Microline Surgical ReNew 3900 Serie Instrucciones De Uso página 2

Piezas de mano para laparoscopia con gatillo y sin gatillo

Ocultar thumbs Ver también para ReNew 3900 Serie:

Manual del usuario (18 páginas)

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While immersed, use a soft bristled brush to remove all visible soil from the articles. Pay attention to any challenge areas

and actuate any

movable parts while brushing for one (1) minute.

While immersed, use a lumen brush to brush the interior lumen for one (1) minute.

Note that the lumen may not be entirely brushed. Approximately 1cm of the distal shaft and just inside the luer fitting

may be safely brushed without potentially causing damage to the device.

Remove the articles and rinse under lukewarm running tap water for one (1) minute while actuating movable parts.

Insert a 60 ml luer type syringe filled with lukewarm tap water where the cautery plug was removed and flush with 60 ml.

Repeat filling the syringe and flushing the shaft for a total of three (3) times and 180 ml. Ensure that clear water exits the

other side while flushing. Alternatively, the device may be attached to an automated flush device to allow 180 ml of

lukewarm tap water to flow through the device in a similar manner.

(CAUTION: Water temperatures >45°C may cause scalding).

Rinse the articles in Reverse Osmosis/ deionized (RO/DI) water. Repeat two (2) additional times for a total of three (3)

10.

RO/DI rinses.

While rinsing, actuate movable parts.

Insert a 60 ml luer type (or equivalent) syringe filled with warm* deionized (RO/DI) water where the cautery plug was

11.

removed and rinse with 60 ml of deionized water. Repeat filling the syringe and flushing the shaft and tip three (3) times for

a total of 180 ml. Alternatively, the device may be attached to an automated flush device to allow 180 ml of warm* deionized

(RO/DI) water to flow through the device in a similar manner.

Dry the articles completely using clean lint-free cloth.

12.

Visually inspect the device and device components in a well-lit area to ensure all surfaces are clean. Repeat cleaning steps

13.

if visible soil is still observed or dispose of the device.

Inspect the instrument for functionality and package appropriately for sterilization.

14.

*Note: According to the U.S. Pharmacopeia (USP), "warm" is any temperature between 30°C to 40°C.

AUTOMATED CLEANING

Detach tips and non-latex rings before cleaning and sterilization. The minimum automated cleaning requirements are as follows:

Rinse with running tap water while actuating moving parts to remove gross soil.

Through the luer connection, flush the device with lukewarm tap water while fully immersed in a bath of lukewarm tap

water (CAUTION: Water temperatures >45°C may cause scalding).

Use a lumen brush to clean hard to reach areas.

Load device(s) into automated washer. Load device(s) in the open position.

Note – The device must be loaded into the automated washer without a tip attached.

Automated wash cycle parameters as follows:

Instrument Cycle: High

Phase

Pre-Wash

Wash 1

Rinse 1

PURW Rinse

Dry

And separately, for German market and referencing the VARIO TD program:

Phase

Pre-Wash

Wash 1

Rinse 1

Final Rinse

Disinfect: "The A 0 concept (ref. DIN EN ISO 15883) and its national requirements must be taken into consideration in the

on-site process validation, carried out by the user."

Visually Inspect to ensure all soil is removed. Repeat cleaning steps if visible soil is still observed or dispose of the device.

STERILIZATION

The device must be sterilized without a tip attached.

Prior to sterilization, the device must be thoroughly cleaned.

Wrap the device in 2 layers of 1-ply FDA-cleared polypropylene wrap using sequential

envelope folding techniques.

Microline Surgical recommends using the following validated steam sterilization cycles as guidelines:

Sterilization Cycle

Gravity Cycle

Pre-Vacuum Cycle

STERILIZATION PARAMETERS FOR EUROPEAN COUNTRIES

Microline Surgical recommends the following parameters as sterilization cycle parameters for Europe, except for France and Switzerland:

Sterilization Cycle

Pre-Vacuum Cycle

For France and Switzerland, the following sterilization cycle parameters are recommended:

Sterilization Cycle

Pre-Vacuum Cycle

PRECAUTIONS

Do not use handpiece if the O-ring located on the distal end of the shaft appears worn, damaged, or missing.

If the blades/jaws are not completely closed when screwed onto the handpiece, they may not cut or grasp completely at the

distal tip.

CAUTION: Prior to use, assure that the plastic hub of tip is fully in contact with the insulation tube of handpiece and that no

gap exists

between the two parts at that contact point.

WARNINGS

• Failure to adequately process and sterilize the device could lead to infection.

• The device is not intended to be bent, used to pry, or for any other use beyond the indications listed above.

• Bending or using the device to pry could cause the device to fail and/or harm the patient.

• No modification of this device is allowed.

