Meshgraft II Tissue Expansion System Instruction Manual Rev Feb 2011

The Dermacarrier II Skin Graft Carriers should be used at room temperature. Procedures such as placing them in warm solutions or allowing them to become heated causes softening of the plastic and results in incomplete and poor cutting of the skin. Do not place the Dermacarrier II Skin Graft Carrier in an autoclave because it will melt and may bond to the metal surface of the instrument.

IMPORTANCE OF THE NEED TO ADHERE TO A CARE REGIMEN The Meshgraft II Tissue Expansion System should be inspected prior to each use. •

Visually inspect for damage and/or wear.

•

Check the action of moving parts to ensure smooth operation throughout the intended range of motion.

•

The Meshgraft II Tissue Expansion System should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued accuracy. Note: If damage or wear is noted that may compromise the function of the instrument, do not use. Refer to RETURN AUTHORIZATION AND REPLACEMENT INFORMATION section.

RECEIVING INSPECTION After receiving the Meshgraft II Tissue Expansion System, examine the unit for external signs of damage. Retain all packing material until the contents have been verified and an initial operational check has been performed. If the device has been damaged, forward an immediate request to the delivering carrier to perform an inspection and prepare a “Concealed Damage” report. The terms of all Zimmer Surgical sales agreements concerning this unit are F.O.B., Dover, Ohio, U.S.A., and the responsibility of Zimmer Surgical ends with delivery to the first carrier. Thereafter, the shipment becomes the property of the customer. Any claims for loss, damage, or non-delivery must be made against the delivering carrier within 10 days of shipment. Your Zimmer distributor or local Zimmer representative may assist you in determining the cost of replacement or repair so that a proper claim may be filed with the delivering carrier. Note: Do not attempt to return damaged goods without first securing proper authorization from the delivering carrier.

SETUP INSTRUCTIONS •

Prior to initial usage, the Meshgraft II Tissue Expansion System must be cleaned and sterilized per instructions. (See MANUAL AND AUTOMATED CLEANING AND DISINFECTION PROCESS INSTRUCTIONS as well as the STERILIZATION RECOMMENDATIONS)

•

Observe sterile field precautions per hospital protocol.

•

The Meshgraft II Tissue Expansion System is placed on its side on the table with the extension of the knurled roller facing up. (See Fig. 7.)

•

The ratchet handle is placed on the knurled roller extension so that the “THIS END OUT” note is facing out. (See Fig.8.)

•

The ratchet handle is fully inserted when the end of the knurled roller extension is flush with opposite side of the ratchet. (See Fig. 9.) Do not force or pound ratchet onto the Meshgraft II Tissue Expansion System.

•

If there is trouble with the insertion, verify that the correct ratchet handle is being used. If the correct ratchet handle is being used, then the roller extension end may be misaligned with the similarly shaped end of the ratchet handle. To facilitate alignment, grasp the knurled roller and keep it stationary, then turn the ratchet handle until the two shapes match and then push the ratchet on completely.

•

To ensure that the ratchet handle will not come off when the Meshgraft II Tissue Expansion System is being used, take the set screw wrench (supplied with the ratchet handle), and turn the set screw down until it is tight against the knurled roller extension. (See Fig. 10.)

•

Once the ratchet handle is attached, the Meshgraft II Tissue Expansion System is ready for use.

•

During set-up procedure, visually inspect for damage and/or wear. If damage or wear is noted that may compromise the function of the instrument, do not use.

OPERATING INSTRUCTIONS The Meshgraft II Tissue Expansion System has been preset to mesh skin grafts between .008 and .017 in. (0.2 and 0.4 mm). However, best results are obtained with grafts between .012 and .015 in. (0.3 and 0.38 mm) thick. •

Select the Dermacarrier II Skin Graft Carrier with the appropriate expansion ratio.

•

The Dermacarrier II Skin Graft Carrier is aseptically removed from its sterile package and introduced onto the sterile field.

•

The carrier is placed grooved side up on the table.

•

Place the graft on the grooved side of the carrier. The grooved side of the carrier must be up and the smooth side down to ensure a proper mesh. (See Fig. 4.)

•

Place the graft on the carrier epidermal side up. However, the graft may be placed dermal side up to facilitate direct transfer from the carrier to the transplant site.

•

Smooth the graft out on the carrier. Sterile water may be poured over the graft to facilitate smoothing it out on the carrier.

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•

Place the carrier, with the skin side up, on the guidance plateau and push against the raised portion of the guidance plateau. The guidance plateau is used to ensure straight entry into the gap between the cutter and the knurled roller.

