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BeneVision N1 Patient Monitor Operator’s Manual

23 - 1

23

Accessories

The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the
patient monitor. The accessory material that contacts the patients has undertaken the bio-compatibility test and
is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use
provided with the accessory.

WARNING

•

Use accessories specified in this chapter. Using other accessories may cause damage to the monitor
or not meet the claimed specifications.

•

Single use accessories are not designed to be reused. Reuse may cause a risk of contamination and
affect the measurement accuracy.

CAUTION

•

The accessories may not meet the performance specifications if stored or used outside the specified
temperature and humidity ranges. If accessory performance is degraded due to aging or
environmental conditions, contact your service personnel.

•

Check the accessories and their packages for any sign of damage. Do not use them if any damage is
detected.

•

Use the accessories before the expiry date if their expiry date is indicated.

•

The disposable accessories shall be disposed of according to hospital's regulations.

23.1

ECG Accessories

23.1.1

ECG Electrodes

23.1.2

12-Pin Trunk Cables

Model

Part No.

Description

Usage

Applicable patient

31499224

0010-10-12304

Electrode, Kendall, 10 pcs/package

Disposable

Adult

2245-50

9000-10-07469

ECG electrode, 3M, 50 pcs/package

Disposable

Pediatric

1050NPSMKittycat

0681-00-0098-01

NEO pre-wired electrode radio
Opaque

Disposable

Neonate

1051NPSMKittycat

0681-00-0098-02

NEO pre-wired electrode radio
Transluent

Disposable

Neonate

Model

Part No.

Description

Usage

Applicable patient

EV6201

0010-30-42719

12Pin 3/5-Lead ECG trunk cable,
defibrillation-proof

Reusable

Adult/Pediatric

EV6202

0010-30-42720

12Pin 3-Lead ECG trunk cable,
defibrillation-proof

Reusable

Pediatric/Neonate

EV6203

0010-30-42721

12Pin 12-Lead trunk cable,
defibrillation-proof

Reusable

Adult/Pediatric

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Summary of Contents for BeneVision N1

Page 1: ...BeneVision N1 Patient Monitor Operator s Manual...

Page 2: ...zhen Mindray Bio Medical Electronics Co Ltd All rights reserved Release time June 2019 Revision 7 0 WARNING Federal Law USA restricts this device to sale by or on the order of a physician or other pra...

Page 3: ...k owned by Mindray in China and other countries All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them They are the propert...

Page 4: ...sed 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 da...

Page 5: ...ral 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 e...

Page 6: ...ar Rack 2 7 2 7 2 Removing the N1 or External Parameter Module from the Modular Rack 2 7 2 7 3 Installing the Modular Rack to the Dock 2 8 2 7 4 Removing the Modular Rack from the Dock 2 8 2 7 5 Insta...

Page 7: ...13 3 8 2 Setting the Date and Time 3 13 3 8 3 Enabling Auto Daylight Saving Time 3 13 3 8 4 Setting the Unit 3 14 3 8 5 Adjusting the Screen Brightness 3 14 3 8 6 Adjusting the Key Volume 3 14 3 9 Sta...

Page 8: ...r Information 4 3 4 3 8 Setting Monitor Location 4 4 4 3 9 Setting Patient Location 4 4 4 3 10 Hiding Patient Name 4 4 4 4 Transferring Patient Data 4 4 4 5 Setting the Dock 4 5 4 5 1 Setting the Work...

Page 9: ...2 Alarm Safety Information 7 1 7 3 Understanding the Alarms 7 1 7 3 1 Alarm Categories 7 1 7 3 2 Alarm Priorities 7 2 7 3 3 Alarm Indicators 7 2 7 3 4 Alarm Status Symbols 7 3 7 4 Accessing On screen...

Page 10: ...n an Alarm Occurs 7 15 8 Monitoring ECG Arrhythmia ST and QT 8 1 8 1 ECG Introduction 8 1 8 2 ECG Safety Information 8 1 8 3 ECG Display 8 2 8 4 Preparing for ECG Monitoring 8 2 8 4 1 Preparing the Pa...

Page 11: ...ronization Pulse Output 8 24 8 13 ECG Troubleshooting 8 24 9 Resting 12 Lead ECG Analysis 9 1 9 1 Resting 12 Lead ECG Analysis Introduction 9 1 9 2 Entering the 12 Lead Screen 9 1 9 3 Initiating Resti...

Page 12: ...ng FastSAT for Masimo SpO2 11 5 11 6 6 Displaying SIQ for Masimo SpO2 11 6 11 6 7 Changing the Sensitivity 11 6 11 6 8 Monitoring SpO2 and NIBP Simultaneously 11 6 11 6 9 Changing the Sweep Speed of t...

Page 13: ...NIBP Accuracy Test 13 6 13 11 NIBP Troubleshooting 13 6 14 Monitoring Invasive Blood Pressure IBP 14 1 14 1 IBP Introduction 14 1 14 2 IBP Safety Information 14 1 14 3 Preparing for IBP Monitoring 14...

Page 14: ...2 Alarm Settings 15 8 15 7 2 Changing the CO2 Unit 15 8 15 7 3 Setting the CO2 Waveform 15 8 15 7 4 Setting the RR Source 15 8 15 7 5 Entering the Standby Mode 15 8 15 7 6 Entering the Intubation Mode...

Page 15: ...re EWS 17 1 17 1 1 Displaying the EWS Numerics Area 17 1 17 1 2 Accessing the EWS Screen 17 2 17 1 3 Performing EWS Scoring 17 3 17 1 4 Changing EWS Settings 17 4 17 2 Glasgow Coma Scale GCS 17 5 17 2...

Page 16: ...and Formulas for Renal Calculations 18 7 19 Printing 19 1 19 1 Printer 19 1 19 2 Setting the Printer 19 1 19 3 Setting Patient Information on the Reports 19 1 19 3 1 Setting Patient Information on EC...

Page 17: ...leaning 21 3 22 Maintenance 22 1 22 1 Maintenance Introduction 22 1 22 2 Maintenance Safety Information 22 1 22 3 Maintenance and Testing Schedule 22 2 22 4 Checking Version Information 22 2 22 5 Test...

Page 18: ...EDs A 4 A 7 1 Main Unit A 4 A 7 2 Dock A 4 A 7 3 Transport Dock A 4 A 7 4 AC Adapter A 5 A 8 Audio Indicator A 5 A 9 Monitor Interface Specifications A 5 A 9 1 Interface Specifications of the Main Uni...

Page 19: ...D 1 Physiological Alarm Messages D 1 D 1 1 General Physiological Alarm Messages D 1 D 1 2 Arrhythmia Alarm Messages D 1 D 1 3 Resp Physiological Alarm Messages D 2 D 1 4 SpO2 Physiological Alarm Messa...

Page 20: ...Resistance E 2 E 5 Earth Leakage Test E 2 E 6 Patient Leakage Current E 3 E 7 Mains on Applied Part Leakage E 3 E 8 Patient Auxiliary Current E 4 F SpO2 Sensor Accuracy F 1 F 1 The Accuracy of Mindray...

Page 21: ...correct working order and operating condition To avoid risk of electric shock the equipment must only be connected to mains power with protective earth If a protective earth conductor is not provided...

Page 22: ...rce Dry the equipment immediately in case of rain or water spray Some settings are password protected and can only be changed by authorized personnel Contact your department manager or biomedical engi...

Page 23: ...ngress of foreign objects no less than 12 5 mm and against access to hazardous parts with finger protected against harmful effects of vertically falling water drops with the device tilted at any angle...

