PRESENTATION OF MANUAL

INSTRUCTIONS OF USE
EQUIPMENT:
Technical name: Odontological X -Ray
Trade name: Timex 70 E - X-Ray
Brand: GNATUS
Trade models:
• Timex 70 E X-Ray Mobile Column
• Timex 70 E X-Ray Wall
• Timex 70 E X-Ray Pantographic Mobile Column
• Timex 70 E X-Ray Pantographic Wall
• Timex 70 E X-Ray Pantographic Fixed Column

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 - [email protected]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412

Registration ANVISA nº: 10229030030

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.

• This manual was originally written in Portuguese.

• Manual Review: 00

2
INDEX
PRESENTATION OF MANUAL ............................................................................ 02
IDENTIFICATION OF EQUIPMENT..................................................................... 05
-Dear Customer ................................................................................................. 05
-Identification .................................................................................................... 05
-Principles and bases applied to the functioning of the product.................................. 06
-Description of Equipment ................................................................................... 06
-Indication of Equipment ..................................................................................... 06

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION ........ 07

TECHNICAL SPECIFICATIONS .......................................................................... 09
-General Technical specifications ........................................................................... 09
-Cooling ............................................................................................................ 12
-Thermal protection ............................................................................................ 12
-Protection against acidental activation .................................................................. 12
-Under current protection .................................................................................... 12
-Overvoltage Protection ....................................................................................... 12
-Undervoltage Protection .................................................................................... 12
-Trigger ............................................................................................................ 13
-Protection by distance against parasite radiation .................................................... 13
-How to regulate the arm tension ......................................................................... 13
-Radiation quality - Ingress of quality equivalence ................................................... 14
-Parametes for charge exposure............................................................................ 14
-Transmitter assembly.......................................................................................... 15
-Standards applied ............................................................................................. 15
-Dimension ........................................................................................................ 16
-Symbologies of packaging .................................................................................. 21
-Symbologies of product ...................................................................................... 21
-Contents of the accessible and inaccessible markings ............................................. 22
-Tube letters with technical characteristics.............................................................. 26

INSTALLATION OF EQUIPMENT
-Dimensions and positioning Chassis command box X-Ray Wall Model......................... 28

OPERATION OF EQUIPMENT
-Instructions of transmitter assembly operation (how to move the cylinder head) ........ 30
-Operating instructions......................................................................................... 30
-Operating Instructions “Smaller colimator rectangular kit and extension with
colimator cone kit”.............................................................................................. 31
-Limitation and indication of bunch extension of x radiation ..................................... 31
-Precaution to be observed before 1st application of load ......................................... 31
-Bunch radiation characteristics ............................................................................ 32
-Radiographic techniques letters ........................................................................... 33
-Procedure for development with recent chemical reagent ........................................ 33
-Radiographic testing .......................................................................................... 34

PRECAUTIONS, RESTRICTIONS AND WARNINGS

-Conditions of transport and storage ..................................................................... 35
-Environmental conditions of operation .................................................................. 35
-Sensitiveness to environmental conditions foreseeable in normal situations of use ..... 35
-Precautions and warnings “during the installation” of equipment .............................. 35

3
INDEX
-Precommendations for preserving the equipment ................................................... 36
-Precautions and warnings “during the use” of equipment ........................................ 36
-Precautions and warnings “after” the use of equipment .......................................... 37
-Precautions and warnings during the “cleaning and disinfection” of equipment ........... 37
-Precautions in case of alteration in the functioning of equipment ............................. 37
-Precautions to be adopted against foreseeable or uncommon risks, related to the
deactivation and abandoning of equipment ............................................................ 37

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

-Additional procedures for reuse............................................................................ 38
-Disinfection ...................................................................................................... 38
-Cleaning .......................................................................................................... 38
-Preventive maintenance .................................................................................... 39
-Corrective maintenance ..................................................................................... 39

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................... 40

WARRANTY OF EQUIPMENT ............................................................................. 41
FINAL CONSIDERATIONS ................................................................................. 41

4
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.

Identification
Technical name: Odontological X -Ray
Trade name: Timex 70 E - X-Ray
Trade models:
• Timex 70 E X-Ray Mobile Column
• Timex 70 E X-Ray Wall
• Timex 70 E X-Ray Pantographic Mobile Column
• Timex 70 E X-Ray Pantographic Wall
• Timex 70 E X-Ray Pantographic Fixed Column
Brand: GNATUS

5
Description of the Equipment
Principles and bases applied to the functioning of the product
Photomultipliers set, which are generated in X-rays tubes that transform light energy
into electric energy, and then a circuit set forms the image, in order to diagnose or to guide
evasive medical procedures and dental treatments.

