A-Space SIBD and ArcadiusXP L Instruments Instructions for Use

en

AESCULAP® A-Space SIBD and ArcadiusXP L Instruments Legend

Contents

1 Packing Block (SJ604R) 2 Tamp (SJ608R) 3 T-Handle (SJ033R) 4 Handle (FW440R) 5 Ratchet Handle (SJ705R) 6 Slap Hammer Handle (SJ708T) 7 Slap Hammer Extension (SJ709R) 8 Implant Introducer (SJ605R)* 9 Trial Insertion Instrument (ME020R) 10 Implant Inserter Manipulator (ME015R) 11 U-Joint Screwdriver (ME014R) 12 Straight Ball Hex Screwdriver (ME013R) 13 Straight Hex Screwdriver (ME016R) 14 U-Joint Bone Awl (ME190R) 15 Straight Bone Awl (ME017R) 16 Straight Drill (SJ725R) 17 U-Joint Drill (ME189R) 18 Straight Drill Guide (SJ724R) 19 Angled Drill Guide (SJ722R) 20 Impactor (SJ606R) 21 Implant Extraction Instrument (ME018R) 22 Trial Implant (SJ664T – SJ798T: 36 sizes) 23 Distractor 10 mm–20 mm (SJ020R, SJ022R, SJ024R, SJ026R, SJ028R, SJ030R) * Instrument offered upon customer request only, not included in the instrument set.

1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.3.6 2.3.7 3. 3.1 3.2 3.3 3.4 3.5 3.6 3.6.1 3.6.2

3.6.3 3.6.4 3.6.5 3.7 3.7.1

2

About this document... 3 Scope... 3 Safety messages... 3 Clinical use... 3 Areas of use and limitations of use... 3 Intended use... 3 Indications... 4 Contraindications... 4 Safety information... 4 Clinical user... 4 Product-specific safety information... 4 Sterility... 4 Application... 4 Distraction... 5 Selection of Implant Size Using Trial Implants... 5 Filling the Implant... 5 Implant Placement and Positioning... 6 Bone Screw Placement... 6 Revision... 8 General... 8 Validated reprocessing procedure... 9 General safety instructions... 9 General information... 9 Reusable products... 10 Preparations at the place of use... 10 Preparing for cleaning... 10 Disassembly... 10 Straight Ball Hex Screwdriver (ME013R) and Straight Hex Screwdriver (ME016R)... 10 U-Joint screwdriver (ME014R), U-Joint Bone Awl (ME190R) and Implant Extraction Instrument (ME018R)... 10 Implant Inserter Manipulator (ME015R) and Implant Introducer (SJ605R)... 11 Trial Insertion Instrument (ME020R)... 11 U-Joint Drill (ME189R)... 12 Cleaning/Disinfection... 12 Product-specific safety information on the reprocessing method... 12

en 3.7.2 3.8 3.8.1 3.8.2 3.9 3.9.1 3.10 3.10.1 3.10.2 3.10.3 3.11 3.11.1 3.11.2 3.12 3.12.1 3.12.2 3.12.3 3.12.4 3.12.5 3.12.6 3.13 3.14 3.15 4. 5.

Validated cleaning and disinfection procedure... 13 Manual cleaning/disinfection... 15 Manual cleaning with immersion disinfection... 15 Manual cleaning with ultrasound and immersion disinfection... 16 Mechanical cleaning/disinfection... 18 Mechanical alkaline cleaning and thermal disinfecting... 18 Mechanical cleaning/disinfection with manual pre-cleaning... 18 Manual pre-cleaning with a brush... 19 Manual pre-cleaning with ultrasound and brush... 19 Mechanical alkaline cleaning and thermal disinfecting... 20 Inspection... 21 Visual inspection... 21 Functional test... 21 Assembly... 21 Straight Ball Hex Screwdriver (ME013R) and Straight Hex Screwdriver (ME016R)... 21 U-Joint screwdriver (ME014R) and Implant Extraction Instrument (ME018R)... 22 Implant Inserter Manipulator (ME015R) and Implant Introducer (SJ605R)... 22 Trial Insertion Instrument (ME020R)... 23 U-Joint Drill (ME189R)... 23 U-Joint Bone Awl (ME190R)... 24 Packaging... 24 Steam sterilization... 25 Storage... 25 Technical service... 25 Disposal... 25

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 A-Space SIBD and ArcadiusXP L instruments. Note The applicable CE mark for the product can be seen on the label or packaging of the product. Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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

The A-Space SIBD and ArcadiusXP L Instruments are used for the implantation of A-Space SIBD and ArcadiusXP L devices into the lumbar spine.

