Vatech PaX-i3D, PaX-i3D Green, PHT-60CFO User Manual

(PHT-60CFO)

User Manual

Version 1.5.0

E n g l i s h

PaX-i3D Green (PHT-60CFO) User Manual

Notice

Notice

Thank you for purchasing the

PaX-i3D Green

The

TM

is an advanced digital dental diagnostic system that

PaX-i3D Green

TM

extra-oral imaging system.

incorporates PANO, CEPH, and 3D CT imaging capabilities into a single
system.

This manual describes how to operate the

PaX-i3D Green

TM

system. It is
recommended that you thoroughly familiarize yourself with this manual in order
to make the most effective use of this equipment.

Observe all cautions, safety messages and warnings which appear in this
manual.

The QR code linked to video le about image capture for the

CEPH Lateral

and

is provided in the manual. The smart phone and pad which

PANO Standard

have the QR code reader application program can be used to watch video.

Due to a constant technological improvement, the manual may not contain
the most updated information, subjecting to change without prior notice to the
persons concerned. For further information not covered in this manual, please
contact us at:

VATECH Co., Ltd.

Phone: [phone]

E-mail: [e-mail]

This document is originally written in English.

The PaX-i3D Green

Manual Name: PaX-i3D Green

Version: 1.5.0

Publication Date: 2016-05

TM

is referred to as Equipment in this manual.

TM

(Model: PHT- 60CFO)

05

PaX-i3D Green (PHT-60CFO) User Manual

Table of Contents

Table of Contents

Notice ......................................................

1

1.1

1.2

1.3

2.

2.1

2.2

2.3

2.4

3

3.1

General Information ....................................... 12

Manufacturer's Liability ........................................................ 12

Owner and Operator's Obligations ...................................... 12

Conventions in this Manual ................................................. 13

Warnings and Precautions ............................16

General Safety Precautions ................................................. 16

Electricity-related Safety Precautions .................................. 20

Radiation Safety .................................................................. 21

Warnings ............................................................................. 22

PaX-i3D Green Imaging System Overview ... 26

Introduction .......................................................................... 26

05

3.1.1 System Components.............................................................26

3.1.2 Features ................................................................................26

3.1.3 The PaX-i3D Green Model Series (Optional)........................28

3.1.4 Standards and Regulations...................................................29

3.2

3.3

3.3.1 Control Panel ........................................................................33

3.3.2 Touch Screen ........................................................................34

3.3.3 Emergency Stop Switch ........................................................39

3.3.4 The Exposure Switch ............................................................39

3.3.5 Components and Positioning Accessories ............................40

3.4

06

Imaging System Structure ................................................... 30

General View of the PaX-i3D Green .................................... 31

Marks and Symbols ............................................................. 41

PaX-i3D Green (PHT-60CFO) User Manual

Table of Contents

4

4.1

4.2

4.3

4.3.1 PANO .................................................................................... 50

4.3.2 CEPH ...................................................................................55

4.3.3 CBCT ...................................................................................57

5

5.1

5.2

5.2.1 Creating a New Patient Record ............................................65

5.2.2 Retrieving Patient Records ...................................................67

5.3

Software Overview ......................................... 44

PC System Requirements (Recommended) ....................... 44

EasyDent / EzDent-i ............................................................ 45

Imaging Software Overview ................................................. 46

Getting Started ............................................... 64

Turning on the PaX-i3D Green ............................................ 64

Running the Image Viewer .................................................. 65

Initiating the Imaging Program ............................................. 69

6

6.1

6.2

6.3

6.3.1 PANO Standard and Bitewing mode ..................................... 82

6.3.2 TMJ Open .............................................................................86

6.3.3 TMJ Close ............................................................................89

6.3.4 Sinus .....................................................................................90

6.4

7

7.1

7.2

7.2.1 Lateral / Full Lateral ............................................................101

7.2.2 Frontal (PA) ......................................................................... 102

Acquiring PANO Images ................................ 72

PANO Imaging Program ...................................................... 72

Setting Exposure Parameters .............................................. 77

Positioning the Patient ......................................................... 81

Initiating X-ray Exposure ..................................................... 93

Acquiring CEPH Images ................................ 96

Setting the Exposure Parameters ........................................ 96

Positioning the Patient ....................................................... 100

