EnCor Operators Manual

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INTRODUCTION ...2 Description ...2 Intended Use ...2 Contraindications ...2 Warnings ...2 Precautions ...3

2.

ENVIRONMENTAL AND TECHNICAL INFORMATION ...4 Environmental ...4 Technical Information...4

3.

UNPACKING INSTRUCTIONS...5

4.

COMPONENT LAYOUT AND CONTROLS ...6 Vacuum System ...7

5.

INITIAL SET-UP INSTRUCTIONS ...8

6.

CONTROL MODULE – SCREEN DESCRIPTIONS ...13 Screen Descriptions...13

7.

OPERATING INSTRUCTIONS ...15

8.

SYMBOL DEFINITIONS ...20

9.

CLEANING AND DISINFECTING ...21 Disposal of Equipment...21

10. ROUTINE MAINTENANCE ...22 11. CONFORMANCE TO STANDARDS ...24 12. WARRANTY ...25

Operator’s Manual’s • EnCor® System

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1.

INTRODUCTION

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. DESCRIPTION The SenoRx EnCor System is designed to provide control operations for specialized SenoRx diagnostic and surgical devices. The EnCor System includes: •

Control Module (CM 3000)

•

Vacuum System (VS 3000)

•

Cart (CART01)

The Control Module provides interface between Drivers and the Vacuum System. SenoRx Biopsy Probes, Vacuum Tube Sets, Canisters, and accessories are available separately. The EnCor System 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. INTENDED USE The EnCor Breast Biopsy System is indicated to acquire tissue for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the 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. CONTRAINDICATIONS This device is not intended for use except as indicated. In addition, it is not intended for use under conditions where breast tissue excision is contraindicated. WARNINGS Warning: The EnCor System must be properly grounded to ensure patient safety, and is supplied with a medical grade power cord with AC plug. Do not connect the power cord to extension cords or three-prong to two-prong adapters. Warning: To minimize interference with other equipment, leads or cables should be positioned to prevent contact with other leads. Warning: Only SenoRx accessories can be used with the EnCor System. Potentially hazardous conditions may exist if non-SenoRx accessories are used. Warning: Do not remove covers. Removing covers may cause electrical shock. Contact SenoRx for service.

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SenoRx, Inc.

Warning: In service or operation area – sound levels for generated tones are to be measured when standing in front of the Control Module enclosure. Warning: The CART01 with equipment installed is stable on a slope of up to 10°. PRECAUTIONS Caution: This equipment is intended for use by qualified personnel only. Caution: Locate the SenoRx EnCor System 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: Inspect tubing connections to the vacuum canister and the disposable tubing set to ensure proper vacuum levels are achieved and maintained during use. Caution: Inspect the Vacuum Canister to insure no damage has occurred during shipping or installation. A heavily scratched canister can break during use. Caution: Do not leave the EnCor System powered on overnight. Damage may occur to the tubing set. Caution: Connect the power cord to a Hospital Grade wall outlet having the correct voltage or product damage may result.

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2.

ENVIRONMENTAL AND TECHNICAL INFORMATION

ENVIRONMENTAL Required Conditions for Operation Ambient temperature

15° - 35° C (59° - 95° F)

Relative humidity

30% - 75%, non-condensing

Atmospheric pressure

700 - 1060 millibar

Required Conditions for Storage Ambient temperature

-40° - 70° C (-40° - 158° F)

Relative humidity

10% - 95%, non-condensing, STP

Atmospheric pressure

500 - 1060 millibar

TECHNICAL INFORMATION Class

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

EnCor System Power: Maximum Ratings

100 – 120 VAC 10A, 50/60 Hz, 3-wire, grounded with removable power cord 220 – 240VAC 5A, 50/60 Hz, 3-wire, grounded with removable power cord

Nominal Ratings

Standby (Ready for biopsy) Voltage/Frequency Current VA (Calculated) Watts Power factor

Nominal Ratings

115 VAC/60 Hz 0.65 A 74.8 63 0.856

230 VAC/50 Hz 0.54 A 124.2 71 0.571

115 VAC/60 Hz 6.89 A 792.4 741 0.950

230 VAC/50 Hz 3.81 A 876.3 729 0.833

Operating (Ready for biopsy) Voltage/Frequency Current VA (Calculated) Watts Power factor

EnCor System Dimensions

16” Wide x 34” Deep x 48” High (40.64 cm x 86.4 cm x 121.92 cm)

EnCor System Weight

155 lb (70.3 Kg)

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SenoRx, Inc.

3.

