Mindray VS-900 Operator'S Manual Download Page 187

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F-1

Symbols and Abbreviations

F.1

Symbols

μA

microampere

μV

microvolt

μs

Microsecond

ampere

ampere hour

bpm

beat per minute

bps

bit per second

centigrade

centimeter

decibel

dyne second

fahrenheit

gram

GHz

gigahertz

hour

hertz

inch

kilo

kilogram

kPa

kilopascal

litre

pound

meter

mAh

milliampere hour

mega byte

milligram

min

minute

milliliter

millimeter

Summary of Contents for VS-900

Page 1: ...VS 900 Vital Signs Monitor Operator s Manual ...

Page 2: ......

Page 4: ...s without the intention of improperly using them They are the property of their respective owners Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice All information contained in this manual is believed to be correct Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the fur...

Page 5: ... man made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people Malfunction of the instrument or part whose serial number is not legible enough Others not caused by instrument or part itself Compa...

Page 6: ...s an integral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical professionals who are expected to have corresponding working knowledge of medical procedures practices and terminology as required for monitoring of patients Illustrations All illustrations in this manual serve as...

Page 7: ...ns 3 1 3 1 Installation 3 1 3 1 1 Unpacking and Checking 3 2 3 1 2 Environmental Requirements 3 2 3 2 General Operation 3 3 3 2 1 Connection to AC Power 3 3 3 2 2 Using a Battery 3 3 3 2 3 Connecting Accessories 3 4 3 3 Turning On Off Power 3 4 3 3 1 Check before Power On 3 4 3 3 2 Turning Power On 3 4 3 3 3 Turning off the Monitor 3 5 3 4 Using Key Knob Touchscreen 3 6 3 4 1 Using Keys 3 6 3 4 2 ...

Page 8: ...1 Spot Check Trends 4 7 4 4 2 Continuous Trends 4 8 4 4 3 Graphic Trends 4 9 4 5 Transferring Data from the Monitor to USB Drive 4 10 5 Managing Configurations 5 1 5 1 Overview 5 1 5 2 Accessing Manage Configuration Menu 5 1 5 2 1 Setting Default Configuration 5 2 5 3 Saving Current Settings 5 2 5 4 Deleting a Configuration 5 2 5 5 Transferring a Configuration 5 3 5 6 Loading a Configuration 5 3 5...

Page 9: ...Setting the Alarm Level for SpO2 Sensor Off Alarm 7 6 7 6 Measurement Limitations 7 6 7 7 Masimo Information 7 7 7 8 Nellcor Information 7 7 8 Monitoring PR 8 1 8 1 Overview 8 1 8 2 PR Source 8 1 8 3 Pulse Tone 8 1 9 Monitoring NIBP 9 1 9 1 Overview 9 1 9 2 Safety 9 2 9 3 Measurement Limitations 9 3 9 4 NIBP Measurement Mode 9 3 9 5 Measuring NIBP 9 4 9 5 1 Preparing the Patient 9 4 9 5 2 Preparat...

Page 10: ...play 10 12 10 3 6 Troubleshooting 10 12 10 3 7 Cleaning and Disinfecting the Tympanic Thermometer 10 12 11 Monitoring CO2 11 1 11 1 Overview 11 1 11 2 Safety 11 1 11 3 Measurement Limitations 11 1 11 4 CO2 Display 11 2 11 5 Measuring CO2 11 2 11 6 Automatic CO2 Module Zeroing 11 4 11 7 Changing CO2 Settings 11 4 11 7 1 Changing CO2 Alarm Settings 11 4 11 7 2 Setting the Apnea Alarm Delay 11 4 11 7...

Page 11: ...6 Removing Paper Jam 13 4 13 7 Cleaning the Recorder Printhead 13 4 14 Network 14 1 14 1 Network Connection 14 1 14 2 Network Type and Settings 14 1 14 2 1 Wireless Network 14 2 14 2 2 WLAN Test 14 2 14 3 Setting Data Send Method 14 3 14 3 1 ADT Communication Setup 14 3 14 3 2 EMR Communication Setup 14 3 14 3 3 NTP Server Setup 14 3 14 3 4 Realtime Date Send Interval for HL7 only 14 4 14 3 5 Alar...

Page 12: ...torage Card 16 10 16 9 Modifying Password 16 10 17 Accessories 17 1 17 1 SpO2 Accessories 17 1 17 2 NIBP Accessories 17 3 17 3 Temp Accessories 17 4 17 3 1 SmarTemp Accessories 17 4 17 3 2 THP79JU Ear Thermometer Accessories 17 5 17 3 3 GeniusTM 2 Tympanic Thermometer Accessories 17 5 17 4 CO2 Accessories 17 5 A Product Specifications A 1 A 1 Classifications A 1 A 2 Environmental Specifications A ...

Page 13: ...tion E 1 E 1 Power Cord Plug E 1 E 2 Device Enclosure and Accessories E 2 E 3 Device Labeling E 2 E 4 Protective Earth Resistance E 2 E 5 Earth Leakage Test E 3 E 6 Patient Leakage Current E 3 E 7 Mains on Applied Part Leakage E 4 F Symbols and Abbreviations F 1 F 1 Symbols F 1 F 2 Abbreviations F 3 ...

Page 14: ...8 FOR YOUR NOTES ...

Page 15: ...stem into operation the operator must verify that the equipment connecting cables and accessories are in correct working order and operating condition To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth If the installation does not provide for a protective earth conductor disconnect it from the power line and operate it on battery power if ...

Page 16: ...ed on the equipment are for reference only and cannot be directly used for diagnostic interpretation and replace the competent judgment of a clinician To avoid inadvertent disconnection route all cables in a way to prevent a stumbling hazard Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel When disposing of the packaging material be sure to ob...

Page 17: ...l of the equipment please contact Mindray Magnetic and electrical fields are capable of interfering with the proper performance of the equipment For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements Mobile phone X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of ele...

Page 18: ...ftware errors is minimized This manual describes all features and options Your equipment may not have all of them During normal use the operator is expected to face the front of the equipment The equipment uses a mains plug as a means of isolation to the mains power supply Do not position the equipment in a place difficult to access the mains plug Only the central monitoring system with a software...

Page 19: ...N PROOF TYPE CF APPLIED PART Input Output DEFIBRILLATION PROOF TYPE BF APPLIED PART Equipotentiality USB connector MANUFACTURER Serial number DATE OF MANUAFACTURE AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Protection against fluid ingress CATALOGUE NUMBER Humidity limitation Temperature limit Atmospheric pressure limitation Interference may occur in the vicinity of equipment marked with t...

Page 20: ...efinition of the WEEE label applies to EU member states only This symbol indicates that this product should not be treated 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 dis...

Page 21: ...cal staff under the direction of physicians WARNING This equipment 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 2 Applied Parts The applied parts of the monitor include followings SpO2 sensor and cable NIBP tubing and c...

Page 22: ...n 3 Temperature module and base The monitor can be configured with any one of the following modules SmarTempTM module measures predictive temperature THP79JU module measures ear temperature GeniusTM 2 module measures tympatic tempearature The temperature module varies in appearance The above figure shows the main unit with the SmarTempTM module 4 AC power indicator On indicates that the monitor is...

Page 23: ...r is connected Off indicates that the battery is not installed Flash indicates that the monitor is powered by battery 7 Alarm Reset key Press this key to disable the audio of present alarms Press and hold this key for more than 2 seconds to pause or restore alarms 8 NIBP Start Stop key Press to start or stop NIBP measurements 9 Admit patient key Press this key to admit a new patient Press this key...

