Midmark 60-A0001 Installation Manual

Progeny Vantage Panoramic X-ray System
Installation Guide
ECN: P3774
00-02-1608, Rev. J
Effective Date 02-15-2016
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Table of Contents
Contents ........................................................................................................................................................ 2
1 Regulatory Information ............................................................................................................................... 3
2 Introduction .............................................................................................................................................. 16
Product Description ........................................................................................................................ 16
Disclaimer about the Manual ......................................................................................................... 16
Symbols and Conventions ............................................................................................................. 17
Obtaining Technical Support .......................................................................................................... 18
3 System Overview ..................................................................................................................................... 19
About the Vantage System ............................................................................................................ 19
About the Panoramic X-ray Device ................................................................................................ 19
About the Optional Cephalometric Extension ................................................................................ 20
4 Pre-Installation Planning .......................................................................................................................... 25
Environmental Requirements ......................................................................................................... 25
Support Requirements ................................................................................................................... 26
Power and Cable Requirements .................................................................................................... 26
Space Requirements ...................................................................................................................... 27
Network and System Requirements .............................................................................................. 29
5 Installation ................................................................................................................................................ 30
About Installation ............................................................................................................................ 30
Installing the Vantage Panoramic Device on a Wood Stud Wall ................................................... 31
Installing the Vantage Panoramic Device on a Free Standing Base ............................................. 40
Optional Right Entry Configuration ................................................................................................ 46
6 Installing the Cables ................................................................................................................................. 47
Connecting the Vantage to your network ....................................................................................... 47
Installing the Exposure Button ....................................................................................................... 48
7 Starting Up ............................................................................................................................................... 49
Turning the Vantage System On .................................................................................................... 49
Checking Image Quality ................................................................................................................. 50
8 Vantage Software Client Setup ................................................................................................................ 52
About .............................................................................................................................................. 52
Installation Procedure .................................................................................................................... 52
Connecting to Vantage................................................................................................................... 56
Installing the Vantage Cephalometric Extension on a Vantage Panoramic Device ...................... 59
Progeny Support Information ……………………………………………………………………………84
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1 Regulatory Information
In this Chapter
Indications for Use Contraindications Warnings and Precautions Compliance with Applicable Standards Certified Components Device Labeling EC Declaration of Conformity EMC Statement Authorized Representatives
Indications for Use
Statement of Indications for Use
The indications for use of the Progeny Vantage® Panoramic X-ray System are to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the Cephalometric option, the system will also provide cephalometric radiographic examinations for the use in orthodontic treatment planning and evaluation.
Guidelines for Patient Selection
The guidelines for use of the Progeny Vantage® Panoramic Extraoral X-ray
System are described in the “ADA/FDA Guide to Patient Selection for Dental Radiographs.” This device is to be operated only for the intended use as
indicated by prescription of a qualified dental practitioner.
Contraindications
None known at this time.
Adverse Reactions
None known at this time.
Indications of Sterility
This production is not provided sterile. See Maintenance section of this Manual.
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Warnings and Precautions
Radiation Safety
Only qualified and authorized personnel may operate this equipment observing all laws and regulations concerning radiation protection.
The operator during X-ray production must remain 2 m [6 ft.] from the focal
spot and the X-ray beam for 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 radiation.
Electrical Safety
Only qualified and authorized service personnel should remove covers on
the equipment.
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.
Before cleaning or disinfecting, this equipment must always be turned off.  The Progeny Vantage® X-ray System is ordinary medical equipment without
Explosion Safety
This equipment must not be used in the presence of flammable or potentially explosive gases or vapors, which could ignite, causing personal injury and/or damage to the equipment. If flammable disinfectants are used, the vapor must be allowed to disperse before using the equipment.
Damage and Injury
Do not place permanent or non-mobile structures beneath the device. Device movement may result in damage to the device or structure, or in injury to the operator or patient.
