Mindray Passport V Operating Instructions Manual Download Page 253 | Manualshive

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Performance Characteristics

Appendix

19 - 18

0070- 0-0704-02

Passport V Operating Instructions

Masimo SET

®

Reference notes

The Masimo SET MS-3 pulse oximeter with LNOP

®

•Adt sensors has been validated for no

motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies in the range of 70% to 100% SpO

2

against a laboratory co-oximeter and ECG

monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.

The Masimo SET MS-3 pulse oximeter with LNOP

®

•Adt 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% to 100% SpO

2

against a laboratory co-oximeter and

ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.

The Masimo SET MS-3 pulse oximeter with LNOP

®

•Neo and Neo•Pt sensors has been

validated for neonatal motion accuracy in human blood studies on neonates while moving
the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.

The Masimo SET MS-3 pulse oximeter has been validated for low perfusion accuracy in
bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal
strengths of greater then 0.02% and a % transmission of greater than 5% for saturation's
ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus
or minus on standard deviation encompasses 68% of the population.

Low Perfusion Performance

LOW PERFUSION CONDITIONS

PULSE

AMPLITUDE

%

TRANSMISSION

SATURATION

ACCURACY

PULSE RATE

ACCURACY

> 0.02%

> 5%

± 2 digits

± 3 digits

Pulse Rate Range and Accuracy

ACCURACY

PATIENT SIZE

PULSE RATE

RANGE

NO MOTION

CONDITIONS

DURING

MOTION

CONDITIONS

Adult / Pediatric / Neonate

25 to 240 bpm

± 3 digits

± 5 digits

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Summary of Contents for Passport V

Page 1: ...Operating Instructions Passport 0070 01 0704 02_PPV ops color indd 1 2 17 11 4 23 PM ...

Page 2: ...Operating Instructions Passport 0070 02 0704 02_PPV ops b_w indd 1 2 17 11 4 32 PM ...

Page 3: ...Oridion Medical Ltd Microstream is a U S registered trademark of Oridion Medical Ltd Mindray is a trademark or registered trademark of Shenzhen Mindray Bio Medical Electronics Co Ltd NavigatorTM is a U S trademark of Mindray DS USA Inc NellcorTM is a U S trademark of Nellcor Puritan Bennett Inc NIV LineTM is a trademark of Oridion Medical Ltd Oxiband is a U S registered trademark of Nellcor Purita...

Page 4: ... Network 2 4 Monitor Setup Menu 2 6 Advanced Setup 2 7 How to Set the Clock Date and Time 2 8 Transferring Monitor Default Settings 2 8 Configuration Management 2 9 Patient Management 3 1 Description 3 1 Setting up Patients 3 2 Patient Menu 3 2 Discharging a Patient 3 4 Data Transfer 3 5 Transferring User Configuration 3 5 Remote View 3 6 Monitor Display Troubleshooting 3 11 ECG Monitoring 4 1 Des...

Page 5: ... FIB Alarm 4 25 Ventricular Tachycardia V TACH Alarm 4 26 Non Lethal Arrhythmia Alarms 4 26 Bigeminy Alarm 4 26 Brady Bradycardia Alarm 4 26 Couplet Alarm 4 26 Irregular Heart Rate Alarm 4 27 PVC minute Alarm 4 27 Run Alarm 4 27 Trigeminy Alarm 4 27 Ventricular Rhythm V Rhythm Alarm 4 27 Arrhythmia Analysis Optional 4 28 Arrhythmia Analysis Setup 4 29 ST Analysis Optional 4 30 Numeric Tile ST 4 31...

Page 6: ...t Functions 7 10 Indirect BP Measurements and Associated Errors 7 10 Recommendations for Automatic Blood Pressure Measurements 7 11 Cuff Size 7 11 Other Factors 7 11 User Verification of Passport V Blood Pressure Measurements 7 11 Newborn NIBP Technique 7 11 NIBP List Tile 7 12 Adaptive Inflation Pressure 7 12 NIBP Troubleshooting 7 13 Temperature Monitoring 8 1 Description 8 1 Temperature Screens...

Page 7: ...f Anesthetic Agents 11 6 Gas Module 3 Pre use Test 11 8 Gas Module Troubleshooting 11 8 Drug Calculations 12 1 Description 12 1 Drug Calculations 12 1 Alarms 13 1 Alarms 13 1 Adjusting Alarms 13 1 Alarm Limits 13 3 Auto Set Alarms 13 5 Alarm Violations 13 6 Verifying Alarm Functionality 13 8 Alarm Troubleshooting 13 9 Messages 14 1 Physiological Alarm Messages 14 1 HR 14 1 Arrhythmia 14 1 RESP 14 ...

Page 8: ...inting 16 1 Description 16 1 Print Setup Menu 16 1 Local Printer Optional 16 2 Remote Local Printer Troubleshooting 16 4 User Maintenance 17 1 Description 17 1 Care and Disinfection of the Passport V Monitor 17 2 Care and Cleaning of SpO2 Sensors 17 3 Care and Cleaning of Reusable Temperature Probes 17 3 Care and Cleaning of Reusable Cuffs 17 4 Reusable Cuffs with Bladders 17 4 Reusable Bladderles...

Page 9: ... Performance Characteristics 19 6 ECG Specifications 19 6 RESP 19 12 IBP 19 13 NIBP Performance and Functional Characteristics 19 14 Masimo SET SpO2 Performance Requirements 19 16 DPM SpO2 Performance Requirements 19 19 Nellcor SpO2 19 20 CO2 Performance Characteristics 19 21 Temperature Performance Characteristics 19 25 Gas Module Performance Characteristics 19 26 Input Output Communications 19 2...

Page 10: ...857 461 6 011 986 6 035 223 6 157 850 6 226 539 6 263 222 6 411 833 6 422 240 6 437 316 6 463 310 6 501 975 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 foreign equivalents and Masimo patents www masimo com patents htm Possession or purchase of this device does not convey any express or implied license to use the ...

Page 11: ...nnected to a patient Ensure that the total chassis leakage currents of all connected units does not exceed 300µA Use an IEC 60601 1 approved isolation separation transformer if required Do not simultaneously touch the patient and any piece of electrical equipment if any cover has been removed from the equipment WARNING Electrode polarization some electrodes may be subject to large offset potential...

Page 12: ...ional law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified packed marked classified labeled and documented according to D O T and I A T A regulations Please refer to the applicable I A T A Dangerous Goods Regulations and or the Code of Federal Regulations 49 Transportation Parts 171 180 for further information WARNING Route ...

Page 13: ...sive scavenge vacuum may result in damage to the Gas Module s internal pump WARNING When monitoring CO2 the maximum sampling rate at the nasal cannula is 150ml min with the DPM CO2 module This device should not be used on patients whose breathing could be impaired by these vacuum flow rates WARNING When monitoring an anesthesized patient in an operating room environment connection from the exhaust...

Page 14: ...ter trap breaks or becomes damaged during operation there is a risk that bacteria and or mucus may contaminate the Gas Module WARNING The Gas Module must not be used with flammable anesthetic agents WARNING SpO2 sensors SpO2 accessories and temperature probes should be disposed of in accordance with local regulations WARNING Shut down the monitor and disconnect all power cords from the outlet befo...

Page 15: ...mounted to another item e g a rolling stand or Gas Module 3 CAUTION Never place fluids on top of this monitor In case of accidental spillage wipe clean immediately and have the monitor serviced to ensure no hazard exists CAUTION To avoid possible damage to the Passport V and to provide protection against the effect of the discharge of a cardiac defibrillator and against burns use only approved ECG...

Page 16: ...BP measurement is performed on patients suffering from sickle cell disease or are expected to have skin injuries CAUTION Observe caution when NIBP measurement is performed on a patient s limb with venous transfusion or catheters CAUTION Tissue damage or inaccurate measurements may be caused by incorrect SpO2 sensor application or use such as wrapping too tightly applying supplemental tape failing ...

Page 17: ...tes and patients of poor perfusion or with skin sensitive to light check every 2 3 hours more frequent examinations may be required for different patients Change the sensor site if signs of circulatory compromise occur CAUTION When equipped with Masimo SET SpO2 use only Masimo SET Oxygen Transducers including Masimo SET LNOP and LNCS Patient Dedicated Adhesive Sensors and Masimo SET PC Series Pati...

Page 18: ...formation over its entire area Do not cover any part of the monitor display with tape or labels CAUTION A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or a pulse oximeter monitor CAUTION Replace lithium ion batteries with part number M05 010001 06 Mindray or 0146 00 0099 ONLY CAUTION Gas Module 3 must be moisture protected whenever transported This can be don...

Page 19: ...e IEC 60601 1 1 Please contact Technical Support if you have any questions about connecting devices to the data port CAUTION The Gas Module must be power cycled if the Passport V monitor is powered off Avoid simultaneous contact with the patient and the SP1 and SP2 ports on the Passport V to avoid excessive leakage current Notes NOTE This unit is not designed to be used with a peripheral pulse sen...

Page 20: ...p to two 2 channels Respiration Rate waveform derived from ECG or CO2 CO2 inspired and end tidal waveform Anesthetic agents O2 inspired and expired Temperature IV Drug Calculations The target populations are adult pediatric and neonate except Arrhythmia Detection and ST Segment Analysis for which the target populations are adult and pediatric only and IV Drug Calculations for which the target popu...

Page 21: ...Proof Type CF Equipment Alternating Current AC Alarm Off Icon Direct Current DC Alarm Silence Icon Power On Off Alarm Silence Permanently Icon Data Input Earth Ground Data Output Protective Earth Ground Data Input Output Full Battery Gas Port Input Low Battery Gas Port Output No Battery Present Chart Local Printer Output Battery Charging Video Output NIBP Connection Manufacturer Separate treatment...

Page 22: ...edical Device Directive CEXXXX represents the Notified Body number Classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 NO 601 1 IEC 60601 1 1 IEC 60601 2 25 IEC 60601 2 27 IEC 60601 2 30 IEC 60601 2 34 IEC 60601 2 49 CS1 Port Connection The wireless status icon indicates that the 2 4 GHz radio is ac...

Page 23: ...xx 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 24: ...Passport V Operating Instructions 0070 0 0704 02 1 1 1 0 General Product Description FIGURE 1 1 The Passport V Patient Monitor 0 ...

Page 25: ...M CO2 MicroStream CO2 Anesthetic Gases DPM SpO2 Nellcor OxiMax SpO2 three trace Local Printer and 2 4 GHz wireless networking Digital displays are provided for Heart Rate Non invasive Blood Pressure NIBP Pulse Oximetry SpO2 Respiration Rate and Temperature Optional digital areas provided for Invasive Blood Pressure up to two Anesthetic Agents O2 and N2O ST CO2 and MAC The optional local printer pr...

Page 26: ...2 Nellcor OxiMax SpO2 Temperature One channel for 400 series probes Respirations Lead selectable Impedance DPM CO2 Microstream CO2 Gas Module with Automatic Agent ID Trend Tabular and Graphic trends with 6000 trend data entries Power Internal isolated power module Second lithium ion battery Lithium ion battery Printing Local Printer Remote Printer External Interfaces Gas Module Nurse Call systems ...

Page 27: ...key to see multiple leads of ECG when using the 5 lead ECG cable Press this key repeatedly to toggle between multi lead view large numeric display and normal screen 4 Start Press this key to begin an NIBP measurement or to begin or re start automatic interval measurements 5 Interval Press this key to modify the NIBP interval measurement time The choices are Off STAT 1 min 2 min 3 min 5 min 10 min ...

Page 28: ...t Selection is set to Yes in the Installation Menu 10 Silence Press this key to suspend audio alarms on all currently alarming parameters The alarms remain suspended for a user selected amount of time as set in the Alarm Setup Menu or until the alarm condition is no longer present Any new alarms that occur while the alarm tone is silenced will disable the silence and sound the alarm tone While the...

Page 29: ...cleared in the STANDBY mode When the STANDBY mode is released NIBP INTERVAL is in IDLE MODE and requires reactivation via the START key The CO2 pump automatically reactivates if the DPM or Microstream sensor is in place Press the Standby key to exit the STANDBY mode and return to the normal screen When exiting from the standby mode to the monitoring mode the monitor responds as follows Restores pa...

Page 30: ...rging LED A green LED located above the battery icon indicates that the battery charger is active The charger will not always be active when AC power is present It is dependent on the battery charge condition The LED is not an indication of the condition of the batteries or their charge level Charged batteries must be installed in the monitor to ensure uninterrupted operation while switching from ...

Page 31: ...rea The waveform area is used to display windows which contain parameter waveforms Up to 8 waveforms may be displayed The top waveform is always set to display the ECG waveform and cannot be changed By default SpO2 Pleth waveform will appear as the second waveform Respiration will appear as the third waveform If pressure transducers are plugged into the P1 and P2 ports the screen will reformat to ...

Page 32: ...tor to monitor 3 Parameter Menus The Parameter Menus enable the user to review and customize various parameter display and alarm attributes Use the Navigator Knob to access these menus Parameters supported include ECG ST ART CVP SpO2 NIBP Resp CO2 optional and Gas optional 4 Numeric Tiles The numeric tiles display digital data for each available parameter 5 Status Icon Area Battery Status Icon Whe...

