation constant should be adjusted in accordance with the manufacturer s instructions for use Switch Auto IT on and the injectate temperature is automatically obtained When...

Page 129: ...utomatically calculate and display the averaged C O and C I values When injecting the stopcock to the PA catheter is open and the stopcock to the injectate solution is closed After the measurement is...

Page 130: ...the Temperature Unit In the C O Setup menu select Temp Unit to toggle between C and F 12 6 2 Setting the Interval between Measurements To avoid inaccurate measurements a certain period of time should...

Page 131: ...tory gas sample is measured with a photodetector From the amount of IR light measured the concentration of CO2 is calculated There are two methods for measuring CO2 in the patient s airway 1 Mainstrea...

Page 132: ...module microstream CO2 module and mainstream CO2 1 Setup key to enter the CO2 setup menu 2 Measure standby 3 Gas outlet 4 Slot for CO2 watertrap 5 Connector for sampling line 6 Connector for CO2 tran...

Page 133: ...ndow Operating Mode Measure The message CO2 Startup is displayed 3 After start up is finished the CO2 module needs time to warm up to reach the operating temperature The message CO2 Sensor Warmup is d...

Page 134: ...compromise the performance of the filter or even block the airway In this case replace the watertrap Replacing the watertrap once a month is recommended 13 3 2 Using a Microstream CO2 Module 1 Connect...

Page 135: ...e message CO2 Sensor Warmup is displayed 3 After warm up is finished connect the transducer to the airway adapter 4 Perform a zero calibration per the Zeroing the Sensor section 5 After the zero calib...

Page 136: ...operating mode is standby when the monitor is switched on You can start the CO2 module by selecting the hardkey or the CO2 parameter window Operating Mode Measure When the monitor restarts the CO2 mo...

Page 137: ...ensations are not required For the mainstream CO2 module in the CO2 Setup menu respectively select Balance Gas and toggle between Room Air and N2O Select Room Air when air predominates in the ventilat...

Page 138: ...patient has stopped breathing for longer than the preset apnea time 13 4 7 Choosing a Time Interval for Peak Picking For microstream and mainstream CO2 modules you can select a time interval for picki...

Page 139: ...works incorrectly check if the sampling line is kinked If not remove it from the watertrap If the monitor gives a message indicating the airway still works incorrectly it indicates that the watertrap...

Page 140: ...is used You reconnect the sensor to the module You see the message CO2 Zero Required In this case check the airway adapter for any blockage e g mucus etc If a blockage is detected clear or replace the...

Page 141: ...merica Oridion Patents This device and the CO2 sampling consumables designed for use herewith is covered by one or more of the following USA patents 4 755 675 5 300 859 5 657 750 5 857 461 and interna...

Page 142: ...Monitoring Carbon Dioxide 13 12 FOR YOUR NOTES...

Page 143: ...hough an IR absorbing gas is measured From the amount of IR light measured the concentration of gas present can be calculated Oxygen does not absorb IR light as other breathing gases and is therefore...

Page 144: ...anesthetic gases for display on the monitor including CO2 O2 N2O and AA waves awRR airway respiratory rate MAC minimal alveolar concentration End tidal Et and fraction of inspired Fi numerics for CO2...

Page 145: ...ondensed in the sampling line and therefore prevents them from entering the module If the collected water reaches to a certain amount you should drain it to avoid blocking the airway z The watertrap h...

Page 146: ...rea you can access that gas s setup or waveform menu 14 5 2 Selecting an Anesthetic Gas for Monitoring As the M type module cannot automatically identify 5 anesthetic gases you need to select an anest...

Page 147: ...dule automatically continues with the previously chosen operating mode 14 5 7 Setting the Automatic Standby Time The AG module enters standby mode automatically when no breath is detected for a config...

Page 148: ...ccurs Condensed water may enter the module and cause contamination and or internal occlusions In this case the message AG Airway Occluded will be displayed To remove the occlusion Check for any occlus...

Page 149: ...es in impedance from systole to diastole to calculate hemodynamic parameters 15 2 Safety WARNING z Apply ICG monitoring to adult patients in height of 122 to 229 cm weight of 30 to 159 kg only z ICG m...

Page 150: ...lue is directly derived from the ICG module 15 3 2 Calculated Parameters Abbreviation Unit Full spelling BSA m2 Body surface area C O L min Cardiac output C I L min m2 Cardiac index SV ml Stroke volum...

