Sendoline S5 User manual

Instructions for use of S5 Endo Motor
0413

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Contents
Sendoline Symbols...................................................................................................................................................................................3 – 5
1. Introduction....................................................................................................................................................................................6 – 8
2. Electromagnetic compatibility (EMC) ............................................................................................................................................... 9
3. Scope of delivery................................................................................................................................................................................ 10
4. Safety notes.............................................................................................................................................................................. 11 – 16
5. Description – Charging station..........................................................................................................................................................17
6. Description – Handpiece drive / Rechargeable battery / Contra-angle head / S5 Apex Clip...................................................... 18
7. Starting operation – Charging station............................................................................................................................................. 19
8. Starting operation – switch on / switch off S5 Endo Motor........................................................................................................... 20
9. Starting operation – Assembly / removal of the contra-angle head ............................................................................................ 21
10. Changing the root canal instrument................................................................................................................................................ 22
11. Attaching the S5 Apex Clip................................................................................................................................................................. 23
12. Connecting the instrument to an endometer ........................................................................................................................ 24 – 25
13. Mounting and removing the S5 Insulating Sleeve........................................................................................................................... 26
14. Test run................................................................................................................................................................................................27
15. Operating – Adjust torque........................................................................................................................................................ 28 – 29
16. Operating – Auto Forward and Auto Reverse mode................................................................................................................30 – 31
17. Changing the rechargeable battery................................................................................................................................................. 32
18. Description of failure / Remedy........................................................................................................................................................ 33
19. Hygiene and maintenance....................................................................................................................................................... 34 – 42
20. Sendoline Accessories.............................................................................................................................................................. 43 – 44
21. Servicing .................................................................................................................................................................................... 45 – 46
22. Technical data........................................................................................................................................................................... 47 – 48
20. Recycling and Disposal ..................................................................................................................................................................... 49
Explanation of warranty terms ................................................................................................................................................................... 50
Authorized Sendoline service partner ........................................................................................................................................................ 51

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Sendoline Symbols
WARNING!
(Risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations,
without risk to
persons or objects
Sterilizable
up to the stated temperature
Thermo washer
disinfectable
Only for USA
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.
Symbols in the Instructions for use
Service

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Sendoline Symbols
Symbols on rechargeable battery / charging station / contra-angle head / handpiece drive
Consult Instructions for use
Class II equipment
Date of manufacture
Catalogue number
REF
Serial number
SN
Do not dispose of with domestic
waste
Revolutions per minute
(rpm = min-1)
rpm
Alternating current
AC
WElectric power input of the unit
Supply voltage
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
MEDICAL – GENERAL MEDICAL
EQUIPMENT WITH RESPECT TO
ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL60601-1:2006,
CAN/CSA-C22.2 No. 601.1-M90,
CAN/CSA-C22.2-No. 60601-1:08,
ANSI/AAMI ES 60601-1:2005.
25UX (Control No.)
Newton centimetres
Ncm
Milliampere hours
mAh
CE 0413: CE mark and
identification number of Notified
Body
0413

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Sendoline Symbols
Symbols on the packaging
This way up 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
Fragile, handle with care
Keep away from rain
»Der Grüne Punkt«
Identification mark of Duales
System Deutschland AG
R
E Y
General symbol for recovery/
recyclable
CE 0413: CE mark and
identification number
of Notified Body
Data Matrix Code for product
identification, e.g. in hygiene /
maintenance process
Temperature limits
Humidity limitation
0413

1. Introduction
For your safety and the safety of your patients
These instructions explain to you how to handle your Sendoline 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 is of paramount
importance to us.
It is therefore essential to read the safety notes on pages 11 to 16.
Intended use
The Sendoline S5 Endo Motor is a modular electrical system comprising a handpiece drive, a rechargeable battery, a contra-angle
head and a charging station for mechanical preparation of the root canal. The application area extends to endodontic procedures
using a special root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of the
root canal.
Misuse may damage the S5 Endo Motor and hence cause risks and hazards for patients, users and third parties.
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Introduction
Qualifications of the user
We have based our development and design of the S5 Endo Motor on the »dentists« target group.
Skilled application
The S5 Endo Motor is intended only for informed use in the medical dental field, according to its purpose of use in compliance with
the valid health and safety at work regulations, the valid accident prevention regulations as well as in compliance with these
Instructions for Use. The S5 Endo Motor should be maintained according to the manufacturer‘s recommendations and in line with
infection control procedures for the safety and well-being of patients. Improper use, (e.g. poor hygienic maintenance),
non-compliance with our instructions or the use of accessories and spare parts which are not approved by Sendoline, invalidate all
claims under warranty and any other claims.
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8
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
> S5 Endo Motor (charging station, drive handpiece, contra-angle head and rechargeable battery Li-Ion 3.7 V)
in the condition as delivered 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 S5 Endo Motor it is used
in compliance with the following directions:
> The S5 Endo Motor must be used in accordance with these Instructions for use.
> The S5 Endo Motor has no components that can be repaired by the user. Assembly, modifications or repairs must only
be undertaken by an authorized Sendoline service partner (see page 51).
> 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 equipment 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.
Sendoline guarantees the compliance of the device with the EMC requirements only when used with original Sendoline
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 obtain the current EMC manufacturer’s declaration 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. Scope of delivery
After unpacking the following parts must be present:
REF 1100000
❍drive handpiece REF 1100001
❍contra-angle head REF 1100002
❍charging station REF 1100003
❍rechargeable battery Li-Ion 3.7 V REF 1100004
❍mains cable REF 05464400 (Europe)
❍S5 Apex Clip REF 07735600
alternative specification
❍mains cable REF 05456100 (USA, CAN, J) / REF 05457700 (UK, IRL) / REF 05467600 (AUS, NZ)

