Synthes SENTIO MMG Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Synthes Manuals
  4. Medical Equipment
  5. SENTIO MMG
  6. Instructions for use manual

Synthes SENTIO MMG Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
0902-90-147 Rev. B
Instructions for Use (IFU)
Information for Safety
This document is valid only on the date printed. If unsure of the print date, please
2019-03-27 12:29:39
re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com).
1 of 36
The onus resides with the user to ensure that the most up-to-date IFU is used.

Advertisement

Table of Contents
loading
Need help?

Need help?

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

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Synthes SENTIO MMG

Summary of Contents for Synthes SENTIO MMG

  • Page 1 0902-90-147 Rev. B Instructions for Use (IFU) Information for Safety This document is valid only on the date printed. If unsure of the print date, please 2019-03-27 12:29:39 re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). 1 of 36 The onus resides with the user to ensure that the most up-to-date IFU is used.
  • Page 2 For patent information about this product, go to www.depuysynthes.com/patentmarking. Trademarks SENTIO™ is a trademark of DePuy Synthes, Inc. Microsoft is a registered trademark of Microsoft Corporation. ® Windows™ is a trademark of Microsoft Corporation Notice Information contained in this document is subject to change without notice.

  • Page 3: Table Of Contents

    10.1 Electro Surgical Unit (ESU) Safety Considerations for SENTIO MMG .......

  • Page 4: Customer Service

    1.0 Customer Service CUSTOMER SERVICE, SUPPORT, AND SALES General customer service and technical support: Phone: +1-800-227-6633 Fax: +1-800-446-0234 Email: Csordering@its.jnj.com Hours: Monday-Friday, 08:30am to 06:00pm EST PRODUCT COMPLAINT When contacting Customer Service, please have the appropriate product number, product serial number, date of purchase, and nature of inquiry available, if possible.

  • Page 5: Limited Warranty

    2.0 Limited Warranty PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS, ARE HEREBY DISCLAIMED.

  • Page 6: Purpose Of This Manual

    3.0 Purpose of this Manual The objectives of this manual are to instruct you in accomplishing the following: • Connect all components of the SENTIO MMG System (hereafter referred to as SENTIO MMG) • Describe operation of controls and settings •...

  • Page 7: Warnings And Caution Messages

    4.1 Warnings and Precautions It is important the SENTIO MMG operator be familiar with this manual, its precautions, procedures and safety issues. Three labels are used in this manual to identify important concerns, conditions, or procedures: •...

  • Page 8: Precautions

    W9. To avoid the risk of fire or explosion, do not use SENTIO MMG in the presence of flammable anesthetics and/or oxygen rich environments. The device is not explosion proof. W10. To avoid electrical shock, do not attach unapproved components or accessories to SENTIO MMG.
  • Page 9 SENTIO MMG and disconnect the power. AP5. SENTIO MMG operates from power sources of 50 to 60 Hz at 100/240 VAC. Use only hospital-grade power cords and the connectors supplied with SENTIO MMG. Be sure power cords and connectors are in good condition. Never apply a voltage to the equipment that is outside the range specified for its connectors.

  • Page 10: Introduction

    5.4 Unpacking SENTIO MMG When you unpack SENTIO MMG, save the cartons and packing material in which your system arrived. If the device is to be shipped from one location to another, the custom designed shipping package will provide the best protection. When the box is unpacked, check the contents of the box against the items listed on the packaging slip.
  • Page 11 SENTIO MMG Tablet with SENTIO MMG Software SENTIO MMG Control Unit SENTIO MMG Power Supply SENTIO MMG USB Type C Cable SENTIO MMG User Manual (www.e-ifu.com or printed upon request) SENTIO MMG Transport Case This document is valid only on the date printed. If unsure of the print date, please 2019-03-27 12:29:39 re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com).

  • Page 12: Sentio Mmg Quick Setup

    Special precautions should be taken to assure the SENTIO MMG Tablet is only mounted to sturdy table tops or similar rigid fixtures. Position the SENTIO MMG Tablet outside the sterile field so the screen is clearly visible by all operating room personnel, while taking care to avoid placements that could interfere with OR workflow.
  • Page 13 All probe controls remain active even if other stimulation accessories are being used to deliver stimulation. STERILITY The SENTIO MMG Probe is supplied as sterile (Ethylene Oxide). SENTIO MMG Sensors and Ground Patch are supplied as non-sterile. Sterile instruments will be clearly labeled as such on the package label. The sterility of instruments supplied as sterile can only be assured if the packaging is intact.

  • Page 14: Control Unit

    Additional sterile stimulation accessories utilizing a 1.5mm touchproof connector may be compatible with SENTIO MMG with the following connections to the Control Unit ports labeled: • Stimulation “s1” OR “s2” in lieu of the “Probe” port. • Bipolar “+” AND “ – “; used for lower levels of stimulation with finer resolution in a bipolar application, output limited to 0-2mA in 0.1mA increments.
  • Page 15 Check the polarity and function before inserting peripheral connectors. All SENTIO MMG cables and accessories will mate easily with the SENTIO MMG Control Unit and SENTIO MMG Tablet if proper alignment is attained. Damage will occur if excessive insertion force is used.

  • Page 16: Sentio Mmg Software Interface

    7.0 SENTIO MMG Software Interface 7.1 Normal Operation To power ON the SENTIO MMG Tablet, press the power button located on the top right of the Tablet (see blue arrow on the image to the right). The SENTIO MMG software will automatically launch, opening up the main menu and prompting the user to enter procedure information.
  • Page 17 The user may also apply an electrical stimulation ramp in either the upward or downward direction by respectively pressing the “↑ ramp” or “↓ ramp” icons on the main screen (or by holding either the “+” or “ – ” button on the SENTIO MMG Probe handle for at least 2 seconds).

