GEM FlowCOUPLER GEM1020M Manual page 5

NOTE: Patient isolation from the AC power is accomplished in the following ways: First, an external
medical grade power supply is used to provide DC operating voltage for the FlowCOUPLER System.
Both DC power output lines from the power supply are isolated from the AC power in the DC power
supply. There is no connection between the "green" safety ground and the Monitor. The implanted probe is
further isolated by use of an RF isolation transformer that isolates both signal and ground leads between the
Monitor and the probe. The probe's coaxial shield is connected to the Monitor chassis ground through two
safety capacitors. Both the capacitors and the isolation transformer have a 4000VAC dielectric withstand
voltage. The 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.
3. Place the Monitor on a suitable stand, cart or table outside the sterile field, in close proximity to
the physician who will be using the FlowCOUPLER System. The Monitor should not be used
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 in close proximity to electrically active conductors, such as an electro-surgery
cables or a 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.
4. Refer to GEM FlowCOUPLER Device and System Instructions for Use for handling of the
FlowCOUPLER Device.
5. Transfer the free connector of the external lead (supplied with the FlowCOUPLER device)
outside the sterile field. Insert this free connector into either receptacle A or receptacle B on the
front panel of the Monitor.
6. Turn the Monitor on by depressing the Power Switch.
7. Ensure that the Channel Selection Switch (A or B) corresponds with the chosen receptacle.
8. 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.
9. Adjust the volume by depressing and holding the Volume Increase Switch or Volume Decrease Switch
to the desired level. If a strong audible signal is not identified, irrigate the anastomotic site with saline.
During irrigation, an audible signal from the Monitor verifies proper function of the device.
SPECIAL INSTRUCTIONS:
Maintenance and Cleaning:
The Monitor requires minimal maintenance. Keep it clean and free of dust. The exterior may be
cleaned using the following steps:
1. After every use, check the Monitor for any sign of damage or wear.
2. Wipe the Monitor with a dry or water-moistened soft cloth.
3. Wipe the Monitor with Isopropyl alcohol (70%) moistened soft cloth. Ensure any residual organic material
is removed. Do not pour 70% isopropyl alcohol directly on the Monitor. Allow to air dry before use.
4. Do not put liquid near the speaker.
Battery Replacement:
Make sure that the Monitor power is turned OFF by depressing the Power Switch push-button so
that no LED's are illuminated.
Unscrew and remove the battery compartment cover of the Monitor, exposing the battery holder
within the compartment. Slide the battery holder out of the compartment. Remove both of the battery
holder covers exposing the old batteries. Replace old batteries with new, AA (LR6) size alkaline
batteries. Observe the battery polarity markings that are molded into the battery holder. Replace the
battery holder covers and return battery holder to battery compartment. Replace battery compartment
cover and tighten screws. Properly dispose of old batteries according to local regulations.
NOTE: Remove batteries during prolonged storage. Do not install backwards, charge, put in fire, or mix
with other battery types. May explode or leak causing injury. Replace all batteries at the same time.
THE FOLLOWING SECTIONS APPLY TO THE FLOWCOUPLER 20 MHZ DOPPLER
PROBE
Acoustic Output:
There are no user controls meant to affect acoustic outputs. All acoustic outputs are below the
application specific pre-amendments acoustical output limit of an I
Explanation of Derivation of Derating Factor
The derated intensity calculations are based on the measured center frequency of the acoustical
signal (f, MHz) and the distance from the transducer under test to the hydrophone (z, cm) using the
derating factor e .
-0.069 fz
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of 94 mW/cm and a MI of 1.9.
2
spta.3