Stryker CrossFlow Service Manual

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CrossFlow™ Integrated Arthroscopy Pump

0450000000

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Table of Contents

Warnings ...........................................................................................................................................3

Operator Prole �� 3 Prior to Surgery �� 3 During Surgery �� 4 After Surgery ��4

Cautions ............................................................................................................................................5

About Your Product .........................................................................................................................6

Product Description/Intended Use ��6 Indications �� 7 Contraindications �� 7 Package Contents �� 7 Part Numbers and Available Accessories* �� 7 Approved Resection Consoles ��7 Front Panel ��8 Rear Panel ��8

Setup and Device Conguration ..................................................................................................9

Operation ........................................................................................................................................12

Starting a Procedure ��12 During a Procedure ��15 After a Procedure ��18

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Menu Features ...............................................................................................................................20

Opening and Closing the Main Menu ��20 Programming the Wash and Clear Functions Settings �� 20 Programming the Resection Integration Settings ��21 Programming the Footswitch and Formula Shaver Settings ��22 Loading User Preference Files��24 Navigating to the Settings Menu ��25 Navigating to the Help Menu ��27

System Feedback ...........................................................................................................................27

Audible Feedback ��27 Error Messages ��27

Troubleshooting ............................................................................................................................29

Cleaning, Maintenance, and Disposal .......................................................................................32

Clean the Components ��32 Replace the Fuses ��32 Perform Annual Inspection ��33 Perform Preventive Maintenance and Calibration ��35 Expected Life ��35 Disposal ��35

Technical Specications ...............................................................................................................36

Equipment Information ��36

EN-1

Electromagnetic Compatibility ��37 Regulatory Information ��38

Symbols and Terminology ...........................................................................................................40

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EN-2

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�

Warnings

Operator Prole

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 qualied 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�

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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� 4� If the pump is installed with other equipment in a stacked conguration, 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 elds 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 dierent outlets� 6� Place the pump at the same height as the joint to ensure accurate pressure readings. 7� Ensure 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 certied hospital cart� The use of a portable multiple

socket outlet can lead to a reduced level of safety� 8� 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� 9� Do not connect items which are not specied as part of the system� The use of accessories, transducers,

and cables other than those specied in this manual may result in increased emissions, decreased

immunity of the equipment, or unintended, unsafe operation of the system� 10� Examine all electrical connections to the pump before use� Improper connection may result in

malfunction or unintended surgical eects� 11� Do not touch or insert any objects, other than the cassettes, inside of the cassette holders as this may

EN-3

damage the pressure sensor or cause injury� Place only the cassettes in the cassette holders� 12� Set the alarm volume to a level that is audible in the operating room environment� 13� Ensure 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� Using uid to distend the joint carries the possibility of uid extravasation into surrounding tissue� Select

the optimal pressure based on the patient prole, 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 dierent parameters� 2� The Wash function may cause high pressure within the joint, which may lead to uid extravasation�

Carefully monitor joint pressure when using this function� 3� The Clear function may cause excessive uid usage� Monitor the use of this function and the uid level in

the irrigation bags� 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 inow tubing outside of the joint, all of the inow tubing clamps open, and no

hardware attached� Failure to remove air from the tubing can cause overpressure in the joint� 6� The pump is only intended for use with exible uid containers� Do not use glass containers as they

might implode due to the vacuum being generated inside of the container� 7� Do not use this system in the presence of oxidizing agents or ammable materials (e�g� anaesthetics,

gases, uids, skin prepping agents, and tinctures)� Observe appropriate re precautions at all times� 8� 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� 9� Keep the LCD screen and speaker in the eld of view and hearing at all times during use� These are

important safety features� 10� Failure of the system may result in an unintended increase or decrease in ow and/or pressure� Carefully

the monitor the joint when using the system� 11� Do not allow extended exposure of suction to tissue associated with procedures that require either no or

low-ow suction� Always consider the type of tissue associated with the surgical procedure before using

this system� Failure to comply may result in severe injury�

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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 ammable 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�

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Cautions

1� No modication 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 and 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�

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EN-5

About Your Product

Product Description/Intended Use

The Stryker CrossFlow Integrated Arthroscopy Pump is a uid management system� Illustrated below, the system is composed of a pump console with inow-only and inow/outow modes, disposable cassette tubing, a wired hand control, and a wired footswitch� The system integrates with approved resection consoles�

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1� CrossFlow Integrated Arthroscopy Pump (featured in this manual) - Compatible with the Crossre

Console, CrossFlow Footswitch, Autoclavable Hand Control, iSwitch Wireless Universal Foot Control,

