Instructions for Use
148 Pages
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ENGLISH EnCor UltraTM Breast Biopsy System Instructions for Use Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
A. DEVICE DESCRIPTION The EnCor UltraTM Breast Biopsy System provides control operations for specialized biopsy instruments intended to acquire tissue samples of suspected breast abnormalities. The EnCor UltraTM Breast Biopsy System may be used with EnCor® drivers, foot pedals and probes. EnCor® Biopsy Probes and EnCor UltraTM vacuum tubing and Canisters are available separately. Reference Figure 1 – Figure 3 for photographs of the above mentioned accessories.
Figure 1 – EnCor® Biopsy Probes
Figure 2 – EnCor® Driver and Probe
Figure 3 – EnCor® Foot Pedal
B. INDICATIONS FOR USE The EnCor UltraTM Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. •
It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
•
It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor UltraTM Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
C. CONTRAINDICATIONS 1.
This device is not intended for use except as indicated.
2.
The EnCor UltraTM Breast Biopsy System is contraindicated for those patients where, in the physician’s judgment, there is an increased risk of complications associated with percutaneous removal of tissue samples.
D. WARNINGS 1.
The EnCor UltraTM Breast Biopsy System must be properly grounded to ensure patient safety. The system is supplied with a medical grade power cord with AC plug. Do not connect the included power cord to extension cords or three-prong to two-prong adapters. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.
2.
To minimize interference with other equipment, cables should be positioned in such a manner to prevent contact with other cables.
3.
Use of accessories not compatible with the EnCor UltraTM Breast Biopsy System may create potentially hazardous conditions.
4.
Only use EnCor® drivers with script version 1.23 or greater, with the EnCor UltraTM Breast Biopsy System. The system is not compatible with earlier driver scripts.
5.
The EnCor UltraTM Breast Biopsy System console may not be placed in an MRI suite.
6.
No modification of this equipment is allowed. Do not remove the EnCor UltraTM Breast Biopsy System housing. Removal of the housing may cause electrical shock. Contact Bard for service.
7.
The EnCor UltraTM Breast Biopsy System is not classified as an AP or APG classified device. The system is not suitable for use in the presence of flammable anesthetic.
E. PRECAUTIONS 1.
This equipment should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.
2.
Locate the EnCor UltraTM Breast Biopsy System as far as possible from other electronic equipment to minimize interference.
3.
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.
4.
Inspect tubing connections to the vacuum canister and the vacuum tubing to ensure proper vacuum levels are achieved and maintained during use.
5.
Inspect the vacuum canister to ensure the lid is secure and that no damage has occurred during shipping or installation. A heavily scratched canister can break during use.
6.
Do not leave the EnCor UltraTM Breast Biopsy System powered on overnight. Damage may occur to the vacuum tubing.
7.
Connect the power cord to a hospital grade wall outlet having the correct voltage or product damage may result.
8.
Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.
9.
As with any biopsy instrument, there is a potential for infection.
10. All breast biopsies should be performed under imaging guidance to confirm the probe position relative to the target region to be sampled and to help mitigate the occurrence of a false negative biopsy. 11. When performing a biopsy with EnCor® probes, the orientation of the sample notch is dictated by the image guidance selected. Prior to initiating the procedure, confirm that the sample notch orientation is correct for the image guidance being used. 12. Ensure that the EnCor UltraTM Breast Biopsy System is positioned in such a way that the power cord and retainer are accessible. In the event that the system power switch is inoperable, release retainer and remove cord to shut off system power. 1
F.
POTENTIAL COMPLICATIONS
1.
Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast.
G. EQUIPMENT REQUIRED The following equipment is required for a biopsy procedure: • • • •
Appropriate imaging modality and accessories EnCor® Driver EnCor® Probe EnCor UltraTM Vacuum Tubing and Canister
• • • • •
Tissue Marker (optional) Surgical gloves and drapes Local anesthetic Scalpel Other equipment as necessary
H. DIRECTIONS FOR USE Unpacking Instructions Carefully remove the EnCor UltraTM Breast Biopsy System from the packaging. Thoroughly inspect the packaging materials and the system for any signs of transit damage. Do not use the unit if it appears to have any damage. Contact Bard Customer Service for instructions on how to report shipping damage.
