Heart XS Retractor System Instructions for Use

2.2.3

en ®

Aesculap Heart XS Median Retraction System

Sterility

Non-sterile packaged products The product will be delivered non-sterile. ► Clean brand-new product after removal of the transport packaging and before the first sterilization. Sterile packaged products

Legend 1 Retractor FC137R a Retractor arm fixed b Retractor arm moving c Pinion with crank d Pinion e Recess for insert blank f Locating pin for retractor blade g Stopper h Mark i Grooves 2 Insert blank FC136R 3 Retractor blade 4 Suture fixation FC135SU a Mark b Suture slot c Suspension lug 5 Fixation clamp FC138R a Tension screw

1.

To this document

Note General risks of surgical interventions are not described in these instructions for use.

1.1

Scope

These instructions for use apply to all components of the Heart XS median retraction system. 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 and material compatibility and lifetime information, see B. Braun eIFU at

eifu.bbraun.com

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may emerge during the use of the product. Warnings are marked as follows: WARNING Indicates a potential danger. If these are not prevented, minor or moderate injuries may result. CAUTION Indicates a potential damage to property. If these are not prevented, the product may be damaged.

2.

Clinical application

2.1

Areas of application and restrictions on use

2.1.1

Purpose

The Heart XS median retraction system is used in cardiac surgery to expand the surgical wound or access to the site. It is suitable for the median access in cardiothoracic surgery and is a module-based sternum retraction system for open median sternotomy. The Heart XS suture fixation (FC135SU) is used in conjunction with the Heart XS median retraction system for temporary holding and fixation of suture material. The Heart XS fixation clamp (FC138R) is used to connect and flexibly position optional accessories. The Heart XS insert blank (FC136R) is used to fixate the Heart XS retractor blades in the retractor.

2.1.2

Indications

Note Use of the product contrary to the indications mentioned above and/or described applications is outside the manufacturer's liability. For indications, see Purpose.

2.1.3

Absolute contraindications

No absolute contraindications known.

2.1.4

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 case of relative contraindications, the user shall decide on the use of the product on an individual basis.

2.2

Safety instructions

2.2.1

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. 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.

2.2.2

Product specific safety information

► Combine only Aesculap products.

Art. no.

Name

FC135SU

Suture fixation

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

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

2.3

Application

WARNING Risk of injury and/or malfunction! ► Check product for loose, bent, broken, cracked, worn or broken parts before every application. ► Perform functional tests before every use.

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.

Name

FC135SU

Suture fixation

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

3.4

Reusable products

There are no known effects of processing resulting in damage to the product. Evidence of biocompatibility and reprocessability for the product has been provided by the manufacturer after a certain number of reprocessing cycles. Product

Reprocessing cycles

Heart XS fixation clamp FC138R

45

Other products

200

Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product, see Inspection.

3.5

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.

3.6

Preparation before cleaning

► Disassemble product before cleaning, see Disassembly.

3.7

Disassembly

3.7.1

Remove fixation clamp from retractor

► Loosen the clamping screw 5a and remove the fixation clamp 5, see Fig. F.

3.7.2

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

Remove the suture fixation from the retractor arm

infection procedures.

► Grasp suture fixation 4 on the suspension lug 4c and pull upwards, see Fig. E.

3.7.3

Remove the insert blank from the retractor arm

► Pull insert blank 2 from recess for insert blank 1e, see Fig. A and Fig. B.

3.7.4

Remove the retractor blade from the retractor arm

► Loosen retractor blade 3 from locating pin for retractor blade 1f and remove, see Fig. A and Fig. B.

3.7.5

Disassemble retractor

► Turn crank 1c counter-clockwise until moving retractor arm 1b is completely detached from pinion 1d, see

Fig. A. ► Remove tooth drive 1c from moving retractor arm 1b.

