Midmark Preva User Manual
Preva Dental X-ray System
User Manual
Effective: May 2018
00-02-1576 Rev. X01
Preva Dental X-ray System — User Manual
Preva Dental X-ray System
User Manual
Lincolnshire, Illinois 60069 USA
Phone: 800-MIDMARK 800-643-6275
© Midmark Corporation 2018, U.S. Patents D470237, D469182, D470589, and 6,837,468
Midmark Corporation
675 Heathrow Dr.
Fax: (847) 415-9801
midmark.com
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Preva Dental X-ray System — User Manual
Table of Contents
GENERAL INFORMATION .......................................................................................................................... 4
INTENDED USE ............................................................................................................................................. 4
WARNINGS / PRECAUTIONS ........................................................................................................................... 5
X-RAY PROTECTION ..................................................................................................................................... 6
PRODUCT DESCRIPTION ................................................................................................................................ 6
CERTIFIED COMPONENTS .............................................................................................................................. 8
AUTHORIZED REPRESENTATIVES .................................................................................................................... 8
EXPLANATION OF SYMBOLS ON TECHNICAL LABELS ........................................................................................ 9
COMPLIANCE WITH APPLICABLE
OBTAINING TECHNICAL SUPPORT ................................................................................................................ 13
OPERATING INSTRUCTIONS ................................................................................................................... 14
USING THE OPERATOR PANEL ..................................................................................................................... 14
TAKING AN X-RAY ....................................................................................................................................... 16
ABOUT THE 20CM CONE (30-A2195) AND THE 30 CM CONE (30-A2200) ....................................................... 17
RECOMMENDED MAINTENANCE ........................................................................................................... 18
REGULAR MAINTENANCE............................................................................................................................. 18
CLEANING AND DISINFECTING ...................................................................................................................... 18
S
TANDARDS
............................................................................................ 10
CHECKING SYSTEM FUNCTIONS ........................................................................................................... 19
SYSTEM FUNCTION CHECKLIST ................................................................................................................... 20
NEW TUBE SEASONING PROCEDURE ............................................................................................................ 21
SOLVING PERFORMANCE ISSUES ......................................................................................................... 22
PERFORMANCE ISSUES ............................................................................................................................... 22
OBTAINING TECHNICAL SUPPORT ................................................................................................................ 22
SYSTEM CONFIGURATION ...................................................................................................................... 23
PREPROGRAMMED EXPOSURE TIMES ........................................................................................................... 23
CHANGING LANGUAGE ................................................................................................................................ 24
SYSTEM CONFIGURATION MODE .................................................................................................................. 25
ADJUSTING THE DISPLAY ............................................................................................................................ 26
CHANGING PREPROGRAMMED EXPOSURE SETTINGS ..................................................................................... 27
RECORD YOUR EXPOSURE SETTINGS (8” [20 CM] CONE) ............................................................................... 29
RECORD YOUR EXPOSURE SETTINGS (12” [30 CM] CONE) ............................................................................. 30
SHOWING CURRENT SYSTEM CONFIGURATION ............................................................................................. 31
CHANGING THE CONE SIZE ......................................................................................................................... 32
DIAGNOSTIC MODE ..................................................................................................................................... 33
SPECIFICATIONS ...................................................................................................................................... 34
PREVA DENTAL X-RAY SYSTEM ................................................................................................................... 34
STATEMENTS AND INFORMATION ACCORDING TO 21 CFR SUB CHAPTER J ..................................................... 35
THERMAL CHARACTERISTICS CHARTS .......................................................................................................... 36
STATEMENTS AND INFORMATION ACCORDING TO CANADIAN RADIATION EMITTING DEVICES REGULATIONS, PART II
SCHEDULE II ......................................................................................................................................... 37
OF
DOSE INFORMATION ................................................................................................................................... 39
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Preva Dental X-ray System — User Manual
General Information
Intended Use
The intended use of the Preva Dental X-Ray System is to act as a diagnostic source for
radiographic dental imaging.
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Preva Dental X-ray System — User Manual
Warnings / Precautions
Radiation Safety
•
radiation.
To avoid the risk of electric shock, this equipment
•
USB connector on the
Before cleaning or disinfecting, this equipment must always be
ray System is ordinary type medical equipment
leak inside the equipment.
Explosion Safety
This equipment must not be used in the presence of flammable or
vapor must be allowed to disperse before using the equipment.
