English
5
MyoSure
®
XL Tissue Removal Device for Fluent
Recommended Separation Distances
The following lists the recommended separation distances between portable and mobile RF communications equipment and the FLUENT FLUID
MANAGEMENT SYSTEM.
Recommended Separation Distances
The FLUENT FLUID MANAGEMENT SYSTEM is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. The customer or the user of the FLUENT FLUID MANAGEMENT SYSTEM can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the FLUENT FLUID MANAGEMENT SYSTEM as
recommended below, according to maximum output power of the communications equipment.
Rated maximum output power of transmitter
[W]
Separation distance according to frequency of transmitter [m]
150 kHz to 80 MHz
d = 1.2
√
P
80 MHz to 800 MHz
d = 1.2
√
P
800 MHz to 2.7 GHz
d = 2.3
√
P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated by
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts [W]
according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people
Tissue Removal Device for Fluent: 50-601XL/50-603XL
The MyoSure XL Tissue Removal Device for Fluent is shown in Figure 1. It is a hand-held
unit which is connected to the Fluent Fluid Management System via a 6-foot (1.8-meter)
flexible drive cable and to the Out-FloPak via a 10-foot (3-meter) suction tube. Cutting action
is activated by a foot pedal. The tissue removal device is a single-use device designed to
hysteroscopically remove intrauterine tissue.
The flexible drive cable is inserted into the drive cable adapter on the front panel of the Fluent
Fluid Management System.
The proximal end of the suction tube is connected to the Out-FloPak of the Fluent Fluid
Management System.
The suction pressure draws fluid and resected tissue through the tissue removal device’s
cutting window.
Set-up
The tissue removal device is EtO sterilized. Verify that the tissue removal device is sterile prior
to use.
Do not use if the package is opened or damaged. Discard all opened, unused devices.
CAUTION:
The tissue removal device is intended for single use only. DO NOT RE-
STERILIZE. DO NOT REUSE. Discard tissue removal device after use. Dispose of
the tissue removal device and packaging according to your facility’s policies
and procedures concerning biohazardous materials and sharps waste.
WARNING - DANGER: Risk of explosion if used in the presence of flammable
anesthetics.
1. Review the System Configuration Diagram in Figure 2 for set-up outline.
2. Refer to the Fluent Fluid Management System Operator’s Manual for instructions on how to set up the Fluent Fluid Management System.
3. Connect the foot pedal tube to the connector on the front of the Fluent Fluid Management System console.
Figure 1. MyoSure XL Tissue Removal Device
for Fluent
Figure 2. System Configuration