Description of Equipment
This device is for intraoral radiography of patient’s dentition with the purpose of making
a diagnostic.
It is a unit of X- Ray for odontological use, with nominal tension of 70kVp and current
in the tube of
7,0 mA. It has a centesimal digital timer, particularly developed for using with digital
radiographic sensors, it reduces the time of radiation exposure and also it is indicated for
conventional radiographic films.
Fixed column with the option of mobile column with 4-caster base; super steady columns,
painted in epoxy at 250º C, and option of base for mounting on the wall built in steel, painted
in epoxy and covered by a cover in polystyrene of high impact.
It is composed of type-pantographic arm (when pantographic model), which allows
better reach and use in many positions.
Tube (ampoule), with focal point of 0,8 x 0,8mm, filtration with aluminum equivalence
of 3,22 mm, cylindrical guide made in radiopaque polymer in order to avoid secondary
radiations, wound completely immersed in special oil.
Manual trigger at a distance of 5m. Duly tested by legal body, respecting the rules in effect
of radiological protection and elaborated by National Nuclear Energy Commission - CNEN.
The test method for measuring tension parameters of mean peak in the x- ray tube
(kVp), mean current in the x-ray tube (mA), application time of load on x-ray tube(s) and
product current X time in the x-ray time (mAs), adopted is the following:
It is used for measuring the device Dynalyzer III digital display, connected to a high
tension unit. This unit consists of a resistive tension divisor of 1:20.000.
For odontological x-ray equipment it is used an adapter system in order to make a
connection of the device Dynalyzer III. “In order to check the results obtained, it is connected
to high tension unit The digital storage oscilloscope 2230 produced by Tektronix which gives
the possibility to store an electrical signal to which is subject the x-ray tube, thus allowing
an inspection of mean peak in the x-ray tube and the application time of load. Such results
can be compared with those obtained from Dynalyzer III”.
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).

Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certified 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.

6
MODULES, ACCESSORIES, OPTIONS AND MATE-
RIALS OF CONSUMPTION
14 15

03
4A 06

03
02
01
08
05 03
02 07 5A
06 04
07
02
05
08
01 06

07
01
09
08 09
11
10
10
12
13

01 - Radiation transmitter Assembly x (cylinder head)

02 - Graduated scale
03 - Pantographic Arm
04 - Fixed arm (type Floor) The contents of this page are of an
4A - Fixed arm (type Wall) informative nature, the equipment being
05 - Electronic command able to differ from that illustrated. So, upon
5A - Electronic command (type Wall) acquiring the product check the technical
06 - Main switch - On / Off compatibilty between equipment, coupling
07 - Fuse box and accessories.
08 - Distance Control with cable
09 - Column
10 - Power - in cable Note: This equipment is designed for
11 - Base (mobile type) stationary use.
12 - Wheels
13 - Base (fixed type)
14 - Smaller colimator rectangular kit (optional)
15 - Extension with colimator cone kit (optional)

7
MODULES, ACCESSORIES, OPTIONS AND MATE-
RIALS OF CONSUMPTION
14 15

4B 3A 3A 4A 06

01

02 08
05
02 07 5A
06

07 01

09
08

11

12
10

01 - Radiation transmitter Assembly x (cylinder head)

02 - Graduated scale
3A - Adjustable arm
4A - Fixed arm (type Wall) The contents of this page are of an
4B - Fixed arm (type Mobile) informative nature, the equipment being
05 - Electronic command able to differ from that illustrated. So, upon
5A - Electronic command (type Wall) acquiring the product check the technical
06 - Main switch - On / Off compatibilty between equipment, coupling
07 - Fuse box and accessories.
08 - Distance Control with cable
09 - Column
10 - Power - in cable Note: This equipment is designed for
11 - Base (mobile type) stationary use.
12 - Wheels
14 - Smaller colimator rectangular kit (optional)
15 - Extension with colimator cone kit (optional)

8
TECHNICAL SPECIFICATIONS
Technical features
General
Model
• Timex 70 E X-Ray Mobile Column
• Timex 70 E X-Ray Wall
• Timex 70 E X-Ray Pantographic Mobile Column
• Timex 70 E X-Ray Pantographic Wall
• Timex 70 E X-Ray Pantographic Fixed Column

Classification of Equipment as per ANVISA:

Class III
Classification of Equipment as per standard IEC 60601-1:
Protection against Electric Shock - Type B and Class I Equipment (IEC 60601-1)
Degree of safety of application in presence:
Equipment not suited to an anesthetic mixture inflammable with air, oxygen or nitrous
oxide.
Mode of Operation
Continuous operation with intermittent load
Protection against Dangerous Ingress of water
Common device (Equip. Closed without protection against ingress o water)
Generator
Immersed in Oil
Transformer Oil
Lubrax Industrial AV-58-BR-Petrobras
Cylindrical Collimator
Totally armored
Tube Model
The model/tube type and its serial number are in the product’s certificate
Target Material
Tungsten
Reference Axis
19o in relation to anode
Target Angle
19o

