Mindray BeneHeart D3 Operator'S Manual Download Page 158

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A-12

Vibration

Complies with requirements of 21.102, ISO9919.

Bump

Complies with the requirements of 6.3.4.2, EN1789.

Peak acceleration: 15g

Duration: 6ms

Number of impacts: 1000

Impact direction: vertical impacts are applied when the equipment under test is placed at normal operating position.

Free fall

Complies with the requirements of 6.3.4.3, EN1789.

Drop height: 0.75 m

Number of drops: once for each of the six surfaces

Summary of Contents for BeneHeart D3

Page 1: ...BeneHeart D3 Defibrillator Monitor Operator s Manual...

Page 2: ......

Page 4: ...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 reproduction distri...

Page 5: ...of this product only if all installation operations expansions changes modifications and repairs of this product are conducted by Mindray authorized personnel the electrical installation of the relev...

Page 6: ...man made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper...

Page 7: ...n integral 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 wh...

Page 8: ...VI FOR YOUR NOTES...

Page 9: ...iew 2 8 2 3 3 Rear View 2 9 2 3 4 External Paddles 2 10 2 4 Display Views 2 11 3 Basic Operations and Settings 3 1 3 1 Installation 3 1 3 1 1 Unpacking and Checking 3 1 3 1 2 Environmental Requirement...

Page 10: ...Alarms Off 5 7 5 8 Pausing Alarm Sounds 5 8 5 9 Switching Off Alarm Sounds 5 8 5 10 Reminder Tones 5 8 5 11 Latching Alarms 5 9 5 12 Clearing Technical Alarms 5 9 5 13 When an Alarm Occurs 5 10 6 Moni...

Page 11: ...ation Procedure 8 3 8 4 1 Using Pediatric Paddles 8 5 8 4 2 Using Internal Paddles 8 5 8 5 Synchronized Cardioversion 8 6 8 5 1 Performing Synchronized Cardioversion 8 7 8 5 2 Delivering Additional Sy...

Page 12: ...8 Measurement Limitations 12 5 12 9 Masimo Information 12 6 12 10 Nellcor Information 12 6 13 NIBP 13 1 13 1 Introduction 13 1 13 2 Safety 13 1 13 3 Measurement Limitations 13 2 13 4 Measurement Modes...

Page 13: ...18 3 18 5 Loading Paper 18 3 18 6 Removing Paper Jam 18 4 18 7 Cleaning the Recorder Print head 18 4 19 Configuration Management 19 1 19 1 Introduction 19 1 19 2 Password 19 1 19 3 Accessing Configura...

Page 14: ...22 2 22 3 1 Power on Tests 22 2 22 3 2 Shift Check 22 3 22 3 3 Automated Tests 22 3 22 3 4 User Test 22 4 22 3 5 Recorder Inspection 22 6 22 3 6 ECG Cable Test 22 7 22 3 7 Manual Defibrillation Test 2...

Page 15: ...cal Alarm Messages D 2 E Electrical Safety Inspection E 1 E 1 Power Cord Plug E 1 E 2 Device Enclosure and Accessories E 1 E 3 Device Labelling E 2 E 4 Protective Earth Resistance E 2 E 5 Earth Leakag...

Page 16: ...8 FOR YOUR NOTES...

Page 17: ...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 18: ...ng condition z Make sure the synchronous input system is applied to this equipment and the input signal is correct if necessary z The equipment must be connected to a properly installed power outlet w...

Page 19: ...he guidelines regulating the disposal of such products to avoid contaminating the environment z Magnetic and electrical fields are capable of interfering with the proper performance of the equipment F...

Page 20: ...current Battery indicator Audio paused Alarm off Audio off Alarm paused Marker Lead select Gain select Event summary NIBP start stop key Graphical recorder Menu Unlocking Network connector Shock butt...

Page 21: ...very recyclable Electrostatic sensitive devices Mark of conformity to European Medical Device Directive 93 42 EEC Authorised representative in the European community DEFIBRILLATION PROOF TYPE CF APPLI...

Page 22: ...1 6 FOR YOUR NOTES...

Page 23: ...red use of Manual Defib Mode may be password protected The Pacer Mode offers non invasive transcutaneous pacing therapy Pace pulses are delivered through multifunction electrode pads Use of Pacer Mode...

Page 24: ...on 2 2 3 Noninvasive Pacing Noninvasive pacing therapy is intended for patients with symptomatic bradycardia It can also be helpful in patients with asystole if performed early 2 2 4 ECG The ECG monit...

