SCHWIND Sirius Anleitung zur Verwendung
Short Manual “Calibration”
Original Instruction
Copyright © 2015-2019 SCHWIND eye-tech-solutions All rights reserved
Scheimpflug Analyzer
Distributed by SCHWIND eye-tech-solutions GmbH
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SCHWIND eye-tech-solutions GmbH Mainparkstrasse 6-10 63801 Kleinostheim Germany
Short Manual “Calibration” 3.7.01
General Information
Page 2 of 8
Table of Contents
1GENERAL INFORMATION..................................................................... 3
1.1 Device Identification Data ....................................................................................3
1.2 Symbols for Warnings, Precautionary Measures and Notes .......................................4
1.3 Notes on the Short Manual, Purpose and Scope ......................................................4
1.4 Intended Use of the SCHWIND SIRIUS...................................................................4
2CALIBRATION .................................................................................... 5
2.1 When to Calibrate? .............................................................................................5
2.2 How to Calibrate? ...............................................................................................5
Current document status: Version 3.7.0 dated 2019-06-26
Short Manual “Calibration” 3.7.01
General Information
Version 3.7.0 / 2019-06-26 Page 3 of 8
1GENERAL INFORMATION
1.1 Device Identification Data
Product name: SCHWIND SIRIUS
Product description: System combination consisting of a lifting table with Panel PC
(Workstation) and a diagnostic device SCHWIND SIRIUS (rotating
Scheimpflug camera and a Placido disc topographer).
Application: Topography measurements:
Anterior corneal surface
Corneal Wavefront
Keratoconus Screening
Pupillometry, Link to Static Cyclotorsion Control (SCC),
Data export to AMARIS laser systems, IOL Calculation Function,
Tear Analysis, CL Fitting tool, Print function via WLAN
Software version: Phoenix 3.7.01 and higher
Medical Device Class: Im (SCHWIND SIRIUS)
I (SCHWIND WORKSTATION)
CE labelling of the
manufacturer: 0051 (C.S.O Srl) (SIRIUS)
(SCHWIND WORKSTATION)
Approved device
combination:
Only products specified by SCHWIND eye-tech-solutions acc. to
Declaration of Conformity EWG 12 for system combination:
Combi / Single Workstation
SCHWIND PERAMIS
Corneal Wavefront Analyzer (OPTIKON Keratron Scout)
SCHWIND CAM
Manufacturer: SCHWIND SIRIUS
C.S.O. Srl – Costruzione Strumenti Oftalmici
Via degli Stagnacci 12/E – 50010 Badia a Settimo, Florenz
www.csophthalmic.com
SCHWIND WORKSTATION
SCHWIND eye-tech-solutions GmbH
Mainparkstrasse 6-10
63801 Kleinostheim, Germany
System intergration and delivery: SCHWIND eye-tech-solutions GmbH or authorized distributor
Short Manual “Calibration” 3.7.01
General Information
Version 3.7.0 / 2019-06-26 Page 4 of 8
1.2 Symbols for Warnings, Precautionary Measures and Notes
The following conventions are used in this manual:
IMPORTANT NOTE
This symbol provides the user with useful or additional information.
CAUTION!
The symbol informs the user that particular care is required for safe and efficient
operation of the system.
1.3 Notes on the Short Manual, Purpose and Scope
This Short Manual contains the procedure of the Calibration for the SCHWIND SIRIUS.
The purpose of the user manual is to familiarize operator(s) of the SCHWIND SIRIUS with the topic
mentioned above.
This document addresses users, operators, clinic’s technical servicing people.
IMPORTANT NOTE
This SHORT MANUAL does not contain all information which is necessary for safe
and effective operation and application of the SCHWIND SIRIUS according to its
intended use.
Refer to the related SIRIUS documents as listed in the SCHWIND Short Manual
“PERAMIS-SIRIUS Measurement Evaluation” and in the SCHWIND User Manual
“WORKSTATION”.
Do not use the SCHWIND SIRIUS before reading the documents listed in the
SCHWIND Short Manual “PERAMIS-SIRIUS Measurement Evaluation”! Follow all
instructions and notes, which cover the regulatory requirements.
Keep the Short Manual and all related documents close to the medical device(s).
Always allow any user access to this user manual at all times, store it readily
available.
IMPORTANT NOTE
The present manual contains the ORIGINAL INSTRUCTIONS, which are legally
binding.
Translations of these must bear the words “Translation of the Original
Instructions”.
1.4 Intended Use of the SCHWIND SIRIUS
Refer to the CSO manual “Instructions for Use and Maintenance”.
Short Manual “Calibration” 3.7.01
Calibration
Version 3.7.0 / 2019-06-26 Page 5 of 8
2CALIBRATION
Calibration of the keratoscope is essential for
obtaining accurate measurements.
To calibrate correctly, follow the instructions given
step-by-step on the screen and carry out all needed
captures according to the calibration standards.
IMPORTANT NOTE
The room light conditions for patient examination and calibration should be the
same, not brighter than mesopic.
2.1 When to Calibrate?
After installation.
In case the room light conditions have been changed.
2.2 How to Calibrate?
Place the calibration bar on the chin rest in front of the
SIRIUS instrument.
Start the PHOENIX software and select the button “Calibrate
SIRIUS” on the main page.
After pressing the calibration button a new
window “Starting calibration” appears.
Confirm with “OK” to start the calibration.
Calibration bar with calibration sphere
Short Manual “Calibration” 3.7.01
Calibration
Version 3.7.0 / 2019-06-26 Page 6 of 8
The following window appears:
Click “Next” to start calibration.
CAUTION!
Depending on the SIRIUS device a “linear calibration” and a “curvature calibration”
or only a “curvature calibration” is required.
In case the SIRIUS calibration does not require the linear calibration go on with
“curvature calibration”.
Perform “Linear calibration” first:
Focus on the “flat calibration disk” of the
calibration bar (named with DISK CAL.)
Center the SIRIUS device with the joystick until
the red cross is in the middle of the Placido disc.
When you see the image sharp and centered,
press the joystick button.
Check that the red curves match with the
outermost external ring and the horizontal red line
crosses the center of the placido rings as best as
possible.
If necessary move the blue arrows.
Press “Next” to go on with “curvature calibration”
Short Manual “Calibration” 3.7.01
Calibration
Version 3.7.0 / 2019-06-26 Page 7 of 8
Perform “curvature calibration”:
Move the SIRIUS in front of the calibration
sphere R.8 with radius 8.00 mm.
Align top view image:
The cornea reflex must be
tangential to the red line.
(Image in the superior part
of the window).
Align Placido image:
The red cross must be in the
center of the placido rings
(image in the inferior part of
the window).
When both images are in the correct position, press the joystick button.
When the calibration was successful the
following window appears:
Click “OK” to confirm the calibration.
If the calibration was unsuccessful, repeat the
whole calibration procedure.
Short Manual “Calibration” 3.7.01
Calibration
Version 3.7.0 / 2019-06-26 Page 8 of 8
At the end measure the curvature sphere of
the calibration tool once and compare the
achieved average value of the K-readings
Meridians @3mm with the value of the
calibration sphere. The average (Avg) shall be
8.00mm±0.03mm (42.2D±0.16D).
If the measured average K-value is out of
range repeat the calibration procedure.
Finally check acquisition quality, the keratoscopy centration shall be 100% ± 3%.
Now the instrument is ready for use.
End of manual
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