9
TECHNICAL SPECIFICATIONS
Technical features
General
Nominal Focus Point Value
(0,8 x 0,8mm) positioned in relation to the reference axis of the XR tube in compliance
with IEC336/1982)
Tube Conditioning
At iddle position the Cone should always be directed downwards
kVp tube (average)
70 kVp (for max. tube current 7.0 mA)
kVp (average) beam peak
70 kVp +/- 10%
Net weight Gross weight
Timex 70 E X-Ray Mobile Column
50 kg 64,5 kg
Net weight Gross weight
Timex 70 E X-Ray Wall
25 kg 29 kg
Net weight Gross weight
Timex 70 E X-Ray Pantographic Mobile Column
61,5 kg 75,5 kg
Net weight Gross weight
Timex 70 E X-Ray Pantographic Wall
31 kg 34,5 kg
Net weight Gross weight
Timex 70 E X-Ray Pantographic Fixed Column
35,6 kg 41 kg

Power Supply
Nominal Supply Type
Model Tension Rate Freq Consumption
Installation
127V~ 125V~ + 4% 60Hz 10A Mobile
220V~ 220V~ + 4% 60Hz 6A Mobile
Timex 70 E
Mobile Column 220V~ 220V~ + 4% 50Hz 6A Mobile
230V~ 230V~ + 4% 50Hz 5,5A Mobile
240V~ 240V~ + 4% 50Hz 5A Mobile

10
TECHNICAL SPECIFICATIONS
Technical features
Power Supply
Nominal Supply Type
Model Tension Rate Freq Consumption
Installation
127V~ 125V~ + 4% 60Hz 10A Fixed
220V~ 220V~ + 4% 60Hz 6A Fixed
Timex 70 E Wall 220V~ 220V~ + 4% 50Hz 6A Fixed
230V~ 230V~ + 4% 50Hz 5,5A Fixed
240V~ 240V~ + 4% 50Hz 5A Fixed

Nominal Supply Type

Model Tension Rate Freq Consumption
Installation
127V~ 125V~ + 4% 60Hz 10A Mobile
220V~ 220V~ + 4% 60Hz 6A Mobile
Timex 70 E
Pantographic 220V~ 220V~ + 4% 50Hz 6A Mobile
Mobile Column
230V~ 230V~ + 4% 50Hz 5,5A Mobile
240V~ 240V~ + 4% 50Hz 5A Mobile

Nominal Supply Type

Model Tension Rate Freq Consumption
Installation
127V~ 125V~ + 4% 60Hz 10A Fixed
Timex 70 E 220V~ 220V~ + 4% 60Hz 6A Fixed
Pantographic
220V~ 220V~ + 4% 50Hz 6A Fixed
Fixed Column /
Wall 230V~ 230V~ + 4% 50Hz 5,5A Fixed
240V~ 240V~ + 4% 50Hz 5A Fixed

Power Power in stand by

1200VA 15VA
No of phase:
Single Phase / Biphasic
Fuses: 127V~ Fuses: 220 à 240V~
F1 and F2 15A delayed action F1 and F2 8A delayed action
F3 0,2A quick action
Type of fuses
Crystal 20 mm

11
TECHNICAL SPECIFICATIONS
Technical features
Cooling - Sb
The device presents protection against excessive heating of the tube.
A new image can be performed only after a time equivalent of 30 times the trigger time,
necessary time for natural cooling and return of normal functions.
Ex: Trigger time = 0,06 seconds.
Cooling time = 0,06seconds X 30 = 1,8 seconds.

Thermal protection
The device has a safety mechanism against temperature elevation of the transmitter
assembly.
A thermal protection turn the device’s functions off if the internal temperature of the
transmitter assembly overpasses the allowed limit , damaging the internal components of
the assembly.

Protection against acidental activation

The equipment has an electronic blocking mechanism against acidental activations,
preventing consecutive activations, eliminating unecessary exposure to radiation and
overheating of the emission set.

Under current protection

The equipment features a safety device for over-current by means of 3 fuses, being 2
of them for power supply and one for electronic circuit.

Overvoltage Protection
The device has a safety mechanism for overvoltage in device power supply that does
not allow trigger when power supply overpasses approximately 3 Volts of specified limits.

Undervoltage Protection
The device has a safety mechanism for undervoltage in device power supply that does
not allow trigger when power supply it goes inferior the 10 V~ of specified limits.

12
TECHNICAL SPECIFICATIONS
Technical features
Trigger
The button must be continuously pressed until the end of transmission, monitored by
a sound signal (beep), that is, if the button activation is interrupted, the transmission will
also be automatically interrupted , by indicating at display “A4”.

Distance protection against parasite radiation

The operator must use the safety device of the equipment (distance activation cable),
remaining at a minimum distance of 3 meters from the X-radiation beam during the charge
application. The user must wear the protection clothes (lead apron and lead collar) they
are not provided with the product

Lead apron and collar,

(They are not provided with
the product).

How to regulate arm tension

If the arm assembly/cylinder head loses its balance condition, a Technician authorized
by Gnatus shall be called in order to make the adjustment.

