IM3 Ultra-S Manual de usuario

Instructions for Use

Piezoelectric Ultrasonic Scaler

U8200, U8300

ultra-S

ultra-ST

Contents

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

1. Introduction............................................................................................................................................................................................... 5

2. Electromagnetic compatibility (EMC)..................................................................................................................................................... 7

3. Unpacking .................................................................................................................................................................................................. 8

4. Scope of delivery ....................................................................................................................................................................................... 9

5. Safety notes ............................................................................................................................................................................................ 10

6. Description .............................................................................................................................................................................................. 13

Control unit U8200............................................................................................................................................................................. 13

Control unit U8300............................................................................................................................................................................. 14

LED Handpiece ................................................................................................................................................................................... 15

Foot Control U8007............................................................................................................................................................................ 16

7. Start-up .................................................................................................................................................................................................... 17

8. Operation ................................................................................................................................................................................................. 19

Handpiece Assembly/Removal......................................................................................................................................................... 19

Changing the tip ................................................................................................................................................................................. 20

Control unit - Startup ......................................................................................................................................................................... 23

Control unit - Functions .................................................................................................................................................................... 24

Contents

9. Error messages ....................................................................................................................................................................................... 25

10. Hygiene and maintenance................................................................................................................................................................... 26

11. Maintenance.......................................................................................................................................................................................... 27

Manual cleaning................................................................................................................................................................................. 28

Inspection, Maintenance and Testing.............................................................................................................................................. 30

Exchanging the supply hose O-rings................................................................................................................................................ 31

U8300.................................................................................................................................................................................................. 32

12. Servicing ................................................................................................................................................................................................ 33

13. iM3 accessories and spare parts........................................................................................................................................................ 35

14. Technical data....................................................................................................................................................................................... 36

15. Disposal................................................................................................................................................................................................. 38

Explanation of warranty terms .................................................................................................................................................................. 39

Authorised iM3 service partners................................................................................................................................................................ 40

Symbols

Consult Instructions for Use

Foot control

Catalogue number

Serial number

DataMatrix Code

for product information

including UDI (Unique

Device Identification)

Do not dispose of with

domestic waste

Date of manufacture Non-ionizing electromagnetic

radiation

DC – direct current

Supply voltage

Electric power consumption

Frequency of the

alternating current

Coolant volume

Upper limit of temperature

+30°C Max.

(+86°F)

ESI (External System Interface)

CE mark

XXXX

Follow Instructions for Use

ATTENTION!

(to prevent damage occurring)

WARNING!

(risk of injury)

General explanations, without

risk to persons or objects

Type B applied part

(not suitable for intracardiac

application)

Sterilisable up to the

stated temperature

Thermo washer disinfectable

1. Introduction

For your safety and the safety of your patients

These Instructions for Use explain how to use your device. 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.

Observe the safety notes.

Intended use

U8200, U8300:

Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal

of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

Foot control for operation of the electrical equipment.

FOR VETERINARY DENTAL USE ONLY.

Misuse may damage the device and hence cause risks and hazards for user and third parties.

Introduction

Responsibility of the manufacturer

The manufacturer can only accept responsibility for the safety, reliability and performance of the device when it is used in

compliance with the following directions:

> The device must be used in accordance with these Instructions for Use.

> Only the components approved by the manufacturer may be replaced (O-ring, coolant filter, pump cartridge).

> Modifications or repairs must only be undertaken by an authorised iM3 service partner (see page 40).

> The device has no components that can be repaired by the user.

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

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

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

Improper use, unauthorised assembly, modification or repair to the device, non-compliance with our instructions or the use of

accessories and spare parts which are not approved by iM3, invalidates all claims under warranty and any other claims.

FOR VETERINARY DENTAL USE ONLY.

2. Electromagnetic compatibility (EMC)

Electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into operation in

accordance with the EMC notes included.

iM3 guarantees the compliance of the device with the EMC requirements only when used with original iM3 accessories

and spare parts. The use of accessories and spare parts not approved by iM3 can lead to an increased emission of

electromagnetic interference or to a reduced resistance against electromagnetic interference.

HF communication equipment

Portable HF communications equipment (including peripherals such as antenna cables and external antennas) should

be used no closer than 30 cm (11.8 inches) to the device. Otherwise, degradation of the performance of this device could

result.

The device may be interfered by other equipment, even if these other devices comply with CISPR (International

special committee on radio interference) emission requirements.

The device is not intended for use in the vicinity of HF surgical devices.

3. Unpacking

Remove the insert.

Remove the control unit,

the coolant tank (U8300)

and the foot control.

Remove the Instructions for

Use and the accessories.

iM3 packaging is environmentally friendly and can be disposed of by industrial recycling companies.

However, we recommend that you keep the original packaging.

4. Scope of delivery

Control unit (100–230 V) U8200

ULTRA-S

U8300

ULTRA-ST

REF 02675000 Coolant filter X

REF 05075600 Coolant hose (Ø 6 mm, approx. 2 m) X

REF 08016690 Power supply with adaptor X X

REF 07991190 Coolant tank X

5. Safety notes Control unit/Foot control/ Handpiece

> Before using the device for the first time, store it at room temperature for 24 hours.

> Check the device for damage and loose parts each time before using.

> Do not operate the device if it is damaged.

> Always ensure the correct operating conditions and cooling function.

> Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction

(the exception are endodontics applications).

> In case of coolant supply failure, the device must be stopped immediately.

The exception to this is in endodontic applications, where coolant is not used.

Maximum operating time without coolant: > 2 minutes for the power range 1–30

> 30 seconds for the power range 31–40

> Perform a test run each time before using.

> Never touch the patient and the electrical contacts on the device simultaneously.

> Check the parameter settings every time you restart.

> Make sure that the supply hose is dry. Moisture in the supply hose can lead to a malfunction (risk of short circuit).

> Do not look directly into the optic (LED) outlet.

> Replace damaged or leaking O-rings immediately.

> Do not twist, kink or squeeze the supply hose (risk of damage).

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