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Integra MAYFIELD - User Manual

Integra MAYFIELD
64 pages
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MAYFIELD®
Infinity Support System
( A1112)
Instruction Manual
Manufacturer:
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, OH 45227, USA
Tel: 513-533-7979
Fax: 513-271-1915
integralife.com
Integra LifeSciences Services
Immeuble Séquoïa 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest - France
Tel: 33 (0) 4 37 47 59 10
EN
ENGLISH ......................................................................................................
FR
FRANÇAIS ................................................................................................... 
IT
ITALIANO ..................................................................................................... 
DE
DEUTSCH ..................................................................................................
ES
ESPAÑOL ....................................................................................................
NL
NEDERLANDS ...........................................................................................
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Summary

Symbols and Markings

Warning and Caution Symbols

Explains hazards associated with caution and warning symbols for equipment damage or personal injury.

Regulatory and Identification Symbols

Covers symbols for regulatory compliance, manufacturer, representative, restricted use, and product identification.

Indications, Safety, and Initial Setup

Product Description and Intended Population

Describes the system and specifies limitations for pediatric use, requiring caution.

Inspection and General Safety Warnings

Details inspection requirements and lists critical safety warnings, including MR environment use and device alteration.

Mounting the Coupler to Base Unit

Guides on mounting the Coupler to the Base Unit and O.R. Table, including loosening post screws and securing.

Assembly and Headrest Mounting

Securing and Adjusting the Base Unit

Guides on locking the Base Unit handles, sliding the Coupler, and adjusting lateral positions via the Gear Box.

Mounting Headrests and Gel Pads

Explains how to mount the Headrest to the Coupler and position replacement gel pads.

Application Procedures

Headrest Adjustment and Gel Pad Placement

Covers tightening T-knobs, adjusting faceplates, and positioning mini gel pads.

Simultaneous Skull Clamp Application

Details the simultaneous application of a Skull Clamp for patients aged 5 and older.

Cleaning and Sterilization

General Cleaning and Component Classification

Outlines disassembly, cleaning with detergent, and classifies components into Group 1 (Headrests) and Group 2 (Gel Pads).

Gel Pad Handling and Sterilization Warnings

Warns against immersing gel pads in liquid or heat, and prohibits steam sterilization due to potential damage.

Cleaning Methods

Manual Wash Method

Provides detailed step-by-step instructions for manual cleaning using neutral pH enzymatic detergent and soft bristle brushes.

Optional Automatic Wash;Disinfect

Explains the process for automated cleaning and disinfection, including cautions on detergent and water quality.

Maintenance and Care

Maintenance Schedule and Lubrication

Recommends annual device inspection/servicing, bi-annual routine inspections, and lubricating metal movable parts.

Device Disposal Guidelines

Instructs users to follow hospital procedures for the disposal of the device.

Warranty and Service Information

Integra Standard Warranty Terms

Outlines the one-year warranty against manufacturing defects and limitations on liability and implied warranties.

Service and Repair Contact Information

Provides contact information and instructions for obtaining service and repair within and outside the United States.

Summary

Symbols and Markings

Warning and Caution Symbols

Explains hazards associated with caution and warning symbols for equipment damage or personal injury.

Regulatory and Identification Symbols

Covers symbols for regulatory compliance, manufacturer, representative, restricted use, and product identification.

Indications, Safety, and Initial Setup

Product Description and Intended Population

Describes the system and specifies limitations for pediatric use, requiring caution.

Inspection and General Safety Warnings

Details inspection requirements and lists critical safety warnings, including MR environment use and device alteration.

Mounting the Coupler to Base Unit

Guides on mounting the Coupler to the Base Unit and O.R. Table, including loosening post screws and securing.

Assembly and Headrest Mounting

Securing and Adjusting the Base Unit

Guides on locking the Base Unit handles, sliding the Coupler, and adjusting lateral positions via the Gear Box.

Mounting Headrests and Gel Pads

Explains how to mount the Headrest to the Coupler and position replacement gel pads.

Application Procedures

Headrest Adjustment and Gel Pad Placement

Covers tightening T-knobs, adjusting faceplates, and positioning mini gel pads.

Simultaneous Skull Clamp Application

Details the simultaneous application of a Skull Clamp for patients aged 5 and older.

Cleaning and Sterilization

General Cleaning and Component Classification

Outlines disassembly, cleaning with detergent, and classifies components into Group 1 (Headrests) and Group 2 (Gel Pads).

Gel Pad Handling and Sterilization Warnings

Warns against immersing gel pads in liquid or heat, and prohibits steam sterilization due to potential damage.

Cleaning Methods

Manual Wash Method

Provides detailed step-by-step instructions for manual cleaning using neutral pH enzymatic detergent and soft bristle brushes.

Optional Automatic Wash;Disinfect

Explains the process for automated cleaning and disinfection, including cautions on detergent and water quality.

Maintenance and Care

Maintenance Schedule and Lubrication

Recommends annual device inspection/servicing, bi-annual routine inspections, and lubricating metal movable parts.

Device Disposal Guidelines

Instructs users to follow hospital procedures for the disposal of the device.

Warranty and Service Information

Integra Standard Warranty Terms

Outlines the one-year warranty against manufacturing defects and limitations on liability and implied warranties.

Service and Repair Contact Information

Provides contact information and instructions for obtaining service and repair within and outside the United States.

Integra MAYFIELD Specifications

General IconGeneral
Product TypeSkull Clamp
Patient PopulationAdult and Pediatric
ManufacturerIntegra LifeSciences
Sterilization MethodAutoclave
Number of Skull Pins3
SterilizationReusable, sterilizable
CompatibilityCompatible with Mayfield headrest systems
MaterialStainless Steel
WeightVaries by model

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