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4

Company Contact

Notification of Adverse Events

As a health care provider, you may report the occurrence of certain events to SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent
authority of the Member state in which the user and / or patient is established.

These events, include device-related death and serious injury or illness. In addition, as
part of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD. requests to be notified of device failures or malfunctions. This
information is required to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS
CO., LTD. provides only the highest quality products.

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address

Mindray Building, Keji 12th Road South, High-tech Industrial Park,
Nanshan, Shenzhen 518057, P.R.China

Website

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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Summary of Contents for VS 8A

Page 1: ...VS 9 VS 9A VS 9C VS 8 VS 8A VS 8C Vital Signs Monitor Operator s Manual ...

Page 2: ......

Page 3: ...1 Copyright 2020 2021 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights reserved Release time 2021 04 Revision 4 0 ...

Page 4: ...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 changes without prior notice All information contained in this manual is believed to be correct Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing pe...

Page 5: ...of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel This warranty shall not extend to Malfunction or damage caused 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 damage c...

Page 6: ...ICAL ELECTRONICS CO LTD requests to be notified of device failures or malfunctions This information is required to ensure that SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD provides only the highest quality products Manufacturer Shenzhen Mindray Bio Medical Electronics Co Ltd Address Mindray Building Keji 12th Road South High tech Industrial Park Nanshan Shenzhen 518057 P R China Website www min...

Page 7: ... to your product If you have any question please contact 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 clinical professionals who are expected to have a working knowledge of medical procedures practices and terminology as required for monitoring of cri...

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Page 9: ...2 6 2 7 5 Rear View VS 9 Series 2 7 2 7 6 Rear View VS 8 Series 2 8 3 Getting Started 3 1 3 1 Equipment Preparation Safety Information 3 1 3 2 Unpacking and Checking 3 2 3 3 Environmental Requirements 3 2 3 4 Setting Up the Equipment 3 3 3 4 1 Installing a Battery 3 3 3 4 2 Connecting the AC Mains 3 4 3 4 3 Connecting a Barcode Reader 3 5 3 4 4 Connecting a Digital Scale 3 5 3 5 Turning on the Mon...

Page 10: ... 4 1 4 1 Admitting a Patient 4 1 4 1 1 Automatically Admitting a Patient 4 1 4 1 2 Manually Admitting a Patient 4 1 4 2 Managing Patient Information 4 2 4 2 1 Entering the Patient Management Menu 4 2 4 2 2 Editing Patient Information 4 2 4 3 Discharging a Patient 4 2 4 3 1 Manually Discharging a Patient 4 3 4 3 2 Auto Discharging a Patient after Monitor Power Off 4 3 4 3 3 Changing Patient Managem...

Page 11: ...Tone Properties 7 5 7 6 3 Setting the Alarm Delay Time 7 6 7 6 4 Setting the Apnea Delay Time 7 6 7 6 5 Restoring the Default Alarm Settings 7 6 7 6 6 Setting the CMS and eGateway Disconnection Alarm 7 7 7 6 7 Setting the Switch of the SpO2 Desat Alarm Off 7 7 7 6 8 Setting the Switch of the Apnea Alarm Off 7 7 7 7 Pausing Alarms Pausing Alarm Tones 7 7 7 7 1 Defining the Pause Function 7 7 7 7 2 ...

Page 12: ...rmation 8 14 9 Monitoring PR 9 1 9 1 PR Introduction 9 1 9 2 PR Display 9 1 9 3 Changing the PR Settings 9 1 9 3 1 Changing the PR Alarm Settings 9 1 9 3 2 Changing the Pulse Volume 9 2 9 3 3 Enabling Irregular PR 9 2 10 Measuring Temperature Temp 10 1 10 1 Temp Introduction 10 1 10 2 Temp Display 10 1 10 3 Monitoring Temp with SmarTemp Module 10 2 10 3 1 Measuring Temp 10 3 10 3 2 Disinfecting Te...

Page 13: ... 8 11 7 4 Performing Sequence Measurement 11 8 11 8 Changing NIBP Settings 11 9 11 8 1 Setting the NIBP Alarm Properties 11 9 11 8 2 Setting the NIBP Interval 11 9 11 8 3 Enabling the NIBP End Tone 11 9 11 8 4 Setting NIBP Sequence 11 9 11 8 5 Setting the NIBP Display Format 11 10 11 8 6 Setting the NIBP Alarm Limits Display Switch 11 10 11 8 7 Selecting NIBP Measurement Algorithm 11 10 11 8 8 Set...

Page 14: ... Resp Safety Information 13 1 13 2 RR Display 13 1 13 3 Measurement Limitations of SpO2 Sourced RR 13 2 13 4 Manually Inputting RR Value 13 2 13 5 Changing the RR Settings 13 2 13 5 1 Enabling SpO2 Source for RR Measurement 13 2 13 5 2 Enabling RR Alarms 13 2 13 5 3 Setting RR Alarms 13 3 13 5 4 Setting the Apnea Alarm Delay 13 3 13 5 5 Setting Timer Interval 13 3 14 Manual Parameters 14 1 14 1 Ma...

Page 15: ...e Display of the Targeted Goal Screen 15 14 15 4 3 Operating the Targeted Goal Screen 15 14 16 Recording 16 1 16 1 Recorder 16 1 16 2 Starting Recordings 16 1 16 3 Stopping Recordings 16 2 16 3 1 Stopping Recordings Manually 16 2 16 3 2 Stopping Recordings Automatically 16 2 16 4 Recording Related Flags 16 2 16 5 Setting the Recorder 16 2 16 6 Loading Paper 16 3 16 7 Removing Paper Jam 16 3 17 Rev...

Page 16: ... 4 The Manual Input Tab 18 14 18 9 5 The Pain Score Tab 18 14 18 9 6 The Other Tab 18 14 18 10 The Unit Settings 18 15 18 11 The Time Settings 18 15 18 11 1 The Time Synchronization Tab 18 15 18 11 2 The Daylight Savings Time Tab 18 16 18 12 The Version Tab 18 16 18 13 The Battery Information Settings 18 16 18 14 The Scanner Settings 18 16 18 14 1 The Scanner Info Tab 18 16 18 14 2 The JADAK Barco...

Page 17: ...20 1 20 1 Care and Cleaning Introduction 20 1 20 2 Care and Cleaning Safety Information 20 1 20 3 Cleaning and Disinfecting the Main Unit 20 2 20 3 1 Cleaning the Main Unit 20 2 20 3 2 Disinfecting the Main Unit 20 2 20 3 3 Approved Cleaning and Disinfecting Agents for Main Unit 20 2 20 4 Cleaning and Disinfecting the Accessories 20 5 20 4 1 Cleaning and Disinfecting Agents for the NIBP Air Hose 2...

Page 18: ... 7 22 5 Others 22 9 A Product Specifications A 1 A 1 Classifications A 1 A 2 Environmental Specifications A 1 A 2 1 Main Unit A 1 A 2 2 SmarTemp Temperature Module A 2 A 2 3 Genius 3 Temperature Module A 2 A 2 4 Exergen TemporalScanner Thermometer A 2 A 2 5 HeTaiDa Infrared Thermometer A 2 A 3 Power Supply Specifications A 3 A 3 1 AC Power Supply Specifications A 3 A 3 2 Battery Specifications of ...

Page 19: ...C 2 1 Alarm Default Settings C 7 C 2 2 Parameter Color Default Settings C 7 C 2 3 Display Default Settings C 8 C 2 4 Volume Default Settings C 8 C 2 5 Record Setup C 8 C 2 6 System Time Default Settings C 9 D Alarm Messages D 1 D 1 Physiological Alarm Messages D 1 D 1 1 General Physiological Alarm Messages D 1 D 1 2 SpO2 Physiological Alarm Messages D 1 D 1 3 PR Physiological Alarm Messages D 1 D ...

Page 20: ...12 D 2 9 Other System Technical Alarm Messages D 10 E Abbreviations E 1 F Declaration of Conformity F 1 ...

Page 21: ...quipment is used for single patient at a time To avoid explosion hazard do not use the equipment in the presence of oxygen rich atmospheres flammable anesthetics or other flammable agents The equipment is not intended to be used within the Magnetic Resonance MR environment Before connecting the equipment to the power line check that the voltage and frequency ratings of the power line are the same ...

Page 22: ...and alarm messages provided by the monitor should not be used as the sole basis for diagnosis or therapy decisions They must be used in conjunction with clinical signs and symptoms Misinterpretation of the measured values or other parameters can endanger the patient Do not place the equipment or accessories in any position that might cause it to fall on the patient Do not start or operate the equi...

Page 23: ...Do not loop the patient cabling into a tight coil or wrap around the device as this can damage the patient cabling Dispose of the package material as per the applicable waste control regulations Keep it out of children s reach At 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 If you...

Page 24: ...anufacture Direct current Alternating current Battery indicator Input output USB connector Equipotentiality DEFIBRILLATION PROOF TYPE BF APPLIED PART DEFIBRILLATION PROOF TYPE CF APPLIED PART Gas inlet Gas outlet Graphical record Alarm Reset NIBP Start Stop key Admit patient Stand by Computer network General warning sign Temperature limit ...

Page 25: ...duct bears CE mark indicating its conformity with the provisions of the REGULATION EU 2017 745 on medical devices and fulfills the general safety and performance requirements of Annex I of this regulation Note The product complies with the Council Directive 2011 65 EU TrueBP is Mindray s new non invasive blood pressure measurement algorithm using linear inflation technology which can measure the b...

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Page 27: ... clinical evaluation and residual risk evaluation for the intended patients there is no known side effects that can occur during or after the use of the medical device And there is no need for the operator to make extra preparations Thus no residual risk associated with using the medical device should be disclosed due to the risk management report 2 2 Intended Users The VS Series Monitors are to b...

Page 28: ...nsport hospital ambulance or home use 2 5 Contra indications None 2 6 Applied Parts The applied parts of the monitor are SpO2 sensor Temp probe NIBP cuff CO2 sampling line nasal sampling cannula 2 7 Main Unit 2 7 1 Front View VS 9 Series 1 Alarm indicator 1 2 3 4 ...

Page 29: ...screen 3 AC power indicator On indicates that the monitor is connected to the AC power Off indicates that the monitor is not connected to the AC power 4 Battery LED Green the battery is fully charged Yellow the battery is being charged Flashing green the monitor runs on battery power Flashing yellow the battery malfunctions Off no battery is installed or the AC mains is not connected when the moni...

Page 30: ...ed Yellow the battery is being charged Flashing green the monitor runs on battery power Off no battery is installed or the AC mains is not connected when the monitor is powered off 5 Alarm Reset Pause key Press this key to reset the alarm system Press and hold this key for more than 2 seconds to pause or resume alarms 6 NIBP Start Stop key Press to start or stop NIBP measurement 7 Admit patient ke...

Page 31: ...connector 4 CO2 gas outlet 5 CO2 sampling line connector 6 Power switch Press this key to turn the monitor on When the monitor is on if no measurement is being performed press this key to enter standby mode When the monitor is on press and hold this key for above 3 seconds to turn the monitor off An indicator is built in this switch It turns on when the monitor is on and turns off when the monitor...

Page 32: ...2 6 7 NIBP cuff connector 2 7 4 Side View VS 8 Series 1 Handle 2 Recorder 3 SpO2 cable connector 4 NIBP cuff connector 5 USB connector 6 Network connector 4 1 2 3 5 6 ...

Page 33: ...nt and other devices are to be used together their equipotential grounding terminals should be connected together to eliminate the potential difference between them 2 USB connector 3 Network connector 4 Multi function connector 5 External battery connector 6 AC power input 4 2 1 6 5 3 ...

