Medtronic MiniMed 2007C Implantable Insulin Pump User Manual Dmp9196021 011 c

Medtronic MiniMed, Inc. Implantable Insulin Pump Dmp9196021 011 c

physician part1

1 Table of ContentsCHAPTER 1 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System . . . . . . . . . . 11Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Implantable Insulin Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Insulin medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Personal Pump Communicator (PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18CHAPTER 2 Indications and Contraindications . . . . . . . . . . 21Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Possible adverse effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22CHAPTER 3 Personal Pump Communicator (PPC) . . . . . . . 25Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25PPC Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26PPC buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27 Communicating with the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28Dmp9196021-011_c.book Page 1 Thursday, April 4, 2002 8:15 AM
2Install/Replace the main battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29Part 1: PPC/Pump system initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Initialize the PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Set the time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34Set alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35Set maximum bolus, basal rate and time display format . . . . . . . . . . . . . . .36Lock maximum bolus/basal, enter personal ID and password, stop Pump .38Program a basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Part 2: Additional PPC programming features . . . . . . . . . . . . . . . . . . . . . . . . . . . .42Main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42Program a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42Set a normal bolus with the variable bolus feature turned off . . . . . . . . . . .42Set a normal bolus with the variable bolus feature turned on . . . . . . . . . . .44Set a square wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45Set a dual wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47Review bolus history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49Suspend mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49Programming a basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50Programming basal delivery pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50Setting basal rate profiles in each delivery pattern . . . . . . . . . . . . . . . . . . .51Program a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52Set a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52Stop a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54Personal events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56Setup Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59Initialize PPC to Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 Exit setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Dmp9196021-011_c.book Page 2 Thursday, April 4, 2002 8:15 AM
3Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61Audio bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61Activating the audio bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61Set an audio bolus from the main menu bolus screen . . . . . . . . . . . . . . . . .62Variable bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62Refill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65Diagnostic rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67Initialize to factory defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69Download software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70Stop Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72Supervisor password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72Exit supervisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73Personal Pump communicator messages . . . . . . . . . . . . . . . . . . . . . . . . . . .73Clinical history codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75 Clinical history pump codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75CHAPTER 4 Pump Implantation . . . . . . . . . . . . . . . . . . . . . . 77Preprogramming and pre-testing the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77Registration card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78Emptying and filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79Remove shipping fluid from the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80Rinse the Pump with insulin (IN1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82Fill the Pump with insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Measure stroke volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86Prepare the Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88Performing the surgical procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93Dmp9196021-011_c.book Page 3 Thursday, April 4, 2002 8:15 AM
4Pre-operative evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93Formation of the pump pocket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93Catheter placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95Post-operative management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95Post-operative hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95Post-operative x-rays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96CHAPTER 5 Pump Refill Procedure . . . . . . . . . . . . . . . . . . . 97Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98Prepare for pump refill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99Perform the refill procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100Fill out the refill form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100Label syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100Prepare the refill syringe for emptying the Pump . . . . . . . . . . . . . . . . . . . . . .100Prepare the refill syringe for filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . .101Empty the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102Refill the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104Calculate extracted and refill amounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106Calculate refill accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106CHAPTER 6 Explanting the Pump System . . . . . . . . . . . . . 107Explant considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107Returning devices/components to MiniMed . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107Dmp9196021-011_c.book Page 4 Thursday, April 4, 2002 8:15 AM
5CHAPTER 7 Warnings And Precautions . . . . . . . . . . . . . . . 109Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Ultrasound therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Diagnostic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Therapeutic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Elevated anti-insulin antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113Emergencies and the use of conventional insulin supplies . . . . . . . . . . . . . . .113PPC reliability requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113Maximum dosages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114Electrical and magnetic fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114CHAPTER 8 Adverse Reactions. . . . . . . . . . . . . . . . . . . . . . 115Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116CHAPTER 9 System Alarms and Messages . . . . . . . . . . . . 117Pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118Alarm feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118Pump low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118Depleted pump battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119Dmp9196021-011_c.book Page 5 Thursday, April 4, 2002 8:15 AM
6System error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119Pump self test fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120PPC low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120PPC depleted battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121PPC needs servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122Low reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122Empty reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122Telemetry communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123Communication error during download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123Initialize alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124PPC not initialized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125Initialize to factory defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126Pump stopped . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126Pump suspended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127Hourly maximum exceeded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127Pump alarm table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128CHAPTER 10 Troubleshooting Pump System Under-delivery 131Diagnostic procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131Under-delivery caused by backflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131Under-delivery caused by catheter occlusion . . . . . . . . . . . . . . . . . . . . . . . . .132Dmp9196021-011_c.book Page 6 Thursday, April 4, 2002 8:15 AM
7CHAPTER 11 MiniMed 2007C Implantable Insulin Pump System. . . . . . . . . . . . . . . . . . . . . . . . . . 133Implantable Insulin Pump MMT-2007C . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133Personal pump communicator (PPC) model MMT-3150 . . . . . . . . . . . . . . . .134Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135APPENDIX A Label Information . . . . . . . . . . . . . . . . . . . . . . 137Symbol dictionary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140APPENDIX B Implant Worksheet . . . . . . . . . . . . . . . . . . . . . 141Implant worksheet form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141APPENDIX C Refill Form . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Pump refill data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143APPENDIX D Precautions and General Procedures . . . . . . . 145Special note and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145General procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146Locating the pump fill port and the side port . . . . . . . . . . . . . . . . . . . . . . . . . .147Accessing the pump inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148Venting the Minimed refill syringe (optional) . . . . . . . . . . . . . . . . . . . . . . . . .149Dmp9196021-011_c.book Page 7 Thursday, April 4, 2002 8:15 AM
