36-0160 12-18-17 Proofed by: Date: David Knuth Vernon Hills, IL Dimensions checked: Copy checked:

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. e s o i o f n r ™ en Component Familiarization

Components of the Veress Needle. (Figure 1)

1 Outer sheath

2 Inner sheath

3 Spring cap

4 LL connection

5 Cock plug

: 5 : d 1 e e t k

a 2 4 c D e

3 h

c

y

p

Figure 1

o

C

Component Familiarization

Components of the Injection Needle. (Figure 2)

1 Needle

2 LL connection

1 2

:

d

Figure 2

e

k

c

e

h Catalog Numbers: All products covered by these instructions for use

c

are listed in the appendix. : s y n b

o Caution: The instrument may only be used by qualified specialist

i d s personnel. Federal (USA) law restricts this device to sale by or on the e n f e

o order of a physician or other licensed practitioner. o m i r Explanation of Symbols P D

WARNING : Indicates a danger which can result in death or L

I serious injury if not avoided.

, h s l t l i u 7 n H

0 CAUTION: Indicates a danger which can result in injuries if not

1 K - 6 n avoided. 8 1 o d i 1 0 n v - - r IMPORTANT : Indicates measures in order to prevent damage to property. a 2 6 e D 1 3 V 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. Possible Complications • Infection • Injury Safety Instructions Risk of infection from non-sterile instruments • Prepare the instrument before each use. • Prepare the instrument before returning it to the dealer. Risk of Injury • The instrument may only be used by qualified medical and technical specialist personnel. • Only use original accessories. • Do not use damaged instruments and do not repair. • Remove from the packaging with care. • Do not touch the sharp edges and tips • Do not touch the distal end. • Do not exchange the outer and inner sheaths of the same insufflation cannula.

1 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.

• Loss of pneumoperitoneum due to leaking stopcocks.

• Risk of injury to internal organs due to the sharp tip, if the inner sheath is

not released immediately after the puncture.

Assembly Instructions of Veress Needle

1. Attach the outer sheath and screw tight. (Figure 3)

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: d

e 1 e t k

a 2 c D e

h

c

y

p

o

C

Figure 3

2. Position the cock plug in the stopcock body so that the pin is in the

window.

3. Screw the spring cap onto the cock plug. (Figure 4)

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e

k

c

e

h

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: s y n 1 b o

i d s e n f e o o m i r P D

Figure 4 L I

Disassembly Instructions of Veress Needle , h s

l 1. Unscrew the outer sheath. (Figure 5) t l i u 7 n H 0

1 K - 6

n 2 1 8 1 o d i 1 0 n v - - r a 2 6 e D 1 3 V

Figure 5

2. Unscrew the spring cap and remove the cock plug. (Figure 6)

Figure 6

2 Disassembly Instructions of Injection Needle The injection needle cannot be disassembled.

Application for Veress Needle

WARNING : Risk of infection from non-sterile instruments.

• Prepare the instrument before use.

Prerequisite: Lever is closed so that no gas can escape.

• Connect the instrument to the insufflator’s gas supply via the LL

connection.

:

:

d • Pull back the inner sheath. e e t

k Note: The pointed tip of the outer sheath is visible. (Figure 7) a c D e

h

c

y 1

p

o

C

Figure 7

CAUTION : Risk of injury due to bending of the instrument

sheath.

:

• During the incision, hold the instrument between your thumb and index

d

e finger and stabilize it with your index finger at the center of the sheath.

k

c

• CAUTION! The distal end of the outer sheath is pointed.

e

h

Carefully make the incision via the navel and let the inner sheath go

c

immediately in order not to damage the inner organs. : s y n • Open the lever. b o

i d s • Grip the patient’s tissue in your hand and pull it up slightly. e n f

e • Hold the instrument between your thumb and index finger and puncture o o m the area of the navel. i r P D

• Remove the instrument following creation of pneumoperitoneum. • Reprocess the instrument. Application for Injection Needle L I

, h s l t

l WARNING : Risk of infection from non-sterile instruments. i u 7 n H 0

1 • Reprocess the instrument before each use. K - 6 n

8 1 o d i 1 0 n v - - r a 2 6 e CAUTION : Tissue is punched when a trocar sleeve with an D 1 3 V overly large diameter is used. • Only use trocar sleeves with a diameter which is slightly larger than that of the instrument.

WARNING : Risk of injury from the use of incompatible instruments. • Only use original accessories. Notice: You can introduce contrast media via the LL connection. • Insert the instrument via a trocar sleeve. • Perform the intervention. • Remove the instrument. • Reprocess the instrument.

3 Accessories and Spare Parts

WARNING : Risk of injury from the use of incompatible

instruments.

• Only use original accessories.

