DYONICS Handpieces Instructions for Use Rev N

English

DYONICS™ Handpieces Instructions for Use

Device Description

Target Patient Group

Smith & Nephew DYONICS Handpieces (also known as motor drive units or MDUs) can be used with a wide range of Smith & Nephew Disposable Arthroscopic Blades and Burrs for resection of soft and osseous tissue.

The targeted patient population for the DYONICS Handpieces, Blades, and Burrs is patients requiring surgical procedures as determined to be necessary by the prescribing health care professionals.

DYONICS Handpieces can be used with the Smith & Nephew DYONICS POWER II Control System (REF 72200873).

Expected Clinical Benefit

For more information regarding the DYONICS POWER II Control System, see the Operations/Service Manual (REF 10600181).

Intended Users The Smith & Nephew DYONICS Handpieces, Blades, and Burrs are intended for use by health care professionals in accordance with these instructions for use. The use environment is a professional healthcare facility.

Intended Use For resection of soft and osseous tissue.

Indications for Use The DYONICS Handpieces are indicated for use, when used with appropriate procedure-specific blades or burrs, for resection of soft and osseous tissue including, but not limited to, use in large articular cavities, and small articular cavities.

Contraindications

Facilitate successful resection of soft and osseous tissue.

Warnings • Do not use DYONICS Disposable Arthroscopic Blades and Burrs if the product sterilization barrier or its packaging is compromised. • The DYONICS Handpiece is shipped non-sterile. It must be cleaned and sterilized before every use. • The DYONICS Disposable Arthroscopic Blades and Burrs are supplied sterile and intended for SINGLE USE ONLY. DO NOT RESTERILIZE or REUSE DYONICS Arthroscopic Blades and Burrs as this may result in product malfunction, failure, or patient injury and may expose the patient to the risk of transmitting infectious diseases. Discard any open, unused product. Do not use after the expiration date. • It is the health care professional’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use.

• Smith & Nephew DYONICS Handpieces and Disposable Blades and Burrs should not be used with patients exhibiting ankylosis and also lacking adequate joint space or distention. Abrasion arthroplasty may not be effective in treating heavy patients or those with ankylosis, instability, or expectations beyond the relief of pain.

• Before using DYONICS Handpieces for the first time, review all available product information. Blades and burrs can injure healthy articular soft tissue and cartilage. Use every available means to avoid such injury.

• Varus or valgus deformity is not itself a contraindication in patients with a good range of motion and without gross instability or extreme malalignment (15° varus, 30° valgus).

• Only Smith & Nephew DYONICS Disposable Arthroscopic Blades and Burrs can be used with the DYONICS POWER II Control System. The blades and burrs are intended for single use only. Do not resterilize. Do not lubricate blades or burrs. Discard all blades and burrs after use.

• Intracortical abrasion arthroplasty may be contraindicated in patients who do not qualify for high tibial osteotomy or total knee replacement.

• DYONICS Disposable Arthroscopic Blades and Burrs are packaged as a set. They must be used as supplied. Do not interchange blade components.

• Synovectomy is contraindicated when the disease has progressed beyond the phase of synovial proliferation and advanced rheumatoid arthritis, when erosion of the articular cartilage is present.

• Periodic irrigation of the blade and burrs is recommended to provide adequate cooling of the device and to prevent accumulation of excised materials in the surgical site. Ensure that suction of 128 mmHg minimum is flowing while the instrument is running.

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English • When using a footswitch, ensure that the footswitch is not accidentally activated while inserting the blade or plugging the connector cable into the control unit. • Inadvertently depressing a footswitch while plugging in a handpiece will activate the handpiece. • To avoid patient burns, do not place the handpiece on the patient when it is not in use. • Do not use a DYONICS™ Short Sheath with 17 mm length burr. • DYONICS Disposable Arthroscopic Blades and burrs contain magnets that may be attracted to other instrumentation when placed in direct contact.

