Elcomed SA-310 Instructions for Use

Contents W&H Symbols... 3 – 6 1. Introduction... 7 – 8 2. Electromagnetic compatibility (EMC)...9 3. Unpacking...10 4. Scope of delivery...11 5. Safety notes... 12 – 16 6. Description of front panel...17 7. Description of rear panel...18 8. Description of foot control...19 9. Description of motor with cable... 20 10. Starting operation – General...21 11. Switch-on / switch-off Elcomed... 22 12. Control unit operation – Setup settings...23 13. Control unit operation – General settings...24 – 30 14. Control unit operation – Elcomed settings...31 – 36 15. Control unit operation – Main menu settings...37 – 42 16. Foot control operation...43 17. Error messages...44 – 45 18. Hygiene and maintenance...46 – 51 19. W&H Accessories...52 – 54 20. Servicing...55 – 56 21. Technical data...57 – 58 22. Recycling and disposal...59 Training certificates...61, 63 Explanation of warranty terms...65 Authorized W&H service partners... 66 2

W&H Symbols Symbols in the Instructions for use

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

3

W&H Symbols Symbols on the control unit

4

Follow instructions for use

Do not dispose of with domestic waste

REF Catalogue number

Consult instructions for use

Foot switch

SN

Serial number

Class II equipment

On / Off

V

Supply voltage of the control unit

Date of manufacture

Electric fuse

AC

Alternating current

Not suitable for intracardiac application – Type BF applied part

USB connection

VA

Electric power input of the control unit

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.)

Data Matrix Code for product identification, e.g. in hygiene / maintenance process

A

Supply current

Hz

Frequency of the alternating current

Revolutions per minute rpm (rpm = min-1)

W&H Symbols Symbols on the packaging This way up

Temperature limits

Fragile, handle with care

Humidity limitation

Keep away from rain

CE 0297 from the manufacturer

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

»Der Grüne Punkt« Identification mark of Duales System Deutschland AG

RE Y

General symbol for recovery / recyclable 5

W&H Symbols Symbols on the irrigation tubing set

6

Sterilized using ethylene oxide

Consult instructions for use

Do not reuse

CE 0481 from the manufacturer

Latex free

Non-sterile

Use by

Sterilizable up to the stated temperature

Batch code

Caution, consult accompanying documents

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 12 to 16.

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.

7

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 66). > 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.

8

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.

9

3. Unpacking  Lift out the insert with the stand and the foot control.

 Lift out the insert with the control unit.

 Remove the carton with motor, accessories and instruments (optional).

W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging.

 Remove the irrigation tubing set.

10

4. Scope of delivery REF 15933100 REF 05513400 REF 436360 REF 06290700 REF 15933102 REF 05513400 REF 436360

Accessories REF 06202400 REF 04653500 REF 06177800 REF 04005900 REF 04006800

Control unit with documentation Motor with 1.8 m cable incl. 5 clips Irrigation tubing set 2.2 m (3 pcs, disposable) USB flash drive Control unit without documentation Motor with 1.8 m cable incl. 5 clips Irrigation tubing set 2.2 m (3 pcs, disposable)

Foot control S-N1 Handle for foot control S-N1 Motor support Stand Locking pin (2 pcs)

REF 15933101 REF 06205800 REF 436410 REF 06290700 REF 15933103 REF 06205800 REF 436410

Control unit with documentation Motor with 3.5 m cable incl. 10 clips Irrigation tubing set 3.8 m (3 pcs, disposable) USB flash drive Control unit without documentation Motor with 3.5 m cable incl. 10 clips Irrigation tubing set 3.8 m (3 pcs, disposable)

Mains cable REF 01343700 (EU) REF 04280600 (CH) REF 05901800 (DK) REF 02821400 (USA, CAN, J) REF 03212700 (UK, IRL) REF 02909300 (AUS, NZ) 11

5. Safety notes Please observe the following instructions under all circumstances > Before using the Elcomed for the first time, store it at room temperature for 24 hours. > Check the Elcomed, the straight or contra-angle handpiece and the motor with cable for damage and loose parts each time before using. Correct any faults or refer to an authorized W&H service partner (see page 66). Do not operate the Elcomed if it is damaged. > Check the parameter settings every time the device is restarted. > Perform a test run each time before using. > Make sure that the operation can be completed safely even if a device or instrument malfunctions. > Never touch the chuck mechanism of the straight or contra-angle handpiece during operation or while they are still running down. > Only fit the straight or contra-angle handpiece onto the motor, when the motor is at a complete standstill. > Never touch the rotary instrument which is still rotating. > Always ensure correct operating conditions and that sufficient and adequate cooling is delivered. > Avoid overheating at the treatment site. > When changing the fuse, disconnect the device from the power supply and only use W&H original fuses. > Never touch the patient and the connection for the foot control simultaneously. > The ESD spring contact on the underside of the foot control must touch the floor during operation. Use only suitable and serviceable tools Ensure that you comply with the manufacturer’s instructions for surgical straight and contra-angle handpieces with respect to maximum speed, maximum torque, clockwise and anticlockwise rotation. Inappropriate use Improper use, in addition to incorrect assembly, installation, modification or repairs of the Elcomed or failure to comply with our instructions invalidates all claims under warranty and any other claims. 12

