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

Medtronic MiniMed, Inc. Implantable Insulin Pump Dmp9196021 011 c

physician part2

85Fill the Pump with insulin1. Remove another refill syringe (IN2) from a refill kit package.2. Firmly attach the two-way stopcock to the refill syringe and attach an18 gauge needle to the stopcock. Label the syringe IN2.3. Draw 20 mL of INSULIN (two vials) into the IN2 syringe.4. Remove the 18 gauge needle and expel all air bubbles in the syringe.5. Close the stopcock.6. 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. Shake vigorously for a minimum of 30 seconds to degas the INSU-LIN.8. Point the syringe tip upward and slowly open the stopcock to vent thesyringe.9. Release the locking ring on the refill syringe.10. Expel the air in the syringe and carefully observe it to ensure no airbubbles remain in the syringe. If air bubbles are noted, repeat steps5 - 10.11. Fill the hub of the refill needle with INSULIN and attach it to thestopcock.12. Prime the needle and close the stopcock.13. Place a sterile beaker or sterile barrier towel on the scale and tare it(position balance at 0.)14. Weigh the refill syringe and record the weight on the Implant Work-sheet.Dmp9196021-011_c.book Page 85 Wednesday, April 3, 2002 5:04 PM
8615. Press the refill syringe into the Pump fill port, open the stopcock andallow the Pump vacuum to draw INSULIN into the reservoir until thefluid level stops moving. Close the stopcock.16. Remove the IN2 syringe and prepare for aspiration without expellingany fluid. Obtain a vacuum by pulling back on the plunger until itlocks. Press the lock into the plunger groove to be sure it is firmlysecured.17. Reenter the Pump fill port with the stopcock closed.18. Open the stopcock and withdraw 2 mL in order to activate the nega-tive pressure safety feature of the Pump. Close the stopcock andremove the syringe.19. Weigh the IN2 syringe to calculate the Pump refill amount. Subtractthe weight after the fill and 2 mL withdrawal from the weight beforethe fill and record the difference on the Implant Worksheet.Measure stroke volume1. Place the PPC in the sterile bag. Enter the Supervisor Mode. Thescreen displays “PUMP REFILL”. Press ACT until the “SETREFILL AMOUNT” screen appears. When filling the Pump for thefirst time, set the “EXTRACTED AMOUNT” to zero. Otherwise,enter the amount of insulin extracted. Then use the ▲▲▲▲ and ▼▼▼▼ buttonsto enter the refill amount from the Implant Worksheet. Program thePump.2. Again, enter the Supervisor Mode and program “STOP PUMP”.From the screen “PUMP STOPPED”, press SEL. “PUMPSTOPPED” will begin flashing. Press both the ▲▲▲▲ and ▼▼▼▼ buttons atthe same time, until the screen changes to the password screen. Reen-ter the password and the screen will change to “PUMP REFILL.”Press SEL to reach the “PRIMING” screen. “NO” will be flashing.Use the ▲▲▲▲ and ▼▼▼▼ buttons to select “YES,” then press ACT. When theword “CONFIRM” is highlighted, press ACT again. Place the PPCnear the Pump to complete the communication process. Record theDmp9196021-011_c.book Page 86 Wednesday, April 3, 2002 5:04 PM
87time the priming bolus was initiated on the implant worksheet. If you have removed the plastic tubing placed on the Pump outlet, DO NOT TRY TO REPLACE THE TUBING BACK ON THE PUMP OUTLET. You can displace or damage the “O” ring placed around the outlet. To measure the stroke volume, you need to use the procedure described in Appendix G, after the Catheter has been attached.3. Listen for five beeps and observe that fluid is being pumped from tub-ing attached to the Pump outlet.4. Attach the 18 gauge needle (from the 3 ml syringe filled with RINSEBUFFER) to the plastic tubing from the Pump outlet.5. Remove the 3 ml syringe and fill the needle hub.6. Insert the pipette into the hub. A meniscus of fluid will be present inthe pipette. This should be done on a flat surface with the pipette/tub-ing assembly horizontal. (see Figure 8).Figure 8: Testing Pump Stroke Volume with a Pipette7. Note the exact location of the fluid meniscus in the pipette.8. Measure the stroke volume by noting the volume displaced by a mini-mum of 10 pulses. Record the total volume delivered and the numberof pulses on the Implant Worksheet. Divide the total volume deliv-ered by the total number of pulses used to deliver that volume. Thevolume per stroke must be between 0.40 and 0.60 µL. Record thisvalue on the Implant Worksheet.!WARNINGDmp9196021-011_c.book Page 87 Wednesday, April 3, 2002 5:04 PM
