Canon CR-2 manuale d’uso

Digital Retinal C amera Operat ion Manual Make sure you read this manual before u sing the instru ment. Keep this manual in a s afe place so that you ca n use it in the fu ture.[...]

2 Tha nk yo u for pu rcha sin g the Ca non D igi tal R etin al Ca mer a CR-2 (referred to as “CR-2” in this man ual ). The ope rati on ma nua ls for th is in stru me nt con sis t of the “D igi ta l Retin al Ca mer a CR-2 Op erati on Ma nu al” a nd the “ Retin al i magi ng co ntrol s of t ware N M 2 Op erati on M anu al. ” Be sure to rea[...]

3 1 In t ro d uc t i on ................................................................................................. 4 Featur es ...................................................................................................... 4 Indicati ons for U se ..................................................................................... 4 C[...]

4 F eatures The Canon Digital Ret inal Camera CR- 2 takes digital pho t ographic re tinal images o f patient’ s eyes acro ss a n ang le of v iew of 45 d eg ree s, in a n atura ll y dil ated state wi thou t us ing myd ri atic s. Th e CR-2 has th e foll owin g featu res: Reduced flash intensit y Th e CR-2 can ta ke imag es at IS O 80 0/1 6 0 0 at t[...]

1 Introduction 5 Checking Included Items Digital Retinal Camera CR-2 Main unit Di git a l ca me ra c over Protects the c ab le th at is connected t o the digital camera. Digital camera Di git al c am er a spe ci al ize d for the CR-2 . Chin rest paper 1 0 0 s he ets prov id ed. Power c or d Con ne cts the C R-2 t o an AC outl et. (3 m ) USA an d Ca[...]

6 1 Introduction Con v entions Used in This Manual Sy mbols to i ndica te safet y prec aut ions Thi s ma nua l use s the fo llow ing sy mb ols to ind icate sa fet y prec au tion s that are i mpo r ta nt for u sin g the CR-2 safel y . A lways fol low the ad vi ce in th es e safet y p rec auti ons. WA R N I N G A war nin g that inc or rec t ope rati [...]

7 2 Safe t y Regulatory Information Th e foll owin g se ctio ns lis t the cl as si fi catio ns a ppl ica bl e to the CR-2 and the di rec tive s and s tan da rds that the CR -2 compli es w ith. Device Classification Protectio n ag ain st el ec tri c sh ock Cla ss I e qui pm ent De gre e of protec tion a ga inst e le ctr ic s ho ck T ype B a pp lie d[...]

8 2 Safe t y European Union 93/ 42/EE C Medical Device Directiv e E N 6 0 6 0 1-1 : 19 9 0 + A 1: 19 9 3 + A 2: 19 9 5 EN 6060 1 - 1 : 2 006 Me dic al e le ctr ica l eq uip me nt – Par t 1 : G en er al requ irem ents fo r safet y IEC 60 6 01 - 1 - 1 : 2001 Me dic al e le ctr ica l eq uip me nt – Par t 1 - 1 : G en er al requ irem ents fo r safe[...]

2 Safe t y 9 Safety Precautions T o p revent i nju ri es a nd da ta los s, op erate the C R-2 corre ctl y by follow ing th e safet y p rec au tion s. WA R N I N G T o avoid t he r is k of ele ct r ic s hock , t hi s eq ui pm ent m us t on ly be co nn ec ted to a s u pp ly m ai ns wi t h pr otec t ive ear t h. Prohibited Do not da ma ge t he p ower [...]

10 2 Safe t y WA R N I N G Prohibited Do not us e a power s u pp ly volt a ge ot he r t ha n th at s p eci fi ed on t he r at i ng la b el. Do no t use any pow er cord other than the one supplied. Use the p ower vol tag e sp eci f ied o n the rati ng la be l. Oth er wise, f ire or e le ctr ic sh oc k may r esult. Th e sup pli ed p ower c ord is d e[...]

