Safety Information

Minerva EAS^® Endometrial Ablation System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

The Minerva EAS^® Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

Contraindications

The Minerva EAS Endometrial Ablation System is contraindicated for use in:

• patient who is pregnant or who wants to become pregnant in the future.

Pregnancies following ablation can be dangerous for both mother and fetus.

• patient with known or suspected uterine cancer or pre-malignant conditions of the endometrium, such as unresolved adenomatous hyperplasia.
• patient with any anatomic condition (e.g., history of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the Minerva EAS procedure) or pathologic condition (e.g., requiring long-term medical therapy) that could lead to weakening of the myometrium.
• patient with a history of endometrial ablation and/or resection (including endometrial ablation/resection performed immediately prior to Minerva EAS procedure) regardless of the modality by which it was performed.

REPEAT ABLATION MAY RESULT IN SERIOUS PATIENT INJURY.

• patient with active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis).
• patient with an intrauterine device (IUD) currently in place and which is not removed prior to the Minerva EAS procedure.
• patient with a uterine cavity length less than 4 cm. The minimum Plasma Formation Array length is 4 cm. Treatment of a uterine cavity with a length less than 4 cm may result in thermal injury to the endocervical canal.
• patient with a narrow uterine cavity.
• patient where the Array Opening Indicator is in the Red Zone following deployment of the Minerva EAS Disposable Handpiece.
• patient with active pelvic inflammatory disease.
• patient with undiagnosed vaginal bleeding.

Warnings

Uterine Perforation Warnings

• Use caution not to perforate the uterine wall when sounding, dilating or inserting the Minerva EAS Disposable Handpiece.
• Activation of the Minerva EAS Disposable Handpiece in the setting of a uterine perforation is likely to result in serious patient injury.
• The risk of uterine perforation is increased in patients with abnormal or obstructed uterine cavities including obstruction by fibroids that distort the uterine cavity.
• It has been reported in the literature that patients with a severely anteverted, retroflexed or laterally displaced uterus are at greater risk of uterine wall perforation during any intrauterine manipulation.
• If the Minerva EAS Disposable Handpiece is difficult to insert into the cervical canal, use clinical judgment to determine whether or not further dilation is required. Forcibly advancing the Minerva EAS Disposable Handpiece against resistance is likely to increase the risk of perforation or creation of a false passage. Sufficient dilation is required for safe insertion.
• To prevent injury to the endocervical canal, ensure the Plasma Formation Array is unlocked before removing the Minerva EAS Disposable Handpiece from the uterus.
• Excessive force applied during placement of the Minerva EAS Disposable Handpiece may result in tissue injury including perforation.
• Use caution during placement of the Minerva EAS Disposable Handpiece in severe uterine angulations to prevent perforation.
• The Minerva EAS System performs an integrity test to evaluate the integrity of the Minerva EAS Disposable Handpiece and indirectly assess the integrity of the uterine cavity (Uterine Integrity Test) and sounds an alarm warning prior to treatment if the test fails.
• If the UTERINE integrity TEST fails after reasonable attempts to implement the troubleshooting procedures, abort the procedure.
• Although designed to detect a perforation of the uterine wall, this test is an indicator only and it might not detect all perforations. Clinical judgment must always be used.
• If a uterine perforation is suspected and/or confirmed, the procedure should be terminated immediately.
• For patients in whom the procedure was aborted due to a suspected uterine wall perforation, a work-up for perforation should be considered prior to discharge.
• Post-treatment, any patient-reporting signs/symptoms that could indicate a serious complication, e.g., bowel injury, should be thoroughly evaluated without delay.

General Warnings

• Endometrial ablation using the Minerva EAS System is not a sterilization procedure. Therefore, the patient should be advised of appropriate birth control methods.
• Endometrial ablation is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following the procedure. Pregnancy following ablation may be dangerous for both mother and fetus.
• Endometrial ablation does not eliminate the potential for endometrial hyperplasia or cancer of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology.
• Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. This can occur as late as 10 years post procedure.
• The Minerva EAS procedure should not be performed concomitantly with placement of the Essure device.
• The safety and effectiveness of the Minerva EAS System has not been evaluated in patients with the Essure device.

Technical Warnings

• The Minerva EAS Disposable Handpiece is supplied sterile. Do not use the sterile single-patient use Minerva EAS Disposable Handpiece if the packaging appears to be damaged or there is evidence of tampering.
• For single-use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the Minerva EAS Disposable Handpiece and/or lead to failure of the Minerva EAS Disposable Handpiece which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the Handpiece 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 Handpiece may lead to injury, illness or death of the patient.
• The used Minerva EAS Disposable Handpiece must be treated as biohazardous waste and disposed of in accordance with hospital or clinic standard practice where the treatment is performed.
• If any hysteroscopy procedure is performed with hypotonic solution immediately prior to Minerva EAS procedure, then the uterine cavity must be flushed with normal saline prior to treatment with the Minerva EAS System. The presence of hypotonic fluid may reduce the efficiency of the Minerva EAS System.
• Plugging the Minerva EAS Disposable Handpiece into the Minerva EAS RF Controller starts the pre-insertion Handpiece integrity check. CO₂ is delivered to the Minerva EAS Disposable Handpiece to verify patency. This test takes approximately 10 seconds to complete and must be performed with the Minerva EAS Disposable Handpiece external to the patient to eliminate the risk of air or gas embolism as well as any false readings. The Minerva EAS RF Controller touch screen will display the progress of the test. After the test image disappears, it is safe to insert the Minerva EAS Disposable Handpiece.
• The Minerva EAS Endometrial Ablation System may interfere with normal functions of some types of implanted pacemakers or implanted cardioverters/defibrillators. The Minerva EAS System should not be used with patients who have pacemakers or other electrical implants. Check if the patient has pacemaker or implanted cardioverter/defibrillator prior to use. Consult the cardio-rhythm device manufacturer for information about the effects of RF energy on these devices.
• Care should be taken to ensure the patient does not contact metal parts which are earthed or which have an appreciable capacitance to earth, such as direct contact with the metal on tables.
• Danger: explosion hazard. Do not use in the presence of a flammable anesthetic mixture. Do not use in the presence of flammable gases or liquids.
• Failure of the Minerva EAS RF Controller could result in an unintended increase in output power.
• Do not use the Minerva EAS System near or in a magnetic resonance (MR) environment.

