natus Xltek EMU40EX User manual

EMU40EX Battery Pack
User Manual

Publisher’s Notice
033980 Rev 1 03/2021
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone]
Website: natus.com
EU Representative / Importer
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
Associated Product Part Numbers:
002874 and 002876
Copyright © 2021 by Natus Medical Incorporated.
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
Neurology 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 Neurology Incorporated or its distributors. Natus Neurology Incorporated makes no
representations or warranties of any kind whatsoever with respect to this document. Natus
Neurology Incorporated disclaims all liabilities for loss or damage arising out of the possession,
sale, or use of this document.
CaviWipes is a trademark of Metrex Research, LLC. Sani-Cloth is a registered trademark of PDI,
Inc.

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TABLE OF CONTENT
WARNINGS AND PRECAUTIONS.......................................................................4
ABOUT EMU40EX BATTERY PACK...................................................................5
INTENDED USE ...................................................................................................7
INTENDED USERS AND PATIENT TARGET GROUP........................................7
CLINICAL BENEFITS...........................................................................................7
CONTRAINDICATIONS AND SIDE EFFECTS ....................................................7
CHARGING THE BATTERY PACK......................................................................7
USING THE EMU40EX HEADBOX WITH THE BATTERY PACK.......................8
USEFUL TIPS.......................................................................................................8
MAINTENANCE....................................................................................................9
SPECIFICATIONS................................................................................................9
COMPLIANCE STANDARDS.............................................................................10
DISPOSAL INSTRUCTIONS..............................................................................10
DISCLAIMER......................................................................................................11
INSTRUCTIONS TO ACCESS THE eIFU...........................................................11
GLOSSARY OF SYMBOLS ...............................................................................12

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WARNINGS AND PRECAUTIONS
WARNING
Refers to a hazardous situation that could result in death or serious injury if not avoided.
•Information on how the hazardous situation is avoided.
CAUTION
Refers to a hazardous situation that could result in minor or moderate injury or material damage
if not avoided.
•Information on how the hazardous situation is avoided.
WARNING
System components immersed or in contact with liquids may cause electrical shock.
•The Battery Pack is classified as an IP0 –ordinary degree of protection against ingress of water
according to IEC 529. The Battery Pack is not water proof. Prevent detergent solution or cold
sterilization agents from seeping into the electronics of the system.
Battery pack stored by plugging into the charging source reduces the battery life.
•Do not store the battery pack plugged in to the charging source.
Cleaning the device while it is connected to an EMU40EX amplifier or a charger could lead to
electric shock to the user.
•Do not clean the device when it is connected to an amplifier or a charger.
CAUTION
Unauthorized use of the battery pack can affect function and performance.
•Use with EMU40EX Breakout Box only.
Unauthorized modification of the battery pack can affect function and performance.
•Do not attempt to disassemble the Battery Pack. It does not have any serviceable parts.

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CAUTION
Disposal of battery pack in the fire could lead to explosion.
•Do not dispose the Battery Pack by burning.
Device used at higher temperature than the intended leads to functional failure.
•Do not use the Battery pack under ambient temperature higher than +40C°.
Device exposed at higher temperature than the intended leads to functional failure.
•Do not expose the Battery Pack to temperatures higher than +60C°. It may cause fire or
permanent damage to the Li-ion battery.
Battery Pack completely discharged for a long time before storing could lead to failure of
battery.
•Do not keep the Battery Pack completely discharged for a long time. Optimal is to pre-charge it to
50~75% before storage (i.e. charge it for about 2 hours).
Device dropped or damaged in transit/use could lead to loss of function or delayed diagnosis.
•Inspect the device prior to each use and do not use if damaged.
Modifications to the device can affect function and performance.
•Do not modify device or use unauthorized accessories supplies or components.
ABOUT EMU40EX BATTERY PACK
Thank you for purchasing the EMU40EX Battery Pack from XLTEK, one of the world's top manufacturers
of neurodiagnostic equipment and software. XLTEK is an ISO13485 certified company committed to
providing you with technologically advanced products that are practical and easy to use.
We encourage your feedback and suggestions regarding any aspect of the NeuroWorks system,
documentation, accessories, and support services.
The Battery Pack for EMU40EX Breakout Box is a portable power source consisting of the following four
parts:

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Fig.1. Battery Pack
Fig.2. USB Power Adapter
Fig.3. USB power Cable
Fig.4. EMU40EX Power Cable