13
TECHNICAL SPECIFICATIONS
Radiation quality
Ingress of quality Parametes for charge exposure
equivalence 0,32s
FILTERS Tube crystal Tension
1,26 mm Al 70 kVp ± 10%
Insulating oil, column 17mm Current
0,64 mm Al 7 mA ± 1,5 mA
Window Power
0,32 mm Al 0,49 kW
Additional filter (aluminum) Product current time
1,00 mm Al 2,24 mAs
TOTAL FILTRATION = 3,22 mm Al Highest energy applied in intermittent
mode during 1 h
170 KJ
Note:
Filtration with thickness equivalency of aluminum.
- Using as method an x-ray tube tension of 70 kVp and 2.5 mmAl of semiconducting
reductor.
-The method using the measurement of the first semireductor layer was in narrow beam
conditions, with the x-ray equipment operating with x-ray tube tension value of 70 kVp with
anodic current of 7mA and exposure time of 1.0 second.

Timex 70E X-Ray

Mili Amper scale X Time
Set mA c/ Set mA c/ OBS.:
Set x Real Set x Real
Time Real
KVp AVG
Time Real
KVp AVG
The specified field
(seconds) Time (seconds) Time for time irradiation
0,06 1,46 81,4 0,56 7,20 70,6 compliance is
0,07 1,46 80,7 0,63 7,39 70,8 comprehended
within 0.06 and 3.2
0,08 2,36 79,5 0,71 7,37 70,7
seconds.
0,1 3,91 79,4 0,8 7,48 70,7
0,12 4,21 76,5 1 7,58 70,7
0,14 4,42 75,8 1,25 7,58 70,6
0,16 4,74 75,1 1,4 7,70 70,7
0,2 5,44 73,7 1,6 7,56 70,6
0,25 5,94 72,6 2 7,69 70,9
0,28 6,30 72,0 2,5 7,80 70,7
0,32 6 ,59 71,5 2,8 7,64 70,0
0,4 6,71 71,0 3,2 70,59 70,7
0,5 6,97 70,6 ----- ----- -----

14
TECHNICAL SPECIFICATIONS
IMPORTANT: Information referring to x-ray dosage, radiation leak can be found in the
conformity report attached to this manual.
NOTE:
- The serial number of the dome, beam limiter and radiation source is the same of the
equipment, and it is stated in the product’s label.

Transmitter assembly

06 05 04

03 02 01

10 09 08 07

01 - Complementary cone 06 - External cover

02 - Aluminum filter (1mm a1) 07 - Insulating oil
03 - Collimator 08 - Focal point
04 - Collimator O-ring 09 - High tension coil
05 - X-ray tube 10 - Electronic plate Assembly

Standards applied:
This product was tested and approved as per the standards:
IEC 60601-1: (1988); IEC 60601-2-7: (1998); IEC 61000-4-3: (2006);
Amendment 1: (1993); IEC 60601-2-28: (1993); IEC 61000-4-4: (2004);
Amendment 2: (1995); IEC 60601-2-32: (1994); IEC 61000-4-5: (2005);
IEC 60601-1-2: (2001); CISPR 11, edição 3.1 (1999); IEC 61000-4-6: (2006);
IEC 60601-1-3: (1994); IEC 61000-4-2: (2001); IEC 61000-4-11: (2004);
NBR-IEC série 601-1 Equipamento Eletromédico - Parte 1: Prescrições gerais para
segurança;
EN 980:2003 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
ISO 14971: 2007
ISO 9687: 1993 - Dental equipment - graphical symbols;
ISO 7494 - 1:2004 - Dental Units - Port 1: General requeriments and test methods
ISO 13485:2003
ISO 780:1997
ISO 11144:1995

15
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Model: Mobile Column

16
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Model: Wall

17
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Model: Pantographic Mobile Column

18
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Model: Pantographic Fixed Column

19
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Model: Pantographic Wall

20
TECHNICAL SPECIFICATIONS
Packing symbols
Maximum stacking: Packing to be transported and
It determines the maximum / or stored avoiding humidity,
quantity of boxes which can be rains and wet floor.
stacked during transportation
and storage “as per packaging”.

Packing to be transported and / or The packing must be stored and

stored with the harrows up. transported away from direct
sun light exposure.

Packing to be transported and / Temperature limit for the

or stored with care (should not packing to be stored or
suffer drop and neither receive transported.
impact).

Product symbols
Careful: It indicates an important Turned on
instruction for the operation of the
product. Not following it can cause
dangerous malfunctioning.
Turned off

Note: It indicates useful

B type equipment
information for operation of the
product.

Important: It indicates an Trigger Time Indicator Display

instruction of safety for operation and Many messages
of the product. Not following it,
can lead to serious danger to the
patient.

Landing (in many parts of the x-ray transmission indicator

equipment) indicates the condition LED (yellow)
of being landed.

“Focal Point”- indicates the “Radiation”- indicates that

exact position Of radiation the device issues Ionizing
transmitter center radiation

21
TECHNICAL SPECIFICATIONS
Product symbols

Dangerous electrical tension

Button to reset the display

Trigger key
indicator for x-ray emission
time.

