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