bon E-50 Instruction Manual Download Page 15

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Appendix

bon

E-50

EU - KONFORMITÄTSERKLÄRUNG

EC – DECLARATION OF CONFORMITY

Hersteller-Adresse:

(Manufacturer’s address)

bon
Optic Vertriebsgesellschaft mbH
Stellmacherstraße 14
D-23556 Lübeck

Gerätetyp / UMDNS-CODE:

(Device type/ UMDNS-CODE)

Untersuchungs-/Behandlungsplatz (18-014)
Examination/treatment (18-014)

Gerätebezeichnung:

(Device name)

Refraktionseinheit bon E-50
Refraction unit bon E-50

Klassifizierung:

(Classification)

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

(MDD 93/42/EEC, appendix 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 Directive
93/42/EEC on 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, 24 October 2005

(H. Jochen Kaber, managing director)

GA bon E-50 Rev 1.0 E 211005.doc

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Summary of Contents for E-50

Page 1: ...nternet www bon de Sparkasse zu Lübeck Sort code 230 501 01 Acc No 1 014 885 Swift BIC HSHN DE H1 SPL IBAN DE 2305 0101 0001 0148 85 Commerzbank Lübeck Sort code 230 400 22 Acc No 0 107 755 Postbank Hamburg Sort code 200 100 20 Acc No 409 22 204 Refraction unit bon E 50 bon Optic Vertriebsgesellschaft mbH managing director H Jochen Kaber HR Lübeck HRB 3475 VAT No 161662634 ...

Page 2: ...bly repair 7 5 Service 8 5 1 Powering up 8 5 2 Description and operation of the components 8 5 2 1 Adjustable table 8 5 2 2 Patient s chair 9 5 2 3 Phoropter arm 9 5 2 4 Projector column 9 6 Maintenance and care 10 6 1 Care 10 6 2 Maintenance and safety checks 10 6 3 Repairs you can carry out yourself 10 6 3 1 Changing the fuses 10 7 Guarantee and disposal 11 8 Technical data 12 Appendix EC Declar...

Page 3: ...tructions Caution Please observe safety instructions with this symbol to prevent personal danger or damage to property Important Indicates particularly important information to maintain the function of the device system or to extend its life Note Indicates information for correct use so that errors may be avoided This publication may not be copied or transferred without prior agreement from bon Op...

Page 4: ...regulations of Directive 93 42 EWG on medical devices MDD 2 3 Liability The refraction unit is manufactured according to the current technical status and the recognised safety regulations and is tested in accordance with strict quality criteria bon Optic only accepts liability for the safety reliability and performance of the device if any changes or repairs have been carried out by a person autho...

Page 5: ...very 1 x refraction unit bon E 50 as per version ordered 2 x plugs for table apparatus only for version with adjustable table 1 x 1 5 m power cable 1 x instruction manual Fuse kit with 2 x T 3 15 A for fuses F1 F4 2 x T 5 0 A for fuses SF5 F6 1 x T 4 0 A for fuse F2 1 x T 6 3 A for fuse F3 ...

Page 6: ...ity of the patient s chair 3 is 170kg and should not be exceeded The lifting column of the patient s chair is not designed for extended use After being used for 60 seconds the lifting column must be left to cool for 9 minutes Ensure that the adjustable table 2 does not collide with the patient s legs when the patient s chair 3 is being moved upwards Do not sit on the moveable table 2 Avoid placing...

Page 7: ...cal devices that are linked to the electricity supply of the refraction unit must be shown to comply with DIN EN IEC specifications All configurations must meet the requirements of the DIN EN 60601 1 1 IEC 601 1 standard Non electrical devices that are connected to the unit must not affect the safety level of the unit Changes to the refraction unit must not endanger patients users and the surround...

Page 8: ...it lamps and ophthalmometers These devices can be moved with the adjustable table into operating positions 1 and 2 Use the table lock 2 for this GA bon E 50 Rev 1 0 E 211005 doc 8 15 1 Potentiometer 2 Table lock Fig 5 1 Operating position 1 Fig 5 2 Operating position 2 When moving between operating positions 1 and 2 the supply voltage is automatically connected for the appropriate table device The...

Page 9: ... When it is in place the phoropter arm will sit firmly in a stable position The phoropter arm is to be used only for phoropters Do not hang any other objects on it You can change the height and angle of the phoropter arm using the adjustable screws 5 2 4 Projector column The projector column is used for chart projectors Attach the apparatus by using the aforementioned power cable By using the adju...

Page 10: ... 0751 in connection with the electricity supply 6 3 Repairs you can carry out yourself 6 3 1 Changing the fuses Use only type T fuses with the fuse values shown in Table 1 GA bon E 50 Rev 1 0 E 211005 doc 10 15 1 Disconnect the refraction unit from the mains before changing a fuse 2 Open the appropriate fuse element with a screwdriver 3 Remove the old fuse from the holder and insert a new fuse of ...

Page 11: ...een used properly and in accordance with the conditions of use Repairs have not been carried out by anyone other than the bon Optic customer service team or persons authorised by bon Optic Guarantee services do not result in extension of the guarantee nor do they represent the start of a new guarantee The sales guarantee is not applicable to second hand products The terms and conditions of trade o...

Page 12: ...50 kg Electrical date for refraction unit Mains voltage 230 V AC Mains frequency 50 60 Hz Connection power 750 VA Output 1 Adjustable table 6 V AC 12 V AC Output 2 Adjustable table 6 V AC 12 V AC Max power output 1 output 2 88 W Safety class I Apparatus type B Safety type IP 21 Operating conditions refraction unit Air temperature 10 C up to 40 C Relative humidity 30 to 75 Air pressure 700 hPa to 1...

Page 13: ... Description 60 EIN2 Connection for jumper 61 AC1 Connection for jumper 62 AC2 Connection for jumper 63 AC2 Voltage for control 14 V AC 64 AC1 EIN1 Voltage for control 8 3 V AC 65 AC0 Output voltage for tabletop unit Ground 66 AC0 Output voltage for tabletop unit Ground 67 TG1 Output voltage for tabletop unit 1 6 V AV 12 V AC 68 TG2 Output voltage for tabletop unit 2 6 V AV 12 V AC 70 E_WTEIN Swit...

Page 14: ...se contact bon Optic customer support Label Symbols Transport requirements Fuse Temperature 5 C to 45 C 23 F to 113 F Read instruction manual Air pressure 650 hPa to 1100 hPa Application part type B Relative humidity 25 to 80 Maximum conditions no longer than 60 days in a row GA bon E 50 Rev 1 0 E 211005 doc 14 15 ...

Page 15: ...inie 93 42 EWG Anhang IX Regel 1 1 MDD 93 42 EEC appendix 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 Directive 93 42 EEC on medical devices Angewandete Normen Applicable standards DIN EN 60601 1 03 96 DIN EN 60601 1 2 09 94 EN 1441 10 97 Überwachun...

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