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St. Jude Medical QUANTIEN, Instructions For Use Manual

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St. Jude Medical QUANTIEN Instructions For Use Manual Download Page 89

 

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the costs of replacing or repairing the goods. 
EXCEPT FOR MANDATORY TERMS IMPLIED BY LAW, MANDATORY CONSUMER 
GUARANTEES, OR AS EXPRESSLY PROVIDED IN THIS WARRANTY, ST. JUDE MEDICAL 
DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. 
See the Terms and Conditions of Sale for further information. 
 

State: Released

  

Date: 2019.03.06 22:30 GMT

Summary of Contents for QUANTIEN

Page 1: ...QUANTIEN Measurement System Diagnostic Computer C12787 Instructions for Use State Released Date 2019 03 06 22 30 GMT ...

Page 2: ...at the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical LLC and its related companies Pat http patents sjm com 2019 St Jude Medical LLC All Rights Reserved State Released Date 2019 03 06 22 30 GMT ...

Page 3: ...er Wireless AO Source 12 Install Wi Box AO Transmitter 13 Unpack QUANTIEN Measurement System 13 Mount QUANTIEN Main Unit in the Cath Lab 14 Room Configuration 16 Measure FFR or RFR 17 Warnings and Precautions 17 Live Window 18 FFR RFR Measurement Procedure 19 Review Recordings 25 Review Window 25 Study Summary 26 Review Recording 26 Export Data 28 Review Archived Studies 30 Archive Window 30 Expor...

Page 4: ...Leakage Adapters 75 Service or Repair 75 Technical Specifications 75 Pressure Measurement 75 Electrical Specifications 75 Specifications Interfaces 75 Dimensions 77 Environmental Conditions 77 Isolation Diagram 78 File Formats 79 Compliance with Regulatory Requirements 79 Compliance with Standards and Directives 79 Guidance and Manufacturer s Declaration Electromagnetic Emissions 80 Guidance and M...

Page 5: ...rding this information could result in injury CAUTION These instructions point out special service procedures or precautions that you must follow to avoid damaging the device Note This provides information you might find especially useful or information that facilitates maintenance or clarifies important instructions The following abbreviations and terms are used in this IFU Table 1 Abbreviations ...

Page 6: ... cycle where the Pd Pa ratio is minimal RFR is designed to be used at rest and in contrast to Pd Pa at rest is a sub cycle metric These physiological parameters are measured when the QUANTIEN measurement system is used with the manufacturer s distal intracoronary pressure transducer and a proximal aortic pressure transducer The physician may use the FFR Pd Pa at rest and RFR parameters along with ...

Page 7: ...te and display various physiological parameters based on the output from one or more electrodes transducers or measuring devices Contraindications The device has no patient alarm functions Do not use it for cardiac monitoring Users Normal operation The QUANTIEN measurement system should be handled by or supervised by a physician with training in catheterization laboratory procedures Preventative m...

Page 8: ...N PressureWire IN on PressureWire interface Pd signal from PressureWire guidewire white sleeve Connection to applied part 7 AUX IN 1 AO signal from cath lab recording system yellow sleeve 8 AUX IN 2 ECG signal from HRS black sleeve 9 AUX OUT 1 Pa Pd or reference signal output grey sleeve 10 AUX OUT 2 Pa Pd or reference signal output grey sleeve 11 N A Heat sink and connection block for mounting br...

Page 9: ...n Follow instructions for use Symbol appears blue on product labeling Affixed to this device in accordance with European Council Directives 2002 96 EC and 2006 66 EC These directives call for separate collection and disposal of electrical and electronic equipment Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal dis...

Page 10: ...onformity affixed according to the relevant provisions of MD directives 93 42 EEC and 2011 65 EU and RE directive 2014 53 EU Annex II Hereby St Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives The full text of the European Union RE directive 2014 53 EU declaration of conformity is available at the following internet a...

