Idmed ToFscan User Manual
Euromuscular transmission monitor
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Also See for ToFscan:
- Service manual (28 pages) ,
- User manual (24 pages) ,
- Quick start (2 pages)
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Summary of Contents for Idmed ToFscan
- Page 1 User Manual NeuroMuscular Transmission Monitor Version 1.8 EN - DR Last Update 2021/03/05 Ref: TOF-IFU_EN_DR User Manual ToFscan...
- Page 2 User Manual ToFscan...
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Page 3: Table Of Contents
Warning ..........................5 Caution ..........................6 Explanation of the symbols ..................8 I General information ..................9 Overview of the ToFscan and its accessories ..........9 Main menu, Display screen ..................10 Menu selection ....................... 10 Battery / AC power supply operation ..............10 II ToFscan setup ....................11... -
Page 4: About This Product
This operating manual provides the instructions on how to configure and use the ToFscan from IDMED. It also describes the specific procedures to clean and verify the device as part of the necessary maintenance. This manual is intended to be used only by qualified medical personnel. -
Page 5: Safety Measures
• A NOTE provides relevant information about a function or procedure. EXPLANATION OF THE SYMBOLS The symbols which may be displayed on the ToFscan screen are recapitulated and explained at the end of this section. Any serious incident occurring in relation to the device must be notified to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. -
Page 6: Caution
Do not use if a part is damaged Handle the device with care to prevent any fall. The ToFscan should be used during a limited time on one patient at a time and cleaned between patients. The ToFscan can be used fully or partially during the surgery. The duration should not exceed 24H. - Page 7 After an extended period of disuse (storage), recharge the ToFscan battery for at least 2 hours before use. If the ToFscan does not switch on when the wheel selector is pressed, the battery needs to be replaced. Only qualified technicians are authorised to carry out repairs or maintenance procedures with the consent of IDMED.
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Page 8: Explanation Of The Symbols
Manufacturing Date Caution: USA federal law restricts this device to sale by or on the order of an anesthesiologist or other qualified practitioner. Symbols displayed on the ToFscan screen Battery level Symbol for the intensity of the (green, yellow, red) -
Page 9: I General Information
Auto-TOF mode On No reference value is A reference value is available registered Disrupted measuring conditions I General information Overview of the ToFscan and its accessories Electrodes cable Display screen /Thumb sensor Electrode/ Selection wheel Sensor cable Power supply unit... -
Page 10: Main Menu, Display Screen
Menu selection The menus, options and various tests are accessed using the selection wheel on the front of the ToFscan. The user navigates through the various menus by turning the wheel (clockwise or anti-clockwise). To select a menu or function, press the wheel an release the wheel button(holding it down for less than 1 second). -
Page 11: Tofscan Setup
II ToFscan setup Cable / Cable connection The user connects the sensor+ electrode cable to the ToFscan prior to use. The user will make sure sensor symbol is displayed in green on the right side of the screen after this cable is connected to the ToFscan. -
Page 12: Placing Of The Sensor
This tape must be adapted to a medical usage and allow a reliable fixing during the whole duration of the monitoring. Positioning of the ‘eyebrow sensor’ on the patient’s eyebrow User Manual ToFscan... -
Page 13: Skin Impedance
This must remain limited, harmless and not look like an injury. Skin impedance The ToFscan is an electrical stimulator with a constant current. Therefore, irrespective of skin impedance it will stimulate the patient with an identical current. It will function in this way so long as the needed voltage is below 300 V. -
Page 14: Connecting The Cable To The Tofscan
All modes are selected by a brief push on the wheel button. Once in the submenu, press and hold the wheel button to start the electrical stimulation. The ToFscan will give a “beep” simultaneously to the start of the electrical stimulation. -
Page 15: Tof Mode
4th response against the first (ratio T4/T1 TOF as a %) in yellow in the middle of the screen. The ToFscan also displays a bar graph allowing the visualization of the range of the different responses. - Page 16 (for at least 2 seconds). The first stimulation is delivered 4 seconds after the selection wheel has been pressed. To stop a programme, press the selection wheel; the ToFscan then returns to the “AUTO TOF” menu.
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Page 17: Tet Mode
Tetanic stimulation or “TETANUS” stimulation is used to stimulate a patient for 5s at 50 Hz. As the ToFscan does not display a measurement at the end of this test, no user validation is expected at the end of the stimulation in order to reactivate the selection wheel navigation function. - Page 18 TOF stimulation, a PTC stimulation will be applied. After all stimulations (TOF or PTC) the ToFscan displays the results. If the patient has had at least one response to TOF stimulation, the ToFscan will then display the measured results and there will be a pause of 30s before the next set of TOF stimulation.
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Page 19: St Mode
ATP mode will stop. The waiting time required by the ToFscan following “PTC” stimulation or “ATP” mode is 3 minutes. It is important to remember that “PTC” stimulations is only normally used when no responses to “Single Twitch”... -
Page 20: Parameters Menu
The “Parameters” menu will enable the user to modify the standard parameters of the ToFscan. This menu is represented on the screen by the following icon: To go to the “Configuration” menu, the selection wheel must be pressed and held (2s). -
Page 21: Servicing, Disinfection Cleaning
Only qualified technicians are authorised to carry out repairs or maintenance operations with the consent of IDMED. Battery Charge The battery is charged with the charger supplied by IDMED. It can charge a flat battery in less than 8 hours. Icon for battery charge in progress or icon for operation on the AC power adaptor The battery can be charged regardless of its level. -
Page 22: Cleaning And Disinfection
ToFscan. When cleaning the cables of the ToFscan, be careful not to create excessive traction on the splint that could cause premature breakage of the wires inside the sheath. -
Page 23: Technical Specifications And Warranty
Unsorted electronic waste products are potentially hazardous to the environment. Packaging materials must be disposed of or recycled in accordance with the regulations in force. VI Technical specifications and warranty The ToFscan comes with a microcontroller and a colour LCD screen for optimal legibility and ease of use. Safety •... - Page 24 The ToFscan may temporarily not dis- ± 2 kV ± 2 kV play result during transient electro- Electrical fast 100 kHz 100 kHz magnetic disturbances such as the transients / 61000-4-4 repetition repetition use of electrosurgery device. In that bursts...
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Page 25: Environment
Risk of explosion: do not use the ToFscan in a flammable environment or in locations where flammable anaesthetics may be accumulated. The ToFscan is not designed to operate in an environment where there are SCANNERS, M.R.I.’s or any other devices creating large magnetic fields. In order to limit electrostatic discharge, the humidity must be maintaining above 35% and an antistatic floor is recommended. -
Page 26: Accessories
VII Accessories The ToFscan (reference : TOF-MU) is delivered with a number of accessories. Here is a list of the main accessories with their designations and IDMED references. The complete accessories list is available from the ToFscan distributor. Accessories of medical device ToFscan... - Page 27 User Manual ToFscan...
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Questions and answers
do you have validation data from TOFScan that would rebut the information presented in the Anesthesiology paper previously attached? That's being used as a key piece of the resistance to implementation at FRH, and is difficult to rebut. Without this, "TOFScan as a random number generator " is a difficult message to counter.