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Pulsair Intellipuff Tonometer by KEELER

Consult instructions for use

General warning sign

Date of manufacture

Warning: Non-ionizing radiation

Manufacturer’s name and

address

Warning: Electricity

Country of manufacture

Warning: Optical radiation

Waste Electrical and Electronic

Equipment (WEEE) recycling

Warning: Floor level obstacle

This way up

Keep dry

Type BF applied part

Fragile

Temperature limit

Do not use if package is

damaged

0120

United Kingdom Conformity

Assessed, with the Notified

Body number for SGS UK

1639

Conformité Européene, with the

Notified Body number for SGS

Belgium NV

REP

Authorised representative in the

European Community

REP

Authorised representative in

Switzerland

Catalogue number

Class II equipment

Serial number

Atmospheric pressure limitation

Medical device

Humidity limitation

Translation

The Keeler Pulsair Intellipuff Tonometer is designed and built-in conformity with Directive 93/42/EEC, Regulation (EU)

2017/745 and ISO 13485 Medical Devices Quality Management Systems.
Classification: CE / UKCA: Class IIa

FDA: Class II

The information contained within this manual must not be reproduced in whole or part without the manufacturer’s

prior written approval. As part of our policy for continued product development we the manufacturer reserve the right

to make changes to specifications and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2023. Published in the UK 2023.

Содержание Pulsair Intellipuf

Страница 1: ...Non Contact Tonometer INSTRUCTIONS FOR USE EN BG RU HY HR SR...

Страница 2: ......

Страница 3: ...Intellipuff 22 Pulsair Intellipuff 64 Pulsair Intellipuff Tonometer Instructions For Use 1 Pulsair IntelliPuff 85 Tonometar Pulsair Intellipuff Upute za upotrebu 43 SR Pulsair Intellipuff tonometar Up...

Страница 4: ......

Страница 5: ...EYE 7 7 NAMES OF CONTROLS AND COMPONENTS 7 8 MEASUREMENT PROCEDURE 10 8 1 PREPARING THE DEVICE 10 8 2 PREPARING THE PATIENT 11 8 3 TAKING THE READING 11 9 DISPLAY EXAMPLES 13 10 PRINTING 14 10 1 SAMP...

Страница 6: ...Authorised representative in Switzerland Catalogue number Class II equipment Serial number Atmospheric pressure limitation Medical device Humidity limitation Translation The Keeler Pulsair Intellipuf...

Страница 7: ...f the cornea and the detection of the pre defined deformation of the cornea through optical means and reflections from the corneal surface 1 2 INTENDED USE PURPOSE OF INSTRUMENT The Pulsair IntelliPuf...

Страница 8: ...EP29 32777 or instrument may malfunction Do not remove the labels covering the key holes unless wall mounting the Pulsair IntelliPuff The owner of the instrument is responsible for training personnel...

Страница 9: ...th local environmental guidelines WEEE 2 3 CONTRAINDICATION There is no restriction to patient population this device can be used with other than those outlined in the contraindications stated below A...

Страница 10: ...MOUNTING Your Pulsair IntelliPuff is supplied with a sturdy wall mounting bracket 1 The bracket has four holes allowing it to be securely fixed to an appropriate wall or vertical surface 2 Choose car...

Страница 11: ...ecognise the readings and emit a sound notification when two consecutive readings are 1mmHg of each other indicating that further measurements may not be required 7 NAMES OF CONTROLS AND COMPONENTS 1...

Страница 12: ...alibration systems checking and data output located on rear of instrument 6 Power Input Insert the low voltage power lead located on rear of instrument using only Keeler power supplies 7 Forehead Rest...

Страница 13: ...10 Print Menu button A press of less than one second will print the acquired data press and hold for more than 3 seconds to access the User Menu Options Refer to page 14 for full instructions on the U...

Страница 14: ...gh which the Pulsair IntelliPuff is aligned and a gentle puff of air is emitted 16 Alignment LEDs The two green LEDs located on the front of the Hand Unit act as a guide when you are lining up the pat...

Страница 15: ...efore taking a reading you should 1 Ask the patient to blink to ensure a good and reflective tear film 2 Ensure the patient and tonometer optics are not positioned under direct lighting i e spot light...

Страница 16: ...within 1mmHg of each other are not obtained Keeler recommend taking up to four readings 9 When two consecutive readings are within 1mmHg an audible sound will be heard indicating that sufficient readi...

Страница 17: ...isplay that the reading is the first or average of more than 1 IOP greater than 25mmHg When a pressure IOP of greater than 25mmHg is detected the unit will display 25 the puff intensity will automatic...

