TRIXELL PIXIUMDS3543PR Docking Station User Manual 61676632 108 Ad1 Pixium 3543pR General caution

TRIXELL Docking Station 61676632 108 Ad1 Pixium 3543pR General caution

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PIXIUM 3543 pR

General caution and standard prescriptions

applying to system integration

This manual describes all caution and safety information for PIXIUM 3543 pR system integration.

It also provides information to satisfy standards agreements of detector integrated into a system.

It is intended for use by a system designer. Please read this manual carefully before performing,

designing or qualifying a system installation.

Document history

Version

Date Author Modification

- 16/01/2008 O.CHASTEL Création

Adraft1 24/01/08 O.CHASTEL Add requirements from R&TTE. Add remark on

water tightness. Update WiFi Indonesia and Taiwan

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Table of contents

GENERAL............................................................................................................................................................... 3

CAUTION AND SAFETY INFORMATIONS .................................................................................................... 3

2.1

EDICAL

.......................................................................................................................................................... 3

2.2

X-R

ADIATION

................................................................................................................................................... 3

2.3

ROTECTIVE

ARTH

(

) .................................................................................................................................. 4

2.4

LECTRO MAGNETIC COMPATIBILITY

(EMC) ................................................................................................... 8

2.4.1

Cables and connectors................................................................................................................................ 8

2.5

COMMUNICATION

........................................................................................................................................ 9

2.5.1

RF features.................................................................................................................................................. 9

2.5.2

RF specifications ........................................................................................................................................ 9

2.6

OWER SUPPLY

............................................................................................................................................... 11

2.7

SAPM

INSTALLATION

.................................................................................................................................... 12

2.8

ECHANICAL INSTALLATION

......................................................................................................................... 12

2.9

PERATION

.................................................................................................................................................... 14

2.10

VERHEATING PROTECTION

........................................................................................................................... 14

2.11

AINTENANCE

............................................................................................................................................... 14

2.12

THERS

.......................................................................................................................................................... 14

2.13

SER INFORMATION

................................................................................................................................ 15

STANDARDS........................................................................................................................................................ 17

3.1

IEC60601-1 / UL60601-1 / CAN/CSA C22.2

STANDARDS

........................................................................... 17

3.2

IEC/EN 60601-1-2

STANDARD

...................................................................................................................... 18

3.2.1

Performance ............................................................................................................................................. 18

3.2.2

Electromagnetic emissions ....................................................................................................................... 18

3.2.3

Electromagnetic immunity........................................................................................................................ 19

3.3

IEC60601-1-3

STANDARD

.............................................................................................................................. 21

3.4

IEC 60825-1 S

TANDARD

................................................................................................................................ 22

3.5

93-42-EEC

STANDARD

................................................................................................................................... 22

3.6

R&TTE

DIRECTIVE

........................................................................................................................................ 22

3.7

FCC

RULES

.................................................................................................................................................... 25

3.8

CANADA (IC) .............................................................................................................................................. 27

3.9

NCC (T

AIWAN

).............................................................................................................................................. 28

3.10

MIC (K

OREA

) ................................................................................................................................................ 29

3.11

USSIA

FAC (D

C) ....................................................................................................................................... 29

3.12

ANATEL (B

RAZIL

) ....................................................................................................................................... 29

3.13

MII

SRMC

(

CHINA

) .......................................................................................................................................... 30

3.14

DGPT

(

INDONESIA

).......................................................................................................................................... 30

3.15

ISO 10993

STANDARD

................................................................................................................................... 30

3.16

FDA: CFR21 §I –

PART

1020 ........................................................................................................................ 30

DISPOSAL............................................................................................................................................................. 32

4.1

ATTERY

........................................................................................................................................................ 32

4.2

RONT

, D

OCKING

TATION

, B

ACKUP CABLE AND

SAPM....................................................................... 32

4.3

RID

RAME

.................................................................................................................................................. 32

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1 GENERAL

The PIXIUM 3543 pR is part of a digital image acquisition chain in an overall Radiological

System. It includes a portable equipment (Front-End) designed for mobile applications.

The PIXIUM 3543 pR detector package is split into two devices: the “Detector Front-End”

(PIXIUM FE 3543 pR or “FE” herewith) and the “Docking Station” (PIXIUM DS 3543 pR or “DS”

herewith). The customer interface and the customer power supply are connected to the Docking

Station. The communication between FE and DS (both for data and control) are managed through a

WiFi link, or using an optional electric cable.

The PIXIUM FE 3543 pR is hand-held equipment.

2 CAUTION AND SAFETY INFORMATIONS

2.1 MEDICAL

Medical diagnostic radiology: The final destination of the PIXIUM 3543 pR is the medical

diagnostic radiology. This one must be carried out in presence of a qualified medical

personal. The possible clinical parameters are under the control of the system manufacturer.

Applied parts: PIXIUM 3543 pR Front-End has applied parts (there is direct contact between

the patient and the detector, except when it is mounted in a bucky table or a wall-stand

Radiological System..

Biocompatibility: The PIXIUM FE 3543 pR is design to be safe in case of short-term contact

with damaged skin (less than 1 hour). Nevertheless, if such case occurs, the FE will be

preferably wrapped with sterile plastic bag.

The detector is not a device delivered in a sterile state.

2.2 X-RADIATION

X-Ray source: The emission of the ionizing radiation is controlled by the system

manufacturer.

