Integra A2012 User manual

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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: [phone]
Fax: [phone]
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
[phone]
0086

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3
Integra
Brain Retractor System
( A2012)
Instruction Manual
Distributed by:
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, OH 45227, USA
Tel: [phone]
Fax: [phone]
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
[phone]
0086
EN – English

4
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

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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)

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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.

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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

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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.

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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.

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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