eG1 High Speed Attachments Assembly and Disassembly

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Contents Symbols Glossary...1 Manual Cleaning...2 Mechanical/Automated Cleaning...7 Sterilization...14

Symbols Glossary Consult Operating Instructions

Direction of rotation

Keep Dry (A.K.A. Protect from Moisture)

Direction of rotation for lock position

Indicates position, alignment, or location.

Indicates setting, position, or location.

Direction of rotation

Indicates setting, position, or location.

Indicates position or location

Direction of rotation

CAUTION: Refer to accompanying documentation

Indicates action of rotation and position for Secure (LOCK) and Release (UNLOCK).

Symbol with yellow background: CAUTION: Refer to accompaning documentation.

Indicates the attachment setting, refer to MA-DRIVER & MA-D20 section in this document for further details

Indicates the drill tip exposure

Direction of rotation for lock position

Located on the Handpiece this indicates position of the knurl knob to the desired location.

Lock (Run) Humidity Limits

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Anspach Product Icon

Unlock (Load) 00/0000

Use By Date (A.K.A. Expiration Date, Expiry)

Temperature Limits

Sterile unless damaged or open

CE Mark (A.K.A. CE Mark [notified body number], with applicable EEC Directives

United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider

Reference Number (A.K.A. Item Number, Catalog Number, Part Number)

Lot (A.K.A. Lot Number, Batch Number, Batch Code)

Serial Number

Quantity

Manufacturer

Authorized European Union Representative

Sterilized Using Irradiation

Single Use Only (A.K.A. Do Not Reuse)

Européenne) 2797 Conformité Meaning: Device complies

Date of Manufacture

(01)

Global Trade Item Number (GTIN)

(10)

Batch or Lot Number

(17)

Expiration Date

(21)

Serial Number

GTIN

Global Trade Item Number

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Manual Cleaning Warnings: • Cannulations must be cleaned with appropriate brushes as described in cleaning instructions. • At the point of use the device must be cleaned as soon as possible after use to prevent drying of blood, tissue, other biological debris and contaminants on the device. • National regulations must be observed. • You must follow standard hospital procedures. • You must follow manufacturer’s recommendations for any detergents, disinfectants and washing equipment used. • Do not reprocess dissection tools. Dissection tools are disposable and SINGLE USE ONLY.

Cautions: • Rx Only: United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider. • Do not use any alkaline detergent with a pH greater than 11. Alkaline detergents with higher pH attack grease and seals which can increase wear and cause device to malfunction. • Do not use ultrasonic equipment. • Do not use hypochlorite solution (i.e. bleach). • Handpieces must not be immersed in cleaning solution but may be sprayed with it. • Fully demineralized (deionized, distilled, or purified) water must be used during final rinse to prevent corrosion and spots. • The Minimal Access Attachment Bearing Sleeves are non-repairable. Reuse until bearing wear is detected and then replace. No bearing sleeve service or repair will be provided. Note: Use of alkaline detergents can cause device color to fade but this does not impair function.

Operating Room (OR) Personnel Instructions 1. After completion of procedure, remove external debris by wiping attachments and handpiece. 2. Dispose of open or used dissection tools.

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Reprocessing Personnel Instructions Handpiece

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Note: The instructions in this section are specific to the eG1 Electric Handpiece. 1. Preparation • Assemble all necessary supplies including Attachment Cleaning Brush (ACB), sponge, lint-free cloth and soft bristle brush. • Remove attachment and dissection tool from handpiece. 2. Rinse • Rinse handpiece with distal end pointing down under running cold deionized, distilled or purified water for a minimum of 2 minutes. • Use a sponge, soft lint-free cloth or soft bristle brush to assist in removing gross soil. Caution: Do not immerse. Do not use high pressure water or air. Do not allow running water to enter distal end of handpiece or console connector (end of cable). 3. Clean • Prepare cleaning solution using alkaline detergent or neutral pH enzymatic detergent per manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and product concentration/dilution. • With distal end pointing down spray and wipe using cleaning solution for a minimum of 2 minutes. • Use a sponge, soft lint-free cloth or soft bristle brush to remove all visible soil. • Hold handpiece with distal end pointing down and insert ACB wetted with cleaning solution into distal end of handpiece. Warning: ACB is single use and should only be used to clean one handpiece and associated attachments. Caution: Do not immerse. Do not allow running water to enter distal end of handpiece or console connector. Do not insert ACB beyond last bristle. Do not force ACB into handpiece. Do not use pipe cleaners.

