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

Medtronic MiniMed, Inc. Implantable Insulin Pump Dmp9196021 011 c

physician part4

145APPENDIX D Precautions and General Procedures Special note and precautions Before beginning the implant, refill, stroke volume measurement, rinse/flush, or pressure measurement procedure, carefully read this Appendixand keep the information in mind as you perform each procedure.1. All procedures should be performed using ASEPTIC TECHNIQUE.2. Air in the Pump System has been shown to be a significant contribut-ing factor to aggregation of insulin. Proper degassing of all solutionsthat enter the Pump is essential. Read the insert in the syringe packag-ing about the degassing procedure.3. When using the refill kit, never release the syringe-locking ring whilethere is a vacuum within the refill syringe. The plunger of the syringewill snap back forcefully and may rupture the syringe and eject thecontents.4. It is important that the syringe needle is perpendicular to the fill portto prevent binding when entering or exiting.5. The Side Port Catheter attachment site contains up to 20 units ofINSULIN. The distal portion of the Catheter and the tubing can con-tain up to 13 units of INSULIN. However, the INSULIN in the Pumpfluid pathway and the side port receptacle can be cleared by followingthe procedure to pull RINSE BUFFER through the side port. DuringDmp9196021-011_c.book Page 145 Wednesday, April 3, 2002 5:07 PM
146a flush procedure to push out a catheter tip blockage, the 13 units inthe distal catheter will be delivered to the patient. The 13 units can bemanaged by programming cautions bolus amounts prior to the proce-dure, or with the use of oral or IV glucose as needed during the proce-dure. Individual patient response to INSULIN bolus amounts must beconsidered.6. Patient blood glucose monitoring must be performed during, and up toone hour after the procedure. Oral and intravenous glucose should beavailable for glycemic management.7. After the flush procedure, at least 13 units of RINSE BUFFER willremain in the distal portion of the catheter. Programmed bolusamounts to remove the RINSE BUFFER may be completed beforethe patient leaves the clinic. A prescribed INSULIN basal rate shouldbe programmed when the system is clear of RINSE BUFFER.8. Never push down on the plunger to fill the Pump. When the MiniMedrefill needle is properly seated in the fill port, the vacuum in the reser-voir will draw the fluid from the syringe.9. Each step of the procedure will list the syringes and appropriate fluidsneeded for that step. It is suggested that the syringes be prepared andlabeled prior to the start of the procedure.10. The Side Port Catheter is intended to be accessed only during theimplant procedure, the combined rinse/flush procedure, the catheterflush procedure, and for diagnostic procedures. The catheter is notintended to provide access to the peritoneum for bolus injections offluids or for withdrawal of body fluids.General procedures Before beginning any of the procedures, be sure you are familiar with thegeneral techniques for locating the Pump fill port and the Side Port Cath-eter, accessing the Pump inlet, venting the refill syringe, and preparing thesyringes.Dmp9196021-011_c.book Page 146 Wednesday, April 3, 2002 5:07 PM
Special note and precautions 147Locating the pump fill port and the side portFigure 16: Template and Placement on Skin with Guide Needles in Position1. Locate the Pump, then aseptically prep and drape the Pump area. Usetopical or local anesthetic if desired.2. To locate the Pump fill port, located in the center of the Pump, alignthe sterile template (MMT-4106) over the Pump by palpating thePump circumference. Then insert an 18 gauge needle into the centralPump fill port as shown in below:3. To locate the side port, palpate around the circumference of the Pump.It is helpful to grasp the side port between the thumb and index fingerwhen aligning the template.4. Using the template as a guide, insert the second 18 gauge needle intothe side port as shown. The side port can be accessed by inserting theguide needle just inside the outer edge of the side port connection.Dmp9196021-011_c.book Page 147 Wednesday, April 3, 2002 5:07 PM
148This outer edge is raised around the outer aspect of the side port, inorder to help guide the needle into the port.Accessing the pump inletTo enter the Pump fill port or the side port, make sure the refill syringestopcock is closed, then pass the MiniMed refill needle (MMT- 4102)through the 18 gauge guide needle. Pull back slightly (approximately 2mm) on the guide needle to allow the MiniMed refill needle to enter thePump fill port or the side port. The refill needle entry opens the inletvalve of the Pump fill port.After passing through the septum and seating in the valve, you can feelthe increased force, about 0.5 pounds, required to move the valve 0.5 mil-limeter to open. Maintain this downward pressure in the pump fill port toensure that the inlet valve remains open. In the case of the side port, a downward pressure is not required after theneedle is completely inserted.Figure 17: Inlet ValveDmp9196021-011_c.book Page 148 Wednesday, April 3, 2002 5:07 PM
Special note and precautions 149Venting the Minimed refill syringe (optional)In order to fill the Pump, it may be necessary to vent the headspace in theMiniMed refill syringe. Refill syringes do not have lubricant on thesyringe housing or on the plunger tip. Some syringes may be “sticky” andrequire the venting procedure described below to assist the vacuum in thePump to overcome this condition.To vent, hold the syringe with the refill needle pointing down. Vent thesyringe headspace by pulling back firmly on the plunger until the secondsealing ring on the rubber cap passes beyond the vent hole as shown inFigure 18. Figure 18: Venting the Refill SyringeDmp9196021-011_c.book Page 149 Wednesday, April 3, 2002 5:07 PM
150NOTE: Be sure that the plunger is retracted far enoughthat the vent hole is exposed. The syringe must beheld with the needle facing down and used within10 minutes once it is vented. If this time limit isexceeded, repeat the degassing procedure.Dmp9196021-011_c.book Page 150 Wednesday, April 3, 2002 5:07 PM
