Enztec Limited Devices Important Medical Information

EN - ENGLISH MATERIALS AND INTENDED USE The device supplied by Enztec Limited (Enztec) is a surgical instrument intended for transient use during orthopaedic surgery. It is intended to be used in the manner described in the Surgical Protocol provided by Enztec or its representatives, as applicable. The device is manufactured from medical grade metals and plastics, and is supplied non-sterile. Prior to use, the operating surgeon shall have given careful consideration to all aspects of the surgical intervention as well as to the limitations of the device. To ensure a safe connection and minimise the risk of patient or user harm, when instruments are driven by powered devices, the powered device must be used per the manufacturer’s instruction for use, ensuring that the speed selected is appropriate for the application and does not result in excessive heating of the device. Reaming instruments should not be operated at speeds above 250rpm or with an input torque exceeding 17Nm. EXAMINATION PRIOR TO USE The device is supplied non-sterile, in device containers or individually packaged. Device packaging must be intact when received, and removed prior to sterilisation. The device must be carefully and completely examined for wear or damage by doctors and staff in operating centres prior to surgery. The examination shall include a visual and functional inspection of the working surfaces, and must verify the cleanliness of the device and the absence of wear and damage. Evidence of damage or wear on a device may include but is not limited to corrosion, discoloration, excessive scratches, flaking, distortion, wear, cracks, and loosening of components. Improperly functioning devices, devices with unrecognisable markings, and damaged or excessively worn devices should not be used. Like any precision surgical instrument, the device must undergo regular checks by authorised personnel to ensure that the device remains in good condition and continues to act as intended. End of useful instrument life is generally determined by wear or damage in surgical use. However, instruments with sharp or cutting edges may have a limited life and should be discarded when they become dull. WARNINGS AND PRECAUTIONS Enztec devices must only be used by surgeons who are fully familiar with the surgical technique required and who have been trained to this end. The operating surgeon must take care not to exert inappropriate stress on the device and must fully comply with the operating procedure described in the Surgical Protocol. Incorrect maintenance, cleaning or handling may render the device unsuitable for its intended use, cause corrosion, dismantling, distortion and/or breakage, or cause injury to the patient or operating staff. Enztec shall not be responsible in the event of a device being used which is damaged, incomplete, showing signs of excessive wear and tear, or that has been repaired or modified (either permanently or temporarily) outside the control of Enztec or its representatives. As a result of mechanical features required, the device is made of non-implantable materials. In the event of the device breaking, no fragment must remain in the patient as this could cause post-operative complications such as allergies, infections, or complications of a biological nature associated with the release of non-implantable components, possibly requiring further intervention. These instruments are not intended for use in a MR (Magnetic resonance) environment. STORAGE The device should be stored in individual packages or in containers. After use they must be stored in a clean, dry and temperate place. DISPOSAL Devices must be disposed of in accordance with the health care facility’s procedures, ensuring protection from physical hazards such as exposed edges. Care must be taken to ensure that used devices are decontaminated following the cleaning and sterilisation instructions described within this document, or otherwise disposed of as infectious waste. Devices should be destroyed in a manner that prevents potential reuse. COMPLAINTS Any health professional having a complaint or grounds for dissatisfaction relating to the quality of the product, its identity, durability, reliability, safety, effectiveness, and or its performance, should notify Enztec or their representatives. Moreover, if the device has malfunctioned, or is suspected of having malfunctioned, Enztec or their representative must be advised immediately. If an Enztec product has ever worked improperly and could have caused or contributed to a serious incident, serious injury, or death, Enztec or their representative, as well as the competent authority of the Member State in which the user and/or patient is established, must be informed as soon as possible by telephone or in writing. 3

For all complaints, please include the device name and catalogue number, a full description of any markings, contact name and address, and an exhaustive description of the event to help Enztec understand the causes of the complaint. Please retain the device for investigation purposes. CLEANING AND STERILISATION For safety reasons, non-sterile devices must be pre-cleaned, cleaned (manual cleaning OR automated cleaning), and sterilised before use. Moreover, for good maintenance, reusable devices must be pre-cleaned, cleaned (manual cleaning OR automated cleaning), and sterilised after surgery following the sequence of steps described below: Point of Use

-

Remove gross contamination

Transport to Processing Area

-

Avoid damage Minimise time before cleaning

Preparation for Cleaning

-

Disassemble where possible following disassembly instructions, as applicable Instruments must be cleaned separately from instrument trays and cases

Pre-cleaning

-

Submerge in enzymatic detergent prepared according to manufacturer’s recommendations Soak for 10 minutes at 40°C (104°F) Scrub while submerged with soft sponge and agitate Use pipe cleaner or non-metallic brush for lumens and crevices. Actuate moving parts to loosen trapped soil Rinse in 38°C-49°C (101°F-120°F) tap water for 1 minute Thoroughly flush all lumens and difficult to reach areas Actuate while rinsing

