Sirona Heliodent Plus User Manual

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Sirona Dental Systems GmbH Table of contents
Operating Instructions HELIODENT
PLUS

Table of contents

1
2
General data............................................................................................................ 5
1.1 Preface ......................................................................................................... 5
1.2 General information about this operating manual ........................................ 5
1.3 Contact information ...................................................................................... 6
1.4 Warranty and liability .................................................................................... 6
1.5 Intended use................................................................................................. 7
1.5.1 Indication and contraindication........................................................ 7
1.6 Structure of the document ............................................................................ 8
1.6.1 Identification of the danger levels.................................................... 8
1.6.2 Formats and symbols used ............................................................. 8
Safety information.................................................................................................... 9
2.1 Information on the unit.................................................................................. 9
2.2 Risk of crushing............................................................................................ 9
2.3 Maintenance................................................................................................. 10
2.4 Modifications to the product ......................................................................... 10
2.5 Condensation ............................................................................................... 10
2.6 Qualifications of operating personnel ........................................................... 10
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2.7 Radiation protection ..................................................................................... 11
2.8 Hygiene ........................................................................................................ 11
2.9 Trouble-free operation.................................................................................. 11
2.10 Interference with electronic devices ............................................................. 11
2.11 Risks of electromagnetic fields..................................................................... 12
2.12 Electromagnetic compatibility....................................................................... 12
3
4
Technical description............................................................................................... 13
3.1 Technical data .............................................................................................. 13
3.2 Diagrams ...................................................................................................... 15
3.3 Certification, registration and standards....................................................... 16
Controls and functional elements ............................................................................ 17
4.1 Operating and Display Elements.................................................................. 17
4.2 Meaning of the icons .................................................................................... 18
4.3 Display structure........................................................................................... 19
4.4 Version Ceiling model/Ceiling combination.................................................. 19
4.5 Mobile stand variant ..................................................................................... 20
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Table of contents Sirona Dental Systems GmbH
Operating Instructions HELIODENT
4.6 Version Unit model........................................................................................ 22
4.7 Accessories................................................................................................... 23
4.8 Exposure times ............................................................................................. 24
4.8.1 Possible exposure times in seconds ................................................ 24
4.8.2 Pre-programmed exposure times for films of sensitivity class E and with a 200 mm (8") FHA cone
4.8.3 Pre-programmed exposure times for films of sensitivity class E and with a 300 mm (12") FHA cone
4.8.4 Pre-programmed exposure times for XIOS XG sensors with 200 mm (8") FHA cone
4.8.5 Pre-programmed exposure times for XIOS XG sensors with 300 mm (12") FHA cone (round or square cone)
PLUS
24
25
26
27
5
6
Operation.................................................................................................................. 28
5.1 Preparing the exposure................................................................................. 28
5.1.1 Switch the unit on............................................................................. 28
5.1.2 Selecting the tooth icon.................................................................... 28
5.1.3 Selecting the patient symbol ............................................................ 29
5.1.4 Checking the kV value: .................................................................... 29
5.1.5 Plus/Minus keys ............................................................................... 29
5.1.6 Checking the imaging technology .................................................... 29
5.2 Positioning the patient/X-ray tube assembly ................................................. 30
5.3 Releasing the exposure ................................................................................ 31
5.4 Adapting basic settings ................................................................................. 33
Maintenance............................................................................................................. 35
6.1 Cleaning and care ......................................................................................... 35
6.1.1 Cleaning ........................................................................................... 35
6.1.2 Disinfecting....................................................................................... 35
6.1.3 Maintenance of accessories............................................................. 36
6.2 Inspection and maintenance ......................................................................... 37
7
8
9
10
Error messages ........................................................................................................ 38
7.1 List of error messages................................................................................... 38
Dismantling and disposal ......................................................................................... 40
8.1 Dismantling and reinstallation ....................................................................... 40
8.2 Disposal ........................................................................................................ 40
8.2.1 Disposal of the X-ray tube assembly................................................ 41
Dose area product (DFP) ......................................................................................... 42
Brief Operating Instructions...................................................................................... 45
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Sirona Dental Systems GmbH 1General data
Operating Instructions HELIODENT
PLUS

General data

1
1.1Preface
1.1
1.2
Observe the Operating Instructions Please familiarize yourself with the unit by reading through these
Keep documents safe Always keep the Operating Instructions handy in case you or another

Preface

Dear Customer,
Thank you for purchasing the HELIODENT
This system can be used to take intraoral X-rays.
Please familiarize yourself with the unit by reading through these Operating Instructions before taking any X-rays of patients. Please comply with the applicable radiation protection regulations and warnings at all times.
SIRONA requires regular constancy tests to ensure image quality.
PLUS
Your HELIODENT
team
PLUS
X-ray system.

General information about this operating manual

Observe the Operating Instructions
Operating Instructions before putting it into operation. It is essential that you comply with the specified warning and safety information.
Storage of documents, on line portal, help
user require(s) information at a later point in time. Save the Operating Instructions on the PC or print them out.
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If you sell the unit, make sure that the Operating Instructions are included with it either as a hard copy or on an electronic storage device so that the new owner can familiarize himself with its functions and the specified warning and safety information.
Online portal for technical documents We have set up an online portal for the Technical Documents at http://
www.sirona.com/manuals. From here, you can download these Operating Instructions along with other documents. Please complete the online form if you would like a hard copy of a particular document. We will then be happy to send you a printed copy free of charge.
Help If you reach an impasse despite having thoroughly studied the operating
instructions, please contact your dental depot.
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1General data Sirona Dental Systems GmbH
1.3Contact information Operating Instructions HELIODENT
PLUS
1.3
Customer service center In the event of technical queries, please use our online contact form at

