Benesta Rod Lens Hysteroscope Instructions for Use

Symbol Glossary Symbol

ISO 7000 Reg. no.

ISO 152231 or Other

Indicates the medical device manufacturer.

3082

5.1.1

Indicates the authorized representative in the European community.

N/A

5.1.2

Date of Manufacture

Indicates the date when the medical device was manufactured.

2497

5.1.3

Use by Date

Indicates the date after which the medical device is not to be used.

2607

5.1.4

2492

5.1.5

2493

5.1.6

Indicates a medical device that has been sterilized using ethylene oxide.

2501

5.2.3

Indicates a medical device that is not to be re-sterilized.

2608

5.2.6

Indicates a medical device that should not be used if the package has been damaged or opened.

2606

5.2.8

Indicates a medical device that has not been subjected to a sterilization process.

2609

5.2.7

Indicates a medical device that needs to be protected from moisture.

0626

5.3.4

Temperature Limit

Indicates the temperature limits to which the medical device can be safely exposed

0632

5.3.7

Humidity Limitation

Indicates the range of humidity to which the medical device can be safely exposed

2620

5.3.8

1051

5.4.2

Indicates the need for the user to consult the instructions for use.

1641

5.4.3

Consult Instructions for Use, or For Instructions for Use Refer to

Indicates the need for the user to consult the instructions for use and where the electronic instructions for use (eIFU) and symbols glossary can be found.

1641

5.4.3

Follow Instructions for Use

Refer to Instruction manual/booklet; on medical electrical equipment, Follow Instructions for Use

ISO 7010M002

N/A

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

0434A

5.4.4

General Warning Sign

N/A

Signifies Applied Part Type

N/A

Title/ Meaning/ Referent

Function/ Description Manufacture

Manufacturer EU Authorized Representative

Batch Code Catalogue number Sterilized Using Ethylene Oxide Do Not Re-sterilize Do Not Use If Package Is Damaged Non-sterile

Indicates the manufacturer's batch code so that the batch or lot can be identified. Indicates the manufacturer's catalogue number so that the medical device can be identified. Sterility

Storage Keep Dry

Do Not Re-use Consult Instructions for Use [IFU URL]

General Warning Type BF Applied Part IPX2

Ingress Rating Non-Ionizing Electromagnetic Radiation

Safe Use Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

Signifies that the device is rated to level 2 for water ingress protection, and that water splashing against the enclosure from any direction shall have no harmful effect. Indicates generally elevated, potentially hazardous levels of non-ionizing radiation, or to indicates equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment. Other

ISO 7010W012 IEC 605175840

N/A

N/A

N/A

IEC 604175140

Packaging Unit

Indicates the number of pieces in the package.

2794

N/A

Prescription Only

Requires prescription in the United States of America.

N/A

21 CFR 801.109

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The following is an explanation of symbols that may be used on Caldera Medical’s products and packaging:

NOTE: Prior to initiation of surgical procedure, confirm compatibility with all equipment to be used with the Benesta Hysteroscope, as not all equipment may be compatible and pose a risk if not used in conjunction with the manufacturer’s specifications

Table 1. Components of the BenestaTM Hysteroscope Set (CAL-TR111)

Caldera Medical Catalog Code CAL-TR113 CAL-TR112 CAL-TR121 CAL-TR122 CAL-TR123 CAL-TR124 CAL-TR125 CAL-TR126

Description Benesta Hysteroscope Benesta Outflow Channel Benesta Hysteroscope Light Post Adapter – Large (Storz/Olympus) Benesta Hysteroscope Light Source Adapter – Small (Dyonics/Wolf) Benesta Valve Lever and Cap x 3 Benesta Hysteroscope/Outflow Channel End Cap x 2 Benesta Working Channel Brush, 3mm Benesta Inflow Channel Brush, 2mm

• To visualize the endometrial cavity, a remote light source is connected to the hysteroscope light-post adapter via a fiber optic (or similar) cable. The light source is typically coupled to a camera system that allows display of the operative field on a video monitor. NOTE: Selection of a video monitor and camera cable is at the discretion of the user. To connect with the hysteroscope eyepiece, the camera coupler must be compatible with the 32 mm (1.25 in) diameter eyepiece and provide sufficient brightness/contrast and resolution to accurately visualize the endometrial cavity.

