PLATINUM Handpiece Instructions for Use Rev C

English

PLATINUM◊ Handpiece Instructions for Use

Device Description

The Smith+Nephew PLATINUM handpiece can be used with a wide range of DYONICS◊ DisposableArthroscopic Blades and Burrs for resection of soft and osseous tissue. The PLATINUM handpiece can be used with the Smith+Nephew DYONICS POWER II Control System (REF 72200873). For information regarding the DYONICS POWER II Control System, refer to the Operations/Service Manual (REF 10600181). The DYONICS POWER II Control System is herein referred to as “Control Unit” throughout the rest of the document.

How Supplied

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Target Patient Group

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

Expected Clinical Benefit

Facilitate successful resection of soft and osseous tissue

The Smith+Nephew PLATINUM handpiece is supplied non-sterile.

Intended Users

The Smith+Nephew PLATINUM handpiece and DYONICS Disposable Arthroscopic 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. All personnel should become familiar with the handpiece before it is set up for use in any procedure. Personnel trained should include, but not be limited to, central processing personnel, members of the surgical team, and the biomedical engineering department.

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Intended Use

The Smith+Nephew PLATINUM handpiece is intended for resection of soft and osseous tissue.

Indications for Use

The PLATINUM handpiece is 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 •

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The Smith+Nephew PLATINUM handpiece and DYONICS Disposable Arthroscopic 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. 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). Intracortical abrasion arthroplasty may be contraindicated in patients who do not qualify for high tibial osteotomy or total knee replacement.

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.

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Warnings

Do not use DYONICS Disposable Arthroscopic Blades and Burrs if the product sterilization barrier or its packaging is compromised. The PLATINUM 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 Disposable Arthroscopic Blades or 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 device that has been opened from sterile packaging, even if the device was unused. 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. Before using the PLATINUM handpiece for the first time, review all available product information. DYONICS Disposable Arthroscopic Blades and Burrs can injure healthy articular soft tissue and cartilage. Use every available means to avoid such injury. Only Smith+Nephew DYONICS Disposable Arthroscopic Blades and Burrs can be used with the PLATINUM handpiece. 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. DYONICS Disposable Arthroscopic Blades and Burrs are packaged as a set. They must be used as supplied. Do not interchange blade components. Periodic irrigation of the blade and burr 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.

Instructions for Use

10601552 Rev. B C

3

English •

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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 the possibility of patient burns, do not place the handpiece on the patient when it is not in use. Do not use a DYONICS◊ Disposable Short Sheath with 17 mm length Burr. DYONICS Disposable Arthroscopic Blades and Burrs may contain magnets that may be attracted to other instrumentation when placed in direct contact.

Precautions • •

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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 this 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. 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, and will result in irreversible damage to blades or burrs. 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 handpiece 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 Instructions for Use. The use of automated washers/disinfectors does not eliminate the manual cleaning methods 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: 10601552 Rev. B C

Instructions for Use

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– 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 ORBIT◊ Blade tip position. Do not turn the 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 Arthroscopic 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 contain 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 the PLATINUM handpiece to the Control Unit, ensure that the system has been set up as defined in the Operations/Service Manual (REF 10600181). The handpiece can be connected to the connection ports on the Control Unit front panel. The Control Unit retains set speeds for Forward/Reverse and Oscillate modes independently and in increments of 100 rpms. The PLATINUM handpiece and its cable are autoclavable (refer to “Cleaning, Disinfecting, and Sterilizing”). 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. Note: Compatible with tubing with an ID of 1/4 inch. 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.

English

Suction

Periodic irrigation of the blade and burr 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. 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, and will result in irreversible damage to blades or burrs. 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 (Figure 1). • Move the lever away from the blade/burr to decrease suction.