Contact information

Worldwide customer service
www.sirona.com. In the navigation bar, go to the menu commands
"CONTACT" FORM FOR TECHNICAL QUESTIONS"
Manufacturer's address Sirona Dental Systems GmbH
Manufacturer's address (w orl d wi de )
/
"Customer Service Center"
and then click the
button.
"CONTACT
Fabrikstrasse 31 64625 Bensheim Germany
Trademark
Phone: +49 (0) 6251/16-0 Fax: +49 (0) 6251/16-2591 e-mail: contact@sirona.com www.sirona.com
1.4

Warranty and liability

Maintenance In the interest of the safety and health of patients, users and other
persons, inspection and preventive maintenance must be performed at scheduled intervals to ensure the operational reliability and functional safety of your product (IEC 60601-1 / DIN EN 60601-1 etc.).
The system owner must ensure that all inspections and maintenance events take place.
As manufacturers of medical electrical equipment, we can assume responsibility for the safety properties of the system only if maintenance and repair work on the system is performed by ourselves or by agencies expressly authorized by us, and if components affecting safe operation of the system are replaced by original spare parts in case of failure.
Exclusion of liability If the system owner fails to fulfill the obligation to have inspections and
maintenance work performed or ignores error messages, Sirona Dental Systems GmbH and its authorized dealers cannot assume any liability for resulting damage.
Certificate of work We suggest that you request a certificate, showing the nature and extent
of the work performed, from those who carry out such work, and specify that the certificate show any changes in rated parameters or working ranges, as well as the date, the name of the firm and a signature.
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Sirona Dental Systems GmbH 1General data
Operating Instructions HELIODENT
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1.5Intended use
1.5

Intended use

This system must not be used in areas subject to explosion hazards.
Intended use ww
The HELIODENT
PLUS
is an extraoral X-ray system. It is intended for use in dental radiographic examination and diagnosis of diseases and disorders of the teeth, the jaw and oral structures.
With room temperatures > 35°C (> 95°F) Sirona recommends the use of an air conditioning system. Recommended operating temperature: 18 °C - 35 °C (64 °F - 95 °F)
United States only CAUTION Federal law (USA) restricts sale of this device to or on the order of a physician, dentist, or licensed practitioner.

1.5.1 Indication and contraindication

Indications in the areas:
Intraoral indication
● Conservative dentistry
● Caries diagnosis, especially of proximal lesions
● Endodontics
● Periodontology
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● Prosthodontics
● Functional diagnosis and therapy of craniomandibular dysfunctions
● Surgical dentistry
● Implantology
● Oral and maxillofacial surgery
● Orthodontics
Contraindications:
Intraoral contraindication
● Display of cartilage structures
● Display of soft tissue
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1General data Sirona Dental Systems GmbH
1.6Structure of the document Operating Instructions HELIODENT
PLUS
1.6

Structure of the document

1.6.1 Identification of the danger levels

To prevent personal injury and material damage, please observe the warning and safety information provided in the present operating instructions. Such information is highlighted as follows:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily injury or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the product or an object in its environment.
IMPORTANT
Application instructions and other important information.
Tip: Information on making work easier.

1.6.2 Formats and symbols used

The formats and symbols used in this document have the following meaning:
Prerequisite
1. First action step
2. Second action step
or
Alternative action
Result
➢ Individual action step
See "Formats and symbols used [ → 8]"
● List Designates a list.
"Command / menu item" Indicates commands, menu items or
Requests you to do something.
Identifies a reference to another text passage and specifies its page number.
quotations.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions HELIODENT
PLUS

Safety information

2
2.1Information on the unit
Accompanying documents
2.1
2.2

Information on the unit

Accompanying document s
This symbol is affixed next to the unit rating plate.
Meaning: When operating the unit, observe the operating instructions.
This symbol is affixed on the unit rating plate.
Meaning: The accompanying documents are available on the homepage of Sirona.

Risk of crushing

Risk of crushing
CAUTION
Gaps appear between the internal hinges when moving the angular support arm.
Fingers may be crushed in these gaps.
➢ Ensure that you never place your fingers in the gaps between the
hinges, neither during operation nor for cleaning purposes.
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2Safety information Sirona Dental Systems GmbH
2.3Maintenance Operating Instructions HELIODENT
PLUS
2.3
2.4

Maintenance

In the interest of the safety and health of patients, users and other persons, inspection and preventive maintenance must be performed at scheduled intervals to ensure the operational reliability and functional safety of your product (IEC 60601-1 / DIN EN 60601-1 etc.).
The system owner must ensure that all inspections and maintenance events take place.
If the system owner fails to fulfill the obligation to have inspections and maintenance work performed or ignores error messages, Sirona Dental Systems GmbH and its authorized dealers cannot assume any liability for resulting damage.
As manufacturers of medical electrical equipment we can assume responsibility for the safety-related features of the equipment only if maintenance and repair are carried out only by ourselves or agencies expressly authorized by us, and if components affecting safe operation of the system are replaced with original spare parts upon failure.
We suggest that you request a certificate showing the nature and extent of the work performed from those who carry out such work; it must contain any changes in rated parameters or working ranges (if applicable), as well as the date, the name of the company and a signature.

Modifications to the product

2.5
2.6
Modifications to this product which may affect the safety of the operator, patients or third parties are prohibited by law!

Condensation

Safety information for condensatio n: Customer
Extreme fluctuations of temperature may cause condensation inside the unit. Do not switch the unit on before it has reached normal room temperature. See the chapter on “Technical data”.

