Table of Contents
Troubleshooting
Summary of Contents for Flowonix Prometra Patient Therapy Controller
- Page 1 ® Prometra ® Patient Therapy Controller (PTC ) Guide ® For use with Prometra Programmable Infusion Systems MR Unsafe Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
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Page 2: Fcc Information
Explanation of Symbols Refer to the package and product labeling to see which symbols apply to this product. Catalog number Serial number Date of manufacture Non-sterile Caution, consult accompanying documents Consult instructions for use MR Unsafe Keep dry Non-ionizing electromagnetic radiation Electrical Safety Type BF Applied Part Waste must be controlled according to local regulation and collection schemes for disposal of... - Page 3 (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Flowonix Medical, Inc., could void the FCC Certification and negate your authority to operate this product.
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Page 4: Table Of Contents
Table of Contents Explanation of Symbols ....................... 2 FCC Information ........................3 Glossary 5 Patient Therapy Controller ....................6 ® Description ....................... 6 Purpose of the PTC ® (FDA approved indications).............. 6 Potential Benefits ......................6 Potential Risks ........................6 Radio Signals ........................ -
Page 5: Glossary
Glossary Bolus or Drug Bolus – supplement drug dose prescribed by your doctor. This drug dose has a set amount and is delivered in a set amount of time. PTC® – Patient Therapy Controller Dose per Bolus – the amount of medication that will be delivered by your pump. Drug Bolus Duration –... -
Page 6: Patient Therapy Controller
Patient Therapy Controller Software Revision: 2.01.1 PTC® Description The Patient Therapy Controller is an accessory to the Prometra ® Programmable Infusion System that allows you to periodically deliver additional doses of Infumorph® (a drug bolus) as prescribed by your doctor. When you activate the delivery of a drug bolus with the Patient Therapy Controller, it communicates with the implanted Programmable Pump and tells it to deliver the drug bolus. -
Page 7: Radio Signals
Patient Therapy Controller Potential Risks (continued) • Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. Pain, redness, or swelling at the injection site may occur if this medication is given into a muscle or under the skin. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. -
Page 8: Ptc® Overview
• Lockout Duration: The length of time that you must wait between bolus deliveries. If you have any questions concerning the use of your Patient Therapy Controller, call Flowonix Medical’s Technical Solutions Department at 855- 356-9665 or contact your physician. -
Page 9: Ptc® Orientation
Patient Therapy Controller PTC® Orientation The signal used to program the Programmable Pump can travel up to 2 inches (5 cm). If the Patient Therapy Controller is not positioned close enough to the pump or is not oriented correctly over the pump, the Patient Therapy Controller will not be able to communicate with the pump. -
Page 10: Warnings
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Patient Therapy Controller including cables specified by Flowonix. Otherwise, degradation of the performance of this equipment could result. -
Page 11: Precautions
Precautions • Carefully read and follow all instructions prior to use. • Use of the equipment by untrained or non-qualified personnel could lead to serious harm to the patient. • The wireless communication signal used to inquire and program the Programmable Pump (referred to as telemetry) can travel about 2 inches (5 cm). - Page 12 How to Initiate a Bolus using the PTC® 2. Prior to using, ensure your Patient Therapy Controller is charged. To charge, plug in your included Micro USB Charger into the USB port located at the bottom of the Patient Therapy Controller. Then, connect it to an AC outlet. When charging, the Patient Therapy Controller is disabled and cannot be used.
- Page 13 How to Initiate a Bolus using the PTC® Note: While the battery is charging, the Patient Therapy Controller does not indicate the amount of charge. To determine the percentage of battery charged, simply unplug the device from the charger and press the power button. You will feel and hear a “click” when it is pressed. The amount of charge will be displayed at the top of the screen.
- Page 14 How to Initiate a Bolus using the PTC® 4. After you Press the “Rx” button on your Patient Therapy Controller, the screen will display “Place Programmer over Pump to deliver bolus”. Place and hold the Patient Therapy Controller over the Programmable Pump until the display reads that bolus delivery was successful and success tone is heard.
