Amadeus Operator Manual V3.3

A MADEUS Microkeratome

4 0120 65RM UL 2601-1 Microkeratome Model MK32 Medical electrical Equipment With respect to electric shock, fire, mechanical hazards only In accordance with CAN/CSA C22.2 No. 601.1

The AMADEUS Microkeratome is designed and built in accordance with the present state of technology and the recognised rules of safety engineering. The AMADEUS Microkeratome, model MK32 adheres to the Class II Medical Device standard (MDD, 93/42/EEC). SGS Yarsley International Certification Services Ltd. UK-Somerset BS22 0WA Certificate Number C50802

and UL 2601-1

Caution Federal (U.S.) law restricts this device to sale by, or on the order of, a physician.

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A MADEUS Microkeratome

Description The A MADEUS Microkeratome is a medical instrument exclusively designed for use in ophthalmic surgery. This Operators' Manual provides important information regarding the use of the A MADEUS Microkeratome. Physicians using the A MADEUS Microkeratome should read the manual thoroughly prior to operating the device. Additional information can be obtained at your local SIS representative.

Unique features of the A MADEUS Microkeratome

• Elegant and simple to use touch screen Control Unit • Single-handed operation • Visual contact whilecreating the flap • Integrated blade loading system • Vacuum level displayed on LCD display • Fully enclosed gearless drive eliminates risk of gear jams • Advanced design to eliminate on-eye assembling of dovetails or gears • One-way assembly to reduce the risk of pre-operative error • Multiple safety checks to ensure consistently smooth, high quality keratectomies

Indications for Use

The A MADEUS Microkeratome is a precision manufactured instrument specifically designed for cutting a precise corneal disc of preselected thickness and diameter. This device is intended for use in performing lamellar corneal resections.

Site Preparation, Unpacking and Installation

Unpacking and installation should be done only after reading this manual thoroughly. Please check all items relating to the device against the packing list (see Components list on page 71 for details). Each item should be inspected and any damage noted and reported within 30 days of reception to the local SIS representative

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A MADEUS Microkeratome

How to use this manual Do not use the A MADEUS Microkeratome without having a thorough understanding of instrument assembly, sterilization procedures, operation and all components, functions, controls and limitations of the instrument. This manual is about using the A MADEUS Microkeratome. It does not give instructions on clinical procedures to do keratoctomies. The manual is divided into 7 chapters: Chapter 1

Components on page 1 gives you an overview on the components of the A MADEUS Microkeratome. It defines the parts and their names.

Chapter 2

Safety instructions on page 11 specify the safety icons used in this manual and include guidelines concerning appropriate handling of the instrument. Read this chapter very carefully.

Chapter 3

Procedure on page 15 instructs you how to assemble, set up and use the instrument for surgery. Cleaning is also covered.

Chapter 4

Control Unit description on page 37 details the user interface (display, messages etc.) and how to set parameters.

Chapter 5

Care and maintenance on page 47 provides instructions concerning the backup battery, software update etc.

Chapter 6

Trouble shooting on page 55 gives instructions to cope with general trouble and how to interpret the messages on the display.

Chapter 7

The Appendix on page 71 provides the functional specifications, the component list, a short glossary, the symbols used on the instrument and the warranty information.

Typographical conventions

Italic style

is used for highlighting references to other locations in this document.

This font

names items of the user interface on the touch screen (window headings, buttons etc.)

S MALL CAPS

Samll caps are used for branded names such as A MADEUS Microkeratome.

Component Name Components of the product are capitalized to distinguish them from ordinary words.

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A MADEUS Microkeratome

Contents Description... iv How to use this manual... v

Chapter 1:

Components... 1 Control Unit... 2 Handpiece... 3 Suction Unit... 4 Blade Holder... 5 Motor Unit... 6

Control Pedals... 7 Accessories... 8 Disposable accessories... 10

Chapter 2:

Safety instructions... 11 Notes on safety and icons... 11 Defined purpose of AMADEUS Microkeratome... 11

Basic safety information... 12 Operational considerations... 12 Operational user qualification... 12 Single-use disposable accessories... 12 Power failure and vacuum... 13 Handling... 13 Cleaning... 14 Maintenance... 14

Chapter 3:

Procedure... 15 Primary decisions... 15

Assembly of AMADEUS system... 16 Inserting the SUREPASS sterilized blade... 19

Handpiece assembly... 21 Fasten Blade Holder to Motor Unit... 21 Apply the Suction Unit... 22 Connect the vacuum tube... 24

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A MADEUS Microkeratome Surgery... 25 Check operation parameters... 26 Surgery procedure... 27

Dismantling... 29 Dismantling the Handpiece... 29 Prepare for storage... 29

Cleaning... 30 Cleaning mechanical and electric components... 31 Cleaning the Suction Unit... 32 Cleaning the Blade Holder... 33 Disinfecting electrical components... 34 Sterilization... 35

Chapter 4:

Control Unit description... 37 Operator-machine interface... 37 Appearance of the display... 37 Acoustic signals... 38 Status messages... 38 Define numeric values... 38 Select from predefined values... 39 Confirmation and withdrawal... 39 Values not permitted... 39 Use of the Pedals (foot switches)... 40

