USER INSTRUCTIONS AND OPERATIONS GUIDE www.mammotome.
Table of Contents CHAPTER 1 INTRODUCTION ................................................................................................................................... 1-1 Indications ........................................................................................................................................................... 1-1 Contraindications ................................................................................................................................................
1. Powering on the Control Module ........................................................................................................... 3-3 2. Connecting the Holster to the Control Module ...................................................................................... 3-4 3. (OPTIONAL) Attaching the EX Holder (Cart Detachable Component) to the Cart .................................. 3-6 4. (OPTIONAL) Connecting the Remote Footswitch to the Control Module ..................................
Instructions for Use ............................................................................................................................................. 6-2 Steps for Tissue Sampling ............................................................................................................................... 6-2 Other Instructions ...........................................................................................................................................
RFID Frequency Information ............................................................................................................................. 10-6 WEEE (The Waste Electrical and Electronic Equipment Directive .................................................................... 10-7 All Other Symbol and Labeling Information...................................................................................................... 10-7 How Supplied ........................................................
Chapter 1 INTRODUCTION Please read all information carefully. WARNING: FAILURE TO FOLLOW THE INSTRUCTIONS MAY LEAD TO SERIOUS SURGICAL CONSEQUENCES. All information in this guide applies to Stereotactic Guided Procedures (ST) and Ultrasound Guided Procedures (U/S, EX) unless otherwise stated. IMPORTANT: This document is designed to provide instructions for use of the Mammotome revolve Dual Vacuum-Assisted Biopsy System. It is not a reference to surgical technique. Access to the internet and a .
General o the Mammotome revolve Dual Vacuum-Assisted Biopsy System is used in the presence of flammable anesthetics. Avoid at all costs. o As with any medical procedure, there is potential risk for infection. o Minimally invasive instruments may vary in dimensions (e.g., diameter) from manufacturer to manufacturer. When minimally invasive instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure.
o Attempts to disassemble or service any Mammotome product other than in the manner described in the product’s accompanying labeling, or by anyone other than a qualified technician, may cause injury because of electrical shock. o All appropriate surgical rom safety precautions should be observed and implemented before and during the tissue sampling procedure. o Inspect the power cords on the holster, remote footswitch, and remote keypad for fraying or damage prior to each use.
o Avoid scraping of the needle tip against the protective sleeve should remain on the probe needle until you are ready to perform the tissue sampling procedure. o and injury while removing the protective sleeve. o Disconnect the saline spike from the saline bag. Discard the saline bag using standard medical techniques after each patient use. o Keep hands clear of the sample aperture and probe needle tip at all times. o Do not probe tubing pathways should be free from debris during use.
• • • • • • • • • Mammotome revolve Cart Mammotome revolve ST Holster Mammotome revolve ST Probe (with attached Specimen Management System and Vacuum Tube Set) Mammotome revolve Remote Footswitch Mammotome revolve Remote Keypad Mammotome revolve System Software o The Mammotome revolve ST Holster and ST Probes are only compatible with Mammotome revolve System Software.
Chapter 2 SYSTEM DESCRIPTION All information in this guide applies to ST, U/S, and EX modalities, unless otherwise stated. Overview—System Description The Mammotome revolve Dual Vacuum-Assisted Biopsy System allows the user to sample breast tissue that has been identified as suspicious under imaging guidance. Multiple tissue samples can be taken without removing the needle. The user may identify the tissue as it is collected to correspond with the imaging display.
The Mammotome revolve Dual Vacuum-Assisted Biopsy System comprises the following components and input devices: Figure 1.
Control Module The Control Module is an electronic device that runs the software necessary to operate the Mammotome revolve Dual Vacuum-Assisted Biopsy System. The device also houses the vacuum pump, power supply, valve actuators, user touchscreen interface, and control electronics. Figure 2.
Figure 3. Cart Illustration and Nomenclature EX Holders (Cart Detachable Component) The EX holders are designed exclusively for use with the Mammotome revolve Cart to contain the Mammotome revolve EX Holster and/or EX Probe in the clinical environment. Figure 4.
control module vacuum connection slot, 2) to the vacuum canister port, and 3) to a saline bag. For further convenience, the probe includes a Specimen Management System consisting of 12 proximal specimen collection chambers. Each collection chamber is designed to capture and hold excised tissue. The specimen collection chambers are designed to be removed from the fluid management manifold in two separate trays (of six chambers each).
Figure 6. Vacuum Tube Set Illustration and Nomenclature Table 1. Mammotome revolve ST Probe Specifications Dimension (mm) 8G 9cm 8G 12cm MST0809 MST0812 A: Needle Height 5.6 5.6 B: Needle Width 4.4 4.4 C: Tip to Center 21.0 21.0 D: Tip to Thumbwheel 91.5 121.5 E: Dead Space 9.5 9.5 F: Aperture Length 23.0 23.0 Fill Volume (cc) 9 9 Firing Distance 19.3 19.3 8G 15cm MST0815 10G 9cm MST1009 10G 12cm MST1012 10G 15cm MST1015 5.6 4.4 21.0 151.5 9.5 23.0 10 19.3 4.9 3.45 17.5 90.0 8.0 19.05 8 19.3 4.9 3.
Figure 7. Mammotome revolve ST Probe Illustrations U/S Probe and Vacuum Tube Set The U/S Probe (along with its integrated components: Specimen Management System and Vacuum Tube Set) is a sterile, single-patient use device that may be used with imaging guidance to excise a tissue sample for diagnosis. The probe is designed to be loaded onto the U/S holster. The body of the probe contains a locking tab to secure the probe to the U/S holster.