3

en 2.1.2

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.

2.1.3

Contraindications

No known contraindications.

2.2

Safety information

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.

4

2.2.2

Product-specific safety information

► Always follow the instructions for use of the A-

Space SIBD and ArcadiusXP L implants (TA013175 and TA015555) and the respective surgical techniques. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. Products ME014R, ME018R, ME189R, ME190R Note The product is partially made of NiCoCrMo (MP35N). The material contains cobalt.

2.2.3

Sterility

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

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.

en 2.3.1

Distraction

WARNING Risk of damage to the spinal cord, spinal nerve roots, adjacent intervertebral bodies or soft tissue when inserting and using the Distractor! ► Do not over insert the Distractor into the disc space. ► Do not over distract the disc space. ► Desired distraction of the vertebral bodies can be

achieved by using the Distractors (SJ020R– SJ030R). ► Desired working height can be gradually achieved by coupling a Distractor to a T-Handle (SJ033R), inserting horizontally into the disc space and rotating by 90°.

2.3.2

Selection of Implant Size Using Trial Implants

► Attach selected Trial Implant to the Trial Insertion

Instrument (ME020R) by inserting the Instrument into the anterior face of the Trial Implant. Turn the wheel clockwise to engage the Trial Implant onto the Trial Insertion Instrument. WARNING Risk of over distracting, damaging the endplates, or adjacent vertebral bodies in the course of incorrectly applying the Trial Insertion Instrument! ► During the Trial Implant insertion, do not apply an excessive bending/tilting/levering force to the Trial Insertion Instrument (ME020R). ► Keep the instrument directly in the plane of the disc.

WARNING If the Trial implant is inserted too deep there is a risk of damage to the spinal cord, spinal nerve roots, posterior structures! ► Always use the Trial Insertion Instrument (ME020R) with a depth stop. ► Do not apply excessive hammering force. ► Under lateral and anterior-posterior fluoroscopy

confirm the: – Implant depth, height, and lordosis – Endplate coverage (anterior-posterior/mediallateral) – Midline placement – Implant rotation WARNING Risk of selecting incorrect implant size! ► X-ray is mandatory to confirm the final Trial Implant size. ► Trial Implant must provide good contact with the inferior and superior endplates. Therefore the proper footprint, height, and lordotic angle should be chosen for the disc space. ► Select the implant size that corresponds with the

final Trial Implant size chosen.

2.3.3

Filling the Implant

► Fill the implant with bone or bone replacement

material by using the Packing Block (SJ604R) and Tamp (SJ608R).

► To advance the Trial Implant into the disc space use

either a mallet or a Slap Hammer Extension (SJ709R) assembled onto a Slap Hammer Handle (SJ708T).

5

en 2.3.4

Implant Placement and Positioning

► Securely attach the implant (corresponding to the

final Trial Implant size) to the distal end of the insertion instrument by turning the wheel clockwise. The laser markings (CRANIAL/CAUDAL) on the implant insertion instrument indicate the correct orientation for implant engagement: ■ The Implant Inserter/Manipulator (ME015R) will grip the implant utilizing the two lateral implant screw holes. ■ The Implant Introducer (SJ605R) will grip the implant utilizing the two medial implant screw holes. WARNING Inaccurate marking of the midline may result in incorrect positioning of the implant! ► Always mark the midline under X-ray visualization. ► Determine the center of the vertebral disc using the midline marker, under X-Ray visualization. WARNING If the implant is inserted too deep, the spinal canal and other posterior elements may be compressed! ► Always use the Implant Inserter/Manipulator (ME015R) with a depth stop. ► Excessive hammering may over-insert implant. ► Use appropriate care when inserting the implant.

– Drive the Implant into the disc space using either a mallet or the Slap Hammer Extension (SJ709R) assembled onto the Slap Hammer Handle (SJ708T).