8APPENDIX E Pump Rinse Procedure . . . . . . . . . . . . . . . . . . .151Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153Prepare syringes for emptying the Pump . . . . . . . . . . . . . . . . . . . . . . . . . .153Prepare syringes for filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .153Program minimal basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153Remove insulin from the Pump and fill with NaOH . . . . . . . . . . . . . . . . .154Equilibrate and pull NaOH through system . . . . . . . . . . . . . . . . . . . . . . . .156Remove NaOH and fill with rinse buffer . . . . . . . . . . . . . . . . . . . . . . . . . .157Equilibrate and pull rinse buffer through system . . . . . . . . . . . . . . . . . . . .159Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . . .159Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . . .161Remove guide needles and record fill amount . . . . . . . . . . . . . . . . . . . . . .162Program new basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162APPENDIX F Side Port Catheter Flush Procedure . . . . . . . . .163Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165Prepare syringes for emptying the Pump . . . . . . . . . . . . . . . . . . . . . . . . . .165Prepare syringes for filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .165Prepare syringe for flushing the Side Port Catheter . . . . . . . . . . . . . . . . .166Flushing the Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Program minimal basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Remove insulin and fill with rinse buffer . . . . . . . . . . . . . . . . . . . . . . . . .167Equilibrate and pull rinse buffer through system . . . . . . . . . . . . . . . . . . . .169Flush side port catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .170Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . . .170Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . . .172Remove guide needles and record refill amount . . . . . . . . . . . . . . . . . . . .173Program new basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174Remove rinse buffer from catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174Dmp9196021-011_c.book Page 8 Thursday, April 4, 2002 8:15 AM
9APPENDIX G Stroke Volume Measurement . . . . . . . . . . . . . .175Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .175Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176Measuring stroke volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179APPENDIX H Pressure Measurement Using The Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184Prepare syringes for emptying the pump . . . . . . . . . . . . . . . . . . . . . . . . . .184Prepare syringes for filling the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .184Prepare syringe for priming the test setup . . . . . . . . . . . . . . . . . . . . . . . . .184Measuring pressure in the side port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185Program minimal basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185Remove insulin and fill with rinse buffer . . . . . . . . . . . . . . . . . . . . . . . . .185Equilibrate and pull rinse buffer through system . . . . . . . . . . . . . . . . . . . .186Perform pressure test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . . .191Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . . .192Remove guide needles and record refill amount . . . . . . . . . . . . . . . . . . . .194Dmp9196021-011_c.book Page 9 Thursday, April 4, 2002 8:15 AM
10Dmp9196021-011_c.book Page 10 Thursday, April 4, 2002 8:15 AM
11CHAPTER 1 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump SystemIntroductionThe Medtronic MiniMed 2007C Implantable Insulin Pump System bringstogether sophisticated new technologies to provide continuous intraperi-toneal insulin therapy for patients with Insulin Dependent Diabetes Melli-tus (IDDM). The development of the Medtronic MiniMed 2007CImplantable Insulin Pump System is the result of years of cooperativeresearch and development between MiniMed and:The Johns Hopkins University, Applied Physics Laboratory.U.S. National Aeronautics and Space Administration, Goddard SpaceFlight Center. U.S. National Institutes of Health.This manual is intended for use by the physician, surgeon, nurse specialistand all other members of the healthcare team who care for patients withthe Medtronic MiniMed 2007C Implantable Insulin Pump System.The Medtronic MiniMed 2007C Implantable Insulin Pump System usesonly special insulin formulations. The only insulin available today for usein the Pump is HOE 21 PH U-400, manufactured by Aventis.Dmp9196021-011_c.book Page 11 Thursday, April 4, 2002 8:15 AM
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System12The system consists of three major components:• Implantable Insulin Pump• Side Port Catheter• Personal Pump Communicator (PPC)Each of these components, as well as system safety features, are discussedin detail in the following sections.Figure 1: Personal Pump Communicator (PPC) and Implantable Insulin PumpDmp9196021-011_c.book Page 12 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump 13Implantable Insulin PumpThe Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches)in diameter, 2.0 cm (0.8 inches) thick. The Pump weighs 131 grams (4.6ounces) when empty. The outside case of the Pump is made of titanium.Titanium is a biocompatible metal used in many types of implantablemedical devices. A tangential Side Port Catheter is attached to the Pumpprior to implant, using a locking connector (see Figure 2).Figure 2: The Implantable Insulin PumpThe Implantable Insulin Pump is an advanced insulin infusion device withsophisticated microelectronics. It delivers a special insulin medication,using a pulsatile solenoid pumping mechanism that is hermetically sealedinside the biocompatible titanium case. Insulin delivery rates and profilesare programmed using an external device, the Personal Pump Communi-cator (PPC). Specific information on the Implantable Insulin Pump fea-tures is outlined in the following sections. Dmp9196021-011_c.book Page 13 Thursday, April 4, 2002 8:15 AM
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System14The Pump has six major components. These components are outlinedbelow: • medication reservoir• pumping mechanism• microelectronics• antenna•battery • tone transducerOther components of the Pump include the inlet valve, fill port, septum,Freon gas and 20µm filter. Figure 3 shows the interior components of thePump.Figure 3: Interior of the Implantable Insulin PumpDmp9196021-011_c.book Page 14 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump 15The Medication Reservoir stores approximately 15 ml or 6,000 units ofa special U-400 insulin. Depending on an individual’s insulin require-ments, the medication reservoir is refilled once in approximately everytwo to three months. The medication reservoir is maintained at a negativepressure (vacuum) at all times to allow for safe and reliable filling. Thisvacuum prevents any risk of insulin leakage in the event of a breach in thePump case or reservoir. The reservoir is refilled with a special needle(MiniMed Refill Needle MMT-4102). The fill port has a 20 micron filterto prevent particulate material from entering the Pump and a redundantseptum and valve configuration to prevent entry of body fluids. The Pumping Mechanism is a solenoid-operated, hermetically-weldedpulsatile system. The pumping mechanism is designed to seal automati-cally to prevent leakage both into and out of the reservoir under physio-logic temperatures and pressures. The mechanism is designed to providean insulin delivery accuracy of +10% from its labeled stroke volume.Individual Pumps are calibrated to one of seventeen different stroke vol-umes, ranging from 0.42 µL to 0.58 µL per stroke, in increments of0.01 µL.The Microelectronics act as the brain of the Pump. The microelectronicscontain two microprocessors which monitor and control all pump-strokeactivity. All commands delivered from the PPC via RF telemetry to thePump are then acknowledged back at the PPC. The Pump has a largememory which stores Pump specifications and programming history.The Antenna receives radiowaves from the PPC and delivers PPC pro-gramming 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 to10 years of service, depending on the infusion rate (refer to pump specifi-cations).The Tone Transducer emits beeps to indicate certain alarm conditions.These beeps are designed to be audible through the skin and can be setwith the PPC to one of two volumes. The Pump can also be programmedto emit beeps that signal a programmed change in the medication deliveryrate.Dmp9196021-011_c.book Page 15 Thursday, April 4, 2002 8:15 AM
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System16Radio-Opaque Identification the Implantable Insulin Pump features radio-opaque identification. In the event of an emergency, the name of the manufacturer and the Pump model number can be identified with an x-ray.Insulin medicationOnly Aventis HOE 21 PH U-400 insulin can be used with the MedtronicMiniMed 2007C Implantable Insulin Pump System. HOE 21 PH U-400 is a highly purified, semi-synthetic human insulinwith 0.2% phenol as a preserving agent, glycerol as an isotonic compo-nent, TRIS as a buffer, plus zinc and Genapol® as stabilizing agents.HOE 21 PH U-400 is equivalent in mode of action to normal (soluble)insulin. A special U-400 insulin concentration has been developed for usein the Implantable Insulin Pump and is supplied in 10mL vials (400U/mL) from Aventis.Side Port CatheterThe Side Port Catheter (Catheter) transports insulin from the Pump into an individual’s peritoneum where it is absorbed. The Catheter is made of polyethylene-lined silicone rubber, which is biocompatible with subcuta-neous and intraperitoneal tissues and supports the stability of the special insulin. The Catheter is designed with two perpendicular sections: a proximal subcutaneous section which attaches tangentially to the Pump with a locking connector, and a distal section which is placed in the peri-toneum (see Figure 4). To enable post-implant localization, a radioopaque stripe runs the length of the Catheter. Dmp9196021-011_c.book Page 16 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump 17Figure 4: The Intraperitoneal Catheter and Side PortThe Catheter side port is intended to provide access to the Catheter andPump outlet, in order to perform the non-surgical interventions and diag-nostic procedures described in Appendices E, F and G. The side portallows for the introduction of a needle and small syringe to clear Catheterobstructions using pressures up to 100 psi. It also allows for the introduc-tion of a needle to verify Pump stroke volume and permit non-surgicaldiagnoses of Catheter blockages by direct pressure measurement.Dmp9196021-011_c.book Page 17 Thursday, April 4, 2002 8:15 AM
