natus Dantec Keypoint G4 Manual

Dantec®Keypoint® G4
User and Service Guide
Part Number: 9031M1506 Rev F 23/NOV/2022
System Model Number: 9031A0701
© 2016 - 2022 Natus Medical Incorporated or one of its subsidiaries. All rights reserved. Natus is a registered trademark of Natus Medical
Incorporated. All product names appearing on this document are trademarks or registered trademarks owned, licensed to, promoted or
distributed by Natus Medical Incorporated, its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

2
Contact Information
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
natus.com
Technical Support / Customer Service
Domestic & International:
Natus Medical Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
Email: [e-mail]
Phone: [phone]
1-608-829-8500
Fax: [phone]
Germany:
Email: [e-mail]
Phone: [phone]
Fax: [phone]
France:
Email: [e-mail]
Phone : [phone]
Fax: [phone]
Arazy Group Switzerland GmbH
Bruderholzallee 53
4059 Basel
Switzerland
[e-mail]
Natus Nicolet UK Ltd
Baynards Green Trading Estate
Prospect House
Oxfordshire
Bicester
OX27 7SG
England, United Kingdom
Copyright © 2016-2022 Natus Medical Incorporated. All Rights Reserved.
This manual contains proprietary information, which is protected by copyright laws and may not be copied in whole or in part except with the
prior written permission of Natus Medical Incorporated. The copyright and the foregoing restrictions on the copyright use extend to all media
in which this information is preserved.
This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its distributors,
including without limitation the Natus Software License Agreement. Natus Medical Incorporated makes no representations or warranties of
any kind whatsoever with respect to this document. Natus Medical Incorporated disclaims all liabilities for loss or damage arising out of the
possession, sale, or use of this document.

3
Glossary of Symbols
The following labels and symbols may be affixed to the Dantec Keypoint G4 system:
Symbol Standard Reference Standard Title of Symbol
Symbol Title as
per Referenced
Standard
Explanation
ISO 15223-1
Symbol 5.7.7
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Medical Device This product is a medical
device.
Medical Device
Directive 93/42/EEC
or
Medical Device
Regulation 2017/745
as applicable
Council Directive
93/42/EEC
Regulation (EU) 2017/745
CE Marking of
Conformity
Signifies European
technical conformity.
Notified body number
appears under symbol if
applicable.
UK MDR 2002 UKCA Mark UKCA Mark
Signifies Great Britain
(England, Wales, and
Scotland) conformity.
UK Approved Body
number appears under
symbol.
Swiss Medical Device
Ordinance (MedDO)
Swiss Authorized
Representative
Swiss authorized
representative
Indicates the Authorized
representative in
Switzerland.
21 CFR 801.109(b)(1) Labeling – Prescription
Devices
Device is cleared
for the US market
as requiring a
prescription
Indicates that the product
is authorized for sale by
or on the order of a
licensed healthcare
practitioner.
IEC 60601-1, Reference
no. Table D.2, Symbol
20 (ICE 60417-5333)
Part 1: General
requirements for basic
safety and essential
performance.
Type BF applied
part
To identify a type BF
applied part complying
with IEC 60601-1.
ISO 15223-1
Symbol 5.1.7
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied.
Serial number
Indicates the
manufacturer's serial
number so that a specific
medical device can be
identified.
ISO 15223-1
Symbol 5.1.5
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Batch code or Lot
code
Indicates the
manufacturer's batch
code so that the batch or
lot can be identified.

4
Symbol Standard Reference Standard Title of Symbol
Symbol Title as
per Referenced
Standard
Explanation
ISO 15223-1
Symbol 5.1.6
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Catalogue number
Indicates the
manufacturer’s catalogue
number so that the
medical device can be
identified.
ISO 15223-1
Symbol 5.1.11
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Country of Origin Indicates the country of
origin.
ISO 15223-1
Symbol 5.1.1
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Legal
Manufacturer
Indicates the medical
device manufacturer.
ISO 15223-1
Symbol 5.1.3
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Date of
manufacture
Indicates the date when
the medical device was
manufactured.
ISO 15223-1
Symbol 5.3.7
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Temperature limit
Indicates the (storage)
temperature limits to
which the medical device
can be safely exposed.
ISO 15223-1
Symbol 5.3.8
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Humidity limit
Indicates the range of
(storage) humidity to
which the medical device
can be safely exposed.
ISO 15223-1
Symbol 5.3.9
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Atmospheric
pressure
limitation
To indicate the
acceptable upper and
lower limits of
atmospheric pressure for
transport and storage.
ISO 15223-1
Symbol 5.4.2
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Do not re-use
Indicates that the medical
device is intended for one
use, or for use on a single
patient during a single
procedure.