Page 24: ... 2 Recorder indicator 3 Start stop recording key 4 Paper outlet 5 Recorder door 6 Connector for NIBP cuff 7 Connector for SpO2 cable 8 CO2 gas outlet 9 CO2 sample line connector 10 Recorder latch SpO2 NIBP CO2 1 2 3 4 9 5 10 6 7 8 ...

Page 25: ...onnector used to communicate with external devices such as central monitoring system Gateway or upgrade the system 4 Multi function connector connects to the hospital s nurse call system or connects external devices through DIAP protocol 5 USB connector connects to barcode scanner or USB disk 6 AC power input 7 Equipotential grounding terminal When the equipment and other devices are to be used to...

Page 26: ...2 6 2 3 4 Bottom View 1 Battery compartment door 2 Hole for installing a support 1 2 ...

Page 27: ...2 7 2 4 Main Screen There are three display modes of main screen They are all parameter screen trend screen and NIBP list screen All Parameter Screen 3 6 8 7 1 4 5 2 ...

Page 28: ...2 8 Trend Screen NIBP List Screen 1 Patient Information System Message Area 10 3 6 8 7 2 1 9 3 5 6 8 7 2 1 5 ...

Page 29: ...e This area does not display by default Refer to 4 2 Manually Input Patient Data for additional information 5 Menu QuickKeys Main Accesses the Main screen to configure the monitor or quickly returns to the main screen Scoring Accesses the screen to evaluate a patient s condition Refer to 12 Clinical Scoring Patient List Accesses the Local Patient List and ADT Database screen to admit a patient sto...

Page 30: ...ly in NIBP List screen mode 2 5 Menu A menu in this monitor is usually composed of 1 Heading gives a sum up for the current menu 2 Main body displays options buttons prompt messages etc A menu button followed with enlarges a secondary window to reveal more options or information 3 select to exit the current menu 2 6 Operating Modes 2 6 1 Monitor Mode The monitor will automatically enter monitor mo...

Page 31: ...de and Spot Check modes have all the features in common except the following Functions Monitor Mode Spot Check Mode Configure and use Sat Seconds Nellcor Yes No Access Alarm Setup tab Yes No Access Continuous Trends tab Yes No Access Graphic Trends tab Yes No Connect to the central monitoring system Yes No Measure CO2 Yes No 2 6 3 Standby Mode In standby mode the monitoring for current patient is ...

Page 32: ...admit the patient for the monitoring 2 6 4 Demo Mode Demo mode is password protected and it is used for demonstration purpose only To enter Demo mode 1 Select Main Maintenance 2 Select Demo Enter required password Select Ok To exit Demo mode 1 Select Main Maintenance 2 Select Exit Demo WARNING The Demo mode is for demonstration purpose only To avoid that the simulated data are mistaken for the mon...

Page 33: ...or information technology equipment and IEC 60601 1 safety standards for medical electrical equipment The system configuration must meet the requirements of the IEC 60601 1 medical electrical systems standard Any personnel who connect devices to the equipment s signal input output port is responsible for providing evidence that the safety certification of the devices has been performed in accordan...

Page 34: ...e used if the equipment must be reshipped 3 1 2 Environmental Requirements The equipment is suitable for use within the patient environment The operating environment of the equipment must meet the requirements specified in this manual The environment where the equipment is used shall be reasonably free from noises vibration dust corrosive flammable and explosive substances If the equipment is inst...

Page 35: ...the installation or its arrangement is in doubt the equipment shall be operated from the battery 3 2 2 Using a Battery This monitor can be equipped with rechargeable Lithium ion battery If a battery is installed the monitor system will automatically switch to battery for power supply if AC power is interrupted Installing a Battery Battery compartment cover is at the bottom of monitor Refer to 15 3...

Page 36: ...on of all accessories to monitor is secured 3 3 2 Turning Power On Once the monitor is installed you can get ready for measurement 1 Check the monitor for any mechanic damage and make sure that all external cables plug ins and accessories are properly connected 2 Check the power supply specification is met if mains power is used Only use a power outlet that is properly grounded 3 Plug the power co...

Page 37: ...ent monitoring data as required Press and hold the power on off switch for above 2 seconds to turn off monitor CAUTION Although not recommended you can press and hold the power on off switch for 10 seconds to forcibly shut down the monitor when it could not be shut down normally or under some special situations This may cause data loss of the monitor The monitor restores the latest configuration i...

Page 38: ...ired For example the confirm pop up key appears only when you need to confirm a change 3 4 2 Using the Knob Using the knob on the front panel of the monitor can do the following operations Rotate the knob clockwise or anti clockwise to move the cursor Press the knob to select one item such as accessing a menu or confirming the selection 3 4 3 Using the Touchscreen Select screen items by pressing t...

Page 39: ...select the desired language 3 Restart the monitor 3 5 3 Configuring the Timeout of Clinician ID You can configure the retention time of a clinician ID each time it is entered 1 Select Main Maintenance User Settings Enter the required password Select Ok and then access User Settings menu 2 Select Clinician ID Time out and then set the time 3 5 4 Showing Hiding Patient Name You can show or hide the ...

Page 40: ...rightness automatically 1 Select Main General Setup 2 Select Brightness and select the appropriate setting for the screen brightness 10 is the brightest and 1 is the least bright 3 5 8 Setting Screen 1 Select Main General Setup 2 Select Display Setup and set the main screen to different layout All Parameters display Trend display or NIBP List display All Parameters display includes parameter area ...

Page 41: ...nd toggle between yyyy mm dd mm dd yyyy and dd mm yyyy 4 Select Time Format and toggle between 24h and 12h CAUTION Changing date and time affects the storage of trends and events and may cause data missing 3 5 12 Configuring Unit To enter the Unit Setup menu select Main General Setup Unit Setup 3 5 13 Configuring Printout You can select the items to be printed on the strip By default all items are...

Page 42: ...3 10 FOR YOUR NOTES ...

Page 43: ... and networking devices NOTE If the monitor enters and then exits Standby mode during patient monitoring you must re admit the patient for the monitoring 4 1 1 Admitting a Patient by the Admit Patient Hardkey 1 Press the Admit Patient hardkey to access Patient Demographics menu 2 Enter the demographic details If the monitor is connected to ADT database through Gateway when you input patient MRN th...

Page 44: ...to the eGateway If a clinician ID is entered but no operation on the monitor for a certain time the monitor will clear up the ID Refer to 3 5 3 Configuring the Timeout of Clinician ID 4 1 2 Admitting a Patient by Barcode Scanner The monitor provides the ability to admit a patient through linear or two dimension barcode scanner NOTE If the patient demographics is obtained from barcode scanner the p...

Page 45: ...e data for selectable patient demographics For example the monitor has an option of Adult for patient category In your hospital barcode the text may read as Adu You need to input Adu for the field Adult to establish the relationship The following aspects need to establish the relationship Patient Category Gender Month 4 Select to save the configuration and exit the 2D Barcode Setup menu 5 Select t...

Page 46: ...phics menu 4 Select Ok If necessary you can modify patient information and then select Ok In Local Patient List you also can Select Add New and then Patient Demographics menu displays Input patient information and then select Ok to admit the patient Select Delete to remove currently selected patient from the monitor Select Delete All to remove all the patients from the monitor NOTE When a patient ...

Page 47: ...ect Ok If necessary you can modify patient information and then select Ok 4 2 Manually Input Patient Data You can choose whether to display the manual input area on the screen and configure the items to be displayed in the manual input area 1 Select Main Maintenance User Settings enter the required password Select Ok to access User Settings menu 2 Select Manual Inputs 3 In the Manual Inputs Setup ...