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System18Personal Pump Communicator (PPC)The Personal Pump Communicator (PPC) is the hand-held component ofthe MiniMed 2007C Implantable Pump System (see Figure 5). The PPC allows the physician and patient to communicate with the Pumpby transmitting radio frequency messages when the PPC is held within 3”of the Pump. Additionally, the PPC stores important programming infor-mation in its memory.Figure 5: Personal Pump Communicator (PPC) Dmp9196021-011_c.book Page 18 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump 19The PPC has been designed so the physician and patient can:• Program basal infusion rates (48 basal rates, 3 different patterns)• Deliver or suspend an immediate, square wave, or dual wavebolus of insulin• Deliver or cancel a temporary basal rate • Review the delivery history• Enter personal events (meal, snack, exercise)Independent of the programming function, the PPC is able to receive andrecord certain programming data from the Pump. The recorded informa-tion is accessible and can be displayed on the screen.Dmp9196021-011_c.book Page 19 Thursday, April 4, 2002 8:15 AM
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System20Dmp9196021-011_c.book Page 20 Thursday, April 4, 2002 8:15 AM
21CHAPTER 2 Indications and ContraindicationsIndications for useThe Medtronic MiniMed 2007C Implantable Insulin Pump System isindicated for intraperitoneal administration of exogenous insulin inpatients with diabetes mellitus.Only Aventis HOE 21 PH U-400 insulin is indicated for use in theMedtronic MiniMed 2007C Implantable Insulin Pump System.Contraindications for use The Medtronic MiniMed 2007C Implantable Insulin Pump System is con-traindicated in patients who:• are unwilling or unable to monitor their blood glucose level atleast four times per day.• are unwilling or unable to make programming modifications tothe Pump based on glucose level readings.• are unable or unwilling to administer insulin by other means, ifnecessary.• are unable or unwilling to comply with the guidance and adviceof their treating physician and other healthcare providers. Dmp9196021-011_c.book Page 21 Thursday, April 4, 2002 8:15 AM
Indications and Contraindications22• reside at or travel (other than by pressurized commercial aircraft)at elevations above 8,000 feet.• have other medical or mental conditions which may place thepatient at risk. • are unwilling or unable to return for routine insulin refills accord-ing to their dosage requirements (approximately once every 2-3months).• present or have a history of sensitivity to titanium alloy, polysulfone or silicone materials used in the implanted compo-nents of the system.Possible adverse effectsThe MiniMed 2001 Implantable Insulin Pump System has undergone anextensive clinical evaluation. The model 2007C is essentially identical tothe model 2001 Pump except for the use of updated electronics and bat-tery. Evaluation of components used in the MiniMed 2001 Systemspanned a period of ten years and involved approximately 650 patientsfrom both the U.S. and Europe. Although clinically relevant over-deliveryof insulin did not occur during the ten year evaluation period, there is apotential for such an occurrence. The following are specific adverse effects which should be understood bythe physician and explained to the patient. These do not include alladverse effects which can occur with surgery in general or with the use ofthis device, but are important considerations, particularly in the treatmentof diabetic patients. The general surgical risks, as well as operative sitecosmetic risks, should be explained to the patient prior to surgery.Dmp9196021-011_c.book Page 22 Thursday, April 4, 2002 8:15 AM
Possible adverse effects 23Abdominal Pain Foreign Body ReactionAbnormal Healing Skin DisorderInfection Urinary DisorderNecrosis Psychiatric DecompensationRetinal Disorder Skin ErosionAbnormal Liver Function Kidney DisorderIleus Pocket Lymph EdemaInflammation at Refill Site Pump FailureHyperglycemia Catheter Occlusion/EncapsulationHypoglycemia Battery DepletionKetoacidosis PPC FailureDmp9196021-011_c.book Page 23 Thursday, April 4, 2002 8:15 AM
Indications and Contraindications24Dmp9196021-011_c.book Page 24 Thursday, April 4, 2002 8:15 AM
25CHAPTER 3 Personal Pump Communicator (PPC)IntroductionThe Personal Pump Communicator (PPC) has a comprehensive set of pro-gramming features to control the Implantable Insulin Pump in the treat-ment of IDDM. The PPC cannot be used by the patient until it has beeninitialized by the healthcare professional. This chapter of the manual isdivided in two parts:The first part (Part 1) will describe the PPC/PUMP system initializationprocess that will be performed the day prior to implant.The second part (Part 2) will describe how to use the additional featuresthat the healthcare professional or patients can activate.Dmp9196021-011_c.book Page 25 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)26PPC IconsAfter initialization, the PPC Main Screen displays the time (12hr. or 24hr.format), month, day and a variety of icons. The type and purpose of theseicons are as follows:Certain features of the PPC such as programming and dosing limits can beset only by the healthcare professional in a password-protected modecalled the Supervisor Mode. Information pertaining to initializing thePPC and entering the PPC Supervisor Mode is not included in the PatientUser Manual.Bell Icon:Displayed when the PPC receives a telemetry message from the Pump indicating that the Pump has detected an alarm condition, when a PPC error is detected and when the Pump is Suspended or Stopped.Reservoir Level Indicator Icon:The reservoir icon is composed of 4 segments that indicate how full the Pump reservoir is, based on the history of Pump delivery.Insulin Delivery Icon: The PPC simulates spinning the delivery icon when insulin delivery is in progress by displaying alternating patterns, the pattern changes every 4 seconds. When the Pump is delivering a bolus, the pattern will show three delivery segments. When the Pump is delivering a basal rate, the pattern will show one delivery segment. When the Pump is not delivering, all four segments will be displayed.Dmp9196021-011_c.book Page 26 Thursday, April 4, 2002 8:15 AM
Introduction 27PPC buttonsSelect:SELActivate: The SEL button steps through each of the displays andmenus.ACTActivate: The ACT button activates programming changes in thePump, new information to be entered into the PPC mem-ory, and alarms to be turned off. As a safety check, ACTmust be pressed to complete any programming changes.A single beep is heard after activating a change.Up and Down Arrows:▲▲▲▲ or ▼▼▼▼The ▲▲▲▲ or ▼▼▼▼ arrows allow changes in the screen set-tings. Pressing ▲▲▲▲ once will find the next highest set-ting, and pressing ▼▼▼▼ once will find the next lowestsetting. Holding down either button will rapidly scrollthrough the list of preset values. Desired values can thenbe programmed by pressing ACT.Sound Icon the Up ArrowWhen the Audio Bolus feature is turned on, pressing ▲▲▲▲allows programming an Audio Bolus.Light Icon the Down Arrow:From the main operating screen, pressing ▼▼▼▼ once willturn on the backlight. The backlight allows the Pump tobe programmed in the dark. The backlight will turn offautomatically after four seconds. Dmp9196021-011_c.book Page 27 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)28 Communicating with the pumpPlace the PPC near the Pump when the screen displays, “PPC COMMU-NICATING.” The word "COMMUNICATING" will blink as indication ofsuccesfull communication. If a communication link between the PPC andPump is not established, a “TELEMETRY COMM ERROR 3” messagewill appear. The PPC will beep six times once every minute until thescreen is acknowledged by pressing SEL and ACT. The screen will thendisplay “PPC COMMUNICATING” again.After a communication is established between the PPC and Pump andprogram information is successfully transferred to the Pump, the PPC willbeep once and return to the Time/Date screen.• Always press the PPC buttons slowly and firmly. Wait until thescreen changes before pressing the button again. • A flashing value on the screen means that the value is activated,and can be changed by pressing the arrow buttons.• The PPC cannot be turned off. Once the battery has beeninstalled, the PPC is on and remains on until the battery isremoved.• Certain types of Radio Frequency (RF) generating equipmentcould affect PPC communication with the Pump. If you are expe-riencing communication difficulties, change locations.• The time and date settings must be correct to ensure appropriatecalculation of insulin delivery and display of daily totals andactivity history.Dmp9196021-011_c.book Page 28 Thursday, April 4, 2002 8:15 AM
Introduction 29Install/Replace the main batteryThe battery used to power the PPC is a 1.5v AA alkaline. The life of thebattery is approximately 8 weeks during normal usage conditions. If thevibrator mode is selected, the battery life is approximately 6 weeks.• Locate the battery door on the back of the PPC.• Slide the locking bar to the left.• Push the middle part of the PPC box (under the battery door) andlift by gently pulling up the battery door to unlatch.• Remove the old battery, noting the polarity. The screen will beblank.• Position the new battery so the + and - markings on the batterymatch the polarity diagram in the battery compartment.• Close the battery door.• Slide the locking bar to the right.