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DEUTSCH

ENGLISH

FRANÇAIS

ITALIANO

ESPAÑOL

NEDERLANDS

PORTUGUÊS

SVENSKA

Dust Protection Cover

1802304

HS Lenspen

1820415

9.2 Legal regulations

• Haag-Streit maintains a quality management system in accordance with EN ISO

13485. The device has been developed and designed taking into consideration

all the standards listed in chapter 'Observed standards'.

• This is a Class IIa device in accordance with Appendix IX of Directive 93/42/

EEC. By affixing the CE mark we confirm that our device complies with the

applicable standards and directives.

• You can request a copy of the declaration of conformity for the device from

Haag-Streit at any time.

9.3 Classification

EN 60601-1:2006+A1:2013/AN

Continuous operation

EN 60825-1:2014

Laser class I

EN 60529:1991+A1:2000

Enclosure protection IP20

EN 62471:2008

Exempt group

EN ISO 15004-2:2007

Group 2

ISO 19980:2012

Corneal topographer, type A

93/42/EEC (medical devices)

Class IIa

9.4 Disposal

Electrical and electronic devices must be disposed of separately

from household waste! This device was made available for sale

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

electromagnetic compatibility (EMC)
9.6.1 General

This device fulfills the requirements on electromagnetic compatibility according to

IEC 60601-1-2:2014 (4th Edition). The device is built so that the generation and

emission of electromagnetic interference is limited to the extent that other devices

are not disturbed in their use in accordance with the regulations and so that the

device itself is suitably immune to electromagnetic interference.

WARNING!

• Electrical medical devices and systems are subject to special EMC

measures and must be installed in accordance with the EMC

instructions contained in this accompanying document.

• Portable and mobile HF communication systems may interfere with

electrical medical devices.

• Use of accessories, transducers and cables other than those

specified or provided by Haag-Streit could result in increased

electromagnetic emissions or decreased electromagnetic immunity

of this device and result in improper operation.

Содержание Eyestar 900

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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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