Customizing... 41 General cutting parameters... 43 Zero Position Stop... 43 Suction OFF... 43

System Information... 44 Self tests... 45

Chapter 5:

Care and maintenance... 47 Master reset... 47 Remove and restore back plate... 48 Maintain the battery... 49 Replacing fuse... 52 Software update... 52

Chapter 6:

Trouble shooting... 55 Displayed messages... 56 General trouble... 58 Motor Unit separated... 60

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A MADEUS Microkeratome De-blocking Handpiece... 62

Messages... 63

Chapter 7:

Appendix... 71 Components list... 71 Required disposable accessories and options... 71

Technical specifications... 72 Glossary... 74 Symbols on the instrument... 74

Warranty information... 75

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A MADEUS Microkeratome

Components

Components The complete A MADEUS Microkeratome system consists of these major items: • Control Unit integrating a control computer, a touch screen, backup battery and backup vessel for the vacuum. • Handpiece with Blade Holder and the Suction Unit placed on the eye, and the Motor driving the Blade of the microkeratome. • Pedals to control the operation alternatively to touching the screen. • Vacuum tubing and blades are single-use accessories

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A MADEUS Microkeratome

Components

Control Unit The Control Unit comprises an integrated computer system, which stores cutting parameters, controls activation of the microkeratome motors, provides audible and visual signals for safeguard monitoring of the surgery, and provides a measurement and regulation of the vacuum. The Control Unit includes power supply with back up battery, vacuum pump and vacuum backup vessel, a computer driven controller with a touch screen interface. Fig. 1: Front view 1 2 3 4 5

Display with touch screen Connector for Handpiece Mount for Handpiece Connector for vacuum tubing Connector for Pedals

3 1

4

5

2

Fig. 2: Rear view 1 2 3 4 5

Mains switch Mains input plug Rear connector for Pedals Name plate Fuse box

5 4

1 2

3

2

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A MADEUS Microkeratome

Components

Handpiece The Handpiece creates the keratectomy: The Motor Unit (1) moves the Blade Holder (5) across the Suction ring (7) of the Suction Unit. The Motor Unit also oscillates the Blade (6) within the Blade Holder (5). Motor Unit (1) and Suction Unit (3) are held together by the locking pins of the Tappet (4).

Fig. 3: Handpiece in exploded view 1 2 3 4 5 6 7

2 4

Motor Unit Connection cable Suction Unit ‘locks’ into Motor Unit Tappet with locking pins Blade Holder Blade (to be inserted) with plastic pieces for handling Suction ring

1 3

7

5 6

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A MADEUS Microkeratome

Components

Suction Unit The Suction ring (1) comprises two concentric axially displaced conical surfaces with recess. When applied to the eye the Suction ring forms a vacuum chamber. The Suction ring is connected to the Control Unit via disposable silicone tubing at (2). Fig. 4: Suction Unit 1 2 3 4

Suction ring Vacuum connection Tappet ‘locks’ Suction Unit to Motor Unit and releases tension on power cable Indication of flap diameter (stamp): 8.5 mm or 9.5 mm

3

4 2 4

1

Fig. 5: Suction ring 1 2

Tracks for Blade Holder Indication of flap diameter (engraved) 8.5 mm or 9.5 mm

1

4

2

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A MADEUS Microkeratome

Components

Blade Holder The Blade Holder houses the disposable S URE P ASS cutting blade and is placed in a linear guiding rail that moves across the cornea. The cutting action is not gear-driven, thus providing smooth blade movement across the cornea and less wear and tear on the Handpiece. Absence of gears also eliminates the potential of engagement of foreign materials in the gears that can cause cutting complications or deposit foreign materials on the cornea. The Blade Holder comprises an applanation plate (4) that controls the depth of the cut. The blade oscillates in the direction of the cutting edge; parallel to the level of the applanation plate that can offer various flap thicknesses depending on the Blade Holder selected. Fig. 6: Blade Holder 1 2 3 4 5 6 7 8

2

Entry for motor shaft Head face Spring loaded buttons (on both sides) Applanation plate Slit to insert blade Railings fitting into the tracks of the Suction Unit Slit opening (where the blade acts) Indication of flap thickness (here: 180 micron)

8 1

5 3

4

6

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A MADEUS Microkeratome

Components

Motor Unit Two separate motors provide independent movement of the cutting blade. One motor controls forward and reverse movement of the blade across the cornea while the second motor oscillates the blade. The cable that connects the motors to the Control Unit is highly flexible to avoid force on the Handpiece during cutting action. Fig. 7: Motor Unit 1 2 3

Rails for fixation in Mount at the Control Unit Shaft of oscillation motor Stepper motor link for advancing and retreating the Blade

1

3 2 If the stepper motor link (3) is not in its initial position as shown here, the Motor Unit can not be assembled with the Suction Unit.