6

► Confirm an anatomically suitable position and ori-

entation of the implant. It is recommended to confirm implant position prior to removing the implant inserter. – Obtain an AP fluoroscopic image to confirm midline placement of the device. – Obtain a lateral fluoroscopic image to confirm that the anterior edge of the implant is seated flush with the anterior border of the vertebral body. – Observe the X-Ray markers in both the AP and lateral views to ensure that the implant is not rotated within the disc space. ► Use Impactor (SJ606R) to adjust the position (in AP direction) of the implant as necessary.

2.3.5

Bone Screw Placement

► Use the bone awls (Straight Bone Awl (ME017R) or

U-Joint Bone Awl (ME190R)) and the drills (Straight Drill (SJ725R) or U-Joint Drill (ME189R)) to prepare a pilot hole for the bone screws at the intended screw placement site. WARNING Risk of damaging biological structures (spinal cord, spinal nerve roots, ligaments, vessels, soft tissues, etc.) with the drills and the bone awls, especially if the PEEK cage is placed off midline! ► The instruments are sharp, always use the bone awls/drills under X-Ray control. WARNING Risk of damaging biological structures (spinal cord, spinal nerve roots, ligaments, vessels, soft tissues, etc.) due to Straight Bone Awl tip or Straight Drill tip breaking! ► Do not apply an excessive bending/tilting/levering force to the Straight Bone Awl (ME017R) or Straight Drill (SJ725R).

en WARNING Risk of damaging PEEK cage with incorrectly applied Straight Drill Guide (SJ724R)! ► Do not apply an excessive bending/tilting/levering force to the instrument.

WARNING Applying too much torque may result in damage to the bone screws and the PEEK cages! ► Do not apply an excessive screw tightening torque.

WARNING Applying a mallet to advance the U-Joint Bone Awl (ME190R) instrument into the bone may result in damage to the A-Space SIBD or the ArcadiusXP L cages! ► Do not use a mallet with the U-Joint Bone Awl. ► The U-Joint Bone Awl must be advanced into the bone by hand only.

WARNING Risk of damage to the PEEK cage, or the bone screw head in the course of incorrectly driving the bone screw! ► Do not apply an excessive bending/tilting/levering force to the Straight Hex Screwdriver (ME016R) or Straight Ball Hex Screwdriver (ME013R) engaged in the bone screw. ► Keep the screwdrivers directly aligned with the axis of the bone screws.

► Always use the Drills and Straight Bone Awl with

the drill guides (Straight Drill Guide (SJ724R) or Angled Drill Guide (SJ722R)).

► Turn the screwdriver in a clockwise motion to

advance the bone screw into the vertebral body. WARNING Engaging the screwdriver incorrectly when turning the bone screw into the PEEK cage may result in damage to the bone screws! ► Fully insert the tip of the screwdriver into the bone screw. ► Attach bone screw of appropriate length to the

selected self-retaining screwdriver (Straight Hex Screwdriver (ME016R), Straight Ball Hex Screwdriver (ME013R), or U-Joint Screwdriver (ME014R)). WARNING Risk of damaging biological structures (spinal cord, spinal nerve roots, ligaments, vessels, soft tissues, etc.) while advancing incorrectly sized bone screws, especially if the PEEK cage is placed off midline! ► Always advance the bone screws, especially the diverging lateral screws, under X-Ray control. ► Follow Surgical technique, or training by Aesculap.

WARNING The screws could back out or loosen if they are not fully inserted into the cage! ► Insert the bone screw until it is fully engaged. ► Follow Surgical technique, or training by Aesculap. ► Insert the bone screws until they reach the final

seated position, ensuring full engagement of the two locking mechanisms. WARNING Risk of insufficient stability or implant failure if fewer than four screws are used! ► Apply all four screws or use an additional supplemental spinal fixation system such as the Aesculap S4 Spinal System. ► Repeat the bone screw placement steps outlined

above to insert the remaining bone screws through the implant.

► Place a bone screw through selected screw hole on

the anterior face of the implant.