Page 33: ...ssage area is located above the ECG waveform window Messages regarding the ECG heart rate alarm status physiological alarms and technical alarms are displayed here Physiological alarms are located on the left side Technical alarms are located on the right side ECG prompts are located at the top of waveform 1 7 Message Area B This message area is located below the last row of numeric tiles Messages...

Page 34: ...access to most main functions 2 Navigator Knob Rotates clockwise and counter clockwise to navigate through menu selections It also can be pressed to select a highlighted item 3 Display Displays all waveforms and numeric data 4 Alarm Light Indicates that an alarm has been activated Alarm Light not shown The WARNING or Priority 1 LED is red The CAUTION or Priority 2 LED is yellow 1 2 3 4 0 ...

Page 35: ...g Provides equipotential grounding of hospital equipment 4 Main I O Connector Ports Area dedicated for the use of an optional communication port MP1 Allows connectivity to one of the following Nurse Call or Defibrillator SB1 SB2 Allows copying and transferring of patient data and user settings RD1 Allows duplicate display of the main display on an SVGA compatible monitor CS1 Allows connectivity vi...

Page 36: ...t Side Panel FIGURE 1 6 Left Side Panel 1 P1 Connector optional 2 P2 Connector optional 3 T1 Connector 4 ECG EKG Connector 5 SpO2 Connector Masimo or Nellcor shown in figure 6 NIBP Rectus Connector 7 Battery Compartment 8 CO2 Input Optional DPM CO2 shown in figure 9 CO2 Exhaust Connector 1 2 5 3 4 6 7 8 9 0 ...

Page 37: ...1 7 Right Side Panel 1 Power Switch A momentary switch that turns power ON or OFF but does not prevent charging of the batteries Press the top of the switch once to turn the unit ON Press the top of the switch again to turn the unit OFF 2 Local Printer optional A thermal strip chart local printer with integral paper spool 2 1 0 ...

Page 38: ...ysical Views 1 5 5 Top View FIGURE 1 8 Top View 1 Soft Grip Module Handle This integrated grip handle is used for carrying the Passport V WARNING Do not carry the Passport V using the integrated grip handle if the unit is mounted to another item e g a rolling stand or Gas Module 3 1 0 ...

Page 39: ...Physical Views General Product Description 1 16 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 40: ...stallation Menu The Installation Menu allows the user to change and save default configuration settings for the Passport V such as date format time format and temperature units All the hard keys are disabled except the Navigator Knob in Installation Mode FIGURE 2 1 Installation Menu 0 ...

Page 41: ...ve Current Select to save current settings as defaults Select Language ENGLISH FRENCH GERMAN ITALIAN SPANISH PORTUGUESE RUSSIAN DUTCH Set up at factory Select to change language Date Format Y M D M D Y D M Y M D Y Select to change date format Time Format 12 hour 24 hour 12 hour Select to change time format NIBP Timeout 15 min 30 min 45 min 60 min 15 min Select to change NIBP time out Temperature U...

Page 42: ...ync Nurse Call Select to change the function of the Auxiliary Output interface Nurse Call Mode Normally Open Normally Close Normally Open Select to change the type of Nurse Call system Set up Serial Port 1 None DIAP Gas Module None Select to set up comm port Set up Serial Port 2 None DIAP Gas Module None Select to set up comm port Copy Monitor Defaults to Storage Device Select to copy monitor defa...

Page 43: ...he Passport V 2 Press and hold the Discharge key on the front panel Simultaneously power up the Passport V monitor 3 Release the Discharge key when the Installation Menu is displayed 4 Rotate the Navigator Knob to navigate and select the Advanced Installation Setup Menu 5 Set each item as necessary using the Navigator Knob 6 To save all of the chosen settings select Previous Menu Save Current 7 To...

Page 44: ...led Connect To Central Station Yes No No Select No to disable communication with the Central Station Select Yes to enable communication with the Central Station If communication has failed the message No Arrhythmia Detection at Central is displayed IP Address 7 6 6 50 Select to set up the IP address Subnet Mask ID 255 255 255 0 Select to set up subnet mask ID Configure Wireless AP Press to enable ...

Page 45: ...sired 4 To exit press the Normal Screen key on the front panel The following table describes the Monitor Setup Menu selections MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS Normal Screen Select to return to Normal Screen or press the Normal Screen key on the front panel Display Setup Select to make changes to the display format Save as defaults if desired Alarm Volume low to high volume Mid l...

Page 46: ... to select it 3 Configure the settings as desired 4 To exit press the Normal Screen key on the front panel The following table describes the Advanced Setup selections MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS Previous Menu Select to return to the previous menu Set Date Select to set date Set Time Select to set time NIBP Start Mode Interval Mode Timer Mode Interval Mode Select Interval mod...

Page 47: ...stalling several Passport V monitors with identical display and alarm settings it is not necessary to set each unit separately A DPM storage device may be used to copy the settings from monitor to monitor NOTE Use only storage devices supplied by Mindray CAUTION Do not unplug the storage device from any of the SB ports on the Passport V while transferring data as indicated on the menu or prompt ar...

Page 48: ... or battery depletion monitor settings are recovered as follows If the monitor is restarted within 60 seconds the latest user settings will be restored If the monitor is restarted after 60 but before 120 seconds the settings restored may be either the latest user settings or the user saved settings If the monitor is restarted after 120 seconds the user saved configurations will be restored 0 ...

Page 49: ...Configuration Management System Configuration 2 10 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 50: ... begin monitoring without setting any of the waveforms parameters alarms or functions However all of these settings can be changed for specific patient or departmental needs Certain operating characteristics are based on the selected patient size e g NIBP start pressure The patient size selection should be matched to the actual patient before monitoring begins 0 ...

Page 51: ...ff etc 3 Enter patient information into the Passport V via the Patient Menu check patient size 4 If desired press the START key to initiate a non invasive blood pressure measurement 3 2 1 Patient Menu To display the Patient Menu 1 On the front panel Press the Normal Screen key to return to the normal screen 2 On the normal screen Select Patient by rotating the Navigator Knob 3 Use the Navigator Kn...

Page 52: ...ing a Bed a unique number for each bed should be used The following standard format for this demographic is recommended Patient Menu MENU ITEM SELECTIONS COMMENTS Normal Screen Select to return to Normal Screen or press the Normal Screen key on the front panel Patient Size Adult default Pediatric Neonate Note When changing Patient Size some patient info may need to be re entered Gender Unspecified...

Page 53: ...ge key or On the normal screen Select Patient Discharge Discharging a patient from the Passport V clears the following Patient information except Patient Size and Bed No Physiological alarms and technical alarms Prompt messages irrelevent with the patient management Corresponding history data includes Trend data Events OxyCRG Trend data Dose calculations Operations in process includes local printi...

Page 54: ... of data download or upload is about 1 min The transferred patient data includes the following Patient demographics not including Bed No Trend Event Data NOTE Newly generated trend or event data or on going changed patient demographics may not be transferred during the downloading process CAUTION Do not unplug the storage device from any of the SB ports on the Passport V while transferring data as...

Page 55: ...Menu enables the user to view the numeric data and two selectable waveforms of another patient who is being monitored at a remote location The monitor at the remote location is defined as the remote monitor Visual and audio alarms occurring at the remote monitor are also received through the Remote View Menu at the host monitor FIGURE 3 2 Remote View Menu on Main Display The Enable Network option ...

Page 56: ...low the alarm settings at the remote monitor displaying in a priority appropriate reverse video color If the remote monitor is placed into Standby mode the message In Standby is displayed in the Remote View Window NOTE Respiration alarm text messages are also displayed in the displayed in the message area upper part of the Remote View Menu window as follows The Remote View Menu also provides the f...

Page 57: ...able on the remote monitor will be listed as selections for this menu item The menu selections for Wave 1 will not include the waveform that is currently selected as Wave 2 Waveform 2 All waveforms available on the remote monitor Only waveforms available on the remote monitor will be listed as selections for this menu item The menu selections for Wave 2 will not include the waveform that is curren...

Page 58: ...t 6 Remote Silence All this selection silences the audio alarm tones of all remote alarms for the duration that is selected from the Remote Silence All For list in the Remote View Setup Menu The factory default is 2 minutes While the audio alarms are silenced the visual alarm indicators remain displayed the message All Alarms Silenced For X XX mins is displayed in the message area of the Remote Vi...

Page 59: ...View Menu If an alarm is acknowledged while a lethal condition still exists the audio alert of the alarm will be silenced for XX minutes where XX is the number minutes selected in Remote View Menu Setup Remote Silence For or Remote Silence All For However the visual alert of the alarm and the alarm message will continue to remain active in the Remote View Message Area If a new lethal condition occ...

Page 60: ...ck is drained plug into an AC outlet to recharge the battery A period of 5 5 hours monitor OFF or 8 5 hours monitor ON is required for a full charge of lithium ion batteries Monitor or display is damaged Contact Customer Support Disabled Alarm Tone Silence key pressed Check for alarm silence symbol and message Beep volume low Increase beep volume Cooling Fan Failure The unit running on AC power an...

Page 61: ...Monitor Display Troubleshooting Patient Management 3 12 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 62: ... acquire the ECG with excellent base line stability recovery from defibrillation and minimum artifact from patient movement With the Passport V ECG can be obtained by using a 3 or 5 lead ECG cable in conjunction with a 3 or 5 lead set and skin electrodes For best performance and safety inspect the ECG cables and electrodes daily Features Provides the function of ECG1 cascade display on the normall...

Page 63: ...not displayed when ST segment analysis is OFF and Combine HR ST is set to Off or not installed HR source NOTE In Large Numeric Screen ST values and PVC min are not displayed in the ECG numeric tile FIGURE 4 1 ECG numeric tile without ST displayed FIGURE 4 2 ECG numeric tile with ST displayed ECG Label HR Unit HR Source HR Measured Value PVCs Measured Value High Alarm Limit Low Alarm Limit High Ala...

Page 64: ... A pacer marker is displayed when an external pace pulse is detected ECG Prompt Messages are displayed in the top of ECG1 waveform area Message Pacer Reject On is displayed in the right top of waveform area Other ECG prompt messages are displayed in the middle top of ECG1 waveform area FIGURE 4 3 ECG waveform 3 lead normal monitoring cascade is turned on FIGURE 4 4 ECG waveform 5 lead normal monit...

Page 65: ...ECG Screens ECG Monitoring 4 4 0070 0 0704 02 Passport V Operating Instructions FIGURE 4 5 ECG waveform 1mV scale overrange 0 ...

Page 66: ...ress to change ECG1 waveform size The ECG1 Size menu option in the ECG Sizes Menu has the same function In All ECG View this key is disabled VIEW Press to display the All ECG View screen In All ECG View the order of the waveforms displayed is I II III aVR aVL aVF V Press this key repeatedly to toggle between multi lead view large numeric display and normal screen When returning to Normal Screen fr...

Page 67: ...4 4 Menus ECG Main and Submenus 4 4 1 ECG Menu FIGURE 4 6 ECG Menu To display the ECG Menu 1 On the front panel Press the Normal Screen key to return to the normal screen 2 On the normal screen Select Parameters ECG or Select the ECG tile 3 To exit press the Normal Screen key on the front panel 0 ...

Page 68: ...etting Speed 6 25 mm s 12 5 mm s 25 mm s default 50 mm s Select to change the trace speed mm s of the ECG waveform Applies to all ECG leads Arrhythmia Menu Select to open the Arrhythmia Menu Available only if Arrhythmia option is installed Disabled if Patient Size Neonate ST Menu Select to open the ST Menu Available only if ST option is installed Disabled if Patient Size Neonate Relearn Select to ...

Page 69: ... are displayed with 1cm mV gain in the All ECG View via View key All ECG waveforms are displayed with the user selected gain after exiting the All ECG View All ECG waveform gains remain unchanged after switchover between 3 lead and 5 lead modes NOTE The SIZE key on the front panel is used to change ECG1 waveform size The ECG1 Size menu option in the ECG Sizes Menu has the same function In All ECG ...

Page 70: ... The factory default for all arrhythmia alarms is On All On Select to set all arrhythmia alarms to On Non lethals off Select to set all non lethal arrhythmia alarms to Off All Off Select to set all arrhythmia alarms to Off All Off is displayed only if Enable Arrhythmia All Off Selection Yes in the Installation Menu Relearn Select to manually initiate the relearning process for ST Measurements or A...

Page 71: ...Size Neonate Asystole Delay 3 to 10 seconds default 5 Select to change the Asystole Delay Time V Tach Rate 100 to 180 BPM default 130 Select to change the V Tach alarm rate limit V Tach PVC 3 to 15 default 3 Select to change the required number of PVCs detected in a continuous sequence before V Tach is detected and labeled Arrhythmia Menu MENU ITEM SELECTIONS COMMENTS 0 ...

Page 72: ... set to ST or Diagnostic when ST Analysis is set to On the ST analysis uses the Filter setting The filter displayed in ECG waveform areas is coincident with actual filter mode Combine ST HR On default Off Select to determine location of ST values Combine moves ST to heart rate window On ST values are displayed in the HR numeric tile Off ST values are displayed in the ST numeric tile Relearn Select...

Page 73: ...l screen 2 On the normal screen Select Parameters ECG ECG Sizes Menu or Select the ECG tile ECG Sizes Menu 3 To exit press the Normal Screen key on the front panel 4 4 5 ECG Setup Menu FIGURE 4 10 ECG Setup Menu J ST 4 to 200 msec Select to adjust J and ST measurement points Adjustable in 8 msec increments ST pt 40 msec 60 msec default 80 msec 60 80 msec Select to adjust distance of ST point to th...