Table 2. Components not provided with the BenestaTM Hysteroscope Set

CAL-TR131 N/A* N/A* N/A*

Description

Outflow channel

Benesta Tissue Removal Device, 1-pack Benesta Tissue Removal Device, 3-pack Benesta Fluid Pack with Y-Tubing and 2 Single-Use Seals (5 pack) Benesta Sterilization Tray Fluid Source – either Hanging Fluid Bag or Fluid Management System

Hysteroscope

Light Source Camera / Video System

Figure 1. BenestaTM Hysteroscope and removable Outflow Channel

Device Description Valve Lever

The BenestaTM Hysteroscope is intended for use in visualizing the uterine cavity and performing diagnostic and operative hysteroscopy procedures, including use with the BenestaTM Tissue Removal Device. BenestaTM Hysteroscope system includes the hysteroscope and removable outflow channel. The removable outflow channel provides a fluid outflow lumen when the hysteroscope is being used in a diagnostic mode. The removable outflow channel includes a sealed entry port to permit the introduction of instrumentation.

Valve lever and cap

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Caldera Medical Catalog Code CAL-TR1511 CAL-TR1513 CAL-TR1415

Valve Cap

End Cap

• The reusable hysteroscope utilizes rod lenses for visualization and fibers for illumination. The hysteroscope includes a working channel designed to accommodate the respective BenestaTM Tissue Removal Device. (See Figure 1). The components of the Benesta Hysteroscope set are listed in Table 1 and the hysteroscope components are shown in Figure 2.

Eyepiece

Figure 2. BenestaTM Hysteroscope components

Indications for Use

• The Operative Hysteroscopy System can be used with a hanging bag or a fluid management system (FMS) to provide continuous flow of distending media.

The BenestaTM Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative/ surgical procedures.

NOTE: Selection of a FMS is at the discretion of the user. FMS equipment should be capable of a minimum operating pressure of 40 mmHg to maintain appropriate intrauterine distention and be capable of measuring fluid deficit to monitor fluid absorption by the patient. 3

Contraindications

• This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures:

Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent: • Acute pelvic inflammatory disease • Inability to distend the uterus • Cervical stenosis • Cervical/vaginal infection • Uterine bleeding or menses • Known pregnancy • Invasive carcinoma of the cervix • Recent uterine perforation • Medical contraindication • Severe anemia • Inability to circumnavigate a myoma due to myoma size • Intolerance to anesthesia

– Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Connect the pieces of equipment into different outlets or circuits. – Consult a biomedical engineer. • All equipment performance is considered to be safety-related including any degradation of performance caused by reciprocal interference. If the product is not put into service in accordance with the electromagnetic safety requirements in this manual and fails to perform as specified, the procedure should be aborted immediately, and biomedical engineering staff should be alerted to the observed issues.

• After every hysteroscopic procedure, if the hysteroscope light-post adapters have been used, they should be removed from the hysteroscope, appropriately disassembled, and then cleaned and sterilized before subsequent use.

Warnings • Before using the BenestaTM Hysteroscope for the first time, please review all available product information.

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• The hysteroscope and outflow channel are shipped non-sterile. They must be thoroughly cleaned and sterilized before use.

• Uterine perforation can result in injury to bowel, bladder, major blood vessels, and ureters.

• For use only by physicians trained in diagnostic hysteroscopy and hysteroscopic surgery

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

• Careful pre-operative assessment, including imaging, should be performed on each patient prior to a hysteroscopic procedure to evaluate for conditions which may, depending on their severity or extent, affect the appropriateness of hysteroscopy. • Hysteroscopic myomectomy should not be undertaken without

adequate training, preceptorship, and clinical experience. Patients should be carefully evaluated to determine the presence of clinical conditions that can significantly complicate a hysteroscopic myomectomy.