Precautions

• A false passage can occur during any procedure in which the uterus is instrumented, especially in cases of a severe anteverted retroflexed or a laterally displaced uterus. Use caution to ensure that the Minerva EAS Disposable Handpiece is properly positioned in the uterine cavity.
• Patients who have undergone endometrial ablation and are later placed on hormone replacement therapy should have a progestin included in their medication regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy.
• The safety and effectiveness of the Minerva EAS System has not been fully evaluated in patients:
  • with a uterine sound measurement greater than 10 cm;
  • with submucosal fibroids that distort the uterine cavity;
  • with bicornuate, septate or sub-septate uteri;
  • with medical (e.g., GnRH agonist) or surgical pretreatment; or
  • who have undergone a previous endometrial ablation including the Minerva EAS endometrial ablation procedure.

• The Minerva EAS System consists of the following components:
  • Single-patient use Minerva EAS Disposable Handpiece with connecting cord and desiccant
  • Minerva EAS RF Controller with footswitch and power cord
  • Minerva EAS CO₂ canister
  • Minerva EAS argon canister
• To ensure proper operation, never use other components with the Minerva EAS System. Inspect the components regularly for damage, and do not use them if damage is apparent. The use of any cables or accessories other than those specified in these instructions may result in increased emissions or decreased immunity of the Minerva EAS RF Controller.
• The Minerva EAS Disposable Handpiece should only be used by physicians trained in the use of the Minerva EAS Disposable Handpiece.
• The Minerva EAS Disposable Handpiece must be used only in conjunction with the Minerva EAS RF Controller. No other handpieces can be used with the Minerva EAS RF Controller.
• Patients must be informed of the risks and possible adverse events associated with the endometrial ablation procedure and use of the Minerva EAS Endometrial Ablation System.
• The user should inspect the Minerva EAS Disposable Handpiece for damage prior to use.
• The Minerva EAS Desiccant is non-sterile, and the packaging should not be placed in the sterile field.
• Do not use the Minerva EAS Desiccant if desiccant material is pink in color.
• The Minerva EAS Disposable Handpiece must be external to (outside of) the patient before plugging the connecting cord into the appropriate port on the front panel of the Minerva EAS RF Controller.
• Do not use the Minerva EAS Endometrial Ablation System in presence of volatile solvents or flammable anesthetics.
• In the event of a Minerva EAS RF Controller failure, disconnect the Minerva EAS Disposable Handpiece, use the ON/OFF Switch, or unplug the power cord to stop Argon and CO₂ flow, and RF energy delivery.
• Do not operate unit in a moist environment, as a shock hazard may exist. If liquids have entered the unit, the Minerva EAS RF Controller must be returned to the manufacturer for testing prior to use.
• Interference produced by the operation of high-frequency equipment, such as the Minerva EAS RF Controller, may adversely affect the operation of other electronic medical equipment such as monitors and imaging systems. If electromagnetic interference with other equipment is suspected, reorient the Minerva EAS Disposable Handpiece or remove possible sources of interference (e.g., cellular phones, radios, etc.) from the room.
• It is recommended that any monitoring equipment or leads be placed as far as possible from the Plasma Formation Array when high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high frequency current-limiting devices are recommended for use.
• Do not use the Minerva EAS Disposable Handpiece if wires are exposed as this increases the risk of an electrical shock or fire.
• Failure of the Minerva EAS Endometrial Ablation System equipment could result in an unintended increase of output power.
• Use of accessories and cables, other than those specified for the Minerva EAS Endometrial Ablation System, may result in increased emissions or decreased immunity of the system.
• Use only the hospital grade power cord and Minerva EAS Footswitch supplied with the Minerva EAS RF Controller.
• Removing screws and opening of the Minerva EAS RF Controller will invalidate the warranty.
• The Minerva EAS RF Controller contains no user serviceable parts. Return to manufacturer for repairs.
• Do not restrict the openings on the Minerva EAS RF Controller enclosure, as they provide the required airflow for cooling.
• The patient should not come into contact with earthed metal parts or parts with appreciable capacitance to earth. The use of antistatic sheeting is recommended.
• Position the Minerva EAS Disposable Handpiece connecting cord such that contact with patient or other electrical leads is avoided.
• Position the Minerva EAS RF Controller on a flat surface for clinical use.
• Care should be taken not to damage the silicone membrane of the Plasma Formation Array during preparation and use.
• Careful measuring of the uterus is important for safe and proper Minerva EAS Disposable Handpiece PFA length setting to prevent thermal injury to the endocervical canal.
• If during the ablation cycle the cervical balloon does not adequately seal the cervical canal, unintended thermal damage to the endocervical canal may occur as a result of hot fluid leaking from the uterine cavity into the canal. Use clinical judgment to continue with the ablation procedure if such a leak is suspected.
• During the ablation cycle, ensure the connection tubing is not kinked or twisted which could reduce the flow of argon gas and reduce the effect of ablation.
• During ablation, do not unlock the Minerva EAS Disposable Handpiece handle or retract or remove the Minerva EAS Disposable Handpiece.
• The Minerva EAS RF Controller is for use without a neutral electrode.
• Use non-flammable agents for cleaning and disinfecting wherever possible.
• Flammable agents used for cleaning, disinfecting, or as solvents of adhesives should be allowed to evaporate before application of RF energy.
• Flammable solutions can pool under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Fluids pooled in the body depressions and cavities should be evacuated before the Minerva EAS RF Controller is used.
• Endogenous gases (e.g., cotton and gauze saturated with oxygen) may be ignited by sparks produced during normal use of the Minerva EAS RF Controller.
• Do not position the Minerva EAS RF Controller such that it is difficult to connect/disconnect the Minerva EAS Disposable Handpiece connector.
• To avoid risk of electric shock, the Minerva EAS RF Controller must only be connected to a mains supply with protective earth.
• Do not modify the Minerva EAS RF Controller without authorization from Minerva Surgical.
• The Minerva EAS RF Controller needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the operators manual.
• The use of Portable and Mobile RF Communications Equipment can affect the Minerva EAS RF Controller.
• The Minerva EAS RF Controller should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Minerva EAS RF Controller should be observed to verify normal operation in the configuration in which it will be used.
• The power cord connection to the Minerva EAS RF Controller provides a means of isolation. The Minerva EAS RF Controller should be positioned so as to provide easy access to the power cord connection in the event that the unit must be quickly unplugged.
• Confirm that the vaginal speculum is an adequate size (width and length) to assure full separation of vaginal and vulvar tissue away from the sheath of the device, to avoid inadvertent thermal injury, and to provide visibility of the cervix.
• Leave the vaginal speculum in place throughout the procedure.

