User's Manual
Table Of Contents
- Table of contents
- List of figures
- CHAPTER 1 Description
- CHAPTER 2 Indications and contraindications
- CHAPTER 3 Personal Pump Communicator (PPC)
- CHAPTER 4 Pump implantation
- Preprogramming and pre-testing the Pump
- CHAPTER 5 Pump refill procedure
- CHAPTER 6 Explanting the Pump System
- CHAPTER 7 Warnings and precautions
- CHAPTER 8 Adverse reactions
- CHAPTER 9 System alarms and messages
- Pump alarms
- Alarm feedback
- Pump low battery
- Depleted pump battery
- System error
- Pump self test fail
- PPC low battery
- PPC alarms
- Low reservoir
- Empty reservoir
- Telemetry communication error
- Initialize alarm
- PPC not initialized
- Battery replacement
- Initialize to factory defaults
- Pump stopped
- Pump suspended
- Auto off
- Hourly maximum exceeded
- Pump alarm table
- Pump alarms
- CHAPTER 10 Troubleshooting Pump System under-delivery
- CHAPTER 11 Technical specifications
- APPENDIX A Label information symbol dictionary
- APPENDIX B Implant worksheet
- APPENDIX C Refill form
- APPENDIX D Precautions and general procedures
- APPENDIX E Pump rinse procedure
- APPENDIX F Side Port Catheter flush procedure
- Supplies and solutions
- Preparing for the procedure
- Flushing the Side Port Catheter
- Program minimal basal rate
- Remove insulin and fill with rinse buffer
- Equilibrate and pull rinse buffer through system
- Flush side port catheter
- Remove rinse buffer and fill with insulin
- Equilibrate and pull insulin through system
- Remove guide needles and record refill amount
- Program new basal rate
- Remove rinse buffer from catheter
- APPENDIX G Stroke volume measurement
Description
5
The Pumping Mechanism is a solenoid-operated, hermetically-welded pulsatile
system. The pumping mechanism is designed to seal automatically to prevent
leakage both into and out of the reservoir under physiologic temperatures and
pressures. The mechanism is designed to provide an insulin delivery accuracy of
within 10% from its labeled stroke volume. Individual Pumps are calibrated to
one of seventeen different stroke volumes, ranging from 0.42 µL to 0.58 µL per
stroke, in increments of 0.01 µL.
The Microelectronics act as the brain of the Pump. The microelectronics contain
two microprocessors which monitor and control all pump-stroke activity. All
commands delivered from the PPC via RF telemetry to the Pump are then
acknowledged back to the PPC. The Pump has a large memory which stores
Pump specifications and programming history.
The Antenna receives radiowaves from the PPC and delivers PPC programming
commands to the Pump microelectronics.
The Battery is a custom-made lithium carbon mono-fluoride power cell, which
supplies energy to the pumping mechanism and microelectronics. It is similar to
batteries used in pacemakers and is designed to provide 6 to 10 years of service,
depending on the infusion rate (refer to pump specifications).
The Tone Transducer emits beeps to indicate certain alarm conditions. These
beeps are designed to be audible through the skin and can be set with the PPC to
one of two volumes. The Pump can also be programmed to emit beeps that signal
a programmed change in the medication delivery rate.
Radio-Opaque Identification is featured in the Implantable Insulin Pump. In
the event of an emergency, the name of the manufacturer and the Pump model
number can be identified with an x-ray.
Insulin medication
Only specially formulated U-400 insulins that are specifically labeled for use
with the Medtronic MiniMed Implantable Insulin Pump System can be used in
the model 2007D Pump.
These special U-400 insulins are supplied in 10mL vials.