Page 24: ...in accordance to your country s requirements Authorised representative in the European Community The product bears CE mark indicating its conformity with the provisions of the Council Directive 93 42...

Page 25: ...lso provides an interpretation of resting 12 lead ECG All the parameters can be monitored on single adult pediatric and neonatal patients except for the following PAWP is intended for adult and pediat...

Page 26: ...adjusts screen brightens according to the strength of ambient light 3 Display 4 Battery LED 5 External power LED On when external power supply is connected Off when external power supply is not connec...

Page 27: ...CG cable connector 5 SpO2 sensor connector 6 NIBP cuff connector 7 Multifunctional connector outputting analog and defib synchronization signal 8 IBP cable connector 9 Temperature probe connector 1 2...

Page 28: ...ase button pressing this button releases the Modular Rack from the Dock 2 Multi pin connector connects the Modular Rack and Dock 3 2 1 1 Multi pin connector connects the Modular Rack and N1 2 Infrared...

Page 29: ...and angle that Dock can rotate when Dock is fixed onto a transverse or a vertical rod 1 2 3 1 Multi pin connector power input and communication connector of the N1 2 Connection status LED it is on whe...

Page 30: ...ector 2 Equipotential grounding terminal when using the monitor together with other devices connect their equipotential grounding terminals together to eliminate the potential difference between them...

Page 31: ...ular Rack if you cannot pull it out NOTE To prevent N1 or the external module from falling off after insert N1 or the external module into the Modular Rack always check that N1 or the external module...

Page 32: ...ing the Modular Rack from the Dock To remove the Modular Rack from the Dock follow this procedure 1 Press and hold down the release button at the top of the Modular Rack 2 Pull the Modular Rack out as...

Page 33: ...When the N1 is connected to the BeneVision N series monitor or BeneView T series monitor the N1 works as the parameter module while BeneVision N series monitor or BeneView T series monitor works as t...

Page 34: ...m falling off catch it with another hand while pulling it out from the module rack NOTE There is no module rack for the BeneVision N22 or BeneVision N19 monitor The N1 can be connected to the BeneVisi...

Page 35: ...Indication for Use PN H 046 011365 00 WARNING The monitor must only be connected to mains power with protective earth and the connection should be performed by qualified service personnel Ensure that...

Page 36: ...hat the proposed combination will not negatively affect the devices themselves or the patient s safety If the accuracy of any value displayed on the monitor central station or printed on a report is q...

Page 37: ...itor can be powered by AC power supply when it is connected to the AC adapter or Dock Before connecting the equipment to the AC mains check that the voltage and frequency ratings of the power line are...

Page 38: ...gnals are presented correctly when the equipment is powered on Do not use the patient monitor for any monitoring procedure on a patient if you suspect it is not working properly or if it is mechanical...

Page 39: ...nector on the Dock NOTE You can use the Mindray custom barcode reader to scan both the 2D and 1D barcodes Using other barcode readers can only output the patient s medical record number MRN and visit...

Page 40: ...fying the Barcode Reader for the non Mindray Custom 2D Barcode Reader When you are using barcode readers other than HS 1R or HS 1M you should select the barcode reader from the USB device list so that...

Page 41: ...al alarm information area displays physiological alarm message 6 System status information area displays alarm symbol battery status network status currently connected CMS and system time For more inf...

Page 42: ...m off status Audible alarm tones are paused Audible alarm tones are turned off Alarms are acknowledged and the alarm system is reset The battery works correctly The green portion represents the remain...

Page 43: ...ff Symbol Label Function Symbol Label Function Alarm Reset Acknowledges the ongoing alarms Screen Setup Enters the Screen Setup menu Alarm Pause Pauses the current alarms Print Starts printing a real...

Page 44: ...surement Stop All Stops all NIBP measurements Zero IBP Starts IBP zero calibration PAWP Enters the PAWP screen Venipuncture Opens the Venipuncture window ECG Lead Gain Enters the ECG Lead Gain menu Re...

Page 45: ...r connection of the N1 and the host monitor see section 2 8N1 in Use with the Host Monitor The N1 monitor has the following features when it enters the module mode The patient information parameter se...

Page 46: ...alarm occurs 3 7 3 2 Exiting the Privacy Mode The monitor automatically exit the privacy mode in any of the following situations The monitor disconnects from the CMS The low battery alarm occurs You...

Page 47: ...brightness to the dimmest after entering the standby mode for 30 seconds WARNING Pay attention to the potential risk of placing the monitor to standby In the standby mode the monitor stops all paramet...

Page 48: ...uage 3 8 2 Setting the Date and Time To set the system time follow this procedure 1 Select the Main Menu quick key from the System column select Time 2 Set Date and Time 3 Set Date Format 4 If you wan...

Page 49: ...volume follow this procedure 1 Select the Main Menu quick key from the Display column select Display 2 Set the Key Volume 3 9 Starting Monitoring a Patient After turning on your monitor follow this p...

Page 50: ...cessing Parameter Setup Menus Each parameter has a setup menu in which you can adjust the alarm and parameter settings You can enter a parameter setup menu by using any of the following methods Select...

Page 51: ...key select the Tile Layout tab Select the Main Menu quick key from the Display column select Tile Layout 2 Click the parameter area where you want to display the timer and then select a timer from th...

Page 52: ...ck and the external display using the VGA cable 2 Connect the Dock and the external display using the USB cable accompanying the external display 3 Connect the external display to the AC mains and tur...

Page 53: ...f the OxyCRG screen Problem Corrective Actions Image offset Adjust the external display by using the auto adjust function or adjust the external display manually No image or the image displays abnorma...

Page 54: ...diting ABD Events To edit ABD events follow this procedure 1 Select the Mark button to enter the Mark dialog box 2 Drag the event list upwards and downwards to select the desired event 3 Select the pa...

Page 55: ...column select Maintenance input the required password select 2 Select the Patient Management tab select the Discharge tab 3 Select a time for Auto Discharge When Power Off The monitor will automatica...

Page 56: ...the following methods to enter the Patient Management menu Select the patient information area at the top left corner of the screen Select the Main Menu quick key from the Patient Management column se...

Page 57: ...atient s monitoring data is not changed and the patient is not discharged 4 3 5 Selecting Query Criteria for Searching Patients in ADT Server You can define which criteria can be used to search patien...

Page 58: ...ut the required password select 2 Select the Patient Management tab 3 Select the Display tab 4 Set the following switches as desired Switch off Primary Screen Display Full Name does not display patien...

Page 59: ...orization Setup page from the Maintenance menu Host Mode the patient location settings facility department room number and bed number printer settings and authorization settings are from the Dock You...

Page 60: ...tab 4 Set the Work Mode to Host Mode 5 Select the IP tab and set Network Type to WLAN 6 Select how to get the IP address of wireless network Obtain IP Address Automatically the monitor automatically...

Page 61: ...data and alarms Patient information alarm settings and alarm status can be synchronized between the monitor and the CMS You can start or stop NIBP measurements from the CMS In case of network disconne...

Page 62: ...default configurations provided for your monitor are department oriented You can choose either from General OR ICU NICU CCU Each department has three different sets of configurations tailored for adu...

Page 63: ...rent Settings 3 Input the configuration name 4 Select OK to save current settings as a user configuration 5 5 Deleting a Configuration To delete a configuration follow this procedure 1 Select the Main...

Page 64: ...herefore the monitor allows you to load a desired configuration to ensure that all the settings are appropriate for your patient To load a configuration follow this procedure 1 Select the Main Menu qu...

Page 65: ...t in network disconnection Contact your service personnel if you have any problems on setting the IP address 6 3 Connecting the Monitor to the CMS To connect the monitor to the CMS follow this procedu...