Precautions U.S. Federal law restricts these devices to sale by or on the order of a physician. • Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device. • In all cases, the judgment of the physician (in the best interest of the patient) may take precedence over the procedures described in these Instructions for Use. • All Smith & Nephew DYONICS Disposable Arthroscopic Blades and Burrs are preassembled, packaged sterile, and ready for use. Irreversible damage will result from any attempt to disassemble curved blades. Damaged blades will not be replaced by Smith & Nephew. • Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry). • Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope. Damage to both instruments is likely. Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo. If such contact does occur, inspect the tip. If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately. • Do not operate the handpiece in the open air for an extended period. Lack of irrigation may cause the motor or blade to overheat and seize. • Excessive side-loading on the blade and burr does not improve cutting performance and, in extreme cases, may result in wear and degradation of the inner assembly. • Dried blood, saline, and other deposits inside the handpieces are a major cause of equipment malfunction. • Take special care when making curved cuts to avoid locking the blade. Always keep the blade free to complete its stroke. • Do not cool the handpiece by immersing it in cold water. • Do not use an ultrasonic cleaner or any other automated sterilizing or cleaning equipment other than those specifically identified in the “Cleaning, Disinfecting, and Sterilizing” section of this manual.

• The use of automated washers/disinfectors does not eliminate the manual cleaning methods previously described. Manual cleaning with the appropriate brushes must be completed prior to additional processing. • To prevent damage to the control unit connector ports, do not plug in wet. Ensure that cleaned or sterilized cable connectors are completely dry prior to connecting to the control unit. • Electrical Interference: This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures: – Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Connect the pieces of equipment into different outlets or circuits. – Consult a biomedical engineer. • Environmental Protection: This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional policy relating to obsolete electronic equipment. • Make sure the handpiece is off while changing Disposable ORBIT™ blade tip position. • Do not turn the Disposable ORBIT Blade adjustment collet beyond the limits of travel, doing so may result in damage to the blade. • Hazards associated with reuse of the blades or burrs include, but are not limited to, patient infection and/or device malfunction. • The DYONICS Disposable Blades and Burrs are made of stainless steel which may contain trace amounts of Cobalt. Cobalt is defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Use of these devices may expose patients to Cobalt in levels above 0.1% weight/weight. • After use, these devices may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements. • These products contains Nickel (Ni) which may cause allergic reactions.

Adverse Event Reporting If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. complaints@smith-nephew.com

Instructions for Use Prior to connecting handpieces to the DYONICS POWER II Control System, ensure that the system has been set up as defined in the Operations/Service Manual (REF 10600181).

Instructions for Use

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English A variety of DYONICS™ handpieces can be used with the DYONICS POWER II Control Unit. All handpieces can be connected to the connection ports on the control unit front panel. The control unit automatically detects the type of handpiece connected. When a non-hand-control handpiece is connected to the control unit, the LCD screen on the control unit displays the warning message, “Footswitch Required” until a footswitch is connected to the footswitch port. The control unit retains set speeds for Forward/ Reverse and Oscillate modes independently and in increments of 100 rpms.

Figure 2.  The DYONICS POWERMINI™ with hand controls and suction lever

Each handpiece model and its cable are autoclavable (see “Cleaning and Sterilizing”).

Hand-Control Handpieces

Suction is connected to a portal on the proximal end of the handpiece and removes fluid and debris drawn through the blade window. In addition to removing fluids, the suction cools and lubricates the motor drive.

The hand-control handpieces (REF 72200616 and REF 72200872) feature push-button controls for Forward, Reverse, Oscillate, Blade Window Lock, and Speed Shift on the distal end of the handpiece. With these models, blade/burr action can be controlled with either the handpiece (Table 1) or the footswitch.

Cutting takes place when the blade edge rotates across the blade’s outer window. The blade action alternately opens and closes the window to the suction flow. The Blade Window Lock feature sets the handpiece to stop the blade in a specific position. The window can be set to fully open, partially open, or closed, depending on what is required for the technique.