•

The leading end of the Dermacarrier II Skin Graft Carrier is firmly introduced into the Meshgraft II Tissue Expansion System making sure the entry is straight. Apply firm pressure to the opposite end of the Dermacarrier II Skin Graft Carrier to assist the cutter in the initial engagement, as the ratchet handle is slowly turned clockwise. (See Fig. 5.)

•

After the Dermacarrier II Skin Graft Carrier has been turned through approximately 1/2 in. (1.25 cm), stop and check the cut portion of the skin graft. If the graft has not disengaged from the cutter, grasp the leading end of the graft with forceps, and disengage the entire meshed portion of the skin from the cutter. Avoid damaging the blades of the cutter during this action.

•

Check the uncut portion of the skin graft. The uncut portion must be kept taut at all times when turning the Dermacarrier II Skin Graft Carrier through the instrument.

•

Apply constant downward pressure on the leading end of the Dermacarrier II Skin Graft Carrier while turning it through the Meshgraft II Tissue Expansion System (See Fig. 2). This is done to ensure that the skin graft will not engage in the cutter. Rotate the ratchet handle back and forth from the 10 o’clock to the 2 o’clock position until the carrier exits the back of the mesher. Note: The ratchet mechanism operates only when there is a carrier in the unit.

•

Once the graft covered carrier has been transferred to the operative site, remove the meshed skin from the carrier and expand it as desired. Apply the expanded skin to the prepared transplant site.

•

If it is necessary to remove the carrier after it has been inserted, the ratchet handle should be removed and the back side of the handle attached to the knurled roller extension. Rotating the ratchet handle back and forth from the 10 o’clock to the 2 o’clock position will cause the carrier to reverse direction and exit from the front of the mesher.

CLEANING PRECAUTIONS All subsequent cleaning and sterilization steps are facilitated by not allowing blood, tissue debris, or disinfectants to dry on used instruments. Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must not be used. Saline solution has a corrosive effect on stainless steel and should not be used. Never clean in an ultrasonic cleaner. Ultrasonic cleaning will dislodge oil from the bearings and may render the instrument inoperative. Ultrasonic cleaning may affect calibration of the Meshgraft II Tissue Expansion System. Steam sterilize the Meshgraft II Tissue Expansion System. Follow instructions in STERILIZATION RECOMMENDATIONS.

MANUAL AND AUTOMATED CLEANING AND DISINFECTION PROCESS INSTRUCTIONS •

The following instructions and charts detail the cleaning and disinfection process for the Meshgraft II Tissue Expansion System.

•

Safely dispose of all used carriers in accordance with hospital policy for contaminated waste.

•

Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with a damp cloth. The damp cloth is utilized to assist in the prevention of the un-removed soil drying prior to cleaning and disinfection process. Body fluids and tissue should not be allowed to dry on instruments prior to cleaning.

•

Universal precautions for handling contaminated/biohazardous materials should be observed.

•

Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning.

•

Prepare cleaning agents at the use-dilution and temperature recommended by the manufacturer.

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Follow the Manual Cleaning Instructions (Chart 1) or the Automated Cleaning Instructions (Chart 2).

•

Following the cleaning procedure, visually inspect for damage and/or wear.

•

Check the action of moving parts to ensure smooth operation throughout the intended range of motion. Note: If damage or wear is noted that may compromise the function of the instrument, do not use. Refer to RETURN AUTHORIZATION AND REPLACEMENT INFORMATION section.

•

Steam sterilize only. Follow instructions in STERILIZATION RECOMMENDATIONS.

3

Cleaning Steps

Chart 1. Validated Manual Cleaning and Disinfection Procedure Step

Step Description

Step Instruction

Accessories

Duration

l

Contamination Removal

Rinse product under Cold/ Room Temperature running tap water removing any visible organic material with assistance of a soft bristle brush

- Cold/Room Temperature Tap Water

Until all visible soil is removed

Dry the device utilizing a dry non-shedding wipe. Medical quality filtered air may be utilized if available

- Non- shedding wipe

Apply Neutral pH disinfectant to the device's surface area per manufacturer's recommendations

- Neutral pH disinfectant

While Neutral pH disinfectant is on the device surface clean all contact surfaces, joints, mated areas utilizing a clean soft bristle brush

- Clean Soft bristle brush

2

Disinfection Steps

3

4

Drying

Disinfection Application

Manual Disinfection

- Soft bristle brush (Do not utilize metal cleaning brushes)

- Medical quality filtered compressed air

- Spray bottle or other manual applicator (Do not submerge the device)