151APPENDIX E Pump Rinse Procedure The purpose of this procedure is to dissolve insulin deposits within thePump reservoir, pumping mechanism, and the Side Port Catheter “port.”Supplies and solutions Prior to performing this procedure, assemble the necessary supplies andsolutions as outlined below:Supplies• Steri-Strips® and markers • Local anesthesia (if necessary)• Sharps container• Safety glasses• PPC• Oral or IV glucose• Glucose monitoring equipment•Drapes• One (1) scale - 0.01 gram resolution• One (1) 250 ml sterile beaker• One (1) sterile bag for PPC (intestinal or cassette bags work well)• One (1) Side port locating template, MMT-4106• Seven (7) Refill kits, MMT-4105Dmp9196021-011_c.book Page 151 Wednesday, April 3, 2002 5:07 PM
152• Seven (7) MiniMed MMT-4102 refill needles. (Extra needlesshould be available to use as needed)• Eight (8) sharp 18 gauge regular bevel needlesSolutions• 50 mL’s sterile 0.1 M NaOH (0.4 grams NaOH per 100 ml ofSterile water for injection)• Seven (7) 10 ml vials, Aventis rinse buffer solution• Five (5) 10 ml vials, Aventis HOE 21 PH, U-400 Insulin The 0.1 M of NaOH used in this proce-dure can cause permanent eye dam-age. Safety glasses must be worn during this procedure.!WARNINGDmp9196021-011_c.book Page 152 Wednesday, April 3, 2002 5:07 PM
153Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volumemeasurement, carefully read Appendix D, Precau-tions and General Procedures, and keep thisin mind as you perform each procedure.In order to prepare for the Side Port Catheter rinse and flush procedure, atotal of seven syringes will need to be labeled and then prepared with dif-ferent solutions. Table 1 defines the syringe numbers and correspondingsolutions:Prepare syringes for emptying the PumpSyringe 1 is used for emptying the Pump. Label and prepare syringe 1 perTable 1.Prepare syringes for filling the PumpDuring the Catheter rinse/flush procedure, syringes 2, 3, 4, 5, 6, and 7 areused for filling the Pump. Each of these syringes needs to be labeled withits solution and syringe number, and then filled and degassed per Table 1.Program minimal basal ratePlace the PPC in a sterile bag and program the Pump to “SUSPEND”mode, the basal rate will be 0.2 U/h.Syringe # Syringe Type Volume Solution Refill 5 ml RINSE BUFFERRefill 20 ml NaOHRefill 30 ml NaOHRefill 20 ml RINSE BUFFERRefill 30 ml RINSE BUFFERRefill 20 ml INSULINRefill 30 ml INSULINDmp9196021-011_c.book Page 153 Wednesday, April 3, 2002 5:07 PM
154Remove insulin from the Pump and fill with NaOHINSULIN is removed from the Pump and then the Pump is filled withNaOH. The following volumes are used:• Syringe 1 - 5 ml RINSE BUFFER• Syringe 2 - 20 ml Naoh• Syringe 3 - 30 ml NaOHFollow the steps below to perform this procedure:Syringe 1: Rinse Buffer1. Prime the needle. Weigh the syringe and record the weight on therefill form (Line A).2. Close the stopcock. Obtain a vacuum by pulling back on the plungeruntil it locks. Press the lock into the plunger groove to be sure it isfirmly secured.3. Enter the Pump with the refill needle.4. Open the stopcock; withdraw the INSULIN. After the INSULINappears to have stopped rising in the syringe, wait an additional 30seconds to make sure all of the INSULIN and air is removed. NOTE: Air in the Pump System has been shown to be asignificant contributing factor to aggregation ofINSULIN. Proper degassing of all solutions thatenter the Pump is essential.5. When the 30 second time has elapsed, close the stopcock, remove thesyringe. Weigh the syringe and record the weight on the refill form.Discard the INSULIN in the syringe except for a 5 ml barrier. Thissyringe will be used to pull NaOH through the side port. Attach andprime a new refill needle.Dmp9196021-011_c.book Page 154 Wednesday, April 3, 2002 5:07 PM
155The 0.1 M NaOH used in this procedure can cause permanent eye damage. Safety glasses must be worn during this proce-dure.Syringe 2: NaOH6. Prime the needle. Close the stopcock7. Enter the Pump with the refill needle.8. Open the stopcock and allow the Pump to fill completely with NaOH.When the fluid level stops moving, the Pump is filled.9. Close the stopcock. Remove the syringe.10. Prepare syringe 2 for aspiration. Remove the air from the syringe.Close stopcock and obtain a vacuum by pulling back on the plungeruntil it locks. Press the lock into the plunger groove to be sure it isfirmly secured.11. Re-enter the Pump.12. Open the stopcock and remove the NaOH. After the fluid level stopsmoving, wait an additional 30 seconds for all the NaOH to beremoved.13. When the time has elapsed, close the stopcock and remove thesyringe. Discard syringe 2.!WARNINGDmp9196021-011_c.book Page 155 Wednesday, April 3, 2002 5:07 PM
156Syringe 3:NaOH (degassed)14. Prime the needle. Close the stopcock.15. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill completely with NaOH.When the Pump is filled, approximately 10 ml will remain in thesyringe. Leave this NaOH in the syringe, and leave this syringe inplace for the next step.Equilibrate and pull NaOH through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and NaOH is pulled through the pumping mechanism. This pro-cedure uses the following volumes in syringes 3 and 1:• Syringe 3 with residual NaOH from the previous section.• Syringe 1 with 5 ml insulin/buffer mixture from previous section.Syringe 3: NaOH (residual)1. Verify that the stopcock on syringe 3 is open .2. Prime the needle. Close the stopcock .3. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.4. Enter the side port with the stopcock closed.5. Open the stopcock.6. Program and deliver a 4 unit bolus to open the valve in the Pumpmechanism.7. Observe syringe 3. When the level of the NaOH approaches 2 ml,close the stopcock to prevent air from entering the Pump. Observesyringe 1. At least 1 ml of NaOH must pass into syringe 1 in order tothoroughly clean the Pump mechanism. If less than 1 ml enters, repeatDmp9196021-011_c.book Page 156 Wednesday, April 3, 2002 5:07 PM
157the bolus from Step 6, some pumps may require 3 successive bolus toobtain 1 ml.NOTE: In order to completely dissolve deposits in thePump mechanism, it is important to maintain avacuum with syringe 1 and deliver the entirebolus.8. After the bolus, close the stopcock on syringe 1. Remove bothsyringes. Set aside syringe 3 for use in removing the NaOH from thePump fill port in the next step. Discard syringe 1.Remove NaOH and fill with rinse bufferThe NaOH is removed from the Pump and the system is filled withRINSE BUFFER. This procedure uses the following volumes in syringes3, 4, and 5:• Syringe 3 with residual of at least 5 ml NaOH from the previousstep• Syringe 4 with 20 ml RINSE BUFFER• Syringe 5 with 30 ml RINSE BUFFERSyringe 3: NaOH (residual)1. Prepare syringe for aspiration. 2. Close the stopcock and obtain a vacuum by pulling back on theplunger until it locks. Press the lock into the plunger groove to besure it is firmly secured.3. Enter the Pump with the refill needle.4. Open the stopcock and withdraw all the NaOH. After the NaOHappears to have stopped rising in the syringe, wait an additional 30seconds to make sure all the NaOH and air is removed.5. When the time has elapsed, close the stopcock, remove the syringe,and discard.Dmp9196021-011_c.book Page 157 Wednesday, April 3, 2002 5:07 PM
