Snowden-Pencer Laparoscopic Suction-Irrigation Reprocessing Guide

en Component Familiarization

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Components of the ergonomic suction-irrigation system. (Figure 1) A B 1 2 3 4 5

Suction-irrigation tube Ergonomic suction-irrigation handle Suction-irrigation holes Spring cap Control lever Suction tube connection Irrigation tube connection 1

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2 B 3

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Figure 1: Suction-irrigation system with ergonomic suction-irrigation handle. Components of the suction-irrigation system. (Figure 2) A B 1 2 3 4

Suction-irrigation tube Suction-irrigation handle with control Suction-irrigation holes Thread Tube connection Control for suction-irrigation function 1 2

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A

3 B 4

Figure 2: Suction-irrigation system with suction-irrigation handle. Catalog Numbers: All products covered by these instructions for use are listed in the appendix. Caution: The instrument may only be used by qualified medical and technical specialist personnel. Federal (USA) law restricts this device to sale by or on the order of a Physician or hospital.

Explanation of Symbols WARNING: Indicates a danger which can result in death or serious injury if not avoided. CAUTION: Indicates a danger which can result in injuries if not avoided. IMPORTANT: Indicates measures in order to prevent damage to property. Refer to the BD Symbols Glossary for symbol definitions not listed above at www.bd.com/symbols-glossary.

General References/Precautionary Measures Use this product only for the purposes described in these instructions. A non-sterile product must be prepared appropriately before first use and before each reuse. All products should be stored in a dry place and should not be exposed to extreme temperatures. Do not exceed an irrigation pressure exceeding 600mbar.

Possible Complications • •

Infection Injury

Safety Instructions Risk of Infection • Reprocess the instrument before use. • Reprocess before returning to the dealer.

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Risk of Injury • The instrument may only be used by qualified medical and technical specialist personnel. For surgical use by doctors only. • Only use original accessories. • Do not use damaged instruments and do not repair. Risks as a Result of Improper Use • Material fatigue and loss of functionality if the product lifetime is exceeded. • Tissue is punched when a trocar sleeve with an overly large diameter is used.

Assembly Instructions of the Ergonomic Suction-irrigation Handle WARNING: Risk of infection from non-sterile instruments. • Reprocess the instrument before assembly. 1. Insert the cock plug and screw on the spring cap. (Figure 3)

1

Irrigation

Closed

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Suction

Figure 3 Assembly Instructions of the Suction-irrigation Handle WARNING: Risk of infection from non-sterile instruments. • Reprocess the instrument before assembly 1. When inserting the stopcock, make sure that the guiding pin is aligned with the opening in the tube connection and that the lever (in open position) faces the opening. 2. Screw stopcock together with the spring cap. (Figure 4)

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Figure 4 3. Check the instrument for proper function.

Disassembly Instructions of the Ergonomic Suction-irrigation Handle Note: The suction-irrigation tube cannot be disassembled. 1. Unscrew the spring cap and remove the cock plug. (Figure 5)

1 Irrigation

Closed

2 Suction

Figure 5

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Disassembly Instructions of the Suction-irrigation Handle Note: Please disassemble only pre-washed instruments. The suctionirrigation tube cannot be disassembled. 1. Screw off tube if necessary. 2. Screw off the spring cap and remove the stopcock. (Figure 6)

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2

Figure 6

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The functional test shows whether perfect functioning of the instrument and its components can be ensured. Perform the functional test immediately after assembly. Note: Perform the functional test for the suction-irrigation handle. Prerequisite: The instrument is assembled. • Push control to “Suction” and “Irrigation” position. (Figure 7) The control can be moved easily.

Irrigation

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Performing a Functional Test

Suction

Figure 7 Application

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WARNING: Risk of infection from non-sterile instruments. Reprocess the instrument before each use.

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WARNING: Risk of injury from the use of incompatible instruments. Only use original accessories.