The PIXIUM 3543 pR is not designed to control the emitted X-ray dose.

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! ! ! CAUTION ! ! !

Whatever possibility is used, the X-ray Enable signal only indicates to the System that

the detector is ready to receive X-radiation. It is the System manufacturer responsibility

to control the actual emission of X-Radiation.

! ! ! ATTENTION ! ! !

Quel que soit le mode d’utilisation, le signal X-Ray Enable indique seulement au système

que le détecteur est prêt à recevoir le rayonnement X. Il est de la responsabilité du

constructeur du système de contrôler l’émission de rayonnement X.

System accompanying documents must indicate:

– Procedure for X-ray alignment measurement (system maintenance manual)

– Prohibition to order any radiation when a dysfunction is noticed by the operator, whatever

this dysfunction (system user manual)

Tolerance, selection and bending of the system must be in accordance with detector field

limitation requirements.

2.3 PROTECTIVE EARTH (PE)

PIXIUM 3543 pR participates in the earthing diagram of the Medical System. The detector is

provided with a protective earth terminal (specified bolt) located on the DS and on SAPM

devices. The FE does not contain any PE.

Safe design: The system-earthing diagram must be in accordance with PIXIUM 3543 pR

Electrical Interface Specification (galvanic separation of electrical circuits).

! ! ! CAUTION ! ! !

Connector and cable shields must not be used as protective earth connection. The

specified bolt must not be used for any other purpose than protective earth connection.

Removing this connection must need a service tool.

! ! ! ATTENTION ! ! !

Les connecteurs et les blindages des câbles ne doivent pas être utilisés pour la mise à la

terre du détecteur. Le goujon spécifique doit être utilisé exclusivement pour la mise à la

terre du détecteur. Le démontage de cette connexion doit nécessiter un outil.

System integration: System Design must be in accordance with insulation design of detector

given hereafter. Note that customers using their own battery-charging module (SAPM not

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their requirements. Nevertheless, they remain responsible for the complete earthing diagram.

The system manufacturer must take care of deported box or extension cable to stay compliant

with this insulation diagram.

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Host system

Docking Station

Front

End

+24V +19V

FreeScale

PC syst.

Ethernet link or other

<0.1Ω

ΩΩ

Ω

Electronic

SAPM in DS

CPT

<0.1Ω

ΩΩ

Ω

Ethernet

F2 F1

GND

+19V

GND

J’

CPT

<0.1Ω

ΩΩ

Ω

+19V

SAPM in WS or BT

Insulation

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Location

Dielectric

strength (UL

20.1 only)

Insulation

type Reference

voltage Air

clearance Creepage

distance Test

voltage Comments

B A-e DI 230 VAC 5 mm 8 mm 4000V Parasitic capacitance and

leakage impedance between

MAIN and 24V must

guarantee a maximum

leakage current of 10 µADC

and 100 µAAC

C A-b BI 24VDC+19VDC

1.2 mm 2.3 mm 500V Leakage impedance between

primary and secondary must

guarantee a maximum

leakage current of 10 µADC

D A-a1 BI 24 VDC 1 mm 2 mm 500V

E A-e DI 19 VDC 2 mm 4 mm 500V DI is also required between

+19V and +5V layout on DS

board

F - OP - - - NA

G - OP - - - NA

H A-e DI 19 VDC 2 mm 4 mm 500V

I A-b BI 24VDC+5VDC 1 mm 2 mm 500V Leakage impedance between

primary and secondary must

guarantee a maximum

leakage current of 10 µADC

J - OP - - - NA

J’ A-c DI 2.5 VDC 1.6 mm 3.4 mm 500V

L A-e DI 230 VAC 5 mm 8 mm 4000V

Q A-c DI 19 VDC 2 mm 4 mm 500V

R A-a1 BI 24 VDC 1 mm 2 mm 500V

S A-e DI 230 VAC 5 mm 8 mm 4000V

T A-e DI 19 VDC 2 mm 4 mm 500V WARNING : T is Double

Insulation

Notes:

1. On this diagram, only appear constraints on host system (written in blue)

2. F1 prevents DS against excessive temperatures in SFC.

3. F2 prevents FE and SAPM against excessive temperatures in SFC.

4. F3 prevents SAPM against excessive temperatures in SFC.

5. DS and SAPM are double isolated (either BI + earth or DI).

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6. SAPM’s power supply is not isolated

F1: UL Fast fuse of 4A rated current, blowing or tripping after maximum 50s for 250% of rated current, BUT

withstanding 250% of rated current during at least 0,5s.

F3: UL Fast fuse of 3A (TBC) rated current, blowing or tripping after maximum 50s for 250% of rated current,

BUT withstanding 250% of rated current during at least 0,5s.

2.4 ELECTRO MAGNETIC COMPATIBILITY (EMC)

Medical electrical equipment needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided in the

accompanying documents.

Radio frequency (RF) communications: Portable and mobile RF communications

equipment can affect medical electrical equipment. Because both of the FE and the DS

contain RF devices, system manufacturer must take care of interferences caused by the

PIXIUM 3543 pR.

WARNING: the use of accessories, transducers and cables other than those specified may

result in increased emissions or decreased immunity of the equipment.

AVERTISSEMENT : L’utilisation d’accessoires, de transducteurs et de câbles autres que

ceux spécifiés peuvent parasiter ou dégrader la protection de l’équipement.