158Syringe 4: Rinse Buffer degassed)6. Prime the needle. Close the stopcock.7. Enter the Pump with the refill needle and syringe. 8. Open the stopcock and allow the Pump to fill completely with RINSEBUFFER. When the fluid level stops moving, the Pump is filled.9. Close the stopcock. Remove the syringe. 10. Prepare syringe 4 for aspiration. Obtain a vacuum by pulling back onthe plunger until it locks. Press the lock into the plunger groove to besure it is firmly secured.11. Re-enter the Pump.12. Open the stopcock and remove the RINSE BUFFER. After the fluidlevel stops moving, wait an additional 30 seconds for all the RINSEBUFFER and air to be removed.13. When the time has elapsed, close the stopcock and remove the syringeand set aside.Syringe 5: Rinse Buffer (degassed)14. Prime the needle. Close the stopcock.15. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill completely with RINSEBUFFER. When the fluid level stops moving, the Pump is filled.When the pump is filled, approximately 10 ml of RINSE BUFFERwill remain in the syringe. Leave the RINSE BUFFER in the syringeand leave the syringe in place for the next step.Dmp9196021-011_c.book Page 158 Wednesday, April 3, 2002 5:07 PM
159Equilibrate and pull rinse buffer through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and RINSE BUFFER is pulled through the fluid system. Thisprocedure uses the following volumes in syringes 4 and 5:• Syringe 4 with RINSE BUFFER. Expel all RINSE BUFFERexcept 5 ml. Change refill needle if desired.• Syringe 5 with residual RINSE BUFFER from previous stepSyringe 5: Rinse Buffer1. Verify that the stopcock on syringe 5 is open.2. Prime the needle of syringe 4. Close the stopcock.3. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.4. Enter the side port with the stopcock closed.5. Open the stopcock.6. To open the valve in the Pump mechanism, program and deliver a 4unit bolus using the PPC.7. Observe syringe 4. When at least 1 ml of RINSE BUFFER hasentered syringe 4, close both stopcocks and remove the syringes. Ifless than 1 ml enters, repeat the bolus from Step 6. Some Pumps mayrequire 3 successive boluses to obtain 1 ml. Discard syringe 4 and setaside syringe 5 to be used later to remove RINSE BUFFER.Remove rinse buffer and fill with insulinThe RINSE BUFFER is removed from the Pump fluid system and thesystem is filled with INSULIN. This procedure uses the following vol-umes in syringes 5, 7, and 8:• Syringe 5 with residual RINSE BUFFER from the previous steps• Syringe 6 with 20 ml INSULINDmp9196021-011_c.book Page 159 Wednesday, April 3, 2002 5:07 PM
160• Syringe 7 with 30 ml INSULINSyringe 5: Rinse Buffer (residual)1. Prime the needle. Close the stopcock.2. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.3. Enter the Pump with the refill needle and syringe.4. Open the stopcock and remove the RINSE BUFFER. After the fluidlevel stops moving, wait an additional 30 seconds to make sure all theRINSE BUFFER and air is removed.5. When the time has elapsed, close the stopcock, remove the syringe,and discard. Syringe 6: Insulin (degassed)6. Prime the needle. Close the stopcock .7. Enter the Pump fill port with the refill needle and syringe.8. Open the stopcock and allow the Pump to fill completely with INSU-LIN. When the fluid level stops moving, the Pump is filled.9. Close the stopcock and remove the syringe. 10. Prepare syringe 6 for aspiration. Prime needle and close stopcock.Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.11. Re-enter the Pump.12. Open the stopcock, remove the INSULIN. After the fluid level stopsmoving, wait an additional 30 seconds for all the INSULIN and air tobe removed.13. When the time has elapsed, close the stopcock and remove thesyringe. Discard all but 5 ml of solution. Remove any air, prime nee-Dmp9196021-011_c.book Page 160 Wednesday, April 3, 2002 5:07 PM
161dle and close stopcock. Set aside the syringe.Syringe 7: Insulin (degassed)14. Prime the needle on syringe 7. Weigh and record the combined weightof syringes 6 and 7 on the Refill Form.15. Close the stopcock. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill completely with INSU-LIN. When the fluid level stops moving, the pump is filled. When thePump is filled, approximately 10 ml of INSULIN will remain in thesyringe. Leave the syringe in place for the next step.Equilibrate and pull insulin through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and INSULIN is pulled through the fluid system. This procedureuses the following volumes in syringes 6 and 7:• Syringe 7 with residual INSULIN from previous step• Syringe 6 with 5 ml solution. To perform this procedure withsyringes 6 and 7, follow the steps below:Syringe 6: Insulin (residual) Syringe 7: Insulin (residual) 1. Maintain syringe 7 with approximately 10 ml of residual INSULIN inthe Pump fill port. Verify that the stopcock on syringe 7 is open.2. Prime the syringe 6 needle. Close the stopcock.3. Obtain a vacuum in syringe 6 by pulling back on the plunger until itlocks. Press the lock into the plunger groove to be sure it is firmlysecured.4. Enter the side port with syringe 6 - stopcock closed.5. Open the stopcock on syringe 6.Dmp9196021-011_c.book Page 161 Wednesday, April 3, 2002 5:07 PM
