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®
®
Aesculap
M-TRAC
Support arm
Legend
1 Support arm
2 Proximal part of the support arm
3 Fastening element
4 Silicone washer
5 Clamping handle
6 Distal part of the support arm
7 Quick-release coupling
8 Sleeve
9 Instrument shaft
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 to the M-TRAC
►
For article-specific instructions for use as well as information on material compatibility and lifetime 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.
2.
Clinical use
2.1
Areas of use and limitations of use
2.1.1
Intended use
®
The M-TRAC
support arm is used in minimally invasive surgery to support e.g. optical systems, cameras, instruments
and trocars.
Additionally, a fastening element is used at the proximal end of the support arm and an adapter (e.g. NeuroPilot®)
at the distal end.
The maximum support capacity of the support arm is 40 N.
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
Sterility
Non-sterile packaged products
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
Assembly
WARNING
Injuries caused by unstable fixation of optics, cameras, instruments, trocars, support arms and fastening ele-
ments!
►
Apply appropriate care when supporting and fixing optical systems, cameras, instruments or trocars.
►
Tighten the clamping handle and check the fixation of the support arm.
►
Do not overload the support arm.
►
Ensure that the instrument shaft engages properly.
►
With the instrument shaft engaged, turn the sleeve clockwise.
►
Firmly tighten the fastening element at the operating table rail and the support arm.
►
To separate the sterile region from the unsterile region, slide silicone washer 4 over the rod, starting from the
bottom end.
►
Fasten holding arm 1 using fastening element 3 FF151R*, FF280R* or RT090R* to the operating table rail, see
Fig. C.
*Optional accessory, not part of delivery scope
►
Check for correct fixation of support arm 1: Slide the support arm 1 vertically and horizontally.
►
Insert instrument shaft 9 into the sleeve 8, see Fig. D.
Quick-release coupling 7 is locked automatically.
►
Position instrument shaft 9 at angles of 60°, see Fig. E.
►
To secure quick-release coupling 7 against inadvertent opening, rotate sleeve 8 clockwise, see Fig. D.
®
support arm FF168R.
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.
WARNING
Injuries caused by unstable fixation of optics, cameras, instruments or trocars!
►
Apply appropriate care when supporting and fixing optical systems, cameras, instruments or trocars.
►
Tighten the clamping handle and check the fixation of the support arm.
►
Do not overload the support arm.
CAUTION
Damage to the joints of the support arm!
►
Loosen the clamping handle before changing the position of the support arm.
Note
The holding arm 1 is fitted with insulation in the distal part 6 to isolate the connected instrument shaft 9 from earth.
►
Ensure that the insulation during HF application is not bypassed.
►
Lift the distal part of the support arm 6 and loosen the clamping handle 5 by turning it counterclockwise b, see
Fig. A.
►
Position support arm 1 in the operating field.
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Tighten clamping handle 5 by turning it clockwise a.
The joints of support arm 1 are fixated simultaneously.
►
Check the fixation of support arm 1.
2.5
Disassembly
►
Remove any optical systems, cameras, instruments or trocars coupled to the support arm from quick-release cou-
pling 7.
►
Turn sleeve 8 of quick-release coupling 7 counterclockwise.
Sleeve 8 of quick-release coupling 7 is unlocked.
►
Pull sleeve 8 of quick-release coupling 7 towards instrument shaft 9, see Fig. B.
Instrument shaft 9 is pushed out from quick-release coupling 7.
►
Remove fastening element 3 and silicone washer 4 from the support arm.
3.
Validated reprocessing procedure
3.1
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 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.
►
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
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.
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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
►
Disassemble the product prior to cleaning, see Disassembly.
►
Tighten the clamping handle by turning it clockwise.
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