88Prepare the Side Port CatheterThe Side Port Catheter (“Catheter”) is attached to the Pump before implantation; however, it must be primed with INSULIN and inspected before being attached to the Pump.Never insert a needle into the connector end of the Catheter for priming or for testing. there may be a precision sealing surface in the connector that will be damaged by the insertion of any needle.1. Keep the Catheter in its package until the Pump is prepared and strokevolume has been verified. Remove the Catheter from its sterile pack-age and document the serial number on the Implant Worksheet.2. Using the last insulin syringe (IN2) from the Pump preparation proce-dure, enter the Catheter port cone and push a small volume of insulinout of the connector end of the Catheter. This primes the proximalportion of the Catheter and cleans any debris from the connector out-let. Remove the syringe.3. Remove the plastic tubing and tubing retainer from the Pump outlet.Remove the tubing retainer, by rotating it one-quarter turn clockwiseto disengage it from the connector flange.Then lift and remove thetubing and retainer together from the Pump outlet.Dispose of the tub-ing and retainer.!WARNINGDmp9196021-011_c.book Page 88 Wednesday, April 3, 2002 5:04 PM
89Figure 9: Rotate Tubing Retainer Figure 9-2: Pull Tubing Retainer off Pump.Dmp9196021-011_c.book Page 89 Wednesday, April 3, 2002 5:04 PM
90Figure 9-3: Tubing and Retainer Removed.Step 4 Inspect the outlet of the Pump for debris. Debris, espe-cially fibers, left in the fluid path will compromise thefunction of the Catheter check valve. Rinse the outlettube of the Pump with water from a syringe, if necessary.Avoid wiping the Pump with gauze or drapes that willleave fibrous debris. Use caution when removing debris from the outlet of the Pump. There is a precision rubber seal on the outlet that will be dam-aged by handling with surgical instru-ments.Step 5 Pull the locking bar out and gently push the Catheterstraight down onto the Pump outlet. Never twist theconnector.!WARNINGDmp9196021-011_c.book Page 90 Wednesday, April 3, 2002 5:04 PM
91Step 6 Only after the Catheter is seated, squeeze the connector,1, firmly against the Pump between the thumb and fore-finger of one hand. Then push the locking bar, 2, intoplace with the thumb of the other hand.Figure 10: Proper Attachment of the Side Port Catheter to PumpDmp9196021-011_c.book Page 91 Wednesday, April 3, 2002 5:04 PM
92Step 7 Verify the Catheter is securely attached to the Pump.Look into the connector and observe the position of thelocking bar with respect to the Pump connector outlet.Check the side port connector hub for abnormalities(e.g., cracks, misalignment.)Step 8 Using the IN2 refill syringe, enter the Catheter side portcone and push a small amount of INSULIN out the Cath-eter tip. Verify that no insulin flow is observed at Pump/Catheter interface. Remove and reseat Catheter if flow isnoted. Remove the syringe.Step 9 Confirm insulin delivery from the tip of the Catheter andnote it on the Implant Worksheet. The INSULIN willform a dome on the tip of the Catheter. Pulsatile deliverywill not be obvious. If the priming bolus has alreadyended, program an immediate bolus (about 20 units) toconfirm delivery. (This bolus may be canceled afterdelivery is verified.)Step 10 At the end of the bolus, rinse the outside of the Pumpthoroughly with sterile water to remove traces of INSULIN. The Catheter tip should not be placed in thewater. Protect the Pump with sterile drapes until the sur-geon is ready to implant it. Verify that the priming bolusis finished or canceled prior to the implantation. The Pump and Catheter are now ready for implantation.Dmp9196021-011_c.book Page 92 Wednesday, April 3, 2002 5:04 PM