Страница 18: ...ed to zero decimal places xx 11 REPLACING THE PRINTER PAPER 1 Access to the printer paper is via the Printer Cover pull the lip on the top of the Cover and gently pull towards you to open the Printer...

Страница 19: ...ull Self test RUN TEST TEST WAIT The last choice above Run Test selected by pressing DEMO button would start a Self test program around 45 seconds the result of which should be printed 13 CALIBRATION...

Страница 20: ...accessories have been used in compliance with these instructions Proof of purchase accompanies any claim The manufacturer declines any and all responsibility and warranty coverage should the instrume...

Страница 21: ...missions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Complies 16 2 ELECTROMAGNETIC IMMUNITY Guidance and manufacturer s declaration electromagnetic immunity The Keeler Pulsair I...

Страница 22: ...n a typical professional healthcare facility environment Note UT is the a c mains voltage prior to application of the test level Immunity test IEC 60601 Test level Compliance level Electromagnetic env...

Страница 23: ...ble and mobile RF communications equipment and the Keeler IntelliPuff The Keeler Pulsair IntelliPuff Tonometer is intended for the use in an electromagnetic environment in which radiated RF disturbanc...

Страница 24: ...ient s cornea Displayed scale 4 character dot matrix scrolling Illumination system LED infra red Length of umbilical cord 2m Complies with Electrical Safety Medical IEC 60601 1 Electromagnetic Compati...

Страница 25: ...l of old electrical and electronic equipment This symbol on the product or on its packaging and instructions indicates that this product shall not be treated as household waste To reduce the environme...

Страница 26: ...R 1 24 1 1 24 1 2 24 2 24 2 1 24 2 2 25 2 3 26 3 26 3 1 26 3 2 27 4 27 4 1 27 5 27 6 27 7 28 8 31 8 1 31 8 2 32 8 3 32 9 34 10 35 10 1 35 11 35 12 35 13 36 13 1 36 13 2 37 14 37 15 37 16 37 16 1 38 16...

Страница 27: ...KEELER F 0120 SGS UK 1639 Conformit Europ ene withtheNotified Body number for SGS Belgium NV REP EC REP CH II Pulsair Intellipuff Keeler 93 42 EE 2017 745 ISO 13485 CE UKCA IIa II Keeler UK Keeler USA...

Страница 28: ...24 BG Pulsair Intellipuff KEELER 1 Pulsair IntelliPuff 1 1 1 2 Pulsair IntelliPuff 2 2 1 Keeler 24 Keeler Ltd...

Страница 29: ...25 BG Pulsair Intellipuff KEELER 2 2 Keeler Ltd Keeler Keeler EP29 32777 Pulsair IntelliPuff Keeler...

Страница 30: ...26 BG Pulsair Intellipuff KEELER Keeler Pulsair IntelliPuff Demo 1 2 3 3 3 1 1 2 3 4...

Страница 31: ...27 BG Pulsair Intellipuff KEELER 3 2 1 2 70 IPA 2 3 4 4 4 1 IEC 60320TYPE 7 5 Pulsair IntelliPuff 1 2 IntelliPuff 3 4 5 6 7 Pulsair IntelliPuff 6 Pulsair IntelliPuff Keeler...

Страница 32: ...28 BG Pulsair Intellipuff KEELER 4 Pulsair IntelliPuff 1 mmHg 7 1 Pulsair IntelliPuff LED 2 3 LED...

Страница 33: ...29 BG Pulsair Intellipuff KEELER 4 5 6 Keeler 7 8 OD OS OD OS 2 1 3 4 5 6 7 8 14 10 12 13 11 9...

Страница 34: ...30 BG Pulsair Intellipuff KEELER 9 4 15 4 16 3 14 2 16 9 62 8 4 15 7 16 1 mmHg 10 3 35 11 R Pulsair OD OS Demo easy Pulsair Intellipuff Pulsair IntelliPuff...

Страница 35: ...31 BG Pulsair Intellipuff KEELER 12 Demo Demo 13 OD OS 35 14 15 Pulsair IntelliPuff 16 LED LED 8 8 1 1 2 3 4 5 LED Pulsair IntelliPuff 9 16 15 3 4 1 5 6 2...

Страница 36: ...32 BG Pulsair Intellipuff KEELER 6 Pulsair IntelliPuff Demo 8 2 Pulsair IntelliPuff 1 2 3 Clear Demo 1 2 3 4 8 3 Pulsair IntelliPuff 1 Pulsair IntelliPuff OD OS 2 LED 3 30 12 4 Pulsair IntelliPuff...