Page 25: ...2 3 2 3 Main Unit 2 3 1 Front View Area 1 Alarm lamp Area 2 External paddle Handle Area 3 Microphone Speaker...

Page 26: ...cross Flashing when a failure is detected or when battery is not installed if No Battery is configured as Status Indicator ON 5 Status indicator green tick Illuminated when AC mains is connected and t...

Page 27: ...on to start a recording or stop the current recording 4 Alarm Pause button Press this button to pause reactivate or switch off the alarms 5 Mark Event button Press it to manually mark specified events...

Page 28: ...perating mode or turn the equipment off 2 Energy Select button In Manual Defib mode press this button to select energy level 3 Charge button Press this button to charge the defibrillator 4 Shock butto...

Page 29: ...ey to start a recording or stop the current recording 2 Indicator Illuminated when the recorder works correctly Flashes when an error occurred to the recorder or the recorder runs out of paper 3 Paper...

Page 30: ...2 8 2 3 2 Side View Therapy port is used to connect paddles cable or pads cable 1 Recorder 2 ECG ECG cable connector 3 SpO2 SpO2 sensor connector 4 NIBP NIBP cuff connector Therapy port 1 2 4 3...

Page 31: ...uld be connected together to eliminate the potential difference between them 4 External power input It connects an AC power cord or a DC AC adapter to run the equipment respectively on the external AC...

Page 32: ...2 10 2 3 4 External Paddles 1 Shock button 2 Energy Select button 3 Shock indicator 4 Charge button 5 Shock button 1 2 4 5 3 Sternum paddle Apex paddle...

Page 33: ...ed indicates all alarms are turned off indicates alarm sounds are paused indicates alarm sounds are turned off 3 Physiological Alarm area This area shows physiological alarm messages When multiple ala...

Page 34: ...rea This area shows the selected defibrillation energy shock counter as well as prompt related to manual defibrillation 9 Runtime area This area shows the equipment s operating time since it is turned...

Page 35: ...is not evident from the equipment specifications whether a particular combination is hazardous for example due to summation of leakage currents consult the manufacturers or else an expert in the field...

Page 36: ...e turning on the equipment check for any mechanical damage and make sure that all external cables plug ins and accessories are properly connected 2 Plug the power cord into the AC power source If you...

Page 37: ...t configuration if restarts within 60 seconds it load the user configuration if restarts 120 seconds later after the power failure it may load either the latest configuration or the user configuration...

Page 38: ...Key Volume and then select an appropriate value 0 means key volume off and 10 is the maximum volume You can also change key volume by entering configuration mode and selecting Others from the Configur...

Page 39: ...make changes as desired 2 Select Others to edit more patient information Archive ID is created automatically when the equipment is turned on It is unchangeable When the equipment is turned off the cur...

Page 40: ...4 2 FOR YOUR NOTES...

Page 41: ...r value that violates set alarm limits or by an abnormal patient condition Physiological alarm messages are displayed in the physiological alarm area In AED mode no physiological alarm will be present...

Page 42: ...tion which may compromise a certain function but will not threaten the patient s life 5 3 Alarm Indicators When an alarm occurs the equipment indicates it to the user through visual or audible alarm i...

Page 43: ...atches the alarm level For physiological alarms High level alarms red Medium level alarms yellow Low level alarms yellow For technical alarms High level alarms red Medium level alarms yellow Low level...

Page 44: ...power off You can also set alarm volume in configuration mode In this case the setting will be saved NOTE z You cannot adjust alarm volume when an alarm is switched off 5 4 2 Setting the Interval betw...

Page 45: ...nd related waveforms is possible when a measurement alarm occurs To reset the default settings select the Defaults button NOTE z You cannot simultaneously switch on HR and PR alarms In the case that P...

Page 46: ...ult pediatric 35 to 240 Neonate 55 to 225 Resp RR RR 0 5 or 6 min whichever is greater RR 10 or 30 min whichever is greater RR 1 5 or 30 min whichever is lower RR 25 or 85 min whichever is lower Adult...

Page 47: ...automatically deactivated You can also cancel the alarm paused status by pressing the hardkey The default alarm pause time is 2 minutes To change alarm pause time 1 Press the Main Menu button on the f...

Page 48: ...alarm status is the same with that when alarm tones are paused The audio off status is exited when The hardkey is pressed In this case the equipment enters the alarm paused status and the alarm volum...

