Gnatus Syncrus POP User manual

PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
Technical Name: Dental Chair
Brand: Gnatus
Trade Name: Syncrus POP Dental Chair
Manufacturer/ Distribuitor:
GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA. Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500 Ribeirão Preto - S.P. - Brasil Fone +55 (16) 2102-5000 - Fax +55 (16) 2102-5001 C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115 www.gnatus.com.br - gnatus@gnatus.com.br Technical Duties: Gilberto Henrique Canesin Nomelini CREA-SP: 0600891412
Registration ANVISA nº: 10229030041
ATTENTION
For greater safety:
Read and understand all the instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all the operators
of this Equipment.
2
INDEX
PRESENTATION OF MANUAL ........................................................................02
IDENTIFICATION OF EQUIPMENT .................................................................04
- Purpose of equipment ....................................................................................04
- Description of Equipment ...............................................................................05
- Indication of Equipment ................................................................................05
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....06
TECHNICAL SPECIFICATIONS .......................................................................07
- Standards applied .........................................................................................08
- List of pieces and circuit scheme .....................................................................08
- Electromagnetic emissions ..............................................................................09
- Contents of the accessible and inaccessible markings ........................................12
- Dimensional .................................................................................................13
- Symbologies of packaging .............................................................................14
- Symbologies of product .................................................................................14
INSTALLATION OF EQUIPMENT ....................................................................15
OPERATION OF EQUIPMENT .........................................................................17
PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................19
- Conditions of transport, storage and operation ..................................................19
- Sensitiveness to environmental conditions foreseeable in normal situations of use .19
- Precautions and warnings “during the installation” of equipment ..........................19
- Recommendations for preserving the equipment. ...............................................20
- Precautions and warnings “during the use” of equipment ....................................20
- Precautions and warnings “after” the use of equipment ......................................20
- Precautions and warnings during the “cleaning and disinfection” of equipment .......21
- Precautions in case of alteration in the functioning of equipment ..........................21
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment ......................................21
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............22
- Additional procedures for reuse .......................................................................22
- Cleaning ......................................................................................................22
- Disinfection ..................................................................................................22
- Preventive maintenance .................................................................................23
- Corrective maintenance..................................................................................23
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................23
WARRANTY OF EQUIPMENT ..........................................................................24
FINAL CONSIDERATIONS ..............................................................................24
33
DESCRIPTION OF THE EQUIPMENT
Dear Customer
Congratulations. You have made a good choice when you decided to buy a GNATUS QUALITY product comparable to the best products available in the World. This manual is a general presentation of your product and it will give you important details to help you to solve possible problems.
Please, read it and keep this with you.
Identication
Technical Name Dental Chair Trade Name: Syncrus POP Dental Chair Brand: GNATUS
Purpose of the equipment
Chair for patient accommodation during dental treatment.
4
DESCRIPTION OF THE EQUIPMENT
Description of Equipment
Dental chair for patients during dental treatment, ambidextrous (for right-handers and left-handers) with automatic movements, activated by a motor reducer using direct current. Activation by means of multifunctional foot control, which activates the dental light, moves the backrest and seat and returns to zero. Power input cable (optional item).
Bold design, with rounded lines, looking modern and harmonious. Spacious, curved backrest, which as well as providing comfort to the patient, allows easier access for the dental surgeon.
Base made of steel, with 4 holes for fastening to the oor.
Structure of the unit made of dense steel, with surface treatment using nanotechnology, coated with smooth, highly shiny resistant material, with rounded edges.
Highly shiny smooth paint with an epoxy base, polymerized in an oven at 250ºC, resistant to corrosion and cleaning materials.
Anatomic headrest, with height adjustment. Optional neck rest, providing the patient with greater comfort.
Support of the xed arm with a rounded nishing, planned to facilitate access to the
patient and increase the professional’s productivity, dispense with movement, and facilitate cleaning and disinfection (optional right arm).
Large upholstery, with lumbar support, assembled on a rigid structure covered with highly resistant injected polyurethane, covered with laminated, seamless material.
ISO 9001/2000 and ISO 13485/2003 Quality System, assuryng the products are manufactured under standart procedures.
