UltraPro S100 System NCS EMG User Guide Rev 06 Sept 2020

Table of Contents

Table of contents Indications for use statement ... a Specification and accuracy information... b Contact information... b Labels and symbols ... c Read the safety reference guide ... e Electromagnetic Compatibility (EMC) ... e Safety summary ...f Maintenance... h Inspecting the system... h Decontamination... h Cleaning instructions ... h Disinfection procedure... i Preventative maintenance ...j Safety checks ... j Safety ... k Disposal at end of operating life instructions ... l Copyright ...m Software copyright protection ... n

Introduction

1-1

Technical description ...1-3 Installation and servicing instructions ... 1-5 Device continuity maintenance and installation test ...1-5 UltraPro S100 amplifier and system essential performance ...1-5 Protective and equipment classifications ...1-5 Using this guide ...1-6 About the system ...1-6 Ancillary accessories ... 1-7 Connecting the system components ...1-7 Entering commands ...1-7

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UltraPro S100

System Overview

2-1

UltraPro S100 Base...2-3 UltraPro S100 system interface ...2-3 Cable connections - Generation #1 ...2-4 Right side panel - Generation #1 ...2-5 Rear panel - Generation #1 ...2-6 Cable connections - Generation #2 ...2-7 Right side panel - Generation #2 ...2-8 Rear panel - Generation #2 ...2-9 Cable Connections - Generation #3 ...2-10 Right side panel - Generation #3 ...2-11 Left side panel - Generation #3...2-11 Rear panel - Generation #3 ...2-12 Control Panel Functions - Generation #1 and #2 ...2-13 Power On/Standby indicators- ...2-14 Screen navigation / software functions- ...2-14 Display keys-...2-14 Stimulus- ...2-15 Stimulus Intensity / Duration / Repetition Rate- ...2-15 Audio / Volume / Cursor Mode / Trace / Marker / Trigger - ...2-16 Control panel - Generation #3-...2-18 Control Panel Functions - Generation #3...2-19 Power On/Standby indicators ...2-19 Software functions ...2-19 Display keys ...2-19 Stimulus ...2-20 Stimulus intensity...2-20 Run selectors ...2-21 Audio Volume ...2-21 Delete and Move ...2-22 Test Selection...2-22 UltraPro S100 amplifier module - 3 and 4 channels ...2-23 Current stimulator ...2-25 Safety information ...2-25 Stimulator ...2-25 Stimulus electrodes ...2-25 Stimulus probe ...2-26 Changing polarity on the Comfort Probe RS10- ...2-27 Footswitch with 3 pedals (option) ...2-28 Powering the system ...2-29 ii

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Table of Contents Shutting down the system ... 2-29 Software Warning and Error Codes ...2-29 UltraPro S100 acquisition software installation... 2-30 1.Acquisition software installation ...2-30 2.Create and apply UltraPro S100 software license ...2-30 Technical specifications ... 2-30

Patient Information

3-1

The Patients screen ...3-3 Entering a new patient ...3-3 Selecting / editing patient information ... 3-4 Starting a new visit ...3-4 Recalling a patient for testing ...3-5 Recalling an exam for review ...3-5 Deleting exams from a patient file...3-6 Deleting a patient...3-6

Performing an Exam

4-1

Setting up the system ...4-3 Getting started...4-3 Using UltraPro S100, Study Menu vs Test Menu ... 4-4 Test menu ...4-4 Study menu ...4-4 Testing using Study menu ...4-5 Testing using Test menu... 4-5 Patient to report in seven steps ... 4-5 Example Motor Nerve Conduction Study... 4-6 About the waveform screen... 4-6 Select the exam...4-7 Select a protocol (only if using Test Menu) ...4-7 Motor NCS electrode placement ...4-7 Sensory NCS electrode placement...4-8 Acquire the data...4-8 Marking data...4-9 Resetting the markers ...4-9 Erasing data ... 4-10 Deleting data...4-10 Superimposing traces...4-10 Calculate the velocity ... 4-11 Trace analysis and display ... 4-11 Displaying large Results Tables ...4-11 15 September, 2020

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UltraPro S100 Graphs ...4-11 Acquiring EMG ...4-12 Scoring muscles ...4-12 EMG screen displays ...4-13 Storing data ...4-14 Adding a screen shot to a report ...4-14

Backup and Restore Data 5-1 Backing up files...5-3 Restoring files...5-4

Electromagnetic Compatibility (EMC)

6-1

List of UltraPro S100 items; additional and optional parts ...6-3 Table 1 - Electromagnetic emissions ...6-6 Table 4 - Immunity Test Levels - Enclosure Port...6-6 Table 5 – Immunity Test Levels – Input A.C. Power Port ...6-7 Table 7 – Patient Coupling Port...6-7 Table 8 – Immunity Test Levels - Signal Input / Output Parts Port ...6-8 Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment...6-9

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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.