Figure 8. U/S Probe and Vacuum Tube Set Illustration and Nomenclature Table 2. Mammotome revolve U/S Probe Specifications Dimension (mm) 8G MHUS08 A: Needle Height 5.6 B: Needle Width 4.4 C: Tip to Center 21.0 D: Needle Length 123.55 E: Dead Space 9.5 F: Aperture Length 23.0 Fill Volume (cc) 9 10G MHUS10 4.9 3.45 17.5 124.04 8.0 19.
Figure 9. Mammotome revolve U/S Probe Illustrations EX Probe, Vacuum Tube Set, and Sleeve The EX Probe (along with its integrated components: Specimen Management System, Vacuum Tube Set, and Optional Sleeve) is a sterile, single-patient use device that may be used with imaging guidance to excise a tissue sample for diagnosis. The probe is designed to be loaded onto the EX holster. The body of the probe contains a locking tab to secure the probe to the EX holster.
Figure 10. EX Probe, Vacuum Tube Set, and Sleeve Illustrations and Nomenclature Table 3. Mammotome revolve EX Probe Specifications Dimension (mm) A: Needle Height B: Needle Width C: Tip to Center D. Needle Length E: Dead Space F: Aperture Length Fill Volume (cc) 8G MHEX08 AND MHEX08S 5.99 mm (6.0) 4.26 mm (4.3) 23.3 mm 92 mm 10.8 mm 25.
Figure 11. Mammotome revolve EX Probe Illustrations Input Devices The buttons used to activate the clinical functions of the Mammotome revolve Dual Vacuum-Assisted Biopsy System are located on an input device. Three input devices are available for use with the system: 1. Holster (ST or U/S or EX) 2. Remote Footswitch (optional) 3. Remote Keypad (optional) Except for arming and firing the holster/probe assembly, only one input device can be active at a time.
Figure 12. ST Holster Illustration and Nomenclature NOTE: Figure 12 shows the left-hand side of the holster. The placement of the holster buttons on the right-hand side of the holster is directly opposite those on the left-hand side. U/S Holster The Mammotome revolve U/S Holster is a non-sterile, reusable instrument with one electrical cable for transmitting information to the control module.
Figure 13. U/S Holster Illustration and Nomenclature EX Holster The Mammotome revolve EX Holster is a non-sterile, reusable instrument with one electrical cable for transmitting information to the control module. The EX Holster communicates with the control module and EX probe to drive the basic functionality for the procedure, including the advancement and retraction of the cutting mechanism.
NOTE: The sample collection area can be manually rotated by holding the outside of the sample collection area to move to next desired chamber. • VACUUM (VAC) button. Activates vacuum aspiration and probe clearing. o Press and hold to activate vacuum aspiration for the duration of the press. The cutter retracts and vacuum is applied for up to 15 seconds. o Press and immediately release to activate a short vacuum and saline pulse.
Figure 16.
Table 4. Input Device Button Operations for ST and U/S Only Button Description ST Holster U/S Holster Remote Footswitch Remote Keypad Activates tissue sampling. When the BIOPSY button is depressed, the specimen management system first indexes to the next available chamber, to receive the attempted specimen. BIOPSY • Press and release for single specimen acquisition. • Press and hold for continuous sampling.
Button Description ST Holster U/S Holster Remote Footswitch Remote Keypad Activates vacuum aspiration and probe clearing. VAC (VACUUM) • Press and hold to activate vacuum aspiration for the duration of press. The cutter retracts and vacuum is applied for up to 15 seconds. • Press and immediately release to activate a short vacuum and saline pulse.
Table 5. Input Device Operations for EX Only Button Description EX Holster Remote Footswitch Remote Keypad Activates tissue sampling. BIOPSY When the BIOPSY button is pressed, the previous specimen advances to sample collection area. • Press and release for single specimen acquisition. • Press and hold for continuous sampling. Activates vacuum aspiration and probe clearing. VAC (VACUUM) • Press and hold to activate vacuum aspiration for the duration of press.
Table 6. Input Device Button Operations for ST Holster Only Button Description ST Holster Retracts the trocar shaft (needle). ARM • Press and hold ARM until blue LEDs flash (about 1 second) to automatically retract the trocar shaft to the pre-fire position. Fires the trocar shaft (needle). SAFETY UNLOCK and FIRE • Press and hold the mechanical safety unlock button while simultaneously pressing the FIRE button to advance the trocar shaft to the post-fire position.
System Software The Mammotome revolve Dual Vacuum-Assisted Biopsy System arrives loaded with applicable system software. System software functions are described in Chapter 8: Software Description.
Chapter 3 INITIAL INSTALLATION AND GETTING STARTED Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. All information in this guide applies to ST, U/S, and EX modalities unless otherwise stated. PRECAUTION: Inspect each item (e.g., Control Module, Cart, etc.) for damage before use. Do not use a damaged item.
Unpacking the Cart The cart comes fully assembled. • Remove cart from packaging. • The cart comes assembled with the Stereotactic Holster Docking Station on the right side of the cart and the Ultrasound Docking Station on the left side. To switch docking station locations, use a 4mm hex key to remove and reattach each docking station.