Suction CAUTION: Do not operate the handpiece in the open air for an extended period. Lack of irrigation may cause the motor or blade/ burr to overheat and seize. A lever on the distal end of the handpiece provides suction flow control. The lever can be adjusted from fully open to fully closed to provide immediate manual control of the suction rate. • Push the lever toward the blade/burr to increase suction (Figures 1 and 2). • Move the lever away from the blade/burr to decrease suction.

The DYONICS POWERMINI (REF 72201500) features push-button controls for Forward, Reverse, Oscillate and Blade Window Lock (Figure 4). The distal button activates Forward and Reverse. The proximal button activates Oscillate and Blade Window Lock. Note: The DYONICS POWERMINI Handpiece uses only the DYONICS POWERMINI Blades and Burrs.

Non-Hand-Control Handpieces The non-hand-control handpieces (REF 72200617, and REF 72201503) are hand-held motor drives that are electrically connected to the control unit via a 10-foot (3-meter) cable. The non-hand-control handpieces are activated by a footswitch. These handpieces run a variety of DYONICS Disposable Arthroscopic Blades and Burrs. The handpieces are designed to sense the blade type installed and communicate that information to the control unit, which sets the appropriate operating parameters for the blade/burr. Note: The DYONICS POWERMINI Handpiece uses only the DYONICS POWERMINI Blades and Burrs.

Figure 1.  Suction levers on the DYONICS POWERMAX™ Elite Handpieces Handpiece/REF

Forward

Reverse

Oscillate

Blade Window Lock

Speed Shift

Press >>

Press <<

Press <>

Press and hold <>

Press and hold >> or <<

Three-button handpieces DYONICS POWERMAX ELITE (REF 72200616, 72200872)

Table 1.  Button Operation for Hand-Control Handpieces

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English Handpiece

DYONICS™ POWERMAX™ ELITE (REF 72200616, 72200617, 72200872)

DYONICS POWERMINI™ (REF 72201500, 72201503)

Maximum (Speed) RPM

Forward (RPM)

Reverse (RPM)

Oscillate Mode 1 (RPM)

Oscillate Mode 2 (RPM)

Range

Default

Range

Default

Range

Default

Range

Default

3000

100–3000

2000

100–3000

2000

500–3000

2000

1–9 (1 Rev) 1–8 (2 Rev)

8 (2 Rev)

5000

100–5000

2000

100–5000

2000

500–3000

2000

1–9 (1 Rev) 1–8 (2 Rev)

8 (2 Rev)

8000

500–8000

4000

500–8000

4000

500–3000

2000

1–9 (1–2 Rev)

9 (2 Rev)

10000*

500–10000

5000

500–10000

5000

500–3000

2000

1–9 (1–2 Rev)

9 (2 Rev)

3000

100–3000

2000

100–3000

2000

500–3000

3000

1–9 (1–2 Rev)

8 (2 Rev)

5000

100–5000

3500

100–5000

3500

500–3000

3000

1–9 (1–2 Rev)

9 (2 Rev)

6000

500–6000

6000

500–6000

6000

500–3000

3000

1–9 (1–2 Rev)

9 (2 Rev)

Table 2.  Programmed Blade/Burrs Speeds

* Only in the DYONICS POWERMAX ELITE Handpieces that will support the maximum speeds of up to 10000 (REF 7200616, 72200617, and 72200872).

Installing and Removing a Blade or Burr in a Handpiece

Positioning Smith & Nephew DYONICS ORBIT™ Curved Blades

1. Remove the disposable blade or burr from the sterile package and insert the collar into the handpiece.

CAUTION: Make sure handpiece is off while changing blade tip position.

Notes: – The Ultra Series curved blades and the Ultra Series TURBOWHISKER™ Blades may be used in all Smith & Nephew handpieces, with the exception of the DYONICS POWERMINI.