WARNING: the detector should not be used adjacent to or stacked with other equipment and

if adjacent or stacked use is necessary, the operability of the detector must be tested in the

modified configuration.

AVERTISSEMENT : Le détecteur ne doit pas être utilisé posé ou adjacent à un autre

équipement. Dans le cas contraire, son fonctionnement doit être contrôlé dans la

configuration d’utilisation.

2.4.1 Cables and connectors

The system integrator must take care of the kind of cables used to connect the Pixium DS

3543 pR to the system:

• Power supply cable must be shielded. The shielding must be properly connected to the

DB15 connector metallic body in order to insure a good electrical connection between

cable shielding and Pixium DS 3543 pR housing.

• The Ethernet cable must be FTP or STP type, category 5 or above (5E or 6).

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2.5 RF COMMUNICATION

Since the FE can be used without any cable, it exchanges data (as commands, synchronization

images…) thanks to radio frequency modules which are able to operate in the ranges 2.412

GHz…2.484 GHz; 5.150 GHz…5.250 GHz or 5.470 GHz…5.825 GHz.

PIXIUM 3543 pR contains all allowed frequency ranges for each country in which the

PIXIUM 3543 pR is certified. It is the responsibility of the system manufacturer to be sure to

properly configure the PIXIUM 3543 pR with the correct code of the country and disable the

RF functions for countries where certification is not obtained.

The maximum emitting power can be set by the system. It the responsibility of the system

manufacturer to check the emitting power with respect to the maximum power allowed in the

corresponding country. TRIXELL recommends setting the nominal power to its strict

necessary minimum value (10 mW for the FE and 20 mW for the DS).

!!! CAUTION !!!

Avoid to place the PIXIUM FE 3543 pR or the PIXIUM DS 3543 pR too close to life-

supporting devices (see IEC60601-1-2 version 2001)

! ! ! ATTENTION ! ! !

Eviter de placer le PIXIUM FE 3543 pR ou la PIXIUM DS 3543 pR trop près d’appareils

de maintien de la(voir IEC60601-1-2 version 2001).

2.5.1 RF features

• Operate at ISM frequency bands (2.4GHz and 5GHz) with 54Mbps data rate

• IEEE standards compatible : IEEE 802.11a, IEEE 802.11b and IEEE 802.11g

• WPA2 coding supported

2.5.2 RF specifications

Main chipset

TBD

Functional specifications

Standard IEEE 802.11a; IEEE 802.11b; IEEE 802.11g

Data rate 802.11a: 9, 12, 18, 24, 36, 48, 54 Mbps

802.11b: 11, 5.5, 2, 1 Mbps;

The availability of some specific channels and/or operational frequency bands are country

dependent and are firmware programmed at the factory to match the intended destination.

The firmware setting is not accessible by the end user.

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802.11g: 11, 5.5, 2, 1 (DSSS/CCK); 6, 9, 12, 18, 24, 36, 48, 54 Mbps (OFDM)

Radio technology 802.11g: DSSS/CCK, OFDM

Modulation techniques OFDM/CCK

Network architecture Infrastructure mode (PIXIUM DS 3543 pR as Access Point)

Operating channels 802.11a:

4: (channels 34-46) – N. America

4: (channels 34-46) – Japan

15: (channels 36-48 / 100-140) –

Europe ETSI

5: (channels 149-165) – Taiwan

9: (channels 36-48 / 149-165) –

Australia

5: (channels 149-165) – China

4: (channels 36-48) – Korea

15: (channels 36-48 / 100-140) –

Russia

9: (channels 36-48 / 149-165) –

Mexico

15: (channels 36-48 / 100-140) –

Brazil

802.11b and 802.11g:

11: (channels 1-11) – N. America

14: (channels 1-14) – Japan

13: (channels 1-13) – Europe ETSI

11: (channels 1-11) – Taiwan

13: (channels 1-13) – Australia

13: (channels 1-13) – China

13: (channels 1-13) – Korea

13: (channels 1-13) – Russia

11: (channels 1-11) – Mexico

13: (channels 1-13) – Indonesia

13: (channels 1-13) – Brazil

Frequency range 802.11a:

5.150 ~ 5.250 GHz – N. America

5.150 ~ 5.250 GHz – Japan

5.150 ~ 5.250 GHz /

5.470 ~ 5.725 GHz – Europe ETSI

5.725 ~ 5.825 GHz – Taiwan

5.150 ~ 5.250 GHz /

5.725 ~ 5.825 GHz – Australia

5.725 ~ 5.825 GHz – China

5.150 ~ 5.250 GHz – Korea

5.150 ~ 5.250 GHz /

5.470 ~ 5.725 GHz – Russia

5.150 ~ 5.250 GHz /

5.725 ~ 5.825 GHz – Mexico

5.150 ~ 5.250 GHz /

5.470 ~ 5.725 GHz – Brazil

802.11b and 802.11g:

2.412 ~ 2.462 GHz – N. America

2.412 ~ 2.484 GHz – Japan

2.412 ~ 2.472 GHz – Europe ETSI

2.412 ~ 2.462 GHz – Taiwan

2.412 ~ 2.472 GHz – Australia

2.412 ~ 2.472 GHz – China

2.412 ~ 2.472 GHz – Korea

2.412 ~ 2.472 GHz – Russia

2.412 ~ 2.462 GHz – Mexico

2.412 ~ 2.472 GHz – Indonesia

2.412 ~ 2.472 GHz – Brazil

Transmit output power 802.11a:

• +17.5 dBm @ 6, 9, 12, 18,

24Mbps

802.11b:

• +17 dBm @ 1, 2, 5.5, 11Mbps

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• +16 dBm @ 36Mbps

• +14.5 dBm @ 48Mbps

• +13 dBm @ 54Mbps

802.11g:

• +16.5 dBm @ 6, 9, 12, 18,

24Mbps

• +16 dBm @ 36Mbps

• +14.5 dBm @ 48Mbps

• +13.5 dBm @ 54Mbps

Receiver sensitivity 802.11a:

• -87 dBm @ 6Mbps

• -67 dBm @ 54Mbps

802.11b:

• -94 dBm @ 1Mbps

• -87 dBm @ 11Mbps

802.11g:

• -87 dBm @ 6Mbps

• -70 dBm @ 54Mbps

Antenna type PIXIUM DS 3543 pR:

• Type: Patch antenna

• Number : 2

PIXIUM FE 3543 pR

• Type: 3D antenna

• Number: 2

Security WPA2 (can be disabled on request)

2.6 POWER SUPPLY

Power supply: The power supply of the PIXIUM 3543 pR is not carried out by MAINS, but

by Safety Extra Low Voltage source. The detector power supply must be used to power the

detector only.

!!! CAUTION !!!

Power supply polarity inversion or out of range power supply (including a missing

power supply) may harm the detector. Be sure to correctly connect and clamp the power

supply cable and the connector.

! ! ! ATTENTION ! ! !

Une inversion de polarité ou une alimentation hors gamme peut endommager le détecteur.

Vérifier le raccordement et la fixation des connecteurs.

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System integration: Power supply voltage must be checked continuously by the system.

Power supply connector pin-out: The power supply connector is located on the PIXIUM DS

3543 pR and the pin-out is given herebelow:

Pin #

Voltage

Description

1, 2, 3, 9,

10, 11

0 V 24V power supply GND. Isolated

from other PixBox local GND, and

from the connector shield.

6, 7, 8, 13,

14, 15

24 V 24V power output. The total current

shall not exceed 4A.

4, 5, 12

NC Reserved, do not connect.

9 15

The Docking Station power cable must be shielded for EMC purposes. The shield must be 360°

connected on the Docking Station connector. The shield must be connected to mechanical ground

on the Docking Station side. The connector type must be DB15 male connector.

2.7 SAPM INSTALLATION

In order to secure the tray opening of the SAPM, two switches are demanded to control the SAPM

module. For more information about electrical connection, please refer to SAPM module user

manual.

2.8 MECHANICAL INSTALLATION

Accessible parts: PIXIUM FE 5343 pR and PIXIUM DS 5343 pR devices (and the PIXIUM

SAPM 5343 pR if used by the system manufacturer) are considered as accessible part. They

do not need to be wrapped.

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Constraints: The detector is qualified to be subjected to variations of accelerations defined in

User Manual - environmental conditions section. The detector can’t be used with non-natural

variations of pressure.

Tightness: The detector is an ordinary equipment without protection against ingress of water.

Nevertheless, the PIXIUM FE 3543pR is specified IPX1 regarding the functionality and

image performance. However, any liquid flowing on the FE can be stuck behind the rim and

TRIXELL take no responsibility for any biological contamination risk.

Battery charging-module: A special care must be taken with the battery charging-module.

The system manufacturer must guarantee that no voltage appears on the pins when the FE is

not properly installed or the tray opened.

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2.9 OPERATION

When detector is powered, the system must check the result of the Pixium 3543 pR internal

self-tests.

During operation, Trixell recommends the system to check continuously:

– the header of every image sent by the detector,

– all internal voltages of the detector.

– if possible, the internal temperature

2.10 OVERHEATING PROTECTION

The battery pack includes a thermal protection that shuts down the battery power in case of

very high temperature causing the Front End unusable. Two situations can occur:

- Software protection: the battery pack will be usable as soon as the temperature drops

below a specified limit

- Hardware protection: the battery pack must be exchanged

2.11 MAINTENANCE

System maintenance manual must indicate:

– Inspection of the detector after a collision implying the detector,

–

Inspections during preventive maintenance,

– At least annual calibration of Detector front-end,

– Periodic control of detector performance (image quality) (acceptance and constancy

testing).

2.12 OTHERS

Toxic substances: PIXIUM 3543 pR contains Thallium-doped Cesium Iodide scintillator

material, and lead protection plates. TRIXELL ensures the recycling of the detector, so it

must be returned to TRIXELL when recycling is needed.

Hazard Analysis: TRIXELL provides to its customers a specific Hazard Analysis reference

61658545_530 (and the Risk Management Summary reference 61658546_530 associated)

linked to the use of the PIXIUM 3543 pR. Nevertheless, TRIXELL recommends to work out

an Hazard Analysis accounting the integration of the detector in the system, and to carry out

the qualification tests corresponding.

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2.13 END USER INFORMATION

The end users must be aware about several risks linked to the use of the PIXIUM 3543 pR.

The following information must be clearly indicated in the radiology system’s User Manual:

- In case of collision of the FE with a tough surface or in case of rough shock, a visual

inspection is required in order to detect any mechanical deformation. In such case, the use

of detector must be considered as hazardous and the detector must be send back to after

sale service for repair.