Only qualified and authorized personnel may operate this equipment
observing all laws and regulations concerning radiation protection.
• The operator at all times must remain at a safe distance from the focal
spot and the X-ray beam for operator protection.
• Full use must be made of all radiation safety features on the equipment.
• Full use must be made of all radiation protection devices, accessories
and procedures available to protect the patient and operator from X-ray
Electrical Safety
WARNING:
must only be connected to supply mains with protective earth.
Because the design of the Preva power supply circuit may momentarily
draw high current, do not use this device with any wall outlet that has
a GFCI (Ground Fault Circuit Indicator). Outlets with GFCI breakers
are designed to trip when they sense a small amount of current passing
from the line to earth ground. Outlets with GFCI could compromise the
operation of the intra-oral X-ray device and the GFCI circuit itself.
• Only qualified and authorized service personnel should remove covers
on the equipment.
• All maintenance that requires removing of protective covers must be
executed by service personnel when the patient is not present.
• The sensor shall only be replaced when the operator and any part of the
machine does not touch the patient.
CAUTION: Operator is not to touch the
Articulated Arm.
• This equipment must only be used in rooms or areas that comply with all
applicable laws and recommendations concerning electrical safety in
rooms used for medical purposes, e.g., IEC, US National Electrical code,
or VDE standards concerning provisions of an additional protective earth
(ground) terminal for power supply connection.
•
disconnected from the main electrical supply.
• The Preva Dental X-
without protection against ingress of liquids. To protect against shortcircuit and corrosion, no water or any other liquid should be allowed to
potentially explosive gases or vapors, which could ignite, causing personal
injury and/or damage to the equipment. If such disinfectants are used, the
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Preva Dental X-ray System — User Manual
Control Unit
The Control Unit provides for the input power connection and control of the
consists of the mounting base and Operator Panel.
Tubehead
The Tubehead contains the X-ray tube, high voltage circuit, and a round
hole be blocked as it provides an air vent to allow the
Articulated Arm
The Articulated Arm provides the articulation support for the Tubehead and
Attention:
The equipment must only be installed and operated in accordance with the safety procedures and
operating instructions given in this manual and in the Installation Guide for the purposes and
applications for which it was designed. Modifications and/or additions to the equipment may only
be carried out by Midmark Corporation or by third parties expressly authorized by Midmark
Corporation to do so. Such changes must comply with legal requirements as well as with the
generally accepted technical rules. It is the responsibility of the user to ensure that existing legal
regulations regarding installation of the equipment with respect to the building are observed.
CAUTION: Do not hang lead aprons on the horizontal extension arm.
X-Ray Protection
X-ray equipment may cause injury if used improperly.
It is recommended that operators of an intraoral dental X-ray device stand a minimum of 2 meters
(6.6 feet) away from the focal spot and out of the path of the X-ray beam.
The Preva Dental X-ray System provides a high degree of protection from unnecessary X-radiation.
However, no practical design can provide complete protection nor prevent operators from exposing
themselves or others to unnecessary radiation.
The instructions contained in this manual must be read and followed when operating the
Preva. Your Midmark Sales Corporation dealer will assist you in placing the Preva in
operation.
Product Description
The Preva Dental X-ray System is a high-frequency intra-oral X-ray machine. The Preva consists of
five components, as shown in Figure 1 Component Diagram: the Control Unit, the Tubehead, the
Articulated Arm, the Horizontal Arm, the Cone, and the Remote Control option.
Tubehead and Operator Panel. It provides automatic line voltage
compensation, kVp control, and exposure time control. The Control Unit
Cone. The tubehead is shipped already assembled to the Articulated Arm.
WARNING: There is a small hole in the plastic handle covering
the back of the Tubehead. Under no circumstances should this
Tubehead oil to expand and contract as the unit is operated.
the reach and coverage of the Tubehead to the patient.
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Preva Dental X-ray System — User Manual
Horizontal Arm
The Horizontal Arm helps provide the necessary reach for the Preva. It
56, 66, 76 and 82 inches [142, 167, 193, 208 cm].
Modular Beam
The Cone establishes the distance from the X-ray tube to the patient’s skin.
(30-A2200) can be ordered as an option.
Handswitch
To make exposures in addition to or replacing the use of the exposure
Model
The Preva is available as both a wall mount and mobile unit. See the Preva
Installation and
The Preva Dental X-ray System should only be installed and serviced by
f you need assistance locating an
back cover of this manual.
