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Defibrillator/Monitor Operator’s Manual

2 - 3

2.3

Applied Parts

The applied parts of the equipment are:

■

ECG electrodes and leadwires

■

SpO

sensor

■

NIBP cuff

■

sampling line/Nasal sampling cannula, airway adapter

■

External defibrillation paddles

■

Internal defibrillation paddles

■

Multifunction electrode pads

■

CPR sensor

2.4

Main Unit

2.4.1

Front View

Alarm Pause

NIBP

Event

Handle External paddles

Area 1

Area 3

Area 2

Speaker

Содержание BeneHeart D2

Страница 1: ...BeneHeart D3 BeneHeart D2 Defibrillator Monitor Operator s Manual...

Страница 2: ......

Страница 4: ...r editorial purposes without the intention of improperly using them They are the property of their respective owners Responsibility on the Manufacturer Party Contents of this manual are subject to cha...

Страница 5: ...d by improper use or 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 dama...

Страница 6: ...us This manual is an 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 clini...

Страница 7: ...4 3 Right View 2 8 2 4 4 Rear View 2 8 2 5 External Paddles 2 9 2 6 Display Views 2 10 3 Basic Operations and Settings 3 1 3 1 Equipment Installation 3 1 3 1 1 Unpacking and Checking 3 1 3 1 2 Enviro...

Страница 8: ...larms Off 4 6 4 8 Switching Off Alarm Sounds 4 6 4 9 Resetting Alarms 4 6 4 10 Latching Alarms 4 7 4 11 Clearing Technical Alarms 4 7 4 12 Testing Alarms 4 7 4 13 Actions When an Alarm Occurs 4 8 5 Mo...

Страница 9: ...ock Advised NSA 6 4 6 7 CPR 6 4 6 7 1 CPR Metronome 6 4 6 8 AED Sound Recording 6 5 6 9 AED Setup 6 5 7 Manual Defibrillation 7 1 7 1 Manual Defibrillation Introduction 7 1 7 2 Manual Defibrillation S...

Страница 10: ...odules 12 1 12 3 SpO2 Safety Information 12 1 12 4 SpO2 Measurement Limitations 12 2 12 5 SpO2 Display 12 3 12 6 SpO2 Monitoring Procedure 12 4 12 7 Changing SpO2 Settings 12 4 12 7 1 Changing the Spe...

Страница 11: ...tion 14 1 14 3 CO2 Measurement Limitations 14 1 14 4 CO2 Display 14 2 14 5 Preparing for Measuring CO2 14 2 14 5 1 Measuring CO2 Using the CO2 Module 14 2 14 5 2 Zeroing the CO2 Sensor 14 3 14 6 Chang...

Страница 12: ...2 19 5 Setting the Recorder 19 3 19 5 1 Selecting Waveforms for Recording 19 3 19 5 2 Setting the Realtime Recording Length 19 3 19 5 3 Changing the Recording Speed 19 3 19 5 4 Switching Gridlines On...

Страница 13: ...etup 21 13 21 6 19 Others Menu 21 14 22 Battery 22 1 22 1 Battery Introduction 22 1 22 2 Battery Safety Information 22 1 22 3 Installing the Battery 22 2 22 4 Battery Alarms 22 2 22 4 1 No Battery Ala...

Страница 14: ...iscellaneous 25 6 A Specifications A 1 A 1 General Specifications A 1 A 1 1 Safety Specifications A 1 A 1 2 Physical Specifications A 1 A 1 3 Display Specifications A 1 A 1 4 Audio Indicators A 1 A 1...

Страница 15: ...io Regulatory Compliance C 4 D Defibrillator Shift Checklist D 1 E Alarm Messages E 1 E 1 Physiological Alarm Messages E 1 E 2 Technical Alarm Messages E 2 F Electrical Safety Inspection F 1 F 1 Power...

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Страница 17: ...current can cause operator or bystander severe injury or even death Keep distance from the patient or metal devices connected to the patient during defibrillation Do not disassemble the defibrillator...

Страница 18: ...place electrode pads or paddles away from internal pacemaker generator if possible to help prevent damage to the pacemaker Do not place the equipment or accessories in any position that might cause i...

Страница 19: ...equipment uses a mains plug as isolation means to the mains power supply Do not locate the equipment in a place difficult to operate the mains plug During normal use the operator shall stand in front...

Страница 20: ...ve 93 42 EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive Note The product complies with the Council Directive 2011 65 EU The following definition of...

Страница 21: ...e offers non invasive transcutaneous pacing therapy Pace pulses are delivered through electrode pads Use of Pacer mode may also be password protected The equipment can be powered by smart lithium ion...