Figure 1.  Suction lever on the PLATINUM◊ handpiece

Button Controls

The PLATINUM handpiece (REF 72205321) features push-button controls for Forward, Reverse, Oscillate, Blade Window Lock, and Speed Shift on the distal end of the handpiece. The blade action can be controlled with either the handpiece or the footswitch. Refer to Table 1, Button Control Operation. Handpiece/REF PLATINUM (REF 72205321)

Forward

Reverse

Press

Press

Oscillate Press

Blade Window Lock

Speed Shift

Press and hold < >

Press and hold >> or <<

Table 1.  Button Control Operation

Blade/Burr Speeds

Refer to Table 2 for the available programmed blade blade/burr speeds. Handpiece/REF

PLATINUM

(REF 72205321)

Maximum (Speed) RPM

Forward (RPM)

Reverse (RPM)

Oscillate Mode 1 (RPM)

Range

Default

Range

Default

Range

3000

100–3000

2000

100–3000

2000

500–3000

5000

100–5000

2000

100–5000

2000

8000

500–8000

4000

500–8000

10000

500–10000

5000

500–10000

Default

Oscillate Mode 2 (RPM) Range

Default

2000

1–9 (1 Rev) 1–8 (2 Rev)

8 (2 Rev)

500–3000

2000

1–9 (1 Rev) 1–8 (2 Rev)

8 (2 Rev)

4000

500–3000

2000

1–9 (1–2 Rev)

9 (2 Rev)

5000

500–3000

2000

1–9 (1–2 Rev)

9 (2 Rev)

Table 2.  Programmed Blade/Burr Speeds

Instructions for Use

10601552 Rev. B C

5

English

Installing and Removing a Blade or Burr in a Handpiece

1. Remove the blade or burr from the sterile package and insert the collar into the handpiece. 2. To insert a blade or burr, align the key slot (A) on the handpiece and the key (B) on the blade/burr (Figure 2). 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.

Figure 2.  Key slot (A) and key (B) 3. Press the Forward button and observe the blade/burr action to verify that it is properly installed. 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 handpiece (motor drive).

Note: For all three control modes: when the blade is in the best stopping position for the procedure, release the Window Lock button. The new Window Lock position is set.

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 handpiece. 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 Control Unit 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. Note: Speed Shift is not applicable in Oscillate mode and does not work through any footswitch.

Set Forward or Reverse Speed

1. On the handpiece, press the Forward or Reverse button. 2. On the Control Unit 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. Note: Speed setting may change if a blade is removed or a blade of a different type is installed.

Positioning Smith+Nephew DYONICS◊ ORBIT◊ Cleaning, Disinfecting, and Sterilizing Curved Blades Note: The following cleaning, disinfecting, and sterilization CAUTION: Make sure the handpiece is off while changing ORBIT Blade tip position. 1. Grasp blade hub or handpiece (if blade is already inserted) with one hand and black collet with the other (Figure 3). Rotate collet to desired blade curve position (Figure 4).

instructions only apply to the handpiece. Dispose of the DYONICS Disposable Arthroscopic Blades or Burrs 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. Refer to Table 3 for the recommended detergents used in the validation of the cleaning processes for the Smith+Nephew handpiece device. Figure 3.   Black Collet Figure 4.   Blade Curve Position 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

Blade Window Lock, which can be set from the handpiece, Footswitch, or Control Unit, determines the stop position of the inner blade relative to the opening at the top of the outer blade. Handpiece Operation: Press and hold the << >> (Oscillate) button on the handpiece for one second. Footswitch Operation: Press and hold the Window Lock button on the footswitch to rotate the blade. Control Unit Operation: Press and hold the Window Lock button that appears on the Control Unit screen. 6

10601552 Rev. B C

Instructions for Use

Detergent

Concentration*

mL/L

Prolystica Neutral

2X or equivalent

N/A

Prolystica Enzymatic Presoak**

2X Concentrate

1 to 4

*Use as recommended by the detergent manufacturer. **(neutral pH enzymatic detergents manufactured by STERIS Corporation)

Table 3.  Detergents

Manual Cleaning

CAUTION: Dried blood, saline, and other deposits inside the handpiece are a major cause of equipment malfunction. CAUTION: 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 Instructions for Use. 1. Dispose of the blade(s) or burrs used during the operation following standard procedures for disposal of biohazardous waste.

