natus UltraPro S100 User manual

UltraPro S100
Natus Neurology Incorporated
UltraPro S100 User Guide
September 13, 2018
Part Number: 269-653300 Rev 05
UltraPro S100
User Guide
© 2016 - 2018 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.

13 September, 2018 a
Preface
Indications for use statement
The UltraPro S100 is intended for the acquisition, display, analysis, storage,
reporting, and management of electrophysiological information from the human
nervous and muscular systems including Nerve Conduction (NCS),
Electromyography (EMG), and Autonomic Responses.
The UltraPro S100 may be used to determine autonomic responses to physiologic
stimuli by measuring the change in electrical resistance between two electrodes
(Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing
also includes assessment of RR Interval variability. The UltraPro S100 is used to
detect the physiologic function of the nervous system and to support the
diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general,
•Nerve Conduction Studies measure the electrical responses of the nerve.
•Electromyography measures the electrical activity of the muscle.
•Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory
Evoked Potentials (AEP), and Somatosensory Evoked Potentials (SEP).
The UltraPro S100 is intended to be used by a qualified healthcare provider.

UltraPro S100
b13 September, 2018
Specification and accuracy information
Please see the system Specification sheet 169-443700.
Contact information
CE mark
Compliant to Medical Device Directive 93\42\EEC
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
608-829-8500
1 800-356-0007
Fax: [phone]
www.Natus.com
Technical Support
Domestic
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
1-800-356-0007
[email protected]
www.Natus.com
International
Natus Neurology Incorporated
Phone: [phone]
Fax: [phone]
[email protected]
www.Natus.com
European Authorized Representative
Natus Manufacturing Limited
IDA Business Park
Gort, Co.Galway, Ireland

13 September, 2018 c
Preface
Labels and symbols
The following labels and symbols may be affixed to the UltraPro S100 system:
When applied on device: Attention: Consult Accompanying Doc-
umentation (ISO 7000-0434A)
When used in documentation: Caution, Warning or Precaution
follows.
Consult Operating Instructions. Failure to follow operating instruc-
tions could place the patient or operator at risk (ISO 7010 M002).
Image on blue background.
Consult Operating Instructions. (ISO 7000-1641)
European Authorized Representative
Manufacturer
Disposal at end of operating life instructions.
When the equipment comes to the end of its operating life, it should
be disposed of in accordance with local waste regulation authority,
which is typically within the local government office.
CE Mark and Notified Body
(Compliant to Medical Device Directive 93/42/EEC)
Type BF equipment.
RX Only CAUTION: USA Federal law restricts this device to sale or on the
order of a licensed medical practitioner.

UltraPro S100
d13 September, 2018
Read the safety reference guide
Please read thoroughly the Additional Information and Safety Notes for Assorted
Nicolet Brand Products Reference Guide included on a CD included with your
system, paying special attention to the Safety information before applying
power to and using your system.
Electromagnetic Compatibility (EMC)
Please refer to the Electromagnetic Compatibility section of this
manual.

13 September, 2018 e
Preface
Safety summary
In this manual, two labels identify potentially dangerous or destructive
conditions and procedures:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
Do NOT use outside of the published specification ranges. Use of device outside
of the specified ranges may result in inaccurate results.
Aliasing of the displayed data can occur if the time base and
the data displayed are not appropriate for the data acquired. Example, if
the time base of a response normally displayed at 10 milliseconds is
displayed at a time base of 1 second the data will be decimated and aliasing
will occur. Remember to adjust the time base to be appropriate for the type
of signal being acquired. Slow (long responses) should be displayed with a
long time base, short (fast responses) should be displayed at a short time
base.
Prolonged electrical stimulation can cause a patient burn.

UltraPro S100
f13 September, 2018
Table 1 describes the minimum size of the stimulus electrode needed to not
exceed 0.25 W/cm2to guard against the possibility of causing a burn due to
excessive densities at the site of prolonged stimulation.
Table 1
Legend for Table 1
Resistance is the impedance of the stimulus electrodes in ohms.
Max Current Used is the maximum stimulus intensity you plan on using in
milliamperes (mA).
Stim Duration is in microseconds (us).
Rate is the maximum rate of stimulus you plan on using.
Surface area is the miniumum surface area of the stimulus electrodes that should
be used.
Required diameter of disc is the minimum diameter of a round disc electrode
that should be used.
The diameter of disk = 20 * square root(surface area/3.14159) millimeters (mm)
Resistance
(Ohms)
Max Current
Used (mA)
Stim Duration
(us) Rate (Hz)
Surface area
(cm2)
Required
Diameter of
disc (mm)
2000 25 100 2 0.001 0.356824974
2000 25 100 5 0.0025 0.564189822
2000 50 100 2 0.004 0.713649948
2000 50 100 5 0.01 1.128379644
4000 25 100 2 0.002 0.504626718
4000 25 100 5 0.005 0.797884898
4000 50 100 2 0.008 1.009253435
4000 50 100 5 0.02 1.595769796
2000 25 200 2 0.002 0.504626718
2000 25 200 5 0.005 0.797884898
2000 100 1000 100 8 31.91539591
4000 100 1000 100 16 45.13518575

13 September, 2018 g
Preface
Maintenance
Inspecting the
system
Routinely check the instrument for exterior damage.
Follow your medical facilities safety guidelines.
Decontamination Decontamination that can be performed by the operator is limited to cleaning and
disinfecting the device. Any maintenance inside the device must be performed by
qualified service personnel only.
Cleaning
instructions
Regular cleaning maintenance should be performed according to frequency of
use of the device. Always observe your local hygiene authority’s guidelines, and
the following points below:
•Disconnect the mains power before cleaning the equipment.
•Clean the equipment surfaces with a clean, slightly damp cloth with a mild
detergent (e.g., Wet Wipes®), and wipe it dry.
•Make sure that no liquids enter the device at push buttons and other openings
in the enclosure.
Do not use cleaning detergents, or cleaning agents based on sol-
vent, silicon-based, abrasive and/or flammable substances.
Disinfection
procedure
When disinfecting the equipment, if required, surgical spirit (70%), a Chlorine
(1000ppm), or ethanol (70%) detergent may be used. Carefully follow the
disinfectant manufacturer’s instructions for use, and the steps under the Cleaning
Instructions section above.

UltraPro S100
h13 September, 2018
Preventative maintenance
Safety checks The following safety checks should be conducted by qualified personnel only at
least once a year and in the event of repair:
1. Inspection for visible damage to device.
2. Inspection of mains cord and connecting cables.
3. Check of electrode cables and patient connections.
4. Measurement of insulation resistance.
5. Measurement of leakage currents.
6. Measurement of resistance of protective earth conductor.
7. Measurement of resistance of protectively earthed enclosure and cart parts.