Alarms and Attention Alarms Pairing Failed Attention Alarm When the pump and remote were not able to complete the pairing process, the Pairing Failed Attention Alarm displays. This may be caused by wireless communication interference. 2. Press to acknowledge the attention alarm. 3. Make sure the pump and remote are within 2 inches (50 mm) of each other and away from other electronics. 4. Use to highlight the pump’s serial number on the remote, then press . 5.
When you have paired your pump to the spare remote, the original remote will generate a Pairing Lost Attention Alarm when you bring your pump back in range. 5. If this attention alarm is displayed again, contact your specialty pharmacy for technical assistance. 1. Press to silence the attention alarm. 2. Press to acknowledge the attention alarm. 3. Make sure the pump and remote are within 2" (50 mm) of each other and away from other electronics. 4. You will need to pair again to your original remote.
Alarms and Attention Alarms Pump Idle Attention Alarm When the pump has not been delivering medication for 15 minutes, the Pump Idle Attention Alarm displays. 1. Press to silence the attention alarm. c. Remove and reinsert the pump battery into the pump. d. Listen for the confirmation beep on the pump. e. Connect the pump to the cassette. f. Wait for the self test to complete and then reconnect the infusion set tubing to the catheter. g.
When the pump battery will be depleted in 8 hours or when the pump battery does not have enough charge for full therapy, a Pump Battery Low Attention Alarm displays. DKPI-09153-001-Rev. 1.4 1. Press to silence the attention alarm. 2. Press to acknowledge the attention alarm. 3. Replace the pump battery with a fully charged pump battery by performing a cassette change. See "Cassette Change" on page 59.
Alarms and Attention Alarms Remote Battery Low Attention Alarm When the remote’s battery needs to be charged, a Low Battery Attention Alarm displays along with a message that the Remote battery is low. Charge soon. When the battery symbol in the top right of the remote screen is full green, the remote is fully charged. 1. Press to silence the attention alarm. 2. Press to acknowledge the attention alarm. 3. Use the supplied AC Adapter and USB Cable to connect the remote to a power source (e.g.
Alarms and Attention Alarms Request Refused Attention Alarm When the remote sends a command to the pump and an error occurs, a Request Refused Attention Alarm displays. 1. Press to silence the attention alarm. 2. Press to acknowledge the attention alarm. 3. Retry the command. DKPI-09153-001-Rev. 1.
Alarms and Attention Alarms Software Version Error Attention Alarm 5. Contact your specialty pharmacy to obtain a replacement pump. When the pump is not able to deliver medication due to incompatible software on the pump and remote interface, a SW Version Error Attention Alarm with a Pump version not compatible message is displayed. 1. Press to silence the attention alarm. 2. Press to acknowledge the attention alarm. 3. Gather a spare pump. 4. Pair spare pump with remote.
When the remote has encountered an error, the Tech Att. Alarm displays along with the Error code, TS (Date and Time stamp), SysTime, and SW. 1. Press to silence the attention alarm. 2. Use the to scroll through the Tech Attention Alarm information. 3. This alarm does not represent an emergency, but should be reported to your specialty pharmacy. 4. If this attention alarm repeats you should switch to your spare remote and request a replacement from your specialty pharmacy.
Alarms and Attention Alarms Walkaway Attention Alarm When the pump previously lost communication with the remote for the user settable amount of time, the Walkaway Attention Alarm displays along with a Remote stopped communicating with the pump message. 2. Press to acknowledge the attention alarm. 3. If the attention alarm appeared while you had your remote with you, this may have been caused by wireless communication interference. You may need to move 0.
Maintenance and Troubleshooting Maintenance and Troubleshooting Contact your specialty pharmacy for assistance with any of the maintenance and troubleshooting instructions. Pump Maintenance 176 Remote Maintenance 177 Troubleshooting Battery Charger 178 Troubleshooting Remote 182 Troubleshooting Pump 189 Pump Sounds 197 Frequently Asked Questions (FAQ) 199 DKPI-09153-001-Rev. 1.
Maintenance and Troubleshooting Pump Maintenance Dust, lint, and debris on or in the pump may have the following effects on the system: • • • • • • Decrease the water ingress protection rating. Interfere with the electrical connection between the pump and battery causing Alarms to occur. Cause the pump to fail start up tests. Interfere with the electrical connections between the remote or pump battery charger and pump battery causing the battery not to charge or to charge slowly.