CAUTION: Tissue is punched when a trocar sleeve with an overly large diameter is used. • Only use trocar sleeves with a diameter which is slightly larger than that of the instrument. Note: During suctioning tissue fragments may settle in the suction-irrigation holes. For this reason, rinse the suction-irrigation tube several times outside of the surgical site during the intervention. • Screw the suction-irrigation tube into the suction-irrigation handle. (Figure 8)

Figure 8

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Insert the instrument via a trocar sleeve. Connect the tube connections with a suction-irrigation device. When doing so pay attention to the arrow marking. Arrow points in the direction of the tube connection: Suction Arrow points away from the tube connection: Irrigation. Note: With suction-irrigation handles with a control, you are free to choose which connection should be used for irrigation and which for suction. Perform the intervention. Remove the instrument. Reprocess the instrument.

Accessories and Spare Parts

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WARNING: Risk of injury from the use of incompatible instruments. Only use original accessories.

WARNING: Risk of injury from improper repairs. Only allow repairs to be performed by the manufacturer or by persons authorized by the manufacturer. The following parts can be ordered individually: Handles, tubes, spring knobs, spring caps and handle valves. •

Indications For Use

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The instruments are designed for use in minimally invasive surgery and, in particular, laparoscopy. The suction-irrigation tube serves to irrigate the surgical site and to suction away any fluids and tissue fragments which may collect during the intervention.

Intended Use Reusable surgically invasive devices for temporary use.

Contraindications This instrument is not designed for use on the central nervous and circulatory system.

Product Description The suction-irrigation tube is connected with the suction-irrigation handle and inserted via a trocar sleeve into the surgical site. Additional holes on the suction-irrigation tube enlarge the suction-irrigation range. You can switch between the suction and irrigation function using a control on the handle. (Figure 7) Note: The ergonomic suction-irrigation handle is marked with arrows to prevent the tube connections from being mixed up. Arrow points in the direction of the tube connection: Suction Arrow points away from the tube connection: Irrigation

Contraindications This instrument is not designed for use on the central nervous and circulatory systems.

Combination with Other Products/Instruments Select the trocar sleeve according to the diameter of the instrument: Suction-Irrigation Tube

Compatible Trocar Sleeve

Dia. 3 mm

Dia. 3.5 mm

Dia. 5 mm

Dia. 5.5 mm

Dia. 10 mm

Dia. 11 mm

Instructions for Use Before using the instrument, read and follow the Instructions for Use. Keep in a place where they can be easily seen for reference at a later date. The instruments should always be examined for correct assembly and function, surface damage, tears, and bent or worn parts. Damaged or defective instruments or individual parts may no longer be used. The following procedure is recommended for the cleaning and preparation of suction-irrigation system instruments. Procedure: Automated or Manual Cleaning Process Products:

Suction-irrigation system instruments

Limitations on Reprocessing For all suction-irrigation tubes and handles, the useful life of this product is ≤ 1,000 cycles or ≤ 5 years. For all ergonomic suction-irrigation handles, the useful life of this product is ≤ 400 cycles or ≤ 5 years.

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Cleaning – General Instructions • • • • •

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All devices must be cleaned in the disassembled configuration. Note that disassembly should not involve the use of any mechanical tooling (i.e. screwdriver, pliers, etc.). All ports shall remain in the fully open position. Devices may be cleaned by following either the Manual or Automatic Cleaning Instructions. In the case of manual cleaning, the individual parts of the instruments must be soaked in an active cleaning and disinfection solution. Observe the instructions of the disinfectant manufacturer. All surfaces, including those of internal cavities, lumens and openings, must come into contact with the solution. “Drinking water” refers to water which meets the specifications for Utility Water listed in AAMI TIR34. “Treated water” refers to water which meets the specifications for Critical Water listed in AAMI TIR34, and is extensively treated (for example by deionization, distillation, or reverse osmosis) to ensure that microorganisms and the inorganic and organic material are removed from the water.

WARNING: Risk of infection due to insufficient reprocessing. • Remove protective caps (if relevant). IMPORTANT: Avoid damaging product. • Do not use abrasive brushes or scourers. • Only use the cleaning agents which are listed in the individual sections. • With plastic instruments, avoid contact with hydrogen peroxide (H2O2).

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WARNING: Risk of infection due to insufficient reprocessing. Special reprocessing requirements must be observed if there is a suspicion of prions and Creutzfeldt-Jakob disease.