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Natus UltraPro S100

Specification and accuracy information Please see the system Specification sheet 169-443700.

Contact information Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI USA 53562 608-829-8500 1 800-356-0007 Fax: 608-829-8589 natus.com European Authorized Representative Natus Manufacturing Limited IDA Business Park Gort, Co.Galway, Ireland

b

Technical Support Domestic Natus Medical Incorporated 3150 Pleasant View Road Middleton, WI USA 53562 1-800-356-0007 [email protected] natus.com International Natus Medical Incorporated Phone: 0049 (0) 180 501 5544 Fax: 0049 (0) 89 83942777 [email protected] natus.com

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Preface

Labels and symbols The following labels and symbols may be affixed to the UltraPro S100 system: Symbol

Reference

Description

ISO 60601-1 Table D.2 #2

Warnings associated with this device. A warning indicates that there is a risk of death or serious injury to the user or patient.

ISO 15223-1 Symbol 5.4.4 ISO 60601-1 Table D.1 #10

Cautions associated with this device. A caution indicates that there is a risk of injury to the user or patient or risk of damage to the device.

ISO 15223-1 Symbol 5.4.3 ISO 60601-1 Table D.1 #11

Consult instructions for use.

ISO 60601-1 Table D.2 #10

Follow instructions for use.

IEC606011: 2005+AMD1:2012 EN 60601-1: 2006+A1:2013

Type BF Applied Part

Please read the instruction manual before using this device.

Defines the degree of protection against electric shock. Complies with Type BF requirements of IEC 60601-1: 2005+AMD1:2012 and EN 60601-1:2006+A1:2013.

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EN 50419

Defines the correct disposal Information, provided in the Waste Management section

ISO 15223-1 Symbol 5.1.6

Reference Number. This is the part number for the device.

ISO 15223-1 Symbol 5.1.7

Includes the year of manufacture, a letter, the serial number of the device, and a three-letter revision code.

ISO 15223-1 Symbol 5.1.1

The manufacturer information is adjacent to this symbol

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Natus UltraPro S100

Rx Only

ISO 15223-1 Symbol 5.1.3

The manufacture date is adjacent to this symbol.

ISO 15223-1 Symbol 5.1.2

Authorized EC Representative

N/A USA Federal law restricts this device to sale or on the order of a licensed medical physician.

Medical Device

N/A

Medical Device. Indicates that the item is a medical device.

ISO 15223-1 Symbol 5.3.7 ISO 15223-1

Indicates the upper and lower limits of temperature to which the medical device can be safely exposed.

Symbol 5.3.8

Indicates the upper and lower limits of humidity limitation to which the medical device can be safely exposed.

ISO 15223-1

Do not use if package is damaged.

Symbol 5.2.8

Referenced standards

• ISO 15223-1:2016: Medical devices - Symbols to be used with medical device

labels, labeling and information to be supplied - Part 1: General requirements.

• IEC 60601-1:2005+AMD1:2012 Consolidated version General requirements for basic safety and essential performance.

• IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety.

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Preface

Read the safety reference guide Please read the Additional Information and Safety / EMC guides included in the 482-638702 disk supplied with your system, paying special attention to the Safety Information, Cautions, and Warnings before applying power to and using your system.

Electromagnetic Compatibility (EMC) Please refer to the Electromagnetic Compatibility section in this manual.

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Natus UltraPro S100

Safety summary In this manual, two labels identify potentially dangerous or destructive conditions and procedures: Caution

A caution indicates that there is a risk of injury to the user or patient or risk of damage to the device.

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

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. Any serious incident that occurs in relation to the Natus UltraPro should be reported to Natus Medical Incorporated and the competent authority of the Member State in which the user and/or patient is established.

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Preface

Table 1 describes the minimum size of the stimulus electrode needed to not exceed 0.25 W/cm2 to guard against the possibility of causing a burn due to excessive densities at the site of prolonged stimulation.