Stryker rewire-compatible devices, and approved resection consoles� 2� CrossFlow Cassette Tubing - Compatible with the CrossFlow Integrated Arthroscopy Pump, 4-bag

adapter with inow cassettes, luer-lock connectors, standard irrigation uids, suction connectors, and

waste management systems� The user may elect to employ one of two modes of operation:

• Inow-Only Mode: utilizes only the inow function of the pump via the Inow Cassette Tubing or the Day-Use Inow Cassette/Patient-Use Tubing

• Inow Cassette Tubing - The Inow Cassette Tubing transmits uid from saline bags to the inow cannula at the surgical site and is disposed of after each case�

• Day-Use Inow Cassette/Patient-Use Tubing - The Day-Use Inow Cassette Tubing is used for a single day’s cases, and the Patient-Use Tubing is connected to the Day-Use Inow Cassette Tubing for a single case, then removed and discarded�

• Inow/Outow Mode: utilizes both the inow and outow functions of the pump via the Inow Cassette Tubing and Outow Cassette Tubing�

3� CrossFlow Footswitch (optional) - Provides remote foot control of pump operation� 4� Autoclavable Hand Control (optional) - Provides remote hand control of pump operation�

EN-6

Indications

The CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide uid distension and irrigation of the knee, shoulder, hip, elbow, and ankle and wrist joint cavities and uid 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 Integrated Arthroscopy Pump and ensure all components are accounted for and remain undamaged from shipment� If damage to any component is detected, refer to the standard warranty�

• (1) CrossFlow pump

• (1) Hospital power cord

• (2) Approved resection console power cord

• (1) User manual

• (1) Warranty and return policy

Part Numbers and Available Accessories*

The CrossFlow Integrated Arthroscopy Pump is featured in this manual� Refer to individual manuals for all other products and accessories�

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Part Number Description

0350220000 Autoclavable Hand Control* 0450000000 CrossFlow Integrated Arthroscopy

Pump 0450000100 CrossFlow Inow Cassette Tubing 0450000110 CrossFlow Day-Use Inow Cassette

Tubing 0450000120 CrossFlow Patient-Use Tubing 0450000200 CrossFlow Outow Tubing 0450000300 CrossFlow Integrated Cassette

Tubing 0450000500 CrossFlow Footswitch*

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 • Dyonics Power • Stryker CORE

• Arthrex OPES • Dyonics Power II • Stryker SERFAS

• Arthrocare ATLAS • Linvatec Advantage • Stryker TPS

• Arthrocare Quantum • Mitek VAPR

• Arthocare Quantum II • Smith and Nephew Vulcan

EN-7

Front Panel

1� LCD Touchscreen 2� Outow Cassette Ejection Button 3� Outow Cassette Holder 4� Hand Control Receptacle 5� Footswitch Receptacle 6� Auxiliary Receptacle 7� USB Port 8� Power Button 9� Inow Cassette Holder 10� Inow Cassette Ejection Button

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Rear Panel

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

1� Speaker 2� Power Outlet for Approved Resection RF

3� Power Outlet for Approved Resection

Shaver Console 5� Fuse Drawer 6� Global Fuse Holders 7� Equipotentiality Ground Plug 8� SFB Connector Ports

T10A 250V

T3A 250V

Console

4� AC Power Inlet

EN-8

Setup and Device Conguration

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 sta 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 aect 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

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cord to the AC inlet on the rear console panel�

• Connect the other end to a hospital-grade 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

• 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 of the power cords together�

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

EN-9

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�

• 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 to 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�

Note: The pump’s screen will display the specic components that are connected when the device is powered on�

Warning

When the CrossFlow pump is interconnected with other electrical devices, leakage currents may be additive, resulting in electromagnetic emissions that can interfere with the normal function of electronic medical equipment� To properly control electromagnetic emissions and avoid potential harm to the patient or user, ensure all electrical devices are installed and interconnected according to the requirements of IEC 60601-1-1�

Caution

Ensure the approved resection consoles are connected to the correct power outlets on the rear panel of the pump�

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EN-10

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

diagram�

Note: Stryker recommends using the SIDNE USB2�0 Flash Disk, 512MB (P/N 0105-201-529)�

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

powered on�

Caution

• Do not connect an ethernet cable to the auxiliary port�

• 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� For tubing connection instructions, refer to the CrossFlow Inow and Outow Cassette Tubing and the

CrossFlow Day-Use Inow Cassette and Patient-Use Tubing manuals�

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EN-11

Operation

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

commonly used terms�

Starting a Procedure

To start a procedure, perform the following steps:

1� Power the Pump On and O 2� Insert the Inow/Outow Cassette 3� Select the User Preference File 4� Select the Joint 5� Prime the Inow Tubing and Operate the Pump

Power the Pump On and O

1� Press

the front panel to power on the pump� When this button is illuminated by a green LED, the system is powered on� The pump will display a splash screen while the software is loading�

2� To power o the system, press

located at the bottom left corner of

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Insert the Inow/Outow Cassette

Warning

The choice of irrigation uid should be determined by the physician, based on the operation method to be employed�

Caution

again�

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

EN-12

1� Align the colored side of the cassette(s)

with the colored button(s) on the pump as depicted in the diagram� The Inow Cassette is blue and the Outow Cassette is red�

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

until it clicks into place�

• When the Inow Cassette is inserted, a green check mark will appear on the cassette, and the screen will advance to the User Preference File Selection screen�

• When the Outow Cassette is inserted, “Outow” will appear at the bottom of the screen� A green check mark will appear on the cassette if it is inserted before the

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3� Connect the tubing:

Inow Cassette (depicted in this scenario)�

• For the Inow and Outow Cassette Tubing, refer to the instructions in the CrossFlow Inow and Outow Cassette Tubing manual�

• For the Day-Use Inow Cassette and Patient-Use Tubing, refer to the instructions in the CrossFlow Day-Use Inow Cassette and Patient-Use Tubing manual�

Select the User Preference File

User preference les 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 ow rate and button assignments for the hand control and footswitch�

EN-13

Select the Joint

1� To scroll up and down the user preference le

list, press

2� Press the name of the desired user preference

le to highlight it� In this scenario, “Doctor 1” is highlighted�

3� When the desired user preference le is

highlighted, press selection and advance to the next screen�

1� Select the joint:

• Press

2� When the desired joint is highlighted, the

screen will advance to the next screen� Note: Press preference le selection screen�

and

to select the shoulder; to select the knee; to select the hip; to select the small joint�

�

to conrm the

to return to the user

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Prime the Inow Tubing and Operate the Pump

Warning

• Start the pump with the inow tubing outside of the joint, all of the inow tubing clamps open, and no hardware attached� Failure to remove air from the tubing can cause overpressure in the joint�

1� Press

to

inow tubing� Note: This step must be performed each time a new Inow Cassette is inserted into the pump�

remove air from the

EN-14

1� Press

2� Once the air has been removed and tubing is

3� Open the pinch clamps or stopcock to

4� Press

to

inow tubing� The the pump is operating� Note: This step must be performed each time a new Inow Cassette is inserted into the pump�

completely lled with uid, close the pinch clamps or stopcock�

proceed with pump operation�

remove air from the

icon indicates that

to start/stop the pump�

During a Procedure

Changing the Pressure and Flow

Note: Follow these instructions to select or change pressure and ow settings if the user preference le does

not specify these settings� Adjusting the settings will override the default and user preference le 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

DRAFT

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

dierent parameters� Select the optimal pressure based on the patient prole, including, but not limited to, blood pressure, height, weight, age, and tissue quality�

1� If necessary, press

or decrease the Set Pressure (adjust in increments of 5mmHg from 15–150mmHg) and Flow or Suction (adjust in increments of 10% from 0–100%)� In this scenario, the pump is operating in Inow/Outow mode� The Set Pressure is set at 45mmHg, and the Suction is set at 50%� Note: A green box will surround the suction/ ow value when the pump reaches the ow limit� The pump is operating in constant ow mode� Once the ow limit is reached, it will operate in constant ow mode� (The pump will attempt to operate at the set pressure until the ow limit is reached�)

and

to increase

EN-15

Changing the User Preference File or Joint Selections

1� If the pump is running, press

stop the pump�

2� Press

the screen�

3� Press

le selection menu� Press the Run Screen�

4� Follow the instructions in the “Select the User

Preference File” and “Select the Joint” section to change the user preference le and/or joint�

Changing the Hardware Combination Selections

Note: Adjusting the settings will override the default and user preference le settings�

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

Hardware option

Alternate hardware combination selections

Low Flow x ≤ 1 Medium Flow 1 > x ≥ 2 High Flow x > 2

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

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Cannula diameter-scope diameter = x

in the lower left-hand corner of

to return to the user preference

to return to

to

Note: If the user preference le does not specify a hardware combination, follow these instructions to change a hardware combination�

EN-16

1� If the pump is running, press

stop the pump�

2� Press the hardware combination selection to

return to the hardware combination selection menu�

to

3� Select the scope/cannula combination

for option hardware combination list, press

4� Press the desired hardware combination to

highlight it� In this scenario, “5�8mmx140mm cannula with 4�0mm scope” is highlighted� (Select Low, Medium, or High Flow if the desired hardware combination does not appear on the list�)

