CSI Diamondback DB-2000 User manual

©2009 Cardiovascular Systems, Inc. 90074-00.F
Controller Manual Part I
Instructions for Use
Model DB-2000

2
©2009 Cardiovascular Systems, Inc. 90074-00.F
Introduction
This document describes the components and use of the Diamondback 360º® Orbital Atherectomy Controller
(Controller). The Controller is a component of the Diamondback Orbital Atherectomy System (OAS). Read this
document thoroughly before using the OAS, Controller, or any other components. Review the contraindications,
restrictions, warnings, and precautions carefully. Additional instructions and information are found in the
Diamondback Orbital Atherectomy Device (OAD) Instructions for Use and package inserts included with separately
packaged components. Read all instructions completely before using the OAS or any components.
Indications for Use
The Diamondback Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as
therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for
percutaneous transluminal atherectomy.
The OAS is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).
Diamondback 360 Orbital Atherectomy System (OAS) Description
CSI Supplied Equipment
•Orbital Atherectomy Device (OAD)
•Controller
•Guide Wire - as specified in the OAD Instructions for Use
•Gas input line and connector – connects from the controller to the air supply
Additional Components
These are independently obtained, as listed below. Follow the original manufacturer’s instructions for each
independently sourced component.
•Guide Catheter / Sheath Introducer – See the appropriate Instructions for Use for recommended guide catheter
sheath introducer sizes.
•Compressed Gas Cylinder or house air supply – The gas must be air or nitrogen.
•Cylinder Pressure Regulator – The regulator must be capable of delivering at least 5 scfm (140 liter/min) at 85-
100 psi (5.8-6.9 bar).
•Normal Saline Solution for Injection – At least one full 1-liter bag must be available.
•Other equipment as needed for interventional procedures.
Diamondback 360 Orbital Atherectomy Controller
This document explains the function of the Orbital Atherectomy Controller (Controller). Device specific instructions
for use are available separately as packaged with the Orbital Atherectomy Device (OAD).
The Orbital Atherectomy Controller (Controller) is an electro-mechanical control system. The functions of the
Controller include:
•Regulation of gas pressure to the turbine that controls Shaft/Crown rotational speed..
•Recording of operation time including event time, and total time.
•Regulation of saline flow through the Sheath covering the Shaft.
Contraindications, Restrictions, Warnings and Precautions
Contraindications
Refer to the OAD Instructions for Use for the associated contraindications.
Restrictions
•The OAS should only be used by physicians who are experienced in peripheral angioplasty at his or her
institution and trained on the use of the OAS.
•Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Warnings
•If mechanical failure of the Controller occurs before or during the atherectomy procedure, discontinue use
immediately and return the product to Cardiovascular Systems, Inc. Do not attempt to use a damaged OAD,
Controller, or other system component. Use of damaged components may result in system malfunction or
patient injury.

3
©2009 Cardiovascular Systems, Inc. 90074-00.F
•Never connect the Controller to an oxygen cylinder or use oxygen as the compressed gas for the system. Use of
oxygen may result in an explosion. Only use compressed air or nitrogen.
•Do not operate the Controller with gas pressures in excess of 100 psi (6.9 bar). If a hissing noise is noted from
the Controller, check to make sure that the gas pressure supplied to the Controller (located at the rear of the
controller) is properly attached via the gas line connector and the supply pressure does not exceed 100 psi (6.9
bar). The Controller is equipped with a pressure relief valve to protect against excessive inlet pressure.
•Never operate in the presence of flammable gas.
•Do not remove controller cover due to electrical shock hazard. Refer servicing to qualified personnel.
Precautions
•Do not place items on the controller box, spill saline or other fluids on the Controller. Saline or fluids inside the
Controller may result in corrosion or electrical hazard.
•Make sure the cylinder pressure regulator’s fitting is compatible with the gas cylinder used.
•Verify the type of gas coupling provided with the Controller prior to procuring a pressure regulator and
connecting hose. If necessary, use suitable adapters to make the connection.
•Do not connect anything to the monitor connections other than the intended components.
•The controller should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, the Controller and Orbital Atherectomy System should be observed to verify normal operation
•The Controller is only to be used with the supplied foot pedal. Use of other non-Cardiovascular Systems, Inc
supplied foot pedals may result in increased emissions or decreased immunity of the orbital atherectomy
system.
Controller
User Interface
(Monitor)
Controller Box
Foot Pedal and
Housing
Castors
Gas Input
Connector
(Backside of
Controller Box)