Maintenance and Troubleshooting Remote Maintenance Clean the remote as needed to keep the remote free of dust, lint and debris. • • • • When cleaning do not submerge in water. Do not place the remote in the dishwasher to clean. Gently wipe all surfaces with a cloth or paper towel moistened with mild soap and water (dish detergent or hand soap is acceptable). Thoroughly dry with a dry cloth or paper towel if any moisture is present. DKPI-09153-001-Rev. 1.
Maintenance and Troubleshooting Troubleshooting Battery Charger Table 8: Battery Charger status light(s) do not turn on Problem Possible Causes Corrective Actions Battery Charger status light(s) do not turn on (is not charging the pump battery). Battery Charger is not plugged into a power source. Make sure the AC Adapter or USB Cable is plugged into the Battery Charger and connected to a power source (e.g., wall outlet). 178 DKPI-09153-001-Rev. 1.
Problem Possible Causes One or more components is defective: • USB Cable • AC Adapter • Battery Charger • Battery DKPI-09153-001-Rev. 1.4 Corrective Actions One at a time, swap a component listed on the left with its replacement from the starter kit. If the replacement fixes the problem, contact your specialty pharmacy to replace that defective component. If the replacement does not fix the problem, swap back to the original component, then try replacing the next component on the list.
Maintenance and Troubleshooting Table 9: Battery Charger status light(s) turn red when a pump battery is installed Problem Battery Charger status light turns red when a pump battery is installed. 180 Possible Causes Corrective Actions Pump Battery is too hot or too cold. Make sure the temperature of the battery, or location where you charge the battery, is between 59 ºF (15 ºC) and 95 ºF (35 ºC). Charging will start automatically when battery temperature is within that range. DKPI-09153-001-Rev. 1.
Problem DKPI-09153-001-Rev. 1.4 Possible Causes Corrective Actions Pump Battery and/or Battery Charger contacts are covered with dirt or dust. Disconnect from power source. Then, use a dry cloth or soft bristle brush to clean the contacts. One or more components is defective: • Battery Charger • Pump Battery One at a time, swap a component listed on the left with its replacement from the starter kit.
Maintenance and Troubleshooting Troubleshooting Remote Table 10: Remote does not turn on Problem Remote does not turn on. 182 Possible Causes Remote has timed out or powered off. Corrective Actions Press the remote’s side button to wake up the remote. If this does not work, press and hold the side button for about ten seconds to power on the remote (the remote will vibrate when it powers on). DKPI-09153-001-Rev. 1.
Maintenance and Troubleshooting Table 10: Remote does not turn on Problem DKPI-09153-001-Rev. 1.4 Possible Causes Corrective Actions Remote is not charged. Charge the remote using the USB Cable and AC Adapter provided in the starter kit. Remote is broken. Use the spare remote provided in the starter kit. Contact your specialty pharmacy for a replacement remote.
Maintenance and Troubleshooting Table 10: Remote does not turn on Problem Possible Causes One or more components is defective: • USB Cable • AC Adapter • Remote 184 Corrective Actions One at a time, swap a component listed on the left with its replacement from the starter kit. If the replacement fixes the problem, contact your specialty pharmacy to replace that defective component.
Problem Possible Causes Corrective Actions Pump battery does not charge in the back of the remote when plugged in (the status light does not turn on). Remote is not plugged in to a power source. Make sure AC Adapter and USB Cable are plugged into the Remote and connected to a power source (e.g., wall outlet). Pump Battery and/or Battery Charger contacts are covered with dirt or dust. Disconnect from power source. Remove the battery from the battery bay.
Maintenance and Troubleshooting Table 11: Pump battery does not charge when in the back of the remote Problem Possible Causes One or more components is defective: • USB Cable • AC Adapter • Remote • Pump Battery (if in the remote’s battery bay) 186 Corrective Actions One at a time, swap a component listed on the left with its replacement from the starter kit. If the replacement fixes the problem, contact your specialty pharmacy to replace that defective component.
