Supplementary CALCULATIONS GUIDE For use with Intrathecal Catheter For use with Prometra Programmable Pump

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1 Supplementary CALCULATIONS GUIDE For use with Intrathecal Catheter For use with Prometra Programmable Pump

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3 Contents Pump Fluid Volumes Easy Reference...1 Catheter Fluid Volumes Easy Reference...2 Constant Values and Terminology...3 Variable Values and Terminology...4 Calculations Easy Reference...5 Calculations...6 Bolus Drug Dose from Manual Bolus Injection/Flushing or Myelography...6 Catheter Aspiration Volume...6 Catheter Implanted Volume...6 Changing Drug Concentration...7 Refill Syringe Concentration...7 Bridge Bolus with Aspiration...8 Bridge Bolus after Manual Bolus Injection/Flushing or Myelography...8 Bridge Bolus without Aspiration...9 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

4 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

5 Pump Fluid Volumes Easy Reference Pump Fluid Pathway Volume = Drug Metering Volume + T-Stem Volume ml = ml ml Drug Metering Controller Volume: ml T-Stem Volume: ml ml CALCULATIONS GUIDE, For use with Prometra Programmable Pump Page 1

6 Catheter Fluid Volumes Easy Reference ml Catheter Fluid Pathway Volume = Catheter Access Chamber Volume + T-Stem Volume ml = ml ml ml Catheter Access Chamber Volume: ml T-Stem Volume: ml ml Page 2 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

7 Constant Values and Terminology Term Abbreviation Value Definition Catheter Access Chamber Volume Catheter Fluid Pathway Volume Intrathecal Catheter Linear Volume Maximum Delivery Rate Pump Drug Metering Controller Vol Pump Fluid Pathway Volume Cath Access Vol ml The volume in the catheter access chamber beneath the catheter access septum. Cath Path Vol ml The total volume from the catheter access chamber to the distal end of the pump stem, not including the pump drug metering controller. It includes the catheter access chamber volume and the pump T-stem volume. Cath Linear Vol ml/cm The volume in each centimeter length of the intrathecal catheter. Max Del Rate 0.02 ml/min The maximum rate of drug delivery. Drug Meter Vol ml The volume in the pump drug metering controller. Pump Path Vol ml The total volume from the drug refill reservoir to the distal end of the pump stem, not including the catheter. It includes the pump drug metering controller volume and the pump T-stem volume. Pump T-Stem Volume T-Stem Vol ml The volume in the pump T-stem connecting the pump drug metering controller with the catheter. Reservoir Residual Volume Res Residual Vol 3 ml The volume in the drug refill reservoir after emptying. Total Catheter Length Total Cath Length 110 cm The length of the catheter as supplied, before trimming. CALCULATIONS GUIDE, For use with Prometra Programmable Pump Page 3

8 Variable Values and Terminology Term Abbreviation Definition Bridge Bolus Bridge Bolus A transitional dose and duration to ensure that the patient is receiving the new changed drug concentration or solution at the prescribed dose. The bridge bolus takes into consideration the old drug concentration being cleared from the pump and catheter fluid pathway before the new programmed regimen takes over. Implanted Catheter Length (cm) Impl Cath Length The length of catheter implanted in patient, after trimming. This is determined by subtracting the length of the trimmed portion of catheter from the total catheter length. Implanted Catheter Volume (ml) Impl Cath Vol The infusate volume in the implanted catheter. This volume is dependent on the implanted catheter length. Manual Bolus Injection/Flushing Man Bolus Manual bolus of infusate remaining in the catheter access chamber, pump T-stem and intrathecal catheter. This is done by injection through the catheter access septum. New Drug Concentration (mg/ml) New Conc The target drug concentration when changing drug concentration during a refill procedure. Old Drug Concentration (mg/ml) Old Conc The drug concentration of infusate remaining in the implanted pump and catheter. This is the same as the new drug concentration calculated at the previous pump refill procedure. Refill Syringe Concentration (mg/ml) Refill Conc The drug concentration required in the refill syringe to achieve the desired patient dose. If changing drug concentration or solution, this needs to consider residual volume of Old Drug Concentration in the pump drug refill reservoir after emptying. Refill Volume (ml) Refill Vol The volume infused into pump drug refill reservoir during a refill procedure. Targeted Daily Rate (mg/day) Targ DRate The desired daily dose rate for the patient. Trimmed Catheter Length (cm) Trimmed Cath Length The length of catheter trimmed and removed during implant. This must be measured in order to calculate implanted catheter length and volume. Page 4 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