1626. Using the PPC, program and deliver a 4 unit bolus.7. Observe syringe 7. If the level of INSULIN approaches 2 ml, closethe stopcock to prevent air from entering the Pump. Observe syringe6. At least 1 ml of INSULIN must pass into syringe 6 to assureremoval of all the RINSE BUFFER from the side port. If less than 1ml enters, repeat the bolus from Step 6, some Pumps may require 3successive boluses to obtain 1 ml.8. Close both stopcocks. Remove syringe 7 from the Pump. Set asidethe syringe to be weighed.9. With the stopcock closed, remove syringe 6 from the side port.Syringe 6 will have a vacuum from the previous step. Enter the Pumpfill port with syringe 6 and open the stopcock to remove 2 ml. Thiswill restore the negative pressure safety feature of the Pump.10. Close the stopcock, remove syringe 6 from the Pump, and set it asideto be weighed.Remove guide needles and record fill amountAt this point, the 18 gauge guide needles should be removed and the refillamount should be calculated and recorded. Follow the steps below:1. Remove the 18 gauge guide needles. Apply pressure to the needleinsertion sites.2. Weigh syringes 6 and 7 and record on the refill form. Subtract thecombined weight from the weights obtained in step 14 of the section,“Remove RINSE BUFFER and Fill with Insulin.” The result is thenew refill amount.3. Record the extracted and new refill amounts in the PPC.Program new basal rateUsing the patient’s PPC, cancel the SUSPEND mode, to return to the nor-mal patient’s basal rate and modify if needed.Dmp9196021-011_c.book Page 162 Wednesday, April 3, 2002 5:07 PM
163APPENDIX F Side Port CatheterFlush Procedure When delivery of insulin is impaired due to catheter tip obstruction, theCatheter may be flushed using 5 - 10 mL of RINSE BUFFER. Supplies and solutions Prior to performing this procedure, assemble the necessary supplies andsolutions as outlined below:Supplies• Steri-Strips® and markers • Local anesthesia• Sharps container• PPC• Oral or IV glucose• Glucose monitoring equipment•Drapes• One (1) scale - 0.01 gram resolution• One (1) 250 mL sterile beaker• One (1) sterile bag for PPC (intestinal or cassette bags work well)• One (1) Side port locating template, MMT-4106• Five (5) Refill kits, MMT-4105• Six (6) MiniMed MMT-4102 refill needles. (Extra needlesDmp9196021-011_c.book Page 163 Wednesday, April 3, 2002 5:07 PM
164should be available to use as needed)• Eight (8) sharp 18 gauge regular bevel needles• One (1) 10 or 20 mL Luer Lock® syringe• One (1) stopcock - 2 waySolutions• Seven (7) 10 mL vials, Aventis rinse buffer solution• Five (5) 10 mL vials, aventis HOE 21 PH, U-400 Insulin NOTE: One-handed flush with a 10-20 mL syringe only.Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volumemeasurement, carefully read Appendix D, Precau-tions and General Procedures, and keep this inmind as you perform each procedure.In order to prepare for the Side Port Catheter rinse and flush procedure, atotal of five different refill syringes and one 10 or 20 ml syringe will needto be labeled and prepared with different solutions. Table 2 defines thesyringe numbers and corresponding solutions.Dmp9196021-011_c.book Page 164 Wednesday, April 3, 2002 5:07 PM
165Table 2: Preparation and Labeling of SyringesRecord patient’s blood glucoseRecord the patient’s blood glucose value at the start of the procedure.Monitor blood glucose every 30 minutes, or as needed.Prepare syringes for emptying the PumpSyringe 1 is used for emptying the Pump. Label and prepare syringe 1 perTable 2. Special attention should be observed regarding the Precautionsand General Procedures section in Appendix D of this manual. After the syringe is prepared, weigh the syringe and enter the weight onthe Refill Form.Prepare syringes for filling the PumpDuring the Catheter rinse/flush procedure, syringes 2, 3, 5, and 6 are usedfor filling the Pump. Each syringe should be labeled with its solution andsyringe number, then filled and degassed per Table 2 and the General Pro-cedures section in Appendix D of this manual.Syringe # Syringe Type Volume Solution #1 Refill 5 mL RINSEBUFFER #2 Refill 20 mL RINSEBUFFER #3 Refill 30 mL RINSEBUFFER #4 10ml or 20 ml 5-10 mL RINSEBUFFER #5 Refill 20 mL INSULIN #6 Refill 30 mL INSULINDmp9196021-011_c.book Page 165 Wednesday, April 3, 2002 5:07 PM
166Prepare syringe for flushing the Side Port CatheterDuring the Catheter flush procedure, syringe 4 is used for flushing theSide Port Catheter. This syringe needs to be labeled and then prepared byfollowing the steps below:1. Firmly attach a stopcock to the 10 or 20 ml Luer Lock connector of a10 or 20 ml syringe. Then attach an 18 gauge needle to the stopcock.NOTE: Use only a 10-20 ml Luer Lock syringe for thisprocedure. Smaller syringes will damage theCatheter or Pump.2. Draw 5-10 mL of RINSE BUFFER into the syringe.3. Expel all air from the syringe.4. Close the stopcock and remove the 18 gauge needle from the syringe.5. Fill the hub of the MiniMed refill needle with RINSE BUFFER fromthe syringe and attach it to the syringe.6. Prime the MiniMed refill needle completely.7. Close the stopcock.8. Set the syringe aside.Dmp9196021-011_c.book Page 166 Wednesday, April 3, 2002 5:07 PM
167Flushing the Side Port Catheter Program minimal basal ratePlace the PPC in a sterile bag and program the pump to “SUSPEND”mode, the basal rate will be 0.2 U/h.Remove insulin and fill with rinse bufferThe INSULIN is removed from the Pump and the system is filled withRINSE BUFFER. This procedure uses the following volumes in syringes1, 2, and 3:• Syringe 1 with 5 mL RINSE BUFFER• Syringe 2 with 20 mL RINSE BUFFER• Syringe 3 with 30 mL RINSE BUFFERSyringe 3: Rinse Buffer (residual) 1. Prime the needle and close the stopcock. Weigh the syringe.2. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove and be sure it is firmly secured.3. Enter the Pump with the refill needle.4. Open the stopcock and withdraw the INSULIN. After the INSULINappears to have stopped rising in the syringe, wait an additional 30seconds to make sure all of the INSULIN and air are removed. NOTE: Air in the Pump System has been shown to be asignificant agonist to aggregation of INSULIN.Proper degassing of all solutions that enter thePump is essential.5. When the time has elapsed, close the stopcock, remove the syringe.Weigh the syringe and record the weight on the Refill Form.Dmp9196021-011_c.book Page 167 Wednesday, April 3, 2002 5:07 PM
168Syringe 5: Insulin6. Prime the needle and close the stopcock.7. Enter the Pump with the refill needle.8. Open the stopcock and allow the Pump to fill completely with RINSEBUFFER. When the fluid level stops moving, the Pump is filled.9. Close the stopcock and remove the syringe.10. Prepare syringe 2 for aspiration. Obtain a vacuum by pulling back onthe plunger until it locks. Press the lock into the plunger groove andbe sure it is firmly secured.11. Re-enter the Pump.12. Open the stopcock and remove the RINSE BUFFER. After the fluidlevel stops moving, wait an additional 30 seconds for all the RINSEBUFFER and air to be removed.13. When the time has elapsed, close the stopcock and remove thesyringe.Syringe 3: Rinse Buffer14. Prime the needle and close the stopcock .15. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill complete with RINSEBUFFER. When the fluid level stops moving, the Pump is filled.When the Pump is filled, approximately 10 mL of RINSE BUFFERwill remain in the syringe. Leave the RINSE BUFFER in the syringe,and leave the syringe in place for the next step.Dmp9196021-011_c.book Page 168 Wednesday, April 3, 2002 5:07 PM