Trocar sleeve for injection needle

Only use original trocar sleeves with 5.5 mm.

Indications For Use

These instruments are designed for use in minimally invasive surgery

:

:

d and, in particular, laparoscopy. e e t k a The veress needle is used to pierce the abdominal wall at the start of a c D e

laparoscopic procedure and for the insufflation of carbon dioxide. h

c

The injection needle can be used for the following surgical procedures:

y

p

• Puncturing the surgical site to introduce contrast media. o

C

• Puncturing cysts

• Taking biopsies

Intended Use

These instruments are reusable surgically invasive devices for

temporary use.

The injection needle is inserted via a trocar sleeve.

Product Description

The veress needle serves to blow in carbon dioxide for laparoscopic

:

interventions. The inflowing gas lifts the abdominal wall and thus d

e

minimizes the risk of damage to internal organs during surgery.

k

c

e The veress needle is inserted via the navel and comprises an inner and

h

c

outer sheath. When the incision is made the inner sheath is pushed

: s

y back via a spring to expose the tip of the outer sheath. Following this, n b o

i the blunt, distal end of the inner sheath slides forward again in order to d s e n cover the top of the outer sheath and prevent the internal organs from f e o being damaged. o m i r

P D The injection needle enables the introduction of contrast media into the

surgical site. The contrast media can be introduced via an LL connection. L

I Note: The instrument is inserted via a trocar sleeve. Select the trocar

, according to the diameter of the instrument. h s l t l i u 7 n H 0

1 K - 6 n CAUTION : Risk of injury from the use of unsuitable 8 1 o d i 1 0 n

v components. - - r a 2 6 e • Do not exchange the outer and inner sheaths of the same veress needle. D 1 3 V Contraindications These instruments are not designed for use on the central nervous and circulatory systems. 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 veress and injection needles. Procedure: Automated or Manual Cleaning Process Products: Veress Needle Injection Needle Limitations on Reprocessing For all veress needles, the useful life of this product is 200 cycles or ≤ ≤ 5 years. For all injection needles, the useful life of this product is 1,000 cycles ≤ or 5 years. ≤

4 Cleaning – General Instructions • 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

:

: d contact with the solution. e e t k

a • “Drinking water” refers to water which meets the specifications for Utility c D e

Water listed in AAMI TIR34.

h

c • “Treated water” refers to water which meets the specifications for Critical

y

Water listed in AAMI TIR34, and is extensively treated (for example by

p

o deionization, distillation, or reverse osmosis) to ensure that

C

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 that are listed in the individual sections.

: • With plastic instruments, avoid contact with hydrogen peroxide (H 2O2).

d

e

k

c

e WARNING : Risk of infection due to insufficient reprocessing.

h

c • Special reprocessing requirements must be observed if there is a

: s suspicion of prions and Creutzfeldt-Jakob disease. y n b o

i Transportation d s e n f Store and transport the device safely to the cleaning area to avoid any e o o m damage and contamination to the environment. i r P D

Pre-Processing Instructions • To prevent surgical residue from drying on, initiate decontamination and pre-cleaning directly after surgery . L

I • Rinse the instrument, remove coarse dirt and rinse out the cavities with

, cold water. h s l t l i u Note: If it is not possible to rinse with cold water, the instrument must 7 n H 0

1

K be wrapped in a moist cloth to prevent any residues from drying on. - 6 n

8 1 o d i 1 0

n Tip: Remove caked-on tissue residues with a plastic brush. v - - r a 2 6 e • Immerse the instrument in a cold water bath with 0.8% cleaning solution D 1 3 V for at least 5 minutes. • Brush the instrument under cold water until all visible signs of soiling have been removed. • Dismantle the instrument and open stopcock. 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.

5 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

:

: d ultrasonic bath. e e t k

a 7. Rinse out cavities, drill holes and threads with a cleaning gun with cold c D e

drinking water for at least 20 seconds at 3-5 bar.

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c 8. Immerse the instrument in deionized water and rinse through the cavities

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several times with deionized water.

p

o

Note: Also clean the inner chambers of the instrument below water C

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.

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. d

e

k 3. Clean all components using the automatic cleaning parameters below.

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e

MINIMUM DETERGENT TYPE AND h

WATER

c

PHASE RECIRCULATION CONCENTRATION

: TEMPERATURE s TIME (IF APPLICABLE) y n b o

i Cold Drinking Water d s e n Pre-Wash 1 Minute 1°C - 25°C N/A f e o (33°F - 77°F) o m i r

P D Cold Drinking Water

Pre-Wash 3 Minutes 1°C - 25°C N/A (33°F - 77°F) • Detergent: pH- L I

neutral/enzymatic , h s l t Wash 5 Minutes 45°C (113°F) • Concentration: Per the l i u

7 detergent manufacturer's n H 0

1 K - 6 recommendations n

8 1 o d i 1 0

n Hot Treated Water v - - r

a Rinse 3 Minutes 43°C - 82°C N/A 2 6 e D 1 3 V (110°F - 179°F) Hot Treated Water Rinse 2 Minutes 43°C - 82°C N/A (110°F - 179°F) 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.