Страница 37: ...33 BG Pulsair Intellipuff KEELER 5 6 7 15 mm Pulsair IntelliPuff 8 Pulsair IntelliPuff 1 mmHg 1 mmHg Keeler 9 1 mmHg 10 11 12 13 3 7 OD OS 3 7...

Страница 38: ...ff KEELER 9 Standby STBY System Initialisation WAIT OK OK OD 14mmHg LED OD OS 0 1 0 1 1 25 mmHg 25 mmHg 25 RUN TEST 15 OD OS Refer to the User Menu Options section in this manual for guidance on runni...

Страница 39: ...35 BG Pulsair Intellipuff KEELER 10 10 1 20 Name Date Time 11 1 2 3 4 12 1 Print Menu 3 2 PRNT ON PRNT OFF 3 2 1...

Страница 40: ...Change 4 Print Menu Buzzer Control 5 OD OS Menu Change DEMO OD OS Menu Change button 6 4 5 Pulsair IntelliPuff PRNT OFF ON BUZ OFF ON XX XX X RUNTEST TEST WAIT RunTest DEMO 45 13 Keeler Keeler Ltd 13...

Страница 41: ...37 BG Pulsair Intellipuff KEELER 13 2 Pulsair IntelliPuff Off 14 Keeler Pulsair Keeler Keeler 15 Keeler 2 Keeler Ltd Keeler Keeler 16 Pulsair IntelliPuff Keeler...

Страница 42: ...eler CISPR 11 1 Pulsair IntelliPuff Keeler CISPR 11 Pulsair IntelliPuff Keeler IEC 61000 3 2 IEC 61000 3 3 16 2 Pulsair IntelliPuff Keeler IEC 55015 ESD IEC 61000 4 2 8 kV 15 kV 8 kV 15 kV 30 IEC 6100...

Страница 43: ...UT 0 250 300 UT 0 0 5 0 45 90 135 180 225 270 315 UT 0 1 UT 70 25 30 0 UT 0 250 300 Pulsair IntelliPuff Keeler 50 60 Hz IEC 61000 4 8 30 A m 30 A m UT a c IEC 60601 Pulsair IntelliPuff Keeler IEC 610...

Страница 44: ...liPuff Keeler 2 150kHz 80 MHz 10V m 16 3 Pulsair IntelliPuff Keeler Pulsair IntelliPuff Keeler Pulsair IntelliPuff Keeler Pulsair IntelliPuff Keeler W m 150 kHz 230MHz d 1 2 p 80MHz 800MHz d 1 2 p 800...

Страница 45: ...465 Kg 0 890 Kg 5 mmHg 50 mmHg 5 5 mmHg 95 20 mm 15 mm 4 LED 2 m IEC 60601 1 IEC 60601 1 2 BS EN ISO 15004 1 BS EN ISO 15004 2 110 240V 10 EN 60601 1 EN 61000 6 2 EN 61000 6 3 30VA 12V DC 2 5A 50 60...

Страница 46: ...55 C 10 C 95 10 1060 hPa 700 hPa 70 C 40 C 95 10 1060 hPa 500 hPa 10 Hz 500 Hz 0 5 g 30 g 6 ms 10 g 6 ms 18 2208 L 7008 Intellipuff 2414 P 7011 Pulsair IntelliPuff EP39 70304 2415 P 7038 19 B2B Compli...

Страница 47: ...LJUDSKOM OKU 48 7 NAZIVI KONTROLA I DIJELOVI 49 8 POSTUPAK MJERENJA 52 8 1 PRIPREMA URE AJA 52 8 2 PRIPREMA BOLESNIKA 53 8 3 O ITAVANJE REZULTATA 53 9 PRIMJER PRIKAZA NA ZASLONU 55 10 ISPIS 56 10 1 OG...

Страница 48: ...Europskoj Zajednici REP CH Ovla teni zastupnik u vicarskoj Katalo ki broj Oprema klase II Serijski broj Ograni enje atmosferskog tlaka Medicinski proizvod Ograni enje vla nosti Prijevod Keeler tonomet...

Страница 49: ...u opti kih sredstava i refleksije s povr ine ro nice 1 2 NAMJENA SVRHA URE AJA Beskontaktni tonometar Pulsair IntelliPuff indiciran je za mjerenje intraokularnog tlaka bez kontakta s okom kao pomo za...

Страница 50: ...klonite ih samo ako postavljate tonometar Pulsair IntelliPuff na zid Vlasnik ure aja je odgovoran za obuku osoblja o njegovoj ispravnoj upotrebi Nemojte nikada koristiti ure aj ako su ambijentalna tem...

Страница 51: ...IKACIJE Ne postoje ograni enja za bolesnike na kojima se ovaj ure aj smije koristiti osim onih ograni enja navedenih u kontraindikacijama u nastavku Poznato je da na to nost mjerenja intraokularnog tl...

