Integra LifeSciences Corporation

MAYFIELD Ultra Base Unit Rev DAB Instruction Manual

Instruction Manual

60 Pages

Table of Contents EN – English�� 2 FR – Français... 9 IT – Italiano... 17 DE – Deutsch... 25 ES – Español... 33 NL – Nederlands... 41 SV – Svenska... 49

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File Name: Integra LifeSciences Corporation - 451A2101 - MAYFIELD Ultra Base Unit Rev DAB Instruction Manual - 2021-03.pdf

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MAYFIELD® Ultra Base Unit - A2101 & A2102) ( 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

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Table of Contents EN – English�� 2 FR – Français... 9 IT – Italiano... 17 DE – Deutsch... 25 ES – Español... 33 NL – Nederlands... 41 SV – Svenska... 49

EN – English 2

6 7

1 8

Figure 1 1. Locking Lever

6. Transitional Member

2. Connecting Tube

7. Base Handle

3. Adjustment Screw 8. End Bracket 4. Tension Knob

Figure 4

9. Adjustment Wrench

1. Pressure

5. Locking Screw

2 3 1

Figure 2 1. 6” Transitional

4. Locking Lever

2. Receptacle

5. Base Handle

Figure 5

3. Shock Cushion

1. Transitional member 2. Lock lever 3. Retaining ball 4. Pull from this side 5. Push from this side

Figure 3 2

EN – English

Meaning Of Symbols Used In This Manual CAUTION! Hazards which could result in equipment or property damage

WARNING! Hazards which could result in severe personal injury or death

Caution, consult accompanying documents

Product complies with the requirements of MDR 2017/745

Manufacturer

Authorized Representative in the European Community

Consult Instructions for Use

Caution: Federal (USA) Law restricts this Device to sale by or on the order of a Licensed practitioner

This device is not indicated for use in the MR environment

Catalog number

Date of Manufacture

Lot Number

Serial Number

Medical Device 3

EN – English

Indications for Use/Intended Purpose/ Description

locked position without a transitional member in its receptacle (Fig. 2). Failure to do so may result in damage to the equipment.

The MAYFIELD® Ultra Base Unit (REF A2101 or A2102) is designed for patient positioning in the prone, supine, and sitting positions. The MAYFIELD Ultra Base Unit can be easily readjusted to fit most operating tables. It is used in conjunction with the MAYFIELD Ball Socket Swivel Adaptor (REF A1064), the MAYFIELD Swivel Adaptor (REF A1018), or the MAYFIELD Tri-Star Adapter (REF A2008) for attachment of various MAYFIELD Neurosurgical Headrests and Skull Clamps. The MAYFIELD Crossbar Adaptor (REF A1015 or A1016) and the MAYFIELD Universal Side Rail Fitting (REF A1060) are required for the sitting position.

NOTE: It is important to periodically adjust the tension of the Locking Lever to compensate for changes which occur with normal usage.

Care and Handling 1. Release Locking Lever by pulling upward (Fig. 1). 2. Remove the Adjustment Wrench from its receptacle on the right End Bracket by turning counter-clockwise. 3. Insert the Adjustment Wrench into the Lock Screw located at the center of the Tension Knob at the base of the Base Handle (Fig. 3). Turn the Adjustment Wrench counterclockwise several turns in order to unlock the Tension Knob.

The End Brackets of the MAYFIELD Ultra Base Unit are equipped with internal isolation caps to help provide insulation against stray electrical current.

4. Turn the Tension Knob counter-clockwise to loosen tension or clockwise to tighten tension on the Locking Lever.

NOTE: The MAYFIELD Neurogen Adaptor (REF A1113) may be required for those operating tables not designed to accept the MAYFIELD Ultra Base Unit. (REF A2101 or A2102). The MAYFIELD Ultra Base Unit (Fig. 1), is supplied with an Adjustment Wrench (REF 41A1284), and a 6” Transitional Member (REF 41B1171).

5. Test the tension on the Locking Lever by depressing and releasing the Lever. Movement should be smooth, but firm. 6. Test stability by placing the Base Unit on top of the O.R. Table. In the unlocked position place the Base Handle and Transitional Member in a straight line of 45° to the table and depress the Locking Lever (Fig. 4). Exert pressure in a downward direction on the Transitional Member. No movement should be observed.

