MEDISTIM VQ1001, User Manual

Page 1: ...MEDISTIM VeriQ SYSTEM USER MANUAL Mod VQ4122 VQ2111 VQ1111 VQ4001 VQ2011 VQ1011 VQ1001 ...

Page 2: ...on 11 5 5 Tasks during procedure by operator 11 5 5 1 Doppler measurements 11 5 5 2 Performing vessel search 12 5 5 3 Detect position and quantify a stenosis 12 5 5 4 Transit time flow measurements 12 5 5 5 Optimizing the Doppler and flow display 12 5 5 6 Saving Measurements 13 5 5 7 Memory scroll and trace review 13 5 5 8 Review of recorded data 13 5 6 Tasks during operation by surgeon 14 5 6 1 D...

Page 3: ...age to personnel devices and the operating environment can occur The man ufacturer cannot be held liable for injury or damage if these precautions are disregarded Note A Note contains important tips recommendations and sup plementary information intended to optimize the use of the system 1 4 2 User Manual language options The User Manual is upon request available in English French Spanish Swedish ...

Page 4: ... measure blood volume flow or velocities prior to performing the surgical intervention Manipulation of vessels with thrombus calcification or other conditions may have serious consequences for the patient and represents a contraindication for the Measurement of blood flow Sound medical judgment should therefore be exercised and the final responsibility for measuring flows in diseased vessels lies ...

Page 5: ...iathermy interferes with the measurements and can make them unreliable 2 9 Consumables Necessary consumable items to perform an operation Various probes Sterile Ultrasound couplant Ink cartridges for color printer Printer paper 2 10 Access to spare parts and service Please contact your local representative to request VeriQ service or spare parts Refer to our website www medistim com for a list of ...

Page 6: ... VeriQ system has 2 USB 2 0 ports located on the left side of the front panel for connecting external equipment like a memory stick to import or export data Warning The front panel USB connector has no galvanic separation In order to maintain continued patient safety no equipment powered by an external power source must be connected to the USB port during clinical use of the system 3 2 Principle o...

Page 7: ...ence will take approximately 35 seconds before the system is ready for use 4 5 Initial configuration Start the VeriQ and select the system settings screen The system setup menu is accessed by pressing the System settings icon in the top left of the screen Software version The software version currently installed on the system can be identified by opening the System Information page located on the ...

Page 8: ...ing the calibration menu and selecting the appropriate saved profile 4 6 2 Calibrating the AUX channel for pressure Turn on the system and insert the cable from the signal mon itor For calibration a simulator that emits known signals can be used Select the Live session screen and the auxiliary curve window will appear Depending on the signal strength the monitored curve may be visible straight awa...

Page 9: ...creen for flow measure ments and can be accessed by pressing the Measure screen tab or by pressing OK on the patient data screen Systems installed based on a pay per procedure model must be activated by using a smart card On screen prompts will assist in system activation and when a smart card has not been inserted into the system the message Insert valid smart card to activate will be shown in th...

Page 10: ...ar 4 Single use Imaging Add On 5 Single use flow Imaging 6 Time Limited full function transit time and Doppler 7 Time Limited flow Imaging The single use licenses are disposable and require that a new card be used for every new procedure The time limited licenses opens the given functionality for a period of time At the first use the current time is registered in the card and the countdown timer s...

Page 11: ...ction will be displayed under current graft directly above the OK button To finish press OK 4 to select or can cel to go back to the measurement without doing the change selection When generating a report or reviewing the case at a later time the vessel name will be important Note The source may be omitted when obvious and is primarily intended for sequential grafts The top five most commonly used...

Page 12: ...also need to be changed when the probe is on a narrow stenosis causing the peak velocity to increase by four times As soon as a stable measurement is reached or whenever the surgeon says so save the measurement by pressing the Save button 5 5 4 Transit time flow measurements The VeriQ displays the flow curve at a defaulted 5 seconds sweep rate upon probe connection Look for a green Acous tical Con...