5
Symbol Standard Reference Standard Title of Symbol
Symbol Title as
per Referenced
Standard
Explanation
Directive 2012/19/EU
Waste Electrical and
Electronic Equipment
(WEEE)
Disposal at end of
operating life
instructions
Indicates that electrical
and electronic equipment
waste should not be
discarded together with
unseparated waste but
must be collected
separately.
ISO 15223-1
Symbol 5.4.3
Annex A #A.15
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Consult
Instruction for Use
Indicates an instruction to
consult an electronic
instruction for use
ISO 15223-1
Symbol 5.4.4
Medical devices —
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
Caution
Indicates the need for the
user to consult the
instructions for use for
important cautionary
information such as
warnings and precautions
that cannot, for a variety
of reasons, be presented
on the medical device
itself.
IEC 60601-1
Table D.1 #10
Medical electrical
equipment — Part 1:
General requirements for
basic safety and essential
performance.
IEC 60601-1
Table D.2 #10
Medical electrical
equipment – Part 1:
General requirements for
basic safety and essential
performance.
Follow Instructions
for Use
Refer to instruction
manual/Booklet.
NOTE on ME EQUIPMENT
“Follow Instructions for
use”.
IEC 60601-1
Table D.2 #2
Medical electrical
equipment — Part 1:
General requirements for
basic safety and Essential
performance.
Warning
Indicates a hazard of
potential personal injury to
patient or operator.
UL Listing N/A UL Classification
Mark
Nationally Recognized
Testing Laboratories
(NRTL) certifications
UL Listing N/A UL Recognized
Component Mark
The optional C-UL-US
Component Recognition
Mark indicates compliance
with both Canadian and
U.S. requirements.

6
Table of Contents
Contact Information................................................................................................................................................2
Glossary of Symbols ................................................................................................................................................3
Table of Contents....................................................................................................................................................6
General Information ...............................................................................................................................................9
User Guide ..........................................................................................................................................................9
Intended Use ......................................................................................................................................................9
System Overview ................................................................................................................................................9
Clinical Performance...........................................................................................................................................9
Clinical Benefits ..................................................................................................................................................9
Medical Conditions.............................................................................................................................................9
Intended Users ...................................................................................................................................................9
Patient Population and Target Group...............................................................................................................10
Residual Risks and Side Effects.........................................................................................................................10
General and Network Security Measures.........................................................................................................10
General Security Policies ..............................................................................................................................10
Networked Environments ............................................................................................................................10
Windows Systems Secure Access.................................................................................................................10
Data Confidentiality .....................................................................................................................................10
Data Protection ............................................................................................................................................10
Protective and Equipment Classification ..........................................................................................................10
Accuracy of Controls.........................................................................................................................................10
Ancillary Accessories.........................................................................................................................................11
Safety, Warnings and Precautions ........................................................................................................................12
Contraindications .............................................................................................................................................12
Warnings...........................................................................................................................................................12
Cautions............................................................................................................................................................13
Safety Requirements ........................................................................................................................................14
Classification.....................................................................................................................................................14
Excerpt from the IEC 60601-1 Standard ...........................................................................................................15
Source Voltage..................................................................................................................................................15
Stimulation Electrodes: Maximum Current Density .........................................................................................15
Stimulation Pulse Terminology.........................................................................................................................16
Accuracy of Controls.........................................................................................................................................16
SystemHardware ....................................................................................................................................................17
Workstation......................................................................................................................................................17
Cable Connection Overview .............................................................................................................................18
Cable Connections ............................................................................................................................................18
Connection Panel..............................................................................................................................................19
Isolation Transformer .......................................................................................................................................19