Page 151: ...Left ventricular ejection time VEPT ml Volume of electrically participating tissue 15 4 Understanding the ICG Display The ICG monitoring provides a continuous display of the impedance waveform and 4...

Page 152: ...monitor 2 Connect the patient cable to the ICG module 3 Prepare the patient s skin and place ICG electrodes on the patient 4 Connect the ICG sensor connector end to the patient cable 5 Set up the pati...

Page 153: ...Setting up the Patient Information 1 Select the ICG parameter window to enter the ICG Setup menu 2 Select Patient Demographics 3 Select Height and Weight and then select the appropriate settings The p...

Page 154: ...arameter window to enter the ICG Setup menu 2 Select Change Secondary Parameters 3 Select three parameters from the popup menu 15 7 3 Checking Sensors During ICG monitoring the ICG sensors should be c...

Page 155: ...s forehead to capture electroencephalographic EEG signals from which several numerics are derived including a single BIS between 100 wide awake and zero absence of brain electrical activity that repre...

Page 156: ...f sensors and connectors should not come into contact with other conductive parts including earth z To reduce the hazard of burns in the high frequency surgical neutral electrode connection the BIS se...

Page 157: ...ects the electrical power of muscle activity and high frequency artifacts The minimum possible EMG is about 25 dB EMG 55 dB this is an acceptable ECG EMG 30 dB this is an optimal EMG 3 Suppression Rat...

Page 158: ...e sure the patient s skin is dry A wet sensor or a salt bridge could result in erroneous BIS and impedance values 5 Connect the BIS sensor to the patient interface cable As soon as a valid sensor is d...

Page 159: ...e message BIS Ground Checking is displayed on the monitor during the check If the ground electrode does not pass this check another check is initiated This continues until the ground electrode passes...

Page 160: ...check manually you can either Select Cyc Imped Check in the BIS Setup menu and then select On Press the hardkey on the BIS module Select Start Cyc Imped Check in the BIS sensor window The cyclic impe...

Page 161: ...s impedance checks 3 Time of the most recent impedance check 4 Show sensor information The measured electrode to skin impedance and electrode status are displayed above each electrode Status Descripti...

Page 162: ...en choose either 15 s this gives increased responsiveness to changes in the patient s state 30 s this gives a smoother BIS trend with decreased variability and sensitivity to artifacts 16 9 Setting up...

Page 163: ...gas concentration information is used to calculate flow The volume information is obtained by integrating the flow signal From these three parameter other parameter such as RR I E Compl etc are deriv...

Page 164: ...meters TVi inspiratory tidal volume unit ml TVe expiratory tidal volume unit ml MVi inspirator minute volume L MVe expiratory minute volume L 4 Other parameters RR respiratory rate unit rpm I E ratio...

Page 165: ...nsor selection may produce excessive ventilation resistance or introduce excessive airway deadspace as well as inaccurate scales and alarm limits z Periodically check the flow sensor and tubing for ex...

Page 166: ...the patient circuit and the patient connection 4 Select the RM parameter window to open the RM Setup menu 5 Select Sensor Type and then choose either Disposable or Reusable according to the selected s...

Page 167: ...e Paw and Flow waveforms or the Paw and Vol waveforms in the waveform area 1 Paw waveform 2 Flow waveform 3 Paw parameter window 4 Flow parameter window 5 Vol parameter window In the Paw parameter win...

Page 168: ...onitor will alarm if the patient has stopped breathing for longer than the preset apnea time 17 5 3 Selecting TV or MV for Display To select tidal volume TV or minute volume MV for display in the Vol...

Page 169: ...changes automatically if Scaling is set to Auto 1 Select your desired waveform to enter its waveform menu 2 Select Scaling and then select Auto To manually adjust the wave scale take the Paw wave for...

Page 170: ...the screen select Setup Display Loop and then toggle between PV Loop and FV Loop Recall a reference loop select Setup Reference Loop On and then select a saved reference loop Change the size of the P...

Page 171: ...e RM Setup menu select Zero RM 17 8 Calibrating the Flow Sensor A calibration must be performed every time when the flow sensor is changed 1 In the RM Setup menu select Calibrate RM 2 Enter the positi...

Page 172: ...Monitoring RM 17 10 FOR YOUR NOTES...

