Warning; Device Description; Indications For Use; Contraindications - Boston Scientific Resectr 5F Manual Del Usuario

Resectr
™
Tissue Resection Device
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

warninG

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston
Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the
device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also
create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
ConTenTs: (1) RESECTR DEvICE AnD (1) vACUUm TUBE ADApTER.

DeviCe DesCripTion

Resectrs are non-powered, hand-held, and hand-manipulated manual surgical instruments to dissect, resect, and/or remove tissue. Resectrs may
be used through the working channel of an appropriately sized hysteroscope as an accessory instrument. Resectrs consist of a non-oscillating
outer cannula, and an internal rotating-oscillating Blade. Resectr dimensions are determined by the model number:
Model outer Diameter
5F 5 F (1.65 mm)
9F 9 F (3.0 mm)

inDiCaTions for Use

Resectrs are single-use, non-powered, hand-held, and hand-manipulated manual surgical instruments intended to be used in various hysteroscopic
surgical procedures to dissect, resect, and/or remove tissue.

ConTrainDiCaTions

• Acute pelvic inflammatory disease.
• Inadequate uterine distention and/or visualization.
• Cervical stenosis.
• Cervical/vaginal infection.
• Uterine bleeding or menses.
• Known pregnancy.
• Cervical malignancies and/or invasive carcinoma of the cervix.
• Recent uterine perforation.
• Patients receiving anti-coagulant therapy or who may have bleeding disorders.
• Medical contraindication or intolerance to anesthesia.
• Severe anemia.
• Inability to circumnavigate a myoma due to myoma size (e.g., predominantly intramural myomas with small submucous components).
Cannula length
36 cm
36 cm
Resecting Window and Internal Oscillating Blade
Rotating Cannula Collar
Outflow port and vacuum Tube Adapter
Front Handle (Grip and squeeze with index finger high on the Front Handle)
3
resecting window length
5.0 mm
7.5 mm
Black (K) ∆E ≤5.0