natus Dantec Clavis User manual

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

Dantec Clavis User Guide
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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. 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.
Dantec is a registered trademark of Natus Medical Incorporated. Clavis is a trademark of Natus.

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Table of Contents
Description of Symbols.........................................................................................................4
Safety Information................................................................................................................6
Safety Requirements ................................................................................................................6
Intended Use.............................................................................................................................6
Essential Performance..............................................................................................................6
Contraindications......................................................................................................................7
Side Effects...............................................................................................................................8
Residual Risks..........................................................................................................................8
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.............................................................................................................................................11
EMG Buttons ........................................................................................................................................12
Stimulation Mode....................................................................................................................12
Electrodes.............................................................................................................................................12
Stimulation Buttons .............................................................................................................................13
Maintenance.......................................................................................................................15
Cleaning..................................................................................................................................15
Replacing the Battery..............................................................................................................15
Neurodiagnostic Supplies...................................................................................................17
Technical Data.....................................................................................................................18
Mode of Operation..................................................................................................................18
WEEE Statement .................................................................................................................19
Safety & Standards Conformity .........................................................................................20
Standards of Compliance and Normative References............................................................20
Declaration of Compliance for IEC 60601-1-2, 4th Edition......................................................22
Declaration of Compliance for FCC ........................................................................................25

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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”.
ISO 60601-1
Table D.2 #2
Warnings associated with this device. A warning indicates that there is a risk of
death or serious injury to the user or patient.
ISO 15223-1
Symbol 5.4.4
ISO 60601-1
Table D.1 #10
Cautions associated with this device. A caution indicates that there is a risk of in-
jury to the user or patient or risk of damage to the device.
ISO 15223-1
Symbol 5.4.3
ISO 60601-1
Table D.1 #11
Consult instructions for use.
Indicates the need for the user to consult the instructions for use. Please read the
instruction manual before using this device.
ISO 60601-1
Table D.2 #10
Follow instructions for use.
IEC 606011:2005+
AMD1:2012
EN 60601-1:2006+A1:2013
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 60601-1:2005+AMD1:2012 and EN 60601-1:2006+A1:2013.
Double Insulated (Class II) symbol.
EN 50419
Defines the correct disposal Information, provided in the Waste Management
section
ISO 15223-1
Symbol 5.1.6
Reference Number. This is the part number for the device.
ISO 15223-1
Symbol 5.1.7
Includes the year of manufacture, a letter, the serial number of the device, and a
three-letter revision code.
ISO 15223-1
Symbol 5.1.1
The manufacturer information is adjacent to this symbol

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ISO 15223-1
Symbol 5.1.3
The manufacture date 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 device for at least 10 minutes
according to IEC 60529.
Medical device listing mark for U.S. and Canada by Intertek Testing Service.
The device is not user serviceable.
Battery type.
Rx Only
CAUTION: USA Federal law restricts this device to sale or on the order of a
licensed medical physician.
Medical
Device
Medical Device.
Indicates that the item is a medical device.
ISO 15223-1
Symbol 5.3.7
Indicates the upper and lower limits of temperature to which the medical device
can be safely exposed. The temperature is indicated adjacent to the horizontal
lines.
ISO 15223-1
Symbol 5.3.8
Indicates the upper and lower limits of humidity limitation to which the medical
device can be safely exposed. The humidity limitation is indicated adjacent to the
horizontal lines.
Dantec®CLAVIS™ device.
Carton.
ISO 15223-1
Symbol 5.2.8
Do not use if package is damaged.
Referenced standards
ISO 15223-1:2016: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
IEC 60601-1:2005+AMD1:2012 Consolidated version General requirements for basic safety and
essential performance
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety

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Safety Information
Safety Requirements
This device is intended to be used by qualified medical personnel, knowledgeable in the field of
electrophysiology 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 temper-
atures may affect operation or cause damage.
Do not use damaged or defective devices. Protect this instrument from immersion, spills, the impact of fall-
ing objects, and exposure to excessive smoke, dust, mechanical vibration, or shock.
Any serious incident that has occurred in relation to the Dantec Clavis device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is
established.
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.
Essential Performance
Essential performances of the Dantec Clavis product are identified in the standard IEC 60601-2-40:2016
specifying requirements for the basic safety and essential performance of electromyography 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 monitor 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.

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Contraindications
Patients with an implanted electronic device, e.g., a cardiac pacemaker or with cardiac abnormalities
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.
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
external 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
protection 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 distances.

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Side Effects
There are no known side effects for procedures performed with Clavis.
Residual Risks
All risks related to the use of the device have been mitigated. Control measures including device labeling
and information in the Instruction for Use are in place. Residual risk is outweighed by medical benefit use of
device. 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.
Clinical Benefits
Dantec Clavis assists the physician during needle electrode examinations in the treatment of neuromuscu-
lar diseases such as Dystonia, Strabismus, Essential Tremor, Spasticity, and Temporomandibular
Dysfunction. The portable, battery-operated unit provides easy transport and convenient access
to patients.
Patient Target Group
The target patient population is the pediatric and adult patient population with neuromuscular disease.
Intended Users
The Dantec Clavis is intended for use by skilled physicians trained in the specialty of neuromuscular
diseases, including Neurologists and Physiatrists.
Patient Population
The Dantec Clavis assists the physician in the treatment of patients with neuromuscular diseases such as
Dystonia, Strabismus, Essential Tremor, and Spasticity for pediatric and adult patients.

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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. The CCS provides
current pulses used to stimulate muscles and nerves.
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 low 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 Battery
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
6 mA LED: The reference Voltage is too high
7 mA LED: Overload detection failure
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, or the
speaker is not functioning, the device should not be used. Please contact your local Natus
representative 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
monitoring 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 connectors
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.
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 delivered
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.

