Manual Part 2
Table Of Contents
- Fill the Pump with insulin
- Measure stroke volume
- Prepare the Side Port Catheter
- Performing the surgical procedure
- Post-operative management
- Post-operative x-rays
- CHAPTER 5 Pump Refill Procedure
- CHAPTER 6 Explanting the Pump System
- CHAPTER 7 Warnings And Precautions
- CHAPTER 8 Adverse Reactions
Warnings
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Elevated anti-insulin antibodies
The result of clinical investigations suggest a small population of patients
may develop anti-insulin antibodies when using the MiniMed 2007
Implantable Pump System and HOE 21 PH U-400 insulin. Patients with
multiple autoimmune disorders may be more susceptible to developing
high titers of anti-insulin antibodies, which in turn may cause symptoms.
There was no correlation between length of exposure to the study drug
and the resultant titer of anti-insulin antibodies. Elevated levels of anti-
insulin antibodies alone have been proven not to interfere with diabetes
management using continuous intraperitoneal insulin infusion with this
system.
Environmental conditions
The Medtronic MiniMed 2007C Implantable Insulin Pump System should
not be exposed to extreme electrical or magnetic fields. Although it is not
possible to include every environmental condition that may affect the
Pump, most are listed below. Please contact MiniMed when in doubt if
certain environmental exposure will affect the pump.
DO NOT EXPOSE THE MINIMED 2007 IMPLANTABLE
INSULIN PUMP SYSTEM TO ANY OF THE FOLLOWING
CONDITIONS
• Magnetic Resonance Imaging (MRI) Procedures.
• Lithotripsy Treatment.
• Large Rotating Magnetic Fields -
- -
- Refers to large industrial rotat-
ing magnetic fields, such as those found in Industrial Power
Plants.
• Magnets Held Directly Over the Pump.
• High Power Radio or Satellite Transmitting Towers.
• Altitudes Above 2,400 meters (8,000 feet).
The Medtronic MiniMed 2007C Implantable Insulin Pump System is not
designed for use at elevations above 2,400 meters (8,000 feet). Use of the
Pump System at higher elevations may result in insulin over delivery,
which may cause personal injury or death. Therefore, patients who live at
Dmp9196021-011_c.book Page 111 Wednesday, April 3, 2002 5:04 PM