Unpacking the Holster Lift the holster from the box and remove the protective wrapping. • Items included in the shipping box: o o o ST Holster with attached electrical cable OR U/S Holster with attached electrical cable OR EX Holster with attached electrical cable WARNING: Before using the holster, inspect its electric cable for fraying or damage. Do not use the instrument if the cable shows signs of damage or wear or if the enclosure is broken.
c. Flip the On/Off switch at the back of the control module to the ON (I) position. Once the switch is in the ON position, the power button in the front illuminates amber, indicating the machine is receiving power but the control module is not active. d. Press the amber power button on the front of the control module until it illuminates GREEN. The title screen appears on the display and the system proceeds to the first software screen prompt.
c. Place the holster in its designated docking station: ST Side U/S Side EX Side U/S Side NOTE: To ensure the holster is secure in its docking station on the cart, ensure the probe tubing (if a probe is attached to the holster) and holster electric cable are out of the way and do not obstruct placement.
WARNING: Use care when placing the holster in its docking station, to ensure it does not slip out of its cradle. NOTE: The cart arrives with the U/S docking station on the left side and the ST docking station on the right side. The two can be switched if desired. (See instructions for unpacking the cart.) The EX Holder (docking station) arrives not attached to the cart. Removal and Installation instructions and tools are provided in the EX Holder packaging. 3.
b. Place the assembled vacuum canister in the well at the top of the Mammotome revolve Control Module. NOTE: Ensure that the canister and lid are correctly assembled to prevent a vacuum error. Incorrect assembly can prevent the system from completing initialization. Connect the control module’s flexible vacuum source tube to the center vacuum port on the vacuum canister lid. d.
d. When the sleeve is fully engaged with Mammotome revolve EX Holster, vertically lift them off the docking station. With the second hand, pull the assembly collar down the length of the Mammotome revolve EX Holster cable until the folded material on the collar has reached its full length, partially down the EX Holster cable. NOTE: Ensure that the sleeve extends as far down the cable as its length allows. NOTE: Ensure that the holster-probe assembly does not touch the cart during undocking and docking.
1. Instructions for attaching probe to holster (ST). 2. Instructions for attaching probe to holster (U/S). 3. Instructions for attaching probe to holster (EX). NOTE: Do not attempt to attach the probe to the holster when the holster is still docked. • This is a standby state, confirming to the user which devices are detected (attached). If an alternate input device is attached (such as a remote footswitch or remote keypad) it appears at the base (bottom) of the screen.
NOTE: Steps d. through g. below are specific to each probe: o ST Probe or o U/S Probe or o EX Probe ST Probe Only NOTE: Ensure the holster’s firing fork is securely tightened before attempting to load the probe. If it is loose, use a coin to tighten it. DO NOT OVER-TIGHTEN. d. Before the probe is attached to the holster, ensure that the Specimen Management System’s marker port is aligned with the alignment indicator on the probe body, as shown below.
The locking mechanism engages to confirm attachment. g. Carefully place holster/probe assembly on the cart’s ST docking station until you are ready to initiate the tissue sampling procedure. U/S Probe Only d. Before the probe is attached to the holster, ensure that the Specimen Management System’s marker port is aligned with the alignment indicator on the probe body, as shown below. Ensure the SMS is fully seated on the probe, and that the tissue strips are fully seated in the SMS chambers. e.
g. Carefully place the holster/probe assembly on the cart’s U/S docking station until the tissue sampling procedure is ready to be initiated. WARNING: When placing or removing the holster/probe assembly to or from the docking station on the cart, ensure no contact is made between sterile and non-sterile surfaces (e.g., needle tip to cart surfaces or control module). EX Probe Only d. Grasp the holster (with or without sleeve attached) and move toward the middle of the probe body. e.
NOTE: Care should be taken to prevent the holster from being dropped during probe attachment. Dropping the holster may damage the holster. g. Carefully place the holster/probe assembly on the cart’s EX Holder (docking station) for the probe until the tissue sampling procedure is ready to be in initiated. i. Place the tip of the sleeve protector (tip protector) into the semi-circular opening; ii. Align the sleeve protector tab to the slot in the EX holder; iii.
slippage or device damage can occur. NOTE: Do not disconnect the tubing while the system is on. iii. Hang the saline bag on the saline pole at the back of the control module by moving the bag around the right side of the control module to the back. PRECAUTION: The saline spike should be below the saline bag when the bag is hung on the saline pole, ensuring the spike tubing is not kinked. Separate the tubing lines between the canister connector and the saline spike if more tubing is needed. b.
c. Connecting the Vacuum Tube Set to the Control Module i. Using sterile technique, remove the vacuum tube set from the probe package. To avoid damage, do not flip the device into the sterile field. Note: ii. iii. Prior to use, remove and discard the retainers that secure the vacuum lines in the packaging. Align the valve cartridge with the vacuum connection slot on the front of the control module, making sure the locking tab is facing up and the filters are above the tab.
To initialize the system: a. Touch the forward arrow on the touchscreen interface to proceed with initialization. When initialization is complete, the Touchscreen interface instructs the user to select an operating side at the holster (ST Only). For Ultrasound guided procedures (U/S and EX), the software goes directly from Initialization to the Ready Screen. NOTE: Avoid pressing multiple buttons at once.
on the left-hand side. To change the selected operating side of the ST holster: a. Press and hold (~2 seconds) any button on the opposite side of the holster to prompt the system to change sides. The blue LEDs on both sides of the holster flash slowly, prompting the user to touch any button on either side of the holster to identify the desired operating side. USER ACTION ST HOLSTER RESPONSE (flashing LEDs) b.