Problem Remote status light turns red when a Pump Battery is installed. DKPI-09153-001-Rev. 1.4 Possible Causes Corrective Actions Pump Battery is too hot or too cold. Make sure the temperature of the battery, or location where you charge the battery, is between 59 ºF (15 ºC) and 95 ºF (35 ºC). Charging will start automatically when battery temperature is within that range. Pump Battery and/or Remote contacts are covered with dirt or dust. Disconnect from power source.
Maintenance and Troubleshooting Table 12: Remote status light turns red when a Pump Battery is installed Problem Possible Causes One or more components is defective: • Remote • Pump Battery (if in the Remote’s battery) 188 Corrective Actions One at a time, swap a component listed on the left with its replacement from the starter kit. If the replacement fixes the problem, contact your specialty pharmacy to replace that defective component.
Maintenance and Troubleshooting Troubleshooting Pump Table 13: Cannot connect cassette to infusion set tubing Problem Cannot connect cassette to infusion set tubing. DKPI-09153-001-Rev. 1.4 Possible Causes Damaged connector on cassette or infusion set. Corrective Actions If connector on cassette is damaged, discard and obtain a new cassette. If connector on infusion set is damaged, discard and obtain a new infusion set.
Maintenance and Troubleshooting Table 13: Cannot connect cassette to infusion set tubing Problem Cannot connect cassette to infusion set tubing. 190 Possible Causes The infusion set is not approved for use with the cassette. Corrective Actions Verify you are using one of these approved infusion sets with the cassette: • Medtronic Quick-set (MMT-392, MMT-393) • Medtronic Silhouette (MMT-373) • Smiths Medical Cleo 90 (21-7230-24, 21-722024) DKPI-09153-001-Rev. 1.
Problem No fluid is visible at end of infusion set when priming. DKPI-09153-001-Rev. 1.4 Possible Causes Corrective Actions Priming Aid is not fully rotated. Fully rotate the arrow on the priming aid to the lock symbol on the cassette to begin priming. Tubing is occluded Inspect tubing and straighten any kinked tubing.
Maintenance and Troubleshooting Table 15: The self test passes, but the pump sounds an Attention Alarm sound when the pump button is pressed Problem The self test passes, but the pump sounds an attention alarm tone when the pump button is pressed. Possible Causes Delivery rate needs to be set or updated. Corrective Actions Move the pump or remote within 12 inches of each other to enable wireless communication. When you reconnect to the remote, a Basal Not Started Attention Alarm will display.
Maintenance and Troubleshooting Table 16: Self test does not start Problem Self test does not start. DKPI-09153-001-Rev. 1.4 Possible Causes Corrective Actions Pump is not properly attached to cassette. Make sure the pump is properly attached to the cassette. Remote is not paired to the correct pump. In the remote’s Setup menu, pair the remote to the pump you are currently using. See "Pair to a Spare Pump" on page 118.
Maintenance and Troubleshooting Table 17: Pump sounds an Attention Alarm signal when the pump battery is installed Problem Pump sounds an Attention Alarm tone when the pump battery is installed. 194 Possible Causes Corrective Actions Pump battery is not fully charged. Install a fully charged pump battery. Battery is not seated properly. Try removing and reinstalling the battery in the back of the pump. DKPI-09153-001-Rev. 1.
Problem Pump sounds an Alarm tone when the pump battery is installed. DKPI-09153-001-Rev. 1.4 Possible Causes Pump is broken. Corrective Actions Use the replacement pump provided in the starter kit. Contact your specialty pharmacy for a replacement pump.
Maintenance and Troubleshooting Table 19: Pump doesn’t make a sound when pump battery is installed Problem Pump doesn’t make a sound when pump battery is installed. 196 Possible Causes Corrective Actions Pump battery is depleted. Install a fully charged pump battery into pump. Pump is broken. Use the replacement pump provided in the starter kit. Contact your specialty pharmacy for a replacement pump. DKPI-09153-001-Rev. 1.
Maintenance and Troubleshooting Pump Sounds Table 20: Pump Sounds Sound from Pump Status Description Ready Ready to progress to next step. Continue setup. Busy Pump is busy. Wait until pump is ready. Delivering Pump is delivering medication. Confirm the remote displays green Delivering header. This tone is also an indication when exiting out of airplane mode. One beep One repeating beep Escalating Four-tones DKPI-09153-001-Rev. 1.
