STATLOCK IV SELECT, Руководство пользователя

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Catheter Stabilization Device
Read carefully before use.
Safety and Efficacy Considerations:
Rx only. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Sterilized by Ethylene Oxide. Single use only.
Do not resterilize. Do not use if package is damaged. Fluid path (if present) is nonpyrogenic.
Product code,
lot number and expiration date information – see packaging.
Do not alter the S
tat
L
ock
® or components. Procedure must be performed by trained personnel with
knowledge of anatomical landmarks, safe technique and potential complications.
LATEX FREE
Indications for use:
The S
tat
L
ock
®
stabilization device is for compatible medical tubes and catheters.
Contraindications:
Known tape or adhesive allergies.
Warnings and Precautions:
1. Do not use the S
tat
L
ock
®
stabilization device where loss of adherence could occur, such as with
a confused patient, diaphoretic or nonadherent skin or when the access device is not monitored
daily .
2. Observe universal blood and body fluid precautions and infection control procedures, during
application and removal of the S
tat
L
ock
®
stabilization device.
3. SUTURE THE S
tat
L
ock
®
STABILIZATION DEVICE PAD TO SKIN IF DESIRED OR DEEMED
NECESSARY.
4. Avoid the S
tat
L
ock
®
stabilization device contact with alcohol or acetone, both can weaken bonding
of components and the S
tat
L
ock
®
stabilization device pad adherence.
5. Minimize catheter/tube manipulation during application and removal of the S
tat
L
ock
®
stabilization
device.
6. Remove oil and moisturizer from targeted skin area.
7. The S
tat
L
ock
®
stabilization device pad adherence and catheter/tube position should be routinely
inspected.
8. Orient the S
tat
L
ock
®
stabilization device so arrow points toward catheter tip.
9. The S
tat
L
ock
®
stabilization device should be replaced at least every 7 days.
10. This is a single use device. Reuse and/or repackaging may create a risk of patient or user
infection, compromise the structural integrity and/or essential material and design characteristics
of the device, which may lead to device failure, and/or lead to injury, illness or death of the
patient.
11. Do not re-sterilize. The sterility of the single use device is not guaranteed following re-sterilization
because of an indeterminable degree of potential pyrogenic or microbial contamination which
may lead to infectious complications. Re-sterilization may compromise the structural integrity,
essential material and/or design characteristics and may lead to an unpredictable loss of
functionality and/or device failure.
Use sterile technique for appication and removal of the S
tat
L
ock
®
stablization device. See illustrations for specific
details.
Application:
1. PREP: Prepare the targeted S
tat
L
ock
®
stabilization device area as follows:
a. Alcohol - to degrease skin and remove Betadine, then
b. Skin prep (if included) - to enhance adherence and protect skin, then
ALLOW TO DRY COMPLETELY.
2. PRESS: Before applying the S
tat
L
ock
®
stabilization device pad to skin, secure tube or catheter to
the S
tat
L
ock
®
stabilization device retainer.
3. PEEL: Peel off the S
tat
L
ock
®
stabilization device paper backing, and
4. PLACE: Place the S
tat
L
ock
®
stabilization device on targeted skin one side at a time
Note:
• The S
tat
L
ock
®
stabilization device pad can be adhered after X-ray confirmation of proper catheter/
tube position.
Removal:
Carefully remove overlying dressing using stretch technique and sutures (if applicable).
1. DISSOLVE the
S
tat
L
ock
®
stabilization device adhesive with alcohol swab while gently lifting the
S
tat
L
ock
®
stabilization device pad.
2. DISENGAGE catheter/tube from the S
tat
L
ock
®
stabilization device retainer.
3. DOCUMENT the S
tat
L
ock
®
stabilization device dressing change in the patient chart.
4. DISPOSE of all equipment in appropriate containers.
Extenson Set
Indications for Use:
For use as an extension to the IV fluid delivery system. The S
tat
L
ock
® stabilization device extension
set male Luer adapter is specifically designed to secure the extension set when used as part of the
S
tat
L
ock
® stabilization device stabilization system.
Directions for Use:
Use aseptic technique.
1. Tighten all connections.
2. Remove Protector Caps (A)
as required.
3. Connect Female Port (B) to fluid
delivery line or device and prime/
flush.
4. Connect Male Port (C) to catheter
hub.
5. Open Slide Clamp (D) for
unimpeded flow.
6. Swab septum of injection site and
needleless valve (if present) with
preferred antiseptic.
General Precautions:
1. Avoid air trapped in set. Puncturing
tube can cause air embolism or
leakage.
2. Avoid contact with alcohol, it
can alter the structure of plastic
components.
Options / Precautions:
Needleless Valve (E) and Y-Site w/ Needleless Valve (F)
1. Connect fluid line or device to center of valve using Luer Lock connections only.
2. Do not use with a blunt tip cannula or conventional needle. If a needle must be used, attach a
PRN adapter and use as a standard injection site.
T-Connector (G)
Stopcock (H)
1. Position handle over port you wish to close.
2. Open port for fluid delivery.
3. Close and cap available port when not in use.
Standard Y-Ste (I)
1. Use with a conventional needle only. Do not use with a blunt tip cannula.
NOTES
1. Tubing is non-DEHP PVC
2. Dispose used set in appropriate container.
3. Replace extension set and ports per CDC guidelines.
Fill Volumes:
Manufacturer:
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 USA
800-443-5505, 801-522-5000
www.bardaccess.com
Assembled in Mexico
Authorized Representative in the
European Community
Bard Limited
Forest House, Brighton Road
Crawley, West Sussex
RH11 9BP UK
ENGLISH
0086
DELIVERY LINE
E
A
A
H
B
D
F
I
or
or
Options:
Options:
CATHETER HUB
C
A
G
2403097 1405R
Bard and StatLock are trademarks and/or registered trademarks of C. R. Bard, Inc.
All other trademarks are the property of their respective owners.
Fill Volume (mL)
Micro No Valve W/Valve
12” (304.8mm) ext set 0.40 NA
4” (101.6mm) ext set with SmartSite® 0.18 0.27
6” (152.4mm) ext set with bonded MicroClave® NA 0.26
6” (152.4mm) ext set with SmartSite® 0.25 0.34
6” (152.4mm) ext set with UltraSite® 0.25 0.62
8” (203.2mm) ext set with 3-way stopcock 0.36 0.55
9” (228.6mm) bifurcated ext set with SmartSite® (2) 0.57 0.75
Macro
6” (152.4mm) ext set with Bonded MicroClave®
NA 0.97
6” (152.4mm) ext set with Smart Y® and SmartSite® 0.90 1.06
6” (152.4mm) ext set with SmartSite® 0.90 0.99
6” (152.4mm) ext set with UltraSite® 0.90 1.26