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Mindray uMEC10, Operator'S Manual

The Mindray uMEC10 Service Manual can be easily accessed and downloaded for free from our website. This comprehensive manual provides detailed instructions and guidance on operating and maintaining your uMEC10 device. Make the most of this valuable resource to optimize your product's performance and efficiency.

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2-2 

 

2.2 Front View 

 

 

 

 

(1) Display 

Screen 

(2) Alarm 

lamp 

When a physiological alarm or technical alarm occurs, this lamp will flash as defined 

below. 

‹

 

High level alarms:   the lamp quickly flashes red. 

‹

 

Medium level alarms:    the lamp slowly flashes yellow. 

‹

 

Low level physiological alarms:    the lamp lights yellow without flashing. 

‹

 

Low level technical alarms:    the lamp does not light. 

(3) 

 Press to reset alarms. 

(4) 

  Press to pause or restore alarms. 

(5) 

  Press to start or stop NIBP measurements. 

(6) 

 Press to freeze or unfreeze waveforms. 

 

(8)

(2)

(1) 

(3)

(4)

(5)

(6)

(7)

(11)

(10)

(9)

Summary of Contents for uMEC10

Page 1: ...uMEC10 uMEC12 uMEC15 Patient Monitor Operator s Manual ...

Page 2: ......

Page 3: ...2016 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights reserved For this Operator s Manual the issue date is 2016 1 WARNING z Federal Law USA restricts this device to sale by or on the order of a physician ...

Page 4: ...confidential information Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden Release amendment reproduction distribution rental adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden and are the registered trademarks or trademarks owned by Mind...

Page 5: ...rmance of this product only if all installation operations expansions changes modifications and repairs of this product are conducted by Mindray authorized personnel the electrical installation of the relevant room complies with the applicable national and local requirements the product is used in accordance with the instructions for use WARNING z This equipment must be operated by skilled trained...

Page 6: ...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 7: ...12th Road South Hi tech industrial park Nanshan Shenzhen 518057 P R China Website www mindray com E mail Address service mindray com Tel 86 755 81888998 Fax 86 755 26582680 EC Representative Shanghai International Holding Corp GmbH Europe Address Eiffestra e 80 20537 Hamburg Germany Tel 0049 40 2513175 Fax 0049 40 255726 ...

Page 8: ...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 critically ill patients Illustrations All illustrations in this manual serve as e...

Page 9: ...ing and Checking 3 1 3 1 2 Environmental Requirements 3 2 3 2 Getting Started 3 3 3 2 1 Turning Power On 3 3 3 2 2 Starting Monitoring 3 3 3 3 Disconnecting from Power 3 4 3 4 Using Keys 3 4 3 5 Using the Touchscreen 3 5 3 6 Setting the Screen 3 5 3 7 Using the On screen Keyboard 3 6 3 8 Using the Main Menu 3 7 3 9 Changing General Settings 3 8 3 9 1 Setting up a Monitor 3 8 3 9 2 Changing Languag...

Page 10: ... USB Drive 4 4 4 4 1 Transferring Data from the Monitor to a USB Drive 4 5 4 4 2 Viewing Data on the Monitor via USB Drive 4 5 4 4 3 Transferring Data from the USB Drive to Monitor 4 6 4 5 Connecting to a Central Monitoring System 4 7 5 Managing Configurations 5 1 5 1 Introduction 5 1 5 2 Entering the Manage Configuration Menu 5 2 5 3 Setting Default Configuration 5 2 5 4 Saving Current Settings 5...

Page 11: ...tting the Interval between Alarm Sounds 7 5 7 4 4 Changing the Alarm Tone Pattern 7 6 7 4 5 Setting the Reminder Tones 7 7 7 5 Understanding the Alarm Setup Menu 7 7 7 5 1 Setting Alarm Properties for All Parameters 7 8 7 5 2 Adjusting Alarm Limits Automatically 7 9 7 5 3 Setting Alarm Delay Time 7 12 7 5 4 Setting SpO2 Technical Alarm Delay 7 12 7 5 5 Setting Recording Length 7 13 7 6 Pausing Ala...

Page 12: ...6 2 Changing ST Filter Settings 8 11 8 6 3 Understanding the ST Display 8 12 8 6 4 Saving the Current ST Segment as Reference 8 13 8 6 5 Changing the Reference Segment 8 13 8 6 6 Deleting a Reference Segment 8 14 8 6 7 Recording the ST Segment 8 14 8 6 8 Changing the ST Alarm Limits 8 14 8 6 9 Setting the ST Alarm Delay Time 8 14 8 6 10 Adjusting ST Measurement Points 8 14 8 7 About Arrhythmia Mon...

Page 13: ...on Mode 9 4 9 8 Changing Resp Wave Settings 9 5 9 9 Setting RR Source 9 5 9 10 Setting Alarm Properties 9 6 9 11 Switching Resp Measurement On Off 9 6 10 Monitoring PR 10 1 10 1 Introduction 10 1 10 2 Setting the PR Source 10 1 10 3 Selecting the Active Alarm Source 10 2 10 4 QRS Tone 10 2 11 Monitoring SpO2 11 1 11 1 Introduction 11 1 11 2 Safety 11 2 11 3 Applying the Sensor 11 2 11 4 Changing S...

Page 14: ...Properties 12 8 12 8 3 Displaying NIBP List 12 8 12 8 4 Setting the Pressure Unit 12 8 12 8 5 Switching On NIBP End Tone 12 8 13 Monitoring Temp 13 1 13 1 Introduction 13 1 13 2 Safety 13 1 13 3 Making a Temp Measurement 13 1 13 4 Understanding the Temp Display 13 2 13 5 Setting the Temperature Unit 13 2 14 Monitoring IBP for uMEC12 uMEC15 14 1 14 1 Introduction 14 1 14 2 Safety 14 1 14 3 Zeroing ...

Page 15: ...ings 16 6 16 6 1 Changing CO2 Alarm Settings 16 6 16 6 2 Changing the CO2 Unit 16 6 16 6 3 Setting the CO2 Waveform 16 6 16 6 4 Setting the RR Source 16 6 16 6 5 Entering the Standby Mode 16 7 16 6 6 Setting the Auto Standby 16 7 16 6 7 Setting the Gas Compensations 16 7 16 6 8 Setting Humidity Compensation 16 8 16 7 Calibrating the CO2 Module 16 8 17 Freezing Waveforms 17 1 17 1 Freezing Waveform...

Page 16: ...ecording Length 20 3 20 4 4 Setting the Interval between Timed Recordings 20 3 20 4 5 Changing the Recording Speed 20 3 20 4 6 Clearing Recording Tasks 20 4 20 5 Loading Paper 20 4 20 6 Removing Paper Jam 20 5 20 7 Cleaning the Recorder Printhead 20 5 21 Printing 21 1 21 1 Printer 21 1 21 2 Connecting a printer 21 1 21 3 Setting Up the Printer 21 2 21 4 Starting Report Printouts 21 2 21 5 Stopping...

Page 17: ...re and Cleaning 24 1 24 1 General Points 24 1 24 2 Cleaning 24 2 24 3 Disinfection 24 3 24 4 Sterilization 24 3 25 Maintenance 25 1 25 1 Regular Inspection 25 1 25 2 Maintenance and Testing Schedule 25 2 25 3 Checking Monitor and Module Information 25 3 25 4 Calibrating ECG 25 3 25 5 NIBP Tests 25 4 25 5 1 NIBP Leakage Test 25 4 25 5 2 NIBP Accuracy Test 25 5 25 6 CO2 Tests 25 6 25 6 1 CO2 Leakage...

Page 18: ... 2 Radio Regulatory Compliance B 6 C Default Configurations C 1 C 1 Parameters Configuration C 1 C 2 Routine Configuration C 12 C 3 User Maintenance Items C 15 D Alarm Messages D 1 D 1 Physiological Alarm Messages D 1 D 2 Technical Alarm Messages D 3 E Electrical Safety Inspection E 1 E 1 Power Cord Plug E 1 E 2 Device Enclosure and Accessories E 2 E 3 Device Labelling E 2 E 4 Protective Earth Res...

Page 19: ...ot avoided could result in death or serious injury CAUTION z Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE z Provides application tips or other useful information to ensure that you get the most from your product ...

Page 20: ... or death could result z Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level or off may result in a hazard to the patient Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring z The physio...

Page 21: ...power line check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment s label or in this manual z Always install or carry the equipment properly to avoid damage caused by drop impact strong vibration or other mechanical force z Dry the equipment immediately in case of rain or water spray 1 1 3 Notes NOTE z Put the equipment in a location where y...

Page 22: ... USB connector Network connector Gas outlet Serial number Inserted direction Protection against vertically falling water drops Manufacturer Date of Manufacture The product bears CE mark indicating its conformity with the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive Note The product complies with the Cou...

Page 23: ...d as household waste By ensuring that this product is disposed of correctly you will help prevent bringing potential negative consequences to the environment and human health For more detailed information with regard to returning and recycling this product please consult the distributor from whom you purchased it For system products this label may be attached to the main unit only ...

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

Page 25: ...oxide CO2 The monitors are to be used in healthcare facilities by clinical professionals or under their direction WARNING z This patient monitor is intended for use only by clinical professionals or under their guidance It must only be used by persons who have received adequate training in its use Anyone unauthorized or untrained must not perform any operation on it 2 1 2 Applied Parts The applied...

Page 26: ...lamp quickly flashes red Medium level alarms the lamp slowly flashes yellow Low level physiological alarms the lamp lights yellow without flashing Low level technical alarms the lamp does not light 3 Press to reset alarms 4 Press to pause or restore alarms 5 Press to start or stop NIBP measurements 6 Press to freeze or unfreeze waveforms 8 2 1 3 4 5 6 7 11 10 9 ...

Page 27: ...d battery is malfunction or no AC source is connected when the patient monitor is power off Flash when the patient monitor operates on battery power 9 AC power LED It turns on when AC power is connected 10 Power On Off LED It turns on when the patient monitor is on and turns off when the patient monitor is off 11 Knob Rotate the Knob clockwise or anti clockwise With each click the highlight jumps ...

Page 28: ...ff switch Pressing this switch turns the patient monitor on When the monitor is on pressing and holding this switch turns the monitor off 3 Connector for Temp probe 4 Connector for SpO2 cable 5 Connector for ECG cable 6 Connector for NIBP cuff 1 3 4 5 2 6 ...

Page 29: ...2 5 2 3 2 uMEC12 uMEC15 1 6 7 2 8 9 10 3 4 5 ...

Page 30: ...Connector for Temp probe 8 Connector for SpO2 cable 9 Connector for ECG cable 10 Connector for NIBP cuff 2 4 Rear View 1 VGA Connector It connects a secondary display which extends the display capability of your monitor The contents displayed on the secondary display screen accords with those displayed on the monitor screen 2 Multifunctional Connector It outputs defibrillator synchronization signa...

Page 31: ...itor to PC for system upgrade 5 Equipotential Grounding Terminal When the patient monitor and other devices are to be used together their equipotential grounding terminals should be connected together eliminating the potential difference between them 6 AC Power Input 7 Power mousing hook 2 5 Display Screen This patient monitor adopts a high resolution TFT LCD to display patient parameters and wave...

Page 32: ...nical alarm list will be displayed 4 Physiological Alarm Area This area shows physiological alarm messages When multiple alarms occur they will be displayed circularly Select this area and the physiological alarm list will be displayed 5 Waveform Area This area shows measurement waveforms The waveform name is displayed at the left upper corner of the waveform Select this area and the corresponding...

Page 33: ...ns QuickKeys that give you fast access to functions 2 6 QuickKeys A QuickKey is a configurable graphical key located at the bottom of the main screen They give you fast access to functions Their availability and the order in which they appear on your screen depend on how your patient monitor is configured The following QuickKeys can be displayed on the screen Symbol Label Function Scrolls left to ...

Page 34: ...guration menu Start C O Starts cardiac output procedure Calculations Performs calculations Others Has a split screen view of another patient s conditions oxyCRG Has a split screen view of OxyCRG trends 7 lead ECG Enters the full screen 7 lead ECG screen 12 lead ECG Enters the full screen 12 lead ECG screen Parameters Enters the Parameters menu NIBP STAT Starts NIBP STAT measurement Print Setup Ent...

Page 35: ...d QuickKeys to display on the screen 1 Select Main Menu Maintenance Manage Configuration enter the required password Ok 2 Select Edit Config Edit Screen Setup 3 In the Select QuickKeys screen select your desired QuickKeys and arrange them ...