Страница 52: ...tor IEC 60320 tip 7 nije isporu en 5 POSTAVLJANJE NA ZID Va tonometar Pulsair IntelliPuff isporu uje se sa sna nim nosa em za postavljanje na zid 1 Nosa ima etiri rupe koje omogu uju sigurno fiksiranj...

Страница 53: ...prepoznati o itanja i oglasiti zvu ni signal kada su dva uzastopna o itanja 1 mmHg jedno od drugog ukazuju i da daljnja mjerenja mo da ne e biti potrebna 7 NAZIVI KONTROLA I DIJELOVI 1 Prekida On Off...

Страница 54: ...provjeru sustava i izlaz podataka nalazi se sa stra nje strane ure aja 6 Strujni ulaz Umetnite niskonaponski strujni vod nalazi se sa stra nje strane ure aja koriste i samo dodatni pribor za napajanj...

Страница 55: ...od jedne sekunde ispisat e se dobiveni podaci pritiskom u trajanju vi e od 3 sekunde pristupit e se Korisni kom izborniku Pogledajte stranica 56za cjelovite upute za Korisni ki izbornik 11 Tipka Revie...

Страница 56: ...telliPuff pomo u kojeg se ure aj poravnava te iz kojeg se ispu ta nje ni ispuh zraka 16 LED svjetla za poravnanje Dva zelena LED svjetla smje tena s prednje strane ru nog upravlja a slu e kao vodi i z...

Страница 57: ...e bolesnika da trepne okom kako biste se uvjerili da e oko imati dobar i reflektivni suzni film 2 Vodite ra una da bolesnik i opti ki dijelovi tonometra nisu pozicionirani ispod izravne svjetlosti npr...

Страница 58: ...ni kom izborniku Ako dobivena uzastopna o itanja nisu 1 mmHg jedno od drugog tvrtka Keeler preporu uje do 4 o itanja 9 Kada su dva uzastopna o itanja u rasponu od 1 mmHg oglasit e se zvu ni signal koj...

Страница 59: ...na zaslonu nema informacije da je o itanje prvo ili prosje no za i ve e od 1 Intraokularni tlak je ve i od 25 mmHg Kada je utvr en intraokularni tlak ve i od 25 mmHg na zaslonu e biti prikazano 25 ja...

Страница 60: ...ale xx 11 ZAMJENA PAPIRA ZA PISA 1 Pristup papiru pisa a omogu en je kroz vrata ca pisa a povucite jezi ac na gornjem dijelu vrata ca i nje no povucite prema sebi da bi ih otvorili Uklonite praznu rol...

Страница 61: ...OP a XX XX X Cjelovito samotestiranje RUN TEST POKRENI SAMOTESTIRANJE TEST WAIT TEST EKAJ Posljednji izbor iznad Run Test odabrati pritiskom tipke DEMO pokrenut e program samotestiranja oko 45 sekundi...

Страница 62: ...izvodnji Instrument i dodatni pribor su kori teni sukladno ovim uputama Dokaz kupovine treba prilo iti uz svaki zahtjev Proizvo a odbija svaku odgovornost i opseg jamstva ako e ure aj biti neovla teno...

Страница 63: ...napona IEC 61000 3 3 Sukladno 16 2 ELEKTROMAGNETSKI IMUNITET Smjernica i izjava proizvo a a elektromagnetski imunitet Keeler tonometar Pulsair IntelliPuff namijenjen je za upotrebu u elektromagnetsko...

Страница 64: ...jom napajanja treba biti na razini karakteristi noj za uobi ajenu lokaciju profesionalne zdravstvene ustanove Napomena UT je napon izmjeni ne struje prije primjene ispitne razine Ispitivanje otpornost...

Страница 65: ...ENI SIGURNOSNI RAZMAK Preporu eni sigurnosni razmak RF komunikacijske opreme i Keeler prijenosnog biomikroskopa Keeler tonometar Pulsair IntelliPuff namijenjen je za upotrebu u elektromagnetskom okru...

Страница 66: ...ka Prikazano mjerilo 4 znaka dot matrix opcija kretanja Sustav osvjetljenja LED infracrveno Du ina kabela 2m Sukladno Sigurnost medicinskih elektri nih ure aja IEC 60601 1 Elektromagnetska kompatibiln...

Страница 67: ...CIJE O PAKIRANJU I ODLAGANJU Odlaganje stare elektri ne i elektroni ke opreme Simbol na proizvodu ili na pakiranju i upute navode da se s ovim proizvodom ne e postupati kao s ku nim otpadom Kako bi se...

