Varian Medical Systems X Ray RTL8812AU PaxScan 4336Wv4 Digital Image Recepter User Manual 4336Wv4 M01R1 0 Operating Instructions

Varian Medical Systems, Inc. X-Ray Products PaxScan 4336Wv4 Digital Image Recepter 4336Wv4 M01R1 0 Operating Instructions

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Digital Image Receptor

The PaxScan 4336Wv4 is a radiographic

digital x-ray imaging sub-system

UNRELEASED – DRAFT 090315

109724-000 Rev B 09/2015

Abstract The Operating Instructions (P/N 109724-000) covers safety, setup, operation, and maintenance

of the PaxScan 4336Wv4 radiography digital image receptor. The imager is a component sub-

system intended for integration by a qualified systems integrator.



Varian Medical System, Inc

X-Ray Products

1678 So. Pioneer Rd

Salt Lake City, UT 84104

United States

+ 1 801 972 5000 Phone

Varian Medical Systems UK Ltd.

Gatwick Road, Crawley

West Sussex RH10 9RG

United Kingdom

Notice Information in this manual is subject to change without notice. Varian is not liable for errors or

omissions contained in this manual or for any damages incurred in connection with furnishing or

use of this material.

This document contains proprietary information protected by copyright. No part of this document

may be reproduced, translated, or transmitted without the express written permission of Varian

Medical Systems, Inc.

Updates For updates to these instructions, please refer to the Release Notes.

Trademarks PaxScan® is a registered trademark and ViVA™ is a trademark of Varian Medical Systems, Inc.

Microsoft® is a registered trademark and Windows™ is a trademark

Use is prohibited without Varian’s express written consent

Proprietary & Confidential Information

How To Reach Us

Technical

Support

In order to provide you with the most comprehensive technical support, (hardware or

software), pleas

e complete the problem report in Chapter 10 of this manual and email to:

PAXSCAN.RMA@varian.com

before contacting your Varian representative.

To speak with our technical support personnel call:

x Call (800) 432-4422 dial 8.

For Warranty and Returns ple

ase refer to:

x https://www.varian.com/x-ray-imaging-components/service-support

 International Offices

Sales

 Italy

Corso Susa, 299B

10098 Rivoli (Torino), Italy

+ 39 011 955 03 96 Phone

+ 39 011 953 62 59 Fax

 Japan

6F METLIFE Kabutocho Bldg.

5-1 Nihonbashi Kabutocho

Chuo-ku Tokyo 103-0026, Japan

+ 81 3 4486 5070 Phone

+ 81 3 4486 5069 Fax

 Neitherland

Zutphensestraat 160A

6971 ET Brummen

The Netherlands

+ 31 575 566 093 Phone

+ 31 575 566 538 Fax

 Switzerland

P.O. Box 38

1714 Heitenried – Switzerland

+ 41 26 495 32 58 Phone

+ 41 26 495 32 59 Fax

Sales and Technical Support

 China

Varian Pan-Pacific Beijing Branch

No. 8 Yun Cheng Street

Beijing Economic – Technological Dev

elopment

Area (BDA)

Beijing 100176, China

E-mail: xraychina@varian.com

+ 010 8785 8785 Phone

+ 010 8785 8954 Fax

Varian Pan-Pacific Shanghai Branch

Room 2208, Central Plaza

227 North HuangPi Road

Shanghai 200003, China

+ 86 21 6375 8953 Phone

+ 86 21 6375 8957 Fax

Sales, Technical Service and Warehouse

 Germany

Karl-Arnold-StraBe 12

D-47877 Wilich, Germany

Sales, Technical Service and Warehouse

E-mail: sales-xray@varian.com

+ 49 2154-92 4980 Phone

+ 49 2154-92 4994 Fax

General Safety Information

PLEASE READ THIS ENTIRE MANUAL BEFORE USING. PRIOR TO USING

PLEASE

ENSURE UNDERSTADING OF THE WARNING, PRECAUTIONS AND

ADVERSE EFFECTS RELATING TO THIS DEVICE.

Safety Warnings, Precautions and Contraindications

Warning:

For portable applications, the operator and end-user must take precautions

to protect themselves against dangerous X

ray exposure when using the

flat panel imager in the X-ray beam path of an X-ray source.

Warning:

The 4336Wv4 is not intended to be used as a primary barrier to X-rays.

The user is responsible for ensuring the safety of the operator, bystanders,

and the subjects being radiographed

Warning:

The equipment is not suitable for use in the presence of a flammable

anesthetic mixture with air, oxygen or nitrous oxide.

Warning:

Do not exceed maximum load weight of 100kg over a diameter of 40mm

and 150kg distributed around the entire surface of the panel.

This device is not intended to supply heat to a patient. However,

during normal use surfaces will become heated due to power

dissipation in the imager.

Be aware that the 4336Wv4 is an applied part (patient contact

device) and the surface shall not excee

d 41 degrees C. See

Figure

-0 for the view of the patient contact surfaces.

Internal temperature

sensor data is provided in the diagnostic data attached to each image.

These temperature measurements are well correlated with the panel

external surface

temperature. It is advisable to monitor this

diagnostic

data as an additional safety precaution.

Note:

There are no contraindication situations

Explanation of Symbols

On (power: connection

to the mains)

Caution / Warning /

Important: Describes

action or conditions

that could result in

equipment damage,

data loss, or personal

injury

Protective Earth

Ground

Alternating Current

Off (power:

disconnection from the

mains)

Direct Current

Handle With Care

Indicates step-by-step

escription of the

respective function

follows

Useful / Important

information

Authorized

Representative in the

European

Community/European

Union

Manufacturer

Consult Instruction

for Use

IP5

Protected from limited

dust ingress

Protected from

con

densation -

PaxScan 4336Wv4

Receptor

Heated Surface

Type B Applied Part

Load Weight

Restriction

Temperature Limits

Non

ionizing radiation

IP20

Protected from touch

by objects greater than

12 millimeters, not

protected from liquids

–

Varian Battery

Charger

Chapter Summary

Introduction

Getting Started

PaxScan Software

Modes of Operation

Calibration Procedures

Image Acquisition

Safety

Maintenance

Trouble Shooting

Problem Report

Appendix

Index

How To Reach Us ............................................................................................................................................... 2

General Safety Information ................................................................................................................................. 4

Safety Warnings, Precautions and Contraindications .......................................................................................... 4

Explanation of Symbols ...................................................................................................................................... 5

Introduction ......................................................................................................................................................... 9

Shipment Contents............................................................................................................................................... 9

Optional Parts ...................................................................................................................................................... 9

Intended Use ...................................................................................................................................................... 10

Figure 1-0 Patient Contact Surfaces – 4336Wv4 ...................................................................................... 10

Getting Started ................................................................................................................................................... 11

System Overview ........................................................................................................................................... 11

Figure 2-0 Imager Configuration .............................................................................................................. 11

