natus XactTrace User manual

1
The Single Use Pre-Sized XactTrace belt system (XactTrace belts) is
used during sleep studies to acquire and transfer data related to thoracic
and abdominal respiratory effort to a compatible sleep recorder.
This document describes how to use the XactTrace belts and includes
information on intended use, warnings and cautions, system
components, adjusting and attaching the belts, storage and cleaning.
Intended Use
The XactTrace®Single Use Respiratory Effort Belt System is intended to
measure respiratory effort to assist in the diagnosis of sleep disorders or
sleep related respiratory disorders. The respiratory effort signals
measured are processed to provide electrical signals suitable for
connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers,
sleep clinics.
The XactTrace®Single Use Respiratory Effort Belt System is intended for
diagnostics purposes only and is not intended to be used as an apnea
monitor.

XactTrace® Single Use Pre-Sized Belt System User Instructions
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Warnings and Cautions
XactTrace belts shall be worn over the patient's clothing The belts
are single use.
Do not stretch the belts too tightly around the patient as this may
cause discomfort
Caution must be taken to ensure that cables do not encircle the
patient's neck. Special attention is needed in the case of children.
Use the device only under the direction and supervision of a
physician or trained technologist.
Avoid all unnecessary contact with moisture when using the device.
Do not use damaged belts, sensors or cables.
Caution: U.S. Federal law restricts this device to sale by, or on the
order of, a physician.
This product is for diagnostic purposes only, and is not to be used as
an apnea monitor.
Do not use the device in an explosive environment—in other words,
in the presence of flammable liquids, such as an anesthetic mixture
with air, or with oxygen or nitrous oxide.
Connect the XactTrace belts only to an input that is electrically
isolated from the mains power. Do not plug the cables into electrical
outlets, as this could result in serious electrical shock.
Portable and mobile RF communications can affect the performance
of the device.
Electrostatic discharges (ESD) may cause artifacts in the signal from
the device. A trained operator should be able to recognize these
artifacts easily. Avoid conditions where electrostatic charge can build
up due to low humidity and friction against carpets, clothing, and
sheets made from artificial fibers.
Universal applications require an external inductive interface cable
which 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.

XactTrace® Single Use Pre-Sized Belt System User Instructions
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System Components
The system consists of a belt and a snap sensor with a cable that
connects directly to an input on the recording device. The system
converts changes in inductance to a digital signal that provides both
qualitative and quantitative information on respiratory effort. An optional
inductive interface cable can be purchased to interface the locks with
most PSG systems that accept the 1.5mm female touchproof
connectors.
Belt
Sensor
Fitting the XactTrace Belts
The belts are intended to be worn over nightclothes and should fit the
patient snugly without being uncomfortably tight. Avoid all unnecessary
contact with moisture when using the XactTrace belts.
Note: Do not use two thorax sensors or two abdomen
sensors in the same recording. Using two sensors of the
same type will cause interference between the sensors and
could result in poor signal quality.
Choosing a Belt Size
The XactTrace belts come in four sizes: Large, Medium, Small and
Pediatric. The length of the belt size can be adjusted to ensure a good fit.
The belts should fit the patient snugly without being uncomfortably tight.
Measure the patient’s circumference and use the table below as a
guideline. The belts are single use.

XactTrace® Single Use Pre-Sized Belt System User Instructions
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XactTrace Belt Sizes
Full Size
Reduced Size
cm
Inches
cm
Inches
Large
127 - 190
50 - 75
102 - 165
40 - 65
Medium
96 - 140
38 - 55
76 - 119
30 - 47
Small
61- 89
24 - 35
40 - 69
16 - 27
Pediatric
35 - 56
14 - 22
28 - 48
11 - 19
Adjusting the Belt Size
Adjust the belt by sliding the loop buckles on each end to maintain a
snug fit around the patient circumference.
Attaching the Belts to the Patient
1. Encircle the belt around the patient chest and secure the snap
ends of the belt to the buckle with the “blue” connector as shown
in the figure below. The belt should fit snugly without being
uncomfortably tight.
2. Prepare the abdomen belt in the same manner, only this time, fit
the belt around the patients stomach and attached the snap ends
of the belt to the buckle with the “yellow” connector.

XactTrace® Single Use Pre-Sized Belt System User Instructions
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3. Connect the abdominal (yellow) and the thoracic (blue)
XactTrace belt connectors to the appropriate color-coded inputs
on the recording device.
4. External inductive interface cables are required only with non-
Embla amplifiers, referred to as “universal” applications. When
using the inductive interface cables, insert the connector from
the Chest belt into the processor module labeled THORAX, and
then insert the connector from the Abdomen belt into the
processor module labeled ABD. Both the Thorax (blue) and
Abdomen (yellow) belt locks and inductive interface cable labels
are color coded for easy identification and connection.