93Performing the surgical procedurePre-operative evaluationThe Pump implant depth should not exceed 5 cm (2 inches) beneath thesurface of the skin. If the Pump is implanted too deeply in the subcutane-ous tissue it may be difficult to access the refill port.Formation of the pump pocketPump implantation can be performed either under local or general anes-thesia. After satisfactory anesthesia, a pre-selected abdominal site isprepped and draped in the customary surgical method.A transverse or longitudinal incision is made and deepened through theskin and subcutaneous tissue. Care should be taken in choosing the loca-tion of the incision so the suture line is next to but not over the Pump inletfill port or the Catheter side port. A subcutaneous blunt dissection is per-formed to create a pocket large enough to accommodate the Pump.Meticulous hemostasis should be established with electrocautery. Figure 11 indicates a possible Pump placement and corresponding inci-sion sites.The Pump is secured to the fascia of the abdominal musculature using thethree suture tabs provided. Securing the Pump with all three suture tabs isrecommended, as it will prevent migration, rotation or inversion in thepocket and possible dislodgment of the Catheter.Dmp9196021-011_c.book Page 93 Wednesday, April 3, 2002 5:04 PM
94Figure 11: Example of Pump PlacementDmp9196021-011_c.book Page 94 Wednesday, April 3, 2002 5:04 PM
95Catheter placementThe Catheter is not designed to be tunneled subcutaneously. The Catheterinsertion should be at the extreme edges of the Pump pocket.At a site not directly beneath the Pump, the layers of abdominal muscula-ture are divided to expose the peritoneum. Concentric purse string suturesare placed and the peritoneum is exposed with a 1 cm incision. The distaltip of the Catheter is placed in the peritoneal space. The flange of theCatheter is sutured firmly to the fascia of the abdominal musculature.Sutures should only be placed on the reinforced flange of the Catheter.Sutures must not be placed directly on the Catheter itself.Never trim or cut the tip of the Catheter.The implant site should be irrigated with an antibiotic solution. Inter-rupted absorbable sutures should be used to approximate the subcutane-ous tissues and the skin closed with a running subcuticular absorbablesuture. The wound is dressed using standard surgical technique. At theend of the surgery, place an abdominal binder over the implant site. Thisbinder must be worn until the capsule has formed (about 1 month.) Thebinder is recommended because it will obtain a better cosmetic result andminimize the post operative swelling.Post-operative managementPost-operative hospitalizationAfter implantation, the surgical incision should be inspected for any signsof unusual swelling, tenderness, pain, or drainage. Potential post-opera-tive complications include Pump pocket seroma, wound dehiscence,wound infection, and catheter dislodgment.Length of post-operative hospitalization depends upon how rapidly thepatient adjusts to the Pump and how quickly blood glucose levels!WARNINGDmp9196021-011_c.book Page 95 Wednesday, April 3, 2002 5:04 PM
96stabilize. During post-operative hospitalization, the Pump can be repro-grammed to accommodate the needs of the patient. As post-operativestress decreases, insulin requirements may decline. It may be necessaryto make several changes in insulin delivery rates during the first few daysfollowing implantation.Patients must be thoroughly educated in all aspects of follow-up care withthe Pump. The MiniMed Patient Manual should be used to supplementpatient education. Prior to discharge, patients should:• Fully understand how to use their PPC;• Know what to do in the event of Pump or PPC difficulties;• Have scheduled their first refill appointment;• Have set an appointment for their first follow-up visit;Post-operative x-raysThe Catheter has been designed with a radio-opaque stripe for identifica-tion after implantation. A lateral and anterior X-ray is recommended afterimplantation to locate and document the position of the Catheter. Thisradiograph should be kept with the patient’s records for future reference.Dmp9196021-011_c.book Page 96 Wednesday, April 3, 2002 5:04 PM
97CHAPTER 5 Pump Refill ProcedureIntroductionInitial appointments for Pump Refills should be made with patients at thetime of implantation. Subsequent appointments should be made inadvance, normally during each refill procedure. The Pump stores approx-imately 6,000 units of insulin medication and typically requires a refillevery two to three months. In order to maintain the physical stability ofthe insulin, the Pump must be refilled at a maximum interval of no morethan 90 days. The PPC will display warning messages to alert the patientof calculated low or emptied reservoir volumes.The low reservoir message will appear when the PPC calculates that 800(2 ml) or fewer units of insulin medication remain in the Pump. Theempty reservoir message will appear when the PPC calculates that 400 orfewer units (1 ml) of insulin remain. The time to medication depletiondepends upon the delivery rate of the Pump.The Pump refill procedure should always be scheduled in advance of PPC “low reservoir” or “empty reservoir” messages.!WARNINGDmp9196021-011_c.book Page 97 Wednesday, April 3, 2002 5:04 PM