Page 66: ...the hospital servers via HL7 protocol To do so follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required password select 2 Select the Network...

Page 67: ...e View 6 7 1 2 About the Remote View The following figure shows the Remote View window 1 2 1 Alarm watch area Display all the monitored remote beds Each bed displays the room number bed number connect...

Page 68: ...icon in the alarm watch tile if the tile is configured to display on the main screen 2 In the Select Bed window select a bed at the A W1 or A W2 area and then select Clear Bed If you want remove all...

Page 69: ...n the Remote View For more information see 6 7 1 2 About the Remote View 6 7 2 2 Displaying the Alarm Watch Tile on the Main Screen To configure the alarm watch tile to be displayed on the monitor s m...

Page 70: ...ng the Wireless Network To disconnect the wireless network manually follow this procedure 1 Swipe the screen from top down with a single finger 2 Select To reconnect the wireless network after it is d...

Page 71: ...vel For Others to set the service quality of network connection for non realtime monitoring for example history data printing and as on 6 8 7 Selecting Data Encryption Type To set data encryption type...

Page 72: ...follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required password select 2 Select the Authorization Setup tab 3 From the Maintenance area se...

Page 73: ...iod If you use the password saved in the MLDAP server to access the Maintenance menu alarm settings and arrhythmia settings you can set the password timeout period If the timeout period is reached you...

Page 74: ...2 high alarm limit to 100 which is equivalent to switching the alarm off When the alarm sound is switched off the monitor gives no alarm tones even if a new alarm occurs Be careful about whether to sw...

Page 75: ...rea the monitor only displays the messages of the highest priority alarm When multiple alarms of the same priority levels occur simultaneously and should be displayed in the same area all the alarm me...

Page 76: ...ect the physiological alarm information area to enter the Alarms window 2 Select the Physiological Alarms tab 7 6 Changing Alarm Settings From the Alarm column of the main menu select desired buttons...

Page 77: ...onitor is connected to the CMS and Minimum AlarmVolume is set to 0 Minimum Alarm Volume automatically changes to 2 if the CMS is disconnected 7 6 2 3 Setting the Audible Alarm Tone Pattern You can dis...

Page 78: ...larm volume automatically increases by two levels 1 Step if an alarm is not reset within the designated delay time after the alarm occurs the alarm volume automatically increases by one level Off if a...

Page 79: ...8 Mean 15 or 35 whichever is greater Mean 0 86 35 Mean 15 or 95 whichever is smaller Adult 30 to 230 Pediatric 30 to 165 Neonate 25 to105 Temp T1 C T1 0 5 T1 0 5 T1 0 5 T1 0 5 1 to 49 T2 C T2 0 5 T2 0...

Page 80: ...Maintenance input the required password select 2 Select the Alarm tab Other tab 3 Set ST Alarm Delay IBP CVP LAP RAP UVP P1 P4 Venous pressure IBP M Mean 0 75 Mean 0 75 Mean 1 25 Mean 1 25 3 to 40 CO2...

Page 81: ...m Setup quick key select the Setup tab Select the Main Menu quick key from the Alarm column select Setup 2 Select the Setup tab 3 Set Printing Duration On Alarm 7 6 7 Setting the Switch of the CMS and...

Page 82: ...off Enable you can switch off the zero RR alarm For more information see 10 5 1 Setting the Resp Alarm Properties WARNING If you switch off the zero RR alarm the monitor will not issue the zero RR ala...

Page 83: ...ause 10 min or Pause 15 min NOTE Prolonging alarm pause time does not affect the setting of alarm pause time You can not prolong the pause time if the Pause Time is set to Permanent 7 7 2 3 Selecting...

Page 84: ...enters the alarm tone paused status For more information see 7 7 2 2 Prolonging the Alarm Pause Time NOTE Prolonging alarm pause time does not affect the setting of alarm tone pause time 7 7 3 3 Setti...

Page 85: ...alarms are switched off but the alarm lamp remains flashing Off When Reset when the alarm system is reset both the alarm tone and alarm lamp of the current alarms are switched off 7 9 Latching Alarms...

Page 86: ...To exit the CPB mode select the Main Menu quick key from the Alarm column select Exit CPB Mode 7 11 Intubation Mode Intubation mode is available for Resp and CO2 monitoring When performing intubation...

Page 87: ...des the same alarm tone pattern for the remote device alarms as those for your monitor alarms by default You can change the alarm tone pattern of the remote monitor see 37 3 4 5Setting the Tone Patter...

Page 88: ...12 6 Switching Off the Remote Device Disconnection Alarm The monitor can provide an alarm if remote devices are disconnected By default the function is enabled To disable the alarm follow this procedu...

Page 89: ...oof ECG cables during defibrillation Do not touch the patient or metal devices connected to the patient during defibrillation To reduce the hazard of burns during high frequency surgical procedure ens...

Page 90: ...odes To connect ECG cables follow this procedure 1 Check that electrode packages are intact and the electrodes are not past the expiry date Make sure the electrode gel is moist If you are using snap e...

Page 91: ...nt is illustrated using the AHA naming convention 8 4 4 1 3 leadwire Electrode Placement The following is an electrode configuration when a 3 leadwire cable is used RA placement directly below the cla...

Page 92: ...ectrode Placement The chest electrode can be placed at the following positions V1 placement on the fourth intercostal space at the right sternal border V2 placement on the fourth intercostal space at...

Page 93: ...ctrosurgical units ESU the ECG electrodes should not be located between the surgical site and the ESU return electrode Never entangle the ESU cable and the ECG cable together When using ESU never plac...

Page 94: ...diatric and neonatal patients For non paced patients you must set Paced to No 8 4 7 Enabling Pacer Rejection The pace pulse rejection function is disabled by default To enable this function follow thi...

Page 95: ...highest signal to noise ratio Selecting the optimal leads is important for detecting beats classifying beats and detecting ventricular fibrillation 8 5 3 2 Changing ECG Waveform Size If the ECG wavefo...

Page 96: ...the ECG numeric area or waveform area to enter the ECG menu 2 Select the Setup tab 3 Switch on or off Notch Filter NOTE The notch filter can only be switched on or off when ECG Filter is set to Diagno...

Page 97: ...ct the ECG numeric area or waveform area to enter the ECG menu 2 Select the Setup tab and set Filter to Monitor 3 Select the QRS Threshold tab 4 Select up or down arrow buttons to adjust the minimum t...

Page 98: ...er of consecutive PVCs is greater than or equal to the V Tach PVCs limit and the ventricular rate is greater than or equal to the V Tach rate limit Vent Brady The number of consecutive PVCs is greater...

Page 99: ...pulse for paced patients only Pacer not Pacing No pace pulse detected for 1 75 x average R to R intervals following a QRS complex for paced patients only Missed Beats At least 3 consecutive Ns and Th...

Page 100: ...rhythmia alarms the monitor will not alarm for any arrhythmia event This may result in a hazard to the patient Always keep the patient under close surveillance NOTE If any of the lethal arrhythmia ala...

Page 101: ...Brady PVCs and V Brady Rate to set the threshold of desired PVC related alarms The following figure illustrates the conditions under which PVC alarms will be generated if V Tach PVCs is set to 6 V Tac...

Page 102: ...ains and 8 6 5 2 Setting Arrhythmia Alarm Timeout Period 8 6 5 1 Arrhythmia Alarm Chains If multiple alarms overlap announcing all of the detected alarm conditions would be confusing and a more seriou...

Page 103: ...thm has been tested for accuracy The significance of ST segment changes needs to be determined by a physician This monitor provides ST deviation level change information The clinical significance of t...

