Benutzeranleitung / Produktwartung CR-2 des Produzenten Canon
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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.
3 1 In t ro d uc t i on ................................................................................................. 4 Featur es ...................................................................................................... 4 Indicati ons for U se .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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) .
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.
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 circle.
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) .
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.
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).
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.
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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 .
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.
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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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