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145

APPENDIX 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 Appendix

and 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 solutions

that 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 while

there is a vacuum within the refill syringe. The plunger of the syringe

will snap back forcefully and may rupture the syringe and eject the

contents.

4. It is important that the syringe needle is perpendicular to the fill port

to prevent binding when entering or exiting.

5. The Side Port Catheter attachment site contains up to 20 units of

INSULIN. The distal portion of the Catheter and the tubing can con-

tain up to 13 units of INSULIN. However, the INSULIN in the Pump

fluid pathway and the side port receptacle can be cleared by following

the procedure to pull RINSE BUFFER through the side port. During

Dmp9196021-011_c.book Page 145 Wednesday, April 3, 2002 5:07 PM

Summary of content (50 pages)

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Dmp9196021-011_c.book Page 145 Wednesday, April 3, 2002 5:07 PM 145 APPENDIX 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 Appendix and keep the information in mind as you perform each procedure. 1. All procedures should be performed using ASEPTIC TECHNIQUE. 2.
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Dmp9196021-011_c.book Page 146 Wednesday, April 3, 2002 5:07 PM 146 a flush procedure to push out a catheter tip blockage, the 13 units in the distal catheter will be delivered to the patient. The 13 units can be managed by programming cautions bolus amounts prior to the procedure, or with the use of oral or IV glucose as needed during the procedure. Individual patient response to INSULIN bolus amounts must be considered. 6.
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Dmp9196021-011_c.book Page 147 Wednesday, April 3, 2002 5:07 PM Special note and precautions Locating the pump fill port and the side port Figure 16: Template and Placement on Skin with Guide Needles in Position 1. Locate the Pump, then aseptically prep and drape the Pump area. Use topical or local anesthetic if desired. 2. To locate the Pump fill port, located in the center of the Pump, align the sterile template (MMT-4106) over the Pump by palpating the Pump circumference.
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Dmp9196021-011_c.book Page 148 Wednesday, April 3, 2002 5:07 PM 148 This outer edge is raised around the outer aspect of the side port, in order to help guide the needle into the port. Accessing the pump inlet To enter the Pump fill port or the side port, make sure the refill syringe stopcock is closed, then pass the MiniMed refill needle (MMT- 4102) through the 18 gauge guide needle.
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Dmp9196021-011_c.book Page 149 Wednesday, April 3, 2002 5:07 PM Special note and precautions Venting the Minimed refill syringe (optional) In order to fill the Pump, it may be necessary to vent the headspace in the MiniMed refill syringe. Refill syringes do not have lubricant on the syringe housing or on the plunger tip. Some syringes may be “sticky” and require the venting procedure described below to assist the vacuum in the Pump to overcome this condition.
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Dmp9196021-011_c.book Page 150 Wednesday, April 3, 2002 5:07 PM 150 NOTE: Be sure that the plunger is retracted far enough that the vent hole is exposed. The syringe must be held with the needle facing down and used within 10 minutes once it is vented. If this time limit is exceeded, repeat the degassing procedure.
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Dmp9196021-011_c.book Page 151 Wednesday, April 3, 2002 5:07 PM 151 APPENDIX E Pump Rinse Procedure The purpose of this procedure is to dissolve insulin deposits within the Pump reservoir, pumping mechanism, and the Side Port Catheter “port.
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Dmp9196021-011_c.book Page 152 Wednesday, April 3, 2002 5:07 PM 152 • Seven (7) MiniMed MMT-4102 refill needles. (Extra needles should be available to use as needed) • Eight (8) sharp 18 gauge regular bevel needles Solutions • 50 mL’s sterile 0.1 M NaOH (0.4 grams NaOH per 100 ml of Sterile water for injection) • Seven (7) 10 ml vials, Aventis rinse buffer solution • Five (5) 10 ml vials, Aventis HOE 21 PH, U-400 Insulin WARNING ! The 0.
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Dmp9196021-011_c.book Page 153 Wednesday, April 3, 2002 5:07 PM 153 Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precautions and General Procedures, and keep this in mind as you perform each procedure. In order to prepare for the Side Port Catheter rinse and flush procedure, a total of seven syringes will need to be labeled and then prepared with different solutions.
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Dmp9196021-011_c.book Page 154 Wednesday, April 3, 2002 5:07 PM 154 Remove insulin from the Pump and fill with NaOH INSULIN is removed from the Pump and then the Pump is filled with NaOH. The following volumes are used: • Syringe 1 - 5 ml RINSE BUFFER • Syringe 2 - 20 ml Naoh • Syringe 3 - 30 ml NaOH Follow the steps below to perform this procedure: Syringe 1: Rinse Buffer 1. Prime the needle. Weigh the syringe and record the weight on the refill form (Line A). 2. Close the stopcock.