Page 49: ...ear the latched alarms by pressing the hardkey 5 12 Clearing Technical Alarms For some technical alarms their alarm lamp flashing and alarm tones are cleared and the alarm messages change to prompt me...

Page 50: ...actions 1 Check the patient s condition 2 Confirm the alarming parameter or alarm category 3 Identify the alarm source 4 Take proper action to eliminate the alarm condition 5 Make sure the alarm condi...

Page 51: ...r be sure to select correct paced status Otherwise the pacing pulses may be counted in the case of cardiac arrest or some arrhythmias Do not completely rely on the heart rate reading or the heart rate...

Page 52: ...n sites to remove dead skin cells Thoroughly clean the sites with mild soap and water We do not recommend using ether or pure alcohol because this dries the skin and increases the resistance Dry the s...

Page 53: ...nding to those on the left VE placement over the xiphoid process V7 placement on posterior chest at the left posterior axillary line in the fifth intercostal space V7R placement on posterior chest at...

Page 54: ...anterior lateral placement 3 If multifunction electrode pads are used connect the pads to the pads cable 4 Connect paddles pads cable with the equipment if not connected Anterior lateral Paddles Pads...

Page 55: ...uld mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak Do not rely entirely on rate meter alarms when monitoring patients with pacemakers Always keep these patients under...

Page 56: ...ent 1 Select Main Menu Others Configuration enter the required password 2 In the Configuration Main menu select ECG Setup ECG Standard and then select AHA or IEC according to the standard that is appl...

Page 57: ...e faster the wave sweeps the wider the wave is You can also access Sweep to adjust wave speed from the ECG Setup menu in the Configuration mode In the ECG Setup menu select ECG Cascade and toggle betw...

Page 58: ...analyze the arrhythmia information with other clinical findings z The arrhythmia detection is not intended for neonatal patients 6 7 1 Understanding the Arrhythmia Events Arrhythmia event Description...

Page 59: ...within the set time threshold of pause Irr Rhythm Consistently irregular rhythm indicates that this arrhythmia alarm is not presented when Paced is set to Yes indicates that this arrhythmia alarm is n...

Page 60: ...r off 6 7 4 Changing Arrhythmia Threshold Settings To change arrhythmia threshold settings select the ECG parameter window Arrhythmia Arrh Threshold In case an arrhythmia violates its threshold an ala...

Page 61: ...category is changed The paced status is changed Arrhythmia analysis is switched on Stop Calibrating is selected after ECG calibration is completed 6 8 Calibrating ECG The ECG signal may be inaccurate...

Page 62: ...6 12 FOR YOUR NOTES...

Page 63: ...ed and entry of patient information is disabled Additionally the Lead Select Alarm Pause and Main Menu buttons are inactive 7 2 Safety DANGER z Defibrillation current can cause operator or bystander s...

Page 64: ...z Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads Discard the pads if they become damaged z For patients with implantable pacemaker the sensitivity a...

Page 65: ...e soft key 6 Press the Shock button if prompted Once charging is complete the equipment gives prompt Do Not Touch Patient Press Shock Button Make sure no one is touching the patient bed or any equipme...

Page 66: ...d or have been fully charged you can remove the charged energy at any time by pressing the Pause for CPR soft key For defibrillation of adult patients recommended energy level is 200 Joules 7 6 No Sho...

Page 67: ...t rhythm again at any time by pressing the Resume Analyzing soft key in CPR status 7 7 1 CPR Metronome The equipment provides a CPR metronome feature that can be used to encourage rescuers to perform...

Page 68: ...he sounding recording 1 Move the Mode Select knob to Monitor Manual Defib or Pacer Press the Main Menu button on the front panel and then select Others Configuration Enter the required password 2 Sele...

Page 69: ...re injury or even death Never touch the patient or any equipment connected to the patient including the bed or gurney during defibrillation z Avoid contact between parts of the patient s body such as...

Page 70: ...vent the paddles from being corroded z Prior to using this defibrillator disconnect from the patient all equipment that is not defibrillator protected z Do not charge the equipment and deliver shock f...

Page 71: ...shave excessive chest hair 2 Connect the therapy cable to the therapy port Push until you hear it click into place 3 Apply multifunction electrode pads or external paddles to the patient If multifunc...

Page 72: ...on is shown in the defibrillation information area as shown below 6 Charge Press the Charge button on the front panel If external paddles are used the Charge button on the paddles may be used instead...