• The PPC screen will reappear within 30 seconds:1. The PPC will beep 6 times, and after afew seconds, the screen will display“CHECK PUMP STATUS”.2. Press SEL then ACT, and place the PPCnear the Pump.3. Wait a few seconds for the communica-tion to complete. PPC 4 102 100 PUMP __ __ __08:26 JAN O2CHECKPUMP STATUSPPCCOMMUNICATINGDmp9196021-011_c.book Page 29 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)30NOTE: When the PPC displays “PPC LOW BATTERY”,the message can be cleared, and programmingcontinued. There should be sufficient energy inthe battery to communicate with the Pump a fewmore times, but the battery should be changed assoon as possible.NOTE: If while programming the PPC, the screen goesblank, the PPC beeps six times and then the“CHECK PUMP STATUS” message appears, thebattery needs to be replaced. Dmp9196021-011_c.book Page 30 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization 31Part 1: PPC/Pump system initializationThe Implantable Insulin Pump arrives from MiniMed with preset factorydefault values. During the initialization process these preset values aredownloaded into the PPC memory. The preset values can then be changedby the healthcare professional, allowing the system to be personalized foreach patient. The factory default values are as follows:Bolus Delivery Type Normal Off Locked Maximum status OffMaximum Bolus 25 U Password YIQ8Audio Bolus Off Personal EventsstatusOFFAudio Feedback Disabled Personal ID 000(32 characters)Auto Off duration Off PPC alarm type HighBasal Delivery Pattern ARefill Amount 25 gMaximum Basal Rate 35 U/H Time Format 12 hoursInsulin Concentration 400 U/ml Variable Bolus status OffDmp9196021-011_c.book Page 31 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)32Initialize the PPCWhen the healthcare professional receives a new PPC it must be “mar-ried” to the Pump. Following are the basic steps used to initialize a PumpSystem the day prior to implant: 1. The PPC is delivered without a battery inplace. After installing a new battery, thePPC will beep six times and the screenwill identify the PPC software used (seeChapter 1, Install/Replace the Main Battery).2. The screen now changes to, “PPC NOTINITIALIZED”, and the PPC will beep sixtimes once every minute until the initial-ization process is started. Press SEL andthen ACT, then quickly place the PPCover the Pump.3. When a communication link has beenestablished, the screen will read, “PPCCOMMUNICATING”, and then willchange to the next screen.4. “NO” is blinking. Check to make sure theserial number displayed on the screenmatches the Pump serial number. Presseither ▲▲▲▲ or ▼▼▼▼ once to change “NO” to“YES” and then press ACT. Place thePPC over the Pump.5. The screen again reads “PPC COMMUNI-CATING”, and the PPC will beep 3 timesat the end of the programming sequence.During this process, the PPC receives allof the factory preset values contained inthe Pump memory.PUMP PPC 4 162 100__ __ __ PPC NOT INITIALIZED PPCCOMMUNICATINGINITIALIZING "NO"PPC to PUMP..........................................................47568COMMUNICATINGPPCDmp9196021-011_c.book Page 32 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization 336. The screen will read “PUMP SUS-PENDED”. The Pump and PPC arenow “married”.7. Press SEL, then ACT and place the PPCnear the Pump.8. The screen now reads“PUMP INITIALIZED”.9. Press SEL and then ACT again, and thePPC will display the Time/Date screen.NOTE: When the alarm type is set to “VIBRATE” thebeeps from the PPC during normal programmingwill be low volume.PUMP SUSPENDEDPPC COMMUNICATING PUMP INITIALIZED11:16 JAN O2Dmp9196021-011_c.book Page 33 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)34Set the time and dateThe time and date settings must be correct to ensure accurate calculationof insulin delivery, daily totals, and the proper display of insulin activityhistory.1. Press SEL until the “SETUP PUMP”screen is displayed, then press ACT twotimes. The first two digits of the time(hours) will be flashing. Use the ▲▲▲▲ and ▼▼▼▼buttons to select the correct hour, thenpress ACT. The last two digits of the time(minutes) will be flashing. Use the ▲▲▲▲ and ▼▼▼▼ buttons to select the cor-rect minute, then press ACT. Repeat the programming process toenter information for the year, month and day.2. After completing the programming pro-cess, quickly place the PPC near thePump. The PPC will display “PPCCOMMUNICATING” while transfer-ring the time and date information to thePump. The PPC will then move to thenext screen, “AUTO-OFF.” Skip the “AUTO-OFF” screen by press-ing SEL once to reach the next screen, “ALARMS”.08:32 Jan 02SET 2000 TIME-DATEPPCCOMMUNICATINGDmp9196021-011_c.book Page 34 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization 35Set alarmsAlarms alert the user in the event the PPC or Pump recognizes an insulindelivery problem. The Alarm Feedback screen must always be in the“ON” position.1. Press ACT to enter the “ALARMS”menu.2. The PPC has three alarm options, twoaudible tones (Low/High) and a vibratemode. Press the ▲▲▲▲ and ▼▼▼▼ buttons toselect the desired alarm, then press ACT.3. The screen will now display “SETALARM FEEDBACK”. This settingshould always be “ON”. Press ACT.4. Place the PPC near the Pump. When thecommunication is completed, the PPCscreen will change to “SELF TEST” andthen to the Time/Date screen.NOTE: When the alarm type is setto “vibrate” the beeps from the PPC during nor-mal programming will be low volume.ALARMSSETPPCALARM TYPELOW/HIGH/VIBRATESETALARMFEEDBACK ON/OFFPPCCOMMUNICATINGDmp9196021-011_c.book Page 35 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)36Set maximum bolus, basal rate and time display formatThis programming is performed in the “SETUP II” menus. These screensallow healthcare professionals to limit the maximum amount of insulin apatient can deliver, either when taking a bolus or setting a new basal rate.Access to the “SETUP II” menus is through the “SETUP PUMP” screen.1. Press SEL until the “SETUP PUMP”screen is displayed. Press ACT and pressSEL to reach the “SETUP II” screen. Press ACT and then SEL to reach the“MAX BOLUS” screen.2. Press ACT and the maximum bolusamount (units) will start flashing. Pressthe ▲▲▲▲ and ▼▼▼▼ buttons to change the maxi-mum allowable bolus (0.0 to 25.0 units)and then press ACT again.3. Place the PPC near the Pump and com-plete the communication process. ThePPC screen will automatically change tothe “MAX BASAL” screen.4. Press ACT and the screen will change to“SET MAX BASAL RATE”. The maxi-mum basal amount will start flashing.Press the ▲▲▲▲ and ▼▼▼▼ buttons to change themaximum allowable basal rate (0.2 to35.0 units/hour) and then press ACTagain.5. Place the PPC near the Pump and com-plete the communication process. ThePPC screen will automatically change to“TIME FORMAT.”MAX BOLUS-- u MAX BOLUS--- ----- u SETPPCCOMMUNICATINGMAX BASAL RATE0.2u/h SETPPCCOMMUNICATINGDmp9196021-011_c.book Page 36 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization 376. Press ACT and the screen will change to“SET TIME FORMAT.” Press the ▲▲▲▲ and▼▼▼▼ buttons to select either a 12 hour (AM/PM) or 24 hour (military time) format,and then press ACT.7. Place the PPC near the Pump and com-plete the communication process. ThePPC screen will return to the “PER-SONAL EVENTS” screen. Allow thePPC to time out and return to the Time/Date screen.NOTE: Adding screens to the main menu, such as“PERSONAL EVENTS” increases the number ofSEL button presses required to reach “SETUPPUMP.”SETTIME FORMAT 12/24 HOURPPCCOMMUNICATINGDmp9196021-011_c.book Page 37 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)38Lock maximum bolus/basal, enter personal ID and password, stop PumpTo access the Supervisor Mode press SEL until the “SETUP PUMP”screen is displayed. Then press and hold down the ▲▲▲▲ and ▼▼▼▼ buttonssimultaneously until the “ENTER SUPERVISOR PASSWORD” screenappears.Patients should not be given the Supervisor Mode password, to avoid the accidental programming of a large priming bolus (99.8 U) or diagnostic insulin rate.1. The first zero will be flashing. Press the▲▲▲▲ and ▼▼▼▼ buttons to select the first digit,then press ACT.The screen advances tothe second zero. Press the ▲▲▲▲ and ▼▼▼▼ but-tons to select the second digit, then pressACT. Repeat for the last two digits. Thefactory pre-set password is YIQ8.2. Entry into the Supervisor Mode is indi-cated by the screen “PUMP REFILL.”3. Press SEL until the “SET MAXIMUMSSCREEN” is displayed, and then ACT toreach “SET MAXIMUMS”. Press the ▲▲▲▲ and ▼▼▼▼ buttons to select“ON” if the patient is not given access tothis feature, or “OFF” if the patient is per-mitted access. Press ACT again.!WARNINGENTER SUPERVISOR PASSWORD 0000PUMPREFILLSET MAXIMUMS OFF/ONDmp9196021-011_c.book Page 38 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization 394. Place the PPC near the Pump and com-plete the communication process. ThePPC screen will automatically advance tothe “PERSONAL ID” screen. PressACT.5. The first of the 32 possible ID locations isflashing. Enter the patient ID (alpha-numeric) by pressing the ▲▲▲▲ and ▼▼▼▼ but-tons and then ACT after each entry. Con-tinue to press ACT, activating each “0”until the screen changes.6. Place the PPC near the Pump and com-plete the communication process.7. Press SEL until the “SUPERVISORPASSWORD” screen is displayed. Thenpress ACT.8. The screen now reads, “SET SUPERVI-SOR PASSWORD”. Press ACT. Use the▲▲▲▲ and ▼▼▼▼ buttons to enter a new supervi-sor password (alphanumeric), pressingACT after each entry. NOTE: Record the password in the patient’s chart.PPCCOMMUNICATINGSET PERSONAL ID...................................................20KOLO5PPCCOMMUNICATINGSET SUPERVISORPASSWORD Y1Q8SETSUPERVISORPASSWORD 0000Dmp9196021-011_c.book Page 39 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)40Program a basal rate1. From the Time/Date screen, press SELuntil the “BASAL RATE” screen is dis-played. Preset delivery pattern “A”, abasal rate of 0.2 U/H, and the word“NOW” is flashing. Press ACT. 2. A “1” now appears to the right of the “A”indicating that this programming willeffect the 1st basal change within the “A”pattern, (there are 3 patterns available[A,B,C] and 48 basal changes possiblewithin each pattern). The flashing 0.2 U/H indicates the value can be changed. Use the ▲▲▲▲ and ▼▼▼▼ but-tons to change the value and then press ACT. NOTE: 00:00 indicates a start time of MIDNIGHT in24hr. display mode. In 12hr. display mode, thescreen indicates the start time as 12:00am.3. The screen now displays “SET TIME”,and a time of 00:30 or 12:30 am (24 or 12hour respectively) and a “2.” If one basal is all that will be used, pressACT two times. If more than one basalrate is to be programmed, enter a starttime and amount of the new basal rate for that time period, then pressACT and enter the new basal rate. The user can enter a new basal rate at 30 minute intervals, up to 48basal rates.4. Place the PPC near the Pump and com-plete the communication process.08:26 OCT 12 BASAL RATE : A NOW 00:00 0.2u/h -- U/H00:30 SET RATE BASAL RATE: A PPCCOMMUNICATINGDmp9196021-011_c.book Page 40 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization 415. The PPC will briefly display the calcu-lated total basal dose for 24 hours, basedon the values and times entered in theBasal Rate programming screen. In thisexample, the total basal dose is 4.8 U/day.24 HOUR TOTAL4.8U Dmp9196021-011_c.book Page 41 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)42Part 2: Additional PPC programming featuresMain menuThis second part will develop how to program the additional features thatthe patient or the healthcare professional can activate.Program a bolusA properly initialized PPC is now ready to program a bolus.The PPC/Pump allows you to set and deliver a bolus of insulin wheneverneeded. The PPC has several special features which allow you to custom-ize the programming and delivery of boluses.