Keeler D-KAT Z Instructions For Use Manual Download Page 56

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EP59-11410 Issue B

Date of Issue 3/3/2023

Contact

Manufacturer

Keeler Limited

Clewer Hill Road

Windsor

Berkshire

SL4 4AA UK

Freephone

0800 521251

Tel

+44 (0) 1753 857177

Fax

+44 (0) 1753 827145

USA Sales Office

Keeler USA

3222 Phoenixville Pike

Building #50

Malvern, PA 19355 USA

Toll Free

1 800 523 5620

Tel

1 610 353 4350

Fax

1 610 353 7814

Representatives

REP

Medicel AG, Dornierstrasse 11

CH -9423 Altenrhein, Switzerland

REP

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

Wagle Industrial Estate

Thane West – 400604, Maharashtra

INDIA

Tel

+91 22 4124 8001

SGS United Kingdom Ltd

Inward Way, Rossmore Business Park

Ellesmere Port, Cheshire, CH65 3EN

United Kingdom

Tel +44 (0) 151 350 6666

Notified Body

1639

0120

China Office

China Office

Halma China Group

名称：沃迈（上海）机电有限公司
地址：上海市闵行区元科路

155

号

幢一层

电话：

021‐61519088

SGS Belgium NV

SGS House, Noorderlaan – 87,

Antwerp, 2030, Belgium

Tel +32 3 545 44 00

Summary of Contents for D-KAT Z

Page 1: ...EN RO Keeler Digital Applanation Tonometer D KAT Z type INSTRUCTIONS FOR USE...

Page 2: ......

Page 3: ...EN RO Tonometru D KAT tip Z Instruc iuni de utilizare 26 D KAT Z Type Tonometer Instructions For Use 1...

Page 4: ......

Page 5: ...Y STATUS 11 7 MEASUREMENT PROCEDURE 11 7 1 INSTALLATION ON TO THE SLIT LAMP 11 7 2 PREPARING THE PATIENT 12 7 3 PREPARING THE SLIT LAMP INSTRUMENT FOR EXAMINATIONS AT 10X MAGNIFICATION 13 7 4 USING TH...

Page 6: ...KAT Z Type Tonometer by KEELER 13 SERVICING AND CALIBRATION 22 13 1 BATTERY REPLACEMENT 22 14 WARRANTY 23 15 TECHNICAL SPECIFICATIONS 23 16 ACCESSORIES AND SPARES 24 17 PACKAGING AND DISPOSAL INFORMAT...

Page 7: ...in the European Community REP CH Authorised representative in Switzerland Catalogue number Serial number Translation Medical device The Keeler D KAT Z Type Tonometer is designed and built in conformit...

Page 8: ...ucoma The Digital Keeler Applanation Tonometer D KAT Z type is intended to determine the intraocular pressure IOP by exerting an external force against the eye which provides reading of the resistance...

Page 9: ...ons in order to ensure safe operation of the instruments WARNINGS Never use the instrument if visibly damaged and periodically inspect it for signs of damage or misuse Check your Keeler product for si...

Page 10: ...e is intended to be used only by suitably trained and authorised healthcare professionals This product should not be immersed in fluid Electrical equipment can be affected by electromagnetic interfere...

Page 11: ...estriction to patient population this device can be used with and there are no known contraindications associated with the device Do not use contact tonometry on those with ruptured globe corneal lesi...

Page 12: ...ometer prism is physically clean before exposed to the disinfection process 1 min 3 Immerse the Tonometer prism in the disinfectant fluid Types of disinfectant fluid vary 4 Rinse the disinfectant from...

Page 13: ...using the following Alcohol Acetone UV radiation Sterilisation Immersion in fluid for more than one hour Temperatures greater than 60 C 4 TONOMETER PRISM FIELD CHECK Check the Tonometer prism under t...

Page 14: ...reading The D KAT can be switched off by pressing the function button again The unit will power down when not in use after 3 minutes 6 2 CHANGING DECIMAL POINT SETTING Turn on the D KAT and press the...

Page 15: ...ced immediately The battery should be replaced using a 1 5V AA Alkaline type 7 MEASUREMENT PROCEDURE 7 1 INSTALLATION ON TO THE SLIT LAMP 1 Secure the tonometer mount onto the slit lamp using the prov...

Page 16: ...roll orientation If the ZKAT is in more than 1 degree roll adjust the mounting of the slit lamp 8 Re check ZKAT prism is still concentric to the viewing optics re adjust if required 7 2 PREPARING THE...

Page 17: ...ribed in section 3 of this document Check prisms for damage prior to use 7 3 PREPARING THE SLIT LAMP INSTRUMENT FOR EXAMINATIONS AT 10X MAGNIFICATION Before beginning measurement check that the eyepie...

