Electromagnetic Safety; System Components; Control Unit-Front Panel; Power Switch - Hologic MyoSure Manuel D'utilisation

ENGLISH
• Do not allow the rotating portion of the tissue removal device
to touch any metallic object such as a hysteroscope or sheath.
Damage to both instruments is likely. Damage to the tissue removal
device can range from a slight distortion or dulling of the cutting
edge to actual fracture of the tip in vivo. If such contact does occur,
inspect the tip. If you find cracks, fractures or dulling, or if you have
any other reason to suspect a tissue removal device is damaged,
replace it immediately.
• Do not operate the tissue removal device in the open air for an
extended period, as the lack of irrigation may cause the tissue
removal device to overheat and seize.
• Excessive leverage on the tissue removal device does not improve
cutting performance and, in extreme cases, may result in wear,
degradation, and seizing of the inner assembly.
• Do not sterilize or immerse the MyoSure Control Unit in disinfectant.
• Do not cool the tissue removal device by immersing it in cold water.
• Electrical safety testing should be performed by a biomedical
engineer or other qualified person.
• This equipment contains 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.

Electromagnetic Safety

• The MyoSure Hysteroscopic Tissue Removal System needs special
precautions regarding electromagnetic safety and needs to be
installed and put into service according to the electromagnetic
safety information provided in this manual.
• This equipment is designed and tested to minimize interference
with other electrical equipment. However, if interference occurs
with other equipment it may be corrected by one or more of the
following measures:
Reorient or relocate this equipment, the other equipment, or both.
•
Increase the separation between the pieces of equipment.
•
Connect the pieces of equipment into different outlets or circuits.
•
Consult a biomedical engineer.
•
• All equipment performance is considered safety-related
performance. That is, the failure or degradation of the performance
specified in this manual will pose a safety risk to the patient or
operator of this equipment.
• Note: If the MyoSure Hysteroscopic Tissue Removal System
is put into service in accordance to the safety instruction in
this manual, the product should remain safe and provide the
performance listed above. If the product fails to provide this
level of performance, the procedure should be aborted and the
biomedical staff alerted to the observed problem. The problem
needs to be corrected before continuing or starting a new
procedure.
• Portable and mobile RF communications equipment, including
cellular telephones and other wireless devices can affect
medical electrical equipment. To insure safe operation of the
MyoSure Hysteroscopic Tissue Removal System, do not operate
communications equipment or cellular telephones at a distance
closer than specified in Table 4 of this manual.
• The MyoSure Hysteroscopic Tissue Removal System is not designed
to work with or in the vicinity of electrical surgical equipment. If
electrical surgical equipment must be used in the same area as
the MyoSure Hysteroscopic Tissue Removal System, the MyoSure
Hysteroscopic Tissue Removal System should be observed for
proper operation before performing a procedure. This includes
operating the electrical surgical equipment in its active mode at a
power level suitable for the procedure.
• For more information regarding the electromagnetic safety of this
product, please see Tables 1–4 in the back of this manual.

System Components

MyoSure Control Unit (REF 10-550)
Control Unit—Front Panel
The MyoSure Control Unit front panel includes power switch, tissue
removal system timer display, foot pedal, and tissue removal device
connectors (Figure 1).
FIGURE 1. MYOSURE CONTROL UNIT—FRONT PANEL

Power Switch

The power switch is the power ON / OFF switch for the entire system
and must be activated prior to use.
NOTE: If system is turned off for any reason, wait at least
15 seconds before turning power back on.

Timer Display Window

The MyoSure Control Unit displays the elapsed operating time for the
tissue removal device in MIN:SEC format.

MyoSure Foot Pedal and Tissue Removal Device Connectors

The foot pedal and tissue removal device connectors are located on
the front panel.
MyoSure Control Unit—Rear Panel
There is one connector and equipotential compensator terminal on the
rear panel (Figure 2).
FIGURE 2. MYOSURE CONTROL UNIT
(*=EQUIPOTENTIAL COMPENSATOR TERMINAL)
The 3-pronged electrical connector allows any 100–120/200–
240 VAC, 50/60 Hz, ISO VA source using the power cord supplied with
the system. The MyoSure Control Unit power supply automatically
detects the local power standard and adapts the tissue removal
device to that standard. The equipotential compensator terminal
permits connection of the MyoSure Control Unit to an external earthing
system (not shown).
WARNING: To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth.
4
*
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REAR PANEL