CrossFlow Integrated Arthoscopy Pump User Guide Rev H March 2013

Page 1

CrossFlow™ Integrated Arthroscopy Pump

0450000000

Note:

The Day-Use Cassette Tubing is pending clearance by the FDA and is not yet available for purchase in the United States. As a result, the software features associated

with the Day-Use Cassette Tubing will remain inactive. When the Day-Use Cassette Tubing is available for purchase, inserting it into the CrossFlow Integrated

Arthroscopy Pump will activate the associated software.

Page 4

Programming Footswitch and CrossFire 2 Shaver Settings ��������������������������������������������������������23

Programming Resection Integration Settings ���������������������������������������������������������������������������������26

Adjusting the Wash and Clear Function Settings ���������������������������������������������������������������������������������������������� 27

Navigating to the Help Menus ��������������������������������������������������������������������������������������������������������������28

System Feedback............................................................................................................................28

Audible Feedback ��������������������������������������������������������������������������������������������������������������������������������������28

Error Messages ��������������������������������������������������������������������������������������������������������������������������������������������29

Troubleshooting.............................................................................................................................32

Cleaning, Maintenance, and Disposal........................................................................................35

Cleaning the Components ���������������������������������������������������������������������������������������������������������������������35

Replacing the Fuses ����������������������������������������������������������������������������������������������������������������������������������36

Performing Annual Inspection ��������������������������������������������������������������������������������������������������������������36

Performing Preventive Maintenance and Calibration ������������������������������������������������������������������38

Expected Life �����������������������������������������������������������������������������������������������������������������������������������������������38

Disposal ���������������������������������������������������������������������������������������������������������������������������������������������������������39

Technical Specifications................................................................................................................39

Equipment Information ���������������������������������������������������������������������������������������������������������������������������39

Electromagnetic Compatibility �������������������������������������������������������������������������������������������������������������40

Regulatory Information ���������������������������������������������������������������������������������������������������������������������������42

Symbols and Terminology............................................................................................................44

EN-2

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Please read this manual and follow its instructions carefully. The words warning, caution, and note

carry special meanings and should be carefully reviewed:

• Warning: Indicates risks to the safety of the patient or user. Failure to follow warnings may result

in injury to the patient or user.

• Caution: Indicates risks to the equipment. Failure to follow cautions may result in product

damage.

• Note: Provides special information to clarify instructions or present additional useful information.

Critical Safety Warnings

1. Place the pump at the same height as the joint to ensure accurate pressure readings.

2. Using fluid to distend the joint carries the possibility of fluid extravasation into surrounding tissue. Select

the optimal pressure based on the patient profile, including, but not limited to, blood pressure, height,

weight, age, and tissue quality. Recommended pressure settings are included in this manual; however,

these are only suggestions, and each surgery and each patient may require different parameters.

3. The Wash function may cause high pressure within the joint, which may lead to fluid extravasation.

Carefully monitor joint pressure when using this function.

4. Use the scope and cannula as selected on the pump. Incorrect scope and cannula use can cause

overpressure if it does not match the selected scope and cannula.

5. Start the pump with the inflow tubing outside of the joint, all of the inflow tubing clamps open, and no

hardware attached. Failure to remove air from the tubing can cause overpressure in the joint.

Warnings

Operator Profile

1. Federal (USA) law restricts this device to sale by or on the order of a physician.

2. The operator of the CrossFlow™ system should be a qualified health care professional having complete

knowledge of the use of this equipment and awareness of the risks associated with arthroscopic

procedures.

3. The operator of the system should be experienced in arthroscopic practices and techniques.

4. The operator of the system should read this manual thoroughly and be familiar with its contents prior to

operating the equipment.

Prior to Surgery

1. Carefully unpack the CrossFlow Integrated Arthroscopy Pump and ensure that all components listed in

the “Package Contents” section of this manual are accounted for and remain undamaged from shipment.

If damage to any component is detected, refer to the standard warranty.

2. Install the system in an operating room that complies with all applicable IEC, CEC, and NEC requirements

for safety of electrical devices.

3. Install and use the system according to the information provided in the “Electromagnetic Compatibility”

section of this manual.

EN-3

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4. If the pump is installed with other equipment in a stacked configuration, observe the pump to verify

normal operation.