Page 11: ... value is always highlighted 2 OK Enter Confirm the selection of a menu button or function or confirm entered values 3 AO Open the Pa drop down menu in Live window allow zero of the AO pressure 4 PW Open the Pd drop down menu in Live window allow zero of the PressureWire guidewire 5 Live Main function key start stop recording go directly to Live window 6 EQUALIZE Equalize AO and Pd pressures 7 MAR...

Page 12: ...c for each system Service kit Used when testing leakage current and PW IN OUT on the QUANTIEN measurement system Also used for testing AO IN OUT on the Wi Box AO transmitter AUX Out cable Optional For export of Pa or Pd analog signal to an external measuring instrument Table 4 Devices and Accessories from Other Suppliers Device Comments Aortic pressure AO transducer Required Transducer shall compl...

Page 13: ...t sterilize the QUANTIEN measurement system or any of its parts Do not use this system or any of its parts if it has been sterilized The QUANTIEN measurement system contains a lithium battery for the system real time clock Danger of explosion Battery is not intended to be replaced Do not leave the QUANTIEN measurement system unattended when logged in as a Site Administrator To protect the privacy ...

Page 14: ...nteractions are performed directly on the touch screen or by using the remote control limited options Surgical gloves or plastic cover protection do not affect the touch screen functionality The graphical interface is dynamic and will change appearance depending on the selected menu measurement mode or current state of the instrument To change the user interface language see Regional Settings page...

Page 15: ...pen menu currently selected 4 Menu Tree 5 Main Menu bar Setup Installation and setup Patient Enter New Patient Live Real time FFR measurement Review Review recordings on active patient Archive Recording archive 6 Live main function button Go direct to Live window Start Stop recording or other functions depending on active window NOTE Some features may not be available for all users Refer to User S...

Page 16: ...eWire guidewire connection indicator A signal beep will be heard when PressureWire guidewire signal is connected to QUANTIEN measurement system Basic Setup Using Wi Box AO Transmitter Wireless AO Source An FFR or RFR procedure requires a proximal pressure Pa signal from an AO transducer and a distal pressure Pd signal from a PressureWire guidewire This chapter describes the basic configuration of ...

Page 17: ...he AO pressure transducer signal is connected to the Wi Box AO transmitter and then passed through unaffected to the HRS The Wi Box AO transmitter transmits the AO pressure wirelessly to the QUANTIEN measurement system or other St Jude Medical FFR measurement systems NOTE Reference the IFU for the Wi Box AO transmitter for complete installation instructions and safety information Unpack QUANTIEN M...

Page 18: ...dings of data Contact St Jude Medical representatives or technical support for further instructions Do not use the QUANTIEN measurement system if there is reason to believe the system s security has been compromised or if the system was unaccounted for a period of time i e misappropriated modified or tampered with To protect the privacy and security of sensitive information including electronic pr...

Page 19: ...owing the instructions provided with the bracket 2 Mount the QUANTIEN main unit in the desired place in the cath lab Do not tilt the main unit backward more than a maximum of 45º from the vertical line Do not mount the main unit tilted forward to prevent risk of ingress of liquids such as IV infusion etc WARNING Do not use QUANTIEN measurement system if it has been exposed to liquids when NOT moun...

Page 20: ...l always perform a normal start up Shutting Down Press the switch on the bottom panel to OFF to shut down CAUTION The power switch will shut down the QUANTIEN measurement system but there is still power in the mains cable and power supply unit To fully disconnect from mains power remove the mains power plug from the wall socket Room Configuration After logging into the QUANTIEN measurement system ...

Page 21: ...cal support for further instructions Do not use the QUANTIEN measurement system if there is reason to believe the system s security has been compromised or if the system was unaccounted for a period of time i e misappropriated modified or tampered with The operator should not touch QUANTIEN measurement system non CF connectors or other non medical equipment and the patient or patient leads at the ...

Page 22: ...art rate 4 Main graph Pa Pd phasic and average pressure traces Optional ECG signal trace import would appear in the top area of the graph 5 Trend graph or FFR RFR graph 6 Pa button Pa average systolic diastolic values touch for drop down menu 7 Pd button Pd average systolic diastolic values touch for drop down menu 8 Equalize touch for drop down menu 9 Index value 10 Study summary Summary list of ...