Page 74: ...ter setting The filter displayed in ECG waveform areas is coincident with the actual filter mode HR Source Auto default ECG Art UA LV PA SpO2 Select to change heart rate source The selections are available if the corresponding parameters are configured The selections are in order of priority from high to low Auto ECG ART UA LV PA SpO2 If Auto is selected the monitor will switch to the current high...

Page 75: ...transients may resemble actual cardiac waveforms thus inhibiting heart rate alarms Check lead wires for damage and ensure good skin contact prior to and during use Always use fresh electrodes and follow proper skin preparation techniques WARNING This device is not intended for direct cardiac application ECG Cable Auto Default 3 Lead 5 Lead Select to change the ECG cable type being used ECG Noise A...

Page 76: ... and open just prior to use NOTE Avoid more than one type of electrode on a patient because of variations in electrical resistance NOTE Avoid placing electrode patches directly over bone prominences or over any high activity movement areas such as shoulders or arms because muscle motion produces electrical activity If an electrode patch is placed over a large muscle such as the pectorals the monit...

Page 77: ...les hoses and wires are kept away from patient s neck to avoid strangulation Keep floors and walkways free of cables to reduce risk to hospital personnel patients and visitors NOTE It is recommended that electrode patches be changed at least every 24 36 hours to maintain proper contact with the skin Some patients may require electrodes to be changed more often Electrode patches are disposable and ...

Page 78: ...ommended 3 wire lead placement is as follows FIGURE 4 11 3 wire Lead Placement AHA FIGURE 4 12 3 wire Lead Placement IEC Place the RA white electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the LA black electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the LL red electrode on the patient s lo...

Page 79: ...domen within the rib cage frame Place the RL green electrode on the patient s lower right abdomen within the rib cage frame Place the V brown electrode in one of the V lead positions V1 V6 depicted in the following section Place the R red electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the L yellow electrode under the patient s left clavicle ...

Page 80: ... Place the LL red electrode on the patient s lower left abdomen within the rib cage frame Select ECG Lead II on the monitor Lead II is the direct electrical line between the RA white electrode and the LL red electrode Place the R red electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the L yellow electrode under the patient s left clavicle at th...

Page 81: ... MCL1 monitoring Lead I is the direct electrical line between the RA white electrode and the LA black electrode Select ECG Lead II for MCL6 monitoring Lead II is the direct electrical line between the RA white electrode and the LL red electrode Place the R red electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the L yellow electrode on the right ...

Page 82: ...follows FIGURE 4 19 Neonatal 3 wire Lead Placement AHA FIGURE 4 20 Neonatal 3 wire Lead Placement IEC Place the RA white electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the LA black electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the LL red electrode on the patient s lower left abdomen wi...

Page 83: ...f the chest WARNING Pacemaker patients rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter alarms Keep pacemaker patients under close surveillance See the Appendix section of this manual for disclosure of the pacemaker pulse rejection capability of this instrument CAUTION Some pacemakers may contain a re...

Page 84: ...nclude poor skin preparation improperly attached electrodes dried electrode gel defective lead wires and patient movement The algorithm uses several techniques to differentiate a patient s QRS complexes from noise sources If noise levels are too high for a particular lead a message is posted and the data is dropped from analysis until the signal quality is re established If noise levels are too hi...

Page 85: ...e a learn can be effective 4 6 6 Beat Detection and Typing The following table describes the leads that are used to measure beat detection and beat typing The search for the next beat begins after a refractory period to avoid detecting T waves as valid QRS complexes For all patient sizes the minimum QRS amplitude that can be detected is between 0 15 and 0 45 mV depending on the width of the QRS co...

Page 86: ...condition still exists the audio portion of the alarm will be silenced for the duration that is selected from the Silence For list in the Alarm Setup menu but the alarm message will remain in message area A If a new lethal condition occurs while the initial lethal alarm is silenced the new lethal alarm will not break through but not be silenced If the lethal condition is resolved while the alarm i...

Page 87: ...n lethal Arrhythmia is user selectable between 1 and 2 NOTE Non lethal arrhythmia alarms are not latched alarms and can be acknowledged at any time To acknowledge a non lethal arrhythmia alarm press the Silence key on the keypad 4 7 2 1 Bigeminy Alarm The Bigeminy alarm is activated when three or more cycles of one PVC coupled to one normal beat are detected The Bigeminy alarm is an alarm event th...

Page 88: ...s V TACH V FIB and Asystole 4 7 2 6 Run Alarm The Run alarm is activated when the number of consecutive PVCs occur at a rate that equals or exceeds the user defined V Tach Rate The number of consecutive PVCs that constitute a Run is one beat less than the minimum used to identify V Tach The Run alarm is an alarm event that produces Alarm visual and audio alarm indicators A RUN text message above t...

Page 89: ... analysis is enabled if the option is installed FIGURE 4 26 Arrhythmia Menu Arrhythmia alarm calls are classified as Priority 1 or Priority 2 Asystole Ventricular Tachycardia and Ventricular Fibrillation are classified as Priority 1 and the priority level cannot be changed by the user In addition these alarms will sound continuously until the user presses the Silence or Silence All key regardless ...

Page 90: ...s only available if Enable Arrhythmia All Off Selection is set to Yes in the Installation Menu 4 8 1 Arrhythmia Analysis Setup ARR TYPE OPTION DESCRIPTION Asystole Asystole Delay No QRS complex is detected within the set Asystole Delay which is judged as one Asystole event V Tach V Tach Rate V Tach PVC HR is greater than or equal to the set V Tach Rate and the number of continuous PVCs is greater ...

Page 91: ... from the algorithmically determined end point of the QRS J Point In addition the user can also select from three 3 different settings for the ST measurement point 80 60 or 40 ms from the J point and independent of heart rate These measurements are valid only on normal beats Abnormal beats like ventricular beats are excluded from the analysis of the ST segment Ventricular paced beats are also reje...

Page 92: ...are rounded off to 1 decimal place 4 9 2 ST Analysis Setup ST analysis begins when the feature is turned on from Parameters ST Menu By default ST data will appear in the Heart Rate Tile when using a 3 lead or 5 lead leadset When using a 3 lead leadset ST Analysis is performed on the lead chosen as ECG1 With a 5 lead leadset ST Analysis is performed on all seven leads To display ST data in a separa...

Page 93: ...ry 5 Scroll to the J ST point heading Adjust the J ST point by pressing the Navigator Knob and turning to adjust the orange and green J ST reference lines Press the Navigator Knob when the J ST points are satisfactory 6 To adjust the ST pt scroll to the ST pt heading and press the Navigator Knob to display a list of ST measurement point settings Select the appropriate setting then press the Naviga...

Page 94: ...Whenever the Relearn function is selected from the ST ECG or Arrhythmia Menus The monitor switches between 3 lead and 5 lead mode Manual Relearning To initiate a manual relearn select Relearn from the ECG Menu Arrhythmia Menu or ST Menu It is recommended to initiate a manual Relearn after one or more of the following The ECG electrodes have been repositioned Sufficient time has passed since the la...

Page 95: ...tion Electrode to lead lead to cable cable to monitor Electrodes dry or loose Re prep skin and apply fresh moist electrodes Cable or lead wires damaged Check with continuity tester Excessive alarms heart rate lead fault Electrodes dry Re prep skin and apply fresh moist electrodes Alarm limits set too close to patient s normal heart rate Readjust R wave wrong size Must have a higher amplitude than ...

Page 96: ...ely Secure lead wires and cable to patient Patient s respiration Reposition electrodes Electrodes dry or loose Re prep skin and apply fresh moist electrodes Static build up around patient Check with local biomedical personnel ECG Filter set to ST or Diagnostic mode Set ECG Filter to Monitor mode MESSAGE PROBLEM REASON SOLUTION 0 ...

Page 97: ...ECG Troubleshooting ECG Monitoring 4 36 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 98: ...e Passport V The first method is thoracic impedance through the ECG signal The respiration signal is measured between two ECG electrodes RA and LA of ECG Lead I or RA and LL of ECG Lead II The second is by CO2 exchange via internal CO2 or via the external Gas Module Section 5 3 1 discusses the monitoring of CO2 with thoracic impedance Chapter 10 0 discusses the monitoring of CO2 with Sidestream an...

Page 99: ...ile displays the following Parameter name Resp Measured value RR is for CVA or Apnea Respiration Source ECG Alarm limits RR unit RPM FIGURE 5 1 Resp Numeric Tile 5 2 2 Waveform Resp The Resp waveform tile displays the following Resp waveform Waveform size FIGURE 5 2 Resp Waveform Tile High Alarm Limit Low Alarm Limit Resp Label Resp Unit RR Value 0 ...

Page 100: ...TEM SELECTIONS COMMENTS Normal Screen Select to return to Normal Screen or press the Normal Screen key on the front panel Resp Lead I II default Select to change respiration lead for ECG When the current Resp Lead drops the Resp waveform will be a straight line Resp On default Off Select to turn respiration on or off On Opens the Resp Module to start respiratory measurement Off Closes the Resp Mod...

Page 101: ...he heart rate The Passport V warns the operator when the respiration value equals the heart rate by displaying CVA If the patient s airway is obstructed and the patient attempts to breath then the chest wall can move and create a respiratory signal even though no gas flow is occurring in the patient CAUTION Some pacemakers may contain a respiratory sensor that may produce artifact on an ECG wavefo...

Page 102: ... be too low Change Respiration scale No Resp Waveform or Rate Displayed Respiration turned Off Off will be displayed in Resp tile Turn respiration On Patient connected using ESIS choke cable Check that proper patient cable is used Use approved non ESIS patient cable Cable not connected CO2 not selected in Display Setup Menu Check cable Set CO2 in Display Setup Menu CHK Lead Message Increased imped...

Page 103: ...municate with module Contact Technical Support Resp Communication Error System can t communicate correctly with Resp module and receive the error data packets Restart the monitor If the error still appears please contact Technical Support Resp Communication Stop As the Resp module communication stops the data packets sent by the module can not be received Contact Technical Support Resp High Impeda...

Page 104: ...070 0 0704 02 6 1 6 0 SpO2 Monitoring 6 1 Description The Passport V supports the following SpO2 modules Masimo SpO2 Module DPM SpO2 module Nellcor SpO2 module SpO2 measurement provides two parameters SpO2 and PR and one waveform Pleth 0 ...

Page 105: ...ed When the set amount of time has been reached the SpO2 alarm will sound The Sat Seconds icon displays and fills regardless of the NIBP Simultaneous setting 6 2 2 Waveform SpO2 The SpO2 waveform tile displays the following Pleth waveform FIGURE 6 2 SpO2 Pleth Waveform NOTE Wave speed The Passport V does not provide a separate Pleth speed setting ECG speed setting is valid for both Pleth and ECG w...

Page 106: ...erent SpO2 menus according to the SpO2 module type FIGURE 6 3 SpO2 Menu Nellcor SpO2 SpO2 Menu MENU ITEM SELECTIONS COMMENTS Normal Screen Select to return to normal screen or press the Normal Screen key on the front panel NIBP Simultaneous Off default On Select On when monitoring SpO2 and NIBP on the same limb simultaneously On During NIBP measurement SpO2 and PR alarm status is locked until the ...

Page 107: ...s 25 seconds 50 seconds 100 seconds Sets the Sat Seconds limit When Sat Seconds reaches or exceeds the set limit the low SpO2 alarm is triggered If SpO2 measurement fluctuates outside the set limit for three times within 1 minute the low SpO2 alarm will be triggered even though the set Sat Seconds limit is not reached The Sat Seconds function does not affect the Desat alarm Once the SpO2 is below ...

Page 108: ... sub system incorporates automatic calibration mechanisms No other calibration is required Auto Scaling The pleth waveform is automatically scaled and is not proportional to the patient s pulse volume There is no adjustment that can be made to the pleth waveform CAUTION Tissue damage or inaccurate measurements may be caused by incorrect SpO2 sensor application or use such as wrapping too tightly a...

Page 109: ...mise occur CAUTION When cleaning SpO2 sensors do not use excessive amounts of liquid Wipe the sensor surface with a soft cloth dampened with cleaning solution Do not attempt to sterilize 6 4 1 Masimo SET SpO2 Passport V monitors equipped with Masimo SET SpO2 allow the user to adjust Sensitivity and SpO2 Average Time The user should choose the sensitivity mode depending upon signal quality and pati...

Page 110: ...r until expiration date is reached NOTE Consideration should be given to the disposal of packaging waste To order all Nellcor accessories and sensors call 1 888 744 1414 Selecting a Nellcor Sensor Sensors are designed for specific sites on patients with designated weight ranges To select the appropriate sensor consider the patient s weight level of activity adequacy of perfusion which sensor sites...

Page 111: ... 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 In this example the patient SpO2 drops to 88 2 points and remains there for 2 seconds Then it drops to 86 4 points for 3 seconds and then to 84 6 points for 6 seconds The resulting Sat Seconds are After approximately 10 9 seconds a Sat Second alarm woul...

Page 112: ...he key slot on the connector on the end of the SpO2 extension cable with the SpO2 receptacle on the right side panel of the Passport V Push the connector into the SpO2 receptacle until a click is heard The SpO2 measurement displays when the Passport V detects that the sensor is connected to the patient A plethysmogram displays to the left of the SpO2 numeric tile if SpO2 is selected in the TRACE S...