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4. Rinse Thoroughly • With distal end pointing down rinse device thoroughly using running hot deionized, distilled or purified water for a minimum of 2 minutes. • Hold handpiece with distal end pointing down and flush inside of distal end using a syringe or pipette filled with hot deionized, distilled or purified water. Caution: Do not immerse. Do not use high pressure water or air. Do not allow running water to enter distal end of handpiece or console connector (end of cable). 5. Inspect • Visually inspect handpiece. Repeat Steps 2 thru 5 if visible soil remains. 6. Go to Sterilization section for further instructions. Attachments Note: The instructions in this section are specific to the G1 Attachments and MA Bearing Sleeves listed in Table 1 in the Mechanical/Automated Cleaning section of this document. 1. Preparation • Assemble all necessary supplies including Attachment Cleaning Brush (ACB), Small Diameter Cleaning Brush (SDCB), sponge, lintfree cloth and soft bristle brush. • Remove attachment and dissection tool from handpiece. 2. Rinse • Rinse attachment under running cold deionized, distilled or purified water for a minimum of 2 minutes. • Manipulate any moving parts such as release sleeves under running cold deionized, distilled or purified water to loosen or remove gross soil. • Use a sponge, soft lint-free cloth or soft bristle brush to assist in removing gross soil. Caution: Do not use high pressure water or air. Do not rinse attachment with saline solution. 3. Clean • Prepare cleaning solution using alkaline detergent or neutral pH enzymatic detergent per manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and product concentration/dilution. 4

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• Fully immerse attachment in cleaning solution in a suitable container and manually agitate for 2 minutes. • Use a sponge, soft lint-free cloth or soft bristle brush to remove all visible soil. • Gently use a brush to clean cannulations of attachment while immersed in cleaning solution. Use ACB for all attachments except MA-D20-G1 and Minimal Access Attachment Bearing Sleeves. Use SDCB for MA-D20-G1 and Minimal Access Attachment Bearing Sleeves. If attachment has a release sleeve (Figure 1), move sleeve and brush exposed area. Note: Brushes may be inserted from distal or proximal end of attachments and bearing sleeves. Warning: ACB and SDCB are single use and should only be used to clean one set of attachments. Caution: For MA-D20-G1 and Minimal Access Attachment Bearing Sleeves use SDCB only. Do not force ACB or SDCB into or through attachments or bearing sleeves. Do not use pipe cleaners.

Figure 1 Release Sleeve

4. Rinse Thoroughly • Rinse device thoroughly using running hot deionized, distilled, or purified water for a minimum of 2 minutes. • Use a syringe or pipette filled with hot deionized, distilled or purified water to flush lumens or channels. • Manipulate any moving parts such as release sleeves (Figure 1). Caution: Do not use high pressure water or air. Do not rinse attachment with saline solution. 5. Inspect • Visually inspect attachment for visible soil. Repeat Steps 2 thru 5 if visible soil remains.

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6. Lubricate Caution: This step is for attachments only. Do not lubricate handpieces. Option 1: 05.001.078, Lubricant for Anspach Systems, 110 ml Warning: Do not use Gravity Air Displacement Steam Autoclave Sterilization Process. • For the following attachments apply one (1) spray pump spray to the proximal end of the attachment. SHORT-G1 SHORT-HD-G1 MEDIUM-G1 MEDIUM-HD-G1

LONG-G1 LONG-HD-G1 MIA16-G1 CRANI-A-G1

CRANI-L-G1 CRANI-P-G1 MA-10S MA-10C

MA-15S MA-15C MA-15ST MA-19ST

• For the following attachments apply one (1) spray pump spray to the distal end of the attachment and one (1) to the proximal end of the attachment. MA-D20-G1 CSR60-G1

