Instructions for Use

Relieva Luma®
Sinus Illumination System
Relieva Luma Sentry™
Sinus Illumination System

IFU005055 Rev A

CAREFULLY READ ALL INSTRUCTIONS PRIOR
TO USE.
CAUTION: Federal (U.S.A.) law restricts this device
to sale by or on the order of a physician.
STERILITY: The Relieva Luma Sinus Illumination
System and the Relieva Luma Sentry Sinus
Illumination System are sterilized with ethylene
oxide gas.
SINGLE USE: The Relieva Luma Sinus Illumination
System and the Relieva Luma Sentry Sinus
Illumination System are intended for single
patient use only. DO NOT resterilize and/or
reuse, as it may result in compromised device
performance, risk of improper sterilization and cross
contamination.
STORAGE: Store in a cool, dry place.
DESCRIPTION
The Relieva Luma Sinus Illumination System and the
Relieva Luma Sentry Sinus Illumination System are 0.035”
compatible flexible instruments that transmit light from the
proximal to distal tip. The Relieva Luma Sinus Illumination
System consists of a fixed light guide cable connector, a
flexible instrument body, and a distal light lens (see figure
1). The Relieva Luma Sentry Sinus Illumination System
consists of a removable light guide cable connector, a
flexible instrument body, and a distal and proximal light lens
(see figure 2). The Relieva Luma Sentry Sinus Illumination
System also incorporates depth markers on the flexible
instrument body which can be used to help determine the
distance the flexible tip has been advanced into the nasal
cavity. The Relieva Luma Sinus Illumination System and
the Relieva Luma Sentry Sinus Illumination System are
supplied with a pre-shaped distal tip.
LIght Guide Cable connector
Light Lens
Pre-shaped distal tip
Figure 1
Distal Light Lens
Distal Depth Marker Proximal Depth Markers
Removable Connector
Figure 2
Acclarent, Inc., 1525-B O’Brien Drive, Menlo Park, CA 94025
Customer Service: 1-877-SPLASTY
+1-650-687-5888
www.acclarent.com
Instructions for Use
Relieva Luma® Sinus Illumination System
Relieva Luma Sentry™ Sinus Illumination System
INDICATIONS FOR USE
The Relieva Luma Sinus Illumination System is intended to
provide a means to access the sinus space for diagnostic
and therapeutic procedures in conjunction with other nasal
and sinus products. It is also intended to illuminate within
and transilluminate across nasal and sinus structures.
The Relieva Luma Sentry Sinus Illumination System is
intended to provide a means to access the sinus space
for diagnostic and therapeutic procedures in conjunction
with other nasal and sinus products. It is also intended to
illuminate within and transilluminate across nasal and sinus
structures.
CONTRAINDICATIONS:
None.
WARNINGS
• Do not use a device where the integrity of the sterile
packaging has been compromised or if the device
appears damaged.
• Never advance or retract the Relieva Luma Sinus
Illumination System or the Relieva Luma Sentry Sinus
Illumination System against unknown resistance as this
can cause tissue trauma or device damage.
• Only physicians trained in the use of Balloon
Sinuplasty™ technology should use this instrument.
• Do not use the Relieva Luma Sentry Sinus Illumination
System with light sources whose bulbs are less than 20
hours old. Device damage may occur.
PRECAUTIONS
• The Relieva Luma Sinus Illumination System or the
Relieva Luma Sentry Sinus Illumination System are
precision optical instruments and must be handled with
care. Do not pinch or kink the body of the Relieva Luma
Sinus Illumination System or the Relieva Luma Sentry
Sinus Illumination System.
• Do not attempt to alter the distal tip of the Relieva Luma
Sinus Illumination System or the Relieva Luma Sentry
Sinus Illumination System, as this may result in device
damage.
• If using the Relieva Luma Sinus Illumination System or
the Relieva Luma Sentry Sinus Illumination System to
trans-illuminate the frontal sinus, pre-operative review
of a CT, x-ray or other image is recommended to help
facilitate identification of the frontal sinus.
• Use only Relieva light guide cables with the Relieva
Luma Sinus Illumination System and the Relieva Luma
Sentry Sinus Illumination System, as standard light guide
cables may damage the optical components.
• Light from the tip of the Relieva Luma Sinus
Illumination System and Relieva Luma Sentry Sinus
Illumination System may transcutaneously illuminate
tissue structures. The location and intensity of the
transcutaneous illumination will depend on the sinus
Proximal Light Lens entered, orientation of the Sinus Illumination System, and
patient characteristics.
• To ensure maximum light transmission for subsequent
uses in the same patient, rinse the distal tip of the
Relieva Luma Sinus Illumination System and the Relieva
Luma Sentry Sinus Illumination System in saline after
use in each sinus.
• Do not advance the black, proximal end of the instrument
body of the Relieva Luma Sentry Sinus Illumination
System through a sinus guide catheter, Relieva StratusTM
Frontal Deployment Guide or into nasal anatomy, as this
could cause device damage or tissue trauma.
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• When sliding the Relieva Luma Sentry’s flexible
instrument body out of the removable connector, ensure
that the button is depressed. Device damage may occur
if the button is not depressed.
COMPATIBILITY
The Relieva Luma Sinus Illumination System and Relieva
Luma Sentry Sinus Illumination System are only compatible
with Acclarent Balloon Sinuplasty™ instruments that
use 0.035” Sinus Guidewires. Use with other products
