Natus Ultrapro s100 Manual

Natus UltraPro S100

User and Service Guide

Part Number: 269-653300 Rev 07 06/23/2023

System Model Numbers: 982A0594, 982A0596

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.

Contact Information

Natus Neurology Incorporated

3150 Pleasant View Road

Middleton, WI USA 53562

1 608-829-8500 or 1 800-356-0007

Fax: 1 608-829-8589

natus.com

Technical Support

Domestic & International

Natus Medical Incorporated

3150 Pleasant View Road

Middleton, WI USA 53562

1-800-356-0007

1-608-829-8500

[email protected]

natus.com

Germany:

Email: [email protected]

Phone: +49 89 83942 0

Australia and New Zealand:

Email: [email protected]

EU Representative / Importer

Natus Manufacturing Limited

IDA Business Park

Gort, Co. Galway, Ireland

Arazy Group Switzerland GmbH

Bruderholzallee 53

4059 Basel

Switzerland

[email protected]

Natus Nicolet UK Ltd

Baynards Green Trading Estate

Prospect House

Oxfordshire

Bicester

OX27 7SG

England, United Kingdom

RxOnly

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

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.

Glossary of Symbols

The following labels and symbols may be affixed to the UltraPro S100 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

An indication

of Medical

Device

This product is a

medical device.

Medical Device

Directive 93/42/EEC

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.

ISO 15223-1

Symbol 5.1.2

Medical devices

— Symbols to be

used with

information to be

supplied by the

manufacturer —

Part 1: General

requirements

Authorized

representative

in the

European

Community

Indicates the

Authorized

representative in the

European

Community.

(www.gov.uk/guidance)

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.

Symbol Standard Reference Standard Title

of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

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, Table D.2,

Symbol 20 (IEC 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.

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.

Symbol Standard Reference Standard Title

of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

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 5.1.8

Medical devices

— Symbols to be

used with

medical device

labels, labelling

and information

to be supplied

Importer

Indicates the entity

importing the

medical device into

the locale. This

symbol shall be

accompanied by the

name and address of

the importing entity,

adjacent to the

symbol.

Symbol Standard Reference Standard Title

of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

ISO 15223-1

Symbol 5.1.9

Medical devices

— Symbols to be

used with

medical device

labels, labelling

and information

to be supplied

Distributor

Indicates the entity

distributing the

medical device into

the locale. This

symbol shall be

accompanied by the

name and address of

the distributing

entity, adjacent to

the symbol

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

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

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.

Symbol Standard Reference Standard Title

of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

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.

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

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.

Symbol Standard Reference Standard Title

of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

IEC 60601-1

Table D.2 #10

Medical electrical

equipment – Part

1: General

requirements for

basic safety and

essential

performance.

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

Nationally Recognized

Testing Laboratories

(NRTL) certifications

Table of Contents

CONTACT INFORMATION ...................................................................................................................2

GLOSSARY OF SYMBOLS .....................................................................................................................3

1GENERAL INFORMATION ..........................................................................................................14

User Guide ............................................................................................................................................................... 14

Intended Use............................................................................................................................................................. 14

Clinical Performance................................................................................................................................................ 14

Clinical Benefits........................................................................................................................................................ 14

Medical Conditions .................................................................................................................................................. 15

Intended Users......................................................................................................................................................... 15

Patient Population and Target Group ...................................................................................................................... 15

Residual Risks and Side Effects ................................................................................................................................ 15

UltraPro S100 System Essential Performance.......................................................................................................... 15

General and Network Security Measures................................................................................................................ 15

Networked Environments........................................................................................................................................ 16

Protective and Equipment Classifications ................................................................................................................ 16

Ancillary Accessories................................................................................................................................................ 16

2SAFETY, WARNINGS AND PRECAUTIONS ..................................................................................18

Contraindications..................................................................................................................................................... 18

Operating Environment: Inflammable Vapors or Gases .......................................................................................... 18

