SenoRx CM 3000 Control Module

Operator’s Manual

IU0030E
November 2005
INTRODUCTION............................................................................................................. 3

Intended Use ............................................................................................................. 3

Contraindications ..................................................................................................... 3

CM 3000 System........................................................................................................ 3

UNPACKING INSTRUCTIONS....................................................................................... 4

Unpacking.................................................................................................................. 4

Inspection .................................................................................................................. 5

WARNINGS AND PRECAUTIONS ................................................................................ 6

Warnings.................................................................................................................... 6

Mises en garde .......................................................................................................... 7

Precautions ............................................................................................................... 8

SYMBOL DEFINITIONS ................................................................................................. 9

SCREEN DESCRIPTIONS ........................................................................................... 12

Startup Screen ........................................................................................................ 12

Language Screen .................................................................................................... 12

Connect Device Screen .......................................................................................... 12

Intensity Adjust ....................................................................................................... 13

Audio Adjust............................................................................................................ 13

Device Detected ...................................................................................................... 13

Alarm – General ...................................................................................................... 13

INSTALLATION INSTRUCTIONS ................................................................................ 14

Front Panel Display and Controls ......................................................................... 14

Rear Panel Connections and Controls.................................................................. 15

1
REAR PANEL TEXT..................................................................................................... 16

Rear Panel Symbols ............................................................................................... 17

ENVIRONMENTAL CONDITIONS ............................................................................... 18

OPERATING INSTRUCTIONS ..................................................................................... 19

General Information and Application .................................................................... 19

SenoRx Device Connection ................................................................................... 24

Accessing the Language Screen........................................................................... 24

Alarm Conditions and Troubleshooting................................................................ 24

CLEANING AND DISINFECTING ................................................................................ 26

Cleaning Recommendations.................................................................................. 26

Disposal of Equipment ........................................................................................... 26

ROUTINE MAINTENANCE........................................................................................... 27

Fuse Replacement .................................................................................................. 27

WARRANTY ................................................................................................................. 28

SENORX CONTACT INFORMATION .......................................................................... 31

2
INTRODUCTION
Intended Use
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE
BY OR ON THE ORDER OF A PHYSICIAN.
The SenoRx CM 3000 Control Module is designed to provide control operations for
specialized SenoRx surgical devices.

The CM 3000 provides interface between SenoRx surgical devices and accessory
equipment, such as the SenoRx VS 2000 and VS 3000 Vacuum Systems, and the
SenoRx ES 300, ES 2000 and ES 3000 Electrosurgical Generators.

The CM 3000 is intended for use in conjunction with specific SenoRx Generators for
general surgical procedures where electrosurgical cutting or coagulation of soft tissue is
required.

Note: Read the instructions, cautions, and warnings provided with the SenoRx
Generators and Electrosurgical Disposable Accessories before use.

Contraindications
Contraindicated for use under conditions where electrosurgery is contraindicated.

CM 3000 System
The CM 3000 system includes:

ƒ Control Module – SenoRx Catalog No. CM 3000

ƒ User Manual – SenoRx No. IU0030

SenoRx Electrosurgical Accessories are available under separate catalog numbers.

3
UNPACKING INSTRUCTIONS
Unpacking
Using Figure 1A below as a guide, carefully unpack the CM 3000 Control Module.
Retain the packing list and save all packing material in case of shipping damage.

Fig. 1A

CM 3000 carton contents shown in Figure 1A:

1. Carton
2. Bottom Insert
3. CM 3000 Control Module
4. Top Insert
5. CM 3000 Instructions for Use

CM 3000 Basic System:

9 One Control Module – SenoRx Cat. No. CM 3000

9 One User Manual – SenoRx No. IU0030

4
Accessories:

9 One detachable AC Power Cord – SenoRx Cat. No. PC3100

9 One 12” AC Power Jumper Cord – SenoRx Cat. No. PC3150-001
9 One 18” AC Power Jumper Cord – SenoRx Cat. No. PC3150-002 for use with
SenoRx Cart
9 One 53” AC Power Jumper Cord – SenoRx Cat. No. PC3150-003 for use with
SenoRx Cart
9 One Generator Cable – SenoRx Cat. No. CB3000
9 One Footswitch – SenoRx Cat. No. FS3000
9 One CM 3000 to VS 3000 Cable – SenoRx Cat. No. CB3100
9 One SenoRx Vacuum System – SenoRx Cat. No. VS 3000
9 One SenoRx Cart – SenoRx Cat. No. CART01

Note: Cables and accessories are packaged separately from the CM 3000.

