User Manual

MiniMed
®
Personal Pump Communicator
REF MMT-3150 Personal Pump
Communicator (English)
** NOTE **
Please refer to the physician and patient manual for
instructions for use and detailed information regarding the
Medtronic MiniMed Implantable Pump System.
INTRODUCTION
The Medtronic MiniMed Implantable Pump System is a
sophisticated combination of technologies developed to
address the requirements of continuous intraperitoneal insulin
delivery for patients with Insulin Dependent Diabetes Mellitus
(IDDM). The system is comprised of: Implantable Pump,
Side Port Catheter, Personal Pump Communicator, and
accessory syringe, needle, template, and pipette. The pump
and catheter are designed for implantation. The Personal
Pump Communicator is designed to provide the patient a
variety of insulin delivery options. The accessory items are
specifically designed to facilitate refill of the implanted pump
and pump functions.
INDICATIONS FOR USE
The Medtronic MiniMed Personal Pump Communicator is
intended to be used with the Medtronic MiniMed Implantable
Pump. Specific indications for use of the Implantable Pump
System are provided in the Implantable Pump Package Insert.
CONTRAINDICATIONS
The Medtronic MiniMed Implantable Pump System is
contraindicated in patients who:
• Are unwilling or unable to monitor their blood/glucose
level at least four times per day.
• Are unwilling or unable to make programming
modifications to the pump based on glucose level
readings.
• Are unable or unwilling to administer insulin by other
means if necessary.
• Are unable or unwilling to comply with the guidance and
advice of the treating physician and other healthcare
providers.
• Reside at or travel (other than by commercial aircraft) at
elevations above 8000 feet.
• Have other medical or mental conditions which may
place the patient at risk.
• Are unwilling or unable to return for routine insulin refill
(approx. 2-3 months) according to dosage.
• Present current or history of sensitivity to titanium alloy
or silicone materials used in the manufacture of system
implanted components.
PRECAUTIONS
Patients should always maintain conventional insulin supplies
in the event of pump and or Personal Pump Communicator
(PPC) failure. Delivery of insulin can become impaired due
to pump failure or catheter occlusion. In the event of
impaired insulin delivery, replacement of the pump or catheter
may be required. Physicians should review Physicians
Manual for full description of Pump replacement procedure
and catheter clearing procedures. The Medtronic MiniMed
Pump and Catheter Implants should NOT be used if damaged
prior to or during implantation procedures. The pump should
not be placed in contact with other metal implants.
WARNINGS
Physicians should be completely familiar with the function of
the pump, catheter, and personal pump communicator prior to
use of this device. Patients should be provided a complete
copy of the Patient Manual and have demonstrated the ability
to program the Personal Pump Communicator (PPC),
recognize and respond to safety alarms, and care of the
device prior to discharge.
The Medtronic MiniMed Implantable Pump System should not
be exposed to therapeutic ultrasound. Exposure to ultrasound
therapy may cause damage to the pump that may not be
apparent.
Only special U400 insulins may be used in the Medtronic
MiniMed Implantable Pump System. Use of other insulin
types may cause damage to the pump mechanism resulting in
impaired insulin delivery or pump failure.
Any unauthorized changes or modifications made to any
component of the system may prevent effective use of that
and other components.
POSSIBLE ADVERSE EFFECTS
The Medtronic MiniMed Implantable Pump System has
undergone an extensive clinical evaluation. Evaluation of the
system spanned a period of ten years and involved over 600
subjects in the United States and Europe. Though over
delivery of insulin did not occur during the ten year evaluation
period, there is a potential for such occurrence. The
following are specific adverse effects which should be
understood by the physician and explained to the patient.
These do not include all adverse effects which can occur with
surgery in general or with the use of this devise, but are
important considerations particularly in the treatment of
people with diabetes. The general surgical risks as well as
operative site cosmetic risks should be explained to the
patient prior to surgery.
Abdominal Pain Foreign Body Reaction
Abnormal Healing Skin Disorder
Infection Urinary Disorder
Necrosis Psychiatric Decompensation
Retinal Disorder Skin Erosion
Abnormal Liver Function Kidney Disorder
Ileus Pocket Lymph Edema
Inflammation at Refill Site Pump Failure
Hyperglycemia Catheter Occlusion/
Hypoglycemia Encapsulation
Ketoacidosis Battery depletion
PPC Failure
DEVICE PACKAGING
The Medtronic MiniMed Personal Pump Communicator (PPC)
is packaged in a specially prepared carton to secure the
product from damage. A 1.5v battery (replaceable power
source) has been included in the carton. The Personal Pump
Communicator should not be used if there are obvious signs
of damage to the device.
PRESCRIPTION DEVICE
Caution: Federal (U.S.) law restricts this device to sale by or
on the order of a physician.
FCC Notice
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference and
(2) This device must accept any interference received,
including interference that may cause undesirable
operation.
CAUTION: Any changes or modifications not expressly
approved by Medtronic MiniMed could void your ability to
operate the equipment.