Page 23: ...all users Refer to User Settings for more information page 35 Depending on the step in the procedure additional buttons fields may appear AO source not available or not selected red frame Time equalize function failed or is turned off and may affect the accuracy of the calculated index yellow Color Coding Red represents the Pa measurement on the screen However a red frame around any of the boxes o...

Page 24: ...er logging into the system Select the room to be used by touching the corresponding Room button NOTE If the room has been set as default this screen will not be displayed For detailed instructions refer to Room Setup page 32 Select or Create New Patient After room selection the Patient window is displayed There are three optional ways to create or select a patient for the new study 1 Create new pa...

Page 25: ...changes to Zero OK close the transducer manifold open to patient Figure 7 Zeroing the Pa Connect the PressureWire Guidewire 1 Unpack PressureWire guidewire using regular sterile routine Leave the PressureWire guidewire in the packaging coil Place the packaging coil flat on the table Figure 8 Preparing the PressureWire Guidewire 1 Flush the packaging coil with saline solution through the luer conne...

Page 26: ...ssures 1 Insert the PressureWire guidewire in the guiding catheter and advance it until the sensor element of the PressureWire guidewire is just outside the tip of the guiding catheter Figure 10 Advance PressureWire Guidewire 2 Make sure the AO transducer is positioned at the same height as the patient s heart Press Equalize and again press Equalize on the drop down button or using preparation scr...

Page 27: ...press the Mark button 6 Press the Stop button main function button The recording is automatically saved and the Review window is opened RFR Pullback The system is now ready to measure RFR 1 Advance the PressureWire guidewire distal of the lesion 2 Press Pullback on the main function button to start recording 3 Record the region of interest 4 To place a marker in the recording at any time press the...

Page 28: ... Figure 12 Location of Camera Icon The measurement window will change to a status bar to count the next five heartbeats NOTE The cancel button is active to exit the snapshot progress Figure 13 Status Bar After the snapshot recording the recording is automatically saved and the review window is opened State Released Date 2019 03 06 22 30 GMT ...

Page 29: ...during recording or review 3 Index value box Indicates the index value at the cursor position 4 Study Summary button Summary list of recordings in study Press to open Study list indicates additional recordings Yellow for FFR recordings Blue for RFR pullbacks 5 Main function button Return to Live window 6 Annotation bar Open Annotation window 7 Recording number indicator in Review mode with time fi...

Page 30: ...list Delete button Delete recording Only visible in Study list Study Summary Figure 15 Study Summary Box 1 Time stamp 2 Type of study 3 Index value 4 Vessel NOTE PBK indicates a RFR pullback recording Review Recording The Review window displays the recording with a primary cursor line colored indicating the index value An additional secondary cursor in white can be added The primary cursor is auto...

Page 31: ...is displayed on top Touch the Study Summary button to expand a list of all the recordings in the study Select the recording of interest for review delete or export it using the Delete or Export buttons see Export Data page 28 Press the Live button to return to the Live window to perform a new measurement for the same patient or select a new patient to start a new study RFR FFR Hybrid Method Result...

Page 32: ...ts 50 8 219 431 46 0 55 6 54 3 234 431 49 5 59 1 Export Data NOTE Patient information will not be encrypted Data export is managed from the Review window or from the Archive window In the Review window use the Study Summary button to open the list of recordings Select the recording of interest and press the Export button The Export dialogue window will appear see figure below Using the Export butt...

Page 33: ...ent system internal raw data format Compatible with RadiView PC software requires activated compatibility mode 5 Spreadsheet Raw data in tab delimited text file txt Compatible with standard spreadsheet software such as MS Excel3 6 Picture The QUANTIEN screen as standard picture PNG 7 Export All Recordings in Study Check this box to export all recordings in study to the selected destination and in ...

Page 34: ...e for that patient at a later date a new study will be created An unnamed default patient without recordings will automatically be deleted at instrument restart Archive Window The Archive window has two appearances List of Studies and List of Study Recordings The List of Studies window is shown in the upper half of the figure below The list can be sorted by any heading the heading marked with an a...