4
©2009 Cardiovascular Systems, Inc. 90074-00.F
User Interface
The touch screen display of the Controller displays the following:
Operation Window
The operations window allows user to Turn the pump on, Change IV Bag and Turn the system off
Upon selecting “Turn the pump on” display of the Controller displays the following:
User Controls Area:
Contains controls that allow user to do the following:
Pump On/Off button
Speed gauge and speed selection control
Speed increment/decrement controls
Speed set point display
System Status Area:
Feedback about the system status is displayed in this area. Includes state and notification information and user
prompts.
System / Notification Status
Indicate system status information. A notification condition describes the active notification.
System / Notification Prompt
System prompt shows the prompt text for action required by the system status.
Notification prompt tells the operator what can be done from a user perspective about an active notification condition.
Therapy Status Area:
The Therapy Status Area displays the following therapy information:
Speed is the actual speed of the OAD in thousands of RPM
Event time is the elapsed time between therapy (OAD) start and stop for the last therapy session. When the turbine is
started for the next session the event time is reset to zero.
Total time is the summation of all event times. This value is only zero after power up.
Controller Front Panel
Turbine Gas Connect – The Turbine Gas Hose of the OAD connects to the Turbine Gas Connection on the front of
the controller by pushing in until it locks in place. It can be released by pressing down on the release connection on
the controller fitting
Optical Tachometer Fiber Connect – The Optical Tachometer Fiber connects to the Optical Tachometer Fiber
connector on the front of the controller by pushing in until it locks in place. It can be released by pressing down on
the release connection on the controller fitting
The Optical Tachometer Fiber carries light from the Control Handle to the Controller to measure Shaft/Crown
rotational speed.

5
©2009 Cardiovascular Systems, Inc. 90074-00.F
Controller Front Panel Controller Back Panel
Controller Back Panel
Power On/Off Switch – The power switch is used to turn the Controller On and Off. The power down sequence is to
turn off the user interface first via the touchscreen and then hard power down via controller switch.
Power Input – The power cord plugs into the Controller and a conventional 100-240 VAC receptacle, 1A at 50-60
Hz(as indicated on the label located on the back of the Controller) and provides power to the Controller. Fuse rating
is 250 V, 4A Slow Blow, Type T
Gas Input – Standard, hospital supplied tubing connects the regulator of the compressed gas cylinder to the
Controller allowing for gas to be supplied to the Turbine.
Potential equalization terminal - For the purpose of testing the grounding of the controller. Note: remainder of roll
stand may not be grounded.
Controller Side Panel
Roller Pump – Pumps saline from the 1000 ml saline bag through the Sheath and around the Shaft.
Foot Pedal
Foot Pedal Housing – The basket below the Controller houses the Foot Pedal and power cord for storage
Foot Pedal
The Foot Pedal comes pre-connected to the Controller. When the pump is on and a speed setting selected,
depressing the electrical Foot Pedal once causes saline to flow at the high pump speed. Depressing the Foot Pedal
again (within five seconds) opens the compressed gas line and starts the turbine, which results in Shaft/Crown
rotation. Releasing the Foot Pedal closes the compressed gas line and stops Shaft/Crown rotation. The pump speed
automatically resets to low pump speed within 7 seconds after release of the foot pedal.
Compressed Gas Cylinder and Regulator
Additional equipment needed to operate the OAS includes a compressed gas cylinder and cylinder pressure regulator
or a hard plumbed compressed air line set between 85-100 psi.
Compresses Gas System
A compressed gas system must contain air or nitrogen. A cylinder capacity of at least 80 standard cubic feet (2250
liter) is recommended and will provide approximately 20 minutes of service with the OAS running at full speed.
Larger cylinders may be used. A fully charged spare cylinder should always be available.
Cylinder pressure regulator – The cylinder pressure regulator must be capable of delivering at least 5 scfm (140
liter/min) at 85-100 psi (5.8-6.9 bar). A relieving type cylinder pressure regulator is preferred. The regulator’s
cylinder filling capability should be compatible with the gas cylinder being used.
Hospital Air System
A hospital compressed air or nitrogen system can be used in place of a gas cylinder and regulator.
1. The compressed gas must be air or nitrogen.
2. The gas must be clean, dry, and oil free.
3. The gas pressure must be 80-100 psi (5.8-6.9 bar, 551.6-689.6 kPa) at the inlet to the Controller.
4. The system must be capable of supplying gas at a rate of 5 scfm (140 liter/min).
Power On/Off Gas Input
Power Input
Saline Pump