• A sterile, backup hysteroscope and accessories are recommended in case of device breakage or other accidental loss of function.

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

• A pregnancy test before the performance of hysteroscopy is recommended whenever the possibility of pregnancy exists. • The BenestaTM Hysteroscope is to be used only in conjunction with accessories that comply with the following safety standards: National/Regional versions of IEC 60601-1, the general safety requirements for medical devices; and, as applicable, IEC 60601-2-18 or IEC 60601-2-2. Before using any accessory, be sure to follow the instructions provided with the accessory to determine criteria for safe use.

– Not for use in an oxygen-rich environment. – No modification of this equipment is allowed. – Potential complications of hysteroscopy with fluid media:  Hypothermia  Pulmonary edema  Cerebral edema  Hyponatremia (if electrolyte free media are used) Uterine perforation resulting in possibly injury to bowel,  bladder, major blood vessels, and ureters

• For any accessories or electrical equipment intended to be used with the BenestaTM Hysteroscope, please consult device instructions for use to determine safety criteria and risk mitigations when used with hysteroscopic equipment. • Interconnections conditions require the applied parts of other medical electrical equipment used within the configuration for endoscopic application to be Type BF applied parts or Type CF applied parts. • The Benesta™ Hysteroscope is not intended for use with electrosurgical equipment. 4

NOTE: It is recommended to have access to another hysteroscope in case of any droppage, contamination, damage and/or malfunction.

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

Supplies Needed for Indicated Procedures (Table 2)

• If liquid distension media is used, strict fluid intake and output surveillance should be maintained. If a low viscosity isotonic liquid distention medium is used, intrauterine instillation exceeding 2500mLshould be followed with great care to the possibility of fluid overload. Possible complications of continuous flow hysteroscopy: o

Hyponatremia

o

Hypothermia

o

Uterine perforation resulting in possible injury to bowel, bladder, major blood vessels, and ureter

o

Pulmonary edema

• Benesta Tissue Removal Device Placement of Single-Use Seals Both the hysteroscope and the outflow channel require installation of single-use seals at the proximal end of their working channels. Figure 3 below illustrates the seal installation process.

Cerebral edema

• To reduce the risk and amount of systemic media absorption,

End Cap

intrauterine distension pressure should be maintained at the lowest pressure necessary to distend the uterine cavity and ideally should be maintained below the mean arterial pressure (MAP).

Seal

• Do not use the seals if the sterile package is open or appears compromised. Do not use the device if damage is observed. • Avoid exposing the hysteroscope to sudden temperature changes. Do not immerse hot hysteroscopes in cold liquids.

Figure 3. Seal installation

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o

• Benesta Fluid Pack (1 Single-use Y-Tubing and 2 single-use seals)

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

1.

Remove end caps from hysteroscope and outflow channel.

2.

Place seal within inside end cap in the orientation shown in Figure 3.

• To avoid perforation, do not use the hysteroscope tip as a probe and

3.

Screw end caps into place on the hysteroscope and outflow channel.

4.

Insert the removable outflow channel into the hysteroscope’s working channel. Reverse this process to remove the outflow channel.

exercise caution when the hysteroscope is being inserted through the cervix and when the hysteroscope tip is near the uterine wall.

SET-UP Inspection Prior to Use

Connecting Inflow Tubing

Prior to each use, the outer surface of the insertion portion of the hysteroscope should be inspected to ensure there are no unintended rough surfaces, sharp edges or protrusions. Ensure that the single-use seals have been appropriately positioned in both the hysteroscope and the outflow channel. Before each use or after a change of viewing modes / settings on a camera control unit, check to ensure the observed view provides a live image (rather than a recording) and has the correct image orientation. Equipment Needed for Indicated Procedures (Table 2) • Fluid source or system • Video / Camera System • Endoscopic light source (e.g. Metal-Halide or Xenon) with compatible fiber optic light guide (not supplied with this product). NOTE: The BenestaTM Hysteroscope is compatible with Metal-Halide and Xenon light sources with up to 300 watts of power. 5

1.