Transportation Store and transport the device safely to the cleaning area to avoid any damage and contamination to the environment.

Pre-Processing Instructions

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To prevent surgical residue from drying on, initiate decontamination and pre-cleaning directly after surgery. • Rinse the instrument, remove coarse dirt and rinse out the cavities with cold water. Note: If it is not possible to rinse with cold water, the instrument must be wrapped in a moist cloth to prevent any residues from drying on. Tip: Remove caked-on tissue residues with a plastic brush. • Immerse the instrument in a cold water bath with 0.8% cleaning solution for at least 5 min. • Brush the instrument under cold water until all visible signs of soiling have been removed. • Dismantle the instrument and open stop cock. Note: Rinse the instrument under the surface of the water. This prevents contamination of the surrounding area. • Brush the outside and inside under cold water with a round brush until no more residue is visible. • Rinse out cavities, drill holes and threads (if relevant) with a cleaning gun for at least 10 seconds at 3-5 bar. • Remove from the water bath and rinse off with cold water. • Immerse in combined cleaning and disinfectant solution until subsequent cleaning to prevent any residue from drying on. WARNING: Risk of infection and pyrogenicity from residues if unsuitable cleaning agents are used. • Do not use fixing agents. • Do not rinse with hot water. IMPORTANT: Avoid damaging product. • Do not use abrasive brushes or scourers. • Only use the cleaning agents which are listed in this section. • Use disinfectant with corrosion protection.

Manual Cleaning: Enzymatic/Neutral pH Detergent 1. Ensure all pre-processing and disassembly instructions are followed prior to cleaning. 2. Place the instrument in cold drinking water for at least 10 minutes. 3. Brush the instrument under cold drinking water until all visible signs of soiling have been removed. 4. Rinse out cavities, drill holes and threads with a cleaning gun with cold drinking water for at least 20 seconds at 3-5 bar. 5. Clean the components in an ultrasonic bath with 0.8% cleaning agent at 40-45°C (104-113°F), 35 kHz for 10-15 minutes. 6. Turn and move the components several times during cleaning in the ultrasonic bath.

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7. Rinse out cavities, drill holes and threads with a cleaning gun with cold drinking water for at least 20 seconds at 3-5 bar. 8. Immerse the instrument in deionized water and rinse through the cavities several times with deionized water. Note: Also clean the inner chambers of the instrument below water using a clean brush. 9. Dry on the inside and outside for at least 10 minutes at 50-100°C (122-212°F) and/or blow through with sterile compressed air. 10. Disinfect with a pH 10.5 disinfectant for at least 10 minutes.

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Automatic Cleaning: Enzymatic/Neutral pH Detergent 1. Ensure all pre-processing and disassembly instructions are followed prior to cleaning. 2. Immerse the instrument in an ultrasonic bath at 40-45°C (104-113°F), 35-45 kHz for 10-15 minutes. Turn and move the components several times during cleaning. 3. Clean all components using the automatic cleaning parameters below. PHASE

MINIMUM RECIRCULATION TIME

WATER TEMPERATURE

DETERGENT TYPE AND CONCENTRATION (IF APPLICABLE)

Pre-Wash

1 Minute

Cold Drinking Water 1°C - 25°C (33°F - 77°F)

N/A

Pre-Wash

3 Minutes

Cold Drinking Water 1°C - 25°C (33°F - 77°F)

N/A

Wash

5 Minutes

45°C (113°F)

• Detergent: pHneutral/enzymatic • Concentration: Per the detergent manufacturer's recommendations

Rinse

3 Minutes

Hot Treated Water 43°C - 82°C (110°F - 179°F)

N/A

Rinse

2 Minutes

Hot Treated Water 43°C - 82°C (110°F - 179°F)

N/A

Completely desalinated water, the thermal disinfection is carried out at temperatures >65°C and corresponding application time Automatic according to the A0 concept, DIN EN ISO 15883 (e.g. A0 3000 = Disinfection 90°C and 5 minutes application time). The operator is responsible for the implemented A0 value. Note: 95°C is the maximum temperature to be utilized during this step.