Page 34: ...tor for an external battery 3 AC power input 4 Equipotential grounding terminal When the equipment and other devices are to be used together their equipotential grounding terminals should be connected together to eliminate the potential difference between them 1 4 2 3 ...

Page 35: ...med in accordance to the IEC 60601 1 If you have any questions please contact Mindray The monitor and parameter monitoring accessories are suitable for use within the patient environment For other equipment and accessories connected to the monitor consult corresponding manufacturers for the suitability within the patient environment If it is not evident from the equipment specifications whether a ...

Page 36: ...er or us If the packing case is intact open the package and remove the equipment and accessories carefully Check all materials against the packing list and check for any mechanical damage Contact us in case of any problem NOTE If your monitor contains the internal CO2 module connect the CO2 adapter to the CO2 receptacle soon after you unpack the monitor to avoid losing the CO2 adapter 3 3 Environm...

Page 37: ... the monitor to ensure normal monitoring in case of accidental power failure Follow this procedure VS 9 series monitors 1 Make sure the monitor is off and disconnected with any cable 2 Lay the monitor down to expose the bottom of the monitor 3 Open the battery compartment door 4 Turn the latch aside 5 Insert the battery into the battery compartment with the battery terminal inwards 6 Turn the latc...

Page 38: ...ale end of the power cord and the male end of the power cord to a wall AC outlet 2 Check that the external power supply indicator is on The external power supply indicator lies in the lower right corner of the display When the AC mains is not connected the external power supply indicator is off When AC mains is connected the external power supply indicator is illuminated in green WARNING Always us...

Page 39: ...mp illuminates one after the other in red yellow and cyan This indicates that the visible and audible alarm indicators function correctly CAUTION Check that visual and auditory alarm signals 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 mechanically damaged Cont...

Page 40: ...numeric area or waveform area or by selecting the Main Menu quick key from the Parameters column select Setup 3 7 1 Using the Touchscreen For monitors configured with touchscreen you can touch the screen or swipe across the screen with your fingers to operate the monitor 3 7 1 1 Tapping the screen or Swiping across the Screen Tapping the screen To select an item from menus or lists or select a qui...

Page 41: ...eyboard The on screen keyboard enables you to enter information Enter the information by selecting one character after another Select the Backspace key to delete single characters or select to delete the entire entry Select the Caps Lock key to access uppercase letters Select the Enter key to confirm the entry and close the on screen keyboard Select to show the password that has been input 3 7 4 U...

Page 42: ...nt workflow Select this area and you can switch to another workflow 2 Patient information area displays patient information including patient ID name gender and so on The displayed patient information is configurable Selecting this area enters the Patient Management menu 3 Parameter area displays parameter values waveforms alarms and so on Selecting a parameter area to display the corresponding pa...

Page 43: ...attery status network status blue tooth status etc 7 System time displays the current system time 8 Clinician information displays login information of clinician Select this area to log in or out 3 8 2 Menus All menus have similar style and structure see the figure below 1 Menu heading 2 Tabs enters submenus 3 Main body area includes menu items and options 4 Operation buttons 5 Exit button closes ...

Page 44: ...ymbol Label Function Symbol Label Function Review Enters the Review menu Patient Displays the patient list Save Saves the input information Clear Clears all input information Main Menu Enters the main unit More Shows more quick keys Next Shows the next screen Back Shows the previous screen Alarm Pause Pauses the physiological alarms Alarm Reset Resets the alarm system Targeted Goal Enters the Targ...

Page 45: ... your monitor is installed at a fixed position or Neonate male blue Neonate female pink Wired network is connected Wired network is not connected All alarms are paused Individual physiological alarms are turned off or the monitor is in the alarm off status Audible alarm tones are paused Alarms are acknowledged and the alarm is reset Audible alarm tones are turned off CMS is connected Press this bu...

Page 46: ... you can change alarm settings Every time you switch to a workflow the pre defined settings are loaded 3 9 2 1 Accessing the Workflow Setup Menu Access the Workflow Setup menu in the following ways Select the Main Menu quick key from the Configuration column select Workflow input the required password select Select the Main Menu quick key from the Configuration column select Manage input the requi...

Page 47: ...cess the Parameters Setup menu in the Edit Workflow menu select Parameters Setup The settings under the tabs might be different for different departments and work modes For details see the table below Tab Menu Item Description Work Mode NIBP NIBP End Tone If enabled a reminder tone is issued at the completion of NIBP measurement Both Display Format Selects the type and sequence of displayed NIBP r...

Page 48: ...thostatic BP Measurement is enabled BP Averaging Selects whether to enable BP averaging Available only when Department is set to Physician Office Spot Check Number of Measurements Sets the number of measurement to be performed in a group of BP measurements for averaging Available only when Department is set to Physician Office Discard First Group of Readings Selects whether to include the first gr...

Page 49: ... until the NIBP measurement ends Continuous Monitoring PR Pulse Volume Sets the pulse volume Both Irr PR Switch Selects whether to enable the Irregular PR function If enabled you can mark the pulse as regular or irregular on the PR screen Spot Check Temp Measurement Site Manual Sets the default measurement site for Temp measurement Both RR Timer Reminder Interval Sets the interval of reminder tone...

Page 50: ...ng gas N2O Compensation AG Compensation Speed Sets the speed of CO2 waveform CO2 Scale Sets the scale of CO2 waveform Waveform Type Sets the type of CO2 waveform Pain Default Method Sets the default pain scale for scoring Both Pain Score Setup See 18 9 5 The Pain Score Tab EWS Default Adult Score Sets the default scoring protocol for adult patients Spot Check Default Ped Score Sets the default sco...

Page 51: ...the auto refreshing score function For details see 15 1 5 2 Auto Refreshing Scores Alarm Selects whether to enable EWS alarms For details see 15 1 5 EWS Alarm EWS Score 3 in single parameter EWS Pe d Neo Score Continuous Monitoring Auto Scoring Selects the condition to start auto scoring If none of the options is checked auto scoring is switched off For details see 15 1 4 2 Enabling Auto Scoring I...

Page 52: ...When the monitor enters Standby mode the screen will change to the least brightness automatically 3 9 4 Adjusting the Volume To adjust the volume follow this procedure 1 Select the Main Menu quick key from the Device column select Volume 2 You can set Alarm Volume Pulse Volume and Key Volume Select to decrease or increase the volume or select to turn it off 3 9 5 Changing Measurement Colors You ca...

Page 53: ...re information see 18 11 The Time Settings CAUTION Changing the date and time affects the storage of trends and events and may result in loss of data NOTE If your monitor is connected to a central monitoring system CMS or hospital clinical system HIS the date and time are automatically taken from the CMS In this case you cannot change the date and time from your monitor 3 9 8 Setting Parameter Uni...

Page 54: ...rovides spot check mode and continuous monitoring mode It works based on the workflow you selected 3 10 1 1 Continuous Monitoring Mode The continuous monitoring mode is used for long term patient monitoring To switch to monitoring mode select the workflow area and select a workflow under Continuous Monitoring 3 10 1 2 Spot Check Mode The spot check mode is intended for on spot measurement in a sho...

Page 55: ...nter standby mode automatically To switch the monitor to standby mode 1 Press the power switch or select the Main Menu quick key from the Patient Management column select Standby 2 If the monitor is in Continuous Monitoring mode select a location in the drop down list to define where the patient is when the monitor enters the standby mode If the monitor is in Spot Check mode skip this step 3 Selec...

Page 56: ...or enters standby mode in Spot Check mode you can select anywhere on the touchscreen to exit the standby mode 3 10 2 Inputting Patient Information It is recommended to input the patient information correctly before monitoring Follow this procedure 1 Select patient information area and the Patient Management menu is displayed 2 Input the Patient ID name date of birth Patient Category and Gender 3 S...

Page 57: ...2 Disconnect the cables and sensors from the patient 3 Make sure to save or clear the patient monitoring data as required To turn off the monitor press and hold the power switch for 3 seconds Turning off the monitor does not disconnect the monitor from the AC mains To completely disconnect the power supply unplug the power cord CAUTION Press and hold the power switch for 10 seconds to forcibly shu...

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Page 59: ...itted For more information see 4 2 2 Editing Patient Information for details WARNING The setting of patient category always contain a default value regardless of whether the patient is admitted or not Check if the setting is correct for your patient 4 1 2 Manually Admitting a Patient You can admit a patient from ADT Database if available and Local Patient List You can also admit a new patient Foll...

Page 60: ...t Number of a patient other information will automatically fill in if the patient is in the Local Patient List or ADT Database if the monitor is connected with the Admit Discharge Transfer ADT server through the eGateway NOTE The monitor will reload the configuration if you changed the patient category 4 3 Discharging a Patient The monitor discharges a patient in the following situations After a p...

Page 61: ... Menu quick key from the System column select Maintenance input the required password select 2 Select the Patient Management tab select the Discharge tab 3 Select a time for Auto DischargeWhen Power Off The monitor will automatically discharge the patient at next startup after being switched off for the selected period of time The default is Never That is to say the monitor will not discharge a pa...

Page 62: ...3 5 Setting Patient Location To set patient location follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required password select 2 Select the Patient Management tab 3 Select the Location tab 4 Input patient location as desired 4 4 Deleting Patient Data To delete the data of discharged patients follow this procedure 1 Select the Patient quick ...

Page 63: ...rtments You can change some settings from a certain set of configuration and then save the changed configuration as a user configuration The default configurations provided for your monitor are department oriented You can choose any of the following department Wards Emergency Department Physician Office Ambulatory Surgery Center WARNING The configuration management function is password protected T...

Page 64: ... configuration from monitor to monitor 5 5 1 Exporting a Configuration To export the current monitor s configuration follow this procedure 1 Connect a USB drive to the monitor s USB port 2 Select the Main Menu quick key from the Configuration column select Manage input the required password select 3 Select Export Configuration 4 Select the workflows and User Maintenance Settings to export 5 Select...

Page 65: ...atically During operation you may make changes to some settings However these changes may not be saved as user configuration To prevent the changes from losing in case of a sudden power failure the equipment stores the configuration in real time The saved configuration is the latest configuration In case of a temporary power failure if the power is restored within 30 minutes monitoring will resume...

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Page 67: ...tal for all network functions The hospital is responsible for ensuring the security of the virtually isolated network WPA2 PSK and WPA2 Enterprise verification and encryption should be used if possible Otherwise the equipment may not be able to work or patient information may be divulged WPA2 Enterprise and a long password are recommended Keep network authentication information for example passwor...

Page 68: ... to the CMS when network is reconnected For more information on the CMS see the operator s manual of corresponding central monitoring system To select a CMS select the system status information area at the top right corner of the main screen Select the desired CMS from the popup CMS list NOTE You can select CMS only when the Select CMS switch is on For more information refer to 18 16 5 The Transfe...

Page 69: ...details about the settings see 18 16 8 The MLDAP Tab 6 6 Connecting the Wireless Network You can add up to five wireless networks for the monitor If connecting the current wireless network fails the monitor automatically connects other wireless networks in the order when they were added To manually switch the wireless network from the system status information area on the top right corner of the s...

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Page 71: ...ecessary alarm limits are active and set according to the patient s clinical condition Setting alarm limits to extreme values may cause the alarm system to become ineffective For example high oxygen levels may predispose a premature infant to retrolental fibroplasia If this is a consideration do not set the SpO2 high alarm limit to 100 which is equivalent to switching the alarm off When the alarm ...

Page 72: ...iority levels High priority alarms indicates a life threatening situation or a severe device malfunction High priority alarms require an immediate response Medium priority alarms indicates abnormal vital signs or a device malfunction Medium priority alarms require a prompt response Low priority alarms indicates a discomfort condition a device malfunction or an improper operation Low priority alarm...

