Avedro KXL System Manual de usuario

KXL Operator’s Manual Rev A

ML-00040

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Avedro, Inc.

KXL System

Operator’s Manual

Printed in U.S.A.

KXL Operator’s Manual Rev A

ML-00040

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Patents, Trademarks, Copyrights

The KXL System may be covered by one or more patent applications issued or

pending in the United States and worldwide.

“KXL” and the Avedro logo design are registered trademarks or trademarks of

Avedro, Inc. All software and documentation is subject to Avedro, Inc. copyrights.

Microsoft and Windows are registered trademarks and trademarks, respectively,

of Microsoft Corporation. Any other trademarks or service marks contained

within this manual are the property of their respective owners.

For more information, contact: Your Local Avedro-authorized distributor

Avedro, Inc.

201 Jones Road

Waltham, MA 02451

EMERGO EUROPE

Prinsessegracht 20

2514 AP, The Hague

The Netherlands

Phone: +31.70.345.8570

Fax: +31.70.346.7299

0086

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Table of Contents

1Foreword........................................................................................................7

1.1 Intended Use of Manual............................................................................7

1.2 Intended Use / Indications for Use............................................................7

1.3 Design Change Disclaimer........................................................................7

1.4 Reproduction Disclaimer...................................................................................7

1.5 User Operation Assistance Statement................................................................7

1.6 Contraindications, Warnings and Cautions........................................................8

1.6.1 Contraindications ...................................................................................8

1.6.2 Warnings ................................................................................................8

1.6.3 Electrical Safety Warnings.....................................................................8

1.7 Radiation Safety Warnings ..............................................................................10

1.8 Patient Safety...................................................................................................11

1.9 Additional Safety Considerations....................................................................11

1.10 FCC Compliance Notice..................................................................................11

2Introduction.................................................................................................13

2.1 System Overview.............................................................................................13

2.1.1 Major Components...............................................................................14

3System Operation........................................................................................16

3.1 Touchpad/Keyboard Use .................................................................................16

3.2 UV Energy (Dose) ...........................................................................................19

3.3 Preparing the System .......................................................................................19

3.4 Important Steps before Turning on the System ...............................................20

3.5 Powering Up the System..................................................................................20

3.6 Existing Patient Data........................................................................................21

3.7 Add New Patient..............................................................................................21

3.8 Create New Treatment Plan.............................................................................22

3.8.1 Select Eye to Treat ...............................................................................23

3.8.2 Select Treatment Type .........................................................................23

3.8.3 Adjusting Treatment Parameters..........................................................24

3.9 Select Treatment Mode....................................................................................26

3.9.1 Continuous UV Mode ..........................................................................26

3.9.2 Pulsed UV Mode..................................................................................28

3.10 Starting a Treatment.........................................................................................28

3.10.1 Insert Treatment / RFID Activation Card ..........................................28

3.10.2 Single-use Activation Cards...............................................................29

3.10.3 Multi-use Activation Cards................................................................30

3.10.4 RFID card controlled limits................................................................32

3.10.5 Sync Alignment Remote ....................................................................33

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3.11 Preparing the Patient........................................................................................35

3.11.1 Applying Riboflavin...........................................................................36

3.12 Initiating Treatment .........................................................................................38

3.13 Monitoring Treatment......................................................................................39

3.14 Pausing a Treatment.........................................................................................40

3.15 Cancelling Mid Treatment...............................................................................41

3.16 Capturing Images.............................................................................................43

3.17 Treatment Complete.........................................................................................44

3.18 Reviewing Images............................................................................................45

3.19 Deleting Photos................................................................................................45

3.20 Patient Treatment Report.................................................................................48

3.20.1 Adding Notes to a Patient Treatment Report.....................................49

3.20.2 Exporting Treatment Report...............................................................50

3.20.3 Viewing a Treatment Report..............................................................53

3.21 Powering Down the System.............................................................................57

3.22 Using the System Settings Menu.....................................................................59

3.22.1 Service Settings..................................................................................60

3.22.2 Editing System Language...................................................................60

3.22.3 Editing Alignment Crosshairs Intensity.............................................60

3.22.4 Editing System Volume .....................................................................61

3.22.5 Export Service Log.............................................................................62

3.22.6 Editing Beep Intervals........................................................................63

3.22.7 Editing Camera White Balance..........................................................64

4Maintenance / Service.................................................................................66

4.1 Installation Policy ............................................................................................66

4.2 Customer Maintenance ....................................................................................66

4.3 Warranty Information ......................................................................................66

4.4 Service Contract Information...........................................................................66

4.5 Per Patient Disposables....................................................................................66

4.6 Trouble Shooting .............................................................................................67

4.7 Directions for Sterilization or Disinfection......................................................68

4.8 Cleaning the System ........................................................................................68

4.9 Cleaning the Aperture......................................................................................68

4.10 Articulating Arm Adjustment..........................................................................68

4.11 Moving the System..........................................................................................68

4.12 Storing the System...........................................................................................69

4.13 Software...........................................................................................................69