Page 113: ...sensor belt with V edge into the V groove on the corresponding side of the sheath Repeat with the other side ensuring the belt is secure but comfortably placed on the patient If necessary adjust the belt using the second lock bar 4 Ensure the sensor s LED and pulse detector sides are opposite each other 5 Check sensor site frequently If the sensor is too tight it may cause venous pulsation and the...

Page 114: ... In electrosurgery make sure sensor is not too close to ESU devices or cables Check to make sure the site area is clean non greasy Clean site and sensor if needed CAUTION A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or a pulse oximeter monitor NOTE If the supply mains has been interrupted during SpO2 monitoring the Passport V will switch power to battery ba...

Page 115: ...Alarm Messages and Prompt Messages Low amplitude SpO2 signal SpO2 sensor on same limb as cuff Check sensor placement move as necessary Patient has poor perfusion Switch limb Notify physician in Digital Data Data is above maximum value Data is below maximum value Parameter is not available Lead or sensor is off Check sensor placement move as necessary Switch limb Notify physician PROBLEM REASON SOL...

Page 116: ...n method within the limits prescribed by the American National Standard Electronic or automated sphygmomanometers 7 1 1 Displaying Measured Pressure A valid value is displayed as Sys Dia Mean When a reset is performed or the patient size is changed the data is displayed as dashes Upon measurement failure XXX will be displayed During an NIBP measurement the real time cuff pressure is displayed in t...

Page 117: ...ents the interval will change to a 10 minute interval During the automatic measurement pressing the STOP key on the front panel will stop the automatic measurement The message NIBP Idle will be displayed until START is pressed again NOTE If the interval is changed during the Automatic measurement interval the new interval starts from the time when such change is made NOTE In Automatic Mode a measu...

Page 118: ...e following NIBP label The measured results Sys Dia and Mean Unit of measurement Interval Elapsed time from the last successful measurement The cuff pressure Alarm limits for Sys Dia and Mean BP FIGURE 7 1 NIBP Numeric Tile NIBP Label Unit of Pressure Systolic Value Mean Value Measurement Interval Time Elapsed From Last Valid Measurement Diastolic Value 0 ...

Page 119: ...Displays the last 5 NIBP measurements Contents to display NIBP label Systolic pressure Diastolic pressure Mean pressure Interval Time Unit of measure Time measurement was completed FIGURE 7 2 NIBP List Display NIBP Label Unit of Pressure Systolic Value Measurement Interval Time Mean Value Diastolic Value 0 ...

Page 120: ...P Menu NIBP Menu MENU ITEM SELECTIONS COMMENTS Normal Screen Select to return to normal screen or press the Normal Screen key on the front panel Set Start Pressure Adult 100 to 280 default 180 Pediatric 60 to 180 default 140 Neonate 40 to 120 default 100 Select to adjust initial NIBP pump up pressure in increments of 5 The selection range varies according to the Patient Size The Set Start Pressure...

Page 121: ...al cannot be changed during an NIBP measurement or the five minutes STAT measurement NIBP End Tone On default Off Select to turn NIBP End Tone On or Off On A dual beep tone sounds on completion of a successful NIBP measurement Off Tone does not sound after the measurement Note A single beep tone will always sound in the event of an unsuccessful measurement after all retries have been attempted The...

Page 122: ... The pressure on the limb may not fall to zero between measurements if the cuff is wrapped too tightly Therefore ensure that the cuff is properly applied NOTE The skin is sometimes fragile i e on pediatrics geriatrics etc In these cases a longer interval between measurements should be considered to decrease the number of cuff inflations over a period of time In extreme cases a thin layer of soft r...

Page 123: ...igher inflation pressure 50 mmHg in adult or pediatric mode 40 mmHg in neonate mode 9 The patient should remain still to avoid the introduction of unnecessary motion artifact After the cuff pressure drops below the diastolic pressure the results of the measurement are displayed 10 If NIBP End Tone is set to On in the NIBP Menu a double tone will sound to indicate a successful NIBP measurement The ...

Page 124: ...nt sequence or to end a measurement cycle already in progress deflate cuff 2 Press START to take an immediate measurement and resume a suspended timed measurement sequence NOTE You can press STOP at any time to postpone a scheduled measurement or to terminate a measurement cycle already in progress CAUTION Observe caution on all patients Neonates Pediatrics and Adults when NIBP is set to STAT Mode...

Page 125: ...t the newly chosen interval Interval Mode is set and you press the Stop key during the measurement The cuff deflates and interval measurements are suspended Interval Mode is set and you change the interval The measurement cycle is reset with the new interval A measurement will be taken after you press the Start key 7 4 9 NIBP Auto Time Out Functions The NIBP data will time out on the display under...

Page 126: ...ult if cardiac rhythm is irregular Irregular cardiac rhythm changes the stroke volume from beat to beat This changing stroke volume may increase the time it takes the Passport V to take a measurement The Passport V makes up to four successive attempts to obtain a measurement If a measurement cannot be taken after four tries the numeric displays are zeroed 7 4 14 User Verification of Passport V Blo...

Page 127: ...splay up to five of the most recent NIBP measurements in row form These measurements are displayed from newest in the top row to oldest in the bottom row As shown in the example of FIGURE 7 4 each row displays a time stamp the three digit systolic and diastolic pressures separated with a and the three digit mean pressure in parentheses FIGURE 7 4 Example NIBP List Tile The NIBP List tile can be co...

Page 128: ...ired to complete a measurement and may cause measurement cycle to extend beyond a point where a measurement can be completed MESSAGE PROBLEM REASON SOLUTION Unable to obtain a BP Patient movement Wait until patient is calm or gently hold limb Cuff or hose NOT attached leaking Check all connections HR irregular arrhythmia present Check Patient and notify Physician Blood pressure is out of range Che...

Page 129: ...NIBP Troubleshooting NIBP Monitoring 7 14 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 130: ...on Intended patient types Adult Pediatric Neonate The temperature measurement function of the Passport V is designed to take a continuous temperature reading from 400 series or compatible probes Temp units of C and F are available The temperature units can be adjusted in the Installation Menu 0 ...

Page 131: ...asurement results Temp unit Alarm limits FIGURE 8 1 Temperature Numeric Tile If a temperature transducer cable is plugged into the T1 port but no measurement is performed or the measured value is invalid dashes are displayed in the Temp numeric tile If a cable is not plugged into the T1 port the Temp numeric tile is not displayed at all High Alarm Limit Temp Label Temp Unit Temp Measured Value Low...

Page 132: ... the thermistor is 0 2 Celsius in the range of 5 Celsius to 45 Celsius The assembly is disposable single use only and packaged sterile This device is intended for use with electronic temperature monitors accepting 400 series thermistor sensors or equivalent that are equipped with alarms To interconnect the probe with the instrument use cable part number 0012 00 0975 Electrical leakage current of t...

Page 133: ...or accurate measurement of core body temperature as well as transmission of heart and lung sounds Heart and lung sounds are transmitted across a thin cuff wall through the side and distal openings of the tube Made of a special material which optimizes sound transmission and remains both durable and flexible the cuff maintains its integrity and prevents secretion from entering the tube For connecti...

Page 134: ...e stethoscope in accordance with currently acceptable medical procedures 3 Verify position of the stethoscope by direct laryngoscopy or other acceptable medical techniques 4 Align the sensor s connector with the monitor cable s connector and push firmly to assure full contact Forced mating of the connectors without proper alignment may cause damage to the connectors and interruption in electrical ...

Page 135: ...9 and 12 French This device is intended for use with electronic temperature monitors accepting 400 series thermistor sensors or equivalent that are equipped with alarms To interconnect the probe with the instrument use cable part number 0012 00 0975 Electrical leakage current of the device sensor and PVC tube when used with monitor and cable comply with IEC 601 1 EN 60601 1 Indications The Esophag...

Page 136: ... procedures to minimize conditions of the thermistor and lead wires functioning as an alternate path for radio frequency current to return to ground causing localized tissue burns Procedures which may minimize risk of electro surgical burns are keep both active and ground electrodes of the electro cautery system in close proximity so that the temperature sensor is outside the radio frequency curre...

Page 137: ... MESSAGE PROBLEM REASON SOLUTION Temperature Probes not Working Poor contact from probes to body Check the body surface contact at the probe tip Reposition or apply thermoconductive gel Temperature not displayed Improper display setup Check Display Setup in Monitor Setup Menu and change as desired Cable not plugged in Check the cable 0 ...

Page 138: ...sure measurement is an option for the Passport V The Passport V supports the measurements of two invasive blood pressures It provides systolic pressure diastolic pressure and mean pressure values When measuring Art UA LV PA pressure the channel can serve as an HR source When displaying a pulsatile pressure the format shall be SYS DIA MEAN When displaying non pulsatile pressure the format shall be ...

Page 139: ...le defaults to 0 160 mmHg The measured systolic value is displayed When Mean is selected the channel displays data in non pulsatile pressure format MEAN SYS DIA and the waveform scale defaults to 0 20 mmHg The measured mean pressure value is displayed For all other pressure labels the data will be displayed in a fixed format depending on the Measure Pressure selection in the IBP Menu If Pulsatile ...

Page 140: ...satile Mean Sys Dia Alarm limits Unit of measurement mmHg Display requirements Resolution 1 mmHg FIGURE 9 1 Arterial Pressure Numeric Tile Art FIGURE 9 2 Central Venous Pressure Numeric Tile CVP Systolic Value Arterial Pressure Label Unit of Pressure Mean Value Diastolic Value Systolic Alarm Limits Mean Alarm Limits Diastolic Alarm Limits Systolic Value Central Venous Pressure Label Unit of Pressu...

Page 141: ...704 02 Passport V Operating Instructions FIGURE 9 3 ICP Numeric tile with Cepp parameter 9 2 2 IBP Waveform FIGURE 9 4 IBP waveform tile Art Intracranial Pressure Label ICP Value Cerebral Perfusion Pressure Unit of Pressure Alarm Limits CePP Value 0 ...

Page 142: ...ile for example Art or CVP FIGURE 9 5 IBP Menu Art IBP Menu MENU ITEM SELECTIONS COMMENTS Normal Screen Select to return to normal screen or press the Normal Screen key on the front panel Label Art PA UA CVP LV LA RA ICP P1 P2 P1 default Art P2 default CVP Measure Pressure Pulsatile Mean Select to change measure pressures for P1 P2 Available when pressure channel is labeled P1 or P2 Speed 12 5 mm ...

Page 143: ...ing is linked to both IBP channels Zero Select to zero IBP channel The IBP transducer must be zeroed before initial measurements during setup to obtain correct pressure value If the transducer is not zeroed the measured value will be displayed as XXX Implement IBP zeroing when any of the following occurs Use of new sensor or sensor cables Reconnection of the sensor with the monitor After monitor r...

Page 144: ...sor 3 Connect catheter line with flushing device to a pressure transducer 4 Zero pressure transducer as follows a Open transducer vent to atmosphere b Press the IPB Zero All key on the front panel or individually zero pressure lines by opening individual IBP menus After the automatic zero process is complete the pressure display should indicate zeros NOTE If an IBP channel zeroing failed for Pulsa...

Page 145: ...heter partially occluded with clot Consult physician IBP not Displayed No IBP Waveform Improper Setup Check display setup in monitor setup Cable not plugged in Check cable Transducer not connected Check transducer connection Stopcock turned improperly Check transducer Transducer not zeroed Check and zero the transducer Dashes are displayed The measured result is invalid or out of range IBP might b...

Page 146: ...scription Intended patient types Adult Pediatric Neonatal The Passport V supports the following CO2 modules Sidestream DPM CO2 module M02B Microstream Oridion Medical miniMediCO2 module The Passport V provides three parameters ET CO2 InspCO2 and awRR and a CO2 waveform for CO2 measurement 0 ...

Page 147: ...e displays the following Parameter name of CO2 module Units of measure Measured values of ET CO2 InspCO2 and awRR High and low alarm limits for ET CO2 CO2 Source Int CO2 or GM FIGURE 10 1 CO2 Numeric Tile 10 2 2 Waveform CO2 The CO2 waveform tile displays the following Waveform Waveform scale values Unit of measurement FIGURE 10 2 Resp Waveform Tile ...

Page 148: ...2 Monitoring optional CO2 Menu 10 3 CO2 Menu To display the CO2 Menu 1 On the front panel Press the Normal Screen key to return to the normal screen 2 On the normal screen Select Parameters CO2 or Select the CO2 tile FIGURE 10 3 CO2 Menu DPM Sidestream CO2 0 ...

Page 149: ...adjust waveform speed Scale mmHg 15 mmHg 20 mmHg 25 mmHg 50 mmHg default 80 mmHg 2 0 2 5 3 5 7 0 default 10 0 kPa 2 0kPa 2 5kPa 3 5kPa 7 0kPa default 10 0kPa Select to change CO2 scale The unit of measure for CO2 can be selected in the Installation Menu The choices are mmHg kPa and Preferred CO2 Source Gas Module default Internal CO2 Module If a CO2 source Module is OFF that Module option shall be...