Cleanliness
To prevent cross contamination, always clean the patient contact areas and always install a fresh protective sheath over the bite guide before positioning a patient. The sheath recommended for this application is the TIDI Products, part number 21008.
protection against ingress of liquids. To protect against short-circuit and corrosion, no water or any other liquid should be allowed to leak inside the equipment.
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Laser Safety
Do not stare into the beam. Do not place eyes closer than
100 mm. This equipment contains class 2 lasers of 3 mW output at 650 nm. The beam is a 40° fan line. The lensing on the laser is not removable. Laser on time does not exceed 100 seconds.
Use of procedures other than those contained within this manual may result in exposure to damaging laser light.
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Compliance with Applicable Standards
Standard
Content
IEC 60825-1:2001
Safety of Laser Equipment
IEC 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-1
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-2-7
Medical electrical equipment - Part 2-7: Particular requirements for the safety of high­voltage generators of diagnostic X-ray generators
IEC 60601-2-28
Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-1-3
Medical electrical equipment – Part 1-3: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-2
EMI/RFI
CAN/CSA 22.2 No.
601.1-M90
Canadian standard for medical electrical equipment
IEC 60601-2-32: 1994
Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment
Radiation Protection
The certified components of the Progeny Vantage Panoramic Dental X-ray System comply with Radiation Performance Standards 21 CFR, Subchapter J, at the time of manufacture.
Performance Standards
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Certified Components
Component
Reference Number
Vantage System, Domestic
60-A0001
Sensor Assembly, Panoramic
60-A1010
Ceph Extension, with Sensors (option)
60-A1009 Pan tube head assembly
60-A1014
Primary collimator assembly
60-A2009
Pan X-ray power supply assembly
60-A2035
Sensor Assembly, Cephalometric (option)
60-A1004
Collimator, secondary, Ceph (option)
60-F4051
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Device Labeling
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Optional Cephalometric Extension Labeling
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EC Declaration of Conformity
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Name and Description of Product
Progeny Vantage Panoramic Dental X-ray System
Catalog V5000 US Domestic Market Model 60-A0001 system
Catalog V5100 Export Market Model 60-A0001 system
Catalog: V5050 Progeny Vantage Panoramic with Ceph Sensor, Domestic Model: 60-A0008
Catalog: V5150 Progeny Vantage Panoramic with Ceph Sensor, Export Model : 60-A0008
Catalog: V5000C Progeny Vantage Panoramic with Cephalometric Extension, 2 Sensor System, Domestic Model: V5000 + C6000
Catalog: V5100C Progeny Vantage Panoramic with Cephalometric Extension, 2 Sensor System, Export Model: V5100 + C6000
Catalog: V5050C Progeny Vantage Panoramic with Cephalometric Extension, 1 Sensor System, Domestic Model: V5050 + C4000
Catalog: V5150C Progeny Vantage Panoramic with Cephalometric Extension, 1 Sensor System, Export Model: V5150 + C4000
Catalog: C6000 Cephalometric Extension with Sensor Model: 60-A1009
Catalog: C4000 Cephalometric Extension without Sensor Model: 60-A1019
Catalog: Ceph Sensor only Model: 60-A1004
Catalog: Panoramic Sensor Model: 60-A1010
Class: llb
Reference Numbers to which Conformity is Declared
The following regulatory documents apply: UL 2601-1 IEC 60601-1-2 IEC 60601-1-3 IEC 60601-2-7 IEC 60601-2-28 IEC 60601-2-32 IEC 60825-1 Medical Device Directive ISO 13485 Machinery Directive
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Declaration
Midmark Corporation declares that the products described herein meet all the applicable Essential Requirements of the EC Medical Device Directive 93/42/EEC in Annex I. For Class IIb products described herein, the product is manufactured, inspected, tested, and released in accordance with the approved quality assurance system established in accordance with ISO 13485 and Annex II of the EC Medical Device Directive under the Supervision of the SGS United Kingdom Ltd., a Notified Body.
