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Avedro KXL System Скачать руководство пользователя страница 8

Chapter 1: Forward

KXL System Operator’s Manual,
Rev G
1-2

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.

Prior corneal surgery

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

1.6.3

Electrical Safety Warnings

For Equipment Classifications please refer to chapter 5.0 Equipment Classifications

WARNING: To avoid the risk of shock this equipment must only be
connected to a supply mains with protective earth.

Even with power cord removed there is the potential for an electrical shock
from the 12VDC internal power source.

The system is designed for continuous operation using the external
connector or its internal rechargeable battery.

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,
including to the rechargeable battery, is performed only by qualified
Avedro service personnel.

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Содержание KXL System

Страница 1: ...Avedro Inc KXL System Operator s Manual ML 00002 Revision G Copyright 2012 All Rights Reserved Printed in U S A...

Страница 2: ...rights All rights reserved 2012 Microsoft and Windows are registered trademarks and trademarks respectively of Microsoft Corporation Any other trademarks or service marks contained within this manual...

Страница 3: ...Charging the KXL Battery 3 1 3 2 Touchpad Keyboard Use 3 1 3 3 UV Dose 3 3 3 4 Preparing the System 3 3 3 5 Important Steps before Turning on the System 3 3 3 6 Powering Up the System 3 3 3 7 Setting...

Страница 4: ...ections for Sterilization or Disinfection 4 3 4 8 Cleaning the System 4 3 4 9 Cleaning the Aperture 4 3 4 10 Articulating Arm Adjustment 4 3 4 11 Performing Periodic Maintenance 4 4 4 12 Moving the Sy...

Страница 5: ...maining 3 8 Figure 3 10 System Setup Status 3 9 Figure 3 11 Prepare Patient Screen 3 10 Figure 3 12 Align Crosshairs during induction 3 11 Figure 3 13 Induction Complete 3 11 Figure 3 14 Treatment Scr...

Страница 6: ...KXL System Operator s Manual Rev G vi This page is left blank intentionally...

Страница 7: ...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 A...

Страница 8: ...ent corneal erosion corneal dystrophy Epithelial healing disorders 1 6 3 Electrical Safety Warnings For Equipment Classifications please refer to chapter 5 0 Equipment Classifications WARNING To avoid...

Страница 9: ...to the USB during treatment 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...

Страница 10: ...erates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications However there is no gu...

Страница 11: ...oximate diameter of 9 mm Alignment lasers are used to aid the user in focusing the beam on the patient s cornea Fine alignment of the UV beam through observation of the alignment lasers is controlled...

Страница 12: ...he major components of the KXL System include the following Optics Head with UV source KXL console with user interface Wireless remote control with replaceable batteries KXL Accelerated Crosslinking T...

Страница 13: ...Chapter 2 Introduction KXL System Operator s Manual Rev G 2 3 Figure 2 2 System Illustrations with Callouts Figure 2 3 Wireless Remote...

Страница 14: ...Chapter 2 Introduction KXL System Operator s Manual Rev G 2 4 Figure 2 4 KXL Label Figure 2 5 UV emitting Label Figure 2 6 Laser Classification Label...

Страница 15: ...dro Service Representative NOTE the battery pack on the system should last for 16 hours during normal operation The software system will notify the user when the battery needs to be charged The KXL is...

Страница 16: ...k button various Clinical Protocol screens and Device Settings screen Directs the system to accept the current screen entries and to proceed to the next step Cancel Session button various Clinical Pro...

Страница 17: ...ers to secure the device s position Make sure the system is turned ON Check glass window of beam aperture for dust and dirt See sections 4 8 and 4 9 for cleaning instructions 3 5 Important Steps befor...

Страница 18: ...rvice immediately 3 7 Setting Treatment Settings To begin patient treatment press the Start New Treatment button Specify the desired induction period 1 30 min for the patient When finished entering pa...

Страница 19: ...3 45 mW cm2 NOTE Total Energy will be displayed in the lower orange box The maximum permissible total Energy density is 10 J cm2 When finished entering treatment parameters press the Checkmark button...

Страница 20: ...stem Operator s Manual Rev G 3 6 3 8 Starting Treatment Place the disposable kit which is unique for each patient or an activation card on the RFID reader and hold in place until the system emits a be...

Страница 21: ...disposables Figure 3 6 Reading Tag Screen Hold until read is complete and discard tag or activation card 3 8 2 Multi use disposables Once a multi use activation card has been scanned the display will...

Страница 22: ...Chapter 3 System Operation KXL System Operator s Manual Rev G 3 8 Figure 3 8 Final Treatment Figure 3 9 No Treatments Remaining...