Maintenance and Troubleshooting Table 20: Pump Sounds Sound from Pump Status Three beeps Repeats every 15 seconds + Description Attention Alarm Pump status changed. Check the remote for more information. Alarm Medication delivery has stopped. Check the remote for more information. , + Three tone, Two-tone, Three-tone, Two-tone Repeats every 10 seconds 198 DKPI-09153-001-Rev. 1.
Below are the answers to some frequently asked questions. The Remote, Battery Charger, and AC Adapter are NOT waterproof and should be kept clean and dry. Table 21: FAQ FAQ What To Do How do I know when it's time to change my cassette? The remote's Home screen displays the hours remaining until you need to change your cassette. How often must I change the pump battery? What about the remote battery? The remote's Home screen displays how much battery life remains in the pump and remote.
Maintenance and Troubleshooting Table 21: FAQ FAQ What To Do Keep these items on hand so that you can change a depleted cassette whenever needed and keep receiving your medication: I have to travel, what should I bring with me to ensure I keep receiving my medication? What should I do with the extra tubing? • Spare Pump and Remote • Extra non-expired Pharmacy-Filled Cassette packages (enough for the number of days you will be traveling) in its unopened packaging.
FAQ What To Do Yes, the pump can tolerate immersion in fluid to depths of up to 8 ft for 30 minutes, and up to 12 feet for 3 minutes. Can I swim with my pump? The Remote, Battery Charger, and AC Adapter are NOT waterproof and should be kept clean and dry. What should I do if I travel on an aircraft? If requested to turn off all electronic devices during commercial flight, follow instructions to put the pump in Airplane Mode. See "Airplane Mode" on page 137.
Maintenance and Troubleshooting Table 21: FAQ FAQ What To Do What should I do when an Alarm or Attention Alarm appears on my remote? If the remote displays an alarm or attention alarm, refer to the section on "Alarms and Attention Alarms" on page 147. Turn to the specific page within that section referencing the resolution to the alarm or attention alarm you see on the remote screen. How do I stop medication delivery without my remote? Disconnect the infusion set tubing from the infusion site.
FAQ What To Do 1. When the pump and remote are not in communication or the remote is OFF, the following functionality is still available: What should I do when I don’t have access to my remote? • A Cassette Change can still be performed. • The pump continues to deliver the programmed medication. • Fault detection and Alarm generation is still intact. 2. If your pump is sounding an audible alarm, disconnect the infusion set tubing from the infusion site and perform a Cassette Change. 3.
Maintenance and Troubleshooting Table 21: FAQ FAQ What To Do Why won't my remote power on? 1. If the remote does not power on, try connecting it to the AC power adapter first. 2. Make sure you press and hold the power button long enough to power On the remote. 3. If the remote is broken, call technical support for troubleshooting and a possible replacement. Why won't my pump pair with the remote? 1. Make sure the pump is not attached to the cassette. 2.
Maintenance and Troubleshooting Table 21: FAQ FAQ What To Do How do I change my battery without changing to a new cassette? Ideally the pump battery change should coincide with the cassette change. To change the battery without changing the cassette, follow these steps: 1. Disconnect the infusion set tubing from the catheter. 2. Stop medication delivery on the remote. 3. Replace the pump battery. 4. Connect the cassette to the pump. 5. Connect the infusion set to the catheter. 6.
Maintenance and Troubleshooting Table 21: FAQ FAQ My battery charger is blinking red where I inserted the battery. What should I do? There are different sounds that come from the pump. How do I know which one is which? 206 What To Do 1. Try reinserting the battery in the battery charger. 2. If the light continues to blink red, try inserting the battery into another bay. 3. If the issue persists, contact your Specialty Pharmacy. The pump will make sounds to let you know when its status has changed.
Service and Support Service and Support Technical Support 208 Parts and Accessories 208 Approved Infusion Sets DKPI-09153-001-Rev. 1.
Service and Support Technical Support Parts and Accessories Discontinue use of any system component, switch to the corresponding spare if available and contact your specialty pharmacy to obtain replacement components in the event a component stops working as expected. In the event a component stops working as expected, discontinue use and switch to a spare part (if available), and contact your specialty pharmacy to obtain a replacement.