5� If no other hardware combination options are

required, proceed to step 6�

6� If necessary, press

combinations for these options� Note: Hardware enabled if the hip joint is selected�

7� Repeat steps 3 and 4 to select the scope/

cannula combination for options and/or In this scenario, “4�0x120mm cannula with 2�7mm scope” is highlighted for option

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8� When the desired hardware combinations

are highlighted, press selections and advance to the Run screen�

;

�

to view the available scope/cannula

�

to scroll up and down the

and

,

and

, and/or

are only

,

to conrm the

,

�

Swapping Between Hardware Combination Selections During the Case

The “Hot Swap” function allows the user to switch the cannula through which the inow tubing is attached without requiring recalibration� Depending on the surgical site, up to four cannulas can be utilized by this function�

Warning

Use the scope and cannula as selected on the pump� An incorrect scope and cannula selection may cause overpressure in the joint�

EN-17

1� Press

box will briey appear displaying the new hardware combination selection�

2� Ensure the correct hardware combination

is displayed� If the incorrect hardware combination selection is displayed, or to change the hardware combination selection, follow the instructions in the “Change Hardware Combination Selections” section�

3� Press

combination

Performing the Wash Function

The Wash function increases the set pressure and ow limit by a user-specied percentage over a userspecied duration (for Inow-only mode), or increases set pressure and suction by a user-specied percentage over a user-specied duration (for Inow/Outow mode)�

to change to option

to change to hardware

�

� A green

1� While the pump is running, press

perform the Wash function� Follow the instructions in the “Program the Wash and Clear Function Settings” section to adjust the default settings�

2� Press

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Performing the Drain Function

The Drain function is only available in the Inow/Outow mode� It operates the outow pump to remove uid from the surgical site for 30 seconds or until the user stops the pump� 1� Press 2� Press 3� Press

to

to remove uid from the joint�

to repeat or stop the Drain function�

stop the pump�

function�

to repeat or stop the Wash

to

After a Procedure

Remove 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 Outow Cassette if it gets stuck as it may damage the pump or the cassette� Follow the instructions in the “Troubleshooting” section in this manual to resolve this problem�

1� Press 2� Close all pinch clamps�

EN-18

to

stop the pump�

3� Refer to the CrossFlow Day-Use Inow Cassette and Patient-Use Tubing and the CrossFlow Inow and

Outow Cassette Tubing manual on instructions on how to disconnect and discard the tubing� Always maintain a sterile technique�

4� Press the Inow Cassette Ejection button (blue) and/or the Outow Cassette Ejection button (red) on the

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

5� Discard the cassettes and tubing appropriately�

DRAFT

EN-19

Menu Features

Opening and Closing the Main Menu

1� If the pump is running, press

stop the pump� 2� Press 3� Press

to open the Main Menu� to close the Main Menu�

to

Programming the Wash and Clear Functions Settings

Note: Adjusting the settings will override the default and user preference le settings�

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1� Press 2� Press

Setting Function

Wash • Inow-only mode: Increases set pressure and ow limit by user-specied percentage over

Clear • Inow-only mode: Increases ow limit by user-specied percentage over user-specied

to open the Main Menu�

to open the Wash and Clear Settings Menu�

user-specied duration� By default, the set pressure will increase by 50% of the current setting, and the ow limit will increase by 100% of the current setting for 30 seconds�

• Inow/Outow mode: Increases set pressure and suction by user-specied percentage over user-specied duration� By default, the set pressure will increase by 50% of the current setting, and the suction will increase by 100% of the current setting for 30 seconds�

duration� By default, the ow limit will increase by 100% of the current setting for 30 seconds�

• Inow/Outow mode: Increases suction rate by user-specied percentage over userspecied duration� By default, the outow will increaseby 100% of the current setting for 30 seconds�

EN-20

Wash Function Settings

Clear Function Settings

1� Press to program the settings for the

Wash function�

2� Press and to adjust the Pressure,

Flow, or Duration� In this scenario, the pressure will increase by 50% and the ow will increase by 100% for 30 seconds�

1� Press

Clear function�

2� Press

Duration� In this scenario, the ow will increase by 100% for 30 seconds�

to program the settings for the

and

to adjust the Flow or

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Programming the Resection Integration Settings

Note: Adjusting the settings will override the default and user preference le settings�

1� Press 2� Press

to open the Main Menu�

to open the Resection Integration Settings Menu�

EN-21

Shaver Console Settings

RF Console Settings

1� Press

• Press

In this scenario, the CrossFire console is selected�

2� Press

the Suction (adjust in increments of 10% from 0–100%)� In this scenario, the Suction is set at 50%�

1� Press

• Press

DRAFT

• Press In this scenario, an approved resection console with a suction probe is selected�

2� Press

the Suction (adjust in increments of 10% from 0–100%)� In this scenario, the Suction is set at 50%�

to specify the shaver console:

console;

resection console;

use�

and

to specify the RF console:

console;

resection console (Press “Suction” if the RF probe is a suction probe�);

and

to select the CrossFire

to select an approved

if no shaver console is in

to increase or decrease

to select the CrossFire

to select an approved

if no RF console is in use�

to increase or decrease

Programming the Footswitch and Formula Shaver Settings

1� Press 2� Press

Setting Function

Wash • Inow-only mode: Increases set pressure and ow limit by user-specied

Clear • Inow-only mode: Increases ow limit by user-specied percentage over user-

Drain • Operates the outow pump to remove uid from the surgical site for 30

EN-22

to open the Main Menu�

to open the Footswitch/Formula Shaver Settings Menu�

percentage over user-specied duration�

• Inow/Outow mode: Increases set pressure and suction by user-specied percentage over user-specied duration�

specied duration�

• Inow/Outow mode: Increases the suction by user-specied percentage over user-specied duration�

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� Flow Up/Down • Inow-only mode: Increases/decreases the ow limit�

• Inow/Outow mode: Increases/decreases suction�

None • No function�

CrossFlow Footswitch

iSwitch Footswitch

1� Press the CrossFlow button

settings for the CrossFlow Footswitch�

2� Press the black foot pedal (highlighted with

green border) to select its function�

3� Press

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�

and

DRAFT

1� Press the iSwitch icon

settings for the iSwitch Footswitch�

2� Press the appropriate button/pedal

(highlighted with green border) to select its function�

3� Press

function list�

4� Press the function of choice to assign the

function to the button/pedal� In this scenario, the “Flow Up” function is selected for Button I�

5� Repeat step 2–4 to program each button/

pedal�

and

to program

to scroll up and down the

to program

to scroll up and down the

EN-23

Crossre Footswitch

Formula Shaver

1� Press the Crossre icon

settings for the Crossre Footswitch�

2� Select a button/pedal in the left-hand menu

to program it� Note: Only one button or pedal may be assigned a function�

3� Press

function list�

4� Press the function of choice to assign the

function to the button/pedal� In this scenario, the “Wash” function is selected for Button I�

1� Press the Formula icon

settings for the hand control�

2� Select a button in the left-hand menu to

DRAFT

program it� In this scenario, Button III is selected� Note: Only one button or pedal may be assigned a function�

3� Press

function list�

4� Press the function of choice to assign the

function to the button/pedal� In this scenario, the Flow Down is selected for Button III�

and

to scroll up and down the

to program

Loading User Preference Files

1� Press 2� Press

EN-24

to open the Main Menu�

to open the User Preference Menu�

Transferring Files to/from a USB drive

1� Press

USB drive�

2� Connect the USB drive according to the

instructions in the “Setup and Device Conguration” section�

3� Press

le list�

4� Select the le to transfer or delete�

In this scenario, the “Doctor 1” le is selected�

5� Press

the USB drive to/from the pump�

6� Press

delete the selected le�

7� To delete the selected le, press

cancel the operation, press

to upload/download les to/from a

and

below the USB or pump list to

DRAFT

to scroll up and down the

to transfer les to/from

� To

�

Transferring Files to the Crossre System

Navigating to the Settings Menu

1� Press 2� Press

to open the Main Menu�

to open the Settings Menu�

1� Press

the Crossre system�

2� Press

le list�

3� Select the le to transfer�

Note: Only preference les containing Crossre settings will appear in this menu�

4� Press

system�

to transfer a user preference le to

and

to transfer the le to the Crossre

to scroll up and down the

EN-25

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

Adjusting the Actual Pressure Display

DRAFT

1� Press

Menu� 2� Adjust the Volume 3� Adjust the Brightness 4� Press

preference� 5� To upgrade the software:

• Connect the USB drive according to the

• Press

1� Press

selection menu� 2� Select the desired display icon� The selection

will be highlighted with a green box�

to open the General Settings

�

and

instructions in the “Setup and Device Conguration” section� The current software version appears in the box� In this scenario, version 00�02�10 is installed�

system will automatically restart once the software is succesfully upgraded�

to open the Actual Pressure Display

to select the language

to upgrade the software� The

Accessing the Stryker Settings Menu (For Stryker use only)