Contact
Technical Support Midmark Corporation
Phone: 800-MIDMARK (1-800-643-6275)+1 847-415-9800 Fax: 847-415-9801
imagingtechsupport@midmark.com
Hours: 8:00 a.m. – 5:00 p.m. Central Time
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EMC Statement
Guidance and manufacturer's declaration - electromagnetic emissions
The Progeny Vantage Dental X-ray System is intended for use in the electromagnetic environment specified below. The customer or the user of the Progeny Vantage Dental X-ray System should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emission CISPR 11
Group 1
The Progeny Vantage Dental X-ray System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11
Class B
The Progeny Vantage Dental X-ray System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emission IEC 61000-3-2
Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Complies
Guidance and manufacturer's declaration - electromagnetic immunity
The Progeny Vantage Dental X-ray System is intended for use in the electromagnetic environment specified below. The customer or the user of the Progeny Vantage Dental X-ray System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic
environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2
± 6 kV contact ± 8 kV air
± 6 kV contact ± 8 kV air
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 IEC 61000-4-4
± 2 kV for power supply lines ± 1 kV for input/output lines
± 2 kV for power supply lines ± 1 kV for input/ output lines
Mains power quality should be that of a transient/ burst supply lines typical commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV line(s) to line(s) ± 2 kV line(s) to earth
Not Applicable.
Voltage dips, interruptions, and voltage variations on power supply input lines IEC 61000-4-11
< 5% UT (>95% dip in UT) for
0.5 cycle < 40% UT (60% dip in UT) for 5 cycles < 70% UT (30% dip in UT) for 25 cycles < 5% UT (>95% dip in UT) for 5 s
Not Applicable.
Power frequency (50/60 Hz) magnetic field 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.
Information regarding potential EMC interference and advice for avoidance
The Progeny Vantage Panoramic Dental X-ray System is considered as non-life-supporting equipment. While using the Progeny Vantage X-ray System adjacent to other equipment, the configuration should be carefully adjusted to ensure that electromagnetic interference (EMI) does not degrade performance. Specifically, mobile RF communications equipment can effect medical electrical equipment. Please refer
to the EMC table below.
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Guidance and manufacturer's declaration - electromagnetic immunity
The Progeny Vantage Dental X-ray System is intended for use in the electromagnetic environment specified below. The customer or the user of the Progeny Vantage Dental X-ray System should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Complian
ce level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Progeny Vantage Dental X-ray System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF IEC 61000­4-6
3 V 150 kHz to 80 MHz
3 V
𝑑 = 1.2 ×√𝑃 Radiated RF
IEC 61000­4-3
3 V/m 80 MHz to
2.5 GHz
3 V/m
𝑑 = 1.2 ×√𝑃 80 MHz to 800 MHz 𝑑 = 2.3 ×√𝑃 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: 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, 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 Progeny Vantage Dental X-ray System is used exceeds the applicable RF compliance level above, the Progeny Vantage Dental X-ray System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re­orienting or relocating the Progeny Vantage Dental X-ray System.
b
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
Progeny Vantage Dental X-ray System
The Progeny Vantage Dental X-ray System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The 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 communications equipment.
Rated maximum output power of transmitter, W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
𝑑 = 1.2 ×
𝑃
80 MHz to 800 MHz
𝑑 = 1.2 ×
𝑃
80 MHz to 2.5 GHz
𝑑 = 2.3 ×
𝑃
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
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For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be 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 guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Authorized Representatives
North America
MIDMARK CORPORATION 675 Heathrow Dr. Lincolnshire, Illinois 60069 U.S.A. Phone: 800-MIDMARK (1-800-643-6275) +1 847-415-9800 Fax: 847-415-9801
Europe
CE Partner 4U Esdoornlaah 13 3951DB Maarn The Netherlands www.cepartner4u.eu
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2 Introduction
In this Chapter
Product Description Disclaimer about the Manual Symbols and Conventions Obtaining Technical Support
Product Description
The Progeny Vantage Panoramic X-ray System is an easy to use and easy to install digital panoramic X-ray system.