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Models: 9031D040x / 9031D041x................................................................................................................19
Isolation Transformer Classification.............................................................................................................20
Control Panel ....................................................................................................................................................21
Control Functions..............................................................................................................................................21
Software Navigation / Software Functions ..................................................................................................21
Sweep Speed / Sensitivity Level ...................................................................................................................22
Stimulation ...................................................................................................................................................22
Stimulus Intensity / Duration / Repetition Rate...........................................................................................22
Loudspeaker / Volume / Cursor Mode / Trace / Marker / Trigger...............................................................23
Rear Panel ....................................................................................................................................................23
Amplifiers .........................................................................................................................................................23
Amplifier Modules: 3, 4, 6, and 8 Channels .................................................................................................23
Rear Panel ....................................................................................................................................................25
EP Amplifier Module ― 6 Channels..............................................................................................................25
Stimulators .......................................................................................................................................................26
Advanced Stimulation Handgrip (optional)..................................................................................................26
*Buttons 5 and 6: .........................................................................................................................................27
Constant Current Stimulators ......................................................................................................................27
Stimulation Electrodes .................................................................................................................................28
Footswitch (optional) .......................................................................................................................................28
Power Up Test ..................................................................................................................................................29
Additional Keypoint G4 Accessories and Software Options .............................................................................30
Additional Accessories .................................................................................................................................30
Software Options .........................................................................................................................................30
System Operation .................................................................................................................................................31
Starting Dantec Keypoint.NET...........................................................................................................................31
Home Page ...................................................................................................................................................31
New Study - Patient Data .............................................................................................................................32
Study List ......................................................................................................................................................32
Test Menu ....................................................................................................................................................34
Test Example1: Motor Nerve Conduction ........................................................................................................36
Overview − Motor ........................................................................................................................................36
Notes on Functions and Views .....................................................................................................................36
Selecting a New Site .....................................................................................................................................36
Saving the Recorded Traces .........................................................................................................................37
The History and Acquire Views ....................................................................................................................37
Stimulation Settings .....................................................................................................................................37
Stimulator Overload.....................................................................................................................................38
Loudspeaker Control Panel ..........................................................................................................................38
Markers ........................................................................................................................................................38
Impedance....................................................................................................................................................39
Working with the Result Tables....................................................................................................................40
Nerve Conduction Data Page .......................................................................................................................41
Settings and Design ......................................................................................................................................41
Reassigning Traces in Motor NCS.................................................................................................................41
Test Example2: EMG ........................................................................................................................................42
Overview −Acquire View..............................................................................................................................42
Notes on Functions and Views .....................................................................................................................42
Window Trigger............................................................................................................................................43
The Digital Tape Recorder ............................................................................................................................44
Exporting a Recording ..................................................................................................................................44
Findings ........................................................................................................................................................44
Note Window ...............................................................................................................................................44
Reassign traces in standard needle EMG .....................................................................................................45
MUP Analysis (optional) ...............................................................................................................................46

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Motor Unit Potentials (MUP) (optional) ......................................................................................................46
MUP − Review Page .....................................................................................................................................49
Other Functions ................................................................................................................................................50
Backup..........................................................................................................................................................50
Screen Print ..................................................................................................................................................50
Demo Mode .................................................................................................................................................50
Right-Click.....................................................................................................................................................50
Maintenance, Cleaning .........................................................................................................................................51
Maintenance.....................................................................................................................................................51
Safety Inspection Checks ...................................................................................................................................51
Troubleshooting Noisy Data .............................................................................................................................51
Cleaning Instructions ........................................................................................................................................52
Disposal at End of Operating Life Instructions .................................................................................................52
Natus Technical Support Contact Information .................................................................................................53
Electromagnetic Compatibility (EMC)...................................................................................................................54
Maintaining ......................................................................................................................................................54
EMC Acceptance Criteria ..................................................................................................................................54
Deviations from collateral standard .................................................................................................................55
Electromagnetic Emission.................................................................................................................................55
Electromagnetic Immunity ...............................................................................................................................55
Technical Specifications ........................................................................................................................................58
Keypoint G4 Specifications ...............................................................................................................................58
Rating Frequency..............................................................................................................................................60
Fuse ..................................................................................................................................................................60
Auxiliary Outlets ...............................................................................................................................................60
Weight and Dimensions....................................................................................................................................60
Data Sampling...................................................................................................................................................60
Amplitude resolution ...................................................................................................................................60
Stored sampling frequency ..........................................................................................................................60
Displayed sampling frequency .....................................................................................................................61