Page 48: ...ata will be saved locally and meanwhile sent to the external devices when the Save QuickKey is selected and confirmed and or Automatically Record On Manual Save the data will be saved locally and meanwhile printed by recorder when the Save QuickKey is selected and confirmed Clear Clinician ID at Saving the data saves locally and the monitor clears the clinician ID when the Save Quickkey is selecte...

Page 49: ... the Spot Check Trends screen 1 Tabular trend 2 Button area 3 Data status 4 Parameter value triggering alarm In this tab you can Select MRN or Name and then select the desired patient Select Filter to select parameter trends you want to review Select the page key for example and then use up or down arrow beside the key to turn the page Select Edit to edit patient demographics or manual input data ...

Page 50: ...has a red background parameter value triggering medium or low level alarm has a yellow background The required patient demographics that is not fully filled displays as Patient data successfully sent to the EMR displays as Patient data that failed to transmit to the EMR displays as Patient data that is cached on the device but not transmitted displays as 4 4 2 Continuous Trends Select Continuous T...

Page 51: ...s tab to access the Graphic Trends screen The Graphic Trend screen displays the current patient s physiological trend 1 Event mark area 2 Time scale 3 Graphic area 4 Parameter area 5 Cursor 6 Button area A timestamp indicating your current position is displayed above the parameter area The parameter value corresponding to the cursor time appears in the parameter area The measurement value that tri...

Page 52: ...ght be overwritten by later ones if the storage memory reaches capacity 4 5 Transferring Data from the Monitor to USB Drive 1 Insert a USB drive to the USB connector on the monitor 2 Select Main Maintenance User Settings enter the required password select Ok to access User Settings menu 3 Select Transfer Data to USB 4 Select Period and select your desired time 5 Select Transfer Data CAUTION The US...

Page 53: ...ration 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 alarm switch alarm limits Conventional configuration items These items define how the monitor works e g display setup print and alarm settings User main...

Page 54: ...can be either factory configuration or saved user configuration Take adult as an example select Default Adult Config and toggle between Defaults and user configuration s NOTE When the equipment starts it shows what configuration is restored at the prompt information area for about 30 seconds 5 3 Saving Current Settings Current settings can be saved as user configuration Up to 3 user configurations...

Page 55: ...ration menu 3 In the Import Config menu select the configurations and the user maintenance settings to be imported Then select the Import button A status message will report completion of the transfer 5 6 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 Theref...

Page 56: ...res the configuration in real time The saved configuration is the latest configuration The monitor 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 configura...

Page 57: ...pment s alarms can be classified into two categories physiological alarms and technical alarms 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 The physiological alarms occur only in Monitor mode 2 Technical alarms Technical alarms also called system status alar...

Page 58: ...meters 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 6 3 Alarm Indicators When an alarm occurs the equipment will indicate it to the user through visual or audible alarm indications Alarm la...

Page 59: ...ges When an alarm occurs an alarm message will appear in the technical or physiological alarm area The alarm message has different background color which matches the alarm level High level alarms red Medium level alarms yellow Low level alarms yellow For physiological alarms the asterisk symbols before the alarm message match the alarm level as follows High level alarms Medium level alarms Low lev...

Page 60: ...et indicates the alarm sound is turned off 6 4 Setting Alarms You can set the switch limit and level of physiological alarms Select Main Alarm Setup and then access the Alarm Setup screen Auto Set The monitor will create new alarm limits based on the measured values Restore Defaults The restored defaults depend on the settings in Select Default Config screen If the latest configuration is set as t...

Page 61: ...and 10 is the maximum volume When alarm volume is set to 0 the alarm sound is turned off and a symbol appears on the screen 6 5 2 Setting the Minimum Alarm Volume 1 Select Main Maintenance User Settings Enter the required password Select Ok to access User Settings menu 2 Select Alarm Setup to access Alarm Setup menu 3 Select Minimum Alarm Volume and then select the appropriate settings The minimum...

Page 62: ...ct Main Alarm Setup Auto Set Select Ok in the pop up window The monitor will create new alarm limits based on the measured values Before applying these automatically created alarm limits confirm if they are appropriate for your patient If not you can adjust them manually The monitor calculates the auto limits based on the following rules Parameter Low alarm Limit High alarm Limit Auto set alarm li...

Page 63: ...05 mmHg Temp T 0 5 C T 0 5 C T 0 5 C T 0 5 C Same as the measurement range EtCO2 0 to 32 remains the same 0 to 32 remains the same 0 to 32 remains the same 0 to 32 remains the same Same as the measurement range 33 to 35 29 33 to 35 29 33 to 35 41 33 to 35 41 Same as the measurement range 36 to 45 EtCO2 6 36 to 45 EtCO2 6 36 to 45 EtCO2 6 36 to 45 EtCO2 6 Same as the measurement range 46 to 48 39 4...

Page 64: ...larm paused status by pressing and holding the hardkey for more than 2 seconds 6 7 Switching Off Alarm Sound When alarm volume is set to 0 the alarm sound is turned off In audio alarm off status The Audio Off symbol is displayed Audio indication of all alarms is suspended You can cancel the alarm sound off status by setting alarm volume to a value from 1 to 10 WARNING Pausing or switching off alar...

Page 65: ...s when the alarm system is reset For some technical alarms including the NIBP related alarms a appears before the alarm message and appears in the alarm symbol area indicating that the alarm is acknowledged The indication of the alarm lamp depends on the alarm light setting Some technical alarms are changed to the prompt messages Some technical alarms are cleared The monitor gives no alarm indicat...

Page 66: ...priority alarms are latched Hi Med both high priority alarms and mediate priority alarms are latched All all alarms are latched and Off no alarm will be latched Only the unacknowledged physiological alarm can be latched The latched alarms will be cleared when the monitor enters alarm reset state NOTE Changing of alarm priority may affect the latching status of corresponding alarm Please determine ...

Page 67: ...rm condition 4 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 5 Select Alarm Level and set the alarm level for nurse call triggering alarms 6 Select Alarm Category and then select the category to which the ...

Page 68: ...6 12 FOR YOUR NOTES ...

Page 69: ...tion of arterial blood SpO2 percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin 4 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 acce...

Page 70: ...g MRI Induced current could potentially cause burns The sensor may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements 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 Chan...

Page 71: ...cording to the module type patient category and weight 2 Clean the application site For example remove colored nail polish 3 Apply the sensor to the patient 4 Select an appropriate adapter cable according to the connector type and plug this cable into the SpO2 connector 5 Connect the sensor cable to the adapter cable 7 5 Changing SpO2 Settings 7 5 1 Accessing SpO2 Menu By selecting the SpO2 parame...

Page 72: ...gen saturation level but the measurement accuracy will be improved For critically ill patients selecting shorter averaging time will help understanding the patient s state To set the averaging time For Mindray SpO2 module select Sensitivity in the SpO2 Setup menu and then toggle between High Med and Low which respectively correspond to 7 s 9 s and 11 s For Masimo SpO2 module select Averaging in th...

Page 73: ...t the SpO2 saturation falls outside the alarm limit is multiplied by the number of seconds that it remains outside the limit This can be stated as the equation Sat Seconds Points Seconds Only when the Sat Seconds limit is reached the monitor gives a Sat Seconds alarm For example the figure below demonstrates the alarm response time with a Sat Seconds limit set at 50 and a low SpO2 limit set at 90 ...

Page 74: ...larm Level for SpO2 Sensor Off Alarm In the SpO2 Setup menu select SpO2 Sensor Off Lev and then select the appropriate setting 7 6 Measurement Limitations If you doubt the measured SpO2 check patient vital signs first Then check the equipment and SpO2 sensor The following factors may influence the accuracy of measurement Ambient light Physical movement patient and imposed motion Diagnostic testing...