- Neutral pH disinfectant

Until product is visually dry

Contact time will vary per product usage; minimum of one (1) minute is recommended

Manual cleaning time duration is complete when the device's surface, joints, & crevices have been manually cleaned

5

Final Rinse

Rinse product under Room Temperature Distilled/ Filtered Water

- Room Temperature Distilled/Filtered Water

Minimum of 30 seconds

6

Final Drying

Dry the device utilizing a dry non-shedding wipe. Medical quality filtered air may be utilized if available

- Non- shedding wipe

Until product is visually dry

4

- Medical quality filtered compressed air

Chart 2 Validated Automated Cleaning and Disinfection Procedure Step

Step Description

Step Instruction

Accessories

Duration

1

Gross Soil Contamination Removal

Rinse product under Cold/Room Temperature running tap water removing any visible organic material with assistance of a soft bristle brush

- Cold/Room Temperature Tap Water

Until all visible soil is removed

Place device with cutter and ratchet handle removed into Immersion Container containing water and liquid cleaner

- Tap water at manufacturer’s recommended temperature

Cleaning Steps

2

Pre-soak (Optional)

- Soft bristle brush (Do not utilize metal cleaning brushes)

- Neutral pH disinfectant/cleanera

Contact time will very per product usage; minimum of fifteen (15) minutes is recommended

- Appropriate Immersion Container 3

Pre-soak Rinse

Rinse product under Cold/Room Temperature running tap water with assistance of a soft bristle brush

- Cold/Room Temperature Tap Water

Minimum of 30 seconds

- Neutral pH disinfectant/cleaner - Soft bristle brush

4

5

Drying

Automated Washer

Dry the device utilizing a dry non-shedding wipe. Medical quality filtered air may be utilized if available

- Non-shedding wipe

Place entire disassembled device with cutter and ratchet handle removed into the automated washer

- Automated Washer

- Medical quality filtered compressed air

- Disassembled Device - Washer Cleaning Solutionb

Until product is visually dry

Minimum total cycle time: 34 minutes when including all steps below

- Washer Neutralizing Solutionc (If Applicable)

Disinfection Steps

Recommended Automatic Washer Cycle Step

Minimum Time

Recommended Temperature

Pre-Wash

3:00minutes

Water Temperature 65°C

Cleaning I-

3:00minutes

Water Temperature 85°C

Cleaning IIcOr Neutralizing

1:00minutes

Water Temperature10°C

Rinse I

1:00minutes

Water Temperature 10°C

Rinse II(Final)

1:00minutes

Water Temperature 80°C

Thermal Disinfection & Drying

25:00minutes

Chamber Temperature 110°C

a: Pre-soak cleaner solution may be surfactant or protease/enzymatic based cleaning solution compatible with aluminum b: Washer cleaning solution should be a neutral pH or solution compatible with aluminum c: Neutralizing solution should be appropriate for the utilized cleaning solution, based upon the manufacturers’ recommendation. Certain cleaning solutions do not require a neutralization post-application of the cleaner. If Neutralization is not required, initiate a second cleaning application.

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STERILIZATION RECOMMENDATIONS Steam sterilization is safe and effective and is the only recommended method for the Meshgraft II Tissue Expansion System. There are no contraindications for sterilizing the Meshgraft II Tissue Expansion System. Do not autoclave Dermacarrier II Skin Graft Carriers. •

Place cleaned instrument in an instrument tray or fully perforated autoclave case. The Meshgraft II Autoclave Case (REF 00-2195-006-00) is recommended. An alternative sterilization case may be utilized when validated by the end user.

•

If the Meshgraft II Autoclave Case is used, the instruments are to be wrapped, two double thicknesses of #140 thread count wrappers, or equivalent. If sterilization wraps are used, they must be free of detergent residues. Foam sheets should not be reused. They may have trapped impurities from the steam supply, and subsequently may form deposits on the instruments. Textiles that have been scorched by overheating also may form deposits on instruments. Exposure times are the same for wrapped or unwrapped instruments.

•

Follow instructions in RECOMMENDED STEAM STERILIZATION PARAMETERS.

•

Do not immerse in liquid to cool. Cool by exposure to room temperature or cover with a cold, sterile towel.