Page 13: ...Archive screen or Paused mode when editing curves 5 5 8 Review of recorded data All stored measurement data can be reviewed A thumbnail of each stored data set is presented on the screen and the number of thumbnails visible on a single page can be adjust ed System settings description 1 Press the Data screen tab 1 to enter the explorer screen 2 Use the scroll bar 2 to view any thumbnails may not b...

Page 14: ...he vessel or using a different probe size If there is a gap between the vessel wall and the probe surface the probe is too large and a smaller probe should be used If parts of the vessel are squeezed out of the probe the probe is too small and a larger probe should be used To ensure accurate flow measurement it is important that the probe is placed perpendicular to a straight segment of the measur...

Page 15: ...icating that they are selected for reporting The report can either be printed directly by pressing the Print report button or stored as a PDF file locally or on a remov able USB stick The report layout can be changed in the Report layout pop up Measurements that have been reported will be flagged with a green check mark and the text Qualified These Qualified measurements should not be changed as t...

Page 16: ...re and sound velocity settings Measure and Analyze index selection and ACI Flow wizard Displays standard flow curves when commonly used vessel names are chosen Invert If the flow curves goes below the baseline pressing this button will invert the curve Export report Selected measurements are exported to an external memory device in PDF format Print All selected measurements will be printed Delete ...

Page 17: ...selecting desired number of curves per page in the patient report 5 Probe report indicates the usage status of each probe being used on the system 6 The manage projects setting allows creating projects names for sub groups of patients 7 The advanced system functionality setting allows for management of patient database and other rarely used system operations There are 4 pull down menus 1 System pr...

Page 18: ...fault the system measures all velocities at depths between 2 mm and 8 mm The field of measurement and the sample volume can be changed To change sample volume 1 Press the button 3 in the Doppler display to in crease the sample volume 2 Press the button 4 in the Doppler display to de crease the sample volume 3 To increase or decrease depth press the top or bot tom of the scale respectively As shown...

Page 19: ...e flow curve backwards dragging the baseline up or down changing the scale of the measurements or editing the ves sel name The scale and the position of the baseline cannot be changed on Doppler measurements Move between the selected measurements by pressing the arrows visible at the bottom of the screen To store the edited curves press the Save button The old measurement will then be overwritten ...

Page 20: ...he desired flow and pressure probes and press the button Derived curves Choose the desired calculations of traces and press OK 5 12 1 Fast Fourier Transformation FFT Included in the M A software is a capability of doing Fourier analysis frequency analysis The analysis can be performed on all flow pressure and AUX curves including derived curves By using this capability it is possible to analyze th...

Page 21: ...nts e g injection of medication can be reviewed Pressing Save will make the screen Event description appear Fill in a description of the event and press Done Repeat this until all the events are saved and the desired sweep time The trend measurement is automatically saved every minute and is stored as a whole after logging To review or edit the trend curves go to the Archive screen Select the meas...

Page 22: ...oving the cursors C1 and C2 the corresponding values are updated The values shown for all the indexes except for C1 and C2 are based on the interval between the two cursors For in stance the Max index displays the highest value measured in the interval between the cursors ...

Page 23: ...ERATION System does not start when pressing power button System not connected to mains Check that power plug is properly connected to a pow ered grounded outlet CONNECTING PROBES Probes Aux or Pressure contacts cannot be inserted into port Pinhole s of port obstructed Use other port if available Report to technician Until resolved block failing port with tape Flow Doppler Probe not detected when i...

Page 24: ...l currently selected probes from the list The deleted probes may still be listed by using the Deleted probes filter The Print selected button prints a probe report containing the selected probes The following filters are available Button Explanation All Probes Lists all non deleted probes used with the system Safety check required Lists all imaging probes that require regular safety checks used mo...