Part Number Cassette with Filling Aid DKPI(Sterile) 11022-001 Quantity Approved Infusion Sets 1 Part Description Part Number Quantity 1 Medtronic Quickset MMT-392, MMT393 1 MMT-373 1 21-7230-24, 217220-24 1 Dual USB AC Adapter DKPI40033-001 USB Cable 3.3 feet (1 meter) DKPI40034-001 1 Medtronic Silhouette Belt Clip DKPI31326-001 1 Smiths Medical Cleo 90 Clear Pump Dust Cover DKPI31219-001 1 DKPI-09153-001-Rev. 1.
Service and Support This page intentionally left blank. 210 DKPI-09153-001-Rev. 1.
Appendix A Appendix A Technical Specifications 212 Environmental Protection Ratings 215 Start-up Graph 216 Trumpet Curve 217 Remunity System Radio Specifications 223 Quality of Service Provisions 224 Guidance and Manufacturer’s Declaration Electromagnetic Emissions 225 Guidance and Manufacturer’s Declaration Electromagnetic Immunity 226 DKPI-09153-001-Rev. 1.
Appendix A Technical Specifications The Remunity™ Pump for Remodulin® (treprostinil) Injection consists of two main components; a wearable pump and a hand held remote. These two subsystems communicate via radio. The remote provides a means of programming/controlling the pump and viewing data logs. The pump is designed to deliver Remodulin subcutaneously based on a programmed delivery rate, and is to be worn for up to three days at a time.
Occlusion Detection Time: • • Rate: 16 µL/h Detection Time: 8 h Rate: 42 µL/h Detection Time: 8 h The unintended Bolus volume following the release of an Occlusion is ≤40 µL (Typically <15 µL) for all delivery rates.
Appendix A • • The Remunity™ Pump for Remodulin® (treprostinil) Injection infusion set and catheter are TYPE BF APPLIED PARTS. The following list of components are Applied Parts: - Infusion Set - Catheter The stated accuracy is valid when used with the listed infusion sets within the environmental conditions described in this User Guide. 214 DKPI-09153-001-Rev. 1.
The pump when connected to the cassette has a rating of IP58, indicating protection from dust and continuous immersion in water. The pump can tolerate immersion to depths of up to 8 feet for 30 minutes and 12 feet for up to 3 minutes. The remote does not have an IP rating. It should be kept dry and avoid exposing it to dust and dirt. The pump battery charger does not have an IP rating. It should be kept dry and avoid exposing it to dust and dirt. The AC adapters do not have an IP rating.
Appendix A Start-up Graph This stability curve shows the average flow rate over 30 minute periods. The measurements were taken at an intermediate basal rate of 42 µL/hr, in accordance with IEC 60601-2-24:2012, at room temperature while delivering Remodulin at a concentration of 1 mg/mL. 216 DKPI-09153-001-Rev. 1.
Appendix A Trumpet Curve This trumpet curve shows the accuracy of the flow rate during a 4 hour and 46 minute period (100 deliveries) as a function of an averaging window. The reported percent error deviation is calculated from the overall weight increase over the full T2 time period. The data was collected at room temperature while delivering Remodulin at a concentration of 1 mg/mL. The average shot cycle, for calculations per equations 21, 23 & 24 in subclause 201.12.1.
Appendix A Table 22: Alarm Volume Specifications Alarm Volume Specifications Specification Details The following components generate the following sound pressures when alarms are fully escalated: Pump 52 - 60 dBA Remote 56 - 66 dBA Table 23: Pump and Cassette Specifications Pump and Cassette Specifications Specification Details Pump FCC ID 2ATGA01 Size 6 cm x 6 cm x 2 cm Weight 50 g Storage Environmental Range Temperatures of -13 ˚F (-25 ˚C) to 158 ˚F (70 ˚C) Non-condensing humidity up to
Appendix A Table 23: Pump and Cassette Specifications Pump and Cassette Specifications Specification Details Operating Environmental Range Temperatures of 41 ˚F (5 ˚C) to 104 ˚F (40 ˚C) Non-condensing humidity up to 90% Pressures of 700 hPa - 1060 hPa Infusion Accuracy 6% Maximum Infusion Pressure < 113 kPa Programmable Range 16 µL/h (0.016 mL) to 225 µL/h (0.225 mL), in 1µL/h (0.001 mL) increments Pump Runtime with fully charged battery Rate: 42 µL/h Runtime: >63.