Page 75: ...f one or more of the patents relating to this device 7 8 Nellcor Information Nellcor Patents This device may be covered by one or more of the following US patents and foreign equivalents 5 485 847 5 676 141 5 743 263 6 035 223 6 226 539 6 411 833 6 463 310 6 591 123 6 708 049 7 016 715 7 039 538 7 120 479 7 120 480 7 142 142 7 162 288 7 190 985 7 194 293 7 209 774 7 212 847 7 400 919 No Implied Li...

Page 76: ...7 8 FOR YOUR NOTES ...

Page 77: ... tester or SpO2 simulator can be used to determine the pulse rate accuracy 8 2 PR Source The current pulse source is displayed in the PR parameter area The pulse rate is stored in the monitor s database and reviewed in the graphic tabular trends sent via the network to the central monitoring system if available 8 3 Pulse Tone You can change the pulse tone volume by adjusting Beat Volume in the SpO...

Page 78: ...8 2 FOR YOUR NOTES ...

Page 79: ...n 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 pressure and...

Page 80: ...be affected by the measurement site the position of the patient patient movement or the patient s physiologic condition If the NIBP measurement seems out of range or inaccurate determine the patient s vital signs by alternative means and then verify that the monitor is working correctly Make sure the air hose connecting the NIBP cuff and the monitor is not blocked twisted or tangled Do not apply t...

Page 81: ...a that reduces blood flow to the peripheries Obesity where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery 9 4 NIBP Measurement Mode There are the following modes of measuring NIBP Manual measurement on demand Auto continually repeated measurements at set intervals STAT continually rapid series of measurements over a five minute period then return to the pre...

Page 82: ...select the hardkey Patient Demographics Patient Category and set the patient category to Adult Pediatric or Neonatal 3 Connect the NIBP hose to the monitor 4 Select the appropriate sized cuff by referring to the limb circumference marked on the cuff The width of the cuff should be 40 50 for neonates of the limb circumference or 2 3 of the upper arm s length The inflatable part of the cuff should b...

Page 83: ...b with the cuff Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color warmth and sensitivity If any abnormity occurs move the cuff to another site or stop the blood pressure measurements immediately 9 5 4 Stopping NIBP Measurement Press the hardkey on the monitor s front panel to stop a manual NIBP measurement or a continuous NI...

Page 84: ... NIBP Setup menu 9 7 1 Setting Interval In NIBP Setup menu you can select Interval and set to Manual NIBP measurement is started manually 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 The monitor automatically measures NIBP based on the specified time interval Program 1 and Program 2 The monitor automatically measures NIBP based on a program configured by user 9 7 2 Set...

Page 85: ...time clock For example if Clock is set to On and Interval is set to 20min and then you start an 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 9 7 5 Configuring a Custom Program In NIBP Setup menu you can select Custom Program and configure the duration of automatic measurement cycle and the time interval ...

Page 86: ...ment 3 Program name 4 Cycle name 5 NIBP measurement Interval 9 7 6 Setting NIBP Alarm Properties Select Alarm Setup from NIBP Setup menu You can set the alarm properties for this parameter in the popup menu 9 7 7 Setting the Pressure Unit 1 Select Main General Setup Unit Setup 2 In the popup menu select Pressure and toggle between mmHg and kPa 1 2 3 4 5 ...

Page 87: ... appropriate Change it if necessary 2 Select VeniPuncture key 3 Puncture vein and draw blood sample 4 When the puncture is complete select VeniPuncture key or press the hardkey on the monitor s front panel to deflate the cuff The cuff deflates automatically after a set time if you do not deflate it During puncture the NIBP display shows the real time inflation pressure of the cuff destination infl...

Page 88: ...9 10 FOR YOUR NOTES ...

Page 89: ...The temperature probe cover is disposable Re use of probe cover may result in patient cross contamination Use disposable probe covers for temperature measurement Failure to use a probe cover can cause inaccurate temperature readings and patient cross contamination Check the disposable probe cover for damage before using Never use any probe cover for temperature measurement in case of damage or con...

Page 90: ...iscomfort and inaccurate measurements Improper use of probe may also cause patient s discomfort and inaccurate measurements 10 1 1 Setting Temp Select Temp parameter area to access Temp Setup menu You can set Temp type Predictive or Monitor Temperature measurement site the measurement site is related to the probe type When using oral axillary probe you can select the site Oral and Axillary when us...

Page 91: ...en the dynamic symbol appears it indicates that the monitor starts to take the measurement When taking an oral temperature apply the probe under the patient s tongue from either side of the mouth Verify that the probe reaches the rear sublingual pocket Have the patient close his her lips to hold the probe Hold the probe in place Make sure that the probe contacts with the patient s oral tissue thro...

Page 92: ...robe is placed in the probe well 2 Verify that the temperature measurement type and site are correct 3 Unplug the probe from the probe well and insert it into a cover in the probe cover pack Press the probe handle down firmly until the cover engages with the probe 4 Place the probe to the measurement site and then start measuring Refer to Step 4 in 10 1 2 4 Taking a Temperature in Predictive Mode ...

Page 93: ...nitor The monitor displays and stores the transferred temperature measurement Read the ear thermometer manufacturer s instructions for use before attempting to configure use troubleshoot or maintain the thermometer WARNING No alarm is provided for the ear temperature measurement CAUTION Do not submerge the thermometer probe into liquids or expose it to direct moisture The ear thermometer may not f...

Page 94: ...ng the plug 3 Place the ear thermometer on the dock 10 2 1 2 Installing a Probe Cover Package To install the probe cover package into the temperature dock 1 Remove the ear thermometer from the dock 2 Remove the probe cover loader by pressing the button on the right side of the dock and moving the loader forwards 3 Rotate the loader cap counterclockwise and then lift the cap ...

Page 95: ...cap 6 Push back the loader into the dock 7 Replace the ear thermometer to the dock 10 2 1 3 Taking an Ear Temperature WARNING Do not reuse the probe cover Always use a new undamaged and clean probe cover for a measurement Use only the specified probe cover To take an ear measurement and transfer it to the monitor 1 Power on the monitor 2 Remove the ear thermometer from the dock 3 Slide the lever t...

Page 96: ...ermometer for 1 second until you hear a long beep sound Then you can read the temperature measurement from the thermometer and the monitor 9 When you finish measuring push up the probe cover ejector and remove the used probe cover 10 Replace the thermometer to the dock When the monitor receives a measurement the monitor displays and stores the measurement 10 2 2 Understanding the Numerics 1 Thermo...

Page 97: ...he ear thermometer is not functioning properly Unload the thermometer battery wait for one minute and then repower the thermometer If the message reappears contact us for service Therm software error Therm hardware error1 Therm hardware error2 10 2 4 Cleaning and Disinfecting the Ear Thermometer Refer to the THP79JU Infrared Ear Thermometer instructions for use for cleaning and disinfection inform...

Page 98: ...mer Scan button When the thermometer is on press the scan button to initiate a temperature measurement When the thermometer is off press the scan button to turn on the device 10 3 3 Equivalence Mode Temperature The thermometer can measure the ear temperature and acquire the equivalence temperature A patient s temperature at the site of mouth rectum or core would be slightly different from the ear ...

Page 99: ...wipe or lint free swab 3 Press the scan button to verify functionality and mode selection on the LCD screen 4 Install a probe cover by firmly inserting the probe tip into a probe cover Make sure that the probe cover is fully seated 5 Place the probe in the ear canal 6 Once positioned lightly in the ear canal press and release the scan button 7 Remove the probe from the ear as soon as the triple be...