Time selector - decrease Time selector - increase

Content of accessible and non-accessible demarcations

01

02

22
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations

03

04

06

05

23
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations

07 11

08

09 10

24
TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations
Description Fixation local
01 - Product identification tag Cabinet cover
02 - Product identification tag Cylinder head
03 - Ades. tag. Pantographic Arm Cabinet cover
04 - Ades. tag. Adjustable arm Cabinet cover
05 - Ades tag. radiation Cylinder head
06 - Ades tag. CE 0499 Packing
07 - Ades tag. identification Tension Cylinder head Cylinder head
08 - Ades tag. electro medic safety seal Packing and Cylinder head
09 - Product identification tag X-Ray control
10 - Ades tag. - warning Arm articulations and cabinet
cover
11 - Ades tag. – tape removal Arm

25
TECHNICAL SPECIFICATIONS
Tube letters with technical characteristics

26
TECHNICAL SPECIFICATIONS
Tube letters with technical characteristics

27
INSTALLATION OF EQUIPMENT
Dimensions and positioning
Chassis command box X-Ray Wall Model
Recommendations for pre-installation preparation of X-Ray
Wall model:
In order to assure the perfect functioning of wall model x-ray,
we recommend that the services of pre-installation be performed
by professionals duly qualified.
Any damages that may occur to the device, caused by fault
at pre-installation will not be covered by warranty.
“For more information, refer to pre-installation manual”.

Chassis positioning related to the floor.

Electrical
passage box

Chassis Dimensional “template for

wall drilling”

Distance
from floor
to first hole

28
INSTALLATION OF EQUIPMENT
The installation of this equipment requires specialized technical
assistance (Gnatus).

OBS: These information also make part of the Manual of Installation

and Maintenance of the equipment that can be found with the
authorized Gnatus technician.

- This equipment shall only be able to be unpacked and installed by a Gnatus authorized
technician, under penalty of losing the warranty, as only (s)he has the information, suitable
tools and training required to execute this task.
- Gnatus bears no responsibility for damages or accidents caused by poor installation
executed by a technician not authorized by Gnatus.
- Only after the equipment has been installed and duly tested by the authorized technician
representing Gnatus, will it be ready to start work operations.

29
OPERATION OF EQUIPMENT
Operating Instructions of Transmitter Assembly How to move
the cylinder head
- When moving the cylinder head, grasp the cylinder (02) and back part (01) as shown
in the picture.

Operating Instructions
Only after an authorized technician have properly installed
and tested the equipment, it will be ready to work.
Verify if the equipment is connected to the main grid.
Turn on the general switch (09) and a green light will 01
turn on.
Choose the time scale from 0 to 3.2 seconds according
to the work to be performed. “See radiographic technique
chart on page 33” and set it through the buttons (04 and
05) located on the control.
When the patient is properly prepared for the 02
radiography:
Remove the support control, press the shutter-button 03
(06) (Beep beeping) and keep it pressed.
The “yellow” LED must be lighted during radiation 04
emission. 06
Note: Turn off the general key (09) whenever the 05
equipment is not in use. 07
Always keep the remote control in its holder.
08
Note: If the messages appear on the display:
• A1 •A2
• A3 •A4 09
•Sb •A5

See page 40 “Unforeseen situations”

NOTE:
The value indicated on the digital command display refers to the exposure time. To
obtain the charge application time, add 0.2 seconds (pre-warming) to any value indicated
on the display.

- As it is a pulse device and depends on the wiring frequency, it is not possible to provide
time of 0,063s belonging to geometric series within the range of ± 10%.
( IEC 60601-2-7 : 29.1.106 E)

30
OPERATION OF EQUIPMENT
Operating Instructions “Smaller colimator rectangular kit and
extension with colimator cone kit”
By applying a slight effort, press the cover (01) against the adapter (02) observing the
alignment of openings (A) with catches (B) “click system”.
After assembling cover (01) and adaptor (02), attach the assembly mounted in the
complementary cone (03), afterwards attach to the cylinder head (04).
The attachment between the couplings shall be performed with rotation movements,
and the alignment between locking cams shall be observed (C).

Smaller colimator Extension with

rectangular kit (optional) colimator cone kit 04
03
(optional)
04

02 02 C

B B
C C

C C
01 01
A A

WARNING
The operator shall keep a bigger distance between the distal extreme of limiting bunch
device and patient’s surface.

Limit and x-ray beam extension recommendation

The X-Ray field is confined within the limits of opening of the Diaphragm (11,2mm -
fixed).

Precautions to be observed before the 1st charge application

- Check that all the items from the instructions operations manual have been
concluded.
- Place yourself behind the head (opposite the beam) at a minimum distance of 2.5m,
to carry out the activation.

31
OPERATION OF EQUIPMENT
Radiation bunch characteristics
The pictures below present radiation bunch characteristics with and without the use of
extension whit colimador cone.
The extension whit colimador cone is used to apply the parallelism technique which
gives less distortion to the image generated due to x-ray from film/sensor presented less
inclination related to reference axis.