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4. Safety notes
It is essential to comply with the following instructions
> Before using the handpiece drive and the charging station for the first time, store it at room temperature for 24 hours.
> Check the handpiece drive, the contra-angle head, the charging station and the mains cable for damage and loose
parts prior to every use. Correct any faults or refer to an authorized Sendoline service partner (see page 51). Do not
operate the S5 Endo Motor if it is damaged.
> Always ensure the correct operating conditions.
> Only use REF 1100002 Sendoline contra-angle head.
> Perform a test run prior to each treatment.
> Do not activate the press-button of the contra-angle head during operation or slowing down.
This leads to detachment of the root canal instrument and overheating of the press button.
> Avoid contact between the instrument head and soft tissue (danger of burning due to the press-button heating up).
> The drive handpiece should only be placed in the holder as it may heat up. Do not place it on the patient’s body!
> Always use rubber dam during endodontic treatment.
Hygienic maintenance prior to initial use
The items are in a clean condition when delivered.
> Disinfect the handpiece drive and charging station (see page 35).
> Sterilize and lubricate the contra-angle head.

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Safety notes
It is essential to comply with the following instructions when using the rechargeable battery.
> The Li-lon 3.7 V rechargeable battery is not sterilizable.
> Only use Sendoline rechargeable batteries REF 1100004. Other types of rechargeable battery may lead to a risk of fire
or explosion.
> Only use the Sendoline rechargeable battery REF 1100004 in connection with the Sendoline handpiece drive
REF 1100001 and the battery charging station REF 1100003.
> The rechargable battery used in the unit may cause a risk of fire or acid burns if not used properly (e.g. charging in a
charging station other than the one provided).
> The rechargeable battery must not be taken apart, heated to above 100 °C (212 °F) or burnt.
> Do not short-circuit a rechargeable battery.
> Do not subject rechargeable batteries to mechanical shock.
> Defective or disused rechargeable batteries must be disposed of immediately.
> In the event of a rechargeable battery leaking, do not allow the liquid to come in contact with the skin or eyes. If contact
has been made, wash the affected area with copious amounts of water ans seek medical advice.
> Keep the rechargeable battery out of the reach of children.
Use only suitable and serviceable tools
Always follow the instructions of the manufacturer of the root canal instruments (e.g. in terms of speed, torque,
described application).
Improper use
Inproper use, in addition to incorrect assembly, installation, modification or repairs of the S5 Endo Motor or
non-compliance with our instructions invalidates all claims under warranty and any other claims!

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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 device 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).

1414
Safety notes
Danger zones M and G
In accordance with IEC 60601-1/ANSI/AAMI ES 60601-1, the S5 Endo Motor is not suitable for use in potentially explosive
atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide.
The S5 Endo Motor 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.
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Safety notes

1515
Safety notes
The S5 Endo Motor (handpiece drive / charging station)
The unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water).
The Sendoline handpiece drive is intended for use with the charging station. Use of other handpiece drives / charging
stations could damage or destroy the electronics / the rechargeable battery.
Mains cable
Only use the mains cable supplied.
Set up the charging station so that the power switch is easily accessible.
In dangerous situations, the charging station 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 charging station.
System failure
A total system failure of the S5 Endo Motor does not constitute a critical fault.
Simply switch the device off and then on again.

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Safety notes
The »patient zone« (see diagram) represents an area of 2.50 m
above and 1.83 m around the patient.
Do not use the charging station in the patient zone.
1,83 m
2,5 m
1,83 m1,83 m

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5. Description – Charging station
charging slot for
handpiece drive
power socket
power switch
ON / OFF (I / 0)
charging control LED (charge)
(orange)
control LED (power) ON
(green)

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6. Description – Handpiece drive / Rechargeable battery / Contra-angle head / S5 Apex Clip
button for:
unit ON and
torque settings
plug contact into
handpiece drive
torque display
4,0 = 4 Ncm max 400 gcm
button for:
unit ON and
motor ON / OFF
Sendoline coupling for contra-angle head
charging contacts
press-button
rechargeable
battery cover
rechargeable battery-
capacity display
control LED ring for torque

S5 Apex Clip

7. Starting operation – Charging station
Plug the mains cable into
the charging station.
Rechargeable battery is
charged.
Charge control LED
(orange) comes on.
Place the handpiece drive in
the charging station.
Note the positioning.
All the handpiece drive
LEDs light up briefly.
> Charge the rechargeable battery completely before the first use. This will take about 100 minutes.
> The handpiece drive can remain on the switched-on charging station until the next use.
> If the rechargeable battery has enough capacity, the charge control LED (orange) will light up briefly (for about 1 sec.).
Rechargeable battery is not charging.
> If the rechargeable battery does not have enough capacity, the charge control LED (orange) lights up.
Rechargeable battery is charging.
Always place the charging station on a flat level surface.
Ensure that the charging station can be disconnected easily from the power supply.
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8. Starting operation – switch on / switch off S5 Endo Motor
Turn the S5 Endo Motor on at
the power switch.
Power control LED
(green) lights up.
Switch on S5 Endo Motor
Connect the S5 Endo Motor to
the power supply.
Switch off S5 Endo Motor
Turn the S5 Endo Motor off at
the power switch.
Disconnect the S5 Endo Motor
from the power supply.