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Summary of Contents for MEDISTIM VQ4122
- Page 1 MEDISTIM V Q™ SYSTEM USER MANUAL Mod. VQ4122 | VQ2111 | VQ1111 | VQ4001 | VQ2011 | VQ1011 | VQ1001 |...
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Page 2: Table Of Contents
Preparations by system operator ....10 List of available Medistim probes ....31 5.3.1... -
Page 3: Introduction
To avoid risk of electric shock, this equipment must only be In the incidence of additional modifications to the VeriQ™, connected to a supply mains with protective earth a new revision of the Medistim VeriQ™ User Manual will be distributed by Medistim ASA. Warning Equipment connected to the systems signal input/ output shall comply with iec 60601-1 clause 16 1.4 Warning statements and safety markings... -
Page 4: Indications For Use
Warning vested mammaries. In these vessels, thrombus or calcified Do not use this device for other applications than the intend- ed use. The Medistim VeriQ™ System is not intended for any plaque will not be present. kind of fetal applications. However, thrombus or calcified plaque may be present before... -
Page 5: Possible Operational Influence
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 local contacts and distributors. Warning No modification of this equipment is allowed. -
Page 6: Technical Description
Through its capability to measure transit time volume Transit time flow volume flow and Doppler flow velocity, the VeriQ™ can help develop Medistim transit time probes surround the vessel, gener- optimal grafting strategies and to document graft patency. ating a uniform ultrasound field across the vessel lumen. Ultrasound pulses are transmitted from a crystal on one side The VeriQ™... -
Page 7: Delivery And Configuration
Please refer to the instructions provided with each crate for and Experimental. adapting the available vessel names to the proper unpacking. selected profile. Each profile can be edited, and operating surgeons can be stored under each profile. Select the ap- Medistim recommends that the original packing materials be propriate profile by pressing the drop-down menu “System used when the system is transported between facilities. For profile” service purposes, a specially-designed container is available through your local representative. -
Page 8: Auxiliary Inputs
VeriQ™ to coil the cable(s). All probes Note should be unplugged and stored properly if not sent to clean- When using the Medistim VeriQ™ System with more than one ing and sterilization. monitoring system that requires independent adjustments, different calibration settings can be saved under a profile name, such as OT 1 and OT 2. -
Page 9: Operating The Veriq
On Pay-Per-Procedure (PPP) systems a field in the top right corner will display the remaining proce- dure time once a procedure has been activated. All Medistim probes require very little force to be inserted The VeriQ™ has five main screen views: or removed. If excessive force is needed to plug a probe... -
Page 10: Preparations By System Operator
Note For each entered probe a vessel name dialog box Medistim recommends that the patient name is entered in an will appear. For the probe verification purpose the orderly and uniform way for easy storage and retrieval, e.g. vessel name is not important, just press cancel until always with the last name first. -
Page 11: Defining The Vessel Names
5 seconds sweep rate as soon as a probe is connected, as previous. shown on figure below. The selection 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. © MEDISTIM 2015... -
Page 12: Performing Vessel Search
This will increase the height of the displayed signal. Adjusting baseline position The baseline position can be changed by dragging the base- line up or down. The Doppler baseline can only be adjusted when recording ”live”, while the flow and AUX channels can be changed in ”Pause”, “Edit” and live recording modes. © MEDISTIM 2015... -
Page 13: Saving Measurements
”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- © MEDISTIM 2015... -
Page 14: Tasks During Operation By Surgeon
Me- distim ASA are used on the probe. An updated list of tested 5.6.2 Flow measurements solutions may be found on our web site, www.medistim.com As with the Doppler measurements, the operator needs to be 5.7.3 Sterilization informed which type of conduit, connection, and target ves- sel is being measured. When the flow probe is placed onto a... -
Page 15: Reporting
The selected measurements will be marked with a green check-mark, indicating 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- 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 they are now re- garded as valid documentation for the performed procedure. © MEDISTIM 2015... -
Page 16: Icon Description
Increase Doppler gain - The spectrum will become darker with the possibility of increased noise. Used Measure and Analyze - Displays calculated values with the Medistim Doppler probe. and measurement tools. Decrease Doppler gain - The spectrum will become Volume control - The lowest position will turn sound more transparent with less noise. -
Page 17: System Settings Description
Show scale buttons displays the buttons to increase and decrease vertical scale Use automatic vessel pop up will prompt use for vessel name each time a probe is connected Enable Auto Invert automatically invert the flow curve when mean flow is below baseline Show Button Help Text explains the function of each screen icon. © MEDISTIM 2015... -
Page 18: Other Adjustments
Press the ”-”button (2) in the lower right part of Dop- pler display to decrease the gain if the spectrum appears noisy. Change of sample volume By default the system measures all velocities at depths between 2 mm and 8 mm. The field of measurement and the sample volume can be changed. © MEDISTIM 2015... -
Page 19: Data Management
Note database. The data available for export is: The project can be used to identify patients part of a study making search easier. • Entire patient database • Language files • System settings • GUI configuration • Probe usage information © MEDISTIM 2015... -
Page 20: Safe Removal Of Storage Devices
This is done by adding, subtracting or dividing the Note traces of two inputs. Resistance can be calculated by divid- The raw patient data files can only be read by VeriQ™ or ing pressure by flow. When measuring the carotid bifurcation, Medistim workstation program. the flow in the Carotis Externa and the Carotis Interna can be derived into one total flow amount. 5.11.4 Safe removal of storage devices For enabling derived traces, enter the ”Measure screen”,... -
Page 21: Trend Measurements
To stop the trend logging, press the ”Trend setup” button and choose ”Stop logging”. Answer ”OK” to the question ”Stop trend data collection?” The trend measurement will be Note automatically saved. Not all indexes/measurements are visible in live mode. © MEDISTIM 2015... - Page 22 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. © MEDISTIM 2015...