5. Portable and mobile RF communications equipment may interrupt system operation. When the

pump is in use, the conducted and radiated electrical fields may interfere with other electrical medical

equipment. If this occurs, power down all electrical equipment not in use, increase distance of other

electrical equipment, and/or connect the pump and other equipment into different outlets.

6. Ensure that the proper connection of the primary power cord of the pump to a grounded receptacle

with the correct mains voltage. To prevent the risk of electric shock, do not use extension cords or

portable multiple socket outlets that are not a part of a certified hospital cart or boom. The use of a

portable multiple socket outlet can lead to a reduced level of safety.

7. Position any cables extending from the pump to avoid contact with the patient, electrodes, other cables,

and any electrical leads which provide paths for high frequency current.

8. Do not connect items which are not specified as part of the system. The use of accessories, transducers,

and cables other than those specified in this manual may result in increased emissions, decreased

immunity of the equipment, or unintended, unsafe operation of the system.

9. Examine all electrical connections to the pump before use. Improper connection may result in

malfunction or unintended surgical effects.

10. Do not touch or insert any objects, other than the cassettes, inside of the cassette holders, as this may

damage the pressure sensor or cause injury. Place only the cassettes in the cassette holders.

11. Do not clean the inside of the cassette holders, as this may damage the pressure sensor or cause injury.

12. Set the alarm volume to a level that is audible in the operating room environment.

13. Ensure that the system functions as outlined in this manual prior to a surgical procedure. The system was

fully tested at the factory before shipment.

During Surgery

1. The Clear function may cause excessive fluid usage. Monitor the use of this function and the fluid level in

the irrigation bags.

2. The pump is only intended for use with flexible fluid containers. Do not use glass containers as they

might implode due to the vacuum being generated inside of the container.

3. Do not use the system in the presence of oxidizing agents or flammable materials (e.g. anaesthetics,

gases, fluids, skin prepping agents, and tinctures). Observe appropriate fire precautions at all times.

4. Keep the pump dry. If liquid has accidentally leaked into the pump from the cassette(s), change the

cassette(s), restart the system, and verify operation.

5. Keep the LCD screen and speaker in the field of view and hearing at all times during use. These are

important safety features.

6. Failure of the system may result in an unintended increase or decrease in flow and/or pressure. Carefully

monitor the joint when using the system.

7. Do not partially open the stopcock(s) on the dual stopcock cannula, as this may lead to overpressure

within the joint. Each stopcock must be completely open or completely closed.

8. Do not position both stopcocks on the dual stopcock cannula to be in the open position at the same

time, as this may lead to overpressure within the joint. (Note: This warning does not apply to dedicated

inflow/outflow cannulas). To prevent overpressure within the joint:

• When the inflow stopcock is open, ensure that the outflow stopcock is closed.

• When the outflow stopcock is open, ensure that the inflow stopcock is closed.

9. Do not allow extended exposure of suction to tissue associated with procedures that require either no or

low-flow suction. Always consider the type of tissue associated with the surgical procedure before using

the system. Failure to comply may result in severe injury.

EN-4

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After Surgery

1. Do not remove the cover of the console, as this could cause electric shock and product damage.

2. Disconnect the pump from the electrical output when cleaning, servicing, or inspecting fuses.

3. Do not make any internal repairs or adjustments. Units requiring repair should be returned to Stryker.

Decontaminate the pump and accessories prior to returning them to Stryker. Stryker may refuse to carry

out repairs if the products are contaminated.

4. Do not use flammable agents for cleaning and disinfecting the system.

5. Do not sterilize the pump.

6. Follow the instructions in the “Disposal” section of this manual to adequately dispose of system

accessories.

Cautions

1. No modification of this equipment is allowed.

2. Insert the cassette prior to spiking the saline bag. Failure to do so may damage the pump or the cassette.

3. Do not remove the cassettes while the pump is in use. The pump or the cassette may be damaged. The

cassettes can only be removed when the pump is stopped.

4. Stryker does not accept any liability for direct or consequential damages if:

• the pump or the accessories are used improperly

• the instructions and rules in the manual are not followed

• the pump or the accessories are improperly connected or maintained

• non-authorized persons perform repairs, adjustments, or alterations to the pump or accessories

• non-authorized persons open the pump

• the prescribed inspection and maintenance schedules are not followed

The warranty is void if any of these warnings or cautions is disregarded.

EN-5

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About Your Product

Product Description/Intended Use

The Stryker CrossFlow Integrated Arthroscopy Pump (CrossFlow Pump) is a fluid management system.