Radiation bunch X without extension whit colimador cone

(203,2mm)

Radiation bunch X with extension whit colimador cone

(304mm)

NOTE: If the extension whit colimador cone is not used, it does not affect the
safety level to patient during use of this device.

32
OPERATION OF EQUIPMENT
Radiography technical letter
Standard table for exposure time with type E film in adult individuals using the bisector
periapical technique.
DEP - Skin penetration dose (mGy)
DEP - 3,5 mGy - Standard level established by ordinance 453 (D.O.U. 103 02/06/98) for
a periapical exame of typical adult patient and film of group E. (Extaspeed/Agfa M-4)
Film D (Ultra-speed/Agfa M-2) double the time;
Children, con-sider 2/3 of time;
Angle with the vertical.

Time DEP Time DEP

Region Angle
(E group film) (mGy) (Digital Sensor) (mGy)

Superior Jaw
Incisor +40º 0,32 - 0,40 1,1 - 1,5 0,06 0,10
Canine +45º 0,40 - 0,50 1,5 - 2,0 0,08 0,16
Pre-molar +30º 0,40 - 0,50 1,5 - 2,0 0,08 0,16
Molar +20º 0,50 - 0,64 2,0 - 2,6 0,10 0,24

Lower Jaw
Incisor -15º 0,32 - 0,40 1,1 - 1,5 0,06 0,10
Canine -20º 0,32 - 0,40 1,1 - 1,5 0,06 0,10
Pre-molar -10º 0,32 - 0,40 1,1 - 1,5 0,06 0,10
Molar -5º 0,40 - 0,50 1,5 - 2,0 0,08 0,16

Bitewing
Anterior +8º 0,32 - 0,40 1,1 - 1,5 0,06 0,10
Posterior +8º 0,32 - 0,40 1,1 - 1,5 0,06 0,10

Oclusal
Upper Jaw +60º 0,50 - 0,63 2,0 - 2,6 --- ---
Lower Jaw -70º 0,40 - 0,50 1,5 - 2,0
--- ---

Procedure for processing with recent chemical agents

Process Temperature (oC) 18 - 20 21 -22 23 - 25 26 - 28 29 - 31

Process Time (min) 5,0 4,0 3,0 2,0 1,0

33
OPERATION OF EQUIPMENT
Radiography test
After the assembly of the equipment the authorized
technician must carry out a radiography test, using
the materials (film, dark room, processor and fixator) 23
supplied by the client, following the instructions
below:
24
Place the head directed downwards (90o position)
next to an horizontal surface (aprox. 50 mm).
Centralize the film (25) utilizing for such the
auxilliary points (24) existing on the Collimator Cylinder 25
(23), put over the film (25), a metallic object (26). (Ex.:
clips or coin) as in the figure below:
26
Select a time scale of 0.32 seconds.
Activate the button “Start” (06) (see pg. 30).

NOTE:
The material (clips, coins, film, etc) will not be
contaminated, and can be taken out after trigger.
Develop the film at Dark Room with the following
times:
- 1 minute at development;
- 1 minute at fixation.
Afterwards, check if radiography is according to indicated
standard.
In case of differences in comparison, see page 40
Radiography carried out with “fault”.
• Kodak Film. If it is not possible to test by the authorized technician
• Ektaspeed Type (because of lack of material) the proprietary will be
It is not provided with the product responsible for it before initiating operations.

Caution:
Never test the device with the cylinder aimed to you, or people that are next to the place
Always do the test with the cylinder aimed downwards, by keeping a minimum distance
of 2m.

34
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Transportation and storage
This equipment must be transported and stored observing the following directions:
- Avoid falls and impacts;
- Keep it dry, do not expose it to rain, water drops or wet floor;
- Keep it away from water and direct sunlight, and in it original wrapping;
- Don’t move it over irregular surfaces, protect it from rain and observe the maximum
stack quantity specified in the packaging;
- Transportation and storage temperature range: -12°C to 50°C;
- Transportation and storage relative humidity range: 0°C to 90°C;
- Atmospheric pressure range: 500hPa to 1060hPa (375 mmHg to 795 mmHg).

Operation ambient conditions

- Ambient temperature range: +5°C to +45°C;
- Ambient temperature range recommended by Gnatus: +15°C to +30°C;
- Operation relative humidity range: 30% to 75% (non condensing);
- Atmospheric pressure range: 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).

Sensitivity to environmental conditions in normal situations

of use
- The equipment has been planned not to be sensitive to interference such as magnetic
fields, external electrical factors, electrostatic discharge, pressure or variance of pressure,
provided that the equipment is installed, maintained, clean, preserved, transported and
operated as per this instruction for use.