Qualifications of operating personnel

Operating personnel
The system may only be operated by skilled or properly trained personnel.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions HELIODENT
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2.7Radiation protection
2.7
2.8

Radiation protection

Safety information for Heliode nt rad ia tion protection: Customer
The valid radiation protection regulations and measures must be observed. The statutory radiation protection equipment must be used. In order to reduce radiation exposure, Sirona recommends using bismuth or lead shields or aprons, especially for pediatric patients.
During an exposure, the operator should move as far away from the X-ray tube assembly as the coiled cable of the manual release permits.
With the exception of the patient, no other persons without radiation protection are allowed to stay in the room during an exposure. In exceptional cases, a third person may provide assistance, but not the practice staff. If the patient is within reach of the unit including its operating elements, they must be supervised. Visual contact with the patient and the unit must be maintained throughout the entire exposure.
In case of malfunctions, cancel the exposure immediately by letting go of the exposure release button.

Hygiene

Suitable hygienic measures must be taken to prevent cross contamination among patients, operators and other persons.
Before positioning the patient in the unit, you must ensure that
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2.9
2.10
● all auxiliary X-ray equipment is used and prepared (sterilized and/or disinfected) in accordance with manufacturer specifications (e.g. hygienic protective sleeves).
Compliance with the hygienic measures prevents the transmission of infections that can trigger severe illnesses.

Trouble-free operation

Generally valid
Use of this system is permissible only if it works properly without malfunctions. If trouble-free operation cannot be ensured, the unit must be taken out of service, checked by authorized technicians for malfunctions and, if necessary, repaired.
Unit cover
The device may only be operated with a complete cover and protective hood.

Interference with electronic devices

To prevent the malfunctioning of electronic devices and data storage devices, e.g. radio-controlled watches, telephone cards, etc., these objects must be removed prior to X-raying.
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2Safety information Sirona Dental Systems GmbH
2.11Risks of electromagnetic fields Operating Instructions HELIODENT
PLUS
2.11
2.12

Risks of electromagnetic fields

The function of implanted systems (cardiac pacemakers or cochlear implants, for example) can be affected by electromagnetic fields. Before commencing treatment, ask if the patient has a cardiac pacemaker or any other implanted system. Any prevailing risks are listed in the documentation provided by the equipment manufacturer.

Electromagnetic compatibility

The acquisition unit complies with the requirements of the standard IEC 60601-1-2.
Medical electrical devices are subject to special precautionary measures with regard to EMC. It must be installed and operated as specified in the document “Installation Requirements”.
Portable and mobile RF communications equipment may interfere with medical electrical equipment.
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Sirona Dental Systems GmbH 3Technical description
O
Operating Instructions HELIODENT
PLUS

Technical description

3
3.1Technical data
3.1

Technical data

Technical data AL1.5 WW
Nominal voltage: 120V, 200V– 240V
Permissible fluctuation: ± 10%
Rated current: At 120 V: 10A
At 200 – 240 V: 6 – 5 A
Nominal frequency: 50 Hz / 60 Hz
Internal line impedance: At 120 V 0.3 ohms
At 200 – 240 V 0.8 Ohm
Main building fuse: 16 A slow blow
Power input during radiation: 1.2 kW
Power input in standby mode:
Tube voltage: 60 kV / 70 kV switchable
Tube current: 7 mA (max. tolerance ± 1.4 mA)
High-voltage waveform: DC high frequency
High voltage generation frequency:
Radiation time: 0.01 – 3.2 s
Pulse/pause ratio: automatic monitoring from 1:1 to 1:60
Total filtration of X-ray tube assembly:
Radiation field: Ø < 60 mm
Dose rate: 8.5 mGy/s ±40% at 60 kV
Measuring instruments: PTW Nomex with an ionization space of
Measuring conditions: 200 mm focus-meter space
Focal spot size as specified in IEC 60336:
Focal spot marking O:
< 20 W
(max. tolerance ± 5 kV)
residual ripple value ≤ 4 kV
50 kHz - 70 kHz
(max. tolerance ± 10% +1 ms)
> 1.5 AI / 70 IEC 60522
11 mGy/s ±40% at 70 kV
3
1 cm
or Unfors mult-o-meter
230 V nominal voltage
0.4
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3Technical description Sirona Dental Systems GmbH
3.1Technical data Operating Instructions HELIODENT
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Source-skin distance: FHA 200 mm (8") - standard or 300 mm
(12")
Class I device Degree of protection against electric shock:
Degree of protection against ingress of water:
Type B device
Ordinary equipment (without protection against ingress of water)
Year of manufacture:
(on the rating plate)
Operating mode: Continuous operation
X-ray tubes: Petrick P470/8.35/12G
Nominal continuous power
26 W
rating of the X-ray tube:
Power rating of X-ray tube
490 W
(70kW/7mA):
Anode material: Tungsten
Anode angle: 12°
Exposure parameters for
0.12 mA / 70 kV determining leakage radiation:
Leakage radiation at 1 m
< 0.25 mGy/h
distance:
Transport and operating conditio ns
Transport and operating conditions:
Transport and storage
-40°C – +70°C (-40°F – 158°F) temperature:
Air humidity: 10% – 95%
Operating conditions as specified in IEC 60601-1:
Ambient temperature +10 °C – +40 °C (50 °F – 104 °F)
Relative humidity: 30% – 75%
Operating altitude: ≤ 3000 m
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Sirona Dental Systems GmbH 3Technical description
90
80
70
50
30
20
0
10 20 30 40 50 60 70 80 90 100 170 t (min)
Joule x10
3
110 120 130140 150 160
10
40
60
1 2 3 4 t (min)
5000
4000
3000
2000
1000
0
Joule
120
100
80
60
40
20
0
20 40 60 80 100 120 140 160 180 200 220 t (min)
Joule x10
3
Operating Instructions HELIODENT
PLUS
3.2Diagrams
3.2