Appendix A Table 24: Pump Battery Specifications Pump Battery Specifications Specification Details Pump Battery Service Life 3 months Allowable Temperature Range for Charging the Batteries 59 ˚F (15 ˚C) to 95 ˚F (35 ˚C) Table 25: Remote Specifications Remote Specifications Specification Details Remote Interface FCC ID 2ATGA02 Size 9.8 cm x 5.5 cm x 1.8 cm Weight 102 g Battery Life The remote will typically need to be charged daily and should run all day on a charge.
Appendix A Table 25: Remote Specifications Remote Specifications Specification Details Storage Environmental Range Temperatures of -13 ˚F (-25 ˚C) to 158 ˚F (70 ˚C) Non-condensing humidity up to 90% Pressures of 500 hPa - 1060 hPa Operating Environmental Range Temperatures of 41 ˚F (5 ˚C) to 104 ˚F (40 ˚C) Non-condensing humidity up to 90% Pressures of 700 hPa - 1060 hPa Expected Service Life 3 years Table 26: Battery Charger, AC Adapter, and USB Cable Specifications Battery Charger, AC Adapter,
Appendix A Table 26: Battery Charger, AC Adapter, and USB Cable Specifications Battery Charger, AC Adapter, and USB Cable Specifications Specification Details Operating Environmental Range Temperatures of 41 ˚F (5 ˚C) to 104 ˚F (40 ˚C) Non-condensing humidity up to 90% Pressures of 700 hPa - 1060 hPa Allowable Temperature Range for Charging the Batteries 59 ˚F (15 ˚C) to 95 ˚F (35 ˚C) Service Life Battery Charger: 3 years AC Adapter: 3 years USB Cable: 3 years Table 27: Belt Clip Specifications B
Appendix A Remunity System Radio Specifications Pursuant to FCC 15.21 of the FCC rules, changes not expressly approved by the party responsible for compliance might cause harmful interference and void the FCC authorization to operate this product. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2.
Appendix A Quality of Service Provisions Interruption or corruption of communication between the Remote Interface and Pump can lead to interruptions in status updates and to making changes to therapy parameters. Momentary losses of communication will be indicated by the status bar at the top of the Remote Interface screen being gray. Interruption of communication for more than 2 hours will result in the Remote Interface declaring a No Communication Attention Alarm.
The Remunity™ Pump for Remodulin® (treprostinil) Injection is intended for use in the electromagnetic environment specified below. The user of the Remunity™ Pump for Remodulin® (treprostinil) Injection should ensure that it is used in such an environment.
Appendix A Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level +/-2 kV, +/-4 kV, +/-6 kV, +/-8 Electrostatic kV contact discharge (ESD) IEC +/-2 kV, +/-4 kV, +/-8 kV & +/61000-4-2 15 kV air 226 Compliance Level Electromagnetic Environment Guidance +/-2 kV, +/-4 kV, +/-6 kV, +/-8 kV contact +/-2 kV, +/-4 kV, +/-8 kV & +/-15 kV air Use in professional healthcare facility and
Immunity Test IEC 60601 Test Level Electromagnetic Environment Guidance Use in professional healthcare facility and home healthcare environments, excluding near high frequency surgical equipment or near MR machines. Portable communications equipment that transmit at frequencies below 80 MHz (such as 10 V/m 80 MHz to 2.7 Walkie-Talkies and hand held HAM radios) should be kept at least 1.0 GHz m [3 ft 3 inches] away from the 1 kHz 80% Remunity™ Pump for Remodulin® AM carrier (treprostinil) Injection.
Appendix A Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level 27 V/m 380 MHz – 390 MHz 18 Hz PM carrier 28 V/m 430 MHz – 470 MHz 1 kHz FM carrier 9 V/m 704 MHz – 787 MHz 217 Hz PM carrier 228 Compliance Level Electromagnetic Environment Guidance 27 V/m 380 MHz – 390 MHz 18 Hz PM carrier Mobile RF communications equipment that transmit at frequencies below 80 MHz (such as radios in Police cars, Ambulances, Fire trucks, and vehicle mounted
Immunity Test IEC 60601 Test Level 28 V/m 800 MHz – 960 MHz 18 Hz PM carrier 28 V/m 1700 MHz – 1990 MHz 2400 MHz – 2570 MHz 217 Hz PM carrier 9 V/m 5.1 GHz – 5.8 GHz 217 Hz PM carrier DKPI-09153-001-Rev. 1.4 Compliance Level Electromagnetic Environment Guidance 28 V/m 800 MHz – 960 MHz 18 Hz PM carrier 28 V/m 1700 MHz – 1990 MHz 2400 MHz – 2570 MHz 217 Hz PM carrier Cell phones, Wi-Fi equipment, Bluetooth devices and RFID readers should be kept at least 0.
