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Appendix 

 

   bon 

E-20 

SE 

 

EU - KONFORMITÄTSERKLÄRUNG 

 

 

EC – DECLARATION OF CONFORMITY 

 

 

 

Hersteller-Adresse: 

(Manufacturer adress) 

bon  
Optic Vertriebsgesellschaft mbH 
Stellmacherstraße 14 
D-23556 Lübeck

 

 

 

Untersuchungs-/Behandlungsplatz (18-014) 

Gerätetyp / UMDNS-CODE: 

(Device typ/ UMDNS-CODE) 

 

 

Gerätebezeichnung: 

(Device name) 

Refraktionseinheit bon E-20/E-20 SE 
Refraction unit bon E-20/E-20 SE 

 

 

Klassifizierung: 

(Classification) 

1

 (Richtlinie 93/42/EWG, Anhang IX, Regel 1) 

1

 (MDD 93/42/EEC, annex IX, rule 1) 

 

 

Wir erklären hiermit die Übereinstimmung des vorgenannten Produkts mit der  
EU-Richtlinie 93/42/EWG über Medizinprodukte. 
 
We declare the compliance of the device with the requirements of the Derective  
93/42/EEC about medical devices.

 

 

 

Angewandete Normen: 

(Applicable standards) 

DIN EN 60601-1 

 (03/96) 

  

DIN EN 60601-1-2 

 (09/94) 

EN 1441 

 

 (10/97) 

 

 

 

Überwachungsbehörde/ ID-Nr.: 

(Notified body/ Identification number)

TÜV Berlin / 0197 

 

 

Das Gerät ist gekennzeichnet mit / The device is marked with

   

 

 

 

 

 

Lübeck,  01 June 2004 

 

 
 

(H. Jochen Kaber, managing director) 

 

 

 

23/23

 

 

 

Содержание E-20 SE

Страница 1: ...de Internet www bon de Sparkasse zu L beck Sort code 230 501 01 Acc No 1 014 885 Swift BIC HSHN DE H1 SPL IBAN DE 2305 0101 0001 0148 85 Commerzbank L beck Sort code 230 400 22 Acc No 0 107 755 Postb...

Страница 2: ...DS 2 23...

Страница 3: ...e 9 5 2 Commissioning 9 5 3 Description and function of the components 10 5 3 1 Translation table 10 5 3 2 Patient chair 11 5 3 3 Phoropter arm 11 5 3 4 Contact lens fitting table with trial lens tray...

Страница 4: ...n the operating instructions Caution Please observe safety instructions with this symbol to prevent personal danger or damage to property Important Indicates particularly important information to main...

Страница 5: ...product class 1 2 3 Liability The Refraction Unit is manufactured according to the recognized technical safety regulations and is tested to the strictest quality measures The company bon Optic accepts...

Страница 6: ...onfiguration purchased Fig 2 1 bon E 20 SE with maximum parts and accessories 2 Pieces of Table connections for the table top devices only supplied when a table is supplied 1 Mains cable 1 5 m 1 Instr...

Страница 7: ...table 7 are swung into position There is a scissor movement This presents a risk of trapping The elevation column of the patient chair is not designed for continuous use After continuous use for 60 s...

Страница 8: ...dical devices which are to be connected to the electrical supply of the refraction unit must be proved to fulfill their DIN EN as well as IEC specifications All configurations must fulfill the require...

Страница 9: ...nt chair 9 23 Fig 5 1 Switches on the control console 5 2 Commissioning 1 Please ensure that the refraction unit is connected to the power supply with the intended power cable 2 Press the On Off switc...

Страница 10: ...8 Technical Data Power will be supplied automatically to the table top device on switching into working position 1 or 2 The translation table ensures a via a potentiometer the smooth introduction of...

Страница 11: ...oropter back into the rest position 11 23 Position 1 Rest position Position 2 Phoropter arm angled Position 3 Phoropter arm in extamination position Fig 5 3 Phoropter Arm Positions The phoropter arm s...

Страница 12: ...6 3 Repairs that can be carried out by the user The following repairs can be carried out by the user 6 3 1 Changing the bulb in the examination lamp Bulb used Halogen mirror lamp with reflector and sa...

Страница 13: ...fects Component Defect Fuse Fuse Value Chair elevation Up and down movement of patient chair does not function F1 T 3 15 A Translation table Examination instruments The table cannot be locked the inst...

Страница 14: ...ns apply in both instances The invoice with the purchase date applies The device was used according to the instructions and for the specified purpose Any repairs were carried out by bon personnel or p...

Страница 15: ...tion unit bon E 20 SE View from above Other Dimensions Width Base plate 96 cm Depth Base plate 66 cm Height without projector standard components 165 cm Height Translation table 85 cm Seat Height At l...

Страница 16: ...20 W Protection class I Device type B Protection type IP 21 Maximum Output Power Output 1 Output 2 88 W Conditions of Use Refraction Unit Ambient temperature 10 C to 40 C Relative air humidity 30 to 7...

Страница 17: ...ge for tabletop unit 2 6 V AV 12 V AC 70 E_WTEIN Switching voltage 12 V AC 71 GND Switching voltage Ground 72 12 V DC Switching voltage 12 V DC 73 10VAC SB Operating voltage 10 V AC 74 Operating volta...

Страница 18: ...8 Technical data bon E 20 SE Fig 8 3 Circuit diagram 18 23...

Страница 19: ...8 Technical data bon E 20 SE Fig 8 4 Connecting diagram refraction unit bon E 20 SE 19 23...

Страница 20: ...8 Technical data bon E 20 SE Fig 8 5 Connecting diagram control console Fig 8 6 Connecting diagram fuse back control console 20 23...

Страница 21: ...8 Technical data bon E 20 SE Fig 8 7 Connecting diagram adjustable table 21 23...

Страница 22: ...of it Instead it should be handed over to an applicable collection point for the recycling of electrical and electronic equipment If you have any further questions please contact bon optic In the cas...

Страница 23: ...1 Richtlinie 93 42 EWG Anhang IX Regel 1 1 MDD 93 42 EEC annex IX rule 1 Wir erkl ren hiermit die bereinstimmung des vorgenannten Produkts mit der EU Richtlinie 93 42 EWG ber Medizinprodukte We decla...

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