Precautions and warnings “during the installation” of

quipment
- The equipment should only be installed by Gnatus authorized technical assistance or
technicians.
- Check that the socket in which the device will be connected has a ground connection.
According to the ABNT standard, this is essential for the safe operation of the system;
- Position the unit in a place where it will not get wet.
- Install the unit in a place where it will not be damaged by the pressure, temperature,
humidity, direct sunlight, dust, salts, or sulfur compounds.
- The unit should not be submitted to inclination, excessive vibrations, or blows (including
during transportation and handling).
Removing the tape from the arm:
- If you early remove the adhesive tape, safety risk may occur. In order to remove it,
please press the adjustable arm taking pressure off the tape. After removing it, slowly
loose the arm.
- The equipment should be transported with the arms overlaid as illustrated. In this form
it will have its stability enhanced.
- This equipment was not planned for use in an environment where vapors, anesthetic
mixtures inflammable with air, or oxygen and nitrous oxide can be detected.
- Check the voltage of the equipment at the moment of executing the electrical
installation.
- The equipment must be grounded correctly.
- Before the first use and/or after long interruptions from work such as vacations, clean
and disinfect the equipment.

35
PRECAUTIONS, RESTRICTIONS AND WARNINGS
These information also make part of the Manual of Installation and
Maintenance of the equipment that can be found with the authorized
Gnatus technician.

Recommendations for the dental equipment maintenance

Your Gnatus equipment has been designed and developed according to the standards
of modern techology. Similarly to other kinds of equipment, it requires special care, which
is many times neglected due to several reasons and circunstances.
Therefore, here are some important reminders for your daily routine. Try to follow these
simple rules, which will save you a lot of time and will avoid unnecessary expenses once
they start making part of your working procedure.

Precautions and warnings “during the use” of equipment

- The equipment should only be operated by duly enabled and trained technicians (Dental
Surgeons, Capacitated Professionals)
- If any maintenance should be required, only use services of the Gnatus Authorized
Technical Assistance.
- The equipment has been manufactured to handle both continuous and intermittent
operation; so follow the cycles described in these Instructions for Use.
- Because of the emission of ionised radiation, this equipment can cause collateral effects
in case users don’t follow the protection requirements.
- In case of oil spilling in the Emission Set, the precautions below must be carried out:
- Avoid skin extended contact; wash the contaminated parts with soap and water.
- In case of skin or eyes irritation, visit a doctor.
- Do not throw it into water, soil or sewage. In case of spilling, absorb it with sawdust
or similar material.
- The used oil is recyclable. For disposal, send the oil for re-refining according to the
local law. Preserve the environment.
- Although this equipment has been planned in accordance with the standards of
electromagnetic compatibility, it can, in very extreme conditions, cause interference with
other equipment. Do not use this equipment together with other devices very sensitive to
interference or with devices which create high electromagnetic disturbance.
- Do not expose the plastic parts to contact with chemical substances, use in the routines
of dental treatment, such as: acids, mercury, acrylic liquids, amalgams, etc.

Gnatus shall not be responsible for:

- Use of the equipment differing from that for which it is intended.
- Damages caused to the equipment, the professional and/or the patient by the incorrect
installation and erroneous procedures of maintenance, differing from those described in these
Instructions for use which come with the equipment or by the incorrect operation of it.

36
PRECAUTIONS, RESTRICTIONS AND WARNINGS

- When using the equipment,

take care with the parts that
can clamp your fingers as
illustrated.

Precautions and warnings “after” the use of equipment

- Turn off the main switch of the dental set when it is not in use for an extended period
of time.
- Always maintain the equipment clean for the next operation.
- Do not modify any part of the equipment. Do not disconnect the cable or other
connections without need.
- After using the equipment, clean and disinfect all the parts which may be in contact
with the patient.

Precautions and warnings during the “cleaning and disinfection”

of equipment
- Before cleaning the equipment, turn off the main switch.
- Avoid spilling water, even accidentally, or other liquids inside the equipment, which
could cause short circuits.
- Do not use microabrasive material or steel wool when cleaning, or employ organic
solvents or detergents which contain solvents such as ether, stain remover, gasoline etc.

Precautions in case of alteration in the functioning of

equipment
- If the equipment has any abnormality, check if the problem is related to any item
listed in the topic of unforeseen events (failures, causes and solutions). If it is not possible
to resolve the problem, turn off the equipment, remove the power supply cable from the
socket and contact your representative (Gnatus).

Precautions to be adopted against foreseeable or uncommon

risks, related to the deactivation and abandoning of
equipment
In order to avoid environmental contamination or undue use of the Equipment after it
has become useless, it should be discarded in the suitable place (as per the local legislation
of the country).
- Pay attention to the local legislation of the country for the conditions of installation
and disposal of residue.

37
CORRECTIVE AND PREVENTIVE MAINTENANCE
AND PRESERVATION
Additional procedures for reuse
The equipment can be reused in undetermined, i.e. unlimited, quantities, only needing
to be cleaned and disinfected.

Disinfection
Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment.
Never use corrosive disinfectants or solvents.

Cleaning
The cleaning procedure below should be executed at the start of the
working day and after each patient.
Always turn off the main switch before executing the procedures of
daily maintenance.