Appendix A Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance 217 Hz PM carrier 20 V/m 2.4 GHz – 2.5 GHz 111.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance +/-2 kV 100 kHz repetition frequency Mains power quality should be that of a typical professional healthcare facility and home healthcare environments.
Appendix A Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level 0% UT for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° phase angles Voltage dips, short interruptions and 0% UT for 1 cycle voltage variations on power supply input 70% UT for 25 cycles at 50 Hz, lines IEC 61000-430 cycles at 60 Hz 11 0% UT for 250 cycles at 50 Hz, 300 cycles at 60 Hz 232 Compliance Level 0% UT for 0.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance 0% UT for 250 cycles at 50 Hz, 300 cycles at 60 Hz Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 DKPI-09153-001-Rev. 1.4 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Appendix A Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test Magnetic Fields generated by: • Metal Detectors • EAS Systems and Tag Deactivators (No Standard Applied) IEC 60601 Test Level N/A Compliance Level 300 A/m 0.1 kHz — 3.5 kHz 50 A/m 10 kHz - 60 kHz 30 A/m 50 kHz - 135 kHz Electromagnetic Environment Guidance Use in professional healthcare facility and home healthcare environments, excluding near high frequency surgical equipment or near MR machines.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Note: UT is the AC mains voltage prior to application of the test level. DKPI-09153-001-Rev. 1.
Appendix A This page intentionally left blank. 236 DKPI-09153-001-Rev. 1.
Appendix B Appendix B Patient-Filled Cassette Change 238 Supplies Needed for Cassette Change with Remote 239 Stop Delivery with Remote 241 Disconnect Infusion Site 243 Disconnect Cassette from Pump and Dispose 244 Replace Pump Battery 246 Prepare and Fill Cassette 248 Connect and Prime Infusion Set 253 Stop Priming and Remove Priming Aid 256 Connect Cassette to Pump 258 Connect to Catheter 261 Start Delivery 261 DKPI-09153-001-Rev. 1.
Appendix B Patient-Filled Cassette Change The Patient-Filled Cassette Change is only used when instructed by your specialty pharmacy. 1. Before you start, wash your hands with soap and water. It is a step-by-step process for replacing the pump battery, the infusion set, and an empty cassette with a patient-filled cassette.
Appendix B Supplies Needed for Cassette Change with Remote The following supplies should be kept on hand and are needed to facilitate a Cassette or Pump Battery Change. Table 31: Components for Cassette Change Remote with One Fully Charged Pump Battery DKPI-09153-001-Rev. 1.
Appendix B Table 32: Disposables for Cassette Change Remodulin Non-expired Disposable Kit, Syringe and Needle Infusion Sets Use only one of the following Infusion Sets • Medtronic Quickset Infusion Set (MMT-392, MMT393) • Medtronic Silhouette Infusion Set (MMT-373) • Smiths Medical Cleo 90 Infusion Set (217230-24, 21-7220-24) Always refer to your specific infusion set instructions. 240 DKPI-09153-001-Rev. 1.
Appendix B Stop Delivery with Remote Cell phones, Bluetooth devices, RFID readers, and Wi-Fi equipment may affect the communication between the Pump and Remote or interrupt operation of the Pump. Keep the Pump and Remote at least 0.8 m [3 ft] away from these items. See Table 28 on page 223 and See Table 30 on page 226 for more information. 1. Press the side button to wake up the remote. Your delivery rate and the hours remaining on the cassette displays. DKPI-09153-001-Rev. 1.4 2.
Appendix B 3. Press to select Change Cassette. A Delivery must be stopped before changing the cassette message displays. 4. Press to stop medication delivery. A Sending request to the pump message displays. 242 DKPI-09153-001-Rev. 1.