Figure 3-0 Imaging System Overview - without Router ......................................................................... 12

Figure 3-1 Imaging System Overview - with Router .............................................................................. 12

Figure 4-0 Imaging System Overview – Cable Connection ..................................................................... 13

Power on Sequence ........................................................................................................................................ 14

Figure 5-0 4336Wv4 Receptor Power/LED ............................................................................................. 14

Figure 5-1 4336Wv4 LED Status - Details ............................................................................................... 15

PaxScan System Software ................................................................................................................................. 17

Modes of Operation ........................................................................................................................................... 18

Table 1-0 PaxScan 4336Wv4 Operational Modes .................................................................................... 18

Default Mode ..................................................................................................................................................... 19

Operation States ............................................................................................................................................. 19

Calibration Procedures ...................................................................................................................................... 20

Offset Calibration .............................................................................................................................................. 20

Preview Offset Calibration ............................................................................................................................. 20

Gain Calibration ................................................................................................................................................ 22

Table 2-0 Gain Calibration: All Modes ................................................................................................... 23

Radiographic Mode Gain Calibration ............................................................................................................ 24

ViVA Mode Settings ......................................................................................................................................... 26

Image Acquisition ............................................................................................................................................. 28

Radiography Mode ......................................................................................................................................... 28

Safety ................................................................................................................................................................. 31

Electro-Magnetic Interference ........................................................................................................................ 31

Table 3-0 Guidance and Mfgr Declaration - Electromagnetic Emissions ................................................ 31

Table 4-0 Guidance and Mfgr Declaration - Electromagnetic Immunity ................................................. 32

Table 5-0 Recommended Separation Distance Between .......................................................................... 34

Portable and Mobile RF Communications and the PaxScan 4336Wv4 .................................................... 34

Electrical Protection .......................................................................................................................................... 35

Environment Limits ........................................................................................................................................... 35

Temperature, Humidity & Atmospheric Pressure .......................................................................................... 35

Altitude Limits .................................................................................................................................................. 35

Varian Lithium-Ion Rechargeable Battery ..................................................................................................... 36

Lithium-Ion Battery Handling, Storage, & Shipping ..................................................................................... 36

Regulatory ......................................................................................................................................................... 37

Radio Frequency (RF) Compliance Information ............................................................................................... 38

FCC/IC Compliance ....................................................................................................................................... 38

Industry Canada Notice .................................................................................................................................. 39

European Community – CE Notice ................................................................................................................ 39

Maintenance ...................................................................................................................................................... 43

Cleaning and Disinfection .............................................................................................................................. 43

Repairs............................................................................................................................................................ 44

Proper Disposal ................................................................................................................................................. 44

Troubleshooting ................................................................................................................................................. 45

PaxScan 4336Wv4 Problem Report Customer Information .............................................................................. 46

Appendix A ....................................................................................................................................................... 47

Battery Installation/Removal for 4336Wv4 ...................................................................................................... 47

Battery Charger ................................................................................................................................................. 49

Figure A-1 3-Bay Battery Charger Status Indicators .............................................................................. 50

Figure A-2 1-Bay Battery Charger Status Indicators .............................................................................. 51

Chapter 1

9 © Varian Medical Systems | X-Ray Products

Introduction

The PaxScan 4336Wv4 is a radiographic digital image receptor commonly referred to as a flat panel detector

(FPD). The detector together with image processing and command software called Varian Smart Panel (VSP) is

designed for integration into a complete X-ray system. The imaging system has two main system components:

The flat panel sensor, and VSP Software.

Shipment Contents

Flat Panel Receptor Assembly (includes a back-up cable for image recovery)

PaxScan Receptor Test Results DVD

(Files specific to the receptor in the shipment)

PaxScan Software DVD

VSP/ViVA System Software M01

PaxScan 4336Wv4 Operating Instructions

Optional Parts

Lithium-ion Battery – Varian model

– P/N 30773 (gray), 57834 (white), 81701 (black)

Battery Charger – Varian model

Laptop Style Power Supply for 1-Bay Battery Charger (includes power cable)

– P/N 82351 (black)

(OEM) Electrochem Solutions, Inc

Laptop Style Power Supply for 3-Bay Battery Charger (includes power cable)

– P/N 35205 (gray/white), 82350 (black)

(OEM) Electrochem Solutions, Inc.

Laptop Style Power Supply for 1-Bay Battery Charger (includes power cable)

– P/N 117402

Laptop Style Power Supply for 3-Bay Battery Charger (includes power cable)

– P/N 44666

Customer Specific Overlay

Immediately upon receipt, inspect the shipment and its contents against the Delivery Note enclosed with the

shipment for evidence of damage or missing components. Save all shipping containers in case a return is

warranted. If there is any discrepancy, please call the PaxScan Service Center at (800) 432-4422 or (801) 972-

5000.

Intended Use

The PaxScan 4336Wv4 receptor is a light weight, wireless flat panel detector designed for medical and

veterinary use. The 4336Wv4 fits standard bucky trays and its wireless communication enables easy migration

between table, above the table, chest stand, and mobile cart applications. This family model will acquire image

over a wide range of dosage, while providing maximum access to the patient, with a minimum possible border

on the active imaging area. An additional cable is supplied with the receptor to allow for set-up of the wireless

interface and retrieve images from the receptor in the case of failed wireless transmission.

Figure 1-0 Patient Contact Surfaces – 4336Wv4

Chapter 2

Getting Started

System Overview

In medical applications, the function of the 4336Wv4 FPD is to absorb the X-rays that pass through the

patient’s anatomy and convert them into a digital image. The wireless access point is the interface between

the FPD and the imaging system and may be mounted in an equipment enclosure, or it may also be wall or

ceiling mounted to maximize wireless signal strength. The Receptor is provided with a software application

package, Virtual Command Processor (VSP), which performs all the interface functions with the receptor;

such as, communication and respective calibration. During operation, the Receptor is often draped or

bagged to ensure cleanliness and sterilization, and is manipulated such that the Receptor’s input window is

located near, but on the opposite side of the patient, from the X-ray source.

Figure 2-0 shows the configuration of the Receptor in the context of the overall imaging system. The

dimensions for receptor are 459.5mm x 383.5 x 15.13mm.

Figure 2-0 Imager Configuration

Figure 3-0 Imaging System Overview - without Router

Figure 3-1 Imaging System Overview - with Router

Figure 4-0 Imaging System Overview – Cable Connection

Note:

There is one (1) cable connections for the 4336Wv4 Flat Panel Receptor

which is the back

-up cable.

This cable functions as an interface between the

receptor and the workstation by providing a 100T Ethernet connection for set-

up of the wireless interface and retrieval of images in the case of wireless

transmission failure.

Power on Sequence

Step

Action / Results

Place battery into receptor making sure the battery latches into place. The receptor will

automatically power on when battery is inserted.

The yellow and green LEDs are solid while receptor boots.