Page 173: ...Freeze menu 3 All displayed waveforms are frozen i e the waveforms stop being refreshed or scrolling The freeze feature exerts no effect on the split screen view of minitrends oxyCRG and other patient...

Page 174: ...uickKey again or Perform any other action that can cause the screen to be readjusted or open a menu such as plugging in or out a module pressing the hardkey etc 18 4 Recording Frozen Waveforms 1 In th...

Page 175: ...ey or Main Menu Review 2 Select Graphic Trends Tabular Trends NIBP Arrh Events Alarms Full Disclosure or 12 Lead Analysis to access their respective review windows For details about reviewing arrhythm...

Page 176: ...e axis In this review window To select parameters for viewing you can either Select respective parameter combo boxes and then select your desired parameters or Select Trend Group and then select a gro...

Page 177: ...on To browse the graphic trends you can either select or to move the cursor one step to the left or right to navigate through the graphic trends or Select or to move the cursor one page to the left or...

Page 178: ...ect the parameters you want to view from the popup menu You can set the start time of the trends you want to view by selecting Start Time You can change the resolution of the trend data by selecting I...

Page 179: ...to drag the scrollbar up or down to view more measurement values or Select or to scroll up or down to view more measurement values By selecting the Record button you can print out the currently displa...

Page 180: ...wer left corner In this review window Up to 10 measurements can be displayed at a time You can select or beside the Scroll button to view more measurements By selecting the Record button you can print...

Page 181: ...vents stored in the database If you set a time that is too early the earliest alarm event will be recalled If you set a time that is too late the last alarm event will be recalled You can view the des...

Page 182: ...er combo box B Slider C Parameter value D Full disclosure waveform E Time axis In this review window To review full disclosure waveforms you need to save waveforms first Select Save Waves and then sel...

Page 183: ...values corresponding to the cursor location are displayed in the left side of the Waveforms window and change as the cursor is moved You can change the wave gain by selecting Gain and then selecting t...

Page 184: ...Review 19 10 FOR YOUR NOTES...

Page 185: ...lect Main Menu Calculations or the Calculations QuickKey and then select the calculation you want to perform NOTE z The calculation feature is independent of other monitoring functions and can be ther...

Page 186: ...s of which Drug A through Drug E are for those not specified in this library Drug A B C D E Aminophylline Dobutamine Dopamine Epinephrine Heparin Isuprel Lidocaine Nipride NItroglycerin Pitocin 3 The...

Page 187: ...C Aminophylline Dobutamine Dopamine Epinephrine Isuprel Lidocaine Nipride and NItroglycerin use the unit series g mg and mcg Drug D Heparin and Pitocin uses the unit series Unit KU kilo units and MU m...

Page 188: ...n window A titration table will be displayed as follows In the titration table when you change Reference Interval Dose Type The titrated values change accordingly You can also Select or or or beside t...

Page 189: ...und will highlight in yellow You can select Range to view its normal range in the unit field For those who are within the range their unit fields appear blank Invalid values are displayed as In the Ox...

Page 190: ...g L hemoglobin CaO2 ml L arterial oxygen content CvO2 ml L venous oxygen content VO2 ml min oxygen consumption RQ None respiratory quotient ATMP mmHg atmospheric pressure Height cm height Weight kg w...

Page 191: ...lect Range to view its normal range in the unit field For those who are within the range their unit fields appear blank Invalid values are displayed as In the Ventilation Calculation window you can Ch...

Page 192: ...en level TV ml tidal volume RQ None respiratory quotient ATMP mmHg atmospheric pressure 20 4 3 Calculated Parameters Abbreviation Unit Full spelling PAO2 mmHg alveolar oxygen level AaDO2 mmHg alveolar...

Page 193: ...P are automatically taken from the currently measured values If you just have performed C O measurements C O is the average of multiple thermodilution measurements Height and Weight are the patient s...

Page 194: ...he currently displayed renal calculations are printed out by the recorder Review the previously performed calculations by selecting Review Switch to other calculation window by selecting Other Calcs a...

Page 195: ...scular resistance index PVR DS cm5 pulmonary vascular resistance PVRI DS m2 cm5 pulmonary vascular resistance index LCW kg m left cardiac work LCWI kg m m2 left cardiac work index LVSW g m left ventri...

Page 196: ...ed value is outside the range its background will highlight in yellow You can select Range to view its normal range in the unit field For those who are within the range their unit fields appear blank...