• Normal Bolus and Audio Bolus• Square Wave Bolus• Dual Wave BolusNOTE: To use the Variable bolus programming options,(e.g. square, dual), this option needs to be pro-grammed “ON” in the SETUP II menu. If it is not“ON” only the default bolus, “Normal bolus”,will be available.Set a normal bolus with the variable bolus feature turned off1. From the Time/Date screen, press SEL.The “BOLUS” screen is displayed, withthe time and date flashing.2. Press ACT and the “SET BOLUS” screenappears.The dashes under “IMM” areflashing. Press the ▲▲▲▲ and ▼▼▼▼ buttons toenter an immediate bolus amount.08:13 Jan 02BOLUS PROG -- IMM EXT 10 U -- USET BOLUS IMM -- UDmp9196021-011_c.book Page 42 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 433. Press ACT and the “CONFIRM” screenis displayed, with the screen flashing.Confirm the bolus amount by pressingACT again.4. Place the PPC near the Pump and com-plete the communication process.5. When the bolus programming is com-plete, the PPC will beep once and thenbriefly display the amount of insulin cur-rently delivered.The Pump will beep at each of the first five strokes (if audio feedback isON). The PPC beeps and at the end of the bolus. Three segments of theinsulin delivery icon will be displayed and spinning slowly during thebolus delivery. By pressing SEL you can read the amount of insulin deliv-ered.CONFIRM IMM 2.6UPPCCOMMUNICATINGBOLUS 0.0U08:13 Jan 02Dmp9196021-011_c.book Page 43 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)44Set a normal bolus with the variable bolus feature turned on1. From the Time/Date screen press SELuntil the “BOLUS” screen is displayed.The last bolus value programmed and theTime and Date will be flashing.2. Press ACT and the “SET BOLUS TYPE”screen appears. If “NORMAL” is notflashing, use the ▲▲▲▲ and ▼▼▼▼ buttons toselect “NORMAL.” Press ACT.3. The “SET BOLUS” screen appears, withdashes under “IMM” flashing. Use the ▲▲▲▲and ▼▼▼▼ buttons to enter an immediatebolus amount.4. Press ACT and the “CONFIRM” screenis displayed, with the screen flashing.Confirm the bolus amount by pressingACT again.5. Place the PPC near the Pump and com-plete the communication process.6. When the bolus programming is com-plete, the PPC will beep once and thenbriefly display the amount of insulin cur-rently delivered.The Pump will beep at each of the first five strokes (if audio feedback isON). The PPC beeps at the end of the bolus. Three segments of the insulindelivery icon will be displayed and spinning slowly during the bolusdelivery. By pressing SEL you can read the amount of insulin delivered.08:13 Jan 02BOLUS IMM EXT -- U -- USET NORMALBOLUS TYPESET BOLUS IMM --- --- UCONFIRM IMM 2.6uPPCCOMMUNICATING08:23 JAN 04 0.0UBOLUSDmp9196021-011_c.book Page 44 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 45Set a square wave bolusA Square Wave Bolus of insulin is delivered evenly over a preset periodof time, from 30 minutes to 4 hours. A Square Wave Bolus may be desir-able when eating long meals such as banquets or receptions, high fatmeals, or to compensate for gastroparesis. During a Square Wave Bolus,the programmed basal rate is also delivered.To access this feature you must first turn the Variable Bolus feature “ON”in the “SETUP II” menu.1. From the Time/Date screen, press SEL.The “BOLUS” screen is displayed, show-ing the last bolus programmed with thetime and date flashing. 2. Press ACT and the “SET BOLUS TYPE”screen appears. Press the ▲▲▲▲ and ▼▼▼▼ but-tons to select “SQUARE”. Press ACT.3. The “BOLUS” screen appears, withdashes under “EXT” flashing. Use the ▲▲▲▲and ▼▼▼▼ buttons to enter an extended bolusamount. Press ACT.4. Blinking dashes will now appear underthe bolus amount entered.Use the ▲▲▲▲ and ▼▼▼▼ buttons to enter a timeduration for the Square Wave Bolus, inone-half hour increments from 30 min-utes to four hours. 5. Press ACT and the “CONFIRM BOLUS”screen is displayed, with the screen flash-ing. Confirm the Square Wave Bolus bypressing ACT again.08:13 Jan 02BOLUS PROG -- IMM EXT 10 U -- USET SQUAREBOLUS TYPESET BOLUS IMM EXT -- U 4.0USET BOLUS IMM EXT -- U 4.0U 2:00CONFIRM BOLUS IMM EXT -- U 4.0U 2:00Dmp9196021-011_c.book Page 45 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)466. Place the PPC near the Pump and com-plete the communication process.7. When the bolus programming is com-plete, the PPC will beep once and thenbriefly display the amount of insulin cur-rently delivered.The Pump will beep at each of the first five strokes (if audio feedback isON). The PPC beeps at the end of the bolus. Three segments of the insulindelivery icon will be displayed and spinning slowly during the bolusdelivery. By pressing SEL you can read the amount of insulin delivered.PPCCOMMUNICATING16:06 JAN 03 0.0U BOLUSDmp9196021-011_c.book Page 46 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 47Set a dual wave bolusThe Dual Wave Bolus programs a Normal Bolus immediately followedby a Square Wave Bolus.To access this feature you must first turn the Variable Bolus feature ON inthe SETUP II menu.1. From the Time/Date screen, press SEL.The “BOLUS” screen is displayed, show-ing the last bolus programmed with thetime and date flashing.2. Press ACT and the “SET BOLUS TYPE”screen appears. Press the ▲▲▲▲ and ▼▼▼▼ but-tons to select “DUAL.” Press ACT.3. The “BOLUS” screen appears, withdashes under “IMM” flashing. Use the ▲▲▲▲and ▼▼▼▼ buttons to enter the immediateportion of the Dual Wave Bolus. PressACT.4. The “BOLUS” screen now shows dashesflashing under “EXT.” Use the ▲▲▲▲ and ▼▼▼▼ buttons to enter theextended portion of the Dual WaveBolus. Press ACT.5. Blinking dashes will now appear underthe bolus amount entered.Use the ▲▲▲▲ and ▼▼▼▼ buttons to enter a timeduration for the Square Wave Bolus, inone-half hour increments from 30 min-utes to four hours.08:13 Jan 02BOLUS --- --- IMM EXT --- --- U ---- ---- USET DUALBOLUS TYPESET BOLUS IMM 2.0uSET BOLUS IMM EXT 2.0u 2.0uSET BOLUS IMM EXT 2.0u 2.0u 2:00Dmp9196021-011_c.book Page 47 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)486. Press ACT and the “CONFIRM BOLUS”screen is displayed, with the screen flash-ing. Confirm the Dual Wave Bolus bypressing ACT again.7. Place the PPC over the pump and com-plete the communication process.8. When the bolus programming is com-plete, the PPC will beep once and thenbriefly display the amount of insulin cur-rently delivered.The pump will beep at each of the first five strokes (if audio feedbackis ON). The PPC beeps at the end of the bolus. Three segments of theinsulin delivery icon will be displayed and spinning slowly during thebolus delivery. By pressing SEL, you can visualize the amount ofinsulin delivered.CONFIRM BOLUS IMM EXT 2.0u 2.0u 2:00PPCCOMMUNICATING16:06 JAN 03 BOLUS 0.0uDmp9196021-011_c.book Page 48 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 49Review bolus historyTo review the type, amount, time and day of your last 512 insulin boluses.1. From the Time/Date screen, press SEL.The “BOLUS” screen is displayed, show-ing the last bolus programmed. Use the ▲▲▲▲ and ▼▼▼▼ buttons to display pre-vious boluses, along with the time andday each bolus was delivered.Suspend modeThe Suspend Pump mode allows the user to cancel a bolus delivery, whilestill delivering a basal rate of 0.2 U/hr.1. From the Time/Date screen, press SELuntil the “SUSPEND PUMP” screen isdisplayed. Press ACT. The screen willdisplay a flashing “SUSPEND PUMP”message. Press ACT again.2. Place the PPC near the Pump and com-plete the communication process.3. When the communication is complete, thePump will beep 3 times and the PPCscreen will change to “PUMP SUS-PENDED”. All four segments of theinsulin delivery icon are shown. The PPCwill beep every half-hour as long as thePump remains suspended.NOTE: To restart the pump, press SEL. The “PUMP SUSPENDED” screen will begin flashing. Thenpress ACT.08:23 Jan 02BOLUS --- --- IMM EXT ---- U --- --- UPROGSUSPEND PUMPPPCCOMMUNICATING08:13 OCT 12PUMP SUSPENDEDDmp9196021-011_c.book Page 49 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)50Programming a basal rateBasic basal rate programming was described in earlier in this chapter.This section describes additional basal rate options.Programming basal delivery patternThe PPC allows three basal delivery patterns. One such basal patterncould be used for a working day, another for a weekend day, etc. Each ofthe basal delivery patterns is a set of up to 48 basal rates, one for eachhalf-hour of the day. Pattern A is the factory pre-set. To access profiles Bor C you must enter the “SETUP I” screens. 1. Press SEL until the “PUMP SETUP”screen is displayed. Press ACT. PressSEL again to access the basal rate profilescreen, “DELIVERY PATTERN”.2. Press ACT and the screen will change to“SET DELIVERY PATTERN”. Use the▲▲▲▲ and ▼▼▼▼ keys select the pattern pre-ferred; A, B, or C. Each pattern can con-tain up to 48 different basal rates. PressACT after choosing a pattern.3. Place the PPC near the Pump and allowthe communication to complete.NOTE: When the PPC times out, press SEL until the“BASAL RATE” screen is displayed. The basalpattern selected in SETUP II will now appear tothe right of “BASAL RATE” A, B, or C.DELIVERY A PATTERN SETDELIVERY A,B,CPATTERNPPCCOMMUNICATINGDmp9196021-011_c.book Page 50 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 51Setting basal rate profiles in each delivery patternEach of the basal delivery patterns is a set of up to 48 basal rates, one foreach half-hour of the day.1. Press SEL until the “BASAL RATE”screen is displayed. A basal pattern isselected (for example Pattern A). PressACT.2. A “SET RATE” and “1” is now displayedto the right of the “A” indicating this pro-gramming will set the 1st basal ratewithin the “A” profile. The “0.2U/H” isnow flashing, indicating the value can bechanged. Use the ▲▲▲▲ and ▼▼▼▼ arrow keysto program a new value, for example “0.4 U/H”, and then press ACT.NOTE: 00:00 indicates a start time of MIDNIGHT in 24hr.display mode. 12:00am indicates a start time ofMIDNIGHT in 12hr. display mode.3. The screen now displays “SET TIME”,with a time of “00:30” or “12:30am”flashing (24 or 12 hour respectively) anda “2.” This screen allows the second basalrate to be set. Enter a start time for the 2ndbasal rate within the “A” profile, forexample “04:30.” Press ACT. (Example: a second basal rate of 0.4U/H starting at 04:30.)4. This screen changes to “SET RATE”again, indicating the 2nd basal