Diagrams

Curves
Cooling curve of tube housing
Cooling curve of X-ray tube
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Heating curve of tube housing
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3Technical description Sirona Dental Systems GmbH
0123
3.3Certification, registration and standards Operating Instructions HELIODENT
PLUS
3.3

Certification, registration and standards

CE mark
The HELIODENT others:
● IEC 60601-1
● IEC 60601-1-3
● IEC 60601-2-65
The dental X-ray equipment for intraoral radiography HELIODENT
Original language: German
This product bears the CE mark in accordance with the provisions of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (MDD).
PLUS
complies with the following standards, among
PLUS
D3507 complies with IEC 60601-2-65.
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Sirona Dental Systems GmbH 4Controls and functional elements
L
M
K
N
30
60
6
0
9
0
I
H
G
F
E
D
C
B
A
J3
R
J1
A
J1
J2
I
H
G
F
E
D
C
B
S
Operating Instructions HELIODENT
PLUS

Controls and functional elements

4
4.1Operating and Display Elements
4.1

Operating and Display Elements

A Main ON/OFF switch
B Readiness for operation indicator (LED)
C Optical radiation indicator for X-ray
D Plus/minus keys for exposure time
E Digital display of exposure time
F Child/Adult pre-selection key
G Pre-selection keys and display of 60 kV/70 kV
H Pre-selection keys and display of digital mode and film
mode
I Keys and display for tooth selection/image type
J1 Manual release J1 Depending on
J2 Release button J2 on the Remote Timer
J3 Release button J3 on the remote control
K X-ray tube unit
L Scale for adjusting the angle of inclination
M Radiation field limitation
N Cone extension
R Remote control
S Remote Timer
the installed version
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4Controls and functional elements Sirona Dental Systems GmbH
+
_
4.2Meaning of the icons Operating Instructions HELIODENT
PLUS
4.2

Meaning of the icons

Patient symbol
Adult
Child
Plus key
Minus key
Exposure release button
Maxillary front tooth
Maxillary canine/premolar
Maxillary molar
Bite-wing exposure
Mandibular front tooth
Mandibular canine/premolar
Mandibular molar
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions HELIODENT
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4.3Display structure
4.3
4.4

Display structure

The background lighting of the display indicates the current status of the unit.
Background color Meaning
Blue Ready for radiation
Yellow Radiation
White Service
Red Error

Version Ceiling model/Ceiling combination

Ceiling model
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Ceiling combination with LEDview
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4Controls and functional elements Sirona Dental Systems GmbH
A
B
C
D
A
B
C
D
4.5Mobile stand variant Operating Instructions HELIODENT
PLUS
4.5

Mobile stand variant

Mounting of the wall model with round or angular support arm (only support arm length short possible) on a mobile stand for mobile use.
Secure the tube assembly with the fastening strap (B).
Use the two handles (A) on the side to move the mobile stand.
The mobile stand must be moved slowly on an even surface.
CAUTION
Risk of injury!
When changing the treatment station, the stay arm must be secured with the fastening strap provided (B). The mobile stand must be moved extremely carefully using the handholds provided (A). Particular care must be taken when crossing floor beams. The mobile stand may need to be lifted a little if necessary.
The mobile stand has 4 rollers with brakes.
To lock the rollers in place, press the locking lever (C) down ↓ , and to release lift it up ↑ .
CAUTION
Always apply the brakes (C) before setting up the X-ray tube assembly.
The mobile stand can be fitted with a tray (D).
CAUTION
This tray may hold a maximum of 5 kg.
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Sirona Dental Systems GmbH 4Controls and functional elements
610 24”
540°
550
21 5/8”
973
38 3/8”
782
30 3/4”
1740
68 1/2”
1330
52 3/8”
1001
39 3/8”
180°
Operating Instructions HELIODENT
PLUS
4.5Mobile stand variant
End stop
Rotation option of the round/angular support arm is 180°.
CAUTION
When the angular support arm moves, gaps are created between the support arm and the tray.
Fingers can be crushed in these gaps.
➢ Be careful not to put your fingers in the space between the moving
arm and the tray, either during operation or when cleaning.
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4Controls and functional elements Sirona Dental Systems GmbH
1400
55 1/8”
2250
88 9/16”
500
19 5/8”
200
7 7/8”
300 11 7/8
*
B
A
E
1360
53 1/2”
C
180°
D
4.6Version Unit model Operating Instructions HELIODENT
PLUS
4.6

Version Unit model

HELIODENT Plus at a treatment center, only possible with angular support arm system.
Rotation option of the angular support arm is 180°.
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions HELIODENT
PLUS
4.7Accessories
4.7

Accessories

Information about accessor ies
IMPORTANT
Not all of the accessories listed here are included in the scope of supply.
Test phantom
Only required in countries in which the constancy test is mandatory.
Phantoms for consistency checks on conventional imaging technology
Order No. 59 69 779
Only required in countries in which the constancy test is mandatory.
Phantoms for consistency checks on the Sirona XIOS XG sensor Order no. 64 00 449
Phantoms for consistency checks on the Sirona XIOSPlus sensor Order no. 62 09 634
Phantoms for consistency checks on the Sirona XIOS sensor Order no. 61 37 447
Accessories
Cone extension to 300 mm FHA (12")
Order No. 62 41 983
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Square cone extension to 300 mm FHA (12")
Order No. 62 41 975
Radiation field limitation white size 0 with rotary handle for Sirona XIOS XG size 0 sensor and conventional imaging technology
Order No. 64 00 142
Radiation field limitation blue 3 x 4 cm with rotary handle for Sirona XIOS XG size 2 sensor, Sirona XIOS
Plus
/XIOS size 2 sensor and conventional
imaging technology
Order No. 62 41 991
Radiation field limitation black 2 x 3 c m with rota r y handle f o r Sirona X IOS
Plus
XG size 1 sensor, Sirona XIOS
/XIOS size 1 sensor and conventional
imaging technology
Order No. 62 42 007
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4Controls and functional elements Sirona Dental Systems GmbH
4.8Exposure times Operating Instructions HELIODENT
PLUS
4.8