Wireless connected is green blinking.

The yellow LED indicates the status of the receptor. Refer to Figure 5-1 for explanation of LED

status indicators.

Figure 5-0 4336Wv4 Receptor Power/LED

Figure 5-1 4336Wv4 LED Status - Details

Note

The

blinking behavior occurs based on a 4Hz clock.

Each digit for the

blinking pattern represents 1/4s

Important:

The

Service Cable

does not provide power to the receptor when tethered.

Before servicing, ensure that a fully charged battery is inserted.

Warning:

PaxScan 4336Wv4 Moisture Resistance Level Tested, horizontal position,

-ray window face up, without backup cable attached; protected a

gainst

falling water equivalent to 3

5mm rainfall per minute for duration of 10

minutes.

Receptor

Ingress Dust Level Tested,

not entirely prevented, but must not

enter in

sufficient quantity to interfere with the satisfactory operation of

the equipment; c

omplete protection against contact (dust proof)

Caution:

Accessory or optional equipment connected to the analog and digital

interfaces must be certified to the respective IEC standards (i.e., IEC

60950

-1 for data processing equipment and IEC 60601-

1 for medical

equipment). Furthermore, all configurations shall comply with the

system standard IEC 60601

-1-

1. Anyone connecting additional or

optional equipment to the signal inputs or signal outputs as part of a

configuration for medical equipment

is therefore responsible for

compliance with the equipment standard IEC 60601

1. If in doubt,

consult our technical support personnel

Warning:

Precautions should be taken to not open the receptor module.

Depending upon the type of scintillator used, opening the receptor

module may expose the user to potentially toxic materials.

Warning:

Changes or modifications not expressly approved by the

manufacturer could void the user’s authority to operate the

equipment

Chapter 3

PaxScan System Software

The PaxScan 4336Wv4 receptor is part of a new series of Flat Panel Detectors which deploy the Varian Smart

Panel (VSP) architecture. Imager software is composed of two parts: 1. Software necessary to capture, process,

and correct x-ray images is embedded within the receptor; 2. The VSP COMM workstation libraries comprise the

VSP SDK. Because the main software is embedded within the receptor, the only software required on the

workstation is a small set of DLLs that should be copied from the DVD to the workstation.

The VSP COMM libraries are copied to the workstation. Software interfacing to this receptor will make API calls

to these SDK libraries to control the image acquisition process. These libraries manage connections to the

receptor and the transfer of files from the receptor to the workstation.

The contents of the DVD include the following files:

1. VSP COMM (SDK) files:

a. libvsp.dll

b. libvsp-zf.dll

c. libwinpthread.dll

d. vspcs.dll

e. vsp.h

This set of files should be copied to the workstation. For customers working with C/C++, a vsp.h header file is

included along with the libraries. For customer working with C#, the vspcs.dll provides the C# wrapper interface.

2. FP2032_VarianSmartPanel_SoftwareInterfaceSpecification.pdf – This .pdf file provides API

documentation for the software.

3. Bonjour installation files

a. Bonjour.msi

b. Bonjour64.msi

Bonjour is an optional installation and is required if you use the List()/vsp_list() API function.

4. Sample Code

a. vsp-example.cs – C# sample code project

b. vsp-example.c– C/C++sample code project

5. Utility software

a. vsp-example.exe

The vsp-file.exe utility is used to transfer a configuration file to the receptor.

Important:

or interfaces connection, synchronization and timing diagrams

information

please reference the Software Interface Specification.

Chapter 4

Modes of Operation

The PaxScan 4336Wv4 supports the radiography mode of operation as defined in Table 2-0. In general, there is

a tradeoff between varying operation modes of resolution, or field of view, or cycle time, or noise. The

sensitivity of the imager is optimized to match the X-ray dose used in each mode.

The purpose of each mode is to configure the detector to achieve optimal performance during specific imaging

procedures. Modes are defined by a combination of factors, such as cycle time and analog gain. Each mode

requires a unique set of calibration files.

Note:

The system may be in only one mode at a given moment.

Not every mode will be available with every system. The OEM should

work with PaxScan technical support for configuration of the mode(s)

which best suit the customers intended application

Table 1-0 PaxScan 4336Wv4 Operational Modes

Mode

Cycle

Time

Pixel

Binning

Panel

Scan

Time

X-Ray

Window

Time

Image

Area

Frame

Size

Acquisition

Type

Radiography – Full

Resolution

sec

1 x 1

550ms

35 to 3

.5s

Full Field

2,476 x 3,072

Accumulation

Default Mode

Mode 0 is the default. The default mode will be invoked automatically upon system power-up when a link is

opened or receipt of a reset state command.

Operation States

The operational states of the imager can be categorized as follows:

x Radiography acquisition: (Radiography-type)

x Offset Calibration: (OEM-initiated)

x Gain calibration: (always-OEM initiated)

x Analog offset calibration: (always OEM-initiated)

Each operating mode employs all types of calibration. In radiography-type acquisitions, the PaxScan

4336Wv4 will acquire one frame with its respective offset.

Chapter 5

Calibration Procedures

Offset Calibration

Offset calibration compensates for fixed pattern pixel intensity variations in the image associated with the dark

current and electronic offsets. The Offset reference image is an average of a series of frames acquired without

X-ray illumination and referred to as dark fields. f

x Offset calibration should not be performed during X-ray.

x The X-ray-to-digital conversion factor does not change as a result of calibration.

Preview Offset Calibration

There are two types of offset calibration; one is used for the preview image and the other to calibrate the

final image. Prior to acquiring images, an offset calibration must be performed in each mode. This offset

calibration is used for the preview image. In addition, an offset calibration is automatically performed

after each single acquisition.

Step

Action / Results

To perform offset calibration, click the ViVA icon launches the application

Ensure required receptor appears in the Mode drop down. The 4336WV4 currently supports Rad

1x1 3pf. Click Offset Calib. Button or select from the menu bar under Acquisition.

Step

Action / Results

A Calibration Setting window appears followed by an offset Calibration Progress window.

The number of frames acquired can be selected from the Settings window. Once all frames are

acquired, the receptor is updated with the averaged offset calibration frame for the current mode.

The updated message will show on the progress window and calibration process is complete.

Press Close button to close the window.

Gain Calibration

To compensate for non-uniformities in the Receptor, a gain reference image (flat field) is used by the

Corrections module as required to correct all images. The flat field image must be captured by the Varian

Smart Panel (VSP) prior to acquiring images. The process of capturing the flat field image is known as Gain

Calibration.

Note:

Every time a gain calibration process is run, an offset calibration is

enforced beforehand

. This will ensure that the receptor is properly

calibrated.

Gain calibration is based upon the linear response of the Receptor to dose. Normalization is achieved by

applying the flat field image acquired during the Gain calibration to all images corrected by the VSP.