9 Calculations Easy Reference Bolus Drug Dose during Manual Bolus Injection/Flushing or Myelography Man Bolus Dose (mg) Catheter Aspiration Volume Aspirate Volume (ml) Catheter Implanted Volume Impl Cath Length (cm) Impl Cath Vol (ml) Changing Drug Concentration Refill Syringe Concentration Refill Conc (mg/ml) = [Impl Cath Vol (ml) ml] x Old Conc (mg/ml) = Implanted Catheter Volume (ml) ml = 110 cm Trimmed Cath Length (cm) = Impl Cath Length (cm) x ml/cm = {[New Conc (mg/ml) Old Conc (mg/ml)] x CF} + New Conc (mg/ml), where CF = Reservoir Residual Volume (ml) / Refill Vol (ml) Bridge Bolus with Aspiration or Manual Bolus Injection Bridge Bolus with Aspiration Bridge Bolus after Manual Bolus Injection/Flushing or Myelography Bridge 1 Dose (mg) Bridge 1 Duration (min) = [0.068 ml + Impl Cath Vol (ml)] x New Conc (mg/ml) = [0.068 ml + Impl Cath Vol (ml)] 0.02 ml/min Note: Round up to the next whole number for Bridge 1 duration. Old Conc Dose (mg) Bridge 2 Dose (mg) Bridge 2 Duration (hr) = ml x Old Conc (mg/ml) = Old Conc Dose (mg) x New Conc (mg/ml) Old Conc (mg/ml) = Old Conc Dose (mg) [Targ DRate (mg/day) 24 hr/day] Bridge Bolus Without Aspiration Note: For programmer entry, Bridge 2 duration must be expressed in hh:mm Old Conc Dose (mg) Bridge Dose (mg) Bridge Duration (hr) = [0.205 ml + Impl Cath Vol (ml)] x Old Conc (mg/ml) = Old Conc Dose (mg) x New Conc (mg/ml) Old Conc (mg/ml) = Old Conc Dose (mg) [Targ DRate (mg/day) 24 hr/day] Note: For programmer entry, Bridge 2 duration must be expressed in hh:mm CALCULATIONS GUIDE, For use with Prometra Programmable Pump Page 5

10 Calculations Bolus Drug Dose from Manual Bolus Injection/Flushing or Myelography If no aspiration is performed, a manual bolus injection/flushing or myelography delivers the full drug dose remaining in the catheter as well as the catheter fluid pathway. Refer to Catheter Access Instructions for Warnings, Precautions and Adverse Events. Man Bolus Dose (mg) = [Impl Cath Vol (ml) + Cath Path Vol (ml)] x Old Conc (mg/ml) Example If the Impl Cath Vol = ml, and Old Conc= 8 mg/ml, Then, the Man Bolus Dose (mg) Man Bolus Dose = [Impl Cath Vol (ml) + Cath Path Vol (ml)] x Old Conc (mg/ml) = (0.156 ml ml) x 8 mg/ml = (0.415 ml) x 8 mg/ml = mg Catheter Aspiration Volume Refer to the patient chart or patient implant card for implanted catheter volume. Aspirate Volume = Implanted Catheter Volume (ml) ml Example If the Impl Cath Vol = ml, Then, the Aspirate Volume (ml) Aspirate Volume = Implanted Catheter Volume (ml) ml = ml ml = ml Catheter Implanted Volume Impl Cath Length (cm) Impl Cath Vol (ml) = Total Cath Length (cm) Trimmed Cath Length (cm) = Impl Cath Length (cm) x Cath Linear Vol (ml/cm) Example If the Trimmed Cath Length = 50 cm, Then the Impl Cath Length (cm) Impl Cath Length = Total Cath Length (cm) Trimmed Cath Length (cm) = 110 cm 50 cm = 60 cm, And the Impl Cath Vol (ml) Impl Cath Vol = Impl Cath Length (cm) x Cath Linear Vol (ml/cm) = 60 cm x ml/cm = ml Page 6 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

