Haag-Streit Eyestar 900 Instructions For Use Manual Download Page 8

8

DEUTSCH

ENGLISH 

FRANÇAIS

ITALIANO

ESPAÑOL

NEDERLANDS

PORTUGUÊS

SVENSKA

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05

• The measured results of patients with asteroid hyalosis may not be

accurate (in particular the axial length measurement) and must

therefore be verified by the user in terms of their plausibility.

1.8 IOL calculation

The measurements taken with the Eyestar 900 may serve as the central element for

the calculation of intraocular lenses (IOL). A further important parameter in

calculating the lens to be implanted is the IOL constant. When using the Eyestar

900, only IOL constants optimised for optical biometers should be used. Please

contact your IOL manufacturer for information on optimised IOL constants for optical

biometry. An alternative source of information for IOL constants optimised for optical

biometry is the website of the 'User Group for Laser Interference Biometry' (ULIB)

(

http://ocusoft.de/ulib/c1.htm

). Downloadable IOL Constants files for the Eyestar

900, featuring the ULIB IOL-Constants for the formulas implemented in EyeSuite

IOL are available in the Key-User section of the Haag-Streit homepage.

To further improve the clinical result, Haag-Streit recommends that every surgeon

creates personally optimised IOL constants based on pre-operative measurement

data generated with the Eyestar 900 and reliable postoperative data (e.g., 3 months

after the operation).

1.9 Optical radiation

WARNING!

The light of this device may de dangerous. The risk of eye damage

increases with the number of examinations in succession per eye. An

examination time with this device of over 225 individual examinations

exceeds the risk guideline value.

NOTE!

• This device complies with the light exposure limits for class 2

ophthalmic devices according to EN ISO 15004-2:2007.

• This device is a class 1 laser device in accordance with IEC

60825-1.

• The device complies with the exempt (risk free) group in accordance

with IEC 62471.

1.10 Disinfection

NOTE!

• The device does not need to be disinfected.

• The device complies with the exempt (risk free) group in accordance

with IEC 62471:2006

For more information on cleaning, please refer to the ‘Maintenance’ chapter.

1.11 Warranty and product liability

• Haag-Streit products must be used only for the purposes and in the manner

described in the documents distributed with the product.

• The product must be treated as described in the ‘Safety’ chapter. Improper

handling can damage the product. This would void all guarantee claims.

• Continued use of a product damaged by incorrect handling may lead to personal

injury. In such a case, the manufacturer will not accept any liability.

• Haag-Streit does not grant any warranties, either expressed or implied, including

implied warranties of merchantability or fitness for a particular use.

• Haag-Streit expressly disclaims liability for incidental or consequential damage

resulting from the use of the product.

• This product is covered by a limited warranty granted by your seller.

For USA only:

• This product is covered by a limited warranty, which may be reviewed at

www.haag-streit-usa.com.

1.12 Description of symbols

Follow instruction for use

Read the instructions for use

attentively

General warning: Read the

accompanying documentation

European certificate of

conformity

Date of manufacture

Manufacturer

Summary of Contents for Eyestar 900

Page 1: ...H ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220686 04020 2 Edition 2021 05 INSTRUCTIONS FOR USE Biometer EYESTAR 900 2 Edition 2021 05 ...

Page 2: ...ommissioning this product It contains important information regarding the safety of the user and patient NOTE For USA only Federal law restricts this device to sale by or on the order of a physician or licensed practitioner Intended purpose The EYESTAR 900 is a non invasive non contact biometer used for obtaining following information Corneal shapes Axial eye length Lens dimension and position Ant...

Page 3: ...3 Illumination modalities 14 6 3 1 OCT light source 14 6 3 2 Imaging system light source 14 6 3 3 Primary fixation target 14 6 3 4 Fellow eye fixation target 14 6 4 Measured variables 14 6 4 1 Central Corneal Thickness CCT 14 6 4 2 Anterior chamber depth ACD 14 6 4 3 Lens thickness LT 14 6 4 4 Axial length AL 15 6 4 5 Keratometry K 15 6 4 6 White to white distance WTW 15 6 4 7 Pupillometry PD 15 6...