Potential Electrical Shock (Line Voltage) ................................................................................................................. 18

Patient Supplies/Electrodes Interaction .................................................................................................................. 19

System Installation and Operation .......................................................................................................................... 20

Intraoperative Monitoring....................................................................................................................................... 21

Auditory Stimulation................................................................................................................................................ 22

Pacemakers and Defibrillation................................................................................................................................. 22

Emissions, EMC, EMI................................................................................................................................................ 22

Amplifier Arm .......................................................................................................................................................... 22

Isolation / Isolation Transformer ............................................................................................................................. 23

Preventative Maintenance ...................................................................................................................................... 23

Batteries................................................................................................................................................................... 23

Factors That Could Affect Data................................................................................................................................ 23

Additional Information - Electrical Stimulator......................................................................................................... 24

Stimulation Pulse Terminology ................................................................................................................................ 24

Accuracy of Controls................................................................................................................................................ 25

3SYSTEM HARDWARE...................................................................................................................26

UltraPro S100 Base .................................................................................................................................................. 26

UltraPro S100 System Connections.......................................................................................................................... 26

Cable Connections - Generation #3 ......................................................................................................................... 27

Right side panel -Generation #3 .............................................................................................................................. 28

Left side panel -Generation #3................................................................................................................................. 28

Rear panel - Generation #3...................................................................................................................................... 29

Control Panel Functions - Generation #3 ................................................................................................................. 30

Power On/Standby indicators.................................................................................................................................. 31

Software functions................................................................................................................................................... 31

Display keys.............................................................................................................................................................. 31

Stimulus ................................................................................................................................................................... 32

Stimulus intensity..................................................................................................................................................... 32

Run selectors............................................................................................................................................................ 33

Audio Volume .......................................................................................................................................................... 33

Delete and Move...................................................................................................................................................... 34

Test Selection........................................................................................................................................................... 34

Cable Connections - Generation #1 ......................................................................................................................... 35

Right side panel Generation #1................................................................................................................................ 36

Rear panel - Generation #1...................................................................................................................................... 37

Cable Connections - Generation #2 ......................................................................................................................... 38

Right side panel -Generation #2 .............................................................................................................................. 39

Rear panel - Generation #2...................................................................................................................................... 40

Control Panel Functions - Generation #1 and #2 ..................................................................................................... 41

Power On/Standby indicators.................................................................................................................................. 42

Screen navigation /software functions .................................................................................................................... 42

Display keys.............................................................................................................................................................. 42

Stimulus ................................................................................................................................................................... 43

Stimulus Intensity / Duration / RepetitionRate ....................................................................................................... 43

Audio / Volume / Cursor Mode / Trace / Marker / Trigger...................................................................................... 44

UltraPro S100 Amplifier Module - 3 and 4 Channels................................................................................................ 45

Natus Stimulus Probe............................................................................................................................................... 47

RS10 Comfort Probe Polarity................................................................................................................................... 48

Footswitch with 3 Pedals (Option) ........................................................................................................................... 48

Isolations Transformer............................................................................................................................................. 49

Isolation Transformer Classification ........................................................................................................................ 50

Additional UltraPro S100 Accessories ...................................................................................................................... 51

4SYSTEM OPERATION .................................................................................................................52

Powering the UltraPro and Launching Natus Elite Software ................................................................................... 52

Installing Natus Elite Software................................................................................................................................. 52

Basic System Operations.......................................................................................................................................... 53

Screen Operations ................................................................................................................................................... 53

Software Help .......................................................................................................................................................... 54

Shutting Down the UltraPro System ........................................................................................................................ 54

Software Error Codes............................................................................................................................................... 55

5PATIENT INFORMATION............................................................................................................57

Entering a new patient............................................................................................................................................. 57

Selecting or Editing Patient Information ................................................................................................................. 57

Starting a new visit................................................................................................................................................... 58

Recalling a patient for testing .................................................................................................................................. 58

Recalling an exam for review ................................................................................................................................... 58