Pump Refill Procedure98Supplies and solutionsThe refill kit (MMT-4105) is intended exclusively for use with the Medtronic MiniMed 2007C Implantable Insulin Pump System. The refillkit consists of a specially designed syringe and stopcock for removing flu-ids from and placing fluids into the Pump. Use only refill needles (MMT-4102) available from MiniMed to perform all Pump refill procedures.This 22 gauge needle, featuring a rounded, lubricated tip and a beveledside hole, has been specially developed to mate with the Pump fill port.Use of other needles may result in damage to the Pump septum in the fill port, and may allow body fluids to enter the Pump.Below is a list of the supplies and solutions necessary to perform the refillprocedure:Supplies:• Steri-Strips® and Markers• The Patient’s PPC• Glucose Monitoring Equipment•Drapes• One (1) Scale (0.01 gram resolution)• One (1) 250 ml Sterile Beaker• One (1) Port Locating Template - MMT-4106• Two (2) Refill Kits - MMT-4105• Three (3) MiniMed MMT-4102 Refill Needles (Extra needlesshould be available for use.)• Four (4) Sharp 18 Gauge Regular Bevel NeedlesSolutions:• One (1) 10 ml Vial, Aventis Rinse Buffer Solution• Two (2) 10 ml Vials, Aventis HOE 21 PH, U-400 Insulin!WARNINGDmp9196021-011_c.book Page 98 Wednesday, April 3, 2002 5:04 PM
Introduction 99Prepare for pump refillNOTE: Before beginning any refill, rinse, flush, or pres-sure measurement procedure, carefully readAppendix D, Precautions and General Proce-dures. Never push on the refill syringe plunger to fill the Pump. When the refill needle is properly seated in the Pump fill port, the vacuum in the Pump reservoir will draw the insulin from the syringe into the reservoir.To prepare for emptying and refilling the Pump, perform the followingsteps:• Use the “HISTORY” feature of the PPC to determine the amountof insulin medication remaining in the Pump. Make sure thatACT is pressed on the “READ PUMP DATA” screen to updatePPC history from the Pump. Record this value on the refill work-sheet (Appendix C).• Prepare a sterile field. The physician should scrub, mask andglove for the refill procedure. Refilling the Pump is an asepticprocedure.• (See Appendix D, Precautions and General Procedures.)• Aseptic skin preparation of the patient’s Pump refill site shouldbe performed using your institution’s standard operating proce-dures.!WARNINGDmp9196021-011_c.book Page 99 Wednesday, April 3, 2002 5:04 PM
Pump Refill Procedure100Perform the refill procedureFill out the refill formFill out the top part of the Refill Form (Appendix C) with the patient’sI.D., refill date, insulin lot number, previous refill volumes, insulin medi-cation remaining, and the name of the person performing the refill proce-dure. This information can be helpful for diagnostic purposes.Label syringesUse a sterile marker and Steri-Strips® to label one refill syringe “RB”(rinse buffer syringe) and the other “IN” (insulin syringe).Prepare the refill syringe for emptying the Pump1. Firmly attach the stopcock to the RB refillsyringe and attach the 18 gauge needle tothe stopcock. Check connections toensure they are secure. Draw 5 ml ofRinse Buffer into the RB refill syringe.2. Expel all air bubbles from the refillsyringe. Remove the 18 gauge needlefrom the stopcock.3. Fill the hub of the refill needle with RinseBuffer from the RB refill syringe andattach it to the stopcock. Prime the refillneedle completely. Close the stopcock.4. Obtain the weight and record it on theRefill Form. Set the syringe aside.Figure 12: Filling the Hub of the Refill NeedleDmp9196021-011_c.book Page 100 Wednesday, April 3, 2002 5:04 PM