English WARNING: Only Smith+Nephew DYONICS◊ Disposable Arthroscopic Blades and Burrs can be used with the PLATINUM◊ handpiece. 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. 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 Key Surgical, (or equivalent) in Table 4. – 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. Handpiece REF Lumen Brush 72205321

Brush 1

Blade Port Brush Brush 2

Fork Area Brush Brush 3

Brush 1:

Bristles: antimicrobial nylon, 2.0" area length, .25" (6.35 mm) diameter, 12" length (acrylic tip) Key Surgical, PN AT-12-250*

Brush 2:

Bristles: antimicrobial nylon, 3.0" area length, .187" to .5" (4.75mm to 12.7mm) diameter, 7.0" length (Tapered fan bristle tip) Key Surgical, PN BR-8210*

Brush 3:

Bristles: antimicrobial nylon, 3.0" area length, .500" (12.7mm) diameter, 6.0" length (fan bristle tip) Key Surgical, PN BR-8410*

Table 4.  Brush Identification

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 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.

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 recommended parameters in Table 5, put the devices through the automatic washer cycle. Follow the instructions included with the instrument washer for instrument load and configuration. Phase

Recirculation Time (minutes)

Water Temperature

Prewash 1

5 minutes

Cold tap water

N/A

Enzyme Wash

5 minutes

109º F (43º C)

Prolystica 2X Concentrate Enzymatic Detergent concentration of 2ml per Liter

Wash 1

5 minutes

131º F (55º C)

Prolystica 2X Neutral Enzymatic Detergent concentration of 2ml per Liter

Rinse 1

1 minute

Heated 113º F (45º C)

Detergent Type and Concentration

N/A

Table 5.  Recommended Parameters

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.

* 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.

Instructions for Use

10601552 Rev. B C

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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 196º F (91º 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.

Sterilization Steam Sterilization Parameters

A single absorbent towel (i.e. Huck towel) is used to achieve dryness in the 30 minute drying cycle. 1. Place the protective cap on the connector end of the cable. 2. Set the suction control lever to the fully open or on position. 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 of 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. The following CSR wraps were used for the validation of MDUs: • HAYLARD H-600 can be used for dynamic air, gravity, and STERIS V-PRO cycles. • KIMGUARD can be used for dynamic air and STERIS V-PRO cycles. • Propper Steri-Wrap II can be used for steam cycles. Note: The PLATINUM handpiece may be sterilized by steam, using one of the following methods only. Prevac is the recommended sterilization method for the PLATINUM handpiece. Sterilization via other validated sterilization methods may result in increased wear, impacting the PLATINUM handpiece service life. The minimum recommended parameters for steam sterilization are as follows: Cycle

Temperature

Exposure Time

Dry Time

High Temperature Prevac Steam

270° F (132° C)

4 minutes

30 minutes

High Temperature Gravity Steam, gravity method

270° F (132° C)

15 minutes

30 minutes

UK Cycle

273° F (134° C)

3 minutes

30 minutes

World Health Organization 273° F (WHO) Steam Cycle (134° C)

18 minutes

30 minutes

Note: The UK cycle is not an FDA cleared sterilization cycle and only for use internationally. 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. CAUTION: Do not cool the handpiece by immersing it in cold water. 8

10601552 Rev. B C

Instructions for Use

CAUTION: 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:

STERIS V-PRO Cycles

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 sterilization. Note: These parameters have been validated to ensure sterility.

Storage for Sterile Devices

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. Note to US customers: Only items sterilized in materials cleared by the FDA for maintenance of sterility can be stored. If the PLATINUM handpiece is to be used immediately after sterilization, ensure that all components have sufficiently cooled. Be aware that thicker sections of the device take longer to cool.

Service

Repairs and adjustments to the PLATINUM handpiece are to be performed only by Smith+Nephew authorized service centers. 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. Service items should be carefully disinfected, packaged, and returned postpaid to Smith+Nephew. Smith+Nephew Customer Service can provide additional instructions. 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 may incur additional costs, regardless of warranty status. It is not necessary to include accessory items (i.e., blades/burrs, etc.) when returning a device for service. There are no user-serviceable components, adjustments, or repairs other than those specifically described in this Instructions for Use.