Page 36: ...2 12 FOR YOUR NOTES ...

Page 37: ...viding evidence that the safety certification of the devices has been performed in accordance to the IEC 60601 1 If you have any question please contact us z If it is not evident from the equipment specifications whether a particular combination with other devices is hazardous for example due to summation of leakage currents please consult the manufacturers or else an expert in the field to ensure...

Page 38: ...ammable and explosive substances If the equipment is installed in a cabinet sufficient space in front and behind shall be left for convenient operation maintenance and repair Moreover to maintain good ventilation the equipment shall be at least 2 inches 5cm away from around the cabinet When the equipment is moved from one place to another condensation may occur as a result of temperature or humidi...

Page 39: ...spect it is not working properly or if it is mechanically damaged Contact your service personnel or us NOTE z 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 Contact your service personnel or us 3 2...

Page 40: ...letely disconnect the power supply unplug the power cord 3 4 Using Keys The monitor has three types of keys Softkey A softkey is a graphic key on the screen giving you fast access to certain menus or functions The monitor has two types of softkeys Parameter keys Each parameter area or waveform area can be seen as a softkey You can enter a parameter setup menu by selecting its corresponding paramet...

Page 41: ...be displayed The ECG parameter and the first ECG waveform always display in the first row The configurable areas can be classified as Area A Area B and Area C In Area A you can choose to display the parameters having waveforms and their waveforms Each parameter and the associated waveform are displayed in the same row In Area B you can choose to display the parameters and their waveforms When ther...

Page 42: ...he parameters whose positions are not allocated in the Screen Setup window will not be displayed However the monitor can still give alarms of these parameters 3 7 Using the On screen Keyboard The onscreen keyboard enables you to enter information Use the key to delete the previously entered character Use the key to toggle between uppercase and lowercase letters Select the key to confirm what you h...

Page 43: ...in menu Other menus are similar to the main menu and contain the following parts 1 Heading gives a sum up for the current menu 2 Main body displays options buttons prompt messages etc The menu button with enlarges a secondary window to reveal more options or information 3 Online help area displays help information for the highlighted menu item 4 select to exit the current menu 1 4 2 3 ...

Page 44: ...Monitor Name Department and Bed No and then change their settings 3 9 2 Changing Language 1 Select Main Menu Maintenance User Maintenance enter the required password 2 In the User Maintenance menu select Language and then select the desired language 3 Restart the patient monitor 3 9 3 Adjusting the Screen Brightness 1 Select the Main Menu Screen Setup Brightness 2 Select the appropriate setting fo...

Page 45: ...etween 24h and 12h If your patient monitor is connected to a central monitoring system CMS the date and time are automatically taken from that CMS In that case you cannot change the date and time settings on your patient monitor CAUTION z Changing date and time will affect the storage of trends and events and may cause data missing 3 9 6 Adjusting Volume Alarm Volume 1 Select the Alarm Setup Quick...

Page 46: ...he volume of this tone is user adjustable 1 Select the Volume Setup QuickKey or the ECG parameter window Others or the SpO2 parameter window 2 Select QRS Volume or Beat Vol and then select the appropriate volume 0 means off and 10 the maximum volume 3 10 Setting Parameters 3 10 1 Switching the Parameters On Off To switch the parameters on or off 1 Select Main Menu ė Maintenance ė User Maintenance ...

Page 47: ...jor operating modes 3 11 1 Monitoring Mode This is the normal everyday working mode that you use for monitoring patients Your monitor automatically enters the monitoring mode after being turned on 3 11 2 Night Mode To avoid disturbing the patient night mode may be used To activate the night mode 1 Select Main Menu Screen Setup Night Mode 2 In the pop up menu set the desired brightness alarm volume...

Page 48: ...ntinue but patient data is only visible at the central station Alarms can still be triggered But all audible alarms are suppressed and the alarm light is deactivated at the patient monitor All system sounds are suppressed including heart beat tone pulse tone all prompt tones etc To cancel the privacy mode press any key The patient monitor exits the privacy mode automatically in one of the followin...

Page 49: ... exit the Demo mode select Main Menu Maintenance Exit Demo WARNING z The Demo mode is for demonstration purpose only To avoid that the simulated data are mistaken for the monitored patient s data you must not change into Demo mode during monitoring Otherwise improper patient monitoring and delayed treatment could result 3 11 5 Standby Mode In standby mode you can temperately stops patient monitori...

Page 50: ...3 14 FOR YOUR NOTES ...

Page 51: ... monitoring a new patient Failure to do so can lead to data being attributed to the wrong patient NOTE z Discharging a patient clears the current patient data from the monitor 4 1 1 Auto Discharging a Patient after Monitor Power Off You can let the monitor automatically discharge after the monitor has been switched off for a period of time To set the time period of discharging a patient 1 Select M...

Page 52: ...anually discharged the monitor automatically admits a new patient After being switched off for the selected time period the monitor automatically discharges the previous patient and admits a new patient at startup Always inputs patient information as soon as the patient is admitted For details refer to 4 3 1 Editing Patient Information WARNING z The settings of patient category and paced status al...

Page 53: ...ata 4 3 Managing Patient Information 4 3 1 Editing Patient Information To edit the patient information after a patient has been admitted or when the patient information is incomplete or when you want to change the patient information 1 Select the Patient Setup QuickKey or Main Menu Patient Setup 2 Select Patient Demographics and then make the required changes 3 Select Ok 4 3 2 Querying and Obtaini...

Page 54: ...an associate patient s MRN first name last name date of birth and gender with HIS NOTE z A keyword takes effect only when being defined in eGateway Refer to eGateway Integration Manager Installation Guide for details z The monitor displays corresponding patient information only when all the keywords have been inputted 4 4 Transferring Patient Data via USB Drive You can transfer patient data betwee...

Page 55: ... configured with a storage card 4 4 1 Transferring Data from the Monitor to a USB Drive 1 Select Main Menu Patient Setup 2 Select Transfer to Storage Medium In the popup menu select Ok 3 Wait until the following message appears Transfer to storage medium successful Please remove the USB drive 4 Remove the USB drive from patient monitor 4 4 2 Viewing Data on the Monitor via USB Drive You can view p...

Page 56: ...ads the configuration according to the patient category Same Patient In the popup dialog box you can Select Yes to merge the patient data in the monitor and storage medium Select No to erase all the current patient data in the monitor and to transfer the patient data from the storage medium 4 Wait until the following message appears Transfer from storage medium successful WARNING z The USB drive y...

Page 57: ...transferred to the CMS All patient information measurement data and settings can be displayed simultaneously on the patient monitor and CMS For some functions such as editing patient information admitting a patient discharging a patient starting stopping NIBP measurements etc bi directional control can be achieved between your patient monitor and the CMS For details refer to the CMS s instructions...

Page 58: ...4 8 FOR YOUR NOTES ...

Page 59: ...tion as a user configuration WARNING z The configuration management function is password protected The configuration management tasks must be performed by clinical professionals The system configuration items can be classified as Parameter configuration items These items relates to parameters e g waveform gain alarm switch alarm limits Conventional configuration items These items define how the mo...

Page 60: ...uration The monitor will load the pre set default configuration in the following cases The patient monitor restarts after quitting over 120 seconds A patient is admitted A patient is discharged Patient data is cleared Patient category is changed To set default configuration 1 Select Select Default Config in the Manage Configuration menu 2 In the Select Default Config menu select Load the Latest Co...

Page 61: ...n is restored when the patient monitor starts enter the main screen to check the prompt information at the lower part of the screen displayed for about 10 seconds 5 4 Saving Current Settings Current settings can be saved as user configuration Up to 3 user configurations can be saved To save current settings 1 Select Save Current Settings As in the Manage Configuration menu 2 In the popup dialog bo...

Page 62: ... items of alarm setup will be marked in red 4 You can select Save or Save as to save the changed configuration Select Save to overwrite the original configuration Select Save as to save the changed configuration in another name 5 6 Deleting a Configuration 1 Select Delete Config in the Manage Configuration menu 2 The popup menu shows the existing user configurations on the monitor Selecting Config...

Page 63: ... User Maintenance Settings to import Then select the Import button A status message will report completion of the transfer 5 8 Loading a Configuration You may make changes to some settings during operation However these changes or the pre selected configuration may not be appropriate for the newly admitted patient Therefore the monitor allows you to load a desired configuration so as to ensure tha...

Page 64: ... restore the latest configuration if restarts within 60 seconds after the power failure And it will restore the default configuration rather than the latest configuration if restarts 120 seconds later after the power failure The monitor may load either the latest configuration or the default configuration if restarts from 60 120 seconds after the power failure 5 10 Modifying Password To modify the...

Page 65: ...red password 2 Select Others 3 Select Wave Line and toggle between Thick Mediate and Thin 6 1 2 Changing Measurement Colors 1 Select Main Menu Screen Setup Measurement Color Setup 2 Select the color box next to your desired measurement and then select a color from the popup menu 6 1 3 Changing Screen Layout Select the Screens QuickKey or Main Menu Screen Setup Screen Layout to enter the Screens me...

Page 66: ... Split Screen View of Minitrends You can split the normal screen so that one part of the screen on the left hand side continuously shows graphic minitrends beside waveforms as shown in the figure below To have a split screen view of minitrends you can Select Minitrends QuickKey or Select Screens QuickKey Choose Screen Minitrends Screen or Select Main Menu Screen Setup Screen Layout Choose Screen M...

Page 67: ...Setting Minitrends Select the minitrends area From the pop up Minitrend Setup menu you can Select the parameters to be displayed or Select Minitrend Length and then select the appropriate setting 6 3 Viewing OxyCRG To have a split screen view of OxyCRG you can Select OxyCRG QuickKey or Select Screens QuickKey Choose Screen OxyCRG Screen or Select Main Menu Screen Setup Screen Layout Choose Screen ...

Page 68: ...t to print out the realtime OxyCRG 5 Record Through this button you can print out the currently displayed OxyCRG trends by the recorder 6 4 Viewing Other Patients 6 4 1 Care Group You can select up to 10 patient monitors connected to the same LAN into a Care Group This lets you View information on the monitor screen from another bed in the same Care Group Be notified of physiological and technical...

Page 69: ...al alarms or medium level technical alarms Blue indicates the bed is giving low level technical alarms Grey indicates the bed fails to be networked or stays in the standby mode You can view a Care Group bed s alarms by selecting it from the care group and as well you can select the View This Patient button to view this bed in the View Other Patient window For more details about Care Group alarms r...

Page 70: ...rompt messages coming from the currently viewed patient 5 Alarm Reset button When Reset Other Bed s Alarms is set to On in Maintenance ė User Maintenance ė Alarm Setup the Alarm Reset button appears on the View Other Patient window You can reset the alarm system for the selected monitor by pressing the button Refer to 7 11 3 Resetting Care Group Alarms for details When Reset Other Bed s Alarms is ...

Page 71: ...Key or Main Menu Screen Setup Screen Layout Choose Screen 2 Select Big Numerics You can select your desired parameters to display in this screen select the Screens QuickKey Big Numerics Screen Setup and then select the parameters you want For parameters having a waveform the waveform will also be displayed ...

Page 72: ...6 8 FOR YOUR NOTES ...

Page 73: ...technical alarms and prompt messages 1 Physiological alarms Physiological alarms also called patient status alarms are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition Physiological alarm messages are displayed in the physiological alarm area 2 Technical alarms Technical alarms also called system status alarms are triggered by a device malfun...

Page 74: ...ent s life but may compromise the monitoring of vital physiological parameters Low level Indicate that you patient s vital signs appear abnormal and an immediate treatment may be required Indicate a device malfunction or an improper operation which may compromise a certain monitoring function but will not threaten the patient s life 7 3 Alarm Indicators When an alarm occurs the patient monitor wil...

Page 75: ...3 Flashing Numeric If an alarm triggered by an alarm limit violation occurs the numeric of the measurement in alarm will flash every second and the corresponding alarm limit will also flash at the same frequency indicating the high or low alarm limit is violated 7 3 4 Audible Alarm Tones The alarm tone is distinct from heart beat tone keystroke tone and pulse tone in frequency This monitor has thr...

Page 76: ... status NOTE z When multiple alarms of different levels occur simultaneously the patient monitor will select the alarm of the highest level light the alarm lamp and give alarm sounds accordingly while all the alarm messages are displayed circularly on the screen z Some physiological alarms such as asystole are exclusive They have identical alarm tones and alarm lights with normal high level physio...

