natus Dantec Keypoint G4 User manual

Dantec®Keypoint® G4
Hardware Instructions for Use
9031M1506 Rev. B - EN

Dantec Keypoint G4
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Hardware Instructions for Use
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© 2018 Natus. All rights reserved.
The contents of this manual are the property of Natus. Any reproduction in whole or in part is
strictly prohibited.
At the time of printing / transfer to the DVD, 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 situation voids 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.
Natus Neuro and Keypoint are registered trademarks of Natus Medical Incorporated in the U.S.
and in other countries.
Note that the documentation accompanying the Keypoint devices includes a Software Instructions
for Use manual, a Hardware Instructions for Use manual, a Technical Data Sheet and a Clinical
Reference Manual. Both the Software and Hardware Instructions for Use manuals are necessary
to be able to use the Keypoint.NET application and carry out a test. For advanced use of the
Keypoint.NET application, the Clinical Reference Manual (available in English only) offers a
description of all the functions and tests that can be performed. For technical information, the
Technical Data Sheet (available in English only) offers detailed technical specifications.
Consult Instructions for Use / Attention to Warnings and Cautions
Before starting a test, make sure you read the documentation and fully understand how to
operate the system. Pay special attention to all Warnings and Cautions.
For the list of the general regulatory symbols associated with this device, see the
General Regulatory Symbols section in this manual.

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Hardware Instructions for Use
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Table of Contents
Safety Information ............................................................................................................................ 7
Intended Use .................................................................................................................................... 7
Contraindications.............................................................................................................................. 7
Side Effects........................................................................................................................................ 9
Safety Requirements ......................................................................................................................10
Excerpt from the IEC 60601-1 Standard .........................................................................................12
System Overview ............................................................................................................................ 13
Workstation ................................................................................................................................13
Cable Connection Overview........................................................................................................14
Cable Connections ......................................................................................................................15
Connection Panel........................................................................................................................16
Power Supply / Isolating Transformer Units...............................................................................17
Technical Specifications ..................................................................................................................17
Controls...........................................................................................................................................18
Control Panel ..............................................................................................................................18
Control Functions........................................................................................................................19
Software Navigation / Software Functions............................................................................. 19
Sweep Speed / Sensitivity Level..............................................................................................19
Stimulation..............................................................................................................................19
Stimulus Intensity / Duration / Repetition Rate .....................................................................20
Loudspeaker / Volume / Cursor Mode / Trace / Marker / Trigger......................................... 21
Rear Panel............................................................................................................................... 21
Footswitch (optional)..................................................................................................................22
Amplifiers........................................................................................................................................23
Amplifier Modules: 3, 4, 6, and 8 Channels................................................................................23
Rear Panel...............................................................................................................................25
EP Amplifier Module ― 6 Channels ................................................................................................26
Stimulators..............................................................................................................................28
Safety Information.................................................................................................................. 28
Advanced Stimulation Handgrip (optional) ....................................................................................29
Constant Current Stimulators.........................................................................................................31
Additional information related to stimulation ...............................................................................32
Power Up Test.................................................................................................................................34
Maintenance................................................................................................................................... 35
Safety Checks..................................................................................................................................35
Waste Management .......................................................................................................................35
Classification...................................................................................................................................36
General Regulatory Symbols ...........................................................................................................37
Electromagnetic compatibility........................................................................................................38
List of system items, additional and optional parts........................................................................39

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Hardware Instructions for Use
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Safety Information
The system is intended to be used in electrophysiological tests such as: Electromyography
(EMG), Nerve Conduction Studies (NCS) and Evoked Potential (EP) recordings.
For safety information related to the patient or the use of the Keypoint.NET application software, refer to the
Software Instructions for Use. Make sure to read and understand the information before proceeding to use
this equipment.
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.
Contraindications
It is a medical decision whether the risk of use clearly outweighs any possible benefit in each case.
A patient with an implanted electronic device (i.e., a cardiac pacemaker) should not be subjected to
electrical stimulation unless medical specialist opinion has first been obtained.
In conditions with bleeding tendency certain care should be taken when needles are used.
Conventional precautions should be taken with patients with infectious diseases.
Age and sex do not in themselves present contraindications for any procedure.
For contraindications with needles / electrodes, refer to their accompanying instructions for use.
Danger
Possible explosion hazard, if used in the presence of flammable anesthetics.

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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 compatible for use in an MRI magnetic field.
The device is not intended for direct cardiac application.
The device is not suitable for intensive care monitoring use.
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.
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.
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.
Do not use additional multiple socket-outlets or extension cords.
Use only optional devices specified by Natus in order to comply with IEC 60601-1.

Hardware Instructions for Use
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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.
When operating the current stimulators, be careful not to expose patients to high currents. Before
connecting or disconnecting the stimulation electrode, always “reset” the stimulator.
Pay attention to the intensity indicator during the use of the program. –See the section
Stimulator Overload in the software user guide, and the section Stimulators in this hardware manual
for further information.
Cautions
Always use shielded power line cables from Natus to avoid hum line interference, especially
near the patient, or the amplifier.
Portable and mobile RF communication equipment can affect electrical equipment for medical use.
Electric shock hazard. Do not remove the cover. Refer servicing to qualified service personnel.
Avoid accidental contact between connected, but unapplied electrodes and other conductive parts -
including those connected to protective earth.
Do not use cleaning detergents, or other cleaning agents based on alcohol, solvent, silicon-based,
abrasive and/or flammable substances to clean the equipment.
Side Effects
There are no known side effects for procedures performed with Keypoint G4.

