GE SENOGRAPHE DMR+ User manual

GE Healthcare
Technical
Publications
5128706–1–100
Revision 1
SENOGRAPHE DMR+
pim
Pre–Installation Manual
do not duplicate
CopyrightE2006 by General Electric Co.

ATTENTION
LES APPAREILS À RAYONS X SONT DANGEREUX À LA FOIS POUR LE PATIENT ET POUR LE MANIPULATEUR
SI LES MESURES DE PROTECTION NE SONT PAS STRICTEMENT APPLIQUEES
Bien que cet appareil soit construit selon les normes de sécurité les plus sévères, la source de rayonnement X représente un danger
lorsquelemanipulateurestnonqualifiéounonaverti.UneexpositionexcessiveaurayonnementXentraînedesdommagesàl’organisme.
Par conséquent, toutes les précautions doivent être prises pour éviter que les personnes non autorisées ou non qualifiées utilisent cet
appareil créant ainsi un danger pour les autres et pour elles–mêmes.
Avant chaque manipulation, les personnes qualifiées et autorisées à se servir de cet appareil doivent se renseigner sur les mesures de
protection établies par la Commission Internationale de la Protection Radiologique, Annales 26 : Recommandations de la Commission
Internationale sur la Protection Radiologique et les normes nationales en vigueur.
WARNING
X–RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR
UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED
Though this equipment is built to the highest standards of electrical and mechanical safety, the useful x–ray beam becomes a source of
danger in the hands of the unauthorized or unqualified operator. Excessive exposure to x–radiation causes damage to human tissue.
Therefore,adequateprecautionsmustbetakentopreventunauthorizedorunqualifiedpersonsfromoperatingthisequipmentorexposing
themselves or others to its radiation.
Beforeoperation,personsqualifiedandauthorizedtooperatethisequipmentshouldbefamiliarwiththeRecommendationsoftheInterna-
tional Commission on Radiological Protection, contained in Annals Number 26 of the ICRP, and with applicable national standards.
ATENCION
LOS APARATOS DE RAYOS X SON PELIGROSOS PARA EL PACIENTE Y EL MANIPULADOR
CUANDO LAS NORMAS DE PROTECCION NO ESTAN OBSERVADAS
Aunqueesteaparatoestáconstruidosegúnlasnormasdeseguridadmásestrictas,laradiaciónXconstituyeunpeligroalsermanipulado
por personas no autorizadas o incompetentes. Una exposición excesiva a la radiación X puede causar daños al organismo.
Por consiguiente, se deberán tomar todas las precauciones necesarias para evitar que las personas incompetentes o no autorizadas
utilicen este aparato, lo que sería un peligro para los demás y para sí mismas.
Antes de efectuar las manipulaciones, las personas habilitadas y competentes en el uso de este aparato, deberán informarse sobre las
normas de protección fijadas por la Comisión Internacional de la Protección Radiológica, Anales No 26: Recomendaciónes de la Comi-
sión Internacional sobre la Protección Radiológica y normas nacionales.
ACHTUNG
RÖNTGENAPPARATE SIND EINE GEFAHR FÜR PATIENTEN SOWIE BEDIENUNGSPERSONAL,
WENN DIE GELTENDEN SICHERHEITSVORKEHRUNGEN NICHT GENAU BEACHTET WERDEN
Dieser Apparat entspricht in seiner Bauweise strengsten elektrischen und mechanischen Sichereitsnormen, doch in den Händen unbe-
fugter oder unqualifizierter Personen wird er zu einer Gefahrenquelle. Übermäßige Röntgenbestrahlung ist für den menschlichen Orga-
nismus schädlich.
Deswegen sind hinreichende Vorsichtsmaßnahmen erforderlich, um zu verhindern, daßunbefugte oder unqualifizierte Personen solche
Geräte bedienen oder sich selbst und andere Personen deren Bestrahlung aussetzen können.
VorInbetriebnahmediesesApparatssolltesichdasqualifizierteundbefugteBedienungspersonal mitden geltendenKriterien fürdenge-
fahrlosenStrahleneinsatzdurchsorgfältigesStudiumdesHeftsNr.26derInternationalenKommissionfürStrahlenschutz(ICRP)vertraut
machen: Empfehlungen der Internationalen Kommission für Strahlenschutz und anderer nationaler Normenbehörden.