UNPACKING INSTRUCTIONS

Thoroughly inspect the packaging materials and the EnCor System for any signs of transit damage. Do not use the unit if it appears to have any damage. Contact SenoRx Customer Service for instructions on how to report shipping damage. CART Carefully unpack and remove contents. VACUUM SYSTEM Carefully unpack and remove Vacuum System. CONTROL MODULE Carefully unpack and remove Control Module. SEPARATELY PACKAGED ACCESSORIES 1

AC Power Cord (SenoRx PC3100)

1

18” AC Power Jumper Cord (SenoRx PC3150-002)

1

53” AC Power Jumper Cord (SenoRx PC3150-003)

1

Footswitch (SenoRx FS3000)

1

Control Module to Vacuum System Cable (SenoRx CB3100)

Operator’s Manual • EnCor® System

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4.

COMPONENT LAYOUT AND CONTROLS

FRONT PANEL DISPLAY AND CONTROLS 4

3 2

1

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

REAR PANEL CONNECTIONS AND CONTROLS

1 Footswitch Connector 7

2

2 Not Used 3 Vacuum System Connector 4 Power Inlet Connector 5 Power Outlet Connector 6 Fuse Holder

5

3

1

7 Equipotential Stud

8 4

6

8 Main Power On/Off

REAR PANEL TEXT D

E

K

I

A

B

C

F G

6

H

J

A To SenoRx accessories B To footswitch C To vacuum system D Refer to user manual for instructions E Warning: F Output: 5a max G Input: 7a max H Fuses (2): 100-120v ~ t2.0a, 250v 220 – 240v ~ t1.0a, 250v I Caution: only replace fuses with same type and rating J voltage: 100-240v, frequency: 50/60 Hz, current: 1.8a/.9a max

SenoRx, Inc.

VACUUM SYSTEM Rear Panel POWER Switch

Primary on/off control

Front Panel When active, front panel indicators illuminate as follows: POWER

Green

VACUUM READY

Green

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5.

INITIAL SET-UP INSTRUCTIONS

Tools Required: •

5/64” Allen Key (Supplied)

•

5/32” Allen Key (Supplied)

•

Screwdriver, Phillips (Not Supplied)

Supplied Hardware Qty.

Description

2

¼ - 20 x ½” Flat Head Socket Screw

2

¼-20 x 5/8” Flat Head Socket Screw

1

¼ - 20 x ¾” Flat Head Socket Screw

5

¼” Conical Lock Washer

2

¼ - 20 x 1 ¼” Button Head Cap Screw

2

¼” Flat Washers

2

¼” Internal Tooth Lock Washer

1. Remove Cart, Vacuum System, and Control Module from packing. 2. Remove the power strip cover at the base of the Cart by removing the two screws. Set the cover and screws aside for later re-installation.

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SenoRx, Inc.

3. Route the male end of the 53” Power Jumper Cord from the top shelf of the cart through the Cart’s hollow center post down to the power strip. On the top shelf, temporarily secure the Female end of the Jumper Cord with tape to prevent it from falling down into the post. 4. Route the Male end of the cord up through the right-side oval hole in the bottom of the Power Strip Box. Connect the Male end to the nearest socket in the power strip.

5. Verify that the Vacuum System’s voltage setting by looking at the window on the Input Power Module. If required, refer to the Vacuum System section to change the voltage setting. Verify that the Power Switch is in the “Off” position.

6. Carefully lift the Vacuum System and place onto the bottom shelf of the Cart.

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7. Secure the Vacuum System to the Cart shelf by aligning the knob’s threads with the single threaded insert centered in the bottom of the Vacuum System. Tighten the knob hand tight, securing it to the Cart.

Threaded Knob

Vacuum System Installation Method A

8. Place the Control Module onto the top Shelf of the Cart and align the hole in the Cart with the threaded hole in the Control Module then attach it to the Cart using a ¼ - 20 x ¾“ Flat Head Socket Screw and a ¼” conical lock washer.

9. Ensure that the Control Module Main Power Switch is in the “Off” position. Attach the Female end of the 53” Power Jumper Cord routed up through the center post of the Cart to the Power Inlet Connector on the Rear Panel of the Control Module. 10. At the Power Strip Box, route the 18” Power Jumper Cord from the power strip through a hole in the bottom of the Power Strip Box to the Input Power Module of the Vacuum System.

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SenoRx, Inc.

11. Connect either end of the Vacuum System to Control Module Cable to the blue-banded connector labeled “Vacuum System” on the rear of the Control Module. Route the remaining end down through the center post of the Cart. Guide the end of the Cable out through the hole in the side of the center post of the Cart. Connect the other end to the blue-banded connector marked “Control Module” on the rear of the Vacuum System.

12. Connect the Footswitch to the connector labeled “Footswitch” on the rear of the Control Module.

13. Route the Female end of the gray Power Cord from under the Power Strip Box and up through the left side oval hole on the bottom of the Power Strip Box. Connect it to the left-most Power Strip Connector and secure with the wire latch. Operator’s Manual • EnCor® System

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14. Replace the Power Strip Cover using the previously removed screws to complete the equipment installation. 15. Connect the gray Power Cord from the Cart only to Hospital Grade grounded wall outlets of the correct supply voltage.