rate cannow be programmed. Use the ▲▲▲▲ and ▼▼▼▼arrow buttons to enter a new rate, forexample “0.2U/H”, and then press ACT. BASAL RATE : A NOW 0.2U/H00:00 BASAL RATE : A 0.2U/H00:00 SET RATE BASAL RATE : A 2 SET TIME 04:30 0.4u/h BASAL RATE : 2 SET TIME 04:30 0.4u/hDmp9196021-011_c.book Page 51 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)525. A “3” now appears on the screen with“SET TIME.” Follow the same procedurepreviously described and program a newprofile. If no additional profiles areneeded change the flashing time to dashes(by pressing ▼▼▼▼ ) and press ACT.6. The screen will indicate “PPC COMMU-NICATING.” Place the PPC near thePump and complete the communicationprocess.7. The screen will briefly display the calcu-lated 24 hour basal dose based on thebasal rate programming. In this examplea total of “8.4U” will be delivered.To set multiple basal profiles in the other pat-terns (A,B,C), select the pattern in SETUP II menu and follow the sameprocedure.Program a temporary basal rateA Temporary Basal Rate is often used when a brief change in basal deliv-ery is required, for example during exercise.Set a temporary basal rate1. From the time and date display press SELuntil the “TEMPORARY BASAL”screen is displayed.2. Press ACT and the “SET DURATION”screen appears. The time duration of theTemporary Basal Rate is displayed asflashing dashes. Press the ▲▲▲▲ and ▼▼▼▼ but-tons to enter a time duration, in 30 minuteincrements from 30 minutes to 24 hours. BASAL RATE : 3 SET TIME 05:00 0.2u/hPPCCOMMUNICATING24 HOUR TOTAL8.4u TEMP BASAL --- --- --- --- u/hTEMP BASAL --- --- u/h00:30SET DURATIONDmp9196021-011_c.book Page 52 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 533. Press ACT and “SET AMOUNT” screenappears. The amount of the TemporaryBasal Rate is now flashing. Press the ▲▲▲▲ and ▼▼▼▼ buttons to enter adelivery amount. Press ACT again.4. Place the PPC near the Pump and com-plete the communication process. 5. When the communication is complete, thePump will beep once. The PPC screenwill briefly show the “TEMP BASAL”screen before returning to the Time/Datescreen.NOTE: When the Pump is delivering a Temporary Basalrate, the first screen displayed when SEL ispressed is “TEMP BASAL.” The PPC will alsobeep every 30 minutes to alert the user that aTemporary Basal rate is currently active.TEMP BASAL 1.5u/h00:30SET AMOUNTPPCCOMMUNICATING TEMP BASAL 08:13 OCT 02Dmp9196021-011_c.book Page 53 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)54Stop a temporary basal rate1. From the Time/Date screen press SELuntil the “TEMP BASAL” screen is dis-played. Press ACT and the “SET DURA-TION” appears, with the time durationflashing. Press ▼▼▼▼ once until it resets todashes. Then press ACT.2. Place the PPC near the Pump and com-plete the communication process.3. When the communication is complete, thePPC will briefly return to the “TEMPBASAL” screen with the amount dashesflashing. Allow the PPC to return to theTime/Date screen.Personal eventsThis feature allows the user to enter event codes into the PPC memory,and record the time and date of entry. Preset event codes are: 1 = meal, 2= snack, 3 = sick and 4 = exercise. In addition, other event codes A, B andC can be entered to record other important events. These other eventcodes should be documented prior to their use. To access the “EVENTS” screen in the main menu, “ON” must be acti-vated in the “SETUP II” menu, “PERSONAL EVENTS” screen.1. From the Time/Date screen, press SELuntil “SETUP PUMP” is displayed, thenpress ACT.Press SEL until “SETUP II” is displayed,then press ACT.Press SEL until “PERSONAL EVENTS”is screen is displayed. TEMP BASAL--- --- 1.5u/hSET DURATIONPPCCOMMUNICATINGTEMP BASAL--- --- --- --- u/hSET AMOUNT OFFPERSONALEVENTSDmp9196021-011_c.book Page 54 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 552. Press ACT and “ON” or “OFF” beginsflashing.3. Use the ▲▲▲▲ and ▼▼▼▼ buttons to select “ON”,then press ACT again. The “PERSONALEVENTS” screen will now appear on themain menu. Allow the PPC to return tothe Time/Date screen.4. To set an event: From the Time/Datescreen press SEL until the “EVENT”screen is displayed then press ACT.The screen changes to “SET EVENT”with the word “MEAL” flashing.Use the ▲▲▲▲ and ▼▼▼▼ buttons to select thedesired event.5. Press ACT and the current time willappear flashing.Use the ▲▲▲▲ and ▼▼▼▼ buttons to enter thetime the event occurred.Press ACT when the proper time is dis-played. Then allow the screen return toTime/Date.NOTE: Only historic or current event times can beentered.NOTE: If the Personal Events feature is turned “OFF” in“SETUP II”, events cannot be entered into thePPC. EVENTS PERSONAL ON/OFF SET PERSONAL ON/OFFEVENTSSETEVENTMEALSET TIME EVENTMEAL07:32AmDmp9196021-011_c.book Page 55 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)56HistoryHistorical Pump data, such as insulin medication remaining, amount ofbolus and basal delivery since the last refill, etc., can be accessed and readon the PPC.1. From the Time/Date screen press SELuntil the “HISTORY” screen is dis-played. Press ACT and the “READPUMP DATA” screen will appear flash-ing.Press ACT again.2. Place the PPC near the Pump and com-plete the communication process. ThePPC will acquire data from the Pump.3. The screen will change to “MEDREMAINING”, indicating the estimatedamount of insulin medication remainingin the Pump. Record this number ifrequired.4. Press SEL and the screen will read“INSULIN TOTAL.” Delivered amountsof basal and bolus insulin medication aredisplayed for the date flashing on thescreen. Use the ▲▲▲▲ and ▼▼▼▼ buttons toreview other daily totals.5. Press SEL and the screen will change to“CLINICAL HISTORY PPC”. Use the▲▲▲▲ and ▼▼▼▼ buttons to review other PPCevents.READ PUMP DATA000000000000000000000000000000000000000000010057PPCCOMMUNICATINGMED REMAINING2263 u Jan 02INSULIN TOTAL BASAL BOLUS 9u 22u6:16 Jan 02CLINICAL HISTORY11PPCDmp9196021-011_c.book Page 56 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features 576. Press SEL and the screen will change to“CLINICAL HISTORY PUMP”. Use the▲▲▲▲ and ▼▼▼▼ buttons to review Pump events.7. Press SEL and the screen will change to“EST PUMP BATT”. This screen indi-cates the Pump battery status, during no-load (battery power is not used) and load(extended communication sequence) con-ditions. The Pump is set to alarm for lowbattery when the loaded (LD) voltage is at or below 2.5 volts.8. Press SEL and the screen will read“EXIT HISTORY.” Press ACT. The PPCwill return to the Time/Date screen.6:26 Jan 02CLINICAL HISTORY14 PUMP Jan 02EST PUMP BATTERY 2.9 V 2.7V NO LD LDEXIT HISTORYDmp9196021-011_c.book Page 57 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)58Setup PumpThe “SETUP PUMP” screen permits access to the primary Setup menusfor the Pump. Setup features discussed previously in this chapter are ref-erenced here. Other Setup features not previously discussed are presentedhere. Press SEL until the “SETUP PUMP” screen is displayed, then pressACT to access the SETUP menus.Auto offAuto Off is a safety feature, reminding the user to update insulin medica-tion delivery programming in the Pump. An alarm can be set after aperiod of programming inactivity, from one to 16 hours. At the onset ofthe alarm the Pump will automatically be placed in SUSPEND mode.1. From the “ SETUP PUMP” screen, pressACT. Press SEL to reach the “AUTOOFF” screen, then press ACT. The screenwill display “AUTO OFF” with flashingdashes/time. Use the ▲▲▲▲ and ▼▼▼▼ buttons toselect the number of hours before an“AUTO OFF” alarm occurs.2. Press ACT. In this example, a time dura-tion of 10 hours was selected. The PPCwill alarm if the user did not attempt toprogram the Pump during the previous 10hours and be placed in SUSPEND mode.3. Place the PPC near the Pump and com-plete the communication process.ThePPC will beep once and return to theTime/Date screen.AUTO OFF--- --- HRSSETAUTO OFF10 HRSPPCCOMMUNICATINGDmp9196021-011_c.book Page 58 Thursday, April 4, 2002 8:15 AM
Setup Pump 59Self test1. Self Test allows the user to perform adiagnostic test of the Pump and PPCoperating system. Messages are relayedbetween the PPC and Pump. From the“SETUP PUMP” screen, press ACT.Press SEL until the “SELF TEST” screenis displayed. Press ACT.2. Place the PPC near the Pump and com-plete the communication process.Verify that the following events occur:• A series of tones will be heard from the Pump (4 beeps).• An alarm tone will be heard from the PPC.• The backlight on the PPC will turn on.• The PPC screen will briefly activate all possible display icons,numbers, etc.• The PPC will vibrate. NOTE: If the above test results do not occur or the screendisplays irregular characters, please notifyMiniMed. If the PPC displays the MiniMed logoand software version, the PPC has restarted dueto a low battery. Replace the battery immediately.If all electronics “pass” the Self Test, the screen will automaticallychange to “PPC PASSED/PUMP PASSED.” After several seconds, thescreen will return to the Time/Date screen.SELF TESTPPCCOMMUNICATINGDmp9196021-011_c.book Page 59 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)60Initialize PPC to PumpFrom the “SETUP PUMP” screen press ACT until “INITIALIZE PPCTO PUMP” is displayed. This option “marries” the PPC to the Pump, andit is used to initialize a new PPC. For initialization programming followthe steps described in, Part 1: PPC/Pump sytem initialization.Setup II“SETUP II” permits access to an additional group of Setup menus for thePump. From the “SETUP PUMP” screen, press ACT until the “SETUPII” screen is displayed. Setup II features are presented in the next section. Exit setup menu1. From the SETUP “pump” screen, pressSEL until the “EXIT SETUP MENU”screen is displayed. Press ACT. The PPCwill return to the Time/Date screen.EXIT SETUP MENUDmp9196021-011_c.book Page 60 Thursday, April 4, 2002 8:15 AM
