Satelec Newtron p5xs Bled
Satelec Newtron p5xs Bled
Please refer to the general instructions relating to the comprehensive range of dental
ultrasonic generators by SATELEC® for information about the following:
l documentation format;
l the documentation archiving period;
l warnings concerning user population;
l the treatment area;
l the medical device usage interactions, contraindications and prohibitions;
l electromagnetic compatibility;
l disposal and recycling of the medical device;
l manufacturer responsibility.
Please refer to the accessory cleaning, disinfection and sterilization protocols and the
handpiece predisinfection, cleaning and sterilisation protocols for information about the
following:
l preparation of parts for sterilization;
l detailed manual and automatic protocols;
l information concerning the sterilization;
l recommendations for the inspection of parts.
1 Documentation
This document contains the following information:
l indications for use;
l description of the medical device;
l installation of the medical device;
l use of the medical device;
l preparation for cleaning and disinfection of the medical device;
l monitoring and general maintenance of the medical device;
l maintenance to be performed by the user.
It is important for you to have read and understood the content of the user instructions relating to the use of
your device and its accessories prior to use.
We recommend that you visit the website regularly to consult and/or to download the latest version of your
device's user instructions.
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2 Required information
2.1 Indication for use
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for
preservation and restoration dentistry, including prosthesis.
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2.6 Warranty
The screws marked A, B and C must not under any circumstances be unscrewed by the user as this may void the
warranty for the medical device.
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3 Removal from packaging,
installation, connections
3.1 Unpacking your medical device
When you receive your medical device, check for any damage that may have occurred during transportation.
If you have received this medical device by mistake, please contact the supplier to arrange for it to be
collected.
If you have any questions or requirements, contact your supplier.
The Newtron® P5XS B.LED includes the following items:
l a Newtron® P5XS B.LED unit with non-detachable pedal cord, a non-detachable SLIM cord, a 300 or
500ml tank and a SLIM handpiece support;
l a Newtron® SLIM handpiece, a Quick Start [J12900] and a Quick Clean [J12930];
l tips and wrenches depending on selected options;
l a Quick Start Newtron® P5XS B.LED [J62100];
l a Quick Clean Newtron® P5XS B.LED [J62101].
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Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or
cable tray.
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4 Description of the medical device
4.1 Control unit
The control unit incorporates technology Newtron® patented by SATELEC® .
The patented technology Newtron® controls the tips by Cruise Control® , an automatic system for setting the
frequency and power in real time. This ensures that Satelec® tip vibration is gentle, regular and controlled.
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4.6 Connecting and disconnecting accessories during use
Do not connect/disconnect the cord(s) or the handpiece when the medical device is switched on and
your foot is on the pedal.
Do not tighten or loosen the tips when the handpiece is activated.
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4.13 Initiating irrigation
The medical device must be set to minimum power depending on the required irrigation flow rate. Press the
pedal until a spray appears.
4.18 Switch
The mains switch is used to switch on (position I) or to stop (position O) the medical device.
4.22 Pump
The medical device is fitted with a peristaltic pump. This pump must be replaced yearly by the practitioner
using the F62202 kit or by the After-Sales Department SATELEC® .
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When the irrigation system has been cleaned, perform the following operations:
1. disconnect the handpiece and refer to handpiece predisinfection, cleaning and sterilisation protocols
SATELEC® [J12919];
2. clean and disinfect the medical device as indicated in the chapter Cleaning and disinfection of the
medical device page 15
3. follow the instructions for accessory cleaning, disinfection and sterilization protocols SATELEC®
[J81009] and [J02009].
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5 Cleaning, disinfecting and
sterilizing
The instructions relating to accessory cleaning, disinfection and sterilization protocols provided by SATELEC®
have been approved for each medical device and accessory. The applicable guides are listed in chapter
Associated documentation page 5
They can be downloaded at the following address:
www.satelec.com/documents
In all cases, the local regulations in force relating to the accessory cleaning, disinfection and sterilization
protocols take precedence over the information provided by SATELEC® .
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To prepare for cleaning, remove the various parts of Newtron® P5XS B.LED as shown here.
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6 Monitoring and maintenance of the
medical device
Before and after each use, check that the device and its accessories are not faulty in any way. This is
necessary to detect any isolation fault or damage. If necessary, replace damaged parts.
Monitor the cleanliness of the air inlets on the control unit to prevent any heating.
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7 Maintenance
The only preventive maintenance the medical device requires is:
l checking of accessories;
l everyday cleaning, disinfection and sterilisation procedures;
l cleaning.
