SENZIME TetraGraph SEN 2001 Operating Instructions Manual
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SENZIME TetraGraph SEN 2001 Operating Instructions Manual

Neuromuscular transmission monitor
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Neuromuscular Transmission Monitor
Operating Instructions
TetraGraph Model SEN 2001
INSTRUCTIONS FOR USE
TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07

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Summary of Contents for SENZIME TetraGraph SEN 2001

  • Page 1 Neuromuscular Transmission Monitor Operating Instructions TetraGraph Model SEN 2001 INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07...
  • Page 2 Device layout 1. Battery symbol with charge status indication light. 2. ON switch 3. Cable connector for the TetraCord patient cable. 4. Attachment for the TetraGraph pole clamp. 5. RS 232 port interface for multi-parameter patient monitors. 6. USB-port for the USB cable (power supply and data upload). TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE...
  • Page 3 Start screen layout 7. Battery capacity symbol and precentage 8. External monitor indication 9. Setting symbol 10. OFF switch 11. Auto start button 12. Manual start button 13. Sensor indication symbol INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07...

  • Page 4: Table Of Contents

    Contents Introduction ....................... 5 Warnings and Cautions..................5 Scope of Use and Contraindications ..............5 Intended Users ....................6 Modes of Operation ..................6 Train of Four (TOF), TOF Ratio (TOFR) and TOF Count (TOFC) ......7 Post-Tetanic Count (PTC) ................... 8 Single Twitch (ST) ....................

  • Page 5: Introduction

    1. Introduction These instructions are intended to assist with the operation of the TetraGraph Neuro- muscular Transmission (NMT) monitor and its TetraSens electrodes. A NMT monitor such as the TetraGraph is intended to supplement clinical information obtained with other monitors, such as peripheral oxygen saturation (SpO2), end-tidal carbon dioxide (ETCO2), as well as clinical assessment, to determine the adequacy of ventilation.

  • Page 6: Intended Users

    electromyographic responses that may affect the results of the monitoring. Place the EMG responses in appropriate clinical context. NOTE: TetraGraph is not for use in MRI environment (it is not MRI compatible). WARNING Patients with an implanted electronic device such as a cardiac pacemaker must not be subjected to electrical stimulation until specialist medical opinion has been obtained WARNING Do not use in a flammable atmosphere or in places where flammable anesthetics may concentrate.

  • Page 7: Train Of Four (Tof), Tof Ratio (Tofr) And Tof Count (Tofc)

    commonly used in assessing depth of neuromuscular blockade and recovery during reversal. The first response in the TOF sequence (T1) (before the administration of any neuromuscular block) is stored as a T1 baseline against which further measure- ments may be compared. A T1 baseline above 5 mV indicates an adequate response to provide a good EMG measurement throughout the procedure.

  • Page 8: Post-Tetanic Count (Ptc)

    When depolarizing agents such as succinylcholine (suxamethonium) are used, there is usually no fading, and the TOFR remains close to 100% until all responses disappear. 7. Post-Tetanic Count (PTC) When the Train of Four Count (TOFC) reaches 0, TetraGraph enables its Post Tetanic Count (PTC) mode.

  • Page 9: Single Twitch (St)

    8. Single Twitch (ST) Single Twitch (ST) is a single stimulus used by the monitor to display the peak-to-peak amplitude of the muscle response in millivolts (mV). The frequency of stimulation is 0.1 Hz, corresponding to one stimulus every 10 seconds. ST at a frequency of 1 Hz (one stimulus per second) is delivered as part of the PTC sequence (see above).
  • Page 10 The rechargeable battery is charged using the AC Adapter. This Adapter is configured for local power outlets and connects to the TetraGraph using a USB cable. NOTE: The TetraGraph may not be operated, nor connected to a patient to perform monitoring, whilst connected to a computer.

  • Page 11: Summary Of Warnings, Cautions And Side-Effects

    10. Summary of Warnings, Cautions and Side-Effects In common with all medical devices of this nature there are inherent risks and side effects. Whilst every effort has been made to eliminate these risks, care should be taken when using the device. It is important that the user familiarizes himself/herself with all of the warnings and cautions contained within this document.