Setup II 61Setup II Audio bolusThe Audio Bolus feature allows the user to deliver a bolus without look-ing at the PPC screen. There are two Audio Bolus increments, 0.4U and0.8U. With each press of the ▲▲▲▲ button, the PPC will beep one time (0.4Usetting) or two times (0.8U setting), depending on the delivery amountselected per button press.Activating the audio bolus feature1. From the “SETUP II” screen, press ACT.The “AUDIO BOLUS’ screen is shown.2. Press ACT, and the screen changes to“SET AUDIO BOLUS” with “OFF/ON”flashing. Use the ▲▲▲▲ and ▼▼▼▼ buttons tochoose “ON” to activate the Audio Bolusfeature or “OFF” to disable it. Then pressACT.3. If “ON” was chosen, the “SET STEPAUDIO BOLUS” appears with a stepvalue of 0.4U or 0.8U flashing on thescreen. Use the ▲▲▲▲ and ▼▼▼▼ buttons tochoose between a step rate of 0.4U or0.8U. Press ACT. The Audio Bolus fea-ture is now activated. NOTE: If “OFF” is chosen, pressing the ▲▲▲▲ button willhave no effect.AUDIO BOLUS ON 0.4uSETON AUDIO BOLUS 0.4u SET STEPAUDIO BOLUS 0.4uDmp9196021-011_c.book Page 61 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)62Set an audio bolus from the main menu bolus screen1. From the Time/Date screen press the ▲▲▲▲button. The PPC beeps either one or twotimes, depending upon the audio bolusstep amount set. The user counts thenumber of beeps to determine how muchinsulin was programmed.2. In this example the PPC was programmedfor a 0.8U increment, and the PPC beepstwo times for the 0.8U bolus.Press ACT and the audio sequencerepeats to confirm the bolus amount.Press ACT twice and the Pump will beprogrammed. The PPC beeps once when the programming is com-pleted. Place the PPC on the Pump to complete the communicationprocess.NOTE: While an audio bolus is being delivered, the ▲▲▲▲button will not function.Variable bolusTo access the Variable Bolus feature enter “SETUP II” and press SELone time.The screen will display “VARIABLEBOLUS”. Press ACT.The screen will now display “SET VARI-ABLE BOLUS” and “ON or OFF” will beflashing. Use the ▲▲▲▲ and ▼▼▼▼ buttons to select“ON” or “OFF”, then Press ACT.SET BOLUS 0.8U IMMPPCCOMMUNICATING VARIABLE BOLUS ON SET VARIABLEBOLUSDmp9196021-011_c.book Page 62 Thursday, April 4, 2002 8:15 AM
Setup II 63Place the PPC near the Pump to completecommunication. If “ON” was chosen theVariable Bolus option is now available in theMain Menu/Bolus screen.NOTE: If “OFF” is chosen, the-Variable Bolus option (Square, Dual) will not beavailable in the (Main Menu) Bolus screen.PPCCOMMUNICATINGDmp9196021-011_c.book Page 63 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)64RefillThe refill procedure will be described in Chapter 5 “Pump Refill Proce-dure.” The following screens are used at the end of this procedure, andallow you to enter the new refill volume and to calculate the refill accu-racy. The "PUMP REFILL" screen appears whenyou access the Supervisor Mode. Press ACT.The PPC prompts for the residual amount ofinsulin removed from the Pump. Use the ▲▲▲▲and ▼▼▼▼ buttons to enter the weight (grams) ofextracted insulin.Press ACT and the PPC prompts for the refillinsulin amount. Use the ▲▲▲▲ and ▼▼▼▼ buttons toenter the weight (grams) of insulin refilled inthe Pump.Press ACT. Confirm that the insulin concen-tration defaults to U-400. Press ACT again.Place the PPC near the Pump to complete theprocess.The calculated accuracy will be displayedbriefly. Record this value on the refill form. PUMP REFILL SET EXTRACTED AMOUNT---- ---- g SET REFILL AMOUNT---- ---- g SET INSULIN U400CONCENTRATIONPPCCOMMUNICATINGCALCULATEDACCURACY ---- ---- %Dmp9196021-011_c.book Page 64 Thursday, April 4, 2002 8:15 AM
Setup II 65PrimingA priming bolus is not intended as a therapeu-tic bolus. It should be only used when the Pump is not implanted.The Priming Bolus is used during the preparation of the Pump for implan-tation. This feature “Primes” the Pump piston chamber, outlet port andCatheter. The Pump will pulse approximately 500 times during this func-tion. To access this feature, the Pump must be in “PUMP STOPPED”mode. 1. From the “PUMP STOPPED” screen,press SEL. The screen will begin flash-ing.2. Press the ▲▲▲▲ and ▼▼▼▼ buttons at the sametime until the “ENTER SUPERVISORPASSWORD” screen appears.3. Re-enter the supervisor password, press-ing ACT after each letter or number isentered. The factory preset password is:YIQ8. If the password has been changed,enter the new password. When the Super-visor Password is successfully entered,the screen will change to “PUMP REFILL”. Press SEL until the“PRIMING” screen appears.4. Press ACT and “NO” appears flashing. Press the ▲▲▲▲ and ▼▼▼▼ buttons to change to“YES”, then press ACT.!WARNING08:13 Oct 12 PUMP STOPPEDENTER SUPERVISORPASSWORD YIQ8 PRIMING PRIMING PRIMING NO99.8uDmp9196021-011_c.book Page 65 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)665. The word “CONFIRM” now appears.Press ACT to activate the factory presetpriming bolus of 99.8U.6. Place the PPC over the Pump and com-plete the communication process.7. The progress of the Priming Bolus can beverified by pressing SEL. The PrimingBolus takes approximately 10 minutes tocomplete.NOTE: The PPC will alarm every minute during the Prim-ing Bolus. The Priming Bolus can be terminatedat any time by using the “SUSPEND PUMP” fea-ture. CONFIRMPRIMING YES99.8uPPCCOMMUNICATING08:13 OCT 12 PRIMING 0.0uDmp9196021-011_c.book Page 66 Thursday, April 4, 2002 8:15 AM
Setup II 67Diagnostic rateA diagnostic rate is intended for use only when the Pump is filled with buffer. The Diagnostic Rate feature is used to help “diagnose” Pump deliveryproblems. Fill the Pump with rinse buffer before using this feature. Toaccess this feature, the Pump must be in the “PUMP STOPPED” mode. 1. From the “PUMP STOPPED” screen,press SEL. The screen will begin flash-ing.2. Press the ▲▲▲▲ and ▼▼▼▼ buttons at the sametime until the “ENTER SUPERVISORPASSWORD” screen appears. Re-enterthe supervisor password, pressing ACTafter each letter or number is entered.The factory preset password is: YIQ8.3. When the Supervisor Password is suc-cessfully entered, the screen will changeto “PUMP REFILL”. Press SEL until the“DIAGNOSTIC RATE” screen appears.4. Press ACT and the word “SET” appearsflashing. Use the ▲▲▲▲ and ▼▼▼▼ buttons toenter a Diagnostic Rate (units/hour).5. Press ACT and the word “SET” changesto “DELIVER”. “NO” also appearsflashing. Use the ▲▲▲▲ and ▼▼▼▼ buttonschange “NO” to “YES”, then press ACT. !WARNING08:13 OCT 12 PUMP STOPPED 0000SETSUPERVISORPASSWORD --- --- u/hDIAGNOSTIC RATE 10 u/hSETDIAGNOSTIC RATE 10 u/hDELIVERDIAGNOSTIC RATEDmp9196021-011_c.book Page 67 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)686. The entire screen will be flashing. PressACT again to confirm the DiagnosticDelivery Rate.7. Place the PPC near the Pump and com-plete the communication process.8. The words “DIAGNOSTIC RATE”appear briefly on the screen.The PPCthen returns to the Time/Date screen.NOTE: Press SEL and the PPC will indicate “DIAGNOS-TIC RATE.”NOTE: Diagnostic Rate Delivery can be terminated at anytime by using the “SUSPEND PUMP” feature. 10 u/hCONFIRMDIAGNOSTIC RATEPPCCOMMUNICATING08:13 OCT 12 DIAGNOSTIC RATEDmp9196021-011_c.book Page 68 Thursday, April 4, 2002 8:15 AM
Setup II 69Initialize to factory defaultsThis feature resets all programmed parameters in the Pump to preset fac-tory default values. To access this feature, the Pump must be in the“PUMP STOPPED” mode. 1. From the “PUMP STOPPED” screen,press SEL. The screen will begin flash-ing. 2. Press the ▲▲▲▲ and ▼▼▼▼ buttons at the sametime until the “ENTER SUPERVISORPASSWORD” screen appears. Reenterthe Supervisor Password, pressing ACTafter each letter or number is entered.The factory preset password is: YIQ8.3. When the Supervisor Password is suc-cessfully entered, the screen will changeto “PUMP REFILL”. Press SEL until the“INITIALIZE TO FACTORYDEFAULTS” screen appears.4. Press ACT and the word “CONFIRM”will appear. Press ACT again to activate.5. Place the PPC over the Pump and com-plete the communication process.6. The PPC will now read “PUMP SUS-PENDED.” Press SEL then ACT.08:13 oct 12 PUMP STOPPED ENTERPASSWORDSUPERVISOR 0000INITIALIZE DEFAULTSTO FACTORY INITIALIZE DEFAULTSTO FACTORY CONFIRMPPCCOMMUNICATING08:13 OCT 02PUMP SUSPENDEDDmp9196021-011_c.book Page 69 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)707. Place the PPC over the Pump and com-plete the communication process.8. The PPC now displays the “PUMPRESET” screen, and beeps six timesevery minute until the Pump is restarted. Press SEL then ACT. The PPC returnsto the Time/Date screen. The Pump maynow be reprogrammed.Download softwareThis feature has been disabled at the factory.1. From the “PUMP REFILL” screen in theSupervisor menu, press SEL until the“DOWNLOAD SOFTWARE” screenappears.Stop PumpThis screen allows the Physician to stop the operation of the Pump. From the “PUMP REFILL” screen in theSupervisor Menu, press SEL until the “STOPPUMP” screen appears.Press ACT and the word “CONFIRM”appears highlighted with the entire screenflashing. Press ACT again to confirm.PPCCOMMUNICATING08:13 OCT 02PUMP RESETDOWNLOAD SOFTWARESTOP PUMP STOP PUMP CONFIRMDmp9196021-011_c.book Page 70 Thursday, April 4, 2002 8:15 AM
Setup II 71Place the PPC near the Pump and allow thecommunication to complete.The PPC will beep four times to confirm the“STOP PUMP” command. To restart thePump, press SEL and “PUMP STOPPED”will start to flash. Press ACT. Place the PPCnear the Pump. When the communication iscomplete, the PPC returns to the Time/Datescreen.Supervisor passwordIf the password is lost, access the Supervisor Menu as follows :• Program the time to midnight (12:00 am or 00:00) and the date toJanuary 01.• Enter the password 0000 within one minute. If the password isnot entered within one minute the time will be reset to midnightagain.• Record the new password in the patient’s chart.PPCCOMMUNICATING08:13 OCT 02PUMP STOPPEDDmp9196021-011_c.book Page 71 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)72Exit supervisorTo exit the Supervisor Programming Menu, press SEL until the “EXITSUPERVISOR” screen appears, then press ACT.Personal Pump communicator messagesDisplay Screen Message Message Meaning or Action RequiredAUTO OFF PUMP PUMP SUSPENDEDAuto Off time interval has elapsed. Pump operation is suspended.BOLUS 0.0 u A bolus has been programmed and is being delivered.CHECK PUMP STATUSThe PPC battery has been replaced. The PPC needs to check the Pump status.LOW RESERVOIR The PPC has recognized the Pump has 800 units (2 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump.EMPTY RESERVOIR The PPC has recognized the Pump has 400 units (1 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump.HOURLY MAX EXCEEDEDYou attempt to deliver more than 2.5 times the bolus maximum in one hour. To clear the message, press SEL and ACT. You may exceed this limit by program-ming another bolus within 10 minutes.PPC NEEDS SERVICINGThe internal PPC backup battery is depleted. The PPC can be programmed. Replace the PPC as soon as possi-ble.PPC LOW BATTERY The internal PPC backup battery is low. The PPC can be programmed. Replace the PPC as soon as possible.PPC DEPLETED BATTERYThe PPC cannot be programmed. Replace the PPC AA 1.5 volt alkaline battery.PPC NOT INITIALIZED The PPC has not been initialized to a Pump.PPC LOW BATTERY The PPC can be programmed. Replace the PPC AA 1.5 volt alkaline battery.PUMP LOW BATTERYThe Pump battery energy is low but still functioning. Schedule a replacement as soon as possible.Dmp9196021-011_c.book Page 72 Thursday, April 4, 2002 8:15 AM
