Patient Therapy Controller (PTC
®
) Guide, For use with Prometra
®
Programmable Infusion Systems
10
Patient Therapy Controller
PTC®
Orientation (continued)
3.
Hold the Patient Therapy Controller steady until the tone stops and the message changes on the device’s screen. The Patient Therapy Controller’s
tone lasts up to approximately ten seconds. Once connection is complete, the Patient Therapy Controller sounds a confirmation tone.
Note: If a transaction fails, it may be due to interference or the communication distance being out of range during inquiry or programming.
Refer to the Troubleshooting section (page 11) if there is difficulty with wireless communication.
Warnings
•
Always select and program dosages consistent with the Infumorph
®
labeling to prevent improper drug administration.
•
To avoid electric shock or damage to the Patient Therapy Controller, please avoid contact with water.
•
Only use the Patient Therapy Controller after receiving training specific to this device. Use of this device by non-qualified or untrained personnel
could lead to serious consequences involving under- or over-dosage of Infumorph
®
. In the event of over-dosage, refer to the approved
Infumorph
®
labeling for appropriate treatment.
•
Clinicians programming implanted Programmable Pumps must comply with the instructions for use. Technical errors may result in a return of
underlying symptoms, drug withdrawal symptoms, or clinically significant or fatal over-dose.
•
The handheld Patient Therapy Controller uses electromagnetic energy to program the Programmable Pump. The device’s electromagnetic field
may affect other medical devices. Use or interference with other medical 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 communication problems between the Programmable Pump and the Patient Therapy Controller may occur after exposure to other
therapies or procedures, which may include, but are not limited to: magnetic resonance imaging, diathermy, electrosurgical cautery,
radiofrequency ablation and lithotripsy.
•
Use of a power source other than those provided by Flowonix could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
•
To avoid the risk of shock, when using the AC adapter to charge the Patient Therapy Controller, it must be connected to a grounded AC power
outlet.
•
The Patient Therapy Controller is not intended to be functional and used while it is charging. All inquiring and programming functionality is
disabled.
•
Use of the Patient Therapy Controller adjacent to or stacked with other equipment should be avoided because it could result in improper
operation. If such use is necessary this equipment the other equipment should be observed to verify that they are operating normally.
•
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.
•
Patient Therapy Controllers with software versions prior to 2.01.1 are not compatible with Prometra II 40 mL pumps. Contact Flowonix Medical
Technical Solutions at (855) 356-9665 for more information on software upgrades.
•
MRI Safety:
The Patient Therapy Controller is MR Unsafe.