1. Grasp blade hub or handpiece (if blade is already inserted) with one hand and black collet with the other (Figure 4). Rotate collet to desired blade curve position (Figure 5). Convex

Concave

– DYONICS POWERMINI Blades/Burrs can only be used with the DYONICS POWERMINI Handpieces. 2. To insert a blade or burr, align the key slot (A) on the handpiece and the key (B) on the blade/burr (Figure 5). Insert the blade/ burr into the handpiece so that the key goes into the slot. Push the key in proximally as far as possible for a positive lock.

Collet Figure 4.  

Figure 5.  

2. Lock position by applying pressure and pushing hub (or handpiece and hub) and collet together until a click is felt. 3. To change blade curve position, pull hub (or handpiece and hub) and collet apart until another click is felt. Repeat steps 1 and 2. Note: Blade tip opening will rotate relative to handpiece rotation.

Blade Window Lock

Figure 3.  Key slot (A) and key (B)

Blade Window Lock, which can be set from the DYONICS POWER II control unit, footswitch, or hand-control handpieces, determines the stop position of the inner blade relative to the opening at the top of the outer blade.

3. Press the Forward button and observe the blade/burr action to verify that it is properly installed.

Hand-Control Operation: Press and hold the <> (Oscillate) button on the hand-control handpieces for one second.

4. To remove a blade/burr, depress the key (B) on the blade/burr using a thumb or fingertip. This will disengage the hub from the driveshaft. Withdraw the blade/burr from the motor drive.

Footswitch Operation: Press and hold the Window Lock button on the footswitch to rotate the blade. When the blade is in the best stopping position for the procedure, release the Window Lock button. Instructions for Use

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English Control Unit Operation: Press and hold the Window Lock button that appears on the DYONICS™ POWER II Control screen.

Forward/Reverse Speed Shift Speed Shift enables the user to alternate between preset low and high speeds by pressing and holding the Reverse or Forward buttons on the hand-control handpieces. Press and hold the Forward or Reverse button on the handpiece for one second to alternate between the two preset speeds (high and low) in the forward or reverse direction. Use the Up and Down buttons on the DYONICS POWER II Control screen to adjust the high and low speeds. The high speed setting can be adjusted only when the control unit is in high speed mode. The low speed setting can be adjusted only when the control unit is in low speed mode. If the high and low speeds are not preset, then Speed Shift will not activate. Notes: • Speed Shift is not applicable in Oscillate mode and does not work through any footswitch. • Speed Shift is not available on the DYONICS POWERMINI™ Handpiece.

Set Forward and Reverse Blade Speed 1. On the handpiece, press the Forward or Reverse button. 2. On the DYONICS POWER II Control screen, press the Up button once to increase the speed by one increment. Press the Down button once to decrease the speed by one increment. Press and hold an Up or Down button to quickly make large adjustments to set speed.

Cleaning, Disinfecting, and Sterilizing NOTE: The following cleaning, disinfecting and sterilization instructions only apply to the handpiece. Dispose of the blades after use in accordance with accepted medical practice and applicable local and national requirements.

Detergents Enzymatic detergents with a neutral pH range between 6.0 and 8.0 are recommended. Detergents with a pH outside this range can have an adverse effect or be damaging to some medical devices and containment devices. Enzymatic detergents aid in the removal of organic soil such as blood. Detergents such as Prolystica 2 or equivalent should be used at the concentration and temperature recommended by the detergent manufacturer. 1 to 4 mL/L of Prolystica 2X Concentrate Enzymatic Presoak and cleaner (neutral pH enzymatic detergents manufactured by STERIS Corporation) was used in the validation of the cleaning processes for Smith & Nephew MDU devices.