Page 35: ...llow Export and Delete Files in Archive Open recording for review Press Right Arrow button Delete recording Press Delete button bin Export recording Press Export button see Export Data page 28 Use the New Study button to start a new study for the current patient Free up Storage Space The QUANTIEN measurement system is not intended for long term archiving The Storage Space box in the archive window...

Page 36: ... 16 System Settings Menus and Submenus Display System Service Sweep speed ECG Pressure Trend graph Brightness Video output Other Info Network DICOM Export Regional Security Other Barometer compensation Upgrade Save Setup changes Calibrate screen Export log files Time equalize Room Setup The QUANTIEN measurement system handles different room configurations in the Select Room window This window is d...

Page 37: ...ntification name of the room or Not Set Wi Box number The Wi Box AO transmitter within radio range of the QUANTIEN measurement system ID number of Wi Box device AUX IN 1 Room configured for AO pressure via cable A Wi Box AO transmitter transmitting blue symbol The number of blue lines indicates the signal quality No radio contact with a Wi Box AO transmitter red cross Room lock Room set as default...

Page 38: ...ion number matches the number printed on the Wi Box unit in the current room Touch the AO button to select cabled analog input AO source Refer to Connect AO Via Analog Input AUX IN 1 page 38 for configuration of analog input as source for AO pressure Optional Select the AUX button to configure analog input output channels In 2 Import ECG signal see Connect ECG Via Analog Input AUX IN 2 page 40 Out...

Page 39: ... format is changed no restart is required NOTE A correct time zone time and date are important since all recordings are labeled using current time and date This is especially important if setup includes communication with DICOM User Settings The QUANTIEN measurement system has four types of Users who can access the system 1 Site administrator Site Admin for short The site administrators can a Add ...

Page 40: ... a user to Site Admin 1 Select Users from the Setup menu 2 Select the User from the User screen 3 Touch the Promote User button To demote a Site Admin to a user 1 Select Users from the Setup menu 2 Select the User from the User screen 3 Touch the Demote User button To change a user s password 1 Select Users from the Setup menu 2 Select the User from the User screen 3 Touch the Change Password butt...

Page 41: ... Any person who connects external equipment to signal output or other connectors has formed a system and is therefore responsible for compliance of the system with these requirements If in doubt contact a qualified technician or alternatively a St Jude Medical representative technical support No modification of this equipment is allowed Do not open or remove access covers on the QUANTIEN measureme...

Page 42: ...d AUX IN 1 Product Interface and Symbols page 3 on the QUANTIEN main unit The cable used must be compatible with the specific HRS Setup Setup is performed in Select Room New Room Edit Room AO AUX 1 Zero and Calibrate Before an FFR measurement is performed the AO signal must be zeroed and calibrated After selecting the AO button and selecting AUX 1 in the list of AO sources see figure below you wil...

Page 43: ... the analog output port on the HRS is fixed at 100 mmHg V the nominal sensitivity can be used Check the checkbox Use Nominal Sensitivity Custom Calibration For all other system setup or if there is uncertainty regarding the nominal sensitivity an arbitrary reference level from the HRS may be used to calibrate the AO pressure input port Enter the reference level used from the HRS in the field Refer...

Page 44: ...ernatively IEC 60601 1 ed 3 16 ME SYSTEMS Connection To display Pd pressure on a HRS connect a monitor cable from PressureWire OUT Product Interface and Symbols page 3 to a free input port on the HRS Configuration To ensure equal pressure readings on the HRS and the QUANTIEN measurement system the associated input port must be zeroed Zero the associated input port after PressureWire guidewire has ...

Page 45: ...compromise electrical isolation and cause patient injury It is not allowed to electrically connect the USB device to other devices Network Configuration Configure General Network Settings WARNING The ethernet patch cable with isolation box must be used to assure proper isolation as the ethernet outlet is not isolated The short patch cable shall be positioned between the isolation box and the main ...