Page 73: ...played circularly Audible tone pattern ISO Repeat pattern of triple double triple double beeps Repeat pattern of triple beeps Single beep None Mode 1 Repeat pattern of high pitched single beep Repeat pattern of double beeps Low pitched single beep None Mode 2 Repeat pattern of high pitched triple beeps Repeat pattern of double beeps Low pitched single beep None Alarm message1 White text inside a r...

Page 74: ... the Technical Alarms list 2 From the alarm list select Detail on the right of the desired alarm 7 6 Changing Alarm Settings From the Alarm column of the main menu select desired buttons to set alarm properties 7 6 1 Setting Parameter Alarm Properties Continuous Monitoring Mode For workflows under Continuous Monitoring you can set the alarm properties of physiological alarms of each parameter Ever...

Page 75: ...ng Alarm Tone Properties 7 6 2 1 Changing the Alarm Volume To change the alarm volume follow this procedure 1 Select the Main Menu quick key from the Alarm column select Setup 2 Set Alarm Volume The optional alarm volume is between X to 10 in which X is the minimum volume depending on the setting of minimum alarm volume and 10 is the maximum volume 3 Select High Alarm Volume to set the volume of t...

Page 76: ...information see 18 6 5 The Other Tab The setting of Alarm Delay is not applied to the apnea alarms You can set Apnea Delay separately WARNING The alarm delay time can be set to 15 sec at most Changing this setting to an inappropriate level may result in a hazard to the patient 7 6 4 Setting the Apnea Delay Time To set the apnea delay time follow this procedure 1 Select the Main Menu quick key from...

Page 77: ...t alarm the monitor will not alarm when the patient s SpO2 is extremely low This may result in a hazard to the patient Always keep the patient under close surveillance 7 6 8 Setting the Switch of the Apnea Alarm Off You can choose whether switching off the apnea alarm is permissible or not This setting is password protected For more information see 18 6 5 The Other Tab WARNING If you switch off th...

Page 78: ...ected Alarm pause time Priorities of paused alarms Alarm reset setting Reminder tone settings For more information see 18 6 2 The Pause Reset Tab 7 7 2 1 Setting the Alarm Pause Time The alarm pause time can be set to 1 min 2 min 3 min or Permanent The default alarm pause time is 2 min This function is password protected For more information see 18 6 2 The Pause Reset Tab 7 7 2 2 Prolonging the Al...

Page 79: ...udio Pause pressing the Audio Pause key pauses alarm tone When alarm tones are paused the following rules are followed The sound of all physiological alarms and technical alarms are switched off The remaining audio pause time is displayed in the physiological alarm information area The audio pause symbol is displayed in the system information area When the audio pause time expires the audio paused...

Page 80: ... a red background To exit the audio off status press the Audio Pause quick key again WARNING Pausing or switching off alarm sound may result in a hazard to the patient 7 8 Resetting Alarms Pressing the Alarm Reset quick key to acknowledge the ongoing alarms and reset the alarm system When the alarm system is reset the alarm reset symbol displays in the system status information area for alarm symb...

Page 81: ...eset the alarms If you do not latch physiological alarms their alarm indications disappear when the alarm condition ends If you latch physiological alarms all visual and audible alarm indications remains until you reset the alarms For latched alarms the time when the alarm is last triggered is displayed behind the alarm message You can separately latch visual indications or simultaneously latch th...

Page 82: ...audible and visual alarm indications with the patient s clinical condition 7 11 Testing Alarms The monitor automatically performs a selftest at startup Check that an alarm tone is heard and the alarm lamp illuminates one after the other in red yellow and cyan This indicates that the visible and alarm indicators function correctly To further test individual measurement alarms perform measurement on...

Page 83: ...gen saturation can be calculated This device is calibrated to display functional oxygen saturation SpO2 monitoring is intended for adult pediatric and neonatal patients The following types of SpO2 can be configured for the monitor Mindray SpO2 the connector is blue and no logo is on the monitor Nellcor SpO2 the connector is grey and the logo of Nellcor is on the monitor Masimo SpO2 the connector i...

Page 84: ...s too large due to edema excessive pressure for prolonged periods may result in venous congestion distal from the application site leading to interstitial edema and tissue ischemia When patients are undergoing photodynamic therapy they may be sensitive to light sources Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynam...

Page 85: ...tion Use only SpO2 sensors specified in this manual Follow the SpO2 sensor s instructions for use and adhere to all warnings and cautions Do not place the pulse oximeter where the controls can be changed by the patient If using patient monitor during full body irradiation keep the sensor out of the radiation field If the sensor is exposed to the radiation the reading might be inaccurate or the dev...

Page 86: ...ditions Birthmark s tattoos skin discolorations moisture on skin deformed or abnormal fingers etc Interfering substances Intravascular dyes such as indocyanine green methylene blue indigo carmine etc Dyes in the measure site such as nail polish Environmental conditions Excessive ambient light Electrosurgery equipment Defibrillation may cause inaccurate reading for a short amount of time Excessive ...

Page 87: ...nal caused by arterial pulsation 3 Perfusion index PI gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation PI is an indicator of the pulsatile strength You can also use it to assess the SpO2 signal strength Above 1 is optimal Between 0 3 and 1 is acceptable The PI is displayed with a yellow background Below 0 3 indicates low perfusion The PI is di...

Page 88: ...nt temperatures be careful with measurement sites that are not well perfused because this can cause burns after prolonged application Avoid placing the sensor on extremities with an arterial catheter an NBP cuff or an intravascular venous infusion line For neonatal patients make sure that all sensor connectors and adapter cable connectors are outside the incubator The humid atmosphere inside can c...

Page 89: ...ilable with the Nellcor SpO2 to decrease the likelihood of false alarms caused by motion artifacts With Sat Seconds alarm management high and low alarm limits are set in the same way as those with traditional alarm management A Sat Seconds limit is also set The Sat Seconds limit controls the amount of time that SpO2 saturation may be outside the set limits before an alarm sounds The method of calc...

Page 90: ...of SpO2 points both positive and negative until either the Sat Seconds limit is reached or the patient SpO2 re enters the non alarm range and remains there NOTE The SpO2 Too Low or SpO2 Too High alarm is presented in the case that SpO2 value violates the alarm limits for 3 times within one minute even if the setting of Sat Seconds is not reached 8 6 3 Setting the Nellcor SpO2 Sat Seconds In Contin...

Page 91: ...n Continuous Monitoring mode select the SpO2 numeric area or waveform area to enter the SpO2 menu In Spot Check mode select the Main Menu quick key from the Parameters column select Setup select SpO2 2 Select the Setup tab 3 Set Sensitivity to Maximum Normal or APOD CAUTION When using the Maximum Sensitivity setting performance of Sensor Off detection may be compromised If the equipment and the se...

Page 92: ...s Monitoring mode select the SpO2 numeric area or waveform area to enter the SpO2 menu In Spot Check mode select the Main Menu quick key from the Parameters column select Setup select SpO2 2 Select the Setuptab 3 Switch on Display SIQ 8 6 7 Changing Averaging Time for Masimo SpO2 The SpO2 value displayed on the monitor screen is the average of data collected within a specific time The shorter the ...

Page 93: ...t the Setup tab 3 Set the Sensitivity 8 6 9 Showing Hiding PI You can set whether to display PI in the SpO2 parameter area To do so follow this procedure 1 In Continuous Monitoring mode select the SpO2 numeric area or waveform area to enter the SpO2 menu In Spot Check mode select the Main Menu quick key from the Parameters column select Setup select SpO2 2 Select the Setup tab 3 Switch on or off D...

Page 94: ...equired password select 2 Select the Alarm tab select the Other tab 3 Set SpO2 Sensor Off 8 6 13 Setting the SpO2 Tone Mode The monitor adjusts the QRS tone pitch tone according to the SpO2 values To set the SpO2 tone mode follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required password select 2 Select the Other tab 3 Set SpO2 Tone CAUTIO...

Page 95: ...ayout Dashes display in place of numerics 1 Check that the cable connections of SpO2 sensor and the extension cable are tight Replace the SpO2 sensor or the extension cable if needed 2 Reconnect the SpO2 sensor if the alarm SpO2 Sensor Off appears 3 Check the PI value If the PI value is too low adjust the SpO2 sensor or apply the sensor to the site with better perfusion 4 Move the sensor to the pl...

Page 96: ...n in connection with Purchaser s use of the Masimo Products for their labeled purpose Shenzhen Mindray reserves all rights not expressly granted to Purchaser 2 Ownership of Software Firmware Title to ownership of and all rights and interests in any Masimo software and or firmware and the documentation and all copies thereof remain at all times vested in Masimo Corporation licensor to Shenzhen Mind...

Page 97: ... discarded 6 Transfer Restrictions The software firmware is licensed to the Purchaser and may not be transferred to anyone except other end users without the prior written consent of Shenzhen Mindray In no event may you transfer assign rent lease sell or otherwise dispose of the software firmware or the products on a temporary basis 7 Beneficiary Masimo Corporation is a Beneficiary of this Agreeme...

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Page 99: ...th SpO2 taking precedence 5 Pulse rate PR detected pulsations per minute 6 In Spot Check mode select this area to mark the pulse as regular or irregular It can be switched on or off For details see 9 3 3 Enabling Irregular PR NOTE A functional tester or SpO2 simulator can be used to determine the pulse rate accuracy 9 3 Changing the PR Settings 9 3 1 Changing the PR Alarm Settings In Continuous Mo...

Page 100: ...k key from the Parameters column select Setup select PR 2 Select PR Setup tab 3 Set the Pulse Volume to an appropriate level 9 3 3 Enabling Irregular PR To enable the Irregular PR function follow this procedure 1 Select the Main Menu quick key from the Configuration column select Workflow input the required password select 2 Select on the right of the workflow to be set Make sure the workflow is u...

Page 101: ...ay SmarTemp module Convidien Genius 3 tethered tympanic thermometer Exergen TemporalScanner thermometer HeTaida Thermometer Below is a view of monitors configured with the above modules 1 Probe well 2 Connector for thermometers or Temp sensors 10 2 Temp Display 1 Temp unit 2 SmarTemp Genius 3 TemporalScanner and HeTaida Thermometer 2 1 1 2 5 6 4 3 ...

Page 102: ... only the specified temperature probe and probe cover Using other probe or probe cover or not using probe cover may cause damage to the monitor or failure to meet the declared specifications in this manual The temperature probe cover is disposable Re use of probe cover may result in patient cross contamination Use disposable probe covers for temperature measurement Failure to use a probe cover can...

Page 103: ...ng to patient type and measurement site Using the incorrect probe may cause patient s discomfort and inaccurate measurements Improper use of probe may also cause patient s discomfort and inaccurate measurements 10 3 1 Measuring Temp 10 3 1 1 Selecting Measuring Site The temperature module can be configured with 2 types of temperature probe The blue oral axillary probe shall only be used with blue ...

Page 104: ... probe contacts with the patient s oral tissue throughout the measurement When taking an axillary temperature lift the patient s arm to expose the entire armpit Apply the probe as high as possible in the armpit Check that the probe tip is completely surrounded by the axillary tissue Lower the patient s arm so that it is tightly placed at the patient side Keep the patient s arm and the probe in pla...

Page 105: ...with the probe 5 Place the probe to the measurement site and then start measuring Refer to Step 4 in 10 3 1 2 Taking a Temperature in Predictive Mode for how to place a probe 6 Withdraw the probe Press firmly the ejection button on the top of the probe to eject the probe cover Replace the probe into the probe well NOTE In Monitor mode record the measured value prior to taking away the probe from m...

