Scican Statis 1.1 st User manual

1.1 ST – Straight Attachment

1.1 ST – Fixation directe

1.1 ST – Gerades Handstück

1.1 ST – Attacco diritto

1.1 ST – Conexión directa

Operating instructions

Manuel de l’utilisateur

Benutzerhandbuch

Manuale per operatori

Manual del Operador

Caution: In the U.S.A., Federal Law restricts this device to sale by or on the order of a dentist.

SD- 260 Rev. 3.0

Distributed by:

SciCan Ltd. 1440 Don Mills Road, Toronto ON M3B 3P9 CANADA www.scican.com

Phone: +1 416 445 1600 Toll free: 1-800-667-7733 Fax: +1 416 445 2727

SciCan Medtech

Alpenstrasse 16

6300 Zug

SWITZERLAND

Phone: +41 (0) 41 727 7027

Fax: +41 (0) 41 727 7029

SciCan Inc.

701 Technology Drive

Canonsburg, PA 15317

USA

Phone: +1 724 820 1600

Fax: +1 724 820 1479

Toll free: 1-888-632-6031

Manufactured by:

SciCan GmbH

Kurzes Geländ 10

D-86156 Augsburg

GERMANY

Phone: +49 (0) 821 56 74 56-0

Fax: +49 (0) 821 56 74 56-99

Introduction

Dental straight handpiece, with internal spray, without light, direct ratio, locking ring. Product intended for professional use

only. Use in dentistry for general dentistry work.

Important Information

These instructions, STATIS ™1:1 ST correspond to the product described in the heading.

Never activate the clamping/unclamping ring while the instrument is rotating, as there is a risk of damaging its mechanism

or destroying the motor.

Never mount an instrument on a rotating motor. To ensure the STATIS 1.1 ST functions with maximum efficiency, it must be cooled by an air supply

of 8-10 norm liter/min on the nose of the micromotor.

Application

The STATIS 1.1 ST handpiece is only to be used by a qualified dental practitioner, in conjunction with the provision of dental treatment to dental patients.

Any other use may be dangerous and is strictly forbidden. The STATIS 1.1 ST is a medical product according to the applicable national provisions of law.

Information

The technical specifications, illustrations and dimensions contained in these instructions are given only as a guide. They may not

be the subject of any claim. The manufacturer reserves the right to make technical improvements to its equipment, without

amending these instructions. For all additional information, please contact SciCan at the address indicated on overleaf.

Generalities

The device must be used by a competent person in accordance with the current legal provisions concerning industrial safety,health and accident

prevention regulations, and these working instructions. In accordance with these requirements, the operator:

•

must only use working devices that are in perfect working order; in the event of irregular functioning, excessive vibration, abnormal heating or other

signs indicating malfunction of the device, the work must be stopped immediately; in this case, contact a repair center that is approved by SciCan;

• must ensure that the device is used only for the purpose for which it is intended, must protect himself, his patients and third parties from

any danger, and must avoid contamination through the use of the product.

The device is intended for medical treatment only; any use other than that for which this product is intended is not allowed and may prove to be

dangerous. The medical device meets all the current national legal requirements. Excess material from products used for maintenance (lubricants,

cleaning products and disinfectants) may penetrate into the electric brush motor and interfere with its functioning. It is essential to follow the

maintenance instructions accompanying each product.

Recommendations

Adhere to the Instructions for Use, in accordance with the instructions of the bur manufacturer. Never use a bur with an incorrect shaft, as there is a

risk of this becoming detached during the treatment and causing injury to you yourself, to your patient and to third parties. The only burs to be used

are those corresponding to the ISO 1797 norm. They should be made from steel or hardened metal. Rest the device on a suitable support in order to

eliminate the risk of injury to you yourself, to your patient and to third parties.

Guarantee

The manufacturer grants the operator a warranty covering all functional defects, material or production faults. The device is covered by this warranty

for 2 years from the date of invoicing. In the event of justified claims, the manufacturer or its authorized representative will fulfill the company’s

obligations under this guarantee by repairing or replacing the product free of charge. Any other claims, of whatever nature, in particular in the form of a

claim for damages and interest, are excluded. The manufacturer shall not be held responsible for damage or injury and the consequences thereof,

resulting from:

• excessive wear and tear

• improper handling

• non-observance of the instructions for installation, operation and maintenance

• unusual chemical, electrical or electrolytic influences

• poor connections, whether of the air water or electricity supply.

