natus Dantec Clavis User manual

Dantec®Clavis™
User Guide
9031M6114EN rev.B

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Copyright © 2018 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.
At the time of printing / transfer to the CD-ROM, this manual correctly described the device and its
functions. However, as modifications may have been carried out since the production of this manual,
the system package may contain one or more addenda to the manual. This manual including any such
addenda must be thoroughly read, before using the device.
The following situations void any guarantee(s) and obligations for Natus:
- The device is not used according to the enclosed manuals and other accompanying documentation.
This system is CE marked in conformity with the requirements in the Medical Device Directive
93/42/EEC.
Dantec is a registered trademark of Natus Medical Incorporated. Clavis is a trademark of Natus Neuro.

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Table of Contents
Description of Symbols ..................................................................................................7
Safety Information.........................................................................................................9
Safety Requirements .................................................................................................................................9
Intended Use...........................................................................................................................................9
Essential Performance .............................................................................................................................10
Contraindications .................................................................................................................................10
SIDE EFFECTS............................................................................................................................................11
Operating Dantec Clavis .............................................................................................. 12
Control Panel Overview ...........................................................................................................................12
Start –AutoTest .......................................................................................................................................13
EMG Mode...............................................................................................................................................14
Electrodes .............................................................................................................................................14
EMG Buttons.........................................................................................................................................15
Stimulation Mode ....................................................................................................................................16
Electrodes .............................................................................................................................................16
Stimulation Buttons..............................................................................................................................17
Cleaning ...................................................................................................................................................19
Replacing the Battery ..............................................................................................................................19
Waste Management ................................................................................................................................20
Neurodiagnostic Supplies............................................................................................. 21
Bo-ject® DHN Disposable Hypodermic Needle Electrodes.......................................................................21
Technical Data............................................................................................................. 22
Power Supply ........................................................................................................................................22
Weight ..................................................................................................................................................22
Dimension (L x W x H)...........................................................................................................................22
Operating Conditions............................................................................................................................22
Storage Conditions ...............................................................................................................................22
Mode of operation................................................................................................................................22
EMG Performance ................................................................................................................................22
Stimulator Performance .......................................................................................................................22
Safety & Standards Conformity.................................................................................... 24
Standards of Compliance and Normative References.............................................................................24
Declaration of Compliance for IEC 60601-1-2, 4th Edition .....................................................................26
Declaration of Compliance for FCC..........................................................................................................30
Figures:
Figure 1. Control Panel Overview ...........................................................................................................12
Figure 2. EMG Electrode Connections ....................................................................................................14
Figure 3. Electrode Stimulation Connections..........................................................................................16
Figure 4. Dantec Clavis rear side, the battery compartment. ................................................................20

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Description of Symbols
NOTE: The front panel symbols and buttons can be found in the control panel overview in the section
“Operating Dantec Clavis”.
Warnings associated with this device.
Cautions associated with this device.
Attention: Please read the instruction manual before using this device.
The Dantec Clavis system is certified to carry the CE mark. The CE mark is a declaration that
this product is in compliance with the directive set forth by the European Union for medical
devices.
Defines the degree of protection against electric shock. The Dantec Clavis system is classi-
fied as type BF.
Double Insulated (Class II) symbol.
According to WEEE regulations in Europe, the Dantec Clavis system may not be disposed of
as unsorted, municipal waste. Dantec Clavis system should be returned to the manufacturer
when it is ready for disposal. Contact the manufacturer for more information.
RF Equipment for Non-ionizing Radiation.
REF
Reference Number. This is the part number for the device.
SN
Includes the year of manufacture, a letter, the serial number of the device, and a three-
letter revision code.
The manufacturer information is adjacent to this symbol
The manufacture date/location is adjacent to this symbol.
IPX1
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. Protection from dripping water
from above the device for at least 10 minutes according to IEC 60529.

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Medical device listing mark for U.S. and Canada by Intertek Testing Service.
Follow instructions for use.
The device is not user serviceable.
Battery type.

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Safety Information
Safety Requirements
This device is intended to be used by qualified medical personnel, knowledgeable in the field of electro-
physiology and with the appropriate education and special training. Before using the instrument, please
read these operating instructions carefully. Follow the warnings indicated on the instrument and the
safety precautions recommended in this manual.
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.
Medical electrical equipment needs special precautions regarding EMC, and requires installation and
servicing according to the information
provided in this user guide.
The device has been designed for indoor use at temperatures between +10°C and +40°C (+50°F to
+104°F). Situate the unit away from heat sources such as radiators and warming lamps as exposure to
high temperatures may affect operation or cause damage.
Do not use damaged or defective devices. Protect this instrument from immersion, spills, the impact of
falling objects, and exposure to excessive smoke, dust, mechanical vibration, or shock.
Intended Use
Dantec Clavis is a medical device intended as a stimulator for nerve localization as well as an aid for
guidance of injections into the muscles.