Page 197: ...eight Weight kg weight 20 6 3 Calculated Parameters Abbreviation Unit Full spelling URNaEx mmol 24h urine sodium excretion URKEx mmol 24h urine potassium excretion Na K sodium potassium ratio CNa ml 2...

Page 198: ...a time By selecting or beside Scroll or dragging the horizontal scrollbar you can view more values The values that exceed the range are displayed in yellow background The Unit field displays paramete...

Page 199: ...to three waveforms etc 1 Start Stop key press to start a recording or stop the current recording 2 Indicator On when the recorder works correctly Off when the monitor is switched off Flashes if an er...

Page 200: ...phic trends recording Tabular trends recording NIBP review recording Parameter alarm recording Arrh alarm recording Wave review recording 12 Lead analysis result recording Titration table recording He...

Page 201: ...riggered in the following conditions Timed recordings will start automatically at preset intervals If both Alarm and Alm Rec for a measurement are set on an alarm recording will be triggered automatic...

Page 202: ...After starting a realtime recording the recording time depends on your monitor s settings In the Record Setup menu select Length and toggle between 8 s and Continuous 8 s record 8 second waveforms fr...

Page 203: ...n On and Off On show gridlines when recording waveforms Off hide gridlines when recording waveforms This setting is for all recordings containing waveforms 21 4 7 Clearing Recording Tasks In the Recor...

Page 204: ...tly and the paper end is feeding from the top CAUTION z Use only specified thermal paper Otherwise it may cause damage to the recorder s printhead the recorder may be unable to print or poor print qua...

Page 205: ...ime deposits of paper debris may collect on the printhead compromising the print quality and shortening the lifetime of the roller Follow this procedure to clean the printhead 1 Take measures against...

Page 206: ...Recording 21 8 FOR YOUR NOTES...

Page 207: ...triggered 22 2 Analog Output The patient monitor provides analog output signals to accessory equipment via the Auxiliary Output Connector on the rear of the monitor To obtain analog output signals con...

Page 208: ...aneously only one pulse signal is outputted If an alarm occurs but the previous one is not cleared yet a new pulse signal will also be outputted Continuous the nurse call signal lasts until the alarm...

Page 209: ...no nurse call signal will be triggered whatever alarms occur WARNING z Do not rely exclusively on the nurse call system for alarm notification Remember that the most reliable alarm notification combi...

Page 210: ...Other Functions 22 4 FOR YOUR NOTES...

Page 211: ...ly equal charge capacity or are fully charged On screen battery symbols indicate the battery status as follows indicates that batteries work correctly The solid portion represents the current charge l...

Page 212: ...bly shorter To condition the batteries follow this procedure 1 Disconnect the patient monitor from the patient and stop all monitoring and measuring procedures 2 Insert the two batteries in need of co...

Page 213: ...service personnel NOTE z Life expectancy of a battery depends on how frequent and how long it is used For a properly maintained and stored lithium ion battery its life expectancy is about 3 years For...

Page 214: ...it should be replaced Remove the old battery from the patient monitor and recycle it properly To dispose of the batteries follow local laws for proper disposal WARNING z Do not disassemble batteries...

Page 215: ...o the equipment follow these rules Always dilute according the manufacturer s instructions or use lowest possible concentration Do not immerse part of the equipment into liquid Do not pour liquid onto...

Page 216: ...it from the power line 2 Clean the display screen using a soft clean cloth dampened with a glass cleaner 3 Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner 4 W...

Page 217: ...nspection should be performed by qualified service personnel to ensure the reliability Follow these guidelines when inspecting the equipment Make sure that the environment and power supply meet the re...

Page 218: ...ast once every two years of if you doubt the measured values Defibrillator synchronization At least once every two years or as needed NIBP leakage test At least once every two years or by your hospita...

Page 219: ...area Filter Diagnostic 2 Select Main Menu Maintenance Calibrate ECG A square wave appears on the screen and the message ECG Calibrating is displayed 3 Compare the amplitude of the square wave with th...

Page 220: ...ttle with the tubing using a T shape connector as shown below Check the airway and make sure there are no leaks 5 Vent the tubing to the CO2 opening the gas valve 6 In the Calibrate CO2 menu enter the...

Page 221: ...approximately the same If the deviation is great it indicates that there is an occlusion in the tubing Check the tubing for an occlusion Block the gas inlet of the tubing The Current FlowRate shall fa...