7.2.3 SMV ....................................................................................104

07

PaX-i3D Green (PHT-60CFO) User Manual

Table of Contents

7.2.4 Waters View ........................................................................105

7.2.5 CARPUS .............................................................................106

7.3

8

8.1

8.2

8.3

8.3.1 Starting imaging with the SCOUT feature ...........................121

8.3.2 SCOUT Viewer ...................................................................123

8.4

9

10

10.1

10.2

Initiating X-ray Exposure ................................................... 107

Acquiring CT Images ................................... 112

Setting the Exposure Parameters .......................................11 2

Positioning the Patient ........................................................116

Acquiring a SCOUT Image ................................................ 121

Initiating X-ray Exposure ................................................... 124

Troubleshooting ........................................... 128

Cleaning and Maintenance .......................... 130

Cleaning ............................................................................ 130

Maintenance ...................................................................... 131

10.2.1 Regular Maintenance ..........................................................131

10.2.2 Maintenance Task Checklis ................................................132

11

12

12.1

12.2

12.3

12.4

Disposing of the Unit ................................... 134

Technical Specications .............................. 136

Mechanical Specications ................................................. 136

Technical Specications .................................................... 140

Electrical Specications ..................................................... 145

Environmental Specications ............................................ 145

08

PaX-i3D Green (PHT-60CFO) User Manual

Appendices

Table of Contents

1

2

2.1

2.2

2.3

3

Recommended X-ray Exposure Table ........ 148

X-ray Dose Data ............................................ 150

DAP Table .......................................................................... 150

X-ray Leakage Dose .......................................................... 152

X-ray Scatter Dose ........................................................... 153

Electromagnetic Compatibility (EMC)

Information .................................................... 156

4

Acquiring image for the pediatric dental

patient ............................................................ 161

4.1

4.2

Age group: classication table .......................................... 161

Positioning the pediatric dental patient ............................. 161

4.3

4.4

5

Setting exposure values to the age group ........................ 162

The references pertinent to the potential risks for the pediatric

patients ............................................................................. 162

Abbreviations ............................................... 164

09

1

General Information

1.1

1.2

1.3

Manufacturer's Liability ........................................................ 12

Owner and Operator's Obligations ...................................... 12

Conventions in this Manual ................................................. 13

PaX-i3D Green (PHT-60CFO) User Manual

1 General Information

1 General Information

1.1

Manufacturer's Liability

The manufacturers and/or retailers of this equipment assume responsibility for
the safe and normal operation of this product

■The equipment has been installed by a VATECH authorized technician.

■The equipment has been installed in accordance with all of the cautions and
conditions for installation.

■Genuine VATECH approved equipment and components have been used
at all times.

■All maintenance and repairs have been performed by a VATECH authorized
agent.

■The equipment has been used normally in accordance with the user's
manual.

■The equipment damage or malfunction is not the result of an error on the
part of the owner or operator.

only when:

1.2

Owner and Operator's Obligations

■The owner of this equipment shall perform constancy tests at regular intervals in

■The owner of this equipment shall perform regular inspection and maintenance of

12

order to ensure patient and operator safety. These tests must be performed in
accordance with local X-ray safety regulations.

the mechanical and electrical components in this equipment to ensure safe and
consistent operation (IEC 60601-1). The owner of this equipment shall ensure
inspection and cleaning works are performed in accordance with the maintenance
schedule outlined in

Chapter 10 Cleaning and Maintenance.

PaX-i3D Green (PHT-60CFO) User Manual

1 General Information

1.3

Conventions in this Manual

The following symbols are used throughout this manual. Make sure that you
fully understand each symbol and follow the instructions which accompany it.

To prevent personal injury and/or damage to the equipment, please observe all
warnings and safety information included in this document.

WARNING

CAUTION

X-ray

Indicates information that should be followed
with the utmost care. Failure to comply with a
warning may result in severe damage to the
equipment or physical injury to the operator
and/or patient.

Indicates a situation that demands prompt
and careful action, a specific remedy, or
emergency attention.

Indicates a possible danger of exposure to
radiation.

IMPORTANT

NOTE

SINGLE USE

Indicates a situation or action that could
potentially cause problems to the equipment
and/or its operation.