Page 25: ... Monitor 2 USB connection ports Main power supply switch Channel configuration Printer Smart card entrance SOCKET FOR SYSTEM PRINTER ONLY POWER INLET WITH FUSE HOLDER SOCKET FOR SYSTEM UNIT PC ONLY SOCKET FOR FRONT END UNIT ONLY VERIQ XXXXC SERIES DO NOT CONNECT ANY OTHER TYPE OF EQUIPMENT TO THIS SOCKET ...

Page 26: ...e Approved disinfectants are specified in the Handling Cleaning Disin fection and Sterilization of the Medistim Probes packaging leaflet for each probe type Note that any approved disinfectants are recommended because of their chemical compatibility with product materials not their biological effectiveness For the biological effectiveness of a disinfectant refer to the guidelines and recommendatio...

Page 27: ...n Power 19 TFT LCD IEC60601 1 compliant Surface wave type requires fingertip operation only sharp pointing devices will not work 1280 x 1024 Pixels 12V DC 50W CPU Memory System Storage Smart card reader Ports Sound Printer Intel Core2 dual core 4GB System hard disk 500GB one additional HDD for data storage is optional ISO IEC 7816 compatible 2 x USB 2 0 Stereo speakers for directional Doppler soun...

Page 28: ... depth of view focal point selection Color Doppler VeriQ C Modes Velocity and power Doppler Pulse Repetition Frequency 0 5 6 kHz Screen output Colour map frame rate exposure indices 2D and Doppler Tx frequen cy User settings Colour gain Region Of Interest ROI Beam angle PRF Pulsed Wave PW Doppler Wall filter 50 1500 Hz in steps Pulse Repetition Frequency VeriQ C VeriQ 3 16KHz 4 32kHz Screen output...

Page 29: ...GS FOR ALL CURVES Noise filter 5 10 20 30 50 or 100 Hz Measure Analysis Indices User selectable indices to be displayed Mean averaging time 0 1 10 seconds averaging time selectable Factory setting is 7 sec onds Sweep length 1 60 seconds Max measurement save length 60 seconds for pulsatile curves Trend measurements are limited only by procedure length ENVIRONMENTAL CONDITIONS Storage transport Temp...

Page 30: ...opliteal Artery 3 6 mm 3mm 4mm 5mm and 6mm Medistim TTFM probes PS and PQ probe series Tibial Artery 3 4 mm 3mm and 4mm Medistim TTFM probes PS and PQ probe series Saphenous Vein 4 6 mm 4mm and 5mm Medistim TTFM probes PS or PQ probe series Renal Bypass 4 6 mm 4mm 5mm and 6mm Medistim TTFM probes PS or PQ probe series Descending Artery 20 30 mm Please contact your sales representative or Medistim ...

Page 31: ...bes without handle and part numbers that end with 2 indicate probes with handle Medistim Vascular TTFM probes PV probe series Probe name Probe sizes Part numbers Vascular TTFM probe 6mm 8mm 10mm 12mm 14mm 16mm PV100061 PV100062 PV100081 PV100082 PV100101 PV100102 PV100121 PV100122 PV100141 PV100142 PV100161 PV100162 Medistim PV probe with handle Part numbers that end with 1 indicate probes without...

Page 32: ...e Medistim Doppler probe PD probe Probe name Probe size Part number Medistim Doppler probe Doppler probes are delivered with a removable handle and four stabilizer cups One size PD110752 Medistim PD probe Medistim Cardiac Output TTFM probes PR probe series Probe name Probe size Part number Cardiac Output TTFM probe 25mm 20mm 35mm PR100251 PR100301 PR100351 Medistim Cardiac Output probe ...

Page 33: ...tered trademark of the company ASP RENO Plasma Sterilizers are manufactured by RENOSEM CO LTD Information regarding the sterilization methods approved for each probe series is specified in the probe cleaning manuals See section B 2 Overview of probe cleaning manuals It is very important that the corresponding probe cleaning and disinfection instructions are followed carefully B 2 Overview of probe...

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