Flowonix Prometra Patient Therapy Controller Manual Download Page 23

Patient Therapy Controller (PTC

®

) Guide, For use with Prometra

®

 Programmable Infusion Systems 

 

23 

Legal Notices 

Flowonix Medical, Inc. (“Flowonix”) makes no representations or warranties with respect to Prometra

®

 Patient Therapy Controller, any software, or 

the contents of this documentation, or use of same, and specifically disclaims any express or implied warranties of merchantability or fitness for 
any particular purpose. Further, Flowonix reserves the right to revise the Patient Therapy Controller, any software and/or this publication and to 
make changes to its design or content, at any time, without obligation to notify any person or entity of such revisions or changes except as required 
by law or governing regulatory agencies. This product may require  
export authorization from the U.S. Department of Commerce prior to exporting from the U.S.

 

Warranty 

Flowonix warrants to the first purchaser of this product that this product will be free from defects in materials and workmanship for a period of 
one year from the date of first purchase. 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. 

To the extent allowable by applicable law, this limited product warranty is in lieu of all other warranties, whether express or implied, including, 
but not limited to, any implied warranty of merchantability or fitness for a particular purpose. In no event will Flowonix be liable for any 
incidental or consequential damages resulting from handling or use of this product. 

Some states and/or countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to 
additional remedies under the laws of your state and/or country. 

General Disclaimer 

The examples of the Prometra

®

 Patient Therapy Controller screens shown in this manual are simulations, not exact reproductions of the device 

screens. Every effort has been made to ensure that the contents of these sample screens are complete and accurate; however, there may be 
variations in appearance (text spacing, character font face, etc.) and default settings (default numbers and amounts) between the sample screens 
in this manual and the actual screens in the programmer. 

Trademarks are the property of their respective owners. 

US and Foreign patents issued and pending. Please consult www.flowonix.com for the most up-to-date information. 
 

 

Summary of Contents for 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...

Page 2: ...ep 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 Batteries Latex Free...

Page 3: ...evice 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 vo...

Page 4: ...view 8 PTC Orientation 9 Warnings 10 Precautions 11 How to Initiate a Bolus using the PTC 11 Troubleshooting 15 PTC Battery Messages 15 PTC Wireless Communication Troubleshooting 17 Touchscreen Troubl...

Page 5: ...be delivered by your pump Drug Bolus Duration the length of time that it will take to deliver your bolus Allotted Boluses per day The maximum number of boluses allowed to be delivered within 24 hours...

Page 6: ...ble side effects or your current treatment regimen is not decreasing your symptoms The use of the Patient Therapy Controller may help you better manage your drug delivery therapy from your Programmabl...

Page 7: ...s not a complete list of possible side effects If you notice other effects not listed above contact your doctor Radio Signals Radio signals sent by your Patient Therapy Controller could interfere with...

Page 8: ...ength 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...

Page 9: ...rogrammable Pump follow these steps 1 Horizontally position the Patient Therapy Controller up to 2 inches 5cm above the pump The top of the Patient Therapy Controller should be parallel to the top of...

Page 10: ...cal devices has not been established Schedule regular refill visits to avoid reservoir depletion and possible discomfort Contact your physician if you experience changes in your symptoms Potential com...

Page 11: ...Disassembling the Patient Therapy Controller may damage it or cause it to malfunction Certain electronic equipment may cause interference with the Patient Therapy Controller Interference may also occ...

Page 12: ...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 Controlle...

Page 13: ...ear a click when it is pressed The amount of charge will be displayed at the top of the screen Note Charge will need to be above 5 to deliver bolus 3 Once your Patient Therapy Controller is setup it w...

Page 14: ...until the display reads that bolus delivery was successful and success tone is heard During this process the device will display Programming in progress 5 If you have not positioned the Patient Thera...

Page 15: ...he maximum number of boluses allowed has been reached the countdown timer may display an extended lockout period For example Drug Bolus Duration 30 minutes Lockout Duration 2 hours Allotted Boluses pe...

Page 16: ...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 de...

Page 17: ...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...

Page 18: ...cm If the Patient Therapy Controller is not positioned properly over the pump it may not be able to communicate with the pump and the bolus delivery may fail See the Patient Therapy Controller Orient...

Page 19: ...not currently set to this pump Contact physician Press OK to continue Your Programmable Pump is not setup with your Patient Therapy Controller Contact physician to setup your Patient Therapy Controll...

Page 20: ...Technical Solutions Department identify the issue with the pump Below is an example of what an error message would look like In all cases contact your physician or Technical Solutions Department for...

Page 21: ...leave it as is Then dry the device with a towel and contact your physician Caution If device becomes wet do not use as there is a possible electrical shock hazard Do not store the device in hot or co...

Page 22: ...lly time out after 1 minute of no operation Voltage Rating 5 VDC Regulatory i Degree of electrical insulation Type BF body floating ii Protection against water ingress Ordinary equipment IP22 iii Mode...

Page 23: ...ix 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 To the extent allowable by applicable law t...

Page 24: ...e exposure period has ended Electromagnetic interference has been classified as a minor risk and does not have an impact on safety Specification of RF Frequency Bands Bluetooth is the only RF Frequenc...

Page 25: ...for input output lines Mains power quality should be that of a typical home healthcare environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to...

Page 26: ...onment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 V 0 15 MHz 80 MHz 6 V in ISM bands and amateur radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 10 V m 80 MHz 2 7 GHz 80 AM...

Page 27: ...tween this date and product use the user should contact Flowonix Medical Inc to see if additional product information is available Infumorph is a registered trademark of West Ward Pharmaceuticals Corp...

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