natus Quantum Troubleshooting guide

Quantum
User and Service Manual

Natus Quantum Amplifier User & Service Manual
2
Publisher’s Notice
014556 Rev 06
Quantum User and Service Manual
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone] or Fax: [phone]
Toll Free (US & Canada): 800-303-0306
Technical Support Email: OT[email protected]
Customer Service Email: Oakville_Custom[email protected]
Website: www.natus.com
EUROPEAN AUTHORIZED REPRESENTATIVE
Natus Europe GmbH
Robert-Koch-Str 1
82152 Planegg
Germany
Copyright © 2015 by Excel-Tech Ltd. (XLTEK)
The information in this publication is provided for reference only. All information contained in this publication is believed to
be correct and complete. Excel-Tech Ltd. shall not be liable for errors contained herein nor for incidental or consequential
damages in connection with the furnishing, performance, or use of this material. All product specifications, as well as the
information contained in this publication, are subject to change without notice.
This publication may contain or reference information and products protected by copyrights or patents and does not
convey any license under the patent rights of Excel-Tech Ltd., nor the rights of others. Excel-Tech Ltd. does not assume
any liability arising out of any infringements of patents or other rights of third parties.
All rights reserved. This document contains confidential or proprietary information of Excel-Tech Ltd. No part of this
document may be reproduced or transmitted in any form or by any means without the written permission of Excel-Tech
Ltd.
Excel-Tech Ltd. makes no warranty of any kind with regard to this material, including but not limited to the implied
warranties of merchantability and fitness of a particular purpose.

User & Service Manual Natus Quantum Amplifier
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Table of Contents
INTRODUCTION...........................................................................................................................................6
INTENDED USE..........................................................................................................................................6
SYSTEM COMPONENTS.......................................................................................................................7
OPERATING PRINCIPLE OF THE QUANTUM AMPLIFIER.................................................................................7
USING THE MANUAL..................................................................................................................................7
MANUAL CONVENTIONS......................................................................................................................7
SAFETY & STANDARDS CONFORMITY ...................................................................................................8
STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES.....................................................................8
DECLARATION OF COMPLIANCE FOR IEC 60601-1-2................................................................................10
DECLARATION OF COMPLIANCE FOR FCC ...............................................................................................13
WARNINGS AND CAUTIONS....................................................................................................................14
GENERAL WARNINGS..............................................................................................................................14
ELECTROSTATIC DISCHARGE (ESD) PRECAUTIONS:................................................................................15
ELECTRICAL WARNINGS AND CAUTIONS..................................................................................................16
PATIENT ENVIRONMENT WARNINGS AND CAUTIONS .................................................................................17
TRANSPORTATION WARNINGS.................................................................................................................18
PULSE OXIMETER WARNINGS..................................................................................................................19
PULSE OXIMETER SENSOR WARNINGS ....................................................................................................20
CONDUCTED IMMUNITY WARNINGS..........................................................................................................21
PROCEDURES AND WARNINGS.............................................................................................................22
ELECTROSTATIC DISCHARGE (ESD) HANDLING.......................................................................................22
CONDUCTED IMMUNITY PROCEDURES AND WARNINGS .............................................................................22
DESCRIPTION OF SYMBOLS...................................................................................................................24
SPECIFICATIONS: QUANTUM AMPLIFIER.............................................................................................26
PRODUCT IMAGES ...................................................................................................................................28
QUANTUM SYSTEM .................................................................................................................................28
QUANTUM BASE UNIT.............................................................................................................................29