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General Information
User Guide
This guide provides the basic information needed to setup, operate and maintain the Dantec Keypoint G4 system.
A PDF copy of this user guide is available on the USB drive provided with the Dantec system. Copies of the user guide may also be accessed at
natus.com in the Support section. Scroll to the EMG Product IFUs, select Dantec Keypoint G4 and choose the version for your local language.
The files can be printed, saved, or searched using Adobe Reader. A copy of Adobe Reader can be downloaded directly from Adobe Systems
(www.adobe.com). A paper copy of the Instructions for Use in available languages can be obtained by contacting Natus Technical Support, or
by contacting a Natus representative.
Intended Use
Keypoint G4 is intended as an electrophysiological aid to assess diagnosis and prognosis, and to monitor diseases of the central and peripheral
nervous system. It can also be used to study functional aspects of nerves and muscles in other fields such as rehabilitation (physical medicine),
occupational medicine and sports medicine.
System Overview
The Keypoint G4 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from
the human nervous and muscular systems in adult and pediatric patients. Keypoint G4 provides the ability to conduct electrodiagnostic testing
including nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing and Autonomic studies. It is
designed to address the testing requirements for medical professionals in hospitals and private practice. Optional software programs and
accessories allow the user to customize the Keypoint G4 system to meet specific clinical requirements.
The Primary Operating functions of the Keypoint G4 system include:
•System startup with device check
•Test protocol selection, customization and execution
•Control of amplifier signals
•Control of electrical, visual and auditory stimuli
•User-controlled data review and analysis
•Reporting and test result summaries
•Storage and retrieval of recorded data
Clinical Performance
The Keypoint G4 allows the user to perform a wide range of Nerve Conduction Studies (NCS), Electromyography (EMG), Evoked Potential (EP)
Studies and Autonomic Studies. Separate software programs and optional accessories allow the user to customize the Keypoint G4 to meet
specific clinical and O.R. monitoring needs.
Clinical Benefits
The Keypoint G4 system assists the physician in collecting measurements and waveforms of the nerves and muscles in the body to support the
diagnosis of neuromuscular disease. Disease is indicated when measurements fall outside of expected or normative ranges. The Keypoint G4
system facilitates the diagnostic evaluation of diseases such as carpal tunnel, radiculopathy, nerve lesions, several types of dystrophy, and
other diseases of the nervous and muscular system.
Medical Conditions
Neuromuscular disease is suspected when a patient complains of abnormal sensations such as tingling, numbness, pain, weakness and/or
abnormal movements including tremor or spontaneous contractions. Electrodiagnostic testing and monitoring is performed on patients with
suspected or confirmed neuromuscular diseases including muscular dystrophy, motor neuron disease (ALS), polio, myasthenia gravis,
peripheral neuropathies, radiculopathies, myopathies, carpal tunnel syndrome, and multiple sclerosis.
Intended Users
The Keypoint G4 is intended to be used by a qualified healthcare provider. Qualified healthcare providers include those with specialized
training in the use of Electrodiagnostic (EDX) instrumentation for the acquisition, display, analysis, storage, reporting, and management of
electrophysiological information from the human nervous and muscular system.

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Patient Population and Target Group
The Keypoint G4 assists the physician in the diagnosis of patients with neuromuscular diseases for pediatric and adult patients.
Residual Risks and Side Effects
There are no known residual risks or side effects for procedures performed with the Keypoint G4. Please note the Warnings and Cautions
before applying power to and using the system. Security Measures
Utilize best practice security measures in your clinical environment including the following:
General and Network Security Measures
General Security Policies
•Prevent physical access to the system from unauthorized persons.
•Make frequent backup of the system. Store the backup on a safely stored device.
•Protect the system with updated antivirus.
•Use the Microsoft Windows firewall at all times.
•Store all DCDs and flash drives provided with your system in a safe location.
Networked Environments
•Connect the system on secured networks only. Using the system on a wide-open network, including wi-fi, Bluetooth, etc. based
networks is not recommended.
•Keep the network software updated with latest patches.
•Use encrypted data communication over “less safe” network segments (ipsec, VPN).
•Enforce that all resources within the network (shares, printers, other equipment) can be accessed by authenticated users only.
•All resources within the network can only be accessed by authenticated users.
•Avoid acquisition systems having contact with patient to act as network servers for different functionality.
Windows Systems Secure Access
•Users should require an account with suitable privileges to use the system (note no special elevated rights are required to use the
EMG application).
•Policies should ensure passwords are complex, non-repeated and regularly changed.
•Enable auditing of system use including windows logins in the operating system.
Data Confidentiality
•The user should lock the system manually if they leave it unattended.
•Short inactivity timeouts are always active and lock the system when the timeout expires.
•The EMG application supports the use of windows screen saver, manual lock screen and automatic switch to the home page after
a timeout on review stations to prevent showing confidential information on unattended systems.
Data Protection
•Do not install any 3rd party software which is not intended for use with the application. An unknown software can possess a
potential security risk.
•Encrypt system drives which contain local databases and temporarily store data files/reports.
•Disable unnecessary windows services designed for not work-related features.
Protective and Equipment Classification
This system is intended for continuous operation and has an IEC 60601-1 protective classification of Class I, Type BF applied parts, ordinary
equipment, not suitable for use in the presence of flammable anesthetics.
Accuracy of Controls
Stimulator values are determined by the operator based on the electrophysiological responses and the subjective reaction of the patient to the
stimulus, therefore an accuracy of ±30% provides acceptable levels for safe use of this equipment in the intended applications.