Page 4: ...r than 30 cm 12 inches to any part of the device including cables specified by Haag Streit Otherwise degradation of the performance of this device could result If unexpected disturbances are observed the cause could be a cell phone or radio frequency telephone in the immediate vicinity to the Eyestar 900 Increase the distance to the device until the interference disappears Use of accessories trans...

Page 5: ...olating transformer galvanic Ethernet isolator etc The device must be positioned in such a way that proper heat dispersion ventilation is guaranteed The device should be set up in such a way that the plug is always easily accessible and the device can easily be disconnected from the mains Use of this device adjacent to or stacked with other equipment should be avoided because it could result in im...

Page 6: ...it may suffer damage due to overheating Likewise make sure that the device is switched off before attaching the dust cover Repairs may only be conducted by suitably trained and authorised specialist personnel Incorrect repairs can pose considerable risks for operating staff and patients Housing parts of the device may only be removed by suitably trained and authorised specialist personnel Only ori...

Page 7: ...corneal curvature radius More than 0 3 mm with respect to axial eye length More than 1 D with respect to emmetropic IOL refractive power The user must check the A and B Scan when measuring anterior chamber depth in pseudophakic mode If only one IOL signal is visible it is not clear whether this signal relates to the front or back of the IOL Uncertainty in this case can lead to the displayed readin...

Page 8: ...inations in succession per eye An examination time with this device of over 225 individual examinations exceeds the risk guideline value NOTE This device complies with the light exposure limits for class 2 ophthalmic devices according to EN ISO 15004 2 2007 This device is a class 1 laser device in accordance with IEC 60825 1 The device complies with the exempt risk free group in accordance with IE...

Page 9: ... imaging system sub unit The OCT sub unit performs a three dimensional measurement of all refractive ocular structures in the anterior eye segment curvatures and locations of anterior corneal surface posterior corneal surface anterior crystalline lens surface posterior crystalline lens surface as well as a one dimensional measurement of axial eye length It also generates cross sectional images of ...

Page 10: ...touch screen panel is mounted in the right side from the patient s point of view as a default location I may also be mounted on the rear of the device or on the left Adjustments of the screen location must be carried out by trained service personnel only 3 Device assembly installation WARNING The device must be installed by trained personnel in accordance with the installation instructions provide...

Page 11: ...ng the assessment of measurements on PC viewing stations with an EyeSuite installation For more details on the network and EMR integration capabilities of the device check the EyeSuite software instructions for use accessible in the software 3 4 USB sockets The Eyestar 900 features four 4 USB sockets two features USB 2 0 and two features USB 3 0 standard They may be used to connect an external har...

Page 12: ...on The height adjustment of the chin rest is performed via the touch screen user interface or the two arrow multifunction buttons on top of the device Additional height indication marks at the device cover representing the eye height level and may help position the chin rest in a good initial position Details on the measurement process are described in the software instructions for use of the devi...

Page 13: ...ry map 4 3 4 White to white distance pupillometry and eccentricity of the visual axis The white to white distance WTW is determined using the image of the iris and the eye radii obtained from keratometry The value displayed corresponds to the diameter of an ideal circle Pupil diameter Ø corresponds to the diameter of an ideal circle with the smallest error perpendicular to the established pupil bo...

Page 14: ...fixation target Light source LEDs Wavelength 625 nm red 6 4 Measured variables In vivo repeatabilities reported in this chapter are based on N 46 eyes one eye per subject 32 phakic healthy and cataract and 14 pseudophakic eyes were included In vivo repeatability is calculated as the standard deviation of pairwise differences of three repeated measurements per eye for all eyes Aphakic and oil fille...