Page 46: ...etwork path to which the QUANTIEN measurement system will export data either manually or automatically Requires a functional network connection Annotation server name folder X folder Y If backslash is used instead of slash the system will automatically change them Export path Network pathway User name Network user name with read write access rights Password Network user password Press the Verify b...

Page 47: ...tup Menu System DICOM Worklist SCU Setting made here configures the network settings of the QUANTIEN measurement system enabling it to access the DICOM worklist from the remote host NOTE Time and time zone have to be correct set for retrieval of worklist from DICOM server All network and DICOM settings are case sensitive The following information is required Local AE Title Name of the QUANTIEN mea...

Page 48: ...information is required Local AE Title Remote AE Title Remote Host Hostname IP Address Remote Port Number Modality Select either XA or OT Modality Press the Verify button to apply settings and verify that the connection works Institution Name If required a specific Institution name can be configured in Setup Menu System Info Institution The Institution name will be included in the file information...

Page 49: ...essure disturbances CAUTION An insensitive or overly sensitive averaging of pressure may result in an incorrect FFR value Scale Pressure waveform vertical scale Select 20 80 0 100 0 150 0 200 0 200 80 320 mmHg Factory setting 0 150 mmHg Display Max Min in Review Enable indicators for minimum and maximum diastolic systolic pressure indicators in Review mode Trend Graph Display Trend Graph Turn on o...

Page 50: ...ide the circle and keep finger in place until the circle is filled completely and a beep sounds 3 A circle will appear at the next junction touch inside the circle and wait for the sound signal 4 Continue touching inside each circle that appears in the same way 5 When no more circles appear the screen is recalibrated and the calibration window will close after a short delay Time Equalize Turn time...

Page 51: ...ox AO transmitter page 50 AO Source AUX IN page 51 PW Source PressureWire Wireless guidewire page 51 PW Source PressureWire Cable Connection guidewire page 52 Table 19 System on screen messages Typ e Current Message Reason Action Cancel OK E Failed to connect to DICOM peer Request or query for DICOM worklist failed i e no response from remote host Check settings Check network connection Check remo...

Page 52: ... No Changes the PressureWire guidewire but keeps the current patient W A patient is registered Do you wish to proceed anyway Entering demo mode with an active patient Select Cancel or OK Cancel operation and close window Continue to enter demo mode close window E Failed to load recording header File is missing or corrupt Header file is missing or corrupt e g with checksum error Contact St Jude Med...

Page 53: ...rk with new settings Network not available or network settings not correct Check network settings Check network connection N A Confirm and close window I No response on echo request Failed to verify settings for DICOM SCU Check settings N A Confirm and close window I No response on echo request Failed to verify settings for DICOM export Check settings N A Confirm and close window I Failed to write...

Page 54: ...application failed to upgrade one or several devices The instrument will not function until an upgrade process has been completed Switch the instrument off and on again to retry Upgrade failed Turn off the instrument Contact St Jude Medical N A N A E The main application binary has an invalid checksum It has been damaged or corrupted Please reinstall the system Main Application corrupt Turn off th...

Page 55: ...O USB missing AO USB reports error Restart System Contact St Jude Medical E Red frame Pa Zero failed Pressure transducer not open to air when zeroing Zeroing offset out of range Prepare for zeroing Zero Table 21 AO Source AUX IN Type Current Message on Pa button Event Action E Red frame Pa Interface Error AUX missing AUX reports error Restart System Contact St Jude Medical E Red frame Pa Zero Fail...

Page 56: ...away from the system E Red frame Pd Signal Lost Communication with the PressureWire guidewire broken interrupted The PressureWire wireless guidewire turned off Turn the PressureWire guidewire on Remove reason for interruption breakage of communication E Red frame Pd Interface Error The PressureWire interface missing The PressureWire interface reports error Restart System Contact St Jude Medical E ...

Page 57: ...The PressureWire cable connection guidewire not positioned correctly e g inserted in the blood flow Ensure the PressureWire cable connection guidewire is correctly prepared and positioned Try to zero again Tracing EM Interference The QUANTIEN measurement system uses digital signal processing techniques that operate in the radio frequency RF energy range The system is therefore susceptible to inter...