EN-26

Only authorized Stryker representatives have access to this menu� 1� Press 2� Enter a password� 3� To conrm, press

to open the Stryker Settings Menu�

� To cancel, press

�

Navigating to the Help Menu

1� Press

to open the Help Menu on any screen�

System Feedback

Audible Feedback

Audible Feedback Event Implication

Three high-tone beeps Fault error Refer to “Error Messages” Three high-tone beeps,

pause, two beeps One medium-tone

beep Two medium-tone

beeps One low-tone beep Touchscreen/Hand control/

Three (medium, low, high-tone) beeps

Lockdown error Refer to “Error Messages”

Accessory connection Refer to “Connect the Components” and “Insert

the Inow/Outow Cassette”

Accessory removal Refer to “Connect the Components” and “Insert

the Inow/Outow Cassette” N/A

Footswitch operation Hot swap Refer to “Swap between Hardware Combination

Selections”

Error Messages

DRAFT

The words caution, fault, and lockdown carry special meanings and should be carefully reviewed:

• Caution: Visual popup error is displayed for ve seconds; user may clear the message when the problem is resolved�

• Fault: The pump will stop; user may clear the message when the problem is resolved�

• Lockdown: The pump will stop; reboot system�

Error Message Cause Possible Solution

CAUTION Cassette about to expire (two hours left

before expiration)�

CAUTION Preventative Maintenance required; the

unit has reached its recommended service interval�

CAUTION Inow/Outow RFID read failure: The

Inow or Outow RFID tag cannot be detected while the pump is stopped�

FAULT Priming Error: No uid in the tubing after

ten seconds�

• Replace the cassette�

• Contact your Stryker representative�

• Ensure the Inow or Outow Cassette is fully inserted�

• If the problem persists, replace the cassette�

• If the problem persists, contact your Stryker representative�

• Ensure the pinch clamps on the saline bags are open�

• Ensure the Inow Cassette is fully inserted�

EN-27

Error Message Cause Possible Solution

FAULT Instrument recognition error: The stopcock

on the cannula is closed, the lower clamp on inow tubeset is closed, or no hardware is attached to the tubing�

FAULT Inow and/or Outow Cassette not fully

inserted�

FAULT Cassette is expired (after 24 hours of use)� • Replace the cassette� FAULT The connection to the Crossre console or

approved resection console is lost�

FAULT The Crossre console is specied in the

user preference le, but it is improperly or

DRAFT

not connected to the pump�

LOCKDOWN Hardware fault detected • Reboot the system�

LOCKDOWN Motor defective • Reboot the system�

LOCKDOWN Pressure Transducer out of calibration:

If the pressure is at a value greater than 20mmHg for ve seconds when no cassette is inserted�

LOCKDOWN Possible Overpressure: The pressure is

sustained at 750mmHg for more than one second, or a hardware failure or pressure transducer malfunction has occurred�

• Check the inow tubing from the bags to the joint and ensure the hardware is properly attached�

• Open any closed clamps or stopcocks�

• Repeat the priming step�

• Remove and reinsert the cassette until it clicks into place�

• Ensure the consoles are properly connected to the pump� Follow the instructions in the “Setup and Device Conguration” section in this manual�

• Reboot the system�

• If the problem persists, contact your Stryker representative or return the console for repair�

• Ensure the console is properly connected to the pump� Follow the instructions in the “Setup and Device Conguration” section in this manual�

• Reboot the system�

• If the problem persists, contact your Stryker representative or return the console for repair�

• Reboot the system�

• If problem persists, contact your Stryker representative�

• Reboot the system�

• If the problem persists, contact your Stryker representative or return the console for repair�

EN-28

Troubleshooting

Problem Cause Possible Solution

The pump does not power on (no approved resection console(s) are attached to the pump)�

The pump does not turn on (approved resection console(s) are attached and turn on)�

The pump turns on, but approved resection console(s) do not�

Neither the pump or approved resection consoles turn on�

The pump is plugged in, the fuses are functional and/or have been replaced, and the pump still does not turn on�

The cassette(s) are inserted, but the Run Screen does not appear, and the pump does not start�

The pump turns on, but there is no image on the screen or the screen is frozen�

The hand control or the footswitch are plugged in, but are not activating�

The pump is not plugged in, or the global or main fuses are out�

There is a power supply failure, or the main fuses are out�

There is a problem with the approved resection console(s)�

The pump is not plugged in, or the main fuses are out�

A hardware error occurred� • Plug the pump in to a dierent main

DRAFT

The Inow or Outow RFID tag cannot be detected�

A hardware error occurred� • Reboot the system�

The devices are improperly connected to the pump�

The settings in the Footswitch/Formula Shaver Settings Menu are set to “None�”