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Ancillary Accessories
To facilitate the acquisition of electrophysiological information using this system, there are ancillary accessories that must be used. These
accessories include surface electrodes and needle electrodes that are not included with the system. To ensure proper use of the system;
descriptions, recommendations and or specifications are provided for these ancillary accessories that are deemed compatible with the
Keypoint G4 system.
It is recommended that the surface electrodes selected are those that have been cleared or approved for nerve conduction and or evoked
potential studies. Either disposable or reusable surface electrodes may be used. The size of the electrode should be appropriately selected for
the test being conducted. Reusable surface electrodes are made of metal and are typically fabricated from platinum, gold or silver. Metallic
reusable electrodes must be cleaned and or conditioned for reuse according to instructions provided by the manufacturer of those electrodes.
All surface electrodes used should have a protective pin connector that complies with DIN 42 802 standard. This nonproprietary pin connector is
an industry standard for EMG systems.
Disposable and reusable needle electrodes may be used. Needle electrodes are fabricated from a variety of materials. It is recommended that
the needle electrodes selected are those that have been cleared or approved for electromyography applications. Use a length and gauge
appropriate for the test being conducted. The connector is a circular 5 pin DIN connector. This nonproprietary pin connector is an industry
standard for EMG systems. The pin configuration for this connector is as follows: pin 1 is active, pin 2 is reference, pin 3 and pin 4 are shield
drivers and 5 is patient ground.

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Safety, Warnings and Precautions
This chapter defines Safety, Warnings and Precautions applicable to the Dantec Keypoint G4 system. Read all information in this chapter
thoroughly prior to use of the Dantec Keypoint G4 system.
Two labels identify potentially dangerous or destructive conditions and procedures:
Warning
AWARNING indicates that there is a risk of death or serious injury to the user or
patient.
Caution ACAUTION indicates that there is a risk of injury to the user or patient or risk of
damage to the device.
Any serious incident that has occurred in relation to the Natus Keypoint G4 system be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient is established.
Contraindications
There are no known contraindications under normal clinical use.
Warnings
Do not use this PC-based equipment for anything else other than what it is intended for by the manufacturer
−i.e. carrying out tests on patients and possibly subsequent report generation. Do not install any other software
than the Keypoint.NET Software. Natus assumes no responsibility when the equipment is not used as described
in this manual.
The device is not intended for direct cardiac application.
The device is not suitable for intensive care monitoring use.
Possible explosion hazard, if used in the presence of flammable anesthetics.
Any interruption of the protective earth conductor inside or outside of the device, or disconnection of the
protective earth connector is likely to make the device dangerous. Intentional interruption is prohibited. The
protective earth (ground) conductor should be checked regularly.
Do not connect the "patient ground" to the protective earth connection on the rear panel of the Power Supply
Unit/Isolating Transformer or to any other "ground" connections, as the electrode inputs are galvanically
isolated.
Electrical equipment for medical use requires special EMC precautions and needs to be installed and serviced
according to the EMC documentation of device.
When connecting the integrated LAN port to a network system, the NetBox Ref. 9031G046x must be properly
connected into the LAN line between the LAN port and the network system.
Do not make a direct connection between the PC LAN Port and the Network System!
The NetBox Ref. 9031G046x provides electrical insulation to prevent dangerous electrical current from reaching
the patient in the event that the network system becomes accidentally electrically shorted to a high voltage line.
Failure to properly install the NetBox Ref. 9031G046x when making the LAN connection annuls this product’s
compliance certification with the IEC 60601-1 international safety standards for medical electrical equipment.
The use of accessories, electrodes, and cables other than those specified by Natus may result in increased
emissions, or decreased immunity of the equipment.