The BenestaTM Hysteroscope has two ports that accommodate standard male Luer connectors for fluid inflow.

2.

Connect the single-use Y-tubing to both male Luer connectors on the hysteroscope, as shown in Figure 4. Single-use Y-tubing is provided separately in the fluid pack.

3.

Connect the single arm of the Y-tubing to the fluid inflow source. The Y-tubing can accommodate either a standard male Luer connector or friction connection.

2.

Plug the video cable into the camera control unit (CCU).

3.

Turn on the power to the monitor, CCU, and light source. Adjust the video system components per the manufacturer’s instructions. The system is now ready to use.

NOTE: The inflow of the hysteroscope can be adjusted by opening or closing either of the two inflow valve lever. In order to maintain full fluid inflow, both inflow valve levers must be in the open position. To stop inflow completely, both valve levers must be in the closed position.

CLEANING AND STERILIZATION A manual or automated cleaning procedure may be used, as described below. Proper cleaning must be performed prior to disinfection or sterilization. Figure 4. Y-Tubing attachment

1.

2.

The removable outflow channel includes a port that can accommodate a standard male Luer connector or friction connection. A standard male Luer connection is recommended to minimize fluid leakage. Connect outflow tubing (purchased separately) to the port on the outflow channel.

Ensure the light-post adapter installed on the hysteroscope is compatible with the intended light source. Adapters are available for connection to Storz, Olympus, Dyonics, Wolf, and ACMI light sources as shown in Figure 5.

2.

Ensure the fiber optic surface remains free of foreign matter. Do not use tools to tighten the light post adapters – hand-tighten only.

Completely remove light-post adapter from the hysteroscope.

2.

Remove end caps from the hysteroscope and removable outflow channel and discard all single-use seals.

3.

All valve levers and caps on the hysteroscope and removable outflow channel must be disassembled.

WARNING: Failure to remove the single-use seals from hysteroscope and removable outflow channels will affect proper cleaning and sterilization of the product.

Installing Light-Post Adapter 1.

1.

4.

Fully immerse the hysteroscope, outflow channel, and accessories in a bath with enzymatic cleaning solution for 5 minutes and flush lumens with enzymatic cleaner using a syringe, a minimum of three times.

NOTE: A mild enzymatic cleaner with a near-neutral pH is recommended, such as Enzol. Follow the cleaning solution manufacturer’s recommended processing instructions or facility-validated processing instructions. 5.

ACMI Dyonics/Wolf

Scrub all crevices using a cleaning brush to remove any visible debris, taking care not to scratch any optical surface. Use cleaning brushes that are suitable to contact the full interior dimensions (diameter and length) of the lumens. The following dimensions for cleaning brushes are recommended: o

Hysteroscope working channel: 3.0mm brush diameter and at least 340mm overall length ( CAL-TR125, 3mm Working Channel Brush, or equivalent).

o

Hysteroscope fluid channels: 2.0mm brush diameter and at least 370mm overall length ( CAL-TR126, 2mm Inflow Channel Brush, or equivalent).

o

Removable Outflow Channel: 2.0mm brush diameter and at least 370mm overall length ( CAL-TR126, 2mm Inflow Channel Brush, or equivalent).

Storz/Olympus

Figure 5. Light-post adapters

Directions for Use 1.

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Manual Cleaning

Connecting Outflow Tubing (used with outflow channel)

The hysteroscope may be used by looking through the eyepiece of the hysteroscope directly, however, it may be more convenient to couple a video system to the eyepiece. If a video system is being connected to the hysteroscope, thread an eyepiece coupler onto the camera head and securely attach the eyepiece coupler onto the hysteroscope eyepiece. 6

6.