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Dmp9196021-011_c.book Page 155 Wednesday, April 3, 2002 5:07 PM 155 WARNING ! The 0.1 M NaOH used in this procedure can cause permanent eye damage. Safety glasses must be worn during this procedure. Syringe 2: NaOH 6. Prime the needle. Close the stopcock 7. 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.
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Dmp9196021-011_c.book Page 156 Wednesday, April 3, 2002 5:07 PM 156 Syringe 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 the syringe. Leave this NaOH in the syringe, and leave this syringe in place for the next step.
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Dmp9196021-011_c.book Page 157 Wednesday, April 3, 2002 5:07 PM 157 the bolus from Step 6, some pumps may require 3 successive bolus to obtain 1 ml. NOTE: In order to completely dissolve deposits in the Pump mechanism, it is important to maintain a vacuum with syringe 1 and deliver the entire bolus. 8. After the bolus, close the stopcock on syringe 1. Remove both syringes. Set aside syringe 3 for use in removing the NaOH from the Pump fill port in the next step. Discard syringe 1.
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Dmp9196021-011_c.book Page 158 Wednesday, April 3, 2002 5:07 PM 158 Syringe 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 RINSE BUFFER. 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 on the plunger until it locks.
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Dmp9196021-011_c.book Page 159 Wednesday, April 3, 2002 5:07 PM 159 Equilibrate and pull rinse buffer through system The reservoir pressure in the Pump is equilibrated with outside ambient pressure and RINSE BUFFER is pulled through the fluid system. This procedure uses the following volumes in syringes 4 and 5: • Syringe 4 with RINSE BUFFER. Expel all RINSE BUFFER except 5 ml. Change refill needle if desired. • Syringe 5 with residual RINSE BUFFER from previous step Syringe 5: Rinse Buffer 1.
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Dmp9196021-011_c.book Page 160 Wednesday, April 3, 2002 5:07 PM 160 • Syringe 7 with 30 ml INSULIN Syringe 5: Rinse Buffer (residual) 1. Prime the needle. Close the stopcock. 2. Obtain a vacuum by pulling back on the plunger until it locks. Press the 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.
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Dmp9196021-011_c.book Page 161 Wednesday, April 3, 2002 5:07 PM 161 dle and close stopcock. Set aside the syringe. Syringe 7: Insulin (degassed) 14. Prime the needle on syringe 7. Weigh and record the combined weight of 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.
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Dmp9196021-011_c.book Page 162 Wednesday, April 3, 2002 5:07 PM 162 6. Using the PPC, program and deliver a 4 unit bolus. 7. Observe syringe 7. If the level of INSULIN approaches 2 ml, close the stopcock to prevent air from entering the Pump. Observe syringe 6. At least 1 ml of INSULIN must pass into syringe 6 to assure removal of all the RINSE BUFFER from the side port. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. 8.
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Dmp9196021-011_c.book Page 163 Wednesday, April 3, 2002 5:07 PM 163 APPENDIX F Side Port Catheter Flush Procedure When delivery of insulin is impaired due to catheter tip obstruction, the Catheter may be flushed using 5 - 10 mL of RINSE BUFFER.
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Dmp9196021-011_c.book Page 164 Wednesday, April 3, 2002 5:07 PM 164 should 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 way Solutions • 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.
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Dmp9196021-011_c.book Page 165 Wednesday, April 3, 2002 5:07 PM 165 Table 2: Preparation and Labeling of Syringes Syringe # #1 Syringe Type Refill Volume 5 mL Solution RINSE BUFFER #2 Refill 20 mL RINSE BUFFER #3 Refill 30 mL RINSE BUFFER #4 10ml or 20 ml 5-10 mL RINSE BUFFER #5 Refill 20 mL INSULIN #6 Refill 30 mL INSULIN Record patient’s blood glucose Record the patient’s blood glucose value at the start of the procedure. Monitor blood glucose every 30 minutes, or as needed.
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Dmp9196021-011_c.book Page 166 Wednesday, April 3, 2002 5:07 PM 166 Prepare syringe for flushing the Side Port Catheter During the Catheter flush procedure, syringe 4 is used for flushing the Side Port Catheter. This syringe needs to be labeled and then prepared by following the steps below: 1. Firmly attach a stopcock to the 10 or 20 ml Luer Lock connector of a 10 or 20 ml syringe. Then attach an 18 gauge needle to the stopcock. NOTE: Use only a 10-20 ml Luer Lock syringe for this procedure.
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Dmp9196021-011_c.book Page 167 Wednesday, April 3, 2002 5:07 PM 167 Flushing the Side Port Catheter Program minimal basal rate Place 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 buffer The INSULIN is removed from the Pump and the system is filled with RINSE BUFFER.
