Document Number DKPI-09153-001 Rev. 1.4 2020-06-08 12:55:49 PM Confidentiality Statement DEKA RESEARCH & DEVELOPMENT AND UNITED THERAPEUTICS CORP. PROPRIETARY RIGHTS ARE INCLUDED HEREIN. THIS DOCUMENT CONTAINS DEKA AND UNITED THERAPEUTICS CORP. CONFIDENTIAL INFORMATION AND MAY NOT BE COPIED, TRANSFERRED, OR DISCLOSED EXCEPT AS AUTHORIZED BY DEKA RESEARCH & DEVELOPMENT OR UNITED THERAPEUTICS CORP. Trademarks Remodulin is a registered trademark of United Therapeutics Corp.
CONTENTS About Clinical Overview Essential Performance Indications for Use Contraindications Conventions Symbols Warnings Component Warnings Location of Use Warnings Cassette Change Warnings Medication Delivery Warnings Cautions Introduction System Overview Starter Kit Disposables DKPI-09153-001-Rev. 1.
Pair Remote and Pump for the First Time Enter Delivery Rate Cassette Change Cassette Change with Remote Supplies Needed for Cassette Change with Remote Stop Delivery with Remote Disconnect Infusion Site Disconnect Cassette from Pump and Dispose Replace Pump Battery Prepare Priming Aid Connect and Prime Infusion Set Stop Priming and Remove Priming Aid Connect Cassette to Pump Connect to Catheter Start Delivery Cassette Change Without Remote 2 52 57 59 60 61 63 65 66 68 70 73 75 78 80 81 82 Supplies Need
History Menu Remote Battery Pump Cassette Info Previous 24 Hours Event Viewer Setup Paired Pump Pair to a Spare Pump Pair to a Spare Remote Walkaway Attention Alarm Screen Timeout Remote Audio Change Rate Passcode Airplane Mode Factory Reset Remote Factory Reset Pump Factory Reset System Information Return 111 112 113 114 115 117 117 118 123 127 129 130 133 137 140 140 141 144 145 Alarms and Attention Alarms 147 DKPI-09153-001-Rev. 1.
Remote Battery Low Attention Alarm Request Refused Attention Alarm Software Version Error Attention Alarm Tech Attention Alarm Walkaway Attention Alarm 170 171 172 173 174 Maintenance and Troubleshooting 175 Pump Maintenance 176 177 Remote Maintenance Troubleshooting Battery Charger 178 Troubleshooting Remote 182 Troubleshooting Pump 189 Pump Sounds 197 Frequently Asked Questions (FAQ) 199 Service and Support Technical Support Parts and Accessories Approved Infusion Sets Appendix A 4 207 208 208 209
Replace Pump Battery Prepare and Fill Cassette Connect and Prime Infusion Set Stop Priming and Remove Priming Aid Connect Cassette to Pump Connect to Catheter Start Delivery GLOSSARY INDEX Emergency Contact Information DKPI-09153-001-Rev. 1.
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About The Remunity™ Pump for Remodulin® (treprostinil) Injection is for single-patient use only and the Remunity™ Cassette is for single use only. The Remunity system, which consists of a wearable infusion pump, refill cassettes, remote interface, and accessories, continually delivers Remodulin® subcutaneously (i.e., under the skin). If you have any questions about the Remunity system, talk to your healthcare provider or specialty pharmacy representative.
• • • • • • 8 The Operator is able to adjust the delivery rate as instructed. The Operator understands that only Remodulin Remunity cassettes may be used with the Remunity System. The Operator understands they need to verify the proper Remodulin concentration prior to using a cassette. The Operator is able to execute the proper procedure for changing a cassette. The Operator is able to execute the proper procedure for resolving an alarm.
Clinical Overview DKPI-00061-002 was a single-center, randomized, 6-cohort, prospective study in 60 healthy adult volunteers. The objective of the study was to assess accuracy and reliability of the Remunity™ Infusion System while delivering normal saline. Accuracy was assessed by weighing the Remunity Infusion System using validated methods at specific time points to compare the measured volumetric flow rate to the programmed flow rate.
21% of pump samples alarmed due to early detection of reservoir depletion resulting from an addressable manufacturing defect but did not affect the overall reliability of the devices. No action, other than acknowledgment of the attention alarm/alarm, was required for the remaining attention alarm/alarm. The pump alarmed as expected during the course of the study, and would have prompted the user to take appropriate action (e.g., restart the pump, switch to the spare pump).