4. If visible moisture is present, dry the instrument with a clean, lint-free towel. 5. Visually examine each instrument for cleanliness. 6. If visible soil remains, repeat the cleaning procedure until the device is thoroughly clean.

Automatic Cleaning: Alkaline Detergents 1. Ensure all pre-processing and disassembly instructions are followed prior to cleaning. 2. Immerse the instrument in an ultrasonic bath at 40-45°C (104-113°F), 35-45 kHz for 10-15 minutes. Turn and move the components several times during cleaning. 3. Clean all components using the automatic cleaning parameters below. PHASE

MINIMUM RECIRCULATION TIME

WATER TEMPERATURE

DETERGENT TYPE AND CONCENTRATION (IF APPLICABLE)

Pre-Wash

1 Minute

Cold Drinking Water 1°C - 25°C (33°F - 77°F)

N/A

Pre-Wash

3 Minutes

Cold Drinking Water 1°C - 25°C (33°F - 77°F)

N/A

Wash

5 Minutes

55°C (131°F)

• Detergent: Alkaline • Concentration: Per the detergent manufacturer's recommendations

Neutralization

3 Minutes

Hot Treated Water 43°C - 82°C (110°F - 179°F)

N/A

Rinse

2 Minutes

Hot Treated Water 43°C - 82°C (110°F - 179°F)

N/A

Automatic Disinfection

Completely desalinated water, the thermal disinfection is carried out at temperatures >65°C and corresponding application time according to the A0 concept, DIN EN ISO 15883 (e.g. A0 3000 = 90°C and 5 minutes application time). The operator is responsible for the implemented A0 value. Note: 95°C is the maximum temperature to be utilized during this step.

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Drying Automated Drying: Dry the outer surfaces of the instruments in the drying cycle of your washer-disinfector for 15-25 minutes at 90-110°C (194-230°F). Remove the product immediately at the end of the cycle. If necessary, also blow through the product with sterile compressed air until it is completely dry. If needed, additional manual drying can be performed using a lint-free towel.

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Inspection Proper care and handling is essential for satisfactory performance of any surgical device. The previously listed cautions should be taken to ensure long and trouble-free service. All devices must be examined for full functionality prior to and after use. Moving parts of the device should be easily operable. Inspect devices for broken, cracked, discolored, or tarnished surfaces. Inspect for hindered movement of hinges, loose components, and chipped or worn parts. Inspect insulation for breaks or damage. If any of these conditions appear, do not use the device. Return devices to an authorized V. Mueller representative for repair or replacement. When disposing of or returning devices, products may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable local, state, federal, or country laws and regulations.

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The right care of instruments will lengthen their service life and should therefore be carried out after every cleaning process.

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WARNING: Risk of injury from faulty or damaged components Do not use damaged instruments and do not repair. Check to ensure they are clean and, if necessary, repeat cleaning. Check for damage (e.g., sharp edges, rough surfaces). Replace brittle and cracked seals (if relevant). Lubricate moving parts (e.g., joints, rotating stop cocks) with medical oil. Remove any excess oil. Assemble instruments (if possible) and check to ensure they are in perfect working order.

Packaging The instrument must be packed appropriately prior to sterilization to ensure that the sterile barrier remains intact after removal from the sterilizer. Package the instrument to comply with ISO 11607 and EN 868.

Sterilization General Instructions IMPORTANT: Avoid damaging product. • Observe the device’s maximum load.

• • •

WARNING: Risk of infection due to insufficient reprocessing. Special reprocessing requirements must be observed if there is a suspicion of prions and Creutzfeldt-Jakob disease. Sterilization is performed with the instrument assembled. Open stop cocks and place in sterilization device so that the components are not touching each other and the steam can circulate freely.

Sterilization and Packaging for US Market Packaging Use FDA-cleared sterilization wrap or sterilization container. • Use in accordance with packaging manufacturer’s sterilization instructions while being sure to protect jaws and cutting edges from damage. • Device configuration must meet the requirements of the packaging system. • Sterilization wrap material must be cleared for the applicable sterilization modality by your country’s regulatory body. • When utilizing a sterilization container, refer to container IFU for additional reprocessing instructions.