Page 77: ... Select the appropriate volume from Alm Volume X 10 in which X is the minimum volume depending on the set minimum alarm volume and 10 the maximum volume 3 Select High Alarm Volume to set the volume of the high priority alarm as Alm Volume 0 Alm Volume 1 or Alm Volume 2 4 Select Reminder Vol to set the volume of the reminder tone as High Med or Low When alarm volume is set to 0 the alarm sound is t...

Page 78: ...nitor will give no audible alarm tones even if a new alarm occurs Therefore the user should be very careful about whether to switch off the alarm sound or not z Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level may result in a hazard to the patient Always keep the patient under close surveillance 7 4 4 Changing the Alarm Tone Patte...

Page 79: ...he Reminder Interval if the alarm condition persists To set the interval between reminder tones select Reminder Interval and toggle between 1min 2min and 3min In addition you can set the volume of alarm reminder tones To set the volume of alarm reminder tones select Main Menu Alarm Setup Others or the Alarm Setup QuickKey Others Then select Reminder Vol and toggle between High Medium and Low 7 5 U...

Page 80: ... related waveforms is possible when the measurement s On Off and Record are set on WARNING z Make sure that the alarm limits settings are appropriate for your patient before monitoring z 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...

Page 81: ...rules Module Parameter Low alarm limit High alarm limit Auto alarm limits range Adult pediatric Neonate Adult pediatric Neonate ECG HR PR HR 0 8 or 40bpm whichever is greater HR 30 or 90bpm whichever is greater HR 1 25 or 240bpm whichever is smaller HR 40 or 200bpm whichever is smaller Adult pediatric 35 to 240 Neonate 55 to 225 Resp RR RR 0 5 or 6 rpm whichever is greater RR 10 or 30 rpm whicheve...

Page 82: ... P1 P4 Arterial pressure IBP S SYS 0 68 ˇ10 mmHg SYS 15 or 45mmHg whichever is greater SYS 0 86 ˇ38 mmHg SYS 15 or 105mmHg whichever is smaller Adult 45 to 270 Pediatric 45 to 185 Neonate 35 to 115 IBP D Dia 0 68 6 mmHg Dia 15 or 20mmHg whichever is greater Dia 0 86 32 mmHg Dia 15 or 80mmHg whichever is smaller Adult 25 to 225 Pediatric 25 to 150 Neonate 20 to 90 IBP M Mean 0 68 8 mmHg Mean 15 or ...

Page 83: ...g 35 to 45mmHg etCO2 6 mmHg 35 to 45mmHg etCO2 6 mmHg 45 to 48mmHg 39 mmHg 45 to 48mmHg 39 mmHg 45 to 48mmHg 51 mmHg 45 to 48mmHg 51 mmHg 48mmHg remains the same 48mmHg remains the same 48mmHg remains the same 48mmHg remains the same FiCO2 N A N A Same as the default alarm limit Same as the default alarm limit Same as the measurement range awRR awRR 0 5 or 6 rpm whichever is greater awRR 10 or 30 ...

Page 84: ...word and then select Ok 2 Select Alarm Setup Alarm Delay Alarm delay is not applied to the following physiological alarms Apnea ST alarms Arrhythmia alarms ECG Weak Signal Resp Artifact No Pulse Measurements of noncontinuous parameters over alarm limits HR over alarm limits You can set Apnea Delay and ST Alarm Delay separately 7 5 4 Setting SpO2 Technical Alarm Delay You can set Tech Alarm Delay i...

Page 85: ...and no alarms are sounded No numeric and alarm limit flash No alarm messages are shown The remaining pause time is displayed in the physiological alarm area The alarms paused symbol is displayed in the alarm symbol area The patient monitor enters into the alarm paused status as soon as it is turned on The alarm pause time is fixed to be 2 minutes When the alarm pause time expires the alarm paused ...

Page 86: ...rm off status As for physiological alarms no alarm lamps flash and no alarms are sounded As for physiological alarms no numeric and alarm limit flash No physiological alarm messages are shown Alarm Off is displayed in the physiological alarm area with red background As for technical alarms no alarms are sounded The alarm off symbol is displayed in the alarm symbol area You can cancel the alarm off...

Page 87: ...Light on Alarm Reset is set to Off the alarm lamp stops flashing Technical alarms give different alarm indicators when the alarm system is reset For some technical alarms including the NIBP related alarms a Ĝ appears before the alarm message and appears in the alarm symbol area indicating that the alarm is acknowledged Some technical alarms are changed to the prompt messages Some technical alarms ...

Page 88: ...essage and its background remains when the alarm condition ends When the audible indications are latched the monitor issues alarm sounds when the alarm condition ends To latch a physiological alarm 1 Select Main Menu ė Maintenance ė User Maintenance ėenter the required password 2 Select Alarm Setup ė Latching Alarms 3 In the Latching Alarms menu select how you want to latch the alarms The rules fo...

Page 89: ... background colors of the alarm symbols indicate alarm levels and are the same as those of the corresponding alarm messages If multiple alarms are active in the Care Group the background color is the same as that of the highest level alarm message For more information about the alarm message and background color see7 3 2 Alarm Message When a patient monitor in the Care Group is disconnected the fl...

Page 90: ...elect Main Menu ė Maintenance ė User Maintenance ėenter the required passwordė Alarm Setup 2 In the Alarm Setup menu set Alarm Reset By Other Bed to On 3 In the other monitor select the Alarm Reset button from the View Other Patient window WARNING z Resetting care group alarms may cause a potential hazard Please act with caution 7 12 When an Alarm Occurs When an alarm occurs observe the following ...

Page 91: ... other conductive parts including earth z Periodically inspect the electrode application site to ensure skin quality If the skin quality changes replace the electrodes or change the application site z Use defibrillation proof ECG cables during defibrillation z Do not touch the patient or table or instruments during defibrillation z This equipment is not suitable for direct cardiac application z To...

Page 92: ...ild soap and water solution We do not recommend using ether or pure alcohol because this dries the skin and increases the resistance Dry the skin completely before applying the electrodes 2 Attach the clips or snaps to the electrodes before placing them 3 Place the electrodes on the patient 4 Attach the electrode cable to the patient cable and then plug the patient cable into the ECG connector 8 3...

Page 93: ...right shoulder LA placement directly below the clavicle and near the left shoulder LL placement on the left lower abdomen 5 Leadwire Electrode Placement Following is an electrode configuration when using 5 leadwires RA placement directly below the clavicle and near the right shoulder LA placement directly below the clavicle and near the left shoulder RL placement on the right lower abdomen LL plac...

Page 94: ...the left midaxillary line horizontal with the V4 electrode position V3R V6R placement on the right side of the chest in positions corresponding to those on the left VE placement over the xiphoid process V7 placement on posterior chest at the left posterior axillary line in the fifth intercostal space V7R placement on posterior chest at the right posterior axillary line in the fifth intercostal spa...

Page 95: ...rodes near to the grounding plate of the ESU as this can cause a lot of interference on the ECG signal 8 3 4 Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG The paced symbol is displayed in the ECG waveform area when the Paced status is set to Yes The pace pulse markers are shown on the ECG wave when the patient has a paced signal If Paced is s...

Page 96: ...licable to pediatric and neonatal patients z False low heart rate indicators or false Asystole calls may result with certain pacemakers because of pacemaker artifact such as electrical overshoot of the pacemaker overlapping the true QRS complexes 8 4 Understanding the ECG Display Your display may be configured to look slightly different 1 Lead label of the displayed wave 2 ECG gain 3 ECG filter la...

Page 97: ...tient monitor will use the heart rate from the ECG measurements as the alarm source whenever a valid heart rate is available If the heart rate becomes unavailable for example the ECG module is turned off or becomes disconnected the patient monitor will automatically switch to PR as the alarm source 8 5 3 Setting the ECG Lead Set You can set the Lead Set by selecting ECG Setup Others You can set th...

Page 98: ... ST segment are visible Surgery Use when the signal is distorted by high frequency or low frequency interference High frequency interference usually results in large amplitude spikes making the ECG signal look irregular Low frequency interference usually leads to wandering or rough baseline In the operating room the surgery filter reduces artifacts and interference from electrosurgical units Under...

Page 99: ...hown on the ECG wave and the options of Pacer Reject are invalid 8 5 8 Changing ECG Wave Settings In the ECG Setup menu You can select ECG ECG1 or ECG2 to select a lead to view The waveform of selected lead should have the following characteristics The QRS should be either completely above or below the baseline and it should not be biphasic The QRS should be tall and narrow The P waves and T waves...

Page 100: ...based on the alarm source To adjust the QRS volume select Others from the ECG Setup menu select QRS Volume from the popup menu and select the appropriate setting When valid SpO2 measured value is available the system adjusts the pitch tone of QRS sound based on the SpO2 value 8 5 12 About the Defibrillator Synchronization If a defibrillator is connected a defibrillator synchronization pulse 100 ms...

Page 101: ...Select ST Analysis to toggle between On and Off Reliable ST monitoring can hardly be ensured if You are unable to get a lead that is not noisy Arrhythmias such as atrial fib flutter cause irregular baseline The patient is continuously ventricularly paced The patient has left bundle branch block In these cases you may consider switching ST monitoring off 8 6 2 Changing ST Filter Settings ST segment...

Page 102: ...merics with 5 lead ECG Your monitor screen may look slightly different from the illustration 8 6 3 2 ST Segment ST segment shows a QRS complex segment for each measured ST lead The current ST segment is drawn in the same color as the ECG wave usually green superimposed over the stored reference segment drawn in a different color The information is updated once every ten seconds To display the ST s...

Page 103: ...Analysis menu to save the current segment as reference Up to 20 reference segment groups can be saved NOTE z If the memory is full and you do not delete a group before saving a new one the oldest saved group is deleted automatically 8 6 5 Changing the Reference Segment Select the and arrow keys beside the Change Ref to switch between different reference segment groups ...

Page 104: ...ead and multi lead ST monitoring You can select ST Alarm Setup from ST Analysis menu and then change ST alarm settings for each lead 8 6 9 Setting the ST Alarm Delay Time To set the ST alarm delay time 1 Select Main Menu Maintenance User Maintenance Enter the required password and then select OK 2 Select Alarm Setup ST Alarm Delay 8 6 10 Adjusting ST Measurement Points As shown in the figure below...

Page 105: ...elect ISO J or ST Point and then use the Knob to adjust the position of each point The ISO point isoelectric position is given relative to the R wave peak Position the ISO point in the middle of the flattest part of the baseline between the P and Q waves The J point position is given relative to the R wave peak and helps locating the ST point Position the J point at the end of the QRS complex and ...

Page 106: ...r close surveillance 8 7 1 Understanding the Arrhythmia Events Arrhythmia message Description Category Asystole No QRS detected within the set time threshold in absence of ventricular fibrillation or chaotic signal Lethal arrhythmia VFib VTac A fibrillatory wave for 6 consecutive seconds A dominant rhythm of adjacent Vs and a HR the V Tac HR limit Vtac The consecutive PVCs Vtac PVCs limit and the ...

Page 107: ...R interval or HR is greater than or equal to 100 and the current RR interval is greater than 1000 ms Brady The average heart rate is lower than the bradycardia limit Tachy The average heart rate is greater than the tachycardia limit Vent Rhythm The consecutive PVCs is greater or equal to Vbrd PVCs limit and HR is greater or equal to Vbrd Rate limit but lower than Vtac Rate limit Multif PVC Multifo...

Page 108: ... arrhythmia alarms is always high It is unchangeable 8 7 3 Changing Arrhythmia Threshold Settings Select the ECG parameter window or waveform area Arrh Analysis Arrh Threshold and you can then change threshold settings for some arrhythmia alarms In case an arrhythmia violates its threshold an alarm will be triggered The asystole delay time relates to ECG relearning When HR is less than 30 bpm it i...

Page 109: ...enu Maintenance User Maintenance enter the required password select Alarm Setup and set Extended Arrh to Enable or Disable When Extended Arrh is set to Disable the patient monitor does not analysis the extended arrhythmia events and corresponding alarms are not given CAUTION z Set Extended Arrh to Disable when the patient monitor is connected to the Central Monitoring System of version prior to 06...

Page 110: ...A high heart rate causes the P wave to encroach on the end of the previous T wave The T wave is very flat or T wave are not well defined The end of the T wave is difficult to define because of the presence of U waves QTc measurements are not stable In the presence of noise asystole ventricular fibrillation and ECG lead off For these cases you should select a lead with good T wave amplitude and no ...