3.8

Cleaning/disinfection

3.8.1

Product-specific safety instructions for the processing process

Damage or destruction of the product due to inappropriate cleaning agents/disinfectants and/or excessive temperatures! ► Use cleaning agents and disinfectants approved for stainless steel according to the manufacturer's instructions. ► Observe information concerning concentration, temperature and exposure time. ► Do not exceed a disinfection temperature of 95 °C.

3.8.2

Validated cleaning and disinfection procedures

Validated procedure

Special features

Reference

Manual cleaning using immersion disinfection

► Use suitable cleaning brush. ► Use 20 ml disposable syringe. ► Keep working tips open for

Chapter Manual cleaning/disinfection and sub-section:

■ FC131R ■ FC132R ■ FC133R ■ FC134R ■ FC136R ■ FC137R

■ Chapter Manual cleaning with

cleaning purposes. ► Clean the product having movable joints in the open position or while moving the joints. ► Drying phase: Use lint free cloth or medical compressed air

Manual cleaning using ultrasound and immersion disinfection

■ FC138R

► Use suitable cleaning brush. ► Use 20 ml disposable syringe. ► Keep working tips open for

immersion disinfection

Chapter Manual cleaning/disinfection and sub-section: ultrasound and immersion disinfection

able joints in the open position or while moving the joints. ► Drying phase: Use lint free cloth or medical compressed air ► Place product on screen basket

suitable for cleaning (avoid areas not being reached by water jets).

■ FC131R ■ FC132R ■ FC133R ■ FC134R ■ FC136R

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 procedures.

3.9.2

Manual cleaning with ultrasound and immersion disinfection

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

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*

Chapter Machine cleaning/disinfection and sub-section:

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

■ Chapter Mechanical alkaline cleaning and thermal disinfection

D–W: FD–W:

Manual pre-cleaning using brush and subsequent alkaline machine cleaning and thermal disinfection

■ FC137R

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

■ FC138R

3.9

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.

■ Chapter Manual cleaning with

cleaning purposes. ► Clean the product having mov-

Alkaline machine cleaning and thermal disinfection

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.

► Use suitable cleaning brush. ► Use 20 ml disposable syringe. ► Place product on screen basket

Chapter Machine cleaning/disinfection with manual pre-cleaning and sub-section:

suitable for cleaning (avoid areas not being reached by water jets). ► Clean the product having movable joints in the open position or while moving the joints. ► Drying phase: Use lint free cloth or medical compressed air

■ Chapter Manual pre-cleaning

► Use suitable cleaning brush. ► Use 20 ml disposable syringe. ► Keep working tips open for

Chapter Machine cleaning/disinfection with manual pre-cleaning and sub-section:

cleaning purposes.

with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Chapter Manual pre-cleaning

► Clean the product having mov-

with ultrasound and brush

able joints in the open position or while moving the joints. ► Drying phase: Use lint free cloth or medical compressed air

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection

► Allow the rinsing water to sufficiently drain from the product before manual disinfection to prevent dilution of

the disinfectant solution. ► Visually check visible surfaces for residue after manual cleaning/disinfection. ► If necessary, repeat the cleaning/disinfection process.

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 procedures. 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. ► 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.

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*

3.10 Machine cleaning/disinfection

II

Intermediate rinse

RT (cold)

1

-

D–W

-

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).

III

Disinfection

RT (cold)

5

2

D–W

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

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedures.

3.10.1 Mechanical alkaline cleaning and thermal disinfection

3.11.3 Mechanical alkaline cleaning and thermal disinfecting

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

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

Phase

Step

T [°C/°F]

I

Pre-rinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

3

D–W

-

10

FD-W

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

■ Concentrate, alkaline:

– pH = 13 – <5 % anionic surfactant

– pH ~ 13 – <5 % anionic surfactant

■ 0.5 % working solution

■ working solution 0.5%

– pH = 11*

– pH = 11*

III

Intermediate rinse

>10/50

1

FD-W

-

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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 alcaline

D–W: FD–W:

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

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

3.11 Machine cleaning/disinfection with manual pre-cleaning

3.12 Inspection

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).