Page 58: ...les or other medical equipment away from the system can reduce electromagnetic interference Please answer these questions before contacting your service representative The answers will help a service representative determine if the problem is in the system or in the imaging environment State Released Date 2019 03 06 22 30 GMT ...

Page 59: ...W checks are made Internal failure N A N A Contact St Jude Medical The system stops and indicates HW error in PW Failure in connection to the PressureWire interface unit Cable connection to the PressureWire interface Unit Cable without damage and connected correctly Contact St Jude Medical Internal failure in the PressureWire interface unit N A N A Contact St Jude Medical The system stops and indi...

Page 60: ...rective action Wi Box AO transmitter not possible to select for a room Wi Box unit not powered on or internal failure in Wi Box unit Check LED s of Wi Box AO transmitter Refer to IFU for the Wi Box AO transmitter Refer to IFU for the Wi Box AO transmitter Internal failure of AO part in QUANTIEN main unit Check HW status of AO after self test at power on of QUANTIEN main unit AO status OK Contact S...

Page 61: ... the QUANTIEN measurement system AO status OK Contact St Jude Medical Transducer not connected properly to the Wi Box AO transmitter Connections of monitor cable interface cable and transducer Properly connected Correct the failing connection Defective transducer or transducer interface cable Functioning of transducer and transducer interface cable with a HRS Normal transducer function Replace the...

Page 62: ...vel Refer to IFU for the HRS on how to correct pressure output signal Mismatch between selected calibration level and applied pressure signal from HRS Compare selected calibration level and applied pressure signal from HRS Pressure signal close to selected calibration level Select correct calibration level Unable to zero Pa pressure Varying pressure Check that AO transducer manifold is opened to a...

Page 63: ...gnal Refer to IFU for the HRS on how to correct pressure output signal Table 28 Distal pressure signal on QUANTIEN measurement system when acquired via PW IN Erroneous function Possible cause Check Normal function Corrective action Connection of sensor fail or unable to zero Pd pressure Defective PressureWire guidewire See IFU for the PressureWire guidewire for additional information N A N A Failu...

Page 64: ...IN according to Testing PW IN page 70 Test of PW IN passed without failure Contact St Jude Medical The PressureWire guidewire not correctly connected E g connector not dry connector not fully inserted or connector damaged Connections of the proximal connector and PW interface unit connector Properly connected Correct the failing connection Table 29 Distal pressure signal on QUANTIEN measurement sy...

Page 65: ...de Medical Movement of the PressureWire guidewire causes disturbance to the signal when connecting See Preparations for use in the PressureWire guidewire IFU N A Follow the instruction for preparations The PressureWire guidewire is inserted in patient Position of the PressureWire guidewire The PressureWire guidewire is outside of patient Remove the PressureWire guidewire from patient Unable to zer...

Page 66: ...eading of Pd pressure Defective PressureWire guidewire See IFU for the PressureWire guidewire for additional information N A N A Failure in the PressureWire interface unit Test with another wireless PressureWire guidewire Pressure reading of Pd pressure successful Contact St Jude Medical Table 30 ECG signal on QUANTIEN measurement system Erroneous function Possible cause Check Normal function Corr...

Page 67: ...cable compatibility with the present HRS HRS listed on the actual monitor cable Replace with a correct monitor cable Defective monitor cable Visually check the monitor cable Strain relief intact no other damage Replace the monitor cable Defective PW OUT Test PW OUT according to Testing PW Out page 71 Test of PW OUT passed without failure Contact St Jude Medical Defective HRS input channel Test PW ...

Page 68: ... according to Testing AUX OUT 1 2 page 73 Test of AUX OUT passed without failure Contact manufacturer of the HRS AUX OUT not configured correctly Configuration of AUX OUT in Room Setup AUX OUT configured correctly Edit Room Setup and correct AUX OUT configuration Table 33 DICOM worklist function Erroneous function Possible cause Check Normal function Corrective action No worklist received Network ...