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QUANTUM BREAKOUT BOXES .................................................................................................................30
SETUP ........................................................................................................................................................31
CONNECTIONS........................................................................................................................................31
SETTING THE IP ADDRESS.......................................................................................................................32
AMPLIFIER USAGE AND FEATURES......................................................................................................35
GETTING STARTED .................................................................................................................................35
PLACEMENT OF THE OPERATOR AND PATIENT....................................................................................35
BEGINNING A STUDY .........................................................................................................................35
POWERING DOWN THE SYSTEM ........................................................................................................35
ADDING THE QUANTUM BREAKOUT BOX(ES)TO A HARNESS OR BELT ........................................................36
HARNESS SETUP..............................................................................................................................36
BELT SETUP.....................................................................................................................................37
POTENTIAL EQUALIZATION CONDUCTOR..................................................................................................37
TRANSPORT SYSTEM SPECIFICATIONS AND MAINTENANCE..........................................................38
XLTEK TROLLEY SPECIFICATIONS..........................................................................................................38
CYCLOPS CART WITH MINITOWER PC SPECIFICATIONS.............................................................................39
CYCLOPS CART WITH ALL-IN-ONE PC SPECIFICATIONS............................................................................40
MAINTENANCE........................................................................................................................................42
WARNINGS AND CAUTIONS......................................................................................................................42
ELECTRICAL INPUT AND ISOLATION TRANSFORMER DETAILS....................................................................42
NONIN XPOD PULSE OXIMETER ............................................................................................................43
NO IMPLIED LICENSE ..............................................................................................................................43
INDICATIONS FOR USE.............................................................................................................................43
ACCESSORIES ........................................................................................................................................43
CABLES ...........................................................................................................................................43
AVAILABLE OXIMETRY SENSORS .......................................................................................................44
MEASUREMENTS.....................................................................................................................................45
DISPLAYED RANGES ...............................................................................................................................45
MAINTENANCE, CLEANING, & DISPOSAL.............................................................................................46
QUANTUM AMPLIFIER POUCH,BELT,&HARNESS....................................................................................46
RECOMMENDATIONS ...............................................................................................................................46

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DISPOSAL...............................................................................................................................................47
TROUBLESHOOTING................................................................................................................................48
PROBLEMS WITH SIGNAL QUALITY ..........................................................................................................49
ACCESSORIES & REPLACEMENT PARTS LIST....................................................................................50
GETTING HELP..........................................................................................................................................51
APPENDIX A ..............................................................................................................................................52
DIGITAL TRIGGER INPUT PORT WIRING DIAGRAM.....................................................................................52
HOW THE PULSE OXIMETER WORKS .................................................................................................53
INDEX .........................................................................................................................................................55

Natus Quantum Amplifier User & Service Manual
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Introduction
The Natus Quantum amplifier system is designed for the acquisition of EEG data from both scalp and
intracranial contacts. The Quantum's modular design consists of 128 channel banks that can be
cascaded up to 256 channels, an integrated software controlled Digital Switch Matrix (DSM), integrated
Nonin® pulse oximeter, 16 DC inputs –as well as TCP/IP and USB connectivity for quick and easy
installation. This rugged device was designed with extensive clinical input to meet the workflow and
application needs of the EEG/LTM Lab.
Quantum features include
128 referential channels (cascade-able up to 256).
16 referential inputs per 128 can be configured as 8 differential inputs
16 DC channels,
Pulse Oximeter including SpO2, Pulse Rate and Pleth signals
Digital Trigger Input
Ability to initiate an impedance test, change the threshold, and view the results in the patient
room
Digital Switch Matrix
A small and lightweight wearable breakout box
TCP/IP and USB connectivity
Patient-event switch interface on both the breakout box and base units
Photic stimulator interface for EEG applications
Modular pouch for belt or backpack harness
WARNING: We strongly recommend that you read the Warnings and Cautions section of
this manual before operating this amplifier.
Intended Use
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display,
store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus
NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG)
signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional
mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination
of hardware relays and software controls allowing the user (physician or technologist) to switch electrode
pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.
The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for
use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and
operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

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System Components
The Quantum Amplifier system is provided with optional system components. Computers are intended to
run the NeuroWorks software exclusively. Cameras are intended to acquire synchronized video of the
patient during long-term monitoring. Isolation transformers are intended to provide power for all system
components while ensuring the safety of operators and patients. Carts are intended to support and
facilitate the use of the Quantum amplifier while keeping the system mobile.
Operating Principle of the Quantum Amplifier
The Natus Quantum amplifier is comprised of a base unit and several breakout boxes. It is part of a
system that is made up of a personal computer, a photic stimulator, an isolation transformer, video and
audio equipment, networking equipment, and mechanical supports. The amplifier also contains an
internal switch matrix to allow for a connection to an external cortical stimulator.
EEG and other physiological signals, from scalp electrodes, grid or needle electrodes, and other
accessories such as pulse oximeters can be acquired by the Natus Quantum amplifier. These signals are
digitized and transmitted to the personal computer running the Natus NeuroWorks software. The signals
are displayed on the personal computer and can be recorded to the computer's local storage or to remote
networked storage for later review.
Using the Manual
This manual describes the theory, features, set up, operation and maintenance of the Quantum amplifier.
It also provides information on specifications, troubleshooting and getting help.
When reviewing the procedures, we recommend you read the entire section first, before beginning a
sequence. Please follow the instructions carefully.
Manual Conventions
Various symbols and typographical conventions are used throughout the manual. The following table
illustrates them and describes their meanings and functions.
Symbol/
Convention
Description/Function
This symbol denotes a warning or important information that should not be
missed. Read all warnings and cautions carefully before starting the system for the
first time.
A note that contains important supplemental information.
Bold
Names of control keys, function keys, options, and labels are shown in bold. Bold
text is also used to emphasize important names or ideas.
Italic
Italic text is used for captions.