To clean the equipment, we recommend the use of “BactSpray

(Reg nº MS: 3.2079.0041.001-5) or any other similar product:
Active component: Benzalkonium chloride (tri-quaternary
ammonium)
Solution 50%................................................. 0.329%
Chemical composition: Butyl Glycol, Decyl polyglucose, Sodium
Benzoate, Sodium Nitrate, Essence, Deodorized Propane / Butane,
demineralized Water.
For more information concerning cleaning procedures, see
manufacturer’s instructions.

WARNING:
- In order to prevent risks and damages to equipment, make
sure that the liquid does not enter into the unit.
- The application of other solvent-based cleaning products or
sodium hypochloride isn’t recommended, because they may damage
the equipment.

NOTE: The registration at the Ministry of Health of the

“BactSpray” is executed separately from the product described in
this manual, as the “BactSpray” is not manufactured by Gnatus.

Note: Use gloves Attention: Do not use any

and other systems of disinfectant spray, as the
protection, during the vapor may be inflammable, or
disinfection. it may cause injury.

38
CORRECTIVE AND PREVENTIVE MAINTENANCE
AND PRESERVATION
Preventive Maintenance
The equipment should be calibrated routinely, as per the legislation in force in the
country.
But never with a period exceeding 3 years.
In order to protect your equipment, seek Gnatus technical assistance for periodic revisions
of preventive maintenance.

Corrective Maintenance
If the equipment has any abnormality, check if the problem is related to any of the items
listed in the item Unforeseen Events (situation, cause and solution).
If it is not possible to solve the problem, turn off the equipment, and request Gnatus
technical assistance.

39
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
Upon coming across any problem in operation, follow the instructions below to
check and repair the problem, and/or get in touch with your representative.

Problem Probable cause Solution

- Not functioning pro- -0Damaged fuse. -Turn the device off and call a tech-
perly. nician.
-0Lack of power. -Check the wiring

-At radiography appe- -Wrong positioning of cylin- -Radiograph using the parallelism
ars a semi circle. der. technique, using for that auxiliary
lines of collimator cylinder.

-Radiography totally -Excess of XR time; - Check if the time is well adjusted

dark. according to radiographic techni-
ques table;
-Development; -Check the development time.
-Developer with inadequate -AThe quicker is the developer
temperature. action the bigger is the solution
temperature.
-Developer with inadequate -Prepare the mixture again.
mixture. NOTE: Kodak developer does not
use mixture.
-Radiography with a -Development Camera with -Avoid light output.
dark targe. light penetration.

Message in the Display -Invalid Voltage: -Check the supply voltage

-A1 Voltage higher than the -See about overpotential protection
equipment’s limit. on page 12.

-A2 -Invalid Voltage: -Check the supply voltage

Voltage lower than the -See about overpotential protection
equipment’s limit. on page 12.

-A3/A5 -Fault in electrical network -Turn on the equipment. In case of

failure lasts, request a technician
service.

-A4 -Exposure error: -Turn on the equipment.

Shutter button released be-
fore time.

-Sb -Protection against excessi- -Wait for the correct cooling time to
ve tube heating. reestablish the normal functions –
see page 12 – cooling item.

40
WARRANTY OF EQUIPMENT
This equipment is covered by the warranty terms counting from the date of installation,
as specified below; provided that the defect has occurred in normal conditions of use and
that the equipment has not remained stored for more than 06 months counting from the
issue date of the sales document until the date of the actual installation.
- WARRANTY TERMS: Verify the guarantee certificate;
- LOSS OF THE WARRANTY:
A) Attempt to repair using an inadequate tool or by unauthorized technicians;
B) Installation of the equipment by an unauthorized technician;
C) Damage arising from inappropriate storage or signs of infringement;
D) Incorrect use of the equipment;
E) Use of a cleaning product not indicated by the factory;
F) Falls or blows which the equipment may undergo or lack of observation of an compliance
with the guidelines of the Owner’s Manual, which was delivered with the present document,
together with the equipment. Repair or replacement of parts during the warranty period
shall not extend the validity term of their warranty.
- This warranty doe snot exempt the customer from paying the service charge for the visit
and the travel expenses of the technician, except when the customer sends the equipment
to execute the maintenance inside the establishment of the technical assistance.
“Consumer Defense Code - art. 50, unique paragraph”.
- The Warranty Certificate comes with the product and must be filled in upon the date
of installation by the Gnatus Authorized Technician.
- Queries and information: GNATUS Help Desk (+55) 16 2102-5000.
- Check the warranty term attached to this manual.

FINAL CONSIDERATIONS
The most important aspect related to equipment care is that concerning spare parts.
To guarantee the life span of your equipment, use only original Gnatus spare parts.
They are sure to follow the technical specifications and standards required by Gnatus.
We must also point out to you our chain of authorized dealers. Only dealers that make
part of this chain will be able to keep your equipment constantly new for they count on
technical assistants who have been trained and on spedific tools for the correct maintenance
of your equipment.
Doubts and information: GNATUS Call center (55-16) 2102-5000.

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