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Dmp9196021-011_c.book Page 168 Wednesday, April 3, 2002 5:07 PM 168 Syringe 5: Insulin 6. 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 RINSE BUFFER. 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 on the plunger until it locks.
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Dmp9196021-011_c.book Page 169 Wednesday, April 3, 2002 5:07 PM 169 Equilibrate and pull rinse buffer through system The reservoir pressure in the Pump is equilibrated with outside ambient pressure and RINSE BUFFER is pulled through the fluid system. This procedure uses syringes 2 and 3: • Syringe 2 with RINSE BUFFER. Expel all RINSE BUFFER except 5 mL. Change the refill needle if desired. • Syringe 3 with residual RINSE BUFFER from the previous section. Syringe 3: Rinse Buffer 1.
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Dmp9196021-011_c.book Page 170 Wednesday, April 3, 2002 5:07 PM 170 Flush side port catheter The Side Port Catheter is flushed using syringe 4 which is completely filled with RINSE BUFFER. NOTE: Approximately 13 units of INSULIN remain in the distal Side Port Catheter. This INSULIN will be delivered to the patient rapidly in the next three steps. Alternatively, the INSULIN may be removed prior to flushing by programming cautious bolus amounts.
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Dmp9196021-011_c.book Page 171 Wednesday, April 3, 2002 5:07 PM 171 Syringe 3: Rinse Buffer (residual) 1. Prime the needle. Close the stopcock. 2. Obtain a vacuum by pulling back on the plunger until it locks. Press the 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.
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Dmp9196021-011_c.book Page 172 Wednesday, April 3, 2002 5:07 PM 172 Syringe 6: Insulin 14. Weigh and record the combined weight of syringes 5 and 6 on the Refill 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. Approximately 10 mL of INSULIN will remain in the syringe. Leave the syringe in place for the next step.
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Dmp9196021-011_c.book Page 173 Wednesday, April 3, 2002 5:07 PM 173 7. Using the PPC, program and deliver a 4 unit bolus. 8. Observe syringe 6. If the level of INSULIN approaches 2 mL, close the stopcock to prevent air from entering the Pump. Observe syringe 5. At least 1 mL of INSULIN must pass into syringe 5 to be sure that all of the RINSE BUFFER is removed from the side port. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. 9.
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Dmp9196021-011_c.book Page 174 Wednesday, April 3, 2002 5:07 PM 174 Program new basal rate Using the patient’s PPC, cancel the “SUSPEND” mode and allow the Pump to return to the patient’s original basal rate. Remove rinse buffer from catheter Approximately 13 units of RINSE BUFFER remain in the distal Side Port Catheter. Depending on blood glucose values, program the appropriate bolus amount to remove the RINSE BUFFER from the Catheter. Release the patient when blood glucose levels are stable.
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Dmp9196021-011_c.book Page 175 Wednesday, April 3, 2002 5:07 PM 175 APPENDIX G Stroke Volume Measurement If under-delivery of insulin is noted in a refill procedure or suspected due to blood glucose control, it may be useful to verify the proper stroke volume 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 pipette are measured to calculate the pump stroke volume.
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Dmp9196021-011_c.book Page 176 Wednesday, April 3, 2002 5:07 PM 176 • One (1) MiniMed MMT-4102 refill needle. (Extra needles should be available to use as needed) • One (1) sterile stopcock - 3 way Solutions • One (1) 10 mL vial, Aventis rinse buffer solution Preparing for the Procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precautions and General Procedures, and keep this in mind as you perform each procedure.
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Dmp9196021-011_c.book Page 177 Wednesday, April 3, 2002 5:07 PM 177 Measuring 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 Volume 2. 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.
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Dmp9196021-011_c.book Page 178 Wednesday, April 3, 2002 5:07 PM 178 Figure 20: Closed Stopcock 5. Program a high rate bolus (approximately 20 units) and measure the stroke 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.
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Dmp9196021-011_c.book Page 179 Wednesday, April 3, 2002 5:07 PM 179 Record Patient’s Blood Glucose It is likely that some insulin is pumped out of the Catheter and into the patient in this procedure. Monitor the patient’s blood glucose and release the patient only after blood glucose values are stable.
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Dmp9196021-011_c.