Emphasizes important information or provide
useful tips and hints.

Indicates a component which must be replaced
for each new patient.

13

2

Warnings and Precautions

2.1

2.2

2.3

2.4

General Safety Precautions ................................................. 16

Electricity-related Safety Precautions .................................. 20

Radiation Safety .................................................................. 21

Warnings ............................................................................. 22

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

WA

G

2. Warnings and Precautions

Be sure to strictly observe all warnings and safety

RNIN

instructions included in this manual.

2.1

General Safety Precautions

Operator qualications

This equipment may only be operated by personnel fully trained in its operation.

■To operate this equipment, all operators must:

-have read and understood the user's manual

-be familiar with the fundamental structure and functions of this equipment

-be able to recognize irregularities in the operation of this equipment and
implement appropriate measures to remedy such irregularities.

General safety precautions

■Follow the instructions specied in this manual to ensure the safety of both
the patient and the operator.

■The operator must maintain visual contact with the patient at all times during
imaging.

16

■Do not open or remove the cover panels on this equipment. Always have
a trained and authorized service technician carry out inspection and
maintenance of this equipment.

■Do not place foreign objects on this equipment at any time.

■Do not place any objects within this equipment's eld of operation.

■Do not push or pull the equipment. If equipment overbalances, resulting in
the risk of physical injuries or property damage.

■Operators must ask the patient to remain still until the equipment arm has
stopped moving and the reset motion is complete.

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

CAUTION

■Observe all local re regulations. Always keep a re extinguisher near the
equipment.

■The operator of this equipment must be familiar with this equipment's
emergency protocols.

■Ensure that this equipment is kept away from water, moisture, or foreign
substances at all times.

■If this product is exposed to water, moisture, or a foreign substance,
immediately turn off all power to the equipment and contact your VATECH
technical support representative.

■Immediately cease all operation of this equipment if there are signs of oil
leakage and contact you VATECH technical support representative.

Ventilation

■Do not obstruct the equipment's ventilation for air opening. Improper
ventilation could result in the equipment overheating due to a lack of air
circulation.

■Do not spray any type of liquid or aerosol on this equipment as this
may penetrate the system and damage the electrical and mechanical
components inside.

■Always leave a sufcient amount of space around the PC to allow for proper
ventilation.

Hygiene

Always disconnect the equipment from the power outlet

when disinfecting the surfaces of the equipment.

■All removable patient support components (bite block, chin support, temple
supports) can be cleaned using alcohol-based cleaning solutions.

■Patient support handles can be cleaned using alcohol-based cleaning
solutions.

■Other surfaces of the equipment, including the touch screen, can be
cleaned using a soft cloth dampened with a mild cleaning solution.

17

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

■Disinfect the components (bite block, temple supports etc.) of the equipment

■New hygiene cover must be provided for each new patient to prevent the

IMPORTANT

Condensation

■Extreme fluctuations in temperature may cause condensation to develop

that come into contact with the patient or the operator after each exposure.

transmission of communicable disease.

Do not use aerosol or spray cleaning agents directly on the

surface of the equipment.

inside the equipment. Do not turn on the equipment until it has reached
room temperature.

Cooling

■ Allow the proper amount of cool down time (for the X-ray tube to cool down)
to elapse between each image acquisition.

-Mode of operation: Continuous operation with intermittent loading.

-Exposure time: Max. 20.2 s / Resting time: 5 min.

-Column operation time: 1 min / Resting time: 9 min

■ If the temperature inside the tube head reaches 60 °C, X-ray exposure will
cease and an error message will be displayed. Normal X-ray capabilities will
resume after the generator reaches 58 °C (136.4 ℉).

■ If the fan (optional) is installed, it operates automatically when the

temperature surrounding the tube head reaches the pre-dened level: 40 ℃

(104 ℉). The set point temperature is congurable.

Turning the equipment on / adjusting the height of the equipment

■Do not position the patient in the equipment while it is initiating as the
patient could be injured if the equipment malfunctions.

■Ensure that the patient is kept clear of the mechanism while adjusting the

18

height of the equipment.

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

Emergency stop

■If a problem occurs during image acquisition, press the red emergency
stop button to immediately stop all moving parts and cut off all power to the
equipment.

