Braun Aesculap miaspas Instructions For Use/Technical Description Download Page 2

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Aesculap

miaspas

Instruments

Legend

Instrument that cannot be taken apart, without cover tube

Instrument that cannot be taken apart, with cover tube

Instrument that can be taken apart

Feed spindle

Handle

Base tube

Cover tube

Working end

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:

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

miaspas instruments are designed for use in endoscopic spinal surgery both on the thoracic spine (thoracoscopic)
and on the lumbar spine (laparoscopic).
miaspas instruments are used for cutting, dissecting, removing, exploring and working on bone tissue and interver-
tebral disk tissue, depending on the design of the working ends.

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:

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Use the product only according to these instructions for use.

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Follow the safety and maintenance instructions.

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Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge and experience.

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Store any new or unused products in a dry, clean, and safe place.

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Prior to use, check that the product is in good working order.

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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

Any endoscopic use of the instruments requires detailed knowledge of spinal surgery and of the biomechanical con-
ditions of the spine.

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To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).

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Only use the product under visual control.

2.2.3

Sterility

The product is delivered in an unsterile condition.

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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!

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Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.

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Always carry out a function test prior to each use of the product.

Instruments for endoscopic spinal surgery can be used in conjunction with the Aesculap trocars.

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Before the start of surgery, make sure that
–

the instruments have been processed, see Validated reprocessing procedure.

–

all required instrument parts are present.

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When inserting it into the trocar, snap the cover tube

into the forward position thereby covering the working

end

, see

Fig. 2

(top).

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.
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. Fail-
ure 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 applica-
tion/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.

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Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.

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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

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

3.4

Preparations at the place of use

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If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.

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Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.

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Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Preparing for cleaning

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Disassemble the product prior to cleaning, see Disassembly.