• Not intended for use with silicone or oil-based lubricants.

• Not intended for use with non-Microline, third party devices.

• A thorough understanding of the principles and techniques involved in endoscopic/laparoscopic procedures is essential to

avoid harm to the patient or damage to the device or other medical instruments.

• Do not use device if package is opened or damaged. Examine the device prior to use. Do not use if damage is found.

• Due to the product design, the raw materials used and the intended purpose, it is not possible to determine a precise limit

with regard to the maximum possible number of reprocessing cycles. The serviceable life of the instruments is determined

by their function as well as by careful handling.

• The functional inspection must be completed before each use.

• In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific

reprocessing conditions.

• If an adverse event occurs using this device please report it to Microline Surgical Customer Service and either the

Saudi Food and Drug Authority or the Competent Authority in your country, whichever applies.

• The ReNew Handpiece has a white O-ring at the distal end of the shaft, which is an integral part of the system. Prior to

each use, it is very important to verify that the white O-ring is in place and it is not damaged. If the white O-ring is missing

or damaged, do not use the instrument.

WARNINGS WHEN ACTIVATING FOR ELECTROSURGERY

• Be aware that all exposed metal on the device is capable of treating tissue when the device is activated. Use caution to

avoid inadvertent treatment of tissue.

• A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and

burn hazards to both patient and medical personnel or to avoid damage to the device or other medical instruments.

• DO NOT activate the instrument when not in contact with target tissue, as this may cause injuries due to capacitive

coupling with other surgical equipment.

• The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated.

• ASPIRATE fluid from the area before activating the instrument. Conductive fluids (e.g., blood or saline) in direct contact

with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may

cause unintended burns to the patient.

• Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of

dry gauze.

• The patient should not come into contact with metal parts which are earthed or which have an appreciable capacitance to

earth (for example operating table supports, etc.).

• DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified

professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may

occur, or the implant may be damaged. Place any monitoring electrodes being used as far away as possible from the

device to avoid electrical interference with monitoring equipment.

o Avoid needle-monitoring electrodes.

o Use monitoring systems incorporating high frequency current limiting devices.

o DO NOT use electrosurgery in the presence of flammable anesthetics or other flammable gases, near flammable fluids

or objects, or in the presence of oxidizing agents, as fire could result.

• Inspect the device for breaks, cracks, nicks, or other damage to the electrical insulation before use. Failure to observe this

caution may result in injury or electrical shock.

• DO NOT USE with hybrid trocar systems, i.e., a combination of metal and plastic, when using monopolar active components.

This may result in alternate site burns due to capacitive coupling. Use only all-metal or all-plastic trocar systems.

• Prior to increasing the intensity, check the adherence of the neutral electrode and its connections. Apparent low output or

failure of the device to function correctly at the normal operating settings may indicate faulty application of the neutral

electrode or poor contact in its connections.

• Insulation failures may result in burns or other injuries. Visual inspection alone may not be sufficient to confirm that the

insulation is intact, and dielectric strength testing should be additionally considered.

The exposed metal surface of the device may remain hot enough to cause burns after the radio frequency (RF) current is

deactivated.

• Connect adaptors and accessories to the electrosurgical unit only when the energy is off. Failure to do so may result in an

injury or electrical shock to the patient or operating room personnel.

• Install tips onto the ReNew Modular Handpieces when not connected to the electrosurgical unit (ESU) or when the energy

is off. Failure to do so may result in an injury or electrical shock.

• Aspirate fluid pools from the area before activating RF current to the device. Conductive fluids (e.g., blood or saline) in

direct contact with or in close proximity to the device may carry electrical current or heat away from target tissues, which

may cause unintended burns.

• Use the lowest setting possible on the ESU/RF Generator to achieve the desired tissue effect to avoid overtreatment, which

could result in swelling, fluid, seroma or unintended tissue necrosis.

• Use only with a legally-marketed ESU/RF Generator

• Use only with safety certified ESU/RF generators (IEC 60601-2-2).

• Refer to the ESU/RF generator IFU for operating instructions and warnings.

• Refer to the ESU/RF generator IFU for selection of cable and neutral pad electrode consistent with handpiece ratings.

• DO NOT place instruments near or in contact with flammable materials (such as gauze or surgical drapes). Instruments

that are activated or hot from use may cause a fire.

• Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke plume

and aerosols), protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in both open

and laparoscopic procedures.

• Keep the active electrodes clean. Build-up of eschar may reduce the instrument's effectiveness. Do not activate the

instrument while cleaning. Injury to operating room personnel may result.

• CAUTION: To reduce risk of electrical burn or shock, do not rest fingers or hands near metal parts during use, particularly

near cautery cap connector or between handles.

Time (minutes)

Temperature