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Essential Performance
Essential performances of the Dantec Clavis product are identified in the standard IEC 60601-2-40, Edi-
tion 2.0, 2016-08, Particular requirements for the basic safety and essential performance of electromy-
ographs and evoked response equipment. Essential performance relates to the quality of the signal
recorded from the amplifier.
In the EMG mode:
The essential performance for Dantec Clavis supports 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.
Additional essential performance also includes the ability of the health care professional to inject
any necessary drugs to the patient through the use of the Bo-ject needles.
Stimulation Mode:
The Clavis system can apply a current pulse train to the patient.
The Stimulation Level bar facilitates the monitoring of the stimuli.
Contraindications
Patient with an implanted electronic device –e.g., a cardiac pacemaker, or with cardiac abnormali-
ties should not be subjected to electrical stimulation unless specialist medical opinion has first
been obtained. Please refer to contraindications for implant systems for further information on
pacemakers.

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WARNINGS
The device is not intended for cardiac application.
Do Not apply electrodes:
1. Over the thoracic area
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.
This device must not be used simultaneously with other equipment, or near other equipment,
which might give off electrical energy.
The device is not compatible for use in an MRI magnetic field.
Do not immerse the device in any liquid.
CAUTIONS
Always read the instructions accompanying the needles/electrodes used.
In conditions with bleeding tendency, certain care should be taken when needles are used.
Conventional precautions should be taken with patients with infectious diseases and broken
skin.
Dantec Clavis cannot be sterilized.
After using an alcohol prep to clean the skin, make sure any flammable liquid and/or vapors
have evaporated and dispersed before using the instrument.
Portable RF communications equipment (including peripherals such as antenna cables and ex-
ternal antennas) should be used no closer than 30 cm (12 inches) to any part of the Dantec
Clavis System, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals as well as residential environments This equipment might not offer adequate protec-
tion to radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.
The Dantec Clavis system should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the system should be observed to verify normal operation
in the configuration in which it will be used. Refer to the Recommended Separation Distances
table in the Safety & Standards Conformity section for minimum recommended separation dis-
tances.
SIDE EFFECTS
There are no known side effects for procedures performed with Clavis.

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Operating Dantec Clavis
Control Panel Overview
Dantec Clavis Front Panel
Button/ Symbol
Legend
Figure 1. Control Panel Overview
Patient Ground.
Reference.
EMG input.
1 2 3
1Speaker
2Battery power status indicator–
yellow light.
3Power switch
(on/off toggle).
1 2
EMG
1Activation button.
2Volume controls.
1 2 3 & 4
Stimulation
1Activation button.
2Stimulation Level controls.
3Current Stimulation Level bar/ Green
Lights indicator.
4Yellow Overload Light indicator.
1 2
Pulse
1Pulse Rate button/ Yellow Light
indicator.
2Pulse Width button/ Yellow Light
indicator.

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Start –AutoTest
Power On /Off
Press the Power button to switch on the device.
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.
NOTE: The device automatically switches off after a period of ten minutes, if left unused.
Correct Functioning
1.Sound: The device emits a series of clicks
2. Indicator Lights: All the indicators ―Current Stimulation Level Bar; Pulse Rate /Width; and Bat-
tery Status― will light up for a few seconds.
Incorrect Functioning
If an internal error is found, the device will go on a “Fail Safe” mode. In the Fail Safe mode, the following
failure codes can appear:
1 mA LED: Intensity or Gain too low (first Intensity/Gain combination)
2 mA LED: Intensity or Gain too high (first Intensity/Gain combination)
3 mA LED: Intensity or Gain too low (second Intensity/Gain combination)
4 mA LED: Intensity or Gain too high (second Intensity/Gain combination)
5 mA LED: The reference Voltage is too low (the 3,3V to the PIC® Microcontroller)
6 mA LED: The reference Voltage is too high
7 mA LED: Overload detection failure (detected when not supposed to be present)
8 mA LED: Overload detection failure (Missing detection)
9 mA LED: Critical low battery voltage –exchange battery
10 mA LED: Current Limiter failure
If any of the failure codes appear, only the power button will remain operative. Attempt to power off
and on the device. If the problems persist, please contact your local Natus representative.
NOTE: During the startup auto test the device should emit a series of clicks. If the clicks are not heard,
the speaker is not functioning and the device should not be used. Please contact your local Natus rep-
resentative for support.

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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 moni-
toring the localization of the targeted muscle or nerve.
Note that the Sound Signal flashes a green light when EMG is activated.
Electrodes
CAUTION: Only electrodes recommended by Natus must be used. Refer to the Neurodiagnostics
Supplies section of this user guide for further information.
Connecting the Electrode Leads to the Device
Before starting the procedure, connect the electrode leads to their corresponding color-coded connect-
ors as shown in fig. 2 below.
Figure 2. EMG Electrode Connections
Ref.
Symbol
EMG Electrodes
Color
1
Patient Ground
Green
2
Reference
Red
3
Reference (additional)
Red
4
EMG input (active)
Black
Connect the ground electrode to the green patient ground connector ( ) (1).
Connect the reference electrode to the red reference connector ( ) (2).
If needed to reduce impedance, connect another reference electrode to the additional red reference
connector ( ) (3).
Connect the EMG needle electrode to the black connector ( ) (4).