Inspection
Thoroughly inspect the packaging materials and the CM 3000 for any signs of transit
damage. Do not use the unit if it appears to have any damage. Call SenoRx Customer
Service at 877-210-1300 for instructions on how to report shipping damage.

5
WARNINGS AND PRECAUTIONS

Warnings
Warning: The SenoRx CM 3000 Control Module must be properly grounded to ensure
patient safety, and is supplied with a medical grade power cord with AC plug. Do not
connect the power cord to extension cords or three-prong to two-prong adapters.

Warning: To minimize interference with other equipment, leads or cables should be

positioned to prevent contact with other leads.

Warning: Electrodes and probes of monitoring, stimulating, and imaging devices can
provide paths for high-frequency currents even if they are battery-powered, insulated, or
isolated at 60 Hertz (Hz). The risk of burns can be reduced but not eliminated by
placing the electrodes or probes as far away as possible from the electrosurgical site
and from the dispersive electrode. Protective impedances incorporated into the
monitoring leads may further reduce the risk of these burns. Needle electrodes should
not be used for monitoring unless no other alternatives are available. If needle
electrodes must be used, whenever possible, disconnect the needle electrode
monitoring cables from the monitor during activation of the electrosurgical unit to avoid
the risk of patient burns.

Warning: Only SenoRx accessories can be used with the SenoRx CM 3000 Control
Module. Potentially hazardous conditions may exist if non-SenoRx accessories are
used.

Warning: Any time the SenoRx CM 3000 Control Module is powered on, or a Device is
connected to the CM 3000 while the SenoRx Electrosurgical Generator is powered on,
depressing the Footswitch may generate RF power.

Warning: Do not remove cover. Removing cover may cause electrical shock. Contact
SenoRx for service.

Warning: In service or operation area – sound levels for generated tones are to be
measured when standing in front of the Control Module enclosure.

6
Mises en garde

Mise en garde : Le module de commande SenoRx CM 3000 doit être correctement mis
à la terre afin d'assurer la sécurité du patient. Il est livré avec un cordon d'alimentation
de qualité médicale équipé d'une fiche secteur alternatif. Ne pas raccorder le cordon
d'alimentation à des prolongateurs ou à des adaptateurs tripolaires/bipolaires.

Mise en garde : Afin de réduire les interférences avec d'autres appareils, placer les
cordons et câbles de façon à éviter le contact avec les autres conducteurs.

Mise en garde : Les électrodes et sondes des appareils de surveillance, de stimulation

et d'imagerie peuvent offrir des chemins aux courants à haute fréquence, même si ces
appareils sont alimentés par des batteries ou des piles, isolés ou découplés à 60 hertz
(Hz). Pour réduire le risque de brûlure, sans que cela permette de l'éliminer, placer les
électrodes ou les sondes le plus loin possible du site d'électrochirurgie et de l'électrode
de référence. L'utilisation d'impédances de protection intégrées aux fils de sortie de
surveillance peut également aider à réduire le risque de telles brûlures. N'utiliser des
électrodes-aiguilles pour la surveillance que s'il n'y a aucune autre solution. S'il faut
utiliser des électrodes-aiguilles, débrancher si possible leurs câbles du moniteur lors de
l'activation de l'appareil d'électrochirurgie afin de ne pas risquer de brûler le patient.

Mise en garde : Utiliser exclusivement des accessoires SenoRx avec le module de

commande SenoRx CM 3000. L'utilisation d'autres accessoires peut conduire à des
situations dangereuses.

Mise en garde : Dès que le module de commande SenoRx CM 3000 est mis sous
tension ou qu'un appareil est raccordé au CM 3000 alors que le générateur
d'électrochirurgie SenoRx est sous tension, l'action de la pédale de commande peut
produire de l'énergie RF.