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INTENDED USE
The EMU40EX Battery Pack is intended for use with EMU40EX Breakout Box only, which is used in
combination with NeuroWorks®/SleepWorks™ software to allow a qualified medical practitioner trained in
electroencephalography or polysomnography to acquire, display, archive, review, and analyze
physiological signals. It can be used with patients of all ages, but it is not designed for fetal use.
INTENDED USERS AND PATIENT TARGET GROUP
The intended users of the EMU40EX battery pack are trained medical professionals or someone
instructed by a trained medical professional. At minimum, it is expected that the user has a basic
understanding of clinical EEG and PSG, conducting an EEG or PSG study, proficiency with computers
and modern operating conventions. The user is typically trained on the use of the
NeuroWorks/SleepWorks software to operate the system or conduct a study acquisition using the
EMU40EX amplifier.
CLINICAL BENEFITS
The EMU40EX batter pack extends the period that a patient may be in an ambulatory position or not
physically connected to an amplifier base through a cable to facilitate the continuous recording of a
patient’s physiological parameters.
CONTRAINDICATIONS AND SIDE EFFECTS
There are no known contraindications or side effects for procedures performed with the EMU40EX battery
pack.
CHARGING THE BATTERY PACK
•Connect the Battery Pack (Fig.1) to USB Power Adapter (Fig.2) or to a computer USB port using USB
Power Cable (Fig.3).
•Check that “Charging” yellow light is on. If yellow light is off, it means, that charger does not detect
sufficient power and will not charge properly. Check cable connections and try again.
•Leave the Battery connected to the power source until continuous yellow light (“Charging”) is turned
off and continuous green light (“Battery”) is turned on.
•Unplug USB Power Cable (Fig.4) from the Battery Pack. All lights should be off. The Battery Pack is
now ready to use.
NOTE: Complete charging cycle may take about 3½ hours when using USB Power Adapter (Fig.2) and
5~6 hours when using PC USB port. Charging the Battery Pack from USB port is not recommended
due to longer charging time.

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USING THE EMU40EX HEADBOX WITH THE BATTERY
PACK
•Connect Battery Pack (Fig.1) to EMU40EX Breakout Box using EMU40EX power cable (Fig.4).
•Green light (“Battery”) will keep flashing as long as the battery is at least 20% full.
•When the Battery Pack is discharged to less than 20% of its capacity, flashing light “Battery” changes
its color to RED. This is a warning for you to complete the study or to change the power source in less
than 1 hour.
•Even after the Battery Pack is discharged and all lights are off, there may still be some power available
stored in the internal battery of the EMU40EX Breakout Box.
USEFUL TIPS
•In order to check condition of the battery simply connect the EMU40EX Power Cable (Fig.4). There is
no need to connect the headbox for this check. Three cases are possible:
1. “Battery” LED is off the battery is completely discharged.
2. “Battery” LED is flashing GREEN the battery is more than 20% full.
3. “Battery” LED is flashing RED the battery is less than 20% full.
•Please do not leave EMU40EX Power Cable (Fig.4) plugged if you do not intend to use the Battery
Pack for a long time. When the EMU40EX Power Cable is unplugged, the Battery Pack automatically
enters low-power standby mode prolonging battery life.
•All lithium batteries are “perishable products”. Their life expectancy is limited to 500 charge-discharge
cycles or 5 years due to chemical degradation of active electrodes. You may see very slow degradation
of the lithium cell performance even if it is not used.
•Lithium battery will last much longer when using more shallow charge-discharge cycles rather than
full-charge —full-discharge cycles. Battery life in charge-discharge cycles is specified for the latter
(worst) case. Use fresh or fully charged batteries before beginning a study.
•If you are not going to use Battery Pack for a few weeks or longer, please pre-charge it approximately
to 50~75%. This is optimal for long-term storage. Do not store a totally discharged battery as this may
render the battery pack inoperable.
•Do not continuously leave the battery pack charging. Overcharged cell leads to faster electrode
degradation.
•If you need longer continuous operation two (or more) batteries can be used to prolong disconnected
operation of EMU40EX headbox. This is limited by the memory storage capacity of the EMU40EX
headbox.

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MAINTENANCE
•The battery pack should not be immersed in water or any other fluid.
•Clean with a commercial wipe such as CaviWipesTM or Sani-Cloth®to remove visible soil or use a
lint-free cloth dampened with tap water to wipe the surface area.
•Dry using a lint-free cloth and air dry.
•Do not allow any liquid or cleaning solutions to come into contact with the LED electronics, contacts, or
connectors.
•Do not use alcohol-based or harsh abrasive cleaners.
SPECIFICATIONS
Battery technology ................................. 3.7V, Single cell, Li-polymer
Equivalent Li content .............................. 0.76g (for transportation regulations)
Electrical capacity .................................. 2500~2700mAh
Energy capacity ...................................... 9.8Watt-hours
Input charging voltage ............................ 5~12VDC
Charging current .................................... limited to 500~1000mA @ 4.2V
Charging time ......................................... 3½ hrs
Charge retention/storage > 80% at
Humidity ...................... 65±20RH
-20 to +20°C ...................... 1 year
-20 to +45°C ...................... 3 months
-20 to +60°C ...................... 1 month
Output voltage ...................... 10.7±0.5VDC regulated
Output current ...................... limited to <700mA
”Charging” indicator ...................... yellow LED
”Battery” indicator ...................... green/red LED
Operating Conditions
Temperature ...................... 10°C to 40°C (50°F to 104°F)
Relative Humidity.................... 30% to 75%
Atmospheric Pressure ............ 700 hPa to 1060 hPa
Storage Conditions
Temperature ...................... -40°C to 70°C (-40°F to 158°F)
Relative Humidity.................... 10% to 100%
Atmospheric Pressure ............ 500 hPa to 1060 hPa
Expected Cycle Life ...................... >500 full cycles keeping >70% of initial capacity
Physical dimensions ...................... 131×72×21mm (5.15”×2.8”×0.79”)
Weight ..................... 130g
Regulatory Compliance ...................... RoHS, UL 1642, CSA 22.2 No. 601-1, IEC 601-1

