Instructions For Use; Preparing For Pump Implant - Medtronic SYNCHROMED II Manuel D'implantation

Filename Date Time
UC200xxxxxx EN
4.6 x 6.0 inches (140 mm x 197 mm)

Instructions for use

Implanting physicians should be experienced in pump and catheter implant procedures and
should be thoroughly familiar with all product labeling.
#
Cautions:
▪
Do not implant a pump that was dropped onto a hard surface or shows signs of
damage. Implanting a pump that has been dropped or damaged can result in lack
of intended therapy, and require additional surgery to replace the pump.
▪
Do not implant the pump unless pump operation has been confirmed. Failure to
confirm pump operation before implant can result in additional surgery to replace
the pump.
▪
Do not prematurely activate the pump reservoir valve. Activation of the pump
reservoir valve seals the pump reservoir valve closed. Unusual resistance or the
inability to inject the entire fill volume may indicate activation of the pump reservoir
valve. If the valve closes, a portion of the reservoir contents must be delivered or
removed before filling can be completed. Procedural delays can occur. To prevent
activation of the pump reservoir valve during emptying and filling procedures:
–
completely aspirate all contents of the pump reservoir before filling.
–
do not allow air into the pump reservoir through an open needle in the septum
or an unclamped extension.
–
do not exceed the maximum reservoir volume indicated in the pump labeling.
▪
To use the nonsterile clinician programmer in a sterile field, place a sterile barrier
between the patient and the programming head to prevent infection. Do not sterilize
any part of the clinician programmer. Sterilization may damage the programmer.

Preparing for pump implant

1. Assemble equipment and supplies.
Sterile items
▪
The pump package containing the pump, 22-gauge noncoring needle (for filling the
pump), and 24-gauge noncoring needle (for flushing the catheter access port)
▪
Empty 20-mL syringes (for emptying the pump)
▪
0.22-µm (micron) filter
▪
Syringe containing prescribed fluid (volume not to exceed the reservoir volume of
the pump)
▪
10-mL syringe with 1–2 mL of sterile, preservative-free saline (for flushing the
catheter access port)
Nonsterile items
▪
Medtronic clinician programmer
2. Before opening the shelf package, use the clinician programmer to interrogate the pump
and verify pump battery status and current settings.
M221311A028 Rev A
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