Potential Adverse Events

The most common side effects of endometrial ablation occur during or immediately following the procedure and include uterine cramping, vaginal discharge, bleeding or spotting, nausea and/or vomiting, fatigue, abdominal pain.

As with all endometrial ablation procedures, serious injury or death can occur.

The following adverse events could occur or have been reported in association with the use of other endometrial ablation systems and may occur when the Minerva EAS Endometrial Ablation System is used:

• Post-ablation tubal sterilization syndrome
• Pregnancy-related complications
  NOTE: Pregnancy following endometrial ablation is very dangerous for both the mother and the fetus.
• Thermal injury to adjacent tissue, including bowel, bladder, cervix, vagina, vulva and/or perineum
• Perforation of the uterine wall
• Hemorrhage
• Hematometra
• Difficulty with defecation or micturition
• Uterine necrosis
• Air or gas embolism
• Infection or sepsis
• Muscle stimulation

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using the system must be trained in diagnostic hysteroscopy. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

© Minerva, Genesys HTA, and Symphion are registered trademarks of Axora Medical Inc. HERizon and Resectr are trademarks of Axora Medical, Inc. All other trademarks are property of their respective owners.

Genesys HTA^® System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

The Genesys HTA^® System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Contraindications

The system is contraindicated for use in a patient:

• who is pregnant or wants to be pregnant in the future, as pregnancy after ablation can be dangerous to both mother and fetus;
• who has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia;
• who has active pelvic inflammatory disease or pyosalpinx;
• who has hydrosalpinx;
• in whom a tight cervical seal cannot be established and maintained around the procedure sheath;
• who has any anatomical condition (e.g., history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g., long term medical therapy) that could lead to weakening of the myometrium;
• who has an intrauterine device in place; or
• who has an active genital or urinary tract infection (e.g., cervicitis, endometritis, vaginitis, cystitis, etc.), at the time of treatment.

Warnings

General Warnings

• Although endometrial ablation with the Genesys HTA System significantly decreases the likelihood of pregnancy, it is not a sterilization procedure. The patient should be advised of appropriate birth control methods.
• Endometrial ablation does not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology.
• Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation may be at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. This can occur as late as 10 years post-procedure.
• DO NOT perform same day HTA procedure and hysteroscopic tubal occlusion/sterilization. Ablation may cause intrauterine synechiae which can compromise (i.e. prevent) the 3-month confirmation test (HSG) for the tubal occlusion device. Women who have inadequate 3-month confirmation tests cannot rely on the tubal occlusion device for contraception.
• Bench and clinical studies have been conducted which demonstrate that the HTA procedure can be safely and effectively performed with nickel titanium tubal micro-inserts in place. However, the HTA procedure should only be performed after the 3-month tubal occlusion confirmation test.

Technical Warnings

• The Genesys HTA ProCerva^®Procedure Set is provided sterile and is intended for single use only. Do not attempt to resterilize or reuse any component of the procedure set.
• Scope adapters should be reprocessed in accordance with the validated cleaning and sterilization procedure provided in the operator’s manual, Procedure Sheath Accessories – Sterilization and Assembly. Do not reuse any scope adapter that has not been cleaned and sterilized accordingly.
• Do not use excessive force when attaching the procedure sheath to the scope adapter as such force may damage device components. Thermal injuries to patients have been reported in association with cracked or damaged procedure sheaths/adapters.
• Care must be taken with advancement and movement of the procedure sheath to avoid uterine perforation.
• The physician must maintain control of the procedure sheath (i.e., not hand off to another individual) for the duration of the treatment to avoid compromising the cervical seal. A compromise of the cervical seal could result in fluid leakage through the cervix, which could result in thermal injury to surrounding tissue.
• Once heating has begun maintain a stable sheath position and do not remove the procedure sheath until the post-treatment cooling cycle has been completed as confirmed by the display screen, as heated fluid may cause thermal injury to the patient.
• If system cooling is not possible (i.e., power loss), do not remove the procedure sheath from the patient until fluid in the uterus has cooled. It may take up to 10 minutes to ensure that fluid temperature in the uterus is below 45 °C. Exercise care when handling the procedure set, because the fluid may still be hot.
• Excessive menstrual clotting at the time of treatment may cause the Genesys HTA ProCerva Procedure Set to become clogged. This condition may trigger an alert. If the condition cannot be resolved, the procedure should be discontinued. To avoid clogging the fluid lines with blood clots, the procedure should not be scheduled during menses. Also, consideration should be given to pretreatment with drugs such as GnRH agonists prior to performing the endometrial ablation to help induce a hypoestrogenic state.
• Do not place the procedure sheath tubing over the patient’s leg or in contact with any part of the user’s or patient’s anatomy, as the tubing carries hot fluid and contact could result in thermal injury. The temperature of the tubing could be up to 55 °C.
• Ensure that the temperature of the fluid in the cassette is below 45 °C prior to disconnection of the Genesys HTA ProCerva Procedure Set.
• Do not look directly into the control unit’s laser aiming beam. Light from the LED may cause retinal damage.
• Do not over-dilate the cervix.