ST and U/S • EX Only On these screens, the user can adjust the default settings or continue with tissue sampling as described in Chapter 4 (ST), Chapter 5 (U/S), or Chapter 6 (EX).
Chapter 4 STEREOTACTIC (ST) INSTRUCTIONS FOR USE Overview This chapter provides a step-by-step description for collecting tissue samples using the Mammotome revolve Dual Vacuum-Assisted Biopsy System for a Stereotactic Guided Procedure. Mammotome revolve ST Probe and ST Holster Summary Description The Mammotome revolve ST Probe and ST Holster are used together to perform a stereotactic breast biopsy procedure.
NOTE: The sample aperture is oriented by manually rotating the ST holster aperture rotation knob or the ST probe aperture rotation thumbwheel to the desired position around the sample aperture. • VACUUM (VAC) button. Activates vacuum aspiration and probe clearing. o Press and hold to activate vacuum aspiration for the duration of press. The cutter retracts, and vacuum is applied for up to 15 seconds. o Press and immediately release to activate a short vacuum and saline pulse.
NOTE: If a remote input device is attached (e.g. remote footswitch, remote keypad), the blue LEDs for BIOPSY, VAC, and OPEN/CLOSE on the holster illuminate in the Active (flashing) state only. Preparation for Use To prepare the Mammotome revolve Dual Vacuum-Assisted Biopsy System for tissue sampling, refer to Chapter 3: Initial Installation and Getting Started. Instructions for Use Steps for Tissue Sampling 1. Using sterile technique, insert a Mammotome revolve probe guide into the probe guide holder. 2.
NOTE: The sample aperture is in the CLOSED position after arming. NOTE: The holster cannot operate the ARM/FIRE clinical functions in the variable aperture setting. The aperture must be set to the full (open) setting for the ARM/FIRE clinical function to be activated. WARNING: Ensure that no hard material is forced into the aperture. 8.
NOTE: Immediately after the trocar shaft has disengaged, the sample aperture is in the fully open position. If you wish to have the sample aperture closed, press the open/close button on the input device to move the cutter to the closed position. After the probe has been introduced into the percutaneous site using either of the methods listed above, the device is ready for tissue biopsy: 9.
NOTE: Refer to Chapter 8: Software Description for more information about the clinical function buttons and the touchscreen interface. 10. When the biopsy cycle is complete, as defined above, rotate the aperture rotation thumbwheel on the probe or aperture rotation knobs on the holster to the desired position for the next sample acquisition. 11. Repeat steps 9-10 as necessary to obtain additional tissue specimens. NOTE: One Specimen Management System is designed to take up to 12 individual samples.
14. Perform post biopsy imaging of the patient and specimens as necessary. 15. Place a biopsy site identifier, if desired, by pressing the OPEN/CLOSE button on the input device to Open the aperture. NOTE: Do not activate the probe cutter or other clinical functions while a marker is inserted in the probe. If a marker was inserted in the probe without having the cutter opened, please remove the marker, open the cutter and then re-insert the marker.
c. ii. During sampling, when the cutter reaches the distal end of the sample aperture, it stops moving momentarily and a tone sounds, indicating the biopsy cycle is complete. The green LEDs on the holster interface illuminate to indicate the position of the cutter. iii. Rotate the aperture rotation thumbwheel on the probe or aperture rotation knobs on the holster to orient the sample aperture for the next sample acquisition.
i. Rotate the stopcock so the OFF indicator is pointing toward the injection port. PRECAUTION: Failure to have the stopcock in the OFF position may produce a partial tissue sample or tissue sample of poor quality. j. Press the VAC button for up to 15 seconds to clear fluids from the probe. k. Continue the biopsy procedure, if desired. Clearing a Clogged Probe WARNING: The pressure differential created in the canister during the procedure can cause blood discharge.
c. Disconnect the vacuum tube set line from the vacuum canister. NOTE: Ensure the system is in standby before removing the vacuum tube set lines from the vacuum canister. Do not disconnect tubing while system is at the Ready screen. d. Disconnect the valve cartridge from the front of the control module. e. Optional: Connect the probe’s two lateral vacuum tube set lines to each other and pinch the pinch valve, if desired, for disposal.
Disconnecting Input Devices a. Remove the power connector for the remote footswitch or remote keypad from the control module’s remote device connection port. NOTE: Input devices can be disconnected from the control module at any time. b. Clean and/or disinfect the input device for later use as described in Chapter 7: Cleaning and Disinfection. Disconnecting the Vacuum Canister a. Disconnect the control module’s flexible vacuum source tube from the center port of the lid. b.
Chapter 5 ULTRASOUND (U/S) INSTRUCTIONS FOR USE Overview This chapter provides a step-by-step description for collecting tissue samples using the Mammotome revolve Dual Vacuum-Assisted Biopsy System for an Ultrasound (U/S) Guided Procedure. • SYMBOLS USED S Mammotome revolve U/S Probe and U/S Holster Summary Description The Mammotome revolve U/S Probe and U/S Holster are used together to perform an ultrasound-guided breast biopsy procedure.
• OPEN/CLOSE button. Opens and closes the cutter location in the aperture. • VACUUM (VAC) button. Activates vacuum aspiration and probe clearing. o Press and hold to activate vacuum aspiration for the duration of the press. The cutter retracts, and vacuum is applied for up to 15 seconds. o Press and immediately release to activate a short vacuum and saline pulse.