Safety notes Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator) can be affected by electric, magnetic and electromagnetic fields. > Find out if patient and user have implanted systems before using the product and consider the application. > Weigh the risks and benefits. > Keep the product away from implanted systems. > Make appropriate emergency provisions and take immediate action on any signs of ill-health. > Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD (implantable cardioverter defibrillator).

13

Safety notes Danger zones M and G In accordance with IEC 60601-1 / ANSI/AAMI ES 60601-1, the control unit and the motor with cable are not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide. Elcomed is not suitable for use in oxygen enriched atmospheres. Zone M is defined as a »medical environment« and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anaesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle. Zone G, also known as an »enclosed medical gas system«, does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities. Foot control The foot control is in accordance with IEC 60601-1 / ANSI/AAMI ES 60601-1 approved for use in zone M (AP). Please note that at low speeds, it is more difficult to determine that the motor is running.

14

Safety notes Control unit The control unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water). When using transmission settings 975, WS-75, WI-75, Elcomed must be used exclusively with the following W&H-approved surgical contra-angle handpieces: 975 AE, WS-75 E/KM, WS-75 LED G, WI-75 E/KM and WI-75 LED G. Use of other contra-angle handpieces may result in deviation from the indicated torques and is the user’s responsibility. The specified transmission ratios for the programs 1 to 6 must always be considered. Mains cable Only use the mains cable supplied. Only connect to a grounded socket outlet. Set up the device so that the power switch is easily accessible. In dangerous situations, the device can be disconnected from the power supply using the power switch or mains cable. The power switch can also be used to safely stop the device. Power failure In the event of a power failure, if the Elcomed is switched off, or when switching between programs, the last values set are saved and re-activated when switching on the device again. System failure A total system failure does not constitute a critical fault. 15

Safety notes Intermittent operating mode S3 (2min/10min) The Elcomed is designed for intermittent operating mode S3 with an operating time of 2 minutes and an idle time of 10 minutes. If the operating mode specified is observed no overheating of the system and therefore no injury to the patients, users or third parties arises. The responsibility for the use and timely shutdown of the system lies with the user. Coolant The Elcomed is designed for use with physiological saline solution. Use only suitable irrigation fluids and follow the manufacturer's medical data and instructions. Use the W&H irrigation tubing set or accessories approved by W&H. You can purchase the coolant bottle or the coolant bag at a drugstore. Sterility of irrigation tubing set Sterile irrigation tubings are supplied with the equipment. These irrigation tubings are disposable articles and must be discarded after each treatment! Please note the expiry date and the relevant regulations for disposal of irrigation tubings. Only use disposable irrigation tubings with undamaged packaging. Rotational energy As a result of the rotational energy stored in the drive system – compared to the value set – fast deceleration of the bur can cause the selected torque to be significantly overloaded, at times. Observe the individual manufacturer's Instructions for use when adjusting superstructure screws. We would point out that adjusting these screws with an electric motor presents a potential risk as described above. 16

6. Description of front panel Pump arm

Stand holder

Display

Shift buttons

Pump arm OPEN PLUS / MINUS buttons Motor connecting socket

17

7. Description of rear panel

USB connecting socket (only for REF 15933100 / REF 15933101) Stand holder

Connecting socket for foot control Power socket

18

Power switch ON / OFF Fuse holder with 2 fuses REF 06352200 (250 V – T1,6AH)

8. Description of foot control Handle attach / detach

ORANGE Change program Programs 1 to 6

GREEN Pump ON / OFF

YELLOW Change motor direction Clockwise / anticlockwise rotation

GREY Start motor (pedal) VARIABLE or ON / OFF (Factory setting = variable)

19

9. Description of motor with cable The motor with cable must not be disassembled. The motor with cable must not be oiled (lubricated for life).

To prevent the instrument on the motor attachment from turning during transmission of high torques, the locking pin supplied can be pushed into the designated hole (see illustration). The locking pin can only be used in combination with straight and contra-angle handpieces that have corresponding holes. The motor with cable is defined as a type BF applied part. Temperature information Applied part motor: max. 55 °C (131 °F)

20