Exposure times

4.8.1 Possible exposure times in seconds

0,01 0,02 0,03 0,04 0,05 0,06 0,08 0,10 0,12 0,16 0,20 0,25 0,32 0,40 0,50 0,64 0,80 1,00 1,25 1,60 2,00 2,50 3,20
4.8.2 Pre-programmed exposure times for films of sensitivity
class E and with a 200 mm (8") FHA cone
Exposure times film E cone 200 WW
Upper jaw
Lower jaw
Upper jaw
Lower jaw
Exposure time in seconds with:
60 kV 0,06 0,08 0,10 0,12 0,16 0,20 0,25 0,32
70 kV 0,03 0,04 0,05 0,06 0,08 0,10 0,12 0,16
Freely programmed values
NOTICE
For film of sensitivity class F: Set the exposure time one level lower with the minus button. For films of sensitivity class D: Set the exposure time four levels higher with the plus button. Using a film holder: Set the exposure time one or two levels higher with the plus button.
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions HELIODENT
PLUS
4.8Exposure times
4.8.3 Pre-programmed exposure times for films of sensitivity
class E and with a 300 mm (12") FHA cone
Exposure times film E cone 300 WW
Upper jaw
Lower jaw
Upper jaw
Lower jaw
Exposure time in seconds with:
60 kV 0,12 0,16 0,20 0,25 0,32 0,40 0,50 0,64
70 kV 0,06 0,08 0,10 0,12 0,16 0,20 0,25 0,32
Freely programmed values
bеЦдблЬ
NOTICE
For film of sensitivity class F: Set the exposure time one level lower with the minus button. For films of sensitivity class D: Set the exposure time four levels higher with the plus button. Using a film holder: Set the exposure time one or two levels higher with the plus button.
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4Controls and functional elements Sirona Dental Systems GmbH
4.8Exposure times Operating Instructions HELIODENT
PLUS
4.8.4 Pre-programmed exposure times for XIOS XG sensors
with 200 mm (8") FHA cone
Possible exposure times in seconds
The recommended exposure times are limited to the following values selected from the possible exposure times:
Exposure times XIOS XG sensors cone 8" WW
0.01 0.02 0.03 0.04 0.05 0.06 0.08 0.10 0.12 0.16 0.20 0.25 0.32 0.40
Exposure times by dental region XIOS XG sensors cone 8" WW
Upper jaw
Lower jaw
Upper jaw
Lower jaw
Exposure time in seconds with:
60kV 0.060.080.100.120.16
70kV 0.030.040.050.060.08
Freely programmed values
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions HELIODENT
PLUS
4.8Exposure times
4.8.5 Pre-programmed exposure times for XIOS XG sensors
with 300 mm (12") FHA cone (round or square cone)
Possible exposure times in seconds
The recommended exposure times are limited to the following values selected from the possible exposure times:
0.03 0.04 0.05 0.06 0.08 0.10 0.12 0.16 0.20 0.25 0.32 0.40 0.50 0.64 0.80
Upper jaw
Lower jaw
Exposure times XIOS X G sensors cone 12" WW
Exposure times by dental region XIOS XG sensors cone 12" WW
Upper jaw
Lower jaw
Exposure time in seconds with:
60kV 0.12 0.16 0.20 0.25 0.32
70kV 0.06 0.08 0.10 0.12 0.16
Freely programmed values
bеЦдблЬ
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5Operation Sirona Dental Systems GmbH
B
A
5.1Preparing the exposure Operating Instructions HELIODENT

Operation

5
PLUS
5.1

Preparing the exposure

5.1.1 Switch the unit on

Switch on the unit with the main switch (A) (Position I).
During this process none of the keys of the operating panel must be pressed.
After the unit is switched on, a self-test runs. After approximately 20 seconds, the operational readiness LED (B) is continuously lit and the background lighting of the display changes to blue. The most recent exposure parameters set are displayed.
The unit is ready for radiation.
NOTICE
Error message after the self-test
If an error was detected during the self-test, a corresponding error code is shown on the display. (See chapter entitled "Error Messages"). The LED (B) flashes and the background lighting changes to red. The unit is not ready for operation.
Switch unit OFF and ON again at the main switch (A).
CAUTION
Error message after a repeated self-test
If the error re-occurs, please call your service engineer.

5.1.2 Selecting the tooth icon

Press the key with the tooth icon to denote the region in which you want to take an X-ray.
The programmed exposure time is indicated.
The LED above/below the tooth icon lights up. During bite-wing exposures, the LED to the right of the icon lights up.
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Sirona Dental Systems GmbH 5Operation
60kV
70kV
+
_
Operating Instructions HELIODENT
PLUS
5.1Preparing the exposure

5.1.3 Selecting the patient symbol

Press the button with the adult patient icon if you wish to take an X-ray of an adult.
The programmed exposure time is indicated.
Press the button with the child patient icon if you wish to take an X-ray of a child.
The programmed exposure time is indicated.

5.1.4 Checking the kV value:

Check to see which kV value is set.
Press the 60 kV key to switch to 60 kV.
The exposure time for greater contrast is displayed.
Press the 70 kV button to switch to 70 kV.
The exposure time for enhanced detail recognition with a low level of exposure to radiation is displayed.

