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
Pump implantation
54
• One (1) Pump System: PPC, Pump and Side Port Catheter
• Sterile markers and Steri-Strips
®
• Three (3) refill Kits - MMT-4105:
• 1 kit to remove shipping fluid from Pump
• 1 kit to fill the Pump with U-400 INSULIN (to rinse the pump)
• 1 kit to fill the Pump with U-400 INSULIN (final insulin fill)
• One (1) 3 mL syringe (fluid barrier)
• Three (3) Medtronic MiniMed refill needles, MMT-4102
• Three (3) 18 gauge needles
• One (1) Implant Worksheet
• One (1) Back-up Pump System: PPC, Pump, Port Catheter
Solutions
• One (1) bottle of sterile water, room temperature
• One (1) vial 10 mL Rinse Buffer (RB), MMT-2008
• Four (4) vials 10 mL U-400 INSULIN, stored at room temperature for a
minimum of ten hours prior to surgery.
Emptying and filling the Pump
To prepare the Pump for implantation, the Pump must be emptied and then filled
twice and tested with insulin. These procedures are performed in the operating
room prior to surgery. As this is a surgery, all supplies and required equipment
should be prepared in accordance with the institution’s approved sterile proce-
dures.
When you remove the Pump from the sterile box,
do not remove the plastic tubing placed at the Pump
outlet. Trim the distal part with a scalpel blade. This
tubing will be used for the “Stroke Volume Mea-
surement” procedure.
A sterile field is established in the operating room to prepare the RINSE
BUFFER (RB) syringe and remove the shipping fluid from the Pump. Document
the Pump, Catheter and PPC serial numbers on the Implant Worksheet.
!
WARNING