MEGADYNE Reusable Monopolar Electrosurgical Cable Instructions for Use

English

Non-Sterile, Reusable Monopolar Electrosurgical Cable 10 ft / (3m) 0075 Please read this information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. Go to www.e-ifu.com for latest version of this manual. Important: This package insert is designed to provide instructions for use of the Non-Sterile, Reusable Monopolar Electrosurgical Cable. It is not a reference to surgical techniques A. DEVICE DESCRIPTION The Non-Sterile, Reusable Monopolar Electrosurgical Cable is intended to connect compatible foot activated devices with electrosurgical generators. The device is intended to be used by a healthcare professional trained and experienced in performing surgeries involving the use of electrosurgery. B. INDICATIONS FOR USE The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator to an electrosurgical electrode. The device is intended to be used as a reusable device. It is sold non-sterile. C. CONTRAINDICATIONS None. D. GENERAL WARNINGS 1.

Refer to the generator manufacturer’s operating manual and electrode instruments for use for proper usage of electrosurgical equipment.

E. PRECAUTIONS Refer to the generator manufacturer’s operating manual and electrode instructions for use for proper usage of electrosurgical equipment. 1.

To minimize the chance of corrosion, do not use saline for cleaning.

2.

Follow the instructions and warnings issued by the suppliers of any cleaning agents and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as they are corrosive.

3.

Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device.

F. INSTRUCTIONS FOR USE 1.

Prior to connecting the cable to the generator, ensure the electrosurgical instrument is compatible with the cable.

2.

Fully insert the electrosurgical instrument into the female connector of the cable. Ensure that no bare metal is exposed between the cable and electrosurgical instrument.

3.

If bare metal is exposed, replace the electrosurgical instrument, or cable.

4.

With the generator in the “OFF” or “Standby” mode, fully insert the male end of the cable into the appropriate monopolar jack on the generator.

5.

After completion of the electrosurgical case, turn the generator “OFF” or to “Standby”. Remove the electrosurgical instrument from the cable by grasping the molded cable connector and pulling the instrument out of the connector. Remove the cable from the generator by grasping the molded cable connector and pulling the plug out of the generator.

6.

Do not modify this device.

Cleaning and Sterilization of Foot Control Cable: Instructions for Reprocessing 1.

This device is supplied non-sterile and must be cleaned and sterilized prior to initial and each subsequent use.

2.

Thorough cleaning is necessary to ensure correct proper function of the device.

3.

Each device must be treated individually and matte surfaces must be protected against scratches.

4.

The design of this device permits effective cleaning and reliable sterilization. The user must ensure that cleaning and sterilization are performed in accordance with guidelines, standards and National Health Authority requirements.

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Point of Use Treatment (in the operating room) 1.

Clean device as soon as possible after use.

2.

Remove excessive solids using disposable lint free wipes, enzymatic foam or per hospital procedure. Soiled devices should be separated from unsoiled devices. Soiled Devices should be covered with a lint free towel dampened with tap, sterile or critical water to prevent blood and/or debris from drying. Encrusted soil can increase the time and effort required to complete processing.

3.

If the recommendations in the steps above are not possible, the device may be placed in a container and immersed in tap, sterile or critical water and covered for transport to the processing area. Caution: To minimize the chance of corrosion, do not use saline for cleaning.

4.

Follow the Cleaning and Sterilization instructions below.