Страница 23: ...within the 15 second window displayed on the screen This is required for every procedure NOTE If the light on the remote is flashing two times per second the remote s batteries need to be changed If...

Страница 24: ...ent without head movement Apply a lid speculum and optional drapes using standard clinical technique Apply Riboflavin to the area of treatment in accordance with the Riboflavin Instructions for Use IF...

Страница 25: ...alignment as needed using the wireless remote 3 10 Initiating Treatment When the Induction Time is complete the Begin UV Treatment button will appear Press the Begin UV Treatment button to initiate tr...

Страница 26: ...nt has to fixate on the center of the light beam aperture throughout the treatment Patients should remain still during the treatment 3 12 Stopping a Treatment The treatment stops automatically after t...

Страница 27: ...16 Treatment Complete Screen To exit treatment and or start a new treatment press Start New Treatment If treatments are complete Power OFF the system using the Power Off button on the Main Screen Car...

Страница 28: ...sion is canceled screen displays with Confirm Cancel Session Figure 3 17 Initial Confirm Cancel Session Screen To cancel session press Cancel Session If the session is Paused the screen displays Confi...

Страница 29: ...Chapter 3 System Operation KXL System Operator s Manual Rev G 3 15 The screen displays Partial Treatment Information Figure 3 19 Partial Treatment Information...

Страница 30: ...m Operator s Manual Rev G 3 16 3 15 Powering Down the System It is recommended that the KXL System be plugged into an electrical outlet when not in use or when stored Press the Power Off on the touch...

Страница 31: ...peration KXL System Operator s Manual Rev G 3 17 Turn the system power switch to the Off position Plug the KXL System in to an electrical outlet until next use Figure 3 21 Power Off Position Figure 3...

Страница 32: ...alization screen New Patient Start displayed press and hold the KXL on the touch screen Figure 3 23 Device Settings Menu 3 16 1 Advanced Settings Advanced Settings are only available to Avedro and Ser...

Страница 33: ...of the alignment crosshairs Select the Edit Alignment Crosshairs Intensity button on the Device Settings menu Figure 3 24 Edit Alignment Crosshairs Intensity 3 16 3 Editing System Volume The Edit Vol...

Страница 34: ...atment Select the Copy Treatment Data to USB button on the Device Settings menu Figure 3 26 Device Settings Transfer to USB Insert a USB device to a USB port and then press the Copy treatment data to...

Страница 35: ...Editing Default Treatment Parameters Screen The Edit Default Treatment Parameters option allows a user to set the default treatment parameters that are displayed on entry to the Set Induction Time an...

Страница 36: ...Chapter 3 System Operation KXL System Operator s Manual Rev G 3 22 This page is left blank intentionally...

Страница 37: ...ormal operation should be performed by or with the guidance of an Avedro authorized distributor 4 2 Customer Maintenance In general there is no customer maintenance required for The KXL System All tec...

Страница 38: ...e o If light on the remote is flashing two times per second the remote s batteries need to be changed If the light on the remote is flashing once per second then it is not synchronized o If the remote...

Страница 39: ...0 alcohol or 10 chlorine bleach solution can also be used if necessary DO NOT submerse the system in liquid or pour liquid onto the system CAUTION Remove the power supply cord from the main outlet and...

Страница 40: ...l the components and the main power supply as well Disconnect the power cord physically from its electrical outlet Remove the batteries from the wireless remote Cover the touch screen LCD display and...

Страница 41: ...Common Devices IP20 No protection against ingress of water o Method of sterilization or disinfection Disinfect able device o Degree of protection for use in the presence of a flammable as aesthetic m...

Страница 42: ...Chapter 5 Equipment Classification KXL System Operator s Manual Rev G 5 2 This page is left intentionally blank...

Страница 43: ...ttention Consult ACCOMPANYING DOCUMENTS 4 Ground symbol in circle Protected earth ground 5 Power Switch ON 6 Power Switch OFF 7 Fuse symbol Fuse 8 CE Mark Conformity mark 9 Manufacturer Name and addre...

Страница 44: ...tion Definition 13 Wine glass with crack on it or Contents are fragile handle with care 14 Two up arrows Keep arrows on carton pointing up 15 Water drop in a box Humidity limits percentages below symb...

Страница 45: ...60 x 60 x 150 cm3 Length x Width x Height Weight crated system NW 45 Kg GW 120 Kg Battery Life normal operating conditions 16 hours Environmental Operating Conditions The system operates under the fo...

Страница 46: ...This page is left intentionally blank...

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