Page 104: ...es the ST numeric area does not display A ST value displays in the ECG numeric area When you are using the 5 lead ECG leadwires the ST numeric area displays 7 ST values ST I ST II ST III ST aVR ST aVL...

Page 105: ...rom the bottom of the menu select ST View 8 7 6 Saving the Current ST as Baseline ST deviation is a typically monitored as a relative change from a baseline value Set an ST baseline when ST values bec...

Page 106: ...es the baseline ST value and the green bar cyan yellow or red if an alarm occurs indicates ST 8 8 Changing ST Settings 8 8 1 Setting ST Alarm Properties To set ST alarm properties follow this procedur...

Page 107: ...eform area to enter the ECG menu 2 Select the ST tab select the Setup tab 3 Switch on Show Markers 8 8 1 4 Changing the ST Unit The unit of ST measurements can be millivolt mV or millimeter mm To chan...

Page 108: ...selected the ST point will be positioned 80 ms heart rate 120 bpm or less or 60 ms heart rate more than 120 bpm from the J point 8 9 QT QTc Interval Monitoring The QT interval is defined as the time...

Page 109: ...creen Setup quick key select the Tile Layout tab Select Main Menu quick key from the Display column select Tile Layout 2 Click the parameter numeric area where you want to display the QT numerics and...

Page 110: ...o set the current values as baseline follow this procedure 1 From the QT View window select Set Baseline 2 From the pop up dialog box select OK This baseline will then be used to calculate QTc If you...

Page 111: ...ythmias 8 10 1 Auto ECG Relearning Auto arrhythmia relearning happens in the following situation The ECG lead type or lead label is changed ECG leads are off and are not reconnected within 60 seconds...

Page 112: ...r you have taken corrective actions contact your service personnel Problem Corrective Actions Do not see ECG numeric area or waveform area on the main screen 1 Check that ECG is set to display in the...

Page 113: ...des 3 Check electrode application sites Avoid bone or muscular area 4 Check that electrodes are not dry or used for a prolonged time Replace with fresh and moist electrodes if necessary No ECG Wavefor...

Page 114: ...creen select ECG 12 Lead Select Main Menu quick key from the Display column select Choose Screen select ECG 12 Lead 9 3 Initiating Resting 12 Lead ECG Analysis Before 12 lead ECG interpretation check...

Page 115: ...sgow algorithm the sequence of the chest leads depends on the setting of V3 placement If V3 placement is set to V4R the sequence of chest leads is V4R V1 V2 V4 V5 V6 9 5 Glasgow Resting 12 lead ECG An...

Page 116: ...ow Algorithms To set the 12 lead interpretation report follow this procedure 1 On the ECG 12 Lead screen select Setup to enter the 12 Lead Setup menu 2 Select the Report tab 3 Set the format and items...

Page 117: ...e The respiration measurement does not recognize the cause of zero respiration rate It only indicates an alarm if no breath is detected when a pre adjusted time has elapsed since the last detected bre...

Page 118: ...ure to prepare the patient 1 Shave hair from skin at chosen sites 2 Gently rub skin surface at sites to remove dead skin cells 3 Thoroughly cleanse the site with a mild soap and water solution 4 Dry t...

Page 119: ...he point of maximum abdominal expansion to optimize the respiratory wave In clinical applications some patients especially neonates expand their chests laterally causing a negative intrathoracic press...

Page 120: ...e priority of RR source is first CO2 and then RM and finally ECG When the current RR source does not have valid measurement the system automatically switches the RR Source to Auto 10 5 3 Choosing the...

Page 121: ...false indication of a high respiration or an undetected zero respiration rate condition If you suspect that cardiac overlay is being registered as breathing activity raise the detection level above t...

Page 122: ...trend toward patient deoxygenation is indicated analyze the blood samples with a laboratory co oximeter to completely understand the patient s condition Do not use SpO2 sensors during magnetic resona...

Page 123: ...t including information about parameter measurement performance during motion and low perfusion may be found in the sensor s directions for use DFU Masimo cables and sensors are provided with X Cal te...

Page 124: ...and plug the cable into the SpO2 connector 6 Connect the sensor to the extension cable CAUTION Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulat...

Page 125: ...uent alarms can be distracting Nellcor s Sat Seconds alarm management technique is used to reduce these nuisance alarms The Sat Seconds feature is available with the Nellcor SpO2 to decrease the likel...

Page 126: ...n against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement Maximum Sensitivity is recommended for use...

Page 127: ...et the averaging time follow this procedure 1 Select the SpO2 numeric area or waveform area to enter the SpO2 menu 2 Select the SpO2 Setup tab 3 Set Averaging for Masimo SpO2 module and Sensitivity fo...

Page 128: ...s effective the monitor also adjusts the QRS tone pitch tone according to the SpO2 value For information see11 6 11 Setting the SpO2 Tone Mode 11 7 3 Setting the PR Source Current pulse source is disp...

Page 129: ...see 3 11 2 Displaying Parameter Numerics and Waveforms 2 Check that if the SpO2 parameter switch is enabled If not enable the SpO2 measurement For more information see 3 11 1 Switching On or Off a Pa...

Page 130: ...7 a for Masimo patents http www masimo com patents htm No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized senso...

Page 131: ...creen Setup quick key select the Tile Layout tab Select the Main Menu quick key from the Display column select Tile Layout 2 Select a parameter numeric area or waveform area and then from the popup li...

Page 132: ...lect the Setup tab 3 Switch on T 12 6 Temperature Troubleshooting This section lists the problems that might occur If you encounter the problems when using the equipment or accessories check the table...

Page 133: ...rement Do not apply the higher adult settings for pediatric or neonatal patients Otherwise it may present a safety hazard Do not measure NIBP on patients with sickle cell disease or on the limb where...

Page 134: ...e and continuous patient movement such as shivering or convulsions With cardiac arrhythmias With rapid blood pressure changes With severe shock or hypothermia that reduces blood flow to the peripherie...

Page 135: ...mb directly over the patient s skin as follows a Determine the patient s limb circumference b Select an appropriate cuff by referring to the limb circumference marked on the cuff The width of the cuff...

Page 136: ...Select the Alarm tab 3 Enter the password if required For more information refer to 6 9 3 Selecting Password for User Authentication 4 Set alarm properties as desired 13 8 2 Setting the Initial Cuff...

Page 137: ...t will be taken at 14 23 and then at 14 43 15 03 and so on 13 8 5 Enabling the NIBP End Tone The monitor can issue a reminder tone at the completion of NIBP measurement The NIBP End Tone is off by def...

Page 138: ...the bottom of the menu 4 Puncture vein and draw blood sample 5 Select the NIBP Start Stop quick key to deflate the cuff If you do not deflate the cuff the cuff automatically deflates after a period o...

Page 139: ...disposable pressure transducers Make sure that the applied parts never contact other conductive parts To reduce the hazard of burns during high frequency surgical procedure ensure that the monitor s c...

Page 140: ...more information see 14 6 2 Changing the Pressure Label 5 Zero the IBP transducer For more information see 14 3 3 Zeroing the IBP transducer After a successful zeroing turn off the stopcock to the ai...

Page 141: ...use To zero the ICP transducer follow this procedure 1 Connect the ICP transducer the ICP adapter cable and the monitor 2 Follow the manufacturer s instructions to prepare the ICP transducer 3 Zero t...

Page 142: ...terial pressure the IBP numeric area displays systolic pressure diastolic pressure and mean pressure For venous pressure the IBP numeric area displays only the mean pressure The figure below shows the...