169Equilibrate and pull rinse buffer through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and RINSE BUFFER is pulled through the fluid system. Thisprocedure uses syringes 2 and 3:• Syringe 2 with RINSE BUFFER. Expel all RINSE BUFFERexcept 5 mL. Change the refill needle if desired.• Syringe 3 with residual RINSE BUFFER from the previous sec-tion.Syringe 3: Rinse Buffer1. Maintain syringe 3 with approximately 10 mL of RINSE BUFFER inthe Pump fill port. Verify that the stopcock on syringe 3 is open.Syringe 2: Rinse Buffer (residual)2. Prime the needle. Close the stopcock.3. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.4. Enter the side port with the stopcock closed.5. Open the stopcock.6. Program and deliver a 4 unit bolus to open the valve in the Pumpmechanism.7. Observe syringe 3. When the level of the RINSE BUFFERapproaches 2 mL, close the stopcock to prevent air from entering thePump. Observe syringe 2. When at least 1 mL of RINSE BUFFERhas entered syringe 2 close both stopcocks and remove the syringes.If less than 1 ml enters, repeat the bolus from Step 6, some Pumpsmay require 3 successive boluses to obtain 1 ml. Discard syringe 2and set aside syringe 3 to be used later to remove the RINSEBUFFER.Dmp9196021-011_c.book Page 169 Wednesday, April 3, 2002 5:07 PM
170Flush side port catheterThe Side Port Catheter is flushed using syringe 4 which is completelyfilled with RINSE BUFFER.NOTE: Approximately 13 units of INSULIN remain in thedistal Side Port Catheter. This INSULIN will bedelivered to the patient rapidly in the next threesteps. Alternatively, the INSULIN may be removedprior to flushing by programming cautious bolusamounts. Closely monitor blood glucose duringINSULIN delivery, and administer intravenousglucose, or glucagon as needed.10-20 ml Syringe 4: Rinse Buffer1. Prime the needle. Close the stopcock.2. Enter the side port with the needle.3. When the needle is firmly positioned in the side port, open the stop-cock and quickly push the plunger all the way down. This shouldtake no longer than one to two minutes.4. After flushing, close the stopcock, remove and discard the syringe.NOTE: This is the only time a plunger should be manuallypushed down. Remove rinse buffer and fill with insulinThe RINSE BUFFER is removed form the Pump fluid system and thesystem is filled with insulin. This procedure uses the following volumesin syringes 3, 5, and 6:• Syringe 3 with residual RINSE BUFFER from the previous step• Syringe 5 with 20 mL INSULIN• Syringe 6 with 30 mL INSULINDmp9196021-011_c.book Page 170 Wednesday, April 3, 2002 5:07 PM
171Syringe 3: Rinse Buffer (residual)1. Prime the needle. Close the stopcock.2. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove and be sure it is firmly secured.3. Enter the Pump with the refill needle and syringe.4. Open the stopcock and remove the rinse buffer. After the fluid levelstops moving, wait an additional 30 seconds to make sure all of theRINSE BUFFER and air is removed.5. When the time has elapsed, close the stopcock, remove the syringe,and discard it.Syringe 5: Insulin6. Prime the needle and close the stopcock.7. Enter the Pump fill port with the refill needle.8. Open the stopcock and allow the Pump to fill completely with INSU-LIN. When the fluid level stops moving, the Pump is filled.9. Close the stopcock and remove the syringe.10. Prepare syringe 6 for aspiration. Obtain a vacuum by pulling back onthe plunger until it locks. Press the lock into the plunger groove to besure it is firmly secured.11. Re-enter the Pump.12. Open the stopcock and remove the INSULIN. After the fluid levelstops moving, wait an additional 30 seconds for all INSULIN and airto be removed.13. When the time has elapsed, close the stopcock and remove thesyringe. Discard all but 5 mL of the solution. Remove the air and setaside the syringe.Dmp9196021-011_c.book Page 171 Wednesday, April 3, 2002 5:07 PM
172Syringe 6: Insulin14. Weigh and record the combined weight of syringes 5 and 6 on theRefill Form. Prime the needles.15. Close the stopcock. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill completely with INSU-LIN. When the fluid level stops moving, the Pump is filled. Approx-imately 10 mL of INSULIN will remain in the syringe. Leave thesyringe in place for the next step.Equilibrate and pull insulin through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and INSULIN is pulled through the fluid system. This procedureuses the following volumes in syringes 5 and 6:• Syringe 6 with residual INSULIN from the previous step• Syringe 5 with 5 mL solutionSyringe 6: Insulin (residual)Syringe 5: Solution1. Maintain syringe 6 with approximately 10 mL of residual insulin inthe Pump fill port. Verify that the stopcock on syringe 6 is open.2. Prime the syringe 5 needle and close the stopcock.3. Obtain a vacuum in syringe 5 by pulling back on the plunger until itlocks. Press the lock into the plunger groove and be sure it is firmlysecured.4. Enter the side port with syringe 5 - stopcock closed.5. Open the stopcock on syringe 5.6. Press SEL. When the PPC screen is flashing “PUMP SUSPEND”press ACT. The system is now in normal mode.Dmp9196021-011_c.book Page 172 Wednesday, April 3, 2002 5:07 PM
