72204878

Indications, Safety, and WarningsIndications for use
TruClear™ Elite hysteroscopes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative procedures.Contraindications

Acute pelvic inflammatory disease

Hysteroscopy may 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

Warnings

This product is shipped non-sterile. It must be disassembled, thoroughly cleaned, and sterilized before the first use, and before every subsequent use.

It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.

Suspicion of pregnancy should suggest a pregnancy test before the performance of diagnostic hysteroscopy.

For continuous flow hysteroscopy, if liquid distention medium is used, strict fluid intake and output surveillance should be maintained to ensure that fluid deficit is known at all times. Depending on whether non-electrolyte or electrolyte solution is being used, when excessive fluid deficit occurs, consideration should be given to stopping further infusion and concluding the procedure to prevent fluid overload. Fluid overload, if left untreated, can potentially lead to death.

If CO₂ gas is used as a distension medium, operative hysteroscopy is contraindicated due to the risk of gas embolization. CO₂ gas may be used for diagnostic procedures. It is extremely important that a hysteroscopic insufflator is used. Death has been reported when laparoscopic CO₂ insufflators were used during hysteroscopy. Flow of CO₂ should be limited to <100 mL/minute, and intrauterine pressure should not exceed 100 mmHg.

High energy radiated light emitted from illuminating fiber at the distal end of the operative hysteroscope may give rise to temperatures exceeding 41 C (106 F) (within 8 mm in front of the scope). Do not leave tip of the operative hysteroscope in direct contact with patient tissue or combustible materials, as burns may result. Lower the light source output when working in close proximity to the object.

The operative hysteroscope light post and adapter may exceed temperatures of 41°C (106°F). Operative hysteroscopes should not be placed on the patient or on combustible materials, as burns may result.

To maximize light transmission and minimize heat creation at the light post, the use of a 4 mm light cable is recommended.

If visualization is lost during the procedure, discontinue use of the hysteroscope. 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 recommended to have an additional sterile “stand-by” device during surgical procedures.

When using high frequency (HF) surgical equipment, keep the working part of the active electrode in the field of view to avoid accidental HF burns. Avoid contact with metal parts of the operative hysteroscope and other conductive accessories by ensuring, before activation of the HF output, that the active electrode is at a sufficient distance from the tip of the operative hysteroscope before activation of the HF output as any leakage current may be additive. Ensure that only medical electrical equipment that complies with IEC 60601-1 and its relative standards is connected to, or used in conjunction with, the operative hysteroscope.

Ensure that all medical electrical equipment used in tandem with the TruClear™ Elite hysteroscopes are compliant with IEC 60601-1 and its relative standards. Ensure that all devices connected to electrical systems which come in contact with the patient are Type BF or CF rated. Please follow the instructions for use of all accessory equipment.

No modification of this equipment is allowed.

Vaginal ultrasonography before hysteroscopy may identify clinical conditions that will alter patient management.

When the operative hysteroscopes 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 operative hysteroscope and camera head to prevent camera damage by high-power laser radiation. Contact the laser supplier for details. To prevent operative hysteroscope damage by high-power laser radiation, always ensure that the laser delivery fiber is seen through the operative hysteroscope and not directed at the operative hysteroscope before energizing the laser.

To avoid perforation, exercise caution when the hysteroscope is being inserted through the cervix and when the scope tip is near the uterine wall.

Potential complications of continuous flow hysteroscopy:

Hyponatremia
Hypothermia
Uterine perforation resulting in possible injury to bowel, bladder, major blood vessels, and ureter
Pulmonary edema
Cerebral edema

Precautions

Federal law (United States) restricts this device to sale by or on the order of a physician.

Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device.

Intrauterine fluid distension can usually be accomplished with pressures in the range of 15–75 mmHg. Unless the systemic blood pressure is excessive, it is seldom necessary to use pressures greater than 75–80 mmHg.

If using gravity-fed fluid management, hanging the fluid distension medium 42 inches above the patient can generate intrauterine pressure of approximately 80 mmHg.

Avoid exposing the operative hysteroscope to sudden temperature changes. Do not immerse hot operative hysteroscopes into cold water or liquid. Allow the operative hysteroscope to properly cool after autoclave cycles.

Any mechanical manipulation of the eyepiece may result in seal breakage; therefore, do not attempt to remove the eyepiece.

Do not apply excessive force to the hysteroscope when inserting a device in the hysteroscope working channel. Check for blockage in the working channel if resistance is encountered.

Do not disassemble the hysteroscope while in use.

For more information, refer to the Instructions for Use (IFU).

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