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Monitor not suitable for use in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide.
Not intended for fetal use.
CAUTIONS:
If procedures are not followed, possible equipment or software damage may occur.
The FlowCOUPLER 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 FlowCOUPLER devices.
Only use FlowCOUPLER 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).
No modification of this equipment is allowed.
The FlowCOUPLER Monitor is intended for use by healthcare professionals only.
The FlowCOUPLER Monitor and System may cause radio interference or may disrupt the operation
of nearby equipment.
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 FlowCOUPLER 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 FlowCOUPLER 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 FlowCOUPLER AC Power Supply to Monitor. Connect AC Power
Supply to supplied Power Cord. Connect Power Cord to a grounded, hospital grade outlet.
4
o
o
to +40
C.
o
o
to +40
C.
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