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PROMETRA® II PROGRAMMABLE PUMP (REF 13827)

For use with Intrathecal Catheter

MR Conditional

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Summary of Contents for 13827

Page 1: ...PROMETRA II PROGRAMMABLE PUMP REF 13827 For use with Intrathecal Catheter MR Conditional Caution Federal Law USA restricts this device to sale by or on the order of a physician...

Page 2: ...Programmable Features 23 Programming Medication Regimens 24 Pre Programmed Pump Settings 26 Pump Alarms 27 Implantation Instructions 28 Pre Implant Pump Programming Set Up 28 Pump Priming Preparation...

Page 3: ...refer to the use of Infumorph Contents The following components are sterile and non pyrogenic 1 Prometra II Programmable Pump 1 Needle Non Coring 0 7 mm 22G x 38 mm 1 5 in 1 Needle Catheter Access 0 9...

Page 4: ...of 38 The triple redundancy flow control system is designed to provide a precise and accurate flow rate The flow rate accuracy is independent of normal operating environmental conditions such as altit...

Page 5: ...anium Usable Capacity 20 mL Precision Dosing System Material Titanium MP35N alloy Stainless steel Silicone rubber Refill Septum Septum material Silicone rubber Access needle Huber point 22G non coring...

Page 6: ...natomy is insufficient to accommodate the size of the implanted pump or catheter The pump cannot be implanted 2 5 cm 1 in or less from the surface of the skin Deeper implants could interfere with sept...

Page 7: ...rph labeling for appropriate treatment Clinicians implanting programming accessing or maintaining implanted programmable pumps must comply with the instructions for use Technical errors may result in...

Page 8: ...Reservoir and Catheter into the patient This could result in drug overdose that could lead to serious patient injury or death Prior to initiating the MRI procedure the physician must determine if the...

Page 9: ...agnetically induced deflection force and very strong torque The static and gradient magnetic fields produced by an MRI scanner could potentially interact with the pump and cause vibration However when...

Page 10: ...iate discharge of the contents of the Drug Reservoir and Catheter into the patient This could result in drug overdose that could lead to serious patient injury or death The physician must determine if...

Page 11: ...g Set the flow mode to a constant flow rate of 0 0 mg day Re inquire the pump and print inquiry page to confirm a constant flow rate of 0 0 mg day 3 Empty DrugReservoir Follow the procedures for empty...

Page 12: ...ce needle through center Refill Port Septum until needle tip resides completely inside the Drug Reservoir c Pull a vacuum with the syringe for approximately 10 to 30 seconds to confirm Inlet Outlet Va...

Page 13: ...igns and symptoms of drug overdose and develop a plan for immediate monitoring in a medically supervised and adequately equipped environment Resuscitative equipment should be available as should medic...

Page 14: ...he drug was not removed from the Drug Reservoir prior to the MRI Following an MRI the FAVwill be closed and will prevent further drug delivery to occur until the pump is manually reset after the compl...

Page 15: ...Errors d If no pump errors are displayed proceed to Step 3 FAV Reset Procedure 2 Clear Pump Errors a If pump errors are displayed from the Inquiry performed in Step 1 perform an Emergency Pump Stop u...

Page 16: ...ge for approximately 10 to 30 seconds to confirm Inlet Outlet Valve closure Warning If any significant volume 1ml is retrieved it may be indicative that the pump Inlet Outlet Valves are open providing...

Page 17: ...ontact patient s pump management physician The patient s medical records indicate the pump model and serial number implanted Flowonix provides medical chart labels to facilitate patient record documen...

Page 18: ...Prometra II Pump Patient ID Card Card Front Card Back Prometra Pump Patient ID Card Card Front Card Back Prometra Pump X ray Prometra II Pump X ray Catheter Access Port Flow Activated Valve Pump Mode...

Page 19: ...ph In the event of over dosage refer to the approved Infumorph labeling for appropriate treatment The pump and catheter system should be implanted carefully to avoid any sharp or acute angles which co...

Page 20: ...erapies may have effects on pump operation that are not immediately apparent Potential Adverse Events The use of implanted pumps provides an important means of intrathecally delivering Infumorph Howev...

Page 21: ...rare instances the development of an inflammatory mass at the tip of the implanted catheter may occur which can result in serious neurological impairment Patients should be monitored carefully at eac...

Page 22: ...uffering from cancer pain requiring strong opioids chronic non malignant pain or required an implantable pump system replacement due to malfunction or battery depletion The average patient age at impl...

Page 23: ...Site Irritation Implant Site Necrosis Edema Peripheral Hypersensitivity Extradural Abscess Implant Site Cellulitis Spinal Infection Viral Excoriation Hip Fracture2 Procedural Nausea Balance Disorder...

Page 24: ...g Implantation of the Prometra II Programmable Pump System and subsequent use reprogramming and refill should only be conducted by qualified medical personnel specifically trained for surgical implant...

Page 25: ...ose is delivered and the interval at which the dose is repeated are programmed Periodic Flow Regimen Demand Bolus The Demand Bolus regimen temporarily replaces the current dose regimen to deliver an i...

Page 26: ...specific Drug Drug contained in pump No specified by user Conc Concentration of drug in pump Yes preset to 1 000 mg mL Accum Accumulator Volume Constant e g 2 010 L Yes pump specific Reservoir Volume...

Page 27: ...setting the low reservoir volume and enabling the alarm refer to the Prometra Programmer Instructions Critical Error Alarm The Critical Error Alarm alerts patients and clinicians that the pump has st...

Page 28: ...pump is still in the packaging and facing upward turn the programmer on press inquire and place the programmer over the pump 4 From the Main Menu select Setup Pump Setup and then Patient Name 5 Enter...

Page 29: ...duction in concentration Expected concentration of drug in pump reservoir based on fill method Filling without rinsing Rinsing with 20 mL of drug 86 97 5 If rinsing the pump before filling rinse and d...

Page 30: ...eted or if not completed canceled prior to attaching pump to catheter to avoid medication advancement into the catheter Do not cancel prior to 11 minutes to ensure fluid pathway is fully primed 6 If f...

Page 31: ...theter as per the Prometra Programmable Infusions Systems Intrathecal Catheter IFU Implantation of the Prometra II Programmable Pump 1 USE STERILE TECHNIQUE Always inspect and aseptically prepare the...

Page 32: ...king Warning Always save trimmed portion of catheter to measure length and calculate implanted catheter volume This calculation is required to prevent under or over medication 7 Slide catheter lock on...

Page 33: ...This measurement is required to determine the volume of the implanted catheter 18 Calculate and record the implanted catheter length and volume Implanted Catheter Length cm 110 cm Trimmed Catheter Len...

Page 34: ...changes such as skiing flying hot tubbing or saunas will not affect the operation of the pump Activities that involve an increase in environmental pressure of approximately 1 atmosphere or greater su...

Page 35: ...changes such as skiing flying hot tubbing or saunas will not affect the operation of the pump Temperature related therapies such as deep heat therapy e g diathermy will not affect the operation of the...

Page 36: ...of the pump This margin of safety was designed to offer your patients an additional measure of comfort and safety Pump flow rate accuracy was evaluated at multiple infusion rates 0 05mL day 28 8mL day...

Page 37: ...rate in order to conserve energy required for pump operation The life of the pump is a minimum of 10 years at a drug delivery rate of 0 25mL day Drug Stability Drug stability has been tested for the...

Page 38: ...act Flowonix Medical Inc to see if additional product information is available Trademarks are the property of their respective owners US and Foreign patents issued and pending Please consult www flowo...

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