• Do not use an ultrasonic cleaner or any other automated sterilizing or cleaning equipment other than those specifically identified in the “Cleaning, Disinfecting, and Sterilizing” section of this manual. 1. Dispose of the blade(s) used during the operation following standard procedures for disposal of biohazardous waste. WARNING: Only Smith & Nephew DYONICS™ Disposable Arthroscopic Blades and Burrs can be used with the DYONICS POWER II Control System. The blades are intended for single use only. Do not resterilize. Do not lubricate blades. Discard all blades after use. 2. Disconnect the handpiece cable from the front panel by pulling back the locking collar on the connector, then unplugging it from the control unit. Do not disconnect the cable from the handpiece. 3. Place the protective cap on the connector end of the cable. 4. Set the suction control lever to the fully open position. 5. Rinse thoroughly with warm tap water for a minimum of two minutes, making sure to irrigate all features of the device. 6. Immerse the handpiece and soak for a minimum of five minutes using a neutral pH enzymatic detergent. 7. After immersion of the device into the enzymatic cleaner, agitate the device to ensure all of the air is removed from the device lumen. 8. While the unit is immersed, clean using the specified brushes from Solo Horton Brushes, Inc. (or equivalent) in Table 3. – (If the handpiece has controls) Using the blade port brush, scrub around the hand controls, depressing the buttons with hand during scrubbing. – With the suction control lever in the open position, insert the lumen brush in the device spigot (proximal end of the device) and clean the lumen using twisting and in/out movements of the brush for a minimum of 30 seconds. – Reinsert the lumen brush from the distal end of the device end and clean the lumen from the opposite direction using twisting and in/out movements of the brush for a minimum of 30 seconds. – Using the blade port brush clean the nose cavity using twisting and in/out movements for a minimum of 30 seconds. – Using the fork area brush clean the drive fork area for a minimum of 30 seconds.. Lumen Brush

Blade Port Brush

Fork Area Brush

72200616, 72200617, 72200872

Brush 1

Brush 2

Brush 3

Manual Cleaning

72201500, 72201503

Brush 4

Brush 5

Brush 3

CAUTIONS:

Table 3.  Brush Identification

• Dried blood, saline, and other deposits inside the handpieces are a major cause of equipment malfunction.

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Handpiece REF

English Brush 1: Bristles: Nylon, 2.0" area length, 0.25" diameter (no taper), 14.00" minimum length

Recommended Parameters

Solo Horton Brushes, Inc. PN 86-0002-14ST, or equivalent*

Phase

Brush 2: Bristles: Nylon, 2.25" area length, 0.75" diameter (tapered to 0.50"), 6.00" minimum length

Recirculation Time (Minute)

Water Temperature

Detergent type and Concentration

Prewash 1

5 minutes

Cold tap water

N/A Prolystica 2X concentrate Enzymatic Detergent concentration of 2 ml per Liter Prolystica 2X Neutral Enzymatic Detergent concentration of 2 ml per Liter N/A

Solo Horton Brushes, Inc. PN 86-1234-0006, or equivalent* Enzyme Wash

5 minutes

43° C

Brush 4: Bristles: Nylon, 1.75" area length, .156" diameter (no taper), 14.00" minimum length

Wash 1

5 minutes

55° C

Solo Horton Brushes, Inc. PN 86-0134-14ST, or equivalent*

Rinse 1

1 minutes

Heated 45° C

Brush 3: Bristles: Nylon, 0.75" area length, 0.5" diameter (with ferrule), 6.00" minimum length Solo Horton Brushes, Inc. PN 86-0340-1206, or equivalent*

Brush 5: Bristles: Nylon, 1.75" area length, 0.5" diameter (tapered to 0.25"), 6.00" minimum length Solo Horton Brushes, Inc. PN 86-0212-1234, or equivalent* * Equivalent must include bristle material, bristle area length, and bristle diameter as specified. 9. Scrub crevices and around hinged/mating surfaces with the blade port brush. 10. Rinse thoroughly with warm tap water for a minimum of 30 seconds, making sure to irrigate all features of the device. Ensure that the suction control lever is opened and closed repeatedly while rinsing the device lumen.