Mise en garde : Ne pas retirer le couvercle. Le retrait du couvercle peut entraîner un

choc électrique. Pour le service après-vente, contacter SenoRx.

Mise en garde : Dans la zone de fonctionnement ou d'utilisation, les niveaux sonores

des tonalités émises doivent être mesurés en se tenant devant le boîtier du module de
commande.

7
Precautions
Caution: This equipment is intended for use by qualified personnel only.

Caution: Safe and effective electrosurgery is dependent not only on equipment design
but also, to a large extent on factors under the control of the operator. It is important
that the instructions supplied with this equipment be read, understood, and followed, in
order to enhance safety and effectiveness.

Caution: Locate the SenoRx CM 3000 Control Module as far as possible from other
electronic equipment to minimize interference.

Caution: Inspect accessories and cords for breaks, cracks, nicks, or other damage
before every use. If damaged, do not use. Failure to observe this precaution may
result in injury or electrical shock to the patient or to the operator.

Caution: Connect the power cord to a wall outlet having the correct voltage or product
damage may result.

8
SYMBOL DEFINITIONS

Symbol Description Symbol Description

Attention: Refer to
Instructions for
Loudspeaker
Use for
instructions

Normal run;
Dangerous
normal speed -
Voltage
reverse

Normal run;
Protective earth normal speed -
forward

Fast run; fast

On
speed - reverse

Fast run; fast

Off
speed - forward

Variability Stop (of action)

Movement in one
Pause; interruption
direction - Right

Movement in one
Foot switch
direction - Left

9
Movement in both Slow run; slow
directions speed - reverse

Brightness; Slow run; slow

brilliance speed - forward

Return to initial
Operator
state

Application
General cancel
assistance

Additional
Alarm, general information on
screen

Alarm, urgent Loudness

Rotation around
Alarm, system clear
an axis; axial view

Rotation around
Alarm, inhibit
an axis; side view

Alignment of the
Hand-held switch
target position

Driving to the
Patient
target position

10
Brightness/Contrast Device

Main index page Device, one-button

Page number down Device, two-button

Electrosurgery,
Page number up
cutting mode

Electrosurgery,
blended cutting Return or select
mode

Electrosurgery,
Up, increase
coagulation mode

Loudness –
Down, decrease
decrease

Brightness –
Press button
increase

Brightness -
Press front button
decrease

Push button switch Press rear button

11
SCREEN DESCRIPTIONS

Startup Screen Description

While the CM 3000 initializes, the SenoRx

logo is displayed on the screen

Language Screen

The language screen is accessed during

Power Up. For complete instructions on
accessing the language screen, see the
Operating Instructions – Accessing the
Language Screen Section.

Connect Device Screen

Following initialization, the Connect

Device screen displays. While this screen
is active, connect a Device. For additional
options, press the bottom button to the
right of the display on the Front Panel of
the CM 3000.

12
Intensity Adjust Description

Adjust the display intensity brighter or

dimmer using the corresponding buttons
to the right of the screen icons on the
Front Panel of the CM 3000. Press the
lower right button (Return) to return to the
previous screen.

Audio Adjust

Adjust the audio volume louder or softer

using the corresponding buttons to the
right of the screen icons on the Front
Panel of the CM 3000. Press the lower
right button (Return) to return to the
previous screen.

Device Detected

This screen displays acknowledgement

from the CM 3000 that a SenoRx Device is
connected, and indicates that the Script for
the individual Device is loading.

Alarm – General
The alarm screen displays under any
alarm condition. When applicable,
additional text on the screen identifies the
specific problem. Refer to Operating
Instructions – Alarm Conditions and
Troubleshooting for detailed instructions
on clearing alarm conditions

13
INSTALLATION INSTRUCTIONS
Front Panel Display and Controls

3 4

2
1

Ref. No. Description

1 Power On/Off
2 Display
3 Selection Push Buttons
4 SenoRx Device Connector

14
Rear Panel Connections and Controls

2 7

5 8
1 3

4 6

Ref. No. Description

1 Footswitch Connector
2 Generator Connector
3 Vacuum System Connector
4 Power Inlet Connector
Power Outlet Connector – For Use Only
5 With ES 300 Generator
6 Fuse Holder
7 Equipotential Stud
8 Main Power On/Off

