Appendix B Disconnect Infusion Site 1. Disconnect the infusion set tubing from the catheter. 5. Press to silence the attention alarm. 6. Press to acknowledge the Pump delivery has stopped Attention Alarm. Refer to the instructions provided by your infusion set's manufacturer for guidance. You should consult with your specialty pharmacy about how often to change the catheter. Do not remove the pump from the used cassette until after you have disconnected the infusion set tubing from your body.
Appendix B Disconnect Cassette from Pump and Dispose To avoid unintended medication delivery, disconnect from catheter before detaching the cassette from the pump. 2. You should hear a one beep tone coming from the pump. 1. Holding the cassette still, rotate the pump counterclockwise until the pump-bump is aligned with the Unlock symbol. 244 DKPI-09153-001-Rev. 1.
Appendix B Keep dirt, lubricants and liquids away from all parts on the interior of the pump exposed during the cassette changing process. 4. Dispose of the used cassette and infusion set tubing and catheter (if removed) in the trash. Follow your infusion set’s instructions: 3. Separate the pump from the cassette. Avoid unnecessary contact with all parts on the interior of the pump exposed during the cassette changing process. DKPI-09153-001-Rev. 1.
Appendix B Replace Pump Battery Avoid unnecessary contact with all parts on the interior of the pump exposed during the battery changing process. 2. Before removing the remote from the charging outlet, check that the charging light on the back of the remote is green. This indicates the battery in the bay is fully charged. 1. Turn the pump over and use the end of your finger to remove the battery from the pump. 246 DKPI-09153-001-Rev. 1.
Appendix B 3. Open the clear cover and remove the fully charged battery from the battery bay. Alternatively, you can obtain a fully charged battery from the battery charger. 4. Insert the depleted pump battery into the back of the remote's battery bay. At the end of the day, remember to charge the remote with the inserted battery. Alternatively, you can insert the depleted pump battery into the battery charger to fully charge. DKPI-09153-001-Rev. 1.
Appendix B Prepare and Fill Cassette You can use each cassette for up to three days. Replace the cassette when medication runs out or after three days. Do not use previously opened, expired or damaged disposable components. Doing so may lead to infection. Do not connect to infusion set catheter in the body until after a newly prepared cassette is attached to the pump. Connecting the cassette to the body before attaching the pump may lead to unintended delivery. 5.
Appendix B Note the important areas of the priming aid assembly. 1. Open the disposable kit and remove the priming aid and empty cassette from the package and place the black side down on a flat surface. DKPI-09153-001-Rev. 1.
Appendix B 2. Firmly push down on the top of the priming aid with the palm of your hand until you hear a click. 3. Prepare your injection by removing the syringe and the needle from its packaging. Only use the sterile, single-use, 3 mL syringe and needle to fill the cassette. 250 4. Insert the needle into the syringe Luer Lock and twist until finger tight. 5. Wipe the top of the Remodulin vial with an alcohol wipe. 6. Remove the cap from the needle. 7. Pull the syringe plunger out. 8.
Appendix B 9. Push down on the syringe plunger to pressurize the vial. 11. Fill the syringe with the amount of Remodulin (mL) that is displayed on the remote. 12. With the needle facing up and held vertically, tap on the syringe to remove any air bubbles. 13. Remove the syringe from the vial. 10. While still holding the syringe, flip the vial over so the vial is on top, slowly pull down on the plunger to fill the syringe. DKPI-09153-001-Rev. 1.
Appendix B 14. Insert the syringe into the hole in the priming aid and push down until you feel the needle insert into the cassette's rubber membrane. 252 15. Push down on the syringe plunger to fill the cassette with Remodulin. 16. When the syringe is empty, continue to push down on the plunger while removing it from the priming aid. 17. Dispose of the used syringe and needle in a Sharps container. DKPI-09153-001-Rev. 1.
18. Wipe up any Remodulin medication residue with an absorbent towel or cloth and wash any areas that came in contact with Remodulin with soap and water. DKPI-09153-001-Rev. 1.4 Connect and Prime Infusion Set 1. The infusion set tubing should be changed whenever you are performing a Cassette Change. Obtain a new infusion set package. 253 Appendix B Contact your local authorities to determine the proper method of disposing the syringe and needle.