7

en 2.3.6

Revision

WARNING Risk of injury to the patient! ► Remove implant in the direction it was inserted. ► Excessive force during extraction may cause implant to dislodge suddenly and impact the surrounding tissues. ► Locate implant, which is to be revised, and engage

selected self-retaining screwdriver (Straight Hex Screwdriver (ME016R), Straight Ball Hex Screwdriver (ME013R), or U-Joint Screwdriver (ME014R)) in the bone screw head. ► Retract the bone screw from the vertebral body by turning the screw in a counterclockwise motion. ► Repeat the bone screw removal process with the remaining bone screws in the PEEK cage. ► Engage Implant Extraction Instrument (ME018R) or the Implant Inserter/Manipulator (ME015R) to the implant and remove it from the disc space. Note If a fully seated bone screw is removed from the implant, a small piece of PEEK debris from the locking rim in the locking mechanism may be present.

2.3.7

General

WARNING Activating the "PRESS" button on the handle while actively using the instruments can result in the instrument shaft detaching from the handle! ► Do not cover the "PRESS" button with hand when utilizing fully assembled instruments. ► Caution should be taken while operating the

instruments with quick connect modular handles: T-Handle (SJ033R), Handle (FW440R), Ratchet Handle (SJ705R) and Slap Hammer Handle (SJ708T).

8

WARNING Risk of not being able to securely engage implant or damaging the instrument with incorrectly assembled Implant Inserter/Manipulator (ME015R) or Introducer (SJ605R)! ► Ensure that the instruments are correctly assembled prior to the surgery. WARNING Danger from improperly assembled U-Joint Drill (ME189R): the drill bit may disengage from the instrument shaft! ► Prior to the surgery, ensure that the drill bit is secured to the instrument shaft by firmly tightening the nut until it is fully threaded. WARNING Danger from improperly assembled Straight Hex Screwdriver (ME016R) or Straight Ball Hex Screwdriver (ME013R): the screwdriver bit may disengage from the instrument shaft! ► Prior to surgery, ensure that the screwdriver bit is secured to the instrument shaft, by firmly tightening the nut until it is fully threaded. ► Caution should be taken for assembling the follow-

ing modular instruments: Implant Inserter/Manipulator (ME015R), Implant Introducer (SJ605R), U-Joint Drill (ME189R), Straight Hex Screwdriver (ME016R) and Straight Ball Hex Screwdriver (ME013R).

en 3. 3.1

Validated reprocessing procedure 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. 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".

9

en 3.3

Reusable products

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.

3.4

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

3.6.2

U-Joint screwdriver (ME014R), UJoint Bone Awl (ME190R) and Implant Extraction Instrument (ME018R)

WARNING Risk of injury and/or damage to the gloves and/or spring when removing the spring! ► Do not use too much force to remove the spring. ► Apply both rotational and translational motion to the spring. ► Wear two pairs of gloves while removing the spring. ► Remove the spring 27 covering the u-joint from

the distal end of the shaft, see Fig. 2, see Fig. 3 and see Fig. 4.

Preparing for cleaning

► Disassemble the product prior to cleaning, see Dis-

assembly.

3.6

Disassembly

3.6.1

Straight Ball Hex Screwdriver (ME013R) and Straight Hex Screwdriver (ME016R)

► Unthread the nut 24 from the distal end of the

27 Fig. 2

Disassembling ME014R

27 Fig. 3

Disassembling ME018R

27 Fig. 4

Disassembling ME190R

shaft. ► Remove the screwdriver bit 25 from the shaft. ► Remove the soft tissue protection sleeve 26 from the shaft, see Fig. 1.

26 24 25

Fig. 1

10

Disassembling ME013R and ME016R

en 3.6.3

Implant Inserter Manipulator (ME015R) and Implant Introducer (SJ605R)

► While holding the proximal end (mechanism with

thumb wheel) upright, unthread the nut 28 counterclockwise towards the proximal end. ► With the nut disengaged from its threading, turn the thumb wheel 29 clockwise ("LOCK" - direction) until the sub-assembly 30 disengages from the outer sheath 31. ► Pull out the sub-assembly 30 from the outer sheath 31. ► Remove the depth stopper 32 by pushing it distally parallel along the shaft until it disengages from its rail, see Fig. 5 and see Fig. 6.

29

28 31

30 32

30

Fig. 6

Disassembling SJ605R

3.6.4

Trial Insertion Instrument (ME020R)

► Press the locking mechanism button 33 near the

thumb wheel and pull out the outer sheath 34. ► Remove the inner shaft 35 from the thumb wheel.