Manual Cleaning

-

Automated Cleaning

Soak in ultrasonic bath in neutral pH detergent (Neutrad or acceptable alternative), prepared according to manufacturer’s recommendations Clean for 10 minutes at 40°C (104°F) Rinse with clean, tap water, actuating moving parts while rinsing, for 1 minute Dry thoroughly with clean, lint-free cloth Phase

Recirculation Time

Water Temp

Pre-wash

02:00

Cold Tap Water

N/A

Enzyme wash

02:00

Hot Tap Water

Enzymatic Cleaner

Detergent type

Wash

02:00

65.5°C (150°F)

Neutral pH Detergent

Rinse

01:00

Hot Tap Water

N/A

*Thermal Decontamination

01:00

90°C (194°F)

N/A

Dry

07:00

115°C (239°F)

N/A

*Thermal decontamination may be performed as an additional step to render the devices safe for handling Inspection

Preparation for Sterilisation

-

Inspect for contaminants and damage Repeat cleaning if contaminants remain Contact Enztec or its representatives if device is damaged

-

Reassemble where possible following assembly instructions Instruments with articulating surfaces must be tested for movement. A moist heat compatible, medical grade lubricant should be applied to all articulating joints prior to sterilisation (Rudolf Oil Spray RU8880-00 or acceptable alternative) Place cleaned, dry devices into the specified locations within the cases provided, if applicable, ensuring that the cases have been cleaned following the instructions above; where cases are not provided, package loosely in suitable pouch or cloth wrap. Only legally marketed, and locally approved sterilization barriers (e.g., wraps, pouches or containers) should be used for packaging terminally sterilized devices, in compliance to the manufacturer’s instructions. In the US, it is recommended that system trays be double wrapped using two FDA-cleared wraps prior to sterilisation.

-

4

US Sterilisation

-

Outside US

Steam Sterilisation, Pre-vacuum Cycle Temperature: 132°C (270°F) Exposure time: 4 minutes Dry-time: 40 minutes Cool-time: 20 minutes

-

Steam Sterilisation, Pre-vacuum Cycle Temperature: 134°C (273°F) Exposure time: 3 minutes Dry-time: 60 minutes Cool-time: 30 minutes

Other sterilisation methods are possible but must be validated beforehand. Automatic cleaners and autoclaves must be validated by the hospital and regularly checked to guarantee the recommended sterilisation temperatures are reached for the entire exposure time. If sterilisation containers with paper filters are used, it is advisable to use a new filter for each sterilisation. If after having followed this sterilisation method there is still water in the sterilisation containers or on/inside the device, the device must be dried and sterilisation repeated. WARRANTY STATEMENT Enztec Limited devices are manufactured for use only by qualified medical personnel who are trained in their use. All Enztec Limited devices are warranted to be free from defects in workmanship and materials for one (1) year from the date of sale. Any Enztec Limited device with a defect during the applicable warranty period will be repaired or replaced. Enztec Limited shall not be liable, expressly or impliedly, for: a. Any damages which arise or are caused, whether by the customer or by any of the users of the devices or equipment, as a result of (i) misuse, mishandling, and/or improper operation (ii) repairs, modifications, or alterations performed by any person or entity other than Enztec Limited, or their authorised representatives (iii) incorrect or incomplete inspection, cleaning and/or maintenance, or (iv) use in combination with adaptors and/or equipment, or use in any manner or medical procedure, other than those for which it is designed; and b. Any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the device and equipment. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND ALL OTHER OBLIGATIONS OR LIABILITIES ON “ENZTEC LIMITED” BEHALF. Enztec Limited neither assumes nor authorises any person to assume for it any other liabilities in connection with the sale of said devices and equipment. To ensure proper use, handling, and care of devices and equipment, consult the applicable catalogue, brochure, instruction manual, teaching film, and other literature which is included with the product and/or otherwise available from the company, upon request. For further information relating to the use of this device or complaints please contact your Enztec Limited representative or distributor. Rx: Federal law restricts this device to sale or use by or on the order of a physician. SYMBOL TRANSLATION - see enztec.com/ifu

DIST Distributed by MD

Medical device

QTY Quantity

5

Enztec Limited 3/17 Print Place Middleton Christchurch 8024 NEW ZEALAND Tel: +64 3 348 0203 Email: [email protected]

Advena Ltd. Tower Business Centre, 2nd Flr. Tower Street Swatar BKR 4013 MALTA

2797

Part No.: 10914-00 2021/12 Rev: 11