Instructions for Use Steps for Tissue Sampling 1. Prepare the percutaneous site in accordance with standard surgical technique prior to insertion of the probe. Incise the selected area adequately to accommodate the trocar shaft. NOTE: Ensure that you incise the selected area before penetrating the breast with the probe. NOTE: Ensure that the patient and the probe are in the correct location for tissue biopsy. PRECAUTION: Avoid positioning the aperture too close to the patient’s skin.
• • The biopsy cycle can be interrupted to avoid unnecessary injury or visualize the location of the sample aperture via imaging, if desired. (Refer to Other Instructions: Sample Interrupt.) Do not remove the specimen collection chambers during tissue acquisition. NOTE: Do not move the probe during the biopsy cycle, as defined above. NOTE: Refer to Chapter 8: Software Description for more information about operation of the clinical function buttons and the control module’s touchscreen interface. 5.
9. Perform post-biopsy imaging of the patient and specimens as necessary. 10. Place a biopsy site identifier if desired, by pressing the OPEN/CLOSE button on the input device to Open the aperture. NOTE: Do not activate the probe cutter or other clinical functions while a marker is inserted in the probe. If a marker was inserted in the probe without having the cutter opened, please remove the marker, open the cutter and then re-insert the marker.
iii. c. Rotate the probe/holster assembly to orient the sample aperture for the next sample acquisition. Continue the biopsy procedure at Step 7, removal of the specimen collection chambers from the device. Sample Interrupt The biopsy cycle may be interrupted to avoid unnecessary injury. a. To interrupt the biopsy cycle, push any button other than BIOPSY when the cutter is retracting from position 1 to 3 or when the cutter is advancing from 3 to 2.
k. Continue the biopsy procedure, if desired. Clearing a Clogged Probe WARNING: The pressure differential created in the canister during the procedure can cause blood discharge. NOTE: If tissue, blood, or any other fluid clogs or fills the probe during the procedure, attempt to clear the probe by pressing and immediately releasing the VAC button on the active input device (holster, remote footswitch, or remote keypad) to initiate cutter movement and a vacuum pulse.
f. Discard the probe and vacuum tubing in the appropriate container(s) after use. g. If additional sampling is planned, follow Steps 6-9 in Chapter 3: Initial Installation and Getting Started, Setup to install a new probe on the holster. Disconnecting Input Devices a. Disconnect the remote footswitch or remote keypad from the control module’s remote device connection port. NOTE: Input devices may be disconnected from the control module at any time. b.
o If YES is selected, the green POWER button on the front of the control module turns an amber color, indicating the system has shut down. o Touch NO to return to the previous screen. 3. Turn the control module off at the back of the system (On/Off power switch). 4. Unplug the power cord from the grounded wall outlet. 5. Before disconnecting the holster’s electrical cable from the control module, ensure the probe has been removed from the holster. 6.
Chapter 6 EX INSTRUCTIONS FOR USE Overview This chapter provides a step-by-step description for collecting tissue samples using the Mammotome revolve Dual Vacuum-Assisted Biopsy System for an EX Ultrasound Guided Procedure. Mammotome revolve EX Probe and EX Holster Summary Description The Mammotome revolve EX Probe and EX Holster are used together to perform an ultrasound-guided breast biopsy procedure.
Figure 23. EX HOLSTER LED Functions NOTE: If a remote input device is attached (e.g. remote footswitch, remote keypad), the blue LED on the EX holster illuminates in the Active (flashing) state only. Preparation for Use To prepare the Mammotome revolve Dual Vacuum-Assisted Biopsy System for tissue sampling, refer to Chapter 3: Initial Installation and Getting Started. Instructions for Use Steps for Tissue Sampling 1.
WARNING: Take care to avoid scrapping of the needle tip against the protective sleeve and injury while removing the protective sleeve. 3. Introduce the probe into the percutaneous site through the skin incision. NOTE: To introduce the probe from the percutaneous site, ensure the sample aperture is closed off, either by a biopsy site identifier applicator or a fully closed cutter.
PRECAUTION: The system must be primed with saline before use. Ensure that saline is used for the procedure. The absence of saline may cause a decrease in tissue transport to the chamber. NOTE: Tissue samples can be visually inspected through the viewing window. • • • A biopsy counter on the touchscreen interface keeps track of attempted samples. A number in the center of the SMS graphic represents the number of attempted samples. (See Chapter 8: Software Description.
PRECAUTION: Remove the tray in a slow, controlled manner to prevent the possibility of spilling tissue and fluid. PRECAUTION: Ensure the open area of the tray is facing up when removing it from the fluid management manifold. 9. Perform post-biopsy imaging of the patient and specimens as necessary. 10. Before removing the probe from the percutaneous site, ensure the sample aperture is closed. Press the OPEN/CLOSE button on the input device to Close the aperture, as needed. 11.
ii. Rotate the probe/holster assembly to orient the sample aperture for the next sample acquisition. NOTE: Manual rotation of the specimen collection chambers is necessary for more than 25 tissue samples in a single large chamber. b. Continue the biopsy procedure at Step 8 removal of the specimen collection chambers from the device. Sample Interrupt The biopsy cycle may be interrupted to avoid unnecessary injury. a.
i. Rotate the stopcock so the OFF indicator is pointing toward the injection port. PRECAUTION: Failure to have the stopcock in the OFF position may produce a partial tissue sample or tissue sample of poor quality. j. Press the VAC button for up to 15 seconds to clear fluids from the probe. k. Continue the biopsy procedure, if desired. Clearing a Clogged Probe, Tissue Viewing Window, or Moving Sample to Sample Collection Area a.