2 Safe t y 11 CAUTION Prohibited Do not in st a ll in l oca t ion s expos ed to wa te r , ste am , moi st ur e or dust. Doing so ma y cause problems or malfunctions. Prohibited Do not in st al l in lo cat i ons exp ose d to sa lt , s ul fu r or co rr osi ve gas. Doing so ma y result in corrosion o f th e instrument , problems or malfunct ions. Proh[...]

12 2 Safe t y CAUTION K eep the forehe ad rest and chin rest clean. T o p revent th e ri sk of infe cti on, wip e the fore he ad res t wi th dis infec tant eth an ol for eac h patie nt. T o e ns ure cl ea nli ne ss, re pla ce the c hin re st pa pe r for e ach p atie nt. If the ch in re st pap er i s not be ing u sed, b e sure to dis infec t the c h[...]

2 Safe t y 13 Notes on Using CR-2 Digital camera • The attached digital camera is designed for the CR - 2. The specifications differ from commercially available Canon digital cameras. Use only for obse r ving and taking phot ographs of peoples ’ ey es. Do not detach t he digital camera fr om t he main unit to use separat ely . Other wise, failu[...]

14 2 Safe t y Environment of use • Use, store, and tra nsp or t th e CR-2 in an env iro nme nt that is w ith in the r ang e of the fo llow ing con diti ons. Use th e or igin al pa cka gin g to store or ship i t. T emperature Humidity At mospheric pressure Enviro nme nt of u se 1 0 to 35°C 30 to 90% RH (no con de nsati on) 7 00 to 1 06 0 hPa Stor[...]

2 Safe t y 15 Dis posa l Dis pos al of th is pro du ct in a n un law f ul m ann er m ay have a ne gati ve imp act o n hum an h ea lth a nd on the e nvi ronm ent. Th erefo re, whe n dis po sin g of this p rodu ct, be ab sol utel y ce r ta in to follow th e procedure which conf orms with the laws and regulat ions applicable to your area. Eur op ea n [...]

16 2 Safe t y Rat ing La bel D isp lay Th e pos itio n and c ontents of th e la be l at tach ed o n the CR-2 is sh own be low . Foll ow the info rm ation o n the l abe l to use th e CR-2 appro pri ately . Th e foll owin g tab le d es cri be s the m ar ks an d ind icati ons o n the ra ting l abe l. Alternating current Ty p e B Class I device indicat[...]

17 Retinal C amera 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1 Dig ita l ca mer a 2 Po wer s witch for the digital camera 3 Di gi tal c am er a cove r 4 Obser vation monit or For v iew in g the a nte ri or s eg me nt a nd re tin a. 5 Op erati on leve r 6 Sh ut ter rel ea se bu t ton 7 Alignment button Sw itch e s bet we e n a vi ew of th e an te[...]

18 3 Na mes of Pa r ts 19 20 21 23 22 25 24 26 27 d c b a 1 9 Co nn ec tor for ex ter na l eye fi xati on la mp (wi th ca p) Connector for t he e xternal ey e fixat ion lamp (sold separately) . 20 Forehe ad rest 2 1 Objective lens 22 Objectiv e lens cap 23 H ea d re s t 24 C h i n r e s t 25 I nde ntatio n for li f tin g 26 D io pter com pe ns atio[...]

3 Na mes of Pa r ts 19 Operation Panel 3 5 4 1 2 8 7 6 1 Flash int ensity button/lamp + : F la sh i nten si t y in cre a se s. –: Flash int e nsity decreases. 2 Obser vation light brigh tness butt on/lamp + : Obser vation light brightness incr eases. –: Obser vation light brightness decreases. 3 x 2 ph otogra phy bu t ton/ la mp Ena bl es x 2 p[...]

20 3 Na mes of Pa r ts Obser vation Monitor During anterior segment obser vation 1 2 3 4 5 6 1 Photogr aphy re ady l amp Gre e n: Rea dy to s ho ot Re d: Not re ad y to sh oot 2 Pupil alignment circles 3 Obser vation light brigh tness indicat or 4 Lef t /rig ht eye ind ic ator R: Rig ht eye L: Lef t e ye 5 Di opter c omp en satio n k nob p osi tion[...]