13
When connecting other equipment, attention must be paid to standard IEC 60601-1– Medical Electrical
Equipment Part 1: General requirements for basic safety and essential performance. Failure to comply with this
standard may result in safety risk.
The equipment should not be used adjacent or stacked with other equipment. If adjacent or stacked use is
necessary, the equipment should be observed to verify normal operation in the configuration in which it will be
used.
Dangerous physiological effects! The current stimulator may give off dangerous currents and voltage.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emission or decreased electromagnetic immunity of this
equipment and result in improper operation.
Electric shock hazard. Do not remove the cover. Refer servicing to qualified service personnel.
This device is intended to be used by qualified medical personnel, knowledgeable in the field of neurophysiology
and neurophysiological assessment, as well as in the use of the product / Keypoint equipment.
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 Keypoint system including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Portable and mobile RF communication equipment can affect electrical equipment for medical use.
Dangerous physiological effects! The current stimulator may give off dangerous currents and voltage.
Do not use cleaning detergents, or other cleaning agents based on alcohol, solvent, silicon-based, abrasive
and/or flammable substances to clean the equipment.
Avoid accidental contact between connected, but unapplied electrodes and other conductive parts - including
those connected to protective earth.
Always use shielded power line cables from Natus to avoid hum line interference, especially near the patient, or
the amplifier.
Cautions
Simultaneous connection of a patient to HF surgical equipment may result in burns at the site of the electrical
stimulation or recording electrodes, and possible damage to the electrical stimulator or the electrode input
amplifiers. Operation in close proximity (e.g., 1m) to short wave or microwave therapy equipment may produce
instability in the electrical stimulator output.
When connecting other equipment, qualified attention must be paid to the following excerpt from the medical
safety standard to which this system complies.
Use only optional devices specified by Natus in order to comply with IEC 60601-1.
Use only the 6-outlets safety power supply / isolating transformer unit for all devices of the complete system in
order to comply with the IEC 60601-1. See Isolating Transformer for instructions for use.
Avoid electrical stimulation for an extended period of time.
It is strongly recommended to back up regularly. To back up the database, use the Admin Tool program.
To back up the directory containing archived studies, use the Windows Backup Tool.

14
New reference values are required when changing the algorithm. If you use the reference value system, the
values must reflect the algorithm you select.
New settings require new reference values.
If you use the reference value system, the values must reflect the settings you select.
Due to risk of electric shock, the operator and / or patient must not directly or indirectly touch the metal shield
on the LINK cable attached to the rear of the amplifier.
Do not use additional multiple socket outlets or extension cord.
Pay attention to the intensity indicator during the use of the program. See the section Stimulator Overload, and
the section Stimulators for further information.
Safety Requirements
This device has been designed and tested in accordance with IEC 60601-1 Medical Electrical Equipment, cf. the text on IEC 60601-1 further
below in this section.
The device has been designed for indoor use at temperatures between +10°C and +35°C (+50°F to +95°F).
The mains plug must only be inserted in a mains socket outlet provided with a protective earth contact.
•It is forbidden to use extension cords.
•It is forbidden to use multiple portable socket outlets (MPSO).
Adhere to the following recommendations for safe operation of the device:
•When connecting medical equipment being supplied from an outlet located in a non-medically used room, or when connecting
non-medical electrical equipment to this device, please pay attention to the requirements of IEC 60601-1, Safety Requirements for
medical electrical systems, cf. the text on IEC 60601-1, is found below in this section.
•When the device is connected to its mains supply, connectors may be live, and any opening of covers or removal of parts possible
only with the aid of a tool is likely to expose live parts.
•The device must be disconnected from all voltage sources before being opened for any adjustment, replacement, maintenance or
repair.
•Service must be referred to Natus authorized service personnel, except for such works described in this manual as being
performed by the operator.
•Make sure that only fuses with the required rated current and of the specified type are used for replacement. The use of
makeshift fuses and the short-circuiting of fuse holders are prohibited.
•Where more than one piece of equipment is connected to the patient, attention must be paid to the summation of patient
leakage currents.
•Whenever it is likely that the protection has been impaired, the device shall be made inoperative and be secured against any
unintended operation. Call qualified service personnel to conduct at least a functional test and a safety check that should include
the following:
oInsulation test
oGround continuity test
oLeakage current test, according to IEC 60601-1
•The protection is likely to be impaired if, for example, the device:
oShows visible damage
oFails to perform the intended function(s)
oHas been subject to severe transport stresses
Classification
Type of protection against electric shock: class I:
•Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an
additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in
the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the
basic insulation.