15
Rear Panel Text
D
E I
K

C
B F

G H
J

Ref
English French
Letter
TO ELECTROSURGICAL VERS GÉNÉRATEUR
A
GENERATOR D'ÉLECTROCHIRURGIE
B TO FOOTSWITCH VERS PÉDALE DE COMMANDE
C TO VACUUM SYSTEM VERS CIRCUIT DE DÉPRESSION
REFER TO USER MANUAL FOR CONSULTER LES INSTRUCTIONS DU
D
INSTRUCTIONS MANUEL D'UTILISATION
MISE EN GARDE : RISQUE DE CHOC
WARNING: ELECTRIC SHOCK
ELECTRIQUE. NE PAS RETIRER LE
HAZARD. DO NOT REMOVE COVER.
COUVERCLE. PAS DE PIÈCES
E NO USER SERVICEABLE PARTS
REMPLAÇABLES OU RÉPARABLES À
INSIDE. CONTACT: SENORX INC.
L'INTÉRIEUR. POUR LE SERVICE APRÈS-
FOR SERVICE
VENTE, CONTACTER SENORX INC.
F OUTPUT: 5A MAX SORTIE : 5 A MAX.
G INPUT: 7A MAX ENTRÉE : 7 A MAX.
FUSES (2): 100-120V ~ T2.0A, 250V FUSIBLES (2) : 100-120V ~ T2.0A, 250V
H
220 – 240V ~ T1.0A, 250V 220 – 240V ~ T1.0A, 250V
ATTENTION : REMPLACER
CAUTION: ONLY REPLACE FUSES EXCLUSIVEMENT LES FUSIBLES PAR
I
WITH SAME TYPE AND RATING DES FUSIBLES DE MÊME TYPE ET DE
MÊME CALIBRE
VOLTAGE: 100-240V TENSION : 100-240 V
J FREQUENCY: 50/60 HZ FRÉQUENCE : 50/60 HZ
CURRENT: 1.8A/.9A MAX COURANT : 1,8 A/0,9 A MAX.
SenoRx Inc. SenoRx Inc.
11 COLUMBIA, SUITE A 11 COLUMBIA, SUITE A
ALISO VIEJO, CA USA 92656 ALISO VIEJO, CA USA 92656
K
TOLL FREE: (877) 210-1300 N° GRATUIT : (877) 210-1300
TEL: (949) 362-4800 TÉL. : (949) 362-4800
E-MAIL: customerservice@senorx.com COURRIEL : customerservice@senorx.com

16
Rear Panel Symbols

Symbol Description

Footswitch

Attention: Refer to Instructions for Use for

instructions

Dangerous voltage

Fuse

Equipotential

17
Environmental Conditions
The CM 3000 requires the following conditions for operation:

Operating:
ƒ Ambient temperature range: 15° to 35° C (59° to 95° F)
ƒ Relative humidity range: 30% to 75%, non-condensing
ƒ Atmospheric pressure range: 700 to 1060 millibar

Storage:
ƒ Ambient temperature range: -40° to 70° C (-40° to 158° F)
ƒ Relative humidity range: 10% to 95%, non-condensing, STP
ƒ Atmospheric pressure range: 500 to 1060 millibar

Equipment Classification:
ƒ Class 1 – Connection to a protective earth conductor
ƒ Type – BF defibrillation-proof Patient applied part
ƒ Category – Not AP or APG, not to be used near flammable gases
ƒ Disinfection – Wipe down of enclosure using a disinfectant
ƒ Ingress of Water – Ordinary Equipment
ƒ Operation – Continuous operation

Power:
ƒ Nominal: 100 – 240 VAC~, 50/60 Hz, 3-wire, grounded with removable power
cord
ƒ Input Current Ranges: Maximum input current at 120 VAC, 60 Hz with full rated
output: 2 Amps, Maximum input current at 230 VAC, 50 Hz with full rated output:
1 Amp
Dimensions:
ƒ 12” Wide x 14” Deep x 4” High (30.5 cm x 35.6 cm x 10.2 cm)

Weight:
ƒ 14.6 lbs (6.8 Kg)

18
OPERATING INSTRUCTIONS
General Information and Application
The SenoRx CM 3000 Control Module is designed to recognize individual SenoRx
Devices and provide interface, motor speed control, physician feedback, and to accept
inputs when used for specific procedures. Each SenoRx Device performs unique
functions. The CM 3000 Footswitch, if needed with a particular SenoRx Device, is used
to initiate and maintain the automated device cycle.