Page 69: ... Exchange broken network cables and components Error in network configuration Network configuration in System menu N A Correct network configuration Error in network path Network path system menu Export N A Correct network path File server error Status of file server File server is functional Correct error in file server USB memory export fail No USB stick inserted USB memory stick USB memory stic...

Page 70: ...A Set flag for export in compatibility mode Table 35 External display function Erroneous function Possible cause Check Normal function Corrective action Disturbances or no QUANTIEN display viewed on external monitor Video OUT DVI I not properly connected to external monitor input or bad contact in cable connectors Connection of DVI cable Stress the actual connection mechanically QUANTIEN display v...

Page 71: ... zeroed and functional Correct errors and or perform zeroing of Pa and Pd Too large difference between Pa and Pd Difference between average of Pa and Pd Difference between average of Pa and Pd is less than 30 mmHg Reposition AO transducer and perform a re zeroing of Pa Re zeroing of Pd has been performed when using the wireless PressureWire guidewire N A N A Re initialize the wireless PressureWire...

Page 72: ...with a moist tissue using regular cleaning agents or if necessary alcohol and wipe dry 3 Reconnect the main power cable 4 Press ON OFF switch to ON WARNING Make sure that every part of the unit is dry before reconnecting to the power supply Do not use the QUANTIEN measurement system if liquid is suspected to have penetrated the enclosure or the power supply unit This can cause the user or patient ...

Page 73: ...om Preparation Connect the leakage current adapters to their respective connector on the QUANTIEN measurement system Turn on the QUANTIEN measurement system before starting this control To perform leakage current measurements proceed as follows 1 Connect the applicable leakage current adapters to the leakage current instrument for each test that will be performed The figure below depicts which iso...

Page 74: ...rrent PW OUT OS 50 Patient leakage current PW OUT OSRM 50 Mains on applied part PW IN MA 50 Mains on applied part PW IN MARM 50 Mains on applied part PW OUT MA 50 Mains on applied part PW OUT MARM 50 NC Normal Condition NCRM Normal Condition Reversed Mains OS Open mains Source OSRM Open mains Source Reversed Mains MA Mains on Applied Part MARM Mains on Applied Part Reversed Mains Testing PW IN Too...

Page 75: ...n 293 297 Testing PW OUT and Associated Monitor Channel Tools needed Monitor cable for PW OUT HRS Service report form can be downloaded from sjmprofessional com Preparation Switch on QUANTIEN measurement system at least 10 minutes before starting this test Connect the monitor cable from PW OUT to the associated Pd input channel on the HRS To test the PW OUT proceed as follows 1 Restart QUANTIEN me...

Page 76: ... HRS e g by applying 0 mmHg pressure from a pressure simulator to the HRS and perform a zeroing in the HRS 5 Perform a zeroing of Pa in QUANTIEN measurement system 6 Check that zeroing of Pa is successful and that 0 mmHg is displayed as Pa numerical value and curve In case the zeroing results in an unstable zero or non zero value a second attempt may be necessary 7 Apply reference a signal from th...

Page 77: ... test in the service report Testing AUX OUT 1 2 and Associated Monitor Channel Tools needed AUX OUT cable A measuring device like a multimeter Service report form can be downloaded from sjmprofessional com Preparation Switch on QUANTIEN measurement system at least 10 minutes before starting this test Connect the AUX OUT cable from AUX OUT 1 to a measuring device To test the AUX OUT proceed as foll...

Page 78: ...erating Conditions Operating temperature 15 C to 30 C 59 F to 86 F max 1 C temperature change during calibration control Operating relative humidity 30 75 Transport and storage temperature 40 C to 70 C Transport and storage relative humidity 10 to 100 Cleaning Clean the control probes with a moist tissue using a mild detergent Do not use alcohol based solutions Table 42 Specifications PW Control P...

