Product Specifications - GEM Synovis FLOW COUPLER GEM1020M Manual

MS-12854C IfU, fLOW COUPLER Monitor:Layout 1 9/15/2010 4:23 PM Page 4
The FLOW COUPLER System may be susceptible to picking up interference through the coaxial
cable that connects the probe to the Monitor. Do not use in the presence of any high frequency
equipment, including high frequency surgical generators.
Only use Monitor with FLOW COUPLER devices.
Only use FLOW COUPLER AC Power Supply.
Only use AA (LR6) alkaline batteries.
Monitor and power supply may be returned to manufacturer for proper disposal.
During the use of all ultrasound devices, the operator should minimize the exposure of ultrasound
energy to the patient using the principle of ALARA (As Low As Reasonably Achievable).

PRODUCT SPECIFICATIONS:

Monitor Description (see Figure 1):
1. Power Switch: A push-button switch that turns the unit ON. Power ON is indicated by
illumination of one of the four green Volume Setting LEDs and a red Channel Selection Switch.
When the push-button is depressed a second time the unit is turned OFF.
2. Volume Indicator: A series of four green LEDs that indicate the volume of the audible Doppler
signal.
3. Volume Increase Switch: A push-button switch that will increase the volume of the audible
Doppler signal.
4. Volume Decrease Switch: A push-button switch that will decrease the volume of the audible
Doppler signal.
5. Channel Selection Switch: A push button switch that sets the Doppler to a channel. A red LED
will be illuminated when the channel is selected.
6. Low Battery Indicator: An amber LED which, when illuminated, indicates low battery life. The
system will automatically shut OFF when the battery voltage is too low to maintain proper
operation of the Monitor.
Operation:
Transmission Frequency: 20 MHz
Transmission Characteristic: Pulsed transmission, continuous reception
Sensitivity: See FLOW COUPLER Device and System IFU
Environment:
Ambient Operating Temperature Range: +15
Ambient Storage Temperature Range: +15
IPX 0 (Monitor): No special protection
Power:
Class II External Power Source, A/C to D/C Power Supply
8 AA (LR6) alkaline batteries
Power Requirements: 12 VDC
Physical:
Dimensions: 8.50in D x 5.00in W x 3.88in H. (216 mm x 127 mm x 99 mm)
Weight: 2.5 lb, (1.13 kg)
INSTRUCTIONS FOR USE:
1. Carefully unpack your GEM FLOW COUPLER Monitor. Inspect the monitor for damage. If
the monitor is damaged, contact the manufacturer for further instructions.
2. Monitor can be powered by batteries (8 AA) or with the external power supply.
a. Install the batteries per the instructions in the SPECIAL INSTRUCTIONS section of this
manual. Use only AA (LR6) alkaline batteries.
b. Connect external FLOW COUPLER AC Power Supply to Monitor. Connect AC Power
Supply to supplied Power Cord. Connect Power Cord to a grounded, hospital grade outlet.
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 FLOW COUPLER 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
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to +40 C.
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to +40 C.