Page 150: ...odule OFF OFF None Gas Module OFF ON Internal CO2 Module Gas Module ON OFF Gas Module Gas Module ON ON Gas Module Internal CO2 Module OFF OFF None Internal CO2 Module OFF ON Internal CO2 Module Internal CO2 Module ON OFF Gas Module Internal CO2 Module ON ON Internal CO2 Module Note ON OFF Status of the Module If the Gas Module is connected to a serial port configured to Gas Module and the power is...

Page 151: ...leaky damaged or contaminated FIGURE 10 5 CO2 Setup Menu DPM Sidestream Only CO2 Setup Menu DPM Sidestream Only MENU ITEM SELECTIONS COMMENTS Previous Screen Select to return to the previous menu Humidity Compensation On Off default Select On for Body Temperature Pressure Saturation BTPS Select Off for Ambient Temperature and Pressure Dry ATPD Note If using the Oridion Medical miniMediCO2 module t...

Page 152: ...kwise into the monitor CO2 port until it can no longer be turned to ensure that it is connected securely to the monitor This will assure that there is no leak of gases during measurement at the connection point and that measurement accuracy is not compromised Loose or damaged connections may compromise ventilation or cause an inaccurate measurement of respiratory gases Securely connect all compone...

Page 153: ...ing CO2 Monitoring optional 10 8 0070 0 0704 02 Passport V Operating Instructions 10 4 CO2 Troubleshooting Refer to Chapter 14 0 Messages for Physiological Alarm Messages Technical Alarm Messages and Prompt Messages 0 ...

Page 154: ...s 0070 00 0696 XX for further operation and performance specifications The Passport V supports the Artema Gas Module 3 Anesthetic gases are identified automatically Passport V The following parameters are measured Expired Et and inspired Insp values for CO2 N2O O2 and Agent MAC value awRR CO2 O2 and Agent waveforms are displayed The Gas Module measures the inspired and expired concentrations of an...

Page 155: ...s 1MAC values ET N2O is the end tidal N2O concentration and x N2O is a clinically derived coefficient for N2O also known as the 1MAC value From ISO 21647 2004 E the 1MAC values used in the calculation are NOTE The calculated MAC value is not corrected for ambient pressure altitude barometric effects patient age patient core temperature or any other individual factors influencing the effect of vola...

Page 156: ...nd press the knob to select it 11 2 1 CO2 Numeric Tile The CO2 Numeric Tile displays the following CO2 parameter name Inspired measurement of CO2 Expiratory measurement of CO2 CO2 unit of measurement Insp ET labels Alarm limits Respiration Source Respiration Rate measurement Respiration Rate unit of measurement FIGURE 11 1 CO2 Numeric Tile 11 2 2 Gas Numeric Tile The Gas Numeric Tile displays the ...

Page 157: ...4 0070 0 0704 02 Passport V Operating Instructions FIGURE 11 2 Gas Numeric Tile 11 2 3 Gas Waveform The CO2 O2 or Anesthetic Agent waveform tile displays the following Waveform Scale Values Unit of measurement FIGURE 11 3 Gas waveform CO2 0 ...

Page 158: ...al Screen or press the Normal Screen key on the front panel Speed 3 125mm s 6 25mm s default 12 5mm s 25mm s Select to change respiration trace speed The CO2 Gas and O2 waveform speed settings change simultaneously Agent Scale 1 2 5 5 10 default 15 20 Select to change agent scale The lower limit of all of the gas waveform scales is fixed to 0 The upper limit of the gas waveform scale is user adjus...

Page 159: ...in for Gas Module 3 with a neonatal water trap This device should not be used on patients whose breathing could be impaired by this vacuum flow rate NOTE The Gas Module 3 is equipped with automatic barometric pressure compensation Mixed Agent Audio On default Off Select to turn mixed agents audio alarm on or off On If Mixed agents are detected the Mixed Agent alarm tone will sound Off If Mixed age...

Page 160: ...tients apply the nasal cannula to the patient For intubated patients connect the sample line to the breathing circuit Refer to instruction provided in the sample line packets 7 Connect the other end of the nasal cannula or sample line to the Gas Module at the input port WARNING Connection of the Gas Module exhaust port to the hospital s waste gas scavenging system is strongly recommended to preven...

Page 161: ...he appropriate sampling line is connected DRYLINE Adult Pediatric water trap used with DRYLINE Adult Pediatric sampling line colorless Luer lock nut DRYLINE Neonatal water trap used with DRYLINE Neonatal sampling line blue Luer lock nut 2 Verify that the water trap container is less than half full 3 Occlude the sampling line and verify that the occlusion alarm functions properly 4 Breathe into the...

Page 162: ... concentration based upon patient weight and or drug dosage Drug calculations may also be accessed through the Patient Menu Drug calculations are only available if the Patient Size is set to Adult Drug Calculation Formulas For Drug Concentration the Passport V uses the following formula For a weight based Drug Infusion Rate the Passport V uses the following formula For a non weight based Drug Infu...

Page 163: ...g Calculator Drug Calculator Menu Structure MENU TITLE ON SCREEN MENU CHOICES DEFAULT ACTIONS COMMENTS Normal Screen Select to return to normal screen or press the Normal Screen key on the front panel Drug Name See the GENERIC NAME and BRAND NAME columns of the table in the Adult Medication Choices subsection The Drug A D choices are for drugs that are not listed in the table Unspecified Select to...

Page 164: ...inute Dose hr 0 01 to 10000 00 If the chosen drug is Vasopressin the Default is 12 00 For all other drugs the Default is 60 00 Select to enter dosage of drug to be infused per hour Dose kg min If the chosen drug is Milrinone 0 005 to 2 000 For all other drugs 0 01 to 10000 00 If the chosen drug is Milrinone the Default is 0 375 For all other drugs the Default is 1 00 Select to enter dosage of drug...

Page 165: ...eight based drug and 3 Dose min Dose hr Dose kg min or Dose kg hr is specified If the dose is entered as Dose min then the menu choices will be Dose min or Dose hr If the dose is entered as Dose kg min then the menu choices will be Dose kg min or Dose kg hr If the dose is entered as Dose hr then Dose hr will be the only menu choice for the Print Units If the dose is entered as Dose kg hr then Dose...

Page 166: ...g 250 ml 500 mg Insulin Regular1 Humulin N units 100 ml 100 units Isoproterenol HCL1 Isuprel HCL N mcg 500 ml 2 mg Labetalol HCL1 2 Normodyne N mg 200 ml 200 mg Lidocaine HCL1 2 Xylocaine HCL N mg 500 ml 2000 mg Lorazepam Ativan N mg 500 ml 40 mg Midazolam HCL1 2 Versed Y mg 125 ml 125 mg Milrinone Lactate1 2 Primacor Y mcg 200 ml 20 mg Nicardipine HCL1 Cardene N mg 250 ml 25 mg Nitroglycerin1 Tri...

Page 167: ...Description Drug Calculations 12 6 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 168: ... 13 1 Alarms The Passport V monitor provides a broad range of alarm settings FIGURE 13 1 Alarm Settings Menu 13 1 1 Adjusting Alarms WARNING The user should check that the current alarm settings on the Passport V monitor are appropriate prior to use on each patient 0 ...

Page 169: ...rm delay times and alarm silence features FIGURE 13 2 Alarm Setup Menu Alarm Setup Menu MENU ITEM SELECTIONS COMMENTS Previous Menu Select to return to previous menu Show Limits Off default On Select to display or remove alarm limits from parameter files Silence For 1 min 2 min default 3 min 5 min 10 min Select to choose time period for an individual alarm to be silenced Silence All For Permanent ...

Page 170: ...rm Delay None default 1 second 2 seconds 3 seconds 4 seconds 5 seconds 6 seconds 7 seconds 8 seconds Select to adjust audio alarm delay time Apnea Delay 10 seconds 15 seconds 20 seconds default 25 seconds 30 seconds 35 seconds 40 seconds 45 seconds 50 seconds 55 seconds 1 min Select to adjust apnea delay time ST Alarm Delay 30 seconds default 45 seconds 1 min 90 seconds 2 min 3 min Select to adjus...

Page 171: ... Off 10 50 NIBP Mean mmHg Off 60 200 Off 50 180 Off 40 160 Off 40 140 Off 10 100 Off 10 70 Temp ºF Off 95 110 Off 95 110 Off 95 110 Off 80 100 Off 80 100 Off 80 100 Temp ºC Off 35 43 Off 35 43 Off 35 43 Off 26 38 Off 26 38 Off 26 38 IBP1 Sys mmHg Off 5 300 Off 5 240 Off 5 180 Off 0 150 Off 0 130 Off 0 130 IBP1 Dia mmHg Off 0 140 Off 0 100 Off 0 70 Off 0 120 Off 0 100 Off 0 50 IBP1 Mean mmHg Off 5 ...

Page 172: ... Off 10 80 80 Off 10 80 80 Off 10 80 Off 5 70 Off 5 70 Off 5 70 ET Des Off 2 0 20 0 Off 2 0 20 0 Off 2 0 20 0 Off 0 5 10 0 Off 0 5 10 0 Off 0 5 10 0 Insp Des Off 2 0 20 0 Off 2 0 20 0 Off 2 0 20 0 Off 0 5 10 0 Off 0 5 10 0 Off 0 5 10 0 ET Hal Off 2 0 10 0 Off 2 0 10 0 Off 2 0 10 0 Off 0 5 5 0 Off 0 5 5 0 Off 0 5 5 0 Insp Hal Off 2 0 10 0 Off 2 0 10 0 Off 2 0 10 0 Off 0 5 5 0 Off 0 5 5 0 Off 0 5 5 ...

Page 173: ...o 2 waveforms on a Print on Alarm The print length of the strip 16 or 32 seconds can be set in the Print Setup menu Any other printing in process at the time of the alarm will be aborted An alarm recording is stored in the message queue if the alarm happened when a recording is preceding An asterisk will be marked after the corresponding parameter value For priority 3 Technical alarms SpO2 Sensor ...

Page 174: ...m Setup menu The Apnea Alarm can be set as a Latched or Non latched alarm via the Installation Menu When Apnea Latch is set to Off the Apnea Alarm will silence and cancel itself if patient breathing is again detected When Apnea Latch is set to On default the Apnea Alarm will not be silenced unless the operator acknowledges the alarm by pressing the Silence or Silence All keys The visual Apnea Alar...

Page 175: ...eters for a programmed length of time default is 2 minutes or until the alarm condition is no longer present whichever is shorter Any new alarms that occur during the silenced period will disable the silence and the alarm will sound the tone An Alarm Silence Icon a bell with an X through it is displayed in the upper area of the screen A message and digital timer counts down in the upper message ar...

Page 176: ...ggered the alarm tone will not be presented but the visual signal will be presented during delay time 13 1 6 Alarm Troubleshooting MESSAGE PROBLEM REASON SOLUTION High or Low or No Alarm Sound Alarm limits not set Go to Alarm Setup and adjust alarms Alarm Silence All On time has not expired Press SILENCE ALL to reactivate alarms No Arrhythmia Alarm Sound Arrhythmia option not installed Call Sales ...

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Page 178: ...e 1 Can occur from ECG SpO2 or IBP measurement Dual ST Elevation options 1 2 default Dual ST Depression options 1 2 default ST Elevation options 1 2 default ST Depression options 1 2 default High PVC min options 1 2 default Occurs when Arrhythmia analysis is ON and PVC min high alarm limit is not set to Off ARRHYTHMIA MESSAGE PRIORITY COMMENTS Asystole 1 V Tach 1 V Fib 1 Bigeminy options 1 2 Trige...

Page 179: ...Ventricular Rhythm options 1 2 ALARM MESSAGE PRIORITY COMMENTS High Respiration options 1 2 Low Respiration options 1 2 Apnea 1 ALARM MESSAGE PRIORITY COMMENTS High Temperature options 1 2 Low Temperature options 1 2 ALARM MESSAGE PRIORITY COMMENTS High SpO2 options 1 2 Low SpO2 options 1 2 SpO2 Desat 1 ALARM MESSAGE PRIORITY COMMENTS High NIBP Diastolic options 1 2 Low NIBP Diastolic options 1 2 ...

Page 180: ...options 1 2 High End Tidal CO2 options 1 2 Low End Tidal CO2 options 1 2 ALARM MESSAGE PRIORITY COMMENTS High End Tidal Agent options 1 2 Low End Tidal Agent options 1 2 High Inspired Agent options 1 2 Low Inspired Agent options 1 2 High End Tidal N2O options 1 2 Low End Tidal N2O options 1 2 High Inspired N2O options 1 2 Low Inspired N2O options 1 2 High End Tidal O2 options 1 2 Low End Tidal O2 ...

Page 181: ...nt Connect lead wires ECG Noise 3 External interference Patient movement Check patient Check Electrode Contacts reposition electrodes cable Check environment for source of interference ECG Artifact 3 External Interference Patient movement Check patient Check Electrode Contacts reposition electrodes cable Check environment for source of interference HR Overrange 3 Heart rate outside of measureable ...

Page 182: ... SpO2 Sensor Off 3 Sensor Off Check Patient Apply Sensor Note that the alarm is only active after the sensor has been on a patient SpO2 Overrange 3 SpO2 outside of measurable range Check patient SpO2 PR Overrange 3 PR outside of measurable range Check patient ALARM MESSAGE PRIORITY REASON SOLUTION NIBP Systolic Overrange 3 NIBP systolic pressure exceeds the measurement range Check Patient Ensure t...