Страница 22: ...G The ECG monitoring function is used to monitor and or record the patient s ECG waveform and heart rate 2 2 5 Resp The respiration monitoring function is used to continuously monitor the patient s re...

Страница 23: ...des and leadwires SpO2 sensor NIBP cuff CO2 sampling line Nasal sampling cannula airway adapter External defibrillation paddles Internal defibrillation paddles Multifunction electrode pads CPR sensor...

Страница 24: ...harged or the equipment operates on battery power Off no battery is installed or battery fails 5 Status indicator Flashing red cross when a failure is detected or when battery is not installed if No B...

Страница 25: ...Record button for the equipment without NIBP function press this button to start a recording or stop the current recording 5 Alarm Pause button Press this button to pause reactivate or switch off the...

Страница 26: ...to select the operating mode or turn the equipment off 2 Energy Select button In the Manual Defib mode press this button to select the energy level 3 Charge button Press this button to charge the def...

Страница 27: ...Defibrillator Monitor Operator s Manual 2 7 2 4 2 Left View 1 Recorder 2 ECG cable connector 3 Gas oulet 4 NIBP cuff connector 5 SpO2 sensor connector 6 CO2 sampling line connector 1 2 3 4 5 6...

Страница 28: ...2 8 Defibrillator Monitor Operator s Manual 2 4 3 Right View 2 4 4 Rear View 1 Therapy port It is used to connect the paddles cable or pads cable 1 2 7 6 5 1 3 4...

Страница 29: ...l power input It connects an AC power cord or a DC AC adapter to run the equipment respectively on the external AC mains or DC power supply 5 Network connector It is a standard RJ45 connector 6 USB co...

Страница 30: ...atus indicator It indicates battery status For details refer to 22 Battery 6 Parameter area This area shows measurement parameters Each measurement module has a parameter block and the parameter name...

Страница 31: ...information area This area shows the selected defibrillation energy shock counter as well as prompts related to manual defibrillation 12 Waveform area This area shows measurement waveforms The wavefor...

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Страница 33: ...mpaired by the proposed combination CAUTION The docking station is part of the equipment Use only the specified docking station 3 1 1 Unpacking and Checking Before unpacking examine the packing case c...

Страница 34: ...o the AC mains check that the voltage and frequency ratings of the power line are the same as those indicated besides the AC power input Use the cable retainer to secure the power cord to prevent it f...

Страница 35: ...etails on performing patient monitoring and therapy refer to the corresponding sections 3 2 5 Using the Main Menu To enter the main menu press the Main Menu button on the front panel Other menus are s...

Страница 36: ...Setup through the Configuration Main menu Set paced status when the Paced is set to Yes a paced symbol is displayed in the upper left corner of the main screen 3 Select Others to edit more patient inf...

Страница 37: ...nt For details on connecting the CMS refer to 20 3 Connecting the CMS If the system time is changed through the Configuration Main menu or Configuration View menu the equipment will restart If the sys...

Страница 38: ...hange the operating mode However the setting will not be saved if the equipment is turned off 3 3 5 Adjusting Waveform Position 1 Press the Main Menu button on the front panel and then select Others W...

Страница 39: ...us alarms are triggered by a device malfunction or a patient data distortion due to improper operation or system failure Technical alarm messages are displayed in the technical alarm area 3 Prompt mes...

Страница 40: ...larm occurs the alarm lamp will flash The color and flashing frequency match the alarm level as follows 4 3 2 Audible Alarms The equipment uses different alarm tone patterns to match the alarm level 4...

Страница 41: ...not be saved when the equipment is powered off You can also disable or enable Audio Off set the alarm volume by selecting Alarm Setup from the Configuration Main menu In this case the setting will be...

Страница 42: ...rm in the pop up menu WARNING Make sure that the alarm limits settings are appropriate for your patient before patient monitoring Setting the alarm limit to an extreme value may cause the alarm system...

Страница 43: ...10mmHg SYS 15 or 45mmHg whichever is greater SYS 0 86 38mmHg SYS 15 or 105mmHg whichever is lower Adult 45 to 270 Pediatric 45 to 185 Neonate 35 to 115 NIBP D Dia 0 68 6mmHg Dia 15 or 20mmHg whichever...

Страница 44: ...the Alarm Pause Time is set to Permanent The operating mode is switched to the Manual Defib mode Synchronized cardioversion is exited when operating in the Manual Defib mode The alarm off status is e...

Страница 45: ...ms Technical alarms give different alarm indicators after the Alarm Pause button or Alarm Reset soft key is pressed The technical alarms are classified into three categories for easy clarification Tec...