11 Calculations Changing Drug Concentration When changing drug concentration, the following values must be calculated: Refill Syringe Concentration Bridge Bolus Dose(s) Bridge Bolus Duration(s) Refill Syringe Concentration A correction factor (CF) must be used to calculate refill syringe concentration to account for the old drug concentration in the residual pump reservoir volume. CF = Reservoir Residual Volume (ml) / Refill Vol (ml) Refill Conc (mg/ml) = {[New Conc (mg/ml) Old Conc (mg/ml)] x CF} + New Conc (mg/ml) Example If the Refill Vol = 20 ml, and the New Conc = 12 mg/ml, and the Old Conc = 8 mg/ml, Then, And, CF = Reservoir Residual Volume (ml) / Refill Vol (ml) = 3 ml / 20 ml = 0.15, Refill Conc (mg/ml) = {[New Conc (mg/ml) Old Conc (mg/ml)] x CF} + New Conc (mg/ml) = {(12 mg/ml 8 mg/ml) x 0.15} + 12 mg/ml = {4 mg/ml} x mg/ml = 0.6 mg/ml + 12 mg/ml Refill Conc = 12.6 mg/ml CALCULATIONS GUIDE, For use with Prometra Programmable Pump Page 7

12 Calculations Changing Drug Concentration Bridge Bolus with Aspiration Bridge Bolus after Manual Bolus Injection/Flushing or Myelography A bridge bolus may be performed with or without prior aspiration. A bridge bolus is a transitional dose and duration to ensure that the patient is receiving the new, changed drug concentration or solution at the prescribed dose. The bridge bolus takes into consideration the old drug concentration being cleared from the pump and catheter fluid pathway before the new programmed regimen takes over. After aspiration or manual bolus injection/flushing or myelography, two bridge boluses are programmed. Bridge 1 Bolus moves the old drug concentration to the tip of the catheter. Bridge 2 Bolus delivers the old drug at the new dosing rate and moves the new concentration to the tip of the catheter. Bridge 1 Dose (mg) Bridge 1 Duration (min) Old Conc Dose (mg) Bridge 2 Dose (mg) Bridge 2 Duration (hr) = [T-Stem Vol (ml) + Impl Cath Vol (ml)] x New Conc (mg/ml) = [T-Stem Vol (ml) + Impl Cath Vol (ml)] Max Del Rate (ml/min) Note: Round up to the next whole number for Bridge 1 duration. = Drug Meter Vol (ml) x Old Conc (mg/ml) = Old Conc Dose (mg) x New Conc (mg/ml) Old Conc (mg/ml) = Old Conc Dose (mg) [Targ DRate (mg/day) 24 hr/day] For programmer entry, duration expressed in hours must be converted to hours:minutes. Bridge 2 Duration (hh:mm) = xx.yy hr = xx (hr):[0.yy (hr) x 60 min/hr] (hh:mm) Example If the Old Conc= 8 mg/ml, and the New Conc= 12 mg/ml, and the Impl Cath Vol = ml, and the Targ DRate = 6 mg/day, Then, the Bridge 1 Dose (mg) Bridge 1 Dose And the Bridge 1 Duration (min) Bridge 1 Duration And the Old Conc Dose (mg) Old Conc Dose And the Bridge 2 Dose (mg) Bridge 2 Dose = [T-Stem Vol (ml) + Impl Cath Vol (ml)] x New Conc (mg/ml) = (0.068 ml ml) x 12 mg/ml = (0.224 ml) x 12 mg/ml = mg, = [T-Stem Vol (ml) + Impl Cath Vol (ml)] Max Del Rate (ml/min) = (0.068 ml ml) 0.02 ml/min = (0.224 ml) 0.02 ml/min = 11.2 min. Rounding to next whole number gives = 12 min, = Drug Meter Vol (ml) x Old Conc (mg/ml) = ml x 8 mg/ml =1.096 mg, = Old Conc Dose (mg) x New Conc (mg/ml) Old Conc (mg/ml) = mg x 12 mg/ml 8 mg/ml = mg Page 8 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