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COMPLIANCE STANDARDS
•ISO 10993-1: 2018 Biological evaluation of medical devices —Part 1: Evaluation and testing within a
risk management process
•EN ETSI 300 019-2-1 Environmental Engineering (EE); Environmental conditions and environmental
tests for telecommunications equipment; Part 2-1: Specification of environmental tests; Storage
•EN ETSI 300 019-2-2 Environmental Engineering (EE); Environmental conditions and environmental
tests for telecommunications equipment; Part 2-2: Specification of environmental tests; Transportation
•ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems for
Vibration
•UL1642 and IEC 62133-2:2017 Standard for Safety for Lithium Batteries
•IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
•IEC 60601-1-2 Fourth Edition Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements
and tests
DISPOSAL 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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DISCLAIMER
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) is not responsible for injury, infection or other
damage resulting from the use of this product.
Any serious incident that has occurred in relation to the device should be reported to Natus Medical
Incorporated DBA Excel-Tech Ltd. (Xltek) and the competent authority of the Member State in which the
user and/or patient is established.
Refer to the Natus website for an electronic copy of this document.
INSTRUCTIONS TO ACCESS THE eIFU
A copy of the Instructions for Use in PDF format is in the associated product area:
•Neurology: https://neuro.natus.com/neuro-support
Search for “EMU40EX Battery Pack User Manual” (refer to the Product Part Numbers) and choose the
version for your local language for the instructions to use.
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).

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GLOSSARY OF SYMBOLS
Symbol
Standard
Reference
Standard Title
Symbol Title
Explanation
Not applicable
Not applicable
An indication of
Medical Device
This product is a medical device.
21 CFR Part
801.109(b)(1)
Labeling-Prescription
devices
Prescription only
Indicates that the product is
authorized for sale by or on the
order of a licensed healthcare
practitioner.
ISO 15223-1
Symbol 5.4.5
(Reference
Annex B for
the general
prohibition
symbol)
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Not made with natural
rubber latex
Indicates that the medical device is
not made with natural rubber latex.
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 5.1.1
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Manufacturer
Indicates the medical device
manufacturer.
ISO 15223-1
Symbol 5.1.2
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Authorized
representative in the
European Community
Indicates the Authorized
representative in the European
Community.
ISO 15223-1
Symbol 5.1.3
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Date of manufacture
Indicates the date when the
medical device was manufactured.
ISO 15223-1
Symbol 5.1.6
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Catalogue number
Indicates the manufacturer’s
catalogue number so that the
medical device can be identified.
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 5.4.3
Annex A
#A.15
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Consult instructions for
use
Indicates an instruction to consult
an electronic instructions for use
(eIFU).

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Symbol
Standard
Reference
Standard Title
Symbol Title
Explanation
IEC 60601-1
Table D.2 #10
Medical electrical
equipment —Part 1:
General requirements
for basic safety and
essential performance
Follow instructions for
use
Refer to instruction manual/
Booklet.
NOTE on ME EQUIPMENT
"Follow instructions for use”
ISO 15223-1
Symbol 5.4.4
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
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
IEC 60601-1
Table D.2 #2
Medical electrical
equipment —Part 1:
General requirements
for basic safety and
Essential performance
General warning sign
Indicates a hazard of potential
personal injury to patient or
operator.
MDR
2017/745
EU Medical Device
Regulation
CE marking
Signifies European technical
conformity.
ISO 15223-1
Symbol 5.3.7
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Temperature limit
Indicates the (storage)
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
medical device labels,
labelling and information
to be supplied
Humidity limitation
Indicates the range of (storage)
humidity to which the medical
device can be safely exposed.
ISO 15223-1
Symbol 5.3.9
Medical devices —
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Atmospheric pressure
limitation
Indicates the acceptable upper
and lower limits of atmospheric
pressure for transport and storage.

Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone]
Website: natus.com 033980 Rev 1 03/2021
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