Valve XS – Atrium Lift Retractor – 2nd Generation

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Aesculap Valve XS Atrium Lift Retractor - 2nd Generation

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.

Legend

2.3.2

1 Atrium retractor, fully assembled 2 Rod 3 Clamping lever 4 Retractor blade (for example for mitral valve and tricuspid valve) 5 Holder for rod 6 Gripping surface for insertion instrument 7 Retaining lug 8 Additional lateral blade (single-use product) 9 Insertion instrument 10 Recess 11 Hook 12 Retaining pins

Non-sterile packaged products

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 for the following products: Art. no.

Name

FC420R

Valve XS Atrium lift retractor set

FC423R

Valve XS Insertion instrument

FC424R to FC426R FC428R to FC436R

Valve XS Atrium lift retractor blade

FC427R

Valve XS Atrium lift rod for retractor blade

FC421R

Valve XS Additional lateral blade

Sterility

Art. no.

Name

FC423R

Valve XS Insertion instrument

FC424R to FC426R FC428R to FC436R

Valve XS Atrium lift retractor blade

FC427R

Valve XS Atrium lift rod for retractor blade

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Sterile packaged products Art. no.

Name

FC421R

Valve XS Additional lateral blade

The product is sterilized using irradiation and sterile packaged. ► Do not use any product from open or damaged sterile packaging. ► Do not use the product after the expiry date. ► Do not reuse the product.

Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not process product.

2.4

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.

► For article specific instructions for use and material compatibility and lifetime information, 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

Note The summary on the safety and clinical performance of the product is available in the European Medical Devices Database (EUDAMED).

2.1

Product description

The retractor consists of a rod that can accommodate various retractor blades. The retractor blades for the mitral valve have a holder for an additional lateral blade. The additional lateral blade is optional. It can be deformed and the surgeon can adapt it to the anatomic conditions using an insertion instrument. The complete retractor (consisting of a rod with blade and, if necessary, an additional lateral blade) can be held in the desired position in the following ways: ■ By hand by an assistant ■ Using a holding system (e.g. UNITRAC)

2.2

Areas of use and limitations of use

2.2.1

Intended use

The Valve XS Atrium Lift Retraction Set is used in minimally invasive valve surgery and is intended for the temporary dilatation of the left atrium in mitral valve surgery and for the temporary dilatation of the right atrium in tricuspid valve surgery.

2.2.2

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.

2.2.3

Absolute contraindications

No absolute contraindications known.

2.2.4

Relative contraindications

The conditions listed below, may, individually or combined, result in delayed healing or jeopardize the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities) that could prevent the operation from being successful. In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.3

Safety information

2.3.1

Clinical user

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.

3.

Validated reprocessing procedure

3.1

General safety information

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. 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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Single use products

Art. no.

Designation

FC421R

Valve XS Additional lateral blade

► Do not reuse the product.

Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not reprocess the product.

3.4

Reusable products

Art. no.

Name

FC423R

Valve XS Insertion instrument

FC424R to FC426R FC428R to FC436R

Valve XS Atrium lift retractor blade

FC427R

Valve XS Atrium lift rod for retractor blade

Validated procedure

Specific requirements

Reference

Manual pre-cleaning using ultrasound and brushing and subsequent alkaline machine cleaning and thermal disinfection

Manual pre-cleaning, phase I:

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-sections:

■ Suitable cleaning brush ■ Use an ultrasonic cleaner (frequency 35kHz) to clean the product for at least 10min. Make sure all accessible surfaces are wetted and acoustic shadows are prevented.

■ FC427R

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 option to determine if a product is no longer functional, see Inspection.

■ Flush the flushing holes thor-

3.5

■ Connect the distal end to a sil-

Preparations at the place of use

Preparing for cleaning

■ Rinse the flushing holes thoroughly 3 times using a disposable syringe (5 ml) filled with water.

Disassembly

■ Connect the distal end to a sil-

► When using the additional lateral blade: Grasp the additional lateral blade 8 using the insertion instrument 9

and bend it back to its initial position, see Fig. A. ► Grasp retractor blade 4 using the insertion instrument 9 on the gripping surface 6, see Fig. B. Make sure that the retaining lug 7 engages with the recess 10 of the insertion instrument 9 . ► Loosen the clamping lever 3 at the rod 2 until the angle between the rod 2 and the clamping lever 3 is approx. 90°, see Fig. C. ► Turn the rod 2 counterclockwise out of the rod holder 5 of the retractor blade 4, see Fig. D. Grip the serrated part of the rod 2 in doing so. ► Remove rod 2. ► Remove the retractor blade 4 from the surgical field. ► When using the additional lateral blade: – Slide the additional lateral blade 8 out of the retractor blade 4 in the opposite direction of the arrow, see Fig. F. – Remove the additional lateral blade 8 from the guide groove in the retractor blade 4, see Fig. E.