Normalization will fail with pixels that are responding to dose in a non-linear manner. Pixels responding to

dose in a non-linear manner are usually caused by the saturation of the Receptor, or a low signal-to-noise ratio.

Note:

It is critical to acquire the flat field image within a range that is large

enough to be higher than

the background noise created by the X-ray

source and readout electronics of the Recept

or, but lower than the

saturation point of the imager.

Flat field images acquired near or exceeding the saturation point will cause normalization failures with all

images acquired until a Gain calibration with the correct dose is performed. We recommend that flat field

images be acquired with a median count of approximately 13000 - 14000. This range will ensure that Gain

calibration will meet both the upper and lower dose requirements under all modes of operation. Dose

requirements are determined by the settings of the generator X-ray source.

To reduce the effects of noise, the average of each pixel in the flat field image is calculated by accumulating a

number of frames into an internal memory buffer, then dividing the sum of each pixel by the number of frames

acquired.

Note

Using larger

numbers of calibration frames to capture the flat fi

eld image

will result in more accurate

calibration.

Important:

Gain calibration requires the production of X

rays and therefore certain

precautions must be taken by the

human operator.

The number of calibration frames used during Gain and Offset calibrations can be adjusted under the Mode

Settings pull down menu. We recommend accumulating 32 frames for gain calibration and 8 frames for offset

calibration for optimal image quality. However, the actual number of calibration frames used must be

determined solely by the system integrator depending upon their specific performance requirements.

The general procedure for Gain calibration for all modes is as follows in Table 2-0 and described in the next

section. Detailed instructions on performing gain calibrations are covered in the ViVA Online help

documentation.

Table 2-0 Gain Calibration: All Modes

Step

Action

Results

Warm Up

To ensure proper warm up, the PaxScan 4336Wv4

Receptor must be operational for a least

30 minutes

prior to

Gain calibration.

Offset Calibration

Software performs a new Offset calibration referred to as

dark field acquisition.

Note: X

-Rays must not be used for this part of the

calibration.

X-Ray Radiation

A uniform flat field with no obstructions in the path of the

Ray beam. The radiation should ideally be at a level and

technique representative of the typical radiation dose for

the Receptor during typical procedures, keeping in mind

the general consideration outlined above.

Repeat

The above procedure must be repeated for each of the

stored imaging modes.

Radiographic Mode Gain Calibration

Radiography Gain calibration requires an Offset calibration performed prior to collecting the Flat Field

image. Therefore an Offset Calibration process must be run prior to the gain Calibration. X-Ray

illuminated frames are then offset-corrected and accumulated in the VSP. A series of accumulated frames

equals one radiographic X-ray exposure. Exposures are averaged to obtain the Flat Field image used by the

VSP. The number of exposures acquired can be selected from the Settings window.

Important:

VivA provides a convenience of running Offset Calibration as part of the

Gain Calibration process.

However, API driven Gain Calibrations do not automatically run Offset

Calibration. OEM Applications should be sure to run Offset Calibration

prior to Gain Calibration.

Take the following steps to complete radiographic gain calibration. f

Step

Action / Results

Ensure the desired receptor and imaging mode appears in the Mode drop down.

Click Gain Calibration from the menu bar under Acquisition invokes hardware handshaking for the dark

field calibration.

Finish Offset Calibration process as explained earlier

Step

Action / Results

Use operator control to perform an exposure. Once all x-ray frames have been acquired click

Finish to Complete the calibration.

The number of frames acquired can be selected from the Setting window. Once all X-ray frames

have been acquired, the receptor is updated with the averaged gain calibration from for the current

mode. The

updated message will show on the progress window and calibration process is

complete. Press Close button to close the window.

Note:

Operator Control

is user supplied equipment.

Note:

Gain calibration should be performed at regular intervals, typically once every

six

(6) months, or whenever the central beam of the X-ray source has been

moved relative to the Receptor.

Replacement of the X

-ray tube will require a new gain calibration to be

performed.

Note:

Varian recommends accumulating 32 frames for gain calibration for

optimal image quality.

However, the actual number of calibration frames

used must be determined solely by the system integrator depending upon

their specific performance requirements.

Note:

For additional assistance operatin

ViVA™, use the ViVA Online help

documentation.

ViVA Mode Settings

The calibration and system settings are verified as follows. f

Step

Action / Results

Make sure the desired receptor is selected from the Mode drop down menu; and, that “Hardware

Handshaking”

is “checked” from the menu bar under Acquisition. ViVA will remember your

preference for future launches

Or check the Hardware Handshaking from Radiographic Acquisition Progress window.

Step

Action / Results

System settings are verified as follows.

Chapter 6

Image Acquisition

Once Offset and Gain Calibration is performed, you are ready to acquire images.

Radiography Mode

The Radiography mode provides the technician with superior single-shot, higher resolution images, for

diagnosis. f

Step

Action / Results

Select required receptor from Mode drop down menu

Make sure hardware handshaking is checked.

Step

Action / Results

Select the Acquire Image button to begin acquiring images. Acquisition Progress window will

appear. Click Start Acquisition button.

Press Start Acquisition button

Step

Action / Results

Acquired image can be saved in the desired file format by selecting File / Save As.

Chapter 7

31 © Varian Medical Systems | X-Ray Products

Safety

Electro-Magnetic Interference

This equipment generates, uses and can radiate radio frequency (RF) energy and, if not installed and used

in accordance with the instructions, may cause harmful interference to other devices in the vicinity. In all

circumstances; however, there is no guarantee that interference will not occur in a particular installation. If

this equipment does cause harmful interference to other devices, which can be determined by turning the

equipment off and on, the user is encouraged to try to correct the interference by one or more of the

measures listed in the Troubleshooting section.

This equipment uses wireless LAN (WLAN) radios for transferring images. The WLAN power levels and

antenna configurations have been tested and certified compliant through specific absorption rate (SAR) limit set

by FCC/IC Canada (Less than 1.6W/kG) testing with separations as small as 0 cm between the panel antennas and

human tissue. While compliant, it is still recommended to reduce exposure when possible by 1) positioning

subject to be X-rayed away from the antennas (this also helps reduce image transfer time) and 2) removing the

detector panel promptly when X-ray exposure is complete. The I/O Box shall not be used at a distance of no less

than 20cm to human tissue.

Table 3-0 Guidance and Mfgr Declaration - Electromagnetic Emissions

The PaxScan 4336Wv4 is intended for use in the electromagnetic environment specified

below. The customer or the user of the

PaxScan 4336W should

assure that it is used in

such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The PaxScan 4336W v4 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 emissions

CISPR 11

Class A

The PaxScan 4336Wv4 is suitable for use in all

establishments other than domestic and those directly

connected to the public low

-voltage power supp

ly network

that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

Flicker emissions

IEC 61000-3-3

Complies

Table 4-0 Guidance and Mfgr Declaration - Electromagnetic Immunity

The PaxScan 4336Wv4 is intended for use in the electromagnetic environment specified

below. The customer or the user of the

PaxScan 4336Wv4

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 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

– Only I/O is

patient cable

Mains power quality should be that of a

typical commercial or hospital environment.