b. Disconnect the valve cartridge from the front of the control module. c. Optional: Connect the probe’s two lateral vacuum tube set lines to each other and pinch the pinch valve, if desired, for disposal. NOTE: Do not remove vacuum tubing from the vacuum canister if vacuum is being used (ON). d. To remove the probe from the holster, press down on the locking tab on the back of the probe body. Pull the holster upward about two inches and then backwards to disconnect it from the probe.
iv. Discard the removed sleeve. NOTE: DO NOT attempt to reinstall the probe’s protective sleeve by hand. Doing so may cause injury to the user. PRECAUTION: Discard the probe, sleeve (if used), and vacuum tubing in the appropriate container(s) after use. f. If additional sampling is planned, follow Steps 6-9 in Chapter 3: Initial Installation and Getting Started, Setup to install a new probe and sleeve onto the holster. Disconnecting Input Devices a.
Shutting Down the Mammotome revolve Dual Vacuum-Assisted Biopsy System 1. To shut down the system, press the green power button on the front of the control module. A prompt appears on the screen, asking you to confirm the intended shutdown. 2. Touch YES to proceed to shut down. o If YES is selected, the green POWER button on the front of the control module turns an amber color, indicating the system has shut down. o Touch NO to return to the previous screen.
Chapter 7 CLEANING AND DISINFECTION All information in this guide applies to ST, U/S, and EX modalities, unless otherwise noted. Introduction This chapter includes detailed cleaning and disinfection instructions for the Mammotome revolve Dual VacuumAssisted Biopsy System per ISO 17664. Users in North America should also refer to appropriate sections of AORN Standards & Recommended Practices for additional guidance on cleaning and disinfection. All other localities should refer to appropriate guidelines.
Cleaning the Control Module, Cart, and Remote Footswitch: Option 2 Using Process Chemical Super Sani-Cloth (Manufacturer: PDI): 1. Use the specified wipe to wipe all external surfaces, including crevices to remove any debris. 2. Use the specified wipe to thoroughly wipe all external surfaces including cracks and crevices, ensuring that a wet surface is maintained for 2.5 minutes. Note: Additional wipes may be used to maintain the 2.5 minute contact time. 3.
Note: The gears and electronics on the underside of the Holster should not be wiped with the cleaner. Note: Additional wipes may be used to maintain the 2.5 minute contact time. 4. Allow the holster to air dry. 5. Perform a visual check to ensure all visible contamination is removed from the surface. If contamination is present, repeat steps 1-4 until no visible contamination is present.
sufficiently removed. Purified or deionized water should be used during final rinsing processes, where applicable. (Multiple rinses may be required.) Refer to the manufacturer’s recommendations for the removal of disinfectant residue. NOTE: Disinfected products should be stored in a dry clean environment, protected from contamination, direct sunlight, pests, and extreme temperature and humidity. Do not transport the device in a container prior to disinfection.
1. Using a new wipe, thoroughly wipe the holster holder to maintain the specified contact time, per the wipe manufacturer’s instructions. (See the table above.) Additional wipes may be necessary to maintain the specified wet contact time. 2. Allow the holster holder to air dry. Do not expose the device to heat greater than 54°C. Cleaning the Remote Keypad: Option 1 After each use, manually clean the remote keypad thoroughly using a pH-neutral enzymatic detergent. Proceed with manual cleaning: 1.
solutions, may influence the wear of a device or equipment. 1. Soak a clean cloth in the disinfectant solution. Squeeze the cloth thoroughly to remove all excess solution. 2. Thoroughly wipe down all surfaces (including crevices) of the remote keypad ensuring that a slightly wet surface is maintained for five minutes. 3. Sterile gauze or a clean, soft cloth moistened with purified water should be used to remove the disinfectant from the device. Repeat four additional times to thoroughly remove residue. 4.
Chapter 8 SOFTWARE DESCRIPTION Touchscreens and Screen Button Functions The Mammotome revolve Dual Vacuum-Assisted Biopsy System software guides users through the following functions using touchscreens via Graphic User Interface (GUI) on the control module. Device Confirmation and Initialization Screens Searching for Holster Screen • This screen is displayed when the control module has been turned on but a holster is not detected.
Proceed to Initialization Screen • This screen is displayed when the control module has been turned on, and the system detects a probe attached to the holster. • The user must touch the forward arrow button on the touchscreen to proceed to system initialization. • If the system is turned on with a holster and probe attached, the start-up process takes the user to this screen.
ST and U/S Procedure Screens Procedure Ready Screen • This screen is displayed once the system is fully initialized and ready to perform clinical functions.
Set Aperture • On this Confirm Selection Screen, the user can select one of three options for the length of the sample aperture: o 12mm o 18mm o Full aperture • At Full aperture settings, the 8G Mammotome revolve probe has a 23mm aperture, and the 10G Mammotome revolve probe has a 19mm aperture. • To adjust the setting: First, touch the “Set Aperture” button. Then touch the desired aperture length shown on the screen.
Set View Position • On this Confirm Selection Screen, the user can select from four distinct viewing locations for the most recent tissue sample obtained to be presented for visual inspection. • When a tissue sample is retrieved, it is always deposited into the “top” viewing position first (in line with the alignment indicator on the probe). If an alternate viewing position has been selected, the chambers then rotate to present the specimen to the user in the selected location.