QD8-G1 QD11-G1

QD8-S-G1 QD11-S-G1

QD14-G1 QD14-S-G1

• Applying excess amounts of lubricant will cause the lubricant to drip from the attachment. Clean off any excess lubricant. Option 2: Non-silicone based medical lubricant • Prepare a lubricating solution of instrument milk (non-silicone based medical lubricant) per the manufacturer’s directions. • Fully immerse attachment in lubricating solution, at room temperature, in a suitable container and agitate for 15 seconds. • Remove attachment and allow it to drain completely until no visible droplets are coming from it. Caution: Do not rinse out instrument milk (lubricant). Do not apply mineral oil or other lubricants, which may cause attachment to overheat. 7. Go to Sterilization section for further instructions. Consoles Caution: Do not immerse or sterilize. Do not allow liquid to enter console. Note: Consoles are non-sterile capital equipment and shall always be maintained outside the Operating Room Sterile Field. 1. Disconnect all power from console. 6

2. Clean console by wiping with non-abrasive cloth and neutral pH detergent and deionized, distilled, or purified water after each case. 3. Dry thoroughly with non-abrasive cloth. English

Foot Pedals Caution: Do not immerse or sterilize. Do not allow liquid to enter foot pedal. Note: Foot pedals are non-sterile capital equipment and shall always be maintained outside the Operating Room Sterile Field. 1. Disconnect from console. 2. Clean foot pedal by wiping with non-abrasive cloth and neutral pH detergent and deionized, distilled, or purified water after each case. 3. Dry thoroughly with non-abrasive cloth. Dissection Tools Warning: Do not reprocess dissection tools. Dissection tools are disposable and SINGLE USE ONLY. Dispose of properly in sharps container. Note: The clinical processing instructions provided have been validated by DePuy Synthes Power Tools for preparing a non-sterile medical device; this instruction is provided in accordance with ISO 17664 and ANSI/AAMI ST81.

Mechanical/Automated Cleaning Warnings: • Manual pre-cleaning must be completed prior to mechanical cleaning. • Cannulations must be pre-cleaned with appropriate brushes as described in pre-cleaning instructions. • At the point of use the device must be cleaned as soon as possible after use to prevent drying of blood, tissue, other biological debris and contaminants on the device. • National regulations must be observed. • You must follow standard hospital procedures. • You must follow manufacturer’s recommendations for any detergents, disinfectants and washing equipment used. • Do not reprocess dissection tools. Dissection tools are disposable and SINGLE USE ONLY.

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Cautions: • Rx Only: United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider. • Only the devices listed in Table 1 may be reprocessed using the mechanical/automated cleaning method. • Do not use any alkaline detergent with a pH greater than 11. Alkaline detergents with higher pH attack grease and seals which can increase wear and cause device to malfunction. • Do not use ultrasonic equipment. • Do not use hypochlorite solution (i.e. bleach). • Handpieces must not be immersed in cleaning solution but may be sprayed with it. • Fully demineralized (deionized, distilled, or purified) water must be used during final rinse to prevent corrosion and spots. • The Minimal Access Attachment Bearing Sleeves are nonrepairable. Reuse until bearing wear is detected and then replace. No bearing sleeve service or repair will be provided. Note: Use of alkaline detergents can cause color to fade but this does not impair function of device. Table 1: List of Devices Device Catalog Number EG1A SHORT-G1 SHORT-HD-G1 MEDIUM-G1 MEDIUM-HD-G1 LONG-G1 LONG-HD-G1 MIA16-G1 QD8-G1 QD8-S-G1 QD11-G1

Device Catalog Number QD11-S-G1 QD14-G1 QD14-S-G1 MA-D20-G1 MA Bearing Sleeves* CRANI-P-G1 CRANI-A-G1 CRANI-L-G1 CSR60-G1

*MA-10S, MA-10C, MA-15S, MA-15C, MA-15ST, MA-19ST. Warning: Consult G1 Cleaning and Sterilization Basket Loading Diagram for validated loading configurations. Note: MA Bearing Sleeves are compatible with MA-D20-G1, MA-D20, MA‑DRIVER and MA-D20BM. 8

Operating Room (OR) Personnel Instructions 1. After completion of procedure, remove external debris by wiping attachments and handpiece. 2. Properly dispose of open or used dissection tools. English