1737. Using the PPC, program and deliver a 4 unit bolus.8. Observe syringe 6. If the level of INSULIN approaches 2 mL, closethe stopcock to prevent air from entering the Pump. Observe syringe5. At least 1 mL of INSULIN must pass into syringe 5 to be sure thatall of the RINSE BUFFER is removed from the side port. If less than1 ml enters, repeat the bolus from Step 6, some Pumps may require 3successive boluses to obtain 1 ml.9. Close both stopcocks. Remove syringe 6 from the Pump. Set thesyringe aside to be weighed.10. With the stopcock closed, remove syringe 5 from the side port. It willhave a vacuum inside from the previous step. Enter the Pump fill portwith syringe 5 and open the stopcock and remove 2 ml. This willrestore the negative pressure safety feature of the Pump.11. Close the stopcock, remove syringe 5 from the Pump, and set it asideto be weighed.12. Press SEL until the “SUSPEND PUMP” screen is displayed. ThenPress ACT.Remove guide needles and record refill amountAt this point, the 18 gauge guide needles should be removed, and the refillamount should be calculated and recorded.1. Remove the 18 gauge guide needles and discard them. Apply pressureto the insertion sites.2. Weigh syringes 5 and 6 and record the combined weight on the RefillForm. Subtract the combined weight from the weight obtained in step14 of this section, Remove Rinse Buffer and Fill with Insulin. Theresult is the new refill amount.3. Record the new and extracted refill amount in the PPC.Dmp9196021-011_c.book Page 173 Wednesday, April 3, 2002 5:07 PM
174Program new basal rateUsing the patient’s PPC, cancel the “SUSPEND” mode and allow thePump to return to the patient’s original basal rate.Remove rinse buffer from catheterApproximately 13 units of RINSE BUFFER remain in the distal Side PortCatheter. Depending on blood glucose values, program the appropriatebolus amount to remove the RINSE BUFFER from the Catheter. Releasethe patient when blood glucose levels are stable. Dmp9196021-011_c.book Page 174 Wednesday, April 3, 2002 5:07 PM
175APPENDIX G Stroke Volume Measurement If under-delivery of insulin is noted in a refill procedure or suspected dueto blood glucose control, it may be useful to verify the proper stroke vol-ume of the Pump by accessing the side port.In this procedure, a pipette is attached to a stopcock and refill needle.This system is inserted into the side port. The insulin pulses in the pipetteare measured to calculate the pump stroke volume.Supplies and Solutions Prior to performing this procedure, assemble the necessary supplies andsolutions as outlined below:Supplies• Local anesthesia• Sharps container• PPC• Oral or IV glucose• Glucose monitoring equipment•Drapes• 5 mL or 3 mL syringe• One (1) sterile bag for PPC (intestinal or cassette bags work well)• One (1) Side port locating template, MMT-4106• One (1) sterile 100 microliter pipetteDmp9196021-011_c.book Page 175 Wednesday, April 3, 2002 5:07 PM
176• One (1) MiniMed MMT-4102 refill needle. (Extra needles shouldbe available to use as needed)• One (1) sterile stopcock - 3 waySolutions• One (1) 10 mL vial, Aventis rinse buffer solutionPreparing for the Procedure NOTE: Before beginning any refill, flush, stroke volumemeasurement, carefully read Appendix D, Precau-tions and General Procedures, and keep this inmind as you perform each procedure.Record Patient’s Blood GlucoseRecord the patient’s blood glucose value at the start of the procedure.Monitor blood glucose every 30 minutes, or as needed.Dmp9196021-011_c.book Page 176 Wednesday, April 3, 2002 5:07 PM
177Measuring Stroke Volume 1. In a sterile field immediately before the procedure; prepare the appa-ratus. Prime the stopcock, pipette, and needle.Figure 19: Measuring the Stroke Volume2. Turn the stopcock to close off the needle. 3. Insert the needle into the side port.4. Turn the stopcock. as shown in Figure 19. Dmp9196021-011_c.book Page 177 Wednesday, April 3, 2002 5:07 PM
178Figure 20: Closed Stopcock5. Program a high rate bolus (approximately 20 units) and measure thestroke volume over 20 pulses in the pipette.6. Cancel the bolus at the end of the measurement.7. Turn the stopcock back to the position shown in Figure 20 to close.Remove the apparatus.Dmp9196021-011_c.book Page 178 Wednesday, April 3, 2002 5:07 PM
179Record Patient’s Blood GlucoseIt is likely that some insulin is pumped out of the Catheter and intothe patient in this procedure. Monitor the patient’s blood glucoseand release the patient only after blood glucose values are stable.Dmp9196021-011_c.book Page 179 Wednesday, April 3, 2002 5:07 PM
180Dmp9196021-011_c.book Page 180 Wednesday, April 3, 2002 5:07 PM
181APPENDIX H Pressure MeasurementUsing The Side Port Catheter If under-delivery of insulin is noted by increased insulin needs or bylower than expected actual usage at refills, you may suspect one of twocauses:Insulin deposits have led to under-delivery from the Pump.Catheter blockage has led to under-delivery from the CatheterPressure measurement in the side port can detect pressure build-up due toCatheter tip obstruction. This test, along with the Stroke Volume test,helps to differentiate Pump problems from Catheter problems.NOTE: During this procedure, a 5 unit bolus is pro-grammed. You need to monitor carefully the bloodsugar pre/per/post procedure.Dmp9196021-011_c.book Page 181 Wednesday, April 3, 2002 5:07 PM
182Supplies and solutions Prior to performing this procedure, assemble the necessary supplies andsolutions as outlined below:Supplies• Steri-Strips® and markers • Local anesthesia• Sharps container• Safety glasses• PPC• Oral or IV glucose• Glucose monitoring equipment•Drapes• One (1) scale - 0.01 gram resolution• One (1) 250 ml sterile beaker• One (1) sterile bag for PPC (intestinal or cassette bags work well)• One (1) Side port locating template, MMT-4106• Five (5) Refill kits, MMT-4105• Nine (9) MiniMed MMT-4102 refill needles. (Extra needlesshould be available to use as needed)• Two (2) 10 or 20 ml Luer Lock® syringe• One (1) stopcock - 2 way• One (1) stopcock - 3 way• Syringe filter with luer lock, 0.2 micro (long configuration - notdisk configuration)• Chart recorder• Pressure monitor• Pressure transducerDmp9196021-011_c.book Page 182 Wednesday, April 3, 2002 5:07 PM
183Solutions• Seven (7) 10 ml vials, Aventis rinse buffer solution• Five (5) 10 ml vials, Aventis HOE 21 PH, U-400 Insulin Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volumemeasurement, or pressure measurement proce-dure, carefully read Appendix D, Precautions andGeneral Procedures, and keep this in mind as youperform each procedure.In order to prepare for the Side Port Catheter flush procedure, a total offive different refill syringes and one 10 - 20 ml syringe will need to belabeled and then prepared with different solutions. Table 3 defines thesyringe numbers and corresponding solutions.Table 3: Preparation and Labeling of SyringesSyringe Labeling Solution#1 60 ml RINSE BUFFER#2 60 ml RINSE BUFFER#3 60 ml RINSE BUFFER#410-20 ml5 - 10 ml RINSE BUFFER#5 60 ml INSULIN#6 60 ml INSULINDmp9196021-011_c.book Page 183 Wednesday, April 3, 2002 5:07 PM
