natus Dantec Keypoint Focus User manual

Dantec®Keypoint® Focus
Hardware Instructions for Use
9033M3703EN Rev. C

Hardware Instructions for Use
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Dantec Keypoint Focus
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Copyright © 2019 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 include 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.
Follow 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.

Hardware Instructions for Use
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Dantec Keypoint Focus
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Table of Contents
Intended Use........................................................................................................................................ 7
Safety Information ............................................................................................................................... 7
Contraindications ................................................................................................................................. 7
Danger ............................................................................................................................................... 7
Warnings ........................................................................................................................................... 8
Cautions............................................................................................................................................. 9
Side Effects ............................................................................................................................................. 9
Safety Requirements ............................................................................................................................ 10
Excerpt from the IEC 60601-1 Standard ............................................................................................... 12
System Overview ............................................................................................................................... 13
Keypoint Focus Main Unit .................................................................................................................... 13
System Setups ...................................................................................................................................... 14
KEYPOINT Notebook PC................................................................................................................... 14
KEYPOINT Standard ......................................................................................................................... 14
Cable Connections ................................................................................................................................ 15
Main Unit ............................................................................................................................................. 15
Connection ―Side Panel ................................................................................................................ 15
Rear Panel ....................................................................................................................................... 16
Technical Specifications........................................................................................................................ 17
Controls.............................................................................................................................................. 18
Control Panel........................................................................................................................................ 18
Control Functions ............................................................................................................................ 19
Footswitch (optional) ........................................................................................................................... 22
Amplifiers........................................................................................................................................... 23
Amplifier Module ―3 Channels........................................................................................................... 23
Amplifier Modules ― 3, 4, 6, 8 Channels ............................................................................................. 25
EP Amplifier Module ― 6 Channels...................................................................................................... 28
Current Stimulators............................................................................................................................ 30
Safety Information ............................................................................................................................... 30
Stimulator........................................................................................................................................ 30
Stimulation Electrodes .................................................................................................................... 30
Advanced Stimulation Handgrip (optional).......................................................................................... 31
Multi-Constant Current Stimulator Module ......................................................................................... 33
Additional information related to stimulation ..................................................................................... 34
Source Voltage ................................................................................................................................ 34
Stimulation Electrodes .................................................................................................................... 34
Maximum Current Density .............................................................................................................. 35
Power Up Test.................................................................................................................................... 36
Warnings ............................................................................................................................................. 36

Hardware Instructions for Use
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PC Requirements................................................................................................................................ 37
Safety ................................................................................................................................................... 37
Performance......................................................................................................................................... 37
Maintenance ...................................................................................................................................... 38
Cleaning Instructions............................................................................................................................ 38
Safety Checks........................................................................................................................................ 38
Waste Management........................................................................................................................... 39
Classification ...................................................................................................................................... 39
General Regulatory Symbols .............................................................................................................. 40
Electromagnetic compatibility............................................................................................................ 41
List of system items, additional and optional parts ............................................................................ 42

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Intended Use
Keypoint Focus 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.
Safety Information
The Keypoint Focus 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.
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 MRI compatible.
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.
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 connect the "patient ground" to the protective earth connection on the rear panel of
the 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.

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The use of accessories, electrodes, and cables other than those specified by Natus may result
in increased emissions, or decreased immunity of the equipment.
Use only optional devices specified by Natus in order to comply with IEC 60601-1.
When connecting other equipment, attention must be paid to standard: IEC 60601-1 Medical
Electrical Equipment, (Part 1…). 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.
Electrostatic Sensitive Amplifier Input connectors – Do not touch the Amplifier Input
connectors as it may damage the amplifier, or affect its performance.
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 Focus.

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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 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).
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.

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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 text on IEC 60601-1, further 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:
-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, 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.

Dantec Keypoint Focus
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System Overview
Keypoint Focus Main Unit
1 Main Unit 2 (Notebook PC
3 Rear Panel 4 Side Panel
5 Control Panel

Hardware Instructions for Use
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System Setups
KEYPOINT Notebook PC
KEYPOINT Standard

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Cable Connections
Before operating the device, the system parts need to be connected. Follow the steps 1-3
below.
1. Connect all the signal interface cables (USB / HS-Link) as depicted in the illustrations.
2. Connect all the power interface cables as depicted in the illustrations, except the power
cord.
3. Connect the power cord to the wall outlet.
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 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 Unplugging the power line cable from the mains input on the Main Unit, disconnects
the mains power of the complete system.
NOTE HS LINK can have modules serially connected according to the following configuration
examples:
–Main Unit (3, 6 or 8 ch) Amplifier EP 6-ch Amplifier
–Main Unit (3, 6 or 8 ch) Amplifier Multi-CC stimulator
–Main Unit (3, 6 or 8 ch) Amplifier Focus 3-ch Amplifier
Main Unit
Connection ―Side Panel
VEP
AEP
9033G0704:
9033G0701:
9033G0703:
VEP
AEP
LINK
CC
CC

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CC Stimulator Output (isolated)
The CC stimulator output connectors are electronically isolated.
CC Stimulator Output Socket (isolated)
For connection of stimulation electrodes with DIN plugs. Support
for the active handgrip.
LINK
HS Link Output Connector
－
Amplifier Connection
AEP
AEP Headset Connector
VEP
VEP Goggles Connector
Rear Panel
LINK
HS Link Output Connector
－
Amplifier Connection
Protective Earth
Functional Earth
To be used for suppression of noise.

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Dual USB Connectors – Type A
Limited power available. Only used for memory stick and license
dongle.
USB Connector – Type B
For computer interface.
Footswitch Connector
Input / Output Connector
Input / Output Magnetic Stimulation /tendon hammer, or
synchronization of external trigger, or external stimulation
acquisition.
VEP
VEP Monitor Connector
Power Outlet (only for Notebook PC when not used with the
Isolating Transformer)
Output: Mains 100 - 240VA Max.200VA
Power Inlet
Input: 100-240Vac, 50/60Hz, Max. 300VA
Fuses
F1, F2 : T4A/250V
Technical Specifications
For technical specifications, refer to the Keypoint Focus section in the Technical Data Sheet.

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

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Control Functions
Power On / Stand By Indicators
Power On
Stand By
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 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

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Stimulation Indicator
The Stimulation indicator yellow light (LED) blinks once for Single Stimulation,
and intermittently for Repetitive Stimulation.
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.
Stimulation 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 control knob to the right to increase the stimulation intensity.
Rotate the control 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.