Intended Population

7. Re-lock the Tension Knob by turning the Adjustment Wrench clockwise within the Lock Screw (Fig. 3).Return the Adjustment Wrench to its receptacle.

MAYFIELD Skull Clamp fixation devices are not recommended for use on children under five (5) years of age. Extreme caution should be exercised in pediatric cases because of the thin skull.

NOTE: Over a period of time, the Shock Cushion within the Base Handle may become deformed (Fig. 2). Deformation of the Shock Cushion, visible just below the Locking Lever, is normal and will not affect the operation of the Base Unit. However, deformation of the Shock Cushion in the interior of the receptacle will prevent insertion or ease of movement of the Transitional Member in the receptacle. To prevent this type of deformation, always store the MAYFIELD Ultra Base Unit with a Transitional Member in its receptacle and the Locking Lever depressed (Fig. 2).

Inspection Always inspect instruments before and after use. If a component appears damaged and/or does not seem to function properly, do not use the device and immediately send the instrument to an authorized Integra repair center for evaluation, repair or replacement. Allow your Integra Representative to inspect this device a minimum of two times per year to assist you in its proper function. 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.

Directions for Use 1.Align the two End Brackets of the MAYFIELD Ultra Base Unit with the receptacles at the head end of the operating table.

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.

NOTE: The MAYFIELD Ultra Base Unit is equipped with an adjustable left End Bracket which may be repositioned as needed. 2. Remove Adjustment Wrench from its receptacle by turning counter-clockwise.

WARNING: Do not alter the design of the device in part or whole as serious patient injury could result.

3. Insert the Adjustment Wrench into the Adjustment Screw located on the left End Bracket (Fig. 1). 4. Turn Adjustment Wrench counter-clockwise one full turn so left End Bracket slides smoothly on the Connecting Tube to the required position.

WARNING: This device is not intended for use in or near the vicinity of a strong magnetic field. (MRI)

5. Insert End Bracket into the O.R. table’s receptacles and turn the receptacle fastening screws until fully tightened.

CAUTION: The MAYFIELD Ultra Base Unit must never be stored in the 4

EN – English

Manual Wash

CAUTION: Make sure Base Unit is properly secured to the operating table.

CAUTIONS • Alkaline and highly acidic detergents and solutions cause damage to the devices. • Channels and crevices found on this device require particular attention during cleaning. • Pay special attention to the water quality used throughout reprocessing. Hard water can damage the surface of the equipment. Avoid using hard water. Instead use purified water unless otherwise specified.

6. Hand tighten Adjustment Screw on left End Bracket until secured. CAUTION: Do not over-tighten with Adjustment Wrench. Adjustment Screw can be sufficiently tightened by hand. NOTE: Adjustment Screw will continue to protrude from End Bracket even when adequately tightened. Make certain the Adjustment Screw re-engages the groove on the Connecting Tube so the End Bracket does not turn freely around the Connecting Tube.

Limitations on reprocessing • Repeated processing has minimal effects on these devices. Product life is normally determined by wear and damage due to use. • It is important to have Integra NeuroSpecialists perform routine inspections (twice yearly is recommended). See contact information below.

7. Pull up on the Locking Lever to unlock the Base Unit and position as desired. 8. Depress the Locking Lever to fully secure the Base Unit.

INSTRUCTIONS Containment/Transportation • Follow health care facility protocol for safe containment and transport to the decontamination environment. • It is recommended that devices are cleaned immediately after use.

CAUTION: Always be sure the locking mechanisms are secure after completing adjustments.

To Change Transitional Member. 1. P ull up on Locking Lever (Fig. 5) to unlock system. 2. Hold Transitional Member in one hand and Base Handle with the opposite hand. Pull Transitional Member away from Base Handle while simultaneously pushing the Transitional Member with thumb to disengage it from its receptacle.

Preparation for Cleaning • Disassembly is required. Disassembling Equipment

Inspecting for Cleanliness

NOTE: Rotating the Transitional Member in an upward or downward motion during this procedure allows for easier disengagement and removal.