- The design of the PIXIUM 3543 pR is safe for patients wearing a pacemaker (according

to IEC45502-2-1) and for life supporting device (according to IEC 60601-1-2 edition 2

and above). Nevertheless, we expressly recommend the end users to connect the backup

cable and switch off the wireless function before using the PIXIUM 3543 pR.

- Because the FE is an handled-equipment, the end user must pay attention to avoid any

unwanted movement of the FE during the X-ray exposure that can cause blurred image.

- The image quality is specified for a tilt of 45° max with respect to the X-ray beam axis.

- Before taking any X-ray image, the end user must be sure to use the right FE (attached

with the right DS). A good practice consists into placing coloured labels on FE and DS.

- The end user must take care (for himself and for the patient) of avoiding to stumble on the

cable when the BUC is used. When not used, the BUC must be stored in the DS.

- The FE must be handled with care. In case of falling down on the foot of someone, the FE

can cause injuries to the person.

- The FE is designed to cope with mass up to 150 kg uniformly spread all over the top face

or 100 kg concentrated on a small surface (∅ 40 mm). A risk of patient’s injuries

(mechanical or electrical shock) or bad image quality can happen for heavier loads.

- The FE is designed to cope with falls up to 75 cm without any damage. In case of fall

above this height, the maintenance staff must check the internal shock sensor located into

the battery compartment. If turned to red, the use of detector must be considered as

hazardous and the detector must be send back to after sale service for repairing.

- The end user must be aware that the FE does not include any X-ray barrier protection. He

must not stay behind the FE without individual protection during the X-ray pulses.

- TRIXELL recommends wraping the FE with single use plastic bag in order to prevent

infection by virus or bacteria. If not possible, TRIXELL recommends to disinfect the FE

after each patient.

- TRIXELL recommends avoiding to used female DB15 connector and DB9 Phenix in the

neighborhood of the DS

- Since Pixium 3543 pR is running under Linux Operation System, the risk to be infected

by a virus is not negligible. A special care must be taken by integrator in order to avoid

any risk of virus infection.

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- In case of earthquake, Pixium DS 3543 pR and Pixium FE 3543 pR must be inspected

before being reused.

- If the DS is switched off and the FE is in the DS, the SAPM pins may be blocked outside:

the FE should be removed before switching off!

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3 STANDARDS

The detector is compliant with following standards. However, some items are considered as not

applicable to PIXIUM 3543 pR, and are listed hereafter for clarification purpose.

The compliance of the system requires checking some clauses at system level. These clauses are

noted: “Compliance ensured by system manufacturer if compliance is demanded at system level”.

3.1 IEC60601-1 / UL60601-1 / CAN/CSA C22.2 STANDARDS

Clause Title Compliance ensured by

3 to 59, except points below TRIXELL

6.3a Mains switch clearly identified System manufacturer, if compliance is demanded

at system level.

6.5a Protective earth conductor has

green/yellow insulation System manufacturer, if compliance is demanded

at system level.

6.7a Red indicator lights used

exclusively to indicate a warning

of danger and/or a need for

urgent action

System manufacturer, if compliance is demanded

at system level.

6.7b Color red used only for push-

button by witch a function is

interrupted in case of emergency

System manufacturer, if compliance is demanded

at system level.

6.8.3b Required type and rating of fuses

utilized in the mains supply

circuit external to permanently

installed equipment

System manufacturer: mains supply external circuit

request 4 A fuse or polyswitch.

20 Dielectric strength System manufacturer: schematic insulation

diagram recommended by TRIXELL in general

caution (this document, see §2.3).

24.1 Equipment does not overbalance

during normal use when tilted

through an angle of 10°

System manufacturer: equipment is component

fixed into system.

57.2 Power cord mains plug is

“Hospital Grade” type System manufacturer, if compliance is demanded

at system level.

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3.2 IEC/EN 60601-1-2 STANDARD

3.2.1 Performance

The essential performances of the PIXIUM 3543 pR detector with regard to EMC are:

• Software robustness

• Robustness of the communication link with the system

• No image lost

• Artifacts on the image (correlated noise level).

3.2.2 Electromagnetic emissions

With respect to IEC 60601-1-2, the PIXIUM 3543 pR is intended for use in the electromagnetic

environment specified below. The customer or the user of the PIXIUM 3543 pR should assure that

it is used in such environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11 Group 1 The PIXIUM 3543 pR 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 B

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations /

flicker emissions

IEC 61000-3-3

System

manufacturer, if

compliance is

demanded at

system level

The PIXIUM 3543 pR is suitable for use in all

establishments, other than domestic

establishments and those directly connected to the

public low voltage power supply network that

supplies buildings used for domestic purposes.

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3.2.3 Electromagnetic immunity

With respect to IEC 60601-1-2, the PIXIUM 3543 pR is intended for use in the electromagnetic

environment specified below. The customer or the user of the PIXIUM 3543 pR should assure that

it is used in such 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

Not applicable

Floors should be wood,

concrete or ceramic tile. If

floors are covered with

synthetic materials, the

relative humidity should be

at least 30 %.

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

80 MHz to 1 GHz

3 V/m

80 MHz to 2.5 GHz

80 MHz to 1 GHz

TRIXELL

Interference may occur in

the vicinity of equipment

marked with the following

symbol:

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

Not applicable

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.