The guarantee shall become null and void if the damage and its consequences are due to improper manipulation of the product, or modifications

to the product carried out by persons not authorized by the manufacturer. Claims under the terms of the guarantee will be considered only on

presentation, together with the product, of the invoice or the consignment note, on which the date of purchase, the product reference and the

Serial No. should be clearly indicated.

Installation

The STATIS 1.1 ST should be sterilized prior to being operated for the first time. Do not connect or disconnect the handpiece

while the motor is running. Doing so could result in damage to the handpiece and motor.

Connection:

Push the handpiece onto the E-Type coupling of the motor.

Before each use, check the connection by pulling the contra-angle to be sure it is securely attached.

Disconnection:

Pull off the contra-angle from the E-Type coupling in an axial direction.

Inserting the Bur:

Turn the ring completely counterclockwise, insert the bur all the way. Exert traction on the tool to check that it is correctly in

place. Always wear gloves or other adequate protection when checking and using the device.

Removing the Bur:

After the bur stops rotating, turn the ring completely counterclockwise and remove the bur.

Maintenance

Dental handpieces should be cleaned / disinfected, lubricated and sterilized before the first use and between each

patient use1.

Only use maintenance products and/or components approved by SciCan such as SciCan STATCARE™spray or the SciCan automatic lubrication device

STATMATIC™. The use of other products and components can void the warranty. The device is supplied in non-sterile form. Before use, please follow the

instructions under this heading. Check that the sterilizer and the water that is used are clean. After each sterilization cycle, remove the device from the

sterilizing apparatus immediately, in order to reduce the risk of corrosion. The Statim sterilizer is recommended for maximum longevity.

1) may vary by country regulations.

Recommended reprocessing methods according to DIN EN ISO 17664

The operator should be aware of personal health risks when reprocessing contaminated dental handpieces and should wear gloves and eye protection.

•Wipe off any debris or blood contamination at chair side.

• Do not immerse dental handpieces in disinfection solutions.

• Reprocess immediately after use.

• Remove any rotary instruments (burs, files, etc.) before reprocessing.

Cleaning and Disinfection

Please note that STATIS dental handpieces should not be cleaned in an ultrasonic bath.

Attention: Do not use products containing acetone, chlorine or bleach as disinfectants

Manual External Cleaning and Disinfection

Cleaning:

After each use, the device must be thoroughly scrubbed either under water (potable water) or with 60 - 70% alcohol solution.

Disinfection

Do not use products containing acetone, chlorine or bleach as

disinfectants. When applying disinfection sprays/wipes, follow the

instructions for use of these materials.

FOR GERMAN USERS:

In order to efficiently reprocess dental handpieces, internal cleaning and

disinfection can be achieved through the use of ALPRO WL-clean*, ALPRO

WL-cid* and ALPRO WL-dry*.

Mechanical External and Internal Cleaning and Disinfection

In Europe, a validated washer/disinfector such as Hydrim C51wd or M2 is

recommended. In all cases the instruments need to be thoroughly dried

after the automated washing process.

Be aware of the possible risks from the moist environment of the thermal

cleaning and disinfection unit, when leaving the instruments for extended

periods in the chamber with an unopened door.

Drying

Manual Drying

Apply dry air to the internal and external surfaces until surface water is no

longer visible.

Mechanical Drying

Normally thermal washer/disinfectors have an automatic drying

programme included. Units with active drying for internal lumens are

recommended.

* ALPRO WL-clean, ALPRO WL-cid and ALPRO WL-dry are registered trademarks of ALPRO MEDICAL

GMBH, Mooswiesenstrasse 9, 78112 St. Georgen, Germany.

Lubrication

After cleaning and/or disinfecting the STATIS handpieces it is important to maintain/lubricate the handpieces with SciCan Statcare Spray or use an

automated care system such as the Statmatic maintenance unit.

Lubricate each STATIS Instrument after the cleaning and disinfection process prior to sterilisation. For those countries where sterilisation or thermal