Appendix B 2. Open the infusion set package and remove the infusion set tubing. 3. Connect the infusion set to the cassette by twisting the Luer Lock connectors together. Do not insert the new infusion set catheter into your body until after you have prepared the new cassette and connected it to the pump. Inserting the infusion set catheter before connecting the cassette to the pump may lead to unintended delivery. 254 DKPI-09153-001-Rev. 1.
Appendix B 5. Watch for medication drops to appear at the end of the infusion set. 4. Holding the cassette still, rotate the priming aid clockwise until you hear a click and the arrow is aligned with the drop symbol on the priming aid tab. DKPI-09153-001-Rev. 1.4 Seeing the medication drops indicates the infusion set and cassette are primed.
Appendix B Stop Priming and Remove Priming Aid 2. Rotate counterclockwise until the tab on the priming aid becomes aligned with the Unlock symbol on the cassette. 1. As soon as you see the first drops from the infusion set tubing, rotate the priming aid counterclockwise to end the priming. 256 DKPI-09153-001-Rev. 1.
Appendix B 3. Detach the priming aid from the cassette. 4. Place the cassette down on your workspace. 5. Wipe up medication residue that may have settled on top of the cassette during the filling process with an absorbent towel or cloth. DKPI-09153-001-Rev. 1.4 6. Wipe up any Remodulin medication residue with an absorbent towel or cloth and wash any areas that came in contact with Remodulin with soap and water.
Appendix B Connect Cassette to Pump Do not connect the infusion set tubing to your catheter. 1. Before connecting the pump to the filled cassette, inspect the cassette and infusion set tubing for leaks. If you see any leaks replace the cassette and infusion set tubing. 7. Dispose of the priming aid in the trash. DO NOT dispose of the newly filled cassette. 258 2. Wipe up any medication residue with an absorbent towel or cloth and wash contacted areas with soap and water. 3.
Appendix B 4. Connect the filled cassette to the pump by aligning the pump-bump with the Unlock symbol on the cassette. DKPI-09153-001-Rev. 1.4 5. Push down and rotate the pump clockwise to the Lock symbol.
Appendix B On the remote a Self Test displays. 8. Allow the Self Test on the remote to complete. 6. Pump-bump should align with the infusion set tubing. 7. You should hear a series of beeps coming from the pump followed by a final confirmation beep. 260 Do not connect the infusion set tubing to an inserted catheter before the pump completes the self tests. Doing so may cause an over delivery of medication resulting in harm. DKPI-09153-001-Rev. 1.
1. Connect the infusion set tubing from the pump to the catheter. 2. Consult with your specialty pharmacy about how often you should change the catheter. Refer to your infusion set’s instructions for steps on how to insert the infusion set’s catheter into your body. DKPI-09153-001-Rev. 1.4 Appendix B Connect to Catheter Start Delivery 1. To start medication delivery, press and hold the blue pump button, or on your remote, press to start delivery. 2.
Appendix B 3. Confirm that the remote displays a green header indicating that the pump is delivering. 4. Check to make sure the displayed rate matches your prescribed rate. 262 DKPI-09153-001-Rev. 1.
(sometimes the catheter), and an unfilled cassette with a filled cassette. Catheter B A tubular medical device for insertion into canals, vessels, passageways, or body cavities for diagnostic or therapeutic purposes (as to permit injection or withdrawal of fluids or to keep a passage open Battery Charger A hardware device used to charge the rechargeable batteries. C D Cassette Disposable Kit A hardware component of the Remunity™ system that holds the medication and attaches to the Pump.
GLOSSARY E P Event Prime A historical entry saved within the remote. Examples of events are rate changes, cassette changes, alerts, alarms, and delivery start and stops. The process of filling the infusion set tubing with medication. Priming Aid I A disposable hardware device used to aid in the filling and priming of the Cassette with medication. Infusion Set The device used to connect the Remunity™ pump to your body.