Surge

IEC 61000

-4-5

+1 kV differential mode

+2 kV common mode

+1 kV differential

mode

+2 kV common mode

Mains power quality should be that of a

typical commercial or hospital environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines.

IEC 61000

-4-11

<5 % U

(>95 % dip in U

for 0.5 cycle

40 % U

(60 % dip in U

for 5 cycles

70 % U

(30 % dip in U

for 25 cycles

<5 % U

(>95 % dip in U

for 5 sec

<5 % U

(>95 % dip in U

for 0.5 cycle

40 % U

(60 % dip in

UT)

for 5 cycles

70 % U

(30 % dip in U

for 25 cycles

<5 % U

(>95 % dip in U

for 5 sec

Mains power quality should be that of a

typical commercial or hospital environment.

If the user of the

PaxScan 4336Wv4

requires continued operation during power

mains interruptions, it is recommended that

the

PaxScan 4336Wv4

be powered from an

uninterruptible power supply or battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

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.

Table 4-0 continued

Immunity test

IEC 60601

test level

Complian

ce level

Electromagnetic environment - guidance

Conducted RF

IEC 61000

-4-6

Radiated RF

IEC 61000

-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should

be used no closer to any part of the

PaxScan 4336Wv4

including cables, than the recommended separation distance

calculated from the equation applicable to the frequency of

the transmitter.

Recommended separation distance

Pd 2.1

80 MHz to 800 MHz

Pd 3.2

800 MHz to 2.5 GHz

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and

is the recommended separation distance

in meters (m).

Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey,

should be less than the

compliance level in each frequency range.

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.

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 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 PaxScan 4336Wv4 used exceeds the

applicable RF compliance level above, the

PaxScan 4336Wv4 should be observed to verify norma

l operation. If abnormal

operation is observed, additional measures may be necessary, such as reorienting or relocating the PaxScan 4336Wv4

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

Table 5-0 Recommended Separation Distance Between

Portable and Mobile RF Communications and the PaxScan 4336Wv4

The PaxScan 4336Wv4 is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the

PaxScan 4336W

can help prevent electromagnetic interference by maintaining a

minimum distance between portable and mobile RF communications equipment

(transmitters) and the PaxScan 4336W

as recommended below, according to the

maximum output power of the communications equipment.

Rated maximum

output power

of transmitter

Separation distance according to frequency of

transmitter

150 kHz to 80 MHz

Pd 2.1

80 MHz to 800

MHz

Pd 2.1

800 MHz to 2.5

GHz

Pd 3.2

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in

meters (m) can be estimated using the equation applic

able to the frequency of the transmitter, where P is the

maximum output 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 propogation is affected by

absorption and reflection from structures, objects and people.

Electrical Protection

●

The 4336Wv4 model is internally powered

Environment Limits

Rigorous environmental testing is conducted on an engineering basis using a sample receptor.

Temperature, Humidity & Atmospheric Pressure

Category

Limits

Storage & Transport (ambie

nt)

Receptor: -20º C to +70º C

Battery:

-20º C to +60º C

Battery Charger: -20º C to +60º

Storage

Humidity Range (non-condensing)

Receptor: 10% to 90%

Battery Charger:10% to 90% at 20º C

Normal Operation Temperature (measured at the center

of the back cover)

Receptor: 10º C to 35º C

Operation Humidity (non-condensing)

10% to 90%

Atmospheric Pressure Range

700hPa to 1060hPa

Normal Operation Range (ambient)

Note:

that normal charging must be terminated if

the battery cell temperature is above 45C or

below -20C. Outside of the 0º C to 35C ambient

temperature, the charger will remain active, but

the charge current will be off or limited so that

charge time will be extended.

Battery Charger:

0º C to 35C

Altitude Limits

The Paxscan Digital Imager Receptor is rated to operate at an altitude ≤ 3000m.

The Varian Battery Charger is rated to operate at an altitude -610m to 3050m (-2000 to 10,000 ft)

Varian Lithium-Ion Rechargeable Battery

Please only use the lithium-ion rechargeable battery listed below that is supplied with the receptor.

Battery type: Lithium-ion

Battery model: Varian – P/N 30773 (gray), 57834 (white), 81701 (black)

Rated voltage: 14.8V 2.1Ah, 31.1 Wh

Caution:

Risk of fire, explosion or burns. Do not short circuit, crush, heat above

100ºC, incinerate, or disassemble the battery. Charge only with the

receptor or battery charger supplied

. Please follow local governing

ordinances and recycling plans regarding proper disposal or recycling of

the lithium-ion rechargeable battery.

Note:

Lithium

-ion rechargeable battery is for use with the model PaxScan

4336W

v4.

Lithium-Ion Battery Handling, Storage, & Shipping

Handling

● Do not short circuit, crush, heat above 100ºC, incinerate, or disassemble the battery.

● Do not dispose of battery in fire or water.

● Do not expose battery to temperatures above 60 °C (140 °F).

● Do not use a damage battery.

Storage

● Remove battery and store it separately from device.

● Charge or discharge the battery to approximately 50% of capacity before storage.

● Charge the battery to approximately 50% of capacity at least once every six month.

● Store the battery at temperatures between -20 °C and 60 °C (-4 °F and 140 °F).

Shipping

● Always check all applicable local, national, and international regulations before transporting

a Lithium-Ion battery.

● It is customers responsibility to ship battery according to local and international shipping regulation for

Lithium-Ion battery in effect at the time of shipment.

Regulatory

●

The PaxScan® 4336Wv4 model family is a component sub-system with Type B per

Standard

for Medical Electrical Equipment. The PaxScan® 4336Wv4 model family

and

the Varian Battery Charger are

an associated equipment x-ray medical equipment with

respect to electrical shock, fire and mechanical hazards only in accordance with:

UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for

Safety 1st ed.

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for

Safety 2nd ed.

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for

Basic Safety and Essential Performance 3rd ed.

ANSI/AAMI ES60601-1 (2005) Medical Electrical Equipment – Part 1: General

Requirements for Basic Safety and Essential Performance.

CSA-C22.2 No 60601-1 (2008) Medical Electrical Equipment, Part 1 General

Requirements for Basic Safety and Essential Performance.

CAN/CSA-C22.2 No 601.1-M90, 2005 Medical Electrical Equipment, Part 1

General Requirements for Safety.

EN/IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements

for Basic Safety and Essential Performance Collateral Standard: Electromagnetic

Compatibility 3rd ed.

RF compliant in accordance with FCC Part 15 Subpart C and Part 15 Subpart E.

