Download
Share
Print this page
  1. Manuals
  2. Brands
  3. SENZIME Manuals
  4. Monitor
  5. TETRAGRAPH
  6. Operating instructions manual

SENZIME TETRAGRAPH Operating Instructions Manual

Neuromuscular transmission monitor
Hide thumbs

Advertisement

Quick Links

Download this manual
English
Neuromuscular Transmission Monitor
Operating instructions

Advertisement

loading
Need help?

Need help?

Do you have a question about the TETRAGRAPH and is the answer not in the manual?

Questions and answers

Related Manuals for SENZIME TETRAGRAPH

Summary of Contents for SENZIME TETRAGRAPH

  • Page 1 English Neuromuscular Transmission Monitor Operating instructions...
  • Page 2 Copyright © Senzime AB all rights reserved – updated 2025 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 electronically to other parties.

  • Page 3: Table Of Contents

    Train of Four (TOF), TOF Ratio (TOFR) and TOF Count (TOFC) ....... 6 Post-Tetanic Count (PTC) .........................7 Single Twitch (ST) ...............................7 4. Getting to Know the TetraGraph ..........8 Device Layout ............................... 8 Screen Layout ............................... 9 The Monitor System ............................15 Accessories ................................15...
  • Page 4 Summary of Warnings, Cautions and Side-Effects ............41 Symbols and Icons ............................43 13. Environment ..................46 14. Electromagnetic Compatibility Information ..... 46 15. Product Warranty ................. 50 16. Disposal of Waste Electrical and Electronic Equipment 50 TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 5: Introduction

    Intended Use The Intended Use of the TetraGraph is to deliver stimulations to a nerve and record, measure, analyze and report muscle electrical activity to determine muscle function. TetraGraph is a Neuromuscular Transmission (NMT) monitor intended for use in hospital settings including operating rooms, subsequent recovery areas and in critical care settings.

  • Page 6: Indications For Use Statement

    Federal law restricts this device to sale by or on the order of a physician. (US only) Clinical Benefits The major benefit to the patient, provided by TetraGraph, is the ability to monitor the degree of neuromuscular block when NMBAs are administered in conjunction with surgery and/or mechanical ventilation.

  • Page 7: Post-Tetanic Count (Ptc)

    0 and 20, zero indicating a complete neuromuscular block. After delivery of a PTC sequence, the TetraGraph disables PTC mode for at least 2 minutes. The selection of adaptive, manual or repeated PTC is made in the Settings menu. Adaptive PTC™...

  • Page 8: Getting To Know The Tetragraph

    1. Power On-Off Button 2. Battery Charge Indication Light 3. Front glass with Touch Screen 4. Cable Connector for the TetraCord Patient Cable 5. Port for TetraGraph Power Supply Cable 6. Pole Clamp 7. Pole Clamp Grip Adjusting Screw 8. TetraCord Patient Cable 9.

  • Page 9: Screen Layout

    Press play to start TOF monitoring 2. External Monitor Indication 3. Battery Capacity Indication 4. Button to Open the Settings Menu 5. Auto Start Button Tip: For optimal monitoring conditions, start before administering muscle relaxant INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...
  • Page 10 14. Button to Open the Settings Menu 15. Measurement Result 16. Display Mode Selection 17. On Demand Measurement 18. Time To Next Measurement 19. PTC Mode Indication and On/Off Button TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...
  • Page 11 Baseline). It is recommended to strive for a mV response (Signal Strength) above 5 mV. If monitoring starts on an already muscle relaxed patient TetraGraph Adaptive Intelligence™ provides an estimated signal Signal Strength strength reading to help guide optimal sensor placement.
  • Page 12 Tap on the battery icon to display battery capacity % Indicator information. Tap to open the settings menu and access: Settings New patient, Go to ST Mode / Go to TOF Mode, PTC mode, Stimulation, Device, and Data. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...
  • Page 13 The PTC ON mode can be turned off at any time by pressing the PTC button. PTC Mode During PTC measurement, the PTC button changes to pink. Indication See more detailed information about the different PTC modes in PTC Options on page 23. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...

  • Page 14: Settings Menu Overview

    • IntelliVue Configuration (Password protected) Service (Password protected) Software version and Serial Info number Upload Select and send files. Data Delete/Manage Select and delete files. Case Reference Max 8 digits. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 15: The Monitor System

    Associated Devices / Optional Accessories & Spare Parts • SEN 2017 TetraHub • SEN 2230 18ft TetraCord Patient Cable On receipt and after periods of storage, clean and disinfect the TetraGraph before using it. Further instructions are detailed in section 9. Cleaning and Disinfecting on page 36.