4.14 Identifying Risks Associated with Disposing of Waste Products....................70

4.15 Performing a Visible Check.............................................................................70

5Equipment Classification ...........................................................................71

6Symbol Library...........................................................................................72

7Specifications...............................................................................................74

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Table of Figures

Figure 2-1 Overview Illustration of System ............................................................................................ 14

Figure 2-2 System Illustrations with Callouts.......................................................................................... 15

Figure 2-3 Wireless Remote ................................................................................................................... 15

Figure 3-1 Power Switch......................................................................................................................... 20

Figure 3-2 Patient Database ................................................................................................................... 21

Figure 3-3 Enter Patient Information...................................................................................................... 22

Figure 3-4 Create New Treatment Plan .................................................................................................. 22

Figure 3-5 Select Eye .............................................................................................................................. 23

Figure 3-6 Select Treatment Type........................................................................................................... 24

Figure 3-7 Adjusting Parameters ............................................................................................................ 25

Figure 3-8 Adjusted Treatment Plan....................................................................................................... 26

Figure 3-9 Select Continuous Treatment Mode ...................................................................................... 27

Figure 3-10 Modifying Continuous Treatment Parameters..................................................................... 28

Figure 3-11 Insert Activation Card.......................................................................................................... 29

Figure 3-12 Reading Tag ......................................................................................................................... 30

Figure 3-13 Card Balance: Treatments Remaining .................................................................................. 30

Figure 3-14 Card Balance: 1 Treatment Remaining................................................................................. 31

Figure 3-15 No Treatments Left.............................................................................................................. 31

Figure 3-16 Invalid Treatment Parameters............................................................................................. 32

Figure 3-17 Invalid Treatment Parameters............................................................................................. 33

Figure 3-18 Sync Remote........................................................................................................................ 33

Figure 3-19 Sync process timed out........................................................................................................ 34

Figure 3-20 System Setup Status ............................................................................................................ 35

Figure 3-21 Prepare Treatment: Apply Riboflavin .................................................................................. 36

Figure 3-22 Align Crosshairs during induction ........................................................................................ 37

Figure 3-23 Remote Functions................................................................................................................ 38

Figure 3-24. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment .............................................. 38

Figure 3-25 Start UV Treatment ............................................................................................................. 39

Figure 3-26 Treatment in Progress Screen.............................................................................................. 40

Figure 3-27 Treatment Paused Screen.................................................................................................... 41

Figure 3-28 Confirm Cancel Partial Treatment........................................................................................ 42

Figure 3-29 Treatment Cancelled Confirmation...................................................................................... 42

Figure 3-30 Partial Treatment Not Completed ....................................................................................... 43

Figure 3-31 Capturing Images................................................................................................................. 44

Figure 3-32 Treatment Complete Screen................................................................................................ 45

Figure 3-33 Select Trash to delete .......................................................................................................... 46

Figure 3-34 Select Yes to Delete ............................................................................................................. 47

Figure 3-35 Select Done ......................................................................................................................... 47

Figure 3-36 Sample Treatment Report ................................................................................................... 48

Figure 3-37 Comments Icon.................................................................................................................... 49

Figure 3-38 Comments Section............................................................................................................... 49

Figure 3-39 Exporting Treatment Report................................................................................................ 50

Figure 3-40 Insert USB............................................................................................................................ 51

Figure 3-41 USB Error............................................................................................................................. 51

Figure 3-42 No space left on USB ........................................................................................................... 52

Figure 3-43 Generating treatment report............................................................................................... 52

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Figure 3-44 Treatment report exported ................................................................................................. 53

Figure 3-45 Page 1 of 3: Treatment Details............................................................................................. 54

Figure 3-46 Page 2 of 3: Comments........................................................................................................ 55

Figure 3-47 Page 3 of 3: Photos .............................................................................................................. 56

Figure 3-48 Power Off ............................................................................................................................ 57

Figure 3-49 Power Off ............................................................................................................................ 58

Figure 3-50 Power Off Position .............................................................................................................. 58

Figure 3-51 Press Options button........................................................................................................... 59

Figure 3-52 System Settings Menu ......................................................................................................... 60

Figure 3-53 Edit System Language.......................................................................................................... 60

Figure 3-54 Alignment Crosshairs Intensity ............................................................................................ 61

Figure 3-55 Edit Volume......................................................................................................................... 62

Figure 3-56 Export Service log to USB..................................................................................................... 62

Figure 3-57 Export Service log in Progress.............................................................................................. 63

Figure 3-58 Select Beep Intervals ........................................................................................................... 64

Figure 3-59. Edit Camera White Balance ................................................................................................ 65

Figure 4-1 Alignment Remote Lost Sync ................................................................................................. 67

Figure 4-2 Moving System Configuration ............................................................................................... 69

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1Foreword

1.1 Intended Use of Manual

This manual is designed to serve the operators of the Avedro, Inc. KXL System. All

operating instructions, product illustrations, screen graphics, troubleshooting/error

messages, and other relevant information are contained in this manual. It is the operator’s

responsibility to ensure that all safety instructions in this manual are applied strictly.