Containment and Transportation Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with hospital procedures and local policies. Cleaning (after procedure) Cleaning should be performed as soon as possible after use, preferably within one hour of use. The device has been designed for thorough cleaning and safe sterilization, without disassembly. It is the responsibility of the end user to ensure that the cleaning is performed using appropriate equipment, materials and personnel to achieve the desired result. Caution: Follow the instructions and warnings issued by the suppliers of any cleaning agents and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as they are corrosive. The user must ensure that cleaning and sterilization are conducted in accordance with the appropriate guidelines, standards, or National Health Authority requirements. Hospital grade low foaming neutral pH to mildly alkaline enzymatic detergents, hospital grade low foaming neutral pH detergents (pH 7-9) and hospital grade low foaming mildly alkaline detergents with a pH of ≤ 11 (prepared according to manufacturer’s instructions) should be used. “Detergent(s)” will be used generically throughout the rest of these instructions. Ensure that detergent manufacturer instructions are followed for concentration, temperature and water quality throughout the cleaning process. When using mildly alkaline detergents, critical water should be used throughout the cleaning process. Further information regarding the use of specific cleaning agents, ultrasonic washers, washer-disinfectors, packaging materials or sterilizers during validation studies is available on request. Ethicon used the following detergents during validation of the processing recommendations: Manual Cleaning: Manual Cleaning with Enzol® Enzymatic Detergent – 8 mL/L at 32-39°C Automated Cleaning: Manual Pre-Cleaning with Cidezyme® Enzymatic Detergent – 8 mL/L at 20-25°C Washer-disinfectors cleaning with neodisher® MediClean forte – 2 mL/L at 55°C The chemical quality of the water used during processing can impact device safety. Facilities should use the recommended water quality requirements for device processing in accordance with local guidance (such as AAMI TIR34, Water for the reprocessing of medical devices), detergent manufacturers and these instructions for use. Critical water is recommended for thermal disinfection and final rinsing of devices. For the purpose of these instructions for use, critical water is defined as a treatment process that may include deionization (DI), reverse osmosis (RO) or distillation. Pre-cleaning Instructions (PRIOR to Automatic or Manual Cleaning) 1.

Immerse and soak the device for a minimum of 10 minutes up to 60 minutes in an enzymatic detergent or equivalent prepared according to manufacturer’s instructions for concentration, water quality and temperature.

2.

Remove the device from the detergent.

3.

Immerse the device in a clean sink with cold to warm tap water – not to exceed 40°C. Using a toothbrush style soft bristle (nylon) brush or soft lint free cloth, clean the exterior of the device paying particular attention to crevices, threads and seams. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device.

4.

Rinse the exterior of the device thoroughly under cold to warm running tap water for a minimum one minute.

Note: The use of ultrasonic cleaners is not recommended for the device. Following the pre-cleaning step, the validated automated or manual processing method must be performed. Refer to standard hospital protocol and local/national practices to determine whether disinfection is required. Note that disinfection is mandatory in some areas of the world; e.g. EU. There are different A0 requirements in various countries; e.g, A0 ≥600 (90°C for 1 minute) or A0 ≥3000 (90°C for 5 minutes). The user must ensure that cleaning, disinfection and sterilization are conducted in accordance with the appropriate local guidelines, standards, or National Health Authority requirements.

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Automated Cleaning Method (Preferred Method) Following the pre-cleaning step, the device must be cleaned/disinfected in a validated automated washer-disinfector in compliance to ISO 15883 or equivalent standard, using a typical non-lubricating Instrument, Vario TD Cycle or a program similar to the following cycle, providing the minimum parameters identified below are met: Phase

Recirculation Time (minutes:seconds)

Temperature

Detergent Type

Validated Parameters

Pre-Wash

02:00

Cold Tap Water

N/A

2 minutes cold tap water

Enzyme Wash

02:00

Tap Water <40°C (104°F)

Neutral pH enzymatic detergent or mildly alkaline detergent

no

Wash

03:00

Tap Water ≥40°C (104°F)

Neutral pH detergent or mildly alkaline detergent

5 minutes tap water 55-60°C

Rinse

02:00

Critical Water >40°C (104°F)

N/A

2 minutes critical water

*Thermal Disinfection

01:00 – 10:00

Critical Water ≥90°C (194°F)

N/A

5 minutes 90°C

Drying

30:00

≥115°C (239°F) - not to exceed 134°C (273°F)

N/A

30 minutes at 115°C

Note: Do not expose the device to a lubrication cycle. Note: The automated washer program may or may not include an enzymatic wash phase. Single or combined washing phases should be performed for a minimum of 5 minutes. Temperatures used during the enzymatic and/or wash phases should meet the requirements of the detergent manufacturer’s recommendations. Disinfection Thermal disinfection can be included as part of the automatic cleaning cycle. The device may be thermally disinfected at a temperature between 90°C (194°F) and 100°C (212°F) for one (1) minute up to ten (10) minute(s) to render the device safer for handling. Manual Cleaning Method 1. 2. 3.

Immerse the device for a minimum 5 minutes in a detergent prepared in accordance with manufacturer’s recommendations for concentration, water quality and temperature. Remove the device from the detergent. Immerse the device in a clean sink with cold to warm critical water – not to exceed 40°C. While immersed, use a toothbrush style, soft bristle (nylon) brush or soft lint free cloth to clean the exterior of the device. Pay particular attention to crevices, threads and seams.

Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. 4.

Rinse the exterior of the device thoroughly with critical water for a minimum one minute.

Drying Dry the device with a clean, absorbent lint free cloth. If a washer-disinfector without a drying cycle is used, a hot-air dryer may be used but the device must not be heated to temperatures above 134°C (273°F). The cavities of device parts must be blown out with clean, compressed air, up to 20 psi, in order to eliminate the possibility of any residual water remaining. Inspection Devices do not have an indefinite functional life. All surgical devices are subject to a degree of wear and tear as a result of normal use. They must therefore undergo a regular and precise visual check before each use: 1.

Ensure the complete removal of soil from all device surfaces. If soil or blood is present, clean the device following the PreCleaning and Automated or Manual Cleaning Instructions.

2.

Inspect the cable for any sign of physical damage

3.

Check the continuity of the cable with an ohmmeter.

Discard and replace the instrument if damage or degradation is present. Defective instruments (malfunctioning or difficult to operate instruments and those with stress, corrosion, cracking or pitting, etc.) increase the risk to the patient and must therefore not be used. Sterilization Steam (moist heat) sterilization is recommended in an approved, pre-vacuum cycle listed below. The steam sterilizer must be FDA cleared, if performed in the United States, and validated to the requirements of any local standards and guidance such as EN285, ISO17665 or AAMI/ANSI ST8.

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Prepare Device for Sterilization 1.

Place and wrap device in an approved sterile barrier wrap material per hospital protocol and in accordance with ISO11607-1 and any other local and/or National requirements using standardized wrapping techniques. Or place device in a sterilization tray wrapped using an approved sterile barrier material and standardized wrapping techniques.

2.

Place wrapped device or wrapped tray into autoclave.

3.

Run the device through the autoclave using one of the settings below.

The following steam sterilization cycle parameters are approved for use. Sterilization in the EU: Sterilizer Type

Method

Cycle Time (minimum time at temperature)

Temperature Set Point

Preconditioning Pulses (Minimum)

Drying Time

Pre-Vacuum

Wrapped

3 minutes

134°C (273°F)

3

15 minutes

Sterilization in US or other applicable countries: Sterilizer Type

Method

Cycle Time (minimum time at temperature)

Temperature Set Point

Preconditioning Pulses (Minimum)

Drying Time

Pre-Vacuum

Wrapped

4 minutes

132°C (270°F)

3

15 minutes

Pre-Vacuum

Wrapped

3 minutes

134°C (273°F)

3

15 minutes

Gravity

Wrapped

15 minutes

132°C (270°F)

Not Applicable

15 minutes

Gravity

Wrapped

30 minutes

121°C (250°F)

Not Applicable

15 minutes

Notes: 1.

The above table includes the minimum temperature and cycle time validated to assure sterility.

2.

Based on steam autoclave tolerances, the actual autoclave temperature can exceed the set point temperature by a maximum of +3°C (+5°F).

3.

Health Authorities in some regulated regions do not accept unwrapped sterilization methods; e.g. in the EU. Please review the appropriate guidelines, standards and National Health Authority guidelines when determining acceptable steam sterilization process parameters for use in each respective country.

4.

Immediate-use steam sterilization is only intended for individual devices and should only be performed when approved by local policies. Immediate-use steam sterilization of devices is not supported. It is the sole responsibility of the user to validate immediate-use steam sterilization if performed.

G. UNDESIRABLE SIDE EFFECTS / RESIDUAL RISKS Refer to the generator manufacturer’s operating manual and electrode instructions for use for undesirable side effects and residual risks. H. COMPATIBILITY Megadyne recommends the use of Megadyne Electrosurgical Cable with the Megadyne electrosurgical generator and Megadyne accessory devices (i.e. E-Z CLEAN™ electrodes and return electrodes. Product codes as 0105S, 0018CS, 0019S, 0019LS, 0020S, 0020LS, 0021S, 0021LS, 0022S, 0100S, 0100LS). For Magnetic Resonance Imaging, this device is not MRI safe and is not MRI compatible I. STORAGE AND TRANSPORT CONDITIONS Storage Conditions: Temperature 5ºC to 50ºC Relative humidity 15% to 95% Storage & Transport Conditions: Keep dry Keep away from heat. J. GENERAL TECHNICAL SPECIFICATIONS RF Voltage Rating≤ 5.5 peak kV, consult electrosurgical generator specifications.

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