Codman 3000 Serie Manual De Instrucciones página 2

The Refi ll Kit contains:
[1] 50 mL Calibrated Syringe Barrel
[1] Tubing Set
[1] Stopcock
[2] Huber Point Needles;
22 Gauge x 1.5" (3.8 cm)
[3] POVIDONE IODINE Swabsticks
[3] Alcohol Swabsticks
[6] Gauze Pads
[1] Fenestrated Drape
[1] Data Sticker
[2] Adhesive Bandages
[1] Refill Worksheet
[1] INSTRUCTIONS FOR USE
[2] INSTRUCTION POSTERS
ITEMS NOT PROVIDED IN KIT: Sterile Gloves and Syringes
Required for Procedure.
WARNINGS
The pump must be implanted and refilled only by qualified
medical personnel, knowledgeable in the surgical use and
servicing of implantable devices and catheters, and trained
specifically to implant or refill the pump. Use of the pump
by personnel not properly trained in its implantation and/or
servicing can lead to serious consequences involving
either under or over-delivery of drug to the patient. In the
event of an over-delivery of drug refer to the approved
drug labeling for appropriate action.
Utilization of the pump requires the proper handling (filling,
storage and dispensing) of a significant volume/dosage of
drug. This amount of drug can be extremely harmful to the
patient if delivered suddenly or inappropriately.
Bolus access and pump refill procedures must be
performed using the correct access needle. Never attempt
to refill the pump using a Special Bolus Needle. This use
will result in giving a bolus injection to the patient and can
cause a fatal drug overdose.
The CODMAN 3000 Series Constant Flow Implantable
Pumps contain a safety valve in-line with the bolus
pathway to insure that a bolus procedure can only be
performed when using a properly positioned Special Bolus
Needle (REF AP-04013 or AP-04032).
REVIEW ALL INSTRUCTIONS
BEFORE PROCEEDING:
PRECAUTIONS
CAUTION: Inspect the sterile package carefully.
Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
A needle is provided in this kit. It is critical to the safe
functioning of the pump that no other needle be used
to penetrate the septum.
Do not aspirate fl uid through the Bolus Pathway.
Aspiration will cause blood to be drawn into catheter
and result in occlusion.
It is important to precisely follow the Pump Refi ll
Instructions as detailed in this pamphlet in order to
successfully complete the pump refi ll procedure. If
the needle is not properly positioned, and verifi ed
as detailed in the Pump Refi ll Procedures, there is
a possibility that a drug extravasation will occur.
2
CODFR13007xx02svn.indd 2 CODFR13007xx02svn.indd 2
Refi ll Kit – CODMAN
CONSTANT FLOW IMPLANTABLE PUMPS
CODMAN ® 3000 SERIES Cross Section Schematic
Refi ll Volume:
®
CODMAN 3000-16 ......... 16 mL
CODMAN ® 3000-30 ......... 30 mL
CODMAN ® 3000-50 ......... 50 mL
For 24-Hour Technical Assistance or to arrange an in-service Training Program,
HOW SUPPLIED
The CODMAN Refi ll Kit is intended for SINGLE USE ONLY;
DO NOT RESTERILIZE. Use aseptic technique in all phases
of handling. Codman Single Use devices have not been
designed to undergo or withstand any form of alteration,
such as disassembly, cleaning or resterilization, after
a single patient use. Reuse can potentially compromise
device performance and any usage beyond the design
intent of this single use device may result in unpredictable
loss of functionality.
Codman & Shurtleff 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.
As long as the inner unit is not opened or damaged, the
product is sterile.
REFILL PROCEDURE:
Place patient in a supine position. Expose the pump
pocket site. Palpate the pump site and locate the
raised septum.
1. Fill a syringe with appropriate refi ll solution (refer to
model for proper volume) and a 10 mL syringe with
saline solution.
2. Using sterile technique, open refi ll kit and expose
kit components.
3. Don sterile gloves. Use three iodine swabsticks to prep
the pump site in a circular fashion extending the prepped
area beyond the periphery of the pump. Allow prepped
area to dry. Place fenestrated drape over pump site.
4. Attach the Needle and Stopcock to the Tubing Set.
Stopcock and clamp are in the OPEN position.
Next attach 50 mL calibrated syringe barrel to the
Stopcock. Tighten all connections.
®
3000 Series
Bolus Path
Bolus Safety Valve
Outlet
Catheter
Needle Stop
contact: Codman & Shurtleff, Inc. +1 508 880 8156 or 800 660 2660.
LID
STOPCOCK
OPEN
REF AP-07014
Septum
Flow Restrictor
Drug Reservoir
5. Re-palpate the pump site and locate the raised septum.
6. Insert the non-coring needle PERPENDICULAR to the
pump septum. Advance the needle until it is in contact
with the needle stop.
INCORRECT POSITION INCORRECT POSITION
NEEDLE STOP
CORRECT NEEDLE POSITION
7. Allow pump reservoir to empty (Figure 5). Keep
downward pressure on the needle throughout the
procedure. If no fl uid returns to the syringe, refer to
Troubleshooting Guide for assistance.
RETURN VOLUME
STOPCOCK OPEN
Note: After allowing the pump to "empty" into the syringe
barrel, fl uid from the previous refi ll will remain in the pump.
This residual volume is 2.33 mL for the CODMAN 3000-16
pump, 2.72 mL for the CODMAN 3000-30 pump, and
2.86 mL for the CODMAN 3000-50 pump.
Filter
Propellant Chamber
2/22/2013 3:24:42 PM 2/22/2013 3:24:42 PM