Страница 46: ...ng steps and take proper 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...

Страница 47: ...a pacemaker be sure to select correct paced status Otherwise the pace pulses may be counted in the case of cardiac arrest or some arrhythmias Do not completely rely on the heart rate reading or the he...

Страница 48: ...onductor of electricity To properly prepare the skin choose flat areas and then follow this procedure 1 Shave hair from skin at chosen sites 2 Gently rub skin surface at application sites to remove de...

Страница 49: ...V4 electrode positions V4 placement 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...

Страница 50: ...right torso lateral to the sternum and below the clavicle Place the blue apex pad to the patient s left nipple in the midaxillary line with the center of the electrode in the midaxillary line For ped...

Страница 51: ...l is displayed when the Paced is set to Yes The pace pulse markers are shown on the ECG wave when the patient has a paced signal To change the paced status choose either of the following ways Press th...

Страница 52: ...ard that is applied to your hospital 5 6 3 Selecting the Lead of Displayed ECG Waveform To compute heart rate and to detect and analyze arrhythmia more accurately you can choose a lead of best quality...

Страница 53: ...de pads filter mode is always Therapy and can not be changed To set the ECG filter mode 1 Rotate the Navigation knob to move the cursor on the ECG filter mode 2 Press the Navigation knob to highlight...

Страница 54: ...hmias It is not designed to detect supraventricular arrhythmias It may incorrectly identify the presence or absence of an arrhythmia Therefore a physician must analyze the arrhythmia information with...

Страница 55: ...he Configuration Main menu PVCs min PVCs min exceeds high limit Nonlethal arrhythmia PNP No pace pulse detected for 1 75 x average R to R intervals following a QRS complex for paced patients only PNC...

Страница 56: ...5 7 5 Initiating Arrhythmia Relearning Manually Normally arrhythmia relearning allows the equipment to learn new ECG patterns to correct arrhythmia alarms and heart rate value We suggest you manually...

Страница 57: ...alibration is completed select Stop Calibrating You can print out the waveform and wave scale and then measure the difference between them if necessary If the difference exceeds 5 contact your service...

Страница 58: ...rm Size 2 Perform skin preparation again and re place the electrodes For more information refer to 5 4 Preparing for ECG Monitoring and Measurement 3 Check electrode application sites Avoid bone or mu...

Страница 59: ...he bed or gurney during defibrillation Avoid contact between parts of the patient s body such as exposed skin of head or limbs conductive fluids such as gel blood or saline and metal objects such as a...

Страница 60: ...ompts Once an ECG is detected through the electrode pads the equipment automatically analyzes the patient s heart rhythm and warns you not to touch the patient If a shockable rhythm is detected the eq...

Страница 61: ...resistance between the electrode pads external paddles that the defibrillator must overcome to deliver an effective discharge of energy The degree of impedance differs from patient to patient and is a...

Страница 62: ...ppropriate time or switch it off by selecting AED Setup from the Configuration Main menu After the shock series ECG analysis pauses and the equipment enters the CPR status Analysis resumes at the comp...

Страница 63: ...information during AED therapy The sound recording function can be configured on or off To switch on or off the sounding recording 1 Switch the Mode Select knob to Monitor Manual Defib or Pacer 2 Pres...

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Страница 65: ...uch as gel blood or saline and metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current Do not allow electrode pads and paddles to touch each...

Страница 66: ...chest hair has been clipped If the message persists change the electrode pads and or the pads cable Alarms are switched off automatically and the Alarm Off message is displayed when the equipment ente...

Страница 67: ...5 4 4 ECG Measurement with External Paddles WARNING Hold only the insulating parts of the paddle handles to avoid shock hazard during charging or shock delivery Switch the Mode Select knob to Manual...

Страница 68: ...t 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 clearly and loudly Stay Clear If electrode pads...

Страница 69: ...remove them For details on the defibrillation procedures refer to 7 4 Manual Defibrillation Procedure 7 4 2 Using Internal Paddles To defibrillate using internal paddles 1 Switch the Mode Select knob...

Страница 70: ...esult Clean the internal paddles after each use 7 5 Synchronized Cardioversion Synchronized cardioversion allows you to synchronize delivery of the defibrillator shock with the R wave of the ECG You m...

Страница 71: ...rillation information area 6 Press the Energy Select button to select a desired energy level 7 Press the Charge button on the equipment if using external paddles the Charge button located on the handl...

Страница 72: ...ter the Manual Defib mode 3 Press the Enter Sync soft key 4 Select Remote to access remote synchronized cardioversion Then the message Remote Sync is presented 5 Confirm a square wave on the equipment...

