Environmental Protection
CAUTION: The control unit and tissue removal device contain
electronic printed circuit assemblies. At the end of the useful life
of the equipment it should be disposed of in accordance with
any applicable national or institutional related policy relating to
obsolete electronic equipment.
CAUTION: Tissue removal device (single-use, disposable) may
represent biohazard. Treat and dispose of only in accordance with
any applicable national or institutional related policy.
Preventive Maintenance
Recommended Annual Performance Checks
Hologic recommends that Dielectric Strength, Earth Leakage Current,
and Protective Earth Testing be performed annually to assure continued
compliance with applicable safety requirements. These tests should be
conducted in accordance with specifications UL 2601-1/IEC 60601-1.
CAUTION: Electrical safety testing should be performed by a
biomedical engineer or other qualified person.
Service
The following are replacement parts for the Hologic
MyoSure Hysteroscopic Tissue Removal System:
REF
Description
52124-001
MyoSure Foot Pedal
Service Philosophy
There are no user serviceable components inside the
MyoSure Hysteroscopic Tissue Removal System Control Unit. Repairs
and adjustments are to be performed only by Hologic authorized service
centers.
WARNING: No modification of this equipment is allowed.
If service becomes necessary, refer to the Technical Support Product
Return Information in these instructions for use.
MyoSure Control Unit Fuses
The MyoSure Control Unit is protected by two 1.5 amp/250 V fuses
mounted on the rear panel below the three-pronged electrical connector.
If the MyoSure Control Unit fails to power up when properly connected to
a 100–120/200–240 VAC, 50/60Hz, 150 VA, AC power source, check the
fuses in the rear panel.
To change the rear panel fuse:
1. Disconnect the unit from the power source.
2. Locate the fuse tray just above the power cord socket and just below
the fuse label (refer to Figure 2 rear panel view).
3. Use a slotted screwdriver to press the tabs on either side of the fuse
holder in, toward the center of the tray.
4. Slide the fuse tray out.
5. Replace the fuse with 1.5 amp/250 V Slow Acting fuses.
6. Insert the tray into the holder until the tabs click into place.
7. Reapply power to the unit.
NOTE: Blown fuses usually indicate a short circuit or a failed
component. Make sure components are properly interconnected.
If the problem persists, contact Hologic Technical Support for
troubleshooting assistance.
CAUTION: Electrical safety testing should be performed by a
biomedical engineer or other qualified person.
Troubleshooting
1. The MyoSure Hysteroscopic Tissue Removal System is very simple to
operate. The control unit is switched ON using the front panel power
switch. If the unit does not operate, check the following:
2. Unit is plugged into wall outlet.
3. Wall outlet has power.
4. Power cord is attached to back of MyoSure Control Unit.
5. Foot Pedal has been connected to front panel.
6. Vacuum pressure is available.
7. Vacuum tubing is connected.
If excess force or bend is applied to the MyoSure Tissue Removal Device,
the control unit will shut off the timer display to protect the system. In
this event, switch the main power switch located in the front panel of
the control unit to OFF, wait for 15 seconds and then switch the main
power switch to ON to resume operation of the MyoSure Tissue Removal
System.
NOTE: If the system is turned off for any reason, wait at least
15 seconds before turning the power back on.
Technical Specifications
MyoSure Control Unit (REF 10-550)
Dimensions
Weight
Power
Equipment Classification
Protection against electrical shock class 1 with BF type applied part.
Protection against harmful ingress of water, IPX1.
Not suitable for use in the presence of flammable anesthetics with
mixture of air, oxygen, or nitrous oxide. (Not suitable)
Mode of Operation
Environmental Conditions
Transportation and Storage
Temperature Range:
Relative Humidity:
Air Pressure:
Operation
Temperature Range:
Relative Humidity:
Air Pressure:
Front Panel
Power ON/OFF
Time Display Window
6-character by one-line numeric display which indicates elapsed time
Min:Sec
Connectors
Flexible drive cable connector for tissue removal device.
Foot Pedal cable connector for foot control.
7
7.5" W x 11" L x 3" H
19 cm W x 28 cm L x 7.6 cm H
5.4 lbs / 2460 g
100–240 VAC, 50/60 Hz, 1.5 A
Continuous operation
-15°C to 40°C (5° F to 104° F)
10 to 93% RH, non-condensing
500 to 1060 hPa(15 to 31 in Hg)
10°C to 40°C (50° F to 104° F)
30 to 75% RH
700 to 1060 hPa (21 to 31 in Hg)
Push button switch
ENGLISH