Prevacuum Steam Sterilization Parameters Sterilization Configuration: Wrapped (2-layer 1-ply or 1-layer 2-ply) or containerized Temperature: 132°C (270°F) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

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Sterilization and Packaging for Outside United States Market Packaging Wrap the instruments in the appropriate sterilization wrap according to ISO 11607 and EN 868 and facility guidelines. Sterilization Configuration: Wrapped (2-layer 1-ply or 1-layer 2-ply) or containerized

Prevacuum Steam Sterilization Parameters

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Minimum Preconditioning Pulses: 3 Temperature: 134°C (273°F) - 137°C (278°F) at 3 bar, 44psi Exposure Time: 4 minutes Minimum Dry Time: 30 minutes Note: France and Switzerland require sterilization for at least 18 minutes.

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Storage To avoid reducing durability and forfeiting any resistance to bacteria, the following storage conditions must be observed: • Store the sterile device in a clean, dust-free and dry sterile container. • Protect from direct light. • Store the sterile container in a clean and dry environment with controlled humidity at room temperature. • Do not store the sterile container in the vicinity of aggressive substances (e.g., alcohols, acids, bases, solvents and disinfectants). Note: Also observe your internal storage standards for sterile devices.

Disposal Environmentally sound disposal enables valuable raw materials to be recycled. Dispose of the product in an environmentally friendly manner in accordance with the valid hospital guidelines.

Additional Instructions Any deviation from the validated parameters must be validated by the user. It is the duty of the user to ensure that user facility cleaning and sterilization procedures, resources, materials, equipment and personnel are adequate and capable of achieving the required results. State-of-the-art and national legal guidelines require these procedures, resources, materials, equipment and personnel qualifications to be properly and regularly validated and maintained.

To learn more about US sterilization practices and what is required of manufacturers and end users, visit: • • •

www.aami.org www.aorn.org www.iso.org

Further EU References for the Cleaning, Disinfection and Sterilization of Medical Devices • •

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Internet: http://www.a-k-i.org Hygienic requirements for the preparation of flexible endoscopes and endoscopic auxiliary instruments - recommendation of the commission for hospital hygiene and infection prevention of the Robert Koch Institute (RKI). Internet: http://www.rki.de Hygienic requirements for the preparation of medical devices recommendation of the commission for hospital hygiene and infection prevention of the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) regarding the “hygiene requirements for the preparation of medical devices.”

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Warranty

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All Snowden-Pencer instruments are protected by a full service 1 year warranty and lifetime warranty against manufacturer defects. Damage caused to the instrument by overstress, mechanical shock, improper processing, or repair by a party other than Snowden-Pencer is not covered. Repair, alteration or modification of any product by persons other than SnowdenPencer, or products subjected to misuse or abuse will result in immediate loss of warranty. If Snowden-Pencer instruments are damaged by accident or when used for a purpose other than originally intended, a repair charge will apply.

Repair Service

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WARNING: Risk of injury from improper repairs. Only allow repairs to be performed by the manufacturer or by persons authorized by the manufacturer.

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WARNING: Risk of infection from non-sterile instruments. • Reprocess the instrument before returning it to the dealer. All instrument repairs must be returned to an authorized Snowden-Pencer representative, to the address below or to an authorized representative for international repairs. If the repair is covered under warranty, it will be repaired or replaced at no charge when requested in writing. A nominal service charge will be made for repaired instruments outside the warranty. Note: All instruments being returned for maintenance, repair, etc. must be cleaned and sterilized per these instructions prior to shipment. Send the instrument back to the dealer in a reprocessed state and in its original packaging.

Contact Information: BD Customer Service 800-323-9088 For email inquiries: [email protected] www.bd.com For customers outside of the USA, please contact your local distributor.

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Appendix All product codes covered by this instruction for use are listed in the following tables.

Table 1 SIH3

SI325

SI333

ST325

ST333

ESIH3

SIT333

F265.05

Table 2 - Parts SIHSC-5

ESIHV-5

SIHV-5

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