Manual Cleaning Verification 1. After cleaning, inspect devices under normal lighting to ensure that all visible soil has been removed. 2. If not visibly clean, repeat cleaning and reinspect. For difficult-toview areas, 3% hydrogen peroxide may be applied (bubbling is evidence of the presence of blood). Note: Rinse instruments thoroughly with warm tap water following any hydrogen peroxide testing.

Automatic Cleaning CAUTION: The use of automated washer/disinfectors does not eliminate the manual cleaning methods previously described. Manual cleaning with the appropriate brushes must be completed prior to additional processing. 1. Complete Steps 1-10 detailed in the Manual Cleaning Section. 2. Using the following minimum parameters, put the devices through the automatic washer cycle. Follow the instructions included with the instrument washer for instrument load and configuration.

Automatic Cleaning Verification 1. After automatic cleaning, inspect devices under normal lighting to ensure that all visible soil has been removed. 2. If not visibly clean, repeat cleaning and reinspect. 3. For difficult-to-view areas, 3% hydrogen peroxide may be applied (bubbling is evidence of the presence of blood). Note: Rinse instruments thoroughly with warm tap water following any hydrogen peroxide testing.

Storage after Cleaning Medical devices that will be stored between cleaning and sterilization should be dried with a low-linting, non-abrasive soft cloth to prevent microbial contamination that could result from wet instruments. The handpieces should ALWAYS be thoroughly cleaned prior to storage.

Disinfecting CAUTION: The use of automated washers/disinfectors does not eliminate the manual cleaning methods previously described. Manual cleaning with the appropriate brushes must be completed prior to additional processing. The automatic washer/disinfector must be of proven efficacy complying with the ISO 15883 series standard. It is the responsibility of the user to ensure that their washer/disinfector is capable of achieving these parameters: 1. Perform a thermal disinfection at 196° F (91° C) for at least 1 minute. 2. Ensure Ao value greater than or equal to 600 is achieved. 3. Inspect the devices for wear and damage. If wear or damage is observed, refer to the Expected Life section.

Instructions for Use

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Sterilization

STERIS V-PRO Cycles

Sterilization Parameters Steam Sterilization A single absorbent towel (i.e. Huck towel) is used to achieve dryness in the 30 minute drying cycle. The suction lever must be in the open or on position for sterilization. Use an approved Central Supply Room (CSR) wrap intended for sterilization. All wraps may not be approved for all cycle types. Check with the manufacturer of the wrap for the recommended use. Packaging should provide a sterile barrier, allow for the passage of steam or hydrogen peroxide, be free from loose particles, while guaranteeing sterility under the proper storage conditions. Note to US Customers: Sterilizers and wraps used in your sterilization process must be cleared by the FDA.

Follow all recommended directions and warnings included with the sterilization system: • V-PRO 1 Standard Cycle • V-PRO 1 Plus Lumen Cycle •

V-PRO maX Lumen Cycle

Note: The device can be used immediately after chemical sterilization. Note: These parameters have been validated to ensure sterility.

Storage for Sterile Devices

1. HAYLARD H-600 can be used for dynamic air, gravity, and STERIS V-PRO cycles

Sterile packaged devices should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, vermin, and temperature and humidity extremes. Sterile packaged devices can be stored as long as the sterile packaging is not breached.

2. KIMGAURD can be used for dynamic air and STERIS V-PRO cycles

Note to US customers: Only items sterilized in materials cleared by the FDA for maintenance of sterility can be stored.

3. Propper Steri-Wrap II can be used for steam cycles

If handpiece components are to be used immediately after sterilization, ensure that all components have sufficiently cooled. Be aware that thicker sections of devices take longer to cool.