Cautions

• Endometrial ablation procedures using the Genesys HTA System should be performed only by physicians trained in diagnostic hysteroscopy procedures. Follow all Genesys HTA System instructions to reduce the possibility of compromised safety, malfunction, and/or injury to the patient and/or the user.
• To avoid the risk of electric shock, ensure that the selected electrical supply outlet has a proper ground connection and complies with the information listed on the label located on the rear of the control unit.
• To reduce the risk of explosion, do not operate the Genesys HTA System in the presence of flammable anesthetics or a flammable gas mixture with air, oxygen, or nitrous oxide.
• Never use the Genesys HTA System with equipment that has not been safety tested for excessive leakage current.
• Exercise care when handling liquids around electrical equipment. Do not attempt to operate the Genesys HTA System if liquid has spilled onto the unit.
• The Genesys HTA System must be used only with the procedure sheath provided in the Genesys HTA ProCerva Procedure Set. Use of any other hysteroscopic procedure sheath sets will lead to compromised safety for the patient and user.
• Do not hang more than three liters of saline from the hook on the IV pole.
• Confirm that the vaginal speculum is an adequate size (width and length) to assure full separation of vaginal and vulvar tissue away from the procedure sheath, to avoid inadvertent thermal injury, and to provide visibility of the cervix. The temperature of the sheath at this location could be up to 65°C.
• Do not rest the procedure sheath on the vaginal speculum during the procedure.
• Leave the vaginal speculum in place throughout the procedure.
• Confirm that the height of the control unit handle is properly adjusted to the height of the patient’s uterus to allow proper fluid flow and pressure, during the procedure. The laser aiming beam can be used as a secondary means to assist with proper height adjustment.
• Ensure that the height of the control unit handle is no higher than the height of the patient’s uterus or fluid leakage into the peritoneal cavity and vagina may occur during the procedure.
• Do not grasp the procedure sheath with the tenaculum as doing so may damage the procedure sheath which could result in thermal injury.
• Throughout the procedure, carefully observe the junction of the procedure sheath with the external cervical os to confirm a tight cervical seal and that there is no fluid leakage.
• Be Aware: The fluid loss alarm signals a loss of at least 10mL of fluid. Fluid losses in excess of 10 mL may occur in cases when the alarm is triggered.
• Use caution when handling the fluid in the drainage bag after treatment, as the fluid at this stage may still be hot.
• Follow hospital procedures for handling contaminated fluids and disposables.
• Do not attempt to repair or alter any components/parts of the Genesys HTA System. All repairs and servicing are to be performed only by authorized Boston Scientific service personnel. See Section 8, Service and Warranty.
• Patients who have undergone endometrial ablation, who are later placed on hormone replacement therapy, should have a progestin included in their regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy irrespective of whether total amenorrhea has been achieved after ablation.
• Use caution when performing the Genesys HTA System procedure on patients with nickel sensitivity, as the Genesys HTA ProCerva Procedure Set contains nickel.

The safety and effectiveness of the Genesys HTA System has not been evaluated in patients:

• with a large uterine cavity (> 10.5 cm);
• with a small uterine cavity (< 6.0 cm);
• with submucous myomas and/or polyps;
• with intramural fibroids > 4 cm, as documented on ultrasonogram, thought to be contributing to menorrhagia, such as those which distort the uterine cavity;
• with bicornuate or full septate uterus;
• undergoing repeat endometrial ablation procedures (e.g., resection, ablation); or
• who are post-menopausal.

Potential Adverse Events

The most common side effects of endometrial ablation occur during or immediately following the procedure and include uterine cramping, nausea, vomiting, abdominal pain, urinary tract infection (UTI), Laceration, Endometritis, thermal injury to extremity, vaginal infection, cervical laceration, and Hematoma.

As with all endometrial ablation procedures, serious injury or death can occur. The following adverse events could occur or have been reported in association with the use of the first generation HTA System:

• thermal injury to adjacent tissue, including cervix, vagina, vulva and/or perineum;
• heated saline escaping from the system into the vascular spaces;
• hemorrhage;
• perforation of uterus;
• complications with pregnancy (Note: Pregnancy following any endometrial ablation procedure is dangerous to both the mother and the fetus.);
• risks associated with hysteroscopy;
• post ablation tubal sterilization syndrome;
• infection or sepsis; and
• complications leading to serious injury or death.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using the system must be trained in diagnostic hysteroscopy. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

© Minerva, Genesys HTA, and Symphion are registered trademarks of Axora Medical Inc. HERizon and Resectr are trademarks of Axora Medical, Inc. All other trademarks are property of their respective owners.

Symphion^® Operative Hysteroscopy System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Intended Use/ Indications for Use

Symphion System with Controller (software version 2.1.1 and prior): The Symphion^® System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

Symphion System with Prime Controller (software version 3.#.#): The Symphion System is intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-recirculating/non-filtered distension fluid.

Contraindications

Pregnancy, genital tract infections, and known uterine cancer are contraindications to hysteroscopy.

Use of this device for intrauterine distension is contraindicated whenever hysteroscopy is contraindicated. See the operator’s manual of your hysteroscope for absolute and relative contraindications.

The Symphion System contains a large amount of metal components. Therefore, it is MRI unsafe. Do not use the Symphion System in conjunction with MRI, CT or RFID.

Warnings

General Warnings

• The Symphion System is only intended for use as outlined in above, Intended Use/ Indications for Use.
• Before using the Symphion System, please review all available product information carefully!
• The Symphion System should only be used by physicians trained in hysteroscopy and hysteroscopic surgery using powered instruments. Healthy tissue can be injured, e.g., perforation by improper use of the Resecting Device. Use every available means to avoid such injury.
• Do not use the Symphion System with another fluid management system, endoscope, or controller. Use with another fluid management system, endoscope or controller may result in failure of the device to operate or lead to patient or physician injury.
• DANGER: Do not operate the Symphion System in close proximity to volatile solvents such as methanol or alcohol, or in the presence of flammable anesthetics, as explosion may occur.
• Use Resection and Coagulation modes with caution in the presence of any active implantable or body worn medical devices such as internal or external pacemakers or neurostimulators. Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. The output of the Symphion device might also affect other types of active devices such as implanted neurostimulator devices. Consult the active implantable device manufacturer (for implanted pacemakers and ICDs the hospital cardiology department might also be helpful) for further information when use of myomectomy or tissue coagulation is planned in patients with active implantable devices such as cardiac pacemakers.

Reuse Warning

• The Symphion Resecting Device and Symphion Fluid Management Accessories are supplied STERILE using a Radiation process. Do not use if sterile barrier is damaged. If damage is found, call your Minerva Surgical representative.
• The Symphion Resecting Device and Symphion Fluid Management Accessories are 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

Controller with Integrated Fluid Management Warnings

• Known Risks Associated with use of Electrosurgical Devices:
  • EMC issues – interference causes device failure, interference causes other devices to fail, RF interferes with pacemaker, defibrillator
  • Electrical safety issues – shock, burn – device/ controller overheats, incorrect power source used, water enters the controller, use of incorrect power source, arcing
  • Explosion/fire if operated near volatile solvents
  • Tissue damaged during coagulation/resection
• The Controller should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Controller should be observed to verify normal operation in the configuration in which it will be used.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should not be used closer than 30 cm (12 inches) to any part of the Symphion Fluid Deficit Readout, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• Fluid Overload: There is a risk of distension fluid reaching the circulatory system of the patient by passing into the capillaries of the body cavity. This can be caused by distension pressure, flow rate, perforation of the body cavity and duration of the endoscopic procedure. It is critical to closely monitor the inflow and outflow of the saline at all times. Vital signs recording, physical examination and pulse oximetry is recommended, as it may reduce the risk of fluid overload.
• Fluid Deficit: The fluid absorbed by the patient must be monitored. The following equation should be used to estimate the fluid deficit using a single 3-liter saline bag:
  • 2500 mL - Remaining volume in bag = total fluid deficit
  • 2700 mL – Remaining volume in saline bag – Volume in recovery bag = total fluid deficit (EXPRESS FMA only)