Diagram
pivots around a shaft inserted in the top of the Control Unit and contains an
access cover to connect the cable from the Horizontal Arm to the Control
Unit. It is available in four lengths on wall mount units providing reaches of
Limiting Device
[BLD]
Configurations
Service
It provides positioning assistance and collimates the X-ray beam to within a
defined circle at its end. The Preva is shipped with the standard 8-inch [20
cm] Cone (30-A2195) attached to the Tubehead. A 12-inch [30 cm] Cone
button, an optional Handswitch (30-A2040) can be ordered.
Installation and Service Manual for installation and mounting instructions.
approved Midmark dealer personnel. I
approved dealer, contact Midmark Corporation using the information on the
Figure 1 Component
CAUTION: Do not hang lead aprons on the horizontal extension arm.
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Preva Dental X-ray System — User Manual
Certified Components
System
Component
Modular BLD, Spacer, White
Reference Number
30-A2208
Authorized Representatives
North
Midmark Corporation
Fax: 847-415-9801
Europe
CE Partner 4U
America
Tubehead
Control Unit. Preva
Control Unit. Preva Mobile
Modular BLD, 20 cm Lg., 70 mm Cone, Gray
Modular BLD, 30 cm Lg., 70 mm Cone, Gray
Modular BLD, 20 cm Lg., 60 mm Cone, White
Modular BLD, 30 cm Lg., 60 mm Cone, White
Modular BLD, 30 cm Lg., 60 mm Cone, Gray
Modular BLD, 20 cm Lg., 30x40 mm Cone, White
Modular BLD, 30 cm Lg., 30x40 mm Cone, White
Modular BLD, 20 cm Lg., 20x30 mm Cone, White
Modular BLD, 20 cm Lg., 35x45 mm Cone, Gray
Modular BLD, 20 cm Lg., 35x45 mm Cone, White
Modular BLD, 30 cm Lg., 35x45 mm Cone, Gray
Modular BLD, 30 cm Lg., 35x45 mm Cone, White
Modular BLD, Base, Gray
Modular BLD, Spacer, Gray
675 Heathrow Dr.
Lincolnshire, Illinois 60069 U.S.A.
Phone: 800-MIDMARK (800-643-6275)
30-A1027
30-A0010
30-A0013
30-A2195
30-A2200
30-A2196
30-A2201
30-A2229
30-A2198
30-A2203
30-A2199
30-A2221
30-A2222
30-A2223
30-A2224
30-A2205
30-A2206
Esdoornlaan 13
3951DB Maarn
The Netherlands
www.cepartner4u.eu
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Preva Dental X-ray System — User Manual
Explanation of Symbols on Technical Labels
Type B: Protection against electric shock (IEC 60601.1-1988)
Consult written instructions in User Manual.
WARNING X-RAY
ARE OBSERVED.
X-RAY EMISSION
Mains HOT WIRE
Mains NEUTRAL WIRE
Earth Ground
The symbols appearing on the product and/or in the technical manuals.
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR
UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS
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Preva Dental X-ray System — User Manual
Compliance with Applicable Standards
The following regulatory documents app
ly:
Radiation
The certified components of the Preva Dental X-ray System comply with Radiation
UL 2601-1
Classified by Underwriters Laboratories Inc. with respect to electrical shock, fire
60601-2-28.
General
IEC 60601-1:1995
oxygen or nitrous oxide.
EMI/EMC
IEC 60601-1-2:2007
Degree of
IEC 60529:2001
Imaging
IEC 61223-3-4:2000
EMC
Information regarding potential EMC interference and advice for avoidance
adjacent to other
equipment, configuration should be carefully adjusted to ensure that
electromagnetic interference (EMI) does not degrade performance.
Specifically, mobile RF communications equipment can effect medical
when integrated with
IEC 60601. If not, this may result in degraded electromagnetic
Protection
File Number:
E181750
Safety
Protection
Performance Standards 21 CFR, Subchapter J, at the time of manufacture.