Conducted RF

IEC 61000-4-6

3 VRMS

150 kHz to 80 MHz

3 VRMS

150 kHz to 80 MHz

TRIXELL

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Immunity test IEC 60601 test level

Compliance level Electromagnetic

environment - guidance

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical

commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

< 5 % UT (> 95 %

dip in UT) for 0.5

cycle

40 % UT (60 % dip in

UT) for 5 cycles

70 % UT (30 % dip in

UT) for 25 cycles

< 5% UT (> 95 % dip

in UT) for 5 sec

System

manufacturer, if

compliance is

demanded at system

level

Mains power quality should

that of a typical commercial

or hospital environment.

If the user of the PIXIUM

3543 pR requires continued

operation during power

mains interruptions, it is

recommended that the

PIXIUM 3543 pR be

powered from an

uninterruptible power

supply or battery.

NOTE: UT is the a.c. mains voltage prior to application of the test level

GSM modulation

ENV 50204

3 V/m

900 MHz modulated

@ 200 Hz (square

signal)

3 V/m

900 MHz modulated

@ 200 Hz (square

signal)

TRIXELL

Interference may occur in

the vicinity of equipment

marked with the following

symbol:

NOTE 1: These guidelines might not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

NOTE 2: It is essential that the actual shielding effectiveness and filter attenuation of the shielded

location is verified to assure that they meet the minimum specification

NOTE 3: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)

telephones and land mobile radios, amateur radio, AM and FM radiobroadcast 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 abnormal

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performance is observed, additional measures may be necessary, such as relocating PIXIUM 3543

pR or using a shielded location with a higher RF shielding effectiveness and filter attenuation

3.3 IEC60601-1-3 STANDARD

Clause Title Compliance ensured by

SECTION I – GENERAL -

4. General prescriptions relating to

tests System manufacturer, if compliance is demanded

at system level

6. Identification, marking and

documentation System manufacturer, if compliance is demanded

at system level

6.1 Marking on the outside of the

equipment or parts of equipment -

6.1.201 Prescription of marking in the

paragraphs System manufacturer, if compliance is demanded

at system level

6.1.202 General prescriptions TRIXELL

6.8 Accompanying documents -

6.8.201 References in the paragraphs System manufacturer, if compliance is demanded

at system level

6.8.202 General requirements TRIXELL

SECTION V -

29.201 Radiation quality System manufacturer, if compliance is demanded

at system level

29.202 Limitation and indication of the

X-Ray beam area System manufacturer, if compliance is demanded

at system level

29.203 Relation between X-Ray field

and the image reception area System manufacturer, if compliance is demanded

at system level

29.204 Leakage radiation Not applicable.

29.205 Outdistance between radiation

source and skin System manufacturer, if compliance is demanded

at system level

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Clause Title Compliance ensured by

29.206 Attenuation of the X-ray beam Not applicable.

29.207 Primary protective shielding A lead protective shielding in the FE only protects

the electronic components against excessive X-ray

beam. As consequence, it’s the responsibility of the

system manufacturer to check the compliance with

this clause.

29.208 Protection against stray radiation

System manufacturer, if compliance is demanded

at system level

3.4 IEC 60825-1 STANDARD

Laser classification: PIXIUM 3543 pR is classified Class I equipment, and includes a Class I

laser product with invisible LED radiation in the DS.

3.5 93-42-EEC STANDARD

Clause Title Compliance ensure by

1 to 13 - TRIXELL

Annexe X

General provisions and clinical

investigations Compliance with the essential requirements is not

based on the clinical data. The clinical

investigations are applicable at the complete

medical device, and are under responsibility of the

system manufacturer

3.6 R&TTE DIRECTIVE

The Pxium 3543 pR is certified to be used in the following European countries:

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Albania (AL)

Andorra (AD)

Austria (AT)

Azerbaijian

(AZ)

Belarus (BY)

Belgium (BE)

Bosnia and

Herzegovina

(BA)

Bulgaria (BG)

Croatia (HR)

Cyprus (CY)

Czech

Republic

(CZ)

Denmark

(DK)

Estonia (EE)

Finland (FI)

France (FR)

Germany

(DE)

Greece (GR)

Hungary

(HU)

Iceland (IS)

Ireland (IE)

Italy (IT)

Latvia (LV)

Liechtenstein

(LI)

Lithuania

(LT)

Luxembourg

(LU)

Malta (MT)

Moldova

(MD)

Monaco (MC)

Netherlands

(NL)

Norway (NO)

Poland (PL)

Portugal (PT)

Roumania

(RO)

Russian

Federation

(RU)

San Marino

(SM)

Serbia and

Montenegro

(CS)

Slovakia(SK)

Slovenia (SI)

Spain (ES)

Sweden (SE)

Switzerland

(CH)

The former

Yugoslav

Republic of

Macedonia

(MK)

Turkey (TR)

Ukraine (UA)

United

Kingdom

(GB)

Vatican (VA)

Regulatory Statement:

Operation of this device is subjected to the following National regulations and may be prohibited to

use if certain restriction should be applied.

English:

Hereby, TRIXELL, declares that these PIXIUM FE 3543 pR / PIXIUM DS 3543 pR are in

compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

Finnish:

TRIXELL vakuuttaa täten että PIXIUM FE 3543 pR / PIXIUM DS 3543 pR tyyppinen laite on

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

mukainen.

Dutch:

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Hierbij verklaart TRIXELL dat het toestel PIXIUM FE 3543 pR / PIXIUM DS 3543 pR in

overeenstemming is met de essentiële eisen en de andere relevante bepalingen van richtlijn

1999/5/EG

Bij deze verklaart TRIXELL dat deze PIXIUM FE 3543 pR / PIXIUM DS 3543 pR voldoet aan de

essentiële eisen en aan de overige relevante bepalingen van Richtlijn 1999/5/EC.