Page 183: ... ALARM MESSAGE PRIORITY REASON SOLUTION CO2 ETCO2 Overrange 3 Et CO2 outside of measurable range Check patient CO2 InspCO2 Overrange 3 Insp CO2 outside of measureable range Check patient CO2 Resp Rate Overrange 3 The measured RR value exceeds the measurement range Check Patient Check Airway ALARM MESSAGE PRIORITY REASON SOLUTION GM ETCO2 Overrange 3 The measured ExpCO2 value exceeds the measuremen...

Page 184: ...ort 12V Too Low 1 The monitoring of the internal voltage finds that 12V voltage is too low Contact Technical Support 5V Too High 1 The monitoring of the internal voltage finds that 5V voltage is too high Contact Technical Support 5V Too Low 1 The monitoring of the internal voltage finds that 5V voltage is too low Contact Technical Support 3 3V Too High 1 The monitoring of the internal voltage find...

Page 185: ...uency electrosurgery Unit Interference disappears ECG Signal Invalid Poor leads connection Check Patient Check Leads and leadlines Pacer Rejection On When Pacer Reject is set to On This is normal operation When Pace Reject is set to Off this message disappears Learning Displayed when a learning cycle has been requested for Arrhythmia or ST No Arrhythmia Detection at Central Central Station does no...

Page 186: ...se Low pulse due to poor perfusion External interference Check Patient Reposition sensor Check for source of external interference DPM Nellcor SpO2 Sensor Fault Defective sensor Replace sensor Masimo DPM Nellcor SpO2 Board Fault There is a problem with the SpO2 measurement board Contact Technical Support Masimo SpO2 Initialization Error No response after send order during initialization Contact Te...

Page 187: ...k patient Reposition sensor Change sensor Masimo SpO2 Check Sensor Possible Faulty sensor Replace Sensor Nellcor SpO2 Motion Patient movement Check patient Nellcor SpO2 Pulse Search Monitor searching for pulse Sensor just applied Poor perfusion at sensor site Check patient Reposition sensor Masimo DPM Nellcor ALARM MESSAGE REASON SOLUTION Temp Communication Stop As the Temp module communication st...

Page 188: ...tic Leak Leakage In Pneumatic check air leakage is found in hose Change the cuff NIBP Unable to Measure Unable to make measurement after three automatic retries Check Patient Retry measurement If message reappears power cycle unit If message reappears contact Technical Support NIBP Resetting NIBP Reset Failed Reset has failed Power cycle unit If message reappears contact Technical Support NIBP Idl...

Page 189: ...ntain motion artifact or too much interference Timeout Measurement takes more than 120 seconds in ADU PED mode and 90 seconds in NEO mode Retry Overpressure or bad measurement Retry will be attempted Check for leaks and quality of peripheral pulses Decrease patient movement Switch cuff to another limb Accuracy Testing Appears when press Accuracy Test button in Calibrate NIBP Menu Accuracy Testing ...

Page 190: ...000 operating hours Recalibrate miniMediCO2 Contact Technical Support Oridion CO2 Filterline Disconnected Filterline disconnected Connect Filterline to monitor Oridion microstream CO2 Gas Can Be Removed CO2 gas can be removed Oridion CO2 Purge Sample line is blocked or kinked Wait several seconds The Passport V will return to monitoring or display the message CO2 Occlusion If message is displayed ...

Page 191: ...mple line or the CO2 sample line has been occluded DPM CO2 Initialization Error No response after send order during initialization Contact Technical Support 1DPM 2Oridion CO2 SelfTest Error Module can not work because of software fault circuit error etc Contact Technical Support 1DPM 2Oridion CO2 Communication Error The monitor receives wrong responsion from CO2 module Contact Technical Support 1D...

Page 192: ...lize calibration Repeat calibration procedure If problem persists contact Technical Support Oridion CO2 Zeroing The CO2 module is performing zero Wait for zeroing to complete DPM Oridion CO2 Zero Failed Signal cannot be adjusted to predefined range within zeroing duration Check the CO2 connections After the sensor s temperature becomes stabilized perform a zero calibration again If problem persist...

Page 193: ...ts contact Mindray Technical Support GM N2O Uncalibrated Appears after an unsuccessful calibration attempt of the N2O sensor The numeric data for N2O will appear as XXX and the N2O waveform will be a flatline Ensure proper gas mixture is attached tightly and regulator is on Repeat calibration procedure If problem persists contact Mindray Technical Support GM O2 Uncalibrated Appears after an unsucc...

Page 194: ... Passport V monitor being on Turn Gas Module and Passport V Off Install check sample lines filters water trap and electrical connections Turn off Gas Module Turn on Gas Module and Passport V monitor GM Replace Trap Indicates residue build up on the water trap membrane that is decreasing air flow Replace water trap reservoir GM Exhaust Blocked Appears when the system detects a blockage at the exhau...

Page 195: ...g sent by the Gas Module Ensure Gas Module is turned on and interface cable is properly connected If problem persists contact Technical Support ALARM MESSAGE REASON SOLUTION Power Board Communication Error Abnormal power board communication Contact Technical Support Power Board Initialization Error Contact Technical Support Power Board SelfTest Error Contact Technical Support Power Board Communica...

Page 196: ... 5V Too High The monitoring of the internal voltage finds that 5V voltage is too high Contact Technical Support 5V Too Low The monitoring of the internal voltage finds that 5V voltage is too low Contact Technical Support 3 3V Too High The monitoring of the internal voltage finds that 3 3V voltage is too high Contact Technical Support 3 3V Too Low The monitoring of the internal voltage finds that 3...

Page 197: ...iguration data Downloading Monitor Defaults Remain in the state of configuration data downloading No handling needed Uploading Monitor Defaults Remain in the state of configuration data uploading No handling needed Monitor defaults download complete Configuration data downloading finishes No handling needed Monitor defaults upload complete Configuration data uploading finishes No handling needed L...

Page 198: ... roll of paper Local Printer Unable To Print The system has detected an unrecoverable printer failure Power cycle unit If message reappears contact Mindray Technical Support No printer selected or available No printer selected is available from the network Check the selected printer from the network and make sure the printer model is supported by Passport V monitors Printing The printer is printin...

Page 199: ...Arrhythmia Alarm Sound Arrhythmia option not installed Call Sales Rep to purchase option Arrhythmia Alarms off Go to Monitor Setup Advanced Setup to activate alarm Monitor is in learning mode Wait until learning is concluded and monitor patient closely Alarms continue to Sound despite pressing SILENCE More than one alarm is active Press SILENCE or SILENCE ALL key to silence Check Patient No Alarm ...

Page 200: ...5 1 15 0 Trends 15 1 Description Four types of trend displays are available with the Passport V Quick Trend List Trend Graphic Trend and OxyCRG if patient is neonate All trends are accessed via the TRENDS key and can be printed via the local printer 0 ...

Page 201: ...rom the trend record in order to allow storage of a new entry FIGURE 15 1 Quick Trends Clearing Trend Data To manually clear all trend data including Graphic Trends choose Clear Trends from the menu A confirmation prompt will appear Once cleared the data cannot be restored All trend data is automatically cleared when the patient is discharged from the monitor All trend data is also cleared if the ...

Page 202: ...cal scroll feature to view all the rows of data NOTE When scrolling vertically the first row of data HR remains displayed and does not scroll Scroll bars along the right and bottom sides of the trend display indicate the position of viewed data in relation to the rest of the database The top row of the List Trend display contains markers which indicate that the entry was triggered by an alarm viol...

Page 203: ...luded in the displayed data Trend entries triggered by Interval may be filtered out from the displayed List Trend data To change the amount of interval entries displayed select Interval and set as desired Transferring List Trend Data Between Different Passport V Monitors List and Graphic Trend data along with patient name and demographics may be transferred between Passport V monitors with a DPM s...

Page 204: ...ling vertically the topmost parameter HR remains displayed and does not scroll Time stamps are included in the upper area of the window with the most recent data appearing with the cursor at the right end Use the horizontal Scroll feature to move the display window through time Scroll bars along the right and bottom sides of the Graphic Trend display indicate the position of viewed data in relatio...

Page 205: ...ed in each of the top 5 rows select Group Setup from the Graphic Trend menu Then set Param 1 through Param 6 to the desired parameters Modification of Trend Entry Conditions The Graphic Trend data is the same as that stored for List Trends arranged graphically If data is not available for time period it appears as a gap in the Graphic Trend Refer to the previous section List Trend for modification...

Page 206: ...G This display may also be accessed from the other trend displays via a menu choice FIGURE 15 4 OxyCRG Display The events that trigger the storage of OxyCRG data are Interval events Alarm events and Manually marked events The interval for triggering the interval event is 2s maximally The parameters stored for the OxyCRG are instantaneous values of HR SpO2 RR Resp Wave Temp and IBP1 The time marker...

Page 207: ...the alarm priority 1 level alarm red 2 level alarm yellow If multiple events happen during a time interval the color of the event with the highest priority is shown The order of event priority is manually marked event one level alarm two level alarm Viewing Trend Data The start time for OxyCRG trends is related to the way the user accesses the OxyCRG trends If the user enters the OxyCRG trends by ...

Page 208: ...The OxyCRG screen consists of the following items 1 Menu area Allows operations in the OxyCRG display 2 Event area Shows events markers 3 Time area Shows the time marker of trend entries and cursor in time area There five time markers for trend entries that divide the OxyCRG graph into four equal sections The time marker of entries is accurate to the minute The time marker of the cursor is accurat...

Page 209: ...ons 15 6 Trends Troubleshooting MESSAGE PROBLEM REASON SOLUTION No Trends displayed No Trend triggers set Go to the Monitor Setup Menu and set NIBP Trend Trend Interval or Alarm Trend as desired Trend page is scrolled Use scroll arrows in Trend Menu to scroll to top of Trend Menu 0 ...

Page 210: ...ms may be printed to the following destinations local printer remote printer or remote central station 16 2 Print Setup Menu FIGURE 16 1 Print Setup Menu Printing of Waveform Data The Print Setup Menu allows the user to set up waveforms for printing and gives the user the ability to change the print destination 0 ...

Page 211: ... provide a printed record of all patient parameters It is a three trace thermal strip chart local printer with an integral paper spool The local printer uses plain white thermal paper 5 cm wide NOTE All grid patterns and data are printed by the local printer Operation of the Local Printer 1 Select the waveforms to print to the local printer via the Print Setup Menu using the Navigator Knob To chan...

Page 212: ...th the name of the violated alarm Interval Printing To print waveform strips at regular intervals go to the Print Setup Menu highlight Print Interval and select a time interval to print The selections are Off 1 min 5 min 10 min 15 min 20 min 30 min 1 hr and 2 hr The source of the printout is indicated on the strip as AUTO REALTIME REPORT Trend Printing To print Quick Trend List Trend OxyCRG or Gra...

Page 213: ...tion 16 2 2 Remote Local Printer Troubleshooting MESSAGE PROBLEM REASON SOLUTION Local Printer report appears totally blank Thermal paper may be installed incorrectly up side down Remove paper and re install with paper feeding off of the spool from the bottom Local Printer Out Of Paper Printer out of paper or the printer door is open Replace with a new roll of paper and close the door No print on ...

Page 214: ...assport V monitor is designed for stable operation over long periods of time Under normal circumstances the monitor should not require technical maintenance beyond that described in this section However routine maintenance calibration and safety checks are recommended at least once a year or more often as required by local statutory or hospital administration practice 0 ...

Page 215: ...ed with a clean and soft cloth sponge or cotton ball dampened with either of the following cleaning solutions Mild soap diluted Sodium hypochlorite bleach 10 Isopropyl alcohol 70 Super sani cloth 0 5 quaternary ammonia 55 isopropyl alcohol Virkon To avoid damage to the equipment ALWAYS use solutions in accordance with the manufacturer s instructions ALWAYS wipe off the excess cleaning solution wit...

Page 216: ...enated by wiping with an alcohol wipe and allowing the sensor to thoroughly air dry prior to replacement on the patient Do not immerse any Oxisensor OxiMax Durasensor Oxiband or Duraform oxygen transducers the Nellcor RS 10 or Max Fast oxygen transducers or any Nellcor adhesive in water or cleaning solution Clean Durasensor Oxiband and Duraform oxygen transducers and the Nellcor RS 10 or Max Fast ...

Page 217: ...ed with a damp cloth with 70 isopropanol and water It may also be disinfected with ultraviolet The bladder can only be disinfected with ultraviolet NOTE Prolonged use of disinfectant may cause discoloration of the cuff Replace the bladder after cleaning and disinfecting the cuff as follows 1 Place the bladder on the top of the cuff as the figure shows 2 Roll the bladder lengthwise and insert it in...

Page 218: ...ized with gamma sterilization without affecting the repeated performance of the cuff Steam sterilization is not recommended Use of a washing liquid containing bleach is not recommended because chlorine will chemically break down the urethane on the inside of the cuff Antimicrobial Definition Bladderless cuffs are treated with an antimicrobial coating Antimicrobial technology effectively controls a...

Page 219: ...place CAUTION Replace lithium ion batteries with part number M05 010001 06 Mindray or 0146 00 0099 ONLY NOTE Mindray PM batteries 0146 00 0069 may fit inside the Passport V monitor but they will not properly report charging status Battery Maintenance The batteries may be subject to local regulations regarding disposal At the end of the battery life dispose of the batteries in accordance with any l...