Figure 4 – EnCor UltraTM System with Handle
Figure 5 – EnCor UltraTM System with Optional Tray
The EnCor Ultra Breast Biopsy System is delivered assembled, with the exception of the optional procedure tray, which is detached and supplied and packaged separately. To attach the procedure tray, carefully remove the tray from the packaging. Unlock the rear handle from the system by pressing release button under the system as illustrated in Figure 6. Remove the handle, and replace with the procedure tray stand, aligning the legs of the tray stand into position as illustrated in Figure 7. Place the removal tray on top of the stand. TM
Figure 6 – Release button to attach the procedure tray.
Figure 7 – Insert the procedure tray stand
Procedure Setup Prior to transporting the system, unlock the system casters. When transporting the system, push or pull using the system handle, or the handle located on the optional tray stand. To transport the system outside of normal hospital conditions (e.g. outdoors or to another facility) use Bard supplied packaging. 1. Position the EnCor UltraTM Breast Biopsy System as required for safe use and plug the power cord (located on the rear of the console) into a hospital grade wall outlet. a. The system includes four casters with locking brakes on the front casters. After the system is positioned, lock the casters as illustrated in Figure 8. b. Optional: The tray height may be adjusted by releasing the locking lever on the stand and adjusting the tray up or down as illustrated in Figure 9.
Figure 8 – Locking the system casters
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Figure 9 – Adjusting the tray height
2.
Connect the EnCor® driver to the rectangular connector on the side of the console illustrated in Figure 10. Reference the applicable driver Instructions for Use for further information of driver setup. If desired, connect the appropriate foot pedal to the connector on the rear of the console as illustrated in Figure 11.
Figure 11 – Optional - Install the EnCor® footswitch to the
Figure 10– Install the EnCor® driver to the rectangular connector on the side of the console
round connector on the rear of the console
Figure 12 – Turn on the EnCor UltraTM system using the power switch located on the display panel
3. Turn the system on via the power switch on the display panel as illustrated in Figure 12. 4. Install the vacuum tubing by loading the T-connection, then threading through the Vent control and Vacuum control as illustrated in Figure 13. Install the vacuum canister by placing the canister in the designated location. Attach the system tubing to the VACUUM port, and the disposable EnCor UltraTM Vacuum tubing to the PATIENT port. After installing the vacuum components, the system door may be closed to conceal the components during the biopsy procedure.
Figure 13 – Installing the Vacuum Tubing and Canister
Figure 14 – The EnCor UltraTM system door may be closed during the biopsy to conceal the vacuum components
5. Allow the system to initialize. When the system is ready to calibrate, the READY LED will flash GREEN. Install and calibrate the biopsy probe. Reference the applicable probe Instructions for Use for further information on probe setup. After the probe calibration is complete, the READY will be solid GREEN. The LEDs are illustrated in Figure 15. Reference the Troubleshooting section to address any alerts that occur during initialization and probe calibration.
Figure 15 – System Display
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6. Complete the biopsy procedure per the “Directions for Use” section of the EnCor® Driver Instructions for Use. 7. The EnCor UltraTM Breast Biopsy System status is indicated on the display panel (Figure 15). a. To change the sample mode from normal tissue to dense tissue, press the DENSE tissue button as illustrated in Figure 15. The button will illuminate GREEN when “dense tissue” sampling is selected. Press the DENSE tissue button again to return to normal tissue sampling. After Use 8. Remove disposables and discard per your facility’s procedures. Clean and disinfect the system hardware per the instructions located under the cleaning and maintenance section. Note: The system may be left on if additional procedures are to be performed; it is not recommended to leave the main power on overnight. It is not recommended to unplug the drivers after each use. The drivers and foot pedal may be left connected to the EnCor UltraTM Breast Biopsy system if all procedures are to be performed with the same drivers. 9. To turn off the system, press and hold the switch on the front of the console (illustrated in Figure 12) until the system shuts down.
I.