Perform the refill procedure 101Prepare the refill syringe for filling the Pump1. Firmly attach the stopcock to the IN refill syringe and attach an 18gauge needle to the stopcock. Draw 20 ml of Aventis HOE PH U-400insulin into the syringe.2. Expel all air from the refill syringe. Close the stopcock and removethe 18 gauge needle.3. 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.4. Shake vigorously for a minimum of 30 seconds.5. Point the syringe tip upward and slowly open the stopcock to allow airto enter the syringe.6. Release the locking ring on the refill syringe. With the syringe pointedupward, push on the plunger to expel the air and prime the stopcock.7. Open the stopcock and prime the refill needle. Attach the refill needleto the stopcock. Close the stopcock.8. Inspect the syringe to ensure there are no air bubbles. If air bubblesare noted, remove the refill needle and repeat steps 2 - 7.9. Weigh the refill syringe and record on the refill form.10. Set the syringe aside.Dmp9196021-011_c.book Page 101 Wednesday, April 3, 2002 5:04 PM
Pump Refill Procedure102Empty the Pump1. Obtain a vacuum in the RB syringe by pulling back on the plungeruntil it locks. Press the lock into the plunger groove and be sure it isfirmly secured.2. Locate the fill port by centering the template over the Pump. The cen-ter hole in the template should be directly over the Pump fill port.Insert the 18 gauge guide needle into the Pump fill port. Local anes-thesia may be used prior to insertion of the 18 gauge needle.3. Press the primed refill needle (attached to the RB syringe) into thePump fill port, by sliding it through the 18 gauge guide needle. Pullback slightly (approximately 2 mm) on the guide needle to allow therefill needle to enter the Pump fill port and actuate the inlet valve.4. Actuate the valve by applying a gentle downward force on the refillneedle. This depresses the valve approximately 0.5 mm.5. Open the stopcock and allow residual insulin from the Pump to bedrawn into the RB refill syringe. Maintain a downward pressure onthe syringe to ensure that the inlet valve in the Pump remains open.Wait 30 additional seconds after the insulin level appears to havestopped rising in the RB refill syringe to ensure the Pump is com-pletely emptied.6. When all residual insulin is withdrawn from the Pump, close the stop-cock. Remove the RB refill syringe.NOTE: Do not remove the 18 gauge guide needle.7. Weigh the RB syringe and record on the refill form.Dmp9196021-011_c.book Page 102 Wednesday, April 3, 2002 5:04 PM
Perform the refill procedure 103Figure 13: Operation of the Pump Inlet Valve18G Guide NeedleRefill NeedleValveFilterSeptumSpring2mmSt e p 3 C: A pp ly fi r m pr e s su re t o m o ve t h e va lv e back and allow the insulin to pass above the valve through the filter and into the reservoir.Step 3A: Locate the port using the 18Ga guide needleslide the refill needle down the guide needle.Step 3B: Pull back approxiamately 2mm on the guide needle to enter the Pump.Step3A Step3B Step3CDmp9196021-011_c.book Page 103 Wednesday, April 3, 2002 5:04 PM
Pump Refill Procedure104Refill the Pump1. Use the IN refill syringe containing 20 ml of degassed insulin.2. Enter the Pump by passing the refill needle with the attached IN refillsyringe through the 18 gauge guide needle. Pull back slightly(approximately 2 mm) on the 18 gauge needle to allow the refill nee-dle to enter the Pump and actuate the inlet valve (see Figure 13).3. Open the stopcock. Maintain downward pressure on the IN refillsyringe to ensure the inlet valve in the Pump remains open. Allow thePump to draw in insulin until the fluid level stops moving. Close thestopcock. 4. Remove the IN syringe and prepare for aspiration without expellingany fluid by pulling back on the plunger until it locks. Re-enter thePump, open the stopcock and withdraw 2 ml in order to activate thenegative pressure safety feature of the Pump.Dmp9196021-011_c.book Page 104 Wednesday, April 3, 2002 5:04 PM
Perform the refill procedure 105OPTIONALUse this step only if the plunger is not moving dur-ing the fill of the reservoir. With the refill nee-dle pointing down,vent the syringehead space by pull-ing back firmly onthe plunge until thesecond sealing ringon the black rubbercap passes beyondthe vent hole(see Figure 14).Figure 14: Venting the MiniMed Refill Syringe5. Remove the IN syringe. Remove the 18 gauge needle and apply pres-sure to the insertion site.6. Weigh the IN syringe and record on the Refill Form. Dmp9196021-011_c.book Page 105 Wednesday, April 3, 2002 5:04 PM