Trouble-free operation

■ Never use this equipment in an environment that is susceptible to explosion.

■ Always operate the equipment within a temperature range of 10 °C to 35 °C
(50 ℉ to 95 ℉) for the safe operation. Image quality may deteriorate if the
equipment is operated outside of this range.

■ Always allow the equipment sufcient time to warm up (while switched on) if
it has been exposed to temperatures of below 10 °C (50 ℉).

■ Only perform X-rays of patients if system is in full working order.

■ Always ensure that equipment movement is not obstructed by the patient’s
clothing, medical device (such as a wheelchair), or the patient themselves.

■ Do not leave the patient unattended around the equipment.

■ Remove all radio-controlled devices, mobile phones, etc. from the X-ray
room prior to image acquisition as these objects may cause the equipment
to malfunction.

Modifying the equipment

■Modifying the equipment in any way which may affect the safety of the
operator, patient or other persons is prohibited by law.

■No part of this equipment is serviceable by the user. All maintenance
and repair of this equipment must be performed by a qualified service
technician.

■This product may only be operated with original VATECH accessories or
third-party accessories expressly approved by VATECH.

19

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

2.2

Electricity-related Safety Precautions

■Check the status of the power source, PC and cables prior to operating the
equipment.

■Ensure that the on/off switch is set to off when the equipment is not in use.

■Always disconnect the power supply before cleaning the equipment.

■Always keep electrical cords away from hot appliances or radiators.

■DO NOT place the PC or peripheral equipment connected to the PC in the
immediate vicinity of the patient.

■The equipment and PC should be connected to a common protective earth.

■Never overload the equipment’s circuit by sharing it with too many
appliances.

■Use the same power circuit for the PC and the equipment.

Combining this equipment with other devices

■Do not connect this equipment to devices which are not part of the system.

■Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO)
or extension cord.

Electromagnetic compatibility

■The PaX-i X-ray unit complies with IEC standard 60601-1-2.

■Medical electrical equipment is subject to special EMC preventive

measures. It must be installed and operated as specied in the

Requirements

■If high-voltage systems, radio link systems or MRI systems are located

within 5 m of the unit, please observe the specifications stated in the
installation requirements.

■Portable and mobile RF communications equipment may interfere with

medical electrical equipment. Therefore, the use of mobile wireless phones

in medical ofces or hospital environments must be prohibited.

document.

Installation

20

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

WA

G

WA

G

For more details, refer to the document Electromagnetic Compatibility

Information.

ElectroStatic Discharge

Connector pins or sockets bearing ESD warning labels must not be touched or
interconnected without observing ESD protective measures.

2.3

Radiation Safety

RNIN

■The operator must remain outside a shielded room during X-ray exposure in
order to protect himself/herself from radiation.

■The patient must wear a lead apron with neck and thyroid protection during
X-ray exposure.

■Children and pregnant women must consult with a doctor before X-ray
exposure.

■This equipment must be housed inside an X-ray shielded room.

■During imaging; the operator must maintain visual contact with the patient
from outside the shielded area.

Since rules and regulations concerning radiation safety

differ between countries, it is the responsibility of the

owner and/or operator of this equipment to comply with

all applicable rules and regulations concerning radiation

safety and protection in their area.

■The operator should continuously check the status of the patient and the
equipment during imaging.

■The operator must immediately stop imaging if the equipment malfunctions.

As a manufacturer of radiology equipment that conforms

to stringent protection standards around the world, we

RNIN

guarantee the maximum degree of protection against

radiation hazards for our equipment.

21

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

WA

G

WA

G

WA

G

2.4

Warnings

The following warning statements should be obeyed with the utmost care.
Failure to follow these warnings may cause severe damage to the equipment or
physical injuries to the patient and/or operator.

RNIN

RNIN

X-ray equipment is hazardous to patient and the operator

if proper exposure safety measures and/or operating

instructions are not observed.

It is important to read this user manual carefully and

strictly abide by all warnings and cautions stated within it.

● 3D image should not be used for screening examinations.

Each exam must be justified by demonstrating that the

benets outweigh the risk.

● Where it is likely that evaluation of soft tissues will be

required as part of the patient’s radiological assessment,

conventional medical CT or MR should be used instead of

dental cone beam imaging.