●

Type B Applied Part

●

CE Mark - Varian Medical Systems’ imaging products are designed and manufactured to

meet the Low

Voltage Directive 2006/95/EC, MDD 93/42/EEC, and R&TTE Directive

1999/5/EC

●

MDD Class IIa

●

A Declaration of Conformity has been filed for this product and available upon request by

contacting Varian Medical Systems.

●

The Varian Battery Charger is a Class 1, continuous operation device and meets the

following:

IEC 61000-4-2 Electro-Static

Discharge

IEC 61000-4-3 RF

Electromagnetic Fields Immunity

IEC 61000-4-4 EFT/Burst

IEC 61000-4-5 Surge Immunity

IEC 61000-4-6 Conducted RF

Disturbances Immunity

IEC 61000-4-8 Magnetic Field

Immunity

IEC 61000

-4-11 Dips, Interruptions,

and Variations

IEC 61000

-3-2 Harmonics Current

Emission

IEC 61000

-3-3 Voltage Fluctuation

and Flicker

Radio Frequency (RF) Compliance Information

FCC/IC Compliance

This device complies with Part 15 of the FCC Rules and RSS-Gen (RSS-210, etc.) of IC Rules. Operation

is subject to the following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received, including interference that may cause

undesired operation.

Note: This equipment has been tested and found to comply with the limits for a Class A

digital device, pursuant to part 15 of the FCC Rules and Canadian ICES-003. These limits

are designed to provide reasonable protection against harmful interference when the

equipment is operated in a commercial environment. This equipment generates, uses, and

can radiate radio frequency energy and, if not installed and used in accordance with the

instruction manual, may cause harmful interference to radio communications. Operation

of this equipment in a residential area is likely to cause harmful interference in which case

the user will be required to correct the interference at his own expense.

If this equipment does cause harmful interference to radio or television reception, which can be determined

by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more

of the following measures:

x Reorient or relocate the receiving antenna.

x Increase the separation between the equipment and receiver.

x Connect the equipment into an outlet on a circuit different from the one the receiver is connected to.

x Consult the dealer or an experienced radio/TV technician for help.

The user may find the following booklet prepared by the Federal Communications Commission helpful:

The Interference Handbook

This booklet is available from the U.S. Government Printing Office, Washington, D.C. 20402. Stock No.

004-000-00345-4.

Modifications not expressly approved by the manufacturer could void the user's authority to operate the

equipment under FCC rules.

In the 5150 to 5250 MHz frequency range this transmitter is restricted to indoor use only.

Industry Canada Notice

To prevent radio interference to the licensed service, this device is intended to be operated indoors and

away from windows to provide maximum shielding. Equipment (or its transmitting antenna) that is

installed outdoors is subject to licensing. The installer of this radio equipment must ensure that the antenna

is located or pointed such that it does not emit RF field in excess of Health Canada limits for the general

population; consult Safety Code 6, obtainable from Health Canada's web site www.hc-sc.gc.ca/rpb.

Cet appareil numérique de la classe A est conforme à la norme NMB-003 du Canada

Avis de Conformité à la Réglementation d'Industrie Canada:

Pour empêcher toute interférence aux services faisant l'objet d'une licence, cet appareil doit être

utilisé à l'intérieur seulement et devrait être placé loin des fenêtres afin de fournir un écran de

blindage maximal. L'installateur du présent matériel radio doit s'assurer que l'antenne est située ou

pointée de manière à ce que cette dernière n'émette pas de champs radioélectriques supérieurs aux

limites specifées par Santé Canada pour le grand public; consulter le Code de sécurité 6, disponible

sur le site Web de Santé Canada, à l'adresse suivante: www.hc-sc.gc.ca/rpb.

This equipment complies with FCC RF radiation and RSS 102 exposure limits set forth for an uncontrolled

environment. Body-worn operation and use near the head this device has been tested and meets both FCC/

IC RF exposure guidelines when used within this product guideline. The maximum SAR Value (Head) is

1.34W/kg. The maximum SAR Value (Body) is 1.37W/kg.”

Cet équipement est conforme aux rayonnements RF de la FCC et RSS 102 limites

d'exposition définies pour un environnement non contrôlé. Opération Porté au corps et utiliser près

de la tête de ce dispositif a été testé et répond aux consignes d'exposition à la fois FCC / IC RF

lorsqu'il est utilisé dans ce produit directive. La valeur maximale SAR (Head) est 1.34W / kg. Le

maximum Valeur SAR (Body) est 1.37W/kg.”

European Community – CE Notice

The CE! mark indicates compliance with the essential requirements of Directive 1999/5/EC. Such marking

is indicative that this equipment meets or exceeds the following technical standards:

x EN 300 328

x EN 301 893

x EN 301 489-17

x EN 60950

Marking by the symbol: ! indicates that usage restrictions apply in countries listed on this product’s

packaging.

Europe - Declaration of Conformity in Languages of the European Community.

Česky [Czech]

Varian Medical Systems, Inc

tímto prohlašuje, že tento Radiolan je ve shodě

se základními požadavky a dalšími příslušnými ustanoveními směrnice

1999/5/ES.

Dansk [Danish]

Undertegnede

Varian Medical Systems, Inc. erklærer herved, at følgende

udstyr

Radiolan overholder de væsentlige krav og øvrige relevante krav i

direktiv 1999/5/EF.

Deutsch

[German]

Hiermit erklärt

Varian Medical Systems, Inc., dass sich das Gerät Radiolan

Übereinstimmung mit den grundlegenden Anforderungen und den übrigen

einschlägigen Bestimmungen der Richtlinie 1999/5/EG befindet.

Eesti [Estonian]

Käesolevaga kinnitab

Varian Medical Systems, Inc. seadme Radiolan

vastavust direktiivi 1999/5/EÜ põhinõuetele ja nimetatud direktiivist

tulene

vatele teistele asjakohastele sätetele.

English

Hereby,

Varian Medical Systems, Inc., declares that this Radiolan is in

compliance with the essential requirements and other relevant provisions of

Directive 1999/5/EC.

Español

[Spanish]

Por medio de la presente

Varian Medical Systems, Inc. declara que el

Radiolan

cumple con los requisitos esenciales y cualesquiera otras

disposiciones aplicables o exigibles de la Directiva 1999/5/CE.

Ελληνική

[Greek]

ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ

Varian Medical Systems, Inc. ΔΗΛΩΝΕΙ ΟΤΙ Radiolan

ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ

ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999/5/ΕΚ.

Français

[French]

Par la présente

Varian Medical Systems, Inc. déclare que l'appareil

Radiolan

est conforme aux exigences essentielles et aux autres dispositions

pertinentes de la directive 1999/5/CE.

Italiano [Italian]

Con la presente

Varian Medical Systems, Inc. dichiara che questo

Radiolan è

conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite

dalla direttiv

a 1999/5/CE.

Latviski

[Latvian]

Ar šo

Varian Medical Systems, Inc. deklarē, ka Radiolan atbilst Direktīvas

1999/5/EK būtiskajām prasībām un citiem ar to saistī

tajiem noteikumiem.