5.1.5 Plus/Minus keys

bеЦдблЬ
If you want to increase the exposure time, press the key with the plus symbol until the desired value is displayed.
If you want to decrease the exposure time, press the key with the minus symbol repeatedly until the desired value is displayed.
IMPORTANT
The LEDs above/below the tooth icon previously selected and the patient icon on the display go out.

5.1.6 Checking the imaging technology

If you are working with a digital imaging system (e.g. XIOS XG), the sensor indicator should be lit on the unit. To switch, press the key with the sensor icon.
The exposure time for digital images is displayed.
Set the radiation field limitation for digital imaging technology.
If you wish to take conventional X-ray images (with film), the film indicator should light up on the unit. To switch, press the key with the film icon.
The exposure time for conventional exposures is displayed.
Set the radiation field limitation for conventional imaging technology.
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5Operation Sirona Dental Systems GmbH
660
3030
6060
60
90
5.2Positioning the patient/X-ray tube assembly Operating Instructions HELIODENT
PLUS
5.2

Positioning the patient/X-ray tube assembly

Ask the patient to take a seat on the chair. The operating elements of the unit should be out of reach of the patient.
Touch the tube assembly with both hands to position the tube.
● Parallel technique (with radiation field limitation)
Position the film or the X-ray sensor using a holding system for the parallel technique.
For Sirona X-ray sensors, only the holding systems recommended by Sirona may be used.
Please comply with the operating instructions for intraoral X-rays supplied with the sensors or films.
● Half-angle technique (without radiation field limitation)
Position the film or the X-ray sensor.
● Tilt angle
X-ray tube assembly at the occlusal plane
Upper jaw
Molars 35°
Premolars and canines 45°
Anterior teeth 55°
Bite-wing exposure 10°
-------------------------------------------------------------------- --------
Bite-wing exposure -0°
Anterior teeth -20°
Premolars and canines -10°
Molars -5°
Lower jaw
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Sirona Dental Systems GmbH 5Operation
J1
J2
C
B
J3
C
B
Operating Instructions HELIODENT
PLUS
5.3Releasing the exposure
5.3

Releasing the exposure

CAUTION
Comply with the radiation protection provisions.
NOTICE
When using a digital sensor system, establish exposure readiness in SIDEXIS before you release the exposure, see SIDEXIS User Manual.
● Check the exposure data.
● Keep the patient and unit in sight.
● Press and hold down the release key J1, J2 or J3. The exposure is taken.
The (X-RAY) indicator C remains lit for the duration of the exposure. In addition, an acoustic signal sounds throughout the entire radiation time.
● The exposure has been completed when the radiation indicator goes out automatically and the acoustic signal stops.
● If the dose area product display is activated, the dose area product appears on the display.
If the release key is pressed again, the cooling-off period appears on the display The screen is then white.
bеЦдблЬ
The operational readiness LED B flashes until the automatic cooling-off period of the X-ray tube assembly has expired (automatic exposure block).
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5Operation Sirona Dental Systems GmbH
5.3Releasing the exposure Operating Instructions HELIODENT
PLUS
Canceling an exposure
If you let go of the exposure release button prematurely, the exposure is canceled. The elapsed exposure time flashes. If the device is switched off at the main switch, the exposure is also canceled.
After any key (except for the release button) is pressed, the cooling time starts and the unit is once again ready for operation.
Repeat the X-ray if necessary.
If you are taking an X-ray with film, use a new film.
If you are taking a digital X-ray, ensure that the unit is ready to perform exposures.
NOTICE
Error message
If an error is detected during the exposure, the exposure is automatically canceled. The error code lights up on the digital display. At the same time, the operational readiness LED (B) flashes. In the case of an error code, please call your service engineer.
IMPORTANT
Switch off
If the device is out of use for a lengthy period of time, it can be switched off at the main switch.
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Sirona Dental Systems GmbH 5Operation
+
++
+
_
Operating Instructions HELIODENT
PLUS
5.4Adapting basic settings
5.4

Adapting basic settings

Exposure times for the use of films with the sensitivity class E are factory pre-set, as well as the XIOS XG sensors.
IMPORTANT
The exposure times for sensor and film images are programmed separately. The factory pre-set sensor programming is configured for XIOS XG sensors.
The basic setting must be adjusted for other exposure conditions.
Deviating exposure conditions:
E for films of sensitivity class E such as Kodak Ekta Speed, Agfa-Dentus M2
D for films of sensitivity class D such as Kodak Ultra Speed
Set the exposure time for films of sensitivity class D three levels higher with the plus button.
Film and development conditions
Varying film and development conditions can result in additional deviations of one time level up or down.
IMPORTANT
The configuration of the film and sensor keys permits flexible adjustment to various film sensitivity classes and sensors. It is also possible to set up the exposure adjustment for another film sensitivity class via the sensor key, if no sensor is being used.
bеЦдблЬ
Reprogramming the base values
1. Press the film, sensor and plus buttons at the same time. Service S01 appears in the display.
2. Use the plus or minus key to select the base value that is to be changed: S01 corresponds to the base value for film S02 corresponds to the base value for sensor S03 corresponds to the software version
3. Confirm the entry with the Film key. The current base value for film or sensor is now displayed:
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5Operation Sirona Dental Systems GmbH
S00 / S01
000
_
+
X
5.4Adapting basic settings Operating Instructions HELIODENT
4. The base value can now be adjusted by pressing the plus or minus buttons. Each level corresponds to about a 25% extension or reduction in exposure time.
5. The entry can be confirmed by pressing the button with the adult patient icon. The new base value is now saved in the unit. To cancel this without changing, press the button with the child patient icon. In either case you will return to point 2 and can select the required base value again or conclude the process by switching the device off.
PLUS
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Sirona Dental Systems GmbH 6Maintenance
Operating Instructions HELIODENT
PLUS

Maintenance

6
6.1Cleaning and care
6.1

Cleaning and care

6.1.1 Cleaning

Remove dirt, grime and disinfectant residue regularly using mild, commercially available cleaning agents.
Cleaning the ventilation sl ots
NOTICE
During cleaning or disinfection, liquids may enter the manual release button or unit via ventilation slots.
Electrical components of the system can be destroyed by liquids.
➢ Do not spray any liquids into the ventilation slots or manual release
button.
➢ First spray the liquid onto a cleaning cloth. Then wipe the ventilation
slots or manual release button with the cleaning cloth.
➢ Make sure that no liquids run along the surface and into the
ventilation slots or the manual release button.