RNIN

● PaX-i3D Green system, like other medical equipment,

uses high-frequency electrical signals that can interfere

with implantable devices such as pacemakers and

implantable cardioverter-debrillators(ICDs). If the patient

has such an implantable device, you should be aware of

any interference in its operation and immediately power

off the Dental X-ray system.

● PaX-i3D Green system is designed to withstand the

effects of defibrillation. However, when possible,

disconnect the Dental X-ray systems during debrillation

since a malfunction of the safety controls could otherwise

result in electrical burns for the patient.

22

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

CAUTION

Lasers

■The system incorporates Class 1 laser products. The light localizers used
in this product are intended for correct patient positioning and must not be
used for any other purpose.

■For maximum safety, advise the patient not to look directly at the laser
beam.

■While adjusting the patient, ensure that the laser beam is not directed at the
patient’s eyes.

Risk of eye injury!

Do not use this equipment with any other laser sources

and do not make any changes to the settings or processes

that are described in these operating instructions.

Cleaning

■Never expose this equipment to liquids, mists or sprays. Exposing this
equipment to liquids may cause an electrical shock or otherwise damage
the system.

■Do not use spray cleaners on this equipment, as this could cause a re.

During Operation

■Never use this equipment in an environment that is susceptible to explosion.

■Do not place ammable materials near this equipment.

■Do not operate the PC or Touch screen while the equipment is performing
an operation. Failure to comply with this instruction may result in system
malfunction.

■Immediately stop imaging if the equipment malfunctions in any way.

■If a problem occurs during imaging, press the red emergency stop button to
immediately stop all moving parts and cut off all power to the equipment’s
electrical components.

■Never touch the patient while also touching the SIP/SOP connectors.

23

PaX-i3D Green (PHT-60CFO) User Manual

2 Warnings and Precautions

In case of electrical re

■Use only re extinguishers designed for electrical res to extinguish res on

■Liquid extinguishers, such as those which use water, could damage the

■Unplug the equipment’s power cable before extinguishing any re.

Installation

■In order to avoid improperly balanced equipment, install the device on a at

■If the equipment is not stable, property damage and/or personal injury may

■Do not push or pull the equipment.

■Equipment should only be installed by an authorized technician, complying

this equipment.

equipment and/or cause injury.

surface to maintain stability.

occur.

with proper installation procedures.

24

3

PaX-i3D Green Imaging System Overview

3.1

3.1.1 System Components.............................................................26

3.1.2 Features ................................................................................26

3.1.3 The PaX-i3D Green Model Series (Optional)........................28

3.1.4 Standards and Regulations...................................................29

3.2

3.3

3.3.1 Control Panel ........................................................................33

3.3.2 Touch Screen ........................................................................34

3.3.3 Emergency Stop Switch ........................................................39

3.3.4 The Exposure Switch ............................................................39

3.3.5 Components and Positioning Accessories ............................40

3.4

Introduction .......................................................................... 26

Imaging System Structure ................................................... 30

General View of the PaX-i3D Green .................................... 31

Marks and Symbols ............................................................. 41

PaX-i3D Green (PHT-60CFO) User Manual

3 PaX-i3D Green Imaging System Overview

3 PaX-i3D Green Imaging System Overview

3.1

Introduction

PaX-i3D Green

The
incorporates Panoramic (PANO), Cephalometric (CEPH), and 3D CT imaging
capabilities into a single system.

PaX-i3D Green

The
cephalometric and CT image of the oral and craniofacial anatomy to provide
diagnostic information for adult and pediatric patients. The
system uses the advanced sensors to produce the higher quality of image in 2D
and 3D of the head region, including the dental/maxillofacial regions.

PaX-i3D Green

The
professionals who are licensed to perform X-rays by the law of the region in
which it is being used.

is an advanced digital dental diagnostic system that

system is intended for use to take a panoramic,

may only be used by dentists, X-ray technicians and other

3.1.1 System Components

■PaX-i3D Green digital X-ray equipment

■PC

PaX-i3D Green

■EasyDent / EzDent-i: 2D viewer and patient management software

■Ez3D plus / Ez3D-i: 3D viewer

■Imaging software

3.1.2 Features

■A 3-in-1 imaging solution: PANO, CEPH and CBCT imaging combined in
single equipment.