RECOMMENDED STEAM STERILIZATION PARAMETERS

Cycle Type

Minimum Temperature

6

7,8

Minimum Exposure Time

Wrapped

9

Unwrapped

1,3

Prevacuum/ Pulsating Vacuum

134°C 273°F

3 min

3 min

2,3

Prevacuum/Pulsating Vacuum

132°C 270°F

4 min

4 min

3,4

Prevacuum/Pulsating Vacuum

134°C 273°F

18 min

18 min

Prevacuum/Pulsating Vacuum

132°C 270°F

8 min

8 min

5

Gravity/Gravity Displacement

3,10

Minimum Dry Time

8 minutes

Not recommended due to excessively long sterilization cycles which are not practical.

1. Minimum validated steam sterilization time required to achieve a 10-6 sterility assurance level (SAL). 2. Minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level. 3. Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. 4. Disinfection /steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. 5. For Universal Instrument Cases without defined load configurations. 6. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable. 7. Medical grade steam sterilization compatible wrap equivalent to four thicknesses of 140-thread-count muslin. 8. Rigid sterilization container that complies with ANSI/AAMI ST46. 9. Flash (unwrapped) sterilization by exposure at 132°C/270°F should only be used as an emergency procedure. This device should be cleaned and disassembled. 10. Drying times vary according to load size and should be increased for larger loads. Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly. Flash sterilization (10-minute exposure in a gravity displacement sterilizer in an open tray at 270° F [132° C]) is not recommended for the Meshgraft II Tissue Expansion System as this method may not provide sterility throughout the instrument.

MAINTENANCE The Meshgraft II Tissue Expansion System requires lubrication only if “oil” is stamped on sideplate. As needed, the ratchet handle should be lubricated by placing 1–2 drops of surgical instrument lubricant in the grooved section of the ratchet. Turn the ratchet sections a few times to spread the oil evenly before autoclaving the instrument.

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DISASSEMBLY OF THE RATCHET HANDLE FOR FLASH STERILIZATION The ratchet handle is a three-piece assembly which can be disassembled to facilitate easy cleaning and maintenance. •

Grasp the handle at the knurled end with the slot in the shaft below the ratchet facing you. Take a blunt instrument and insert it in the indentation within the slot on the shaft (See Fig. 13) and pull downward toward the knurled handle. This will release the ratchet, and it should fall out of the assembly. This will expose the next place to disassemble. (See Fig. 14.)

•

Reach into the exposed hole, grasp the pin, and pull it out of the assembly. This completes the disassembly. (See Fig. 15.)

•

Reassemble the instrument by reversing the above procedure.

STORAGE CONDITIONS The system should be stored under normal warehouse conditions.

ACCESSORIES Description: REF:

Meshgraft II Tissue Expansion System Complete (includes 00-2195-001-00, 00-2195-00600, 00-2195-022-00) 00-2195-000-00

Description: REF:

Meshgraft II Tissue Expansion System Instrument 00-2195-001-00

Description: REF:

Meshgraft II Autoclave Case 00-2195-006-00

Description: REF:

Dermacarrier II Skin Graft Carriers (Sold Separately) 00-2195-012-00 1.5:1 Expansion Ratio Box of 20 00-2195-013-00 3:1 Expansion Ratio Box of 20 00-2195-014-00 6:1 Expansion Ratio Box of 20 00-2195-015-00 9:1 Expansion Ratio Box of 20

Description: REF:

Meshgraft II Tissue Expansion System Ratchet Handle 00-2195-022-00

SERVICE INFORMATION The Meshgraft II Tissue Expansion System should be returned to Zimmer Surgical, Dover, OH for servicing. NOTE: Zimmer cannot be held liable for any instrument malfunction resulting from repairs or service performed by an unauthorized service center. Do not attempt to disassemble the unit. It is a factory sealed unit with no user serviceable parts inside. The Meshgraft II Tissue Expansion System should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued accuracy.

RETURN AUTHORIZATION AND REPLACEMENT INFORMATION When it is necessary to return the instrument for inspection and preventive maintenance or repair; within the U.S.A. call 1-800-830-0970 to receive a Return Goods Authorization (RGA) number. Outside the U.S.A., please contact your local Zimmer representative. The instrument must be properly packaged when sent into the factory. If the original packaging is no longer available, proper packaging can be requested when the Return Goods Authorization (RGA) number is received. A purchase order must accompany all equipment for repair. The customer will be responsible for all shipping charges. The expected longevity of the Meshgraft II Tissue Expansion System is ten years. Zimmer recommends that units over this age should be replaced because they have exceeded their normal useful life. Please contact your Zimmer sales representative regarding replacement options.

