natus Dantec Clavis User Manual
  1. Manuals
  2. Brands
  3. natus Manuals
  4. Medical Equipment
  5. Dantec Clavis
  6. User manual

natus Dantec Clavis User Manual

Stimulator for nerve localization
Hide thumbs Also See for Dantec Clavis:
Table of Contents

Advertisement

Quick Links

Dantec
Clavis
®
™
User Guide
9031M6114EN Rev. D
Revision Date: April 15, 2021

Advertisement

Table of Contents
loading
Need help?

Need help?

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

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for natus Dantec Clavis

Summary of Contents for natus Dantec Clavis

  • Page 1 Dantec Clavis ® ™ User Guide 9031M6114EN Rev. D Revision Date: April 15, 2021...
  • Page 2 Guide Copyright © 2021 Natus. All rights reserved. The contents of this manual are the property of Natus Medical Incorporated. Any reproduction in whole or in part is strictly prohibited. This manual correctly describes the device and its functions. However, as modifications may have been car- ried out since the production of this manual, the system package may contain one or more addenda to the manual.

  • Page 3: Table Of Contents

    Clinical Performance ......................... 8 Clinical Benefits ........................8 Patient Target Group ........................ 8 Intended Users .......................... 8 Patient Population ........................8 Operating Dantec Clavis ....................... 9 Description ..........................9 Control Panel Overview ......................9 Start – AutoTest ........................10 EMG Mode ..........................11 Electrodes .............................

  • Page 4: Description Of Symbols

    Follow instructions for use. ISO 60601-1 Table D.2 #10 Type BF Applied Part Defines the degree of protection against electric shock. The Dantec Clavis system is classified as type BF. Complies with Type BF requirements of IEC 606011:2005+ IEC 60601-1:2005+AMD1:2012 and EN 60601-1:2006+A1:2013.
  • Page 5 Dantec Clavis User Guide The manufacture date is adjacent to this symbol. ISO 15223-1 Symbol 5.1.3 Ingress of liquids: The Clavis Unit is classified as an ordinary equipment regarding ingress of liquids; it is not drip-proof, splash-proof, or watertight. IPX1 Protection from dripping water from above device for at least 10 minutes according to IEC 60529.

  • Page 6: Safety Information

    This device has been designed and tested in accordance with the IEC Publication 60601-1 (EN 60601-1) Medical Electrical Equipment. Do not use this device for anything other than what it is intended for by the manufacturer. Natus Neuro assumes no responsibility when not used as described in this user guide.

  • Page 7: Contraindications

    2. Over the left and/or right temporal regions 3. In the orbital region  Use in an anesthetic environment: The Dantec Clavis system is not suitable for use in presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE. ...

  • Page 8: Side Effects

    Please read all safety information before use of the device. Clinical Performance Dantec Clavis is a medical device intended as a stimulator for nerve localization and as an aid for guidance of injections into muscles. Dantec Clavis provides both EMG monitoring and stimulation functions in a single, hand-held device.

  • Page 9: Operating Dantec Clavis

    Operating Dantec Clavis Description Dantec Clavis is a medical device intended to assist in the localization of the muscles and nerves in normal and pathological conditions. It is a handheld, battery-powered device with two main functions: Audio Electromyography (EMG) and Constant Current Stimulation (CCS). The Audio EMG provides a sound- based electromyography signal representing the electrical activity in muscles and nerves.

  • Page 10: Start - Autotest

    Press the Power button again to switch off the device. When you switch on Dantec CLAVIS, it will start an internal auto test, while at the same time it will allow you to verify that the Sound and Indicator Light functions are working properly.

  • Page 11: Emg Mode

    In the EMG mode, the device is used for needle electrode examinations. Throughout the procedure, Dantec Clavis will emit a series of audible signals varying in intensity and frequency that will help monitoring the localization of the targeted muscle or nerve.

  • Page 12: Emg Buttons

    Electrodes Connecting the Electrode Leads to the Device CAUTION: Only electrodes recommended by Natus must be used. Refer to the Neurodiagnostic Supplies section of this user guide for further information. Before starting the procedure, connect the surface and needle electrode leads to their corresponding color-coded connectors as shown in fig.