The panoramic X-ray provides a broad overview of the teeth, jaw, and oral structure of the entire mouth. The X-ray image supplies information about the teeth, upper and lower jawbone, sinuses, and other hard and soft tissues of the head and neck. The panoramic digital receptor is contained in a C-arm that moves around the patient’s head.
The Vantage System has many applications that include evaluation of third molars, evaluation of patients with past and present TMJ (temporomandibular joint) problems, patients who require full or partial removable dentures, dental implants, or braces, those who are at risk or suspected of having oral cancer or other tumors of the jaw, those who have impacted teeth, and those who have had any recent trauma to the face or teeth (i.e., can help identify a fractured jaw).
The optional Cephalometric Extension allows for lateral and PA views of oral structures. The ceph digital receptor is mounted on a transit rail which scans horizontally during ceph examinations. Cephalometric images are typically useful in orthodontic evaluation and treatment.
Disclaimer about the Manual
Midmark pursues a policy of continual product development. Although every effort is made to produce up-to-date product documentation, this publication should not be regarded as an infallible guide to current specifications. We reserve the right to make changes without prior notice. The original language of this manual is English.
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Symbols and Conventions
Symbol
Explanation
Type B: Protection against electric shock (IEC 60601.1-
1988).
Consult written instructions in the User Guide.
ATTENTION RAYONS-X:
OPERATION SEULEMENT PAR DU PERSONNEL AUTORISE. VOIR MANUEL DE L’OPERATEUR.
WARNING X-RAY
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.
X-RAY EMISSION
Mains HOT WIRE
Mains NEUTRAL WIRE Earth Ground
LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT. 650 nm, 3 mW
Power off (circle) Power on (line)
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Obtaining Technical Support
For Technical Support, contact: MIDMARK CORPORATION
675 Heathrow Drive Lincolnshire, Illinois 60069 U.S.A. Phone: 888-924-3800 (U.S. and Canada) +1 847-415-9800 (International) Fax: 847-415-9810
imagingtechsupport@midmark.com
Hours: 8:00 a.m. – 5:00 p.m. CT
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3 System Overview
In this Chapter
About the Vantage System About the Panoramic X-ray Device About the Optional Cephalometric Extension
About the Vantage System
The Progeny Vantage Panoramic X-ray System consists of the panoramic X-ray device, the exposure button, and a Touch Control Panel.
About the Panoramic X-ray Device
The panoramic X-ray device consists of the telescoping column, the overhead assembly, the patient positioning table, and the touch control panel.
Telescoping Column
The telescoping column has two main parts: the fixed section and the moving or telescoping section. The fixed section contains the actuator to control up and down movement of the panoramic X-ray device. The telescoping section mounts the patient positioning features. Optical sensors in the telescoping section define the maximum and minimum extension of the column.
Overhead Assembly
The overhead assembly consists of an overhead arm and C-arm. The overhead arm supports the C-arm, which rotates. The C-arm includes the tubehead and the removable sensor. The tubehead produces the X-ray beam, and the sensor is a digital image receptor.
Patient Positioning Table
The patient positioning table guides and supports the patient’s head during
acquisition of panoramic X-ray images by means of the chin rest, bite guide, and positioning wands. The positioning control on the side of the patient positioning table has 4 buttons for the operator to control the up/down movement of the telescoping column, to apply and release the positioning wands, and to turn on positioning lights. The patient positioning table also contains a storage compartment.
Touch Control Panel
The touch control panel is mounted on the fixed column section under the patient positioning table. It is the main user interface for taking X-ray images with the Vantage System and is activated by touch.
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Exposure Button
The exposure button is used by the operator to take the X-ray. The basic configuration consists of an exposure button connected to the panoramic X-ray device by a coil cord.