Страница 73: ...tive Actions indicates the patient contact is good the impedance is suitable for the defibrillation illuminated in green indicates the patient contact is not good the impedance is slightly higher for...

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Страница 75: ...l time compression waveform CCI graph compression rate and compression depth Review CPR events Charge the CPR sensor configured with a battery Upload the latest one hour data from the CPR sensor For d...

Страница 76: ...waveform removing CPR artifact from the first ECG waveform Compared with viewing the first ECG waveform the filtered ECG is more obvious if you enable CPR filter When viewing the filtered ECG waveform...

Страница 77: ...ion depth scale Interruption time displays interruption time in seconds since the last compression When stopping CPR the compression waveform becomes a straight line The system starts timing the CPR i...

Страница 78: ...ruption time exceeds five minutes You should select Refresh to save a CPR event before disconnecting the CPR sensor from the equipment 8 2 5 Uploading CPR Data If you use the CPR sensor independently...

Страница 79: ...To avoid explosion hazard when pacing a patient who is receiving oxygen delivery properly route the oxygen delivery tube Do not keep it close to the electrode pads Monitoring ECG alone is sometimes no...

Страница 80: ...ixed mode pacing if noise or artifact interferes with proper sensing of R wave or when monitoring electrodes are not available During fixed mode pacing R wave markers do not appear on the paced beats...

Страница 81: ...f 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 Use the Navigation knob to adjust the pacer rate then press the Navigation kn...

Страница 82: ...e occurs capture is indicated by the appearance of a QRS complex after each pace marker and then decrease the output to the lowest level that still maintains capture 8 Verify the presence of a periphe...

Страница 83: ...rm when a pre adjusted time had elapsed since the last detected breath The safety and effectiveness of the respiration measurement method in the detection of apnea especially the apnea of prematurity...

Страница 84: ...caused by the rhythmic blood flow Correct electrodes placement can help to reduce cardiac overlay Avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes Th...

Страница 85: ...ttings Select Gain and then choose an appropriate setting The bigger the gain is the larger the wave amplitude is Select Sweep and then choose an appropriate setting The faster the wave sweeps the wid...

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Страница 87: ...al tester or SpO2 simulator can be used to determine the pulse rate accuracy 11 2 Adjusting Pulse Tone Volume When PR alarm is switched on the equipment gives out pulse tone To change the volume of pu...

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Страница 89: ...of undesirable changes in skin characteristics such as irritation reddening blistering or burns Inspect the sensor site every two hours and move the sensor if the skin quality changes Change the appl...

Страница 90: ...inaccurate or the device might read zero for the duration of the active irradiation period NOTE Additional information specific to the Masimo sensors compatible with the equipment including informati...

Страница 91: ...e measurement device on the same limb as the SpO2 sensor 12 5 SpO2 Display NOTE PI is only available for Masimo SpO2 1 Pleth waveform Pleth visual indication of patient s pulse The waveform is not nor...

Страница 92: ...the alarm sounds each time the limit is violated Such frequent alarm can be distracting The Sat Seconds feature is available with the Nellcor SpO2 module to decrease the likelihood of false alarms cau...

Страница 93: ...procedures or when clinician and patient contact is continuous such as in higher acuity settings CAUTION When using the Maximum Sensitivity setting performance of SpO2 Sensor Off detection may be com...

Страница 94: ...ss the Main Menu button on the front panel and then select Alarm Setup Para Alarm Select the SpO2 parameter area and then select Para Alarm 2 Set Desat NOTE In the case that the SpO2 low limit alarm v...

Страница 95: ...s relating to this device Problem Corrective Actions Do not see SpO2 parameter area or waveform area on the screen Check that the cable connections of SpO2 sensor and the extension cable are tight Rep...

Страница 96: ...ond those provided by 17 U S C 117 5 Use Restriction As the Purchaser you may physically transfer the products from one location to another provided that the software firmware is not copied You may no...

Страница 97: ...alent to those obtained by a trained observer using the cuff stethoscope auscultatory method or an intra arterial blood pressure measurement device within the limits prescribed by the American Nationa...

Страница 98: ...eripheries Obesity where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery 13 4 Measurement Modes There are three modes of measuring NIBP Manual measurement on de...

Страница 99: ...arm s length The inflatable part of the cuff should be long enough to encircle at least 50 to 80 of the limb 4 Apply the cuff to an upper arm or thigh of the patient and make sure the marking on the c...

Страница 100: ...Setting Initial Cuff Inflation Pressure You can set the initial cuff inflation pressure manually 1 Select the NIBP parameter area to enter the NIBP Setup menu 2 Select Initial Pressure and then select...

