eMax 2 Plus Cleaning and Sterilization Instructions for Use

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Contents General Information... 2 Manual Pre-Cleaning... 5 Mechanical/Automated Cleaning... 8 Sterilization... 9

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General Information Device Description

Basket, insert and lid that securely hold Anspach devices while being processed by hospital manual and/or mechanical/automated cleaning and sterilization procedures.

Indications For Use

Intended to securely hold a variety of instruments while being processed by hospital manual and/or automated washing and sterilization procedures.

Mechanical/Automated Cleaning Guidelines

Anspach devices can only be mechanically cleaned under the following conditions: • Cannulations must be pre-cleaned with appropriate brushes as described in pre-cleaning instructions. • Devices must not be cleaned using ultrasonic equipment. • 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. • Devices must be cleaned immediately after use to ensure blood and tissue never dry on them. • 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.

List of Devices

Warning: Do not use to reprocess dissection tools. Dissection tools are disposable and SINGLE USE ONLY. Caution: • Do not use to reprocess any devices not listed in Table 1. • Do not reprocess the following Anspach devices in a mechanical/automated cleaner. • AutoLube Foot Controls • Electric System Consoles and Foot Controls • iMRI System and Foot Control • Powered Irrigation Pump (IRR-PUMP-II)

Table 1 Device Catalog Number Qty. Device Catalog Number Qty. EMAX2PLUS or XMAX 1 QD8 1 SHORT 2 QD11 1 SHORT-HD 1 MA-D20 1 MEDIUM 1 MA Bearing Sleeves* 2 MEDIUM-HD 1 CRANI-P 1 LONG 1 CRANI-A 1 LONG-HD 1 CRANI-L 1 MIA16 1 CSR60 1 *MA-10S, MA-10C, MA-15S, MA-15C, MA-15ST, MA-19ST 2

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 accompanying 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], Conformité Européenne) Meaning: Device complies 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 3

English Sterilized Using Irradiation Date of Manufacture

Single Use Only (A.K.A. Do Not Reuse) (01)

Global Trade Item Number (GTIN)

(10)

Batch or Lot Number

(17)

Expiration Date

(21)

Serial Number

GTIN

Global Trade Item Number

Warnings

Surgeon is responsible for learning proper techniques in use of equipment; improper use may cause serious injury to user or patient or damage to system. • Instrument operator and all operating room personnel must wear eye protection. • Visually inspect devices for damage while cleaning and before use; do not use if damage is evident. • Do not use, or discontinue use of powered equipment exhibiting excessive temperatures that can cause patient injury (necrosis) and/ or user discomfort. • Use of damaged or improperly maintained power equipment and/or misused powered equipment can result in excessive temperatures. • Use caution to avoid cutting or tearing gloves while handling dissection tools. • Use standard protocol for disposal of sharp instruments. • Dissection tools are disposable and intended for single patient use only. Do not re-sterilize and/or re-use dissection tools.

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 if pressure relief valve has cracks or hose has cuts or abrasions. • Use care to protect hose when handling and cleaning. • Damage to hose can cause leaking, rupture, or other related failures. • Do not kink cables; it may damage them. • Do not use ultrasonic equipment. • Use of alkaline detergents can cause color to fade but this does not impair function of device. • Bearings and seals of all devices are exposed to greater stress during mechanical/automated cleaning than manual cleaning. • If devices are mechanically cleaned they must be sent to a DePuy Synthes Power Tools Service Center at least once a year for maintenance. • Do not use accessories other than those provided by DePuy Synthes Power Tools and specified for use with Anspach Systems. • To insure equipment operates as designed, read and follow manufacturer’s instructions, including those for proper service and maintenance.

Latex Information

Not made with natural rubber latex.

Warranty & Return Policies

Warranty and return policy is available upon request. 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/ 4

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.

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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.

Manual Pre-Cleaning Warning: Manual pre-cleaning must be followed by mechanical/automated cleaning.