Страница 68: ...f 1 66 1 1 66 1 2 66 2 66 2 1 66 2 2 67 2 3 68 3 68 3 1 68 3 2 69 4 69 4 1 69 5 69 6 69 7 70 8 73 8 1 73 8 2 74 8 3 74 9 76 10 77 10 1 77 11 77 12 77 13 78 13 1 78 13 2 79 14 79 15 79 16 79 16 1 80 16...

Страница 69: ...uff WEEE BF 0120 SGS 1639 Conformit Europ ene with the Notified Body number for SGS Belgium NV REP EC REP CH II Keeler Pulsair Intellipuff 93 42 2017 745 ISO 13485 CE UKCA IIa FDA II Keeler UK Keeler...

Страница 70: ...66 HY KEELER Pulsair Intellipuff 1 Pulsair IntelliPuff 1 1 1 2 Pulsair IntelliPuff 2 2 1 Keeler 24 Keeler Ltd...

Страница 71: ...67 HY KEELER Pulsair Intellipuff 2 2 Keeler Ltd Keeler Keeler EP29 32777 Pulsair IntelliPuff Keeler...

Страница 72: ...68 HY KEELER Pulsair Intellipuff Keeler Pulsair IntelliPuff 1 Demo WEEE 2 3 3 3 1 1 2 3 4...

Страница 73: ...69 HY KEELER Pulsair Intellipuff 3 2 1 2 70 2 3 4 4 4 1 IEC 60320 TYPE 7 5 Pulsair intelliPuff 1 2 IntelliPuff 3 4 5 6 7 Pulsair IntelliPuff 6 Keeler Pulsair IntelliPuff...

Страница 74: ...70 HY KEELER Pulsair Intellipuff 4 Pulsair IntelliPuff 1 7 1 On Off Pulsair IntelliPuff On Off LED 2 3 LED...

Страница 75: ...71 HY KEELER Pulsair Intellipuff 4 5 6 Keeler 7 8 OD OS OD OS 2 1 3 4 5 6 7 8 14 10 12 13 11 9...

Страница 76: ...ir Intellipuff 9 4 15 4 16 3 14 2 16 9 62 8 4 15 7 16 1 10 Print Menu 3 77 11 Review Easy Pulse R Review Review Easy Pulse Review Pulsair OD OS Review Demo Easy Pulse Review easy Pulsair Intellipuff P...

Страница 77: ...73 HY KEELER Pulsair Intellipuff 12 Demo Demo 13 OD OS 77 14 15 Pulsair IntelliPuff Pulsair IntelliPuff 16 LED LED 8 8 1 1 2 On Off 3 4 5 LED Pulsair IntelliPuff OK 9 16 15 3 4 1 5 6 2...

Страница 78: ...ELER Pulsair Intellipuff 6 Pulsair IntelliPuff Demo Pulsair IntelliPuff 8 2 Pulsair IntelliPuff 1 2 3 Clear Demo 1 2 3 4 8 3 Pulsair IntelliPuff 1 Pulsair IntelliPuff OD OS 2 LED 3 30 12 4 Pulsair Int...

Страница 79: ...75 HY KEELER Pulsair Intellipuff 5 6 7 15 Pulsair IntelliPuff 8 Pulsair IntelliPuff 1 1 Keeler 9 1 10 11 12 Review 13 3 7 OD OS 3 7...

Страница 80: ...76 HY KEELER Pulsair Intellipuff 9 Standby STBY WAIT OK OK OD 14 LED OD OS 0 1 0 1 1 25 25 25 RUN TEST 15 OD OS Error...

Страница 81: ...77 HY KEELER Pulsair Intellipuff 10 Print 10 1 20 Name Date Time xx x xx 11 1 2 3 4 12 1 Print Menu 3 2 PRNT ON PRNT OFF 3 2 1...

Страница 82: ...e OD OS Menu Change 4 Print Menu 5 OD OS Menu Change DEMO OD OS Menu Change 6 4 5 OK Pulsair IntelliPuff PRNT OFF ON BUZ ON OFF XX XX X RUN TEST TEST WAIT Run Test DEMO 45 13 Keeler Keeler Ltd 13 1 Pu...

Страница 83: ...79 HY KEELER Pulsair Intellipuff 13 2 Pulsair IntelliPuff On Off 14 Keeler Pulsair Keeler Keeler 15 Keeler 2 Keeler Ltd Keeler Keeler 16 Keeler Pulsair IntelliPuff EMC...

Страница 84: ...r Pulsair IntelliPuff CISPR 11 1 Keeler Pulsair IntelliPuff CISPR 11 A Keeler Pulsair IntelliPuff IEC 61000 3 2 IEC 61000 3 3 16 2 Keeler Pulsair IntelliPuff IEC 55015 ESD IEC 61000 4 2 8 15 8 15 30 I...

