Embla XactTrace User manual

1
Universal–Single Use XactTrace™
Instructions
The Universal-Single Use XactTrace Respiratory Inductive Plethysmogragh
(RIP) sensor belt is a respiratory effort sensor used in the diagnosis of
sleep disordered breathing. XactTrace measures changes in inductance,
and converts it into a digital signal that gives both qualitative and
quantitative data. This sensor is more sensitive and reliable than typical
respiratory effort sensors, especially in cases of paradoxical breathing.
The Universal-Single Use XactTrace belts consist of a belt roll that can be
cut to appropriate lengths for each patient and two Belt Locks for the
abdomen and thoracic regions.
Fitting the XactTrace Belts
The XactTrace belts must be custom fit for each patient. When using the
XactTrace belts, avoid all unnecessary contact with
moisture.
1. Encircle the belt around the patient’s chest
under the arm to approximate the
circumference for the thoracic belt.
2. When cutting the belt, reduce its circumference by 10-15cm (4-6
in) so it stretches around the thorax. The belt should fit snugly to

Universal–Single Use XactTrace™ Instructions
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prevent slippage during the study. It is important to use sharp
scissors for a clean cut.
The wire should not exceed the end of the belt.
3. Secure the cut ends of the belt into the Belt Lock with the blue
connector according to the following steps:
Twist the top end of the
Belt Lock clockwise to
open the catch. The white
mark on the top should
match the open lock
symbol on the catch.
Insert the cut end
of the belt into
the catch. Make
sure to insert the
end all the way
to the bottom of
the catch.
Twist the top end of the
Belt Lock counter-
clockwise to close the
catch. When the white
mark on the top
matches the closed lock
symbol on the catch, the
Belt Lock is properly
closed.
4. Prepare the abdominal belt in the same manner, only this time, fit
the belt around the patient’s stomach at the navel, and use the
Belt Lock with the yellow connector.
Attaching the XactTrace Belts
The XactTrace belts are intended to be worn over the patient’s
nightclothes.
1. Place the belt with the yellow connector around the patient’s
stomach, at the navel.

Universal–Single Use XactTrace™ Instructions
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2. Take the two components of the Belt Lock and connect them, as
shown below.
3. Place the second belt with the blue connector around the patient’s
chest, under the arm.
4. Connect the second Belt Lock as shown above.
5. Insert the connector from the Chest belt into the driver module
labeled Thorax (* in the following drawing).
6. Insert the connector from the Abdomen belt into the driver module
labeled Abdomen.
7. Plug the thorax module output into the appropriate bipolar input
of your polygraph. The red touch-proof plugs into (+) input, and
the black plugs into (-) input.
8. Plug the thorax module output into the appropriate bipolar input
of your polygraph.

Universal–Single Use XactTrace™ Instructions
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Note: Do not use two abdomen or two thorax modules in the
same recording. This causes interference between the two
sensors, resulting in bad signals.
Storage
Proper storage of the XactTrace Belt Locks between recordings is
important.
To protect the sensor cable from damage, do not wrap it tightly around
the Belt Lock, as it might cause the cable to break where it connects to the
Lock.
Do not wrap the wires around the Belt Locks, as it may cause the
wire
to break.
To save battery power, the modules MUST be disconnected from
the Belt Locks when not in use.
Incorrect
Correct
Cleaning and Disposal
Wipe the Driver Modules and Belt Locks clean with a moist cloth in
hospital-grade laundry detergent, then dry them with a clean, dry cloth.
Take care to avoid contact of the cleaning solution with the sensor
connector and plug of the Belt Lock. The Belt Lock does not require
sterilization.

Universal–Single Use XactTrace™ Instructions
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The belts do not need cleaning, as they should be discarded after use.
Warnings
See the list of warnings below.
Do not stretch the belts too tightly around the patient, as this may
cause discomfort. To prevent the belt from slipping during the
study, fix the position with medical tape.
The belts shall be worn over night clothes.
This product is for diagnostic purposes only, and is not to be used
as an apnea monitor.
Take care not to cut any cables when cutting the belts.
Do not use damaged sensors or accessories.
Be certain that cables or sensors do not encircle the patient’s
neck.
Do not use the equipment in a magnetic resonance imaging
(MRI) environment.
Do not use the device in an explosive environment—in other
words, in the presence of flammable liquids, such as aesthetic
mixture with air, or with oxygen or nitrous oxide.
Connect the XactTrace sensors to an electrically isolated input
only. Do not plug the cables into electrical outlets, as this could
result in serious electrical shock.
The device contains a battery; therefore, it must be disposed of
properly. Local, state, or national laws might prohibit disposal of
batteries in ordinary trash. Contact your local waste authority for
information regarding available recycling and disposable
options.
Portable and mobile radio frequency (RF) communications can
affect the performance of the device.