Illustrated below, the system is composed of a pump console with inflow-only and inflow/outflow modes,

disposable cassette tubing, a wired hand control, and a wired footswitch. The system integrates with

approved resection consoles.

1. CrossFlow Pump (featured in this manual)

2. CrossFlow Cassette Tubing - Includes inflow cassettes with spikes for irrigation fluid units, luer-lock

connectors, and outflow cassettes with suction connectors. The user may elect to employ one of two

modes of operation:

• Inflow-Only Mode: utilizes only the inflow function of the pump via the Inflow Cassette Tubing or

the Day-Use Inflow Cassette/Patient-Use Tubing.

• Inflow Cassette Tubing - The Inflow Cassette Tubing transmits fluid from saline bags to the

inflow cannula at the surgical site and is disposed of after each case.

• Day-Use Inflow Cassette/Patient-Use Tubing - The Day-Use Inflow Cassette Tubing is used for

a single day’s cases, and the Patient-Use Tubing is connected to the Day-Use Inflow Cassette

Tubing for a single case, then removed and discarded.

• Inflow/Outflow Mode: utilizes both the inflow and outflow functions of the pump via the Inflow

Cassette Tubing or the Day-Use Inflow Cassette/Patient-Use Tubing.

3. CrossFlow Footswitch (optional) - Provides remote foot control of pump operation.

4. CrossFlow Hand Control, Autoclavable (optional) - Provides remote hand control of pump operation.

EN-6

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Indications

The CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid

distension and irrigation of the knee, shoulder, hip, elbow, and ankle and wrist joint cavities and fluid suction

during diagnostic and operative arthroscopic procedures.

Contraindications

The use of the CrossFlow Integrated Arthroscopy Pump is prohibited whenever arthroscopy is

contraindicated.

Package Contents

Carefully unpack the CrossFlow Pump and ensure that all components are accounted for and remain

undamaged from shipment. If damage to any component is detected, refer to the standard warranty.

Package contents include:

• (1) CrossFlow Pump

• (1) Hospital power cord

• (2) Approved resection console power cord

• (1) Stryker firewire backbone (SFB) cable

• (1) User manual

• (1) Warranty and return policy

EN-7

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Part Numbers, Accessories, and System Compatibility

The CrossFlow Pump is featured in this manual. Refer to individual manuals for all other products and

accessories.

Part Number

Description

0350220000

Autoclavable Hand Control*

0450000000

CrossFlow Integrated Arthroscopy Pump

0450000100

CrossFlow Inflow Cassette Tubing

0450000110

CrossFlow Day-Use Inflow Cassette Tubing

0450000120

CrossFlow Patient-Use Tubing

0450000200

CrossFlow Outflow Tubing

0450000300

CrossFlow Integrated Cassette Tubing

0450000400

CrossFlow Hand Control, Autoclavable*

0450000500

CrossFlow Footswitch*

0475000000

CrossFire™ Console

0475100000

CrossFire 2 Console

0475000100

CrossFire 2 Footswitch

0277100100

iSwitch Universal Wireless Footswitch

0375704500

Formula® Shaver Handpiece (with buttons)

0375701500

Formula Shaver Handpiece (no buttons)

0375708500

Formula 180 Shaver (Hand Control)

0275601500

TPS Small-Joint Handpiece

* accessories

Approved Resection Consoles

The CrossFlow system is compatible with the following consoles. (Contact Stryker Endoscopy for

compatibility requirements for any non-approved resection consoles.)

•

Arthrex APS II

•

Arthrocare Quantum II

•

Arthrocare ATLAS

•

Dyonics Power II

•

Arthrocare Quantum

•

Mitek VAPR

EN-8

•

Stryker SERFAS

Page 11

Front Panel

1. LCD Touchscreen

6. Auxiliary Receptacle

2. Outflow Cassette Ejection Button

7. USB Port

3. Outflow Cassette Holder

8. Power Button

4. Hand Control Receptacle

9. Inflow Cassette Holder

5. Footswitch Receptacle

10. Inflow Cassette Ejection Button

Rear Panel

7A max. combined output /

Sortie combinée maximale

100-240 V ~ 50/60 Hz 7 A

T10AH 250 V

FCC ID: SSH-XFLOW

This device complies with part 15 of the FCC Rules. Operation is

subject to the following two conditions: (1) This device may not cause

harmful interference, and (2) this device must accept any interference

received, including interference that may cause undesired operation.