Bite Guide
A bite guide helps the patient keep his or her jaw correctly positioned. Additional bite guides may be obtained from Progeny. Always install a fresh protective sheath over the bite guide before positioning a patient. The sheath for this application is the Progeny part number 60-S0027.
Chin Rest
An easily removable chin rest fits into an opening on the patient positioning table. Additional chin rests may be obtained from Progeny.
TMJ Positioner
A TMJ positioner for TMJ X-rays fits into the patient positioning table. TMJ positioners are included with the Vantage.
Emergency Stop Switch
The stop switch, mounted under the left side of the patient positioning table near the telescoping column, is for use by the patient or clinician. Depressing the button will immediately halt all motor movement. Touching the control panel surface will also abort any movement. The button can be released by turning the knob.
About the Optional Cephalometric Extension
The Cephalometric Extension consists of the support arm, the cephalometric scanning mechanism and the cephalometric sensor.
Support Arm
The support arm is an aluminum casting that mounts to the panoramic column’s inner (mobile) component. It mounts via a support casting that allows vertical adjustment of the position of the cephalometric mechanism. The arm can be mounted either to the right, or to the left of the column.
Cephalometric Scanning Mechanism
The cephalometric scanning mechanism is comprised of the rail and the transit assembly. The rail supports the transit mechanism, and houses the motor and bearings that cause the transit mechanism to move. The transit assembly mounts the cephalometric sensor and the secondary collimator, and maintains the alignment of the sensor and secondary collimator to the panoramic tubehead.
The rail also supports the cephalostat, used to position the patient. The cephalostat is comprised of two otic positioning posts which adjust to conform to
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the width of the patients head, and a nasion locator, which adjusts vertically and laterally to align the patients head. The entire cephalostat rotates in 22.5° increments to support many cephalometric imaging positions.
Cephalometric Sensor
The cephalometric sensor is similar in appearance to the panoramic sensor, but houses within a 21cm long digital detector instead of the 14cm digital detector used for normal panoramic exam. The cephalometric sensor can be used in place of the panoramic sensor, but the panoramic sensor will not operate as a cephalometric sensor.
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Vantage System Panoramic X-ray Device
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Vantage System Patient Positioning Table
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Optional Cephalometric Extension
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4 Pre-In stallation Planning
In this Chapter
Environmental Requirements Support Requirements Power and Cable Requirements Space Requirements Network and System Requirements
Environmental Requirements
Temperature
The Vantage panoramic device is intended for indoor use for normal dental applications at temperatures in the range +10 C to +35 C (+50 F to +95 F).
Storage temperature range should not exceed -35 C to +66 C (-31 F to +150 F).
Humidity
Humidity should not cause condensation to form on the device. When the device is being operated, humidity should not exceed 95% RH non-condensing. When the device is being stored, humidity should not exceed 90% RH non-condensing.
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Support Requirements
About Support
The Vantage panoramic device is wall mounted. As an alternative, the Vantage panoramic device can be installed as a free standing unit. If the free standing installation method is used, the free standing base kit must be attached to the unit for support.
Wall Mounted Installation
Wall fasteners for the Vantage panoramic device must be able to withstand a 68 kg (150 lb.) shear force and a 180 kg (400 lb.) tensile (pull-out) load. The floor must be able to support approximately 90 kg (200 lb./sq. ft.) for wall mounted installation.
Free Standing Installation
The floor must be able to support approximately 158 kg (100 lb./sq. ft.) for free standing installation. Free standing installation cannot be used for the Cephalometric Extension.
Power and Cable Requirements
Electrical Outlet Requirements
The Vantage System requires a dedicated, 15 amp minimum circuit. If a fixed connection is used, the length of the whip must conform to local codes. If a standard mains receptacle is used, it must be placed within 2 m (6 ft.) of the device and positioned in compliance with local codes.
Ethernet Connections
Cat 5e grade communications cable is required for connection of the Vantage panoramic system.
Optional Remote Exposure Switch
If a remote exposure switch is used, a four conductor cable capable of RJ 11 termination is required for installation.
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