The following CSR wraps were used for the validation of MDUs

The minimum recommended parameters for steam sterilization are as follows:

Service

Temperature

Exposure time

Dry time

270° F (132° C)

4 minutes

30 minutes

270° F (132° C)

15 minutes

30 minutes

If service becomes necessary, call Smith & Nephew Customer Service prior to returning the device and request a Return Authorization (RA) number. Customer Service can also explain the available Service Replacement and Repair Programs.

134° C (273° F)

3 minutes

30 minutes

Service items should be carefully disinfected and packaged and returned postpaid to Smith & Nephew. Smith & Nephew Customer Service can provide additional instructions.

World Health 273° F Organization (WHO) 18 minutes 30 minutes (134° C) Steam Cycle Steam Note: The UK cycle is not an FDA cleared sterilization cycle and only for use internationally.

Product returned that has been serviced by an unauthorized third party repair shop and/or sterilized with a sterilization method other than one approved by Smith & Nephew and/or damaged by contact with other mechanical devices (such as shavers) may incur additional costs, regardless of warranty status.

Cycle Temperature Prevac Steam, Steam, pre-vacuum High Temperature Gravity Steam, Steam, gravity method UK Cycle

Note: The WHO cycle is not an FDA cleared sterilization cycle and only for use internationally. This sterilization cycle has not been validated for prion inactivation CAUTIONS: • Do not cool the handpiece by immersing it in cold water. • To prevent damage to the control unit connector ports, do not plug in wet. Ensure that cleaned or sterilized cable connectors are completely dry prior to connecting to the control unit.

Chemical Sterilization The handpiece should be wrapped in Central Supply Room (CSR) wrap that is approved for use in chemical sterilization cycles individually or as part of a system. The suction lever must be in the open or on position for sterilization. Sterilize the device using any one of the following sterilization systems: 8

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Repairs and adjustments to the DYONICS™ handpieces are to be performed only by Smith & Nephew authorized service centers.

It is not necessary to include accessory items (i.e., power cords, etc.) when returning a device for service. There are no user-serviceable components, adjustments, or repairs other than those specifically described in this manual.

Expected Service Life Smith & Nephew POWERMAX™ ELITE MDU and POWERMINI™ MDU are reusable instruments. The functional life of these devices depends on various factors, including frequency of use, the method and duration of each use, as well as post-operative methods and handling. Proper maintenance of your equipment is essential to achieve optimal performance over time. The handpiece functionality should be confirmed as part of the system setup prior to use. Refer to the DYONICS POWER II Control System Manual (REF 10600181) Setup section for details.

English During handpiece functionality confirmation, if any of the following warning messages occur, consult DYONICS™ POWER II Control System Manual (REF 10600181).

Smith and Nephew recommends returning the device for service if any of the above warning messages cannot be resolved or as needed to maintain optimal performance. Note: Clean and sterilize this device prior to return or disposal.

– Unknown Handpiece – Handpiece Sensor Fault

Safe Disposal

– Blade Stall

After use, the disposable blades and burrs may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements.

– Handpiece Stall – Handpiece Motor Fault – Handpiece Overload – Handpiece Overload Timeout – Handpiece Error – Short Circuit Detected

Technical Specifications* DYONICS™ POWERMAX™ ELITE Handpieces (REF 72200616, REF 72200872, REF 72200617)

Length: 7.1 in (18.0 cm) Weight: 7.5 oz. (223 grams) Lightweight handpiece with push-button motor controls: Forward, Reverse, Oscillate, Blade Window Lock and Speed Shift. Note: The Non-Hand Control unit, (Ref 72200617) handpiece, is activated by a footswitch. Equipped with 10-foot (3 meter) autoclavable power cord (not field replaceable). Suction control lever Allows for shaver blades to be inserted with the blade window aligned to the suction control lever or 180° opposite the lever. Length: 5.25 in (13.3 cm)

DYONICS POWERMINI™ (REF 72201503)