► Allow product to cool to room temperature. ► Dry wet or damp product.

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

► Make sure all dirt has been removed. Pay particular attention to e. g. fitting surfaces, hinges, shanks, recesses,

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

drilled grooves and the sides of teeth of rasps.

ken parts. ► Check the product for missing or faded labels. ► Check surfaces for variations in roughness. ► Check product for burrs that may damage tissue or surgical gloves. ► Check product for loose or missing parts. ► Immediately single out the damaged product and send it to the Aesculap Technical Service, see Technical service.

3.12.2 Functional check CAUTION The product may become damaged (metal pitting/fretting corrosion) if insufficiently oiled! ► Oil 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® I drip-feed lubricator JG598).

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-

infection procedures. 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.

3.11.2 Manual pre-cleaning with ultrasound and brush 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*

RT (cold)

1

-

► Assemble dismountable product, see Assembly. ► Check product for proper functioning. ► Check all moving parts (e. g. hinges, locks/interlocks, sliding parts, etc.) for full mobility. ► Check compatibility with associated products. ► Immediately single out the defective product and send it to the Aesculap Technical Service, see Technical service.

3.13 Assembly 3.13.1 Install retractor ► Insert the pinion 1c in the hole in the moving retractor arm 1b, see Fig. A. ► Turn crank 1c clockwise until moving retractor arm 1b is fully on pinion 1d.

3.13.2 Install retractor blade on retractor arm ► Slip retractor blade 3 over locating pin for retractor blade 1f and click into place, see Fig. A and Fig. B.

3.13.3 Install insert blank on retractor arm ► Push insert blank 2 into recess for insert blank 1e, see Fig. A and Fig. B.

3.13.4 Remove the suture fixation from the retractor arm

Phase

Rinsing

3.12.1 Visual inspection ► For contaminated products: Repeat cleaning and disinfection procedure. ► Check product for damage, e.g. insulation, corroded, loose, bent, broken, cracked, worn, heavily scratched or bro-

3.11.1 Manual pre-cleaning with a brush

II

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

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh

► Insert/push the suture fixation 4 into the recess for insert blank 1e, see Fig. C; ensuring that the marking on the

retractor 1h and the marking on the suture fixation 4a are aligned and the suture fixation 4 is pushed up against the stopper 1g. This ensures that the suture slots 4b are flush with the retractor grooves 1i, see Fig. D.

3.13.5 Remove fixation clamp from retractor ► Slide fixation clamp 5 onto one of the retractor arms 1a/1b or onto the pinion 1d and tighten the clamping

screws 5a, see Fig. F.

3.14 Packaging ► Allocate product to associated storage or place on suitable screen basket. Ensure that any blades are protected. ► Pack screen baskets properly in accordance with sterilization process (e.g. in Aesculap Sterile Containers). ► Ensure that the packaging prevents any re-contamination of the product during storage.

3.15 Steam sterilization ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedures.

Note The product can be sterilized in both disassembled and assembled state.

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.

► Make sure that the sterilizing agent has access to all external and internal surfaces (e. g. by opening valves and

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.

3.16 Storage

taps). ► Validated sterilization process

– Steam sterilization in fractionated vacuum process – Steam sterilizer in accordance with DIN EN 285 and validated in accordance with DIN EN ISO 17665 – Sterilization in fractionated vacuum process at 134 °C, holding time 5 min. ► When sterilizing multiple products simultaneously in a steam sterilizer: Ensure that the maximum permissible load of the steam sterilizer according to the manufacturer's specifications is not exceeded.

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

4.

Technical service

CAUTION Modifications to medical equipment may result in loss of guarantee/warranty claims and any approvals. ► Do not modify product. ► Contact national B. Braun/Aesculap representative for service and repair. Service addresses Aesculap Technical Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] For more service addresses, see the address above.

5.

Disposal

WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing or recycling the product, its components and their packaging. Note The operator has to process the product before disposal, see Validated reprocessing procedure. TA013781

2021-01

V6

Change No. 64082