IC: 4919C-XFLOW

T3.15AH 250 V

100-240 V ~ 50/60 Hz 10 A

1. Speaker

5. Fuse Drawer

2. Power Outlet for Approved Resection RF Console

6. Global Fuse Holders

3. Power Outlet for Approved Resection Shaver Console

7. Equipotentiality Ground Plug

4. AC Power Inlet

8. SFB Connector Ports

EN-9

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Setup and Device Configuration

Stryker Endoscopy considers instructional training an integral part of the CrossFlow system. Your Stryker

Endoscopy representative will perform at least one in-service at your convenience to help you set up your

equipment and instruct you and your staff on its operation and maintenance. Please contact your local

Stryker Endoscopy representative to schedule an in-service after your equipment has arrived.

1. Choose a location for the CrossFlow pump.

• Place the pump on a Stryker cart or other sturdy platform near a hospital grade outlet.

• Place the pump at the same height as the joint to ensure accurate pressure readings.

• Provide at least four to six inches of space around the sides of the pump to ensure proper ventilation

and allow access to the power cord.

Warning

RF and other mobile communications equipment may affect the normal function of the

CrossFlow pump. When placing the pump, follow the instructions located in the “Electromagnetic

Compatibililty” section of this manual.

2. Connect the AC power.

•

•

Connect the provided hospital power

cord to the AC inlet on the rear console

panel.

Connect the other end to a hospitalgrade power outlet.

Warning

•

•

•

Check the device label on the rear of the pump to determine the operating voltage of the

device.

Check the power cord assembly periodically for damaged insulation or connectors.

To avoid risk of electric shock, this equipment must only be connected to a supply mains with

protective earth.

Caution

•

•

EN-10

When connecting or disconnecting a cable, hold the cable by its connector (its plug, not the

cord). Failure to comply may result in damage to the cable or pump.

Connect the power cords directly to the AC inlet or outlet. Do not connect any power cords

together.

Page 13

If required, connect the pump to a Stryker Firewire-compatible device using one of the SFB connector

ports on each device.

Note: Refer to the manual supplied with each Firewire-compatible device for connection information.

3. If required, connect the approved resection console(s) according to the interconnection diagram. For a

list of approved devices, refer to the “Approved Resection Consoles” section in this manual.

•

•

•

•

Using a #1 Phillips screwdriver, unscrew

and remove the power cord bracket.

Connect the approved resection power

cord to the AC inlet on the approved

resection console. Refer to the manual

supplied with each approved console for

connection information.

Connect the other end of the power cord

to the power outlet for the approved

resection console on the rear panel of

the CrossFlow pump, as marked.

Using a #1 Phillips screwdriver, attach

and secure the power cord bracket.

7A max.

combined

output

100-240 V ~ 50/60 Hz

7A

Note: The pump’s screen will display the specific components that are connected when the device is

powered on.

Warning

When the CrossFlow pump is interconnected with other electrical devices via the AC outlets on the

pump, earth leakage currents may be additive. A medical-grade isolation transformer must be used

when the system’s earth leakage current exceeds acceptable values. Ensure that all electrical devices

are installed and interconnected according to the requirements of IEC 60601-1-1.

Note: Stryker recommends using the Stryker Auxiliary Video Cart Kit (P/N 0240-099-001K), Standard

Video Cart Kit (P/N 0240-099-011K), or Multi-Specialty Video Cart Kit (P/N 0240-099-020K) as a

medical-grade isolation transformer. The user can elect to use another isolation transformer that is

compatible, qualified, and properly installed in accordance with the codes of the health care facility.

Caution

•

•

Ensure that the approved resection consoles are connected to their respective power outlets on

the rear panel of the pump.

Do not connect devices other than those listed in the “Approved Resection Consoles” section in

this manual.

EN-11

Page 14

4. If required, connect the hand control, footswitch, and/or USB drive according to the interconnection

diagram.

Note: A 1.0-compatible USB drive must be used with the CrossFlow pump.

Note: The pump’s screen will display the specific components that are connected when the device is

powered on.

Caution

•

•

•

Do not connect an ethernet cable to the auxiliary receptacle.

Turn the connector of the hand control and footswitch so that the red dot points up.

Do not thread or twist the cable connector for insertion or removal. It is a push/pull connector

and may be damaged by twisting it into or out of place.