CLEANING AND MAINTENANCE
To clean the EnCor UltraTM Breast Biopsy System, turn off power and disconnect the power cord from the AC outlet. Leave all other cables connected. Clean all exposed surfaces of the EnCor UltraTM Breast Biopsy System, cables, and foot pedal with a soft, lint-free cloth dampened with a cleaning solution such as those recommended in the table below. Follow the procedures approved by your facility or use a validated infection control procedure. Always follow the instructions provided by the manufacturer of the cleaner or disinfectant used. Recommended Cleaning Solutions Isopropyl Alcohol Dispatch® Hospital Disinfectant Sani-cloth Disinfectant Wipes CaviWipes Disinfectant Wipes Cidex Disinfectant
Do not use abrasive cleaners or spray any fluids directly onto any part of the EnCor UltraTM Breast Biopsy System or cables. Spraying the system may cause it to malfunction and will void the warranty. Do not submerge any component of the EnCor UltraTM Breast Biopsy System in fluids. Submerging in fluids may cause the system to malfunction and will void the warranty. Sterilization and exposure to fluids may damage the electrical components of the device. If the system is inappropriately cleaned it may cause the system to malfunction and will void the warranty. Do not autoclave any components of the EnCor UltraTM Breast Biopsy System. Do not heat over 54°C (129°F). Disposal of Equipment After following the cleaning recommendations above, there are no biohazard risks involved with the disposal of the EnCor UltraTM Breast Biopsy System or any of the reusable accessories at the end of the EnCor UltraTM Breast Biopsy System’s useable life per Waste of Electrical and Electronic Equipment (WEEE) directive [Directive 2002/96/EC]. Dispose of any single use device per the Instructions for Use for the disposable device. Do not dispose of the EnCor UltraTM Breast Biopsy System by placing into trash receptacles. Routine Maintenance No calibrations or adjustments are necessary for the EnCor UltraTM Breast Biopsy System outside of normal use. In addition, the following routine maintenance activities may be completed: 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. Odor Control Filter Replacement Turn the Power Switch to off. Remove the old Odor Control Filter by rotating it counter-clockwise and discard. Install the new Odor Control Filter (F3000) by rotating clockwise until snug. The location of the Odor Control Filter is identified in Figure 16.
Figure 16
Fuse Replacement The fuse holder is accessible after the power cord is removed. Unplug the EnCor UltraTM Breast Biopsy System from the wall outlet, and remove the power cord from the power inlet connector on the rear panel of the console. Using a small slotted screwdriver, press the release tab located near the center of the fuse holder. Pull the fuse holder assembly outward to remove it. Use Fuse Kit Model Number FK4000. Install the fuse holder, as illustrated in Figure 17. Remove and replace any blown fuses in the fuse holder assembly, and snap it back into place. The fuse holder orientation determines the voltage. Figure 17 illustrates the 115V orientation. Rotate the fuse 180 degrees for 230V orientation. Replace the fuse holder assembly, and reconnect the power cord to the power inlet connector.
J.
TROUBLESHOOTING
The EnCor UltraTM Breast Biopsy System will display any alert conditions that occur on the front display panel illustrated in Figure 15.
Figure 17
Depending on the cause of the alert, different actions may be required to clear the alert. Certain alert conditions, when corrected, allow the system to recover automatically, and return to a ready state. Other alerts require pressing a button on the display panel to clear. If a driver is connected and is the cause of the alert, follow the troubleshooting instructions in the EnCor® Driver Instructions for Use to clear the alert. Some conditions may require the user to clear the alert condition by turning off main power using the power switch on the display panel (illustrated in Figure 12). Wait 20 seconds, and turn the main power back on, and restart the EnCor UltraTM Breast Biopsy System with the power switch on the display panel (illustrated in Figure 12). If any alert condition persists after correcting known problems and clearing the alert condition using the display panel, contact Bard for service. 4
LED Status
System Status and Troubleshooting
READY light is FLASHING GREEN
Ready to Calibrate Probe. Install probe and press SAMPLE on the driver or footswitch to continue.
READY light is SOLID GREEN
System is ready to perform biopsy. Complete the biopsy procedure per the “Directions for Use” section of the EnCor® Driver Instructions for Use.
PROBE light is ORANGE
There is a probe error. Remove the probe to continue. After the system has reset, re-install the probe and press SAMPLE on the driver or footswitch to continue. NOTE: The EnCor Ultra™ system may only use EnCor® probes and is not compatible with EnCor® MRI or EnCor® 360 probes.
RESET VACUUM light is ORANGE
There is a vacuum error. Check and secure the tubing and canister connections. Check for pinched tubing. Ensure the vacuum tubing is loaded properly. Press the RESET VACUUM button to continue. If the problem persists, replace the disposable components. NOTE: The EnCor Ultra™ system may only use EnCor Ultra™ vacuum canisters and vacuum tubing.