  • Page 16: Setting Up

    Connect the TetraGraph to Power 1. Use the Fixed Cable Power Supply included in the system. 2. Connect the USB-C cable to the USB-C port on the back of the TetraGraph and connect the power supply to the mains electricity.

  • Page 17: Pole Clamp

    Pole Clamp 1. Adjust the pole clamp grip range by turning the grip adjustment screw clockwise or counterclockwise. 2. Attach the TetraGraph to the pole/post with the pole clamp. 3. Ensure that the clamp has a sufficient grip Turn On the TetraGraph...

  • Page 18: Preparation And Positioning Of The Sensor

    (abductor digiti minimi muscle), or the thenar muscle below the thumb (adductor pollicis muscle). The distal recording electrode is placed on the little finger or the thumb, as illustrated below. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...
  • Page 19 On the hand: The stimulating electrodes are placed over the ulnar nerve, 1 cm below the wrist crease. On the foot: The stimulating electrodes are placed over the posterial tibial nerve, next to Medial malleolus. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...
  • Page 20 On the foot: The recording electrodes are placed over the flexor hallucis brevis muscle. Connect the TetraCord Cable to the Sensor 1. Insert the sensor connector into the cable connector. 2. Ensure correct orientation as illustrated. A click sound confirms the correct pairing. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 21: Operation

    TetraGraph Adaptive Intelligence™ provides an estimate of the signal strength (shown in parentheses) to provide feedback on sensor placement. • Adaptive PTC™ where the TetraGraph enters PTC mode (deep block mode), and proceeds with tetanic stimulation and PTC measurements, automatically when two consecutive TOFC 0 have been confirmed.

  • Page 22: Information Bar

    Tip: For optimal monitoring conditions, start before administering muscle relaxant 2. Notifications Auto setup in progress followed by Auto setup successful, before starting the first TOF measurement will be displayed. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 23: Ptc Options

    • The Auto setup will proceed after 5 seconds if no option is selected. • When EMG responses are detected TetraGraph Adaptive Intelligence™ provides an estimated signal strength reading to provide feedback on sensor placement.
  • Page 24 • After confirmed TOFC 0, the PTC OFF button switches to white (active). • The first PTC measurement is started manually by tapping the PTC button. The PTC button changes to pink, and the PTC measurements start. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 25: Measurement Time Interval

    1. Tap on the Interval button located at the bottom left of the screen. The current mode is displayed at the top of the window. 2. Select Adaptive. 3. Press OK. 4. The measurement time interval will be adapted to the depth of neuromuscular block. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...
  • Page 26 • In PTC mode if intervals longer than 2 minutes are selected and >2 minutes have passed. Starting On Demand Measurement 1. Tap the On Demand button (double arrow symbol ) located adjacent to the measurement time bar. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 27: Trend View

    The Text and Number of the measurement result is displayed in the center of the Gauge. Text label “TOFR” together with “%” for a measured Train-of-Four Ratio, TOFC for a Train-of-Four Count, or “PTC” for Post Tetanic Counts. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...

  • Page 28: Real-Time View

    • Use controls to zoom-in/-out. • In pause mode a vertical orange line will appear. • Tap on a selected measurement/time point to move the dynamic line and review data. 06:18 08:51 00:05 TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 29: Display Modes

    Alternative Start Modes For alternative start, tap on the Menu button in the upper left corner of the screen. The two alternative start modes on TetraGraph are: Manual / Recovery room • Manual Mode (Recovery Room) Single Twitch / Depolarizing •...

  • Page 30: Start New Measurement

    Senzime sales representative. For data export: 1. Turn the TetraGraph on. 2. Use a USB cable 2.0 or higher with the monitor and connect TetraGraph to the computer´s USB port. 3. Open Settings and tap on Data and select Upload.

  • Page 31: Troubleshooting

    ( good signal or other conditions, electrodes and restart. strength >5 mV) e.g. obese patient, diabetic, or geriatric 3. If position of electrodes is correct patient. proceed monitoring. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...
  • Page 32 The sensor or positioning screen after a few patient cable is 2. Check that the sensor is seconds. disconnected. correctly connected to the patient cable as per Operation on page 21. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...
  • Page 33 Any serious incident that has occurred to the user and/or the patient in rela- tion to the device should be reported to Senzime and the competent authority of the Member State (for Europe) or relevant health authority (for other coun- tries) in which the user and/or patient is located.