15
Method(s) of cleaning recommended by the manufacturer:
•Please see Maintenance and Cleaning.
Degree of protection against electric shock:
•Type BF: applied part providing a particular degree of protection against electric shock, particularly regarding:
•Allowable leakage current
•The applied part is electrically isolated (floating).
•Not intended for direct cardiac application.
Degree of protection against harmful ingress of water:
•IP20: ordinary equipment (enclosed equipment without protection against ingress of water).
•Note the Keypoint Triple Footswitch Ingress Protection: IPX1
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 such a mixture.
Mode ofoperation:
•Continuous operation.
Degree of patient vicinity:
•Whole equipment (system) is suitable for use in the patient environment.
Excerpt from the IEC 60601-1 Standard
Reference: IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance. Chapter 16:
Medical Electrical Systems.
When connecting to a medical appliance with an F-type applied part, or some additional equipment complying not with IEC 60601-1 but with
the relevant safety standard for such equipment, the additional equipment:
1. must either be placed outside the patient environment --the patient environment is any area in which intentional, or unintentional
contact can occur between patient and parts of the system (e.g., a printer, VEP Monitor) or as a result of some other person touching
parts of the system;
or
2. if placed within the patient environment, must be:
a) provided with an additional protective earth connector;
or
b) supplied from a separating transformer, limiting the enclosure/touch leakage current to a value not exceeding: Normal
Condition: 0.1 mA or Single Fault Condition 0.5 mA
Please refer to IEC 60601-1 for further details.
Source Voltage
The source voltage for the current stimulators is approx. 400 V. If the load impedance exceeds 400 V/Iskin, where Iskin denotes the selected
stimulating current, the stimulators will be unable to provide the selected currents. Furthermore, the stimulators will be unable to provide
more than approximately 0.5 W. This may limit the output current for fast stimulations.
Stimulation Electrodes: Maximum Current Density
If the current density exceeds 2 mA rms/cm2, it may require the special attention of the user (the risk of burning the skin). The maximum pulse
current will depend on the frequency of the stimulation, pulse width and the area of the electrode. The current density may be calculated as
follows:
= �(× )×

where f designates the frequency of stimulation, Tp pulse width, I pulse current and A the area of the electrode. In certain cases, however,
e.g., nerve damage, it may be necessary to apply heavier currents.

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Electrode Areas
9031E017 = 0.58 cm2
9013L036 = 0.39 cm2
An example: 9013L036 surface stimulation electrode, felt tips, stimulus frequency 2 Hz, pulse width 0.2 ms:
=√2 × 0.0002 ×
0.392<2 2
<39
Stimulation Pulse Terminology
The term “pulse duration” or “pulse width” refers to the length of time from point A to point B. The “pulse amplitude” refers to the output
level reference from points C and D with the rated load. See Figure 1.
Figure 1
Accuracy of Controls
Stimulator values are determined by the operator based on the electrophysiological responses and the subjective reaction of the patient to the
stimulus, therefore an accuracy of ±30% provides acceptable levels for safe use of this equipment in the intended applications.

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System Hardware
This chapter describes the basic hardware used to operate the Dantec Keypoint G4 system.
Workstation
1
Computer
9
Amplifier Box (optional)
2
Power Switch
10
Connection Panel
3
Monitor
11
Accessory Box Kit (optional)
4
Internal Speaker
12
Mouse
5
Control Panel
13
Printer (optional)
6
PC Keyboard
14
LAN Socket (optional)
7
Electrode Arm (optional)
15
Cart
8
Current Stimulator (optional)
16
Power Supply / Isolating Transformer
NOTE All the positions of the devices shown on the picture are examples only.