21 Flow of Opera tion Th e fl ow of ope rati ons fo r retina l ph otogra phy is a s foll ows. Con ne ct the c ab le s if n ec es sa r y a s de scr ib ed in “C on nec ting Ca bl es” (see p age 22) . Prepa ri ng for a n E xa min ation ( pa ge 22) Patient S etup ( pag e 2 4 ) Ali gn me nt (pa ge 25) Sma ll Pup il Photogr ap hy Functi on (p age 3 0[...]

22 4 Basic Operations Connecting Cables Connect the CR- 2 to a computer in which the supplied so ft ware , the Rics NM 2 , has been installed. WA R N I N G • Do not plug or unplug the po wer plug with wet hands. • Do not u se any p ower c ord othe r tha n the o ne su ppl ie d. Oth er wis e, fire or e le ctr ic s hoc k may res ult. 1 Make sure t[...]

4 Basic Operations 23 3 Remove the objective lens cap an d turn the retinal came ra' s power switch to the ON position. Th e POWER la mp l ights a nd th e set la mp b lin ks. Th e CR-2 automatic al ly do e s an in itia liz atio n seq ue nc e (inter na l che ck a nd in itia liz atio n of dr iv ing pa r ts). After the i ni tial izati on the pa r[...]

24 4 Basic Operations 7 Disinfe ct the forehe ad rest a nd replace the c hin rest pa per . If chi n rest p ape r is n ot bei ng us ed, dis infe ct the c hin re st a lso. CAUTION • T o p revent th e ri sk of infe cti on, wip e the fore he ad res t wi th dis infec tant eth an ol for e ach p atie nt. For det ail s on how to dis infe ct, cons ult a s[...]

4 Basic Operations 25 Alignment 1 Align the retinal c amer a with the eye t o be photogra phed. CAUTION Whe n adj ustin g the po siti on of th e retina l ca mer a in the f ront-back di rec tion, sl owly b ri ng the m ain uni t clo se r to the patie nt wh ile l ook in g at the pati ent ’ s eye f rom th e sid e. The p atie nt’ s eye may be inju r[...]

26 4 Basic Operations 2 Tilt the operation lever for ward or back ward to unif y the top and bottom of the image of the pupil. Whe n th e pup il is s ma ll er th a n the i nne r pu pil a lig nm en t cir cl e, ima ge s ca nn ot be t ake n properly . Dar ken the ro om f ur ther to dil ate the patie nt's pupi l more. If the p atie nt's pupil[...]

4 Basic Operations 27 5 Have the patient stare at the interna l eye fixation lamp to fix the par t for the photogr aph. T a ke the fol lowi ng step s to guide th e pati ent’s eye : Pre ss th e FIX T A RGE T b ut tons up, down, lef t, and rig ht to move the inter na l eye f ixati on la mp to you r de sire d pos iti on an d the n pre ss th e set bu[...]

28 4 Basic Operations Ph ot ograph y 1 Do a prelimina r y ch eck b efore ta king photos. a. Th e photogr aphy re ady l am p lig hts gre en. b. The wo rk in g dis tan ce d ots app ea r sh ar pe st. c. Th e wor ki ng di sta nc e dots are o n the ex te nsi on li ne of the W D gu ide s. d. The s pli t lin es fo rm a s ing le li ne. a b,c d Photography [...]

4 Basic Operations 29 Finishing an Examination 1 Save the images on the Rics NM 2 an d end the examination. Th e set la mp s tar ts bli nk ing a nd the o bse r vati on mo ni tor turn s of f. CAUTION T he m ain u nit a nd th e chi n rest m ove to the center p osi tion w he n a stud y is f in ish ed w ith the contro l sof t wa re. Do not touc h the m[...]

30 The section describes ho w t o use x2 phot ography , small pupil pho t ography funct ion, diopt er compensation , and ant erior segment phot ography . Instructions are also included f or connecting an optional external monitor . x2 P ho to gr a p h y Y ou ca n ta ke and s ave imag es th at are w ithi n the x 2 ph otogra phy ra nge o n the ob se [...]