Страница 101: ...y sampling line from the patient s airway while nebulized medications are being delivered Leakage in the breathing or sampling system may cause the displayed EtCO2 values to be significantly low Alway...

Страница 102: ...he CO2 Module 1 Select an appropriate sampling line according to the patient category 2 Connect the sampling line to the CO2 adapter installed on the equipment 1 CO2 waveform 2 CO2 alarm limits 3 End...

Страница 103: ...ssary do not disconnect the CO2 adapter from the equipment after the first installation This reduces the risk of the CO2 adapter becoming lost or damaged When sample gas of 37 C sample flowrate of 50...

Страница 104: ...panel and then select Others Configuration enter the required password 2 Select CO2 Setup 3 Set Press Unit 14 6 3 Changing CO2 Wave Settings 1 Select the CO2 parameter area to enter the CO2 Setup men...

Страница 105: ...Select Others 3 Respectively select O2 Compen 0 to 100 N2O Compen 0 to 100 AA Compen 0 to 24 The sum of the three compensations should not be greater than 100 14 6 8 Setting Humidity Compensation The...

Страница 106: ...sonnel only once a year or when the readings go far beyond the range For details refer to the relevant service manual CAUTION Connect the gas outlet to the scavenging system when calibrating CO2 14 9...

Страница 107: ...cting Mark Event Setup from the Configuration Main menu Event A is always Generic and cannot be changed To mark an event 1 In the Monitor mode Manual Defib mode or Pacer mode press the Event button on...

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Страница 109: ...cting the Scroll button and then rotating the Navigation knob clockwise or counterclockwise to move the frozen waveforms right or left At the lower right corner of the bottommost waveform there is an...

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Страница 111: ...happened Select Record to print out the current event list Select Previous Menu to return to the previous menu Select Exit to return to the main screen Patient events will be saved as archived events...

Страница 112: ...r Monitor Operator s Manual 17 3 Reviewing CPR Events If CPR is delivered by using the equipment connected with the CPR sensor you can review CPR events on the equipment For details refer to 8 2 4 Rev...

Страница 113: ...he archived patient information when the information is incomplete or changed Archives ID and Patient Cat are unchangeable 1 Press the Main Menu button on the front panel and then select Others 2 Sele...

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Страница 115: ...triggered recordings Alarm recordings triggered by an alarm limit violation or an arrhythmia event Manually triggered task related recordings Frozen wave recording Tabular trends recording Event reco...

Страница 116: ...der Select Record from the current display At the completion of recording two columns of marks will be printed to indicate the end of recording 19 3 2 Automatic Recordings Automatic recordings will be...

Страница 117: ...rent moment 32 s record a waveform 16 seconds before and 16 seconds after the current moment STAT record a waveform from the current moment until stopped manually 19 5 3 Changing the Recording Speed 1...

Страница 118: ...1 Open the recorder door 2 Take out the paper and tear off the draped part 3 Reload the paper and close the recorder door 19 8 Cleaning the Recorder Print Head If the recorder has been used for a lon...

Страница 119: ...down list once successfully stored 1 Press the Main Menu button on the front panel and select Others Configuration enter the required password 2 Select Network Setup 3 Set Site Setup Select Site sele...

Страница 120: ...CMS the equipment can also be connected to Pre Hospital Emergency Information System PHEIS through 4G router For details refer to PHEIS Installation Guide 046 005990 00 20 4 Connecting the HL7 Server...

Страница 121: ...Defibrillator Monitor Operator s Manual 20 3 Send Alarms if set to On alarms will be automatically sent to the specified HL7 server 6 Select Return...

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Страница 123: ...e configuration management 21 2 Modifying Configuration Management Password The required password for entering the Configuration Main menu is set to 315666 You can also modify the configuration passwo...

Страница 124: ...required password 6 Select Config Import 21 6 Changing Configurations You can change configurations either by changing settings in each configuration setup menu or restoring to factory defaults 1 Swit...

Страница 125: ...or the confirmation when you access the Manual Defib mode and Pacer mode Password a dialog box pops up requiring the password when you access the Manual Defib mode and Pacer mode Set Password 4 digits...

Страница 126: ...lt patient Energy 2 Adu Energy 1 to 360J 300 J Energy 1 configurable value Energy 3 Energy 3 Adu Energy 2 to 360J 360 J Energy 2 configurable value Energy 1 Ped 10 J 15 J 20 J 30 J 50 J 70 J 100 J 50...

Страница 127: ...mA 2 mA 5 mA 5 mA Sets the step of paced pulses duration Default Pacer Mode Demand Mode Fixed Mode Demand Mode Sets the pacer mode when entering the Pacer mode Pacer Pulse 20 ms 40 ms 20 ms Sets the...