Setup II 73PUMP INITIALIZED The PPC has been “married” to a Pump . Press SEL and ACT.PRIMING XX U A Priming Bolus has been programmed and is being delivered.PUMP RESET The Pump was reprogrammed to the preset factory val-ues.PUMP SELF TEST FAIL A Pump malfunction was detected during a Self Test. Notify your physician immediately.PUMP STOPPED The Pump is in stop mode.PUMP STOPPED1 or 2 or 3 or 4or 5 or 6When the Pump recognizes a system malfunction, it automatically stops and insulin delivery ceases. Notify your physician immediately.PUMP SUSPENDED The Pump is in suspend modePUMP ERROR0 or 1User attempts to initialize the PPC to a Pump that is not compatible with it. Clear by pressing SEL and ACT. Verify the personal ID of the Pump responding corre-sponds to the personal ID entered into the PPC.PUMP ERROR40 or 41The Pump has invalid data. The PPC will not initializeto Pump.TELEMETRY COMMERROR 3The PPC and Pump are not communicating. Reposi-tion the PPC over the Pump, then press SEL and ACT.If the error message persists, contact MiniMed.TELEMETRY COMM ERROR 20If the response is “NO” to the “INITIALIZE PPC TO PUMP” until this screen appears. Move the PPC away from any other Pump and perform the request again.Display Screen Message Message Meaning or Action RequiredDmp9196021-011_c.book Page 73 Thursday, April 4, 2002 8:15 AM
Personal Pump Communicator (PPC)74Clinical history codesIn the “HISTORY” menu, the user can access clinical history from thePPC and the Pump. Each number code corresponds to a particular event.The following table lists each of the number codes with their correspond-ing events. Clinical history PPC/Pump codesClinical Event Code Clinical Event CodeVersion Error 1 Time Out 2No Response 3 Retry Packet 4No Synchronization 5 Bad CRC 6Invalid transmission 7 RX Overflow 8Invalid Op code 9 TX Underflow 10Bolus Total Error 13 Unknown IRQ Vector 12Bad Duplicates 15 NMI Occurred 14Stop Pump Alarm 17 Suspend Alarm 16Prime Pump Alarm 19 Diagnostic Rate Alarm 18Max Clock Stealer 21 Exclusion List Full 20Non Initialized PPC 23 Min Clock Stealer 22Pump Initialized 25 Pump Self Test Error 24Pump Reset to Defaults 26Dmp9196021-011_c.book Page 74 Thursday, April 4, 2002 8:15 AM
Setup II 75Download Failure 27 Hourly Maximum 28Refill Divide Error 29 Refill Invalid Calculation 30Divide by 0 31 EEPROM Error 32Bad EEPROM 33 Main Battery Low 34Main Battery Depleted 35 Back-up Battery Low 36Temporary Basal Rate 37 Check Pump Status 38Download Complete 39 Invalid Concentration 40Invalid Stroke Volume 41 Battery Removed 42IP Communication Error 1 Charge Time Too Long 2Post-Fire Voltage Reading too High3 Over-Delivery Error 4Under-Delivery Error 5 Dead Battery 6Auto Off Interval Exceeded 7 Low Reservoir 8Empty Reservoir 9 Low Battery 10Normal Delivery Mode 11 Stop Delivery Mode 12Suspend Delivery Mode 13 Diagnostic Rate delivery mode14Priming Bolus Delivery Mode15 Insulin Concentration Change16Clinical Event Code Clinical Event CodeDmp9196021-011_c.book Page 75 Thursday, April 4, 2002 8:15 AM
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77CHAPTER 4 Pump ImplantationPreprogramming and pre-testing the pumpEvery Implantable Insulin Pump is fully tested before shipment and isaccompanied by a package insert indicating the measured stroke volumeand Pump type. Prior to shipping, each Pump is filled with sterile rinsebuffer to assure sterility. Programming of the Pump may be performed a day before Pump implan-tation. The Implantable Insulin Pump may be programmed through theouter tray of the sterile package. First, the PPC needs to be “married” tothe Pump, then the Pump function is verified by performing the initializa-tion procedure described in Chapter 3, PPC/Pump System Initialization.Registration cardTo ensure proper patient identification and device serial number tracking,the Registration Card that accompanies each Pump must be completedand promptly returned to MiniMed.Dmp9196021-011_c.book Page 77 Thursday, April 4, 2002 8:15 AM
Pump Implantation78Supplies and solutionsBefore preparing the Pump, be sure to read Appendix D, Precautions andGeneral Procedures. Assemble the necessary materials prior to startingthe procedure:Supplies• One (1) 100 µL sterile pipette (available non sterile from MiniMed) MMT-4104• One (1) sterile scalpel blade• One (1) scale (0.01g resolution)• One (1) sterile beaker (or sterile barrier towel) for weighing• One (1) sterile bag for PPC• 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) MiniMed refill needles, MMT-4102• Three (3) 18 gauge needles• One (1) Implant Worksheet• One (1) Back-up Pump System: PPC, Pump and Side Port Cathe-terSolutions• One (1) bottle of sterile water, room temperature• One (1) vial 10 mL rinse buffer (RB)• Four (4) vials 10 mL Aventis HOE 21 PH U-400 INSULINDmp9196021-011_c.book Page 78 Thursday, April 4, 2002 8:15 AM
Preprogramming and pre-testing the pump 79Emptying and filling the PumpTo prepare the Pump for implantation, the Pump must be emptied andthen filled twice and tested with insulin. These procedures are performedin the operating room prior to implanting the patient. As this is a surgery,all supplies and required equipment should be prepared in accordancewith the institution’s approved sterile procedures. 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 “StrokeVolume Measurement” procedure. DO NOT TRY TO REPLACE THE TUBING BACK ON THE PUMP OUTLET, or you can dis-place or damage the “O” ring placed around the outlet. A sterile field is established in the operating room to prepare the RINSEBUFFER (RB) syringe and remove the shipping fluid from the pump.Document the Pump, Catheter and PPC serial numbers on the ImplantWorksheet.!WARNINGDmp9196021-011_c.book Page 79 Thursday, April 4, 2002 8:15 AM
Pump Implantation80Remove shipping fluid from the Pump1. Using aseptic technique, open the Pump sterile package. Do notremove the plastic tubing from the Pump outlet. Trim the distal partof the tubing with the scalpel blade.2. Remove the refill syringe from the refill kit package.3. Firmly attach the two-way stopcock to the refill syringe and attach an18 gauge needle to the stopcock.4. Draw approximately 4 mL of RINSE BUFFER into the refill syringe.5. Fill the hub of the refill needle with RINSE BUFFER and firmlyattach it to the stopcock, prime the needle and close the stopcock. Figure 6: Filling the Hub of the Refill NeedleDmp9196021-011_c.book Page 80 Thursday, April 4, 2002 8:15 AM
Preprogramming and pre-testing the pump 816. Retract the plunger until it locks into place. This should be no furtherthan 55 mL. Do not go beyond the vent hole. Press the lock into theplunger groove to be sure it is firmly secured.7. Fill one 3 mL syringe with RINSE BUFFER (RB) and attach a needle.8. Fill the Pump fill port using the 3 mL syringe. Any time a refill nee-dle is to be inserted into the Pump fill port, a fluid barrier must bepresent to prevent air from entering the Pump reservoir.9. With the stopcock still closed, insert the RB syringe into the Pump fillport. Press down with at least one-half pound of force to open theinlet valve. As the needle passes through the septum and seats in thevalve, you can feel approximately 0.5mm of movement as the valve isopened.10. Open the stopcock and allow the syringe vacuum to empty the Pumpof shipping fluid. Allow 30 seconds after the fluid level appears tohave stopped rising in the refill syringe, to assure the Pump is com-pletely emptied. Close the stopcock and remove the syringe.Dmp9196021-011_c.book Page 81 Thursday, April 4, 2002 8:15 AM
Pump Implantation82Rinse the Pump with insulin (IN1)11. Remove the second refill syringe from the refill kit package.12. Firmly attach the two-way stopcock to the refill syringe and attach an18 gauge needle to the stopcock. Use the sterile marker to label thesyringe, “IN1”.13. Draw 20 mL of INSULIN (two vials) into the refill syringe.14. Remove the 18 gauge needle and expel all air bubbles in the syringe.15. Close the stopcock.16. Retract the plunger until it locks into place. This should be no furtherthan 55 mL. Do not go beyond the vent hole. Press the lock into theplunger groove to be sure it is firmly secured.17. Shake vigorously for a minimum of 30 seconds to degas the INSULIN.18. Point the syringe tip upward and slowly open the stopcock to vent thesyringe.19. Release the locking ring on the refill syringe.20. Expel air in the syringe and carefully observe to ensure no air bubblesremain in the syringe. If air bubbles are noted, repeat steps 15 - 20.21. Fill the hub of the refill needle with INSULIN and attach it to thestopcock.22. Prime the needle and close the stopcock.23. Refill the fill port with the 3 mL RINSE BUFFER syringe, as needed,to maintain the fluid barrier.24. Use the “IN1” syringe containing the degassed INSULIN to fill thePump.Dmp9196021-011_c.book Page 82 Thursday, April 4, 2002 8:15 AM
Preprogramming and pre-testing the pump 83OPTIONAL25. Use this step only if the plunger is not moving forward while fillingthe reservoir.26. With the refill needle pointing down, vent the syringe head space bypulling back firmly on the plunger until the second sealing ring on theblack rubber cap passes beyond the vent hole (see Figure 7).Figure 7: Venting the Syringe Head SpaceDmp9196021-011_c.book Page 83 Thursday, April 4, 2002 8:15 AM
Pump Implantation8427. With the stopcock closed, press the refill needle into the Pump fillport.28. Open the stopcock. Maintain downward pressure on the barrel of thesyringe to ensure the inlet valve of the Pump remains open.Never push on the refill syringe plunger to fill the Pump. When the refill needle is properly seated in the fill port of the Pump, the vacuum in the reservoir will draw the insulin from the syringe.29. Allow the Pump vacuum to draw the INSULIN into the reservoir.When the INSULIN stops moving, the Pump is filled. Close the stop-cock and remove the syringe.30. Prepare the IN1 syringe for aspiration. Remove any air from thesyringe, prime the needle, close the stopcock and obtain a vacuum bypulling back on the plunger until it locks. Press the lock into theplunger groove to be sure it is firmly secured. A fluid barrier of atleast 2 mL should remain in the syringe.31. Press the refill needle back into the Pump fill port with the stopcockclosed.32. Open the stopcock and empty the Pump. Allow 30 seconds after theINSULIN level appears to have stopped rising in the refill syringe toassure the Pump is completely emptied.33. Close the stopcock and remove the syringe.!WARNINGDmp9196021-011_c.book Page 84 Thursday, April 4, 2002 8:15 AM

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