Hologic MyoSure 40-250 Instrucciones De Uso página 4

ENGLISH
Indications for Use
The MyoSure Rod Lens Hysteroscope is used to provide viewing
of the cervical canal and the uterine cavity for the purpose of
performing diagnostic and surgical procedures.
Diagnostic Hysteroscopy
• Abnormal uterine bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic Pain
Operative Hysteroscopy
• Directed biopsy
• Removal of submucous fibroids and large polyps
• Submucous Myomectomy (see Contraindications)
• Transection of intrauterine adhesions
• Transection of intrauterine septa
Contraindications
• Acute pelvic inflammatory disease
Hysteroscopy may also be contraindicated by the following
conditions, depending on their severity or extent:
• Inability to distend uterus
• Cervical stenosis
• Cervical/vaginal infection
• Uterine bleeding or menses
• Known pregnancy
• Invasive carcinoma of the cervix
• Recent uterine perforation
• Medical contraindication or intolerance to anesthesia
Contraindications to Hysteroscopic Myomectomy
Hysteroscopic myomectomy should not be undertaken without
adequate training, preceptorship, and clinical experience. The
following are clinical conditions that can significantly complicate
hysteroscopic myomectomy:
• Severe anemia
• Inability to circumnavigate a myoma due to myoma size (e.g.,
predominantly intramural myomas with small submucous
components).
Warnings
• For use only by physicians trained in hysteroscopy
• Suspicion of pregnancy should suggest a pregnancy test
before the performance of diagnostic hysteroscopy.
• The MyoSure hysteroscope is only to be used in conjunction
with accessories that comply with the following safety
standards: National/Regional versions of IEC 60601-1, the
general safety requirements for medical devices; IEC 60601-
1-2, collateral requirements for electromagnetic disturbances;
and, as applicable, IEC 60601-2-18, particular safety
requirements for endoscope equipment and accessories;
and IEC 60601-2-2, particular safety requirements for High
Frequency (HF) surgical equipment and accessories. Before
using any accessory, be sure to follow the instructions
provided with the accessory, including in the case of a HF
electrode, the maximum recurring peak voltage rating.
• When using HF surgical equipment, keep the working part of
the active electrode in the field of view to avoid accidental
burns.
• The hysteroscope and outflow channel are shipped non-sterile.
They must be thoroughly cleaned and sterilized before use.
• If scope light post adapters have been used, they need
to be disassembled, cleaned, and sterilized before every
subsequent use.
• Uterine perforation can result in possible injury to bowel,
bladder, major blood vessels, and ureter.
• High energy radiated light emitted from illuminating fiber
at the distal end of the scope may give rise to temperatures
exceeding 106°F/41°C (within 8 mm in front of the scope). Do
not leave tip of scope in direct contact with the patient tissue
or combustible materials, as burns may result. Lower the light
source output when working in close proximity to the object.
• The hysteroscope light post and adapter may exceed
temperatures of 41°C. Hysteroscopes should not be placed
on the patient or on combustible materials, as burns may
result.
• To prevent potential safety hazard to the patient caused
by accidental loss of function of the device (i.e., front end
damage by surgical instruments) it is recommend to have
an additional sterile "stand-by" device during surgical
procedures.
• When scopes are used with laser equipment, appropriate
filtering spectacles must be worn by the operating team. In
some cases, a specific filter must be put between the scope
and camera head to prevent camera damage by high-power
laser radiation. Contact your laser supplier for details. To
prevent scope damage by high-power laser radiation, always
ensure that the laser delivery fiber is seen through the scope
and not directed at the scope before energizing the laser.
For Continuous Flow Hysteroscopy:
• If liquid distension medium is used, strict fluid intake and
output surveillance should be maintained. Intrauterine
instillation exceeding 1 liter should be followed with care
due to the possibility of fluid overload.
Potential Complications of Continuous Flow Hysteroscopy:
• Hyponatremia
• Hypothermia
• Uterine perforation resulting in possible injury to adjacent
anatomy
• Pulmonary edema
• Cerebral edema
Precautions
• Vaginal ultrasonography before hysteroscopy may identify clinical
conditions that will alter patient management.
• Intrauterine distension can usually be accomplished with
pressures in the range of 35–75 mm Hg. Unless the systemic
blood pressure is excessive, it is seldom necessary to use
pressures greater than 75–80 mm Hg.
• Do not use the seals if the sterile package is open or appears
compromised. Do not use the device if damage is observed.
• Avoid exposing the scope to sudden temperature changes. Do
not immerse hot scopes into cold water or liquid.
• Any mechanical manipulation of the eyepiece may result in seal
breakage, therefore do not attempt to remove the eyepiece.
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