Lietuvių

[Lithuanian]

Šiuo

Varian Medical Systems, Inc. deklaruoja, kad šis Radiolan atitinka

esminius reikalavimus ir kitas 1999/5/EB Dir

ektyvos nuostatas.

Nederlands

[Dutch]

Hierbij verklaart

Varian Medical Systems, Inc. dat het toestel Radiolan in

overeenstemming is met de essentiële eisen en

de andere relevante

bepalingen van richtlijn 1999/5/EG.

Malti [Maltese]

Hawnhekk,

Varian Medical Systems, Inc., jiddikjara li dan Radiolan

jikkonforma mal

ħtiġijiet essenzjali u ma provvedimenti oħrajn relevanti

li hemm fid

-Dirrettiva 1999/5/EC.

Magyar

[Hungarian

]

Alulírott,

Varian Medical Systems, Inc. nyilatkozom, hogy a Radiolan

megfelel

a vonatkozó alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb

elõírásainak

Polski [Polish]

Niniejszym

Varian Medical Systems, Inc.

oświadcza, że Radiolan jest zgodny

z zasadniczymi wymogami oraz pozostałymi stosownymi postanowieniami

Dyrektywy 1999/5/EC.

Português

[Portuguese]

Varian Medi

cal Systems, Inc. declara que este Radiolan

está conforme com

os requisitos essenciais e outras disposições da Directiva 1999/5/CE.

Slovensko

[Slovenian]

Varia

n Medical Systems, Inc. izjavlja, da je ta Radiolan

v skladu z bistvenimi

zahtevami in ostalimi relevantnimi določili direktive 1999/5/ES.

Slovensky

[Slovak]

Varian Medical Systems, Inc

. týmto vyhlasuje, že Radiolan

spĺňa základné

požiadavky a všetky príslušné ustanovenia Smernice 1999/5/ES.

Suomi [Finnish]

Varian Medical Systems, Inc

. vakuuttaa täten että Radiolan t

yyppinen laite on

direktiivin 1999/5/EY oleellisten vaatimusten ja sitä koskevien direktiivin

muiden ehtojen mukainen.

Svenska

[Swedish]

Härmed intygar

Varian Medical Systems, Inc. att denna Radiolan står I

överensstämmelse med de väsentliga egenskapskrav och övriga relevanta

bestämmelser som framgår av direktiv 1999/5/EG.

Europe - Restrictions for Use of 2.4GHZ Frequencies in European Community.

België/

Belgique:

For private usage outside buildings across public grounds over less than 300m no special registration with IBPT/BIPT is

required. Registration to IBPT/BIPT is required for private usage outside buildings across public grounds over more

than

300m. For registration and license please contact IBPT/BIPT.

Voor privé-gebruik buiten gebouw over publieke groud over afstand kleiner dan 300m geen registratie bij BIPT/IBPT nodig;

voor gebruik over afstand groter dan 300m is wel registratie bij BIPT/IBPT nodig. Voor registratie of licentie kunt u contact

opnemen met BIPT.

Dans le cas d’une utilisation privée, à l’extérieur d’un bâtiment, au-dessus d’un espace public, aucun enregistrement n’est

nécessaire pour une distance de moins de 300m. Pour

une distance supérieure à 300m un enregistrement auprès de

I’IBPT est requise. Pour les enregistrements et licences, veuillez contacter I’IBPT.

Deutschland:

License required for outdoor installations. Check with reseller for procedure to follow

Anmeldung im Outdoor-Bereich notwendig, aber nicht genehmigungspflichtig.Bitte mit Händler die Vorgehensweise

abstimmen.

France:

Restricted frequency band: only channels 1 to 7 (2400 MHz and 2454 MHz respectively) may be used outdoors in France.

Bande de fréquence restreinte : seuls les canaux 1- 7 (2400 et 2454 MHz respectivement) doivent être utilisés endroits

extérieur en France. Vous pouvez contacter I’Autorité de Régulation des Télécommuniations (http://www.art-telecom.fr)

pour la procédure à suivre.

Italia:

License required for indoor use. Use with outdoor installations not allowed.

E’necessaria la concessione ministeriale anche per l’uso interno.

Verificare con i rivenditori la procedura da seguire.

Nederland

License required for outdoor installations. Check with reseller for procedure to follow.

Licentie verplicht voor gebruik met buitenantennes. Neem contact op met verkoper voor juiste procedure.

All EU

member states

and EFTA

countries

This device may only be used indoors in the frequency bands 5150 – 5250 MHz and 5250 – 5350 MHz.

To remain in conformance with European spectrum usage laws for Wireless LAN operation, the above

2.4GHz channel limitations apply for outdoor usage. The user should use the wireless LAN utility to

check the current channel of operation. If operation is occurring outside of the allowable frequencies for

outdoor use, as listed above, the user must contact the applicable national spectrum regulator to request a

license for outdoor operation.

Chapter 8

Maintenance

Cleaning and Disinfection

The flat panel receptor and connected cables are likely to be soiled during use. The specific material most

likely to become soiled is the X-ray grade carbon fiber input window and aluminum/magnesium housing.

Cleaning and disinfecting of the input window should be performed as needed. Wiping the surfaces with a

soft cloth dampened with soap and water will generally clean the surfaces.

Proper disinfection requires that a disinfectant solution be used; such as Sani-Cloth® Plus, a hospital grade,

EPA registered low to intermediate-level product for hard, non-porous surfaces and equipment. Use

disinfectants in accordance with the manufacturer’s instructions. Alternatively, the below chemical

cleaning solutions may also be used.

Cleaning and disinfecting of the battery and battery compartment should also be performed as needed

using the same practices described above. Care should be taken when cleaning the battery contacts, use a

non-abrasive cleaner that will not damage the copper contact material.

The battery charger can be cleaned with a wet cloth using one of the chemicals below. The battery charger

cannot be submerged any time during cleaning.

Chemical Cleaning Solutions Recommended:

● Isopropyl alcohol, 70% aqueous solution.

● Mild soap and water.

● Chlorine bleach, 3% aqueous solution. Do not clean electrical contacts or connector with bleach.

● Quaternary ammonium compounds, such as Steris “Coverage Plus NPD” (one part Coverage Plus NPD to

255 parts water).

● CAVI-Wipes. Use in accordance with the manufacturer’s instructions.

Caution:

Do not use flowing liquid or immersion on the receptor, battery, battery

compartment,

or battery charger.

Do not sterilize

Repairs

Note:

No user serviceable parts. If repairs are necessary, please see How To

Reach Us.

The least replaceable units (LRU) are:

x Receptor Assembly

x Back-up Cable

x Varian Battery

x Varian Battery Charger

Proper Disposal

The 4336Wv4 receptor should be returned to Varian Medical Systems for disposal. We request that you obtain

an RMA number using the same procedure for warranty/returns of products.