■Improved image processing algorithms:

-Magic PAN (Optional): A high quality image reconstructed from the optimal
auto-focused images in each segment throughout the panoramic region to
correct the improper patient positioning and rotating unit’s trajectory.

■Metal Artifact Reduction: Metal artifacts are minimized to improve image quality.

26

PaX-i3D Green (PHT-60CFO) User Manual

3 PaX-i3D Green Imaging System Overview

■Fast CEPH: CEPH imaging with low X-ray dose and high speed

■Control Panel: to allow an easy handling of the equipment

■Multi-FOV (Field Of View): FOV is selected, based on the most suitable
ROI.

■Provides an auto-switching between 2 sensors for the PANO and CBCT
imaging, without the intervention of the operator.

■3D Viewer

Ez3D plus / Ez3D-i:

Enables 3D images to be analyzed

accurately, leading to greater diagnostic precision.

■DICOM le support: The standard le format for medical applications.

27

PaX-i3D Green (PHT-60CFO) User Manual

3 PaX-i3D Green Imaging System Overview

3.1.3 The PaX-i3D Green Model Series (Optional)

Model Item Sensor FOV (mm)

PANO Xmaru1501CF -

SP

SC

OP

PANO+CBCT

PANO+CBCT
+CEPH

PANO+CBCT
+CEPH

Xmaru1215CF MP 100 X 80, 80 X 80, 80 X 50, 50 X 50

CT

Xmaru1524CF MP

PANO Xmaru1501CF -

Xmaru1215CF MP 100 X 80, 80 X 80, 80 X 50, 50 X 50

CT

Xmaru1524CF MP

CEPH Xmaru2301CF Scan Type

PANO Xmaru1501CF -

Xmaru1215CF MP 100 X 80, 80 X 80, 80 X 50, 50 X 50

CT

Xmaru1524CF MP

CEPH 1210SGA

160 X 100, 120 X 90, 80 X 80, 80 X 50, 50 X 50

150 X 150, 120 X 90, 80 X 80, 80 X 50, 50 X 50

160 X 100, 120 X 90, 80 X 80, 80 X 50, 50 X 50

150 X 150, 120 X 90, 80 X 80, 80 X 50, 50 X 50

160 X 100, 120 X 90, 80 X 80, 80 X 50, 50 X 50

150 X 150, 120 X 90, 80 X 80, 80 X 50, 50 X 50
One shot Type

12 X 10, 9 X 10, 8 X 8 (inches)

30.48x25.40, 22.86x25.40, 20.32x20.32(cm)

28

PaX-i3D Green (PHT-60CFO) User Manual

3 PaX-i3D Green Imaging System Overview

0434

3.1.4 Standards and Regulations

Standards:

The PaX-i3D Green is designed and manufactured to meet the following
standards:

IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2, IEC/EN 60601-1­3, IEC/EN 60601-2-7, IEC/EN 60601-2-28, IEC/EN 60601-2-32, IEC/EN 60601­2-44, ISO 9001, ISO 13485

NEMA standard publication PS 3.1-3.18, 2008

X-ray source assembly [DG-07C11T2 / DG-07C11C1] IEC 60601-2-28 (1993)

The CE symbol grants this equipment compliance with the European
Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a
class IIb device.

UL symbol grants this equipment compliance with the UL 60601-1 / CAN/
CSA C22.2 No.601.1

Classications (IEC60601-1 6.1):

Protection against the ingress of water: Ordinary Equipment: IPX0

Protection against electric shock: Class 1 equipment, Type B Applied Parts

29

PaX-i3D Green (PHT-60CFO) User Manual

3 PaX-i3D Green Imaging System Overview

NOTE

3.2

Imaging System Structure

RS232 Interface Cable 10 m (32.8’)

1. Signal input/output at the column up/down switch (optional)

External equipment intended for connection to signal

input, signal output or other connectors, shall comply with

relevant IEC Standard (e.g., IEC60950 for IT equipment

and IEC60601-1series for medical electrical equipment). In

addition, all such combination-system-shall comply with

the standard IEC60601-1 and/or IEC60601-1-1 harmonized

national standard or the combination.

30