IQ RESET Knee instrument set Instructions for Use

en ®

AESCULAP IQ RESET Knee instrument set 1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply to all size-specific configurations of instrument sets for the implantation of primary knee implant systems for the models Columbus, Vega and e.motion. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

The IQ RESET knee instrument set is used for the implantation of primary knee replacement prostheses. The instrument set contains all necessary instruments for the preparation of the implant bed, for the function checks and for the final implantation of the components.

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

2.1.2

3.4

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.

2.1.3

Contraindications

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Preparing for cleaning

No known contraindications.

► If applicable, disassemble the product prior to cleaning according to the instruction for use of the instrument. ► Remove the storage template sheet from the tray.

2.2

Safety information

3.6

Cleaning/Disinfection

2.2.1

Clinical user

3.6.1

Product-specific safety information on the reprocessing method

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located.

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for aluminum, plastic materials, and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

3.6.2

Validated cleaning and disinfection procedure

The instruments are stored in cleaning storage devices and can be cleaned in the cleaning storage devices. ► Only clean instruments together with other Aesculap instruments validated for cleaning in the cleaning storage device. ► Complex instruments (e.g. saw guides) or instruments inserted in the medullary cavity (IM) (e.g. drills, reamers and rasps) must be cleaned manually according to the following note.

Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

Note For each individual instrument, the validated reprocessing procedure is available from the Aesculap Extranet (https://extranet.bbraun.com) using the relevant article number. The size-specific instrument sets also contain small labels with symbols for reprocessing, known as IFR (instructions for reprocessing), as well as the number of the instructions for use for cleaning the respective contents of the set.

2.2.2

Validated procedure

Specific requirements

Reference

Manual cleaning and wipe disinfection

–

Chapter Wipe disinfection

Instrument set:

Chapter Mechanical cleaning/disinfection and subsection:

Product

Product-specific safety information Impaired operation outcome as a result of incorrectly selected instruments! ► Ensure that the instrument set is appropriate for the knee system used. ► Follow the operating manuals of the respective knee system. ► Use IQ RESET only in accordance with its intended use, see Intended use. ► Ensure that a sterile instrument set is available for the bordering sizes (next size up and next size down).

2.2.3

Sterility

■ Aluminium graphic templates Mechanical alkaline cleaning and thermal disinfection

■ Instrument set

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.3

Application

3.

Validated reprocessing procedure

3.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

the instructions for use for the instruments.

■ Use a suitable cleaning brush. ■ Use a 20ml syringe. ■ After manual pre-cleaning:

WARNING Risk of injury and/or malfunction! ► Always carry out a function test prior to each use of the product. WARNING Risk of gloves getting caught or damaged when handling the instruments or tray! Risk of injury from sharp, pointed or cutting instruments! ► Handle the instruments and tray with care.

■ Manual pre-clean according to

■ Chapter Mechanical alkaline cleaning and thermal disinfection

place the product in its holder or on a tray, that is suitable for cleaning. Mechanical neutral or mild-alkaline cleaning and thermal disinfection

■ Aluminium graphic templates

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

3.7

Wipe disinfection

3.9.2

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT

1

-

-

Alcohol(s), quaternary compound(s) *

II

Wipe disinfection

RT

≥1

-

-

Alcohol(s), quaternary compound(s) *

RT: *

Room temperature Recommended: Meliseptol® wipes sensitive (B. Braun)

Phase II ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the application time (1 min minimum).

Mechanical cleaning/disinfection

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.8.1

► Assemble disassembled instruments according to their instruction for use. ► Carry out a function check of the instruments and storage device. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.10 Packaging

Phase I ► Remove any visible residues with a disposable disinfectant wipe.

3.8

Functional test

CAUTION Damage (metal cold welding / friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

Both the storage device/cleaning storage device and the instruments of the IQ RESET knee instrument set are colorcoded: ■ Red: Femur ■ Blue: Tibia ■ Yellow: General instrument set ■ Gray: Patella ► Put away instruments in their corresponding storage place according to the storage template sheet. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.11 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by

opening any valves and faucets).

Mechanical alkaline cleaning and thermal disinfection

► Process the implant in its system storage device. ► Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots and damage).

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

3.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alkaline

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.8.2

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical

3

D–W

-

10

FD-W

Neutral:

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline:

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.

6.

Symbols on product and packaging

■ Concentrate:

Mechanical Cleaning

– pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Manual Cleaning

Pre-cleaning with a brush

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

3.9

Pre-cleaning with a brush followed by mechanical cleaning

+ /

Inspection

► Allow the product to cool down to room temperature. ► Dry the instruments if they are wet or damp.

3.9.1

Visual inspection

► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service. TA014608

2021-06

Manual or mechanical cleaning

Change No. AE0060833