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Safety & Standards Conformity
Standards of Compliance and Normative References
Multichannel Sleep/EEG Headbox System, Model Quantum Amplifier, detachable cord connected,
portable 115/230Vac, 50/60Hz, 70VA.
1. Type of protection against electric shock: Class I
2. Degree of protection against electric shock: Type BF
3. Degree of protection against ingress of water: IPX0
4. Degree of safety of application in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa
The Quantum Amplifier and its accessories have been designed to comply with the following national
and international standards.
Table 1 –Safety Standard of Compliance and Normative References
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1:2005 + C1:2006 and C2:2007, Third
Edition
CENELEC EN 60601-1:2006 + A1:2013
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-6:2010, Edition 3.0
Medical electrical equipment –Part 1-6: General
requirements for basic safety and essential
performance –Collateral standard: Usability
IEC 62366:2007, Edition 1.0
Medical devices –Application of usability
engineering to medical devices
IEC 60601-2-26:2012, Edition 3
CENELEC EN 60601-2-26L2003, Edition 2
Medical electrical equipment –Part 2-26: Particular
requirements for the safety of
electroencephalographs
EN ISO 80601-2-61:2011, Edition 1
Medical electrical equipment –Part 2-61: Particular
requirements for basic safety and essential
performance of pulse oximeter equipment

User & Service Manual Natus Quantum Amplifier
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Table 2 –EMC Standard of Compliance and Normative References
IEC 60601-1-2:2007, Edition 3.0
Medical electrical equipment –Part 1-2: General
requirements for safety –collateral standard:
electromagnetic compatibility –requirements and
tests
IEC 61000-4-2:2008, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-2:
Testing and Measurement Techniques -
Electrostatic Discharge Immunity Test
IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010
Electromagnetic Compatibility (EMC) Part 4-3:
Testing and Measurement Techniques - Radiated,
Radio-frequency, Electromagnetic Field Immunity
Test
IEC 61000-4-4:2012, ed 3.0
Electromagnetic Compatibility (EMC) Part 4-4:
Testing and Measurement Techniques - Electrical
Fast Transient/Burst Immunity Test
IEC 61000-4-5:2014, ed 3.0
Electromagnetic Compatibility (EMC) Part 4-5:
Testing and Measurement Techniques - Surge
Immunity Test
IEC 61000-4-6 ed 2.0 with A1:2004 + A2:2006
Electromagnetic Compatibility (EMC) Part 4-6:
Testing and Measurement Techniques - Immunity
to Conducted Disturbances, Induced by Radio-
frequency Fields
IEC 61000-4-8:2009, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-8:
Testing and Measurement Techniques - Power
Frequency Magnetic Field Immunity Test
IEC 61000-4-11:2004, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-11:
Testing and Measurement Techniques - Voltage
Dips, Short Interruptions and Voltage Variations
Immunity Tests
IEC 61000-3-2:2014, ed 4.0
Electromagnetic Compatibility (EMC) Part 3-2:
Limits - Limits for Harmonic Current Emissions
IEC 61000-3-3:2013, ed 3.0
Electromagnetic Compatibility (EMC) Part 3-3:
Limits - Limitation of Voltage Changes, Voltage
Fluctuations and Flicker in Public Low-voltage
Supply Systems
CISPR 11 ed 5.0 with A1:2010
Industrial, Scientific and Medical (ISM) Radio-
Frequency Equipment - Electromagnetic
Disturbance Characteristics - Limits and Methods
of Measurement