Deleting exams from a patient file........................................................................................................................... 59

Deleting a patient .................................................................................................................................................... 59

6PERFORMING AN EXAM............................................................................................................60

Setting up the System .............................................................................................................................................. 60

Getting started......................................................................................................................................................... 60

Using UltraPro S100,Study Menu vs Test Menu....................................................................................................... 60

Testing using Study menu........................................................................................................................................ 60

Testing using Test menu .......................................................................................................................................... 61

Patient to report in seven steps .............................................................................................................................. 61

Example Motor Nerve Conduction Study................................................................................................................. 62

About the waveform screen .................................................................................................................................... 62

Select the exam........................................................................................................................................................ 62

Select a protocol (only if using Test Menu) .............................................................................................................. 62

Motor NCS electrode placement ............................................................................................................................. 63

Sensory NCS electrode placement ........................................................................................................................... 63

Marking data............................................................................................................................................................ 63

Resetting the markers.............................................................................................................................................. 64

Erasing data ............................................................................................................................................................. 64

Deleting data............................................................................................................................................................ 64

Superimposing traces............................................................................................................................................... 64

Calculate the velocity................................................................................................................................................. 64

Graphs...................................................................................................................................................................... 65

Test Menu and History ............................................................................................................................................ 65

Example EMG Study................................................................................................................................................. 65

EMG screen displays ................................................................................................................................................ 66

Example Evoked Potential Study ............................................................................................................................. 67

About the waveform screen .................................................................................................................................... 67

Select the exam........................................................................................................................................................ 67

Select a protocol (only if using Test Menu) .............................................................................................................. 67

Test Menu and History ............................................................................................................................................ 68

Acquire the data....................................................................................................................................................... 68

Marking data............................................................................................................................................................ 68

Resetting the markers.............................................................................................................................................. 69

Erasing data ............................................................................................................................................................. 69

Deleting data............................................................................................................................................................ 69

Superimposing Traces.............................................................................................................................................. 69

Reports..................................................................................................................................................................... 69

Print screen.............................................................................................................................................................. 69

7BACKUPANDRESTOREDATA .....................................................................................................70

Backing Up Files ....................................................................................................................................................... 70

Restoring Files.......................................................................................................................................................... 70

8MAINTENANCE, CLEANING .......................................................................................................71

Maintenance............................................................................................................................................................ 71

Safety Inspection Checks .......................................................................................................................................... 71

Device Continuity Maintenance andInstallation Test .............................................................................................. 71

Troubleshooting....................................................................................................................................................... 72

Noisy Data................................................................................................................................................................ 72

External Artifacts ..................................................................................................................................................... 72

Cleaning Instructions ............................................................................................................................................... 73

Disposal at End of Operating Life Instructions......................................................................................................... 73

Natus Technical Support Contact Information ........................................................................................................ 74

9ELECTROMAGNETIC COMPATIBILITY (EMC)..............................................................................75

List of UltraPro S100 items; additional and optional parts ...................................................................................... 75

Table 1 - Electromagnetic emissions ........................................................................................................................ 77

Table 4 - Immunity Test Levels - Enclosure Port ...................................................................................................... 77

Table 5 – Immunity Test Levels – Input A.C. Power Port ......................................................................................... 78

Table 7 – Patient Coupling Port................................................................................................................................ 78

Table 8 – Immunity Test Levels - Signal Input / Output Parts Port........................................................................... 79

Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment ......... 80

10 SYSTEM SYMBOLS.....................................................................................................................82

IEC 60417 Symbols................................................................................................................................................... 82

UltraPro System Symbols......................................................................................................................................... 83

UltraPro Software Symbols...................................................................................................................................... 84

11 TECHNICAL SPECIFICATIONS .....................................................................................................87

Amplifiers................................................................................................................................................................. 87

Signal Display ........................................................................................................................................................... 87

Filters ....................................................................................................................................................................... 87

Electrical Stimuli ...................................................................................................................................................... 87

Auditory Stimuli ....................................................................................................................................................... 87

Visual Stimuli: Visual Stimulator .............................................................................................................................. 88

Visual Stimuli: LED Goggles...................................................................................................................................... 88

Environmental Limits ............................................................................................................................................... 88

Physical Dimensions................................................................................................................................................. 88

1 General Information

User Guide

This guide provides the basic information needed to setup, operate and maintain the UltraPro S100 system.