The following equation should be used to estimate the fluid deficit using a single 2-liter saline bag:

• 1500 mL - Remaining volume in bag = total fluid deficit.
• 1700 mL – Remaining volume in saline bag - Volume in recovery bag = total fluid deficit (EXPRESS FMA only)

*Take notice of the measurement tolerance of the saline bag (+/-10%)

IMPORTANT: Use a single 2-liter or 3-liter irrigation USP Saline bag* only. Do not use multiple saline bags. Use of multiple saline bags increases the chance of fluid overload.

Note: The Symphion System does not allow for more than 2500 mL to be absorbed by the patient when used in accordance with this manual.

• Fluid Intake: Strict monitoring of fluid intake should be maintained. Intrauterine instillation of saline exceeding 2-liter should be followed with great care due to the possibility of fluid overload.
• Serum Sodium Concentration: As with any normal saline hysteroscopic insufflation, the possibility of fluid intravasation and subsequent electrolyte disturbances may occur. It is important that the physician monitor the patient’s electrolytes if significant intravasation occurs. The Symphion System does not measure sodium or other electrolyte concentrations.
• Rupture of the Fallopian Tube Secondary to Tubal Obstruction: Distension of the uterus may lead to a tear of the fallopian tube should there be an obstruction or permanent occlusion. The rupture could lead to saline flowing into the patient’s peritoneal cavity, resulting in fluid overload. It is critical to closely monitor the input and outflow of saline at all times.
• An air embolism can be the result of air contained in the tubing set or connected instrument reaching the patient. To prevent air from being pumped into the patient ensure that the infusion tubing set is purged prior to start of the procedure and that there is always fluid in the saline bag. If air bubbles are seen in the infusion tubing set prior to the insertion of the scope into the patient, manually purge via turning on infusion while the scope is outside of the patient until there is no longer air in the infusion tubing. If air remains in the infusion tubing following the manual purge or is noted in the infusion tubing at any point during the procedure after the scope has been inserted into the patient, remove the Endoscope from the uterine cavity and discontinue the procedure.
• To prevent hypo/hypernatremia assess electrolytes before and after procedure, and observe for signs of significant electrolyte imbalance (e.g., electrocardiogram and physician examination).
• Use of pressures higher than 100 mmHg is strongly discouraged. Intrauterine pressure should be maintained as low as possible so as to allow adequate visualization and minimize the forces potentially driving fluid, room air and/or gas into circulation. Cavity distension is usually possible with pressure values between 35 to 70 mmHg. A pressure above 75 to 80 mmHg is required only in rare cases or if the patient has unusually high blood pressure.
• While fluids must always be monitored during use, exercise extreme caution and very close fluid monitoring in patients with severe cardiopulmonary disease.
• The Symphion® system permits the operator to select an intrauterine pressure up to 125 mmHg. Clinicians using the Symphion System should be aware of the AAGL practice guidelines regarding uterine cavity distension pressure (i.e. lowest pressure necessary to distend the uterine cavity and ideally should be maintained below the mean arterial pressure) when setting distension pressure on the Symphion System.
• Testing of the Symphion System has not been confirmed in patients with hemoglobinopathies (e.g., Sickle Cell Disease, Beta Thalassemia) and therefore, the possible effects are unknown.
• Hemolysis may occur during recirculation. If significant hemolysis occurs, this may result in electrolyte (e.g., increased serum potassium) changes or decrease in hemoglobin. Hemolysis may reveal red-tinged coloring of the recirculated fluid, but may not be visually apparent. Therefore, assessment of serum electrolytes and hemoglobin level after completion of the procedure is recommended. (Not applicable to EXPRESS FMA)
• Magnetically susceptible medical devices should not be used closer than 15 cm (6 inches) to any part of the Symphion Controller. Otherwise, degradation of the performance of this equipment could result.

Resecting Device Warnings

• Do not operate the Resecting Device without clear visualization. The device resecting window area should be in the field of view while the Resecting Device is operating. If visualization is lost at any point during the procedure, resection/coagulation must be stopped immediately.
• Magnetically susceptible medical devices should not be used closer than 15 cm (6 inches) to any part of the Symphion Controller. Otherwise, degradation of the performance of this equipment could result.

Considerations for Anesthesia

• Nitrous oxide anesthesia may enlarge the size of air bubbles and thus should be avoided, when possible, in operative hysteroscopy.
• Patients at high risk for room air and gas embolism should be managed using controlled ventilation.
• For high-risk patients undergoing operative hysteroscopy, one should consider intra-operative monitoring, such as end-tidal CO₂ monitoring if under general anesthesia and pre-cordial Doppler monitoring to detect room air and gas emboli early.

Warnings Applicable to Air/Gas Emboli Hazards

• Gas bubbles are a normal by-product of electrosurgical procedures performed in liquids. When bubbles occur in the uterus, care should be taken to manage the removal of air/gas bubbles to minimize the inherent risk of emboli. Bubbles produced during tissue vaporization may interrupt surgery by temporarily interfering with field of view and may also result in electrode overheating, causing damage to the electrode tip.
• Surgeons should consider the anticipated length of surgery and size of leiomyomata when selecting patients for procedures.
• Operating room personnel must be trained to purge air from fluid lines prior to surgery, avoid entry of air into fluid lines, and provide constant, careful attention to fluid deficits. Avoid situations where the fluid bag is completely emptied.
• Basic equipment should be available to fulfill the requirements for monitoring of fluid deficit, assessment and control of intrauterine pressure, and anesthesia monitoring. Intrauterine pressure should be maintained as low as possible so as to allow adequate visualization and minimize forces potentially driving air and gas into circulation.
• Surgical team must have access to appropriate resuscitative capabilities.
• Patients should be kept in flat or in reverse Trendelenburg position.
• If room air or gas embolism is suspected, surgeon should consider interrupting surgery, deflating the uterus, and removing sources of fluid and gas until the diagnosis and a management plan are clarified.
• Surgeon should avoid entry of air into uterus by:
  • Carefully purging air from fluid inflow lines and hysteroscopic devices prior to use
  • Following cervical dilation, care should be taken to minimize the exposure of the open cervix to room air
  • Keeping an effective cervical seal during surgery as much as possible once the cervix is dilated
  • Using active fluid outflow to effectively flush the uterus of bubbles and debris
  • Minimizing the frequency of removal and reinsertion of hysteroscopic devices