Page 100: ...C or F 10 3 6 Troubleshooting Message Cause Solution Temp comm abnormal The communication between the monitor and thermometer is abnormal Eject and re install the probe cover And then measure the temperature again 10 3 7 Cleaning and Disinfecting the Tympanic Thermometer Refer to the Genius 2 Tympanic Thermometer instructions for use for cleaning and disinfection information 1 2 4 5 3 ...

Page 101: ... CO2 monitoring is intended for adult pediatric and neonatal patients 11 2 Safety WARNING Remove the airway sampling line from the patient s airway while nebulized medications are being delivered Leakage in the breathing or sampling system may cause the displayed EtCO2 values to be significantly low Always make sure that all components are securely connected EtCO2 values measured from the CO2 modu...

Page 102: ... measurement and a CO2 waveform 1 End tidal CO2 EtCO2 2 Fraction of inspired CO2 FiCO2 3 Airway respiration rate RR 4 CO2 waveform 5 Scale 11 5 Measuring CO2 CAUTION Eliminate the exhausted gas before performing the measurement Connect an exhaust tube to the gas outlet connector of the monitor to vent the calibration gases to a scavenging system Check that the alarm limit settings are appropriate ...

Page 103: ... DRYLINE PRIME mini water trap is automatically blocked when its service life is reached Replace the DRYLINE PRIME mini water trap if the alarm CO2 Change Watertrap occurs The water trap has a filter preventing bacterium water and secretions from entering the module Extended use could destroy the filter in water trap and fail to stop the bacterium water and secretions entering the module result in...

Page 104: ...r waveform area to enter the CO2 Setup menu 2 Select Alarm Setup 3 Set the following alarm properties Switch on or switch off the alarms Adjust the alarm limits and alarm priority 11 7 2 Setting the Apnea Alarm Delay The monitor will alarm if the patient has stopped breathing for longer than the preset Apnea time To set the Apnea delay time follow this procedure 1 Select the CO2 numeric area or wa...

Page 105: ...ric area or waveform area to enter the CO2 Setup menu 2 Set Operating Mode to Standby 11 7 5 Setting the Auto Standby The monitor enters the standby mode automatically 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 Standb...

Page 106: ...ons may cause inaccurate measurement values and result in misdiagnosis To set the gas compensation follow this procedure 1 Select the CO2 numeric area or waveform area to enter the CO2 Setup menu 2 Set the O2 N2O and AA compensation according to the actual amount of the respective gas in the ventilation gas mixture 11 7 8 Automatic Barometric Pressure The CO2 module has the function of automatic b...

Page 107: ...es and clinical responses in the clinical scores are for reference and cannot be used alone for diagnostic interpretation Both MEWS and NEWS are not applicable to pregnant woman COPD Chronic Obstructive Pulmonary Disease patients and those under 16 years old 12 1 1 MEWS Modified Early Warning Score The MEWS calculates a total score and provides a clinical response based on the following five param...

Page 108: ...alue is out of range The available parameters in customizable scoring include Respiration Rate SpO2 Supplemental Oxygen Temperature Systolic NIBP Pulse Rate Level of Consiousness either AVPU or GCS Blood Sugar Urine Output Catheter Pain Score Pain Inspired O2 Airway Three customizable parameters The applicable patient category can be defined with the Mindray Clinical Scoring Config Tool Refer to C...

Page 109: ...ue of all parameters and then total score will be automatically calculated Refer to 12 5 Obtaining the Total Score 3 If necessary record the scoring data Refer to 12 4 Clinical Scoring Screen 12 4 Clinical Scoring Screen 12 4 1 Score Tile in the Main Screen The MEWS NEWS and multi parameter score tile display as following 1 Name for clinical score 2 Total score the background color indicates the c...

Page 110: ...rmal range 12 4 2 Scoring Screen The MEWS NEWS or multi parameter score screen display as following 1 Icon for manual input You need to manually input the parameter 2 Icon for real time monitoring The parameter value is from the monitor 3 Score for single parameter 4 Recommended clinical response The IPS score screen displays as following 1 4 2 3 ...

Page 111: ...n the above screens you can Select Review to open the patient review screen Refer to 4 4 Reviewing Patient Data for details Select Record to print the current patient scoring data with a recorder Select Save to save the scoring data in the Results screen Refer to4 3 Manually Save Patient Data Select Exit to go to the main screen 12 5 Obtaining the Total Score The IPS only calculates the parameter ...

Page 112: ... 20 bpm 300 bpm Systolic NIBP 40 mmHg 270 mmHg Adult 40 mmHg 200 mmHg Pediatric 40 mmHg 135 mmHg Neonate Respiration Rate 0 150 rpm Temperature 0 1 C 50 0 C 32 1 F 122 0 F Level of Consciousness AVPU Alert Reacting to Voice Reacting to Pain Unresponsive GCS 1 15 Supplemental Oxygen Yes No SpO2 0 100 Urine Output 0 300 mml h 0 10 ml h kg Catheter Yes No Blood Sugar 1 0 mg dl 720 0 mg dl 0 06 mmol L...

Page 113: ...oes not provide default scoring To select a default scoring 1 Select Main Maintenance User Settings Enter the required password Manage Scoring Select Default Scoring 2 Set the default scoring for the applicable patient category After the default scoring is set when a patient category is changed the monitor will automatically use the default scoring 12 6 3 Deleting the Scoring To delete the scoring...

Page 114: ...12 8 FOR YOUR NOTES ...

Page 115: ...ndicator On when the recorder works properly Off when the monitor is switched off Flash when an error occurred to the recorder e g the recorder runs out of paper 3 Paper outlet 4 Recorder door 5 Latch 13 2 Loading Paper 1 Press the latch at the upper right of the recorder door to open the door 2 Insert a new roll into the compartment as shown below 3 Close the recorder door 4 Check if paper is loa...

Page 116: ...ng the Recorder Select Main General Setup Print Setup to access the Print Setup menu and select the items as you want 13 4 Starting and Stopping Recordings To manually start a recording you can either Press hardkey on the recorder Select Record key in graphic or tabular trend The monitor will automatically start recording when the Save QuickKey is selected to save the manual input patient data if ...

Page 117: ...c Trend Recording Graphic trend strip includes patient information recording time and graphic trends of all the parameters on the screen In graphic trends strip The mark A is shown on the event time The mark indicates system time changes NIBP measurement taken in Spot mode shows as The predictive temperature and PR from NIBP measurement show as 13 5 3 Continuous Trends Recording The continuous tre...

Page 118: ...cedure to remove it 1 Open the recorder door 2 Take out the paper and tear off the draped part 3 Reload the paper and close the recorder door 13 7 Cleaning the Recorder Printhead If the recorder has been used for a long time 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 T...

Page 119: ...tem through the eGateway The monitor transmits the query command message to the ADT system When the ADT system receives the query command message the ADT system will transmit the patients information to the monitor The monitor transmits numerics of Temp SpO2 NIBP CO2 related alarms and alarm settings patient information operating mode and historical data including trends and events to the EMR When...

Page 120: ... OK to confirm the setting 14 2 2 WLAN Test To test the availability of the wireless network follow this procedure 1 Select WLAN Test in the Network Setup menu 2 Enter the IP Address of wireless AP in the WLAN Test menu 3 Click Connection Test The Wi Fi device used in the monitor is in compliance with IEEE 802 11a b g n You should not change the patient monitor s IP address randomly If you want to...

Page 121: ...lular mobile communication networks microwave ovens interphones cordless phones and electro surgical units is no less than 20 cm 14 3 Setting Data Send Method You can choose to send the monitor data to hospital system through eGateway or HL7 protocol 1 Select Main Maintenance User Settings Enter the required password Select Ok Network 2 Set Data Send Method to eGateway Send or HL7 Direct Send 14 3...