  • Page 18: System Settings

    MMG sensors to employ in a procedure, which can be labeled on the main screen either lumbar (left image below) or cervical muscle names (right image below), or simply channel numbers according to their respective port on the SENTIO MMG Control Unit. The ramp settings tab allows the user to define how the stimula- tion ramps begin and terminate.
  • Page 19 USB flash drive. To copy reports onto a flash drive, the user simply inserts a DePuy Synthes provided flash drive into the SENTIO MMG Control Unit, taps on each desired report to copy from the menu, then presses the copy button on the top right section of the transfer report tab.
  • Page 20 Quick Set-up Guide that includes anatomical location reference for placement of MMG sensors, a video describing how to set up the Sentio MMG system, and Sentio MMG system and software version information. Upon completion of a procedure, the user may exit the software and power OFF the system by pressing the ‘menu’...

  • Page 21: System Messages

    Once stimulation is Energy Detected. taneously pressing the ‘+’ and ‘ – ‘ turned on, the software will enter buttons on the SENTIO MMG ‘standby’ state. System will con- Probe handle. tinue to monitor for spontaneous MMG while in ‘stim off’ state.
  • Page 22 ESU and electrodes and Sentio components. 3. Is in contact, or too close proximity to Sentio 4. Replace Sentio MMG Sensors components. individually until problem resolves. 5. Replace Control Unit. Refer to Section 10 of this manual for additional information.
  • Page 23 All service related inquiries should be forwarded to your local DePuy Synthes representative. An internal fault has been Train of Four self-test Press OK to continue with Train of detected in the hardware.

  • Page 24: Recommended Sentio Mmg Settings And Intraoperative Use

    . While the definition of a working 2, 3 zone may be technique and/or surgeon-specific, SENTIO MMG affords the user the ability to adjust stimulation settings to accommodate a range of desired working zones. At any time during a surgical procedure, the SENTIO MMG stimulation probe may be manipulated about the surgical site to ‘stimulate’...
  • Page 25 When electrical stimulation is active and an MMG response is detected, SENTIO MMG will present the user with a red ‘nerve identified’ notification. In the presence of a ‘nerve identified’ notification, the user may keep the stimulation current constant, at the level at which a response was evoked, and reposition the stimulation instrument (probe, dilator, etc.) while observing the intensity of the MMG response.

  • Page 26: Sensor Placement Guides

    9.0 Sensor Placement Guides False negative responses (failure to locate nerve) may result from Improper placement of SENTIO MMG sensors and/or stimulating electrodes. LOWER EXTREMITY Channel Left Sensor Channel Right Sensor Muscle Innervation Number Placement Number Placement Monitored Source Anatomical Placement...
  • Page 27 False negative responses (failure to locate nerve) may result from Improper placement of SENTIO MMG sensors and/or stimulating electrodes. UPPER EXTREMITY Channel Left Sensor Channel Right Sensor Muscle Innervation Number Placement Number Placement Monitored Source Anatomical Placement Trapezius C3, C4...

  • Page 28: Safety Considerations And User Responsibilities

    Read this manual carefully before attempting to use this device. It is important to note SENTIO MMG is an adjunct and aid for the operative physician in the establishment of a diagnosis.

  • Page 29: Maintenance

    2. Inspect all cords for fraying or other damage. Inspect all plugs and connectors for bent prongs or pins. No service or repair is to be performed on the SENTIO MMG devices. All service related inquiries should be forwarded to your local DePuy Synthes representative.

  • Page 30: Equipment Cleaning

    Equipment should be properly placed in the custom foam designed to maintain system integrity. SENTIO MMG should be stored in a controlled environment when not in use. If transported in extreme environments for extended duration, allow the unit to return to the normal ambient indoor environmental conditions that it is to be used in BEFORE powering on the system.

  • Page 31: Technical Specifications

    1 Hz to 10 Hz Classifications / Certifications SENTIO MMG is a Class I, Type BF Applied Part device with respect to protection against electric shock. SENTIO MMG is certified to EN 60601-1 SENTIO MMG is considered Ordinary Equipment – IPX0 SENTIO MMG is not suitable for use in the presence of flammable, anesthetic mixtures.

  • Page 32: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Guidance and manufacturer’s declaration – electromagnetic emissions SENTIO MMG is intended for use in the electromagnetic environment specified below. The customer or the user of SENTIO MMG should assure that it is used in such an environment. SENTIO MMG is suitable for use in all establishments.

  • Page 33: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    Guidance and manufacturer’s declaration – electromagnetic immunity SENTIO MMG is intended for use in the electromagnetic environment specified below. The customer or the user of the SENTIO MMG system should assure that it is used in such an electromagnetic environment.

  • Page 34: Electromagnetic Compatibility (Emc) Considerations

    Guidance and manufacturer’s declaration – electromagnetic immunity SENTIO MMG is intended for use in the electromagnetic environment specified below. The customer or the user of the SENTIO MMG system should assure that it is used in such an electromagnetic environment.

  • Page 35: Symbols

    7. The minimum contents of ESD precautionary procedure training should include: – ESD training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if equipment are touched by an OPERATOR who is electrostatically charged.
  • Page 36 2400 Le Locle, Switzerland Phone: +1 (800) 451 2006 FAX: +1 (508) 828 3700 Revised March 2019 © DePuy Synthes 2018-2019. All rights reserved. This document is valid only on the date printed. If unsure of the print date, please 2019-03-27 12:29:39 re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com).

Table of Contents