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Declaration of Compliance for IEC 60601-1-2
Table 1 - Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The Quantum is intended for use in the electromagnetic environment specified below. The customer or the user
of the Quantum should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1
The Quantum uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
not likely to cause any interference in nearby
electronic equipment
RF emissions
CISPR 11
Class A
The Quantum is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

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Table 2 - Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Quantum is intended for use in the electromagnetic environment specified below. The customer or the user
of the Quantum should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Complies
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrostatic fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Complies
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
Complies
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 250ec
Complies
Mains power quality should be that of a
typical commercial or hospital environment. If
the user of the Quantum requires continued
operation during power mains interruption, it
is recommended that the Quantum be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
Complies
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC supply voltage prior to application of the test level.

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Table 3 - Electromagnetic Immunity–for EQUIPMENT and SYSTEMS that are not LIFE-
SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The Quantum is intended for use in the electromagnetic environment specified below. The customer or the user
of the Quantum should assure that it is used in such an environment
Immunity test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Quantum, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d=1.2 ×√P 150kHz to 80MHz
d=1.2 ×√P 80MHz to 800MHz
d=2.3 ×√P 800MHz to 2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site1
should be less than the compliance level in
each frequency2.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
1
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Quantum is used exceeds the applicable RF compliance level above, the Quantum should
be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-
orienting or relocating the Quantum.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4 - Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and
the QUANTUM.
The Quantum is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Quantum can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Quantum as recommended below, according to the maximum output power of the communications
equipment.
Rated Maximum Output
Power of Transmitter
(W)
Separation Distance according to Frequency of Transmitter (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Declaration of Compliance for FCC
Note: This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in which case the
user will be required to correct the interference at his own expense.
Warning: Changes or modifications not expressly approved by the manufacturer could void the
user's authority to operate the equipment.

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Warnings and Cautions
General Warnings
NOTE: It is recommended that all data be stored using redundant storage capabilities. This
can help to minimize data loss in the event of a failure of the primary drive.
Do NOT operate the system in the presence of flammable anesthetics.
Check areas of use to avoid using the system in the presence of flammable gases.
Only use the Quantum system in conjunction with approved devices and accessories.
Use of cables other than those specified or sold by the manufacturer on the equipment,
may result in increased emissions or decreased immunity of the equipment and may cause
the system to be non-compliant with the requirements of IEC 60601-1-2:2007
Never use equipment that has parts missing or equipment that might contain loose parts
inside of it (that is, inside an enclosed portion of the equipment). If you suspect a piece of
equipment has missing or loose parts, contact Natus. Routinely inspect system cables and
components for regular wear and tear.
Perform the recommended maintenance. Refer to the Maintenance & Cleaning section for
further details.
Do not immerse the amplifier or any of its components in water or other fluid.
This equipment/system is intended for use by Healthcare professionals ONLY. Please read
this section before installing any of the hardware. Refer to this section when you operate,
transport, store, or re-install the system.
Proper use of this device depends on the careful reading of all instructions and labels that
come with or on the system. Inaccurate measurements may be caused by incorrect
application or use.
When replacing the fuse for the Quantum amplifier, it must be replaced by a fuse with the
same type and rating as the original fuse. Replacement fuses should be purchased from
Natus directly.

