Related Manuals for Flowonix Prometra II
Summary of Contents for Flowonix Prometra II
- 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.
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Page 2: Table Of Contents
Pre-Implant Pump Programming Set Up ..............28 Pump Priming Preparation ..................28 Pump Priming ......................30 Implantation of the Intrathecal Catheter ..............31 Implantation of the Prometra II Programmable Pump ..........31 Patient Implant Card and Registration ............... 33 Pump Explantation ....................33 Calculations ......................34 Patient-Related Variables and Flow Rate Accuracy ............ -
Page 3: Introduction
1 – Warranty Card Description The Prometra II Pump is a battery-powered, teardrop-shaped pump with a rigid titanium housing and a triple redundancy flow controller system. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs. - Page 4 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 altitude, temperature and reservoir volume. PROMETRA® II PROGRAMMABLE PUMP Page 4 of 38...
- Page 5 Specifications of the Prometra II Programmable Pump are: Device Longevity Pump 10 years at 0.25 mL/day Septum (Refill and CAP) 1000 punctures maximum External Properties Titanium Polyphenylsulfone access ports Material Thickness (nominal) 20 mm Diameter (excluding CAP) 69 mm Average Volume Displacement...
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Page 6: Indications
The Patient Information packet contains a patient guide and two patient implant cards to be completed and given to the patient. Additionally, a federally-mandated patient device tracking form is included and needs to be completed and returned to Flowonix. Indications... -
Page 7: Warnings
General WARNING: USE OF UNAPPROVED DRUGS (e.g., DRUG COCKTAILS, PHARMACY-COMPOUNDED DRUGS, MORPHINE WITH PRESERVATIVES, ETC.) WITH THE PROMETRA II PUMP COULD RESULT IN PUMP FAILURE AND/OR SERIOUS ADVERSE EVENTS INCLUDING DEATH. WARNING: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH. -
Page 8: Magnetic Resonance Imaging (Mri)
Warning: EMPTY ALL DRUG SOLUTION FROM BOTH PROMETRA AND PROMETRA II PUMPS PRIOR TO ENTERING THE MRI ENVIRONMENT. If a patient with a Prometra II Pump requires an emergent MRI, please see page 13 of these instructions for more details on the potential risks involved. - Page 9 MR scanning in the Normal Operation Mode at a maximum whole-body averaged specific absorption rate (SAR) of 2 W/kg using a transmit body coil, therefore the Prometra II will experience a similar maximum temperature rise under the same MR scanning conditions.
- Page 10 Warning: EMPTY ALL DRUG SOLUTION FROM BOTH PROMETRA AND PROMETRA II PUMPS PRIOR TO ENTERING THE MRI ENVIRONMENT. If a patient with a Prometra II Pump requires an emergent MRI, please see page 13 of these instructions for more details on the potential risks involved.
- Page 11 2. Pump Programming 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 Drug Reservoir Follow the procedures for emptying the Drug Reservoir in the Refill Kit Instructions for Use. PROMETRA®...
- Page 12 2. Clear Pump Errors a. If pump errors are displayed from the Inquiry performed in Step 1, perform an Emergency Pump Stop using the programmer, and contact Flowonix Technical Solutions for assistance 855-356-9665. b. If pump errors are cleared, proceed to Step 3.
- Page 13 II Programmable Pump (REF 13827) In the event of a medical emergency requiring a STAT MRI, the treating physician must be aware of the following as inputs to decision making regarding proceeding with an Emergency MRI for the Prometra II Pump (REF 13827): WARNING: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH.
- Page 14 In the event that an Emergency MRI scan was performed on a patient with a Prometra II pump in which the drug was NOT removed due to a medical emergency situation, the Prometra II FAV must be reset by performing a reset procedure.
- Page 15 2. Clear Pump Errors a. If pump errors are displayed from the Inquiry performed in Step 1, perform an Emergency Pump Stop using the programmer, and contact Flowonix Technical Solutions for assistance 855-356-9665. b. If pump errors are cleared, proceed to Step 3.
- Page 16 The pump may need to be explanted and replaced. For questions, Contact Flowonix Technical Solutions for assistance at: 855-356-9665. 5. Refill The Drug Reservoir a. Proceed to refill the Drug Reservoir in accordance with the refill procedure defined in the Refill Kit Instructions for Use.
- Page 17 Prometra II on the Programmer’s ® ® Inquiry Screen. Contact Flowonix Technical Solutions at 855-356-9665 if you require access to a Flowonix Programmer. • Patient ID Card: Identifies the pump model either as Prometra II (Model # 13827) or ®...
- Page 18 ® Prometra II Pump Patient ID Card Pump Model Pump Model Identification Identification Card Front Card Back ® Prometra Pump Patient ID Card Card Front Card Back Catheter Access Port Flow Activated Valve ® ® Prometra Pump X-ray Prometra II Pump X-ray PROMETRA®...