The certified components of the Preva Dental X-ray System comply with IEC 606011-3 Radiation protection/X-ray equipment.
and mechanical hazards only in accordance with UL 2601-1, and CAN/CSA C22.2
NO, 601.1-M90, and to the following particular standards, IEC 60601-2-7, IEC
Protection against electrical shock – Class II
Degree of protection against electrical shock – Type BF Applied Part
Degree of protection against ingress of water – IP67
Not suitable for use in the presence of flammable anesthetic mixture with air or with
Degree of protection against ingress of water – IP67
Performance
Statement
Line pair resolution – better than 8 lp/mm
Low contrast resolution – all holes visible
• The Preva Dental X-ray System is considered as non-life-supporting
equipment. While using Preva Dental X-ray System
electrical equipment. Please refer to the EMC table below.
• Usage limitation: Preva Dental X-ray System
ClearVision Sensors shall be used with IEC 60950 or IEC 60601 compliant
computers. Also, any device between the integrated Preva Dental X-ray
System and the computer (USB Hub) shall be compliant with IEC 60950 or
compatibility.
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Preva Dental X-ray System — User Manual
Guidance and manufacturer's declaration - electromagnetic emissions
The Preva Dental X-ray System is intended for use in the electromagnetic environment specified below. The customer or the user of the
Preva Dental X-ray System should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emission
Group 1
The Preva Dental X-ray System uses RF energy only for its internal function. Therefore,
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF emission
CISPR 11
Class B
The Preva Dental X-ray System is suitable for use in all establishments, including
Harmonic emission
IEC 61000-3-2
Class A
Voltage fluctuations/
Complies
Guidance and manufacturer's declaration - electromagnetic immunity
The Preva Dental X-ray System is intended for use in the electromagnetic environment specified below. The customer or the user of the
Preva Dental X-ray System should assure that it is used in such an environment.
Compliance
level
Electromagnetic
environment – guidance
Electrostatic discharge (ESD)
± 6 kV contact
± 6 kV contact
Floors should be wood, concrete or ceramic
tile. If the floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast transient/burst
± 2 kV for power supply lines
± 2 kV for power
output lines
Mains power quality should be that of a
transient/ burst supply lines typical
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Not Applicable.
Voltage dips, interruptions,
IEC 61000-4-11
< 5% UT (>95% dip in UT) for 0.5 cycle
< 5% UT (>95% dip in UT) for 5 s
Not Applicable.
Power frequency (50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
CISPR 11
flicker emissions
IEC 61000-3-3
Immunity test IEC 60601 test level
IEC 61000-4-2
IEC 61000-4-4
and voltage variations on
power supply input lines
± 8 kV air
± 1 kV for input/output lines
< 40% UT (60% dip in UT) for 5 cycles
< 70% U
(30% dip in UT) for 25 cycles
T
its RF
domestic establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
± 8 kV air
supply lines
± 1 kV for input/
commercial or hospital environment.
magnetic field
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Preva Dental X-ray System — User Manual
Guidance and manufacturer's declaration - electromagnetic immunity
The Preva Dental X-ray System is intended for use in the electromagnetic environment specified below. The customer or the user of the
Preva Dental X-ray System should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Portable and mobile RF communications equipment should be used no closer to
equipment, including cables, than the
n applicable to the
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 V
150 kHz to 80 MHz
3 V
= 1.2 ×√
Radiated RF
3 V/m
3 V/m
= 1.2 ×√
= 2.3 ×√ 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W)
is the recommended separation
d by an electromagnetic
Interference may occur in the vicinity of equipment marked with the following
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Recommended separation distances between portable and mobile RF communications equipment and
Preva Dental X-ray System
The Preva Dental X-ray System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The
communications equipment.
Rated maximum output
power of transmitter, W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
= 1.2 ×√
80 MHz to 800 MHz
= 1.2 ×√
80 MHz to 2.5 GHz
= 2.3 ×√
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74 1 1.17
1.17
2.34
10
3.69
3.69
7.38
100
11.67
11.67
23.34
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
any part of the Preva Dental X-ray System
recommended separation distance calculated from the equatio
frequency of the transmitter.
Electromagnetic environment – guidance
IEC 61000-4-3
NOTE 2:
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
Preva Dental X-ray System is used exceeds the applicable RF compliance level above, the Preva Dental X-ray System should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Preva Dental X-ray System.
b
customer or the user of the sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the sensor as recommended below, according to the maximum output power of the
80 MHz to 2.5 GHz
according to the transmitter manufacture and d
distance in meters (m).
Field strengths from fixed RF transmitters, as determine
site survey, a should be less than the compliance level in each frequency range. b
symbol:
80 MHz to 800 MHz
determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These
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