Page 122: ...User Settings Enter the required password Select Ok to access User Settings Menu 2 Select Network EMR Communication 3 Set Real Data Send to an appropriate setting 14 3 5 Alarm Server Setup for HL7 only 1 Select Main Maintenance User Settings Enter the required password Select Ok to access User Settings menu 2 Select Network Alarm Server Setup 3 Set the IP address and port 4 Select Ok to exit the m...

Page 123: ... current monitoring To select the CMS select the prompt message area at the bottom of the screen Then the selected CMS name will display If the CMS you select does not have a name this area displays 14 4 3 Clearing the Selected CMS at Startup You can clear the selected CMS each time the monitor restarts after being powered off for more than 2 minutes To clear the selected CMS 1 Select Main Mainten...

Page 124: ...u need to set the multicast parameters To do so 1 Select Main Maintenance User Settings enter the required password Select Ok Network Multicast Setup 2 Set Multicast Addr and TTL 14 7 DIAP Communication Setup 1 Select Main Maintenance User Settings Enter the required password Select Ok to access user settings menu 2 Select DIAP Communication to access DIAP Communication Setup menu 3 Set up the bau...

Page 125: ...tery symbol indicate the battery status as follows Indicates that battery works correctly The solid portion represents the current charge level of the battery in proportion to its maximum charge level Indicates that the battery has low charge level and needs to be charged Indicates that the battery is almost depleted and need to be charged immediately Otherwise the monitor will shut down automatic...

Page 126: ...must be performed once a year before monitor repairs or whenever the battery is suspected as being the source of the problems Condition the batteries once when they are used or stored for three months or when their run time becomes noticeably shorter Take out the battery before the monitor is transported or will not be used for more than 3 months Remove the battery from the monitor if it is not be...

Page 127: ... power Allow the battery to be charged uninterrupted till the battery is full and the battery indicator is off 4 Remove AC power and allow the monitor to run from the battery until it shuts off 5 Again connect the monitor to AC power Allow the battery to be charged uninterruptedly till the battery is full and the battery indicator is off NOTE The actual battery capacity will decrease over time wit...

Page 128: ... after being fully charged The operating time depends on the configuration and operation For example measuring NIBP more frequently will also shorten the operating time When a battery has visual signs of damage or no longer holds a charge it should be replaced Remove the old battery from the monitor and recycle it properly 15 6 Recycling a Battery When a battery has visual signs of damage or no lo...

Page 129: ...r Do not open the equipment housings All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only No modification of this equipment is allowed The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment 16 1 Cleaning and Disinfection In this chapter we only describe cleaning and disinfection of th...

Page 130: ...ice personnel 16 1 1 Cleaning Your equipment should be cleaned on a regular basis If there is heavy pollution or lots of dust and sand in your place the equipment should be cleaned more frequently Before cleaning the equipment consult your hospital s regulations for cleaning the equipment Recommended cleaning agents are sodium hypochlorite bleach diluted Hydrogen peroxide 3 Ethanol 70 Isopropanol ...

Page 131: ...d condition Make sure that only specified accessories are applied Inspect if the alarm system functions correctly Make sure that the recorder functions correctly and the recorder paper meets the requirements Make sure that the battery meets the performance requirements Make sure that the monitor is in good working condition In case of any damage or abnormity do not use the equipment Contact the ho...

Page 132: ...IBP test Pressure check Leakage test Temp test CO2 test and calibration Leakage test Performance test Calibration Nurse Call Relay Performance Test If user suspects that the nurse call or analog output does not work well Electrical safety tests Electrical safety tests At least once every two years or as required Other tests Power on test 1 When first installed or after reinstalled 2 Following any ...

Page 133: ...on system configuration by selecting Monitor Configuration or status information such as start time self test error and so on by selecting Monitor Log You can print out the log information for the convenience of troubleshooting Select Recorder from the Monitor Log menu to do recording The information will not be saved after system shutdown ...

Page 134: ... the cuff around the cylinder as shown below 4 Select Main Maintenance User Settings Enter required password Module Maintenance NIBP Leakage Test The message Leakage Testing is displayed in the NIBP parameter area After about 20 seconds the monitor will automatically deflate This means the test is completed If the message NIBP Pneumatic Leak is displayed it indicates that the NIBP airway may have ...

Page 135: ...r the reading is 0 3 Select Main Maintenance User Settings Enter required password Module Maintenance NIBP Accuracy Test The message Accuracy Testing is displayed in the NIBP parameter area 4 Check the manometer values and the monitor reading Both should be 0mmHg 5 Raise the pressure in the metal vessel to 50 mmHg with the balloon pump Then wait for 10 seconds until the measured values become stab...

Page 136: ...tain time 2 Block the gas inlet for another 30 seconds If the alarm message does not disappear it indicates that the module does not leak 16 6 2 CO2 Accuracy Test For the CO2 module accuracy test is needed every year or when you suspect the measurement Tools required A steel gas cylinder with 5 0 03 CO2 and balance gas N2 P N 0075 00 0033 01 T shape connector Tubing Follow this procedure to perfor...

Page 137: ...let connector of the monitor to remove the calibration gases to a scavenging system Tools required A steel gas cylinder with 5 0 03 CO2 and balance gas N2 P N 0075 00 0033 01 T shape connector Tubing Follow this procedure to perform a calibration 1 Make sure that the CO2 module has been warned up or started up 2 Check the airway for leakage and perform a leakage test as well to make sure the airwa...

Page 138: ...Touchscreen 1 Select Main Maintenance Calibrate Touchscreen The symbol will appear at different positions of the screen 2 Select in turn the central point of the symbol After the calibration is completed the message Screen Calibration Completed is displayed 3 Select Ok to confirm the completion of the calibration 16 8 Formatting the Storage Card The monitor is configured with an SD card for saving...

Page 139: ...16 11 2 Select Modify Password 3 Enter new password and then select Ok ...

Page 140: ...16 12 FOR YOUR NOTES ...

Page 141: ...r staff has undertaken the bio compatibility test and is verified to be in compliance with ISO 10993 1 Use the accessories before the expiry date if their expiry date is indicated For details about the accessories refer to the instructions for use provided with the accessory 17 1 SpO2 Accessories Extension Cable Module type Remarks Part No Mindray SpO2 Module 7 pins 2 5 m 0010 20 42710 7 pins 1 2 ...

Page 142: ...inger 512E 30 90390 512F Adult Finger split 512F 30 28263 512F Adult Finger integrated 115 012807 00 512G Pediatric Finger 512G 30 90607 512H 512H 30 79061 Masimo SpO2 module Type Model Patient Category Part No Disposable LNCS NeoPt L Pediatric neonate 0010 10 42626 LNCS Neo L Neonate 0010 10 42627 LNCS Pdtx Pediatric 0010 10 42629 LNCS Adtx Adult 0010 10 42630 LNCS NeoPt Neonate 1 kg 040 000295 0...

Page 143: ...e sensor is less than 18 mW The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians for example when photodynamic therapy is performed 17 2 NIBP Accessories Tubing Type Patient Category Part No Reusable Adult pediatric infant 6200 30 09688 Neonate 6200 30 11560 Reusable Cuff Model Patient Category Measurement Site Limb Circumference c...

Page 144: ... 001B 30 70693 CM1500C 5 8 to 10 9 001B 30 70694 CM1500D 7 1 to 13 1 001B 30 70695 CM1500E 8 to 15 001B 30 70681 CM1501 Infant 10 to 19 001B 30 70697 CM1502 Pediatric 18 to 26 001B 30 70698 CM1503 Adult 24 to 35 001B 30 70699 CM1504 Large adult 33 to 47 001B 30 70700 CM1505 Adult Thigh 46 to 66 001B 30 70701 17 3 Temp Accessories 17 3 1 SmarTemp Accessories Probe Well Type Description Part No Reus...