Page 73: ...ibrillate using internal paddles 1 Turn on the defibrillator and enter the manual defib mode 2 Select the appropriate paddle size 3 Connect the paddles to the defibrillator by aligning the white point...

Page 74: ...cardioversion through either Multifunction electrode pads or External paddles To use synchronized cardioversion press the Enter Sync soft key in the asynchronous defibrillation mode Then Sync appears...

Page 75: ...rm that a shock is still indicated and that the equipment has charged to the selected energy level Make sure no one is touching the patient bed or any equipment connected to the patient Call out loudl...

Page 76: ...nect the defibrillator monitor with a bedside monitor through the defibrillator monitor s multifunctional connector 2 Switch on the equipment and enter the Manual Defib mode 3 Press the Enter Sync sof...

Page 77: ...dance are shown as follows indicates the impedance is in normal range indicates the impedance is slightly higher for the defibrillation indicates the impedance is too high for the defibrillation or th...

Page 78: ...8 10 FOR YOUR NOTES...

Page 79: ...5 lead ECG cable and electrodes are required to acquire ECG signal Pace pulses are delivered through multifunction electrode pads However the pads cannot be used to monitor the ECG and deliver pace pu...

Page 80: ...odes and multifunction electrode pads NOTE z If pacing is interrupted for any reason the Start Pacing soft key must be pressed to resume pacing z In pacer mode you cannot change the patient s internal...

Page 81: ...beats z During demand mode pacing spontaneous beats may be presented which are not associated with the delivery of pace pulse If the patient s heart rate is above the pacer rate pace pulses are not d...

Page 82: ...ear above the R waves as shown in the figure below If the R wave markers do not appear or do not coincide with the R waves for example above the T waves select another lead 4 Select pacer rate If nece...

Page 83: ...ton to select the desired lead for viewing 4 Select pacer rate If necessary select pacer output To select pacer rate or pacer output rotate the Navigation knob to select an appropriate value and press...

Page 84: ...zard during pacing z If you are using the pacing function with battery power and the Low Battery alarm is presented connect the equipment to external power or install a fully charged battery CAUTION z...

Page 85: ...quipment screen 10 2 Safety WARNING z When monitoring the patient s respiration do not use ESU proof ECG cables z The respiration measurement does not recognize obstructive and mixed apneas it only in...

Page 86: ...ou can use different ECG cables 3 lead or 5 lead Since the respiration signal is measured between two ECG electrodes if a standard ECG electrode placement is applied the two electrodes should be RA an...

Page 87: ...ses 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 In clinical applications some patients especially neon...

Page 88: ...10 4 FOR YOUR NOTES...

Page 89: ...pO2 parameter 11 2 Adjusting Pulse Tone Volume When PR alarm is switched on the equipment gives out pulse tone You can select the PR parameter area to enter the PR Setup menu and then adjust QRS Volum...

Page 90: ...11 2 FOR YOUR NOTES...

Page 91: ...electrical signal and displays a waveform and digital values for SpO2 and pulse rate This device is calibrated to display functional oxygen saturation It provides the following measurements 1 Pleth w...

Page 92: ...or patients with poor peripheral blood circulation or sensitive skin inspect the sensor site more frequently 12 3 Identifying SpO2 Modules The equipment can be configured with any of the following SpO...

Page 93: ...the SpO2 Setup menu to lock the SpO2 alarm status until the NIBP measurement ends If you switch NIBP Simul off low perfusion caused by NIBP measurement may lead to inaccurate SpO2 readings and theref...

Page 94: ...the equation Sat Seconds Points Seconds Only when the Sat Seconds limit is reached the monitor gives a Sat Seconds alarm The figure below demonstrates the alarm response time with a Sat Seconds limit...

Page 95: ...7 Pitch Tone The pitch tone function enables the equipment to give variable pitches of heartbeat tone or pulse tone as the patient s SpO2 level changes This equipment provides 22 levels of pitch tone...

Page 96: ...ld alone or in combination with this device fall within the scope of one or more of the patents relating to this device 12 10 Nellcor Information Nellcor Patents This device may be covered by one or m...

Page 97: ...nd determines the systolic and diastolic pressures As specified in IEC 60601 2 30 EN60601 2 30 NIBP monitoring is allowed while an electrosurgical operation is in progress or a defibrillation shock is...

Page 98: ...ring NIBP Manual measurement on demand Auto continually repeated measurements at set intervals STAT continually rapid series of measurements over a five minute period then return to the previous mode...