Page 220: ...age of Thermal Chart Paper Thermal Chart Paper is chemically treated and the permanency of a recording is affected by storage and handling conditions These conditions are Ultraviolet Light We recommend storing the recordings in a filing cabinet within a few days of printing Long term exposure to natural or artificial U V sources is detrimental Storage Temperature and Humidity Keep the recordings i...

Page 221: ...ecommended After cleaning the ECG cables and lead wires should be wiped with water using a clean damp cloth then dried with a clean dry cloth The ECG cables and lead wires must be allowed to dry thoroughly before use CAUTION To avoid permanent damage do not expose metal components pins sockets snaps to disinfectants soaps or chemicals NOTE ECG cables and lead wires must never be immersed soaked in...

Page 222: ...of 200 0683 00 0449 01 Radio Opaque Neonatal Pre wired 3 Lead ECG Electrodes AAMI 18 45 7cm Box of 100 packs each pack contains 3 electrodes 0681 00 0098 01 Radio Tranlucent Neonatal Pre wired 3 Lead ECG Electrodes AAMI 18 45 7 cm Box of 100 Packs each pack contains 3 electrodes 0681 00 0098 02 DESCRIPTION PART NUMBER ECG Cable 3 5 lead 10 3 1 m Reusable 0012 00 1745 01 ECG Cable 3 5 lead 20 6 1 m...

Page 223: ...sable 0012 00 1503 10 ECG Lead Wires 5 lead Snap 24 61 0 cm IEC Reusable 0012 00 1503 11 ECG Lead Wires 5 lead Snap 36 101 6 cm IEC Reusable 0012 00 1503 12 ECG Lead Wires 3 lead Snap 18 45 7 cm AAMI Reusable 0012 00 1503 04 ECG Lead Wires 3 lead Snap 24 61 0 cm AAMI Reusable 0012 00 1503 05 ECG Lead Wires 3 lead Snap 36 101 6 cm AAMI Reusable 0012 00 1503 06 ECG Lead Wires 3 lead Snap 18 45 7 cm ...

Page 224: ...F L Infant Single Patient Adhesive Sensors patient weight range 3 to 20 kg 20 box 0600 00 0123 LNCS NEO L Neonatal single patient adhesive sensors patient weight range 3 kg and 40 kg 20 box 0600 00 0124 LNCS NEO PT L Neonatal preterm single patient adhesive sensors patient weight range 1 kg 20 box 0600 00 0125 LNC 4 Masimo LNCS SpO2 Patient Cable 4 1 22m 0012 00 1652 LNC 10 Masimo LNCS SpO2 Patien...

Page 225: ...0600 00 0045 01 Adhesive Tapes for Neonatal Y Single Patient Adhesive Sensors pkg of 100 0600 00 0065 LNOP II Neo Neonatal L Single Patient Adhesive Sensors patient weight range 1 kg and 10 kg pkg of 20 0600 00 0099 Adhesive Tapes for Neonatal L Single Patient Adhesive Sensors pkg of 100 0600 00 0096 LNOP NeoPt Preterm Neonatal Y Single Patient Adhesive Sensors patient weight range than 1 kg pkg 2...

Page 226: ... 518B Reusable Sensor Neonatal Foot Adult Pediatric finger or toe 518B 30 72107 DPM SpO2 512F Reusable Sensor Adult Finger 512F 30 28263 DPM SpO2 512H Reusable Sensor Pediatric Finger 512H 30 79061 DPM SPO2 Cable 6 Pin 0010 20 42594 DPM SpO2 520A Single Patient Use sensor Adult 30 kg pkg of 20 520A 30 64101 DPM SpO2 520I Single patient use sensor Infant 3 to 20 kg 20 pcs box 520I 30 64301 DPM SpO2...

Page 227: ...l Adult 18 to 26cm quick connect box of 10 0683 14 0002 01 Disposable NIBP cuff Adult 25 to 35 cm quick connect box of 10 0683 14 0003 01 Disposable NIBP cuff Large Adult 33 to 47cm quick connect box of 10 0683 14 0004 01 Disposable NIBP cuff Thigh 46 to 66cm quick connect box of 10 0683 14 0005 01 Disposable NIBP Cuff Adult Long 25 35 cm quick connect 0683 14 0006 01 Disposable NIBP Cuff Large Ad...

Page 228: ...ctal 400 Series Disposable Temperature Probe 12 Fr ER 400 12 0206 03 0212 02 Skin 400 Series Disposable Temperature Probe SK 400 0206 03 0300 02 Reusable Instrument Cable 400 Series 040 000091 00 DESCRIPTION PART NUMBER Reusable Temperature Probe Adult Esophageal Rectal 040 000055 00 Reusable Temperature Probe Adult Skin 040 000057 00 Reusable Temperature Probe Pediatric Esophageal Rectal 040 0000...

Page 229: ...ating Instructions 18 5 IBP DESCRIPTION PART NUMBER IBP Cable BD P10EZ 1 P23XL 1 DTX Plus 12ft 040 000053 00 IBP Cable Edwards Life Sciences TruWave PX 12ft 040 000054 00 IBP Cable Hospira Transpac IV 12ft 040 000052 00 IBP Cable Adapter 040 000096 00 0 ...

Page 230: ... Neonatal 2 5 m box of 25 9200 10 10555 CO2 Nasal sample cannula Adult with 7 line box of 25 M02A 10 25937 CO2 Nasal sample cannula Pediatric with 7 line box of 25 M02A 10 25938 CO2 Nasal sample cannula Infant with 7 line box of 25 M02B 10 64509 Dryline airway adapter straight box of 10 9000 10 07486 DPM Sidestream CO2 Kit Adult Includes 2 adult pediatric airway adapter 2 adult pediatric watertrap...

Page 231: ...69 Mounting Plate to Gas Module 3 0386 00 0344 Cable Serial Port to Gas Module 12 30 48 cm 0012 00 1276 01 Cable Serial Port to Gas Module 72 182 88 cm 0012 00 1276 02 Power Cord 120 Volt 0012 00 1081 01 Kit Acc Gas Mod Passport V 110V 0020 00 0119 10 Kit Acc Gas Mod Passport V 120V 0020 00 0119 11 Kit Acc Gas Mod Passport V 240V 0020 00 0119 12 0 ...

Page 232: ...ounting Plate Kit Bedside to Rolling Stand and Wall Mount 115 003234 00 Quick Release Mounting Kit 115 003237 00 Transport Rolling Stand with Mounting Plate PASSVROLLSTD Transport Rolling Stand with Quick Release Mount PASSVROLLSTDQR VHM Wall Mount with Mounting Plate PASSVVHMMT VHM Wall Mount with Quick Release Mount PASSVVHMMTQR Wall Mount with Mounting Plate PASSVWALLMT Wall Mount with Quick Re...

Page 233: ...86 m 0012 00 0994 04 CAT 5 Ethernet Cable Patch STP 6 1 83 m 0012 00 1274 01 CAT 5 Ethernet Cable Patch STP 25 7 62 m 0012 00 1274 02 CAT 5 Ethernet Cable Patch STP 50 15 24 m 0012 00 1274 03 CAT 5 Ethernet Cable Crossover STP 3 0 91 m 0012 00 1392 05 CAT 5 Ethernet Cable Crossover STP 6 1 83 m 0012 00 1392 06 CAT 5 Ethernet Cable Crossover STP 10 3 05 m 0012 00 1392 07 CAT 5 Ethernet Cable Crosso...

Page 234: ...SCRIPTION PART NUMBER Lithium Ion Battery M05 010001 06 Lithium Ion Battery 0146 00 0099 Power Cord 110 Volt 0012 25 0001 Power Cord 220 Volt 0012 25 0002 Power Cord 240 Volt UK 0012 25 0003 Power Cord 250 Volt Brazil 009 001075 00 SB Storage Device 0992 00 0295 001 Paper Thermal Strip Local Printer 12 rolls 0683 00 0505 02 0 ...

Page 235: ...Battery and Miscellaneous Accessories 18 14 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 236: ...to 95 non condensing Non operating storage 10 to 95 non condensing Altitude range Operating 1 000 to 9 841 feet ASL 1 051hPa to 700 hPa 788 mmHg to 525 mmHg Non operating storage 1 000 to 15 000 feet ASL 1 051 hPa to 571 hPa 788 mmHg to 428 mmHg Temperature range Operating 10ºC to 40ºC Non operating storage 40ºC to 70ºC Humidity range Operating 10 to 95 non condensing Non operating storage 5 to 10...

Page 237: ...ed fan is used Below and equal to 27 degree ambient temperature noise 35 dBA measured at a distance of one meter from the device Below and equal to 33 degree ambient temperature noise 40 dBA measured at a distance of one meter from the device Below and equal to 40 degree ambient temperature noise 46 dBA measured at a distance of one meter from the device Conditions NIBP pump and valves not operati...

Page 238: ...ttery M05 010001 06 Mindray Number of batteries 2 maximum one battery operation supported Lithium Battery Index Voltage 11 1VDC Rated Battery capacity 4 4 Ah one battery Battery run time 270min two batteries 130 min one battery Operating conditions 25ºC for new fully charged battery Equipment configuration 5 lead ECG Impedance Repiration Masimo SpO2 Temperature IBP1 IBP2 and NIBP in 15 min Interva...

Page 239: ...ock is powered by an independent battery which runs for over 5 years 19 4 Weight and Dimension Dimension 30 0 cm H x 18 0 cm D x 32 0cm W Weight 11 lb 5 0kg standard configuration including one battery local printer 19 5 Display Specifications Display Type Color anti glare TFT display Rated display Resolution 800 600 Pixels Rated display size 12 1 246 x 184 4 mm Data Update Frequency 60Hz Accuracy...

Page 240: ...f alarm tone adjustment Sound Pressure Range 45 to 85 dB Key pressing prompt tone Provides hard key tones Systole heartbeat tone pulse beat tone Pitch tone Provides 0 to 10 levels of tone adjustment 0 stands for no sound Provides Pitch Tone based on the SpO2 value 19 7 Marking Marking complies with the requirements of the following standards UL 969 2006 21 CFR 801 1 2007 ISO 15223 2000 A1 2001 A2 ...

Page 241: ...articularly in pediatric recordings Heart Rate Meter Accu racy and Response to Irregular Rhythm Ventricular bigeminy 80 bpm Slow alternating ventricular bigem iny 60 bpm Rapid alternating ventricular bigeminy 120 bpm Bidirectional systoles 90 bpm Response time to HR change From 80 to 120 bpm less than 11 s From 80 to 40 bpm less than 11 s Time to alarm for tachycardia 11s measured in accordance wi...

Page 242: ... 4 ECG Signal Range 8mV peak to peak value the output accuracy of signals complies with 50 102 1 of IEC60601 2 27 2005 Calibration Signal 1mV peak to peak value Accuracy 5 or 40µV whichever is greater Detected RTI Range of Measured ECG Signals 4 88 uV 8 mV when gain is 0 125 0 25 0 5 1 2 4 ECG Calibration mode Manual Calibration Input Impedance 5 Mohms Bandwidth 3dB Surgical mode From 1 to 20 Hz M...

Page 243: ...th 4 2 9 3 of ANSI AAMI EC13 2002 ESU Electrosurgical Unit Interference Suppression Incision mode 300W Coagulation mode 100W Recovery time 10s Complies with 4 2 9 14 of ANSI AAMI EC13 2002 RTI Suppression of ESU Electrosurgical Unit ESIS ECG cable is used ECG lead wires complying with AAMI is used compared with ECG baseline the peak to peak RTI value 2mV The testing method complies with 5 2 9 14 o...

Page 244: ...5 PACE Pulse Display On Off indications When Paced is set to On the PACE marker is displayed When Paced is set to Off the PACE marker is not displayed Pace pulse markers PACE markers are displayed on screen for pulses meeting the following requirements Amplitude From 2mV to 700mV Width From 0 1 ms to 2 0 ms Rise time From 10µs to 100µs Pacer tails with amplitudes 2 0mV and time constants from 4 to...

Page 245: ...of ANSI AAMI EC13 2002 HR calculation is not affected for T waves whose QRS complex is 100ms QT interval is 350ms lasting time is 180ms and amplitude less than 1 2mv ST Segment Analysis Scope ST analysis is available for Adult and Pediatric patients only ST Measurement Point ST measurement point can be manually adjusted J 60 and J 80 default J 60 ms ISO point can be manually adjusted from 4 to 200...

Page 246: ...re optionally viewable using a 5 lead lead set Default two waveforms are II V Displayed Parameters HR label HR value HR source HR alarm limit PVCs ST value and unit ECG Multi leads Display Lead Set 5 lead Screen Display Full screen display of seven ECG waveforms I II III aVR aVL aVF and V Data Storage Physiological Parameters HR PVCs ST for 3 lead ST one value of I II or III is stored For 5 lead S...

Page 247: ... Impedance Range From 200 to 2500 ohms use the ECG cable with 1 kohms resistance Respiration Impedance Range From 0 3 to 5 ohms Linear Signal Range Minimum 3 ohms p p Bandwidth From 0 2 to 2 Hz 3 dB RTI Noise 0 1 ohms peak value with standard ECG cables and patient impedance 500 ohms RR spec Range Adult From 0 to 120 RPM Pediatric and neonatal From 0 to 150 RPM Resolution 1 RPM Accuracy From 6 to ...