  • Page 12: Symbols And Icons

    CAUTIONS Before use, ensure the monitor is intact and the battery is fully charged or connected to power supply. Also visually inspect the device and the TetraCord cable for any loose or damaged parts. If the performance of the device changes from that specified, required or expected, take the device out of service immediately.
  • Page 13 Keep away from Do not leave in direct sunlight or close to sources of excessive heat. sunlight Date of manu- Date of manufacture, shown as year and month. facture Manufacturer Name and address of the manufacturer. FCC mark is a certification mark employed on electronic products sold in the United States which certifies that the electromagnetic interfer- FCC mark ence from the device is under limits approved by the Federal Communi-...

  • Page 14: Getting Started

    The following additional symbols are used on the electrodes. The CE Mark w/o any numbers indicated the product is a CE mark self-certified Class I Medical Device. This symbol applies to TetraSens Electrode. The UKCA Mark w/o any numbers indicated the product is UKCA mark a self-certified Class I Medical Device.

  • Page 15: Setting Up

    CAUTION Before use, ensure the monitor is intact and the battery is fully charged or con- nected to power supply. Also visually inspect the device and the TetraCord cable for any loose or damaged parts. 13. Setting Up Do the following: Connect the TetraGraph to power using the USB cable and AC Adapter included in the system.

  • Page 16: Tetrasens Electrodes

    14. TetraSens Electrodes Before the electrodes are placed on the skin, make sure the skin surface is clean and dry. Place the electrode on the hand before connecting the electrodes to the TetraGraph monitor using the cable provided. The electrodes can be applied to either hand, with the stimulating electrodes over the ulnar nerve at the wrist and the evoked response recorded from either the hypothenar muscle below the little finger (abductor digiti minimi muscle), the thenar muscle below the thumb (adductor pollicis muscle) or the first dorsal interosseous...
  • Page 17 Remove the recording (distal, round) electrodes from the liner by lifting the edge of the electrodes and then apply them as illustrated below. Connect the TetraCord cable to the electrodes. On SEN 2100 by squeezing the tabs on the side of the cable connector and fully inserting the blue portion of the TetraSens electrode connector into the cable connector, ensuring the correct orientation as illustrated;...
  • Page 18 Correct versus Incorrect positioning of the Correct versus Incorrect positioning of the TetraSens electrode inserted into the connector TetraSens Pediatric and TetraSensitive electrode inserted into the connector Note: It is important to overcome the resistance and fully insert the sensor into the cable connector.

  • Page 19: Operation

    To remove the electrodes, do the following: Turn the TetraGraph monitor off. Disconnect the TetraCord cable from the TetraSens electrodes by squeezing the tabs on the side (SEN 2100) or by opening the lid (SEN 2111) of the cable connector. Remove the electrode from the skin by gently peeling from the edge.
  • Page 20 If Settings is selected, the screen to the left appears. Press + or – to increase or decrease the brightness. To turn the sound on/off press To select PTC mode, press To select Date and Time press the arrow and press YY/ MM/DD to alternate between the date and format options.
  • Page 21 AUTO START To start Auto mode press the Auto Start button on the start screen. During an automatic setup, the unit will detect the maximal current before the measurement screen appears and will set the cur- rent to 20% above the point of maximal response (supramaximal current level).
  • Page 22 1. Battery indication 2. External monitor indication 3. Settings 5. Total time 4. Off / System menu 6. Auto / Manual 7. Interval indication 9. Information area 8. Measurement result 11. Baseline 10. Graph area 13. Graph tabs 12. Marker 14.
  • Page 23 Component Description Battery indication The battery level is indicated with a graphical representation and a number. External monitor If no monitor has been connected: Empty External monitor connected: Lost connection with external monitor: Settings The symbol is highlighted and can be pressed when the device is paused, otherwise the symbol is faded.
  • Page 24 TOF MODE TOF intervals can be changed while running by pressing Interval. Possible TOF Interval is 20 sec, 1 min, 5 min, 15 min, 60 min. To pause TOF monitoring, press Stimulation stops while monitoring is paused. During all monitoring, the data can be displayed as a bar graph, waveform or trend graph.
  • Page 25 When TOF is running and the result is a TOFR or TOFC above 0, the PTC button is disabled. When TOF is running and the result is a TOFC 0, the PTC button is enabled. On demand PTC: When PTC is started, the Tetra- Graph runs one PTC measurement and then returns to TOF mode.
  • Page 26 MEASUREMENT VISUALIZATION Measurement can be visualized in three different graph tabs: bar, wave and trend view. TREND GRAPH The Trend Graph displays time along the X axis and the TOF ratio, TOF count and PTC along the Y axis. Press to the right on the screen to scroll right and press to the left on the screen to scroll left.
  • Page 27 NOISE NOTIFICATION The noise notification will appear when any electromagnetic interference is detected from any nearby electronic device. This may be as a result of electrocautery activity and the monitoring will resume after the electro- cautery interference ceases. This may also be caused by adjacent equipment. Ensure the Patient Cable is well separated from other electrical equipment and cables.
  • Page 28 If the TetraGraph has been disconnected for more than 5 minutes and thereafter reconnected again, a pop-up window will appear with possibility to continue with the same patient or select new patient. SYSTEM INFORMATION Reprogram (for use by a Service Engineer only) Screen calibration Cal.
  • Page 29 UPLOAD If Upload is selected, the screen to the left will appear. An upload can be performed through the Tetra- Connect as long as the monitor is connected to a computer running the application via the USB cable, the right-hand connector in the photograph below.