Page 222: ...ddress settings If the patient monitor is connected to a CMS its IP address should be set up The user should not change the patient monitor s IP address randomly If you want to know details about IP a...

Page 223: ...essories may cause damage to the patient monitor z Single use accessories are not designed to be reused Reuse may cause a risk of contamination and affect the measurement accuracy z Check the accessor...

Page 224: ...42719 3 5 leadwire AHA IEC ESU proof 0010 30 42723 12 leadwire AHA Defibrillator proof 0010 30 42721 12 leadwire IEC Defibrillator proof Adult pediatric 0010 30 42722 Cable Sets 3 Electrode Cable Set...

Page 225: ...le Sets Type Compatible with Model Patient Category Part No Remark EL6802A 0010 30 42903 Limb IEC EL6804A 0010 30 42905 Chest EL6801A 0010 30 42902 Limb Clip AHA EL6803A Adult pediatric 0010 30 42904...

Page 226: ...Inf L 0010 10 42628 FPS 1860 Pediatric LNCS Pdt 0010 10 42629 Disposable FPS 1859 Adult LNCS Adt 0010 10 42630 FPS 1863 Adult LNCS DC I 0010 10 42600 FPS 1864 Pediatric LNCS DCIP 0010 10 42634 Reusab...

Page 227: ...5 0010 30 42745 CM1302 Pediatric 18 to 26 11 5 0010 30 42746 CM1303 Adult 24 to 35 14 5 0010 30 42747 CM1304 Large adult Arm 33 to 47 17 8 0010 30 42748 CM1305 Thigh Thigh 46 to 66 22 5 0010 30 42749...

Page 228: ...1 30 37398 Disposable MR412 Adult pediatric neonate Skin 0011 30 37397 26 5 IBP ICP Accessories Accessories Kit No Components Part No 12Pin IBP Cable 0010 30 42740 Disposable Transducer 0010 10 42638...

Page 229: ...Cannula Adult M02A 10 25937 Pediatric Nasal CO2 Sample Cannula Pediatric Disposable M02A 10 25938 DRYLINE Airway Adapter Straight 9000 10 07486 Microstream CO2 Module Disposable Airway Sampling Line...

Page 230: ...ate Humidified 0010 10 42574 Mainstream CO2 Module Material Model Patient Category Remark Part No 6063 Disposable 0010 10 42662 6421 Adult Disposable with mouthpiece 0010 10 42663 7007 Adult pediatric...

Page 231: ...w 9000 10 07487 26 9 ICG Accessories Material Part No BioZ tect ICG sensor 0010 10 42675 BioZ Dx Patient Cable 0010 10 42676 BioZ Dx Lead Wire Array 0010 10 42677 26 10 BIS Accessories Material Patien...

Page 232: ...rial Part No USB keyboard 0000 10 11060 USB mice 0000 10 11061 Lithium battery M05 010002 06 3 core power cord 509B 10 05996 Grounding cable 1000 21 00122 Defibrillator synchronization cable 6800 20 5...

Page 233: ...rds of explosion Mode of operation Main unit Not marked Secondary display I Not marked MPM IBP module C O module ICG module CF BIS module AG module CO2 module RM module BF SMR NA Not marked Ordinary N...

Page 234: ...ing 15 to 95 10 to 95 Barometric kPa 430 to 795 430 to 795 Sidestream CO2 module Item Operating conditions Storage conditions Temperature C 5 to 35 20 to 60 Relative humidity noncondensing 15 to 95 15...

Page 235: ...tions Storage conditions Temperature C 0 to 40 20 to 50 Relative humidity noncondensing 10 to 95 10 to 95 Barometric kPa 356 to 760 356 to 760 ICG module Item Operating conditions Storage conditions T...

Page 236: ...erted MPM 0 63 kg 136 5 80 5 102 mm IBP module 0 25 kg 136 5 40 102 mm C O module 0 25 kg 136 5 40 102 mm Sidestream CO2 module 0 48 kg 136 5 80 5 102 mm Microstream CO2 module 0 73 kg 136 5 40 102 mm...

Page 237: ...type Medical grade TFT LCD Screen Size 15 17 or above Resolution 1024 768 pixels EMC MPR II CISPR 11B Third certificate UL C UL TUV CE FCC UL 60601 1 A 3 2 Recorder Method Thermal dot array Horizonta...