LIMITED WARRANTY (U.S.A. only) Zimmer Surgical warrants that the Meshgraft II Tissue Expansion System, along with all parts and accessories, has been tested and inspected, and has left the factory in proper working condition, free from visible defects. Zimmer Surgical warrants to the first consumer purchaser of new Meshgraft II Tissue Expansion Systems, Ratchet Handles, and Autoclave Cases that these products and accessories will, under normal and reasonable use, be free from defects in material and workmanship for one (1) year after the date of shipment from the factory. During the warranty period, Zimmer Surgical shall repair (or at its sole option replace) the defective product or part without cost to the purchaser. Defective parts replaced under this warranty shall become the property of Zimmer Surgical. This limited warranty does not cover damage caused by misuse, abuse, accident, neglect, ordinary wear and tear, or any uses not prescribed in this manual. If the unit becomes defective because of misuse or abnormal conditions of operation, repairs will be billed at our current rate.

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ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN TIME TO THE PERIOD OF THE WARRANTY GRANTED HEREBY. SOME STATES DO NOT ALLOW LIMITATIONS ON THE DURATION OF AN IMPLIED WARRANTY, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. Neither Zimmer Surgical nor the Zimmer distributor who sells the Meshgraft II Tissue Expansion System is responsible for indirect, incidental, or consequential damages. Some states do not allow the exclusion of incidental or consequential damages, so the above limitations or exclusions may not apply to you. Meshgraft II Tissue Expansion Systems requiring service or repair may be returned to: Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 U.S.A. For further information concerning warranties and repairs, contact your Zimmer sales representative or the Zimmer Customer Service Department at 800-348-2759 (inside the U.S.A.).

WARRANTY (Outside U.S.A.) Please contact your local Zimmer representative for warranty information.

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2 D

A

C

B

ENGLISH

ΕΛΛΗΝΙΚΑ

DANSK

ITALIANO

NEDERLANDS

PORTUGUÊS

SUOMI

ESPAÑOL

FRANÇAIS

SVENSKA

A. Meshgraft II B. Ratchet Handle C. Dermacarrier (Sold Separately) D. Autoclave Case

A. Meshgraft II B. Λαβή καστάνιας C. Dermacarrier (Πωλείται ξεχωριστά) D. Θήκη αυτόκαυστου

A. Meshgraf II B. Skraldehåndtag C. Dermacarrier (Sælges separat) D. Autoklaveringskasse

A. Meshgraft II B. Manico a cricchetto C. Dermacarrier (venduto separatamente) D. Contenitore per autoclave

A. Meshgraft II B. Ratelhandgreep C. Dermacarrier (wordt apart verkocht) D. Box voor autoclaaf

A. Meshgraft II B. Pega do roquete C. Dermacarrier (Vendido em separado) D. Caixa de autoclave

A. Meshgraft II B. Vapautuskahva C. Dermacarrier (Myydään erikseen) D. Autoklaavilaatikko

A. Meshgraft II B. Mango de trinquete C. Dermacarrier (se vende por separado) D. Estuche para autoclave

A. Meshgraft II B. Poignée à cliquet C. Dermacarrier (vendu séparément) D. Boîtier à autoclave

A. Meshgraft II B. Spärrhandtag C. Dermacarrier (säljs separat) D. Autoklavbehållare

DEUTSCH

A. Meshgraft II B. Ratschengriff C. Dermacarrier (nicht im Lieferumfang enthalten) D. Autoklavgehäuse

96

5

B

C

A

ENGLISH

ITALIANO

DANSK

PORTUGUÊS

NEDERLANDS

ESPAÑOL

SUOMI

SVENSKA

A. Guide Rail B. Dermacarrier C. Direction of Pressure

A. Guida B. Dermacarrier C. Direzione di pressione

A. Styreskinne B. Dermacarrier C. Trykretning

A. Carril guia B. Dermacarrier C. Direcção da pressão

A. Geleiderail B. Dermacarrier C. Richting drukuitoefening

A. Guía B. Dermacarrier C. Dirección de la presión

A. Ohjainkisko B. Dermacarrier C. Paineen suunta

A. Guideskena B. Dermacarrier C. Tryckriktning

FRANÇAIS

A. Rail de guidage B. Dermacarrier C. Sens de la pression

DEUTSCH

A. Führungsschiene B. Dermacarrier C. Druckrichtung

ΕΛΛΗΝΙΚΑ

A. Οδηγητική ράγα B. Dermacarrier C. Διεύθυνση πίεσης

99

Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622, U.S.A. Revision: 02-11 © 1992, 2009, 2010, 2011 Zimmer Surgical, Inc. 06001810593

Zimmer U.K. Ltd.

P 9 Lancaster Place South Marston Park Swindon, Wiltshire SN3 4FP United Kingdom

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