Flush each lumen with cold water.

7.

Brush all inner and outer surfaces with cleaning brush and appropriately sized lumen brushes under cold water until all visible residues are removed.

8.

If visible contamination remains on the hysteroscope, outflow channel, or other accessory components, repeat all previous cleaning steps until no visible contamination remains.

container which secures the instruments in place, such as the Benesta Sterilization Tray (sold separately). Prior to sterilization, ensure that the hysteroscope and components have been thoroughly cleaned.

9.

Make sure to thoroughly rinse the hysteroscope, outflow channel, and accessory components to completely remove the cleaning solution.

1.

Automated Cleaning Manual Pre-Cleaning

1.

2.

Fully immerse the hysteroscope, outflow channel, and accessories in a bath with enzymatic cleaning solution for 5 minutes, and flush lumens with enzymatic cleaner using a syringe, a minimum of three times.

NOTE: It is recommended to use a mild enzymatic cleaner with a nearneutral pH, such as Enzol. 2. 3.

3.

Brush inner and outer surfaces with cold water until all visible residues are removed.

5.

Clean using a washer or disinfector and follow manufacturer instructions for suggested cycle parameters. •

6.

•

If sterilizing the hysteroscope and components assembled, the valve lever and end cap on the hysteroscope and outflow channel, must be in the open position.

If not using a sterilization tray, wrap the BenestaTM Hysteroscope and assembled or disassembled components in an appropriatelysized, FDA-cleared sterilization wrap. If using a sterilization tray, wrap the outside of the tray that contains the BenestaTM Hysteroscope and components. Utilize wrapping techniques according to the wrap manufacturer’s instructions.

It is recommended that the sequential wrapping technique per AAMI ST:79 be used when utilizing a sterilization tray

Follow standard clinic/ hospital procedures to sterilize the wrapped hysteroscope and components using the settings shown in Table 3.

NOTE: Variables that may affect sterilization and drying times include loading density of the case/tray, instrument configuration, total contents of the sterilizer, steam quality, equipment maintenance, and others.

Washer/Disinfector Cleaning

Place Hysteroscope, outflow channel, and accessories in an instrument basket.

It is recommended that prior to sterilization, all components are disassembled to allow for steam penetration.

•

Flush the inner lumen with cold water using a water jet pistol for at least 20 seconds.

4.

•

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10. Ensure the hysteroscope and hysteroscope accessories are completely dry prior to sterilization or storage. A lint-free cloth and/or filtered compressed air may be used for drying.

When placing instruments and components into sterilization wrap or sterilization tray, be sure the instruments do not experience any undue forces or stress which might damage the system including the delicate internal optics of the hysteroscope.

Table 3. Sterilization parameters

Steam Sterilization, Pre-Vacuum Temperature 132 °C Exposure Time 4 minutes Dry Time 45 minutes

At a minimum, the cycle should consist of two pre-rinses with cold water, one wash at 43°C water, and two final rinses with cold water.

Ensure that the hysteroscope and hysteroscope accessories are completely dry prior to sterilization or storage. A lint-free cloth and/or filtered compressed air may be used for drying.

Steam Sterilization, Gravity 132 °C 15 minutes 45 minutes

IMPORTANT: It is recommended that the institution employ procedures which include the use of biological indicators to determine the effectiveness of the sterilization process.

NOTE: Extra care should be taken to ensure that the lens and eyepiece of the scope are free of cleaning solution or visible residue.

4.

After the autoclave door is opened, all contents must be allowed to cool thoroughly. Place wrapped contents on a wire rack or shelf with linen cover in an area free of traffic and strong air currents for a minimum of 30 minutes, or until cooling is complete. The potential for condensation may increase if the contents are not allowed to cool properly.

5.

If condensation is observed, verify that the steam which is being used for sterilization processing, has a quality of more than 97%. Also confirm that the sterilizers have been inspected for routine maintenance in accordance with manufacturer’s recommendations.