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Cable Connection Overview
A Power Supply / Isolating Transformer F Screen K Loudspeaker
B Printer (optional) G Amplifier Box (optional) L Network Isolator (optional)
C Computer H Stimulator Box (optional) M Cart Enclosure
D PC Keyboard I Mouse N
DC power supply unit (used with
Isolating Transformer)
E Control Panel J Connection Panel O EP Amplifier Box (optional)
Cable Connections
Before operating the device, the system parts should be connected.
1. Connect all the signal interface cables as depicted in the illustration (black thin).
2. Connect all the power interface cables as depicted in the illustration, except for the main cables to the wall outlet (blue dotted).
3. Check voltage:
a. On the Power Supply unit, make sure that the voltage selectors are set to the proper voltage settings.
b. On the Isolating Transformer unit, make sure that the correct voltage type is used.
4. Connect the mains cable to the wall outlet (blue dotted).
5. Press the Power on/off button on the front panel of the computer for the system to turn on.
NOTE Unplugging the power line cable from the mains input on the power supply/Isolating Transformer disconnects the mains power of
the complete system.
NOTE Make sure the device connected to the wall power outlet is positioned in such a way to allow easy disconnection from the mains, if
needed.
NOTE HS LINK – Multiple types of modules can be connected to HS LINK (see G, H, and O in the figure above). Certain types of module
combinations are restricted due to HS LINK power limit. Module restrictions are software controlled.
NOTE HS LINK – Modules (G, H, and O) connected to HS LINK may have certain limitations due to system power consumption conditions.
Limitations are hardware related and can be avoided by using the DC Power Supply (N).

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Connection Panel
Input / Output Connector
Input / Output Magnetic Stimulation / tendon hammer, or synchronization of external trigger, or external
stimulation acquisition.
Footswitch Connector
VEP Pattern Stimulator Connector
AEP Auditory Stimulation Headset Connector
VEP Visual Goggles Stimulator Output Connector
Power ON Indicator
Isolation Transformer
The Isolation Transformer is intended for applications where medical devices require improved electrical isolation and/or reduced leakage
current to comply with existing safety standards.
This device has been designed and tested in accordance with IEC 60601-1 Medical Electrical Equipment standard.
To ensure a safe operation and to maintain the device in a safe condition, follow the instructions in this manual and pay attention to all
warnings and cautions.
Models: 9031D040x / 9031D041x
Function Description
1 Mains Input
Plug the shielded mains power cord supplied with the system into this socket.
NOTE Only use a shielded power cord from Natus.
Rating Frequency: 50/60Hz.
- Continuous Operation: max. 1000VA
- Momentary Operation: max 1500VA
9031D040x: 100/120V~
9031D041x: 200/240V~

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Function Description
2 Fuse
F1 and F2 Mains
9031D040x: 110V/120V: T10A / 250V~
9031D041x: 200/240V: T6.3A / 250V~
3 M4 Thread for Electrical Enclosure Contact and Additional Protective Earth.
4 Potential equalization
Where potential equalization is necessary or desirable, a potential equalization conductor may be connected to this
connector as per DIN 42 801.
5 Spring Retaining Clamp for Power Cord
Place the spring retaining clamp around the power cord to ensure a safe connection.
6 Auxiliary Outlet－6 Outlets: 50/60Hz
9031D040x:
100-120V~ total max.
- Continuous Operation 7.4A
- Momentary Operation 12.4A
7.4A equals 850VA, and 12.4A equals 1425VA at 115V~
9031D041x:
200-240V~ total max.
- Continuous Operation: 3.7A
- Momentary Operation: 6.2A
3.7A equals 850VA and 6.2A equals 1425VA at 230V~
7 SN: Device Serial Number
8 REF: Device Reference Number
NOTE: Unplugging the power line cable from the mains input on the Isolating Transformer disconnects the mains power to all supplied
devices.
Isolation Transformer Classification
Type of protection against electric shock:
•Class I: Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional
safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in the fixed
wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation.
Method(s) of sterilization:
•Device is not intended to be sterilized.
Degree of patient vicinity:
•Device suitable for use in patient environment.
Degree of protection against electric shock:
•Enclosure protectively earthed (treated as applied part Type B).
Degree of protection against harmful ingress of water:
•IP20: Ordinary equipment (enclosed equipment without protection against ingress of water).
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 such a mixture.
Mode of operation:
•Continuous operation at normal load and Momentary operation at high load.
•Momentary operation at high load is used for short time printing with high power laser printers.
•Momentary operation at high load is possible for up to 60 sec per hour at elevated temperatures.
Operation at high load over prolonged time may cause thermal cut out. After cooling down (hours) internal thermal fuse will reset and normal
operation can be resumed.