Page 106: ...tal equivalent temperatures The thermometer is powered by the monitor Refer to the Genius 3 Tethered Tympanic Thermometer Operator s Manual for additional information 10 4 1 Safety Information WARNING No alarm is provided for the temperature measurement CAUTION Used probe covers must be treated as infectious biological waste and disposed of in accordance with current medical practices and local re...

Page 107: ... monitor starts remove the thermometer from the cradle 2 Inspect the probe tip and make sure that the probe tip is clean If it is soiled clean it with a lens wipe or lint free swab 3 Press the scan button to verify functionality and mode selection on the LCD screen 4 Install a probe cover by firmly inserting the probe tip into a probe cover Make sure that the probe cover is fully seated Timer butt...

Page 108: ...mporalScanner Thermometer The TemporalScanner thermometer measures the temperature of the skin over the temporal artery Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery The TemporalScanner is a handheld infrared thermometer used by medical professionals for the intermittent measurement of human body temperature of ...

Page 109: ...e yourself except for the battery which you should replace when low by following the instructions in this manual For service repair or adjustments return your thermometer to Mindray No modification of this equipment is allowed Never drop or insert any object into any opening unless stated in this manual If your thermometer is not used regularly remove the battery to prevent possible damage due to ...

Page 110: ...n the area behind the ear if exposed can be an alternate site Measure straight across the forehead and not down side of face Brush the hair aside if covering the area to be measured Measurement site must be exposed 10 5 2 3 Taking a Temperature on an Adult To take a temperature on an adult follow this procedure 1 Slide across forehead Place probe flush on center of forehead and depress button Keep...

Page 111: ...nner can be used in either F or C To convert from one scale to the other the only tools necessary are a paper clip and the tip of a small screwdriver To convert to Fahrenheit or Celsius 1 Bend one leg of a paper clip and insert it into the hole in the side of the plastic housing 2 Push to release the battery cover and then remove the battery 3 Slide the switch to left Celsius or right Fahrenheit w...

Page 112: ...pack or wet compress is on the forehead Remove ice pack or wet compress wait 2 minutes and re take temperature Measuring a completely diaphoretic patient Complete diaphoresis includes diaphoresis of area behind the ear and suggests that the temperature is rapidly dropping Use an alternative method of temperature measurement in these cases until the patient is dry and the temporal artery measuremen...

Page 113: ...onents allow for completely safe cleaning with 70 isopropyl alcohol but should not be immersed in fluid or autoclaved Cleaning the sensor lens Dirt greasy films or moisture on the lens will interfere with the passage of infrared heat and affect the accuracy of the product Clean the lens every two weeks with a cotton swab dipped in alcohol Use only light force for cleaning to avoid damaging the len...

Page 114: ...t the thermometer to Forehead mode 2 Point the infrared sensor window to the forehead of a patient 3 Press the Start Measurement button and read measurement 10 7 Manually Inputting Temp You can manually input a Temp value and save the data for future reference Follow this procedure 1 Select in the Temp area For monitors configured with Mindray SmarTemp module to input Temp value in Continuous Moni...

Page 115: ...he measurement at deflation stage Deflation the device measures the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure The amplitude suddenly increases as the pulse breaks through the occlusion in the artery As the cuff pressure decreases further the pulsations increase in amplitude reach a maximum which approximates to the mean pressure and then ...

Page 116: ...ure due to connection tubing kinking may cause blood flow interference and resulting in harmful injury to the patient NIBP reading can be affected by the measurement site the position of the patient exercise or the patient s physiologic condition If you doubt the NIBP measurements determine the patient s vital signs by alternative means and then verify that the monitor is working correctly Devices...

Page 117: ...rmia that reduces blood flow to the peripheries On an edematous extremity NOTE The effectiveness of this sphygmomanometer has not been established in pregnant including pre eclamptic patients 11 4 Measurement Modes In Spot Check mode there are three NIBP measurement modes Manual measurement on demand BP Blood Pressure Averaging see 11 9 BP Averaging Orthostatic BP measurement see 11 10 Orthostatic...

Page 118: ...led swipe on the NIBP area to the left or right to switch to orthostatic BP measurement screen For details see 11 10 Orthostatic BP Measurement 6 Mean pressure displayed after measurement completed or cuff pressure dis played during the measurement 7 Diastolic pressure 8 Start Stop NIBP measurement Below is an example of NIBP screen in Continuous Monitoring mode 1 Time of last measurement 2 NIBP u...

Page 119: ...dicate that the measurement is old and exceeds the set time So these values are not recommended for reference 11 6 Preparing for NIBP Measurement 11 6 1 Preparing the Patient for NIBP Measurement In normal use perform NIBP measurement on a patient who is in the following position Comfortably seated Legs uncrossed Feet flat on the floor Back arm and feet supported For patients taking orthostatic BP...

Page 120: ...f the length of the upper arm or the thigh The inflatable part of the cuff should be long enough to encircle at least 50 to 80 of the limb d Apply the cuff to the patient s upper arm or leg and make sure the Φ marking on the cuff matches the artery location The cuff should fit snugly but with enough room for two fingers to be placed between the cuff and the patient s arm on adults and loosely on n...

Page 121: ...ment In Spot Check mode you can perform two times of measurement as a group for clinical evaluation For setting of measurement times see 11 8 8 Setting Measurement Times Below is an example of NIBP screen if Measurements is set to Twice 1 Time of last measurement 2 NIBP unit 3 Patient position and site of the first measurement 4 Patient position and site of the second measurement 5 Differences bet...

Page 122: ...to measurement at 14 03 the next measurement will be taken at 14 23 and then at 14 43 15 03 and so on 7 Select Start NIBP 11 7 3 Performing STAT Measurement To perform STAT measurement follow this procedure 1 Prepare the patient and place the cuff as instructed in 11 6 Preparing for NIBP Measurement 2 Select a workflow under Continuous Monitoring 3 Select to set the patient position and measuremen...

Page 123: ... End Tone The monitor can issue a reminder tone at the completion of NIBP measurement The NIBP End Tone is off by default You can switch on the NIBP tone in workflow setup menu After setting every time you switch to the workflow NIBP End Tone is switched on You can also switch on the NIBP end tone in the NIBP menu follow this procedure 1 In Continuous Monitoring mode select the NIBP numeric area t...

Page 124: ...lect the Main Menu quick key from the System column select Maintenance input the required password select Module 2 Under the NIBP tab set NIBP Measurement Algorithm to Inflation the monitor measures blood pressure during cuff inflation If succeeded this measurement is completed If the measurement fails at the inflation stage the monitor will automatically continue the measurement at deflation stag...

Page 125: ...eed to correct the measurement Add 0 75 mmHg 0 10 kPa to the displayed value for each centimetre higher Deduct 0 75 mmHg 0 10 kPa to the displayed value for each centimeter lower 11 9 BP Averaging In BP averaging mode a group of BP measurement is performed on a patient automatically At the completion of measurement a group of averaged BP readings is displayed 11 9 1 Enabling BP Averaging BP averag...

Page 126: ...cedure 1 Prepare the patient and place the NIBP cuff as instructed in 11 6 Preparing for NIBP Measurement 2 Swipe on the NIBP area to the left or right to switch to BP averaging screen 3 Select to set the patient position and measurement site 4 Select to start the first measurement The monitor starts the first measurement immediately or after the set delay For details see 11 9 4 1 Setting the Dela...

Page 127: ...t Check 3 Select Parameters Setup the NIBP tab 4 Under Average set Number of Measurements 11 9 4 3 Setting Time between Readings You can set the time duration between the starts of two consecutive measurement Follow this procedure 1 Select the Main Menu quick key from the Configuration column select Workflow input the required password select 2 Select on the right of the workflow to be set Make su...

Page 128: ...y when the monitor is working in Spot Check mode To enable Orthostatic BP measurement follow this procedure 1 Select the Main Menu quick key from the Configuration column select Workflow input the required password select 2 Select on the right of the workflow to be set Make sure the workflow is under Spot Check 3 Select Parameters Setup the NIBP tab 4 Under Orthostatic BP Measurement enable Orthos...

Page 129: ...e duration is configurable For details see 11 10 4 1 Setting the Lying Duration of Patient 4 After the lying BP measurement is completed ask the patient to stand up Within 1 minute select on the bottom The monitor automatically takes several times of standing BP measurement depending on your setting of Standing BP Measure ment Interval and Maximum Standing BP Measurements For details see 11 10 4 2...

Page 130: ...ct Workflow input the required password select 2 Select on the right of the workflow to be set Make sure the workflow is under Spot Check 3 Select Parameters Setup the NIBP tab 4 Under Orthostatic BP Measurement set Maximum Standing BP Measure ments 11 10 4 4 Setting Orthostatic BP Symptoms Follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the r...

Page 131: ... Main Menu quick key from the Parameters column select Setup select NIBP 2 Set Venipuncture Pressure 3 Select Venipuncture at the bottom of the menu 4 Puncture vein and draw blood sample 5 Select the Venipuncture again to deflate the cuff If you do not deflate the cuff the cuff automatically deflates after a period of time 170 seconds for adult and pediatric patient 85 seconds for neonatal patient...

Page 132: ...uracy test should be performed once every two years or when you doubt the NIBP measurements The NIBP accuracy test should be performed by Mindray qualified service personnel only 11 13 NIBP Troubleshooting For more information see D Alarm Messages ...

Page 133: ...surement is to monitor the patient s respiratory status CO2 monitoring is intended for adult pediatric and neonatal patients CO2 monitoring is for VS 9 series only CO2 measurement is available when the monitor is in Continuous Monitoring mode 12 2 Safety WARNING Remove the airway sampling line from the patient s airway while nebulized medications are being delivered Leakage in the breathing or sam...

Page 134: ...as follow EtCO2 value is within specification for breath rate 60 bpm and I E ratio 1 1 EtCO2 value is within specification for breath rate 30 bpm and I E ratio 2 1 Measurement accuracy is unspecified for breath rate larger than 60 bpm 12 4 CO2 Display The CO2 numeric and waveform areas provide FiCO2 measurement EtCO2 measurement RR measurement and a CO2 waveform 1 CO2 waveform 2 End tidal CO2 valu...

Page 135: ...t an appropriate sampling line according to the patient category 2 Connect the sampling line to the CO2 adapter that is installed on the monitor 3 Connect the other end of the sampling line to the patient For intubated patients requiring an airway adapter install the airway adapter between the patient circuit and the ventilator Y piece For non intubated patients place the nasal cannula onto the pa...

Page 136: ... adapter from the equipment after the first installation This reduces the risk of the CO2 adapter becoming lost or damaged 12 6 Automatic CO2 Module Zeroing The CO2 module performs zero calibration automatically when needed NOTE The CO2 module temporally stops measuring during zeroing 12 7 Changing CO2 Settings 12 7 1 Changing CO2 Alarm Settings In Continuous Monitoring mode you can change the CO2...

Page 137: ...se the CO2 module for monitoring Select Standby mode when you does not use the CO2 module to prolong the service life of the CO2 module The default operating mode is Measure If you are not using the CO2 module you can proceed as follows to enter the Standby mode 1 Select the CO2 numeric area or waveform area to enter the CO2 menu 2 Select Setup tab 3 Set Operating Mode to Standby 12 7 4 Setting th...

Page 138: ...ropriate compensations may cause inaccurate measurement values and result in misdiagnosis To set the gas compensation follow this procedure 1 Select the CO2 numeric area or waveform area to enter the CO2 menu 2 Select Setup tab 3 Set the O2 N2O and AG compensation according to the actual amount of the respective gas in the ventilation gas mixture 12 7 7 Automatic Barometric Pressure The CO2 module...