Weight: 5.0 oz. (142 grams) Equipped with 10-foot (3 meter) autoclavable power cord (not field replaceable). Suction control lever Allows for shaver blades to be inserted with the blade window aligned to the suction control lever or 180° opposite the lever. Length: 5.25 in (13.3 cm)

DYONICS POWERMINI (REF 72201500)

Weight: 5.0 oz. (142 grams) Standard handpiece with push-button motor controls: Forward, Reverse, Oscillate, Blade Window Lock. Equipped with 10-foot (3 meter) autoclavable power cord (not field replaceable). Suction control lever Allows for shaver blades to be inserted with the blade window aligned to the suction control lever or 180° opposite the lever.

*Specifications subject to change without notice. Handpiece date of manufacture: Date is on box label. Serial number is also traceable to the date of manufacture by Smith & Nephew.

Environmental Conditions Condition

Transport and/or Storage

Use

Temperature

-20º to 60º C

50° to 104° F (10° to 40° C)

Humidity

10% to 90% (no condensation allowed)

30% – 70% (no condensation allowed)

Atmospheric Pressure

415 to 760 mmHg

415 to 760 mmHg Instructions for Use

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For Further Information

Cleaning Standards

If further information, including warranty, on this product is needed, contact Smith & Nephew Customer Service at +1 800 343 5717 in the U.S., or an authorized representative.

• Guidance for Industry and FDA Staff – Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. U.S. FDA March 17, 2015.

References

• American Society for Testing and Materials (ASTM). Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices, F3208.

Sterilization Standards • ANSI/AAMI ST 79. Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.

• American Society for Testing and Materials (ASTM). Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices, F3293.

• ANSI/AAMI/ISO 17665-1. Sterilization of healthcare products – Moist Heat Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices.

• AAMI TlR 12. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers.

• ISO 14937. Sterilization of Health Care Products – General Requirements for Characterization of a Sterilization Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

• AAMI TIR 30. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

• ISO-17664-2. Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices • AAMI TIR 12. Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in HealthCare Facilities: A Guide for Medical Device Manufacturers. • ISO 15883-2, Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. • ISO 15883-5, Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy.

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10600266 Rev. N

Instructions for Use

English

Symbols Glossary 760 mmPa

Manufacturer Date of manufacture

415 mmPa

Oscillate

Atmospheric pressure limitation

Suction on Batch Code

Consult instructions for use Suction off

Catalog number EU: Not for general waste Serial number Unique Device Identifier Caution General warning sign

DYONICS™ Disposable Arthroscopic Blade and Burrs Symbol Glossary Use-by date

Prescription use only Contains hazardous substances

Medical Device

Do not use if package is damaged

Authorized representative in the European community

CE mark

Non-sterile

60°C

Temperature limitation

-20°C

Sterilized using irradiation European Importer

Do not re-sterilize

Do not re-use

Forward

Single sterile barrier system

90%

Humidity limitation

Reverse

10%

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

™Trademark of Smith & Nephew, registered U.S. Patent & Trademark Office.

www.smith-nephew.com ifu.smith-nephew.com +1 978 749 1000 Telephone +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service

Smith & Nephew Operations B.V. Bloemlaan 2 2132 NP Hoofddorp Netherlands

This product may be covered by one or more US Patents. See smith-nephew.com/patents for details. ©2007, 2023 Smith & Nephew, Inc. All rights reserved. 07/2023 Instructions for Use

10600266 Rev. N

11

This product may be covered by one or more US Patents. See smith-nephew.com/patents for details.

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

www.smith-nephew.com ifu.smith-nephew.com +1 978 749 1000 Telephone +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service

Smith & Nephew Operations B.V. Bloemlaan 2 2132 NP Hoofddorp Netherlands

™Trademark of Smith & Nephew, registered U.S. Patent & Trademark Office. ©2007, 2023 Smith & Nephew, Inc. All rights reserved. 07/2023 10600266 Rev. N