Page 111: ...o display QT numerics and Segments 4 Select Main Menu Screen Setup Screen Layout 5 Select the parameter area where you want to display the QT numerics and then select QT The following picture shows the QT parameter area 1 QTc alarm limit if QTc alarm is off the alarm off symbol is displayed 2 Parameter label 3 QTc value 4 QTc value the difference between the current and baseline QTc values 5 QT va...

Page 112: ... ECG Setup menu 2 Select the QT Analysis tab 3 Set QTc and QTc alarm properties 8 8 5 2 Selecting Leads for QT Calculation You can select one lead or all leads for QT calculation To select leads 1 Select the ECG parameter window or waveform area to enter the ECG Setup menu 2 Select the QT Analysis tab 3 Set Analysis Lead All is selected by default This means all leads are used for QT calculation 8...

Page 113: ...s area The area provides information including time duration average HR daytime average HR nighttime avearge HR maximum HR minimum HR and normal HR ratio The normal HR range is set based on HR limits Nighttime Set the period for HR analysis at night time The minimum period can be set to 30 minutes Print Select it to print out HR analysis report which includes patient information information in the...

Page 114: ... learning the message ECG Learning is displayed in the technical alarm area CAUTION z Take care to initiate ECG relearning only during periods of normal rhythm and when the ECG signal is relatively noise free If ECG learning takes place during ventricular rhythm the ectopics may be incorrectly learned as the normal QRS complex This may result in missed detection of subsequent events of V Tach and ...

Page 115: ...and 1 rhythm wave displayed on the screen The rhythm lead is consistent with what is set for ECG1 before entering the 12 lead ECG screen Additionally the 12 lead ECG monitoring has the following features The Filter mode is automatically switched to Diagnostic when the patient monitor accesses the 12 lead full screen the Filter mode resumes to the configuration before accessing the 12 lead full scr...

Page 116: ...ectrodes Defective electrode wires Replace wires if necessary Patient cable or leads are routed too close to other electrical devices Move the patient cable or leads away from the electrical device Excessive Electro surgical Interference Wrong ECG cable used Use ESU proof ECG cables For details refer to 26 1 ECG Accessories Muscle Noise Inadequate skin preparation prior to application of electrode...

Page 117: ...eparing the Patient and Placing the Electrodes This could be the patient s normal QRS complex Verify with another well functioning monitor Electrode could be positioned over a bone or muscle mass Move ECG patches away from the bone or muscle mass No ECG Waveform Gain set too low Set the gain as required For details refer to 8 5 8 Changing ECG Wave Settings Lead wires and patient cable not fully or...

Page 118: ...8 28 FOR YOUR NOTES ...

Page 119: ... be possible for the monitor to detect apnea If you set the detection level too low the monitor is more likely to detect cardiac activity and to falsely interpret cardiac activity as respiratory activity in the case of apnea z The respiration measurement does not recognize the cause of apneas It only indicates an alarm if no breath is detected when a pre adjusted time has elapsed since the last de...

Page 120: ...kin is necessary for a good Respiration signal You can refer to 8 Monitoring ECG for how to prepare the skin As the Respiration measurement adopts the standard ECG electrode placement you can use different ECG cables 3 lead or 5 lead Since the respiration signal is measured between two ECG electrodes if a standard ECG electrode placement is applied the two electrodes should be RA and LA of ECG Lea...

Page 121: ...t affects the Resp waveform is called cardiac overlay It happens when the Resp electrodes pick up impedance changes caused by the rhythmic blood flow Correct electrodes placement can help to reduce cardiac overlay avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes This is particularly important for neonates 9 4 3 Abdominal Breathing Some patients wi...

Page 122: ... between Auto and Manual In auto detection mode the patient monitor adjusts the detection level automatically depending on the wave height and the presence of cardiac artifact Note that in auto detection mode the detection level a dotted line is not displayed on the waveform Use auto detection mode for situations where The respiration rate is not close to the heart rate Breathing is spontaneous wi...

Page 123: ...on 9 8 Changing Resp Wave Settings WARNING z When monitoring in manual detection mode make sure to check the respiration detection level after you have increased or decreased the size of the respiration wave In the Resp Setup menu you can Select Gain and then select an appropriate setting The bigger the gain is the larger the wave amplitude is Select Sweep and then select an appropriate setting Th...

Page 124: ...is from impedance respiration measurement 9 10 Setting Alarm Properties Select Alarm Setup from the Resp Setup menu In the popup menu you can set alarm properties for this parameter 9 11 Switching Resp Measurement On Off To switch Resp measurement on select Imped Resp Measure ON from the Resp Setup menu To switch Resp measurement off select Imped Resp Measure OFF from the Resp Setup menu and then ...

Page 125: ...atabase and reviewed in the graphic tabular trends in trend graphs as the PR curve is in the same color with the PR source it is unlikely to distinguish the PR source is sent via the network to the central monitoring system if available To set which pulse rate as PR source 1 Enter the SpO2 Setup menu 2 Select PR Source and then select a label or Auto from the popup menu The popup menu displays the...

Page 126: ...the ECG measurement as the alarm source whenever the ECG measurement is switched on and a valid heart rate is available If the heart rate becomes unavailable for example if leads becomes disconnected and a pulse source is switch on and available the monitor will automatically switch to Pulse as the alarm source When the Leads Off condition is corrected the monitor will automatically switch back to...

Page 127: ...d hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin 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 quality of SpO2 measurement Above 1 is optimal Between 0 3 and 1 is acceptable Below 0 3 indicates low perfusion When PI is...

Page 128: ...ffect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements z Prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics such as irritation reddening blistering or burns Inspect the sensor site every two hours and move the sensor if the skin quality changes Change the application site every four hours For neonates or patients ...

Page 129: ...tch and alarm recording for Desat When the SpO2 value is below the desat alarm limit and desat alarm switch is set on the message SpO2 Desat is displayed 11 4 3 Changing Averaging Time The SpO2 value displayed on the monitor screen is the average of data collected within a specific time The shorter the averaging time is the quicker the patient monitor responds to changes in the patient s oxygen sa...

Page 130: ...n select the appropriate setting The faster the waveform sweeps the wider the waveform is 11 4 6 Zooming PI Value For Mindray SpO2 module you can display PI value in larger characters for better view To zoom in the display of PI value set PI Zoom to Yes from the SpO2 Setup menu 11 4 7 Setting the Alarm Level for SpO2 Sensor Off Alarm Select Alarm Setup from the User Maintenance menu You can set th...

Page 131: ...nd methemoglobin MetHb Presence of certain dyes such as methylene and indigo carmine Inappropriate positioning of the SpO2 sensor or use of incorrect SpO2 sensor Drop of arterial blood flow to immeaurable level caused by shock anemia low temperature or vasoconstrictor 11 6 Troubleshooting This section lists the problems that might occur If you encounter the problems when using the equipment or acc...

Page 132: ...y the sensor If not contact the service personnel Cables loose not connected Check connections switch cable Ambient light Check if the SpO2 Too Much Light alarm is reported If so move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light No SpO2 waveform Waveform not selected to display Switch the SpO2 monitoring function on as described in 3 10 ...

Page 133: ...llation with the greatest amplitude is the mean pressure This is the most accurate parameter measured by the oscillometric method Once the mean pressure is determined the systolic and diastolic pressures are calculated with reference to the mean Simply stated auscultation measures systolic and diastolic pressures and the mean pressure is calculated The oscillometric method measures the mean pressu...

Page 134: ...on the side of a mastectomy z 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 z Continuous CUFF pressure due to connection tubing kinking may cause blood flow interference a...

Page 135: ...at the level of the right atrium of the heart NOTE z It is recommended that the patient relaxes as much as possible before performing measurement and that the patient does not talk during NIBP measurement z It is recommended that 5 min should elapse before the first reading is taken z The operator should not touch the cuff or tubing during NIBP measurement 12 5 2 Preparing to Measure NIBP 1 Power ...

Page 136: ... or smaller cuff that will fit better 5 Connect the cuff to the air tubing and make sure that the air tubing is not compressed or twisted Air must pass unrestricted through the tubing NOTE z The use of the equipment is restricted to one patient at a time 12 5 3 Starting and Stopping Measurements Select the NIBP Measure QuickKey and you can start the desired measurement from the popup menu You can ...

Page 137: ...ments at the set time interval In auto mode you can enable the clock function to synchronize the NIBP automatic measurements with the real time clock For example when the clock is enabled if interval is 20min and then you start NIBP auto measurement at 14 03 the next measurement will be taken at 14 20 and the following measurement time will be 14 40 15 00 and so on To enable the clock in the NIBP ...

Page 138: ...abnormity occurs move the cuff to another site or stop the blood pressure measurements immediately 12 6 Understanding the NIBP Numerics The NIBP display shows numerics only as below Your display may be configured to look slightly different 1 Time of last measurement 2 Time remaining to next measurement 3 Measurement mode 4 Unit of pressure mmHg or kPa 5 Systolic pressure 6 Diastolic pressure 7 Mea...

Page 139: ... NIBP night time minimum NIBP and normal NIBP ratio The normal NIBP range is set based on NIBP limits Nighttime Set the period for NIBP analysis at night time The minimum period can be set to 30 minutes Print Select it to print out the NIBP analysis report You can also click anywhere in the NIBPAnalysis window to enter the Review window For details refer to 18 Review 12 8 Changing NIBP Settings By...

Page 140: ... most recent NIBP measurements will be displayed And PR displayed is derived from NIBP You can not display NIBP list in some screens such as the big numerics screen 12 8 4 Setting the Pressure Unit Select Unit Setup from the User Maintenance menu In the popup menu select Press Unit and toggle between mmHg and kPa 12 8 5 Switching On NIBP End Tone The monitor can issue a reminder tone at the comple...

Page 141: ...cable from the T1 or T2 connector and the monitor can display the message T1 Sensor Off or T2 Sensor Off and give alarm tones correctly 13 3 Making a Temp Measurement 1 Select an appropriate probe for your patient according to the patient type and measuring site 2 If you are using a disposable probe connect the probe to the temperature cable 3 Plug the probe or temperature cable to the temperature...

Page 142: ...ng is displayed on the monitor as three numerics T1 T2 and TD By selecting this area you can enter the Alarm Setup menu 13 5 Setting the Temperature Unit Select Unit Setup from the User Maintenance menu In the popup menu select Temp Unit and toggle between ºC and ºF ...

Page 143: ...ers z Make sure that the applied parts never contact other conductive parts z To reduce the hazard of burns during high frequency surgical procedure ensure that the monitor s cables and transducers never come into contact with the high frequency surgical units z When using accessories their operating temperature should be taken into consideration For details refer to instructions for use of access...

Page 144: ...ric pressure by turning on the stopcock to the air 3 In the setup menu for the pressure e g Art select Art Zero Zero During zero calibration the Zero button appears dimmed It recovers after the zero calibration is completed To zero all IBP channels select Zero IBP QuickKey and then select Zero All Channels in the popup menu 4 After the zero calibration is completed close the stopcock to the air an...

Page 145: ...sion solution again Air bubble may lead to wrong pressure reading 4 Connect the pressure line to the patient catheter 5 Position the transducer so that it is level with the heart approximately at the level of the midaxillary line 6 Select the appropriate label 7 Zero the transducer After a successful zeroing turn off the stopcock to the atmosphere and turn on the stopcock to the patient Heparinize...

Page 146: ...below shows the waveform and numerics for the Art pressure For different pressures this display may be slightly different 1 Waveform 2 Pressure unit 3 Systolic pressure 4 Diastolic pressure 5 Mean pressure For some pressures the parameter window may show the mean pressure only For different pressures their defaults unit may be different If the Art and ICP pressures are measured simultaneously the ...

Page 147: ...from the list The already displayed labels cannot be selected Label Description Label Description PA Pulmonary artery pressure CVP Central venous pressure Ao Aortic pressure LAP Left atrial pressure UAP Umbilical arterial pressure RAP Right atrial pressure BAP Brachial arterial pressure ICP Intracranial pressure FAP Femoral arterial pressure UVP Umbilical venous pressure Art Arterial blood pressur...

Page 148: ...c time The shorter the averaging time is the quicker the patient monitor responds to changes in the patient s blood pressure Contrarily the longer the averaging time is the slower the patient monitor responds to changes in the patient s blood pressure but the measurement accuracy will be improved For critically ill patients selecting shorter averaging time will help understanding the patient s sta...