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SenoRx, Inc.

6.

CONTROL MODULE – SCREEN DESCRIPTIONS

SCREEN DESCRIPTIONS Startup Screen

While the Control Module initializes, the SenoRx logo is displayed on the screen

Language Screen

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

Connect Device Screen Following initialization, the Connect Device screen displays. While this screen is active, connect a Device. For additional options, press the bottom button to the right of the display on the Front Panel of the Control Module.

Intensity Adjust

Adjust the display intensity brighter or dimmer using the corresponding buttons to the right of the screen icons on the Front Panel of the Control Module. Press the lower right button (Return) to return to the previous screen.

Audio Adjust Adjust the audio volume louder or softer using the corresponding buttons to the right of the screen icons on the Front Panel of the Control Module. Press the lower right button (Return) to return to the previous screen.

Operator’s Manual • EnCor® System

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Device Detected

This screen displays acknowledgement from the Control Module that a SenoRx Device is connected, and indicates that the Script for the individual Device is loading.

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SenoRx, Inc.

7.

OPERATING INSTRUCTIONS

Vacuum System Set-up 1. Position the EnCor System as required for safe use and plug the Power Cord from the Cart into a Hospital Grade wall outlet. 2. Verify that the Vacuum System pinch valves are free of any debris which may inhibit proper function. Install the Canister, Rinse Tube Set and Vacuum Tube Set as shown in the following pictures. 3. All Canister connections must be securely made or a decrease in available vacuum and alarm conditions may result. Verify that the lid is securely snapped onto the Canister Base and that all unused lid port caps are pressed firmly over the unused ports. Place the Canister into the Vacuum System and securely attach the center port.

4. If using the Rinse feature, install a new Rinse Valve Tube Set and Saline Bag by holding the Rinse Valve Tube Set with the saline bag connector in the left hand and the Probe Tube Set connector in the right hand. Line up the black mark on the Rinse Tube Set with the center pinch bar of the Rinse Valve. Pull the Rinse Tube Set down into the Rinse Valve slot until all of the tubing slides down into the Rinse Valve. Connect the saline bag connector (left side of installed Rinse Valve Tube Set) to the saline bag which can be placed into the upper shelf within the Vacuum System.

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5. Install the Vacuum Tube Set:

6. The finished installation should look like:

Rinse Tubing Set

Vacuum Pinch Valves

Rinse Pinch Valve

Vacuum Tubing Set

Vacuum Tubing to Canister

Vacuum Canister Bracket

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SenoRx, Inc.

Probe Tubing Connection to Vacuum System 7. Connect the Probe Tube Set to the Vacuum Tube Set as follows:

8. Connect the Probe Tube Set to the Rinse Tube Set as follows:

Control Module Driver Connection 9. Turn on the power on the rear of the Vacuum System and Control Module. 10. Connect the appropriate Device Driver to the rectangular connector on the front of the Control Module.

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11. Follow the Control Module screen prompts. Calibrate the biopsy disposable. 12. “Vacuum Ready” light should be illuminated indicating correct vacuum level has been achieved to initiate biopsy procedure. Vacuum Ready light will only illuminate if biopsy disposable is installed and calibrated. If the “Vacuum Ready” light does not illuminate check all tubing connections and vacuum canister connections to insure correct installation. .

Operation 13. For Handheld Accessory Devices follow the specific Instructions for Use included with each accessory. Note: If the system fails during use, check rear panel for blown fuse. Replace as needed. 14. After Use Remove disposables and discard per your facilities procedures. Clean and disinfect per the instruction located under the cleaning and disinfecting section. The Device may be left connected to the Control Module if similar procedures are to be performed. Turn the power switches on the rear of the Vacuum System and the Control Module to the “Off” position. Accessing the Language Screen The language screen can only be accessed during Power Up. From the “Off” state, press and release the top left (Power) button on the Front Panel of the Control Module, then quickly press and hold any the top two buttons to the right of the display on the Front Panel. Language selections are scrolled through using the up and down buttons as indicated on the display. To select any language when it is displayed, press the bottom button (Select) to select that language and return to the Main Screen. Alarm Conditions and Troubleshooting The Control Module is programmed to attempt to determine a reason for any alarm condition that occurs. If the Control Module can find a cause for an alarm, the information is displayed on the display screen.

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SenoRx, Inc.

Depending on the cause of the alarm, different scenarios are required to clear the alarm. Certain alarm causes, when corrected, allow the Control Module to recover automatically, and return to a ready state. Other alarms require pressing a button as indicated on the Display of the Control Module 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 Control Module with the Front Panel Power button. If any alarm condition persists after correcting known problems and clearing the alarm condition from the screen, contact SenoRx for service.

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