GE Healthcare SENOGRAPHE DMR+
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i
TABLE OF CONTENTS
CHAPTER TITLE PAGE
                                                        
LIST OF EFFECTIVE PAGES v. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 INTRODUCTION 1–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 1
PURPOSE AND SCOPE OF THIS MANUAL 1–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 2
RESPONSIBILITY OF PURCHASER 1–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 3
PRODUCT IDENTIFICATION 1–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 ROOM REQUIREMENTS 2–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 1
ENVIRONMENTAL REQUIREMENTS/LIMITATIONS 2–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1–1 Room climate 2–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1–2 Equipment heat output 2–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 2
STRUCTURAL REQUIREMENTS 2–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2–1 Floor mounting 2–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2–2 Ceiling/Wall mounting 2–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2–3 Minimum room size 2–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 3
ELECTRICAL REQUIREMENTS 2–4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–1 Line voltage specifications 2–4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–2 Line frequency specifications 2–4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–3 kVA load characteristics 2–4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–4 Input impedance 2–4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–5 Line supply cable 2–5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–6 Main circuit breaker 2–5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–7 Room distribution 2–5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 4
IEC60601-1-2 ELECTROMAGNETIC STANDARDS COMPLIANCE 2–7. . . . . . . . . . . . . . . . . .
4–1 General 2–7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4–2 Electromagnetic Emission 2–7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4–3 Electromagnetic Immunity 2–8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4–4 Recommended Separation Distances for Portable and Mobile RF Communications
Equipment IEC 60601-1-2 2–10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

GE Healthcare SENOGRAPHE DMR+
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TABLE OF CONTENTS (CONT.)
CHAPTER TITLE PAGE
4–5 Use Limitation 2–10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4–6 Installation Requirements and Environmental Control 2–10. . . . . . . . . . . . . . . . . . . . . . . . . .
4–7 Stacked components & equipment 2–11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 5
INSITE CONNECTION 2–12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 PRODUCT PHYSICAL CHARACTERISTICS 3–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 1
DIMENSIONS 3–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 2
MOUNTING REQUIREMENTS 3–11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 3
NOISE 3–11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 4
RADIATION SHIELDING 3–11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 ADDITIONAL PLANNING AIDS 4–1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 1
PRODUCT SHIPPING INFORMATION 4–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 2
TOOLS AND TEST EQUIPMENT 4–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 3
INTERCONNECTIONS 4–3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

GE Healthcare SENOGRAPHE DMR+
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iii
INSTRUCTIONS CONCERNING SAFETY
X–RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND
OPERATOR UNLESS ESTABLISHEDSAFE EXPOSURE FACTORS ARE
STRICTLY OBSERVED
Though this apparatus is built to the highest standards of electrical and mechanical
safety, the useful x–ray beam becomes a source of danger in the hands of the
unauthorized and incompetent operator. Excessive exposure to x–radiation causes
damage to human tissue.
Therefore, adequate precaution shall be taken to make it impossible for
unauthorized and unqualified persons to operate this equipment or to expose
themselves or others to its radiation.
Before operation, those qualified and authorized to operate this apparatus should
become familiar with the established safe exposure factors by a careful study of the
International Commission of Radiological Protection (ICRP) Annals Number 26:
RecommendationsoftheInternationalCommissiononRadiologicalProtectionand
other national standard authorities.


GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
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GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
v
REVISION HISTORY
DATE REFERENCE REASON FOR CHANGE
November 29, 2004 5128706–100 rev. 1 New release based on document 2270822–100.
Added information on compliance with IEC 601–1–2 Edition 2
November 30, 2006 5128706–1–100 rev. 1 New release based on document 5128706–100.
Added information on compliance with CCC requirements for the
line supply cable in Chapter 2, Section 3.5
LIST OF EFFECTIVE PAGES
PAGE
NUMBER REVISION NUMBER PAGE NUMBER REVISION NUMBER PAGE NUMBER REVISION NUMBER
Title page
Safety Instruction 1
1
i thru vi 1
1–1 thru 1–6 1
2–1 thru 2–12 1
3–1 thru 3–12 1
4–1 thru 4–4 1

GE Healthcare SENOGRAPHE DMR+
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INTRODUCTION
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
1–1
CHAPTER 1 – INTRODUCTION

INTRODUCTION
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
1–2
ILLUSTRATION 1–1
SENOGRAPHE BASIC CONFIGURATION

 

INTRODUCTION
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
1–3
SECTION 1
PURPOSE AND SCOPE OF THIS MANUAL
This planning direction provides pre–installation data for the SENOGRAPHE DMR.
It considers only product related pre–installation.
SECTION 2
RESPONSIBILITY OF PURCHASER
SECTION 3
PRODUCT IDENTIFICATION
ComponentsoftheSENOGRAPHEDMR coveredbythispre–installation manualcomprise:
See Illustration 1–1.
DGANTRY (1)
DCONTROL CONSOLE (2)
DGENERATOR (3)
DRAD SHIELD (4)

INTRODUCTION
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
1–4
OPTIONAL EQUIPMENT
DStereotix 2.
DAccessory storage device.
D24 x 30 Bucky + COMPRESSION PADDLE.
DHydraulic chair.
DRad shield 2 or 3.
DDATAFLASH.

