Introduction; C-Trak ® Analyzer And Probe Introduction; C-Trak ® Getting Started Guide - CareWise C-Trak Apollo User Manual

Wireless/wired gamma probe for radio guided surgery
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IMPORTANT
INFORMATION

1.0 Introduction

1.1 C-Trak
Analyzer and Probe Introduction
®
The C-Trak
Apollo system has been designed to detect and
®
quantify the nuclear radiation from gamma emitting isotopes
ranging in energy emissions between 27-600 keV. A clear display
of numeric quantities and an audible signal convey an increase
or decrease in radiation detection allowing the surgeon to
localize radiolabeled tissue for excision. The latest model of the
Apollo system presents maximum flexibility for the User in being
able to operate in one of three modes:
1) Wired gamma probe.
2) USB wired connection of the OmniProbe via the Apollo handset.
3) Wireless connection of OmniProbe via the
Apollo handset using bluetooth technology.
The system is comprised of the C-Trak
analyzer and one or more of the OmniProbe
The OmniProbe
and OmniProbe
®
gamma ray energies up to 364 keV. The OmniProbe
capable of detecting gamma ray energies up to 600 keV.
The analyzer is designed for operation with Care Wise designed
gamma probes. The analyzer may also be supplied with the
Apollo Wireless handset and/or foot pedal.
C-Trak
probes have special collimation and shielding that allow
®
highly directional detection of radiation from sites of interest,
along with greatly reduced detection of background radiation.
The analyzer is designed to operate the probe, display the data
from the detected radiation, and display and control the system's
operating parameters. The result is optimum performance in
measuring gamma radiation from the photopeak of isotopes
such as Technetium-99m (Tc-99m), Indium-111 (In-111),
Iodine-125 (I-125) and Fluorine-18 ([F-18]-FDG) while
minimizing detection of Compton-scattered radiation.
The C-Trak
Apollo system meets ANSI/AAMI ES60601-1: A1:2012,
®
C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO.
60601-1:14, IEC 60601-1 Edition 3.1 (2012) / EN 60601-1:2006
+ A1:2013 + A12:2014 medical safety testing and certification
requirements. Its comprehensive shielding of high voltage sites
within the instrument eliminates the possibility of significant
electrical current leakage to patient or user under normal operating
conditions. The C-Trak
Apollo system has excellent electrical
®
safety; the system is designed to turn off the high voltage if the
current exceeds 10 µA, or if any short circuit is detected.
The system has been designed and manufactured for safe
operation in an operating room environment, as long
as flammable anesthetic gases are not used and
the system is not physically abused.
The C-Trak
Apollo CW4000 System is CE certified
®
and is fully compliant with FDA (21 CFR Part 820),
MDD (93/42/EEC) and CMDR
(SOR/98-282) requirements.
1434
WARNING: No modification of this equipment is allowed.
Apollo touchscreen
®
family of probes.
®
-EL are capable of detecting
®
-PET is
®
Stand Bracket
1.2 C-Trak
Getting Started Guide
®
(1) Attach the Monitor to the Stand. Place the stand on a flat,
stable surface. Slide computer onto stand carefully until
the 'Quick Release' bracket on the back of the computer
locks into the bracket on the stand. Alternatively, if using
an accessory cart, slide computer onto the bracket
mounted on the cart.
(2) Connect the Care Wise provided Power Cord. Check that
the power supply cables are free of any nicks, cuts, exposed
wires or other damage. Connect the power supply to the
computer and to an AC outlet. Turn on the power supply
with the switch on the back of the power supply. An
indicator light on top of the power supply should glow.
(3) Connect the Probe. Check that probe cable is free of any
nicks, cuts, exposed wires or damaged connectors. Connect
the probe to the monitor and then turn the power on using
the power button on the front of the monitor. [Reminder:
The OmniProbe
is a Type B Applied Part
®
The C-Trak
Apollo system takes a few minutes to start up
®
(boot) completely. Once the system displays the Count Screen,
(described in section 2.4-1), it is ready for use.
NOTE: To verify or reset the clock time if the system has been
relocated, press 'Main Menu', then 'Setup', then 'Select Time
Zone' to choose the time zone for your area.
Assembly of the C-Trak
Apollo System
®
Monitor Bracket
Slide computer monitor quick release bracket
over stand bracket until the tab locks into place.
.]
(1) Attach Monitor to Bracket
(2) Connect Power Cord
(3) Connect Probe
3

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