CM 3000 when NOT used with a SenoRx ES 300 Electrosurgical Generator:

Guidance and manufacturer’s declaration – electromagnetic emissions
The Model CM 3000 Control Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model CM 3000 Control Module should assure that it is used in
such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
The Model CM 3000 Control Module uses RF
energy only for its internal function. Therefore its
RF emissions
Group 1 RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic
equipment.
RF emissions The Model CM 3000 Control Module is suitable for
Class A
CISPR 11 use in all establishments other than domestic and
Harmonic emissions those directly connected to the public low-voltage
Class A
IEC 61000-3-2 power supply network that supplies buildings used
Voltage fluctuations/ for domestic purposes.
flicker emissions Complies
IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model CM 3000 Control Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model CM 3000 Control Module should assure that it is used in
such an environment.
IEC 60601 Electromagnetic environment –
Immunity test Compliance level
Test level guidance
Electrostatic +/-6 kV contact +/- 6 kV contact Floors should be wood, concrete or
discharge +/-8 kV air +/- 8 kV air ceramic tile. If floors are covered with
(ESD) synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
Electrical fast +/-2 kV for power +/-2 kV for power Mains power quality should be at that
transient/burst supply lines supply lines of a typical commercial or hospital
IEC 61000-4-4 +/-1 kV for +/-1 kV for environment.
input/output lines input/output lines
Surge +/-1 kV differential +/-1 kV differential Mains power quality should be at that
IEC 61000-4-5 mode mode of a typical commercial or hospital
+/-2 kV common +/-2 kV common environment.
mode mode
Voltage dips, <5% Ut Mains power quality should be at that
short (>95% dip in Ut) Complies of a typical commercial or hospital
interruptions for 0.5 cycle environment. If the user of the CM
and voltage 3000 Control Module requires

19
variations on 40% Ut continued operation during power
power supply (60% dip in Ut) Complies mains interruptions, it is recommended
lines for 5 cycles that the CM 3000 Control Module be
IEC 61000-4- powered from an uninterruptible power
11 70% Ut supply of sufficient capacity.
(30% dip in Ut) Complies
for 25 cycles

<5% Ut EUT recovers with

(>95% dip in Ut) operator restart
for 5 sec
Power 3 A/m 3 A/m Power frequency magnetic fields
frequency should be at levels characteristic of a
(50/60 Hz) typical location in a typical commercial
magnetic field or hospital environment.
IEC 61000-4-8
NOTE Ut is the a.c. mains voltage prior to application of the test level

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model CM 3000 Control Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model CM 3000 Control Module should assure that it is used in
such an environment.
IEC 60601 Electromagnetic environment –
Immunity test Compliance level
Test level guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the CM
3000 Control Module, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.

Recommended separation distance

d = 1.2√P

Conducted RF 3 Vrms 3 Vrms

IEC 61000-4-6 150 kHz to 80 MHz d = 1.2√P 80 MHz to 800 MHz

Radiated RF 3 V/m 3 V/m d = 2.3√P 800 MHz to 2.5 GHz

IEC 61000-4-3 80 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 d is the
recommended separation distance in
meters (m).

Field strengths from fixed RF

transmitters, as determined by an
electromagnetic site survey, a should
be less than the compliance level in
each frequency range. b

20
 Interference may occur in the vicinity
of equipment marked with the
following symbol:

NOTE 1 - At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast 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 CM 3000 Control Module is used exceeds the applicable RF compliance level above, the CM 3000 Control
Module should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the CM 3000 Control Module.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

Recommended separation distances between portable and mobile RF

communications equipment and the CM 3000 Control Module
The Model CM 3000 Control Module is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Model CM 3000 Control Module
can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the CM 3000 Control Module as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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 applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 – At 80 MHz and at 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.