3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method

FC424R to FC427R and FC428R to FC436R: Hazardous to patients! The product must not be manually processed. ► Only mechanically reprocess the product. ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants approved for stainless steel in accordance with the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

icone tube and use a disposable syringe (5ml) to rinse thoroughly 3 times. Machine cleaning:

■ To flush the lumens/channels: Use flush lances or flush sleeves in the injector cart.

3.9

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

3.9.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Clean products having movable

Chapter Manual cleaning/disinfection and subsection:

■ FC423R

hinges in the open position or while moving the joints.

■ Chapter Manual cleaning with

■ FC423R

is suitable for cleaning (avoid rinsing blind spots).

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage. Manual pre-cleaning using ultrasound and brushing and subsequent alkaline machine cleaning and thermal disinfection

■ FC424R to FC426R ■ FC428R to FC436R

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place product on a sterile screen basket suitable for cleaning (make sure all areas will be reached by water jets).

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure.

cloth or medical compressed air

■ Place the product on a tray that

D–W: FD–W:

immersion disinfection

■ Drying phase: Use a lint-free Alkaline machine cleaning and thermal disinfection

cleaning and thermal disinfecting

icone tube and use a disposable syringe (5ml) to flush thoroughly 3 times. Manual pre-cleaning, phase II:

► Do not disassemble anchoring screws/bolts that permanently connect the various components. ► Disassemble the product prior to cleaning, see Disassembly.

3.7

with ultrasound and brush

■ Chapter Mechanical alkaline

oughly 3 times using a disposable syringe (5 ml) filled with cleaning solution.

► 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.

3.6

■ Chapter Manual pre-cleaning

Chapter Machine cleaning/disinfection and sub-sections:

■ Chapter Mechanical alkaline cleaning and thermal disinfection

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.10 Machine 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.

3.10.1 Mechanical alkaline cleaning and thermal disinfection

3.12.1 Visual inspection

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

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

► 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

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

► Check the product for missing or faded labels. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

scratched and fractured components.

– 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

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline

nical service.

3.12.2 Functional test CAUTION The product may become damaged (metal pitting/fretting corrosion) if not sufficiently oiled! ► Oil any moving parts (e.g. joints, spool parts and threaded rods) prior to the functional test using oil suitable for the applied sterilization process (e.g. STERILIT® I oil spray JG600 for steam sterilization or STERILIT® Idrip-feed lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.13 Assembly

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

3.11 Mechanical cleaning/disinfection with manual pre-cleaning 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.

3.13.1 Install the additional lateral blade on the retractor blade (optional) Note The use of the additional lateral blade is optional. The insertion instrument can be used to deform the additional lateral blade after installation. ► Insert the additional lateral blade 8 into the guide groove in the retractor blade 4. Make sure that the hooks 11

on the additional lateral blade engage with the retaining pins 12 on the retractor blade, see Fig. E. ► Press the additional lateral blade 8 all the way into the retractor blade 4 in the direction of the arrow, see Fig. F.

The additional lateral blade 8 audibly clicks into place.

3.11.1 Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

3.13.2 Mount the retractor blade onto the rod ► Grasp the retractor blade 4 using the insertion instrument 9 on the gripping surface 6, see Fig. B. Make sure the

retaining lug 7 engages with the recess 10 of the insertion instrument 9.

-

► Insert the retractor blade 4 into the surgical field. ► Loosen the clamping lever 3 at the rod 2 until the angle between the rod 2 and the clamping lever 3 is approx.

90°, see Fig. C. ► Turn the rod 2 clockwise into the rod holder 5 on the retractor blade 4, see Fig. D. Grip the serrated part of the

rod 2 in doing so. ► Close the clamping lever 3.

Note The screw-in torque of the rod can be used to adjust the holding force of the ball joint.

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

Note If the clamping lever is closed when the rod is screwed into the rod holder, the retractor blade is not fully locked in place. In this case, open the clamping lever and screw the rod in all the way.

3.14 Packaging

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

3.11.2 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: ■ working solution 0.5% – 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: FD–W:

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

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.15 Steam sterilization Note The product may only be sterilized in a disassembled state. ► 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). ► Validated sterilization process

– Disassemble the product – Steam sterilization in a fractionated vacuum process – Steam sterilizer in accordance with EN 285 and validated in accordance with EN ISO 17665 – Sterilization in the 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.

3.16 Storage

– pH ~ 13 – <5 % anionic surfactant

3.12 Inspection

► Secure products having ratchet locks fully opened or locked no further than in the first notch. ► Place the product in its holder or on a suitable tray. 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.

► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Store sterile packaged single-use products in a dry, dark and evenly tempered room.

4.

Technical service

CAUTION Modifications of medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► 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.

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. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA014200

2020-07

V6

Change No. 62704