Integra A2012 Manual de usuario

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Integra®

Brain Retractor System

( A2012)

Instruction Manual

Distributed by:

Integra LifeSciences Corporation

4900 Charlemar Drive, Building A

Cincinnati, OH 45227, USA

Tel: 513-533-7979

Fax: 513-271-1915

integralife.com

Manufacturer:

Mediﬂex Surgical Products

250 Gibbs Road

Islandia, NY 11749 USA

Integra LifeSciences Services France

Immeuble Séquloa 2, 97 allée Alexandre Borodine

Parc Technologique de la Porte des Alpes

69800 Saint Priest - France

+33(0) 437 47 59 1

0086

This page is intentionally le blank

Integra

Brain Retractor System

( A2012)

Instruction Manual

Distributed by:

Integra LifeSciences Corporation

4900 Charlemar Drive, Building A

Cincinnati, OH 45227, USA

Tel: 513-533-7979

Fax: 513-271-1915

integralife.com

Manufacturer:

Mediﬂex Surgical Products

250 Gibbs Road

Islandia, NY 11749 USA

Integra LifeSciences Services France

Immeuble Séquloa 2, 97 allée Alexandre Borodine

Parc Technologique de la Porte des Alpes

69800 Saint Priest - France

+33(0) 437 47 59 1

0086

EN – English

EN – ENGLISH

Meaning Of Symbols Used In This Manual - ENGLISH

CAUTION!

Hazards which could result in equipment or property damage

WARNING!

Hazards which could result in severe personal injury or death

Caution

Product complies with the requirements of directive 93/42/EEC

Manufacturer

Authorized Representative in the European Community

Consult Instructions for Use

Caution: Federal (US) law restricts this device to sale by or on the

order of a licensed healthcare practitioner.

Catalog number

Date of manufacture (YYYY-MM-DD)

Lot number

Serial number

EN – ENGLISH

ENGLISH

Indications for Use

The Integra® Brain Retractor System is indicated for retraction of brain tissue during

neurosurgical procedures. The Integra Brain Retractor may be used in conjunction with

MAYFIELD® Skull Clamps (REF #A1013, A1014, A1059, A1108, A1114, and A2000) or may aach

to the side rails of the operating room table.

The Integra Brain Retractor System also serves to support and position various instruments

and handrests.

Description

The Integra Brain Retractor System is a set of components that allows the surgeon to

construct a framework surrounding the operative site for the purposes of retracting tissue

during neurosurgical procedures. Included are a pair of Primary Bars, with clamps that

aach to the skull clamp aer the sterile draping process. Longer Floating Secondary

Bars are then clamped to either the Primary Bars or to each other. Retractor Arms can

be aached to the Floating Secondary Bars and serve to support and position various

instruments, including the Retractor Blades of the Integra Brain Retractor System.

Suctioning devices, dissectors, scissors, drills, and handrests can also be aached.

System Components

The Integra Brain Retractor System includes the following components (Figure 1):

1. Primary Bars (quantity 2)

2. Floating Secondary Bars (quantity 4)

3. Retractor Arms (quantity 4)

4. Handrest

5. Paie Tray

6. Tapered Retractor Blade, 1/4” to 3/4” (6.4 mm to 19.1 mm)

7. Tapered Retractor Blade, 5/32” to 5/8” (4.0 mm to 15.9 mm)

8. Tapered Retractor Blade, 1/8” to 1/2” (3.2 mm to 12.7 mm)

9. Tapered Retractor Blade, 3/32” to 3/8” (2.4 mm to 9.5 mm)

10. Tapered Retractor Blade, 1/16” to 1/4” (1.6 mm to 6.4 mm)

11. Sterilization Case (not shown)

EN – ENGLISH

Figure 1

Inspection

Always inspect components of the Integra Brain Retractor System before and aer each use.

If a component appears damaged and/or does not seem to function properly, immediately

send the device to Integra LifeSciences, Cincinnati, Ohio, for evaluation and repair or

replacement (see Service and Repair section).

WARNING:

Device must not be used if it appears to be damaged or functioning incorrectly.

Doing so may result in serious patient injury.

EN – ENGLISH

Instructions for Use

Aachment to MAYFIELD Skull Clamp

The following assembly instructions are for aachment of the Integra Brain Retractor

System to a MAYFIELD Skull Clamp (REF A1013, A1014, A1059, A1108, A1114, or A2000).

WARNING:

Device is supplied non-sterile and requires sterilization prior to each use.

WARNING: Failure to read and follow instructions furnished in this product insert

may result in skull pin slippage and serious patient injury, such as scalp lacerations,

skull fracture, or even death.

CAUTION:

The patient should be positioned in the MAYFIELD Skull Clamp and draped in the

usual manner.

WARNING: Failure to properly position patient and to fully tighten and secure all

adjustable portions of this or any similar device may result in skull pin slippage and

serious patient injury, such as scalp laceration, skull fracture, or even death.

From this point, the ﬁeld is sterile. The entire assembly process shown is to be carried out

using sterile technique.

1. Prior to each use, clean and sterilize all system components as described in Cleaning and

Sterilization sections.

2. Locate the MAYFIELD Skull Clamp under the sterile surgical drape. Aach the Primary

Bars over the sterile drape around the vertical uprights of the skull clamp. The Primary

Bars are used to aach the Floating Secondary Bars for mounting the Retractor Arms and

Handrest. Tighten each Primary Bar clamp until there is no movement of the Primary Bar

clamp on the skull clamp upright (Figure 2).

Figure 2

EN – ENGLISH

3. Aach a Floating Secondary Bar to each of the Primary Bars. Tighten each Floating

Secondary Bar until there is no movement on the Primary Bars (Figure 3).

Figure 3

The universal joint of the Floating Secondary Bars facilitates positioning of the bar for

mounting the Retractor Arms and other tools.

EN – ENGLISH

4. The Retractor Arms and the Handrest can be aached to either a Primary Bar or a Floating

Secondary Bar. Position the Retractor Arm or the Handrest where it is needed and tighten

the clamp until there is no movement (Figure 4).

Figure 4

Once the Retractor Arm or the Handrest is in position, tighten the tension-seing knob

to hold it in position. For adjustments to the Retractor Arm or the Handrest, loosen the

tension-seing knob ﬁrst before moving and then re-tighten.

The Paie Tray and Retractor Blades are aached to the ends of the Retractor Arms.

CAUTION:

Forcing the Retractor Arms or the Handrest to move against their tightened tension

may cause the cable in the arm to wear and possibly break. The ball joint segments

may become scored and the arm may tend to dri. Aer a period of time, driing may

be experienced even though the knob is tight. This is usually due to the drawbar threads

becoming worn, necessitating replacement of the part.

EN – ENGLISH

Aachment to Side Rails of Operating Room Table

Aach a Primary Bar to the side rail of the operating room table. Aach a Floating

Secondary Bar to the Primary Bar (Figure 5). Continue to set up the surgical ﬁeld using both

the Floating Secondary Bars and the Primary Bars for aachment of the Retractor Arms,

Retractor Blades, and the Handrest as described above.

Figure 5

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