Precautions

Symphion System General Precautions

• Do not use the Symphion System in patients where anatomy does not support an endoscopic procedure (i.e. cervical stenosis, existence of an IUD, or in conditions that limit access to the target tissue).
• Use Resection and COAG with caution in the presence of any active implantable or body worn medical devices such as internal or external pacemakers or neurostimulators. Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. The output of the Symphion device might also affect other types of active devices such as implanted neurostimulator devices. Consult the active implantable device manufacturer (for implanted pacemakers and ICDs the hospital cardiology department might also be helpful) for further information when use of myomectomy or tissue coagulation is planned in patients with active implantable devices such as cardiac pacemakers.
• If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD manufacturer for instructions before performing myomectomy or tissue coagulation. Electrosurgery or tissue coagulation may cause multiple activations of ICDs.
• Small electrical arcs between the resection electrode and the tissue being resected can produce low-frequency currents that may produce local neuromuscular stimulation. Per standard of care, ensure that the patient’s legs are supported and secured appropriately.
• Prior to use, examine all system components for possible damage and ensure proper function. If any of the system components are damaged, do not use.
• As with all hysteroscopic procedures, device may come into contact with bloodborne pathogens or other potentially infectious materials. Healthcare professionals should follow standard medical facility procedures to minimize the risk of exposure.
• Do not use the Resecting Device or the Fluid Management Accessories if the sterile barrier or sterility is compromised prior to or during the procedure. Failure to maintain sterile technique in the operating room could result in infection.
• Do not lubricate the Resecting Device or the Fluid Management Accessories.
• Do not use the Resecting Device or the Fluid Management Accessories after the expiration date.
• The Resecting Device and Fluid Management Accessories are intended for single use only. Discard the Resecting Device and Fluid Management Accessories after use.
• Do not re-use or re-sterilize the Resecting Device and Fluid Management Accessories. Use of re-processed, single use device(s) may result in patient or physician injury.

Controller Precautions

• Verify the Controller is fully operational prior to starting the clinical procedure. Failure of the Controller could result in an unintended increase of output power.
• Interference produced by the operation of high-frequency equipment may adversely affect the operation of other electronic medical equipment such as monitors, imaging systems.
• Do not operate the Controller in a moist environment, as a shock hazard may exist. If liquids have entered the unit, the Controller must be returned to the manufacturer for testing prior to use.
• Use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the system.
• Return Controller to manufacturer for servicing in the event of failure.
• In case of Controller failure, remove the Endoscope and Resecting Device from the body cavity immediately. Remove the tubing from the pump heads; switch off/ unplug the power cord to stop Controller operation.
• Removing screws and/or opening this device will invalidate the warranty.
• To ensure proper grounding reliability, a Hospital Grade Power Cord must be used with a receptacle marked “Hospital Grade”.
• Do not sterilize the Controller. Sterilization may damage the unit.
• Reconditioning, refurbishing, repair, or modification of the Controller is expressly prohibited as it may result in loss of function and/or patient injury.
• Do not obstruct openings on the bottom and back of the Controller, as they provide required airflow for cooling.
• The Controller needs special precautions regarding EMC and needs to be placed and put into service according to the EMC information provided in this document. Note that portable and mobile RF communication equipment can affect the performance of the Controller.
• The Controller should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Controller should be observed to verify normal operation in the configuration in which it will be used.
• If electromagnetic interference with other equipment is suspected, re-orient the device and/or remove possible sources of interference (e.g., cellular phones, radios, etc.) from the room.
• Needle monitoring electrodes are not recommended.
• Patient should not come into contact with grounded metal parts; the use of antistatic sheeting is recommended.
• Cables to the surgical electrodes are recommended to be positioned such that contact with patient or other leads is avoided.
• Use only normal saline (sodium chloride (0.9% w/v; 150 mmol/L)) irrigation solution. The performance of the system will be adversely affected by use of any other solution.
• All models of the Fluid Management Accessories are designed for use with a SINGLE 2-liter or 3-liter Irrigation USP saline bag:

USE A SINGLE 2-LITER or 3-LITER IRRIGATION USP SALINE BAG ONLY. DO NOT USE MULTIPLE SALINE BAGS. USE OF MULTIPLE SALINE BAGS INCREASES THE CHANCE OF FLUID OVERLOAD.

• Do not open the latch of pumps while hysteroscope is in the patient. This may result in a loss of visualization and/or serious patient injury.
• Do not pinch, step on, kink or otherwise occlude the tubing set. Tubing restrictions can result in high pressure or poor device performance.
• Do not close the latch of the pump on the indicators installed on tubing. This may result in a failure of the pump.
• Continuous, extended RF energy output may cause the Controller to overheat. If this occurs, the Controller must be allowed to cool down before further use.

Resecting Device Precautions

• Excessive force on the Resecting Device tip does not improve resection performance and may increase the risk of perforation or device damage.
• Do not allow the tip of the Resecting Device to touch any hard object. If such contact does occur, inspect the tip. If there are cracks, fractures, or if there is any other reason to suspect the tip is damaged, replace the Resecting Device immediately.
• Any monitoring electrodes are recommended to be placed as far as possible from the Resecting Device when high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient. Monitoring systems incorporating high frequency current-limiting devices are recommended for use.
• Excessive force applied during insertion or removal of the Resecting Device may result in device damage or tissue injury including perforation.
• Insertion and removal of the Resecting Device should always be under direct visualization.
• Do not activate the Resecting Device unless the resecting window and tip are immersed in a saline environment. Electrodes may arc if activated in air, damaging the device.
• Do not activate the Resecting Device while the resecting window section is inside the Endoscope. Ensure that the resecting window is outside the Endoscope working channel in the saline environment before activating RF resection or coagulation.