Page 139: ...0601 1 2 Radiated Immunity 3V m field strengths above 3V m may cause erroneous measurements at various frequencies Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit CAUTION Only use parts and accessories specified in this manual Respiration monitoring is not for use on the patients who are very active as this wil...

Page 140: ... 1 Select in the Resp area A 60s timer is displayed and starts counting seconds 2 Count the total number of Resp of the patient in the past minute 3 Input the number and select 4 Select the Save quick key to save the data 13 5 Changing the RR Settings 13 5 1 Enabling SpO2 Source for RR Measurement In Spot Check mode you can enable the SpO2 source Follow this procedure 1 Select the Main Menu quick ...

Page 141: ...an set the Apnea delay time follow this procedure 1 Select the CO2 numeric area or waveform area to enter the CO2 Setup menu 2 Select Apnea Delay and then select the appropriate setting 13 5 5 Setting Timer Interval A timer is provided when manually inputting RR value A reminder is given at a set interval to assist in counting of Resp number To set the timer reminding interval for manual RR follow...

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Page 143: ...es 14 1 Manual Input Parameters Below is a list of manual parameters provided by default Blood Sugar Height Weight FiO2 O2 Flow Rate I O Fluid LOC GCS LOC AVPU O2 Source LOC ACVPU Supp O2 You can also add new types of parameters to the list For details refer to 14 4 2 Adding a New Parameter 14 2 The Manual Input Display The following figure shows the manual input area Your display may be configure...

Page 144: ... indicates the parameter can be used for EWS calculation 2 Parameter name 3 Parameter setup area select to input a value show the options or a setup menu Parameter Range Blood Sugar 1 0 mg dl 720 0 mg dl 0 06 mmol L 40 00 mmol L Height 20 0 cm 300 0 cm Weight 0 1 kg 499 0 kg FiO2 21 100 O2 Flow Rate 0 1 L min 20 0 L min I O Fluid 1 10000 ml 0 001 10 000 L LOC GCS 3 15 LOC AVPU Alert Reacting to vo...

Page 145: ...Setup Manual Input tab Then select an item and from the popup list select the parameter to be displayed 4 Return to the main screen and switch workflows for the setting to take effect 14 4 2 Adding a New Parameter If you need to add other manual parameters to the Manual Input list follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required pa...

Page 146: ...14 4 After saving the setting you can follow the procedure in 14 4 1 Changing the Display of Manual Parameters to add the new parameter to the Manual Input list displayed on the screen ...

Page 147: ...oring tools Total score A subscore is given for each parameter based on the measured or entered value When all the required parameters are entered or measured the subscores are added together to calculate the total early warning score Each subscore has a color coding to indicate associated level of risk When the total score is outside of the thresholds actions are recommended MEWS NEWS and NEWS2 c...

Page 148: ...Total score The color of the circle indicates the level of risk For IPS no score is displayed Only level of risk is shown white means normal and red indicates alert 4 Risk level indicator The level of risk increases from top down The current level is enclosed by a white square frame For IPS this indicator does not display 5 Subscore area displays the subscore of each parameter 6 Reset available in...

Page 149: ...e slightly different due to the configuration 1 Total score The color of the circle indicates the level of risk For IPS no numeric score is displayed Only level of risk is shown white means normal and red indi cates alert by default 2 Risk level indicator The level of risk increases from top down The current level is enclosed by a white frame For IPS this indicator does not display 3 Parameter are...

Page 150: ...ameter value changes the subscore and total score are recalculated accordingly NOTE Observe the parameter and score changes and save the data timely 15 1 4 EWS Scoring in Continuous Monitoring Mode 15 1 4 1 Performing EWS Scoring To perform scoring follow this procedure 1 Select Reset to clear the previous score and update values of currently monitored parameters and relevant subscores 2 For NEWS2...

Page 151: ...n an alarm occurs to the parameter for scoring If no option is selected the monitor does not initiate auto scoring 15 1 4 3 Setting Auto Scoring Interval In Continuous Monitoring mode you can set the auto scoring interval Follow this procedure 1 From the EWS page select Setup 2 Set Interval By Score the monitor automatically starts scoring as per the interval selected for corresponding total score...

Page 152: ...gured threshold to a lower score The score of auto obtained parameter reaches 3 or falls from 3 to a lower score To enable the auto refreshing score function follow this procedure 1 From the EWS page select Setup 2 Select the Alarm tab 3 Turn on the Auto Refresh Scores switch 15 1 6 Changing EWS Settings 15 1 6 1 Changing the Scoring Protocol The monitor is configured with a default scoring protoc...

Page 153: ... the Main Menu quick key from the System column select Maintenance input the required password select 2 Select the CAA tab select EWS tab 3 From the Select Default Score area set Default Adult Score Default Ped Score and Default Neo Score 15 1 7 Viewing History Scores To view the history scores follow this procedure 1 Select the Review quick key select Scoring Review tab 2 Select PID and from the ...

Page 154: ...ed 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 patient s level of consciousness GCS is intended for adults and pediatric patients CAUTION GCS is intended as an adjunct in patient assessment and must be used in conjunction with observation of clinical signs and symp...

Page 155: ... list as shown below Your display may look slightly different If GCS is not displayed you can follow the procedure in 14 4 1 Changing the Display of Manual Parameters to add GCS to the list 1 GCS label 2 GCS value total score Select this area to enter the GCS menu 1 2 ...

Page 156: ...ect the GCS value to enter the GCS menu 15 2 3 Performing GCS Scoring To perform scoring follow this procedure 1 Subscores 2 Total score and level of consciousness The color of the circle indicates the level of risk 3 Scoring time 1 2 3 1 1 ...

Page 157: ...and low limit for each level 15 2 5 Reviewing GCS Data If the GCS data is correctly saved you can review the GSC data following this procedure 1 Select the Review quick key select Scoring Review tab 2 Select a record from the list and then select Detail 3 Check the LOC GCS value 15 3 Pain Score The monitor provides pain score functions to help assess a patient s pain The following scales are provi...

Page 158: ...to the left or right to select a pain scale 2 Set the pain description if needed 3 Tap the scoring area to select a value or an option for scoring 4 Select the Save quick key to save the data 15 3 3 Adding a Custom Pain Scale You can set up to 2 custom pain scales on the monitor Follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required pass...

Page 159: ...inue to set the Unit and Resolution of the parameter For Text type you need to set the options to be selected At least 2 options need to be set If needed you can select Add to set more options 6 Select Save 15 4 Targeted Goal For patients under continuous monitoring if you are concerned with specific parameters and their trends you can use the Targeted Goal screen The Targeted Goal screen focuses ...

Page 160: ...e target parameter and secondary parameters 5 Other parameter area displays parameter measurements and alarm limits of parameters other than the target parameter and secondary parameters 6 Secondary parameters area displays parameter measurement of PR and PI in big numerics as well as parameter sources and alarm limits 15 4 3 Operating the Targeted Goal Screen You can access parameter setup and tr...

Page 161: ... Select a value on the left of the scale 3 Use the keyboard on the right to change the value 4 Drag the section label on the right of the scale up or down to select a target section The target section is highlighted in green in the SpO2 statistics area 15 4 3 3 Selecting the SpO2 Statistics Length The Duration of SpO2 statistics is configurable From the SpO2 statistics area select the duration to ...

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Page 163: ...he current recording 2 Module status indicator On when the recorder works correctly Off when the monitor is switched off Flashes if an error occurred to the recorder 3 Paper outlet 4 Recorder door 5 Latch pull it backward to open the recorder door 16 2 Starting Recordings Recordings can be started manually In Continuous Monitoring mode to start a recording you can either Press the hardkey on the f...

Page 164: ...corder runs out of paper The recorder has an alarm condition 16 4 Recording Related Flags You can find the following flags on the recording reports For automatically stopped recordings there are two columns of asterisks at the end of the report For manually or abnormally stopped recordings there is one column of asterisks at the end of the report 16 5 Setting the Recorder To set the recorder follo...

Page 165: ...s printhead the recorder may be unable to print or poor print quality may result Never pull the recorder paper with force when a recording is in process Otherwise it may cause damage to the recorder Do not leave the recorder door open unless you reload paper or remove troubles 16 7 Removing Paper Jam If the recorder works incorrectly or produces unusual sounds check if there is a paper jam first I...

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Page 167: ...oping You can also review the events scores and so on 17 2 Review Page The Review page contains tabs to display trend data in tabular graphic or other forms 17 2 1 Accessing the Review Page To enter the review page select the Review quick key 17 2 2 Example Review Page The review pages have similar structure We take the graphic trends review page as an example 3 2 5 11 4 8 10 5 6 7 12 1 9 ...

Page 168: ...alarm priority 11 Event area displays the event of the cursor time Selecting the event access the event list If there is no event at the cursor time the cursor time is displayed 12 Event type indicator different color blocks match different types of events Red high priority alarm event Yellow medium priority alarm event Cyan low priority alarm event White operation related event 17 2 3 Reviewing t...

Page 169: ...numerics and three event related waveforms 16 seconds before and after the event is stored NOTE A total loss of power has no impact on the events stored Alarms are saved as events and will be maintained if the equipment is powered down The time of equipment power down is not recorded as an event and cannot be reviewed Earlier events will be overwritten by later ones if the capacity is reached 17 2...

Page 170: ... of these operations will not be recorded in the system log 17 2 6 2 Viewing Event Details To view waveforms and parameter values at the event time follow this procedure 1 Select Review quick key select Events tab 2 Select an event to be viewed and then select Detail On the Detail page you can also view the details of other events by either selecting and then the desired event selecting or to view...

Page 171: ...eering department for the passwords used at your facility 18 1 Accessing the Maintenance Menu To perform user maintenance follow this procedure 1 Select the Main Menu quick key from the System column select Maintenance input the required password select 2 Select desired tab 18 2 The Device Location Settings Menu Item Default Setting Function Monitor Name Facility Department Room No Bed No Location...

Page 172: ... Default Setting Function Menu Item Default Setting Function Required Selects which items can be displayed and edited from the Patient Management menu Optional Patient ID Age GA Neo Primary Screen Display Full Name On Selects whether patient name is displayed in the patient information area on the primary display Default Admit Patient Method ADT Database Selects the default list from which to admi...

Page 173: ...charge a patient no matter for how long the monitor has been switched off Auto Delete Patient Data if Discharged Auto Automatically deletes patient data when the patient is discharged Clear All Patient Data Deletes all patient information and data Clearing patient data will discharge the current patient Menu Item Default Setting Function Location 1 Location 10 Selects where the patient goes after ...

Page 174: ...cal Password changing alarm switch alarm limit and alarm priority is password protected The monitor s password for changing alarm settings is required Clinician Authentication changing alarm switch alarm limit and alarm priority is password protected The account and password in the MLDAP are required View Discharged Patients No Password Selects whether password or clinician login is needed to view...

Page 175: ... whether clinician and patient information is required before saving physiological data Send After Saving Off Selects whether to automatically send the data after saving Record After Saving Off Selects whether to automatically start recording after saving Log Out After Saving Off Selects whether to automatically log out after saving Discharge Patient After Saving On Selects whether to automaticall...

Page 176: ...f Selects whether to clear data after sending Auto Clear Local Patient List Off Selects whether to clear the patient information and physiological data after sending Section Menu Item Default Setting Function Menu Item Default Setting Function Minimum Alarm Volume 2 Alarm Sound ISO Defines the alarm tone pattern to distinguish the pulse tone and keystroke tone by frequency High Alarm Interval 10 s...

Page 177: ...t within the designated delay time after the alarm occurs the alarm volume automatically increases by one level Off if an alarm is not reset within the designated delay time after the alarm occurs the volume of the alarm tone does not change Increase Volume Delay 20 sec Defines the delay time of alarm volume escalation Defaults Restores default settings on current page Menu Item Default Setting Fu...