7.1.1 No operation
Symptoms: the indicator light on the medical device is off and the medical device is not working.
Possible causes Solutions
No electrical current Contact your electrician
Internal fuse not working Return to After-Sales team SATELEC®
Mains switch in position O Set the mains switch to position I
Faulty connection between the mains cord and the mains
Connect the mains cord to the mains connector
connector
Faulty connection between the mains cord and the electrical
Connect the mains cord to the electrical wall socket
wall socket
Replace the mains fuses with fuses of the same type
Mains fuses in the mains connector not working
and rating
The medical device also has an internal fuse (ref. F1 on the printed circuit board) that cannot be
accessed by the user.
7.1.2 No spray
Symptoms: There is no water spray at the tip.
Possible causes Solutions
Flow configuration button on minimum Adjust the flow configuration button
Tip or file blocked Unblock the tip or file
Incorrect choice of tip Check the tip
Inadequate amount of spray Adjust the spray
No irrigation solution in the tank Fill the irrigation solution tank
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7.1.4 Ultrasounds not working
Symptoms: the tip does not vibrate, vibration cannot be heard.
Possible causes Solutions
Tip loose Tighten the tip using the wrench
Faulty connector contact Clean the cord contacts
Handpiece cord wire(s) cut Return to After-Sales Department SATELEC® to replace the cord
l replace the used fuses with fuses of the same type and same rating;
l place the fuse holder in its recess by pushing it until you hear a click that confirms it is in the correct
position;
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l connect the mains cord to the connector;
l connect the mains cord to the electrical network;
The medical device also has an internal fuse (Ref. FU1 on the printed circuit board) that cannot be
accessed by the user.
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8 Technical specifications for the
medical device
8.1 Identification
Manufacturer SATELEC®
Name of the medical device N EWTRON® P5XS B.LED
8.5 Irrigation
Tank capacity (in ml) 300 or 500
Nominal water output flow at the end of the handpiece (in ml/min) 5 to 40
Nominal water output flow at purge (in ml/min) 80
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8.6 Control pedal
Width (in mm) 70
Height (in mm) 30
Depth (in mm) 95
Weight (in g) 150
Ingress protection rating: IPX1
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9 Regulations and standards
9.1 Official Texts
This medical device complies with the essential requirements of European Directive 93/42/EEC. This
equipment is designed and developed in compliance with Electrical Safety standard IEC60601-1 in force. It was
designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system.
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9.3 Standardised Symbols
Symbols Meaning
BF type
I Class 1
Alternating voltage
EC marking
Year of manufacture
YYYY
Control pedal
O Device OFF
I Device ON
IP : ingress protection ratings procured by a range
IPX1 X : no ingress of protection rating claim against the penetration of solids
1: protects against the vertical falls of drops of water
Caution: US Federal law restricts this device to sale by or on the order of a
Rx Only
Physician
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9.4 Manufacturer identification
SATELEC
A Company of ACTEON Group
17, avenue Gustave Eiffel
BP 30216
33708 MERIGNAC cedex
FRANCE
Tel. +33 (0) 556.34.06.07
Fax. +33 (0) 556.34.92.92
E.mail: [email protected].
www.acteongroup.com
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ACTEON CHINA
9.5 Branch addresses Office 401 - 12 Xinyuanxili Zhong Street -
FRANCE Chaoyang District - BEIJING 100027 - CHINA
SATELEC ACTEON GROUP Tel. +86 10 646 570 11/2/3
17 av. Gustave Eiffel Fax. +86 10 646 580 15
Zone industrielle du phare - B.P. 30216 e-mail: [email protected]
33708 MERIGNAC cedex - France
THAILAND
Tel. +33 (0) 556 34 06 07
ACTEON (THAILAND) LTD
Fax. +33 (0) 556 34 92 92
23/45 Sorachai Building 16th floor - Sukumvit 63
e-mail: [email protected].