6
©2009 Cardiovascular Systems, Inc. 90074-00.F
OAS Assembly and Setup
Pre-Procedure Equipment Setup
Ensure all components are available for system set up.
Note: Hang a full 1-liter bag of saline from the pole on the Controller.
Note: Verify the saline tubing is not kinked or damaged and that the tubing is properly inserted into the roller pump.
Follow the directions below to set up the OAS.
Controller Setup
1. Verify the power cord is connected to the back of the Controller.
2. Insert the other end of the power cord into a properly rated, hospital grade receptacle.
Compressed Gas Cylinder Setup
1. Setup the compressed gas (air or nitrogen), regulator, and tubing according to standard hospital protocol.
2. Connect the gas tubing to the Gas Input connector on the back of the Controller.
Note: Push down on the Release Button to open the connector before inserting the hose connector. Carefully
connect the hose to prevent damage to the connector O-ring. Damage to the O-ring (and “hissing”) can occur if the
connector is plugged into the controller when the mating connector is closed.
OPEN CLOSED
Release Button
Actuator Button
Connector and
O-ring

7
©2009 Cardiovascular Systems, Inc. 90074-00.F
Orbital Atherectomy Device (OAD) Setup
Refer to the OAD Instructions for Use for complete instructions related to OAD setup.
Connecting the OAD to the Controller:
1. Remove the tubing from the OAD package and pass it out of the sterile field to the circulator or non-sterile
personnel.
2. Have the circulator or non-sterile personnel connect the Turbine Gas Intake Hose to the Controller at the Turbine
Gas connector on the front of the Controller.
3. Have the circulator or non-sterile personnel connect the Optical Tachometer Fiber to the Controller at the Optical
Tachometer Fiber connector on the front of the Controller.
Note: Care should be taken to keep the Fiber end clean and free of any material that could interfere with optical
transmissions.
4. The circulator or non-sterile personnel performs the following steps:
a. Ensure the Controller On/Off switch is in the off position.
b. Hang a full 1-liter bag of saline from the pole on the Controller.
c. Connect the saline tubing to the saline bag using standard hospital procedure.
d. Lift the roller pump lever to open the roller pump door.
e. Place the saline tubing into the grooved tubing guides of the roller pump. Ensure that the tubing guide
located on top of the pump housing is appropriately adjusted for tubing diameter. See figure A.
f. Close the roller pump door. See Figure B.
Figure A Figure B
5. Turn the Control Unit on by pressing the Power On/Off switch on the back of the Controller.
6. Turn on the Pump by touching the Turn Pump On button in the operation window.
a. Note: Controller will default to Test Mode (60kRPM) once pump has been turned on.
7. Purge air from the saline tubing:
a. Press the Foot Pedal to start saline flow at high pump speed.
b. Watch for saline to exit from the saline tubing and ensure there are no air bubbles present in the saline
tubing.
c. When all the air is purged from the saline tubing, connect the saline line to the OAD saline connection
and repeat steps a through c to purge air from the OAD sheath.
8. Test the system to confirm device operation by depressing the foot pedal to begin spinning the Crown. Hold the
guide wire firmly during the test. When test mode is complete, an operational device is ready to be inserted into
the introducer in the patient.