5. To disconnect the pump:

• Disconnect the approved resection console(s) from the back of the pump, if applicable.

• Disconnect the hand control, footswitch, and/or USB drive, if applicable.

• Disconnect the pump from the hospital-grade power outlet.

Warning

To prevent the risk of electric shock, do not disconnect the pump before disconnecting the approved

resection console(s); the approved resection console(s) must be disconnected prior to disconnecting

the pump.

EN-12

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Operation

Note: Refer to the “Symbols and Terminology” section in this manual for button and icon definitions and

commonly used terms.

Starting the Pump Tutorial

The Pump Tutorial gives instructions on basic pump setup and operation.

1. To start the tutorial:

• Start the pump according to the instructions in the “Start the Pump” section in this manual.

• Press Help

on the Cassette Insertion screen.

• Press Pump Tutorial: Inflow-only mode

for instructions for Inflow-Only mode.

• Press Pump Tutorial: Inflow/Outflow mode

for instructions for Inflow/Outflow mode.

Starting a Procedure

To start a procedure, perform the following steps:

1. Turn on the Pump

2. Insert the Inflow/Outflow Cassette

3. Select the Surgeon Profile

4. Select the Joint

5. Prime the Inflow Tubing and Operate the Pump

Turning on the Pump

1. Push Power

located at the bottom lefthand corner of the front panel. When this

button is illuminated by a green LED, the pump

is set to the on position. The pump will display

a splash screen while the software is loading.

2. To stop the system, push Power

again.

EN-13

Page 16

Inserting the Inflow/Outflow Cassette

Warning

•

•

Do not insert the cassettes until the software has completely loaded and the cassette insertion

screen (shown below) appears. Inserting the cassettes prior to this point may result in inaccurate

pressure readings.

The choice of irrigation fluid should be determined by the physician, based on the operation

method to be employed.

Caution

The cassettes are color-coded. When inserting the cassettes, make sure to insert them as indicated by

the color-coding.

Note: Press Help

to start to the Pump Tutorial.

(See instructions in the “Starting the Pump Tutorial”

section in this manual.)

1. Align the colored side of the cassette(s) with

the colored button(s) on the pump as depicted

in the diagram. The Inflow Cassette is blue and

the Outflow Cassette is red.

2. Insert the cassette(s). Push with your thumb

until it clicks into place.

• When the Inflow Cassette is inserted, a

green check mark will appear on the screen,

and the screen will advance to the Surgeon

Profile Selection screen.

• When the Outflow Cassette is inserted,

“Outflow” will appear at the bottom of the

screen. A green check mark will appear on

the screen if it is inserted before the Inflow

Cassette (depicted in this scenario).

3. Connect the tubing:

• For the Inflow and Outflow Cassette Tubing,

refer to the instructions in the CrossFlow

Inflow and Outflow Cassette Tubing

manual.

• For the Day-Use Inflow Cassette and

Patient-Use Tubing, refer to the instructions

in the CrossFlow Day-Use Inflow Cassette

and Patient-Use Tubing manual.

EN-14

Page 17

Selecting the Surgeon Profile

Surgeon profiles can be selected through the CrossFlow pump interface. Select from “Standard Settings”

provided with the pump, or contact your Stryker representative to program your own, including settings

for pressure and flow rate, hardware combinations, and button assignments for the hand control and

footswitch.

1. To scroll up and down the surgeon profile list,

press Up

and Down

.

2. Press the name of the appropriate surgeon

profile to highlight it.

(In this scenario, “Doctor 1” is highlighted.)

3. When the appropriate surgeon profile is

highlighted, press Forward

to confirm the

selection and advance to the next screen.

Selecting the Joint

1. Select the appropriate joint:

• Press Shoulder Joint

to select the

shoulder;

• Press Knee Joint

to select the knee;

• Press Hip Joint

to select the hip;

• Press Small Joint

to select the small

joint.

When the appropriate joint is highlighted, the

screen will advance to the next screen.

Note: To return to the surgeon profile selection

screen, press Back

.

EN-15

Page 18

Priming the Inflow Tubing and Operating the Pump

Warning

Air must be removed from the inflow tubing each time a new Inflow Cassette is inserted into the

pump. Failure to remove air from the tubing can cause overpressure in the joint.

1. Prepare the inflow tubing as follows:

• Place the tubing outside of the joint. It is

recommended no hardware is attached to

the tubing.