Page 18: ...the centre of the cornea in the area above the pupil The limbus will be illuminated with a bluish light The examiner will be able to better directly observe this phenomenon from the opposite side As...

Page 19: ...ing measurement The pressure reading is higher than the real intraocular pressure Correction Move the slit lamp back and dry the measuring prism with a wad of sterile cotton wool or lint free cloth Ca...

Page 20: ...surement the slit lamp is moved forward toward the patient or the patient moves toward the slit lamp the sensor arm will be pushed into contact with a stop spring and an audible alarm will sound The a...

Page 21: ...l the two fluorescein semi circles are equal in size The measurement pressure will then be reduced 8 4 THE INSIDE MARGINS OF THE FLUORESCEIN RINGS ARE NOT ALIGNED AND TOUCHING Cause The semicircular i...

Page 22: ...e tonometric examination is not unpleasant When correctly anaesthetised and with their eyes fully open the patient will feel absolutely nothing Therefore we recommend running a preliminary measurement...

Page 23: ...corneal astigmatism of 6 5mm 30 52 diopters 30 and 8 5mm 120 40 diopters 120 the 120 prism value will be aligned with the 43 A mark on the prism support For corneal astigmatism of 8 5mm 30 40 diopter...

Page 24: ...heck is made using the Test arm Figure 5 The arm is engraved with 5 rings The centre ring corresponds to 0 mmHg the immediate left and right rings correspond to 20 mmHg and the outer rings correspond...

Page 25: ...drum in the direction of the arrow until the LED display reads 20 Then continue to rotate the drum slowly until the measurement arm moves backwards Check to ensure the display reads between 19 and 21...

Page 26: ...uthorised service centre or distributor There are no user serviceable parts in this instrument Service manuals will be available to authorised Keeler service centres and Keeler trained service personn...

Page 27: ...manufacturer s instructions There are no user serviceable parts in this instrument Any servicing or repairs should only be carried out by Keeler Ltd or by suitably trained and authorised distributors...

Page 28: ...IONS 55 C 10 C 95 10 1060 hPa 700 hPa TRANSPORT CONDITIONS 70 C 40 C 95 10 1060 hPa 500 hPa Vibration sinusoidal 10 Hz to 500 Hz 0 5g Shock 30 g duration 6 ms Bump 10 g duration 6 ms 16 ACCESSORIES AN...

Page 29: ...mental impact of WEEE Waste Electrical Electronic Equipment and minimise the volume of WEEE entering landfills we encourage at product end of life that this equipment is recycled and reused If you nee...

Page 30: ...BATERIE 36 7 PROCEDUR DE M SURARE 36 7 1 INSTALAREA PE LAMPA CU FANT 36 7 2 PREG TIREA PACIENTULUI 37 7 3 PREG TIREA INSTRUMENTULUI LAMP CU FANT PENTRU EXAMIN RI LA M RIRE DE 10X 38 7 4 UTILIZAREA IN...

Page 31: ...ru D KAT tip Z de la KEELER RO 13 NTRE INERE I CALIBRARE 47 13 1 NLOCUIREA BATERIEI 47 14 GARAN IE 48 15 SPECIFICA II TEHNICE 48 16 ACCESORII I PIESE DE SCHIMB 49 17 INFORMA II PRIVIND AMBALAREA I ELI...

Page 32: ...omunitatea European REP CH Reprezentat autorizat n Elve ia Num r de catalog Num r de serie Traducere Dispozitiv medical Tonometrul Keeler D KAT tip Z este proiectat i construit n conformitate cu Direc...

Page 33: ...ostic ri glaucomului Aplanotonometrul digital Keeler D KAT tip Z este destinat determin rii presiunii intraoculare PIO prin exercitarea unei for e externe asupra ochiului care ofer indica ii privind r...

Page 34: ...ATEN ION RI Nu utiliza i niciodat instrumentul dac este vizibil deteriorat i verifica i l periodic pentru depistarea semnelor de deteriorare sau de utilizare gre it nainte de utilizare verifica i pro...

Page 35: ...toriza i Acest produs nu trebuie imersat ntr un lichid Echipamentele electrice pot fi afectate de interferen e electromagnetice Dac acest lucru se nt mpl n timp ce se utilizeaz acest echipament opri i...

Page 36: ...en i la care acest dispozitiv poate fi utilizat i nu exist contraindica ii asociate cu dispozitivul Nu utiliza i tonometria de contact la persoanele cu ruptur de glob ocular leziuni corneene ulcer sau...

