Warnings; Precautions; Possible Adverse Effects; Materials Required For Use - Boston Scientific Resectr 5F Manual Del Usuario

see the operator's manual of your hysteroscope for absolute and relative contraindications

warninGs

• The Resectr™ Tissue Resection Device has no other user serviceable parts. Do not attempt to repair or to alter the device.
• Any use of this Device, other than those indicated in these instructions is not recommended.
• For use only by physicians trained in hysteroscopy.
• Suspicion of pregnancy should suggest a pregnancy test before performance of hysteroscopy.
• Use care when handling and loading medical devices to avoid damage or injury.
• Use direct visualization during use of any Resectr device.
• Do not use Resectr to resect tissue adjacent to an implant or suture material.
• Do not use Resectr to cut suture material.
• Resectrs are not intended to resect calcified tissue.

preCaUTions

• Do not use if labeling is incomplete or illegible.
• Before using, inspect the blister pouch for any breach of the package to ensure a sterile product and inspect product for any damage.
• If seal has been broken or product is damaged DO NOT USE. Immediately return package and product to your Boston Scientific representative.
• Store the packaged and sealed device in a cool, dry, dark place.
• Do not expose the Resectr device to organic solvents.
• Only use the Resectr device prior to the "Use Before" date noted on the package.
• Prior to use, carefully inspect the package and Resectr device. Do not use if opened, damaged or if damage is suspected.
• Resectr devices should only be manipulated under direct visualization.
• Never advance or withdraw any Resectr device against resistance until the cause of the resistance is determined.
• Movement of any Resectr device against resistance may result in medical device damage, tissue perforation, or other injury.
• Excessive force on the device handle(s) may cause bending or kinking of the cannula.
• Do not force the device handle(s) if binding occurs.
• Intrauterine distention can usually be accomplished with pressures in the range of 35-70 mmHg. Unless the systemic blood pressure is excessive,
it is seldom necessary to use pressures greater than 75-80 mmHg.

possible aDverse effeCTs

Adverse effects are possible during surgical procedures including, but not limited to, the following:
• Uterine perforation resulting in possible injury to bowel, bladder, major blood vessels, and ureter;
• Hemoperitoneum;
• Post-op bleeding;
• Pelvic infection.
see the operator's manual of your hysteroscope for adverse effects related to hysteroscopy�

MaTerials reQUireD for Use

• Hysteroscopy system, which may include a camera, light source, monitor, sheath and introducer.
• F luid delivery and suction, which may include a saline source, pressure infusion bag, vacuum source (pump or wall suction with regulator),
vacuum canister, vacuum tubing, tissue collection filter, or an integrated fluid management system that includes these capabilities.

prepare reseCTr

1. Remove from packaging.
2. Grip the Front Handle with index finger high on the Front Handle.
iMporTanT: Do not squeeze with the index finger low on the Front Handle. Only squeeze the Front Handle with index and middle fingers in
the first two positions.
3. Test squeeze Front Handle 1-2 times to verify movement of the Oscillating Blade inside the Resecting Window.
4. OpTIOnAL: Remove vacuum Tube Adapter and flush the Outflow port with 10 ml of saline while squeezing and releasing the Front Handle.
Reattach the vacuum Tube Adapter.
5. Rotate the Cannula Collar so that the Oscillating Blade closes the Resecting Window (see photo below).
6. Connect vacuum suction tubing to the Outflow port of the Resectr.
Black (K) ∆E ≤5.0
4