User's Manual

Infinity CentralStation Instructions for Use
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Intended Use
The Infinity CentralStation is indicated for use by healthcare professionals for the
purposes of centralized monitoring within the hospital or clinical environment of
adult, pediatric and neonatal patient monitor data on the Infinity patient monitoring
network. The Infinity CentralStation is intended to measure and produce visual and
audible alarms for one or more physiological parameters. The Infinity CentralStation
with Rest ECG can provide interpretive diagnostic statements and reports for adults
and pediatric patients when connected to a monitor with ECG monitoring capability.
Infinity TeleSmart Telemetry System is indicated to be used by healthcare
professionals for the purpose of monitoring ECG and pulse oximetry parameters of
ambulatory and non-ambulatory adult and pediatric patients in healthcare type
facilities. Infinity TeleSmart is intended to operate with the Infinity CentralStation
using wireless communication over the Infinity patient monitoring network.
Infinity Telemetry System is indicated for use in an environment where patient care is
provided by healthcare professionals (physicians, nurses, technicians) when the
professional determines that a device is required to measure and produce visual and
audible alarms for adult and pediatric patient populations. Infinity Telemetry System
transmits via radiofrequency physiological signals for display and/or measurement at
the Infinity CentralStation. The Infinity CentralStation Telemetry System with TruST
is intended for 12-Lead ECG monitoring with a reduced set of electrodes.
Reconstructed leads are intended for real-time assessment of ST segment changes.
NOTE:
! The Infinity CentralStation, Infinity Telemetry receiver, and TeleSmart central
charger are not intended for use in the patient vicinity.
! Federal Law in the U.S. restricts this device to sale by, or on the order of a
physician.
! This device complies with part 15 of the FCC rules:
This device may not cause interference.
This device must accept any interference, including interference that
may cause undesired operation of the device.
! Note for Industry Canada:
This device may not cause interference.
This device must accept any interference, including interference that
may cause undesired operation of the device.
DRAFT