Detergents

A neutral pH enzymatic detergent is recommended. Alkaline detergents with a maximum pH of 11 may be used but user must demonstrate their effectiveness. • The process, detergent and any additives must be discussed with detergent manufacturer. Caution: Do not use any alkaline detergent with a pH greater than 11. Alkaline detergents attack grease and seals which can increase wear and cause device to malfunction. • •

Note: Use of alkaline detergents can cause color to fade but this does not impair function of device.

High Speed Handpieces

1. Preparation • Remove attachment and dissection tool from handpiece. • Electric Systems Only: Place electrical cap onto console connector. (See Figure 1) • Assemble all necessary supplies including Anspach Cleaning Brush (ACB), sponge, lint-free cloth and soft bristle brush.

Figure 1

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. ◄

◄

Distal End

Knurled Knob Figure 2

Caution: Do not use high pressure water or air. Do not allow running water to enter distal end of handpiece. See Figure 2. 3. Manipulate Moving Parts • Manipulate knurled knob under running cold deionized, distilled or purified water to loosen or remove gross soil. See Figure 2. 5

English 4. Clean • Prepare cleaning solution using 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. • With distal end pointing down rinse device thoroughly using running cold deionized, distilled or purified water for a minimum of 2 minutes while manipulating knurled knob. • Use a sponge, soft lint-free cloth, or soft bristle brush to remove all visible soil. • Place the locking mechanism in the “SAFE” position prior to performing the following step. See Figure 3.

Figure 3

• Hold handpiece with distal end pointing down and insert ACB wetted with cleaning solution into distal end of handpiece. See Figure 4. 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. Do not insert ACB beyond last bristle. Do not force ACB into handpiece. Do not use pipe cleaners.

Figure 4

5. Rinse Thoroughly • With distal end pointing down rinse device thoroughly using running hot deionized, distilled or purified water for a minimum of 2 minutes. • Place the locking mechanism in “SAFE” position prior to performing the following step. See Figure 5. • 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. • Place knurled knob in “RUN” position. See Figure 5.

Figure 5

Caution: Do not use high pressure water or air. Do not immerse. Do not allow running water to enter distal end of handpiece. 6. Inspect • Visually inspect handpiece. Repeat Steps 2 thru 6 until no visible soil remains. Warning: Manual pre-cleaning must be followed by mechanical/automated cleaning. 6

Attachments

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1. Preparation • Remove attachment and dissection tool from handpiece. • Assemble all necessary supplies including Anspach Cleaning Brush (ACB), Small Diameter Cleaning Brush (SDCB), sponge, lint-free cloth and soft bristle brush. Note: Red storage cap provided with Perforator Driver (CSR60) is to prevent damage to shaft. Cap is removed for cleaning, washing and sterilization. Cap should be used for non-sterile storage purposes only. 2. Rinse • Rinse attachment 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 use high pressure water or air. Do not rinse attachment with saline solution. 3. Manipulate Moving Parts • Manipulate all moving parts such as release sleeves under running cold deionized, distilled or purified water to loosen or remove gross soil. 4. Clean • Prepare cleaning solution using 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 ACB or SDCB wetted in cleaning solution to clean cannulations of attachment. Brushes may be inserted from distal or proximal end of attachment. Warning: ACB and SDCB are single use and should only be used to clean one set of attachments. Caution: Do not force ACB or SDCB into or through attachment. Do not use ACB or SDCB with MA-D20 and MA-DRIVER. For Minimal Access Attachment Bearing Sleeves use SDCB only. Do not use pipe cleaners. Note: “DO NOT IMMERSE” as marked on the attachment is for Operating Room personnel only. SDCB may be inserted from distal or proximal end of bearing sleeve. 5. 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. Caution: Do not use high pressure water or air. Do not rinse attachment with saline solution. 6. Inspect • Visually inspect attachment. Repeat Steps 2 thru 6 until no visible soil remains. Warning: Manual pre-cleaning must be followed by mechanical/ automated cleaning. 7

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Mechanical/Automated Cleaning Detergents

• A neutral pH enzymatic detergent is recommended. • Alkaline detergents with a maximum pH of 11 may be used but user must demonstrate their effectiveness. • The process, detergent and any additives must be discussed with detergent manufacturer. Caution: Do not use any alkaline detergent with a pH greater than 11. Alkaline detergents attack grease and seals which can increase wear and cause device to malfunction. Note: Use of alkaline detergents can cause color to fade but this does not impair function of device.