Pump Refill Procedure106Calculate extracted and refill amounts1. Calculate the extracted amount by using the calculation section of therefill form.2. Calculate the refill amount by using the calculation section of therefill form.3. Enter the extracted amount (amount withdrawn as calculated on therefill worksheet at line E) and the refill amount (as calculated on therefill worksheet at line G) into the PPC (see Chapter 3).Calculate refill accuracy The PPC automatically calculates the refill accuracy following the PPCrefill programming. You can also follow the calculation section of therefill form to calculate the refill accuracy.Enter the refill accuracy value (IN %) on the line provided on the refillform. It is important to record this value to evaluate the functioning of thePump system.Dmp9196021-011_c.book Page 106 Wednesday, April 3, 2002 5:04 PM
107CHAPTER 6 Explanting the Pump System Explant considerationsWhen the battery in the Pump is depleted or if acceptable glycemic con-trol cannot be achieved, it may become necessary to explant the Pumpsystem.Prior to explantation, it may be possible to perform interventions thatcould correct certain conditions. These procedures are described inAppendices E and F. If all appropriate interventions have been exhausted without an acceptableoutcome, please contact MiniMed prior to scheduling a Pump explanta-tion.Returning devices/components to MiniMedExplanted Pumps and Catheters or other components should be returnedto MiniMed for evaluation. Please call MiniMed and obtain a ReturnedMaterials Authorization (RMA) number prior to each return.Explanted devices must be sealed in an appropriate biohazard containerand packed with a gauze pad soaked with sterile saline. The shipping con-tainer should be water tight. Chemical and reliability analysis require thatthe device not dry out during transportation. Dmp9196021-011_c.book Page 107 Wednesday, April 3, 2002 5:04 PM
Explanting the Pump System108Be certain to include required patient information as well as the RMAnumber, date, and reason for the explant and place all pertinent documen-tation in a water tight document package. Put the RMA number on theshipping label.Please take the necessary precautions when shipping the Pump Systemvia commercial carrier to avoid damage to the Pump. Please returnexplanted Pump Systems to:United States:MiniMed Inc.18000 Devonshire StreetNorthridge, CA 91325Telephone: 1-818-578-6700orEurope:MiniMed S.A.30, Boulevard Vital Bouhot92200 Neuilly-sur-Seine, FranceTelephone: 33 (1) 46 43 16 16Dmp9196021-011_c.book Page 108 Wednesday, April 3, 2002 5:04 PM
109CHAPTER 7 Warnings And Precautions WarningsThe Physician should be completely familiar with the function of thePump, Catheter, and PPC prior to use. Patients should be provided a com-plete copy of the Patient Manual and have demonstrated the ability to pro-gram the PPC, recognize and respond to safety alarms, and take care ofthe device prior to discharge.The Implantable Insulin Pump can only be used with MMT-4027A and4024A Side Port Catheters.Only Aventis HOE 21 PH U-400 insulin may be used in the MedtronicMiniMed 2007C Implantable Insulin Pump System. Use of other insulintypes may cause damage to the Pump mechanism resulting in impairedinsulin delivery or Pump failure.Any unauthorized changes or modifications made to any component ofthe Medtronic MiniMed 2007C Implantable Insulin Pump System mayprevent effective use of that and other components.ElectrotherapyThe Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested in close proximity with electrosurgical, electrocoagulation,and cardiac defibrillation medical equipment. Typical use of this type ofdevice has not affected the Pump. However, patients should be instructedDmp9196021-011_c.book Page 109 Wednesday, April 3, 2002 5:04 PM
Warnings And Precautions110to test Pump function (e.g., program a bolus and then cancel the bolus)after such procedures, to determine that the Pump and PPC are operatingproperly. If the system is not performing correctly, contact MiniMed.Diagnostic ultrasound The Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested during diagnostic ultrasound procedures. These procedureshave no effect on Pump performance. However, patients should beinstructed to test the Pump function (e.g., program a bolus and then cancelthe bolus) after such procedures, to determine that the Pump and PPC areoperating properly. If the system is not performing correctly, contactMiniMed.Ultrasound therapyThe Medtronic MiniMed 2007C Implantable Insulin Pump System shouldnot be exposed to therapeutic ultrasound procedures, such as lithotripsy.Exposure to ultrasound therapy may damage the Pump, and not be imme-diately apparent.Diagnostic radiationThe Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested during diagnostic radiation procedures, such as ComputedTomography and X-ray. These procedures have no effect on Pump perfor-mance. However, patients should be instructed to test the Pump function(e.g., program a bolus and then cancel the bolus) after such procedures, todetermine that the Pump and PPC are operating properly. If the system isnot performing correctly, contact MiniMed.Therapeutic radiationThe MiniMed 2007 Implantable Insulin Pump has been tested duringtherapeutic radiation procedures. These procedures have no effect onPump performance. However, patients should be instructed to test thePump function (e.g., program a bolus and then cancel the bolus) aftersuch procedures, to determine that the Pump and PPC are operating prop-erly. If the system is not performing correctly, contact MiniMed.Dmp9196021-011_c.book Page 110 Wednesday, April 3, 2002 5:04 PM
Warnings 111Elevated anti-insulin antibodiesThe result of clinical investigations suggest a small population of patientsmay develop anti-insulin antibodies when using the MiniMed 2007Implantable Pump System and HOE 21 PH U-400 insulin. Patients withmultiple autoimmune disorders may be more susceptible to developinghigh titers of anti-insulin antibodies, which in turn may cause symptoms.There was no correlation between length of exposure to the study drugand the resultant titer of anti-insulin antibodies. Elevated levels of anti-insulin antibodies alone have been proven not to interfere with diabetesmanagement using continuous intraperitoneal insulin infusion with thissystem. Environmental conditionsThe Medtronic MiniMed 2007C Implantable Insulin Pump System shouldnot be exposed to extreme electrical or magnetic fields. Although it is notpossible to include every environmental condition that may affect thePump, most are listed below. Please contact MiniMed when in doubt ifcertain environmental exposure will affect the pump.DO NOT EXPOSE THE MINIMED 2007 IMPLANTABLE INSULIN PUMP SYSTEM TO ANY OF THE FOLLOWING CONDITIONS• Magnetic Resonance Imaging (MRI) Procedures.• Lithotripsy Treatment.• Large Rotating Magnetic Fields - - - - Refers to large industrial rotat-ing magnetic fields, such as those found in Industrial PowerPlants.• Magnets Held Directly Over the Pump.• High Power Radio or Satellite Transmitting Towers.• Altitudes Above 2,400 meters (8,000 feet).The Medtronic MiniMed 2007C Implantable Insulin Pump System is notdesigned for use at elevations above 2,400 meters (8,000 feet). Use of thePump System at higher elevations may result in insulin over delivery,which may cause personal injury or death. Therefore, patients who live atDmp9196021-011_c.book Page 111 Wednesday, April 3, 2002 5:04 PM
Warnings And Precautions112elevations above 8,000 feet or 2,400 meters should not use the Pump.Patients who use the Pump and who plan to travel to an elevation above2,400 meters (8,000 feet) should first have their Pump reservoir emptiedof insulin, and they must self-administer insulin by other means for theduration of the trip and until their Pump reservoir is refilled again.• This warning does not apply to travel on commercial aircraftbecause normal cabin pressurization is adequate to ensure properoperation of the Pump.• Diving Below 7.6 Meters (25 Feet).• Physical Damage to the Pump or Pump Pocket.Physicians should instruct patients to avoid any sharp blows or pressuredirectly at the Pump location. A direct hit by an object such as a baseballmay damage the Pump and/or injure the Pump pocket. Extreme pressureon the Pump may cause the sutures and the tissue pocket to be damaged.As a result, the Pump may move from its pocket and possibly dislodgefrom the Catheter.If the Pump has been damaged by such a blow, the patient should beinstructed to contact their physician. Physicians may order a pressure ban-dage or a reduction in the patient’s physical activity until the pump pocketreheals completely.• Exposure to Extreme Body TemperaturesExposure to elevated body temperature in excess of 104°F (40°C) willcompromise the negative pressure reservoir safety feature of the MiniMed2007 Implantable Pump. Glucose levels should be monitored closely ifthis occurs.SterilizationThe Pump, Catheter and the refill kit are sterilized with ethylene oxide(EtO).The Pump System is NOT Reusable.If the sterile package has been opened, damaged or tampered with DONOT USE the packaged device.Dmp9196021-011_c.book Page 112 Wednesday, April 3, 2002 5:04 PM