Potential Adverse Events

Potential complications of continuous flow endoscopic surgery include:

• Anesthesia-related; adverse reaction or over-medication
• Uterine perforation
• Damage to Adjacent Organs
• Cervical tear/injury
• Bleeding
• Endometritis
• Urinary tract infections
• Infection, sepsis
• Nausea, vomiting
• Pelvic cramping, abdominal pain
• Cervical stenosis
• Hematometra
• Dysmenorrhea
• Dyspareunia
• Uterine synechiae (Asherman’s syndrome)
• Vaginal discharge
• Fluid overload
• Electrolytic imbalance
• Rupture/obstruction of the fallopian tube
• Hyponatremia
• Hypothermia
• Pulmonary edema
• Cerebral edema
• Idiosyncratic reactions
• Dehydration
• Over-pressurization/over-fill the cavity
• Biohazard exposure to tissue, blood, fluid
• Under-filled cavity
• Loss of visualization
• Incorrect distention media used
• Kinked tubing, leaks in tubing/system
• Cannot create seal with cavity
• Air embolism
• Damage to healthy tissue

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using this device must be trained in diagnostic hysteroscopy and hysteroscopic surgery using powered instruments. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

© Minerva, Genesys HTA, and Symphion are registered trademarks of Axora Medical Inc. HERizon and Resectr are trademarks of Axora Medical, Inc. All other trademarks are property of their respective owners.

Resectr^™ Tissue

Resecting Device

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

Resectr™ is 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

• Use of this device is contraindicated whenever hysteroscopy is contraindicated. See the operator’s manual of your hysteroscope for absolute and relative contraindications.
• Acute pelvic inflammatory disease.
• Inadequate uterine distention and / or visualization.
• Cervical / vaginal infection.
• 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 on patients undergoing hysteroscopic myomectomy.
• Inability to circumnavigate a myoma due to myoma size (e.g., predominantly intramural myomas with small submucous components).

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.
• Do not intentionally bend or break cannula when disposing device.

Cautions

• Before using, inspect the blister pouch for any breach of the package to ensure a sterile product and inspect product for any damage and ensure device is free of foreign material.
• If seal has been broken or product is damaged do not use. Immediately return package and product to your Minerva representative.
• Do not expose the Resectr device to organic solvents.
• Only use the Resectr device prior to the “Use By” date noted on the package.
• Resectr devices should only be manipulated under direct visualization.
• Make certain the Resectr Resecting Window is closed upon insertion / retraction into / from the uterine cavity.
• 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.

Potential Adverse Events

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.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

© Minerva, Genesys HTA, and Symphion are registered trademarks of Axora Medical Inc. HERizon and Resectr are trademarks of Axora Medical, Inc. All other trademarks are property of their respective owners.

HERizon Medical Endoscope Image Processing System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

The Medical Endoscope Image Processing System is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Recognized indications for diagnostic hysteroscopy include:

• Abnormal uterine bleeding
• Infertility & pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain

Contraindications

This product is not suitable for people with the following conditions:

• acute pelvic inflammatory disease
• known or suspected pregnancy

Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent:

• inability to distend the uterus
• cervical stenosis
• cervical/vaginal infection
• uterine bleeding or menses
• invasive carcinoma of the cervix
• recent uterine perforation
• medical contraindication or intolerance to anesthesia

Warnings/Precautions

• Do not attempt to disassemble the hysteroscope or the Image Processor. Do not attempt to open, or gain access into, the Image Processor. Doing so may result in electronic shock.
• Handle the hysteroscope and image processor with care.
• This system cannot be used with high frequency equipment or laser equipment.
• The system does not interfere with other electromagnetic equipment in normal use. If the operating frequency of other equipment is similar to that of the system, it is recommended to maintain a large separation distance.
• During normal use, the medical endoscope image processor does not produce waste or residue. When the product reaches the end of its service life, dispose of the device in accordance with medical device waste regulations. This is to prevent any potential reuse of the materials and to minimize the risk of environmental pollution.  The hysteroscope should be disposed of following its single use in accordance with hospital procedures for biohazardous materials.
• If the hysteroscope does not function properly, replace it with another properly functioning hysteroscope.
• The hysteroscope and accessories must be checked for rough surfaces, sharp edges or protrusions that may cause injury before each use.
• The Image Processor may be used together with other medical electronic equipment. To avoid potential safety hazards, it is recommended to follow the surgical operation guidelines, use and precautions for safe use of other medical surgical equipment.
• It is recommended to use read-write protection software when using an external storage device (UDisk, USB flash drive, etc.) to copy data, in order to prevent the external storage device’s data from being accessed without consent.
• When the external storage device is used for obtaining data from the image processor, an appropriate antivirus software program should be used to check for and remove any potential software virus prior to use with the Image Processor.
• During normal use, the temperature of the hysteroscope should not exceed 41 C°. If an abnormally high temperature is suspected, dispose of the hysteroscope and replace it with another one.
• Do not look straight into the hysteroscope lens as it may cause eye damage from the light source.
• Before use, perform a white balance and make the proper adjustments to the image on the screen.
• Before each use or after changing the viewing settings, the operator should check to ensure that the view observed through the endoscope provides a real-time image (instead of a stored image) and that the image orientation is correct to prevent potential patient injury.
• Users should maintain and securely position the Medical Endoscope Image Processor in a stable position, while also ensuring proper ventilation and protection against moisture and dampness.
• When not in use, it is recommended to store the Medical Endoscope Image Processor in the original packaging.
• The Medical Endoscope Image Processor should not be subjected to any sharp or blunt force impact.
• Do not place the Medical Endoscope Image Processor in environments with high temperatures, humidity, dust, direct sunlight or corrosive gases and/or fluids.
• Only personnel who have been trained or whose knowledge and practical experience are sufficient to ensure correct operation should operate and use this system.
• Only those who have read the appropriate IFUs and know the correct use of the system and accessories can operate it.
• If this system is to be used with other equipment, the user should consult applicable IFUs and receive appropriate training on the use of the equipment and use it strictly in accordance with its IFU.
• This product is by prescription only.
• The Image Processor is nonsterile and reusable. The disposable electronic hysteroscope is ethylene oxide (EO) sterilized and for single use only.
• This system can only be used with compatible accessories as defined by the manufacturer.
• Do not use the System near or in a Magnetic Resonance (MR) environment.