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The amplifier base unit is classified as an IPx-0 –ordinary degree of protection against
ingress of water according to IEC 60529.
The amplifier Breakout is classified as body worn and has an IPx-1 rating while inside the
pouch (-61) and meets IEC 60601-2-26 spillage requirement without the pouch.
The Quantum system is classified as a class I device according to IEC 60601-1.
To ensure the validity of signals, do not operate the device near any sources of
electromagnetic interference.
WARNING: Third-party software installed on the acquisition computer may interfere with
the operation of the Natus software. Please consult Natus Technical Support before
installing third-party software on the computer.
WARNING: No modification of this equipment is allowed.
Electrostatic Discharge (ESD) Precautions:
Electrostatic Discharge (ESD) Precaution: Be sure to take the appropriate
Electrostatic Discharge (ESD) precautions. Disconnect the cables before
moving, cabling, or performing any set up procedures. Connectors marked with
the ESD protection symbol should not be touched. For detailed handling
procedures, refer to the Electrostatic Discharge (ESD) Handling
Procedures and Warnings section.
Turn off all system power and disconnect the power cord from the system and the wall
before attempting to clean the unit. The Quantum unit can be wiped clean with a soft, damp
cloth using non-conductive distilled water, electrically non-conductive inert surfactants or a
Natus approved cold sterilizing agent. It is important to dry off the unit quickly. Avoid letting
liquid seep into any of the internal electronics of the system. Do not use any abrasive
cleaner on the system.
Natus systems are not AP or APG rated. DO NOT USE a Natus system in the presence of
a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Device accessories may include several kinds of disposable, sterile needle electrodes.
These needles are labeled as STERILE and the method of sterilization is documented on
the packaging. These electrodes should not be used if the sterile packaging has been
tampered with.
The Quantum amplifier needs special precautions regarding Electromagnetic Compatibility
(EMC) and must be installed and operated according to EMC guidelines. Refer to the EMC
Standard of Compliance and Normative References table in the Safety & Standards
Conformity section.

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Using the Quantum amplifier with cables and accessories not approved by Natus may
negatively affect EMC performance, including electromagnetic immunity. Refer to the
Electromagnetic Immunity table in the Safety & Standards Conformity section.
External equipment may interfere with the performance of the Quantum amplifier, even if
other equipment complies with CISPR Emission requirements. Refer to the EMC
Standard of Compliance and Normative References table in the Safety & Standards
Conformity section.
The Quantum amplifier should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the amplifier should be observed to verify normal
operation in the configuration in which it will be used. Refer to the Recommended
Separation Distances table in the Safety & Standards Conformity section for minimum
recommended separation distances.
Do not connect items which are not specified as part of the Quantum system to the system.
Electrical Warnings and Cautions
Natus systems are intended for connection to a properly grounded electrical outlet only.
Conductive parts of electrodes and their connectors are not to contact other conductive parts
and earth.
Do not place MULTIPLE PORTABLE SOCKET-OUTLETS (MPSOs) on the floor.
Do not connect additional MPSOs or extension cords to the Quantum Amplifier system.
ELECTRICAL SHOCK HAZARD: Do NOT turn on the system power until all cables have
been connected, verified and visually inspected for any damage. Failure to inspect the cables
may result in electrocution. Verification of electrical safety should be performed routinely.
ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified
personnel only. Do NOT use repaired components without proper testing.
Do not use the MPSO with the Quantum Amplifier system for supplying power to any
equipment that is not part of the system.

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To avoid the possible hazards caused by the summation of leakage currents when all the
parts of the system are interconnected, no equipment other than devices connected to the
Quantum Amplifier system may be powered by the isolation transformer.
The current rating of the isolation transformer must be sufficient to operate all of the devices
powered by it. Refer to the current ratings of the isolation transformer and current rating for
each individual device connected.
Do NOT connect non-medical equipment which has been supplied as part of the system
directly to the wall outlet when the system is supplied, via MPSO, with a separating
transformer.
Do NOT connect electrical equipment which has not been supplied as a part of the system to
the MPSO.
The Quantum amplifier is NOT designed to work with defibrillators. The Quantum system
could be damaged when used with this device.
Ensure that the Quantum Amplifier system is solely connected to a three-wire, grounded,
hospital-grade receptacle.
Patient Environment Warnings and Cautions
NOTE: The patient environment is defined as the area within 1.5 meters of the patient
laterally and within 2.5 meters of the floor in the area occupied by the patient.
Connect all patient electrodes to fully electrically isolated physiological devices only.
Connecting patient electrodes to any other device or external outlet may result in personal
injury.
If a computer is located in the patient environment and is connected to a network, a network
isolator MUST be used.
The patient event button attached to the Quantum Amplifier system is NOT intended for
critical patient-safety-related incidents.
Patient connections are NOT intended for direct cardiac contact.
As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.