184Record patient’s blood glucoseRecord the patient’s blood glucose value at the start of the procedure.Monitor blood glucose every 30 minutes, or as needed.Prepare syringes for emptying the pumpSyringe 1 is used for emptying the Pump. Label and prepare syringe 1 perthe Precautions and General Procedures section in Appendix D of thismanual. After the syringe is prepared, weigh it and record the weight onthe Refill Form.Prepare syringes for filling the pumpDuring the pressure test procedure, syringes 2, 3, 5, and 6 are used for fill-ing the Pump. Each of these syringes need to be labeled with its solutionand syringe number, and then filled and degassed per the General Proce-dures in Appendix D of this manual.Prepare syringe for priming the test setupDuring the pressure test procedure, syringe 4 is used to prime the needle,filter, and the 3-way stopcock. This syringe needs to be labeled and thenprepared by following the steps below:1. Attach an 18 gauge needle to the syringe. Draw 5 - 10 ml of RINSEBUFFER into the syringe.2. Expel all air from the syringe.3. Attach a 3-way stopcock to the syringe.4. Turn the stopcock to close off the syringe.Dmp9196021-011_c.book Page 184 Wednesday, April 3, 2002 5:07 PM
185Measuring pressure in the side portProgram minimal basal ratePlace the PPC in a sterile bag and program the Pump in SUSPEND mode,the basal rate will be 0.2 U/h.Remove insulin and fill with rinse bufferThe INSULIN is removed from the Pump and the system is filled withRINSE BUFFER. This procedure uses the following volumes in syringes1, 2, and 3:• Syringe 1 with 5 ml RINSE BUFFER• Syringe 2 with 20 ml RINSE BUFFER• Syringe 3 with 30 ml RINSE BUFFERSyringe 1: Rinse Buffer1. Prime the needle and close the stopcock.2. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.3. Enter the Pump with the refill needle.4. Open the stopcock and withdraw the INSULIN. After the INSULINappears to have stopped rising in the syringe, wait an additional 30seconds to make sure all of the INSULIN and air is removed. 5. When the time has elapsed, close the stopcock, remove the syringe.Weigh the syringe and record the weight on the Refill Form.Syringe 2: Rinse Buffer6. Prime the needle and close the stopcock.7. Enter the Pump with the refill needle.8. Open the stopcock and allow the Pump to fill completely with RINSEBUFFER. When the fluid level stops moving, the Pump is filled.Dmp9196021-011_c.book Page 185 Wednesday, April 3, 2002 5:07 PM
1869. Close the stopcock and remove the syringe.10. Prepare syringe 2 for aspiration. Obtain a vacuum by pulling back onthe plunger until it locks. Press the lock into the plunger groove to besure it is firmly secured.11. Re-enter the Pump.12. Open the stopcock and remove the RINSE BUFFER. After the fluidlevel stops moving, wait an additional 30 seconds for all the RINSEBUFFER and air to be removed.13. When the time has elapsed, close the stopcock and remove thesyringe. Syringe 3: Rinse Buffer14. Prime the needle and close the stopcock.15. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill complete with RINSEBUFFER. When the fluid level stops moving, the Pump is filled.When the Pump is filled, approximately 10 ml of RINSE BUFFERwill remain in the syringe. Leave the RINSE BUFFER in the syringe,and leave the syringe in place for the next step.Equilibrate and pull rinse buffer through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and RINSE BUFFER is pulled through the fluid system. Thisprocedure uses the following volumes in syringes 2 and 3:• Syringe 2 with RINSE BUFFER. Expel all RINSE BUFFERexcept 10 ml. Change the refill needle if desired.• Syringe 3 with residual RINSE BUFFER from the previous sec-tion.Dmp9196021-011_c.book Page 186 Wednesday, April 3, 2002 5:07 PM
187Syringe 3: Rinse Buffer (residual)1. Verify that the stopcock on syringe 3 is open.2. Prime the needle. Close the stopcock.3. Obtain a vacuum by pulling back on the plunger until it locks. Pressthe lock into the plunger groove to be sure it is firmly secured.4. Enter the side port with the stopcock closed.5. Open the stopcock.6. Press SEL key. When “PUMP SUSPENDED” is flashing on thescreen press ACT. This will place the system in normal mode.7. Program and deliver a 4 unit bolus to open the valve in the Pumpmechanism.8. Observe syringe 3. When the level of the RINSE BUFFERapproaches 2 ml, close the stopcock to prevent air from entering thePump. Observe syringe 2. When at least 1 ml of RINSE BUFFERhas entered syringe 2. If less than 1 ml enters, repeat the bolus fromStep 6, some Pumps may require 3 successive boluses to obtain 1 ml.Close both stopcocks and remove the syringes. Discard syringe 2 andset aside syringe 3 to be used later to remove the RINSE BUFFER.Perform pressure testSyringe 4: Rinse Buffer1. Plug in the chart recorder and the monitor. Attach the monitor cables.The pressure gauge is set to 1 volt = 1 psi. When knob 2 is set to 6volts, then the full scale reading on the paper chart is 6 psi.2. Set the switches and knobs of the chart recorder as follows: Switch 1to “V” position, Knob 2 to “6” volts full scale, Knob 5 t “6” cm/minute setting, Switch 9 to “_ _ _” icon (Direct Current)Dmp9196021-011_c.book Page 187 Wednesday, April 3, 2002 5:07 PM
1883. Open the chart recorder cover at “A.” Remove the pen cap. Retain thepen cap as it must be replaced after the procedure to prevent the penfrom drying out.4. Inspect the tubing and the stopcock coming from the pressure trans-ducer. It must be completely free of bubbles. Inject sterile water witha very long needle to displace any bubbles present. Use a syringe toadd water to the stopcock to form a positive meniscus.5. Assemble the following sterile components in a sterile field per :Syringe, Filter, 3-way Stopcock, MiniMed refill needle (MMT-4102)Prime the stopcock, filter and needle using the RINSE BUFFER fromthe syringe. Form a positive meniscus on the end of the filter.6. Carefully join the 2-way stopcock to the filter. A sterile person musthold the filter assembly and a non-sterile person must hold the stop-cock. From this point, the sterile person will manipulate the needleand stopcock to perform the measurements.7. Push switch 7 to “I Pen.” This puts the pen in contact with the paper.8. Set the “0” adjustment. Maintain switch 3 to the right position andadjust the thumbwheel 4, until the pen is at “0.”9. Initialize the chart by pushing switch 6 to the right “Prot” momen-tarily. The pen will write the chart settings.10. Tape the transducer securely to a table or any stable surface roughly atthe level of the implanted Pump. Hold the refill needle at the level ofthe patient’s pump and open both the 2-way and the 3-way stopcocks.(The 3-way stopcock is opened to allow flow between the filter andneedle but not to the syringe.) The monitor should display 0 (zero) ora very low number. Close both stopcocks. (The 3-way stopcock isopened between the syringe and the filter; the needle is closed.) Dmp9196021-011_c.book Page 188 Wednesday, April 3, 2002 5:07 PM
