Elcomed SA-310 User manual

Instructions for use
SA-310

2
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

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20. Technical data........................................................................................................................................................................................ 63
21. Disposal.................................................................................................................................................................................................. 65
Explanation of warranty terms....................................................................................................................................................................71
Authorized W&H service partners.............................................................................................................................................................. 72
Contents

4
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

5
W&H Symbols
Symbols on the control unit
Follow instructions for use
Class II equipment
Date of manufacture
Catalogue number
REF
Serial number
SN
Revolutions per minute
(rpm = min-1)
Alternating current
AC
VA Electric power input
of the control unit
Electric fuse
Supply voltage
of the control unit
V
Supply current
A
Frequency of the alternating
current
Hz
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

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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
R
E Y
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

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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

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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.

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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.

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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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3. Unpacking
Lift out the insert with the
stand and the foot control.
Lift out the insert with the
control unit.
Remove the irrigation tubing
set.
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.

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4. Scope of delivery
REF 15933100 Control unit with documentation REF 15933101 Control unit with documentation
REF 05513400 Motor with 1.8 m cable
incl. 5 clips
REF 06205800 Motor with 3.5 m cable
incl. 10 clips
REF 436360 Irrigation tubing set 2.2 m
(3 pcs, disposable)
REF 436410 Irrigation tubing set 3.8 m
(3 pcs, disposable)
REF 06290700 USB flash drive REF 06290700 USB flash drive
REF 15933102 Control unit without documentation REF 15933103 Control unit without documentation
REF 05513400 Motor with 1.8 m cable
incl. 5 clips
REF 06205800 Motor with 3.5 m cable
incl. 10 clips
REF 436360 Irrigation tubing set 2.2 m
(3 pcs, disposable)
REF 436410 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)
Accessories
REF 06202400 Foot control S-N1
REF 04653500 Handle for foot control S-N1
REF 06177800 Motor support
REF 04005900 Stand
REF 04006800 Locking pin (2 pcs)

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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 72). 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.
> Moisture in the plug or motor can lead to a malfunction. (Risk of short circuit)
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.

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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.

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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 and 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 the device on again.
System failure
A total system failure does not constitute a critical fault.

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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.

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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).
Hygiene and maintenance prior to initial use
> Clean and disinfect the control unit, the motor with cable, the motor support and the stand.
> Sterilize the motor with cable and the motor support.

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6. Description of front panel
Shift buttons
PLUS / MINUS buttons
Motor connecting socket
Pump arm
OPEN
Pump arm Stand holder
Display

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7. Description of rear panel
Power socket Fuse holder with 2 fuses
REF 06352200 (250 V – T1,6AH)
Power switch
ON / OFF
Stand holder
USB connecting socket
(only for REF 15933100 / REF 15933101)
Connecting socket
for foot control

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8. Description of foot control
GREY
Start motor (pedal)
VARIABLE or ON / OFF
(Factory setting = variable)
ORANGE
Change program
Programs 1 to 6
Handle
attach / detach
YELLOW
Change motor direction
Clockwise / anticlockwise rotation
GREEN
Pump
ON / OFF