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Figure 3. Electrode Stimulation Connections
Ref.
Sym-
bol
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 reference
connector ( ) (3).
Connect the needle electrode lead to the black connector ( ) (4).
Attaching the Electrodes to the Patient
Once the electrode leads have been connected to the device, you can attach the surface electrode/s (an-
ode) 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 introducing 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.

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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.
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 overload,
press the STIM button to stop the stimulation.
CAUTION: High impedance can be due to a weak connection between the device and the electrodes,
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.
The user/operator shall clean device after every use.
1Before you start cleaning the device, make sure it is switched off and that the electrode leads are
disconnected.
2Wipe the device with a damp cloth.
3Remove any excess of water with a dry cloth.
4 In case additional cleaning is required, gently wipe the device with a cloth moistened with a
maximum of 80% alcohol solution.
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 sec-
tion “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 regulations.

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Neurodiagnostic Supplies
Natus recommends use of the following accessories with the Dantec Clavis.
Bo-ject® DHN Disposable Hypodermic Needle Electrode:
Part Number
Needle Length
Needle
Diameter
Lead Color
Quantity
9013S0422
1” (25mm)
0.30mm (30G)
Tan
1/pouch- 10/box
9013S0432
1” (25mm)
0.41mm (27G)
Pink
1/pouch- 10/box
9013S0442
1.5” (37mm)
0.41mm (27G)
Light Blue
1/pouch- 10/box
9013S0472
1.5” (37mm)
0.46mm (26G)
Brown
1/pouch- 10/box
9013S0452
2” (50mm)
0.51mm (25G)
Grey
1/pouch- 10/box
9013S0462
3” (75mm)
0.71mm (22G)
Light Green
1/pouch- 10/box
Disposable Non-Gelled Surface Electrode:
Dantec reusable cables compatible with 9013L0203:
See the Natus Neurodiagnostic Supplies Catalog for additional electrode options.
The catalog can be downloaded from natus.com
Part Number
Recording Area
Lead Length
Lead Connector
9013L0203
7mm x 4mm
3” (8cm)
0.7mm male touchproof
Part Number
Description
Length
Electrode End
Instrument End
9013C0152
Unsheilded Cable
32” (80cm)
0.7mm female
touchproof
1.5mm female
touchproof
9013C0242
Unshielded Cable
79” (2m)
0.7mm female
touchproof
1.5mm female
touchproof

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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)
140 x 84 x 24 mm\
Operating Conditions
Temperatures: ranging from +10°C to +40°C (ranging from 50°F to 104°F).
Humidity: ranging from 30% to 75%rh.
Atmospheric pressure: ranging from 700hPa to 1060hPa.
Storage Conditions
Temperatures: ranging from -10°C to +50°C (ranging from -40°F to +122°F.).
Humidity: ranging from 10% to 100%rh.
Atmospheric pressure: ranging from 700hPa to 1060hPa.
Mode of Operation
Continuous operation.
EMG Performance
Noise Level
<2µVrms ≈10µVpp
Amplifiers, EMG Mode
Amplifier gain Min. 100,000.
EMG amplifier bandwidth: 627Hz –2.2kHz.
Patient Connections
Active input: black 1.5mm TPC*.
Reference inputs: red 1.5mm TPC*.
Patient ground: green 1.5mm TPC*.
Volume Output
Speaker bandwidth: 200Hz –14kHz.
Stimulator Performance
STIM Mode
Output current: 1.0 –15.0mA ±10%. Adjustable in steps of 1mA.
Electrode impedance: 200 –7 kΩ.
Maximum excitation voltage: 100V
When impedance is higher than 7 kΩ, the device cannot deliver full current stimulus. The Overload indicator will
be activated if the selected current level cannot be delivered.
STIM Level
Stim frequency: 1Hz ±10%, or 2Hz ±10%.
Pulse width: 0.1ms ±10%, or 0.2ms ±10%.
Output waveforms: Monophasic Pulse.

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Stimulator Performance (continued)
Patient Connections
Active output: black 1.5mm TPC*.
Reference output: red 1.5mm TPC*.
* TPC: touch proof connectors.
WEEE Statement
Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and Elec-
tronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste must be
separately collected for the proper treatment and recovery to ensure that 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/
Electrical and electronic equipment (EEE) contains materials, components and substances that may be haz-
ardous and present a risk to human health and the environment when WEEE is not handled correctly. There-
fore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users of electrical
and electronic equipment must not discard WEEE together with other wastes. Users must use the municipal
collection schemes or the producer/importers take-back obligation or licensed waste carriers to reduce ad-
verse environmental impacts in connection with disposal of waste electrical and electronic equipment and
to increase opportunities for reuse, recycling and recovery of waste electrical and electronic equipment.
Equipment marked with the below crossed-out wheeled bin is electrical and electronic equipment. The
crossed-out wheeled bin symbol indicates that waste electrical and electronic equipment should not be dis-
carded together with unseparated waste but must be collected separately.

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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. Degree of protection against ingress of water, IPX1
4. Degree of safety of application in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa
The Clavis System and its accessories have been designed to comply with the following national and
international standards:
Table 1 –Safety Standard of Compliance and Normative References
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1:2005 + C1:2006 and C2:2007,
Third Edition
CENELEC EN 60601-1:2006 + A1:2013
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-6:2010, Edition 3.0 + A1:2013
Medical electrical equipment –Part 1-6: General
requirements for basic safety and essential
performance –Collateral standard: Usability
IEC 62366:2007, Edition 1.0
Medical devices –Application of usability
engineering to medical devices
IEC 60601-2-40:2016
Medical electrical equipment - Part 2-40: Particular
requirements for the basic safety and essential
performance of electromyographs and evoked
response equipment