French:

Par la présente TRIXELL déclare que les appareils PIXIUM FE 3543 pR / PIXIUM DS 3543 pR sont

conformes aux exigences essentielles et aux autres dispositions pertinentes de la directive

1999/5/CE

Par la présente, TRIXELL déclare que ces PIXIUM FE 3543 pR / PIXIUM DS 3543 pR sont

conformes aux exigences essentielles et aux autres dispositions de la directive 1999/5/CE qui lui

sont applicables

Outdoor use limited to 10mW e.i.r.p. within the band 2454 – 2483.5 MHz. Derogation in French

overseas departments of Guyane and La Reunion: outdoor use not allowed in band 2400 - 2420

MHz.

Swedish:

Härmed intygar TRIXELL att denna PIXIUM FE 3543 pR / PIXIUM DS 3543 pR står I

överensstämmelse med de väsentliga egenskapskrav och övriga relevanta bestämmelser som

framgår av direktiv 1999/5/EG.

Danish:

Undertegnede TRIXELL erklærer herved, at følgende udstyr PIXIUM FE 3543 pR / PIXIUM DS

3543 pR overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF

German:

Hiermit erklärt TRIXELL, dass sich PIXIUM FE 3543 pR / PIXIUM DS 3543 pR in

Übereinstimmung mit den grundlegenden Anforderungen und den anderen relevanten Vorschriften

der Richtlinie 1999/5/EG befindet". (BMWi)

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Hiermit erklärt TRIXELL die Übereinstimmung des Gerätes PIXIUM FE 3543 pR / PIXIUM DS

3543 pR mit den grundlegenden Anforderungen und den anderen relevanten Festlegungen der

Richtlinie 1999/5/EG. (Wien)

Greek:

ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ

TRIXELL

∆ΗΛΩΝΕΙ ΟΤΙ

PIXIUM FE 3543 pR / PIXIUM DS 3543 pR

ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩ∆ΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ∆ΙΑΤΑΞΕΙΣ ΤΗΣ

Ο∆ΗΓΙΑΣ 1999/5/ΕΚ

Italian:

Con la presente TRIXELL dichiara che questo PIXIUM FE 3543 pR / PIXIUM DS 3543 pR è

conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva

1999/5/CE.

Spanish:

Por medio de la presente TRIXELL declara que los PIXIUM FE 3543 pR / PIXIUM DS 3543 pR

cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la

Directiva 1999/5/CE

Portuguese:

TRIXELL declara que este PIXIUM FE 3543 pR / PIXIUM DS 3543 pR está conforme com os

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

3.7 FCC RULES

This device complies with Part 15 of the FCC 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.

Federal Communications Commission (FCC) Requirements, Part 15:

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This equipment has been tested and found to comply with the limits for a class B digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection

against harmful interference in a residential installation.

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

in accordance with the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. 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:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

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

Regulatory Information/Disclaimers:

Installation and use of this Wireless LAN device must be in strict accordance with the instructions

included in the user documentation provided with the product. Any changes or modifications

(including the antennas) made to this device that are not expressly approved by the manufacturer

may void the user’s authority to operate the equipment. The manufacturer is not responsible for any

radio or television interference caused by unauthorized modification of this device, or the

substitution of the connecting cables and equipment other than manufacturer specified. It is the

responsibility of the user to correct any interference caused by such unauthorized modification,

substitution or attachment. Manufacturer and its authorized resellers or distributors will assume no

liability for any damage or violation of government regulations arising from failing to comply with

these guidelines.

IMPORTANT NOTE:

FCC Radiation Exposure Statement:

The PIXIUM DS 3543 pR equipment complies with FCC radiation exposure limits set forth for an

uncontrolled environment. This equipment should be installed and operated with minimum distance

20cm between the radiator & your body.

This transmitter must not be co-located or operating in conjunction with any other antenna or

transmitter.

The PIXIUM FE 3543 pR equipment complies with FCC radiation exposure limits set forth for an

uncontrolled environment. End users must follow the specific operating instructions for satisfying

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RF exposure compliance. To maintain compliance with FCC RF exposure compliance

requirements, please follow operation instruction as documented in this manual.

This transmitter must not be co-located or operating in conjunction with any other antenna or

transmitter.

Caution:

1. For operation within 5.15 ~ 5.25GHz frequency range, it is restricted to indoor environment.

2. The availability of some specific channels and/or operational frequency bands are country

dependent and are firmware programmed at the factory to match the intended destination.

The firmware setting is not accessible by the end user.

3.8 CANADA (IC)

Industry Canada statement

This device complies with RSS-210 of the Industry Canada Rules. Operation is subject to the

following two conditions: (1) This device may not cause harmful interference, and (2) this device

must accept any interference received, including interference that may cause undesired operation.

IMPORTANT NOTE:

IC Radiation Exposure Statement:

The PIXIUM FE 3543 pR equipment complies with IC radiation exposure limits set forth for an

uncontrolled environment. This equipment should be installed and operated with minimum distance

20cm between the radiator & your body.

The PIXIUM FE 3543 pR equipment complies with IC radiation exposure limits set forth for an

uncontrolled environment. End users must follow the specific operating instructions for satisfying

RF exposure compliance. To maintain compliance with IC RF exposure compliance requirements,

please follow operation instruction as documented in this manual.