Page 238: ...cted and auto NIBP measurements at intervals of 15 minutes conditions Charge time 6 h at most in standby mode Shutdown delay 10 to 15 min after a low battery alarm first occurs A 3 4 LEDs Physiologica...

Page 239: ...Connector 1 connector RJ11 A 3 7 Outputs Auxiliary Output Standard Meets the requirements of EC60601 1 for short circuit protection and leakage current Output impedance 50 rating ECG Analog Output Ba...

Page 240: ...current 15 mA rating Rising and falling time 1 ms Digital video output DVI D connector Video signals Single Link TMDS DDC Signals 12C compliant A 4 Data Storage Trends Trends 120 hours at 1 min resolu...

Page 241: ...o 150 Hz 0 5 to 40 Hz 1 to 20 Hz Common mode rejection ratio with Notch off Diagnostic mode Monitor mode Surgical mode 90 dB 105 dB 105 dB Notch 50 60 HZ Monitor and surgical mode Notch turns on autom...

Page 242: ...1 s Pace Pulse Pace pulses meeting the following conditions are labelled with a PACE marker Pace pulse markers Amplitude Width Rise time 2 to 700 mV 0 1 to 2 ms 10 to 100 s When tested in accordance w...

Page 243: ...ne impedance range 200 to 2500 using an ECG cable with 1k resistance Differential input impedance 2 5 M Bandwidth 0 2 to 2 Hz 3 dB Sweep speed 6 25 12 5 or 25 mm s Respiration Rate Measurement range A...

Page 244: ...motion 0 to 69 Not specified Refreshing rate 1s PR Measurement range 20 to 254 bpm Resolution 1bpm Accuracy 3 bpm measured without motion 5 bpm measured with motion Refreshing rate 1s Masimo SpO2 Mod...

Page 245: ...ed OxiCliq A OxiCliq N OxiCliq P OxiCliq I 70 to 100 0 to 69 2 5 Not specified D YS DS 100A OXI A N OXI P I 70 to 100 0 to 69 3 Not specified SpO2 measurement range and accuracy MAX R D YSE D YSPD 70...

Page 246: ...s Heart rate range 40 to 240 bpm Adult Pediatric Neonate Systolic 40 to 270 40 to 200 40 to 135 Diastolic 10 to 210 10 to 150 10 to 100 Measurement ranges mmHg Mean 20 to 230 20 to 165 20 to 110 Accu...

Page 247: ...rds Meet standard of EN12470 4 Technique Thermal resistance Measurement range 0 to 50 C 32 to 122 F Resolution 0 1 C Accuracy 0 1 C or 0 2 F without probe Refreshing rate 1s Minimum time for accurate...

Page 248: ...0 to 300 mmHg Resolution 1 mmHg Accuracy 2 or 1mmHg whichever is greater Refreshing rate 1s Pressure transducer Excitement voltage 5 VDC 2 Sensitivity 5 uV V mmHg Impedance range 300 to 3000 A 5 7 C O...

Page 249: ...r of 0 055 inch and a sample flow rate of 150ml min awRR measurement range 0 to 120 rpm awRR measurement precision 0 to 70 rpm 70 to 99 rpm 2 rpm 5 rpm Apnea time 10s 15s 20s 25s 30s 35s 40s Accuracy...

Page 250: ...according to EN864 Section Eleven Part 101 Resolution 1 mmHg Initialization time 30 s typical Response time 2 9 s typical The response time is the sum of the rise time and the delay time when using a...

Page 251: ...greater Measurement range CO2 O2 N2O Des Sev Enf Iso Hal awRR 0 to 30 0 to 100 0 to 100 0 to 30 0 to 30 0 to 30 0 to 30 0 to 30 2 to 100 rpm Resolution CO2 awRR 1 mmHg 1 rpm Accuracy warming up status...

Page 252: ...e 20 to 40 s Refreshing rate 1s CO2 250ms fall time 200ms N2O 250ms O2 600ms Hal Iso Sev Des 300ms Rise time Enf 350ms CO2 250ms fall time 200ms N2O 250ms O2 500ms Hal Iso Sev Des 300ms Rise time Enf...

Page 253: ...pecified 2 bpm Not specified A 5 11 BIS Standards Meet standard of IEC 60601 2 26 Technique Bispectral index Measured parameters EEG BIS 0 to 100 Calculated parameters SQI 0 to 100 EMG SR DSA TP Imped...