Page 149: ...bbles in tubing Eliminate air from tubing as described in 14 4 Setting Up the Pressure Measurement Kinked catheter Change the position of catheter Blood in tubing Pressurize the solution bag to 300 mmHg For details refer to the instructions for use of the solution bag IBP not displayed no IBP waveform Improper setup Check display setup in monitor setup Cable not plugged in Check that the cables ar...

Page 150: ...djust the position of the transducer and make sure that it is level with the heart approximately at the level of the midaxillary line Zero the transducer as described in 14 3 Zeroing the Transducer Unable to Zero Stopcock not open to atmosphere Check the transducer and make sure the stopcock is turned to the air ...

Page 151: ... curve in the C O split screen and the monitor calculates the C O value from this curve The C O value is inversely proportional to the area under the curve As cardiac output varies continuously a series of measurements must be carried out to achieve a reliable C O average value Always use the average of multiple thermodilution measurements for therapy decisions The monitor is capable of storing 6 ...

Page 152: ... is being performed Followings are some technique suggestions to obtain accurate C O Injectate solution must be cooler than the patient s blood Inject solution rapidly and smoothly Inject at end expiration 15 4 Setting Up the C O Measurement WARNING z Use only accessories specified in this manual Make sure that the accessories never come into contact with conductive parts 1 Connect the C O cable t...

Page 153: ...and temperature To change the computation constant select Comp Const and then enter the correct value When a new catheter is used the computation constant should be adjusted in accordance with the manufacturer s instructions for use Set the Auto TI to Manual or Auto If you select Auto the system automatically detects the injectate temperature and the Manual TI is disabled If you select Manual you ...

Page 154: ... figure above during the measurement the currently measured thermodilution curve is displayed At the end of the measurement the thermodilution curve is transferred to one of the 6 measurement windows and the monitor prompts you to wait for a certain period of time before starting a new measurement In Auto measure mode the monitor consecutively takes C O measurements automatically without the need ...

Page 155: ...rea you can Select Start to start a C O measurement Select Stop to stop the current measurement Select Cancel during a measurement to cancel the measurement Selecting it after a measurement deletes the measured results Select Record to print out the curves selected for average calculation numerics and averaged values by the recorder Select Setup to access the C O Setup menu Select Calc ė Hemodynam...

Page 156: ...They will automatically recover as soon as the C O measurements are completed 15 6 Changing C O Settings 15 6 1 Setting the Temperature Unit Select Unit Setup from the User Maintenance menu In the popup menu select Temp Unit to toggle between ć and 15 6 2 Setting Alarm Properties Select Alarm Setup from the C O Setup menu You can set alarm properties for this parameter in the popup menu Balloon Se...

Page 157: ...s calculated CO2 measurements are used to monitor the patient s respiratory status CO2 monitoring is intended for adult pediatric and neonatal patients 16 2 Safety WARNING z Remove the airway sampling line from the patient s airway while nebulized medications are being delivered z Leakage in the breathing or sampling system may cause the displayed EtCO values to be significantly low Always make su...

Page 158: ...on I E ratio 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 16 4 Understanding CO2 Display The CO2 parameter and waveform areas provide FiCO2 measurement EtCO2 measurement awRR measurement and a CO2 waveform 1 CO...

Page 159: ...d then connect the sampling line to the watertrap as shown below If you use DRYLINE PRIME watertrap mini connect the DRYLINE PRIME receptacle to the watertrap receptacle connect the DRYLINE PRIME watertrap mini to the DRYLINE PRIME receptacle adapter and then connect the DRYLINE PRIME sampling line to the watertrap mini as shown below Watertrap receptacle DRYLINE II watertrap Sampling line DRYLINE...

Page 160: ...e the nasal cannula onto the patient 4 Connect the gas outlet to the scavenging system using an exhaust tube After the CO2 module is connected to the SMR it enters measure mode by default and the monitor displays CO2 Starting CO2 can be measured after the start up is complete WARNING z Connect the gas outlet to the scavenging system when measuring CO2 Connect to the patient Connect to the ventilat...

Page 161: ...y the filter in watertrap and fail to stop the bacterium water and secretions entering the module result in damaging the gas module and having infection risk NOTE z Do not apply adult watertrap to the neonate patient Otherwise patient injury could result z To extend the lifetime of the watertrap and module disconnect the watertrap from the module and set the operating mode to Standby mode when CO2...

Page 162: ...CO2 Unit 16 6 3 Setting the CO2 Waveform In the CO2 Setup menu you can Select Wave Type and toggle between Draw and Fill Draw The CO2 wave is displayed as a curved line Fill The CO2 wave is displayed as a filled area Select Sweep and then select the appropriate setting The faster the wave sweeps the wider the wave is Change the size of the CO2 waveform by adjusting the wave Scale 16 6 4 Setting th...

Page 163: ...lly after the configured period of time if no breath is detected since the last detected breath To set the auto standby follow this procedure 1 Select the CO2 parameter area or waveform area to enter the CO2 Setup menu 2 Set Auto Standby 16 6 7 Setting the Gas Compensations The presence of interfering gas affects the CO2 measurement To get the best possible measuring result it is needed to set the...

Page 164: ...BTPS 100 47 2 2 u amb CO P vol CO mmHg P Where 2 CO P partial pressure vol CO2 concentration amb P ambient pressure and unit is mmHg To set the humidity compensation 1 Select the CO2 parameter area or waveform area to enter the CO2 Setup menu 2 Select BTPS Compen and then toggle between On and Off Switch on for BTPS Switch off for ATPD 16 7 Calibrating the CO2 Module A calibration should be perfor...

Page 165: ...he freeze feature exerts no effect on the split screen view of minitrends OxyCRG and other patients 17 2 Viewing Frozen Waveforms To view the frozen waveforms you can either Select the Scroll button and then rotate the Knob clockwise or counter clockwise or Directly select the or beside the Scroll button using a mouse or through the touchscreen The frozen waveforms will scroll left or right accord...

Page 166: ...erform any other action that causes the screen to be readjusted or opens a menu such as plugging in or out a module pressing the hardkey etc 17 4 Recording Frozen Waveforms 1 In the Freeze menu select in turn Wave 1 Wave 2 and Wave 3 and then select your desired waveforms 2 Select the Record button The selected waveforms and all numerics at the frozen time are printed out by the recorder ...

Page 167: ...r respective review windows 18 2 Reviewing Graphic Trends In the Review menu select Graphic Trends to access the following window 1 Event mark area 2 Time axis 3 Graphic trends area 4 Parameter area 5 Cursor Events are marked with colors in the event mark area Red represents high level alarm event Yellow represents medium low level alarm event Green represents manual event 1 2 3 4 5 ...

Page 168: ...r to move the cursor one page to the left or right to navigate through the graphic trends A time indicating your current position is displayed above the parameter area Numeric measurement values corresponding to the cursor location change as the cursor is moved The measurement value that triggered high level alarm has red background The one that triggered medium low level alarm has yellow backgrou...

Page 169: ...elect the parameters for viewing in the popup menu You can change the resolution of the trend data by selecting Interval and then selecting the appropriate setting 5 s or 30 s select to view up to 4 hours of tabular trends at 5 or 30 second resolution 1 min 5 min 10 min 15 min 30 min 1 h 2 h or 3 h select to view up to 120 hours of tabular trends at your selected resolution NIBP select to view the...

Page 170: ...can set and print out the tabular trends report by the printer For how to set the tabular trends report please refer to 21 Printing 18 4 Reviewing Events The monitor saves the events in real time You can review these events In the Review menu select Events to access the following window The events that can be reviewed include parameter alarm events arrhythmia alarm events and manual events When an...

Page 171: ...he saved events z Earlier recorded events might be overwritten by later ones if it reaches capacity 1 Waveform area 2 Parameter area In this window You can select or to navigate through the waveforms You can select or beside the Event button to switch between events You can set the desired Gain for ECG waveform You can set the desired Sweep By selecting the Record button you can print out the curr...

Page 172: ...ither Select or beside the Scroll button to move the cursor one step left or right to navigate through the waveforms or Select or to move the cursor one page left or right to navigate through the waveforms A time indicating your current position is displayed at the top of the waveform area Numeric measurement values corresponding to the cursor location are displayed in the parameter area and chang...

Page 173: ...8 7 By selecting the Record button you can print out the first three waveforms and measurement numerics by the recorder By selecting or beside the Event button you can position the cursor between events ...

Page 174: ...18 8 FOR YOUR NOTES ...

Page 175: ...culations QuickKey and then select the calculation you want to perform NOTE z The calculation feature is independent of other monitoring functions and can be therefore used for patients being monitored by other monitors Any operation in a calculation window does not affect the patient monitoring by the local patient monitor WARNING z After the calculation is finished verify the entered values are ...

Page 176: ...alculated values The user must enter values following the doctor s instructions and then the calculated values can only be used 4 Enter the patient s weight 5 Enter other values 6 Verify if the calculated values are correct 19 2 2 Selecting the Proper Drug Unit Each drug has its fixed unit or unit series Among a unit series one unit may change to another automatically depending on the entered valu...

Page 177: ...val Dose Type The titrated values change accordingly You can also Select or or or beside the vertical scrollbar to view more values Select Record to print out the currently displayed titrated values by the recorder 19 2 4 Drug Calculation Formulas Abbreviation Unit Formula Conc g ml unit ml or mEq ml Amount Volume Dose Dose hr Dose kg min Rate Conc Volume ml Rate Duration Amount g unit mEq Rate Du...

Page 178: ...e values you have entered 3 Select the Calculate button The system performs a calculation per the current settings and displays the calculated values If a calculated value is outside the range its background will highlight in yellow You can select Range to view its normal range in the unit field Invalid values are displayed as In the Hemodynamic Calculation window you can Trigger a recording by se...

Page 179: ...PVR DS cm5 pulmonary vascular resistance 79 96 PAMAP ˉ PAWP C O PVRI DS m2 cm5 pulmonary vascular resistance index PVR BSA LCW kg m left cardiac work 0 0136 APMAP C O LCWI kg m m2 left cardiac work index LCW BSA LVSW g m left ventricular stroke work 0 0136 APMAP SV LVSWI g m m2 left ventricular stroke work index LVSW BSA RCW kg m right cardiac work 0 0136 PAMAP C O RCWI kg m m2 right cardiac work ...

Page 180: ...ion window In this review window You can select or to view more values The values that exceed the range are displayed in yellow background The Unit field displays parameter units If some parameter values are outside of their normal ranges you can view their normal range in the Unit field by selecting Range You can review an individual calculation by selecting its corresponding column and then sele...

Page 181: ...p to three waveforms etc 1 Start Stop key press to start a recording or stop the current recording 2 Indicator On when the recorder works correctly Off when the monitor is switched off Flashes if an error occurred to the recorder e g the recorder runs out of paper 3 Paper outlet 4 Latch 5 Recorder door 3 5 2 1 4 ...

Page 182: ...g and Stopping Recordings To manually start a recording you can either Select the hardkey on the recorder module or Select the Record button from the current menu or window Automatic recordings will be triggered in the following conditions Timed recordings will start automatically at preset intervals If both Alarm and Alm Rec for a measurement are set on an alarm recording will be triggered automa...

Page 183: ... are intended for realtime and scheduled recordings 20 4 3 Setting the Realtime Recording Length After starting a realtime recording the recording time depends on your monitor s settings In the Record Setup menu select Length and toggle between 8 s and Continuous 8 s record 4 second waveforms respectively before and after current moment Continuous record the waveforms from the current moment until...

Page 184: ...as shown below 3 Close the recorder door 4 Check if paper is loaded correctly and the paper end is feeding from the top CAUTION z Use only specified thermal paper Otherwise it may cause damage to the recorder s printhead the recorder may be unable to print or poor print quality may result z Never pull the recorder paper with force when a recording is in process Otherwise it may cause damage to the...

Page 185: ...deposits of paper debris may collect on the printhead compromising the print quality and shortening the lifetime of the roller Follow this procedure to clean the printhead 1 Take measures against the static electricity such as Disposable Wrist Strap for the work 2 Open the recorder door and take out the paper 3 Gently wipe around the printhead using cotton swabs dampened with alcohol 4 After the a...

Page 186: ...20 6 FOR YOUR NOTES ...

