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Medtronic 8626 Manual

Manual is about: Programmable pumps

Summary of 8626

  • Page 1

    1999 197768010 rev x 8626_enfcv.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 synchromed ® el programmable pumps rx only ! Usa implant manual 8626 8626l 8627 8627l.

  • Page 2: Medtronic Confidential

    197768010 rev x 8626_enfcv.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01.

  • Page 3: Medtronic Confidential

    1 197768010 rev x 8626_ensym.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 explanation of symbols on product or package labeling refer to the appropriate product for symbols that apply. Open here do not reuse sterilization: ethylene-oxi...

  • Page 4: Medtronic Confidential

    2 197768010 rev x 8626_ensym.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 medtronic ® and synchromed ® are registered trademarks of medtronic, inc..

  • Page 5: Medtronic Confidential

    197768010 rev x 8626_toc.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 8626/8627 2005-11 english 3 refer to the indications, drug stability, and emergency procedures, reference manual for indications and related information. Refer to th...

  • Page 6: Medtronic Confidential

    4 english 8626/8627 2005-11 197768010 rev x 8626_toc.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 refilling the pump 28 programming the pump 30 after the refill procedure 30 appendix b — accessing the catheter access port 31 contraindi...

  • Page 7: Medtronic Confidential

    8626/8627 2005-11 english 5 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x device description the implantable medtronic synchromed el programmable pump is part of an infusion system that stores and delivers a pr...

  • Page 8: Medtronic Confidential

    6 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x package contents ■ pump ■ needle, 22-gauge (black sheath) ■ needle, 25-gauge (orange sheath) (models 8627-10, 8627-18, 8627l-10, and 862...

  • Page 9: Medtronic Confidential

    8626/8627 2005-11 english 7 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x device specifications table 1. Shipping and operating values for the synchromed el pumps shipping operating fluid in reservoir 10 ml mod...

  • Page 10: Medtronic Confidential

    8 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x table 2. Device specifications for the synchromed el 10 ml pumps a a all measurements are approximate. Models 8626-10 and 8626l-10 model...

  • Page 11: Medtronic Confidential

    8626/8627 2005-11 english 9 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x table 3. Device specifications for the synchromed el 18 ml pumps a a all measurements are approximate. Models 8626-18 and 8626l-18 model...

  • Page 12: Medtronic Confidential

    10 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x device longevity pump service life is a function of flow rate and shelf time. Shelf time is the number of months between the date of ma...

  • Page 13: Medtronic Confidential

    8626/8627 2005-11 english 11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 2. Expected pump service life: 15-, 24-, 36-, and 48-month shelf times. Figure 3. Expected pump service life: 15-month shelf tim...

  • Page 14: Medtronic Confidential

    12 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 4. Expected pump service life: 24-month shelf time. Figure 5. Expected pump service life: 36-month shelf time. 30 40 50 60 70 80...

  • Page 15: Medtronic Confidential

    8626/8627 2005-11 english 13 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 6. Expected pump service life: 48-month shelf time. When the pump is near the end of service life, a low battery alarm sounds. T...

  • Page 16: Medtronic Confidential

    14 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x flow rate accuracy the flow rate accuracy of the synchromed el pump, measured at the catheter tip, is within ±15 % of the programmed fl...

  • Page 17: Medtronic Confidential

    8626/8627 2005-11 english 15 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x instruction for use implanting physicians should be experienced in pump and catheter implant procedures and should be thoroughly famili...

  • Page 18: Medtronic Confidential

    16 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 2. Using a warming blanket or oven, prewarm the pump to 35°c to 40°c (95°f to 104°f) while the pump is in the sterile package. 3. Befor...

  • Page 19: Medtronic Confidential

    8626/8627 2005-11 english 17 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x sterile procedure 1. Open the sterile pump package and remove the pump. 2. Remove the protective cap from the catheter port. 3. Confirm...

  • Page 20: Medtronic Confidential

    18 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 8. Empty the pump while it is submerged in the warm bath. 3. Empty the pump reservoir until air bubbles no longer appear in the ...

  • Page 21: Medtronic Confidential

    8626/8627 2005-11 english 19 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 3. Read the actual fill volume in the syringe. 4. With the pump submerged in the warm bath, insert the needle into the reservoir fill p...

