Aptus Modus Sterile Products Handling Instructions

Sterile Products  |   3

Introduction Medartis products are now also available sterilized and ready for use ­offering several benefits to the surgeon and the hospital. Sterilized implants eliminate: • Risks of reprocessing • Costs of cleaning and disinfecting • Cost of sterilization

Blister type packaging with labels, tubes, blister and cardboard box

Packaging Concept Medartis products are packaged in either of the two packaging types: Blister Type Packaging • Blister type sterile barrier packaging containing an injection molded, laser welded Styrene Methyl Methacrylate (SMMA) tube with metal inserts for product storage

Inner injection molded tube

• Used for screws, short K-wires and short twist drills

Pouch Type Packaging • Pouch type packaging with heat sealed PA / PE pouches • Used for plates, long K-wires, long twist drills and reamers

Pouch type packaging with labels, sealed pouches and cardboard box

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4  |   Sterile Products

Patient Label Overview GS1 DataMatrix code (GTIN, date of manufacture, expiration date, lot number)

2.5TriLock Dist.Rad.Fract.Pl Volar Right A-4750.02S XXXXXXXXXXXX QTY: 1 YYYY-MM-DD (01) 07630037805571 (11) YYMMDD (17) YYMMDD (10)XXXXXXXXXXXX

Product Description - English Article number

Sterilized using irradiation Consult instructions for use

1 / 0001

YYYY-MM-DD

Quantity number Lot number Date of manufacture Use by date CE mark

ML04997/A

www.medartis.com

0197

Do not reuse

(01) 07630037805571 (11) YYMMDD (17) YYMMDD (10)XXXXXXXXXXXX

2.5TriLock Dist.Rad.Fract.Pl Volar Right A-4750.02S XXXXXXXXXXXX QTY: 1 YYYY-MM-DD YYYY-MM-DD

Sterilization Method 2 / 0001

ML04997/A

www.medartis.com

0197

(01) 07630037805571 (11) YYMMDD (17) YYMMDD (10)XXXXXXXXXXXX

2.5TriLock Dist.Rad.Fract.Pl Volar Right A-4750.02S XXXXXXXXXXXX Medartis sterile plates, screws and instruments undergo an for QTY: product storage, or an outer pouch containing an inner 1 YYYY-MM-DD irradiation sterilization process. The sterile barrier packaging

pouch for enhanced handling and safe transport of the

consists of an outer sealed blister package containing a tube

product.

3 / 0001

YYYY-MM-DD

ML04997/A

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0197

2.5TriLock Dist.Rad.Fract.Pl Volar Right A-4750.02S XXXXXXXXXXXX QTY: 1 YYYY-MM-DD (01) 07630037805571 (11) YYMMDD (17) YYMMDD (10)XXXXXXXXXXXX

Handling Instructions 4 / 0001

Prior to Use

YYYY-MM-DD

ML04997/A

www.medartis.com

0197

2.5TriLock Dist.Rad.Fract.Pl Volar Right A-4750.02S XXXXXXXXXXXX • Inspect and verify the physical integrity of the packaging and QTY: 1 YYYY-MM-DD do not use any product where the sterile packaging has been opened or damaged 5 / 0001

• Confirm contents are per surgeon’s request

(01) 07630037805571 (11) YYMMDD (17) YYMMDD (10)XXXXXXXXXXXX

• Check the use by date

YYYY-MM-DD

ML04997/A

www.medartis.com

0197

Notice

2.5TriLock Dist.Rad.Fract.Pl Volar Right Once the sterile packaging has been opened, the product Use by date

Devices are for single use only and may not be reused or resterilized under any circumstances. 6 / 0001

(01) 07630037805571 (11) YYMMDD (17) YYMMDD (10)XXXXXXXXXXXX

A-4750.02S

cannot be resterilized.

QTY: 1

XXXXXXXXXXXX YYYY-MM-DD YYYY-MM-DD

ML04997/A

www.medartis.com

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0197

Non-sterile field

Sterile Products  |   5

Step by Step Opening of Sterile Packages Example: Blister and tube combination • Sterile items should be opened aseptically following specific guidelines • Circulating nurse in the non-sterile field – Break the seal of the exterior box at the serrations and remove the contents – Position the package contents outside the sterile field on a flat dry surface – Check the physical integrity of the outer blister packaging and do not use if opened or damaged

Non-sterile field

Opening the Outer Packaging • Circulating nurse in the non-sterile field – Open the blister pack by peeling back and folding the top half to 2 / 3 of the way down – Make sure there is no contact between the opened lid and the inner rim or any part of the inner blister

Non-sterile field

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6  |   Sterile Products

Removing the Inner Tube or Inner Pouch Inner Tube • Circulating nurse in the non-sterile field – Hold back the peeled back lid with thumb, place trigger finger in channel of blister – Hold front and bottom of blister pack with second hand – Bend blister slowly upwards with trigger finger in channel, while holding the back of the tube with the thumb. The tube which is still covered by the sterile peeled back lid, will tilt upwards

Non-sterile field

• Scrub nurse in sterile field – Scrub nurse to remove the inner tube in the sterile field maintaining item sterility and integrity – Care must be taken that the tube does not touch any part of the packaging that is not sterile

Sterile field

Inner Pouch • Circulating nurse in the non-sterile field – Open the outer pouch with two hands and present the inner pouch to the scrub nurse in the sterile field Notice Sterile articles should never be dropped onto a sterile field as they may roll off the edge, create a hole in the sterile drape, or cause other items to be displaced, leading to contamination of the sterile field. Non-sterile field

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Sterile Products  |   7

• Scrub nurse in sterile field – Scrub nurse to remove the inner pouch with care ensuring there is no contact with any part of the packaging that is not sterile

Removing Contents of Inner Pouch or Tube • Scrub nurse in sterile field – Scrub nurse to open the inner pouch over the sterile field with two hands

Sterile field

– Contents of the inner pouch are to be removed and placed onto a flat surface in the sterile field

Screw Pick-Up • Scrub nurse in sterile field – Hold tube upright and open the inner tube by removing the cap – Insert screwdriver vertically into screw head of the screw in the tube and pick up the screw with axial pressure – Remove screw from the tube. If necessary, hold screw on screwdriver blade with finger

Sterile field

• Alternative method – Remove screw by gently tilting tube and sliding out contents onto the flat surface in the sterile field

Sterile field

Recording of Lot and Implant Information • Circulating nurse in the non-sterile field – Place the patient labels from the used implants in the patients file to enhance lot identification and tracking,

as well as achieve accurate hospital documentation of implant utilization

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CORP-01010001_v2 / © 2020-10, Medartis AG, Switzerland. All technical data subject to alteration.

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Disclaimer: This information is intended to demonstrate the Medartis portfolio of medical devices. A surgeon must always rely on her or his own professional clinical judgement when deciding whether to use a particular product when treating a particular patient. Medartis is not giving any medical advice. The devices may not be available in all countries due to registration and / or medical practices. For further questions, please contact your Medartis representative (www.medartis.com). This information contains CE-marked products. For US only: Federal law restricts this device to sale by or on the order of a physician.