Elcomed SA-310 Manuel utilisateur

Instructions for use

SA-310

Contents

Symbols.......................................................................................................................................................................................................... 4

1. Introduction ............................................................................................................................................................................................... 8

2. Electromagnetic compatibility (EMC)................................................................................................................................................... 10

3. Unpacking ................................................................................................................................................................................................ 11

4. Scope of delivery......................................................................................................................................................................................12

5. Safety notes .............................................................................................................................................................................................13

6. Description of front panel....................................................................................................................................................................... 18

7. Description of rear panel......................................................................................................................................................................... 19

8. Description of foot control...................................................................................................................................................................... 20

9. Description of motor with cable ..............................................................................................................................................................21

10. Starting operation – General................................................................................................................................................................ 22

11. Switch on / switch off Elcomed ............................................................................................................................................................ 23

12. Control unit operation – Setup settings.............................................................................................................................................. 24

13. Control unit operation – General settings .......................................................................................................................................... 25

14. Control unit operation – Elcomed settings......................................................................................................................................... 32

15. Control unit operation – Main menu settings..................................................................................................................................... 38

16. Foot control operation...........................................................................................................................................................................44

17. Error messages ...................................................................................................................................................................................... 45

18. Hygiene and maintenance.................................................................................................................................................................... 47

18. Servicing ................................................................................................................................................................................................ 58

19. W&H Accessories .................................................................................................................................................................................. 60

20. Technical data........................................................................................................................................................................................ 63

21. Disposal.................................................................................................................................................................................................. 65

Explanation of warranty terms....................................................................................................................................................................71

Authorized W&H service partners.............................................................................................................................................................. 72

Contents

W&H

WARNING!

(risk of injury)

ATTENTION!

(to prevent damage occurring)

General explanations,

without risk to persons or objects

Thermo washer disinfectable Sterilizable

up to the stated temperature

W&H Service

Symbols in the Instructions for use

Symbols

W&H Symbols

Symbols on the control unit

Follow instructions for use

Class II equipment

Date of manufacture

Catalogue number

REF

Serial number

Revolutions per minute

(rpm = min-1)

Alternating current

VA Electric power input

of the control unit

Electric fuse

Supply voltage

of the control unit

Supply current

Frequency of the alternating

current

Data Matrix Code

for product identification, e.g.

in hygiene / maintenance process

Not suitable for intracardiac

application – Type BF applied part

Foot switch

Do not dispose of

with domestic waste

On / Off

MEDICAL – GENERAL MEDICAL

EQUIPMENT WITH RESPECT TO

ELECTRICAL SHOCK, FIRE AND

MECHANICAL HAZARDS ONLY IN

ACCORDANCE WITH

UL 60601-1:2006,

CAN/CSA-C22.2 No. 601.1-M90:2005,

CAN/CSA-C22.2 No. 60601-1:2008,

ANSI/AAMI ES 60601-1:2005.

25UX (Control No.)

USB connection

Consult instructions for use

rpm

W&H Symbols

Symbols on the packaging

Caution:

Federal law restricts this device

to sale by or on the order of a

dentist, physician or any other

practitioner licensed by the law

of the state in which he or she

practices to use or order the use

of the device

This way up

Fragile, handle with care

Keep away from rain

Temperature limits

Humidity limitation

CE 0297

from the manufacturer

»Der Grüne Punkt«

Identification mark of

Duales System Deutschland AG

General symbol for

recovery / recyclable

W&H Symbols

Symbols on the irrigation tubing set

Sterilized using ethylene oxide

Do not reuse

Caution, consult

accompanying documents

Sterilizable up to the

stated temperature

Batch code

Latex free

CE 0481

from the manufacturer

Consult instructions for use

Non-sterile

Use by

Caution:

Federal law restricts this device

to sale by or on the order of a

dentist, physician or any other

practitioner licensed by the law

of the state in which he or she

practices to use or order the

use of the device

1. Introduction

For your safety and the safety of your patients

These instructions explain how to use your product. However, we must also warn against possible hazardous situations.

Your safety, the safety of your team and, of course, the safety of your patients are of paramount importance to us.

It is therefore essential that you observe the safety notes on pages 13 to 17.

Intended use

Drive unit for surgical transmission instruments with coupling system according to ISO 3964 (DIN 13.940) with the functions

»mechanical drive« and »supply with coolant«. It is indicated for use in dental, surgical procedures.

Misuse may damage the Elcomed and hence cause risks and hazards for patients, users and third parties.

Qualifications of the user

The W&H Elcomed dental surgical unit is intended for use by suitably qualified and trained medical, technical and specialist staff

only. We have based our development and design of the Elcomed on the »physician« target group.

Introduction

Production according to EU Directive

EU Directive 93/42/EEC has been used as a basis in the design and manufacture of this medical product and it applies to the

dental surgical unit

> Elcomed SA-310

in the condition as supplied by us. This declaration does not apply to non-specified fittings, mountings etc.

Responsibility of the manufacturer

The manufacturer can only accept responsibility for the safety, reliability and performance of the Elcomed

when it is used in compliance with the following directions:

> The Elcomed must be used in accordance with these Instructions for use.

> The Elcomed has no components that can be repaired by the user. Assembly, modifications or repairs must only be

undertaken by an authorized W&H service partner (see page 72).

> The electrical installation at the premises must comply with the regulations of IEC 60364-7-710 (»Installation of

electrical equipment in rooms used for medical purposes«) or with the regulations applicable in your country.

> Unauthorized opening of the device invalidates all claims under warranty and any other claims.

2. Electromagnetic compatibility (EMC)

Notes on electromagnetic compatibility (EMC)

Medical electrical equipment is subject to particular precautions with regards to EMC and must be installed and put into

operation in accordance with the EMC notes included.

W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories

and spare parts. The use of other accessories / other spare parts can lead to an increased emission of electromagnetic

interference or to a reduced resistance against electromagnetic interference.

You can find the current EMC manufacturer’s declaration on our website at

http://wh.com/en_global/emc

Alternatively, you can obtain it directly from the manufacturer.

HF communication equipment

Do not use any portable and mobile HF communication equipment (e.g. mobile telephones) during operation.

These may affect medical electrical equipment.

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