  • Page 22: Medtronic Confidential

    20 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 5. Continue the implant with one of the two following procedures. ■ if the catheter has been replaced or aspirated, proceed to “implant...

  • Page 23: Medtronic Confidential

    8626/8627 2005-11 english 21 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x preparing the pump pocket ■ prepare the subcutaneous pocket using an incision in the lower abdomen. Implanting the pump 1. Remove the f...

  • Page 24: Medtronic Confidential

    22 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 6. Place the filled pump into the prepared pocket. 7. Suture the pump in the subcutaneous pocket using the following steps: a. Suture f...

  • Page 25: Medtronic Confidential

    8626/8627 2005-11 english 23 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 3. If the catheter has not been replaced or aspirated, program the pump to deliver the prescribed infusion. 4. Print out the patient’s ...

  • Page 26: Medtronic Confidential

    24 english 8626/8627 2005-11 8626_ench.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x.

  • Page 27: Medtronic Confidential

    8626/8627 2005-11 english 25 8626_enappa.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x appendix a — refilling the pump contraindication medtronic refill kits are contraindicated for all catheter access port procedures. P...

  • Page 28: Medtronic Confidential

    26 english 8626/8627 2005-11 8626_enappa.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x ■ fenestrated drape ■ template locally supplied: ■ syringe containing prescribed fluid (volume of fluid not to exceed the reservoir v...

  • Page 29: Medtronic Confidential

    8626/8627 2005-11 english 27 8626_enappa.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 9. Close clamp and insert needle into reservoir fill port. 10. Open the clamp and slowly withdraw the fluid from the reservoir...

  • Page 30: Medtronic Confidential

    28 english 8626/8627 2005-11 8626_enappa.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 1. Empty the pump completely. 2. Fill the pump with sterile preservative-free sodium chloride injection, usp. 3. Empty the pump compl...

  • Page 31: Medtronic Confidential

    8626/8627 2005-11 english 29 8626_enappa.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 10. Open clamp and inject into pump reservoir. 5. If you have activated the reservoir valve, complete steps a through f below....

  • Page 32: Medtronic Confidential

    30 english 8626/8627 2005-11 8626_enappa.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x f. Repeat steps 1 through 4. Note: for pumps with a reservoir valve, the amount of time before the valve will release is dependent on...

  • Page 33: Medtronic Confidential

    8626/8627 2005-11 english 31 8626_enappb.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x appendix b — accessing the catheter access port contraindications medtronic catheter access port kits are contraindicated for all ref...

  • Page 34: Medtronic Confidential

    32 english 8626/8627 2005-11 8626_enappb.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x preliminary procedures gather the following sterile equipment: from the appropriate catheter access port kit: ■ extension tubing set ...

  • Page 35: Medtronic Confidential

    8626/8627 2005-11 english 33 8626_enappb.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x 1. Using sterile procedures, assemble the needle, extension tubing, and empty syringe (figure 11). 2. Close the clamp and gently inse...

  • Page 36: Medtronic Confidential

    34 english 8626/8627 2005-11 8626_enappb.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 12. Open clamp and inject into catheter access port. 8. During injection, check the needle puncture site for swelling. 9. When...

  • Page 37: Medtronic Confidential

    8626/8627 2005-11 english 35 8626_enappb.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x figure 13. Open clamp and inject into catheter access port. 5. During injection, check the needle puncture site for swelling. 6. When...

  • Page 38: Medtronic Confidential

    36 english 8626/8627 2005-11 8626_enappb.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 197768010 rev x clearing a catheter occlusion for vascular applications only: 1. Assemble a 10-ml syringe, stopcock, and the correct catheter access ...

  • Page 39: Medtronic Confidential

    8626_enbcv.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 contacts: 197768010 rev x asia: medtronic international ltd. Tel. 02891-4068 fax 02591-0313 medtronic asia ltd. Tel. (02)-548-1148 fax (02)-518-4786 australia: medtronic australas...

  • Page 40: Medtronic Confidential

    © medtronic, inc. 2005 all rights reserved 197768010 8626_enbcv.Fm 10/25/05 3:36 pm uc200xxxxxx en 4.625 x 6 inches (117 mm x 152 mm) medtronic confidential neuroimplant_r01 *197768010* 197768010 rev x manufacturer medtronic, inc. 710 medtronic parkway minneapolis, mn 55432-5604 usa internet: www.Me...