Page 79: ...m s security could be compromised Technical Specifications Pressure Measurement Table 43 Pressure Measurement Pressure range 30 to 300 mmHg Accuracy PressureWire guidewire6 1 mmHg plus 1 of reading over the pressure range 30 to 50 mmHg 3 of reading over the range 50 to 300 mmHg AUX IN 1 AO 1 mmHg or 0 5 whichever is greater Frequency response 0 25 Hz Resolution 0 2 mmHg Electrical Specifications T...

Page 80: ...ype A Receptacle Ethernet 10 100 Mbit s Connector RJ45 DVI Screen resolution of QUANTIEN main unit 1280x800 Output resolutions DVI out Auto Frequency 60 Hz Connector DVI I Integrated digital and analog Connect with a standard VGA cable and DVI to VGA adapter analog signal Connect with a DVI to VGA cable analog signal Connect with a DVI D cable digital signal Connect with a DVI to HDMI cable digita...

Page 81: ...ntal conditions Operating temperature 15 C to 35 C 59 F to 95 F Operating relative humidity 30 75 Operating ambient pressure 525 795 mmHg 700 1060 mbar Transport and storage temperature 20 C to 70 C 4 F to 158 F Transport and storage relative humidity 10 95 Transport and storage ambient pressure 375 795 mmHg 500 1060 mbar State Released Date 2019 03 06 22 30 GMT ...

Page 82: ...PSU 2 Main Unit 3 Plastic Enclosures 4 Touch Screen Display 5 Metal Enclosure Table 47 Isolation Data Isolation Insulation Type Maximum Working Voltage V A 1 MOP 240 VAC B 2 MOOP Uw C 1 MOOP 240 VAC 12 VDC D 2 MOOP 12 VDC State Released Date 2019 03 06 22 30 GMT ...

Page 83: ...al point Pd Pa N A decimal point Heart rate bpm ECG mV DICOM See DICOM Conformance Statement at sjmprofessional com Compliance with Regulatory Requirements Compliance with Standards and Directives St Jude Medical hereby declares that the QUANTIEN measurement system is in compliance with the essential requirements and other relevant provisions of the Medical Device Directive EC Directive 93 42 EEC ...

Page 84: ...C22 2 No 601 1 M90 60601 series Ed 3 the following IEC 60601 1 IEC 60601 1 2 IEC 60601 1 6 IEC 60601 1 9 IEC 60601 2 34 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 08 IEC 62304 IEC 62366 ANSI AAMI BP 22 ASTM D4169 ISO 15223 1 EN 1041 Guidance and Manufacturer s Declaration Electromagnetic Emissions The QUANTIEN measurement system is intended for use in the electromagnetic environment specifi...

Page 85: ...evel Electromagnetic Environment Guidance Electrostatic discharge ESD 7 IEC 61000 4 2 6 kV contact 8 kV air Complies Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Complies Mains power quality should be that ...

Page 86: ... the equation applicable to the frequency of the transmitter Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3V d 1 17 P Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 1 17 P 80 MHz to 800 MHz d 2 33 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in m...

Page 87: ...aration Distances Between Portable and Mobile RF Communications Equipment and QUANTIEN System The QUANTIEN measurement system is intended for use in the electromagnetic environment where radiated RF disturbances are controlled The customer or the user of this system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipme...

Page 88: ... information for either the manufacturer or Australian Sponsor located on the back cover Our goods come with guarantees that cannot be excluded under the Australian Consumer Law You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage You are also entitled to have the goods repaired or replaced if the goods fail to be of a...

Page 89: ... IMPLIED BY LAW MANDATORY CONSUMER GUARANTEES OR AS EXPRESSLY PROVIDED IN THIS WARRANTY ST JUDE MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND EXPRESS OR IMPLIED See the Terms and Conditions of Sale for further information State Released Date 2019 03 06 22 30 GMT ...

Page 90: ...State Released Date 2019 03 06 22 30 GMT ...

Page 91: ...State Released Date 2019 03 06 22 30 GMT ...

Page 92: ...1 756 5833 St Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 St Jude Medical Australia Pty Limited 17 Orion Road Lane Cove NSW 2066 Australia sjm com 2019 02 ARTEN600064528 A State Released Date 2019 03 06 22 30 GMT ...

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