SYSTEM light is ORANGE
There is a system or driver error. Restart the system. If the problem persists, remove and connect a different driver.
DENSE light is GREEN
“Dense tissue” sampling is selected. To turn OFF “dense tissue” sampling, press the DENSE button.
DENSE light is OFF
“Dense tissue” sampling is NOT selected. To turn ON “dense tissue” sampling, press the DENSE button.
K. SPECIFICATIONS Environmental Conditions
Operate the device in ambient conditions (between 15ºC to 25ºC, 30% to 75% relative humidity and 700 to 1060 hPa atmospheric pressure). Transport and store in a cool dry place between -20ºC to +60ºC, 10% to 90% relative humidity and 500 to 1060 hPa atmospheric pressure.
Ingress of Water
Not protected against the ingress of water. IPX0.
Flammability
Equipment not suitable for use in the presence of flammable anesthetic.
Dimensions
20 in x 13 in x 14 in (0.5 m x 0.3 m x 0.4 m)
Weight
50 lbs (23 kgs)
SPECIFICATIONS System Power Ratings
Maximum: 100-120 VAC, 600VA, 50/60 Hz, 3-wire, grounded with removable power cord 220-240 VAC, 600VA, 50/60 Hz, 3-wire, grounded with removable power cord
Electrical Conformity
This medical equipment has passed all required testing for electric shock, fire and mechanical hazards in accordance with UL60601-1, IEC/ EN 60601-1, CAN/CSA C22.2 No 601-1.
Classification
Class I, Type BF equipment. Nominal Ratings Voltage/Frequency
Standby
Nominal Ratings
115 VAC ~ 50/60 Hz 230 VAC ~ 50/60 Hz
Current
Voltage/Frequency
4
VA (Calculated)
Operating 115 VAC ~ 50/60 Hz 230 VAC ~ 50/60 Hz
Current
4
600
VA (Calculated)
600
Watts
450
Watts
450
Power factor
0.75
Power factor
0.75
Electromagnetic Emissions and Immunity Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems Guidance and Manufacturer’s Declaration - Emissions The EnCor UltraTM Breast Biopsy System is intended for use in the electromagnetic environment specified below. The user of the EnCor UltraTM Breast Biopsy System should ensure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF Emissions CISPR 11
Group 1, Class A
The EnCor Ultra Breast Biopsy System 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.
Harmonics IEC 61000-3-2
Class A - Complies
Flicker IEC 61000-3-3
Complies
The EnCor UltraTM Breast Biopsy System is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
TM
Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems Guidance and Manufacturer’s Declaration – Immunity The EnCor Ultra Breast Biopsy System is intended for use in the electromagnetic environment specified below. The user of the EnCor UltraTM Breast Biopsy System should ensure that it is used in such an environment. TM
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Immunity Test
EN/IEC 60601 Test Level
Compliance Level
Electromagnetic Environment – Guidance
ESD EN/IEC 61000-4-2
±2kV, ±4kV, ±6kV Contact discharge ±2kV, ±4kV, ±6kV, ±8kV Air discharge
Pass
Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%
EFT EN/IEC 61000-4-4
±2kV Mains ±1kV I/Os
Pass
Mains power quality should be that of a typical commercial or hospital environment.
Surge EN/IEC 61000-4-5
±1kV Differential ±2kV Common
Pass
Mains power quality should be that of a typical commercial or hospital environment.
Voltage Dips/Dropout EN/IEC 61000-4-11
>95% Dip for 0.5 Cycle
Pass
60% Dip for 5 Cycles
Pass
30% Dip for 25 Cycles
Pass
>95% Dip for 5 Seconds
Pass
Mains power quality should be that of a typical commercial or hospital environment. If the user of the EnCor UltraTM Breast Biopsy System requires continued operation during power mains interruptions, it is recommended that the EnCor UltraTM Breast Biopsy System be powered from an uninterruptible power supply or battery.
3A/m
Pass
Power Frequency 50/60Hz Magnetic Field EN/IEC 61000-4-8
Power frequency magnetic fields should be that of a typical commercial or hospital environment.
Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that are NOT Life-supporting Guidance and Manufacturer’s Declaration – Emissions The EnCor UltraTM Breast Biopsy System is intended for use in the electromagnetic environment specified below. The user of the EnCor UltraTM Breast Biopsy System should ensure that it is used in such an environment. Immunity Test
EN/IEC 60601 Test Level
Compliance Level
Conducted RF EN/IEC 61000-4-6 Radiated RF EN/IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz
Pass Pass
Electromagnetic Environment – Guidance Portable and mobile communications equipment should be separated from the EnCor UltraTM Breast Biopsy System by no less than the distances calculated/listed below: D=(3.5/V1)(√ P) D=(3.5/E1)(√ P) 80 to 800 MHz D=(7/E1)(√ P) 800 MHz to 2.5 GHz where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.
Recommended Separation Distances between portable and mobile RF Communications equipment and the EnCor UltraTM Breast Biopsy System Equipment and Systems that are NOT Life-supporting Recommended Separations Distances for the EnCor UltraTM Breast Biopsy System The EnCor Ultra Breast Biopsy System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the EnCor UltraTM Breast Biopsy System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the EnCor UltraTM Breast Biopsy System as recommended below, according to the maximum output power of the communications equipment. TM
Max Output Power (Watts)
Separation (m) 150kHz to 80MHz D=(3.5/V1)(√ P)
Separation (m) 80 to 800MHz D=(3.5/E1)(√ P)
Separation (m) 800MHz to 2.5GHz D=(7/E1)(√ P) .2333
0.01
.1166
.1166
0.1
.3689
.3689
.7378
1
1.1666
1.1666
2.3333
10
3.6893
3.6893
7.3786
100
11.6666
11.6666
23.3333
Cable Length Cable
Length
AC Power Cord (PC3100/PC3200/PC3300/PC3400/PC3500/PC3600)
12 ft (US) / 2.5m (International)
Equipotential Post: The purpose of the Industry Standard Equipotential Post on the rear of the Encor UltraTM Breast Biopsy System is to provide a connection point to reduce the possibility of voltage potentials between touchable conductive parts of all the different Medical Equipment Systems within the Patient and Operator area. To connect the Encor UltraTM Breast Biopsy System to an Equipotential Network, snap the Equipotential Network Socket over the Equipotential Post on the rear of the Encor UltraTM Breast Biopsy System base unit. To remove The Encor UltraTM Breast Biopsy System from the Equipotential Network, pull the equipotential Network Socket off the Equipotential Post.
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L. HOW SUPPLIED The EnCor UltraTM Breast Biopsy System is supplied non-sterile and should be cleaned prior to first use per the Cleaning and Maintenance instructions. •
EnCor® drivers are sold separately. The drivers are supplied non-sterile. Reference the Instructions for Use included with each driver for Cleaning and Maintenance instructions.
•
The EnCor Ultra™ Vacuum Canister, EnCor Ultra™ Vacuum Tubing, and EnCor® probes are sold separately. The EnCor® probes are supplied sterile. The vacuum canister, vacuum tubing, and probes are for single use only.
M. REFERENCES
IU0072 (EnCor® driver and probe IFU) and IU0073 (EnCor® MRI driver and probe IFU)
N. WARRANTY
Bard Peripheral Vascular warrants to the first purchaser of this product that this product will be free from defects in materials and workmanship for a period of one year from the date of first purchase and liability under this limited product warranty will be limited to repair or replacement of the defective product, in Bard Peripheral Vascular’s sole discretion or refunding your net price paid. Wear and tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty. TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT. Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to additional remedies under the laws of your state/country. Extended warranty service agreements are available. Consult a Bard representative for details regarding terms and conditions. An issue or revision date and a revision number for these instructions are included for the user’s information on the last page of this booklet. In the event 36 months have elapsed between this date and product use, the user should contact Bard Peripheral Vascular, Inc. to see if additional product information is available.
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Manufacturer: SenoRx, Inc. 1625 West 3rd Street Tempe, AZ 85281 USA TEL: 1-480-894-9515 1-800-321-4254 FAX: 1-480-966-7062 1-800-440-5376 www.bardbiopsy.com
Authorised Representative in the European Community Bard Limited Forest House Tilgate Forest Business Park Brighton Road, Crawley West Sussex RH11 9BP, UK
PK1312600 Rev. 0 06/13