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Page 19: Precautions
• Contrast media. Do not inject contrast media into the refill reservoir since this may damage the pump or impair pump function. • External devices. Do not connect any external devices or pumps to the Prometra II Pump. Pressures generated by an external pump could damage the implanted pump/catheter system and result in serious patient injury or death. -
Page 20: Potential Adverse Events
• Radiation. Do not use radiation therapy in the area of the pump. The effects of ionizing radiation on the Prometra II Pump have not been established, and these therapies may have effects on pump operation that are not immediately apparent. - Page 21 Possible Risks Associated with Intrathecal Catheter: • Catheter disconnection • Catheter kinking • Catheter fracture • Catheter migration (unrelated to surgical complication) • Cerebrospinal fluid (CSF) leak • Disconnection • Erosion • Fibrosis • Infection in intrathecal space, including meningitis •...
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Page 22: Clinical Studies
Inflammatory mass has been associated with a wide range of doses and concentrations of opioids. No dose or concentration of Infumorph can be considered completely free of risk from inflammatory mass. The risk of inflammatory mass occurrence appears to be cumulative over time and increases with higher concentrations and doses of opioids. -
Page 23: Equipment
Nausea, Balance Disorder, Burning Sensation, Diplegia, Hypoaesthesia, Neuropathy Peripheral, Tremor, Dyspnoea, Respiratory Depression, Ecchymosis, Rash, Haematoma. Event occurred while patient was being treated with a drug other than Infumorph via Prometra System Equipment Prometra II Programmable Pump • Intrathecal Catheter •... -
Page 24: Programming Medication Regimens
Programming Medication Regimens The Prometra II Programmable Pump can be programmed to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e. - Page 25 Multiple Rates Regimen Periodic Flow The Periodic Flow regimen delivers medication in a sequence of periodic infusions. The medication dose, the time over which the dose 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 immediate, one-time infusion of medication.
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Page 26: Pre-Programmed Pump Settings
Demand Bolus Regimen Pre-Programmed Pump Settings When the Prometra Programmer inquires the Prometra II Pump for the first time, the pump status screens display the pre-programmed pump settings. The clinician can change these presets using the programmer. Parameter Description Data Preset... -
Page 27: Pump Alarms
Pump Alarms The Prometra II Pump has two audible alarms that alert patients and clinicians to low reservoir volume and critical errors that cause the drug delivery to stop. All alarms use the same tone but can be distinguished from each other by the number of “beeps” in a group and the length of each beep. -
Page 28: Implantation Instructions
1. Attach a sterile syringe filled with 5 mL of sterile preservative-free 0.9% saline solution to the 22G non-coring needle provided in the Prometra II Pump tray. 2. Advance needle through center refill septum until needle tip resides completely inside the drug refill reservoir. - Page 29 Attach the syringe filled with the infusate to the 22G non-coring needle provided with the pump. Caution: When first filled, the Prometra II Pump has a small amount (2-3ml) of sterile water in the pump. As a result, there is an approximate 13% dilution of drug in the initial filling of the 20mL drug reservoir.
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Page 30: Pump Priming
Pump Priming Standard Priming Technique 1. Flush 3mL of the 5ml slowly through the Catheter Access septum to remove air from the fluid pathway. Remove the needle and syringe assembly from the Catheter Access chamber and discard. 2. Obtain a 1 L bag of heated (35-40°C) sterile saline. 3. -
Page 31: Implantation Of The Intrathecal Catheter
Implantation of the Intrathecal Catheter 1. Implant the Intrathecal Catheter 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 site according to standard practice. - Page 32 6. Trim the catheter to length at a 90˚ angle allowing sufficient slack for body movement, pump connection, and an additional 2-3 cm in case a pump reconnection is required. Always trim at least 5 cm from the proximal end of the catheter. Assure that the cut is straight and no catheter fragments are produced.
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Page 33: Patient Implant Card And Registration
Pump Explantation The Prometra II Programmable Pump should only be explanted in accordance with the hospital procedures. Explanted product is to be treated as a biohazard. Warning: Prior to cremation, the pump should always be explanted. The pump will explode at high temperatures. -
Page 34: Calculations
Please refer to the supplementary Prometra II Calculations Guide. Patient-Related Variables and Flow Rate Accuracy The Prometra II Pump was designed such that changes in pressure or temperature in normal operating environments do not affect the pump’s operation. Geographical Elevation Activities that involve temperature or elevation changes such as skiing, flying, hot-tubbing, or saunas will not affect the operation of the pump. -
Page 35: Temperature Variation
Temperature Variation Activities that involve temperature or elevation 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 pump. Temperature vs. -
Page 36: Flow Rate Accuracy
Flow Rate Accuracy Although it is strongly recommended to program the low reservoir volume alarm to 2 mL, it is important to know that reservoir volume down to 1 mL will not affect the operation of the pump. This margin of safety was designed to offer your patients an additional measure of comfort and safety. Drug Refill Reservoir Pressure vs. -
Page 37: Device Longevity
Device Longevity The useful life of the Prometra II Programmable Pump is dependent on the drug delivery rate. The Prometra II Pump utilizes an accumulator and dual-gated valve system to regulate the flow 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. - Page 38 An issued or revision date for these instructions is included for the user’s information. In the event two years have elapsed between this date and product use, the user should contact Flowonix Medical, Inc. to see if additional product information is available.