NOTE: Do not use any ultrasonic cleaning methods. The energy transmitted through fluid cavitation will damage seals and optical surfaces and will void the warranty. NOTE: Foreign matter remaining on the fiber surface of the light-post after cleaning may tend to burn and discolor the surface when exposed to a high intensity light source. NOTE: If available, filtered or de-ionized water are recommended for all cleaning steps requiring water. Sterilization

Maintenance

The BenestaTM Hysteroscope, outflow channel, light-post adapters, and end caps can be sterilized in autoclave wrap or, preferably, sterilized in a 7

We recommend that you inspect the hysteroscope carefully before and after the procedure for possible signs of damage.

2.

Check the image quality of the hysteroscope by viewing the monitor. If image quality is impaired:

Table 4. Replacement components

Catalog Code

– Check the distal and proximal lenses of the hysteroscope for cracked or scratched lenses. – Check the surface cleanliness of the distal and proximal lenses. A foggy or cloudy image can be the result of moisture entering the optical system or lack of cleanliness of exterior surfaces. When viewing reflected light, the surfaces should appear smooth and shiny. Check the illumination system of the hysteroscope. Reduced brightness can result from fiber damage:

CAL-TR111 CAL-TR112

BenestaTM Outflow Channel

CAL-TR121

CAL-TR123

Replacement Hysteroscope Light Post Adapter – Large (Storz/Olympus) Replacement Hysteroscope Light Source Adapter – Small (Dyonics/Wolf) Replacement Valve Lever and Cap

CAL-TR124

Replacement Hysteroscope/Outflow Channel End Cap

CAL-TR125

3mm Working Channel Brush

CAL-TR122

– Check for fiber optic damage in the hysteroscope by holding the distal end of the hysteroscope toward a low-power light and observing the light-post on the hub. The center of the light-post should appear clear or white. Noticeable black spots indicate serious damage to the fiber illumination bundle in the hysteroscope. This will affect light transmission and the brightness of the image viewed on the monitor.

Description

BenestaTM Hysteroscope Set.

CAL-TR126

2mm Inflow Channel Brush

Reuse/Use-Life For the hysteroscope, end of life is normally determined by wear and damage due to use. Please consult the Maintenance Section of this document for re-use inspection prior to and for continued usage of the hysteroscope. The hysteroscope should be serviced annually or sooner if problems are found during inspection and maintenance.

WARNING: Do not look directly into distal end of the hysteroscope while it is illuminated as this may damage your eye. Storage

Warranty, Service, and Repair

• The BenestaTM Hysteroscope and Removable Outflow Channel should be stored either in their shipping box or in a sterilization tray. In either case, proper care should be taken to ensure that the hysteroscope and outflow channel are immobile to prevent any damage.

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1.

Please contact Caldera Medical via email ([email protected]) or telephone, at 866-422-5337. Technical Support and Product Return Information

• If stored within a wrapped container, inspect wrap prior to usage. If the wrap is open, damaged, or visible moisture is present, do not use the device until it is reprocessed.

For technical support and product return information, please contact Caldera Medical via email ([email protected]) or telephone, at 866-422-5337.

• The device should not be stored at temperatures below 40°F or above 120°F, or in conditions where the humidity is below 40% or above 60%.

The most current version of the Labeling Symbols Glossary is available for viewing or download here: www.calderamedical.com/medical-professionals/product-instructions-for-use

Service - Accessories The following are replacement/service parts for the BenestaTM Hysteroscope (Table 4).

All Caldera Medical Instruction for Use (IFU) documents are available in print form at no additional cost upon request. If you would like to request a copy please contact us at 818.879.6555, fax 818.879.6556, or email [email protected]. To learn more about Caldera Medical, other products for incontinence, product evaluations, and training opportunities, contact Caldera Medical at 866.422.5337 or visit our website at www.calderamedical.com. Benesta is a trademark of Caldera Medical, Inc. and/or its subsidiaries in the United States.

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