6 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.

MINIMUM DETERGENT TYPE AND

WATER

PHASE RECIRCULATION CONCENTRATION

TEMPERATURE

TIME (IF APPLICABLE)

: Cold Drinking Water : d e

e Pre-Wash 1 Minute 1°C - 25°C N/A t k a (33°F - 77°F) c D e

h

Cold Drinking Water

c

Pre-Wash 3 Minutes 1°C - 25°C N/A

y

(33°F - 77°F) p

o

C • Detergent: Alkaline

• Concentration: Per the

Wash 5 Minutes 55°C (131°F)

detergent manufacturer's

recommendations

Hot Treated Water

Neutralization 3 Minutes 43°C - 82°C N/A

(110°F - 179°F)

Hot Treated Water

Rinse 2 Minutes 43°C - 82°C N/A

(110°F - 179°F)

:

Completely desalinated water, the thermal disinfection is carried

d

out at temperatures >65°C and corresponding application time e

k

Automatic according to the A0 concept, DIN EN ISO 15883 (e.g. A0 3000 =

c

e

Disinfection 90°C and 5 minutes application time). The operator is responsible

h

for the implemented A0 value. Note: 95°C is the maximum c

: s temperature to be utilized during this step. y n b o

i d s Drying e n f e

o Automated Drying: Dry the outer surfaces of the instruments in the o m i r drying cycle of your washer-disinfector for 15-25 minutes at 90-110°C P D

(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 L

I performed using a lint-free towel.

, h s l t Inspection l i u 7 n H

0 Proper care and handling is essential for satisfactory performance of

1 K - 6 n any surgical device. The previously listed cautions should be taken to 8 1 o d i 1 0 n ensure long and trouble-free service. All devices must be examined for v - - r a 2 6 e full functionality prior to and after use. Moving parts of the device D 1 3 V 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. The right care of instruments will lengthen their service life and should therefore be carried out after every cleaning process.

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 stopcocks) 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.

7 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 stopcocks and place in sterilization device so that the components d e e t are not touching each other and the steam can circulate freely. k a c D e

h

c Sterilization and Packaging for US Market

y

p Packaging

o

Use FDA-cleared sterilization wrap or sterilization container. C

• 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.

:

d

Prevacuum Steam Sterilization Parameters e

k

Sterilization Configuration: Wrapped c

e

h (2-layer 1-ply or 1-layer 2-ply) or containerized

c

: s Temperature: 132°C (270°F) y n b o

i Exposure Time: 4 minutes d s e n

f Minimum Dry Time: 30 minutes e o o m i r P D

Sterilization and Packaging for Outside United States Market L I

, Packaging h s l t l i

u Wrap the instruments in the appropriate sterilization wrap 7 n H 0

1 according to ISO 11607 and EN 868 and facility guidelines. K - 6 n

8 1 o d

i Sterilization Configuration: Wrapped (2-layer 1-ply or 1-layer 2-ply) 1 0 n v - - r

a or containerized 2 6 e D 1 3 V Prevacuum Steam Sterilization Parameters 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.

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 valid hospital guidelines.

8 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:

:

: d • www.aami.org e e t k a • www.aorn.org c D e

• www.iso.org h

c

y Further EU References for the Cleaning,

p

o Disinfection and Sterilization of Medical Devices

C

• 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.”

:

d Warranty

e

k All Snowden-Pencer instruments are protected by a full service 1 year

c

e

warranty and lifetime warranty against manufacturer defects. Damage

h

c caused to the instrument by overstress, mechanical shock, improper

: s processing, or repair by a party other than Snowden-Pencer is not y n b o

i covered. Repair, alteration or modification of any product by persons d s

e other than Snowden-Pencer, or products subjected to misuse or abuse n f e o will result in immediate loss of warranty. If Snowden-Pencer o m i r instruments are damaged by accident or when used for a purpose other P D

than originally intended, a repair charge will apply. Repair Service L I

, h s WARNING : Risk of injury from improper repairs. l t l i u

7 • Only allow repairs to be performed by the manufacturer or by persons n H 0

1 K - 6 authorized by the manufacturer. n

8 1 o d i 1 0 n v - - r a 2 6 e WARNING : Risk of infection from non-sterile instruments. D 1 3 V • 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. Appendix All product codes covered by this instruction for use are listed in the following table. Table F270.00 F270.01 F271.00 F271.01 F271.02 F271.03 F271.06

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