• Open the pinch clamp near the inflow

outlet.

2. Press Start/Stop

to remove air

from the inflow tubing. The In Progress icon

indicates that the pump is operating.

3. Once the air has been removed and tubing is

completely filled with fluid, close the pinch

clamp.

4. Connect the hardware to the tubing.

5. Open the pinch clamp to proceed with pump

operation.

6. Press Start/Stop

to start/stop the

pump.

During a Procedure

Changing the Pressure and Flow

Note: Follow these instructions to select or change pressure and flow settings if the surgeon profile does not

specify these settings. Adjusting the settings will override the default and surgeon profile settings.

The system will select the following default settings for the following application areas:

Joint

Default Settings

Knee

45 mmHg

Shoulder

50 mmHg

Hip

50 mmHg

Small

35 mmHg

EN-16

Page 19

Note: Default pressure settings are only suggestions, and each procedure and each patient may require

different parameters. Select the optimal pressure based on the patient profile, including, but not limited to,

blood pressure, height, weight, age, and tissue quality.

1. If necessary, press Increase

and Decrease

to increase or decrease the Set Pressure (in

increments of 5 mmHg from 15–150 mmHg)

and Flow or Suction (in increments of 10% from

0–100%).

(In this scenario, the pump is operating in

Inflow/Outflow mode. The Set Pressure is set at

45 mmHg, and the Suction is set at 10%.)

Note: The pump will attempt to operate at the

set pressure until the flow limit is reached. A

green box will surround the suction/flow value

when the pump reaches the flow limit. Once

the flow limit is reached, it will operate at a

constant flow.

Note: The default suction/flow value changes

when a resection device (cutter, bur, or RF

probe) is activated. To change these values

while the device is activated, follow the

instructions above. To change these values

when the device is not activated, follow the

instructions in the “Programming Resection

Integration Settings” section in this manual. The

new suction/flow values will be maintained for

up to ten resection devices during a case.

Changing the Surgeon Profile or Joint Selections

1. If the pump is running, press Start/Stop

to stop the pump.

2. Press Home

in the lower left-hand corner

of the screen.

3. Press Confirm

to return to the surgeon

profile selection menu. (To return to the Run

Screen, press Cancel

.)

4. Follow the instructions in the “Select the

Surgeon Profile” and “Select the Joint” sections

in this manual to change the surgeon profile

and/or joint.

EN-17

Page 20

Assigning the Hardware Combination Options

The system will select the following default hardware combination if “Standard Settings” is selected or the

surgeon profile does not specify a hardware combination:

Hardware

option

Joint

Default combination

Knee

Stryker 5.8 mm x 140 mm cannula with 4.0 mm scope

Shoulder

Stryker 5.8 mm x 140 mm cannula with 4.0 mm scope

Hip

Stryker 5.0 mm x 165 mm cannula (bridge) with 4.0 mm scope

Small

Stryker 4.0 mm x 75 mm cannula with 2.7 mm scope

—

None

If the appropriate hardware combination does not appear on the list, select one of the following options:

Alternate hardware combination

Cannula diameter - scope diameter = x

Low Flow

x≤1

Medium Flow

1>x≥2

High Flow

x>2

To change a hardware combination selection, follow these instructions:

1. If the pump is running, press Start/Stop

to stop the pump.

2. Press the hardware combination to return to

the hardware combination selection menu.

3. Select the scope/cannula combination for

Hardware Combination Option

; to scroll up

and down the hardware combination list, press

Up

and Down

.

4. Press the appropriate hardware combination

to highlight it, or select Low, Medium, or High

Flow if the appropriate hardware combination

does not appear on the list.

(In this scenario, a 5.8 mm cannula and a

4.0 mm x 140 mm scope are highlighted.)

5. If no other hardware combination options are

required, proceed to step 8.

6. If necessary, press Hardware Combination

Option

,

, and/or

to view the

available scope/cannula combinations for these

options.

7. Note: Hardware Combination Option

and

are only enabled if the hip joint is selected.

EN-18

Page 21

8. Repeat steps 3 and 4 to select the scope/

cannula combination for Hardware

Combination Option

,

, and/or

.

(In this scenario, a 4.0 mm cannula and a

2.7 mm x 120 mm scope are highlighted for

Hardware Combination Option

.)