XactTrace® Single Use Pre-Sized Belt System User Instructions
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5. Plug the thorax and the abdomen module outputs into the
appropriate bipolar inputs on your polygraph. The red touch-
proof plugs into (+) input, and the black plugs into (-) input.
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 –0.03 Hz (or 5 seconds or
longer)
High Frequency Filter –15 to 35 Hz.
Note: Shorter time constants or higher low frequency filter
settings significantly attenuate waveforms.
Technical Specifications
See the table below for technical specifications for the XactTrace belts.
Physical Properties
Belt
Length:
Pre-Sized lengths –Based on sizing chart
found under Fitting the XactTrace Belts.
Material:
Elastic belt
W=25,WHITE,TERYLENE,WITH
WIRE,UL1571 #28,WHITE
Cable
Length:
16 inches (41 cm) –Thorax
26 inches (66 cm) –Abdomen
or
78 inches (200 cm) –Thorax/Abdomen
Material:
CONN,2P+FLAT
CABLE,NONULN#24(46/0.08)*2C,BLACK
Snaps
SCREW,M3,THREAD
L=3.2,L=8.8,D=2.95,D=4.6
Over-
molding
PVC,45P,WHITE,UL94V-0

XactTrace® Single Use Pre-Sized Belt System User Instructions
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Physical Properties
Cable
Extension
(Optional)
Length:
78 inches (200 cm)
Material:
PVC jacketed; zip-style cord
Inductive
Interface
Cable
(Optional)
Box:
ABS
Cable:
PVC jacketed; zip-style cord
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)
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 (Inductive Interface Cable):
Output Signal
Maximum signal
amplitude:
< 2mV
Frequency Range:
0.2 to 3 Hz
Sensitivity:
Approximately 50µV/mm
Hardware Compatibility
Keyhole
Connectors
Embla N7000
Embla S4500
Embletta MPR System
Natus Embla NDx/SDx, Natus Brain Monitor
1.5mm Touch
Proof
Connections
Compatible with Amplifiers that meet the following
input requirements
Can receive 1.5 mm touch proof connectors
Channel input range > 3mV
Amplifier filter characteristics that allows the
following frequency range to pass
Signals from 0.2Hz to 3Hz

XactTrace® Single Use Pre-Sized Belt System User Instructions
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Storage
Proper storage extends the life of the XactTrace belts. To prevent
damage, do the following when storing the sensor and belts between
studies.
The belts are single use and should not be used for more than
one study.
Do not wrap the cable around the sensor.
Incorrect
Correct
Cleaning
Wipe the snap sensor and inductive interface cables (if used) clean with
a moist cloth containing hospital-grade laundry detergent, and dry with a
clean, dry cloth. Take care to avoid contacting the sensor connector and
plug of the snap sensors or processor modules with the cleaning
solution. The snap sensors and inductive interface cables (if used) do
not require sterilization.
The belts should be discarded after use, and do not require cleaning.
Labeling Definitions
This symbol indicates that the item should not be reused and
is intended for a single-use only.
Maintenance
No special maintenance of the XactTrace belts is required.

XactTrace® Single Use Pre-Sized Belt System User Instructions
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Warranty
Natus warrants the sensor to be free of defects in materials and
workmanship for 12 months from the date purchased. The sole liability of
Natus and our distributors is limited to replacement or repair of the
product at the option of Natus, 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 Natus 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 anything 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.

*013190*
REF: 013190, Rev. 08
XactTrace®Single Use Pre-Sized System User Instructions
Copyright © 2019 Natus Medical Incorporated. All rights reserved.
Printed in China.
013190, Rev. 08
Issued in March 2019.
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.
For assistance, please contact Embla Technical Support
([e-mail]).
Embla Systems, a Natus Medical company.
MANUFACTURER
EUROPEAN REPRESENTATIVE
Embla Systems
1 Hines Road, Suite 202
Kanata, ON K2K 3C7
Canada
Tel. : [phone]
Fax : [phone]
Natus Manufacturing Limited
IDA Business Park, Gort,
Co. Galway, Ireland
Tel. : [phone]
Fax : [phone]
TOLL-FREE IN NORTH AMERICA: 888 NO APNEA (888.662.7632)
www.natus.com Ottawa.T[email protected]