Page 15: ...ular corneal shape comprising the following pathologies treatments Keratoconus DSAEK corneal crosslinking Pseudoexfoliation Syndrome corneal transplant susp Salzmann degeneration corneal lesion corneal indentation Only one eye per subject per class healthy cornea irregular corneal shape is included in the analysis Covered area diameter Standard 7 5 mm Extended 12 mm 6 5 1 Invivo repeatability stan...

Page 16: ...d as the standard deviation of pairwise differences of three repeated measurements per eye for all eyes Measurement range SimPK 3 9 9 5 dpt Display resolution SimPK 0 01 dpt In vivo repeatability SimPKmean 1 SD 0 032 dpt In vivo repeatability SimPAST 1 SD 0 029 dpt Measurement range SimPAxis 0 180 Display resolution SimPAxis 1 In vivo repeatability SimPAxis SimPAST 0 5 dpt 1 SD no occurrences Disp...

Page 17: ...ces of three repeated measurements per eye for all eyes Measurement range SimEPK 3 9 9 5 dpt Display resolution SimEPK 0 01 dpt In vivo repeatability SimEPKmean 1 SD 0 019 dpt In vivo repeatability SimEPAST 1 SD 0 023 dpt Measurement range SimEPAxis 0 180 Display resolution SimEPAxis 1 In vivo repeatability SimEPAxis SimEPAST 0 5 dpt 1 SD no occurrences Display resolution Posterior Corneal Shape F...

Page 18: ... to be paid to the following points Only use cleaning liquid evenly spread on the cover towel on following device parts Patient interface chin rest shell including its supporting parts Patient interface forehead rest band including its supporting parts Patient interface handles including their supporting parts Device cover casing User interface display panel User interface display panel surroundin...

Page 19: ... after the 13th August 2005 For correct disposal please contact your Haag Streit representative This will guarantee that no hazardous substances enter the environment and that valuable raw materials are recycled 9 5 Observed standards EN 60601 1 EN 60529 EN 60601 1 2 EN ISO 15004 1 EN 62471 EN ISO 15004 2 EN 60825 1 EN ISO 19980 9 6 Information and manufacturer s declaration concerning electromagn...

Page 20: ...ance RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonics emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Pst 1 0 Plt 0 65 This product is suitable for use in all establis...

Page 21: ...ent Not applicable for DC and I O if cable 3 m Surge IEC 61000 4 5 0 5 1 kV line s to line s 0 5 1 2 kV line s to earth 1 kV line s to line s 0 5 1 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Not applicable for DC and I O if cable 3 m Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0...

Page 22: ...radio amateur band 6 Vrms 150 kHz 80 MHz in ISM bands and radio amateur band 6 Vrms 150 kHz 80 MHz outside ISM bands and radio amateur band 10 Vrms 150 kHz 80 MHz in ISM bands and radio amateur band Radiated RF IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM 1 kHz 5 V m 80 MHz 6 GHz 80 AM 1 kHz Proximity field from RF wireless communication equipment IEC 61000 4 3 27 V m 380 390 MHz 50 PM 18 Hz 28 V m 43...

Page 23: ... W WLAN 802 11 a n max 0 2 W Interference may occur in the vicinity of equipment marked with the following symbol The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 6 795 MHz 13 553 13 567 MHz 26 957 27 283 MHz 40 66 40 7 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz 2 MHz 3 5 4 0 MHz 5 3 5 4 MHz 7 7 3 MHz 10 1 10 15 MHz 14 14 2 MHz 18 07 18 ...

Page 24: ...50 kHz Ð 80 MHz outside ISM and radio amateur bands d 0 58 P 150 kHz Ð 80 MHz in ISM and radio amateur bands d 1 2 P 80 MHz Ð 6 GHz for define RF Wireless transmitters see table before d 1 2 P 0 01 0 06 0 12 0 12 0 1 0 19 0 38 0 38 1 0 60 1 2 1 2 10 1 9 3 8 3 8 100 6 0 12 12 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be d...

Page 25: ...O ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220686 04020 2 Edition 2021 05 Should you have any further questions please contact your Haag Streit representative at Wiki Revision ID 266202 ...

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