Contact: PAXSCAN.RMA@VARIAN.COM

Do not dispose of the lithium-ion rechargeable battery in the garbage. Please consult local governing

ordinances and recycling plans regarding proper disposal.

Warning:

Precautions should be taken to not open the receptor module.

Depending upon the type of scintillator used, opening the receptor

module may expose the user to potentially toxic materials

Chapter 9

Troubleshooting

Problem

Solution

Imager fails to respond.

1. Check wireless connection or cable connections.

Imager causes Electro-Magnetic

Interference

1. Reorient or relocate the receiving device.

Increase the separation between the equipment.

Connect the other device(s) into an outlet on a different circuit.

Consult the manufacturer or field service

technician for help.

Poor Image Quality.

1. Confirm that image corrections are all selected in the Systems

Settings dialog box in ViVA .

Re-acquire gain and offset images.

Assure that the exposures are appropriate for gain calibration

images (not saturated).

Software hangs up.

Restart ViVA.

Acquired image is completely

dark.

Increase the exposure and acquire a new image. If the image is still dark,

verify that all cables are properly connected. Turn the power “OFF” and

“ON”. Acquire a new image.

Out of virtual memory.

Close some of the windows that are currently open.

Residual x-ray image from

previous exposure shows in

current image.

Charge on the sensor pixels from a super saturated exposure may cause a

residual image. It can be erased by taking another image or multiple

images without X

-rays until the residual image is gone.

ViVA error message.

1. Please complete PaxScan 4336Wv4 Problem Report.

Email the error log file generated to:

paxscan.rma@varian.com. This log file is normally

found at C:\users\{username}\AppData\Local\crashdumps\

viva.log

Drop Receptor.

1. Remove battery from receptor and inspect for damage.

If the battery does not appear damage place into battery charger to

see if battery charger reports an error.

Inspect the receptor for any physical damage.

Insert a charged battery into the detector and see if it powers on.

Note: It is best to use a different battery than the one

that was in the receptor when it was dropped.

5. Generate a link to the workstation

6. Acquire an image fr

om the receptor and inspect for regions

of missing data.

For additional information on how to handle dropped receptor refer

to OEM System Service Manual

Chapter 10

PaxScan 4336Wv4 Problem Report Customer Information

Date:

Your Name

Company/Unit Name:

Email:

Phone Number:

Fax Number:

Product Information.

PaxScan Part Number: Imager Serial Number: Software Revision #:

Operation I was trying to perform (be as specific as possible:

What happened (use additional sheets as necessary):

E-mail: PAXSCAN.RMA@varian.com

Chapter 11

Appendix A

Battery Installation/Removal for 4336Wv4

Battery installation

Step

Action / Results

Insert battery at a slight angle so that the side with contacts sits over the adjoining contacts in the

battery compartment.

Press down on the lifted side of battery snapping it into place in the battery compartment. Receptor

is now ready for user.

Battery removal

Step

Action / Results

First ensure that the receptor is powered off. Then slide the battery latch release to the side,

which will cause one side of the battery to life out of the battery compartment.

Grab the lifted side of the battery and finish removing.

Battery Charger

The Varian 1 bay and 3-bay charger is intended for use with the Varian Lithium-ion Battery. The Varian

charger will fully charge a Varian battery in maximum 3 1/2 hours when operating at room temperature

(20º C Ambient) for the 2020mAh battery to 97% of available capacity in the battery. The charge time may

change depending on the battery cell temperature. The charger is used with the PaxScan wireless

radiographic digital image receptors.

Over-Discharged Battery Wake-up

The charger will wake up a battery that is in over-discharge protection mode.

Over-Charge Battery Protection

Over-charge due to excessive or uncontrolled current is prevented by redundant software functions

monitoring a minimum of two independent sources combined with an software independent method.

Over charge due to excessive or uncontrolled voltage is prevented through continual monitoring of two

independent measurement sources. The charger has charge timeout functionality.

Setting Up the Varian Charger

Step

Action / Results

The Varian Charger must be installed near the outlet to which it will be connected.

Do not block the charger’s ventilation slots underneath the charger.

Use the charger only with Varian batteries and the provided external power supply

To connect the charger to power:

x Plug the DC cable from the power supply into the charger

x Plug the AC cable into the power supply

x Plug the AC cable into the appropriate power outlet

The charger is now ready for use.

Battery charging using the stand alone 3-Bay Battery Charger

The Varian 3-bay charger requires

1. 24V DC, 3.3A max input.

2. The output of the charger is 16.8V DC, 1.5A max (+/1 1% and 10 Hz).

Step

Action / Results

Hold battery on end opposite of the contacts with the contacts facing toward the charger.

Gently slide battery into battery compartment on the charger. When properly inserted, a light

next to the battery slot will turn on showing the charge status of the battery. When the battery

is charging the light will be orange, when charging is complete the light will turn green and

when there is a fault the light will be red.

Charging a fully discharged battery will take 3.5 hours maximum and 2.5 hours typical when

operating at room temperature. Up to three batteries can be charged at a time. Refer to below

Figure B-1 for explanation of LED status indicators.

Figure A-1 3-Bay Battery Charger Status Indicators

Battery charging using the stand alone 1-Bay Battery Charger

The Varian 1-bay charger requires:

1. 19V DC, 2.1A max input.

2. The output of the charger is 16.8V DC, 1.4A max (+/-1% and 10 Hz).

Step

Action / Results

The Varian battery communicates with the Varian 1-bay charger when it is plugged into the

charger. The battery monitors its readiness state and is mechanically

keyed to charger for easy

installation.

The charger provides the following LED indicators to identify charge process and charge faults

(see below

Figure B-2).

x When all four (4) green LEDs are continuously illuminated (with the red LED

off), the battery has reached maximum charge. It can either be removed or left

in the charger to maintain full charge. Charging time typically is 2.5 hours,

maximum 3.5 hours.

Figure A-2 1-Bay Battery Charger Status Indicators

Warning:

Do not remove the charger cover. The Charger has no internal user

serviceable parts.

Warning:

Do not use in operating room or other oxygen rich environment.

Do not use in conjunction with flammable agents.

Do not use in an environment with condensing moisture.

Caution:

Do not use flowing liquid or immersion on the receptor, battery, battery

compartment, or battery charger.

Do not sterilize.

Caution:

Do not attempt to insert objects other than the Varian battery into the

charger bay.

Important:

Use the Varian Battery Charger only with the Varian supplied power

supply and power cord.

Important:

Use only the Varian supplied batteries in the battery charger and

receptor. The systems are not designed to work in conjunction with

any other battery type or design.

Varian Medical Systems X Ray RTL8812AU PaxScan 4336Wv4 Digital Image Recepter User Manual 4336Wv4 M01R1 0 Operating Instructions

Varian Medical Systems, Inc. X-Ray Products PaxScan 4336Wv4 Digital Image Recepter 4336Wv4 M01R1 0 Operating Instructions

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