The TruClear™ operative hysteroscope 5C is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Acute pelvic inflammatory disease
This product is shipped non-sterile. It must be disassembled, cleaned, and sterilized before the first use. It must be disassembled, cleaned, and sterilized before every subsequent use.
It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.
Read these instructions completely prior to use.
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.
Potential complications of continuous flow hysteroscopy:
High energy radiated light emitted from illuminating fiber at the distal end of the operative hysteroscope may give rise to temperatures exceeding 106 F (41 C) (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 adaptor may exceed temperatures of 106 F (41 C). 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, a 4 mm light cable is recommended.
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 that the active electrode is at a sufficient distance from the tip of the operative hysteroscope before activation of the HF output. Ensure that only medical electrical equipment that complies with IEC 60601-1 and its relative particular standards is connected to, or used in conjunction with, the operative hysteroscope.
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.
Note: Failure to follow instructions for use, or use of a damaged product, may result in residual risks to the patients, including: infection, uterine perforation, cross-patient exposure to body fluids, fetal distress, metastasis (cancer), air embolism.
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” 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.
In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic, the competent authorities, and any other regulators as required.
For more information, refer to the Instructions for Use (IFU).
Find more information, including other available configurations, for TruClear™ 5C hysteroscope set.
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