  • Page 30: Data Output And Cybersecurity Controls

    16. Data output and cybersecurity controls The TetraGraph cannot be controlled or otherwise accessed via the external con- nections. The monitor transmits data over the USB/serial cable, including the TOF ratio, TOF Count, PTC and Single Twitch. The TetraGraph does not contain or transmit Protected Health Information.
  • Page 31 Note: Any serious incident that has occurred to the user and/or the patient in relation to the device should be reported to Senzime and the competent authority of the Member State (for Europe) or relevant health authority (for other countries) in which the user and/or patient is located.

  • Page 32: Maintenance And Battery Charging

    18. Maintenance and Battery Charging To charge, connect the TetraGraph device to the charger via the USB port using only the cable and charger provided. The TetraGraph can be used while charging. If the device is going to be stored for a long period it should be charged / discharged to 40% battery capacity before storage, checked every 12 months and recharged as required to maintain the 40% battery level.
  • Page 33 Replacement of Power Supply If the power supply, the adapter to power supply or the USB cable is malfunctioning and needs to be replaced, contact your supplier or Senzime AB to acquire these spare parts. Only use the charger and cable provided when connecting to the TetraGraph unit.

  • Page 34: Cleaning And Disinfecting

    19. Cleaning and Disinfecting CAUTION Before cleaning, disconnect the power unit from the mains electrical supply. The TetraGraph and its cables must NOT be immersed in water or other liquids during cleaning or disinfection. CAUTION Do not use abrasive cleaners on the display. Cleansers and disinfectants must be indicated for use on medical devices and specify compatibility with use on plastics and metal surfaces.

  • Page 35: Performance And Technical Specifications

    20. Performance and Technical Specifications Stimulation Patterns Single Twitch (ST) Pulse of 200 or 300 µs duration at 0.1 Hz Automatic Calibration is ST Set of up to 14 pulses of 200 or 300 µs duration repeating automatically at 1 Hz Train-of-Four Ratio (TOFR &...
  • Page 36 Graphics Display Colour LCD, Brightness control, Touch Screen interface MAP (Muscle Action Potentials) Display of waveforms Bar of four pulse amplitudes and %, trend of successive TOFR values TOFC TOF Count, integer and trend Number of post-tetanic ST responses Amplitude of response, mV, series of response amplitudes as bars Settings Setup...

  • Page 37: Environment

    21. Environment Environment during initial transportation Temperature -20°C to 60°C (-4°F to 140°F) for periods not exceeding 5 days Relative humidity 10% to 85% non-condensing Atmospheric pressure 50 kPa to 106 kPa Altitude Height above sea level to be 5000 – 0 m (50-100 kPa) Environment during storage and movement between hospital locations Temperature 5°C to 30°C (41°F to 86°F)
  • Page 38 Guidance and manufacturer’s declaration - electromagnetic emissions The TetraGraph is intended for use in the electromagnetic environment specified below. The customer or the user of the TetraGraph should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1...

  • Page 39: Product Warranty

    23. Product Warranty The product, when new, is guaranteed to be free from defects in materials and workmanship and to perform in accordance with the manufacturer’s specification for a period of one year from the date of purchase from the manufacturer or their approved distributor.
  • Page 40 Copyright © Senzime AB all rights reserved – updated 2023 The information in this document is the property and copyright of Senzime AB. This document is only intended for users of the device and shall not be copied, circulated or transmitted electroni- cally to other parties.

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