5 Photogr ap hy Auxilia r y Function s 31 2 T ake the image. Pres s the sm al l pup il ph otogra phy bu t ton aga in to fi nis h the s mal l pup il ph otogra phy . • Do not u se the s ma ll pu pil p hotogra phy f unc tion i f the p atie nt's pupil is l arg e eno ug h. The i mag e will be o vere xposed. • Th e imag e may c onta in f la re a[...]

32 5 Photogr ap hy Auxilia r y Function s Ante rior S egment Photogr ap hy Th is fu ncti on m akes i t pos si ble to photog rap h the a nteri or se gm ent. It is a lso p oss ibl e to use the x 2 photogr ap hy fun ctio n at the s am e time. Do not a llow ex ter na l lig ht that c onta ins i nfr are d to enter the p osi tion b ei ng ph otogra ph ed. [...]

5 Photogr ap hy Auxilia r y Function s 33 1 Remove the digital camer a cover . 2 Connec t the HDMI cable to the digital ca mer a. 1 . Securely insert the HDMI cable int o the HDMI mini out put t erminal on the digital camera. 2 . Fit th e HDM I ca ble i nto the spa ce in th e cove r , a nd p lac e the c abl e in th e notch. Not ch 3 Attac h the dig[...]

34 Th is se ctio n ou tlin es the m ai ntena nce i nstr uc tion s for the C R-2 : d ail y ins pe ctio n, cle an ing, disinfecting , refilling chin rest paper , and removing/installing the digital camera. CAUTION • For safet y re as ons, b efore u sin g the CR-2 , be su re to per fo rm th e da ily i nsp ec tion. • Have a pe ri odi ca lly i nsp e[...]

6 Main tena nce 35 Cleani ng th e Object ive Lens • Do not w ipe o r ru b the obj ec tive le ns i f the re is dir t or du st on i t. Doin g so co uld s cratch th e sur face of th e le ns. • Do not w ipe th e obje cti ve le ns wi th dis infec ta nt ethan ol, eyegl as s cle a ner , o r sil ico ne -co ated pap er . D oin g so c oul d cor rod e the[...]

36 6 Main tena nce Cleani ng th e Image Se nsor The digital camera has a self -cleaning sensor unit . Dirt and dust on the fr ont surface of t he imaging sen sor a re au tomatic al ly re moved w he n the p ower is tu rn ed o n or of f. Thi s fu ncti on m akes i t pos si ble to remove the ma jo rit y of d ir t a nd d ust th at may inter fere w ith i[...]

6 Main tena nce 37 Disinfecting the F orehead Rest CAUTION • T o p revent th e ri sk of infe cti on, wip e the fore he ad res t wi th dis infec tant eth an ol for e ach p atie nt. • Th e foreh ead re st may b e cor rod ed if a d isi nfec tant oth er th an etha nol i s use d. For det ail s on how to dis infe ct, cons ult a s pe ci ali st. Use a [...]

38 6 Main tena nce Remo ving the digital camera 1 T ur n of f the power to the retinal came ra and re move the plug from the AC outlet. 2 Loose n the cover screw and remove the digital cam era cove r . 3 Remove the cables from the digital ter minal and the remote control terminal. 4 Remove the DC coupler . 1 . Open the batt er y compartment cov er [...]

6 Main tena nce 39 Installing the digital camera 1 First b e sure to check the following items. • Th e power to the reti nal c am er a is of f. • Th e power p lug of th e retina l ca me ra is n ot plug ge d into an e lec tri c outl et. 2 Attac h the digital ca mera to the retinal ca mer a. 1 . Align the posit ions o f the mounting alignment mar[...]

40 If any of the sy mptoms li sted he re oc cur s or i f a war nin g app ea rs i n the R ics N M 2 wh ile u sin g the CR-2 , tr y the re leva nt reme dy d es cr ibe d be low . If thes e rem ed ie s do not e limi nate the sy mptoms or th e war nin g, turn of f the powe r an d cont act your s al es re pre se ntative o r lo ca l Cano n de al er . B e [...]