Products manufactured in agreement with RDC-59 - ANVISA (Sanitary Surveillance National Agency) with guarantees accomplishiment to the sanitary legislation according to BPF (Good Manufacturing Procedures). In order to comply with directive 93/42/EEC for CE
Mark purpose, it is dened that the life span of this product is estimated in 05 years provided
that the enduser follows the requirements and instructions of this manual.
IMPORTANT:
• This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certied professional, according to the legislation of the country) and following
the instructions of the manual. The operation of the equipment required, for the professional, the utilization of correct instruments and it should to be in perfect conditions of the use, and to protect the professional, the patients and others, in the eventual danger situation.
• This equipment can’t be used in the presence of inammable anesthetics or products
that may cause explosion.
• After nish life-cycle of the equipment, this equipment is throw way, so it should to be
destroye in appropriate area (according to the legislation of the country).
• To guarantee the safe functioning of your equipment, use only the assemble
congurations (Dental Chair, Dental and Water Units and Dental Light) supplied by Gnatus
authorized Dealers / Technical Assistance.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certied professional, according to the legislation of the country) and following
the instructions of the manual. The operation of the equipment required, for the professional, the utilization of correct instruments and it should to be in perfect conditions of the use, and to protect the professional, the patients and others, in the eventual danger situation.
55
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
09
02
03
04
05
01
17
08
06
07
10
The Drawing illustrates the equipment with all the optional items. Your delivery unit will only be composed of the items chosen during your purchase option.
The contents of this page are of an informative nature, the equipment being able to differ from that illustrated. So, upon acquiring the product check the technical compatibilty between equipment, coupling and accessories.
WARNING: For the chair with integrated connection box is recommended to x the base of the chair to the oor, as oriented under the item "Installation" of this guide.
01 - Headrest 02 - Chest rest 03 - Foot control 04 - Base 05 - Finishing cover of the motor 06 - On/Off switch
07 - Seat 08 - Fixed left armo 09 - Neck rest * 10 - Fixed right arm * 17 - Headreast double swivel *
* Optional
6
TECHNICAL SPECIFICATIONS
General
Classification of Equipment:
According to norm NBR IEC 60601-1
Supply voltage
127/220 V~ Selecionable
Frequency
50/60 Hz
Electric shock protection type
Class one equipment
Degree of protection against electric shock
B type
Mode of Operation
Continuous with intermittent load: T-on 1min. - T-off 4min.
Water leak protection
IPX0 – All the chair, excepting foot control IPX1 – foot control
Power
200VA
Protection fuses
F1 and F2.... 5A - Time-lag
Rising capacity
200 Kg
Delivery unit tray’s maximum load capacity
Syncrus line HS - 1 Kg Syncrus lines LS and S - 2 Kg
Net Weight
104 Kg
Gross Weight
137,3 Kg
77
TECHNICAL SPECIFICATIONS
Chair for left and right-handed dentists use
Chair was designed for easy installation for left and right handed users, without losing its features.
When the Gnatus authorized technician installs the equipment, tell him whether position you want, and he will make the necessary adjustments.
Current surge protection
Equipment is protected from current surge by 2 fuses of 5 amperes each and it also features internal current surge protection for equipment attached to chair.
Standards applied:
NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para segurança;
NBR ISO 6875:1998 - Equipamento odontológico – Cadeira odontológica de paciente;
NBR ISO 14971:2004 - Medical devices - application of risk management medical devices; NBR ISO 9687: 2005 - Dental equipment - graphical symbols; EN ISO 13485-2003 - Quality systems - medical devices; IEC 60601-1-2:2007 - Compatibilidade Eletromagnética.
List of pieces and circuit scheme
Gnatus Company declares that the supply of the circuit scheme, list of pieces or any
other information that propitiate technical attendance for the user, can be request if there is an agreement between the user and Gnatus Company.
The materials used to produce the equipment are Biocompatible.
8
TECHNICAL SPECIFICATIONS
Electromagnetic emissions
Use of different cables, transducers and accessories from those specied may result
in increased emissions or decreased immunity of the equipment.
99
Loading...
+ 19 hidden pages