Page 145: ...ared ear thermometer 100 000102 00 Probe Cover Type Patient Category Description Part No Disposable Adult Pediatric Neonate Cover 200 pcs pack 100 000103 00 17 3 3 GeniusTM 2 Tympanic Thermometer Accessories Tympanic Thermometer Type Description Part No Reusable Tethered tympanic thermometer 100 000198 00 Probe Cover Type Patient Category Description Part No Disposable Adult Pediatric Neonate Cove...

Page 146: ...0 Nasal gas sampling line Adult 100 000142 00 Nasal gas sampling line Pediatric 100 000143 00 Nasal gas sampling line Neonate 100 000144 00 DRYLINETM PRIME Gas sampling line with airway adapter Adult Pediatric 100 000140 00 Gas sampling line with airway adapter Neonate 100 000141 00 Nasal gas sampling line Adult 100 000145 00 Nasal gas sampling line Pediatric 100 000146 00 Nasal gas sampling line ...

Page 147: ...ee of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE Degree of mobility Portable A 2 Environmental Specifications Main Unit Item Operating conditions Storage conditions Temperature 0 to 40 ºC 20 to 60 ºC Relati...

Page 148: ...e same as those of the main unit A 3 Power Supply Specifications AC Power Line voltage 100 to 240 VAC 10 Current 0 9 to 0 5A Frequency 50 60 Hz 3Hz Fuse T2AL 250V Battery Battery Standard Battery Type LI13I001A Chargeable Lithium Ion Voltage 11 1 VDC Capacity 2600 mAh Run time At least 3 hours when powered by a new fully charged battery at 25 C 5 C with SpO2 cable connected and auto NIBP measureme...

Page 149: ...s to 90 less than 6 5 hours to 100 Monitor power on less than 10 5 hours to 90 less than 11 5 hours to 100 Shutdown delay At least 20 minutes after a low battery alarm first occurs A 4 Physical Specifications Size 178mm 150mm 260mm Weight 2 5 kg with SpO2 module NIBP module recorder module and a battery A 5 Hardware Specifications A 5 1 Display Screen type Color TFT LCD Screen Size diagonal 8 4 Re...

Page 150: ...1 Multi Functions Connector 1 MINI D RIBBON connector A 5 6 Outputs Nurse Call Signal Amplitude High level 3V providing a maximum of 3 mA output current Low level 0 5 V receiving a maximum of 5 mA input current Rising and falling time 1 ms Alarm output Network connector Alarm delay time from monitor to remote equipment The alarm delay time form the monitor to remote equipment is 2 seconds measured...

Page 151: ...00 2 measured without motion in adult pediatric mode 70 to 100 3 measured without motion in neonate mode 0 to 69 Not specified Studies were performed to validate the accuracy 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 o...

Page 152: ...ue to properties of fetal hemoglobin The Masimo pulse oximeter with sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz At an amplitude of 1 to 2 cm and non repetitive motion between 1 to 5 Hz At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 t...

Page 153: ...years Health Black Male 1 28 2 9 19 Healthy Female 1 Yellow Male 3 Female 9 A 6 2 PR Module PR High Limit PR Low Limit Step bpm Mindray SpO2 Module low limit 2 to 254 20 to high limit 2 1 Masimo SpO2 Module low limit 2 to 240 25 to high limit 2 Nellcor SpO2 Module low limit 2 to 300 20 to high limit 2 NIBP Module low limit 2 to 240 40 to high limit 2 PR from Mindray SpO2 Module Measurement range 2...

Page 154: ...P Module Measurement range 40 to 240 bpm Resolution 1 bpm Accuracy 3bpm or 3 whichever is greater A 6 3 NIBP Standards Meet standards of IEC 80601 2 30 ISO 81060 2 Technique Oscillometry Mode of operation Manual Auto STAT and Program Auto mode repetition intervals 1 2 2 5 3 5 10 15 20 30 60 90 or 120 min STAT mode cycle time 5 min Max measurement time Adult pediatric 180 s Neonate 90 s Heart rate ...

Page 155: ...c low limit 5 to 200 Neonate low limit 5 to 135 5 Sys Low 40 to high limit 5 Mean High Adult low limit 5 to 230 Pediatric low limit 5 to 165 Neonate low limit 5 to 110 Mean Low 20 to high limit 5 Dia High Adult low limit 5 to 210 Pediatric low limit 5 to 150 Neonate low limit 5 to 100 Dia Low 10 to high limit 5 Measurement accuracy verification In adult and pediatric modes the blood pressure measu...

Page 156: ...ct mode monitor mode Measurement range Monitor mode 25 C to 44 C 77 F to 111 2 F Predictive mode 35 C to 43 C 95 F to 109 4 F Accuracy Monitor mode 25 C to 32 C not include 32 C 0 2 C 32 C to 44 C include 32 C 0 1 C or 77 F to 89 6 F not include 89 6 F 0 4 F 89 6 F to 111 2 F include 89 6 F 0 2 F Resolution 0 1 C or 0 2 F Minimum measurement time for accurate readings Monitor mode 60 s Predictive ...

Page 157: ...C to 38 9 C 98 1 F to 102 F 0 1 C 0 2 F 16 C to 33 C 60 8 F to 91 4 F 33 C to 42 C 91 4 F to 107 6 F 0 2 C 0 4 F Resolution 0 1 C or 0 1 F A 6 5 CO2 Standard Meet standard of ISO 80601 2 55 Technique Infrared absorption Apnea time 10 s 15 s 20 s 25 s 30 s 35 s 40 s CO2 measurement range 0 to 20 CO2 accuracy Full accuracy mode CO2 concentration 1 1 CO2 concentration 5 5 CO2 concentration 7 7 CO2 co...

Page 158: ...5 Iso 5 Enf 5 Des 15 2 mmHg means an extra error should be added in case of gas interference when CO2 measurements are performed between 0 to 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 Et...

Page 159: ...uld be observed to verify normal operation in the configuration in which it will be used The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Other devices may interfere with this device even though they meet the requirements of CISPR When the inputted signal is below the minimum amplitude provided in tech...

Page 160: ...ly 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 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 nece...

Page 161: ... 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 162: ...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 163: ...se 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 output...

Page 164: ...s 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 This device complies with Part 15 of the FCC Rules and RSS 210 of Industry Canada Operati...

Page 165: ...B 7 point to point operation as stated in RSS 210 WARNING Keep a distance of at least 20cm away from the monitor when Wi Fi function is in use ...

Page 166: ...B 8 FOR YOUR NOTES ...

Page 167: ...ration C 1 1 NIBP Name Default Saved at Power Failure Affected by Defaults Alarm On Off On Yes Yes Alarm Priority Med Yes Yes Interval Manual Yes Yes Clock On Yes Yes NIBP End Tone 0 Yes Yes Program Program 1 Yes Yes Cuff Press in VeniPuncture mmHg Adult 80 Yes Yes Pediatric 60 Neonate 40 Initial Pressure Adult 160 Yes No Pediatric 140 Neonate 90 NIBP Sys High mmHg Adult 160 Yes Yes Pediatric 120 ...

Page 168: ...ate 20 C 1 2 SpO2 Name Default Config Saved at Power Failure Affected by Defaults Alarm On Off On Yes Yes Alarm Priority Med SpO2 High Adult pediatric 100 Neonate 95 SpO2 Low 90 Desat Low 80 Sat Seconds Nellcor 0s NIBP Simultaneous Off Sweep 25 mm sec Beat Volume 2 SpO2 Sensor Off Lev Monitor mode Low Spot Check mode Off Yes No Sensitivity Mindray Med Yes Yes Sensitivity Masimo Normal Averaging Ma...

