Senorx CM 3000 Control Module Operator'S Manual: Iu0030E November 2005
Senorx CM 3000 Control Module Operator'S Manual: Iu0030E November 2005
Senorx CM 3000 Control Module Operator'S Manual: Iu0030E November 2005
Operator’s Manual
IU0030E
November 2005
INTRODUCTION............................................................................................................. 3
Contraindications ..................................................................................................... 3
CM 3000 System........................................................................................................ 3
UNPACKING INSTRUCTIONS....................................................................................... 4
Unpacking.................................................................................................................. 4
Inspection .................................................................................................................. 5
Warnings.................................................................................................................... 6
Precautions ............................................................................................................... 8
Audio Adjust............................................................................................................ 13
1
REAR PANEL TEXT..................................................................................................... 16
Cleaning Recommendations.................................................................................. 26
ROUTINE MAINTENANCE........................................................................................... 27
WARRANTY ................................................................................................................. 28
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:
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
1. Carton
2. Bottom Insert
3. CM 3000 Control Module
4. Top Insert
5. CM 3000 Instructions for Use
4
Accessories:
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: 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 : 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.
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
Attention: Refer to
Instructions for
Loudspeaker
Use for
instructions
Normal run;
Dangerous
normal speed -
Voltage
reverse
Normal run;
Protective earth normal speed -
forward
Movement in one
Pause; interruption
direction - Right
Movement in one
Foot switch
direction - Left
9
Movement in both Slow run; slow
directions speed - reverse
Return to initial
Operator
state
Application
General cancel
assistance
Additional
Alarm, general information on
screen
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
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
11
SCREEN DESCRIPTIONS
Language Screen
12
Intensity Adjust Description
Audio Adjust
Device Detected
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
14
Rear Panel Connections and Controls
2 7
5 8
1 3
4 6
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
Dangerous voltage
Fuse
Equipotential
17
Environmental Conditions
The CM 3000 requires the following conditions for operation:
Operating:
Ambient temperature range: 15° to 35° C (59° to 95° F)
Relative humidity range: 30% to 75%, non-condensing
Atmospheric pressure range: 700 to 1060 millibar
Storage:
Ambient temperature range: -40° to 70° C (-40° to 158° F)
Relative humidity range: 10% to 95%, non-condensing, STP
Atmospheric pressure range: 500 to 1060 millibar
Equipment Classification:
Class 1 – Connection to a protective earth conductor
Type – BF defibrillation-proof Patient applied part
Category – Not AP or APG, not to be used near flammable gases
Disinfection – Wipe down of enclosure using a disinfectant
Ingress of Water – Ordinary Equipment
Operation – Continuous operation
Power:
Nominal: 100 – 240 VAC~, 50/60 Hz, 3-wire, grounded with removable power
cord
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:
12” Wide x 14” Deep x 4” High (30.5 cm x 35.6 cm x 10.2 cm)
Weight:
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.
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
d = 1.2√P
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
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
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
d = 1.2√P
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
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.
24
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.
25
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.
26
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.
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.
27
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
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.
28
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.
29
EXPLANATION OF SYMBOLS ON THE PACKAGE
Batch Code
SN Serial number
Model/Catalogue Number
Keep dry
This way up
Temperature limitation
30
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:
31