13 Calculations Changing Drug Concentration Bridge Bolus with Aspiration Bridge Bolus after Manual Bolus Injection/Flushing or Myelography And the Bridge 2 Duration (hr) = Old Conc Dose (mg) [Targ DRate (mg/day) 24 hr/day] = mg (6 mg/day 24 hr/day) = mg 0.25 mg/hr = hr, or Bridge 2 Duration (hh:mm) = 4 : (0.384 hr x 60 min/hr) Bridge 2 Duration = 4:23 hh:mm Bridge Bolus without Aspiration A bridge bolus may be performed with or without prior aspiration. A bridge bolus is a transitional dose and duration to ensure that the patient is receiving the new, changed drug concentration or solution at the prescribed dose. The bridge bolus takes into consideration the old drug concentration being cleared from the pump and catheter fluid pathway before the new programmed regimen takes over. Without aspiration or manual bolus, one bridge bolus is programmed. This one bridge bolus delivers the old drug at the new dosing rate and moves the new concentration to the tip of the catheter. Old Conc Dose (mg) Bridge Dose (mg) Bridge Duration (hr) = [Pump Path Vol (ml) + Impl Cath Vol (ml)] x Old Conc (mg/ml) = Old Conc Dose (mg) x New Conc (mg/ml) Old Conc (mg/ml) = Old Conc Dose (mg) [Targ DRate (mg/day) 24 hr/day] For programmer entry, duration expressed in hours must be converted to hours:minutes. Bridge Duration (hh:mm) = xx.yy hr = xx (hr):[0.yy (hr) x 60 min/hr] (hh:mm) Example If the Old Conc = 8 mg/ml, and the New Conc = 12 mg/ml, and the Impl Cath Vol = ml, and the Targ DRate = 6 mg/day, Then, the Old Conc Dose (mg) Old Conc Dose And the Bridge Dose (mg) Bridge Dose And the Bridge Duration (hr) Bridge Duration (hh:mm) Bridge Duration = [Pump Path Vol (ml) + Impl Cath Vol (ml)] x Old Conc (mg/ml) = (0.205 ml ml) x 8 mg/ml = ml x 8 mg/ml = mg, = Old Conc Dose (mg) x New Conc (mg/ml) Old Conc (mg/ml) = mg x 12 mg/ml 8 mg/ml = mg, = Old Conc Dose (mg) [Targ DRate (mg/day) 24 hr/day] = mg (6 mg/day 24 hr/day) = mg 0.25 mg/hr = hr, or = 11:(0.55 hr x 60 min/hr) = 11:33 hh:mm CALCULATIONS GUIDE, For use with Prometra Programmable Pump Page 9

14 Trademarks are the property of their respective owners. US and Foreign patents issued and pending. Please consult flowonix.com for the most up-to-date information. Rx Only Page 10 CALCULATIONS GUIDE, For use with Prometra Programmable Pump

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16 Manufactured by: Flowonix Medical Inc. 500 International Drive, Suite 200 Mount Olive, NJ USA T F EC REP EMERGO EUROPE Prinsessegracht AP The Hague The Netherlands 0086 Year of Authorization: 2010 Flowonix Medical Inc All Rights Reserved. PL April 2017