Advance to Chamber 7/Reset Chambers Advance to Chamber 7 / Reset Chambers Advance to Chamber 7 Advance to Chamber 7 (Example below: Three samples have been attempted. • The Advance to Chamber 7 function is used to “Advance to Chamber 7” is available for activation.) skip the remaining chambers in the first set, to start acquiring tissue samples in the second set of chambers (7-12) in the specimen management system.
Biopsy Counter • This number is seen in the center of the SMS graphic and represents the number of attempted samples taken during the biopsy procedure for a single probe. The number increases as each sample is attempted for a single probe. • The biopsy counter automatically resets when a probe is removed from the holster. The user may manually clear the count immediately after “Reset Chambers” is executed by pressing and holding the center of the SMS graphic for ~2 seconds.
SteadyVac (Example below: SteadyVac is ON.) • This setting directs the system to apply a continuous and low-level vacuum to keep the biopsy cavity, probe, and tubing clear, to minimize clogging and incidence of hematoma at the biopsy cavity. • Press the touchscreen icon once to turn the function on. Press again to turn it off. Pressing a clinical function button (e.g. BIOPSY, VAC, Open/Close) while SteadyVac is on disables SteadyVac and returns the system to Ready state.
EX Procedure Screens 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Set Aperture Buttons and Status Aperture and Cutter Position Indicator Saline Level Buttons and Status Biopsy Count Location and Count Reset Button Vacuum Level Buttons and Status Volume Level Button Brightness Level Button Keypad/Footswitch Indicator Standby Button Button Activation Indicator Procedure Ready Screen • This screen is displayed once the system is fully initialized and ready to perform clinical functions.
Set Aperture • On this Confirm Selection Screen, the user can select one of three options for the length of the sample aperture: o 12 mm o 18 mm o 25 mm (Full Aperture) • To adjust the setting: First, touch the aperture size desired. Then touch the Confirm button shown on the screen. • The Aperture length returns to the default setting after initialization of a probe.
Biopsy Counter • This number is seen in the center of the SMS graphic and represents the number of attempted samples taken during the biopsy procedure for a single probe. The number increases as each sample is attempted for a single probe. • The biopsy counter automatically resets when a probe is removed from the holster. The user may manually clear the count by pressing and holding the center of the SMS graphic for ~2 seconds.
Volume and Screen Brightness Volume • Volume and Brightness settings can be accessed from any screen and allow the user to adjust the system volume level and touchscreen brightness for better audible and visible feedback. • Changes to the volume and screen brightness levels are saved on system shutdown and will return to the previously set level the next time the system is powered on.
Standby Screens Standby Main Screen • This screen is displayed when the user places the system into an inactive state. The system displays the detected input devices and holster/probe attachment status.
Shutdown Screen • To shut down the system, the user must select the green power button on the front of the control module. • A prompt then appears on the screen to confirm the intended shutdown. • Touch YES to proceed with shutdown. o If YES is selected, the green power button on the front of the control module turns to an amber color, indicating the system has shut down. o Pressing NO returns to previous screen.
Utilities Main Screen • The main utilities screen allows the user to access system utility settings: • • • Change Language Access Data Logs Access System Information • Utilities can be accessed from the Standby Screen and any time prior to initialization. Language Screen • The Language screen allows the user to view the software screens in alternate languages. • After a selection has been made, press the Utilities icon to exit the screen.
Chapter 9 SERVICE AND TROUBLESHOOTING All information in this guide applies to ST, U/S, and EX unless otherwise stated. Service Do not attempt to disassemble the holster or electrical cable; doing so will void the product warranty. No user-serviceable parts are located inside the holsters. Refer servicing to qualified personnel or contact customer service through one of the phone numbers listed at the end of this chapter. Table 7.
Symptom Possible Cause Corrective Action • Probe/holster did not initialize correctly. NOTE: The probe will make a clicking sound as the SMS chambers are rotated. • Replace the probe on the holster and proceed through initializations. Once the Procedure Ready Screen appears, the next tissue sample will be deposited into Chamber 1. If Chamber 7 is desired for the next sample, select Advance to Chamber 7 on the touchscreen interface. • Remove the probe from the holster.
Symptom Possible Cause Corrective Action rotation knobs are broken. ST Only: Trocar shaft rotation appears extremely uneven. Misalignment of the probe guide peak or probe aperture rotation thumbwheel. Lateral line pinch valve is engaged, preventing vacuum flow. Stopcock valve has closed off the axial vacuum line, preventing vacuum flow. Specimen samples are not consistently transporting into the specimen collection chambers.
Symptom Possible Cause Corrective Action into a different chamber than the expected one. • Sample aperture is not fully closed after initialization. Probe/Holster did not initialize correctly. • • Be sure to press the buttons for the proper duration for a desired function. Pressing a button for too long (or too quickly) can activate the wrong function.
Symptom Possible Cause Fluid does not visibly move in the vacuum tubing when the Vacuum button is pressed and released. Vacuum button is being held too long to trigger Clear/Dry Tap, but not long enough to trigger the Vacuum function. With the SMS removed from the probe, fluid is leaking from the probe’s marker insertion port. Probe is clogged. Cannot insert the valve cartridge into the control module’s vacuum connection slot. Marker insertion is difficult.
Table 8. Mammotome revolve Dual Vacuum-Assisted Biopsy System Software Troubleshooting Tips Symptom Possible Cause System reports “Control Module Malfunction” when powered on. Control module malfunction. Corrective Action • Call Custom Service and report the error code displayed. • Ensure the vacuum tubing is connected to the probe and the vacuum canister, and that the valve cartridge is fully seated into the control module’s connection slot. • Replace the canister.