Page 143: ...and the higher the sensitivity Contrarily the longer the averaging time is the slower the monitor responds to changes in the patient s blood pressure the lower the sensitivity but the measurement acc...

Page 144: ...by a physician According to recent scientific literature the clinical relevance of PPV information is restricted to sedated patients receiving controlled mechanical ventilation and mainly free from ca...

Page 145: ...PAWP only available for the independent external display Pulmonary Artery Wedge Pressure PAWP values used to assess cardiac function are affected by fluid status myocardial contractility and valve an...

Page 146: ...ro the IBP transducer For more information see 14 3 3 Zeroing the IBP transducer 4 Set the IBP label to PA since the PAWP is measured on PA For more information see 14 6 2 Changing the Pressure Label...

Page 147: ...for the minimum time necessary to get an accurate measurement If the PAWP is greater than the PA systolic deflate the balloon and report the incident in accordance with hospital policy Because the pul...

Page 148: ...t if the IBP parameter switch is enabled If not enable the IBP measurement For more information see 3 11 1 Switching On or Off a Parameter 3 Check the connection of IBP cable IBP transducer and module...

Page 149: ...m CO2 measurement Take a sample of the respiratory gas with a constant sample flow from the patient s airway and analyzes it with a remote CO2 sensor built into the Sidestream or Microstream CO2 modul...

Page 150: ...ure that a patient is properly connected when monitoring with the CO2 module 15 3 CO2 Measurement Limitations The following factors may influence the measurement accuracy Leaks or internal venting of...

Page 151: ...e 15 5 1 Preparing to Measure CO2 Using Sidestream CO2 Module To prepare the sidestream CO2 measurement follow this procedure 1 Select the appropriate gas sample line and watertrap according to the pa...

Page 152: ...pling line 3 Connect the other end of the gas sample line to the patient For intubated patients requiring an airway adapter install the airway adapter between the patient circuit and the ventilator Y...

Page 153: ...ement may cause inaccurate CO2 reading or no reading To avoid blocking the airway empty the DRYLINE II watertrap container whenever half full Replacing the DRYLINE II watertrap once a month is recomme...

Page 154: ...monitor displays CO2 Sensor Warmup CO2 can be measured after the start up is complete CAUTION Connect the gas outlet to the scavenging system when measuring CO2 using the microstream CO2 module NOTE...

Page 155: ...position to avoid collection of fluids in the windows of the adapter Large concentrations of fluids at this point will obstruct gas analysis To avoid dead space place the sensor as close to the patien...

Page 156: ...b 3 Enter the password if required For more information refer to 6 9 3Selecting Password for User Authentication 4 Set alarm properties as desired 15 7 2 Changing the CO2 Unit To change the CO2 unit f...

Page 157: ...e auto standby follow this procedure 1 Select the CO2 numeric area or waveform area to enter the CO2 menu 2 Select the Setup tab 3 Set Auto Standby 15 8 2 Setting Humidity Compensation Sidestream and...

Page 158: ...the CO2 menu 2 Select the Setup tab 3 Set Speed and O2 Scale of the O2 waveform 15 10 Setting the Gas Compensation The presence of interfering gas affects the CO2 measurement To get the best possible...

Page 159: ...Both sidestream and microstream CO2 modules have the function of automatic barometric pressure compensation the system automatically measures the barometric pressure to which the patient monitor is e...

Page 160: ...d Used to Determine the Respiration Rate Measuring Range To determine the RR measurement range follow this procedure 1 Connect the 5 CO2 N2 BAL gas cylinder reduction valve rhythm generator and gas sa...

Page 161: ...6 997 880 6 437 316 7 488 229 7 726 954 and their foreign equivalents Additional patent applications pending No Implied License Possession or purchase of this device does not convey any express or im...

Page 162: ...age contains tabs to display trend data in tabular graphic or other forms 16 2 1 Accessing the Review Page To enter the review page select the Main Menu quick key from the Review column select the des...

Page 163: ...length of no trend data cannot be moved within this time length Different color blocks at the time line indicate events of different types See the color definition for the event type indicator 5 Event...

Page 164: ...d data Short interval is especially suited for neonatal applications where the clinical situation may change very quickly In adult monitoring where the patient s status typically changes more graduall...

Page 165: ...ata You can view the recent four hour data 8 hrs 12 hrs 24 hrs 48 hrs the screen displays eight hours 12 hours 24 hours or 48 hours of trend data You can view the recent 120 hours of data 16 2 6 4 Cha...

Page 166: ...re the filter follow this procedure 1 Enter the Events page 2 Select Event List 3 Select Filter Setup and set the desired filter criterion 16 2 7 3 Editing Events To edit events follow this procedure...

Page 167: ...stored in the monitor 4 Select the Display Maximum 3 tab and set the desired waveforms to be displayed on the Full Disclosure page NOTE The more waveforms selected in the Storage column the shorter t...

Page 168: ...eview quick key select the OxyCRG tab Select the Main Menu quick key from the Review column select OxyCRG 16 2 9 2 The Display of the OxyCRG Review Page The following figure shows the OxyCRG screen 16...

Page 169: ...12 Lead ECG Analysis Select the Main Menu quick key from the Review column select 12 Lead ECG 16 2 10 2 Switching to Median Complex for Glasgow Algorithm Only The median complex template displays 12 l...

Page 170: ...pe right across the Minitrends screen with a finger 16 3 3 Setting Parameters To set parameters follow this procedure 1 Enter the minitrends screen 2 Select the minitrends area to enter the Minitrend...

Page 171: ...associated level of risk When the total score is outside of the thresholds actions are recommended Both MEWS NEWS and NEWS2 can give total scores Custom Score is based on user defined parameters MEWS...

Page 172: ...ter the EWS screen Swipe left or right across the touchscreen with two fingers until you switch to the EWS screen Swipe right across the touchscreen with a single finger Select the button Take NEWS2 a...

Page 173: ...me 3 Parameter area display the subscore and parameter value of each parameter The keyboard symbol indicates that the parameter value is manually entered 4 History total scores 5 Selecting this button...

Page 174: ...etting the Scoring Confirmation Switch To select if confirmation is required before saving score follow this procedure 1 From the EWS page select Setup 2 Set Scoring Confirmation switch Off the monito...

Page 175: ...f Coma and Impaired Consciousness A Practical Scale Three aspects of behavior are independently measured eye opening verbal response and motor response The scores are added together to indicate that p...

Page 176: ...ocedure 1 From the Eye Opening area Verbal Response area and Motor Response area respectively select an item that represents the patient s status 2 Select OK to accept the total score The following ta...

Page 177: ...teria and then guides you through the recommended treatment protocol CAUTION SepsisSight is not a diagnostic or therapeutic tool and is not intended to replace the competent judgment of a clinician Se...

Page 178: ...A To clear the score select Reset NOTE The keyboard symbol indicates that the parameter value is manually entered The question mark in the score circle indicates that more parameter values are require...

Page 179: ...Values and waveforms of physiological parameters CPR Dashboard You can output the rescue report The rescue mode is intended for adult and pediatric patients WARNING The rescue mode is not intended for...

Page 180: ...is procedure 1 Connect the N1 and Dock 2 Connect the USB drive to the Dock s USB connector 3 Select Export 17 4 2 5 Customizing Drugs and Treatments Besides sodium bicarbonate vasopressin and atropine...

Page 181: ...ck that the entered values are correct and the calculated values are appropriate We assume no responsibility for any consequences caused by wrong entries and improper operations 18 3 Drug Calculations...

Page 182: ...so that you can display the infusion rate more accurately 18 3 3 Drug Calculation Formula 18 3 4 Titration Table Calculation Formula Description Unit Formula Dose Dose hr Dose min Dose Infusion Rate...