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Page 15: How To Initiate A Bolus Using The Ptc
Estimated date when pump requires refill Troubleshooting If assistance is needed at any time during use, please contact your physician or Flowonix Medical’s Technical Solutions Department at 855-356- 9665. PTC® Battery Messages ® ® Patient Therapy Controller (PTC... - Page 16 The following messages may be displayed on the Patient Therapy Controller depending on the charge level of your device. This message reminds the user that the device cannot be operated at the same time it is charging. The patient does not need to wait for a full charge to deliver a bolus.
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Page 17: Troubleshooting
Troubleshooting PTC® Battery Messages (continued) The Patient Therapy Controller has received a full charge of the battery. To use the Patient Therapy Controller, unplug from the charger. At 10% battery, the charged icon will turn red. The Patient Therapy Controller has enough battery to complete the current task, but you should charge your battery following this use and before your next use. -
Page 18: Ptc® Wireless Communication Troubleshooting
Troubleshooting PTC® Battery Messages (continued) Once the battery charge reaches 5% or lower, the Patient Therapy Controller will not be able to deliver a bolus. You must charge your battery before your next use. PTC® Wireless Communication Troubleshooting The Patient Therapy Controller interacts with the Programmable Pump using a 2-way wireless communication link. The signal used to inquire and program the pump can travel about 2 inches (5 cm). -
Page 19: Messages That Might Appear On Your Ptc's Screen
Troubleshooting Messages that might Appear on Your PTC’s Screen Message on Patient What you should do if this Description of message Therapy Controller message appears Bolus Not Delivered. The Patient Therapy Controller Press OK. If you want to deliver Pump Not Found. was unable to communicate with a bolus, press To Try Again, Press OK. -
Page 20: Ptc® Pump Error Messages
• If you are no longer going to use the Patient Therapy Controller, you should return it to your physician. Your physician will arrange to have it to returned to Flowonix Medical. Batteries for PTC® (Rechargeable/Internal) • Use the supplied Micro USB Charger (AC adapter) to charge the internal battery for the touchscreen using a UL approved power source. -
Page 21: Service
Service The Patient Therapy Controller has no serviceable parts. For technical issues or questions about the programmer, please contact your physician or contact Flowonix Medical‘s Technical Solutions Department. Handling and Care Do not drop the Patient Therapy Controller or subject it to severe shock. If the device becomes damaged, contact your physician. -
Page 22: Patient Therapy Controller Specifications
Patient Therapy Controller Specifications 4.60 inches (11.69 cm) Height Width 3.20 inches (8.13 cm) Depth 1.20 inches (3.05 cm) Approximately 190 grams Weight Telemetry Range Approximately 2 inches (5.08 cm) above the pump. Interference may occur in the vicinity of equipment marked with the following symbol: Rechargeable Lithium ion battery. -
Page 23: Legal Notices
Liability under this limited product warranty will be limited to repair or replacement of the defective product, at the sole discretion of Flowonix, or a refund of the net price paid. Wear and tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty. -
Page 24: Appendix
Appendix Technical Specifications and EMC Tables The Patient Therapy Controller is intended for use in the electromagnetic environment specified in the following EMC tables. The user of the device should assure that it is such an environment. Essential Performance of the Clinician Programmer and PTC Medical Equipment Performance Criteria - unacceptable operating conditions / responses are: When charging in standby mode the Clinician Programmer or PTC does not go into operating mode. - Page 25 Appendix Technical Specifications and EMC Tables (continued) Table 2: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Patient Therapy Controller is intended for use in the electromagnetic environment specified below. The customer and/or the user of this device should assure that it is operated in such an environment.
- Page 26 Appendix Technical Specifications and EMC Tables (continued) Table 3 – Guidance and Manufacturer’s declaration – Electromagnetic Immunity – for Patient Therapy Controller The Patient Therapy Controller is intended for use in the electromagnetic environment specified below. The customer or the user of this equipment should assure that it is used in such an environment.
- Page 27 Issue Date: January 2020 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.