Symptom (continued) System returns to Standby and reports error message: “Vacuum Error, Check Tubing Connections” Error Code 400 or 402. ST Only: System instructs the user to reinitialize the holster: Error Code 904. System reports: “Check Holster and Probe Attachment” during function execution. Error Codes 805 – 819. System reports “Check or Replace Cup” during function execution: Error Codes 705 – 720. Possible Cause (continued) Vacuum canister leak, or vacuum pump is not working properly.
Symptom (continued) Possible Cause (continued) Biopsy button was activated outside of the breast, or excessive usage was detected by the system. Corrective Action (continued) • This is normal operation. The biopsy function will still be available. Vacuum tubing connections at the probe are loose. • Check/tighten all vacuum connections at the probe and canister. Tissue strips in the SMS are loose. • Ensure the tissue trips are fully inserted into the SMS.
Chapter 10 SYSTEM SPECIFICATIONS Classification E350543 Product Code(s) MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2 No.
(for GE Upright Systems) MCANISTER1 Mammotome® revolve Canister X MSMB1208 Mammotome revolve Specimen Management System X MSMB1210 Mammotome revolve Specimen Management System X Storage/Operating Conditions Shipping and Storage -18°C to +54°C 10% to 95% Relative Humidity (MSCM1, MCART1, MSTH1, MHUSH1, MHEXH1) 10% to 90% Relative Humidity (MFOOT1, MHKEYP1) 500 hPa to 1060 hPa Atmospheric Pressure Environmental Operating Conditions 5°C to 32°C 30% to 75% Relative Humidity 810 hPa to 1060 hPa Atmo
WARNING: This medical device emits electromagnetic energy that may interfere with other nearby medical devices, which may cause those devices to malfunction or seriously harm the patient. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Mammotome revolve Dual Vacuum-Assisted Biopsy System is intended for use in the electromagnetic environments specified below.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Mammotome revolve Dual Vacuum-Assisted Biopsy System is intended for use in the electromagnetic environments specified below. The customer or user of the Mammotome revolve Biopsy System should assure that it is used in such an environment.
System Specifications Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Mammotome revolve Dual Vacuum-Assisted Biopsy System is intended for use in the electromagnetic environments specified below. The customer or user of the Mammotome revolve Biopsy System should assure that it is used in such an environment.
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 and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
WEEE (The Waste Electrical and Electronic Equipment Directive This symbol on the product(s) and / or accompanying documents means that used electrical and electronic products should not be mixed with general household waste. For proper treatment, recovery and recycling, please take this product(s) to designated collection points where it will be accepted free of charge.
Calling for Service Call 1-877-926-2666 within the U.S. or contact your local representative. Customer support is also available by emailing us.customerservice@mammotome.com.. Please include 1) your account name and number, 2) your contact information and 3) your question. Once received, a member of the Customer Support Team will reply within one business day. Requesting a Paper Copy of the Information for Use (IFU) Call 1-877-926-2666 within the U.S. or contact your local representative.
Chapter 11 WARRANTY Devicor Medical Products, Inc. warrants this product to be free from defects in material and workmanship under normal use and preventative maintenance for the respective warranty period shown below. Devicor Medical Products, Inc.’s obligation under this warranty is limited to the repair or replacement, at its option, of any product, or part thereof, which has been returned to Devicor Medical Products, Inc.
Chapter 12 STEREOTACTIC (ST) HOLSTER STATES State and Aperture Holster only without Variable Aperture Remote (Keypad or Footswitch) without Variable Aperture • Ready • Closed • Armed • Closed • Armed, Standby • Closed • Just Fired • Open • Ready • Open • Ready • Open • 12th Sample Taken • Closed State and Aperture • Ready • Closed Remote (Keypad or Footswitch) with Variable Aperture ON System cannot ARM with Variable Aperture Set.
MSCM1, MSTH1, MHUSH1, MHEXH1, MCART1, MHEXHOLD1, MHKEYP1, MFOOT1, MST0809, MST0812, MST0815, MST1009, MST1012, MST1015, MHUS08, MHUS10, MHEX08, MHEX08S, MG08A, MG08B, MG10A, MG10B, MCANISTER1, MSMB1208, MSMB1210 Certificate Holder (Brazilian representative company) Hospiline Comércio e Distribuição de Produtos Médico-Hospitalares Ltda. Alameda São Caetano, 713 - Barcelona - São Caetano do Sul - São Paulo - Brasil CEP: 09560-050 – Tel.: +55-11-4226-0666 ©2020 Devicor Medical Products, Inc.
Mammotome revolve Dual Vacuum-Assisted Biopsy System User Instructions and Operations Guide Mammotome revolve User Instructions and Operations Guide (English) ARTWORK NUMBER AW-001413 SCALE REVISION 1:1 C PRODUCT CODE MSCM1, MSTH1, MHUSH1, MCART1, MHKEYP1, MFOOT1, MST0809, MST0812, MST0815, MST1009, MST1012, MST1015, MHUS08, MHUS10, MG08A, MG08B, MG10A, MG10B, MCANISTER1, MSMB1208, MSMB1210, MHEXH1, MHEX08, MHEX08S, MHEXHOLD1 ECN NUMBER DATE ECN-002017 04/30/2020 DRAWN BY A.