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Dmp9196021-011_c.book Page 181 Wednesday, April 3, 2002 5:07 PM 181 APPENDIX H Pressure Measurement Using The Side Port Catheter If under-delivery of insulin is noted by increased insulin needs or by lower than expected actual usage at refills, you may suspect one of two causes: Insulin deposits have led to under-delivery from the Pump. Catheter blockage has led to under-delivery from the Catheter Pressure measurement in the side port can detect pressure build-up due to Catheter tip obstruction.
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Dmp9196021-011_c.book Page 182 Wednesday, April 3, 2002 5:07 PM 182 Supplies and solutions Prior to performing this procedure, assemble the necessary supplies and solutions 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.
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Dmp9196021-011_c.book Page 183 Wednesday, April 3, 2002 5:07 PM 183 Solutions • 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 volume measurement, or pressure measurement procedure, carefully read Appendix D, Precautions and General Procedures, and keep this in mind as you perform each procedure.
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Dmp9196021-011_c.book Page 184 Wednesday, April 3, 2002 5:07 PM 184 Record patient’s blood glucose Record 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 pump Syringe 1 is used for emptying the Pump. Label and prepare syringe 1 per the Precautions and General Procedures section in Appendix D of this manual. After the syringe is prepared, weigh it and record the weight on the Refill Form.
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Dmp9196021-011_c.book Page 185 Wednesday, April 3, 2002 5:07 PM 185 Measuring pressure in the side port Program minimal basal rate Place 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 buffer The INSULIN is removed from the Pump and the system is filled with RINSE BUFFER.
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Dmp9196021-011_c.book Page 186 Wednesday, April 3, 2002 5:07 PM 186 9. Close the stopcock and remove the syringe. 10. Prepare syringe 2 for aspiration. Obtain a vacuum by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 11. Re-enter the Pump. 12. Open the stopcock and remove the RINSE BUFFER. After the fluid level stops moving, wait an additional 30 seconds for all the RINSE BUFFER and air to be removed. 13.
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Dmp9196021-011_c.book Page 187 Wednesday, April 3, 2002 5:07 PM 187 Syringe 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. Press the 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 the screen press ACT.
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Dmp9196021-011_c.book Page 188 Wednesday, April 3, 2002 5:07 PM 188 3. Open the chart recorder cover at “A.” Remove the pen cap. Retain the pen cap as it must be replaced after the procedure to prevent the pen from 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 with a very long needle to displace any bubbles present. Use a syringe to add water to the stopcock to form a positive meniscus. 5.
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Dmp9196021-011_c.
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Dmp9196021-011_c.book Page 190 Wednesday, April 3, 2002 5:07 PM 190 11. Slide switch 6 to its left position to start the paper. Fast forward the paper 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 is closed.
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Dmp9196021-011_c.book Page 191 Wednesday, April 3, 2002 5:07 PM 191 ing ACT on the “SUSPEND” screen. Remove rinse buffer and fill with insulin The RINSE BUFFER is removed from the Pump fluid system and the system is filled with INSULIN. This procedure uses the following volumes 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 INSULIN Syringe 3: Rinse Buffer (residual) 1.
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Dmp9196021-011_c.book Page 192 Wednesday, April 3, 2002 5:07 PM 192 the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 11. Re-enter the Pump. 12. Open the stopcock and remove the INSULIN. After the fluid level stops moving, wait an additional 30 seconds for all the INSULIN and air to be removed. 13. When the time has elapsed, close the stopcock and remove the syringe. Discard all but 5 ml of the solution. Remove the air and set aside the syringe.
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Dmp9196021-011_c.book Page 193 Wednesday, April 3, 2002 5:07 PM 193 1. Maintain syringe 6 with approximately 10 ml of residual INSULIN in the 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 it locks. Press the lock into the plunger groove to be sure it is firmly secured. 4. Enter the side port with syringe 5 - stopcock closed. 5. Open the stopcock on syringe 5. 6.
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Dmp9196021-011_c.book Page 194 Wednesday, April 3, 2002 5:07 PM 194 Remove guide needles and record refill amount At this point, the 18 gauge guide needles should be removed, and the refill amount should be calculated and recorded. 1. Remove the 18 gauge guide needles and discard them. Apply pressure to the insertion sites. 2. Weigh syringes 5 and 6 and record their combined weight on the Refill Form.