Patient Therapy Controller (PTC
®
) Guide, For use with Prometra
®
Programmable Infusion Systems
24
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.
When in wireless link mode, the Clinician Programmer or PTC does not stop communication with the pump. It is acceptable for the Clinician
Programmer or PTC to be temporarily unable to communicate with the pump during the period it is exposed to sources of electromagnetic
interference, provided that the programmer resumes communication once the 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 Frequency used by the Clinician Programmer and PTC for transmission and reception. Bluetooth frequency is 2400 MHz.
Table 1 – Guidance and Manufacture’s declaration – Electromagnetic Emissions –
for all ME Equipment and ME Systems
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.
RF
emissions
CISPR 11
Group 1, Class B
These components use
RF energy only for their
internal functions.
Therefore, RF emissions
are very low and are not
likely to cause any
Harmonic emissions
IEC 61000-3-2
Class A
These components are
suitable for use in all
establishments, including
domestic establishments
and those directly
connected to the public
low- voltage power
supply network that
supplies buildings used
for domestic purposes.
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