7 T roubleshooting 41 Sym ptom Cause a nd re med y Th e spl it li ne s do not a lig n. The diopt er patient ' s eye is out side the range of – 1 0 to + 1 5 D. Use the d iopter c omp en satio n fu ncti on, tur n the foc us r ing, an d focu s on the p osi tio n whe re the i mag es of th e retina l ook c le ar at the sa me tim e. Cannot cap tur[...]

42 Specif ications Field angle 45 ° Phot ographic magnification 1 . 1 x (image size on the sensor) Req uire d pu pil d iam eter 4. 0 mm or gr eater (3.3 mm w he n usi ng sm all p up il ph otograp hy fun ctio n) Working distance 35 mm Focu s adju stme nt ra nge – 1 0 to + 1 5 D (w itho ut c omp en satio n le ns) – 3 1 to – 7 D (whe n us ing n[...]

Appendix 43 EMC (Electromagnet ic Compat ibilit y) Th e CR-2 is des ign ed a nd tested to co mpl y wi th IEC 60 6 01 - 1 -2 (EN 60 601 - 1 -2 ), the app lic ab le re gul ation s reg ardi ng EMC for medical devices. The CR- 2 needs to be installed and pu t int o ser vice according t o the EMC information stated as foll ows. If this e qui pme nt c au[...]

44 Appendix Gui danc e and M anu fact ur er ’ s Declar at ion for E lec tr omagnet ic E miss ion Th e CR-2 is intend ed fo r use i n the e lec trom agn etic e nviro nme nt s pe cif ie d be low . Th e custom er o r the us er of th e CR-2 shou ld as sure th at it is u se d in su ch a n env iron men t. Emission T est Compliance Electr omagnetic Envi[...]

Appendix 45 Gui danc e and M anu fact ure r ’ s D ecla rat ion fo r Elec tr omagnet ic Im muni t y Th e CR-2 is intend ed fo r use i n the e lec trom agn etic e nviro nme nt s pe cif ie d be low . Th e custom er o r the us er of th e CR-2 shou ld as sure th at it is u se d in su ch a n env iron men t. Immunity T e st IEC 6060 1 Te s t L e v e l C[...]

46 Appendix Gui danc e and M anu fact ure r ’ s D ecla rat ion fo r Elec tr omagnet ic Im muni t y Th e CR-2 is intend ed fo r use i n the e lec trom agn etic e nviro nme nt s pe cif ie d be low . Th e custom er o r the us er of th e CR-2 shou ld as sure th at it is u se d in su ch a n env iron men t. Immunity T e st IEC 6060 1 Te s t L e v e l C[...]

Appendix 47 Recommended Separation Distances be t ween P or t able and Mobile RF Commun icat ion s Equi pme nt and D evices or t he CR-2 Th e CR-2 is intend ed for u se i n an e lec trom agn etic e nviro nme nt in w hi ch rad iated R F dist urb anc e s are co ntrol led. Th e custom er o r the us er of th e CR-2 can h elp p revent e le ctro mag neti[...]

48 Appendix W arrant y and Repair Service Ser vice life Th e ser vi ce li fe of this p rod uct i s ei ght ye ar s if sp ec if ie d ins pe cti ons a nd ma inten an ce a re don e. About r epai rs If a problem canno t be solved even after taking t he measures indicat ed in “7 T roubleshooting ” ( see page 40), conta ct you r sa les re pre se ntati[...]

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*L-IE-51 76 C* CAN ON I NC. Me di ca l Equi pm ent G r oup 30 -2 , S him oma ru ko 3-ch ome, Oht a-ku, T ok yo 1 46 -85 01 , Jap an T elephone: ( 8 1 )-3-3 75 8- 2 1 1 1 Dis trib uted by: CANON U .S.A ., INC. Healthcare Solutions Division 1 5955 A lton Pa rk way , Ir vin e, CA 926 1 8, U. S.A . T elephone: ( 1 )-949- 7 53-4 1 60 CAN ON EUR OPA N. V[...]