may result in device damage and/or patient injury. The
Relieva Luma Sinus Illumination System and Relieva Luma
Sentry Sinus Illumination System are compatible with all
Relieva light guide cables, and Xenon light sources (300W
maximum). Please refer to the appropriate Instructions for
Use when using with compatible devices.
INSTRUCTIONS FOR USE
If using the Relieva Luma Sinus Illumination System:
1. Remove the Relieva Luma Sinus Illumination System
from the protective packaging.
2. Connect the light guide cable connector to a Relieva
light guide cable that was specially designed to be used
with the Relieva Luma family of devices.
3. Activate the light source. Confirm that light is visible at
the distal end of the Relieva Luma Sinus Illumination
System.
If using with a Relieva® family Sinus Balloon Catheter:
1. Starting at the distal end of the Relieva Luma Sinus
Illumination System, load the proximal end of the
Relieva Sinus Balloon Catheter onto the Relieva Luma
Sinus Illumination System. This must be performed prior
to insertion into the nasal cavity.
2. Use the Sinus Balloon Catheter per its instructions for
use.
If using to transcutaneously illuminate through sinus
structures:
1. Advance the instrument into the target sinus until some
light resistance is felt.
2. To enhance the intensity of the transcutaneous
illumination provided by the Relieva Luma Sinus
Illumination System, it may be necessary to reduce
the number of competing light sources (i.e. endoscope
or room lights) or to reposition the location of the
instrument tip.
3. Confirm placement and position of the Relieva Luma
Sinus Illumination System with endoscopic, fluoroscopic
and/or transcutaneous illumination visualization.
If using the Relieva Luma Sentry Sinus Illumination
System:
1. Remove the flexible instrument body and removable
light guide cable connector from the protective
packaging.
2. Connect the removable connector to a Relieva light
guide cable that was specially designed to be used with
the Relieva Luma family of devices.
3. Activate the light source.
4. Depress the button on the removable light guide cable
connector.
5. With the button depressed, slide the black, proximal
end of the flexible instrument body into the removable
connector.
Acclarent, Inc., 1525-B O’Brien Drive, Menlo Park, CA 94025
Customer Service: 1-877-SPLASTY
+1-650-687-5888
www.acclarent.com
Instructions for Use
Relieva Luma®Sinus Illumination System
Relieva Luma Sentry™ Sinus Illumination System
6. Confirm that the proximal light lens contacts the
proximal face of the connector by ensuring that the
distal tip of the device is illuminated and the flexible
body will not advance further inside the connector.
7. Release the button on the removable light guide cable
connector.
8. Confirm that light is visible at the distal end of the
Relieva Luma Sentry Sinus Illumination System.
NOTE: For the Relieva Luma Sentry Sinus Illumination
System to transmit adequate light, the proximal light lens
must contact the proximal face of the connector.
If using with a Relieva® family Sinus Balloon Catheter:
1. Starting at the distal end of the Relieva Luma Sentry
Sinus Illumination System, load the proximal end of the
Sinus Balloon Catheter onto the Relieva Luma Sentry
Sinus Illumination System. This must be performed
before insertion into the nasal cavity.
2. Use the Sinus Balloon Catheter per its instructions for
use.
3. The distal depth marker indicates that the tip has exited
the sinus guide catheter. The proximal depth markings
indicate that the tip has been advanced approximately
5cm into the nasal cavity.
If using to transcutaneously illuminate through sinus
structures:
1. Advance the instrument into the target sinus until some
light resistance is felt.
2. To enhance the intensity of the transcutaneous
illumination provided by the Relieva Luma Sentry Sinus
Illumination System it may be necessary to reduce the
number of competing light sources (i.e. endoscope
or room lights) or to reposition the location of the
instrument tip.
3. Confirm placement and position of the Relieva Luma
Sentry Sinus Illumination System with endoscopic,
fluoroscopic and/or transcutaneous illumination
visualization.
If using an exchange technique:
1. Use the sinus balloon catheter per the appropriate
Instructions For Use document.
2. When complete, depress the button on the removable
light guide cable connector.
3. With the button depressed, remove the proximal end
of the flexible instrument body from the removable
connector.
4. Slide the Sinus Balloon Catheter off the proximal end of
the flexible instrument body.
NOTE: If the Relieva Luma Sentry Sinus Illumination
System becomes lodged in a sinus balloon catheter, do not
continue to pull the flexible instrument body through the
balloon. Abandon the exchange technique and thread the
sinus balloon catheter off of the distal end of the Relieva
Luma Sentry Sinus Illumination System.
5. Slide a second sinus balloon catheter or the Relieva
Vortex Sinus Irrigation Catheter onto the proximal end of
the flexible instrument body and advance into the sinus
guide catheter.
NOTE: Use a balloon insertion stylet to straighten out
the inner lumen of the sinus balloon catheter before
completing the exchange, if desired. Straightening the
lumen will ease sliding of the balloon catheter onto the
instrument body.
IFU005055 Rev A
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 Instructions for Use
Relieva Luma® Sinus Illumination System
Relieva Luma Sentry™ Sinus Illumination System