Страница 85: ...1 UT 70 25 30 0 UT 0 250 300 UT 0 0 5 0 45 90 135 180 225 270 315 UT 0 1 UT 70 25 30 0 UT 0 250 300 Keeler Pulsair IntelliPuff 50 60 IEC 61000 4 8 30 30 UT a c IEC 60601 Keeler Pulsair IntelliPuff IEC...

Страница 86: ...elliPuff Keeler Pulsair IntelliPuff 2 150 80 10 16 3 Keeler IntelliPuff Keeler IntelliPuff Keeler Pulsair IntelliPuff Keeler Pulsair IntelliPuff 150 230 d 1 2 p 80 800 d 1 2 p 800 2 7 d 2 3 p 0 01 0 1...

Страница 87: ...x D x W 315 x 150 x 46 H x D x W 2 465 0 890 5 50 5 5 95 20 15 4 LED 2 IEC 60601 1 IEC 60601 1 2 BS EN ISO 15004 1 BS EN ISO 15004 2 110 240 10 EN 60601 1 EN 61000 6 2 EN 61000 6 3 30 12 DC 2 5 50 60...

Страница 88: ...ER Pulsair Intellipuff 55 C 10 C 95 10 1060 700 70 C 40 C 95 10 1060 500 10 500 0 5 30 6 10 6 18 2208 L 7008 Intellipuff 2414 P 7011 Pulsair Intellipuff EP39 70304 2415 P 7038 19 B2B 01691 676124 44 1...

Страница 89: ...7 1 1 87 1 2 87 2 87 2 1 87 2 2 87 2 3 89 3 89 3 1 89 3 2 90 4 90 4 1 90 5 90 6 90 7 91 8 94 8 1 94 8 2 95 8 3 95 9 97 10 98 10 1 98 11 98 12 98 13 99 13 1 99 13 2 100 14 100 15 100 16 100 16 1 101 16...

Страница 90: ...ER Pulsair IntelliPuff RU WEEE B 0120 UKCA SGS UK 1639 CE SGS Belgium NV REP EC REP CH II Keeler Pulsair Intellipuff 93 42 EEC 2017 745 ISO 13485 CE UKCA IIa II Keeler UK Keeler USA Keeler Limited 202...

Страница 91: ...87 KEELER Pulsair IntelliPuff RU 1 Pulsair IntelliPuff 1 1 1 2 Pulsair IntelliPuff 2 2 1 Keeler 24 Keeler Ltd 2 2 Keeler Ltd...

Страница 92: ...88 KEELER Pulsair IntelliPuff RU Keeler Keeler EP29 32777 Pulsair IntelliPuff Keeler...

Страница 93: ...89 KEELER Pulsair IntelliPuff RU Keeler Pulsair IntelliPuff Demo 1 WEEE 2 3 3 3 1 1 2 3 4...

Страница 94: ...90 KEELER Pulsair IntelliPuff RU 3 2 1 2 70 2 3 4 4 4 1 IEC 60320TYPE 7 5 Pulsair IntelliPuff 1 2 IntelliPuff 3 4 5 6 7 6 Keeler Pulsair IntelliPuff...

Страница 95: ...91 KEELER Pulsair IntelliPuff RU Pulsair Desktop 1 7 1 On Off 2 3 Print...

Страница 96: ...92 KEELER Pulsair IntelliPuff RU 4 5 6 Keeler 7 8 OD OS OD OS 2 1 3 4 5 6 7 8 14 10 12 13 11 9...

Страница 97: ...93 KEELER Pulsair IntelliPuff RU 9 4 15 4 16 3 14 2 16 9 62 8 15 7 16 1 10 Print Menu 1 3 98 11 Review Easy Pulse R Easy Pulse OD OS Demo Easy Pulse easy IntelliPuff...

Страница 98: ...94 KEELER Pulsair IntelliPuff RU 12 Demo Demo 13 OD OS Menu Change 98 14 15 16 8 8 1 1 2 3 4 5 IntelliPuff OK 9 6 Pulsair IntelliPuff Demo 16 15 3 4 1 5 6 2...

Страница 99: ...95 KEELER Pulsair IntelliPuff RU 8 2 Pulsair IntelliPuff 1 2 3 Clear Demo 1 2 3 4 8 3 Pulsair IntelliPuff 1 Pulsair IntelliPuff OD OS 2 3 30 12 4 Pulsair IntelliPuff...