Page 178: ...tched 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 Reminder Tone Alarm Reset Reminder On Selects the reminder tone rule when the alarm volume is set to zero or the alarm is reset or switched off On the monitor issues reminder tones at a designated interval Re alarm if the alarm condit...

Page 179: ...ed you can separately latch visual alarm signal If Audible is selected you can latch both audible and visual alarm signals Selecting alarms of lower priority simultaneously latches higher priority alarms Audible Menu Item Default Setting Function Signal Type Continuous Pulse the nurse call signal is a pulse signal and each pulse lasts one second When multiple alarms simultaneously occur only one p...

Page 180: ...vailable only in Continuous Monitoring mode Alarm Delay Alarm Delay 6 sec 1 sec 15 sec for continuously measured parameters the monitor does not present the alarm if the alarm condition is resolved within the delay time Off an alarm is always presented The setting of Alarm Delay is not applied to the apnea alarms Other SPO2 Desat Alarm Off Disable Selects whether the SpO2 Desat alarm can be switch...

Page 181: ...dby screen Auto Enter Standby On If enabled the monitor enters Standby mode automatically if no operation is detected for the time set below Auto Enter Standby Time 10 min Sets the time for the monitor to automatically enter Standby mode Black Screen On Standby Off If enabled the screen turns black after entering Standby mode Menu Item Default Setting Function Default Adult Score NEWS2 Selects the...

Page 182: ...asurement Algorithm Inflation Selects the algorithm for NIBP measurement Inflation The monitor performs NIBP measurement during cuff inflation If measurement fails it will continue the measurement in deflation stage This algorithm is applicable only for adult patients Deflation The monitor performs NIBP measurement during cuff deflation NIBP Accuracy Test To perform a NIBP accuracy test NIBP Leaka...

Page 183: ...fault Setting Function Menu Item Default Setting Function CO2 5 0 Sets the concentration of calibration gas A range of 3 0 to 7 0 is selectable Click Calibrate to start CO2 calibration Zero Recovery For 30s On On After the zero calibration is completed the CO2 module reacquires the CO2 readings During the reacquisition period Zero Recovering is displayed in the CO2 numeric area Off After the zero ...

Page 184: ...AS mm NRS VRS 5 FPS R FLACC Enables or disables the pain scales Custom Pain Score Method Custom 1 Custom 2 Sets custom pain scales and selects whether to display them Add Description Adds descriptions for pain assessment Menu Item Default Setting Function NIBP Timeout 15 min Sets the time for a NIBP value to be displayed as outlined Temp Timeout 30 min Sets the time for a Temp value to be displaye...

Page 185: ...ault Setting Description Time Zone Selects the current time zone NTP Server Start NTP Time Sync Off On enables synchronizing the monitor time with the NTP server time Interval 1 hr Select the time interval for synchronizing the monitor time with the NTP server time Time Server Address 0 0 0 0 The domain name of the time server Time Server The IP address of the time server Connection Status Shows t...

Page 186: ...aylight savings time Tab Default Setting Function Version Displays system software version module hardware and software version and firmware version Tab Default Setting Function Battery1 Displays battery information Battery2 Section Menu Item Default Setting Description Data Parse Mode JADAK Sets the data parse mode JADAK Local and DLL are selectable Data Encoding Type UTF8 Sets the data encoding ...

Page 187: ... Sets the prefix for clinician barcode Postfix Sets the postfix for clinician barcode Remove Prefix Suffix Off Sets whether to remove the set prefix or postfix Section Menu Item Default Setting Description Menu Item Default Setting Function Patient Category Sets the information of JADAK barcode Gender Age Month Tab Default Setting Function Identify Scanner When you are using barcode readers other ...

Page 188: ...tion Report Layout Patient Name Patient ID Patient Category Visit Number Gender Bed No DOB Room No Sets the information to be included in the reports and positions of the information Menu Item Default Setting Function Monitor Auto if WLAN is available on your monitor LAN1 IP if WLAN is not available on your monitor Selects the type of network to be used Auto the monitor automatically identify your...

Page 189: ...up WLAN Band Auto Auto automatically identifies the WLAN band 2 4G Channel All Selects the type of 2 4G channels 5G Channel All Selects the type of 5G channels Certificate Management Local Delete delete the selected certifications USB Drive Select certifications you want to import from the USB memory and then select Import import the desired certifications from the USB memory Menu Item Default Set...

Page 190: ...data Central Station Setup Select CMS On Selects whether to enable the CMS selection function for your monitor Add Central Station Inputs the name department and server address of the CMS You can add up to 30 CMSs for monitor eGate way Setup Server Address Input the server address or IP address of eGateway IP Address 0 0 0 0 Network Test Tests whether the eGateway server is properly connected Data...

Page 191: ...7 protocol ADT Server Address 192 168 0 100 Input the host name or IP address of the ADT gateway IP Address 192 168 0 100 Port 3502 Input the port of the ADT gateway ADT Query Off Selects whether patient information can be loaded to the monitor from the ADT server Network Test Tests whether the ADT server is properly connected The ADT admit discharge transfer gateway is normally deployed in the eG...

Page 192: ...s and so on QoS Level For Others 0 Selects the service quality of network connection for non realtime monitoring for example history data printing and as on Menu Item Default Setting Function Server Address Inputs the name or IP address for the MLDAP server IP Address 0 0 0 0 Port 6665 Network Test Tests whether the monitor is properly connected with the MLDAP server Section Menu Item Default Sett...

Page 193: ...coding type Import Aliases To import Aliases Import Bearer To import Bearer Import Certificate To import certificate Import CSI To import CSI Section Menu Item Default Setting Description Menu Item Default Setting Function Enable Off On the bluetooth function is enabled and the monitor can be found by other bluetooth devices Off the bluetooth function is disabled Auto Unpair On Disconnection 10 mi...

Page 194: ... monitors in the same area Clear CMS IP at startup On Language Parameter Output Setup Configures DIAP protocol parameters to realize communications between the monitor and third party devices Export Patient Data To export the patient data to a USB drive Browse System Log To browse the system log Export System Log To export the system log to a USB drive Modify Password To modify maintenance passwor...

Page 195: ... damage and internal short circuits If a battery has been dropped or banged against 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 The battery should be charged only in this monitor Extremely high ambient temperature may cause battery overheat protectio...

Page 196: ... the estimated run time of the battery indicates that the battery power is low and needs to be charged The red portion represents the remaining charge and the numerics in the middle indicates the estimated run time of the battery indicates that the battery is almost depleted and needs to be charged immediately Otherwise the monitor will soon automatically shut down indicates that no battery is ins...

Page 197: ...n of the monitor and status of the battery Do not rely exclusively on this for operation time estimation in clinical applications 19 3 3 Battery related Alarms Refer to D 2 7 Power Supply Technical Alarm Messages 19 4 Replacing the Battery for VS 9 Series For VS 9 series to replace the battery follow this procedure 1 Turn off the monitor Disconnect the power cable and other cables 2 Lay the monito...

Page 198: ...ment door 4 Disconnect the old battery from the connectors on the left of the battery compart ment and take out the old battery 5 If a 2500 mAh battery is used put a battery support into the battery compartment If a 5000 mAh battery is used the support is not needed 6 Insert the new battery into the battery compartment with the battery terminal outwards Then connect the battery to the connectors o...

Page 199: ...1 Conditioning the Battery The performance of a rechargeable battery deteriorates over time You should condition the batteries every three months If the battery is not conditioned for a prolonged time its charge indication may not be accurate and you may wrongly evaluate the remaining battery runtime To condition a battery follow this procedure 1 Disconnect the monitor from the patient and stop al...

Page 200: ...ly shorter than that stated in the specifications the battery may reach its service life or malfunction If the battery performance meets the requirement fully charge the battery again for use or charge it to 40 60 for storage NOTE Battery operating time depends on equipment configuration and operation For example high display brightness or measuring NIBP repeatedly will shorten the battery operati...

Page 201: ...ery has visual signs of damage The battery fails The battery is aged and its runtime significantly less than the specification The battery service life is reached Properly dispose of batteries according to local regulations WARNING Do not open batteries heat batteries above 60 C incinerate batteries or short the battery terminals They may ignite explode leak or heat up causing personal injury ...

Page 202: ...19 8 This page intentionally left blank ...

Page 203: ...eans for controlling infection For the method to control infection consult your hospital s infection control officer or epidemiologist Be sure to turn off the system and disconnect all power cables from the outlets before cleaning the equipment The responsible hospital or institution shall carry out all cleaning and disinfection procedures specified in this chapter CAUTION Never immerse any part o...

Page 204: ...ectors and metal parts 5 Dry the surface with a clean cloth Allow the equipment and mounting kits air dry in a ventilated and cool place CAUTION During the cleaning procedure disable the touch operation by switching off the monitor or locking the touchscreen Any contact of cleaners or disinfectants with connectors or metal parts may cause corrosion 20 3 2 Disinfecting the Main Unit Disinfect the m...

Page 205: ... Cloth HB Germicidal Disposable Wipe Wipes PDI Inc PDI Sani Cloth Plus Germicidal Disposable Cloth Wipes PDI Inc PDI Super Sani Cloth Germicidal Disposable Wipe Wipes PDI Inc Virex II 256 1 256 Liquid Diversey Inc Virex TB Liquid spray Diversey Inc HEALTH ESSENCE Disinfecting Effervescent Tablets Tablets Beijing ChangJiangMai Medical Science Technology Co Ltd HEALTH ESSENCE Surface Disinfectant Li...

Page 206: ... Liquid spray ANIOS LABORATORIES Wip Anios EXCEL Wipes ANIOS LABORATORIES Aniosurf ND premium 0 25 Liquid ANIOS LABORATORIES Mikrobac Tissues Wipes BODE Chemie GmbH Cleanisept Wipes Wipes Dr Schumacher GmbH mikrozid PAA Wipes Wipes Schülke Mayr GmbH mikrozid Sensitive Wipes Wipes Schülke Mayr GmbH Ecolab Incidin OxyWipe S Wipes Ecolab Deutschland GmbH Glutaraldehyde 2 Liquid Ethanol 70 Liquid Isop...

Page 207: ...er immerse or soak the accessories in any liquid Never clean or disinfect the connectors and metal parts Use only Mindray approved cleaners and disinfectants and methods listed in this section to clean or disinfect the accessories Warranty does not cover damage caused by unapproved substances or methods To avoid long term damage the accessories should be disinfected only when necessary as determin...

Page 208: ...x CaviCide1 Liquid spray METERX RESEARCH Metrex CaviWipes Wipes METERX RESEARCH PDI Sani Cloth AF3 Germicidal Disposable Wipe Wipes PDI Inc PDI Sani Cloth Plus Germicidal Disposable Wipe Wipes PDI Inc PDI Super Sani Cloth Germicidal Disposable Wipe Wipes PDI Inc Virex TB Liquid spray Diversey Inc Clinell Universal Wipes Wipes GAMA Healthcare Ltd Surfa safe Liquid spray ANIOS LABORATORIES Aniosurf ...

Page 209: ...r Disinfectant Towels with Bleach Wipes Clorox professional products company Clorox Healthcare Bleach Germicidal Wipes Wipes Clorox professional products company Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant Wipes Wipes Clorox professional products company Diversey Oxivir TB Wipes Wipes Diversey Inc PDI Super Sani Cloth Germicidal Disposable Wipe Wipes PDI Inc Virex TB Liquid spray Dive...