Keep the unit in the unlocked position and remove the transitional member. DO NOT lock the handle without the transitional member in place.

Pay close attention to the area around the locking mechanism and the teeth of the starburst.

3. Insert desired Transitional Member into either side of the Base Handle until it “Clicks” into full engagement.

Cleaning – Manual Equipment: Water, Neutral pH Detergent, Soft Bristle Brush, Towels

CAUTION: Transitional Member can slide out of the Base Handle if not fully engaged.

Method 1. Prepare neutral pH enzymatic detergent solution (e.g. Endozime® AW Triple Plus with APA (Ruhof), 1:128 ratio) according to detergent manufacturer’s instructions using lukewarm tap water.

CAUTION: Do not use older style Transitional Member with this unit. Older style Transitional Members may not be securely retained in an unlocked position.

2. Prepare equipment for soaking by disassembling removable parts and loosening connections. 3. Rinse equipment in warm water before placing into bath.

4. Reposition the MAYFIELD Ultra Base Unit as desired and depress the Locking Lever to secure system.

4. Completely soak equipment in water/detergent solution for 30 minutes maximum. 5. Clean thoroughly with a soft nylon bristle brush. NOTE – If possible, use a disposable brush.

Cleaning and Sterilization After each use, thoroughly clean and wipe Base Unit with an antiseptic solution.

6. Rinse in warm purified water until all visible substances and residual detergent are removed. NOTE – Make sure to give special attention to hard-to-reach areas.

DO NOT STEAM STERILIZE! Plastic components will be damaged by heat.

7. Thoroughly dry equipment with soft clean towels and use medically compressed air if needed, to dry channels, crevices and lumens. 5

EN – English 8. Inspect the equipment to make sure there is no visible organic debris or residue from cleaning agent.

** Optional phase for disinfection of components – minimum water temperature as indicated or per manufacturer specifications for the thermal rinse cycle.

Repeat process if any soil is detected. Drying • Products should be dry at this point. If wetness or excess liquid is detected, dry with a soft clean towel. • Medically compressed air can be used if needed.

NOTE – Any deviation from this guideline could result in damage to the equipment as well as improper cleaning results.

Optional Automatic Wash / Disinfect

5. Remove from washer and dry completely if needed.

CAUTIONS • Alkaline and highly acidic detergents and solutions cause damage to the devices. • Channels and crevices found on these devices require particular attention during cleaning. • Pay special attention to the water quality used throughout reprocessing. Hard water can damage the surface of the equipment. Avoid using hard water. Instead use purified water unless otherwise specified.

6. Inspect equipment to make sure there is no visible organic debris or residue from cleaning agent.

inse with purified water. Do not perform if parameters cannot R be achieved.

Repeat process if any visible soil is detected. The life expectancy of the MAYFIELD products is expected to be as long as 7 years.

Maintenance and Care To ensure proper function and to extend the life and performance of the equipment, Integra LifeSciences recommends the following:

Limitations on Reprocessing • Repeated processing has negative effects on these devices and is not recommended for routine use. • It is important to have Integra NeuroSpecialists perform routine inspections (twice yearly is recommended). • See contact information. INSTRUCTIONS Cleaning - Automated Equipment: Neutral pH Detergent Method 1. P repare equipment for cleaning by disassembling removable parts and loosening connections.

Recommended Action

Recommended Frequency

Return the device to the Integra LifeSciences Repairs department for detailed inspection and servicing.

Once / year

Request that Integra NeuroSpecialists perform routine inspections of the device.

Twice / year

In the absence of proper care and servicing of the device, negative effects may be seen after repeated processing over time which may lead to reduced performance.

2. Rinse equipment in warm water before placing into washer. 3. Load device into the washer and place small parts in container or tray inside the washer unit in order to avoid losing small components. NOTE – Load devices carefully into washer in order to avoid collision.

Contact information: See the Service and Repair section for contact information on how to return your device for periodic servicing and to request periodic inspections.

4. Follow the instructions listed below and set washer machine to these exact parameters:

See Inspection and /or Service notes section for routine checks to be performed on the device.

Phase

Time (Min.)

Water Temperature

Detergent and Concentration

Pre-wash 1