Indications for Use Conventions The Remunity™ Pump for Remodulin® (treprostinil) Injection (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years old). This table describes typographic conventions that may be used in this document. Table 1: Conventions Convention Contraindications None Boldface type DKPI-09153-001-Rev. 1.
Convention Table 1: Conventions Convention Description Italic type Accentuates words or phrases that appear on the remote screen. Courier New Hyperlink See "Conventions" on the previous page. 12 Used for identifying code samples. Description Select Used to instruct the user to choose from a list of options. Press Used to instruct the user to press down on a physical button. Provides quick and easy access to crossreferenced topics.
Symbols Table 2: Symbols Symbol Source/ID Symbol Definition 21 CFR 801.15(b) This symbol indicates the device is for prescription use only. ISO 7000-1051* This symbol indicates a medical device that is intended for one use. ISO 7000-1135* This symbol indicates a product should be recycled. DKPI-09153-001-Rev. 1.
Table 2: Symbols Symbol Source/ID 14 Symbol Definition ISO 7010-M002* This symbol is used to instruct you to refer to this guide prior to using the Remunity™ Pump for Remodulin® (treprostinil) Injection. Warning / ALARM This is the Warning safety alarm symbol. It is used to notify you of potential hazards. Obey all safety messages that follow this symbol to avoid possible injury. Caution / ATTENTION ALARM These are the Caution safety and attention alarm symbols.
Table 2: Symbols Symbol Source/ID Symbol Definition IEC 60417-5576 This is the Bell cancel symbol. It is used to indicate that an alarm condition has had its audio turned off. Symbol 5.1.1 of ISO 15223-1: 2012(E)* This symbol indicates the medical device manufacturer. Symbol 5.1.3 of ISO 15223-1: 2012(E)* This symbol indicates the date when the medical device was manufactured. DKPI-09153-001-Rev. 1.
Table 2: Symbols Symbol Source/ID 16 Symbol Definition Symbol 5.1.4 of ISO 15223-1: 2012(E)* This symbol indicates the date after which the medical device is not to be used. Symbol 5.1.5 of ISO 15223-1: 2012(E)* This symbol indicates the manufacturer's lot code so that the lot can be identified. Symbol 5.1.6 of ISO 15223-1: 2012(E)* This symbol indicates the manufacturer's Catalog number so that the medical device can be identified. Symbol 5.1.
Table 2: Symbols Symbol Source/ID Symbol Definition Symbol 5.2.4 of ISO 15223-1: 2012(E)* This symbol indicates a medical device that has been sterilized using irradiation. Symbol 5.3.4 of ISO 15223-1: 2012(E)* This symbol indicates a medical device that needs to be protected from moisture. IEC 60417-5333* This symbol indicates that equipment is Type BF which indicates it is electrically isolated and can safely contact a person's skin without risk of electric shock. DKPI-09153-001-Rev. 1.
Table 2: Symbols Symbol Source/ID 18 Symbol Definition Figure 1 of EN 50419: 2006 This symbol indicates that equipment should not be disposed of in the trash. RBRC Li-Ion Battery Recycling Seal This symbol indicates that Lithium batteries should be recycled. IEC 60417-5031* This symbol indicates that a device requires direct current. ‘MR Unsafe’ symbol, Table 1, ASTM F2503-13 This symbol indicates that a device is not safe to have near an MRI. DKPI-09153-001-Rev. 1.
Table 2: Symbols Symbol Source/ID Symbol Definition Note: *For compliance with sub-clause 7.6.2 of IEC 60601-1: 2012. Table 3: Symbols for Shipping Container Markings Symbol Source / ID Symbol 5.3.7 of ISO 15223-1:2012 (E)*, with SYSTEM storage temperature limits included DKPI-09153-001-Rev. 1.4 Symbol Definition This symbol indicates the storage temperature range for the Remunity System.
Table 3: Symbols for Shipping Container Markings Symbol Source / ID Symbol Definition Symbol 5.3.8 of ISO 15223-1:2012 (E)*, with SYSTEM storage humidity limits included This symbol indicates the storage humidity range for the Remunity System. Symbol 5.3.9 of ISO 15223-1:2012 (E)*, with SYSTEM storage pressure limits included This symbol indicates the storage pressure range for the Remunity System. Note: *For compliance with sub-clause 7.6.2 of IEC 60601-1: 2012. 20 DKPI-09153-001-Rev. 1.