English

Expected Service Life

The Smith+Nephew PLATINUM◊ handpiece is a reusable instrument. The functional life of this device depends on various factors, including frequency of use, the method and duration of each use, as well as postoperative methods and handling. Proper maintenance of the equipment is essential to achieve optimal performance over time. The PLATINUM handpiece functionality should be confirmed as part of the system setup prior to use. Refer to the Control Unit Manual (REF 10600181) Setup section for details. During handpiece functionality confirmation, if any of the following warning messages occur, consult the Control Unit Manual (REF 10600181). – Unknown handpiece – Handpiece Sensor Fault – Blade Stall – Handpiece Stall – Handpiece Motor Fault – Handpiece Overload – Handpiece Overload Timeout – Handpiece Error – Short Circuit Detected Smith+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.

Safe Disposal

After use, the DYONICS◊ Disposable Arthroscopic Blades and Burrs may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements.

Compatible Devices • •

Ordering Information Handpiece

The Smith+Nephew handpiece includes:

Length: 7.1 in (18.0 cm)

72205321

PLATINUM handpiece

References Sterilization Standards •

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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.” ANSI/AAMI ST 79, “Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.” 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.” 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.” ISO 17664-1, “Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices-Critical and semi-critical medical devices.”

Push-button motor controls: Forward, Reverse, Oscillate, Blade Window Lock and Speed Shift.

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Suction control lever

Cleaning Standards

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

Description

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.

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Weight: 1.5 lb. (680g)

REF

For Further Information

Technical Specifications* PLATINUM handpiece (REF 72205321)

The handpiece is compatible with the Control Unit that runs software version 2.00 or later. The handpiece is compatible with Smith+Nephew large joint disposable blades/burrs.

Transport and/or Storage

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• Use

Temperature

-20º to 140º F (-29º to 60º C)

50º to 86º F (10º to 30º C)

Humidity

10 – 90% (no condensation allowed)

30 – 75% (no condensation allowed)

Atmospheric Pressure

500 - 1060 hPa

700 - 1060 hPa

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American Society for Testing and Materials (ASTM), “Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices, F3208.” 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.” AAMI TIR 12, “Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in HealthCare Facilities: A Guide for Medical Device Manufacturers.” AMI TIR 30, “A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.” Guidance for Industry and FDA Staff, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. U.S. FDA March 17, 2015.”

Instructions for Use

10601552 Rev. B C

9

English

Symbols Glossary Authorized representative in the European Community

Forward Reverse

Prescription Use Only Importer

General Warning Sign Oscillate Caution

Made in

Suction on Non-sterile Suction off Keep Dry

Manufacturer 140º F (60º C)

Date of manufacture -20º F (-29º C)

Serial number

Temperature limitation

90%

Humidity limitation

Medical Device

1060 hPa 500 hPa

Batch code

Atmospheric pressure limitation Consult instructions for use

EU: Not for general waste

Unique Device Identifier

www.smith-nephew.com ifu.smith-nephew.com +1 978 749 1000 +1 978 749 1108 +1 800 343 5717

10601552 Rev. B C

Contains hazardous substances Do not use if package is damaged Sterilized using irradiation

Catalog number

10

Use-by date

10%

CE Mark

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

DYONICS◊ Disposable Arthroscopic Blades and Burrs

Telephone Fax U.S. Customer Service

Instructions for Use

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

Do not re-sterilize

Do not re-use Single sterile barrier system

◊Trademark of Smith & Nephew. This product may be covered by one or more U.S. patents. See smith-nephew.com/patents for details. ©2023 Smith & Nephew, Inc. All rights reserved. 06/2023

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

www.smith-nephew.com ifu.smith-nephew.com +1 978 749 1000 +1 978 749 1108 +1 800 343 5717

Telephone Fax U.S. Customer Service

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

◊Trademark of Smith & Nephew. This product may be covered by one or more U.S. patents. See smith-nephew.com/patents for details. ©2023 Smith & Nephew, Inc. All rights reserved. 06/2023