NOTE: Use only SenoRx accessories with the CM 3000 Control Module.

21
CM 3000 when used with a SenoRx ES 300 Electrosurgical Generator:
Guidance and manufacturer’s declaration – electromagnetic emissions
The Model CM 3000 Control Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model CM 3000 Control Module should assure that it is used in
such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
The Model CM 3000 Control Module is used as
part of a system where an Electrosurgical
RF emissions
Group 2 Generator must emit electromagnetic energy in
CISPR 11
order to perform its intended function. Nearby
electronic equipment may be affected.
RF emissions The Model CM 3000 Control Module is suitable for
Class A
CISPR 11 use in all establishments other than domestic and
Harmonic emissions those directly connected to the public low-voltage
Class A
IEC 61000-3-2 power supply network that supplies buildings used
Voltage fluctuations/ for domestic purposes.
flicker emissions Complies
IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model CM 3000 Control Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model CM 3000 Control Module should assure that it is used in
such an environment.
IEC 60601 Electromagnetic environment –
Immunity test Compliance level
Test level guidance
Electrostatic +/-6 kV contact +/- 6 kV contact Floors should be wood, concrete or
discharge +/-8 kV air +/- 8 kV air ceramic tile. If floors are covered with
(ESD) synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
Electrical fast +/-2 kV for power +/-2 kV for power Mains power quality should be at that
transient/burst supply lines supply lines of a typical commercial or hospital
IEC 61000-4-4 +/-1 kV for +/-1 kV for environment.
input/output lines input/output lines
Surge +/-1 kV differential +/-1 kV differential Mains power quality should be at that
IEC 61000-4-5 mode mode of a typical commercial or hospital
+/-2 kV common +/-2 kV common environment.
mode mode
Voltage dips, <5% Ut Mains power quality should be at that
short (>95% dip in Ut) Complies of a typical commercial or hospital
interruptions for 0.5 cycle environment. If the user of the CM
and voltage 3000 Control Module requires
variations on 40% Ut continued operation during power
power supply (60% dip in Ut) Complies mains interruptions, it is recommended
lines for 5 cycles that the CM 3000 Control Module be
IEC 61000-4- powered from an uninterruptible power
11 70% Ut supply of sufficient capacity.
(30% dip in Ut) Complies
for 25 cycles

<5% Ut EUT recovers with

(>95% dip in Ut) operator restart
for 5 sec
Power 3 A/m 3 A/m Power frequency magnetic fields

22
frequency should be at levels characteristic of a
(50/60 Hz) typical location in a typical commercial
magnetic field or hospital environment.
IEC 61000-4-8
NOTE Ut is the a.c. mains voltage prior to application of the test level

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model CM 3000 Control Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the Model CM 3000 Control Module should assure that it is used in
such an environment.
IEC 60601 Electromagnetic environment –
Immunity test Compliance level
Test level guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the CM
3000 Control Module, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.

Recommended separation distance

d = 1.2√P

d = 1.2√P 80 MHz to 800 MHz

Conducted RF 3 Vrms 3 Vrms d = 2.3√P 800 MHz to 2.5 GHz

IEC 61000-4-6 150 kHz to 80 MHz
where P is the maximum output power
Radiated RF 3 V/m 3 V/m rating of the transmitter in watts (W)
IEC 61000-4-3 80 MHz to 2.5 GHz according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).

Field strengths from fixed RF

transmitters, as determined by an
electromagnetic site survey, a should
be less than the compliance level in
each frequency range. b

Interference may occur in the vicinity

of equipment marked with the
following symbol:

NOTE 1 - At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast 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

23
location in which the CM 3000 Control Module is used exceeds the applicable RF compliance level above, the CM 3000 Control
Module should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the CM 3000 Control Module.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

Recommended separation distances between portable and mobile RF

communications equipment and the CM 3000 Control Module
The Model CM 3000 Control Module is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Model CM 3000 Control Module
can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the CM 3000 Control Module as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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 applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 – At 80 MHz and at 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.

NOTE: Use only SenoRx accessories with the CM 3000 Control Module.

SenoRx Device Connection

For Electrosurgical Handheld Devices follow the specific Instructions for Use included
with each accessory.