Page 187: ...ith the upgrading of products the monitor will support more printers and no prior notice will be given If you have any doubt about the printer you have purchased contact our company 21 2 Connecting a printer To print the reports or the trend data of a patient you can choose either the local printer Connect the printer and the patient monitor through the network and then start printing what you wan...

Page 188: ...s ECG waveforms and relevant parameter values Select Main Menu Print Setup ECG Reports Print Tabular trends Depend on the selected parameter group resolution and time period Select Main Menu Print Setup Tabular Trends Reports Print or select Main Menu Review Tabular Trends Print Print Graphic trends Depend on the selected parameter group resolution and time period Select Main Menu Print Setup Grap...

Page 189: ...nds Reports Date Select the desired date on which a tabular trends report is recorded for printing Start time You can set a time period whose trend data will be printed out by setting From and Back For example if you set From as 2007 4 2 10 00 00 and Back as 2 h the outputted data will be from 2007 4 2 08 00 00 to 2007 4 2 10 00 00 In addition the Back can be set to either Auto If Report Layout is...

Page 190: ...s similar with tabular trends reports you can refer to the 21 6 2 Setting Up Tabular Trends Reports for details 21 6 4 Setting Up Realtime Reports To set up realtime reports select Main Menu ė Print Setup ė Realtime Reports Sweep set the wave print speed to 12 5 mm s 25 mm s 50 mm s or Auto Select Wave from the popup menu you can Current select the currently displayed waves for printing Select Wav...

Page 191: ...er Status Messages Printer Status Message Possible causes and suggested action Printer unavailable The selected printer is not available Check if the printer is switched on or correctly connected or installed with paper ...

Page 192: ...21 6 FOR YOUR NOTES ...

Page 193: ...rmity and technical alarms into the log You can export the log to a USB drive To export the log 1 Connect a USB drive to the monitor s USB connector See 2 2 3 Rear View for the proper location of the USB connector 2 Select Main Menu ė Maintenance ė User Maintenance ėenter the required passwordė Others 3 Select Export Log 22 3 Transferring Data You can transfer the patient data saved in the monitor...

Page 194: ... network cable to the patient monitor and the other end to the PC 2 Set the IP address of the PC This IP address must be in the same network segment with that of the patient monitor 3 Make sure that the data export system is active on the PC Then follow this procedure to transfer data 1 Select Main Menu Patient Data Transfer Data 2 Select Yes from the popup message box 3 Input the IP address alrea...

Page 195: ... the alarm ends i e the duration of a nurse call signal equals to that of the alarm condition Select Contact Type and toggle between Normally Open and Normally Closed Normally Open select if your hospital s nurse call relay contact is normally open Normally Closed select if your hospital s nurse call relay contact is normally closed Select Alm Lev and set the alarm level for nurse call triggering ...

Page 196: ... Network Setup ė Monitor Network Setup 2 Set Network Type to LAN 3 Set Address Type DHCP the monitor can automatically acquire network parameters Manual you need to manually input the monitor IP address subnet mask and gateway address 22 5 3 Setting the Wireless Network The patient monitors can be connected to a wireless network via a built in Wi Fi module To set the wireless network 1 Select Main...

Page 197: ...ge of the CMS NOTE z The design installation restruction and maintenance of the wireless network s distribution shall be performed by authorized service personnel of our company z The existence of obstacles such as wall will exert impact on data transferring or even cause network interruption z The Central Monitoring System is capable of connecting up to 32 bedside monitors via the wireless networ...

Page 198: ...f admitting a monitor Setting the CMS refer to 22 5 6 1 Setting the CMS for details and then selecting a CMS refer to 22 5 6 2 Selecting a CMS for details 22 5 6 1 Setting the CMS You can configure up to 30 central stations CMS for your monitor To set the CMSs 1 Select Main Menu ė Maintenance ė User Maintenance ėenter the required passwordė Network Setup 2 Set Select CMS to On 3 Select Central Sta...

Page 199: ...shuts down automatically Indicates that no battery is installed The capacity of the internal battery is limited If the battery charge is too low a technical alarm will be triggered and the message or displayed At this moment apply AC power to the patient monitor Otherwise the patient monitor will power off automatically before the battery is completely depleted 23 2 Battery Guidelines Life expecta...

Page 200: ...ditioned before it is used for the first time A battery conditioning cycle is one uninterrupted charge of the battery followed by an uninterrupted battery discharge and charge Batteries should be conditioned regularly to maintain their useful life NOTE z The actual battery capacity will decrease over time with use of batteries When a monitor operates on batteries that have been used before the ful...

Page 201: ...cts its performance directly Please replace the battery or contact with the maintenance personnel if its operating time is significantly lower than the specified time NOTE z The battery might be damaged or malfunctioned if its operating time is too short after being fully charged The operating time depends on the configuration and operation For example measuring NIBP more frequently will also shor...

Page 202: ...23 4 FOR YOUR NOTES ...

Page 203: ...ccessories 24 1 General Points Keep you equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules Always dilute according the manufacturer s instructions or use lowest possible concentration Do not immerse part of the equipment into liquid Do not pour liquid onto the equipment or accessories Do not allow liquid to enter the case Never use abrasive material...

Page 204: ... cleaning the equipment Recommended cleaning agents are Product Name Product Type Ingredient Water Liquid Ethanol Liquid Ethanol 70 Isopropyl alcohol Liquid Isopropyl alcohol 70 Sodium hypochlorite bleach Liquid Sodium hypochlorite bleach 10 Hydrogen peroxide Liquid Hydrogen peroxide 3 1 Propanol Liquid 1 Propanol 50 Rely OnTM Virkon Powder Used as 1 solution prepared the concentration directed by...

Page 205: ...pping from the cloth 3 Wipe off all the cleaning solution with a dry cloth after cleaning if necessary 4 Dry your equipment in a ventilated cool place 24 3 Disinfection Disinfect the equipment as required in your hospital s servicing schedule Cleaning equipment before disinfecting is recommended 24 4 Sterilization Sterilization is not recommended for this monitor related products accessories or su...

Page 206: ...24 4 FOR YOUR NOTES ...

Page 207: ...uipment 25 1 Regular Inspection Before the first use after your patient monitor has been used for 6 to 12 months or whenever your patient monitor is repaired or upgraded a thorough inspection should be performed by qualified service personnel to ensure the reliability Follow these guidelines when inspecting the equipment Make sure that the environment and power supply meet the requirements Inspect...

Page 208: ...O2 tests Leakage test Performance test Calibration Performance Tests ECG test and calibration Performance Test 1 If the user suspects that the measurement is incorrect 2 Following any repairs or replacement of relevant module 3 At least once every two years At least once a year is recommended for NIBP and CO2 Calibration Resp performance test SpO2 test NIBP test Pressure check Leakage test Temp te...

Page 209: ...so view the information about the monitor configuration and system software version by selecting Main Menu Maintenance Software Version 25 4 Calibrating ECG The ECG signal may be inaccurate due to hardware or software problems As a result the ECG wave amplitude becomes greater or smaller In that case you need to calibrate the ECG module 1 Select the ECG parameter window or waveform area Filter Dia...

Page 210: ...nnector on the monitor 3 Wrap the cuff around the cylinder as shown below 4 Select Main Menu Maintenance ė User Maintenance Enter the required password and then select OK 5 Select Module Maintenance ė NIBP Leakage Test The NIBP display shows Leakage Testing After about 20 seconds the monitor will automatically deflate This means the test is completed If the message NIBP Pneumatic Leak is displayed...

Page 211: ...pump after the reading is 0 3 Select Main Menu Maintenance ė User Maintenance Enter the required password and then select OK 4 Select Module Maintenance NIBP Accuracy Test 5 Check the manometer values and the monitor values Both should be 0mmHg 6 Raise the pressure in the rigid vessel to 50 mmHg with the balloon pump Then wait for 10 seconds until the measured values become stable 7 Compare the ma...

Page 212: ... not disappear it indicates that the module does not leak 25 6 2 CO2 Accuracy Test For the CO2 module leakage test is needed every year or when you suspect the measurement Tools required A steel gas cylinder with 6 0 05 CO2 and balance gas N2 T shape connector Tubing Follow this procedure to perform the test 1 Connect the CO2 module with the patient module 2 Wait until the CO2 module warmup is fin...

Page 213: ...NING z Connect an exhaust tube to the gas outlet connector of the monitor to remove the calibration gases to a scavenging system Tools required A steel gas cylinder with 6 0 05 CO2 and balance gas N2 T shape connector Tubing Follow this procedure to perform a calibration 1 Make sure that the CO2 module has been warmed up or started up 2 Check the airway for leakage and perform a leakage test as we...

Page 214: ...bration Completed is displayed in the Calibrate CO2 menu If the calibration failed the message Calibration Failed is displayed In this case perform another calibration 25 7 Calibrating the Touchscreen 1 Select Main Menu Maintenance Cal Touchscreen 2 will in turn appear at different positions of the screen 3 Select each as it appears on the screen 4 After the calibration is completed the message Sc...

Page 215: ...tient monitor or not meet the claimed specifications z Single use accessories are not designed to be reused Reuse may cause a risk of contamination and affect the measurement accuracy z Check the accessories and their packages for any sign of damage Do not use them if any damage is detected z Use the accessories before the expiry date if their expiry date is indicated z The disposable accessories ...

Page 216: ...ble with Type Patient Category Part No 3 leadwire AHA IEC Defibrillation proof Infant neonate 0010 30 42720 3 leadwire AHA IEC ESU proof 0010 30 42724 3 5 leadwire AHA IEC Defibrillation proof Adult pediatric 009 004728 00 3 5 leadwire AHA IEC ESU proof 0010 30 42723 12 leadwire AHA Defibrillation proof Adult 0010 30 42721 12 leadwire IEC Defibrillation proof 0010 30 42722 Cable Sets 3 Electrode C...

Page 217: ...tric 0010 30 42730 1m to 1 4m Long AHA EL6503A 0010 30 42729 1m to 1 4m Long Snap IEC EL6502B 009 004730 00 1 4m for F and N 1m for others Long AHA EL6501B 009 004729 00 1 4m for RL and LL 1m for others Long 12 Electrode Cable Sets for uMEC12 uMEC15 Type Compatible with Model Patient Category Part No Length Remark Clip IEC EL6802A Adult 0010 30 42903 0 8m Limb EL6804A 0010 30 42905 0 6m Chest AHA ...

Page 218: ...oe 009 005089 00 521I 009 005093 00 520N Neonate Foot 009 005090 00 521N 009 005094 00 Reusable 562A All 009 004600 00 518B Neonate Foot 518B 30 72107 518BLH Neonate Foot 115 020887 00 512E Adult Finger 512E 30 90390 512F 512F 30 28263 512FLH 115 012807 00 512G Pediatric Finger 512G 30 90607 512H 512H 30 79061 Wavelength emitted by the sensors is between 600 nm and 1000 nm The maximum photic outpu...

Page 219: ...7 to 13 5 8 040 000968 00 CM1301 Infant 10 to 19 9 2 040 000973 00 CM1302 Pediatric 18 to 26 12 2 040 000978 00 CM1303 Adult 24 to 35 15 1 040 000983 00 CM1304 Large adult 33 to 47 18 3 040 000988 00 CM1305 Large adult Thigh 46 to 66 22 5 040 000993 00 CM1306 Adult Arm 24 to 35 15 1 115 015930 00 CM1307 Large adult Arm 33 to 47 18 3 115 015931 00 Disposable Cuff Model Patient Category Measurem ent...

Page 220: ...nsion cable reusable MR420B Applicable to sensor MR411 and MR412 040 001235 00 Temp Probes Type Model Patient Category Measurement Site Part No Reusable MR401B Adult Esophageal Rectal 0011 30 37392 MR403B Skin 0011 30 37393 MR402B Pediatric infant Esophageal Rectal 0011 30 37394 MR404B Skin 0011 30 37395 Disposable MR411 Adult pediatric Esophageal Rectal 045 001860 00 MR412 Adult pediatric Skin 04...

Page 221: ...posable Pressure Transducer 045 001014 00 045 001016 00 045 001018 00 2 Channel Pressure Transducer 045 001020 00 045 001022 00 045 001024 00 It is proved through tests that the following accessories are compatible with the patient monitor Only the accessories proceeded by are available from our company If you want to purchase other accessories contact respective manufacturers and make sure if the...