Page 99: ...e NIBP Setup menu 2 Select Interval and then select a desired time interval Selecting Manual switches to manual mode 3 Start the measurement manually The equipment will then automatically repeat NIBP...

Page 100: ...ct the appropriate setting The cuff is inflated accordingly at the next NIBP measurement The table below list the setting range of initial cuff inflation pressure Patient category Range mmHg Default m...

Page 101: ...h configuration management Event A is always Generic and cannot be changed To mark an event 1 In Monitor mode Manual Defib mode or Pacer mode press the Event button on the front panel to access the Ma...

Page 102: ...14 2 FOR YOUR NOTES...

Page 103: ...menu pops up as shown below The Freeze soft key changes to Unfreeze while the parameter area remains refreshing properly The equipment can freeze the waveforms for 120 seconds 15 2 Reviewing Frozen W...

Page 104: ...ses the screen to be readjusted or opens a menu such as plugging in or out a module pressing the Lead Select or Main Menu button etc 15 4 Recording Frozen Waveforms 1 In the Freeze menu select in turn...

Page 105: ...ents menu In the Review Events menu you can Select Event Type and then select Operator Initiated Phys Alarm Arrhythmia Tech Alarm or All to review events as desired Select Prev Next to page up down to...

Page 106: ...nds In the Monitor Manual Defib o Pacer mode press the Main Menu button on the front panel select Review Trends or if you are operating in the Monitor mode select the Trends soft key to enter the tabu...

Page 107: ...enu button on the front panel to enter the Main Menu and then select Others Archives A prompt pops up as shown below Select Yes to enter the Archives Main screen as shown below Only in Monitor Manual...

Page 108: ...Main screen 1 Select Export Data to enter the Export Data screen in which select USB Memory Then the system starts searching for USB memory and enters the data export screen if the memory is found 2 S...

Page 109: ...ecordings The task related recordings include Frozen wave recording Tabular trends recording Event recording Parameter alarm recording Event review recording Event Summary Report Check report Configur...

Page 110: ...the Record Setup menu press the Main Menu button on the front panel and select Others Record Setup 18 4 2 Selecting Waveforms for Recording The recorder can record up to 3 waveforms at a time You can...

Page 111: ...waveform area 18 5 Loading Paper 1 Use the latch at the upper right of the recorder door to pull the door open 2 Insert a new paper roll into the compartment as shown below 3 Close the recorder door...

Page 112: ...posits of paper debris may collect on the print head compromising the print quality and shortening the lifetime of the roller Follow this procedure to clean the print head 1 Take measures against the...

Page 113: ...e required password is set to 315666 before the equipment leaves the factory 19 3 Accessing Configuration Management To access configuration management move the Mode Select knob to Monitor Manual Defi...

Page 114: ...tient while performing configuration management 19 3 1 General Setup Menu Menu Item Options Range Default Remark Device Name 20 characters Institution 20 characters Department 20 characters Bed No 20...

Page 115: ...Sync On Off Off Monitor Para SpO2 Off Off Charge Tone Vlm High Med Low Med Contact Impedance Indicator On Off Off 19 3 3 AED Setup Menu Menu Item Options Range Default Remark Shock Series 1 2 3 1 In A...

Page 116: ...ad 3 Lead The default waveform position in Waveform Setup menu is determined according to the setting of Lead set defined in ECG Setup menu QRS Volume 0 to 10 2 This setting is linked with the Beat Vo...

Page 117: ...RR Alm Lev Irr Rhythim High Med Low Med Asystole Delay 3 to 10 5 V Tach Rate 100 to 200 130 V Tach PVCs 3 to 99 6 Vbrd Rate 15 to 60 40 Vbrd PVCs 3 to 99 5 Adu 60 to 300 160 Extreme Tachy Ped 60 to 30...

Page 118: ...pO2 High Neo Low 1 to 100 95 Adu 90 Ped 90 SpO2 Low Neo Desat Limit to High 1 90 Adu 80 Ped 80 Desat Neo 50 to High 1 80 Averaging Masimo SpO2 2 4s 4 6s 8s 10s 12s 14s 16s 8s For Masimo SpO2 module on...

Page 119: ...5 h 2 h 3 h 4 h 8 h Manual Press Unit mmHg kPa mmHg Alarm limits are refreshed in real time when pressure unit is changed NIBP Sys NIBP Dia Alarm NIBP Mean On Off On Alm Lev High Med Med Adu Low 5 to...