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A MADEUS Microkeratome

Components

Control Pedals The two Pedals provide the principle command control for activation and termination of the microkeratome cutting procedure. In the event of malfunction, the touch screen serves as the backup control interface. The activation Pedal (green) initiates vacuum and microkeratome cutting action. The ‘break’ Pedal (red) stops the blade action immediately. The Pedals allow the surgeon to proceed or terminate the microkeratome operation as condition allow. This is indicated on the display. Fig. 8: Pedals (foot switches) 1 2 3 4

3 4

Left Pedal (red) Right Pedal (green) Fixed connection between the Pedals Connection cable to the Control Unit

1 2

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A MADEUS Microkeratome

Components

Accessories Fig. 9: Equipment storage and carrying case 1 2 3 4 5 6 7

Inset for manual (not on picture) Inset for Motor Unit with cable. Pedals Sterilization box Handpiece Mount Mains cable Control Unit

2

5 7

3 6 4

" When storing the Pedals do not excessively bend the cables.

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A MADEUS Microkeratome

Components

Fig. 10: Sterilization and Storage box for two Suction Units and two Blade Holders.

! Standard equipment

Standard equipment comprises only one Suction Unit and one Blade Holder.

Fig. 11: Blade remover

Use the Blade Remover to push the used blade out of the Blade Holder.

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A MADEUS Microkeratome

Components

Disposable accessories Fig. 12: SUREP ASS disposable single-use blade (Box of 10)

Fig. 13: Sterile vacuum tube - unpacked (Box of 10) 1 2 3

3

Reservoir with Velcro (to be attacheched to Control Unit) Connector to Control Unit Tube to be connected to Handpiece

2

1

10

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A MADEUS Microkeratome

Safety instructions

Safety instructions Notes on safety and icons Throughout this manual icons are used to alert the reader of special situations. The following symbols are defined: Symbol

Name and significance

#

Warning A warning indicates an action or procedure which, if not performed correctly, can result in injury or a safety hazard. Comply strictly with the instructions and proceed with care.

"

Caution A caution indicates an action or procedure which, if not performed correctly, can result in incorrect operation or destruction of the device. Comply strictly with the instructions. Note A note indicates an action or procedure which, if not performed correctly, can have an indirect effect on operation or trigger an unexpected response on the part of the instrument. The word ‘Note’ may be replaced by a meaningful title.

!

Defined purpose of A MADEUS Microkeratome The A MADEUS Microkeratome is a precision manufactured instrument specifically designed for cutting a precise corneal disc of preselected thickness and diameter. This instrument is intended for use in performing lamellar corneal resections.

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A MADEUS Microkeratome

Safety instructions

Basic safety information Operational considerations The Operators' Manual serves only to provide the operator and medical assistants with general operating instructions and areas where special attention is required to avoid instrument damage or patient injury. Surgical procedures are recommendations only

References and information concerning the surgical procedure found in this manual is intended to serve as recommendations or guidelines only. The attending physician and/or operator must decide which surgical techniques are to be followed. The manufacturer cannot be held responsible or liable for the techniques chosen and used during the surgery. If there are questions, unclear points or uncertainty remaining after reading this Operators' Manual, then the A MADEUS Microkeratome should not be used. In this case, please consult your SIS representative.

Operational user qualification The A MADEUS Microkeratome is intended solely for use by qualified physicians that have been trained in the operation of Microkeratomes. Any person who has not been trained must not use the A MADEUS Microkeratome. A trained SIS specialist or and SIS certified representative will provide on site training for all A MADEUS Microkeratome installations. All ophthalmologists using the Microkeratome must be trained in the safe use of the instrument and in the performance of lamellar corneal resections.

Single-use disposable accessories Operate only with S URE P ASS blades

The A MADEUS Microkeratome can be operated only with the S URE P ASS single-use, disposable blade. Reusing blades or use of other manufacturers' accessories could result in injury to the cornea or in damage to the instrument.

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A MADEUS Microkeratome

Safety instructions

Dispose according to local rules

Follow local governing ordinances and recycling plans regarding disposable instrument components.

Power failure and vacuum If power fails during surgery, the vacuum is held by the internal reservoir. Power for the motors is held by the backup battery. To remove the vacuum from the Handpiece, disconnect the vacuum tube manually from the Control Unit by pressing on the clip on the outlet.

" Caution

Do not disconnect the vacuum tube at the Handpiece. This would need much force and hence be very uncomfortable for the patient.

Handling The A MADEUS Microkeratome is a precision instrument. The Blade Holder should always be laid on a soft underlay. The instrument may be damaged if not handled properly. Unauthorized use

When not in use, the A MADEUS Microkeratome should be kept in a secure location to prevent use by unauthorized personnel. It is recommended to store and lock the instrument in the original carrying case.

Electric safety

Do not operate the instrument with a defective mains cable, defective plug or outlet. Electric shock may be the result of not observing this rule. Regardless whether the Suction Unit is locked with the Motor Unit, do not pull the cable too tight, even when cleaning. Always handle the Handpiece with care.

Do not use in wet environment

The A MADEUS Microkeratome must not be employed in a wet environment or used in contact with liquids. Disregarding this warning may result in electric shock.

Lock Handpiece only if it is connected to the (powered on) Control Unit

Never lock the Handpiece with the Tappet if the Handpiece is not connected to the Control Unit. This risks damaging the internal electronics.

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