High Speed Handpieces and Attachments

1. Loading the Basket • Load devices in basket by securing them in appropriate brackets as marked on the basket with distal end angled down. Warning: Red protective cap for Perforator Driver (CSR60) must be left off for mechanical/automated cleaning. Caution: Visually inspect electrical contacts and cable of electric handpieces for damage. Connector ends of electric & pneumatic handpieces must be sealed with special seal caps provided. See Figure 6. Note: Before putting on seal cap, turn black cap to wrap cable tight around it.

Figure 6

2. Mechanical/Automated Cleaning Cycle Process Parameters Cycle

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

≥ 90°C

40 minutes

Caution: Do not use neutralizing agent. 3. Inspect • Visually inspect devices. Repeat manual pre-clean and mechanical/ automated clean if visible soil remains. • Remove seal cap from connector end of handpiece and drain until no visible droplets are coming from the handpiece or 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. 8

• For the following attachments apply one (1) spray pump spray to the proximal end of the attachment.

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SHORT LONG CRANI-L MA-15S SHORT-HD LONG-HD CRANI-P MA-15C MEDIUM MIA16 MA-10S MA-15ST MEDIUM-HD CRANI-A MA-10C 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 QD8 CSR60 QD11 • Applying excess amounts of lubricant will cause the lubricant 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. 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 nonsterile 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. 1. Loading the Basket • Load attachments in EM/XM Cleaning and Sterilization Basket by securing them in appropriate brackets as marked on basket with distal end angled down. • Replace seal cap in its bracket and lay handpiece connector in bottom of basket. Warning: Red protective cap for CSR60 must be left off for sterilization. Seal caps must be removed from connector ends of electric and pneumatic handpieces prior to sterilization. Devices must be cleaned prior to sterilization using the validated cleaning method outlined in these instructions. Caution: Black cap must remain on connector end of handpiece. 2. Packaging for Sterilization • When wrapping the basket the lid must be used. • Double wrap basket or instruments in accordance with local procedures, using standard wrap and wrapping techniques such as those described in ANSI/AAMI ST79. Warning: When using a sterilization wrap the basket lid must be used. You must follow manufacturer’s instructions for any wraps used. Do not use individual sterilization pouches. Only use indicated basket for equipment. 9

English 3. Sterilization • Sterilize in accordance with the following guidelines. Warning: Do not use any other sterilization method or cycle than those listed below which have been validated in accordance with ISO 17665. US Steam Autoclave Instructions Option Exposure Temperature 1. Pre-Vacuum* 132°C 2. Gravity Air Displacement* 132°C * Wrapped or unwrapped

Exposure Time 4 minutes

Minimum Dry Time 20 minutes

15 minutes

15 minutes

Outside US Steam Autoclave Instructions Option Exposure Temperature Exposure Time 1. Pre-Vacuum* 132°C 4 minutes 2. Pre-Vacuum* 134-138°C 3-18 minutes 3. Gravity Air 15-18 minutes Displacement* 132-138°C * Wrapped or unwrapped

Minimum Dry Time 20 minutes 20 minutes 15 minutes

Warning: Do not sterilize using STERRAD® sterilization. Caution: It is required to include the drying cycle to avoid possible adverse effects caused by exposure to condensation. Notes: • Steam sterilization validation was performed in accordance with ISO 17665. • 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. 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.

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18-0102 Rev D 01/20

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

For patent information go to www.depuysynthes.com/patentmarking. © DePuy Synthes 2020. All rights reserved.