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Do NOT touch any Quantum system accessible metal parts and the patient simultaneously.
Do NOT touch any earth-grounded components of the Quantum system and the patient
simultaneously.
Do not use the Quantum system in the vicinity of MRI or CT systems.
Connection of a patient to high-frequency surgical equipment and to electroencephalography
equipment simultaneously may result in burns at the site of bio-potential input electrodes and
possible damage to the biological amplifiers. Please consult the user documentation of the
surgical equipment for instruction as to its proper use.
As with all medical equipment, there is a risk of injury if the harness/belt and pouch(es) are
used without ensuring they are secured to the patient properly. Refer to the Adding the
Quantum breakout box(es) to a harness or belt section for details.
REPETITIVE STRESS INJURY HAZARD: Sustained use of this product without ergonomic
consideration may result in repetitive stress injury.
User is not to position ME equipment in such a way as to make it difficult to operate the
disconnection device.
The Quantum Amplifier system does NOT include SpO2 or Pulse Rate alarms.
If a video camera is present in the patient environment, it should be connected via Ethernet
directly to the computer, and not to a network.
If a computer is located in the patient environment, it must be 60601-1 approved or 60950-1
approved and powered by a 60601-1 approved isolation transformer.
Transportation Warnings
Make sure that any platform, table, cart, or other surface used during the operation,
transport, or temporary or permanent storage of the system and its components is
adequate, sturdy, and safe. Natus is not responsible for any injury or damage that may
result from inadequate, poorly constructed, or unapproved transports, carts, or operating
surfaces. Natus is not responsible for any injury or damage that may result from improper
cable storage during transport.

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TIPPING HAZARD: During transport, the user should guide the cart using both hands,
ensuring the wheel base is aligned so that a single caster leads in the direction of motion.
Failure to lead the cart with one wheel could result in a tipping hazard when ascending or
descending steps or thresholds.
Pulse Oximeter Warnings
The Nonin XPOD pulse oximeter is to be operated by qualified personnel only. This manual,
the instructions for use for any pulse oximeter sensor or cable extender, the accessory
directions for use, all precautionary information, and specifications should be read prior to
use.
EXPLOSION HAZARD: Do not use the pulse oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
A pulse oximeter should NOT be used as an apnea monitor.
A pulse oximeter should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter
to completely understand the patient’s condition.
Significant levels of dysfunctional hemoglobins (HbCO or MetHb) may cause inaccurate
measurements.
Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate
measurements.
Excessive illumination may cause inaccurate measurements or loss of pulse signal.
Excessive patient movement may cause inaccurate measurements.
Venous pulsations may cause inaccurate measurements.
Carboxyhemoglobin may erroneously increase readings. The level of increase is
approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance
containing dyes, that change usual arterial pigmentation may cause erroneous readings.
Loss of pulse signal can occur when the patient has hypotension, severe vasoconstriction,
severe anemia or hypothermia.

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Loss of pulse signal can occur when there is arterial occlusion proximal to the sensor.
Loss of pulse signal can occur when the patient is in cardiac arrest or is in shock.
Do not immerse the sensor in water, solvents, or cleaning solutions. Do not sterilize the
sensor by irradiation, steam or ethylene oxide.
Do not immerse patient cables in water, solvents, or cleaning solutions (the patient cable
connectors are not waterproof). Do not sterilize patient cables by irradiation, steam or
ethylene oxide.
As with all medical equipment, carefully route cables and connections to minimize the
possibility of entanglement or strangulation.
Operation of this module below the minimum amplitude of 0.3% modulation may cause
inaccurate results.
Oximeter readings may be affected by the use of an electrosurgical unit (ESU).
Inspection of monitors, cables, and probes should be completed prior to each use to ensure
compatibility and maintain patient safety.
Pulse Oximeter Sensor Warnings
Before using, carefully read the sensor directions for use.
Use only Nonin oximetry sensors, as required, for SpO2 measurements. These sensors are
manufactured to meet the accuracy specifications for the pulse oximeter. Other oxygen
transducers (sensors) may cause improper pulse oximeter performance.
Tissue damage can be caused by incorrect application or use of a pulse oximetry sensor
(i.e. by wrapping the sensor too tightly). Inspect the sensor site as directed in the sensor
directions for use to ensure skin integrity and correct positioning and adhesion of the
sensor.
Patient sensitivity may vary due to medical status or skin condition. Discontinue use of
adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material.
Do not use pulse oximetry sensors during MRI scanning as this could potentially cause
burns. The pulse oximeter may affect the MRI image, and the MRI unit may affect the
accuracy of the oximetry measurements.