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1360 Drainage Kit IFU (50-7500) Drainage Kit
Catalog No. 50-7500
Instructions for Use
Denver Biomedical, Inc.
14998 W. 6th Ave. Bldg. E 700
Golden, CO 80401-5025 USA
European
Telephone: (303) 279-7500
Authorized Representative
(800) 824-8454
The Surgical Company
FAX: (303) 279-7575
Terminalweg 19a
email: dbi-info@denverbio.com
3821 AJ Amersfoort
website: www.denverbiomedical.com
The Netherlands
DENVER
®
and PLEURX
®
are registered trademarks of Denver Biomedical, Inc.
*
U.S. Patent No. 5,484,401
®
* 2
Instructions for Use
Pleurx Drainage Kit
Table of Contents
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
The Pleurx Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
The Pleurx Drainage Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
How to drain using the Pleurx Drainage Kit . . . . . . . . . . . . . . . . . . . . . . . 6
Getting started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Connecting the drainage bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Draining fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Final steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Placing a new dressing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Changing the drainage bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Emptying the vacuum bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Additional Drainage Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
You should have been trained by a nurse or doctor in the
correct way to use the items in this kit. If you have any
problems or questions about draining the fluid from your
chest, contact your doctor or nurse.
Read this entire pamphlet carefully before draining the
fluid from your chest.
Warranty
Denver Biomedical, Inc. warrants that this medical device is free from
defects in both materials and workmanship. THE ABOVE WARRANTIES
ARE IN LIEU OF ALL OTHER WARRANTIES, EITHER EXPRESS OR
IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. Suitability for use of the medical
device for any surgical procedure shall be determined by the user. Denver
Biomedical, Inc. shall not be liable for incidental or consequential
damages of any kind. Pleurx Drainage Kit
Instructions for Use
3
Warnings
Do not drain more than 1000 ml of
fluid from your chest at any one
time.
It is normal to feel some pain when
draining fluid. If you feel pain in
your chest when draining, clamp the
drainage line to slow or stop the
flow of fluid for a few minutes. If
you dont feel better after doing this,
contact your nurse or doctor.
Keep the valve on your Pleurx
Pleural Catheter and the access tip
on the drainage line clean. Keep
them away from other objects to
help avoid contamination.
Do not use scissors or other sharp
objects near the Pleurx Pleural
Catheter.
If you accidentally cut the
catheter follow these steps:
a. Pinch the catheter closed between
your fingers.
b. Slip the blue emergency slide
clamp over the catheter, and
push the catheter completely into
the small
end of the
clamp. This
will close the
catheter.
c. Notify your
doctor
immediately.
Do not put anything except the
access tip of the drainage line into
the Pleurx Pleural Catheter valve,
since this could damage the valve. A
damaged valve might let air be
pulled into your chest cavity or let
fluid leak out through the valve.
Cautions
Federal (U.S.A.) law restricts this
device to sale by or on the order of a
physician.
When not draining, the clamp on
the drainage line must be com-
pletely closed or the vacuum in the
bottle may be lost.
Make sure that the valve and the
access tip are locked together when
draining. If they are accidentally
separated, they may become con-
taminated and the vacuum in the
bottle may be lost. If this occurs,
clean the valve with an alcohol pad
and use a new drainage bottle.
The alcohol pads are flammable. Do
not expose the pads to an open
flame.
Potential complications of draining
the pleural space include but may
not be limited to, pneumothorax,
re-expansion pulmonary edema,
hypotension, circulatory collapse
and infection.
This product contains natural rubber
latex, which may cause allergic
reactions. 4
Instructions for Use
Pleurx Drainage Kit
The Pleurx Catheter
Your doctor has placed the Pleurx Catheter to allow you to drain fluid from
your chest while you are at home. Part of the catheter is inside your chest and
has several holes that allow fluid to enter the catheter. There is a valve at the
outer end of your catheter that prevents air from entering and fluid from
leaking out when you are not draining.
Pleurx Catheter
Always use the Pleurx Drainage Kit for draining fluid from your chest to
avoid damage to the Pleurx Catheter and to provide the best performance.
The Pleurx
Drainage Kit
The Drainage Kit provides the supplies you need to drain the fluid from your
chest. The items in the kit are:
1 - Plastic vacuum bottle (500 ml) with attached drainage line
1 - Procedure Pack containing the following items:
1 - self-adhesive dressing
1 - blue wrapping (wrapped around the following items)
1 - pair of gloves
1 - valve cap
1 - blue emergency slide clamp
4 - gauze pads (4" x 4")
1 - foam catheter pad
3 - Alcohol pads (70% isopropyl alcohol)
Sterility
The Procedure Pack and Vacuum Bottle (with drainage line) in this kit have
been sterilized. As long as the packaging is not damaged or opened, the
contents within each package are sterile. These products are for single use only
and are not to be reused.
Denver Biomedical, Inc. will not be responsible for any product that is
resterilized, nor accept for credit or exchange any product that has been opened
but not used.
Fenestrations (holes)
Polyester
Cuff
Internal Portion
External Portion
Valve Pleurx Drainage Kit
Instructions for Use
5
Plastic Vacuum Bottle
Procedure Pack
Drainage
Line
Access
Tip
Access
Tip
Cover
Pinch Clamp
500 ml
Vacuum
Bottle
Green
Vacuum
Indicator
White Slide
Clamp
Drainage Kit Contents 6
Instructions for Use
Pleurx Drainage Kit
How to drain using the Pleurx Drainage Kit
Now that your doctor or nurse has trained you on the drainage procedure, you
should find it easy to follow these step-by-step directions. You should drain the
fluid from your chest every one to two days or as directed by your doctor.
Getting started
1. Set up a clean, clear workspace on a table or counter.
2. Thoroughly wash your hands with soap and water for at least 1 minute.
3. Remove the dressing from over your catheter.
If you see any redness, swelling or fluid around
the catheter, finish this drainage procedure
and contact your doctor or nurse.
4. Open the Drainage Kit bag.
5. Open the Procedure Pack bag by peeling the
front and the back of the pouch apart, starting
at the top. Set the adhesive dressing aside.
6. Set the bundle with the blue wrapping on your
workspace. Remove the tape. Carefully unfold
the blue wrapping by pulling on the outside of
the wrapping. Leave the enclosed items on the
wrapping. The items and the inside of the
wrapping are sterile, so dont touch them with
your ungloved hands or other non-sterile
items.
7. Pick up the bag that contains the
Vacuum Bottle. Look at the
green vacuum indicator on the
top of the bottle. This indicator
tells you if there is vacuum in
the bottle. The indicator should
be down, not up. If the indicator
is up discard the bottle and use
another.
8. Open the Vacuum Bottle bag and
remove the bottle with the
attached drainage line. The items
in the bag are sterile. It is especially important that the access tip remain
sterile. If the cover has fallen off of the access tip, make sure that you do
not touch the tip with your hand or anythi