Page 120: ...vel Alarm 15 to 100s 20s Latching Alarms Yes No No Displaying Alarm Limits Yes No Yes ECG Lead Off Lev High Med Low Low SpO2 Sensor Off Lev High Med Low Low No Battery Status Indicator On Status Indic...

Page 121: ...ns entering event name using the keyboard included in the Mark Event Setup menu Range 1 to 20 characters After being defined custom event is refreshed in real time in the Mark Event list 19 3 13 Recor...

Page 122: ...ff Off 12h time format 12 00 AM 05 00 AM 03 00 AM Auto Test Time 24h time format 00 00 05 00 03 00 19 3 16 Others Menu Menu Item Options Range Default Brightness 1 to 10 8 Key Volume 0 to 10 2 Wave Li...

Page 123: ...attery and charging is required immediately Battery is not installed You can also check the battery s charge status by pressing the fuel gauge button on the battery to illuminate the battery gauge The...

Page 124: ...r will not be illuminate in the case that battery is not installed the message No Battery will be presented in the Technical Alarm Area 20 3 2 Low Battery Alarm If the equipment is run on battery and...

Page 125: ...stated in the specifications discard the batteries or contact your service personnel NOTE z Life expectancy of a battery depends on how frequent and how long it is used When properly cared for the li...

Page 126: ...icantly longer time to charge the battery Stored batteries should be charged every 2 months to 40 to 60 of full capacity They should be charged to full capacity prior to use NOTE z Do not store a batt...

Page 127: ...you equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules Always dilute according the manufacturer s instructions or use lowest possible concentration Do...

Page 128: ...s 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 clean cloth dampened with a glass cleaner 4 Clean the pad...

Page 129: ...ipment has been used for 12 months or whenever the equipment is repaired or upgraded a thorough inspection should be performed by qualified service personnel to ensure the reliability Items to be chec...

Page 130: ...aintenance and Testing 22 3 1 Power on Tests The equipment performs self test each time you turn it on or restart the equipment If a failure is detect the red status indicator will flash and a message...

Page 131: ...the Configuration Main men and select Test Setup Auto Test Time The default setting is 3 00 am The equipment displays no information on the screen during Auto Test In the case that Auto Test fails th...

Page 132: ...ery and properly place the external paddles in the paddle tray or connect the pads cable and 50 test load Otherwise the User Test will fail 22 3 4 1 Entering the User Test Main Menu To access user tes...

Page 133: ...ailed will be displayed in the technical alarm area when the equipment is restarted We recommend you to perform a successful User Test to clear this alarm 22 3 4 4 Controls Test Controls test covers t...

Page 134: ...ne Test Energy Delivery Test and Controls Test is checked automatically The equipment can be configured to give a User Test Due message to remind you that the equipment is due for User Test The User T...

Page 135: ...ppened 4 Set the analyzer to Energy Measurement mode In this case the energy value should be displayed as 0 or blank 5 Select the energy level to 1J 6 Charge discharge the equipment to verify the ener...

Page 136: ...ddles ECG electrodes on the defibrillator pacer analyzer 2 Set the analyzer to Time Measurement Mode and output normal sinus rhythms e g amplitude value 1mV and HR 60bpm 3 Enter Configuration Manageme...

Page 137: ...tart Pacing soft key Verify that the pacer rate measured by the analyzer is 170 ppm 2ppm and the measured current is 200 mA 10mA 22 3 9 Peforming Testing in Installation Mode You can view software ver...

Page 138: ...mpare the value of manometer with the value displayed on the equipment s screen The difference should be no greater than 3 mmHg 5 Raise the pressure in the metal vessel to 50 mmHg with the balloon pum...

Page 139: ...This means the leakage test is started When the accuracy test is completed the result will be displayed If the message NIBP Pneumatic Leak is displayed it indicates that the NIBP airway may have leak...

Page 140: ...for completing this test are as follows 1 Open the equipment s enclosure remove the multi parameter monitoring module M51A module disconnect the air tube from the pressure measuring sensor component U...

Page 141: ...ucts to avoid contaminating the environment z When using the accessories consider the accessories operating temperature Refer to corresponding accessory s instrution for use for details z The accessor...

Page 142: ...EL6302B Adult pediatric 0010 30 42733 IEC EL6308B Pediatric 0010 30 42901 EL6301B Adult pediatric 0010 30 42734 Snap AHA EL6307B Pediatric 0010 30 42900 5 Electrode Lead Sets Type Compatible with Mode...