Accessing the Language Screen

The language screen can only be accessed during Power Up. From an Off state, press
and release the top left (Power) button on the Front Panel of the CM 3000, then press
and hold any of the three buttons to the right of the display on the Front Panel.
Language selections are scrolled through using the up and down buttons as indicated
on the screen. To select any language when it is displayed, press the bottom button
(Select) to select that language and return to the Main Screen.

Alarm Conditions and Troubleshooting

The CM 3000 is programmed to attempt to determine a reason for any alarm condition
that occurs. If the CM 3000 can find a cause for an alarm, the information is displayed
on the Front Panel screen.

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Depending on the cause of the alarm, different scenarios are required to clear the
alarm. Certain alarm causes, when corrected, allow the CM 3000 to recover
automatically, and return to a ready state. Other alarms require pressing a button as
indicated on the Display of the CM 3000 to clear. If a SenoRx Device is connected and
is the cause of the alarm, follow the specific IFU for that Device to clear the alarm.

When no other actions are indicated, clear any major alarm condition by first turning off
main power using the switch on the Rear Panel. Wait 20 seconds, and turn the main
power back on, and restart the CM 3000 with the Front Panel Power button.

If any alarm condition persists after correcting known problems and clearing the alarm
condition from the screen, contact SenoRx for service.

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Cleaning and Disinfecting
Cleaning Recommendations
To clean the SenoRx CM 3000 Control Module, turn off Power and disconnect the CM
3000 power cord from the AC outlet. Leave all other cables connected. Clean all
exposed surfaces of the CM 3000, cables, and Footswitch with a soft, lint-free cloth
dampened with a cleaning solution or disinfectant. Follow the procedures approved by
your institution or use a validated infection control procedure.

Do not use abrasive cleaners or spray any cleaner directly onto any part of the CM 3000
Control Module System or cables.

Disposal of Equipment
After following the cleaning recommendations above, there are no risks involved with
the disposal of the CM 3000 or any of the reusable accessories at the end of the CM
3000’s useable life. Dispose of any single use device per the Instructions for Use for
the disposable device.

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ROUTINE MAINTENANCE
Electrical safety testing should be performed at intervals no greater than 12 months,
using a standard medical safety analyzer.

Regularly inspect all cables and connectors for possible wear or damage.

The CM 3000 contains no user serviceable parts. There are no calibrations or

adjustments necessary for this unit. All servicing of the CM 3000 should be referred to
SenoRx.

Fuse Replacement
The Fuse Holder is accessible after the Power Cord is removed. Unplug the CM 3000
from the wall outlet, and remove the Power Cord from the Power Inlet Connector on the
Rear Panel of the CM 3000. If the CM 3000 is mounted on a SenoRx Cart, take
precautions to ensure that the Power Cord does not drop down into the center post of
the Cart. Using a small slotted screwdriver, press the release tab located near the
center of the fuse holder, towards the left side. Pull the fuse holder assembly outward
to remove it from the Power Inlet Connector. Remove and replace any blown fuses in
the Fuse Holder assembly, and snap it back into place. Reconnect the Power Cord to
the Power Inlet Connector.

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WARRANTY
Returned Goods

Returned goods will be accepted only with prior authorization by SenoRx Customer
Service who will issue you a Returned Goods Authorization (RGA) number. Returned
items must be in original, unopened SenoRx cartons in saleable condition and must be
accompanied by the RGA number which has been written on the outside of the shipping
box by the customer. Product shipped or ordered in error must be returned within 90
days from original receipt of order. Outdated products are not returnable. Credit will be
issued only for items returned with SenoRx approval.

Damaged Goods

Merchandise should be inspected upon delivery and refused at your receiving

department if damaged. Notify SenoRx Customer Service within 5 working days of
receipt of damaged merchandise. To contact SenoRx concerning product problems call
SenoRx Customer Service or your sales representative.