A PDF copy of this user guide is available on the USB flash drive, Information for Use, provided with your system. Copies of the

user guide may also be accessed at natus.com in the Support section. Scroll to the EMG Product IFUs, select UltraPro S100 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

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.

Clinical Performance

The UltraPro S100 allows the user to perform a wide range of Nerve Conduction Studies (NCS), Electromyography (EMG),

Evoked Potential (EP) Studies and Autonomic Studies as well as Multimodality Programs such as Intraoperative Monitoring

(IOM). Separate software programs and optional accessories allow the user to customize the UltraPro to meet specific clinical

and O.R. monitoring needs.

Clinical Benefits

The UltraPro S100 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 UltraPro S100 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 UltraPro S100 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.

Patient Population and Target Group

The UltraPro S100 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 UltraPro. Please note the Warnings and

Cautions before applying power to and using the system.

UltraPro S100 System Essential Performance

UltraPro S100 systems feature a dedicated control panel, color-coded multifunction soft keys and easy-to-use Windows-based

interfaces to simplify operation.

The UltraPro S100 cart accommodates all system components, including an optional printer.

Innovative software features and an intuitive interface simplify operation. Use the Study feature to create a list of assorted

protocols and select them sequentially using a single button press. This allows for faster testing using standard protocols.

The UltraPro S100 amplifier and system is designed to function under a wide range of environmental conditions without

compromise in performance specifications.

General and Network Security Measures

Utilize best practice security measures in your clinical environment including the following:

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 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.

Secure Access to Windows Systems

•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 Classifications

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.

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 UltraPro S100 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 is driven shield and pins 4 and 5 are patient ground.

2 Safety, Warnings and Precautions

This chapter defines safety Warnings and Precautions applicable to the UltraPro S100 system. Read all Contraindications,

Warnings and Cautions prior to use of the UltraPro system.

Two labels identify potentially dangerous or destructive conditions and procedures:

Warning A WARNING indicates that there is a risk of death or serious injury to the user or patient.

Caution A CAUTION 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 UltraPro S100 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.

Operating Environment: Inflammable Vapors or Gases

The equipment is not designed to be used in locations with inflammable vapors or gases that may cause

explosions. The equipment must not be used in atmospheres with a high concentration of oxygen or in buildings

where inflammable substances or anesthetic agents are present. The atmosphere is considered as oxygen-

saturated when the oxygen or nitrous oxide (N2O) concentration contained in the environment is over 24%.

Potential Electrical Shock (Line Voltage)

System components immersed or in contact with fluids may cause electrical shock. Source currents to the patient

due to use of a repaired components that have not been leakage tested may cause electrical shock.

Loss of AC neutral due to damage to the neutral conductor may cause electrical shock.

Loss of AC ground connection may cause electrical shock.

Over voltage conditions due to a fault in other equipment may cause electrical shock.

Over voltage conditions due to the input voltage exceeding the operating range may cause electrical shock.

Incorrect installation of cables on/to the system may cause electrical shock.

Use of non-Natus supplied, or recommended components or accessories may prevent the application of the risk

control measures unique to Natus parts from being applied, which may cause electrical shock.

Damaged power cord contacting ungrounded metal component(s) may cause electrical shock.

Periodically check the system ground integrity, the system leakage current and the leakage current of the

amplifier.

Source currents to the patient due to use of a repaired components that have not been leakage tested may

cause electrical shock.

Improper external headbox connections may produce sourcing of current to the patient, which may cause

electrical shock.

Plugging an electrode into the headbox or amplifier and allowing the loose ends to make contact with hazardous

voltages can cause electrical shock.