Reprocessing Personnel Instructions Manual Pre-Cleaning of Handpiece Note: The instructions in this section are specific to the eG1 Electric Handpiece. 1. Preparation • Assemble all necessary supplies including Attachment Cleaning Brush (ACB), sponge, lint-free cloth and soft bristle brush • Remove attachment and dissection tool from handpiece. 2. Rinse • Rinse handpiece with distal end pointing down under running cold deionized, distilled or purified water for a minimum of 2 minutes. • Use a sponge, soft lint-free cloth or soft bristle brush to assist in removing gross soil. Caution: Do not immerse. Do not use high pressure water or air. Do not allow running water to enter distal end of handpiece or console connector. 3. Clean • Prepare cleaning solution using alkaline detergent or neutral pH enzymatic detergent per manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and product concentration/dilution. • With distal end pointing down spray and wipe using cleaning solution for a minimum of 2 minutes. • Use a sponge, soft lint-free cloth or soft bristle brush to remove all visible soil. • Hold handpiece with distal end pointing down and insert ACB wetted with cleaning solution into distal end of handpiece. Warning: ACB is single use and should only be used to clean one handpiece and associated attachments. Caution: Do not immerse. Do not allow running water to enter distal end of handpiece or console connector. Do not insert ACB 9

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beyond last bristle. Do not force ACB into handpiece. Do not use pipe cleaners. 4. Rinse Thoroughly • With distal end pointing down rinse device thoroughly using running hot deionized, distilled or purified water for a minimum of 2 minutes. • Hold handpiece with distal end pointing down and flush inside of distal end using a syringe or pipette filled with hot deionized, distilled or purified water. Caution: Do not use high pressure water or air. Do not immerse. Do not allow running water to enter distal end of handpiece or console connector. 5. Inspect • Visually inspect handpiece for visible soil. Repeat Steps 2 thru 5 if visible soil remains. 6. Go to Mechanical/Automated Cleaning section for further instructions. Warning: Manual pre-cleaning must be followed by mechanical/ automated cleaning. Manual Pre-Cleaning of Attachments Note: The instructions in this section are specific to the G1 Attachments and MA Bearing Sleeves listed in Table 1. 1. Preparation • Assemble all necessary supplies including Attachment Cleaning Brush (ACB), Small Diameter Cleaning Brush (SDCB), sponge, lintfree cloth and soft bristle brush. • Remove attachment and dissection tool from handpiece. 2. Rinse • Rinse attachment under running cold deionized, distilled or purified water for a minimum of 2 minutes. • Manipulate any moving parts such as release sleeves under running cold deionized, distilled or purified water to loosen or remove gross soil. • Use a sponge, soft lint-free cloth or soft bristle brush to assist in removing gross soil. Caution: Do not use high pressure water or air. Do not rinse attachment with saline solution.

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3. Clean • Prepare cleaning solution using alkaline detergent or neutral pH enzymatic detergent per manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and product concentration/dilution. • Fully immerse attachment in cleaning solution in a suitable container and manually agitate for 2 minutes. • Use a sponge, soft lint-free cloth or soft bristle brush to remove all visible soil. • Gently use a brush to clean cannulations of attachment while immersed in cleaning solution. Use ACB for all attachments except MA-D20-G1 and Minimal Access Attachment Bearing Sleeves. Use SDCB for MA-D20-G1 and Minimal Access Attachment Bearing Sleeves. If attachment has a release sleeve (Figure 1), move sleeve and brush exposed area. Note: Brushes may be inserted from distal or proximal end of attachments and bearing sleeves. Warning: ACB and SDCB are single use and should only be used to clean one set of attachments. Caution: For MA-D20-G1 and Minimal Access Attachment Bearing Sleeves use SDCB only. Do not force ACB or SDCB into or through attachments or bearing sleeves. Do not use pipe cleaners.

Figure 1 Release Sleeve

4. Rinse Thoroughly • Rinse device thoroughly using running hot deionized, distilled, or purified water for a minimum of 2 minutes. • Use a syringe or pipette filled with hot deionized, distilled or purified water to flush lumens or channels. • Manipulate any moving parts such as release sleeves (Figure 1).