Page 183: ...elect Range to show the normal range of each parameter 18 4 2 Input Parameters for Hemodynamic Calculations NOTE If you enable Use PA D as PAWP PA D value will be used to replace PAWP value for hemody...

Page 184: ...l be automatically converted and updated accordingly Select Range to show the normal range of each parameter systemic vascular resistance index SVRI DS m2 cm5 SVRI DS m2 cm5 SVR DS cm5 BSA m2 pulmonar...

Page 185: ...n C a v O2 ml L C O L min arterial oxygen content CaO2 ml L ml dL CaO2 ml L 10 0 0134 Hb g dl SaO2 0 031 PaO2 mmHg venous oxygen content CvO2 ml L ml dL CvO2 ml L 10 0 0134 Hb g dl SvO2 0 031 PvO2 mmH...

Page 186: ...n the Ventilation page you can also perform the following operations Select Pressure Unit Then corresponding parameter values will be automatically converted and updated accordingly Select Range to sh...

Page 187: ...arrow You can select Range to show the normal range of each parameter 18 7 2 Calculated Parameters and Formulas for Renal Calculations 18 7 3 Calculated Parameters and Formulas for Renal Calculations...

Page 188: ...e ml 24 hrs Cr mol L BSA m2 1 73 1440 fractional excretion of sodium FENa FENa 100 URNa mmol L Cr mol L SerNa mmol L Ucr mol L osmolar clearance Cosm ml min Cosm ml min Uosm mOsm kgH2O Urine ml 24 hrs...

Page 189: ...ht of the printer IP address input box Enter an IP of a printer that is located in the same LAN with the monitor 4 Select Paper Size 5 Select Resolution After finishing configurations you can select P...

Page 190: ...eport 19 5 Manually Starting a Printing Task You can start a printing task manually 19 5 1 Starting Printing from the Current Page From the current page select the button if available to start printin...

Page 191: ...orms to avoid overlapping Off each waveform area has the same sizeon a printout Note This setting is only relevant when 12 1 is selected for 12 Lead Format 12 Lead Format Select the format of 12 lead...

Page 192: ...umn select Maintenance input the required password select 2 Select the Print tab Other tab 3 Enable or disable Second Mark Printer 19 9 Viewing Printer Statuses You can view the status of the most rec...

Page 193: ...tatus The printing statuses are printing failed retrying and waiting 19 10 Printer Out of Paper When the printer runs out of paper the print request will not be responded If there are too many print j...

Page 194: ...a hard surface whether damage is externally visible or not remove the battery from use and dispose of it properly If the battery shows signs of damage or signs of leakage replace it immediately Use ca...

Page 195: ...icates the battery status as follows indicates that the battery works correctly The green portion represents the remaining charge indicates that the battery power is low and needs to be charged indica...

Page 196: ...or not the monitor is currently turned on 20 6 Maintaining the Battery 20 6 1 Conditioning the Battery The performance of the battery deteriorates over time You should condition the battery every two...

Page 197: ...ttery in a cool place with a partial charge of 40 to 60 capacity Condition the stored battery every three months For more information see 20 6 1 Conditioning the Battery NOTE Remove the battery from t...

Page 198: ...procedures specified in this chapter CAUTION Avoid placing the device on surfaces with visible liquid spills Never immerse any part of the equipment or accessories in liquids or allow liquid to enter...

Page 199: ...Unlock quick key until the Lock quick key appears Avoid pouring the liquid on the monitor while cleaning the monitor Do not allow water or cleaning solution to enter the measurement connectors Wipe ar...

Page 200: ...nstructions are delivered with the accessory the instructions given in this chapter for cleaning disinfecting and sterilizing the monitor are applicable 21 8 Impact of Improper Cleaning Using cleaning...

Page 201: ...ailure and possible health hazards could result Do not open batteries heat batteries to above 60 C incinerate batteries or short the battery terminals Batteries may ignite explode leak or heat up caus...

Page 202: ...erformed by Mindray qualified service personnel only Regular check including visual inspection and power on test Printer tests Battery check If your monitor needs a safety test and performance test co...

Page 203: ...est The monitor automatically performs a selftest at startup Check the following items for the power on test The equipment powers on properly The alarm system works properly The monitor displays prope...

Page 204: ...ental conditions contact your service personnel Check the accessories and their packages for any sign of damage Do not use them if any damage is detected Use the accessories before the expiry date if...

Page 205: ...dset snap Reusable Adult Pediatric EL6311B 040 000146 00 3 Lead leadset AHA snap Disposable Pediatric Neonate EL6311A 040 000148 00 3 Lead leadset AHA clip Disposable Pediatric Neonate EY6316B 009 004...

Page 206: ...Reusable Adult Pediatric EY6601A 009 004798 00 6 Lead NewTelemetry AHA pinch 24 Reusable Adult Pediatric EY6602A 009 004799 00 6 Lead NewTelemetry AHA pinch 36 Reusable Adult Pediatric Model Part No...

Page 207: ...N 1864 Reusable Pediatric 10 50 kg LNCS YI 0010 10 43016 SpO2 sensor multisite Masimo P N 2258 Reusable Adult Pediatric Neonate LNCS NeoPt L 0010 10 42626 SpO2 sensor Disposable Neonate 1 kg LNCS Neo...

Page 208: ...or finger band Reusable Pediatric Infant OXI A N 9000 10 07336 SpO2 sensor finger foot band Reusable Adult Neonate MAX AI 0010 10 12202 SpO2 sensor 24 pcs box Disposable Adult 30 kg MAX PI 0010 10 122...

Page 209: ...le Adult CM1204 0010 30 12160 Cuff 33 47 cm Reusable Adult CM1205 0010 30 12161 Cuff 46 66 cm Reusable Adult thigh CM1301 115 027713 00 Cuff 10 19 cm bladerless Reusable Infant CM1302 115 027714 00 Cu...

Page 210: ...le IM2201 001C 30 70759 12 Pin IBP cable ICU Medical Reusable 42584 0010 10 42638 IBP transducer ICU Medical Disposable 42602 M90 000133 Mounting background and accessory for IBP transducer ICU Medica...

Page 211: ...00142 00 DRYLINETM PRIME nasal gas sampling line Disposable Adult 100 000143 00 100 000143 00 DRYLINETM PRIME nasal gas sampling line Disposable Pediatric 100 000144 00 100 000144 00 DRYLINETM PRIME n...

Page 212: ...Reusable Model Part No Description Usage Applicable patient Model Part No Description Usage Applicable patient 6063 0010 10 42662 Airway adapter Disposable Adult pediatric 6421 0010 10 42663 Airway a...

Page 213: ...ed against harmful effects of vertically falling water drops with the device tilted at any angle up to 15 Degree of safety of application in the presence of flammable anesthetic mixture with air or wi...

Page 214: ...modules are the same as those of the main unit Components Item Operating Condition Storage Condition Main Unit Transport Dock AC Adapter Temperature C 0 to 40 30 to 70 Relative humidity noncondensing...

Page 215: ...0 Hz 3 Hz 1 0A to 0 6A Output 12VDC 10 2 5A Dock Input voltage 100 to 240VAC 10 Input current 0 65A to 0 35A Frequency 50 60Hz 3Hz Transport Dock Input 100 to 240 VAC 15 10 50 60 Hz 3 Hz 1 0A to 0 6A...

Page 216: ...90 when the monitor is off no more than 5 hours to 90 when the monitor is on N1 main unit Screen type Color TFT LCD Screen Size diagonal 5 5 inches Resolution 1280 x 720 pixels Pixel per inch PPI 269...