Page 143: ...10 10 12202 MAX P Pediatric 10 to 50 kg 0010 10 12203 MAX I Infant 3 to 20 kg 0010 10 12204 Disposable MAX N Neonate 3 kg Adult 40 kg 0010 10 12205 520A Adult 520A 30 64101 520P Pediatric 520P 30 6420...

Page 144: ...dult 30 kg 0010 10 12202 MAX P Pediatric 10 to 50 kg 0010 10 12203 MAX I Infant 3 to 20 kg 0010 10 12204 Disposable MAX N Neonate 3 kg Adult 40 kg 0010 10 12205 DS 100A Adult 9000 10 05161 OXI P I Ped...

Page 145: ...M1500B 4 3 to 8 2 9 001B 30 70693 CM1500C 5 8 to 10 9 3 8 001B 30 70694 CM1500D Neonate 7 1 to 13 1 4 8 001B 30 70695 CM1501 Infant 10 to 19 7 2 001B 30 70697 CM1502 Pediatric 18 to 26 9 8 001B 30 706...

Page 146: ...ware kit 0651 30 77145 Carrying case and shield cover 115 018610 00 D3 back pouch 115 008708 00 Conducting gel mount kit 115 007857 00 Pothook kit 115 007587 00 Charger Station kit with international...

Page 147: ...ternal defibrillation Mode of operation Continuous Degree of protection against harmful ingress of solid IP4X Degree of protection against harmful ingress of water IPX4 when running on battery IPX1 wh...

Page 148: ...brillator Specifications Defibrillation mode Manual defib synchronous cardioversion AED Defibrillation waveform Biphasic truncated exponential BTE waveform auto compensation according to patient imped...

Page 149: ...6 5 3 5 1 4 9 2J 7 J 6 8 7 6 8 6 6 6 3 6 5 7 2J 8 J 7 8 8 7 8 7 4 7 1 6 8 6 5 2J 9 J 8 8 9 8 8 8 4 8 7 7 7 3 2J 10 J 9 7 10 9 7 9 3 8 9 8 5 8 1 2J 15 J 15 15 15 14 13 13 12 15 20 J 20 20 20 19 18 17 1...

Page 150: ...ous signal AED Shock series Energy level 100 to 360J configurable Shocks 1 2 3 configurable Meeting AHA guidelines 2010 by default Shockable rhythm VF VT HR 150bpm and QRS width 120ms AED ECG Analysis...

Page 151: ...les or multifunction electrode pads Defibrillation electrodes pads paddles 3 lead ECG set I II III ECG inputs 5 lead ECG set I II III aVR aVL aVF V Gain 2 5 mm mV 0 25 5 mm mV 0 5 10 mm mV 1 20 mm mV...

Page 152: ...pm 60 1 bpm 120 1 bpm 90 2 bpm Response to change in heart rate Meets requirements of ANSI AAMI EC13 2002 section 4 1 2 1 f From 80 to 120 bpm less than 11 s From 80 to 40 bpm less than 11 s Meets the...

Page 153: ...g ECG cable with 1 k resistor Difference input impedance 2 5 M Apnea alarm time 10 s 15 s 20 s 25 s 30 s 35 s 40 s Mindray SpO2 Module Measurement accuracy verification The SpO2 accuracy has been veri...

Page 154: ...02 Light penetration 5 Low perfusion SpO2 accuracy 2 PR Measurement range 25 to 240 bpm Accuracy 3 bpm measured without motion 5 bpm measured with motion Low perfusion PR accuracy 3 bpm Nellcor SpO2...

Page 155: ...0 to 100 Diastolic KPa 1 3 to 28 0 1 3 to 20 0 1 3 to 13 3 mmHg 20 to 230 20 to 165 20 to 110 Measurement range Mean KPa 2 7 to 30 7 2 7 to 22 0 2 7 to 14 7 Setting range Default Accuracy Adult 80 to...

Page 156: ...tes of monitoring and six 360J discharges after the low battery alarm occurs Note The specifications above base on a new battery and at 20 C A 6 Recorder Specifications Method High resolution thermal...

Page 157: ...ives Up to 100 A 9 Environmental Specifications Operating environment Operating temperature 0 to 45 C at least 60 minutes of working time when the temperature reduces from room temperature to 20 C Ope...

Page 158: ...EN1789 Peak acceleration 15g Duration 6ms Number of impacts 1000 Impact direction vertical impacts are applied when the equipment under test is placed at normal operating position Free fall Complies w...