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Page 23: Troubleshooting
6. TROUBLESHOOTING 6.1 Service of the VeriQ™ System For service instructions, consult the VeriQ™ System service manual or contact the Medistim service department directly. 6.2 Basic troubleshooting The following are some basic tips in the case that the VeriQ™ System is not operating properly. -
Page 24: Maintenance
7.5 Disposal instructions The following filters are available: The system contains various plactic materials, electronic components and metals. Please follow local rules and reg- ulation swhen disposing. Please follow the hospitals safety regulations for equipment that has ben in contact with blood. © MEDISTIM 2015... -
Page 25: Technical Specifications
Printer Main power supply switch OCKET FOR OCKET FOR YSTEM OCKET FOR RONT OWER NLET WITH (PC) YSTEM RINTER ONLY NIT ONLY OLDER ONLY XXXX ERIES O NOT CONNECT ANY OTHER TYPE OF EQUIPMENT TO THIS SOCKET © MEDISTIM 2015... -
Page 26: Technical Specifications
Avoid excessive use of water or liquids on the system. The touch screen area can be cleaned with anti static cleaning tissues. For cleaning of probes before sterilization consult the “Handling, Cleaning, Disinfection, and Sterilization of the Medistim Probes” pack- aging leaflet for each probe type. Disinfection Approved disinfectants are specified in the “Handling, Cleaning, Disin- fection, and Sterilization of the Medistim Probes” packaging leaflet for... - Page 27 EN 60601-1-2 (ed.3) Biocompatibility ISO10993-1:2009 RoHS EN50581 (ed.1) APPROVALS The Medistim system and probes are approved according to UL 60601-1 & CSA C22.2 No. 601.1 with MET listing number E113031. The Medistim VeriQ™ Systems and probes are CE approved. © MEDISTIM 2015...
- Page 28 Frequency response DC to 100 Hz Sample rate 250 Hz Screen output Pulsatile and mean pressure curve Systolic, diastolic and mean pres- sure value Measure and Analysis Maximum, minimum value, maximum derivative and cursor readings User settings Zero-point, gain and noise filter © MEDISTIM 2015...
- Page 29 60 seconds for pulsatile curves. Trend measurements are limited only by procedure length. ENVIRONMENTAL CONDITIONS Storage / transport Temperature -25°C to 70°C (-13°F to 158 °F) Humidity 20% RH to 95% RH (non-condensing) Atmospheric Pressure 101 kPa +10% to -20% Operation Temperature 0°C to 40°C (32°F to 104°F) Humidity 20% RH to 80% RH Atmospheric Pressure 101 kPa +10% to -20% Transport Use original packaging © MEDISTIM 2015...
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Page 30: Appendix A. Probe Application Overview
All probes are available with or wihout handle. See section A.2 for a full list of available probes. Transplant Surgery Surgery/Vessel Vessel Size Recommended Medistim probes Hepatic Artery 5mm, 6mm, 7mm and 8mm Medistim TTFM probes (PV, PS, or PQ probe series) Surgery/vessel Vessel size Probes w/o handle Probes w/ handle Portal Vein... -
Page 31: List Of Available Medistim Probes
*Part numbers that end with 1 indicate probes without handle and part numbers that end with 2 indicate probes with handle Medistim Vascular TTFM probes - PA & PB probe series (Note: PA & PB probe series will be phased out by end 2015 and will be replaced with the PV probe series.) - Page 32 Medistim Doppler probe One size PD110752 Doppler probes are delivered with a removable handle and four stabilizer cups Medistim PD probe Medistim Cardiac Output TTFM probes - PR probe series Probe name Probe size Part number Cardiac Output TTFM probe 25mm...
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Page 33: Appendix B. Probe Cleaning, Disinfection And Sterilization
APPENDIX B. PROBE CLEANING, DISINFECTION AND STERILIZATION B.2.3 PS-probe series All Medistim probes are validated for different sterilization methods and should be handled differently according to See Probe Manual for the PS-probe series PS499001. Han- these procedures. dling, Cleaning and Sterilization of the Medistim QuickFit TTFM Probes, Steam Autoclaveable (PS). - Page 34 0470 medistim@medistim.com www.medistim.com Medistim ASA (Head office) Medistim Norge AS Medistim Danmark ApS Medistim USA Inc. Medistim Deutschland GmbH Medistim UK Limited Økernveien 94 Økernveien 94 Gøngetoften 13 14000 25th Ave N. Ste. 108 Bahnhofstr. 32 34 Nottingham South Ind Est...
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