Operation - GEM FLOW COUPLER Manual

Operation:

Transmission Frequency: 20 MHz
Transmission Characteristic: Pulsed transmission, continuous reception
Sensitivity: See FLOW COUPLER Device and System IFU
Environment:
Recommended shipping and storage temperature: 5
IPX 0 (Monitor): No special protection
Power:
Class II External Power Supply shipped with the monitor or sold separately (GEM1020PS-2),
A/C to D/C Power Supply Internally rechargeable Lithium Ion Battery, Power Requirements:
12 VDC
Physical:
Dimensions: 8.2in L x 5.7in W x 2.8in H. (216 mm x 127 mm x 99 mm)
Weight: 1.84 lb, (0.835 kg)
Instructions for use:
1. Carefully unpack your FLOW COUPLER Monitor. Inspect the monitor for damage. If the
monitor is damaged, contact the manufacturer for further instructions.
2. Place the Monitor on a suitable stand, cart or table outside the sterile field, near the
physician who will be using the FLOW COUPLER System. Avoid using the Monitor in
the presence of any high frequency equipment, including high frequency surgical
generators. The Monitor has a rating of IPX-0. Keep the Monitor away from all open
liquids.
NOTE: If the external lead is near electrically active conductors, such as electro-surgery
cables or an electronic equipment chassis, signals from the cables or chassis may be
picked up by the Monitor and produce undesired audible signals. This interference is easily
distinguished from blood flow and is remedied by moving the external lead away from the
source of the interference.
3. Connect the Power Supply provided with the monitor or sold separately
(GEM1020PS-2) to the Monitor, if desired. Connect the Power Supply to the appropriate
adaptor plugs supplied with the Power Supply. Connect the adaptor plug to a
grounded hospital grade outlet. The monitor contains internally rechargeable batteries.
If charged, the Power Supply is not required for the operation of the monitor.
NOTE: Patient isolation from the AC power is accomplished in the following ways: The DC
power output lines from the power supply are isolated from the mains in the DC power
supply. There is no connection between the "green" safety ground and the Monitor. The
0 C to 40 0 C, non-condensing
final isolation mechanism is the cable insulation and potting of the probe that provides an
additional insulation layer between the isolated electrical signals and the patient.
4. Turn the Monitor on by depressing the Power Button located on the back of the
monitor.
5. Enter Audio ID and Facility ID. Do not use PII or PHI for IDs.
NOTE: Use instructions for the remote monitoring via APP are included in the User Manual
supplied with the Monitor.
6. Check for the battery level shown in upper right portion of the LCD screen. Connect the
Power Supply to the monitor as instructed in Step 3, if desired.
7. Refer to FLOW COUPLER Device and System Instructions for Use for handling of the
FLOW COUPLER Device. NOTE: Probe leads may be labeled with the Channel
A or B for identification.
8. Transfer the free connector of the external lead (supplied with the FLOW COUPLER
device) outside the sterile field. Insert this free connector into either Channel receptacle
A or Channel receptacle B on the front side of the Monitor.
9. Ensure that correct Channel Selection Button is illuminated and Channel Selection
Indicator on the LCD screen is displayed.
10. Listen for blood flow. Some background noise may be audible.
NOTE: If blood flow is not detected with the Monitor post-operatively, rely on clinical
indications for patient status.
11. Adjust the volume by depressing and holding the Volume Increase Button or Volume
Decrease Button to the desired level. If a strong audible signal is not identified, irrigate
the anastomotic site with saline and inspect the probe is in contact with the vessel.
During irrigation, an audible signal from the Monitor verifies proper function of the
device.
12. Turn off the Monitor after use by depressing the Power Button.
6.