6.1.2 Disinfecting

Only the external surfaces may be disinfected with approved chemical disinfectants. Use only disinfectants that comply with the valid requirements of the respective national regulatory body or whose bactericidal, fungicidal and virucidal properties have been verifiably tested and approved accordingly.
Cleaning and care agents
CAUTION
bеЦдблЬ
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Cleaning and care agents may contain aggressive ingredients.
Unsuitable cleaning and care agents are detrimental to health and attack the surface of the unit.
➢ Do NOT use: Substances containing phenol, peracetic acid,
peroxide or any other oxygen-splitting agents, sodium hypochlorite or iodine-splitting agents.
➢ Use only cleaning and disinfecting agents approved by Sirona!
A continuously updated list of approved agents can be downloaded from the Internet at:
"www.sirona.com"
/
"SERVICE"
/
"Care and cleaning"
/
"Care and
cleaning agents"
Orders WW
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6Maintenance Sirona Dental Systems GmbH
6.1Cleaning and care Operating Instructions HELIODENT
PLUS
If you do not have any access to the Internet, you can order the list in one of the following two ways:
● Order from your local dental depot
● Order from Sirona: Tel: ++49 (0) 62 51 / 16-16 70 Fax: ++49 (0) 62 51 / 16-18 18
REF 59 70 905
Sirona recommends the following disinfectants:
● MinutenSpray classic, by ALPRO®
● MinutenWipes, by ALPRO®
In the USA and Canada:
● CaviCide® or
● CaviWipes ™ .

6.1.3 Maintenance of accessories

IMPORTANT
With regard to accessories, particularly those of sensor and film holder systems, please comply with the cleaning and care instructions in the relevant operating instructions.
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Sirona Dental Systems GmbH 6Maintenance
Operating Instructions HELIODENT
PLUS
6.2Inspection and maintenance
6.2

Inspection and maintenance

Inspection and preventive maintenance must be performed at scheduled intervals to protect the health and safety of patients, users and other persons.
Inspection and maintena nce
The information provided in the document
and safety-related checks"
REF 62 14 923 should be helpful here. The
document can be downloaded at http://www.sirona.com/manuals.
Annual inspection
In order to ensure the operational safety and functional reliability of your product, you as the system owner should check the equipment at regular intervals (at least once a year) or commission your dental depot to do so.
Maintenance by the service engineer
In addition to the annual check to be carried out by the system owner or authorized persons, preventive maintenance must be performed after 4, 7 and 10 years, and then at two-year intervals.
Digital image quality
Image quality check
The image quality should be assessed by the system owner at regular intervals, at least once a year.
On digital image receptor systems, the degree of postprocessing (brightness or contrast adjustment) that is required in the image processing software (e.g. SIDEXIS) to produce satisfactory results is used as an assessment criterion.
Film image quality
For conventional X-rays with film processing, the increase of the exposure time is used as an assessment criterion.
Assessment criteria
If, after taking into account the patient's anatomy and excluding possible sources of error such as incorrect patient positioning, this criterion seems to apply, immediately contact a service engineer to have potential system faults repaired.
Country-specific requirements
Country-specific requirements
"Inspection and maintenance
bеЦдблЬ
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Observe any possible additional country-specific requirements.
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7Error messages Sirona Dental Systems GmbH
7.1List of error messages Operating Instructions HELIODENT

Error messages

7
Errors during the self-test are indicated by a five-digit number lighting up. The background color of the display is red.
PLUS
CAUTION
If an error re-occurs after the unit has been switched off and switched on again, please call your service engineer.
Tell the service engineer which error message was displayed.
7.1

List of error messages

Error code Reason and measures
E3 04 30 Release error - the release button may have been
pressed during switch on Switch the device OFF and then ON again If the error persists, call a service engineer and report the error code
E1 11 88 Display mode ACTIVE - X-ray cannot be release
Call a service engineer and report the error code
E1 04 03 E1 04 04 E1 04 06 E6 04 02
E5 04 50 E6 01 41 E6 01 61 E6 01 62 E6 04 01 E6 04 10 E6 04 11 E6 04 12 E6 04 20 E6 04 21 E6 04 40 E6 04 41 E6 04 42 E7 01 01 E7 01 21 E7 01 51
E5 01 02 E5 01 12 E5 01 14 E5 01 22 E5 01 32 E5 01 42 E6 01 11 E6 01 13 E6 01 23 E6 01 31
Internal error Press any button to acknowledge the error If the error persists, call a service engineer and report the error code
Internal error Switch the device OFF and then ON again and repeat the exposure If the error persists, call a service engineer and report the error code
Internal error Call a service engineer and report the error code
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Sirona Dental Systems GmbH 7Error messages
Operating Instructions HELIODENT
PLUS
7.1List of error messages
Error code Reason and measures
E1 04 51 Safety circuit - the door switch may not be closed
properly Switch the device OFF and then ON again, check the door switch If the error persists, call a service engineer and report the error code
E3 04 31 Button error - a button may have been pressed during
switch on Switch the device OFF and then ON again If the error persists, call a service engineer and report the error code
bеЦдблЬ
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8Dismantling and disposal Sirona Dental Systems GmbH
8.1Dismantling and reinstallation Operating Instructions HELIODENT

Dismantling and disposal

8
PLUS
8.1
8.2

Dismantling and reinstallation

When dismantling and reassembling the unit, proceed according to the installation instructions for new installation in order to guarantee its functioning and stability.