Page 222: ...e 100 000144 00 DRYLINE PRIME Gas Sampling Line With Airway Adapter Adult Pediatric 100 000140 00 DRYLINE PRIME Gas Sampling Line With Airway Adapter Neonate 100 000141 00 DRYLINE PRIME Nasal Gas Sampling Line Adult 100 000145 00 DRYLINE PRIME Nasal Gas Sampling Line Pediatric 100 000146 00 DRYLINE PRIME Nasal Gas Sampling Line Neonate 100 000147 00 DRYLINE PRIME Gas Watertrap Mini 100 000151 00 A...

Page 223: ...0 Defibrillator synchronization cable 009 003118 00 LCD display 19 023 001129 00 USB drive 4G 023 000217 00 023 000218 00 Recorder 115 001290 00 Thermal paper A30 000001 Wall mounting bracket for external display 045 000931 00 Trolley mounting bracket 045 000924 00 045 000921 00 Hook mounting kit 115 037484 00 115 037909 00 Bedrail Hook 8000 30 90169 Cable protecting tube 009 003648 00 Accessories...

Page 224: ...26 10 FOR YOUR NOTES ...

Page 225: ...n Continuous Degree of protection against harmful ingress of water IPX1 Protected against vertically falling water drops A 1 2 Environmental Specifications WARNING z The equipment may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges Main unit Item Operating conditions Storage conditions Temperature ć 0 to 40 20 to 60 Relative humidity ...

Page 226: ...BP measurements at an interval of 15 minutes Charge time When the monitor is powered off less than 3 5 hours to 90 less than 4 hours to 100 When the monitor is in use less than 5 5 hours to 90 less than 6 hours to 100 Shutdown delay at least 5 min after a low battery alarm first occurs Battery optional configuration Battery Type Chargeable Lithium Ion 11 1DVC 5 Ah Run time uMEC15 6 h uMEC10 uMEC12...

Page 227: ...les uMEC12 345 160 255 mm 4 0 kg uMEC10 315 155 220 mm 3 5 kg A 4 Hardware Specifications A 4 1 Display Host display Model Screen Size diagonal Screen type Resolution uMEC15 15 inches color LED backlight LCD at least 1024 768 pixels uMEC12 12 1 inches at least 800 600 pixels uMEC10 10 4 inches External display Screen type Medical grade LED backlight LCD A 4 2 Recorder Method Thermal dot array Pape...

Page 228: ...C power input connector Wired network 1 RJ45 connector 100 Base TX IEEE 802 3 USB 2 connector USB 2 0 Equipotential Grounding Terminal 1 Multifunctional connector 1 VGA connector 1 A 4 6 Outputs Analog Output Standard Meets the requirements of IEC60601 1 for short circuit protection and leakage current ECG Analog Output Bandwidth 3dB reference frequency 10Hz Diagnostic mode Monitor mode Surgical m...

Page 229: ...e width 100 ms 10 Rising and falling time 1 ms Alarm output Network connector Alarm delay time from the patient monitor to remote equipment The alarm delay time from the patient monitor to remote equipment is 2 seconds measured at the monitor s signal output connector A 5 Data Storage Trends Trends 120 hours at 1 min resolution Mid length trends 4 hours at 5 s resolution Long trends 1200 hours at ...

Page 230: ...itivity 1 25 mm mV X0 125 2 5 mm mV X0 25 5 mm mV X0 5 10 mm mV X1 20 mm mV X2 40 mm mV X4 Accuracy 5 Sweep speed 6 25 mm s 12 5 mm s 25 mm s 50 mm s Accuracy 5 Bandwidth 3dB Diagnostic mode Monitor mode Surgical mode ST mode 0 05 to 150 Hz 0 5 to 40 Hz 1 to 20 Hz 0 05 to 40 Hz Common mode rejection ratio with Notch off Diagnostic mode Monitor mode Surgical mode ST mode 90 dB 105 dB 105 dB 105 dB ...

Page 231: ...accordance with the IEC60601 2 27 201 12 1 101 13 the heart rate meter rejects all pulses meeting the following conditions Amplitude Width Rise time 2 to 700 mV 0 1 to 2 ms 10 to 100 μs HR Measurement range Neonate Pediatric Adult 15 to 350 bpm 15 to 350 bpm 15 to 300 bpm Resolution 1 bpm Accuracy 1 bpm or 1 whichever is greater Sensitivity 200 V lead II HR averaging method In compliance with the ...

Page 232: ...4bh range 4b range 4bd range 11 s 11 s 11 s 11 s 11 s 11 s Tall T wave rejection capability When the test is performed based on Clause 201 7 9 2 9 101 b 2 of IEC60601 2 27 the heart rate meter will reject all 100 ms QRS complexes with less than 1 2 mV of amplitude and T waves with T wave interval of 180 ms and those with Q T interval of 350 ms Arrhythmia Analysis Classifications Asystole VFib VTac...

Page 233: ...1k resistance Bandwidth 0 2 to 2 5 Hz 3 dB Sweep speed 3 mm s 6 25 mm s 12 5 mm s 25 mm s or 50 mm s Accuracy 5 Respiration Rate Measurement range Adult Pediatric neonate 0 to 120 rpm 0 to 150 rpm Resolution 1 rpm Accuracy 7 to 150 rpm 0 to 6 rpm 2 rpm or 2 whichever is greater Not specified Apnea alarm time 10 s 15 s 20 s 25 s 30 s 35 s 40 s Alarm limit Range rpm Step rpm RR High Adult pediatric ...

Page 234: ...curacy of Pulse Oximeter with neonatal SpO2 sensors by contrast with a CO Oximeter Some neonates aged from 1 day to 30 days with a gestation age of 22 weeks to full term were involved in this study The statistical analysis of data of this study shows the accuracy Arms is within the stated accuracy specification Please see the following table Sensor type Totally neonates Data Arms 518B 97 51 male 4...

Page 235: ... Medium 11 s when sensitivity is set to Low PR from IBP Module Measurement range 25 to 350 bpm Resolution 1 bpm Accuracy 1 bpm or 1 whichever is greater Refreshing rate 1 s A 7 5 NIBP Standards Meet standards of IEC80601 2 30 Technique Oscillometry Mode of operation Manual Auto and STAT Auto mode repetition intervals 1 min 2 min 2 5 min 3 min 5 min 10 min 15 min 20 min 30 min 1 h 1 5 h 2 h 3 h 4 h...

Page 236: ...147 3 mmHg Static pressure measurement range 0 mmHg to 300 mmHg Static pressure measurement accuracy 3 mmHg PR Measurement range 30 to 300 bpm Resolution 1 bpm Accuracy 3bpm or 3 whichever is greater Alarm limit Range mmHg Step mmHg Sys High Adult low limit 5 to 290 Pediatric low limit 5 to 240 Neonate low limit 5 to 140 NIBP 50 1 NIBP 50 5 Sys Low 25 to high limit 5 Mean High Adult low limit 5 to...

Page 237: ...h this device are in compliance with the American National Standard for Non invasive sphygmomanometers ISO 81060 2 in terms of mean error and stardard deviation by comparing with intra arterial measurements depending on the configuration in a typical patient population A 7 6 Temp Standards Meet standard of ISO 80601 2 56 Technique Thermal resistance Operating mode Direct mode Measurement range 0 t...

Page 238: ...g Zero adjustment range f200 mmHg Impedance range 300 to 3000 Alarm limit Range mmHg Step mmHg Sys High low limit 2 to 300 1 Mean High Dia High Sys Low 50 to high limit 2 Mean Low Dia Low A 7 8 C O for uMEC12 uMEC15 Measurement method Thermodilution method Measurement range C O 0 1 to 20 L min TB 23 to 43 ć TI 0 to 27 ć Resolution C O TB TI 0 1 L min 0 1 ć Accuracy C O TB TI 5 or 0 1 L min whichev...

Page 239: ...LINE II watertrap for adult and pediatric patient 120 ml min Connecting the DRYLINE II watertrap for neonatal patient 90 ml min Connecting the DRYLINE PRIME watertrap 50 ml min Sample flowrate tolerance 15 or 15 ml min whichever is greater Start up time 90 s Rise time Measured with a DRYLINE II neonatal watertrap and a 2 5 meter neonatal sampling line 330 ms 90 ml min Measured with a DRYLINE II ad...

Page 240: ...extra error should be added in case of gas interference when CO2 measurements are performed between 0 40mmHg Inaccuracy specifications are affected by the breath rate and I E change The end tidal gas reading is within specification for breath rate below 15BPM and I E ratio smaller than 1 1 relative to the gas readings without breath Alarm limit Range Step EtCO2 High low limit 2 to 99 mmHg 1 mmHg E...

Page 241: ... be observed to verify normal operation in the configuration in which it will be used z The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below z Other devices may interfere with this device even though they meet the requirements of CISPR z When the inputted signal is below the minimum amplitude provided in t...

Page 242: ...y connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC61000 3 2 Class A Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Complies WARNING z This device is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be nec...

Page 243: ... IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip ...

Page 244: ...00MHz 2 5GHz P d 3 2 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equ...

Page 245: ...use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum outpu...

Page 246: ...at this device does not cause harmful interference Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service This device complies with Canadian ICES 001 Cet appareil ISM est conforme a la norme NMB 001 du Canada The device including the MSD45N wireless module FCC and Industry Canada Radio Compliance Thi...

Page 247: ...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 z Keep a distance of at least 20cm away from the monitor when Wi Fi function is in use ...

Page 248: ...B 8 FOR YOUR NOTES ...

Page 249: ...he following tables is for your notes and review Note In this chapter O M means the monitor s operating mode Column C refers to the settings that can be changed in configuration management Column M refers to the settings that can be changed in monitoring mode C 1 Parameters Configuration C 1 1 ECG ECG Setup Item Name O M General User Defaults C M Lead Set Auto Alm Source HR Alarm On Alm Lev Med HR...

Page 250: ...T Unit is mm 0 20 2 0 ST X Low when ST Unit is mV when ST Unit is mm 0 20 2 0 ISO 80 ms J 48 ms ST J 60 ms X represents I II III aVR aVL aVF V V1 V2 V3 V4 V5 or V6 Arrh Analysis Item Name O M General User Defaults C M Arrhythmia Threshold Settings PVCs min Adu Ped Neo 10 10 Tachy Adu Ped Neo 120 160 180 Brady Adu Ped Neo 50 75 90 Asys Delay Adu Ped Neo 5 5 Vtac Rate Adu Ped Neo 130 160 ...

Page 251: ...eo 35 50 60 Vbrd Rate Adu Ped Neo 40 40 Vbrd PVCs Adu Ped Neo 5 5 Pause Time Ad Ped Neo 2 2 Pause min Ad Ped Neo 8 8 Arrhythmia Alarm Settings PVCs min Alarm Off R on T Alarm Off Nonsus Vtac Alarm Off Vent Rhythm Alarm Off Bigeminy Alarm Off Trigeminy Alarm Off Afib Alarm Off Asystole Alarm On VFib VTac Alarm On Vtac Alarm On Vent Brady Alarm On Extreme Tachy Alarm On ...

Page 252: ...lm Lev High Extreme Brady Alm Lev High Pause Alarm Off Couplet Alm Lev Prompt PVC Alm Lev Prompt Irr Rhythm Alm Lev Prompt PNP Alm Lev Prompt PNC Alm Lev Prompt Missed Beats Alm Lev Prompt Afib Alm Lev Prompt X Alarm Off X Alm Lev Med X Alm Rec Off X represents a certain arrhythmia event Refer to A Product Specifications for details The X in X Alm Lev refers to all arrhythmia events except for tho...

Page 253: ...Lead II Gain X2 RR High Adu Ped Neo 30 100 RR Low Adu Ped Neo 8 30 Apnea Delay Adu Ped Neo 20 15 Detection Mode Auto RR Source Auto C 1 3 PR Item Name O M General User Defaults C M Alarm On Alm Lev Med HR PR High Adu 120 Ped 160 Neo 200 HR PR Low Adu 50 Ped 75 Neo 100 PR Source SpO2 Beat Vol 2 ...

Page 254: ... Alarm On Alm Lev Med SpO2 High Adu Ped Neo 100 95 SpO2 Low 90 Desat Limit 80 Sweep 25 mm s NIBP Simul Off Sensivity Med PI Zoom No C 1 5 Temp Item Name O M General User Defaults C M Alarm On Alm Lev Med T1 T2 High ºC 38 0 T1 T2 Low ºC 35 0 TD High ºC 2 0 ...