Page 254: ...esolution 0 1 cmH2O MVe MVi Measurement range Adult Pediatric Neonatal 2 to 60 L min 0 5 to 15 L min Accuracy 5 reading TVe TVi Measurement range Adult Pediatric Neonatal 100 to 1500 ml 20 to 500 ml R...

Page 255: ...uct Specifications A 23 PEF 2 to 120 L min PIF 2 to 120 L min PIP 0 to 120 cmH2O Pplat 0 to 120 cmH2O Compl 0 to 200 ml cmH2O Raw 0 to 100 cmH2O L s RSBI 0 to 4095 rpm L NIP 0 to 120 cmH2O WOB 0 to 64...

Page 256: ...Product Specifications A 24 FOR YOUR NOTES...

Page 257: ...e inputted signal is below the minimum amplitude provided in technical specifications erroneous measurements could result Guidance and Declaration Electromagnetic Emissions The patient monitor is suit...

Page 258: ...fferential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines...

Page 259: ...fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked w...

Page 260: ...ters m Corresponding to Frequency of Transmitter Rated Maximum Output power of Transmitter Watts W 150k to 80MHz P d 3 5 3 80M to 800MHz P d 3 5 3 800M to 2 5GHz P d 3 7 0 01 0 35 0 35 0 23 0 1 1 11 1...

Page 261: ...nt Demographics Patient Demographics Factory Default Settings Patient Cat Adu Paced No C 2 Alarm Setup Alarm Setup Factory Default Settings Alarm Volume 2 Latching Alarms No Alarm Sound On Alarm Pause...

Page 262: ...ced No Lead Set 5 Lead ECG Display Normal Filter Diagnostic Notch Filter Off Defib Sync Off ST Analysis Adult Pediatric Neonate ST Analysis Off Alarm Off Alm Lev Med Alm Rec Off ST X High 0 2 ST X Low...

Page 263: ...hy On Med Off Brady On Med Off PNP On Med Off PNC On Med Off Missed Beat On Med Off Waveform X Adult Pediatric Neonate HR Source II Gain X1 Filter Diagnostic Sweep 25 mm s Cascade Off X represents lea...

Page 264: ...ec Off SpO2 High 100 100 95 SpO2 Low 90 90 80 Desat Limit 80 80 70 Sensitivity Mindray Med Sensitivity Masimo Normal Averaging Masimo Nellcor 8 s NIBP Simul Off Sat Seconds Nellcor 0 s PR Setup Adult...

Page 265: ...40 Mean High 110 90 70 Mean Low 60 50 25 Dia High 90 70 60 Dia Low 50 40 20 Display NIBP Single group Press Unit mmHg Interval Manual Cuff Press 80 60 40 C 8 Temp Setup Temp Setup Adult Pediatric Neon...

Page 266: ...20 70 90 90 60 70 Art Ao FAP BAP UAP Low Limit 90 50 70 70 40 50 55 20 35 High Limit 35 16 20 60 4 26 60 4 26 PA Low Limit 10 0 0 24 4 12 24 4 12 High Limit 160 90 110 120 70 90 90 60 70 Custom pressu...

Page 267: ...Factory Defaults C 7 C 10 C O Setup C O Setup Factory default settings Alarm On Alm Lev Med Alm Rec Off BT High 39 0 BT Low 36 0 Comp Const 0 542 Auto IT Auto Manual IT 2 0 Temp Unit C Interval s 30...

Page 268: ...20 s Max Hold mainstream 10 s Operating Mode side mainstream Standby Operating Mode microstream Measure O2 Compen side mainstream Off N2O Compen sidestream Off Des Compen sidestream Off Balance Gas ma...

Page 269: ...onate awRR High 30 30 100 awRR Low 8 8 30 EtCO2 High 50 50 45 EtO2 High 684 EtCO2 Low 15 15 30 EtO2 Low 137 FiCO2 High 4 FiO2 High 669 FiCO2 Low 0 FiO2 Low 137 EtN2O High 55 EtHal High 3 0 EtN2O Low 0...

Page 270: ...default settings ICG Setup Adult Pediatric Neonate Alarm On Alm Lev Med Alm Rec Off C I High 5 0 C I Low 1 5 TFC High 60 TFC Low 10 Averaging 30 beats Update Rate 10 beats Patient Demographics LV_D 5...