Road, Klongton Nua - Wattana, BANGKOK 10110
U.S.A. - THAILAND
ACTEON Inc. Tel. +66 2 714 3295
124 Gaither Drive, Suite 140 Fax. +66 2 714 3296
Mount Laurel, NJ 08054 - USA e-mail: [email protected]
Tel. +1 856 222 9988
KOREA
Fax. +1 856 222 4726
ACTEON KOREA Corp.
e-mail: [email protected]
8F Hanil B/D - 132-4 1Ga Bongrae-dong -
GERMANY JOONG-GU – SEOUL - KOREA
ACTEON GERMANY GmbH Tel. +82 2 753 41 91
Industriestrasse 9 – 40822 METTMANN - GERMANY Fax. +82 2,753 41 93
Tel. +49 21 04 95 65 10 e-mail: [email protected]
Fax. +49 21 04 95 65 11
INDIA
e-mail: [email protected]
ACTEON INDIA
SPAIN B-94, GIDC Electronic Estate - Sector 25 –
ACTEON MEDICO-DENTAL IBERICA, S.A.U. GANDHINAGAR 382028 Gujarat - INDIA
Avda Principal n°11 H Tel. +91 79 2328 7473
Poligono Industrial Can Clapers Fax. +91 79 2328 7480
08181 SENTMENAT (BARCELONA) - SPAIN e-mail: [email protected]
Tel. +34 93 715 45 20
LATIN AMERICA
Fax. +34 93,715 32 29
ACTEON LATIN AMERICA
e-mail: [email protected]
Bogotà - COLOMBIA
U.K. Celular: +57 312 377 8209
ACTEON UK e-mail : [email protected]
Unit 1B - Steel Close – Eaton Socon, St Neots
RUSSIA
CAMBS PE19 8TT - UK
ACTEON RUSSIA
Tel. +44 1480 477 307
Valdajski Proezd 16 – office 253
Fax. +44 1480 477 381
125445 Moscow - RUSSIA
e-mail: [email protected]
Tel./Fax. +7 499 76 71 316
MIDDLE EAST e-mail : [email protected]
ACTEON MIDDLE EAST
AUSTRALIA/NEW ZEALAND
Numan Center - 2nd Floor N° 205 - Gardens Street
ACTEON AUSTRALIA/NEW ZEALAND
PO Box 5746 - 11953 AMMAN - JORDAN
Suite 119, 30-40 Harcourt Parade
Tel. +962 6 553 4401
Rosebery NSW 2018
Fax. +962 6 553 7833
Australia
e-mail: [email protected]
Tel. +612 9669 2292
CHINA Fax. +612 9662 2204
e-mail : [email protected]
TAIWAN
ACTEON TAIWAN
14F-1, N°433, Jinping Rd.
Jhonghe Dist., New Taipei City 23563
TAIWAN (R.O.C)
Tel. + 886 926 704 505
e-mail : [email protected]
9.6 Disposal and recycling
As an item of Electrical and Electronic Equipment, the medical device must be disposed of via a specialist
collection, removal, recycling or destruction channel. This applies in particular to the European market, in
reference to Directive 2002/96/EC dated 27/01/2003.
When your medical device has reached the end of its service life, contact your nearest dental equipment
dealer, or ACTEON GROUP head office or one of the company branches to find out how to proceed. The
relevant contact details are given in the chapter Branch addresses page 30.
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Index: 300 ml – humidity
D
10 Index damage 17
demineralised water 13
dental file 7
5 E
500 ml 13
earthing pin 13
Electrical Safety 27
A electronic user instructions 5
end of the day 13
endodontics 7
After installation 13
European Directive 27
air circulation 13
air inlets 13, 17
Altitude 26 F
Amplitude 26
approved dealers 7
fault 17
attachments 9
first inclusion of EC marking 7
first use 13
B fuse 19-20
B.LED 11 G
Bluetooth 11
gas-filled atmosphere 26
C general instructions relating to the comprehensive
range of dental ultrasonic generators 3
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Index: incorrect operation – Vibration frequency
I Q
incorrect operation 19 Quick Clean 5
indicator light 19 Quick Start 5
irrigation flow 11-12
R
K
Regulatory 5, 32
kit F12304 20 removal of the button 11
kit F62202 13, 20 repair 7
L S
LED 11 scaling 7
light function 13 seal 20
light indicator 12 silicone supports 12
Liquids 13 SLIM cord 12, 25
smartphone 11
Software User Manual 5
M spray 13, 19
sterilized 8
mains connector 10, 13, 20
mains fuses 13
mains switch 13 T
Mains switch 19
Manufacturer 25 tablet 11
Medical class 27 tank 13
Temperature 26
tip 5, 7, 19-20
N treatment 11-12
non-use 13
U
P ultrasonic vibrations 7
ultrasound power 11
pedal 13 update 7
periodontics 7 user instructions 5
peristaltic pump 13 User Manual 5
power settings 11
preservation and restoration dentistry 7
Pressure 26 V
prophylaxis 7
prosthesis 7 Vibration frequency 26
purge function 11-12
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Index: water leak – Wrenches
W
water leak 20
wipes 15
Wrenches 5
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