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Safety Requirements
CAUTION 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.
This device has been designed and tested in accordance with IEC Publication 60601-1
Medical Electrical Equipment, cf. the ext 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.
WARNING 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.

Hardware Instructions for Use
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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 ext on IEC 60601-1 further below
in this chapter.
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 is
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:
- Insulation test;
- Ground continuity test; and
- Leakage current test, according to IEC 60601-1.
The protection is likely to be impaired if, for example, the device:
- Shows visible damage;
- Fails to perform the intended function(s);
- Has been subject to severe transport stresses.

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Excerpt from the IEC 60601-1 Standard
CAUTION When connecting other equipment, qualified attention must be paid to the following
excerpt from the medical safety standard to which this system complies.
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), 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 an extra 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.

Hardware Instructions for Use
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System Overview
Workstation
(1) Computer
(2) Power Switch
(3) Monitor
(4) Internal Speaker
(5) Control Panel
(6) PC Keyboard
(7) Electrode Arm (optional)
(8) Current Stimulator (optional)
(9) Amplifier Box (optional)
(10) Connection Panel
(11) Accessory Box Kit (optional)
(12) Mouse
(13) Printer (optional)
(14) LAN Socket (optional)
(15) Cart
(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)

Hardware Instructions for Use
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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:
- On the Power Supply unit, make sure that the voltage selectors are set to the proper
voltage settings.
- 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.
CAUTION Use only optional devices specified by Natus in order to comply with IEC 60601-1.
CAUTION Always use shielded power line cables from Natus to avoid hum line interference,
especially near the patient, or the amplifier.
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

Hardware Instructions for Use
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Power Supply / Isolating Transformer Units
For detailed instructions, refer to the Power Supply or Isolating Transformer manual
accompanying the units.
WARNING Do not use additional multiple socket-outlets or extension cords.
CAUTION 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 the Power Supply / Isolating Transformer accompanying manual for detailed instructions for use.
Power Supply
Isolating
Transformer
Technical Specifications
For technical specifications, refer to the Keypoint G4 section in the Technical Data Sheet.

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Controls
Control Panel
(1) Standby Indicator
(2) Power ON Indicator
(3) Numeric Keypad
(4) Software Navigation Keys
(5) Sweep Speed/Sensitivity Level Arrow Keys
(6) Stimulation Intensity Control Knob
(7) Reset Stimulation Intensity key
(8) Stimulation Duration Arrow Keys
(9) Stimulation Repetition Rate Arrow Keys
(10) Stimulation Indicator
(11) Single Stimulation Key
(12) Repetitive Stimulation Key
(13) Trace/Marker and Trigger Arrow Keys
(14) Volume Indicator
(15) Volume/Cursor Control Knob
(16) Cursor Mode Indicator
(17) Loudspeaker Mute Key / Indicator
(18) Software Function Keys

Hardware Instructions for Use
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Control Functions
Software Navigation / Software Functions
Software Navigation Keys –Color Coded
The Software Navigation keys allow you to navigate through the application tabs.
The 6 Software Navigation keys’colors and functions correspond to those of the Software
Navigation buttons on the application
The Left and Right arrow keys and the Enter key allow you to select tests.
Software Function Keys –Color Coded
The Software Function keys allow you to control the different software functions on
the application.
The 12 Software Function keys’colors and functions correspond to those of the Software
Function buttons on the application.
Sweep Speed / Sensitivity Level
Sweep Speed Arrow Keys
The Right and Left arrow keys allow you to modify the sweep speed.
The Right arrow key increases the sweep speed. The Left
arrow key decreases the sweep speed.
Sensitivity Level Arrow Keys
The Up and Down arrow keys allow you to modify the level of sensitivity.
The Up arrow key increases the sensitivity level.
The Down arrow key decreases the sensitivity level.
Stimulation
Stimulation Indicator
The Stimulation indicator green light (LED) blinks once for Single Stimulation, and intermittently
for Repetitive Stimulation.

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Single Stimulation Key
When the Single Stimulation key is pressed, a single stimulus is released, and the indicator
blinks once.
The Single Stimulation key can also be used to stop Repetitive Stimulation.
Repetitive Stimulation Key
When the Repetitive Stimulation key is pressed, repetitive stimulus is released and the indicator
blinks intermittently.
To stop repetitive stimulation, press either the same Repetitive Stimulation key, or the
Single Stimulation key.
Stimulus Intensity / Duration / Repetition Rate
Stimulation Intensity Control Knob
The Stimulation Intensity control knob allows you to adjust the intensity of the stimulation
released.
Rotate the knob to the right to increase the stimulation intensity.
Rotate the knob to the left to diminish the stimulation intensity.
Reset Stimulation Intensity Key
Press the Reset Stimulation Intensity key to reset the stimulation intensity to its base level.
WARNING: When operating the current stimulators, be careful not to expose the patient to
high currents. Before connecting or disconnecting the stimulation electrode, always reset the
stimulator.
Stimulation Duration Arrow Keys
The Stimulus Duration Up and Down arrow keys allow you to increase/decrease the duration of
the stimulation.
The Up arrow key increases the stimulation duration.
The Down arrow key decreases the stimulation duration.
Stimulation Repetition Rate Arrow Keys
The Stimulus Repetition Rate Up and Down arrow keys allow you to increase/decrease the
stimulation repetition rate.
The Up arrow key increases the stimulation repetition rate.
The Down arrow key decreases stimulation repetition rate.
0mA