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Attaching the Electrodes to the Patient
Once the electrode leads have been connected to the device, you can attach the ground and reference
electrodes to the patient, and when ready, proceed with the EMG needle electrode (active input).
EMG Buttons
Activating the EMG Mode
–Press the EMG button to activate the EMG mode.
–Press the EMG button again to stop the EMG mode.
Adjusting Volume
–Press the Volume Up button to increase the volume.
–Press the Volume Down button to decrease the volume.
–For continuous increase or decrease of the volume press and hold
down the volume buttons.
–Note that the Sound Signal flashes a green light when EMG is
activated.
NOTE: The volume can only be adjusted while in EMG mode.
NOTE: The stimulation level can also be adjusted while in EMG mode. Refer to the Stimulation section
for a description of the stimulation mode and its buttons.

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Stimulation Mode
In stimulation mode, a current pulse train is delivered to the patient.
The flashing indicators in the Stimulation Level bar allow you to control the level of current being deliv-
ered to the patient.
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. 3
below.
Figure 3. Electrode Stimulation Connections
Ref.
Symbol
Stimulation Electrodes
Color
1
Internally disconnected during stimula-
tion
Green
2
Anode
Red
3
Anode (additional)
Red
4
Cathode (needle)
Black
Connect the reference electrode lead to the red reference connector ( ) (2).
If needed to reduce impedance, connect another reference electrode lead to the additional red ref-
erence connector ( ) (3).
Connect the needle electrode lead to the black connector ( ) (4).

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Attaching the Electrodes to the Patient
Once the electrode leads have been connected to the device, you can attach the surface electrode/s
(anode) to the patient, and when ready, proceed with the needle electrode (cathode).
WARNING: Avoid trans-thoracic stimulation. Keep the anode and cathode stimulation sites in
close proximity.
WARNING: Do not use the stimulation mode while attaching the surface electrodes or introduc-
ing the needle electrode into the patient.
Stimulation Buttons
Activating the Stimulation Mode
–Press the STIM button to activate the current stimulation mode.
–Press the STIM button again to stop the current stimulation mode.
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.
–The Green light shows the pulse width selected.
Adjusting the Stimulation Level
–Press the Increase Stim Level button to increase the stimulation level.
It is only possible to increase the STIM Level in steps of 1mA.
–Press the Decrease Stim Level button to decrease the stimulation level.
For continuous decrease of the STIM Level press and hold down the decrease button.

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Stimulation Level Bar
–The Stimulation Level bar ranges from 0mA to 15mA.
–The Stimulation Level indicators show the level of current selected.
–When Stimulation mode is activated, the indicators are flashing.
Overload Indicator
–When the Overload indicator is lit up, it indicates that the device is unable to deliver the
selected current.
CAUTION: Pay attention to the overload indicator during the stimulation mode. In case of over-
load, press the STIM button to stop the stimulation.
CAUTION: High impedance can be due to a weak connection between the device and the elec-
trodes, or due to degradation of the electrodes.

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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.
1Before you start cleaning the device, make sure it is switched off and that the electrode leads are dis-
connected.
2Wipe the device with a damp cloth.
3Remove any excess of water with a dry cloth.
4 In case disinfecting is required, gently wipe the device with a cloth moistened with alcohol. Recom-
mended alcohol solution, max volume 80%.
5 Always wipe the device dry after using the alcohol solution.
WARNING: Do not immerse the device in any liquid, or drip water into the connectors, or any
other openings in the cover.
CAUTION: Do not use solvent silicon based or abrasive cleaning agents to clean the device.
Replacing the Battery
Replace the battery when the indicator emits a yellow light.
Note that the device will automatically go into “Fail Safe” mode when the battery power is so low that it
would affect the performance.
CAUTION: Do not use rechargeable batteries. Use only a standard 9V alkaline battery –see the
section “Technical Data” in this user guide for further information.
CAUTION: Battery Leakage: If the unit is going to be stored for a prolonged period of time, we
recommend that the battery is removed to protect the unit from damage caused by battery
chemical leakage.
NOTE: Always follow the instructions accompanying the batteries.

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Access to the Battery Compartment
Figure 4. Dantec Clavis rear side, the battery compartment.
1 Turn off the device.
2 Slide open the battery compartment lid on the rear of the device.
3 Remove the old battery by pulling it up from the bottom end.
4 Insert the new battery into the battery compartment making sure that the plus and minus contacts
are facing as indicated by the symbols.
5 Slide close the battery compartment lid until it locks in place.
CAUTION: Do not use the device if the battery compartment lid is open, or not correctly locked
in place.
NOTE: It is recommended that the battery be removed from the device if it is not used for an extended
period.
NOTE: Used batteries should be disposed of according to normal hospital/clinic policy or local regula-
tions.
Waste Management
Waste Electrical and Electronic Equipment: Compliance Information.
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product
according to the local regulations.