Precautions 113NOTE: Do Not Re-Sterilize the Implantable Insulin PumpNOTE: Do Not Re-Sterilize the Side Port CatheterNOTE: Do Not Re-Sterilize Components of the Refill Kit.The Pipette (MMT -4104), may be resterilized using autoclave or EtO.The Template MMT-4106 may be resterilized using steam autoclave orEtO. This template is made from polycarbonate plastic and will have alimited life in steam autoclave cycle. The template will not withstand dryheat autoclave cycles.PrecautionsEmergencies and the use of conventional insulin suppliesPhysicians should advise patients who wear the Medtronic MiniMed2007C Implantable Insulin Pump System how to deal with emergencyconditions such as hyperglycemia. Patients should always carry conven-tional insulin supplies with them, including insulin and a means to injectit, in the event of impaired insulin delivery by the Pump System. Deliveryof insulin can become impaired due to a failure of a Pump and/or PPC, ora Catheter occlusion. Replacement of the Pump, PPC or Catheter may berequired. Physicians should review the Pump replacement and Catheterclearing procedures in this Physicians Manual PPC reliability requirementsThe PPC is a sensitive electronic device, and can incur physical damage.If the PPC is dropped or receives an impact, immediately perform a SELFTEST to check the displays for proper operation. If the PPC does not dis-play correctly, a replacement PPC is required. Patients should initiatealternative diabetes management until a replacement PPC is received.The PPC housing is not watertight and it may malfunction if immersed inwater. “Condensing humidity” conditions such as steam rooms shouldalso be avoided, because condensation can also damage the PPC’s micro-Dmp9196021-011_c.book Page 113 Wednesday, April 3, 2002 5:04 PM
Warnings And Precautions114electronics. If either situation occurs, contact MiniMed immediately andarrange for the repair or replacement of the PPC. If the PPC is acciden-tally splashed, sprayed or immersed, remove excess moisture with a softtowel and then place the PPC in a warm place to thoroughly dry. Whendry, perform a “SELF TEST.” If the PPC does not display correctly, callMiniMed to replace the device. Maximum dosagesThe physician can program specific limitations to insulin Basal Rates andBolus amounts, as well as total daily insulin usage. These limitations pro-vide some control of patients’ ability to program their insulin regimens,and to avoid overdosing.Electrical and magnetic fieldsCommon electrical and magnetic fields that do not affect the Pumpinclude microwave ovens, satellite receiving dishes, common householdappliances, security devices found in department stores and airports, stan-dard medical X-rays, cellular phone, and radiowaves.Dmp9196021-011_c.book Page 114 Wednesday, April 3, 2002 5:04 PM
115CHAPTER 8 Adverse ReactionsAdverse reactionsIn clinical studies, adverse reactions associated with the Medtronic Min-iMed 2007C Implantable Pump included hypoglycemia, diabetic ketoaci-dosis, hyperglycemia, skin erosion, infection, abnormal healing, elevatedanti-insulin antibodies, intestinal obstruction, post-operative discomfortand pain, and corrective surgery for Pump and Catheter malfunctions.Pump System malfunctions in order of frequency and seriousness includeinsulin aggregation resulting in Pump under-delivery, Catheter occlusionor tissue overgrowth, premature depletion of the Pump battery, and failureof Pump electronics. Adverse events associated with the use of AventisHOE 21 PH U-400 insulin are described in the package insert accompa-nying the insulin medication.Dmp9196021-011_c.book Page 115 Wednesday, April 3, 2002 5:04 PM
Adverse Reactions116PreventionThe majority of adverse reactions in patients using the Medtronic MiniMed 2007C Implantable Pump System can be prevented by teachingpatients dependable blood glucose monitoring. The patient plays a signif-icant role in diagnosing and correcting Pump System performance prob-lems. Should Pump performance change, the patient would be able todetect a change in blood glucose levels.Patients should be instructed to contact their physician’s office, if they experience unresolvable difficulties with the Pump System. Emergency patient visits and diagnostic procedures may be necessary to correct adverse conditions. !WARNINGDmp9196021-011_c.book Page 116 Wednesday, April 3, 2002 5:04 PM

Navigation menu