Page 217: ...and multi level tone modulation alarm tones comply with IEC 60601 1 8 DC power input connector 1 Multifunctional connector 1 Multi pin connector 1 Communication interface 4 Infrared filter 1 Contact...

Page 218: ...um of 10 mA output current Low level 0 5 V receiving a maximum of 5 mA input current Pulse width 100 ms 10 maximum rising and falling time 1 ms Video Output Video signals VGA signal Alarm output Alarm...

Page 219: ...l electrical systems intended for use in the emergency medical services environment RTCA DO 160G Environmental Conditions and Test Procedures for Airborne Equipment Section 7 Operational Shocks and Cr...

Page 220: ...one monitor can transmit history data The weakest strength of the AP signal where the monitor is located cannot be less than 65 dBm Protocol IEEE 802 11a b g n Modulation mode DSSS and OFDM Operating...

Page 221: ...or and the AP is no less than to 50 meters A 14 Measurement Specifications The adjustable range of alarm limits is the same with the measurement range of signals unless otherwise specified A 14 1 ECG...

Page 222: ...ions are labeled with a PACE marker Amplitude Width Rise time No overshoot 2 mV to 700 mV 0 1 ms to 2 ms 10 s to 100 s less than 10 of pulse width Pace pulse rejection When tested in accordance with t...

Page 223: ...ed on Clause 201 12 1 101 17 of IEC 60601 2 27 2011 the heart rate calculation is not affected for QRS of 1 mV amplitude and 100 ms duration T wave duration of 180 ms and amplitude lower than 1 2 mV a...

Page 224: ...ns are lead I II and Auto Respiration excitation waveform 300 A RMS 62 8 kHz 10 Minimum respiration impedance threshold 0 3 Baseline impedance range 200 to 2500 using an ECG cable with 1k resistance B...

Page 225: ...dden changes from 70 to 100 Accuracy 70 to 100 2 adult pediatric 70 to 100 3 neonate 0 to 69 Not specified One percent was added to the accuracies for neonatal sensors to account for accuracy variatio...

Page 226: ...of the population One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin The Masimo pulse oximeter with sensors has been v...

Page 227: ...to 250 bpm Accuracy 20 to 250 bpm 3 bpm 251 to 300 bpm not specified Refreshing rate 1 s Measurement range 25 to 240 bpm Resolution 1 bpm Response time 20 s normal perfusion no disturbance PR value su...

Page 228: ...Meet standard of IEC 80601 2 30 2013 Technique Oscillometry Mode of operation Manual Auto STAT Sequence Auto mode repetition intervals 1 2 2 5 3 5 10 15 20 30 60 90 120 180 240 or 480 min STAT mode cy...

Page 229: ...tep mmHg NIBP S High Adult low limit 5 to 265 Pediatric low limit 5 to 195 Neonate low limit 5 to 130 NIBP 50 1 NIBP 50 5 NIBP S Low Adult 41 to high limit 5 Pediatric 41 to high limit 5 Neonate 40 to...

Page 230: ...IBP 50 1 IBP 50 5 Mean High Dia High Sys Low IBP 50 49 to high limit 2 IBP 50 50 to high limit 5 Mean Low Dia Low Art S Extreme High High limit 5 to 360 IBP 50 1 IBP 50 5 Art M Extreme High Art D Ext...

Page 231: ...n specification for breath rate 60 rpm and I E ratio 1 1 or breath rate 30 rpm and I E ratio 2 1 CO2 resolution 1 mmHg O2 measurement range 0 to 100 O2 absolute accuracy 0 O2 concentration 25 25 O2 co...

Page 232: ...and a 2 5 meter adult sampling line 5 0 s 120 ml min Rise time For CO2 measurements using external CO2 module without O2 sensor Measured with a DRYLINE II neonatal watertrap and a 2 5 meter neonatal...

Page 233: ...ift Meet the requirement for measurement accuracy within 6 hours Accuracy applies for respiration rate up to 80 rpm For respiration rate above 80 rpm and EtCO2 exceeding 18 mmHg the accuracy is 4 mmHg...

Page 234: ...mmHg 71 to 100 mmHg 101 to 150 mmHg 2 mmHg 5 of the reading 8 of the reading 10 of the reading Accuracy drift Meet the requirement for measurement accuracy within 6 hours Resolution 1 mmHg Rise time...

Page 235: ...be disrupted by the operation of nearby equipment NOTE The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided belo...

Page 236: ...is used in such an environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15kV air 8 kV contact 15kV...

Page 237: ...s W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveyb shoul...

Page 238: ...ion Distances between Portable and Mobile RF Communications Equipment and This Equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are contro...

Page 239: ...y Mindray may cause harmful radio frequency interference and void your authority to operate this equipment The maximum antenna gain permitted complies with the e i r p limits as stated in RSS 210 The...

Page 240: ...100 bpm Priority Med Alarm Outputs Off Alarm Source Auto ECG1 II ECG2 5 lead 6 lead 12 lead V Va V1 Va for 6 lead only Va Vb for 6 lead only Vb ECG Gain 1 Speed 25 mm sec Filter OR Surgery CCU Diagno...

Page 241: ...On Other departments Off Med Off Run PVCs Off Low Off Couplet Off Prompt Off Multiform PVC Off Med Off PVC Off Prompt Off Bigeminy CCU On Other departments Off Med Off Trigeminy CCU On Other departmen...

Page 242: ...2 0 sec 2 0 sec 2 0 sec AF Irr Rhy End Time 2 min 2 min 2 min V Tach Rate 130 bpm 130 bpm 160 bpm V Brady Rate 40 bpm 40 bpm 40 bpm V Tach PVCs 6 6 6 V Brady PVCs 5 5 5 Item Default Setting ST Alarm M...

Page 243: ...ty Med Alarm Outputs Off QTc Alarm switch Off High limit 60 Priority Med Alarm Outputs Off QT Analysis Off QT Lead All Item Default Setting Filter 35 Hz Baseline Drift Removal On Tachy 100 Brady 50 Wa...

Page 244: ...ediatric Auto Neonate II Gain 2 Speed 6 25 mm s Auto Threshold Detection On Item Default Setting Item Default Setting SpO2 Alarm switch On High limit Adult 100 Pediatric 100 Neonate 95 Low limit 90 Pr...

Page 245: ...tputs Off Alarm Source Auto PR Source Auto QRS Volume General OR 2 Other departments 0 Item Default Setting Item Default Setting T1 T2 Alarm switch On High limit 38 0 C Low limit 35 0 C Priority Med A...

Page 246: ...Outputs Off NIBP S Extreme Alarm switch Off High limit Adult 175 mmHg Pediatric 130 mmHg Neonate 95 mmHg Low limit Adult 75 mmHg Pediatric 60 mmHg Neonate 35 mmHg Priority High Alarm Outputs Off NIBP...

Page 247: ...enipuncture Pressure Auto Item Default Setting Item Default Setting IBP S Alarm switch On High limit Art pArt Ao UAP BAP FAP LV P1 P4 arterial pressure Adult 160 mmHg Pediatric 120 mmHg Neonate 90 mmH...

Page 248: ...ty Med Alarm Outputs Off IBP M Alarm switch On High limit Art pArt Ao UAP BAP FAP LV P1 P4 arterial pressure Adult 110 mmHg Pediatric 90 mmHg Neonate 70 mmHg PA Adult 20 mmHg Pediatric and neonate 26...