Page 271: ...actory Defaults C 11 C 14 BIS Setup Factory default settings BIS Setup Adult Pediatric Neonate Alarm On Alm Lev Med Alm Rec Off BIS High 70 BIS Low 20 Smoothing Rate 30 s BIS EEG Waveform Sweep 25 mm...

Page 272: ...Neonate Alarm On Alm Lev Med Alm Rec Off Apnea Time 20 s TV MV TV Sensor Type Disposable Ventilation Mode Spontaneous Alarm Limits Setup RR High 30 30 100 RR Low 8 8 30 PEEP High 10 PEEP Low 0 PIP Hi...

Page 273: ...eld indicates whether all alarm indications except the alarm message can be cleared or not The L field indicates the alarm level H means high M means medium and L means low means the alarm level is us...

Page 274: ...tions PNP M ECG PNC M The pacer appears abnormal Check the pacer Resp Apnea H The respiration signal was so weak that the monitor cannot perform respiration analysis Check the patient s condition and...

Page 275: ...sonnel ECG Lead Off ECG YY Lead Off ECG Note YY represents the leadwires V V1 V2 V3 V4 V5 V6 LL LA RA as per AHA standard or C C1 C2 C3 C4 C5 C6 F L and R as per IEC standard The electrode has become...

Page 276: ...been interfered Check for any possible sources of signal noise from the area around the sensor and check the patient for great motion SpO2 Board Fault There is a problem with the SpO2 measurement boa...

Page 277: ...Comm Err There is a problem with the communication between the CO2 module and the monitor CO2 Sensor High Temp Check stop using or replace the sensor CO2 Sensor Low Temp Check stop using or replace t...

Page 278: ...Make sure that the filterline is connected CO2 Main Board Err CO2 Check Sensor or Main Board CO2 Replace Scrubber Pump CO2 Change Sensor CO2 15V Overrange CO2 Hardware Err CO2 Pump Fault CO2 Pneumati...

Page 279: ...the monitor AG Airway Occluded Check the airway and remove the occlusion AG Zero Failed Re plug the module or restart the monitor and then perform a zero calibration again AG Oxima Depletion Err AG Ox...

Page 280: ...stem power supply Restart the monitor Battery Too Low Connect the monitor to an AC power source and allow the batteries to charge Different Battery Voltages Battery Incompatible Battery Error The two...

Page 281: ...s printhead cools down Recorder out of Paper Open the recorder door and load a new roll of recorder paper Recorder Rec Paper Wrong Pos Re load the recorder paper System Watchdog Err System Software Er...

Page 282: ...strator SMR Unavailable Turn off the monitor and check the connection between the satellite module rack SMR and the monitor and then restart the monitor Net Comm Error Check the network connections an...

Page 283: ...er cm centimeter dB decibel DS dyne second F fahrenheit g gram GHz gigahertz GTT gutta h hour Hz hertz in inch kg kilogram kPa kilopascal L litre lb pound m meter mAh microampere hour Mb mega byte mcg...

Page 284: ...ions E 2 nm nanometer rpm breath per minute s second V volt VA volt ampere ohm W watt minus percent per divide or plus equal to less than greater than less than or equal to greater than or equal to pl...

Page 285: ...ral index BP blood pressure BPSK binary phase shift keying BSA body surface area BT blood temperature BTPS body temperature and pressure saturated C I cardiac index C O cardiac output CaO2 arterial ox...

Page 286: ...ratio Fi fraction of inspired FiCO2 fraction of inspired carbon oxygen FiN2O fraction of inspired nitrous oxide FiO2 fraction of inspired oxygen FPGA field programmable gate array FV flow volume Hal h...

Page 287: ...lobin MRI magnetic resonance imaging MVe expiratory minute volume MVi inspiratory minute volume N A not applied N2 nitrogen N2O nitrous oxide Neo neonate NIBP noninvasive blood pressure NIP negative i...

Page 288: ...RVSWI right ventricular stroke work index SaO2 arterial oxygen saturation SEF spectral edge frequency Sev sevoflurane SFM self maintenance SI stroke index SMR satellite module rack SpO2 arterial oxyg...

Page 289: ...bilical arterial pressure UPS uninterruptible power supply USB universal serial bus UVP umbilical venous pressure VAC volts alternating current VEPT volume of electrically participating tissue VI velo...

Page 290: ...P N 6800 20 50657 1 0...

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