Page 169: ...igured with SmarTempTM Module Name Default Config Saved at Power Failure Affected by Defaults Alarm On Off Off Yes Yes Alarm Priority Med Yes Yes Temp High 38 0 Yes Yes Temp Low 35 0 Yes Yes Temp Type Predictive No No Temp Position Oral Axillary probe Oral for adult and pediatric Axillary for neonate No No Rectal probe Rectal Configured with GeniusTM 2 Module Name Default Config Saved at Power Fai...

Page 170: ... 30 RR Low 8 Parameter EtCO2 Alarm On Off On Yes Yes Alarm Priority Med EtCO2 High 50 EtCO2 Low 25 Parameter FiO2 Alarm On Off On Yes Yes Alarm Priority Med FiCO2 High 4 Apnea Delay 20 s Yes Yes Operating Mode Measure Yes No BTPS Compensate Off Yes Yes Scale 50 Sweep 6 25 mm s Wave Type Draw O2 Compensate 21 N2O Compensate 0 AA Compensate 0 Auto Standby 60 min ...

Page 171: ...ne On Alarm Light on Alarm Reset On C 2 2 Review Name Default Config Saved at Power Failure Affected by Defaults Spot Check Trends Name MRN button MRN Yes No Option for Name MRN button All Filter All Continuous Trends Name MRN button MRN Option for Name MRN button Current patient Interval 30s Graphic Trends Zoom 6 h C 2 3 Record Name Default Config Saved at Power Failure Affected by Defaults SpO2 ...

Page 172: ...t kg Pressure mmHg Temp Glucose mg dl I O Fluid ml Date Current date Time Current time Date Format yyyy mm dd Yes No Time Format 24h Yes No C 3 User Maintenance Items Name Default Config Saved at Power Failure Affected by Defaults Spot Check Off Yes No SpO2 Tone Mode 1 Clinician ID Time Out 10 min Language English Network Type LAN Select CMS On Clear CMS IP at Startup Off Data Send Method HL7 Dire...

Page 173: ... below the desaturation alarm limit Check the patient s condition and check if the alarm limit settings are correct No Pulse High The pulse signal was so weak that the monitor cannot perform pulse analysis Check the patient s condition SpO2 sensor and measurement site Apnea High The patient stops breathing or the respiration signal was so weak that the monitor cannot perform respiration analysis C...

Page 174: ...mit Yes Low NIBP SelfTest Err Yes High SelfTest Failed The cause may be the transducer or A D sampling error Restart the monitor and retry If the error remains contact your service personnel NIBP Init Err Yes Low An error occurred to the NIBP module or there is a problem with the communications between the module and the monitor Restart the monitor If the error remains contact our service personne...

Page 175: ... moves too much Check the patient s condition and reduce the patient motion NIBP Cuff Overpress Yes Low The NIBP airway may be occluded Check the airway and measure again NIBP Signal Saturated Yes Low The NIBP signal is saturated Check the patient s condition and reduce the patient motion or other sources NIBP Air Leak Yes Low The NIBP airway may leak air The NIBP cuff is not properly connected or...

Page 176: ...eck mode The SpO2 sensor 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 Mindray Masimo No Low SpO2 No Sensor Mindray Masimo Nellcor Yes Low SpO2 Unknown Sensor...

Page 177: ...k Adjust the sensor application site SpO2 Weak Signal Nellcor No Low SpO2 Interference Masimo No Low The SpO2 signal has been interfered Check for any possible sources of signal noise around the sensor and check the patient for great motion SpO2 Comm Err Mindray Masimo Nellcor Yes High An error occurred to the SpO2 module or there is a problem with the communications between the module and the mon...

Page 178: ...to the Temp module or there is a problem with the communications between the module and the monitor Restart the monitor If the error remains contact our service personnel Temp Alarm Limit Err No High The alarm limit of Temp is changed inadvertently Contact your service personnel Warmup Timed Out Yes Med The initial probe temperature in measurement is too high Cool the probe and retry Warming Resis...

Page 179: ...e temperature probe is not well placed or not inserted into probe well 1 Check if the probe well is installed 2 Properly re insert the probe into probe well Temp Measuring Timeout Yes Med The measuring time is over 5 minutes in Monitor mode Return the sensor to the probe well and take a temperature again D 2 4 CO2 Alarm Messages Alarm Message Clearable Yes No Alarm Level Cause Solution CO2 Comm Er...

Page 180: ...ied range Contact your service personnel XX represents a measurement or parameter label D 2 5 Recorder Alarm Messages Alarm Message Clearable Yes No Alarm Level Cause Solution Recorder Init Error Yes Low An error occurred to the module or there is a problem with the communication between the module and the monitor Restart the monitor If the problem still exists contact your service personnel Recor...

Page 181: ... Low No High 3 3V Too High No High 3 3V Too Low No High Battery Too Low No Med The battery charge is too low Connect the monitor to an AC power source and allow the batteries to charge immediately Battery Depleted No High The battery charge is almost depleted Power Board Comm Err No High No data from power module has been received for 5 seconds Restart the monitor If the problem still exists conta...

Page 182: ...D 10 D 2 7 System Alarm Messages Alarm Message Clearable Yes No Alarm Level Cause Solution No CMS Yes Low The monitor is disconnected from the CMS Check network connection ...

Page 183: ... procedure Follow the instructions of the analyzer manufacturer he 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 E 1 1 The Power Plug Test Item Acceptance Criteria The power plug The power pl...

Page 184: ...l 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 Labeling Check the labels provided by the manufacturer or the healthcare facility are present and legible Main unit label Integrated warning labels E 4 Protective Earth Resistance 1 Plug the probe...

Page 185: ...1 500 μA in Normal Condition 1000 μA in Single Fault Condition E 6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth All measurements have a true RMS only The following outlet conditions apply when performing the Patient Leakage Current test normal polarity Normal Condition reverse polarity Normal Condition normal polarity with open neutr...

Page 186: ...hen taken between the selected applied part and earth Measurements are taken with the test voltage 110 of mains to applied parts in the normal and reverse polarity conditions The following outlet conditions apply when performing the Mains on Applied Part test Normal Polarity Reversed Polarity LIMITS For CF applied parts 50 μA For BF applied parts 5000 μA NOTE Make sure the safety analyzer is autho...

Page 187: ...re hour bpm beat per minute bps bit per second ºC centigrade cm centimeter dB decibel DS dyne second ºF fahrenheit g gram GHz gigahertz h hour Hz hertz in inch k kilo kg kilogram kPa kilopascal L litre lb pound m meter mAh milliampere hour Mb mega byte mg milligram min minute ml milliliter mm millimeter ...

Page 188: ... mW milliwatt MΩ megaohm nm nanometer rpm breaths per minute s second V volt VA volt ampere Ω ohm W watt minus negative percent per divide or to plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright ...

Page 189: ...rect current Dia diastolic DPI dot per inch EEC European Economic Community EMC electromagnetic compatibility EMI electromagnetic interference EMR Electronic Medical Record GCS Glasgow Coma Scale ID identification IEC International Electrotechnical Commission ISO International organization for standardization IEEE Institute of Electrical and Electronic Engineers IP internet protocol IPS Individual...

Page 190: ...NIBP M NIBP mean pressure NIBP S NIBP systolic pressure P power PD photodetector Ped pediatric Pleth plethysmogram PR pulse rate RAM random access memory ROM read only memory SpO2 arterial oxygen saturation from pulse oximetry TD temperature difference TEMP temperature ...

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