Limited Product Warranty

SenoRx Inc. (“Company”) warrants to the Original Purchaser (as defined below) of the
Company’s instrument that each instrument shall substantially conform to the
specifications for such instrument and be substantially free from defects in material and
workmanship for the warranty period set forth below and when used as originally
intended under normal conditions and in conformity with its directions for use and/or
maintenance instructions. The obligation of the Company under this warranty shall be
limited to the repair or replacement, each at no charge, at the option of the Company, of
the instrument within one year from the date of purchase, as specified on the Original
Purchaser’s bill of lading, if examination shall disclose to the reasonable satisfaction of
the Company that the instrument is non-conforming. The repair or replacement of such
instrument shall be the only remedy to the Original Purchaser and the sole and
exclusive liability of the Company for breach of this warranty.

Because the Company has no control over the operation, inspection, maintenance, or
use of its products after sale and has no control over the selection of patients, this
warranty is made in lieu of all other warranties or conditions, expressed or implied, by
statute, in any communication or otherwise, regarding the instrument, including, but not
limited to, the warranties of merchantability, fitness for a particular purpose, non-
infringement and quality (except as set forth above) and all other obligations or
liabilities, express or implied, on the part of the Company. The Company neither
assumes nor authorizes any other person or entity, or such party’s employees or
representatives, if applicable, to assume for it any other warranties, conditions or
liabilities, express or implied, by statute or in any communication, regarding the
instrument, in connection with the sale or use of the Company’s instrument.

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THIS WARRANTY SHALL NOT APPLY TO: (I) A COMPANY’S INSTRUMENT OR ANY
PART THEREOF WHICH HAS BEEN SUBJECT TO NEGLIGENCE, IMPROPER
MAINTENANCE, ALTERATION, MODIFICATION, ABUSE, MISUSE, ACTS OF
NATURE, VANDALISM, BURGLARY AND/OR THEFT, UNUSUAL PHYSICAL OR
ELECTRICAL STRESS, OR ACCIDENT OR (II) A COMPANY’S INSTRUMENT OR
ANY PART THEREOF WHICH HAS BEEN REPAIRED, MODIFIED OR ALTERED BY
ANYONE OTHER THAN THE COMPANY. THE COMPANY MAKES NO
WARRANTIES WHATSOEVER, EITHER EXPRESS OR IMPLIED, WITH REGARD TO
ACCESSORIES OR PARTS USED IN CONJUNCTION WITH THE COMPANY’S
INSTRUMENT THAT ARE NOT SUPPLIED AND MANUFACTURED BY THE
COMPANY. THE TERM “ORIGINAL PURCHASER," AS USED IN THIS WARRANTY,
SHALL BE DEEMED TO MEAN THAT PERSON OR ENTITY, OR THEIR EMPLOYEES
OR REPRESENTATIVES, IF APPLICABLE, TO WHICH THE COMPANY’S
INSTRUMENT WAS FIRST SOLD BY THE COMPANY. THIS WARRANTY MAY NOT
BE ASSIGNED OR TRANSFERRED IN ANY MANNER.

IN NO EVENT SHALL THE COMPANY BE LIABLE TO THE ORIGINAL PURCHASER

OR ANY THIRD PARTY FOR LOST PROFITS OR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL OR INDIRECT DAMAGES FOR BREACH OF THIS WARRANTY. THIS
LIMITATION SHALL APPLY EVEN WHERE THE COMPANY HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH DAMAGE AND NOTWITHSTANDING THE FAILURE OF
ESSENTIAL PURPOSE OF ANY LIMITED REMEDY STATED HEREIN.

© 2005 By SenoRx Inc. All rights reserved.

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EXPLANATION OF SYMBOLS ON THE PACKAGE

Attention, See Instructions

Conformité Européenne (European

Conformity).
This symbol means that the device fully
complies with European Directive
93/42/EEC

Batch Code

SN Serial number

Model/Catalogue Number

Relative humidity: Moisture content

Keep away from heat

Fragile: Handle with care

Keep dry

This way up

Temperature limitation

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SENORX CONTACT INFORMATION

SenoRx Inc.
11 Columbia, Suite A
Aliso Viejo, CA USA 92656
Toll Free: (877) 210-1300
Tel: (949) 362-4800
Fax: (949) 362-3519
E-mail: customerservice@senorx.com

European Representative:

MPS Medical Product Service GmbH

Borngasse 20
35619 Braunfels
Germany

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