Страница 128: ...III aVL aVR aVF V ECG2 3 Lead I II III If 3 lead is used the default setting of this item is blank and this item is inactivate The options of ECG1 are not available for ECG2 5 Lead I II III aVL aVR a...

Страница 129: ...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 Extreme Tachy Adu 60 to 300 160 Ped 60 to 300 180 Extreme Brady Adu 15 to 120 35 Ped...

Страница 130: ...O2 Alarm On Off On SpO2 Alm Lev High Med Med Sweep 12 5 mm s 25 mm s 25 mm s Sets the SpO2 waveform speed SpO2 High Adu Low 1 to 100 100 Step 1 Ped 100 Neo 95 SpO2 Low Adu Desat Limit to High 1 90 Ped...

Страница 131: ...u Item Options Range Default Description Interval Manual 1 min 2 min 2 5 min 3 min 5 min 10 min 15 min 20 min 30 min 1 h 1 5 h 2 h 3 h 4 h 8 h Manual Sets the interval between NIBP measurements Press...

Страница 132: ...5 mm s Sets the CO2 waveform speed Scale mmHg 15 20 25 40 50 60 80 50 Different options are available to match the selected pressure unit kPa 2 2 5 3 5 5 7 8 10 7 2 2 5 3 5 5 7 8 10 7 EtCO2 High Adu L...

Страница 133: ...display the alarm limits ECGLeadOff Lev High Med Low Low Sets the alarm level for ECG Lead Off SpO2SensorOff Lev High Med Low Low Sets the alarm level for SpO2 Sensor Off No Battery Status Indicator O...

Страница 134: ...em Options Range Default Description Wave Length 8s 16s 32s STAT 8s Sets the recording time of recorded waveform Paper Speed 6 25 mm s 12 5 mm s 25mm s 50mm s 25mm s Sets the recording speed Energy De...

Страница 135: ...est if the recommended test time is reached Auto Test Time 24 h 00 to 23 12 h 12AM to 11PM 3 00 Sets the initiated time for auto test performed every day Menu Item Options Range Default Description Ne...

Страница 136: ...interval for sending data to the HL7 server Send Waveforms On Off Off Sets whether waveforms are automatically sent to the HL7 server HL7 Configuration Alarms Destination Site 0 to 63 characters Sets...

Страница 137: ...acity 40 but 20 of capacity 20 of capacity Low battery 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...

Страница 138: ...is case replace the battery with a fully charged on or connect the equipment to external power supply immediately If the battery is almost depleted a prompt Battery depleted System will shut down imme...

Страница 139: ...o check battery performance The operating time of the batteries reflects their performance directly If the operating time of a battery is noticeably shorter than that stated in the specifications the...

Страница 140: ...of damage the battery fails the battery aged alarm is presented or the batteries has been used for more than two years Properly dispose of batteries according to local regulations WARNING Do not disas...

Страница 141: ...ut all cleaning and disinfection procedure specified in this chapter 23 1 General Points Keep the equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules Al...

Страница 142: ...d and other cables and remove the batteries 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 dam...

Страница 143: ...th any of the equipment contact your service personnel or the manufacturer No modification of this equipment is allowed The service personnel must be properly qualified and thoroughly familiar with th...

Страница 144: ...ff the auto test is performed only when AC mains is connected Thoroughly clean the external paddles and properly place them in the paddle tray after each use The auto test passes only when external pa...

Страница 145: ...y check that external paddles and metal parts of the paddle tray are clean Install at least one battery and properly place the external paddles in the paddle tray or connect the pads cable and 50 test...

Страница 146: ...est is passed the delivered energy accuracy is displayed but it is for your reference only 24 3 2 3 Transmitting the User Test Summaries You can also send the user test summaries to the CMS 1 Press th...

Страница 147: ...played in the alarm information area 24 4 3 Manual Defibrillation Test Test tools defibrillator pacer analyzer Charge Discharge 1 Remove the batteries from the equipment and connect the equipment with...

Страница 148: ...l paddles on the defibrillator pacer analyzer 2 Connect the ECG cable to the equipment and place the ECG electrodes on the defibrillator pacer analyzer 3 Set the analyzer to Time Measurement Mode and...

Страница 149: ...e Monitor Manual Defib or Pacer mode Patient monitoring and therapy automatically end when you enter the installation mode 1 Press the Main Menu button on the front panel and then select Others Mainte...

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Страница 151: ...the end of its service life the equipment as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products to avoid contaminating the environm...