Page 249: ...Adult 35mmHg Pediatric 30 mmHg Neonate 15 mmHg Priority High Alarm Outputs Off Art M Extreme Alarm switch Off High limit Adult 125 mmHg Pediatric 100 mmHg Neonate 75 mmHg Low limit Adult 55 mmHg Pedi...

Page 250: ...Speed 12 5 mm sec PA Scale mmHg 0 30 Overlapping Waveform Setup Left Scale mmHg 0 160 Right Scale mmHg 0 20 CVP Scale mmHg 0 20 ICP Scale mmHg 0 20 PA Scale mmHg 0 30 Speed 25 mm sec Gridlines Off Ite...

Page 251: ...h On High limit 88 Low limit 18 Priority Med Alarm Outputs Off FiO2 Alarm switch On High limit Adult and pediatric 100 Neonate 90 Low limit 18 Priority Med Alarm Outputs Off BTPS Compensation Off O2 C...

Page 252: ...Settings Balance Gas Room Air AG Compensation 0 Operating Mode Measure Item Default Setting Item Default Setting Alarm Volume 2 High Alarm Volume Alarm Volume 2 Reminder Volume 2 Zero RR Delay Adult...

Page 253: ...ages Default priority Cause and solution XX High High Med configurable XX value has risen above the high alarm limit or fallen below the low alarm limit Check the patient s condition and check if the...

Page 254: ...the patient s condition and check if the alarm limit settings are correct Alarm message Default priority Cause and solution No Pulse High The pulse signal was so weak that the monitor cannot perform p...

Page 255: ...atient s condition the ventilated O2 content and the airway connection Alarm message Default priority Indication on alarm reset Cause and solution XX Module Error High C XX module does not work proper...

Page 256: ...extension cable Check the SpO2 cable and the sensor connection If the alarm persists replace the sensor SpO2 Excess Light Low C Ambient light is too strong Move the sensor to a place with lower level...

Page 257: ...le measurement range Check the patient s condition NIBP Excessive Motion Low A Check the patient s condition and reduce patient motion NIBP Cuff Overpressure Low A The NIBP airway may be occluded Chec...

Page 258: ...persists the CO2 module may fail contact your service personnel CO2 Zero Failed Low C For mainstream CO2 module check the connections between the adapter and CO2 transducer Wait till the sensor s tem...

Page 259: ...is connected CO2 Change Watertrap Low C Replace the watertrap CO2 Watertrap and Patient Mismatch Low C Check the patient category and use a correct watertrap Alarm message Default priority Indication...

Page 260: ...priority Indication on alarm reset Cause and solution No CMS Low B The monitor is disconnected from the CMS Check the network connection View Bed XX YY ZZ Network Disconnected Low A The network is int...

Page 261: ...d the Dock 2 If the alarm persists contact your service personnel XX Conflicts XX refers to the module label Prompt The same type of corresponding module being used exceeds the supported number Remove...

Page 262: ...two years The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding as well as total current loads E 1 Power Cord Plug E 2 Device E...

Page 263: ...n Earth Leakage test on the device being tested before performing any other leakage tests The following outlet conditions apply when performing the Earth Leakage test normal polarity Normal Condition...

Page 264: ...rth Single Fault Condition 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...

Page 265: ...Condition reverse polarity Normal Condition normal polarity with open neutral Single Fault Condition reverse polarity with open neutral Single Fault Condition normal polarity with open earth Single Fa...

Page 266: ...1 1488 80 90 1 5224 70 80 1 7336 520P 70 100 1 2520 90 100 1 0370 80 90 1 1660 70 80 1 5222 520N 70 100 1 4023 90 100 1 3253 80 90 1 2187 70 80 1 7246 512H 70 100 1 3518 90 100 1 2644 80 90 1 2367 70...

Page 267: ...90 100 1 2487 80 90 1 6938 70 80 2 4207 512FLH 90 100 1 4192 80 90 1 5238 70 80 2 3300 Sensor Measurement range Accuracy SaO2 Matching results of SpO2 measured by the EUT with 520A SpO2 sensor and the...

Page 268: ...r The Linear Matching Graph of 520N SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 520P SpO2 sensor and the reference equipment SaO2 Matching results of SpO2 measured by the EUT wi...

Page 269: ...r The Linear Matching Graph of 512E SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512H SpO2 sensor and the reference equipment SaO2 Matching results of SpO2 measured by the EUT wi...

Page 270: ...r The Linear Matching Graph of 512G SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 512F SpO2 sensor and the reference equipment SaO2 Matching results of SpO2 measured by the EUT wi...

Page 271: ...or The Linear Matching Graph of 512FLH SpO2 Sensor SaO2 Matching results of SpO2 measured by the EUT with 518B SpO2 sensor and the reference equipment SaO2 Matching results of SpO2 measured by the EUT...

Page 272: ...he Accuracy of Masimo SpO2 Sensors Table information for the plots below show ARMS values measured with Masimo Set Oximetry Technology in a clinical study Adtx Pdtx 4000 4001 Inf Neo NeoPt 4002 4003 4...

Page 273: ...F 8 DCI DCIP 4050 4051 LNCS YI 4053...

Page 274: ...Motion SaO2 vs SpO2 SaO2 Sensor Motion of Data Points ARMS SpO2 Acceptance Criteria 70 100 Pass Fail MAX A MAX P No 976 1 54 2 0 Pass MAX I MAX N No 723 1 41 2 0 Pass DS 100A No 411 2 16 3 0 Pass D YS...

Page 275: ...I MAX N Sensors No Motion SaO2 vs SpO2 SaO2 Modified Bland Altman for SpO2 DS 100A Sensor No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 2 SaO2 3 Upper 95 LoA 4 Mean Bias 5 Lower 95 LoA 1 SpO2 SaO2 2 SaO2 3...

Page 276: ...F 11 Modified Bland Altman for SpO2 D YS OXI A N OXI P I Sensors No Motion SaO2 vs SpO2 SaO2 1 SpO2 SaO2 2 SaO2 3 Upper 95 LoA 4 Mean Bias 5 Lower 95 LoA...

Page 277: ...pere hour bpm beat per 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 k kilo kg...

Page 278: ...millisecond mV millivolt mW milliwatt M megaohm nm nanometer rpm breaths per minute s second V volt VA volt ampere ohm W watt Abbreviation In Full Symbol Explanation minus negative percent per divide...

Page 279: ...BL baseline BT blood temperature BTPS body temperature and pressure saturated CAA Clinical Assistive Application CaO2 arterial oxygen content CCI continuous cardiac index CCO continuous cardiac outpu...

Page 280: ...raph EMI electromagnetic interference Enf enflurane ESU electrosurgical unit Et end tidal EtAA end tidal anesthetic agent EtDes end tidal anesthetic agent EtEnf EtHal EtIso EtSev EtCO2 end tidal carbo...

Page 281: ...spital information system HR heart rate IBP invasive blood pressure IBW ideal body weight ICG impedance cardiography ICP intracranial pressure ICT B intracranial catheter tip pressure transducer ICU i...

Page 282: ...te volume MVO2 O2 minute consumption N A not applied N2 nitrogen N2O nitrous oxide Neo neonate NEWS National Early Warning Score NIBP noninvasive blood pressure NIF negative inspiratory force O2 oxyge...

Page 283: ...istance Rec record recording Resp respiration RL right leg RM respiratory mechanics RQ respiratory quotient RR respiration rate RSBI rapid shallow breathing index SaO2 arterial oxygen saturation ScvO2...

Page 284: ...erature difference Temp temperature TFT thin film technology TI injectate temperature TRC tube resistance compensation UAP umbilical arterial pressure UPS uninterruptible power supply USB universal se...

Page 285: ...digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses...

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