9. When the appropriate hardware combinations

are highlighted, press Confirm

to confirm

the selections and return to the Run screen.

Swapping Between Hardware Combination Options

The pump features a “Hot Swap” function, allowing the user to switch the cannula through which the inflow

tubing is attached without having to recalibrate the pump. Depending on the surgical site, up to four

different hardware combinations can be used.

Warning

Use the scope and cannula as selected on the pump. An incorrect scope and cannula selection may

cause overpressure in the joint.

1. Press Hot Swap

to switch to Hardware

Combination Option

. A green box will

briefly appear displaying the new hardware

combination selection.

2. If the incorrect hardware combination is

diplayed, follow the instructions in the

“Assigning the Hardware Combination Options”

section in this manual to change the selection.

3. To change to Hardware Combination Option

, press Hot Swap

.

Performing the Wash Function

The Wash function operates the inflow pump to introduce an influx of fluid to the surgical site. This function

increases the set pressure and flow limit by a user-specified percentage and duration (for Inflow-only mode),

or increases the set pressure and suction by a user-specified percentage and duration (for Inflow/Outflow

mode).

Warning

The Wash function may cause high pressure within the joint, which may lead to fluid extravasation.

Carefully monitor joint pressure when using this function.

Note: To adjust the default settings, follow the instructions in the “Adjusting the Wash and Clear Functions

Settings” section in this manual.

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1. While the pump is running, press Wash

to

perform the Wash function.

(In this scenario, the orange Wash

icon

indicates that the Wash function is in progress.

Also, “WASH” will show on the top of the screen

when the setting is in use.)

2. Press Wash

to repeat or stop the Wash

function.

Performing the Drain Function

Warning

Prior to performing the Drain function, remove all shavers and probes from the joint to patient injury.

The Drain function operates the outflow pump to remove fluid from the surgical site for 30 seconds or until

the user stops the pump. This function is only available in the Inflow/Outflow mode.

1. Press Start/Stop

to stop the pump.

2. Remove all shavers and probes from the joint.

3. Press Drain

to remove fluid from the joint. The orange Drain

icon indicates that the Drain

function is in progress. Also, “DRAIN” will show on the top of the screen when the setting is in use.

4. Press Drain

to repeat or stop the Drain function.

After a Procedure

Removing the Cassettes

Caution

•

•

•

Do not remove the cassettes while the pump is in use. The pump or the cassette may be damaged.

The cassettes can only be removed when the pump is stopped.

Do not attempt to remove the Outflow Cassette if it does not eject from the pump as doing so may

damage the pump or the cassette. Follow the instructions in the “Troubleshooting” section in this

manual to resolve this problem.

Do not touch or insert any objects, other than the cassettes, inside of the cassette holders, as this

may damage the pressure sensor or cause injury. Place only the cassettes in the cassette holders.

1. Press Start/Stop

to stop the pump.

2. Close all pinch clamps.

3. Refer to the CrossFlow Day-Use Inflow Cassette and Patient-Use Tubing and the CrossFlow Inflow and

Outflow Cassette Tubing manual on instructions on how to disconnect and discard the tubing. Always

maintain a sterile technique.

4. Press the Inflow Cassette Ejection button (blue) and/or the Outflow Cassette Ejection button (red) on the

front panel of the pump to eject the cassette(s).

5. Discard the cassettes and tubing appropriately.

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Pump Customization Menu

The Pump Customization Menu allows the user to:

1. Navigate to the Settings Menu

2. Load Surgeon Profiles

3. Program Footswitch and CrossFire 2 Shaver Settings

4. Program Resection Integration Settings

5. Adjust the Wash and Clear Function Settings

6. Navigate to the Help Menus

Accessing the Pump Customization Menu

1. If the pump is running, press Start/Stop

to stop the pump.

2. Press Open Pump Customization Menu

in

the lower right-hand corner of the screen to

open the menu.

3. Press Close Pump Customization Menu

to

close the menu.

Navigating to the Settings Menu

1. Press Open Pump Customization Menu

to open the menu.

2. Press Settings

to open the Settings Menu.

Adjusting the Volume, Brightness, and Language, and Upgrading Software

1. Press General Settings

to open the General

Settings Menu.

2. Adjust the Volume

.

3. Adjust the Brightness

.

4. Press Up

and Down

to select the

language preference.

5. To upgrade the software:

• Connect the USB drive according to the

instructions in the “Setup and Device

Configuration” section. The current software

version on the drive appears in the box.