A protrusion on the perimeter of the pump. S Subcutaneous Situated or applied under the skin Pump Dust Cover A clear plastic cover that attaches to the bottom of the Pump to protect its internal components from dust, dirt and contamination when the cassette is not attached. GLOSSARY Pump Bump T Tubing Specifically the cassette or infusion set tubing. R Remodulin For the purposes of this User Guide, an infused medication used to treat pulmonary arterial hypertension.
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INDEX occlusion 154 pump error 158 pump failure 159 Appendix 211, 237 A Attention Alarm 147 About 7 alarms 148 attention alarms 148 Accept 36 Access Help 36 Accessories 208 Acknowledge 36 Alarm 147 battery depleted 149 cassette depleted 150 cassette problem 153 adjust pump 160 basal not started 160 delivery stopped 161 depletes soon 162 excessive noise 162 low remote battery 170-171 message timeout 163 no communication 164 pairing failed 166 pairing lost 167 pump battery low 169 cassette removed 151 D
pump idle 168 Cassette 32 software version error 172 connect to pump 78, 97, 258 tech 173 prepare and fill 248 walkaway 174 prepare priming aid 70, 89 Cassette Change 59 B disconnect cassette from pump 66, 85, 244 Battery supplies 61, 83, 239 patient-filled 238 charger 69, 88, 247 Battery Bay 39 Battery Charger status lights 47 with remote 60 without remote 82 Cautions 26 Change Rate 103 Clear Dust Cover 40, 53 C Contraindications 11 Conventions 11 Cancel 36 268 DKPI-09153-001-Rev. 1.
Essential Performance 10 D Delivery start 81, 109, 261 start without remote 99 stop 63, 85, 107, 241 Delivery Rate enter 57 Disposables 33 Drop Icon 74, 93, 255 E Edit 36 Emergency Contact Information 275 DKPI-09153-001-Rev. 1.
pump cassette info 113 prime 73, 92, 253 remote battery charging 112 Infusion Sets 33 remote battery level 112 Introduction 29 Home Screen 38 delivery rate 38 hours remaining 38 pump battery level 38 L Luer Lock 74, 93, 250, 254 remote battery level 38 status bar 38 I Main Menu 102 Maintenance 175 Indications for Use 11 pump 176 Infusion Set remote 177 connect 73, 80, 92, 99, 253, 261 disconnect 65, 243 270 M Menu functions 101 DKPI-09153-001-Rev. 1.
blue button 39 N clothing clip 43 Next Screen 36 dust cover attach 41 dust cover removal 40 how to wear 41 P with cassette 40 Pump Battery Parts 208 charging 46 Power OFF 34 replace 68, 87, 246 Power ON 34 status light 37 Previous Screen 36 Pump Settings 36 Priming Aid 32 Pump Sounds 197 dispose 75, 94, 256 remove 75, 94, 256 Pump 39 belt clip 42 DKPI-09153-001-Rev. 1.
R S Remote Scroll Down 36 back 37 Scroll Up 36 battery charging status lights 50 Service 207 charging 48 Set Up 45, 117 front 35 airplane mode 137 front button screen labels 36 exit airplane mode 139 overview 34 factory reset 140 pairing 52 pair to spare pump 118 pump battery charging 48 paired pump 117 Repeat 36 passcode 133 Return 145 remote audio 130 Return to Previous Menu 102 screen timeout 129 system information 144 272 DKPI-09153-001-Rev. 1.
walkaway alert 127 Troubleshooting 175 Silence Alarm 36 battery charger 178 Starter Kit 31 pump 189 Status Bar remote 182 color indications 38 Support 207 Symbols 13 Syringe U Unlock 36 disposal 252 USB AC Adapter 46 fill 251 USB cable 46 System Overview 30 T W Warnings 21 Technical Specifications 212 cassette change 25 Technical Support 208 component 21 DKPI-09153-001-Rev. 1.
location of use 23 medication delivery 26 Wash Hands 60, 82, 238 274 DKPI-09153-001-Rev. 1.
Emergency Contact Information Remunity™ Pump for Remodulin® (treprostinil) Injection Remunity System is for prescription use only.
Distributed by: United Therapeutics Corp.