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Caution: Do not use high pressure water or air. Do not rinse attachment with saline solution. 5. Inspect • Visually inspect attachment for soil. Repeat Steps 2 thru 5 if visible soil remains. 6. Go to Mechanical/Automated Cleaning section for further instructions. Warning: Manual pre-cleaning must be followed by mechanical/ automated cleaning. Mechanical/Automated Cleaning Note: Prior to using G1 Cleaning and Sterilization Basket for first time, attach connector sleeve to basket by clipping onto internal support structure (Figure 2). The connector sleeve should remain with basket for future use. 1. Loading the Basket • Load devices in G1 Cleaning and Sterilization Basket by securing them in appropriate brackets, as shown in G1 Cleaning and Sterilization Basket Loading Diagram, with distal end angled down where applicable. • Place connector sleeve on connector end of electric handpiece (Figure 3). Caution: Connector end of electric handpiece must be sealed with connector sleeve provided with basket (Figure 3). Warning: Consult G1 Cleaning and Sterilization Basket Loading Diagram for validated loading configurations. Angled attachments must be loaded in the correct orientation as shown in Figure 4.

Figure 2

Figure 3

Figure 4

2. Mechanical/Automated Cleaning Cycle Process Parameters 12

Duration (minimum)

Cleaning Instructions

Rinse

2 minutes

Cold deionized (DI) or purified water (PURW)

Pre-wash

1 minute

Warm DI or PURW water (≥ 40°C); use detergent

Cleaning

2 minutes

Warm DI or PURW water (≥ 45°C); use detergent

Rinse

5 minutes

Rinse with DI or PURW water

Thermal Processing

5 minutes

Hot DI water, ≥ 93°C

Dry

40 minutes

≥ 90°C

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Cycle

Caution: Do not use neutralizing agent. 3. Inspect • Visually inspect devices for soil. Repeat manual pre-clean and mechanical/automated clean if visible soil remains. • Remove connector sleeve from connector end of handpiece and drain until no visible droplets are coming from the handpiece and handpiece connector. 4. Lubricate Caution: This step is for attachments only. Do not lubricate handpieces. Option 1: 05.001.078, Lubricant for Anspach Systems, 110 ml Warning: Do not use Gravity Air Displacement Steam Autoclave Sterilization Process. • For the following attachments apply one (1) spray pump spray to the proximal end of the attachment. SHORT-G1 SHORT-HD-G1 MEDIUM-G1 MEDIUM-HD-G1

LONG-G1 LONG-HD-G1 MIA16-G1 CRANI-A-G1

CRANI-L-G1 CRANI-P-G1 MA-10S MA-10C

MA-15S MA-15C MA-15ST MA-19ST

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• For the following attachments apply one (1) spray pump spray to the distal end of the attachment and one (1) to the proximal end of the attachment. MA-D20-G1 CSR60-G1

QD8-G1 QD11-G1

QD8-S-G1 QD11-S-G1

QD14-G1 QD14-S-G1

• Applying excess amounts of lubricant will cause the lubricant to drip from the attachment. Clean off any excess lubricant. Option 2: Non-silicone based medical lubricant • Prepare a lubricating solution of instrument milk (non-silicone based medical lubricant) per the manufacturer’s directions. • Fully immerse attachment in lubricating solution, at room temperature, in a suitable container and agitate for 15 seconds. • Remove attachment and allow it to drain completely until no visible droplets are coming from it. • Return attachments to basket for further processing. Caution: Do not rinse out instrument milk (lubricant). Do not apply mineral oil or other lubricants, which may cause attachment to overheat. 5. Go to Sterilization section for further instructions. Note: • The clinical processing instructions provided have been validated by DePuy Synthes Power Tools for preparing a non-sterile medical device; this instruction is provided in accordance with ISO 17664 and ANSI/AAMI ST81.

Sterilization Before sterilizing: • Ensure sterilization equipment is in proper working order as specified by manufacturer. • Assure equipment manufacturer’s instructions are properly employed by trained and qualified personnel. • Assure actual cycle employed has been properly validated for the device(s)/load configuration being processed and appropriate sterilization indicator devices are included for each process and cycle.