  • Page 13: Stimulation Buttons

    Dantec Clavis User Guide Figure 3. Electrode Stimulation Connections Ref. Sym- Stimulation Electrodes Color Internally disconnected during stimula- Green tion Anode Anode (additional) Cathode (needle) Black  Connect the reference electrode lead to the red reference connector ( ) (2).
  • Page 14 Dantec Clavis User Guide Setting the Pulse Rate and Width –Press the Hz button to switch between 1Hz and 2Hz pulse rate. –The Green light shows the pulse rate selected. –Press the ms button to switch between 0.1ms and 0.2ms pulse width.

  • Page 15: Maintenance

    Dantec Clavis User Guide Maintenance Dantec Clavis requires no user maintenance other than cleaning the device after each use and replacing the battery periodically. Cleaning The cleaning procedure must be in accordance with your local hygiene authority’s guidelines. The user/operator shall clean device after every use.
  • Page 16 Dantec Clavis User Guide Access to the Battery Compartment Figure 4. Dantec Clavis rear side, the battery compartment. Turn off the device. Slide open the battery compartment lid on the rear of the device. Remove the old battery by pulling it up from the bottom end.

  • Page 17: Neurodiagnostic Supplies

    Dantec Clavis User Guide Neurodiagnostic Supplies Natus recommends use of the following accessories with the Dantec Clavis. ® Bo-ject DHN Disposable Hypodermic Needle Electrode: Needle Part Number Needle Length Lead Color Quantity Diameter 9013S0422 1” (25mm) 0.30mm (30G) 1/pouch- 10/box 9013S0432 1”...

  • Page 18: Technical Data

    Dantec Clavis User Guide Technical Data Power Supply Power supply: internally powered equipment: one 9V alkaline battery. IEC-6LR61, ANSI-1604A. Power consumption: maximum 2 watts. Weight 185 g. with battery (6.526 Oz) 140 g. without battery (4.938 Oz) Dimension (L x W x H)

  • Page 19: Weee Statement

    WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made. Please contact us for details on the collection and recov- ery systems available to you in your region at https://natus.com/...

  • Page 20: Safety & Standards Conformity

    Safety & Standards Conformity Standards of Compliance and Normative References The Dantec Clavis System is powered by a 9V battery with the following levels of protection: 1. Type of protection against electric shock: Class II 2. Degree of protection against electric shock: Type BF 3.
  • Page 21 Dantec Clavis User Guide Table 2 – EMC Standard of Compliance and Normative References IEC 60601-1-2, Edition 4.0, February 1, 2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– collateral standard: electromagnetic compatibility – requirements and tests IEC 61000-4-2:2008, Ed.

  • Page 22: Declaration Of Compliance For Iec 60601-1-2, 4Th Edition

    Guidance and manufacturer’s declaration – electromagnetic emissions The Dantec Clavis is intended for use in the electromagnetic environment specified below. The customer or the user of the Dantec Clavis should assure that it is used in such an environment. Emissions Test...
  • Page 23 Guidance and manufacturer’s declaration – electromagnetic immunity The Dantec Clavis is intended for use in the electromagnetic environment specified below. The customer or the user of the Dantec Clavis should assure that it is used in such an environment. Immunity Test...
  • Page 24 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Dantec Clavis is used exceeds the applicable RF compliance level above, Dantec Clavis should be observed to verify normal operation. If abnor- mal operation is observed, additional measures may be necessary, such as re-orienting or relocating Dantec Clavis.

  • Page 25: Declaration Of Compliance For Fcc

    Dantec Clavis User Guide Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equip- ment Test Band Maximum Distance IMMUNITY fre- Modulation Service Power TEST LEVEL quency (MHz) (V/m) (MHz) Pulse 380 –390 TETRA 400 modulation...
  • Page 26 Dantec Clavis User Guide Please consult natus.com for your local sales & service offices. Natus Manufacturing Limited IDA Business Park Gort, Co. Galway, Ireland Rx only...

Table of Contents