Страница 152: ...te 0010 30 42896 EL6307A Pediatric 0010 30 42898 Snap IEC EL6302B Adult pediatric 0010 30 42733 EL6308B Pediatric 0010 30 42901 AHA EL6301B Adult pediatric 0010 30 42734 EL6307B Pediatric 0010 30 4290...

Страница 153: ...12205 Single patient use 520A Adult 520A 30 64101 520P Pediatric 520P 30 64201 520I Infant 520I 30 64301 520N Neonate 520N 30 64401 Reusable DS 100A Adult 9000 10 05161 OXI P I Pediatric infant 9000...

Страница 154: ...le Type Model Applicable patient PN Disposable MAX A Adult 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 MAX N Neonate 3 kg adult 40 kg 0010 10 12...

Страница 155: ...iatric Disposable 0010 10 42560 FilterLine H Set Adult Pediatric Adult pediatric 0010 10 42561 FilterLine H SetInfant Neonatal Neonate 0010 10 42562 FilterLine Set Adult Pediatric Long Adult pediatric...

Страница 156: ...5 00 Conductive gel 15 25 Consumable 0000 10 10775 Internal paddles MR6501 Pediatric Reusable 1 inch 115 018366 00 MR6502 Adult pediatric Reusable 2 inches 115 018367 00 MR6503 Adult Reusable 3 inches...

Страница 157: ...0 Charger Station kit International BatteryFeed 20 115 009187 00 Charger Station kit US 115 009188 00 Charger Station kit Indian 115 009189 00 Charger Station kit EU 115 009190 00 Charger Station kit...

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Страница 159: ...nternal defibrillation and CPR sensor 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...

Страница 160: ...pedance 10 k Pulse width 5 ms Alarm output Alarm delay time from the equipment to other remote equipment The alarm delay time from the equipment to other remote equipment is 4 seconds measured at the...

Страница 161: ...ischarge delay 60ms from the peak of R wave Remote synchronized discharge delay 25ms from the rise edge of synchronous signal AED Shock series Energy level 100 to 360J configurable for adult 10 to 100...

Страница 162: ...46 140 134 128 122 15 170 J 166 170 166 159 151 145 138 15 200 J 195 200 195 187 178 170 163 15 300 J 292 300 292 280 267 255 244 15 360 J 351 360 350 336 321 306 293 15 Charge time Note at 20 5 C of...

Страница 163: ...4 Pacer mode Demand fixed Output waveform Monophasic square wave pulse pulse width 20 ms or 40 ms Accuracy 5 Pacing rate 30ppm to 210ppm Accuracy 1 5 Resolution 5 ppm Pacing output 0mA to 200mA Accur...

Страница 164: ...Width Rise time 2 to 700 mV 0 1 to 2 ms 10 to 100 s Pace pulse rejection When tested in accordance with the IEC 60601 2 27 201 12 1 101 13 the heart rate meter rejects all pulses meeting the following...

Страница 165: ...uirements in Clause 201 7 9 2 9 101 b 4 of IEC 60601 2 27 the heart rate after 20 seconds of stabilization is displayed as follows Ventricular bigeminy 3a 80 1 bpm Slow alternating ventricular bigemin...

Страница 166: ...screen is updated every second Response time to heart rate change Meets the requirements of IEC 60601 2 27 Clause 201 7 9 2 9 101 b 5 From 80 to 120 bpm From 80 to 40 bpm less than 11 s less than 11 s...

Страница 167: ...100 Accuracy 70 to 100 70 to 100 0 to 69 2 in adult pediatric mode 3 in neonate mode Not specified Refreshing rate 2 s Measurement accuracy verification The SpO2 accuracy has been verified in human e...

Страница 168: ...2 against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population 2 The Masimo pulse o...

Страница 169: ...min STAT mode cycle time 5 min Static pressure measurement range 0mmHg to 300mmHg Static pressure measurement accuracy 3mmHg Maximum measurement time Adult Pediatric Neonate 180s 90s Initial cuff infl...

Страница 170: ...f gas interference when CO2 measurements are performed between 0 40mmHg Inaccuracy specifications are affected by the breath rate and I E change The EtCO2 accuracy is within specification for breath r...

Страница 171: ...set to the factory default without recording Defibrillation 300 discharges 200J discharge the equipment is configured with a 5 lead ECG Resp SpO2 NIBP and CO2 WI Fi is disabled The screen brightness i...

Страница 172: ...tched alarms and unlatched alarms Alarm lamp Independent alarm LED Parameter alarm setting Alarm properties of all available parameters can be set simultaneously in the Para Alarm menu Auto alarm limi...

Страница 173: ...d by a single AP 4 Each equipment can communicate with the CMS The weakest AP signal strength detected at the equipment s position cannot be less than 65 dBm When the distance between interfering devi...