Страница 100: ...96 KEELER Pulsair IntelliPuff RU 5 6 7 15 Pulsair intelliPuff 8 Pulsair intelliPuff 1 1 Keeler 9 1 10 11 12 13 3 7 OD OS 3 7...

Страница 101: ...97 KEELER Pulsair IntelliPuff RU 9 STBY WAIT OK OK OD 14 OD OS 0 1 0 1 1 25 25 25 run test 15 OD OS...

Страница 102: ...98 KEELER Pulsair IntelliPuff RU 10 Print 10 1 20 Name Date Time XX X XX 11 1 2 3 4 12 1 Print Menu 3 2 PRNT ON PRNT OFF 3 OD OS Menu Change 3 2 1...

Страница 103: ...Change DEMO OD OS Menu Change 6 4 5 OK Pulsair IntelliPuff Printer control PRNT OFF ON Buzzer control BUZ ON OFF IOP Format XX XX X Full SelfTest RUNTEST TEST WAIT RunTest DEMO 45 13 Keeler Keeler Ltd...

Страница 104: ...100 KEELER Pulsair IntelliPuff RU 13 2 On Off 14 Keeler Pulsair Keeler Keeler 15 Keeler 2 Keeler Ltd Keeler Keeler 16 Keeler Pulsair IntelliPuff...

Страница 105: ...eler Pulsair IntelliPuff CISPR 11 1 Keeler Pulsair IntelliPuff CISPR 11 A Keeler Pulsair IntelliPuff IEC 61000 3 2 IEC 61000 3 3 16 2 Keeler Pulsair IntelliPuff IEC 55015 IEC 61000 4 2 8 15 8 15 30 IE...

Страница 106: ...315 UT 0 1 UT 70 25 30 0 UT 0 250 300 UT 0 0 5 0 45 90 135 180 225 270 315 UT 0 1 UT 70 25 30 0 UT 0 250 300 Keeler Pulsair IntelliPuff 50 60 IEC 61000 4 8 30 30 UT IEC 60601 Keeler Pulsair IntelliPu...

Страница 107: ...telliPuff Keeler Pulsair IntelliPuff 2 150 80 10 16 3 KeelerTonoCare Keeler Pulsair IntelliPuff Keeler Pulsair IntelliPuff Keeler Pulsair IntelliPuff 150 230 d 1 2 p 80 800 d 1 2 p 800 2 7 d 2 3 p 0 0...

Страница 108: ...0 x x 315 x 150 x 46 x x 2 465 0 890 5 50 5 5 95 20 15 4 2 IEC EN 60601 1 IEC 60601 1 2 BS EN ISO 15004 1 BS EN ISO 15004 2 110 240 10 EN 60601 1 EN 61000 6 2 EN 61000 6 3 30 12 2 5 50 60 Pulsair inte...

Страница 109: ...ulsair IntelliPuff RU 55 C 10 C 95 10 1060 700 70 C 40 C 95 10 1060 500 10 500 0 5 g 30 g 6 10 g 6 18 2208 L 7008 IntelliPuff 2414 P 7011 Pulsair IntelliPuff EP39 70304 2415 P 7038 19 01691 676124 44...

Страница 110: ...JUDSKOM OKU 111 7 NAZIVI KOMANDI I KOMPONENTI 112 8 PROCEDURA MERENJA 115 8 1 PRIPREMA URE AJA 115 8 2 PRIPREMA PACIJENTA 116 8 3 O ITAVANJE 116 9 PRIMERI PRIKAZA 118 10 TAMPANJE 119 10 1 UZORAK TAMPE...

Страница 111: ...H Ovla eni predstavnik u vajcarskoj Katalo ki broj Oprema klase II Serijski broj Grani na vrednost atmosferskog pritiska Medicinsko sredstvo Grani na vrednost vla nosti Prevod Pulsair Intellipuff tono...

Страница 112: ...zovanog paketa vazduha ka centralnom delu ro nja e i detekciju unapred definisane deformacije ro nja e opti kim sredstvima i refleksijama od povr ine ro nja e 1 2 NAMENA SVRHA INSTRUMENTA Beskontaktni...

Страница 113: ...eno napajanje kompanije Keeler EP29 32777 ili instrument mo e da se pokvari Ne uklanjajte nalepnice koje pokrivaju otvore za klju eve osim ako ne montirate Pulsair IntelliPuff na zid Vlasnik instrumen...

Страница 114: ...a proizvoda odlo ite na otpad prema lokalnim smernicama za za titu ivotne sredine WEEE 2 3 KONTRAINDIKACIJE Ne postoji ograni enje u pogledu grupe pacijenata za koju se mo e koristiti ovo medicinsko s...