8
©2009 Cardiovascular Systems, Inc. 90074-00.F
Procedure
Refer to OAD Instructions for Use for procedural information.
Saline Bag Change
When the Saline Low notification appears it is time to change the saline bag.
1. Stop the pump by touching the pump On/Off button.
2. Touch the Change IV Bag Button
3. Remove the bag spike from the bag and hold it for reuse.
4. Remove the empty bag from the pole.
5. Place a new bag on the pole and insert the bag spike.
6. Touch the OK button in the operation window to reset the saline volume to full.
a. If saline bag has not been changed touch Cancel in the operation window
7. Restart the pump by touching the Turn Pump On button in the operation window.
Device Change
To change out a device:
1. Stop the pump by touching the pump On/Off button.
2. Disconnect the tubing from the device handle in use.
3. Attach the tubing to the new device.
4. Touch the Turn Pump On button in the operation window to start the pump to prime saline through the
device. Stepping on the foot pedal will increase the flow rate to high for faster priming
a. Note: Controller will default to Test Mode (60kRPM) once pump has been turned on.
5. Refer to OAD Instructions for Use for procedural information.
Turning Off the Controller
1. Stop the pump by touching the pump On/Off button.
2. Touch the Turn System Off button in the operation window
3. Touch OK to shut down system
4. When the CSI splash screen is seen turn off the main power to the controller by pressing the On/Off button on
the back of the controller.
Cleaning the Controller and Foot Pedal
The Controller System should be cleaned regularly with a soft cloth dampened in water and mild detergent. Isopropyl
alcohol/ water mix (70/30) or Cydex should be used to clean and disinfect the Controller System from blood or other
contaminants. Do not immerse the Controller, Monitor or Foot Pedal in fluid. Avoid use of solvents or abrasive
cleaners, which may damage the Controller System components.
Controller Maintenance and Calibration
The Controller does not require routine or periodic maintenance or calibration. Contact CSI if questions arise related
to Controller function or performance.
Controller Repair and Shipping
Contact CSI if Controller repairs are required or for shipping instructions.
Classifications, per IEC/UL/CSA/EN 60601-1
•Class I Equipment
•Type CF Applied Part
•Degree of protection against the ingress of water: IPX1 (Controller), IPX0 (Monitor), IPX8 (Footswitch)
•Equipment not suitable for use in the presence of flammable anesthetics
•Operation Mode: Continuous
Storage,Transport, and Operating Conditions
Storage and Transport: -50°C to +60°C (-58°F to 140°F), 10% to 100% Relative Humidity, 5000 to 1060 hPA
Operating: 10 to 40°C (50 to 104°F)
Electromagnetic Compliance
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to
be installed and put into service according to the EMC information provided.
a. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical
equipment. This Product is intended for use in the electromagnetic environments specified.
b. The end user of this product should assure it is used in such an environment.
i. Portable and mobile RF Communications equipment should not be used at close distances.
ii. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment.

9
©2009 Cardiovascular Systems, Inc. 90074-00.F
Controller Messages
STATUS
MESSAGE
ACTION
MESSAGE MEANING WHEN DISPLAYED USER ACTION
PUMP OFF START PUMP Pump is off with no notifications Start pump
PUMP ON SET SPEED Pump is on, no speed selected Select speed
LOW SPEED NONE Low speed selected N/A
MEDIUM SPEED NONE Medium speed selected N/A
HIGH SPEED NONE High speed selected N/A
SPEED OUT OF
RANGE CALL SERVICE Speed is detected, when stop has been requested Return controller for service
PUMP FAILURE CALL SERVICE DEFECTIVE PUMP Return controller for
service
PRESSURE OUT
OF RANGE CALL SERVICE Pressure is detected, when stop has been requested Return controller for service
FLUID SUPPLY
EMPTY FLUID SUPPLY EMPTY Controller has calculated that the saline bag is empty Change saline bag and reset
MAX PRESSURE
EXCEEDED MAX PRESSURE EXCEEDED The controller has detected that output pressure exceeded maximum for > 10
seconds
Reselect lower speed or
exchange device
MAX SPEED
EXCEEDED MAX SPEED EXCEEDED The controller has detected that output speed exceeded maximum for > 10
seconds
Reselect lower speed or
exchange device
NO SPEED
DETECTED CHECK AND RETRY No Tachometer reading detected 1. Check fiber optic connections
2. Replace fiber optic
SYSTEM FAILURE CALL SERVICE Controller Failure Return controller for
service
PUMP STOPPED CLOSE DOOR Saline pump is open Close pump
NO SPEED
DETECTED CHECK AND RETRY Speed test failed 1. Check device connections
2. Replace device
SALINE LOW CHECK BAG Controller has calculated a low saline
supply Check saline level and change bag. Reset level
when needed.
EVENT TIME
EXCEEDED NONE Event Time has exceeded 90 seconds Follow event times listed in OAD IFU
APPROACHING
MAX EVENT TIME NONE Event Time is approaching 90 seconds Follow event times listed in OAD IFU
FLOW OUT OF
RANGE NONE Controller has detected improper saline flow rate condition. Call for Assistance
.

10
©2009 Cardiovascular Systems, Inc. 90074-00.F
Appendix A – Symbols
Attention, Consult Accompanying Documents
On
Off
Equal Potential Terminal
Protective Earth
Electrical Safety Rating (Type CF Applied Part, IPX1)
Fuse
Manufacturer
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 60601-1,
IEC/EN 60601-1, CAN/CSA C22.2 No. 601.1
3MSP