Страница 174: ...ondition 30 C to 70 C CO2 module Item Temperature Relative humidity Barometric Operating condition 5 C to 40 C 10 to 95 non condensing 430mmHg to 790 mmHg 57 3kPa to 105 3kPa Storage condition 20 C to...

Страница 175: ...second wave length Database for evaluation of Mindray shockable rhythm analysis algorithm includes MIT BIH The Massachusetts Institute of Technology Beth Israel Hospital Arrhythmia Database from Holte...

Страница 176: ...ation 1997 Vol 95 1677 1682 b Clause 201 7 9 3 103 Essential Performance data of the Rhythm Recognition Detector and clause 201 107 Requirements for Rhythm Recognition Detector International Electrote...

Страница 177: ...nts could result NOTE The equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Portable and mobile RF commun...

Страница 178: ...d be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines length greater than 3 m 2 kV for power supply lines 1 kV for input output lines l...

Страница 179: ...z 9 V m Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection fro...

Страница 180: ...recommended below according to the maximum output power of the communication equipment Rated Maximum Output power of Transmitter Watts W Separation Distance According to Frequency of Transmitter m 15...

Страница 181: ...he external paddles are used a Connect the equipment with AC power supply and the AC power indicator is illuminated b Connect the paddles cable to the equipment and place the external paddles in the p...

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Страница 183: ...low means the alarm level is user adjustable XX represents a measurement or parameter label such as ECG NIBP HR PVCs RR SpO2 PR etc In the Cause and solution column corresponding solutions are given...

Страница 184: ...nd solution Measurement Alarm Message L I Cause and solution XX XX SelfTest Err H C An error occurred to the XX module or there is a problem with the communications between the module and the main uni...

Страница 185: ...r service personnel NIBP NIBP Loose Cuff L A The NIBP cuff is not properly connected or there is a leak in the airway NIBP Air Leak L A NIBP Pneumatic Leak L A Check the NIBP cuff and pump for leakage...

Страница 186: ...control system No Speaker L C Make sure that the speaker is connected Power Board Comm Err H C An error occurred to the power board or there is a problem with the communications between the power boar...

Страница 187: ...pacing function fails Restart the equipment and test pacer function If the problem persists contact your service personnel Disarming Failed H C There is a problem with the therapy module disarming ci...

Страница 188: ...r s Manual NOTE In the L column S refers to special technological alarm The special technological alarms cannot be paused or silenced and the alarm volume is unchangeable These alarms stops only when...

Страница 189: ...al current loads F 1 Power Cord Plug F 2 Device Enclosure and Accessories F 2 1 Visual Inspection F 2 2 Contextual Inspection Test Item Acceptance Criteria The power plug The power plug pins No broken...

Страница 190: ...tion reverse polarity Normal Condition normal polarity with open neutral Single Fault Condition reverse polarity with open neutral Single Fault Condition LIMITS For UL60601 1 300 A in Normal Condition...

Страница 191: ...8 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected Applied Part connector and the remaining Applied Part connector s All measurements may have a true RMS only re...

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Страница 193: ...r minute bps bit per second 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...

Страница 194: ...t VA volt ampere ohm W watt negative minus percent per divide or plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright AaDO2 alveolar art...

Страница 195: ...rdiac index C O cardiac output CaO2 arterial oxygen content CCO continuous cardiac output CCU cardiac coronary care unit CE Conformit Europ enne CIS clinical information system CISPR International Spe...

Страница 196: ...n of inspired carbon oxygen FiN2O fraction of inspired nitrous oxide FiO2 fraction of inspired oxygen FPGA field programmable gate array FV flow volume Hal halothane Hb hemoglobin Hb CO carbon mono xi...

Страница 197: ...ressure MDD Medical Device Directive MetHb methemoglobin MRI magnetic resonance imaging MVe expiratory minute volume MVi inspiratory minute volume N A not applied Neo neonate NIBP noninvasive blood pr...

Страница 198: ...ing Resp respiration RHb reduced hemoglobin RL right leg RM respiratory mechanics RR respiration rate RSBI rapid shallow breathing index SaO2 arterial oxygen saturation SEF spectral edge frequency Sev...

Страница 199: ...al oral temperature Trect rectal temperature TVe expiratory tidal volume TVi inspiratory tidal volume UAP umbilical arterial pressure UPS uninterruptible power supply USB universal serial bus UVP umbi...

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Страница 201: ...erform better service 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...

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Страница 203: ...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...

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Страница 205: ...Defibrillator Monitor Operator s Manual I 1 I Declaration of Conformity...

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