Page 159: ...erroneous measurements could result z Portable and mobile RF communications equipment may affect this equipment Guidance and Declaration Electromagnetic Emissions The equipment is suitable for use in...

Page 160: ...kV differential 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...

Page 161: ...evice including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P V d 1 5 3 P V d 2 12 P E d...

Page 162: ...which radiated RF disturbance are controlled The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF c...

Page 163: ...n use Present Cables not frayed connectors and pins not broken or loose External paddles skip if not in use Cables not frayed connectors and pins not broken or loose Properly placed in paddle tray and...

Page 164: ...med using pads cable or when selftest fails Perform this test only when automatic selftest is not performed using paddles or when selftest fails NOTE z Remember to disconnect the test load when the te...

Page 165: ...alarm level is user adjustable XX represents a measurement or parameter label such as ECG HR PVCs RR SpO2 PR NIBP etc In the Cause and solution column corresponding solutions are given instructing you...

Page 166: ...CG YY Lead Off YY represents the leadwires V LL LA and RA as per AHA standard or C F L and R as per IEC standard L B The ECG electrode has become detached from the patient or the lead wire has become...

Page 167: ...equipment application site meets the environmental requirements and check if there is any source that affects the air pressure NIBP Weak Signal L A The patient s pulse is weak or the cuff is loose Che...

Page 168: ...harge the batteries Battery Err H There is a problem with the batteries Check the batteries for damage verify that correct batteries are used Replace the batteries if necessary Battery Depleted System...

Page 169: ...resume the recording till the recorder s print head cools down Recorder Recorder Overcurrent L A Re load the recorder paper Others Config Err L A Check if the configuration is correct or restore the...

Page 170: ...D 6 FOR YOUR NOTES...

Page 171: ...1 Power Cord Plug Test Item Acceptance Criteria The power plug pins No broken or bent pin No discolored pins The plug body No physical damage to the plug body The strain relief No physical damage to t...

Page 172: ...tance is less than limits LIMITS For all countries R 0 2 Maximum E 5 Earth Leakage Test Run an Earth Leakage test on the device being tested before performing any other leakage tests The following out...

Page 173: ...on LIMITS For CF applied parts 10 A in Normal Condition 50 A in Single Fault Condition For BF applied parts 100 A in Normal Condition 500 A in Single Fault Condition E 7 Mains on Applied Part Leakage...

Page 174: ...Normal Condition normal polarity with open neutral Single Fault Condition reverse polarity with open neutral Single Fault Condition normal polarity with open earth Single Fault Condition reverse pola...

Page 175: ...C centigrade cc cubic centimeter cm centimeter dB decibel DS dyne second F fahrenheit g gram GHz gigahertz GTT gutta h hour Hz hertz in inch J Joule k kilo kg kilogram kPa kilopascal L litre lb pound...

Page 176: ...greater than less than or equal to greater than or equal to plus or minus multiply copyright F 3 Abbreviations and Acronyms AaDO2 alveolar arterial oxygen gradient AAMI Association for Advancement of...

Page 177: ...tem CISPR International Special Committee on Radio Interference CMOS complementary metal oxide semiconductor CMS central monitoring system C O cardiac output CO2 carbon dioxide COHb carboxyhemoglobin...

Page 178: ...io IBP invasive brood pressure ICG impedance cardiography ICP intracranial pressure ICT B intracranial catheter tip pressure transducer ICU intensive care unit ID identification IEC International Elec...

Page 179: ...ratory pressure PEF peak expiratory flow PEP pre ejection period PIF peak inspiratory flow PIP peak inspiratory pressure Pleth plethysmogram Pmean mean pressure PNC pacer not captured PNP pacer not pa...

Page 180: ...ressure Taxil axillary temperature TD temperature difference Temp temperature TFC thoracic fluid content TFI thoracic fluid index TFT thin film technology Toral oral temperature TP total power Trect r...

Page 181: ...e we are going to track our product Please contact us with the device tracking information when you have received your defibrillator monitor Please fill the information in the next page cut the table...

Page 182: ...G 2 FOR YOUR NOTES...

Page 183: ...g Information User Information Customer Name Department name Address City State Zip Post Code Country Contact Person Tel No Fax No Email Address Device Information Product name Serial number Model Ins...

Page 184: ......

Page 185: ......

Page 186: ...P N 046 001653 00 6 0...

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