SCHWIND Sirius Come usare

Short Manual “Calibration”

Original Instruction

Scheimpflug Analyzer

Distributed by SCHWIND eye-tech-solutions GmbH

Tel.: +49-(0)6027-508-0

Fax: +49-(0)6027-508-208

Email: [email protected]et

http:// www.eye-tech-solutions.com

Service Hotline:

Tel.: +49-(0)6027-508-333

Fax: +49-(0)6027-508-245

Email: [email protected]t

Customer Support:

Tel.: +49-(0)6027-508-350

Fax: +49-(0)6027-508–208

Email: [email protected]

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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