INTRODUCTION
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
1–5
 
 
PRODUCT COMPLIES WITH THE FOLLOWING REGULATIONS:
IEC601.2.7; UL187; CSA No. 22.114; CRF21 Part 1020.30; and NFC74100. IEC. 801.2; EN 61000–4–2
SENOGRAPHE DMR V2+
WITH XRAY PROTECTIVE SHIELD
X RAY PROTECTIVE 1 SHIELD
HYDRAULIC CHAIR
ACCESSORIES STORAGE DEVICE
XRAY REMOTE CONTROL
HANDSWITCH
24X30 BUCKY W/24X30
COMPRESSION PADDLE
SPOT ROUND COMPRESSION
PADDLE
BIOPSY OPTIC.LOCALISER
W/BIOPSY PADDLE
ADDITIONAL SET OF 14 MARKERS
(ENGLISH)
STEREOTIX 2 CDRH
DATAFLASH FOR SENO DMR V2+
END
OPTIONAL/ADDITIONALACCESSORIES:
ADDITIONAL 24X30 INJECTED COMPRESSION PADDLE
ADDITIONAL 18X24 INJECTED COMPRESSION PADDLE
ADDITIONAL SQUARE SPOT INJECTED COMPRES. PADDLE
ADDITIONAL MANUAL FILM MARKING DEVICE
20M LENGTH CABLE FOR DATAFLASH OPTION
CONSUMABLES:
PLASTIC FOR AXILARY COMPRESSION
PLASTIC FOR SPOT COMPRESSION PADDLE
BOX OF 10 GUIDES 0.9MM F/NEEDLE 0.8MM
BOX OF 10 GUIDES 1.0MM F/NEEDLE 0.9MM
BOX OF 10 GUIDES 1.2MM F/NEEDLE 1.1MM
BOX OF 10 GUIDES 1.3MM F/NEEDLE 1.2MM
BOX OF 10 GUIDES 1.4MM F/NEEDLE 1.3MM
BOX OF 10 GUIDES 1.8MM F/NEEDLE 1.6MM
BOX OF 10 GUIDES 2.25MM F/NEEDLE 2.0MM
ACCESSORIES
ONLY FOR USA

INTRODUCTION
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
1–6
Blank page.

ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–1
CHAPTER 2 – ROOM REQUIREMENTS
SECTION 1
ENVIRONMENTAL REQUIREMENTS/LIMITATIONS
1–1 Room climate
 
 
  
 
!"#$%& %'()*   !"#$%& %'()*  
       
    !

"!

 !

 !

# $

# $

1–2 Equipment heat output
IN OPERATION: 1.5 KW (4950 BTU/h) during 5 sec. max.
IN STAND–BY: 500 W (1650 BTU/h).

ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–2
%&
+ 



 0.50'
 3.94'
 10'
 1.97'

2' (min.)



0.50'
 10'

2' (min.)

2.14'
 11.5'

5'





 (10')






01'
 



ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–3
SECTION 2
STRUCTURAL REQUIREMENTS
   +    , , - . 
/
2–1 Floor mounting
The stand column is placed directly om‘n the floor. The floor must be stable and flat, and
sufficienntlystrongtoaccepttheweightandtheweight/areadefinedbelowwithoutdistortion
beyond the tolerance given:
Thefloorsurface must remainhorizontal and flatwithin ' $$ ()* $)+)* ,  
 - .+)* /+00+1 1. +2) 3104$
For the stand column only: three anchoring points (see Illustration 3–1, view A).
GEMS provides:
DThree screws 10 dia x 80 mm (25/64” dia x 35/32”) long. Maximum permissible
pull–strength on each bolt: 500 daN (1102 lbs).
Inserts for these three screws are supplied by GEMS for concrete slab only (see Illustration
3–1).
DThe finished floor of the exam room must be flat and within a good horizontal tolerance.
2–2 Ceiling/Wall mounting
None.
2–3 Minimum room size
See Illustration 2–1.
1. Generator.
2. Gantry (column).
3. Control console with rad shield screen.
4. Accessories storage device (option).
5. Wall duct (customer supply).
All interconnecting cables must be protected in a cable housing or ducting, except the
STEREOTIX positioner cable (which requires to be moved).
6. Power Distribution Board (supplied by Customer).
7. Phone outlet.


ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–4
SECTION 3
ELECTRICALREQUIREMENTS
3–1 Line voltage specifications
DSingle–phase input voltage:
 5655"565"  ,'-
3–2 Line frequency specifications
D50 or 60 Hz ('1 Hz).
3–3 kVA load characteristics
D8.5 kVA for exposures up to 4.5 s.
7.5 kVA during 10 s.
DPower factor: 0.61.
3–4 Input impedance
Line impedance at maximum workload: 3.5%.
Line impedances under single–phase installation:

07 +1+0 0) *)//+3) ,+818*)- 1. +2) 3*34+9

06 7 0) *)//+3) ):40)+ +1 09 *);43); +1 6  ,(4+ 10+<)-9
%7 0130 (4+ 10+<)
Rl380 = Rlx (380/U) 2
 =(30 04)> 06 v Ω+ ? $ 7 6 @
0 ONLYforGEMSE:theGenericEDMis associatedwithanexternalmodem(Motorola
3265) mounted on the EDM cabinet.
For GEMSA andGEMSAM theGenericEDM incorporatesamodem boardinsidethe
EDM cabinet. 2) 1(+10 A  / /4((0); +2*14<2 +2)
B? C <+*= ,1$0 10+<) 7   C!-

ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–5
3–5 Line supply cable
Thelinesupplycablecomprisesoftwosupplywiresandagroundcable(i.e.3xAWG10(5.32
mm2)) with the following actual/usable lengths:
 1+0 0)<+2 7  $ ,D-9
 %/E0) 0)<+2 7 F $ ,-
%&
  +
3–5–1 Obtaining a line supply cable
DFor customers in all countries except China, the optional line supply cable (S30331BC)
must be ordered from the Price Book so that it is supplied with the Senographe System.
DFor customers in China, the optional line supply cable from GEMS must not be ordered.
Instead Chinese customers must locally order an equivalent CCC-certified supply cable
from their local electrical supplier.
3–6 Main circuit breaker
0 ONLYforGEMSE:theGenericEDMis associatedwithanexternalmodem(Motorola
3265) mounted on the EDM cabinet.
For GEMSA andGEMSAM theGenericEDM incorporatesamodem boardinsidethe
EDM cabinet. 2) $ 3*34+ E*)@)* / /4((0); E= +2) 34/+1$)* ; $4/+ E)
/G);  331*;3) 8+2 0130 *)<40+1/
Circuit breakers sizes for European market:
 H*1$ 6  4( +1 " > 3*34+ E*)@)*>  7    $<)+3  7   '9
 H*1$   4( +1 " > 3*34+ E*)@)*>  7    $<)+3  7   '
Circuit breakers size and supply conductors for US market: refer to Section 517–71(a)
and Section 517–73(a) (Item 1, 2) of the NEC–1993 (see below).
 2) E*32 3*34+ 4/); $4/+ E) *+);   1* 0)//

ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–6
DNEC 1993 Section 517–73 (a) Item 1:
The ampacity of supply branch circuit conductors and the current rating of overcurrent
protectivedevicesshallnotbelessthan50percentofthemomentoryratingor100percent
of the long-time rating, whichever is greater.
DNEC 1993 Section 517–73 (a) Item 2:
The ampacity of supply feeders and the current rating of overcurrent protective devices
supplying two or more branch circuits supplying x-ray units shall not be less than 50
percent of the momentary demand rating of the largest unit plus 25 percent of the
momentary demand rating of the next largest unit plus 10 percent of the momentary
demand rating of each additional unit. Where simultaneous biplane examinations are
undertakenwiththex-rayunits,thesupplyconductorsandovercurrentprotectivedevices
shall be 100 percent of the momentary demand rating of each x-ray unit.
3–7 Room distribution
The senographe DMR provides a room distribution from the generator cabinet (using the
dedicated board 200PL4).
DSenographe ON lamp: relay rating is 8A @ 250V AC or 5A @ 30V DC
DX–Ray ON lamp: relay rating is 8A @ 250V AC or 5A @ 30V DC
DRoom door switch: relay coil must be supplied with 24V AC
0 ONLYforGEMSE:theGenericEDMis associatedwithanexternalmodem(Motorola
3265) mounted on the EDM cabinet.
For GEMSA andGEMSAM theGenericEDM incorporatesamodem boardinsidethe
EDM cabinet. 00 2*;8*) 14+/;) +2) <))*+1* 3E)+ /
34/+1$)*/4((0);2) 8*) (+2 /;) +2) <))*+1* / ;)+30 +1 +2) .));)*
8*) (+2