Do not allow conductive parts of electrodes and connectors to contact conductive parts or ground.

Equipment not complying with IEC 60601-1 shall be kept outside the patient environment, as defined in the

standard, (at least 1.5m from the patient), which may cause electrical shock.

Observe IEC 60601-1 standards in case of connection with other instruments. The connection of the equipment

with other devices is allowed only when the safety requirements for the patient, the user and the environment

are not compromised.

The potential for electrical shock is present if device covers are removed. Refer servicing to qualified personnel.

Patient Supplies/Electrodes Interaction

Do not measure the impedance of needle electrodes with the needle positioned in the patient. This practice may

result in patient injury.

Do not measure the impedance of electrodes which are in contact with the patient’s cornea or eye. This practice

may result in patient injury.

To reduce the risk of injury, disconnect all recording and stimulating electrodes from the system before you turn

the system power off and on.

Prolonged electrical stimulation can cause a patient burn.

Use only electrodes of adequate size and properly applied by qualified medical personnel to avoid patient skin

reactions or burns.

Using electrodes with current densities greater than 2 mA r.m.s./cm2 may require the special attention of the

operator to avoid patient skin reactions or burns.

Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns. Natus

recommends the use of disposable, pre-gelled, silver/silver chloride electrodes with a contact area of 20 mm

diameter or larger. These electrodes contain an adhesive that maintains the electrode skin position and contact

during electrical stimulation and are designed for use of the maximum output of the electrical stimulator.

The FDA has issued guidance to not exceed 0.25 W/cm

on stimulating electrodes to prevent the possibility of

causing a burn due to excessive current densities at the site of prolonged stimulation. Table #1 below

demonstrates the how different stimulus parameters as well as electrode impedance affect the minimum size.

To help ensure patient safety and prevent cross contamination, reusable electrodes and stimulators must be

properly cleaned and maintained. This maintenance includes cleaning before use on each patient. Always follow

the specific instructions that accompany these patient contacting devices (e.g., electrodes, probe tips) and your

institution's guidelines for cleaning patient contacting devices. --

To help ensure patient safety and prevent infections when using sterile supplies such as needle and corneal

electrodes, always follow the manufacturer’s instructions and your institution's guidelines regarding use of

these devices.

Table 1: Example of Minimum Stimulus Electrode Sizes

Minimum Stimulus Electrode sizes

Resistance

(Ohms)

Max Current

Used (mA)

Stim Duration

(uS)

Rate (Hz)

Surface Area

(cm2)

Required Diameter of disc

(mm)

2000

100

0.001

0.357

4000

100

0.002

0.505

4000

100

0.005

0.798

4000

100

0.008

1.009

4000

100

0.032

2.018

4000

100

500

0.160

4.514

4000

100

1000

0.320

6.383

4000

100

1000

100

45.135

Legend:

• Resistance - is the impedance of the stimulus electrodes in ohms

• Maximum current used - is the maximum stimulus intensity that you plan to use

• Stimulus duration - is the maximum stimulus duration you plan to use

• Rate - is the maximum stimulus rate you plan to use

• Surface area - is the surface area required for each electrode to not exceed 0.25 W/cm2

• Required diameter of disc - is the minimum diameter of the electrode

(to not exceed 0.25 W/ cm2 assuming a round disc)

The Surface Area = ((maximum current/1000)2 *(resistance) * (duration/1000000) * (rate)) / 0.25

The Required Diameter of disk = 20 * square root (surface area/3.14159) millimeters (mm)

System Installation and Operation

Inspect the system prior to first startup and frequently prior to usage for damaged components. Tighten any

loose connections.

Inspect the power cord often for fraying or other damage. DO NOT operate the apparatus if the power cord or

plug is damaged.

The potential for electrical shock is present if device covers are removed. Refer servicing to qualified personnel.

If the system is dropped or otherwise mishandled, check all system functionality and conduct an electrical safety

test before resuming use.

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