Page 210: ... accessories NIBP air hose and SpO2 cable should be disinfected only when necessary as determined by your hospital s policy Cleaning the accessories before disinfecting is recommended 20 5 Sterilization Sterilization is not recommended for this monitor related products accessories or supplies unless otherwise indicated in the Instructions for Use that accompany the products accessories or supplies...

Page 211: ... allowed This equipment contains no user serviceable parts Do not open the equipment housings All servicing and future upgrades must be carried out by the service personnel The safety checks or maintenance involving any disassembly of the equipment should be performed by professional service personnel Otherwise undue equipment failure and possible health hazards could result Do not open batteries ...

Page 212: ...please contact Mindray NOTE If needed contact the manufacture for circuit diagrams component part lists descriptions calibration instructions or other information concerning the repair of the equipment 21 3 Maintenance and Testing Schedule Follow the maintenance and testing schedule or local regulations to perform testing and maintenance Make sure to clean and disinfect the equipment before taking...

Page 213: ...cept the following maintenance tasks all other test and maintenance tasks should be performed by Mindray qualified service personnel only Regular check including visual inspection and power on test Recorder test Battery check Nurse call test If you suspect that the nurse call function does not work properly Electrical Safety Tests Electrical safety tests Once every two years Other Tests Power on t...

Page 214: ...t 21 5 2 Performing Power on Test 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 properly 21 5 3 Testing the Recorder To test the recorder follow this procedure 1 Start a recording task to print waveforms and reports 2 Check that the recorder functions cor...

Page 215: ...formance 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 disposab...

Page 216: ...inger 520I Disposable SpO2 Sensor 009 005089 00 Infant Toe 520N Disposable SpO2 Sensor 009 005090 00 Neonate Foot Adult Finger 521A Disposable SpO2 Sensor 009 005091 00 Adult Finger 521P Disposable SpO2 Sensor 009 005092 00 Pediatric Finger 521I Disposable SpO2 Sensor 009 005093 00 Infant Toe 521N Disposable SpO2 Sensor 009 005094 00 Neonate Foot Disposable bandage for 518C SpO2 Sensor 115 004895 ...

Page 217: ...0 Adult 30kg Finger 4050 Adult RD SET DCI 040 003376 00 Finger Model Patient Category Part No Applicable patient Application site MAXAI Disposable SpO2 Sensor 0010 10 12202 Adult 30 kg Finger MAXPI Disposable SpO2 Sensor 0010 10 12203 Pediatric 10 to 50 kg Finger MAXII Disposable SpO2 Sensor 0010 10 12204 Infant 3 to 20 kg Toe MAXNI Disposable SpO2 Sensor 0010 10 12205 Neonate 3 kg Adult 40 kg Foo...

Page 218: ...201 Infant 10 to 19 0010 30 12157 CM1202 Pediatric 18 to 26 0010 30 12158 CM1203 Adult 24 to 35 0010 30 12159 CM1204 Large adult 33 to 47 0010 30 12160 CM1205 Adult Thigh 44 to 66 0010 30 12161 CM1300 Small infant Arm 7 to 13 040 000968 00 CM1301 Infant 10 to 19 040 000973 00 CM1302 Pediatric 18 to 26 040 000978 00 CM1303 Adult 24 to 35 040 000983 00 CM1304 Large adult 33 to 47 040 000988 00 CM130...

Page 219: ... 35 001B 30 70699 CM1504 Large adult 33 to 47 001B 30 70700 CM1505 Adult Thigh 46 to 66 001B 30 70701 CM1506 Adult Arm 25 to 35 115 016969 00 CM1507 Large adult 33 to 47 115 016970 00 CM1500A Neonate Arm 3 1 to 5 7 125 000051 00 CM1500B 4 3 to 8 0 125 000052 00 CM1500C 5 8 to 10 9 125 000053 00 CM1500D 7 1 to 13 1 125 000054 00 CM1500E 8 to 15 125 000055 00 CM1501 Infant 10 to 19 001B 30 70682 CM1...

Page 220: ...99 MR431 Reusable package Adult Pediatric Neonate Oral Axillary 6006 30 39600 MR432 Adult Pediatric Rectal 6606 30 39601 Model Usage Patient Category Description Part No ST 001 Disposable Adult Pediatric Neonate Cover 20 pcs pack M09A 20 62124 Cover 200 pcs pack M09A 30 62126 Cover 2000 pcs pack M09A 30 62128 Model Usage Description Part No 303075 Reusable Tethered tympanic thermometer 115 038397 ...

Page 221: ...ing line long humidified Adult Pediatric 007738 0010 10 42565 Disposable airway sampling line long humidified Neonatal 009818 0010 10 42566 Disposable nasal sampling line Adult 007266 0010 10 42567 Disposable nasal sampling line Pediatric 009822 0010 10 42568 Disposable nasal sampling line plus O2 Adult 007269 0010 10 42569 Disposable nasal sampling line plus O2 Pediatric 009826 0010 10 42570 Disp...

Page 222: ...erLine Adult Pediatric MVPN 040 006166 00 Nasal CO2 FilterLine Pediatric MVAN 040 006167 00 Nasal CO2 FilterLine Adult MVANH 040 006168 00 Nasal CO2 FilterLine Adult MVA 040 006169 00 Oral Nasal CO2 FilterLine Adult MVP 040 006170 00 Oral Nasal CO2 FilterLine Pediatric MVPNOH 040 006171 00 Nasal CO2 FilterLine w O2 H Pediatric MVAOL 040 006172 00 Oral Nasal CO2 FilterLine w O2 L Adult MVAO 040 006...

Page 223: ...ial Port Cable 022 000248 00 Li ion Battery 10 8V 5600mA LI23I003A VS9 022 000273 00 Li ion Battery 10 95V 5000mAh LI23S005A VS 8 022 000122 00 Li ion Battery 10 95V 2500mAh LI13S001A VS8 045 004267 00 Rolling stand Standard 045 004268 00 Rolling stand with workbench 045 004269 00 Rolling stand with workbench battery 045 003054 00 Wall mount standard 045 003424 00 Quick Release Tray 045 003427 00 ...

Page 224: ...22 10 This page intentionally left blank ...

Page 225: ... TemporalScanner Temp Mode of operation Continuous Degree of protection against harmful ingress of water IPX2 Protection against vertically falling water drops when ENCLOSURE tilted up to 15 Degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTUREWITH...

Page 226: ...on condensing Same as the main unit Same as the main unit Barometric Same as the main unit Same as the main unit Item Operating conditions Storage conditions Temperature 16ºC to 33 ºC 25 to 55 ºC Relative humidity non condensing 10 to 95 10 95 Item Operating conditions Storage conditions Temperature 16 to 40 ºC 20 to 50 ºC Relative humidity non condensing 15 to 95 10 to 95 Barometric 57 0 to 107 4...

Page 227: ...urs when powered by a new fully charged battery at 25 C 5 C on a configuration of SpO2 NIBP SmarTemp and Wi Fi with SpO2 sensor and barcode scanner connected auto NIBP measurement at an interval of 15 minutes and screen brightness set to factory default At least 4 hours when powered by a new fully charged battery at 25 C 5 C on a configuration of SpO2 NIBP CO2 Wi Fi and recorder with SpO2 sensor c...

Page 228: ...o 100 for the 2500mAh battery and no more than 4 hours to 100 for the 5000mAh battery at 25 C 5 C Monitor power on no more than 7 5 hours to 100 for the 2500mAh battery and no more than 11 5 hours to 100 for the 5000mAh battery Shutdown delay At least 20 minutes after a low battery alarm first occurs at 25 C 5 C with SpO2 sensor connected auto NIBP measurement at an interval of 15 minutes and brig...

Page 229: ...rm tones 45 to 85 dB key tones pulse tone power on self check tone support PITCH TONE and multi level tone modulation alarm tones comply with IEC60601 1 8 Power 1 AC power input connector Wired network 1 RJ45 connector USB 2 standard connectors USB 2 0 type A Equipotential Grounding Terminal 1 Multi Functions Connector 1 External battery connector 1 Nurse Call Signal Amplitude High level 3 5 to 5 ...

Page 230: ...The alarm delay time form the monitor to remote equipment is 2 seconds measured at the monitor s signal output connector Standards IEEE 802 11a b g n ac Modulation mode BPSK QPSK 16QAM 64QAM 256QAM Operating frequency 2412MHz 2472MHz 5180MHz 5320Mz 5500MHz 5700MHz 5745MHz 5825MHz Wireless data rate IEEE 802 11a 6 54 Mbps IEEE 802 11b 1 11 Mbps IEEE 802 11g 6 54 Mbps IEEE 802 11n MCS0 MCS7 IEEE 802...

Page 231: ...e effective 2 seconds A 5 9 3 Wi Fi Network Stability There is no communication data loss when the monitor moves at a speed not higher than 3 75 m s in a 15 meter obstacle free linear range 16 monitors are connected to the same AP and each roams for 30 times of which at least 3 monitors roam simultaneously The ratio of the communication data loss on the CMS from any monitor does not exceed 0 1 ove...

Page 232: ...1 3 Line of Sight Distance The line of sight distance between the monitor and the bluetooth node is no less than 10 meters A 6 Measurement Specifications A 6 1 SpO2 Specifications A 6 1 1 Mindray SpO2 Module Specifications Alarm limit Range Step SpO2 High low limit 2 to 100 1 SpO2 Low Mindray Masimo Desat 1 to high limit 2 Nellcor Desat 1 or 20 whichever is greater to high limit 2 Desat 0 to low l...

Page 233: ...neonates Data Arms 518B 97 51 male 46 female 200 pairs 2 38 520N 122 65 male 57 female 200 pairs 2 88 The Pulse Oximeter with neonatal SpO2 sensors was also validated on adult subjects Refreshing rate 1 s Response time 30 s normal perfusion no disturbance SpO2 value sudden change within 70 100 Standards meets the requirements of ISO 80601 2 61 SpO2 Measurement range 1 to 100 PI Measurement range 0...

Page 234: ...an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 to 100 SpO2 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 oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masi...

Page 235: ... high limit 5 Measurement range 20 to 300 bpm Resolution 1 bpm Response time 30 s normal perfusion no disturbance PR value sudden change within 25 220 bpm Accuracy 3 bpm Refreshing rate 1 s Measurement range 25 to 240 bpm Resolution 1 bpm Response time 20 s normal perfusion no disturbance PR value sudden change within 25 220 bpm Accuracy 3 bpm without motion 5 bpm with motion Low perfusion conditi...

Page 236: ...m 3 bpm 251 to 300 bpm not specified Refreshing rate 1 s Measurement range 30 to 300 bpm Resolution 1 bpm Accuracy 3 bpm or 3 whichever is greater Standards Meet standards of IEC 80601 2 30 ISO 81060 2 Technique Oscillometry Mode of operation Manual Auto STAT Sequence and BP averaging Auto mode repetition intervals 1 min 2 min 2 5 min 3 min 5 min 10 min 15 min 20 min 30 min 1 hour 1 5 hours 2 hour...

Page 237: ...tatic pressure measurement accuracy 3 mmHg Resolution 1 mmHg Initial cuff inflation pressurerange mmHg Deflation algorithm Adult Pediatric Neonate 80 to 280 80 to 210 60 to 140 Default initial cuff inflation pressure mmHg Deflation algorithm Adult Pediatric Neonate 160 140 90 Software overpressure protection Adult Pediatric Neonate 297 3 mmHg 297 3 mmHg 147 3 mmHg Hardware overpressure protection ...

Page 238: ...ments depending on the configuration in a typical patient population A 6 4 Temp Specifications A 6 4 1 Specifications of the SmarTemp Temperature Module Sys High Adult low limit 5 to 290 Pediatric low limit 5 to 240 Neonate low limit 5 to 140 50 1 50 5 Sys Low 25 to high limit 5 Mean High Adult low limit 5 to 260 Pediatric low limit 5 to 215 Neonate low limit 5 to 125 Mean Low 15 to high limit 5 D...