Disposal

Based on Directive 2012/19/EU and country-specific disposal directives for waste electrical and electronic equipment, we would like to point out that these must be disposed of in a special way within the European Union (EU). These regulations require environmentally compliant recycling/disposal of waste electrical and electronic equipment. They must not be disposed of as domestic waste. This is shown with the symbol of the crossed out dust bin, which has been in use since March 24, 2006.
Disposal procedure
We feel responsible for our products from the initial idea to their disposal. That is why we give you the option of taking back our waste electrical and electronic equipment.
If disposal is required, please proceed as follows:
In Germany
In order to arrange return of the electrical equipment, please send a disposal request to "enretec GmbH." The following options are available for this purpose:
● On the homepage of enretec GmbH, click on the "Return of electronic equipment" button under the "eom" menu item.
● Alternatively, you may also contact the company directly.
enretec GmbH Kanalstraße 17 16727 Velten
Tel: +49 3304 3919-500 Email: eom@enretec.de
As manufacturers, we assume the costs for disposal of waste from electrical and electronic equipment in accordance with the country­specific disposal regulations (ElektroG). All disassembly, transport and packaging costs are to be borne by the owner/operator.
Proper preparation (cleaning/disinfection/sterilization) of the equipment must be carried out prior to disassembly/disposal.
Any nonpermanently installed equipment will be picked up at its installation site in the practice. Permanently installed equipment will be picked up curbside at your address by appointment.
Other countries
The dental dealers would be glad to provide you with country-specific information.
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Sirona Dental Systems GmbH 8Dismantling and disposal
Operating Instructions HELIODENT
PLUS
8.2Disposal

8.2.1 Disposal of the X-ray tube assembly

Heliodent Plus X-ray tube assembly
The X-ray tube assembly in this device contains a tube which can implode, a lead lining and mineral oil.
bеЦдблЬ
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9Dose area product (DFP) Sirona Dental Systems GmbH
0,20 s
38 mGy cm
2
Operating Instructions HELIODENT

Dose area product (DFP)

9
Information on patient exposure
Explanation
The patient's exposure to radiation can be determined in the tables below.
To compensate for measuring errors as well as for system and instrument variations, a tolerance of 20% must be taken into account.
The radiation exposure is indicated as a dose area product (DFP) of the energy dose (mGy x cm
aperture in the tables below.
Furthermore, the HELIODENT be displayed immediately after exposure. The DFP appears on the display together with the exposure time used. Ask your service engineer about any individual setting requests you may have.
2
) for every available kV level, cone length and
PLUS
also permits the dose area product to
PLUS
Display (sample):
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Sirona Dental Systems GmbH 9Dose area product (DFP)
Operating Instructions HELIODENT
PLUS
Calculation and definition of the dose area product for the HELIODENT
PLUS
Tables with typical values for the dose area product (DFP)
Round cone: with radiation field limitation
Dose area product cone 200 WW
200 mm (8") 3x4 2x3
60 kV 70 kV 60 kV 70 kV 60 kV 70 kV
Time
mGy cm
2
mGy cm
2
mGy cm
2
mGy cm
2
mGy cm
2
mGy cm
2
0,01331111
0,02572311
0,03 8 10 3 4 2 2
0,04 11 14 5 6 2 3
0,05 13 17 6 7 3 4
0,06 16 21 7 9 3 4
0,08 22 28 9 12 5 6
0,10 27 34 12 15 6 7
0,12 32 41 14 18 7 9
0,16 43 55 18 24 9 12
0,20 54 69 23 30 12 15
0,25 67 86 29 37 14 18
0,32 86 110 37 47 18 24
0,40 108 138 46 59 23 30
0,50 134 172 58 74 29 37
0,64 172 220 74 94 37 47
0,80 215 276 92 118 46 59
1,00 269 344 115 148 58 74
1,25 336 431 144 185 72 92
1,60 430 551 184 236 92 118
2,00 538 689 230 295 115 148
2,50 672 861 288 369 144 185
3,20 860 1102 369 472 184 236
bеЦдблЬ
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Dose area product cone 300 WW
43
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9Dose area product (DFP) Sirona Dental Systems GmbH
Operating Instructions HELIODENT
PLUS
Round cone: with radiation field limitation
300 mm (12") 3x4 2x3
60 kV 70 kV 60 kV 70 kV 60 kV 70 kV
Time
mGy cm
2
mGy cm
2
mGy cm
2
mGy cm
2
mGy cm
2
mGy cm
2
0,01121100
0,02331111
0,03452211
0,04572311
0,05793412
0,06 8 10 3 4 2 2
0,08 11 14 5 6 2 3
0,10 13 17 6 7 3 4
0,12 16 21 7 9 3 4
0,16 22 28 9 12 5 6
0,20 27 34 12 15 6 7
0,25 34 43 14 18 7 9
0,32 43 55 18 24 9 12
0,40 54 69 23 30 12 15
0,50 67 86 29 37 14 18
0,64 86 110 37 47 18 24
0,80 108 138 46 59 23 30
1,00 134 172 58 74 29 37
1,25 168 215 72 92 36 46
1,60 215 276 92 118 46 59
2,00 269 344 115 148 58 74
2,50 336 431 144 185 72 92
3,20 430 551 184 236 92 118
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10

Brief Operating Instructions

Page 46
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