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Note: Prior to using G1 Cleaning and Sterilization Basket for first time, attach connector sleeve to basket by clipping onto internal support structure (Figure 2). The connector sleeve should remain with basket for future use. English

Warning: Devices must be cleaned prior to sterilization using the validated cleaning method outlined in these instructions. 1. Loading the Basket • Load devices in G1 Cleaning and Sterilization Basket by securing them in appropriate brackets, as shown in G1 Cleaning and Sterilization Basket Loading Diagram, with distal end angled down where applicable. • Remove connector sleeve from handpiece connector (Figure 1). Replace connector sleeve in its bracket and lay handpiece connector in bottom of basket. Warning: Handpiece connector sleeve must be removed from the handpiece connector prior to sterilization (Figure 1). Consult G1 Cleaning and Sterilization Basket Loading Diagram for validated loading configurations. Angled attachments must be loaded in the correct orientation as shown in Figure 2.

Figure 1

Figure 2

2. Packaging • When wrapping the basket the lid must be used. • In US double wrap basket or instruments with an FDA cleared sterilization wrap using appropriate wrapping techniques described in ANSI/AAMI ST79 (For example: Simultaneous double wrapping or sequential wrapping). • Outside US double wrap basket or instruments in accordance with local procedures, using standard wrap and wrapping techniques such as those describe in ANSI/AAMI ST79. Warning: When using a sterilization wrap the basket lid must be used. Must follow manufacturer’s instructions for any wraps used.

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Do not use individual sterilization pouches. Only use indicated basket for equipment. 3. Sterilization • Sterilize in accordance with the following guidelines. Warning: Do not use any other sterilization method or cycle other than those listed below which have been validated in accordance with ISO 17665. US Steam Autoclave Instructions Option

Exposure Temperature 132°C

1. Pre-Vacuum* 2. Gravity Air 132°C Displacement* * Wrapped or unwrapped

Exposure Time 4 minutes

Minimum Dry Time 40 minutes

15 minutes

40 minutes

Outside US Steam Autoclave Instructions Option

Exposure Temperature

1. Pre-Vacuum* 132°C 2. Pre-Vacuum* 134 - 138°C 3. Gravity Air 132-138°C Displacement* * Wrapped or unwrapped.

Exposure Time

Minimum Dry Time

4 minutes 3-18 minutes

40 minutes 40 minutes

15-18 minutes 40 minutes

Caution: A drying cycle is required to avoid possible adverse effects caused by exposure to condensation. Notes: • Metal devices, tools and equipment are constructed of materials unaffected by normal environmental conditions of current standard sterilization means, when proper operational techniques are employed. • Effectiveness of sterilization equipment or sterilization processes are directly dependent upon numerous factors beyond DePuy Synthes Power Tools control including among other things; sterilization means, processes and wrapping techniques employed, brand, model and condition of sterilization equipment, care and maintenance techniques employed and operator knowledge and experience. • DePuy Synthes Power Tools cannot anticipate all possible equipment, processes and/or conditions that may be encountered. 16

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The suggested operation conditions are to be considered as a starting point for determination of the overall process capability, without regard for type or condition of equipment used or methods, techniques or practices employed by user. Use of proper sterilization indicator devices is strongly recommended. It is recommended that a drying cycle be included to avoid possible adverse effects caused by exposure to condensation. • Packaged and sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity. Use products in the order in which they are received (“first-in, first-out principle”). Warning: All Instrument System components returned for servicing or repair should be properly cleaned and sterilized as applicable prior to shipping.

Warning: Transmissible Spongiform Encephalopathies (TSE) DePuy Synthes Power Tools will not authorize or accept the return of products that directly contact patients or are contaminated with a patient’s body fluids who is suspected or confirmed with a Transmissible Spongiform Encephalopathies/ Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. DePuy Synthes Power Tools recommends that all Anspach products used on a patient confirmed with a TSE/CJD diagnosis be incinerated. Anspach dissection tools used on a patient suspected of TSE/CJD diagnosis must be incinerated. Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment while original equipment is quarantined. Contact the DePuy Synthes Power Tools Customer Service Department regarding TSE/CJD contamination for additional information.

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Manufacturer The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887 / +1 561 627 1080 Fax: (800) 327 6661 / +1 561 625 9110 Web: www.depuysynthes.com Email: [email protected]

Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00

2797 18-0098 Rev K 11/19 For patent information go to http://www.depuysynthes.com/patentmarking © DePuy Synthes 2019. All rights reserved.