Potential Adverse Events

Potential complications of continuous flow hysteroscopic surgery include:

• Anesthesia-related; adverse reaction or over-medication
• Uterine perforation
• Damage to Adjacent Organs
• Cervical tear/injury
• Bleeding
• Endometritis
• Urinary tract infections
• Infection, sepsis
• Nausea, vomiting
• Pelvic cramping, abdominal pain
• Cervical stenosis
• Hematometra
• Dysmenorrhea
• Dyspareunia
• Uterine synechiae (Asherman’s syndrome)
• Vaginal discharge
• Fluid overload
• Electrolytic imbalance
• Rupture/obstruction of the fallopian tube
• Hyponatremia
• Hypothermia
• Pulmonary edema
• Cerebral edema
• Idiosyncratic reactions
• Dehydration
• Over-pressurization/over-fill the cavity
• Biohazard exposure to tissue, blood, fluid
• Under-filled cavity
• Loss of visualization
• Incorrect distention media used
• Kinked tubing, leaks in tubing/system
• Cannot create seal with cavity
• Air embolism
• Damage to healthy tissue

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using the system must be trained in diagnostic hysteroscopy. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Manufactured and packaged for Minerva Surgical, Inc.
by Jiangsu Jiyuan Medical Technology Co.,Ltd.
4255 Burton Drive
Santa Clara, CA 95054
www.minervasurgical.com

JiYuan Medical Endoscope Image Processing System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

The Medical Endoscope Image Processing System is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Recognized indications for diagnostic hysteroscopy include:

• Abnormal uterine bleeding
• Infertility & pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain

Contraindications

This product is not suitable for people with the following conditions:

• acute pelvic inflammatory disease
• known or suspected pregnancy

Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent:

• inability to distend the uterus
• cervical stenosis
• cervical/vaginal infection
• uterine bleeding or menses
• invasive carcinoma of the cervix
• recent uterine perforation
• medical contraindication or intolerance to anesthesia

Warnings/Precautions

• Do not attempt to disassemble the hysteroscope or the Image Processor. Do not attempt to open, or gain access into, the Image Processor. Doing so may result in electronic shock.
• Handle the hysteroscope and image processor with care.
• This system cannot be used with high frequency equipment or laser equipment.
• The system does not interfere with other electromagnetic equipment in normal use. If the operating frequency of other equipment is similar to that of the system, it is recommended to maintain a large separation distance.
• During normal use, the medical endoscope image processor does not produce waste or residue. When the product reaches the end of its service life, dispose of the device in accordance with medical device waste regulations. This is to prevent any potential reuse of the materials and to minimize the risk of environmental pollution.  The hysteroscope should be disposed of following its single use in accordance with hospital procedures for biohazardous materials.
• If the hysteroscope does not function properly, replace it with another properly functioning hysteroscope.
• The hysteroscope and accessories must be checked for rough surfaces, sharp edges or protrusions that may cause injury before each use.
• The Image Processor may be used together with other medical electronic equipment. To avoid potential safety hazards, it is recommended to follow the surgical operation guidelines, use and precautions for safe use of other medical surgical equipment.
• It is recommended to use read-write protection software when using an external storage device (UDisk, USB flash drive, etc.) to copy data, in order to prevent the external storage device’s data from being accessed without consent.
• When the external storage device is used for obtaining data from the image processor, an appropriate antivirus software program should be used to check for and remove any potential software virus prior to use with the Image Processor.
• During normal use, the temperature of the hysteroscope should not exceed 41 C°. If an abnormally high temperature is suspected, dispose of the hysteroscope and replace it with another one.
• Do not look straight into the hysteroscope lens as it may cause eye damage from the light source.
• Before use, perform a white balance and make the proper adjustments to the image on the screen.
• Before each use or after changing the viewing settings, the operator should check to ensure that the view observed through the endoscope provides a real-time image (instead of a stored image) and that the image orientation is correct to prevent potential patient injury.
• Users should maintain and securely position the Medical Endoscope Image Processor in a stable position, while also ensuring proper ventilation and protection against moisture and dampness.
• When not in use, it is recommended to store the Medical Endoscope Image Processor in the original packaging.
• The Medical Endoscope Image Processor should not be subjected to any sharp or blunt force impact.
• Do not place the Medical Endoscope Image Processor in environments with high temperatures, humidity, dust, direct sunlight or corrosive gases and/or fluids.
• Only personnel who have been trained or whose knowledge and practical experience are sufficient to ensure correct operation should operate and use this system.
• Only those who have read the appropriate IFUs and know the correct use of the system and accessories can operate it.
• If this system is to be used with other equipment, the user should consult applicable IFUs and receive appropriate training on the use of the equipment and use it strictly in accordance with its IFU.
• This product is by prescription only.
• The Image Processor is nonsterile and reusable. The disposable electronic hysteroscope is ethylene oxide (EO) sterilized and for single use only.
• This system can only be used with compatible accessories as defined by the manufacturer.
• Do not use the System near or in a Magnetic Resonance (MR) environment.

Potential Adverse Events

Potential complications of continuous flow hysteroscopic surgery include:

• Anesthesia-related; adverse reaction or over-medication
• Uterine perforation
• Damage to Adjacent Organs
• Cervical tear/injury
• Bleeding
• Endometritis
• Urinary tract infections
• Infection, sepsis
• Nausea, vomiting
• Pelvic cramping, abdominal pain
• Cervical stenosis
• Hematometra
• Dysmenorrhea
• Dyspareunia
• Uterine synechiae (Asherman’s syndrome)
• Vaginal discharge
• Fluid overload
• Electrolytic imbalance
• Rupture/obstruction of the fallopian tube
• Hyponatremia
• Hypothermia
• Pulmonary edema
• Cerebral edema
• Idiosyncratic reactions
• Dehydration
• Over-pressurization/over-fill the cavity
• Biohazard exposure to tissue, blood, fluid
• Under-filled cavity
• Loss of visualization
• Incorrect distention media used
• Kinked tubing, leaks in tubing/system
• Cannot create seal with cavity
• Air embolism
• Damage to healthy tissue

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using the system must be trained in diagnostic hysteroscopy. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Distributed by Minerva Surgical, Inc
4255 Burton Drive
Santa Clara, CA 95054 USA
Customer Service: 855-464-7874
www.minervasurgical.com

Legal Manufacturer Jiangsu Jiyuan Medical Technology Co,Ltd.
No.48 CECEP(Taizhou)Environmental Protection Technology Industry
Park,No.59 Meilan Road, Hailing District, Taizhou, Jiangsu, China.