Page 255: ...Press mmHg Adu 80 Ped 60 Neo 40 Initial Pressure mmHg Adu 160 Ped 140 Neo 90 Alarm Limits NIBP S High mmHg Adu 160 Ped 120 Neo 90 NIBP S Low mmHg Adu 90 Ped 70 Neo 40 NIBP M High mmHg Adu 110 Ped 90 Neo 70 NIBP M Low mmHg Adu 60 Ped 50 Neo 25 NIBP D High mmHg Adu 90 Ped 70 Neo 60 NIBP D Low mmHg Adu 50 Ped 40 Neo 20 ...

Page 256: ...Sweep 25 mm s Filter 12 5 Hz Gridlines Off IBP Label Order Setup Art pArt CVP pCVP ICP PA Ao UAP FAP BAP LV LAP RAP UVP P1 P2 P3 P4 Art Ao UAP BAP FAP LV P1 P2 Arterial Pressure Alarm Limits IBP S High mmHg Adu 160 Ped 120 Neo 90 IBP S Low mmHg Adu 90 Ped 70 Neo 55 IBP M High mmHg Adu 110 Ped 90 Neo 70 IBP M Low mmHg Adu 70 Ped 50 Neo 35 IBP D High mmHg Adu 90 Ped 70 Neo 60 IBP D Low mmHg Adu 50 P...

Page 257: ... 26 Neo 26 PA M Low mmHg Adu 0 Ped 12 Neo 12 PA D High mmHg Adu 16 Ped 4 Neo 4 PA D Low mmHg Adu 0 Ped 4 Neo 4 CVP LAP RAP ICP UVP P3 P4 Venous Pressure Alarm Limits IBP M High mmHg Adu 10 Ped 4 Neo 4 IBP M Low mmHg Adu 0 Ped 0 Neo 0 Art Ao BAP FAP LV P1 P2 Arterial Pressure Scale Scale mmHg 0 160 PA Scale Scale mmHg 0 30 CVP LAP RAP ICP UVP Scale Scale mmHg 0 20 ...

Page 258: ... 20 C 1 8 C O for uMEC12 uMEC15 Item Name O M General User Defaults C M Alarm On Alm Lev Med TB High ºC 39 0 TB Low ºC 36 0 Comp Const 0 542 Auto TI Auto Manual TI ºC 2 0 Measuring mode Manual C 1 9 CO2 for uMEC12 uMEC15 Item Name O M General User Defaults C M Alarm On Alm Lev Med Operating Mode Measure Sweep 6 25 mm s Scale mmHg 50 Apnea Delay Adu Ped Neo 20 15 RR Source Auto ...

Page 259: ...pen 0 O2 Compen 21 Des Compen 0 Operating Mode Measure Wave Type Draw Scale 50 mmHg Sweep 6 25 mm s RR Source Auto Alarm Limits EtCO2 High mmHg Adu Ped Neo 50 45 EtCO2 Low mmHg Adu Ped Neo 25 30 FiCO2 High mmHg Adu Ped Neo 4 RR High Adu Ped Neo 30 100 RR Low Adu Ped Neo 8 30 ...

Page 260: ... 30 s C 2 2 Screens Item Name O M General User Defaults C M Choose Screen Normal Screen Display the ST segments on ECG screen Unselected Select QuickKeys NIBP MeasureėStop AllėReviewė Standby Select Wave Sequence for Normal Screen 1 ECG1 2 ECG2 3 SpO2 PR 4 Any IBP 5 Any IBP 6 CO2 11 Resp Select Parameters for Big Numerics Screen Parameter 1 ECG Parameter 2 SpO2 PR Parameter 3 Resp Parameter 4 NIBP...

Page 261: ...low CVP ICP P1 P4 venous pressure Blue LAP Purple RAP Orange UVP Cyan CO2 Yellow RESP Yellow X represents a waveform label such as ECG RESP CO2 and so forth The ECG waveform cannot be set off C 2 4 Review Item Name O M General User Defaults C M Tabular Trends Interval 30 min Trend Group Standard Graphic Trends Trend Group Standard Minitrend Length 2 h Full Disclosure Save Waves Save ECG1 by defaul...

Page 262: ... Speed 25 mm s IBP Overlap Off Alm Rec X Off X represents a parameter label C 2 7 Print Item Name O M General User Defaults C M Paper Size A4 ECG Reports Amplitude 10 mm mV Sweep 25 mm s Auto Interval Off 12 Lead Format 12X1 Tabular Trends Reports Set as End Case Report Unselected Back Auto Spacing Auto Report Layout Parameter Oriented Currently Displayed Trended Parameters Selected ...

Page 263: ... End Case Report Unselected Sweep Auto Select Wave Current C 2 8 Others Item Name O M General User Defaults C M Brightness 5 Key Volume 2 View Other Patient Auto Alarm On C 3 User Maintenance Items Item Name O M General User Defaults C M Changing Bed No Protected Atmospheric Pressure 760 mmHg Height Unit cm Weight Unit kg ST Unit mV Press Unit mmHg CVP Unit cmH2O CO2 Unit mmHg O2 Unit Temp Unit ć ...

Page 264: ... Alarm Reset On Reset Other Bed s Alarms Off Alarm Reset By Other Bed On Minimum Alarm Volume 2 Alarm Sound ISO Reminder Tone On Reminder Interval 3 min Max Alarm Pause 15min Disable ECGLeadOff Lev Low SpO2SensorOff Lev Low IBPSensorOff Lev Med Lethal Arrh OFF Disable Alarm Delay 6 s ST Alarm Delay 30 s Other Bed Disconnection Alm On Extended Arrh Enable Wave Line Mediate ECG Standard AHA Notch Fr...

Page 265: ...witch Authority Unprotected Parameter Switch When Para Switch Authority is set to Protected Unselected When Para Switch Authority is set to Unprotected Selected SpO2 Tone Mode 1 Nurse Call Signal Type Continuous Contact Type Normally Closed Alm Lev High Med Low Alarm Cat Phys Tech ...

Page 266: ...C 18 FOR YOUR NOTES ...

Page 267: ...w means the alarm level is user adjustable XX represents a measurement or parameter label such as ECG NIBP HR ST I PVCs RR SpO2 PR etc In the Cause and Solution column corresponding solutions are given instructing you to troubleshoot problems If the problem persists contact your service personnel D 1 Physiological Alarm Messages Measurement Alarm messages L Cause and solution XX XX Too High M XX v...

Page 268: ...artbeat has interfered with his respiration Check the patient s condition and the Resp connections SpO2 SpO2 Desat H The SpO2 value has fallen below the desaturation alarm limit Check the patient s condition and check if the alarm limit settings are correct No Pulse H The pulse signal was so weak that the monitor cannot perform pulse analysis Check the patient s condition SpO2 sensor and measureme...

Page 269: ...s become disconnected from the adapter cable Check the connections of the electrodes and leadwires ECG YY Lead Off L B Note YY represents the leadwires V LL LA RA as per AHA standard or C F L and R as per IEC standard ECG Noisy L A The ECG signal is noisy Check for any possible sources of signal noise around the cable and electrode and check the patient for great motion ECG Artifact L A Artifacts ...

Page 270: ...or has become detached from the patient or the module or there is a fault with the SpO2 sensor or an unspecified SpO2 sensor has been used Check the sensor application site and the sensor type and make sure if the sensor is damaged Reconnect the sensor or use a new sensor SpO2 Sensor Fault L C SpO2 No Sensor L B SpO2 Unknown Sensor L C SpO2 Sensor Incompatible L C SpO2 Too Much Light L C There is ...

Page 271: ...nal is saturated due to excess motion or other sources NIBP Overrange L A The measured NIBP value exceeds the module measurement range NIBP Excessive Motion L A Check the patient s condition and reduce the patient motion NIBP Cuff Overpress L A The NIBP airway may be occluded Check the airway and measure again NIBP Equip Err H A An error occurred during NIBP measurement and therefore the monitor c...

Page 272: ...tor application site meets the requirements and check for special sources that affect the ambient pressure Restart the monitor CO2 Low Barometric L C CO2 FilterLine Occluded L C The airway or watertrap was occluded Check the airway and remove the occlusion CO2 No Watertrap L B Check the watertrap connections CO2 Check Adapter L A There is a problem with the airway adapter Check clean or replace th...

Page 273: ...nnect the monitor to an AC power source and allow the batteries to charge Different Battery Voltages M C The two batteries have different charge capacity or the batteries unspecified have been used or there is a problem with the batteries Make sure that correct batteries are used and the batteries are not damaged or replace the batteries Battery Overload H C The power consumption of the equipment ...

Page 274: ...A Re load the recorder paper System System Watchdog Err H C An error occurred to the system Restart the monitor System Software Err H C System CMOS Full H C System CMOS Err H C System FPGA Err H C System Err N H C N is within 2 to 12 Other Bed Disconnected L A Check network connection PWR interrupted Check meas state L A Power supply failed accidently Check the measurements when the monitor restar...

Page 275: ...s to the procedure Please follow the instructions of the analyzer manufacturer The electrical safety inspection should be periodically performed every two years The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding as well as total current loads E 1 Power Cord Plug Test Item Acceptance Criteria The power plug The power plug pi...

Page 276: ... or missing parts e g knobs dials terminals etc E 2 2 Contextual Inspection Test Item Acceptance Criteria The enclosure and accessories No unusual noises e g a rattle inside the case No unusual smells e g burning or smoky smells particularly from ventilation holes No taped notes that may suggest device deficiencies or operator concerns E 3 Device Labelling Check the labels provided by the manufact...

Page 277: ...ge Test Run an Earth Leakage test on the device being tested before performing any other leakage tests The following outlet conditions apply when performing the Earth Leakage test normal polarity Normal Condition reverse polarity Normal Condition normal polarity with open neutral Single Fault Condition reverse polarity with open neutral Single Fault Condition LIMITS For UL60601 1 300 A in Normal C...

Page 278: ...ion LIMITS For CF applied parts 10 A in Normal Condition 50 A in Single Fault Condition For BF applied parts 100 A in Normal Condition 500 A in Single Fault Condition E 7 Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage which is 110 of the mains voltage through a limiting resistance to selected applied part terminals Current measurements are then taken between th...

Page 279: ...y Normal Condition normal polarity with open neutral Single Fault Condition reverse polarity with open neutral Single Fault Condition normal polarity with open earth Single Fault Condition reverse polarity with open earth Single Fault Condition LIMITS For CF applied parts 10 A in Normal Condition 50 A in Single Fault Condition For BF applied parts 100 A in Normal Condition 500 A in Single Fault Co...

Page 280: ...E 6 FOR YOUR NOTES ...

Page 281: ...nings F 1 Symbols A ampere Ah ampere hour bpm beats per minute BrPM breaths per minute ć centigrade cc cubic centimeter cm centimeter dB decibel fahrenheit g gram GTT gutta hr hour hPa hundred pascal Hz hertz inch inch kg kilogram kPa kilopascal l litre lb pound m meter mcg micrograms mEq milli equivalents mg milligrams min minute ml milliliter mm millimeters ...

Page 282: ...watt nm nanometer ppm part per million s second V volt VA volt ampere ohm μA microampere μm micron μV microvolt W watt minus percent per divide or power plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright ...

Page 283: ...CISPR International Special Commmittee on Radio Interferennce CMS central monitoring system cmos Complementary Metal Oxide Semiconductor CPU central processing unit CVP central venous pressure D diastolic DC direct current DIA diastolic e g for example ECG electrocardiograph EEC European Economic Community EMC electromagnetic compatibility ERR error ES electrosuigical ESU electrosuigical unit Et e...

Page 284: ...rtria pressure LCD liquid crystal display LED light emitting diode LL F left leg Loop loop read write test fail M mean MAC minimal alveolar concentration MAP mean arterial pressure MDD Medical Device Directive MEAN mean pressure MetHb methemoglobin Mii initialize MII registers fail MRI magnetic resonance imaging N A not applied NEO neonate neonatal NIBP noninvasive blood pressure ND NM NS non inva...

Page 285: ...arization RA R right arm RAM random access memory RAP right atrial pressure Reg test NE2000 registers fail RESP respiration RL N right leg ROM read only memory RR respiration rate S systolic SpO2 arterial oxygen saturation from pulse oximetry SYNC synchronization SYS systolic TEMP temperature TFT Thin Film Technology V C precordial lead chest VGA Video Graphice Array ...

Page 286: ...F 6 FOR YOUR NOTES ...

Page 287: ......

Page 288: ...PN 046 008784 00 1 0 ...

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