B. Braun Aesculap TA014587 Instructions For Use/Technical Description Download Page 2

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Aesculap

4®

Long Tab Instruments

Legend

4®

Long Tab Counterholding instrument FW728R

4®

Long Tab Rod length measuring instrument FW729R

4®

Long Tab Screwdriver FW731R

4®

Long Tab Shaft for torque wrench FW732R

4®

Long Tab Insertion instrument for lock nut FW733R

4®

Long Tab FRI outer sleeve FW737R

4®

Long Tab Tab breaker FW738R

4®

Long Tab Tab protection ring FW739R

Pedicle screw in S

4®

Long Tab FRI outer sleeve FW737R

Movable measuring arms

Circumferential marking

Inspection window with marking

Scale

Body of the pedicle screw

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:

Note

The applicable CE mark for the product can be found 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

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the prod-
uct. Safety messages are labeled as follows:

DANGER

Indicates a potential danger. If it is not prevented, death or severe injuries may result.

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.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The S

4®

Long Tab instruments are used to complement the S

® Spinal System (instruments and implants) when

implanting the S

4®

Long Tab screws.

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 responsi-
ble 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 tech-
niques, 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 regard-
ing the use of the product.

2.2.2

Product specific safety information

►

Read, observe and store the surgical manual S

4®

Long Tab O82302 .

►

Read, observe and store the operating instructions of the S

® Spinal System (instruments and implants), includ-

ing:
–

® Spinal System - Lumbar/Deformity TA011187

–

® MIS Instruments TA014087

–

® Instruments TA012384

–

® MIS Percutaneous instruments TA013496

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

DANGER

Pushing the K wire forward into the aorta risks the life of the patient!

►

When inserting S

® implants or S

® instruments using the guidewire: Observe the markings on the guide

wire.

►

Use X-ray control to check the correct positioning.

►

Use forceps to hold the guide wire.

►

Remove the guide wire in time.

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.

WARNING

Danger of severe injuries from incorrectly positioning implants!
The depth markings and scales on the instruments are for orientation only.

►

Observe the relevant reference points of the markings.

►

Check the correct position of the implants using x-ray.

►

Check the proper rod length using x-ray.

WARNING

Risk of injury and/or malfunction!

►

When screwing the screws into the bone, apply only axial force. Avoid any transmission of lateral forces
when turning the screw.

►

Do not use the insertion instrument for lock nut FW733R to loosen lock nuts.

►

To loosen lock nuts: Use the shaft of the torque wrench FW732R.

►

To tighten the lock nut: Always use the shaft of the torque wrench FW732R in conjunction with the
intended torque wrench in combination with the corresponding counterholding instrument.

CAUTION

The screw flanks may prematurely break off if the protection ring is removed!

►

Keep the tab protection ring FW739R mounted during all surgical steps until the screw flanks are broken
off, see surgical manual S

® Long Tab.

For easy handling, some S

4®

Long Tab instruments have markings or scales:

■

® Long Tab Screwdriver FW731R: The circumferential marking

indicates the end of the protection ring if the

screwdrivers, the protection ring FW739R and the S

4®

Long Tab screw are properly installed.

■

® Long Tab Shaft for torque wrench FW732R: The circumferential marking

indicates the end of the outer

sleeve FW737R/counterholder FW728R if the lock nut has been tightened.

■

® Long Tab Insertion instrument for lock nut FW733R:

–

The circumferential marking

indicates the end of the outer sleeve FW737R/counterholder FW728R if the

lock nut has been screwed in.

–

The circumferential marking

indicates the end of the protection ring FW739R, if the lock nut has been

screwed in.

■

® Long Tab FRI outer sleeve FW737R:

–

The scale

on the outer sleeve refers to the body of the pedicle screw

, see Fig. A. When the edge of the

screw is in line with the marking

in the inspection window, the screw is fully inserted in the outer sleeve.

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 oper-
ator/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 temper-
atures >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.

Art. no.

Designation

FW728R

4®

Long Tab Counterholding instrument

FW729R

2 S

4®

Long Tab Rod length measuring instrument

FW731R

4®

Long Tab Screwdriver