• Press Software Upgrade

to upgrade

the software. The system will automatically

restart once the software is succesfully

upgraded.

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Adjusting the Actual Pressure Display

1. Press Actual Pressure Display Icon Selection

to open the Actual Pressure Display

selection menu.

2. Select the appropriate display icon. The

selection will be highlighted with a green box.

Note: Refer to the “Symbols and Terminology”

section in this manual for icon definitions.

Accessing the Stryker Settings Menu (For Stryker use only)

Only authorized Stryker representatives have

access to this menu.

1. Press Stryker Settings

to open the Stryker

Settings Menu.

2. Enter a password.

3. To confirm, press Confirm

. To cancel,

press Cancel

.

Loading Surgeon Profiles

1. Press Open Pump Customization Menu

to open the menu.

2. Press Surgeon Profile

to open the Surgeon Profile Menu.

Transferring Files to/from a USB drive

1. Press USB Upload

to transfer files to/from

a USB drive.

2. Connect the USB drive according to the

instructions in the “Setup and Device

Configuration” section.

3. Press Up

and Down

to scroll up and

down the file list.

4. Select the file to transfer or delete.

(In this scenario, the “Doctor 1” file is selected.)

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5. Press Right Arrow

and Left Arrow

to

transfer files to/from the USB drive to/from the

pump.

6. Press Delete

below the USB or pump list

to delete the selected file.

7. To delete the selected file, press Confirm

.

To cancel the operation, press Cancel

.

Transferring Files to the CrossFire System

1. Press Send Surgeon Profile to CrossFire

to

transfer a surgeon profile to the CrossFire

system.

2. Press Up

and Down

to scroll up and

down the file list.

3. Select the file to transfer.

Note: Only surgeon profiles containing

CrossFire settings will appear in this menu.

4. Press Right Arrow

to transfer the file to the

CrossFire system.

Programming Footswitch and CrossFire 2 Shaver Settings

1. Press Open Pump Customization Menu

to open the menu.

2. Press Footswitch/CrossFire 2 Shaver Options

to open the Footswitch/CrossFire 2 Shaver Settings

Menu.

Setting

Function

Wash

•

•

Clear

•

•

Inflow-only mode: Increases set pressure and flow limit by user-specified

percentage and duration.

Inflow/Outflow mode: Increases set pressure and suction by user-specified

percentage and duration.

Inflow-only mode: Increases flow limit by user-specified percentage and

duration.

Inflow/Outflow mode: Increases suction by user-specified percentage and

duration.

Drain

•

Operates the outflow pump to remove fluid from the surgical site for 30

seconds or until the user stops the pump.

Pressure Up/Down

•

Increases/decreases the set pressure.

Hot Swap

•

Switches between selected arthroscope/cannula combinations.

Start/Stop

•

Starts/stops the pump.

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Flow Up/Down

•

•

Inflow-only mode: Increases/decreases the flow limit.

Inflow/Outflow mode: Increases/decreases suction.

Vacuum

•

While the pump is operating, uses the shaver for suction to remove loose

tissue, debris, and fluid from the joint without activating the shaver. The

amount of suction can be controlled by the suction lever on the shaver

handpiece. When the shaver is activated, this function is disabled.

None

•

No function.

Note: “WASH”, “CLEAR”, “VACUUM”, or “DRAIN” will show on the top of the screen when the setting is in use.

CrossFlow Footswitch

1. Press CrossFlow Footswitch

to program

settings for the CrossFlow Footswitch.

2. Press the black foot pedal (highlighted with a

green border) to select its function.

3. Press Up

and Down

to scroll up and

down the function list.

4. Press the function of choice to assign the

function to the pedal.

(In this scenario, the “Wash” function is

selected.)

5. Repeat steps 2–4 to program the red foot pedal.

iSwitch Footswitch

1. Press iSwitch Footswitch

to program

settings for the iSwitch Footswitch.

2. Press the appropriate button/pedal

(highlighted with a green border) to select its

function.

3. Press Up

and Down

to scroll up and

down the function list.

4. Press the function of choice to assign the

function to the button/pedal.

(In this scenario, “Flow Up” is selected for Button

I.)

5. Repeat step 2–4 to program each button/pedal.

Note: Button II is reserved for iSwitch toggling

and cannot be programmed by the CrossFlow

pump.

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