NOTE: When sliding a sinus balloon catheter onto the

proximal end of the flexible instrument body, grasp the
sinus balloon catheter at the distal end of the device and
MediMark Europe SARL
slowly advance the balloon.
11 Rue Emile Zola, B.P. 2332
6. If necessary, wipe the proximal light lens with a saline
F-38033 Grenoble Cedex 2, France
soaked gauze pad if it has become soiled during device
exchange.
7. Depress the button on the removable light guide cable
connector.
8. With the button depressed, slide the proximal end of the
flexible instrument body into the removable connector.
9. Confirm that the proximal light lens contacts the
proximal face of the connector by ensuring that the
distal tip of the device is illuminated and the flexible
instrument body will not advance further inside the
connector.
10. Release the button on the removable light guide cable
connector. Confirm that light transilluminates the
appropriate nasal anatomy.
11. Use the second sinus balloon catheter or the Relieva
Vortex Sinus Irrigation Catheter per their instructions for
use.

GRAPHIC SYMBOLS CONTAINED

ON DEVICE LABELING
Rx On Order of
Lot Number
ONLY Physician Only
Sterilized with
Date of Manufacture
ethylene oxide
Consult Instructions
Use by Date
For Use
Diameter
Do not re-use
Compatability

Length 0 Tip

Upper Limit of
Keep Dry
Temperature
Keep Away from
CE Mark
Sunlight
European Authorized
Manufactured By
Representative

1 Contents of
Product Code
Package/Box

Relieva Luma Sentry

Sinus Illumination
System

Product Information Disclosure

Acclarent, Inc. has exercised reasonable care in the manufacture
of this device. Acclarent, Inc. excludes all warranties, whether
expressed or implied, by operation of law or otherwise, including but
not limited to, any implied warranties of merchantability or fitness,
since handling and storage of this device, as well as factors relating
to the patient, diagnosis, treatment, surgical procedures and other
matters beyond Acclarent, Inc.’s control, directly affect this device and
the results obtained from its use. Acclarent, Inc. shall not be liable for
any incidental or consequential loss, damage or expense, directly or
indirectly arising from the use of this device. Acclarent, Inc. neither
assumes, nor authorizes any other person to assume for it, any other or
additional liability or responsibility in connection with this device.

© Acclarent, Inc. 2010 All rights reserved.

Acclarent, Inc., 1525-B O’Brien Drive, Menlo Park, CA 94025 IFU005055 Rev A
Customer Service: 1-877-SPLASTY Page 4/4
+1-650-687-5888
www.acclarent.com