Page 248: ...age 5VDC 2 Sensitivity 5 uV mmHg Volt Resistance range From 300 to 3000 ohms Volume displacement in mm3 100 mm Hg may be provided in the transducer Instructions For Use supplied with the EQUIPMENT Pressure Calibration Supported Pressure Measurement specifications Measurement range From 50 to 300 mmHg ART UA From 0 to 300 mmHg PA From 6 to 120 mmHg CVP From 10 to 40 mmHg RA LA ICP From 10 to 40 mmH...

Page 249: ...ic and mean blood pressure measurements in Neonate Pediatric and Adult modes non invasively using a blood pressure cuff The NIBP function is in accordance with the requirements of EN 60601 2 30 EN 1060 1 EN 1060 3 and SP 10 Systolic Pressure Measurement Diastolic Pressure Measurement Static Pressure Measurement Accuracy Mean error is less than 5 mmHg Standard Deviation is less than 8 mmHg Range Ad...

Page 250: ... with the bleed valves closed is 10 mmHg in 10 seconds as measured with a 500 cc volume at differential pressures of 250 mmHg 150 mmHg and 50 mmHg Reference ANSI AAMI SP10 1992 EN1060 3 1997 Vent Rate A volume of 500 cc when vented is reduced from a pressure of 260 mmHg to a pressure of 15 mmHg in a maximum of 10 seconds For Neonate from a pressure of 150 mmHg to a pressure of 5 mmHg in less then ...

Page 251: ...surement 19 8 5 Masimo SET SpO2 Performance Requirements Sensor Compatibility LNOP and LNCS Series Measured Parameters SpO2 and PR SpO2 Measurement Range From 1 to 100 SpO2 Accuracy A functional tester or patient simulator not used to assess the accuracy of the pulse oximeter probe or a pulse oximeter monitor PATIENT SIZE USER SELECTABLE START PRESSURE RANGE INCREMENT SIZE DEFAULT SETTING Adult Mo...

Page 252: ... a non repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory co oxi meter and ECG monitor This variation equals plus or minus one standard deviation which encompasses 68 of the population Resolution 1 Average Time Optional 2 4 seconds 4 6 seconds 8 seconds 10 seconds 12 seconds 14 seconds 16seconds Refresh Rate ...

Page 253: ...ion Plus or minus one standard deviation encompasses 68 of the population The Masimo SET MS 3 pulse oximeter with LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate s foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard dev...

Page 254: ...o motion conditions on healthy male and femaile adults with light to dark skin pigmentation Sensor Measurement Wavelengths The sensor measurement wavelengths are nominally 660 nm for the red LED and 940 nm for the infrared LED Maximum optical power output for the LEDs is 4 mW This information may be useful to clinicians such as those performing photodynamic therapy 19 8 6 DPM SpO2 Performance Requ...

Page 255: ...the same limb simultaneously users can choose this function to suppress the false alarm during the period of venous block Alarm SpO2 and PR alarms are optional DPM SpO2 Module Accuracy The DPM SpO2 module accuracy has been validated in human studies against arterial blood sample reference measured with a co oximeter Pulse oximeter measurements are statistically distributed and about two thirds of ...

Page 256: ...d infrared light at a wavelength of approximately 900nm The total optical output power of the sensor LEDs is less than 15mW This information may be useful to clinicians such as those performing photodynamic therapy 19 8 8 CO2 Performance Characteristics The CO2 function is in accordance with the requirements of ISO 21647 The Passport V is capable of providing CO2 measurements from either a DPM Sid...

Page 257: ...SFM is triggered under the following conditions During the first hour after entering measurement mode periodically for durations of typically 10 seconds at a rate which limits the total time consumed by SFMs to less than 2 of the time in which active measurements are taken Following the first hour Range 0 99 mmHg CO2 PARTIAL PRESSURE ACCURACY 0 38 mmHg 2 mmHg 39 99 mmHg 5 of reading 0 08 for every...

Page 258: ...and After the 20 second opportunity given to the host to schedule the SFM passes the module schedules the SFM according to a priority determined by current conditions DPM CO2 System Response Time The system response time with a standard length FilterLine which includes the delay time and rise time 10 to 90 in response to a step change in the CO2 concentration is 2 9 seconds typical Rise Time Adult...

Page 259: ...in 3 5s 70ml min Measurement conditions use a neonatal watertrap and 2 5m neonatal sampling line 4s 150ml min 5s 120ml min 5s 100ml min 6 5s 70ml min Measurement conditions use an adult watertrap and 2 5m adult sampling line Response Time 3s 150ml min 3s 120ml min 3 5s 100ml min 4s 70ml min Measurement conditions use a neonatal watertrap and 2 5m neonatal sampling line 4 5s 150ml min 5 5s 120ml mi...

Page 260: ... Yes Clinical Common Range Default of Graphic Trend 32 43 C 90 110 F Quantitative Influence of Interference Gas Interference gas Concentration Level Quantitative Influence When measuring under 0 40mmHg additional error introduced due to gas interference N2O 60 1mmHg HAL 4 1mmHg SEV 5 1mmHg ISO 5 1mmHg ENF 5 1mmHg DES 15 2mmHg Helium Unspecified Xenon Unspecified Start Time 30 s typical 60s maximum...

Page 261: ...perature and humidity should be contained in the probe Instructions For Use 19 8 10 Gas Module Performance Characteristics Technology NDIR type gas analyzer measuring at 3 9 12 8 µm with paramagnetic oxygen sensor Pressure temperature and full spectral interference correction Operating modes Startup ISO accuracy Full accuracy Measured gases CO2 N2O O2 HAL ENF ISO SEV DES Measured parameters Moment...

Page 262: ...tion The Gas Module 3 is equipped with automatic barometric pressure compensation Main Fuse 2x T0 8A 250V 1 Includes interference from other gases 2 The step rise time specification at 200 ml min sample flow includes DRYLINE Water Trap Adult Pediatric and DRYLINE Sampling Line Adult Pediatric 2 5 m 3 The step rise time specification at 120 ml min sample flow includes DRYLINE Water Trap Neonate and...

Page 263: ...acer Enhancement Amplitude 5 V 5 Width 2 10 ms Bandwidth 3 dB referenced to 1 Hz 0 12 5Hz Maximum Transmission Delay 25 ms Sensitivity 1 V 100 mmHg 4 reference frequency 1Hz Connector BNC AUX connector Meets the requirements of EC60601 1 for short circuit protection and leakage current Max time delay 35 ms R wave peak to leading edge of pulse Amplitude High level 3 5 5V providing a maximum of 1 mA...

Page 264: ...t is 2 seconds measured at the Passport V signal output connector 19 11 Data Storage Monitor Configuration Data Storage and Transfer Storage The monitor has the ability to store in non volatile memory the user selectable configuration There is one 1 configuration available for each patient size and the following information is saved Alarm Values Display Configurations NIBP Interval Parameter Setti...

Page 265: ... ANSI AAMI SP10 1992 A1 1996 ANSI AAMI EC11 2001 ANSI AAMI EC13 2002 ASTM E1112 00 CEI IEC60601 1 6 2006 CEI IEC60601 1 8 2006 CSA Standard C22 2 No 601 1M90 EN 60601 1 IEC 60601 1 EN 60601 1 1 IEC 60601 1 1 EN 60601 1 4 IEC 60601 1 4 EN 60601 2 27 IEC 60601 2 27 EN 60601 2 30 IEC 60601 2 30 EN 60601 2 34 IEC 60601 2 34 EN 60601 2 25 IEC 60601 2 25 EN 60601 2 49 IEC 60601 2 49 EN 1060 1 1995 A1 20...

Page 266: ...plosion Not protected ordinary equipment Not for use in the presence of flammable anesthetic mixture O2 or N2O Protection Against Ingress of Liquids Complies with the requirements of IEC60529 2001 IPX1 Complies with the requirements of IEC60601 1 1988 A1 1991 A2 1995 Electrical Connection Between Equipment and Patient Direct electrical or non electrical connection with the patient 19 14 2 Safety P...

Page 267: ...60601 1 1997 clause 21 c Incompatibility with External Connectors Complies with the requirements of IEC 60601 1 1997 clauses 56 3 Complies with the requirements of FDA Reviewer Guidance for Premarket Notification Submission November1993 N2 Rigidity and Strength of Enclosure Complies with the requirements of IEC 60601 1 1997 clauses 21a 16a and 21b Complies with the requirements of UL 60601 1 2003 ...

Page 268: ...nt irrelevant to protective or functional earthing Anti power Interference After interference from ESU defibrillation electrostatic discharge The equipment returns to normal operation mode within 10 seconds The display is able to show physiological parameters and waveforms normally For example the ECG waveform data stored are not lost Protection Against Power Failure Requirements of ISO21647 2005 ...

Page 269: ...Immunity Against Conducted Disturbance Complies with the requirements of IEC 61000 4 6 2006 for 3Vrms Level 2 150 KHz to 80 MHz 3Vrms 80 AM modulation frequency significant for the equipment under test Immunity Against Radiated Electromagnetic Fields Complies with the requirements of IEC 61000 4 3 2001 80 MHz to 2 5 GHz 3V m 80 AM 2 Hz or modulation frequency significant for the equipment under te...

Page 270: ...ations equipment can affect the Passport V See tables 19 1 through 19 4 that follow TABLE 19 1 GUIDANCE AND DECLARATION ELECTROMAGNETIC EMISSIONS The Passport V is intended for use in the electromagnetic environment specified below The customer or the user of the Passport V should assure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissi...

Page 271: ...nment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 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 ...

Page 272: ...survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE The device tha...

Page 273: ... OUTPUT POWER P OF TRANSMITTER IN WATTS W SEPARATION DISTANCE d IN METERS m ACCORDING TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz d 1 2 x 80 MHz to 800 MHz d 1 2 x 800 MHz to 2 5 GHz d 2 3 x 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be det...

Page 274: ...reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Re orient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment to an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an ...

Page 275: ...ompromettre le fonctionnement This equipment complies with FCC IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency RF Exposure Guidelines in Supplement C to OET65 and RSS 102 of the IC radio frequency RF Exposure rules This equipment should be installed and operated keeping the radiator at least 20cm or more away from person s body excluding ext...

Page 276: ...tromagnetic environment specified below The customer or the user of the Gas Module 3 should assure that they are used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The Gas Module 3 uses RF energy only for their internal function Therefore their RF emissions are very low and are not likely to cause any interference in nearby elec...

Page 277: ...nment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 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 ...

Page 278: ...ers m 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 equipment marked with the following symbol NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is af...

Page 279: ...IMUM OUTPUT POWER P OF TRANSMITTER IN WATTS W SEPARATION DISTANCE d IN METERS m ACCORDING TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz d 1 2 x 80 MHz to 800 MHz d 1 2 x 800 MHz to 2 5 GHz d 2 3 x 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be...

Page 280: ...warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use whichever is sooner This warranty does not cover consumable items such as but not limited to batteries external cables sensors cuffs hoses or mounts Mindray DS USA Inc Shenzhen Mindray Bio Medical Electronics Co Ltd will not be liable for any incidental special or...

Page 281: ...e of purchase except that disposable or one time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use whichever is sooner This warranty does not cover consumable items such as but not limited to batteries external cables sensors cuffs hoses or mounts Mindray DS USA Inc Shenzhen Mindray Bio Medical E...

Page 282: ...r to requesting service perform a complete operational check of the instrument to verify proper control settings If operational problems continue to exist contact the Service Department at 800 288 2121 or 201 995 8116 for assistance in determining the nearest field service location Please include the instrument model number the serial number and a description of the problem with all requests for s...

Page 283: ...Manufacturer s Responsibility Appendix 19 48 0070 0 0704 02 Passport V Operating Instructions This page intentionally left blank 0 ...

Page 284: ...ill occur if heart rate and respiration rate are the same CVP Central Venous Pressure label for invasive blood pressure Des Desflurane ECG Electrocardiogram Enf Enflurane ET End tidal etCO2 End tidal CO2 A patient s carbon dioxide level measured at end expiration Hal Halothane HR Heart rate Number of heartbeats per minute ICP Intracranial pressure label for invasive blood pressure IBP Invasive Blo...

Page 285: ...um Alveolar Concentration N2O Nitrous oxide NIBP Non invasive Blood Pressure O2 Oxygen PA Pulmonary artery label for invasive blood pressure PVC Premature Ventricular Contractions RA Right Atrium label for invasive blood pressure Sev Sevoflurane SpO2 Oxygen Saturation ST ST segment value indicating the condition of myocardial ischemia UA Umbilical Artery label for invasive blood pressure 0 ...

Page 286: ...This page intentionally left blank ...

Page 287: ...0070 00 0704 02 Rev 13 0 March 2015 ...

Page 288: ...bridgeshire PE29 6SZ United Kingdom Tel 01480 416840 Fax 01480 436588 Mindray Medical France SARL Europarc Créteil 123 Chemin des Bassins 94035 Créteil Cedex France Tel 0 1 45 13 91 50 Fax 0 1 45 13 91 51 Mindray Medical Germany GmbH Zwischen den Bächen 4 64625 Bensheim Deutschland Tel 49 6251 17524 0 Fax 49 6251 17524 20 Mindray Medical International Ltd 2813 Office Tower Convention Plaza No 1 Ha...

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