189Figure 21: Attaching the Monitor Cables to the Chart RecorderDmp9196021-011_c.book Page 189 Wednesday, April 3, 2002 5:07 PM
19011. Slide switch 6 to its left position to start the paper. Fast forward thepaper as necessary using switch 8.12. Place the refill needle in the side port.13. Program a bolus (5 units) and open both stopcocks. (The 3-way stop-cock is opened between the filter and needle and the syringe isclosed.) Maintain the needle in the side port without movement dur-ing the entire bolus and observe the curve for the duration of the bolusand for 10 minutes after the bolus. If leakage is suspected, the 3-waystopcock may be turned so that the filter is off. If the pressure curveflattens, all of the connections between the transducer and the stop-cock are leak tight.Figure 22: Normal Pressure Curve ExampleA flush of the Catheter tip can be performed at this time. (See AppendixF, Side Port Catheter Rinse Procedure). A repeat pressure tracing shouldbe made subsequent to the flush. Place system in Suspend Mode by press-Dmp9196021-011_c.book Page 190 Wednesday, April 3, 2002 5:07 PM
191ing ACT on the “SUSPEND” screen.Remove rinse buffer and fill with insulinThe RINSE BUFFER is removed from the Pump fluid system and thesystem is filled with INSULIN. This procedure uses the following vol-umes in syringes 3, 5, and 6:• Syringe 3 with residual RINSE BUFFER from the previous steps• Syringe 5 with 20 ml INSULIN• Syringe 6 with 30 ml INSULINSyringe 3: Rinse Buffer (residual)1. Expel all air from the syringe and prime the needle.2. Close the stopcock. Obtain a vacuum by pulling back on the plungeruntil it locks. Press the lock into the plunger groove to be sure it isfirmly secured.3. Enter the Pump with the refill needle and syringe.4. Open the stopcock and remove the RINSE BUFFER. After the fluidlevel stops moving, wait an additional 30 seconds to make sure all ofthe RINSE BUFFER and air is removed.5. When the time has elapsed, close the stopcock, remove the syringe,and discard.Syringe 5: Insulin6. Prime the needle and close the stopcock.7. Enter the Pump fill port with the refill needle.8. Open the stopcock and allow the pump to fill completely with INSU-LIN. When the fluid level stops moving, the Pump is filled.9. Close the stopcock and remove the syringe.10. Prepare syringe 6 for aspiration. Obtain a vacuum by pulling back onDmp9196021-011_c.book Page 191 Wednesday, April 3, 2002 5:07 PM
192the plunger until it locks. Press the lock into the plunger groove to besure it is firmly secured.11. Re-enter the Pump.12. Open the stopcock and remove the INSULIN. After the fluid levelstops moving, wait an additional 30 seconds for all the INSULIN andair to be removed.13. When the time has elapsed, close the stopcock and remove thesyringe. Discard all but 5 ml of the solution. Remove the air and setaside the syringe.Syringe 6: Insulin14. Weigh and record the combined weight of syringes 5 and 6 on therefill form. Prime the needles.15. Close the stopcock. Enter the Pump fill port with the refill needle.16. Open the stopcock and allow the Pump to fill completely with INSU-LIN. When the fluid level stops moving, the Pump is filled. Approxi-mately 10 ml of INSULIN will remain in the syringe. Leave theINSULIN in the syringe, and leave the syringe in place for the nextstep.Equilibrate and pull insulin through systemThe reservoir pressure in the Pump is equilibrated with outside ambientpressure and INSULIN is pulled through the fluid system. This procedureuses the following volumes in syringes 5 and 6:• Syringe 6 with residual INSULIN from the previous step• Syringe 5 with 5 ml solutionSyringe 5: SolutionSyringe 6: Insulin (residual) Dmp9196021-011_c.book Page 192 Wednesday, April 3, 2002 5:07 PM
1931. Maintain syringe 6 with approximately 10 ml of residual INSULIN inthe Pump fill port. Verify that the stopcock on syringe 6 is open.2. Prime the syringe 5 needle. Close the stopcock.3. Obtain a vacuum in syringe 5 by pulling back on the plunger until itlocks. Press the lock into the plunger groove to be sure it is firmlysecured.4. Enter the side port with syringe 5 - stopcock closed.5. Open the stopcock on syringe 5.6. Program and deliver a 4 unit bolus to open the valve in the Pumpmechanism.7. Observe syringe 6. If the level of INSULIN approaches 2 ml, closethe stopcock to prevent air from entering the Pump. Observe syringe5. At least 1 ml of INSULIN must pass into syringe 5 to be sure thatall of the RINSE BUFFER is removed from the side port. If less than1 ml enters, repeat the bolus from Step 6, some Pumps may require 3successive boluses to obtain 1 ml.8. Close both stopcocks. Remove syringe 6 from the Pump. Set asidethe syringe to be weighed.9. With the stopcock closed, remove syringe 5 from the side port.Syringe 5 will have a vacuum inside from the previous step. Enter thePump fill port with syringe 5 and open the stopcock to remove 2 ml.This will restore the negative pressure safety feature of the Pump.10. Close the stopcock, remove syringe 5 from the Pump, and set it asideto be weighed.Dmp9196021-011_c.book Page 193 Wednesday, April 3, 2002 5:07 PM
194Remove guide needles and record refill amountAt this point, the 18 gauge guide needles should be removed, and the refillamount should be calculated and recorded.1. Remove the 18 gauge guide needles and discard them. Apply pressureto the insertion sites.2. Weigh syringes 5 and 6 and record their combined weight on theRefill Form. Subtract the combined weight from the weight obtainedin step 14 of this section, Remove Rinse Buffer and fill with INSULIN. The result is the new refill amount.3. Record the extracted and new refill amounts in the PPC.Using the patient’s PPC, cancel the SUSPEND mode, to return to the nor-mal patient’s basal rate.D9196021-011 12/00Dmp9196021-011_c.book Page 194 Wednesday, April 3, 2002 5:07 PM

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