29

parallel along the shaft until it disengages from its rail.

28

30

32 Fig. 5

► Remove the depth stopper 36 by pushing it distally

33

31

30

34 Disassembling ME015R

35 36 Fig. 7

Disassembling ME020R

11

en 3.6.5

U-Joint Drill (ME189R)

WARNING Risk of injury and/or damage to the gloves and/or spring when removing the spring! ► Do not use too much force to remove the spring. ► Apply both rotational and translational motion to the spring. ► Wear two pairs of gloves while removing the spring. ► Unthread the nut 37 from the distal end of the

shaft. ► Remove the drill bit 38 from the shaft end and slide

the spring 39 off the u-joint, see Fig. 8.

37 Fig. 8

38

39

Disassembling ME189R

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

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 high-grade steel. ► Observe specifications regarding concentration, temperature and exposure time. ► Manually pre-clean the product (using a brush) if bone or tissue residues or residues of additives (e.g. flasking plaster) are present.

12

en 3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection ■ ME013R

■ Cleaning brus:h e.g. TA011944,

Chapter Manual cleaning/disinfection and subsection: ■ Chapter Manual cleaning with immersion disinfection

■ ME014R ■ ME016R ■ ME017R ■ ME018R ■ ME189R ■ ME190R ■ SJ033R ■ SJ604R ■ SJ606R ■ SJ608R ■ SJ722R ■ SJ724R ■ SJ725R ■ SJ020R – SJ030R (6 sizes) ■ SJ664T – SJ798T (36 sizes) Manual cleaning with ultrasound and immersion disinfection ■ ME015R

■ ME020R ■ SJ605R ■ SJ705R ■ SJ708T ■ SJ709R ■ SJ724R

TE654202, GK469200

■ Disposable syringe 20 ml ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air

■ Cleaning brush: e.g. TA011944, TE654202, GK469200

■ Disposable syringe 20 ml ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

Chapter Manual cleaning/disinfection and subsection: ■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Drying phase: Use a lint-free cloth or medical compressed air

13

en Validated procedure

Specific requirements

Reference

Mechanical alkaline cleaning and thermal disinfection ■ ME014R

■ Place the product on a tray that

■ ME017R ■ ME018R ■ ME189R ■ ME190R ■ SJ033R ■ SJ604R ■ SJ606R ■ SJ608R ■ SJ725R ■ SJ020R – SJ030R (6 sizes)

■ To flush the product: Use a

Chapter Mechanical cleaning/disinfection and subsection: ■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection ■ ME013R

■ Cleaning brush: e.g. TA011944,

■ ME016R ■ SJ705R ■ SJ709R ■ SJ722R ■ SJ724R ■ SJ708T ■ SJ664T – SJ798T (36 sizes) Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection ■ FW440R

■ ME015R ■ ME020R ■ SJ605R

is suitable for cleaning (avoid rinsing blind spots). flushing nozzle or flushing sleeve.

■ Place the product on the tray with all product links and joints open.

TE654202, GK469200

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

■ To flush the product: Use a flushing nozzle or flushing sleeve.

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Place the product on the tray with all product links and joints open.

■ Cleaning brush: e.g. TA011944, TE654202, GK469200

■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ To flush the product: Use a flushing nozzle or flushing sleeve.

■ Place the product on the tray with all product links and joints open.

14

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection: ■ Chapter Manual pre-cleaning with a brush

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

en 3.8

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off

for a sufficient length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

3.8.1

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

-

-

-

-

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 ► Note the information on appropriate cleaning

brushes and disposable syringes, see Validated cleaning and disinfection procedure. 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.

15

en 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.

3.8.2

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*

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 ► Note the information on appropriate cleaning

brushes and disposable syringes, see Validated cleaning and disinfection procedure.

16

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

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en 3.9

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.

3.9.1

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/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 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

DW: 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.

3.10 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.

18

en 3.10.1 Manual pre-cleaning with a brush 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

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning

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.

brushes and disposable syringes, see Validated cleaning and disinfection procedure. 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.

3.10.2 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

-

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 disinfection procedure. 19

en 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.

3.10.3 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: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

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 alkaline ► Check visible surfaces for residues after mechanical

cleaning/disinfecting.

20