Страница 115: ...stim nosa em za montiranje na zid 1 Nosa ima etiri rupe koje omoguc avaju da se bezbedno pri vrsti na odgovarajuc i zid ili vertikalnu povr inu 2 Pa ljivo izaberite lokaciju za va IntelliPuff posebno...

Страница 116: ...iste uklju ili ili isklju ili Pulsair IntelliPuff pritisnite dugme za uklju ivanje isklju ivanje zelena LED lampica c e pokazati da je jedinica uklju ena 2 Testno oko Ovo je korisno za obuku korisnika...

Страница 117: ...konaponski kabl za napajanje koji se nalazi na zadnjoj strani instrumenta koristec i samo izvore napajanja kompanije Keeler 7 Naslon za elo Pritisnite da biste otpustili ili pritisnite da vratite nasl...

Страница 118: ...te pristupili opcijama korisni kog menija Pogledajte strana 119 za kompletna uputstva o opcijama korisni kog menija 11 Dugme za pregled Easy Pulse dugme Dugme za pregled R ima dvostruku funkciju Pregl...

Страница 119: ...o vodi kada poravnavate pacijentovo oko za uzimanje o itavanja 8 PROCEDURA MERENJA 8 1 PRIPREMA URE AJA 1 Uklju ite kabl za napajanje u tonometar Uti nica za napajanje se nalazi na zadnjoj strani tono...

Страница 120: ...suzni film 2 Uverite se da pacijent i optika tonometra nisu postavljeni ispod direktnog osvetljenja tj reflektora ili sun eve svetlosti 3 Uverite se da su o i pacijenta potpuno otvorene Ovo poma e u...

Страница 121: ...se ne postignu uzastopna o itavanja unutar 1 mmHg jedno od drugog kompanija Keeler preporu uje da se izvr e do etiri o itavanja 9 Kada su dva uzastopna o itavanja unutar 1 mmHg uc e se zvu ni signal k...

Страница 122: ...ju na ekranu nema indikacije da je o itavanje prvo ili prose no za vi e od 1 IOP vec i od 25 mmHg Kada se detektuje pritisak IOP vec i od 25 mmHg jedinica c e prikazati 25 ja ina mlaza e automatski bi...

Страница 123: ...preko poklopca tampa a povucite ivicu na vrhu poklopca i ne no povucite prema sebi da biste otvorili poklopac tampa a Uklonite praznu rolnu papira 2 Stavite novu rolnu papira u dr a papira pazec i da...

Страница 124: ...rmat XX XX X Potpuno samotestiranje IZVR I TEST TESTIRATI EKATI Poslednji izbor iznad opcije Izvr i test izabran pritiskom na dugme DEMO pokrenuo bi program samotestiranja oko 45 sekundi iji bi rezult...

Страница 125: ...ima Kvar je nastao usled gre ke u proizvodnji Instrument i pribor su kori eni prema ovim uputstvima Dokaz kupovine je prilo en uz zahtev Proizvo a odbija svaku odgovornost i garanciju ako se instrumen...

Страница 126: ...misije treperenja IEC 61000 3 3 Usagla eno 16 2 ELEKTROMAGNETNA OTPORNOST Smernice i deklaracija proizvo a a elektromagnetna otpornost Pulsair IntelliPuff tonometar kompanije Keeler je namenjen za upo...

Страница 127: ...meni ne struje pre primene ispitnog nivoa Ispitivanje otpornosti Ispitni nivo IEC 60601 Nivo usagla enosti Elektromagnetno okru enje smernice Prenosna i mobilna RF komunikaciona oprema ne sme se koris...

Страница 128: ...a kompanije Keeler Pulsair IntelliPuff tonometar kompanije Keeler namenjen je za upotrebu u elektromagnetnom okru enju u kom su kontrolisane emitovane RF smetnje Kupac ili korisnik Pulsair IntelliPuff...

Страница 129: ...acijenta Prikazana skala Skrolovanje ta kaste matrice sa 4 znaka Sistem osvetljenja LED infracrvena Du ina pup ane vrpce 2m Uskla eno sa Elektri na bezbednost medicinska oprema IEC 60601 1 Elektromagn...

Страница 130: ...e elektri ne i elektronske opreme Simbol na proizvodu ili njegovom pakovanju i u uputstvu ukazuje na to da se ovaj proizvod ne sme tretirati kao otpad iz doma instva Da bi se smanjio uticaj otpada od...

Страница 131: ......

Страница 132: ...ornierstrasse 11 CH 9423 Altenrhein Switzerland REP EC Keeler Europe Distribution S L Colom 453 Nau D50 08223 Terrassa Spain India Office Keeler India Halma India Pvt Ltd Plot No A0147 Road No 24 Wagl...

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