Page 239: ... limit 1 C to 44 C 0 1 C Temp Low 25 C to high limit 1 C Clinical BIAS Δcb Limits of Agreement LA Clinical Repeatability σr Oral 0 02 0 33 0 1 Axilla 0 06 0 38 0 13 Rectum 0 05 0 48 0 14 Operating mode Adjusted mode Measurement range 33 0 C to 42 0 C 91 4 F to 107 6 F Accuracy 0 3 C Measurement range 16 0 C to 43 0 C Measurement accuracy 0 2 C Resolution 0 1 C Battery Specifications Type Alkaline ...

Page 240: ...1 mmHg Sample flowrate Connecting the Oridion sampling line 50 ml min Sample flowrate tolerance 15 or 15 ml min whichever is greater Start up time 20 s typical 90 s maximum Response time Measured with an Oridion sampling line 5 s 50 ml min standard sampling line or 6 5 s 50 ml min extended sampling line Measured with a DRYLINETM PRIME sampling line 5 s 50 ml min Rise time Measured with an Oridion ...

Page 241: ... gas readings without breath Alarm limit Range Step EtCO2 High low limit 2 to 99 mmHg 1 mmHg EtCO2 Low 1 to high limit 2 mmHg FiCO2 High 1 to 99 mmHg Alarm limit Range Step rpm RR High RR 20 rpm low limit 2 to 20 rpm RR 20 rpm Adult pediatric low limit 5 to 100 rpm Neonate low limit 5 to 150 rpm 20 1 20 5 RR Low RR 20 rpm 0 to high limit 2 rpm RR 20 rpm 20 to high limit 5 rpm Measurement range 0 t...

Page 242: ...A 18 A 7 Operating Environment Host CPU AM3358 Primary programming language C Operating system Linux 3 2 0 ...

Page 243: ...shielding the location Use of this device adjacent to or stacked with other device should be avoided because it could result in improper operation If such use is necessary this device and the other device should be observed to verify that they are operating normally This device is intended for use in professional healthcare facility EMC environment If it is used in special environment such as magn...

Page 244: ...idance Conducted and radiated RF EMISSIONS CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic device Conducted and radiated RF EMISSIONS CISPR 11 Class A The device is suitable for use in all establishments other than domestic and those directly connected to the public l...

Page 245: ... protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the device Guidance and Declaration Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity test IEC60601 test ...

Page 246: ...ital environment If the user of our product requires continued operation during power mains interruptions it is recommended that our product be powered from an uninterruptible power supply or a battery RATED power frequency magnetic fields IEC 61000 4 8 30 A m 50 Hz 60 Hz 30 A m 50 Hz 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commer...

Page 247: ...ating of the transmitter in watts 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 should be less than the compliance level in each frequency rangec Interference may occur in the vicinity of equipment marked with the following symbol 6 Vrms in ISM bands an...

Page 248: ...ey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device c Over the frequency ranges 150 kHz to 80 MHz field strengths should be less...

Page 249: ...mitted complies with the e i r p limits as stated in RSS 210 The maximum antenna gain permitted complies with the e i r p limits specified for point to point operation as stated in RSS 210 WARNING Changes or modifications not expressly approved by the party responsible compliance could void the user s authority to operate the equipment 100 12 12 23 For transmitters at a maximum output power not li...

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Page 251: ... Off On High Adult and pediatric 100 Neonate 95 Low 90 Priority Med SpO2 Desat On Off On Low 80 Priority High NIBP Simul Off Setup Sat Seconds for Nellcor SpO2 Off Sensitivity for Mindray SpO2 Med Sensitivity for Masimo SpO2 APOD Averaging for Masimo SpO2 8 s Display PI for Mindray SpO2 Masimo SpO2 On Speed 25 mm sec ...

Page 252: ...iatric 160 Neonate 200 Low Adult 50 Pediatric 75 Neonate 100 Priority Med PR Setup Pulse Volume 2 Item Default Setting Alarm Temp On Off Off High 38 0 C Low 35 0 C Priority Med Item Default Setting Alarm NIBP S On Off On High Adult 160 mmHg Pediatric 120 mmHg Neonate 90 mmHg Low Adult 90 mmHg Pediatric 70 mmHg Neonate 40 mmHg Priority Med ...

Page 253: ...mHg Neonate 70 mmHg Low Adult 60 mmHg Pediatric 50 mmHg Neonate 25 mmHg Priority Med NIBP S Extreme On Off Off High Adult 175 mmHg Pediatric 130 mmHg Neonate 95 mmHg Low Adult 75 mmHg Pediatric 60 mmHg Neonate 35 mmHg Priority High NIBP D Extreme On Off Off High Adult 105 mmHg Pediatric 80 mmHg Neonate 65 mmHg Low Adult 35 mmHg Pediatric 30 mmHg Neonate 15 mmHg Priority High Item Default Setting ...

Page 254: ...nate 90 mmHg Interval Sequence Start Mode Clock NIBP End Tone Off Venipuncture Pressure Auto Display Format Sys Dia Mean Display Alarm Limits Off Patient Position Lying Measurement Site Unspecified Sequence Phase A Duration 1 hr Interval 5 min Phase B Duration 4 hrs Interval 15 min Phase C Duration 4 hrs Interval 30 min Phase D Duration Continuous Interval 1 hr Phase E Duration Off Interval 1 hr I...

Page 255: ...ty Med Apnea On Off On Locked Priority High EtCO2 On Off On High Adult and pediatric 50 mmHg Neonate 45 mmHg Low Adult and pediatric 25mmHg Neonate 30 mmHg Priority Med FiCO2 On Off On High 4 mmHg Priority Med Apnea Delay Adult and pediatric 20 sec Neonate 15 sec Setup Operating Mode Measure Auto Standby 60 min BTPS Compensation Off O2 Compensation 21 N2O Compensation 0 ...

Page 256: ...2 Scale 50 mmHg Waveform Type Draw Item Default Setting Item Default Setting EWS Score NEWS2 Score Confirmation On Auto Scoring Off Interval By Score 4 hrs Score 0 2 hrs Score 1 4 1 hr Score 5 6 30 min Score 7 20 Manual Data Timeout SpO2 4 hrs Supp O2 24 hrs PR 1 hr LOC 24 hrs ...

Page 257: ...core Priority Med On Off On High 5 Priority High On Off On High 7 Alarm 3 in single parameter RR Off Med SpO2 Off Med BP S Off Med PR Off Med Temp Off Med Item Default Setting Item Default Setting Alarm Volume 2 High Alarm Volume Alarm Volume 3 Reminder Volume 2 Apnea Delay Adult and pediatric 20 sec Neonate 15 sec Item Default Setting SpO2 Cyan ...

Page 258: ... Yellow Item Default Setting Item Default Setting Screen Lock Duration 10 sec Brightness 5 Brightness On Battery 5 Item Default Setting Alarm Volume 2 High Alarm Volume Alarm Volume 3 Reminder Volume 2 Key Volume 2 Item Default Setting Waveform 1 Off Waveform 2 Off Recording Duration 8 sec Recorder Paper Speed 25 mm sec ...

Page 259: ...C 9 C 2 6 System Time Default Settings Item Default Setting Date Format yyyy mm dd 24 Hour Time On Daylight Savings Time Off ...

Page 260: ...C 10 This page intentionally left blank ...

Page 261: ...rm Messages D 1 3 PR Physiological Alarm Messages Alarm messages Default priority Cause and solution XX High Med 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 patient category and alarm limit settings are correct XX Low Med Alarm message Default priority Cause and solution SpO2 Desat High The SpO2 value falls below ...

Page 262: ...pears before the alarm message indicating that the alarm is acknowledged In the following tables we will use A B and C to refer to the indications on alarm reset Alarm message Default priority Cause and solution NIBP S Extremely High NIBP D Extremely High NIBP M Extremely High High The NIBP value is higher than the NIBP Extreme alarm high limit Check the patient s condition and check if the alarm ...

Page 263: ...ion If the alarm persists replace the sensor SpO2 No Sensor Low A The SpO2 extension cable is detached from the SpO2 module or the SpO2 sensor is detached from the SpO2 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 of ambient light or cover the s...

Page 264: ...ced or the patient s perfusion index is too low 1 Check the sensor and sensor position 2 Reposition the sensor if necessary Replace SpO2 Cable Low C The SpO2 cable expired cannot be recognized or failed Replace the SpO2 cable Prompt The SpO2 cable is about to expire Replace the SpO2 cable Incompatible SpO2 Cable Low C The SpO2 cable connected is not compatible with the equipment Replace the SpO2 c...

Page 265: ...ed A The measured value is invalid Replace the probe and check the value Temp Measuring Timeout for SmarTemp Med B The measurement has exceeded regular measurement time Try another measurement Ambient Temp Overrange for SmarTemp Low A The ambient temperature is too low Move the patient to a warmer place and take temperature measurement again if necessary Temp Overrange for SmarTemp Low C The tempe...

Page 266: ...pecified range Move the patient to a place where the temperature is within in the specified range and take temperature measurement again if necessary Ambient Temp Unstable for HeTaiDa Prompt The ambient temperature changes greatly Move the patient to a place of stable temperature and take temperature measurement again if necessary Measurement Mode Unsupported for HeTaiDa Prompt Change the measurem...

Page 267: ...onnel NIBP Weak Signal Low A The patient s pulse is weak or the cuff is loose Check the patient s condition and replace the cuff application site NIBP Excessive Motion Low A Check the patient s condition and reduce patient motion NIBP Cuff and Patient Mismatch Low A The cuff type mismatches the patient category Verify the patient category or replace the cuff if necessary If patient category is cor...

Page 268: ...o zero the module again If the alarm persists contact your service personnel CO2 Airway Occluded Low C 1 Check if the sample line is kinked or occluded 2 Replace the sample line 3 If the alarm persists contact your service personnel XX Overrange Low C The measured value exceeds the module measurement range Check the patient s condition CO2 No Adaptor Low B Check the adaptor connection Alarm messag...

Page 269: ...ower Board Comm Error High C Restart the monitor If the alarm persists contact your service personnel Battery Error High C The battery may fail Contact your service personnel Battery Charging Error High C The charging circuit fails or the battery fails Contact your service personnel Battery Temperature Too High High C Stop using the monitor after this alarm appears and contact your service personn...

Page 270: ...cts Check the network settings Fail To Get WLAN IP Address Low C Unable to automatically obtain the wireless network IP address Check the network settings Fail To Get LAN1 IP Address Low C Unable to automatically obtain the wired network LAN1 IP address Check the network settings Alarm message Default priority Indication on alarm reset Cause and solution Storage Error High C The storage card fails...

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Page 272: ...D 12 ...

Page 273: ...se DC direct current Dia diastolic DPI dot per inch EEC European Economic Community EMC electromagnetic compatibility EMI electromagnetic interference EMR Electronic Medical Record GCS Glasgow Coma Scale IABP intra aortic balloon pump ID identification I E inspiratory time expiratory time ratio IEC International Electrotechnical Commission ISO International organization for standardization IEEE In...

Page 274: ...blood pressure NIBP D NIBP diastolic pressure NIBP M NIBP mean pressure NIBP S NIBP systolic pressure P power PD photodetector Ped pediatric Pleth plethysmogram PR pulse rate RAM random access memory ROM read only memory SpO2 arterial oxygen saturation from pulse oximetry TD temperature difference TEMP temperature ...

Page 275: ...F 1 F Declaration of Conformity ...

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Page 277: ......

Page 278: ...P N 046 020097 00 4 0 ...

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