Warnings This section provides general warnings related to the use of the Remunity System. Additional and repeat warnings appear throughout this User Guide where appropriate. Component Warnings DO NOT discard this User Guide. Keep it in a safe place for future reference.
Verify sterile components are not expired before use. Using expired sterile components may lead to infection and result in harm. Do not use damaged disposable components. Using damaged disposable components may result in start-up failures, interruptions in therapy, or topical exposure to Remodulin. Keep the pump, cassette, and tubing from contacting sharp objects that can damage the components, as this may result in delivery errors leading to harm.
Avoid exposure of your Pump to temperatures below 41 ˚F (5 ˚C) or above 104 ˚F (40 ˚C). Remodulin solutions freeze near 0 °C (32 °F) and degrades at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your Pump and Remodulin cool. Location of Use Warnings Keep the system components, including pump batteries, away from small children.
The Remunity™ Pump for Remodulin® (treprostinil) Injection may affect nearby electrical and electronic devices, including medical devices. This interference could cause these devices to operate abnormally or stop functioning. If nearby equipment looks like it is being affected by this system, move the Pump, Remote, or Pump battery charger away from these machines. Do not use the system outside of the environmental conditions listed in the user guide.
Cassette Change Warnings Only Remunity cassettes may be used with the Remunity™ Pump for Remodulin® (treprostinil) Injection. Failure to use Remunity cassettes can lead to harm. Damaging the portions of the pump exposed during the cassette and battery changing process can affect pumping accuracy which can lead to harm. Delivery errors may result in adverse medical events (including serious injury) if the cassette, attached tubing, and infusion site catheter are improperly primed.
Medication Delivery Warnings Do not disconnect the pump from the cassette while the cassette is connected to the catheter. Disconnecting the pump from the cassette while the cassette is connected to the catheter may lead to a delivery error which can lead to harm. Do not perform troubleshooting steps while the pump is connected to the catheter. Performing troubleshooting steps while the pump is connected to the catheter can lead to the unintended delivery of Remodulin which can lead to harm.
Risk of fire and burns. Do not open, crush, heat above 140 °F (60 °C), or incinerate the pump battery or remote. Doing so can lead to fire or rapid spreading of fire resulting in harm. This system supports flow rates between 16 µL/h - 225 µL/h. If your flow rate is outside this range please discuss with your physician. Replace pump batteries after three months use. Failure to replace pump batteries after three months of use may lead to Cassette Problem alarms. DKPI-09153-001-Rev. 1.
Contact with oil-based lotions & sunscreens (Banana Boat ® for example) and insect repellents that contain DEET can damage the exposed parts of the bottom of the cassette, which may lead to leaks. This can result in Cassette Problem Alarms and/or exposure to Remodulin. Avoid getting lotions, sunscreens, and insect repellents on the bottom of the cassette.
42 In Your Pocket 43 Introduction Introduction Belt Clip This section introduces you to the Remunity™ Pump for Remodulin® (treprostinil) Injection and provides information about: System Overview 30 Starter Kit 31 Disposables 33 Remote Overview 34 Power OFF 34 Remote Front 35 Front Button Screen Labels Remote Back 36 37 Home Screen 38 Pump Overview 39 Pump with Cassette Attached 40 Remove the Clear Dust Cover 40 Attach the Clear Dust Cover 41 How to Wear Your Pump 41 DKPI-0915
Introduction System Overview 30 DKPI-09153-001-Rev. 1.
Introduction Starter Kit Do not use components from previously opened, expired or damaged sterile packaging. Using such components may lead to infection. When you open your pump box for the first time along with your specialty pharmacist, check that you have all the components in the box. DKPI-09153-001-Rev. 1.
Introduction The Remodulin Cassette Refill Kit is supplied by your specialty pharmacy and contains multiple Disposable Kit packages. Each Disposable Kit consists of a Priming Aid attached to a pharmacy-filled cassette. Each pharmacy-filled cassette contains enough medication for up to 72 hours. The pharmacy-filled cassette with an attached priming aid are supplied sterile using a gamma radiation (R) method. 32 DKPI-09153-001-Rev. 1.
Do not use the disposables if the package has been previously opened or damaged.
Introduction Remote Overview Power OFF Press and hold the Side Button to power on the remote. 1. To Power Off the remote, press and hold the Side Button until the Power Off screen displays. Once the remote has been powered on, the side button functions as a wake up, screen off, or back button. Discontinue use of the remote and switch to your spare remote in the event the remote's screen is missing pixels. 34 2. Press the to power off the remote. DKPI-09153-001-Rev. 1.