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Single Use –Universal XactTrace User
Settings
User settings are described below.
Sensitivity –Adjustment of the sensitivity up or down is typically
required. Response is dependent upon variables, such as sensor
application and patient effort.
Low Frequency Filter / Time Constant –0.16 Hz (or 1 second or
longer)
Shorter time constants or higher low frequency filter settings
significantly attenuate waveforms.
High Frequency Filter –15 to 35 Hz.
Technical Specifications
See the table below for technical specifications for the Single Use –
Universal XactTrace.
Physical Properties
Belt
Length: Roll of 35 yards, cut to fit each
patient.
Material: Elastic band with wire.
Cable
Length: 80 inches (205 cm)
Material: PVC jacketed; zip-style cord
Module
Box: ABS
Cable: PVC jacketed; zip-style cord
Power
Battery
Non-replaceable lithium coin cell battery.
Nominal operation time: 2000 hours
(approximately 250 eight hour studies)
The battery is activated once the sensor
module is connected to the belt.
Environmental Specifications
Temperature
Operation: 40°F to 120°F (+5°C to +50°C)
Storage: 0°F to 120°F (-18°C to +50°C)

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Relative Humidity
Operation: 15 to 95% (non-condensing)
Storage: 10 to 95% (non-condensing)
Pressure
Withstands atmospheric pressures from 7.3
psi to 29 psi
Output Specifications
Output Signal
Maximum signal amplitude: +/- 5mV
Frequency Range: 0.2 to 3 Hz
Sensitivity: Approximately 50µV/mm
Certifications
The Universal Single-Use XactTrace system is certified to
carry the CE mark. The CE mark is a declaration that the
Universal XactTrace system is in compliance with the
essential requirements set forth by the European Union for
medical devices.
The Embla Quality Management System complies with EN ISO
13485:2003. The Universal XactTrace system is manufactured by Embla.
Warranty
Embla Systems warrants the sensor to be free of defects in materials and
workmanship for a period of one year from the date purchased. The sole
liability of Embla Systems and our distributors is limited to replacement or
repair of the product at the option of Embla Systems, with no charge for
parts or labor if any part is proven to be defective in workmanship,
performance, or materials during the warranty period. Under no
circumstances shall Embla Systems or our distributors be liable for any loss
of revenues or damage, direct, consequential, or incidental, including loss
of profit, property damage, or personal injury arising from the use of, or
the inability to use this product. This warranty is intended for the original
buyer and is in lieu of all other warranties or previous agreements,
expressed or implied. This warranty is rendered void if the product is
used for other than its intended purpose or is subject to abuse, misuse,
tampering, neglect or unauthorized modifications. Use of this product
constitutes acceptance of this warranty in total.

*2870114*
REF: 2870114, Rev. 4
Universal–Single Use XactTrace Instructions
Copyright © 2015 Natus Medical Incorporated. All rights reserved.
Issued January 2015. Printed in Taiwan
Product #: 2870114, Rev. 4
Disclaimer
This document may contain technical inaccuracies or typographical errors. Embla
does not accept any liability for the use or misuse, direct or indirect, of this product.
Users must accept all responsibility for any results obtained by or concluded from
the products. All clinical conclusions and decisions that are made based on the use of
this product are the responsibility of the user. Embla does not accept any liability or
responsibility for damages arising out of the use of or inability to use this product.
Copyright
Information in this document, including URL and other Internet website references, is
subject to change without notice. Complying with all applicable copyright laws is the
responsibility of the user. Without limiting the rights under copyright, no part of this
document may be altered for any purpose, without the express written permission of
Embla. The subject matter in this document is the express property of Embla. Unless
specifically provided in any written license agreement from Embla, the furnishing of
this document does not give you any license to these trademarks, copyrights, or
other intellectual property.
Trademarks
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.
For assistance, please contact Embla Technical Support ([email protected]).
MANUFACTURER
EUROPEAN REPRESENTATIVE
Embla Systems
1 Hines Road, Suite 202
Kanata, ON K2K 3C7
Canada
Tel: [phone]
Fax: [phone]
Natus Europe GmbH
Robert-Koch-Str. 1
82152 Planegg
Germany
Tel: [phone]
Fax: [phone]
Toll-Free in North America: 888 NO APNEA (888.662.7632)
www.embla.com s[email protected] [email protected]