Resistance (Ohms)

Max Current Used (mA)

Stim Duration (us)

2000 2000 2000 2000 4000 4000 4000 4000 2000 2000 2000 4000

25 25 50 50 25 25 50 50 25 25 100 100

100 100 100 100 100 100 100 100 200 200 1000 1000

Rate (Hz)

Surface area (cm2)

Required Diameter of disc (mm)

2 5 2 5 2 5 2 5 2 5 100 100

0.001 0.0025 0.004 0.01 0.002 0.005 0.008 0.02 0.002 0.005 8 16

0.356824974 0.564189822 0.713649948 1.128379644 0.504626718 0.797884898 1.009253435 1.595769796 0.504626718 0.797884898 31.91539591 45.13518575

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)

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Natus UltraPro S100

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 solvent, silicon-based, abrasive and/or flammable substances.

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Preface

All external parts of the assembly can be wiped down with the following: Chemical contact will be limited to chemicals specified below to clean the assembly only. Other chemicals may or may not affect the device, but do not fall under tested chemicals for the assembly.

•Water

•Isopropyl Alcohol (70-90% concentration in water) •PDI SaniClothPlus #Q89702 •HB Quat (3M)

•Mild soap solution such as Basis, Cetaphil, Dove in water solution •Ethyl alcohol (70-90% concentration)

•A solution of 1 part household bleach (5-6% concentrate sodium hypocholorite) and 50 parts water.

Do not use alcohol solutions on the plastic component of the probe heads. Use of alcohol on the plastic may cause damage or cracking to the plastic component of the probe heads.

Disinfection procedure

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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.

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Natus UltraPro S100

Preventative maintenance Safety checks

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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.

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Preface

Safety Any interruption of the protective earth conductor inside or outside of the device or disconnection of the protective/functional earth connector is likely to make the device dangerous. Intentional interruption is prohibited. The protective earth / ground conductor should be checked regularly. 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, pay attention to the requirements of IEC 60601-1 (IEC 60601-1-1), Safety Requirements for medical electrical systems, cf. the text on IEC 60601-1 (IEC 60601-1-1), 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 shortcircuiting 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. • 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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Natus UltraPro S100

Disposal at end of operating life instructions Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and Electronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made. Please contact us for details on the collection and recovery systems available to you in your region at natus.com Electrical and Electronic Equipment (EEE) contains materials, components and substances that may be hazardous and present a risk to human health and the environment when WEEE is not handled correctly. Therefore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users of electrical and electronic equipment must not discard WEEE together with other wastes. Users must use the municipal collection schemes or the producer/ importers take-back obligation or licensed waste carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and electronic equipment and to increase opportunities for reuse, recycling and recovery of waste electrical and electronic equipment. Equipment marked with the below crossed-out wheeled bin is electrical and electronic equipment. The crossed-out wheeled bin symbol indicates that waste electrical and electronic equipment should not be discarded together with unseparated waste but must be collected separately.

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Preface

Copyright All rights reserved. This manual contains proprietary information, which is protected by copyright 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 copyright use extend to all media in which this information is preserved. This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its distributors. 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. natus.com

Natus Medical Incorporated 3150 Pleasant View Road Middleton, WI USA 53562

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Natus UltraPro S100

Software copyright protection

This software is protected by state, U.S. and international copyright treaty provisions. These copyright provisions apply to your use of this software regardless of whether or not you agree to the following terms. Under law, copyright infringers may be liable for actual damages sustained by the copyright owner and for punitive damages of up to $100,000 per infringement. Unauthorized copying of computer software, and attempts to do so, are also criminal violations, with penalties that may exceed $100,000 in fines and 10 years in prison. 1.

Unless restricted by an agreement with Natus Medical Incorporated, you are permitted to: a. Use this software on only one computer and by one user at a time. b. Make one copy of this software, provided that: (i) the copy is created as an essential step in the utilization of this software in conjunction with your machine and that it is used in no other manner, or (ii) that the copy is for archival purposes only and that all archival copies are destroyed in the event that your continued possession of this software should cease to be rightful. c. Sell this software, and any archival copy, only as part of the sale of all of your rights in this software, except that adaptations so prepared may be transferred only with the authorization of Natus Medical Incorporated.

2.

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You are not permitted to: a. Make copies of this software or documentation except as described above. b. Alter, modify or adapt this software or documentation except as described above. c. Distribute, lease, rent or sublicense this software or documentation.

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Introduction

1-1