Page 37: ...gura c aceasta este curat din punct de vedere fizic nainte de a fi expus procesului de dezinfec ie 1 min 3 Imersa i prisma tonometrului n lichidul dezinfectant Tipurile de lichide dezinfectante sunt v...

Page 38: ...produsele sau mijloacele urm toare alcool aceton radia ie UV sterilizare imersie n lichide timp de mai mult de o or temperaturi mai mari de 60 C 4 VERIFICAREA PRISMEI TONOMETRULUI PE POZI IE Verifica...

Page 39: ...va prezenta o valoare nominal D KAT poate fi oprit prin ap sarea nc o dat a butonului func ional Unitatea se va opri dup 3 minute dac nu este utilizat 6 2 MODIFICAREA SET RII VIRGULEI ZECIMALE Porni...

Page 40: ...trebuie nlocuit cu una de tip alcalin AA de 1 5 V 7 PROCEDUR DE M SURARE 7 1 INSTALAREA PE LAMPA CU FANT 1 Fixa i suportul de montare a tonometrului pe lampa cu fant folosind urubul mare de blocare fu...

Page 41: ...s fie de maximum 1 grad n cazul n care nclinarea fa de orizontal a ZKAT este mai mare de 1 grad regla i suportul de montare al l mpii cu fant 8 Reverifica i dac prisma ZKAT continu s fie centrat cu si...

Page 42: ...cur ate nainte de prima utilizare conform descrierii din sec iunea 3 din acest document Verifica i prismele pentru eventuale deterior ri nainte de utilizare 7 3 PREG TIREA INSTRUMENTULUI LAMP CU FANT...

Page 43: ...spre nainte pentru a aduce prisma de m surare n contact cu centrul corneei n zona de deasupra pupilei Limbul va fi iluminat cu o lumin alb struie Examinatorul va putea s observe mai bine direct acest...

Page 44: ...Presiunea indicat este mai mare dec t presiunea intraocular real Corectare Deplasa i lampa cu fant spre napoi i usca i prisma de m surare cu un tampon cu vat steril sau cu o lavet care nu las scame C...

Page 45: ...lampa cu fant este deplasat spre pacient sau dac pacientul se deplaseaz spre lampa cu fant bra ul cu senzor va fi mpins i va intra n contact cu un arc de blocare i se va auzi o alarm sonor Suprafa a...

Page 46: ...cele dou semicercuri de fluorescein au dimensiuni egale Astfel presiunea de m surare se va reduce 8 4 MARGINILE INTERIOARE ALE INELELOR DE FLUORESCEIN NU SUNT ALINIATE I NU SUNT N CONTACT Cauz Imagini...

Page 47: ...etric nu este nepl cut Dup ce pacientul a fost anesteziat corect i are ochii larg deschi i acesta nu va mai sim i absolut nimic Prin urmare recomand m realizarea unei proceduri preliminare de m surare...

Page 48: ...tru un astigmatism cornean de 6 5 mm 30 52 dioptrii 30 i 8 5 mm 120 40 dioptrii 120 valoarea de 120 a prismei va fi aliniat cu marcajul 43 A de pe suportul prismei Pentru un astigmatism cornean de 8 5...

Page 49: ...e se realizeaz folosind bra ul de calibrare Figura 5 Pe acest bra sunt gravate 5 inele Inelul central corespunde 0 mmHg inelele aflate imediat n dreapta i n st nga corespund 20 mmHg iar inelele exteri...

Page 50: ...ec ia s ge ii p n c nd afi ajul LED indic 20 Apoi continua i s roti i u or tamburul p n c nd bra ul de m surare se deplaseaz napoi Verifica i pentru a v asigura c afi ajul indic o valoare cuprins ntre...

Page 51: ...istribuitor Acest instrument nu con ine componente care pot fi reparate de utilizator Manualele de service vor fi puse la dispozi ia centrelor de service autorizate de Keeler i personalului de service...

Page 52: ...ui Acest instrument nu con ine componente care pot fi reparate de utilizator Orice lucr ri de service sau de repara ie trebuie efectuate doar de Keeler Ltd sau de distribuitori instrui i n mod corespu...

Page 53: ...ARE 55 C 10 C 95 10 1060 hPa 700 hPa CONDI II DE TRANSPORT 70 C 40 C 95 10 1060 hPa 500 hPa Vibra ie sinusoidal 10 Hz 500 Hz 0 5g oc 30g durata 6 ms Lovire 10g durata 6 ms 16 ACCESORII I PIESE DE SCHI...

Page 54: ...ctrice i electronice asupra mediului i pentru a minimiza volumul de DEEE care ajung la gropile de gunoi ncuraj m reciclarea i reutilizarea acestui echipament la sf r itul duratei de via a produsului D...

Page 55: ......

Page 56: ...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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