Caution:

The device for the band 5150-5250 MHz is only for indoor usage to reduce potential for harmful

interference to co-channel mobile satellite systems.

High power radars are allocated as primary users (meaning they have priority) of 5250-5350 MHz

and 5650-5850 MHz and these radars could cause interference and/or damage to LE-LAN devices.

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3.9 NCC (TAIWAN)

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3.10 MIC (KOREA)

PIXIUM FE 3543 pR / PIXIUM DS 3543 pR contain Korea MIC approved wireless mini-PCI

module, with MIC ID: TXL-CM10

3.11 RUSSIA FAC (DOC)

Подтверждение соответствия Мининформсвязи России:

Декларация соответствия № Д-ТП-xxxx от dd.mm.yyyy года, действительна до dd.mm.yyyy

года, зарегистрирована в Федеральном агенстве связи dd.mm.yyyy года

3.12 ANATEL (BRAZIL)

Este equipamento PIXIUM FE 3543 pR / PIXIUM DS 3543 pR opera em caráter secundário, isto é,

não tem direito a proteção contra interferência prejudicial, mesmo de estações do mesmo tipo,e não

causar interferência a sistema operando em caráter primário.

PIXIUM FE 3543 pR / PIXIUM DS 3543 pR contain Brazil ANATEL approved wireless mini-PCI

module.

TXL-CM10

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3.13 MII-SRMC (CHINA)

PIXIUM FE 3543 pR / PIXIUM DS 3543 pR contain China MII-SRMC approved wireless mini-PCI

module, with MII ID: CM10

3.14 DGPT (INDONESIA)

PIXIUM FE 3543 pR / PIXIUM DS 3543 pR contain DGPT approved wireless mini-PCI module.

3.15 ISO 10993 STANDARD

TBD

3.16 FDA: CFR21 §I – PART 1020

Clause Title Compliance ensured by

1020 Performance standards for ionizing radiation emitting products

1020.10 Television receivers Not applicable

1020.20 Cold-cathode gas discharge Not applicable

1020.30 Diagnostic X-ray systems and their major components

a) Applicability TRIXELL

b) Definitions TRIXELL

c) Manufacturer’s responsibility System manufacturer, if compliance is demanded

at system level.

06137/POSTEL/2008

2510

FID / Document identification

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CONFIDENTIEL TRIXELL

Ils ne peuvent être reproduits ou divulgués sous quelque forme que ce soit sans l’accord préalable écrit de TRIXELL.

TRIXELL PROPRIETARY INFORMATION

property. Any copy and/or disclosure thereof in any form whatsoever are subject to TRIXELL’s prior written consent.

Clause Title Compliance ensured by

d) Assembler’s responsibility System manufacturer, if compliance is demanded

at system level.

e) Identification of X-ray

components System manufacturer, if compliance is demanded

at system level.

f) [Reserved] -

g) Information to be provided to

assembler TRIXELL

h) Information to be provided to

users System manufacturer

i) [Reserved] -

j) Warning label System manufacturer, if compliance is demanded

at system level.

k) Leakage radiation from the

diagnostic source assembly System manufacturer, if compliance is demanded

at system level.

l) Radiation from components

other than the diagnostic source

assembly

Not applicable to PIXIUM 3543 pR.

m) Beam quality System manufacturer, if compliance is demanded

at system level.

n) Aluminum equivalent of

material between patient and

image receptor

Not applicable.

o) Battery charge indicator Not applicable.

p) [Reserved] -

q) Modification of certified

diagnostic X-ray components and

systems

System manufacturer, if compliance is demanded

at system level.

1020.31 Radiographic equipment System manufacturer, if compliance is demanded

at system level.

1020.32 Fluoroscopic equipment Not applicable

1020.33 Computed tomography (CT)

equipment Not applicable

1020.40 Cabinet X-ray systems Not applicable

FID / Document identification

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CONFIDENTIEL TRIXELL

Ils ne peuvent être reproduits ou divulgués sous quelque forme que ce soit sans l’accord préalable écrit de TRIXELL.

TRIXELL PROPRIETARY INFORMATION

property. Any copy and/or disclosure thereof in any form whatsoever are subject to TRIXELL’s prior written consent.

4 DISPOSAL

4.1 BATTERY

The end user must be clearly informed that batteries (Pixium BT 3543 pR) used in the Pixium FE

3543 pR contain hazardous substances for the environment and must take all preventive actions to

manage the battery end of life (recycling plan).

4.2 FRONT END, DOCKING STATION, BACKUP CABLE AND SAPM

Trxiell is in charge of the recycling of the Front End (Pixium FE 3543 pR), the Docking Station

(Pxium DS 3543 pR), the Backup cable (Pixium BC 3543 pR) and the SAPM module (Pixium SM

3543 pR). Trixell’s customers are in charge of managing the way to collect these products (at the

end of their life) and ship them to Trixell for recycling.

4.3 GRID FRAME

Since the grid frame provided by Trixell does not contain the most polluting part (which is the anti-

scattering grid), it is under the responsibility of Trixell’s customers to manage the recycling of this

part.

END OF DOCUMENT

TRIXELL PIXIUMDS3543PR Docking Station User Manual 61676632 108 Ad1 Pixium 3543pR General caution

TRIXELL Docking Station 61676632 108 Ad1 Pixium 3543pR General caution

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