  • Page 34: Maintenance And Battery Charging

    8. Maintenance and Battery Charging To charge, connect the TetraGraph device to the charger via the USB port using only the Fixed Cable Power Supply. 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 35: Periodical Checks

    • When requesting service or maintenance, always quote the serial and reference numbers which are located on a label on the base of the device. • Check the active service life of your device - the service life of the TetraGraph is 7 years after which the device should be decommissioned.

  • Page 36: Safety Test And Replacement Of Power Supply Kit

    9. Cleaning and Disinfecting WARNING Before cleaning, disconnect the power unit from the mains electri- cal supply. The TetraGraph and its cables must NOT be immersed in water or other liquids during cleaning or disinfection. WARNING Reuse of TetraSens electrode is prohibited and may lead to inac- curate measurement, cross-contamination and superficial burns.

  • Page 37: Manual Disinfection

    2, 3, 5, 10 and 15 minutes. Accuracy Pulse amplitude and Pulse duration ±10%. Amplitudes within ±25% when tested according to IEC 60601-2-40. Pulse repetition frequencies ±5%. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...

  • Page 38: Accuracy Of Measurement

    TOFR TOFC TOF Count, integer and trend Number of post-tetanic ST responses Amplitude of response, mV, series of response amplitudes as bars Level-of Block-Gauge™ Dynamic illustration of level of block TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...

  • Page 39: Communication Interface

    If in doubt, contact a certified technician, or alternatively, a Senzime representative or technical support. INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...

  • Page 40: Standards And Regulations Applied

    The parts that are intended to come in contact with patients during normal operation. All electrodes (TetraSens, TetraSens Pediatric and TetraSensitive) are considered Applied Parts and are connected to the BF Defibrillation-proof port on the TetraGraph. The patient cable interconnecting the TetraGraph to the applied part (the sensor) is considered an Applied Part.

  • Page 41: Safety

    • If it is necessary to use the TetraGraph stacked with other equipment, observe both the TetraGraph and the other equipment to make sure that they are operating normally.
  • Page 42 • 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. • Before use visually inspect the device and the TetraCord cable for any loose or damaged parts.

  • Page 43: Symbols And Icons

    SIDE EFFECTS The side effects that can occur from use of TetraGraph and its TetraSens Electrodes are the following: • Allergic reaction to clinical adhesive or hydrogel. • Localized irritation if stimulation electrodes are not securely fitted or are reused.
  • Page 44 Protection against the effects of the discharge of a cardiac proof applied defibrillator is dependent on the use of the specified cable and part electrodes. The following icons are seen on the TetraGraph: Icon Meaning Description Battery Indication on battery level of charge.
  • Page 45 Do not reuse single use only. Non-sterile For the TetraSens/TetraSens Pediatric/TetraSensitive Electrode. Use by date For the TetraSens/TetraSens Pediatric/TetraSensitive Electrode. The following additional symbols are used on the TetraGraph Power Supply: Icon Meaning Description IEC 60417-5172 Class II equipment. IEC 60417-5032 Alternating current.

  • Page 46: Environment

    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. Restriction on other Equipment or Network/Data Couplings to be Connected with this Device on page 39.
  • Page 47 30 cm (12 inches) to any part of the TetraGraph including cables specified by the manufacturer. Exposing the Tetragraph to an electromagnetic environment outside specification could result in degradation of the performance, e.g.
  • Page 48 RF transmitters, as determined according to an electromagnetic site survey, a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...
  • Page 49 Proximity fields from RF wireless communications equipment The TetraGraph is compliant according to test specification for enclosure port Immunity to RF wireless communication equipment per IEC60601-1-2:2014/AMD1:2020. Test Frequency Band Service Modulation Immunity [MHz] [MHz] Test Level [V/m] Pulse 3855385 380 to 390...

  • Page 50: Product Warranty

    If you are unsure of your national requirements with respect to disposal, contact your local authority, dealer, or supplier for further information. Penalties may be applicable for incorrect disposal of this waste, in accordance with national legislation. TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29 INSTRUCTIONS FOR USE...
  • Page 51 INSTRUCTIONS FOR USE TetraGraph Model SEN 2015, INFO0124 (3.0) 2025-01-29...
  • Page 52 Manufacturer: Senzime AB Verkstadsgatan 8 753 23 Uppsala Sweden MEDICAL - APPLIED CURRENT/ENERGY EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH AAMI ES60601- 1:2005/(R)2012 and A1:2012/(R)2012 and A2:2021; IEC 60601-1-6; IEC 60601-2- 40; CAN/CSA-C22.2 No. 60601-1:14 (Reaffirmed 2022); CSA-C22.2 No. 60601-1-6;...