1.2 Intended Use / Indications for Use

The KXL System delivers a uniform, metered dose of UVA light to a targeted treatment

area for the intended use of illuminating the cornea during corneal cross-linking procedures

stabilizing cornea which have been weakened by disease or by refractive surgery.

1.3 Design Change Disclaimer

•Due to design changes and product improvements, information in this manual is

subject to change without notice. Avedro, Inc. (hereafter called “Avedro”)

reserves the right to change product design at any time without notice, which

may subsequently affect the contents of this manual.

•Avedro assumes no responsibility for any errors that may appear in this manual.

Avedro will make every reasonable effort to ensure that this manual is up to date

and corresponds with the shipped KXL System.

•The computer display screens depicted in this manual are representative only.

Depending on the software version of the system, minor differences may appear

between the actual computer displays and those shown in this manual.

•All patient data appearing in this document, including the sample screen

graphics, are fictitious and representative only. No patient’s confidentiality has

been violated, with or without permission.

1.4 Reproduction Disclaimer

Neither this manual nor any part of it may be reproduced, photocopied, or electronically

transmitted in any way without the advanced written permission of Avedro, Inc.

1.5 User Operation Assistance Statement

Should you experience any difficulty in running your KXL System, please contact your

local Avedro authorized representative.

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1.6 Contraindications, Warnings and Cautions

1.6.1 Contraindications

This section describes situations in which the device should not be used because the risk of

use clearly outweighs any possible benefit. Conditions that may contraindicate the use of

the device include:

•Corneal thickness, with epithelium, of less than < 375 microns.

•Corneal melting disorders

•Aphakic patients

•Pseudophakic patients without UV blocking lens implanted

•Pregnant and nursing women

•Children

1.6.2 Warnings

Physicians should evaluate the potential benefits in patients with the following conditions:

•Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal dystrophy

•Epithelial healing disorders

•In this manual, Caution is defined as: a statement that alerts the user to the

possibility of a problem with the device associated with its use or misuse. Such

problems include device malfunction, device failure, damage to the device or

damage to other property. The caution statement includes the precaution that

should be taken to avoid the hazard.

•In this manual, Warning is defined as: a statement that alerts the user to the

possibility of injury, death, or other serious adverse reactions associated with the

use or misuse of the device.

1.6.3 Electrical Safety Warnings

•This equipment requires special precautions regarding electromagnetic compatibility

(EMC). Installation and use should be carried out according to the EMC information

provided in this manual.

•Portable and mobile RF communications equipment can affect medical electrical

equipment such as the Avedro KXL System.

For Equipment Classifications please refer to chapter 5.0 Equipment Classifications

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WARNING: To avoid the risk of shock this equipment must only be

connected to a supply mains with protective earth.

The system is designed for continuous operation using the external

connector.

WARNING: This equipment is operated with hazardous voltages that can

shock, burn, or cause death. To reduce the possibility of electrical shock,

and inadvertent UVA exposure do not remove any fixed panels. Ensure

that all service to the system, beyond what is described in this manual, is

performed only by qualified Avedro service personnel.

WARNING: Power down system and remove the wall plug before servicing

or cleaning (disinfecting) the equipment.

Never pull cords to remove the power cord from the outlet. Grasp the

power cord plug and pull it from the outlet to disconnect.

The equipment must be positioned so that it is not difficult to remove the

power cord from the outlet.

WARNING: Do not operate the equipment with a damaged power cord.

WARNING: Position the power cord so that it cannot be tripped over,

walked on, rolled over, crimped, bent, pinched, or accidentally pulled from

the wall outlet.

WARNING: Do not use the instrument near water and be careful not to

spill liquids on any part of it.

WARNING: Do not operate the KXL System in the presence of flammable

mixtures or anesthetics.

WARNING: Never look directly into the UV light beam. Never direct the

beam towards a person except for therapeutic purposes.

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WARNING: The remote contains replaceable batteries; if system is not

going to be used for an extended period of time remove the batteries.

WARNING: No modification of this equipment is allowed.

WARNING: Use of not included accessories results in non-compliance of

the device

WARNING: System may be interfered with by other equipment even if that

equipment complies with CISPR Emissions requirements. See Table 5-1.

WARNING: System shall not be serviced or maintained while in use with a

Patient.

WARNING: MR Unsafe – Keep away from magnetic resonance imaging

equipment.

1.7 Radiation Safety Warnings

WARNING: Use only laser grade instruments in order to prevent reflected

UV radiation from smooth metallic surfaces.

WARNING: Do not use a damaged or malfunctioning device. Use of such

devices may harm the user and/or patient

WARNING: UV emitted from this product. Avoid eye and skin exposure to

unshielded products. Never direct the beam towards a person except for

therapeutic purposes.

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