The device(s) have reached their expected lifetime�

• Ensure the pump is plugged in to the main outlet�

• Inspect the all fuses�

• Replace the fuse if it is out of service�

• Inspect the main fuses in the fuse drawer�

• Replace the fuses if it is out of service�

• If the problem persists, contact your Stryker representative�

• Inspect the approved resection console(s)�

• If the problem persists, contact your Stryker representative or return the console for repair�

• Ensure the pump is plugged in to the main outlet�

• Inspect the main fuses in the fuse drawer�

• Replace the fuses if they are out of service�

outlet�

• If the problem persists, contact your Stryker representative�

• Ensure the Inow or Outow Cassette is fully inserted�

• If the problem persists, replace the cassette�

• If the problem persists, contact your Stryker representative�

• Ensure the devices are properly connected according to the instructions in the “Setup and Device Conguration” section of this manual�

• Check the settings in the Footswitch/ Formula Shaver Settings Menu�

• Reset the settings to the Default settings�

• Replace the device(s)�

EN-29

There are abnormal pressure or ow rate uctuations�

The pump stops pumping uid, and the pressure indicator continues to blink�

The pinch valves are not engaging�

Bubbles appear in the joint�

The pump cannot achieve the set pressure�

There is insucient pressure in the surgical site�

There is no suction while the pump is running�

There is a pressure sensor error� • Reboot the system� A hardware fault is detected�

The pressure is too high� The actual pressure exceeds 200mmHg for 15seconds or greater than 250mmHg for ve seconds�

There is a pinch valve or hardware error�

There is no more irrigation uid� • Replace or add additional saline bags�

The tubing connection is loose� • Ensure the tubing is securly connected�

A priming error occurred� • Ensure the pinch clamps on the saline

DRAFT

The suction level is set too high� • Decrease the suction level� There is a hardware setup error, the

ow limit is set too low, or the suction level is set too high�

An irrigation problem exists� • Check the stopcock on the arthroscope

The hardware set up is incorrect� • Ensure the hardware is properly

The approved resection consoles are improperly connected�

The tubes on the Outow Cassette are improperly connected�

• If the problem persists, contact your Stryker representative, or return the console for repair�

• Open the valve at the outow tube, the drainage tube, or the stopcock on the instrument to reduce the pressure�

• Examine the pinch valves to ensure they are functioning properly�

• Reboot the system�

• Ensure the pinch clamp is open on the irrigation tube, or the stopcock is open�

• If the problem persists, replace the tubing�

bags are open�

• Ensure the Inow or Outow Cassette is fully inserted�

• Remove the hardware from the tubing and repeat the priming step�

• If the problem persists, replace the cassette�

• Verify the luer-lock is tightly closed, the correct hardware is selected and properly connected, and the dual stopcock cannula is properly set up�

• Increase the ow limit or the set pressure setting�

• Decrease the suction level�

• Press Run/Stop to restart the pump�

and the clamps under the saline bags�

selected and set up�

• Ensure the consoles and the tubes are properly connected according to the instructions in Setup and Device Conguration section of this manual�

Unable to upload les to/from USB drive�

EN-30

A hardware fault occurred� • Ensure the USB drive is functioning

properly and the correct les are on the drive� If the drive is not functioning properly, replace the USB drive�

• Reboot the system�

Sporadic electrical interference is aecting the pump�

The touch screen is unresponsive or inaccurate�

Electrical, RF, and/or mobile communications equipment is aecting the normal function of the pump�

Touch screen is not properly calibrated for the user�

A hardware or software error occurred�

• Power down all electrical equipment not in use�

• Increase the distance of other electrical equipment�

• Connect the pump and other equipment into dierent outlets�

• Reboot the system�

• If the problem persists, contact your Stryker representative or return the console for repair�

A user preference le was accidentally deleted from the pump�

The pump is stopped, but the Outow Cassette is stuck and cannot be ejected�

“Service Pump Soon” The pump is 95% through the current

Unintentional deletion of a user preference le�

The pinch valves do not retract� • Do not attempt to remove the cassette

maintenance period�

DRAFT

• Transfer the user preference le from a USB drive to the pump according to the instructions in the “Transfer Files to/from a USB drive” section of this manual�

as it may damage the pump or the cassette�

• Reboot the system�

• If the problem persists, contact your Stryker representative�

• Contact your Stryker service representative�

EN-31

Cleaning, Maintenance, and Disposal

Warning

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

• To avoid electric shock and potentially fatal injury, unplug the pump from the electrical outlet before cleaning�

Caution

To prevent product damage:

• when cleaning the pump, do not spray cleaning liquid directly onto the pump; spray on the cloth before wiping the pump,

• do not immerse the pump in any liquid,

• do not use corrosive cleaning solutions to clean the pump,

• do not sterilize the pump�

Clean the Components

Pump

Should the pump need cleaning: 1� Spray cleaning liquid onto a dry, sterile cloth� Avoid excess liquid or drips� 2� Wipe the pump� 3� Take extra care when cleaning the front LCD screen� Excess liquid or drips that enter the bottom of the screen

may result in product damage�

DRAFT

Footswitch

Warning

Clean the footswitch prior to rst use and after every subsequent use�

Consult the footswitch manual (P17862) for cleaning instructions�

Hand control

Warning

Clean and sterilize the hand control prior to rst use and after every subsequent use to minimize risk of infection�

Consult the hand control manual for cleaning and reprocessing instructions�

Replace the Fuses

1� Disconnect the pump from the electrical output and remove the power cord from the rear of the pump� 2� Remove the appropriate fuse holder; with a straight blade screwdriver, unlatch the fuse drawer, or turn the

global fuse holders in a counter clockwise direction until the spring pushes out� 3� Remove the fuse(s)� 4� Replace the fuse(s) with a fuse of the same value and rating as indicated on the rear of the pump�

EN-32

5� Follow these steps in reverse for assembly�

• Push in the the fuse drawer until it clicks into place�

• Turn the global fuse holders in a clockwise direction until they are fully pushed in and secure in their original position�

Perform Annual Inspection

Stryker recommends inspections of the system on an annual basis� These inspections evaluate whether the product currently or in the near future may fail in a manner that aects device performance�

Safety Test

Visually inspect the device and its components to ensure the:

• fuses correspond with the specications on the pump,

• labels and device markings are legible,

• mechanical condition of the system (wires, hardware, etc�) allows for its safe use, and

• the system is clean for safe and proper use�

Basic Function Test

Perform a basic function test to analyze the features, displays, and performance of the system� 1� Power

• Power on the pump according to the instructions in “Power the CrossFlow Pump On and O” section of this manual� The power button will be illuminated by a green LED, indicating the system has powered on�

2� Stepper motor

• Insert the cassettes according to the instructions in “Insert the Inow/Outow Cassette” section of this manual�

• Visually inspect the stepper motors located in the cassette holder; they will be disengaged�

• Remove air from the inow tubing according to the instructions in “Prime the Inow Tubing” section of this manual�

• Visually inspect the stepper motors; two motors will be engaged�

• Stop the pump�

• Visually inspect the stepper motors; they will be disengaged�

• Remove the cassettes according to the instructions in “Remove the Cassettes” section of this manual�

3� Device Detection

• Connect the components (for example, the hand control, footswitch, CrossFire system, etc�) according to the instructions in “Connect the Components” section of this manual�

• Ensure the console displays the icon in the bottom of the screen of each component that is connected when the device is powered on�

4� Pressure Sensor

DRAFT

EN-33

1 m / 39 in

• Gather the following equipment:

• disposable Inow Cassette tube set

• container lled with water

• uid bag (3L)

• Follow the instructions in this manual to power on the pump, insert the Inow Cassette, select a preference le, and select a joint�

• Suspend a uid bag 1m/39in on its holder and connect the

h

bag to the tubing according to the diagram�

• Discard the protective cap on the tubing (if needed), and immerse the end of the tubing into a container lled with water�

• Set the Pressure to 50mmHg and Flow to 20%, according to the instructions in the “Set the Pressure and Flow” section of this manual�

• Remove air from the inow tubing according to the instructions in the “Prime the Inow Tubing” section of this manual�

• Press

• Remove the tubing from the container and hold it at a given

completely ll with uid�

will show approximately 0–5 mmHg�

water column height (h) indicated in the table below� Ensure the tubing in the water column is completely lled with uid�

to start the pump� Allow the tubing to

to stop the pump� The actual pressure display

DRAFT

• Read the actual pressure displayed on the pump� The test has been successfully completed if the actual pressure on the pump is within the range indicated in the table below for a given height of the water column�

Height of water column (h)

Inches Centimeters

12 30 20–25 18 45 30–35 24 60 40–45 46 90 65–70

5� Inow Flow Rate

• Gather the following equipment:

• disposable Inow Cassette tube set

• uid bag (3L)

• stopwatch

• one 1L measuring cup

• Follow the instructions in this manual to power on the pump, insert the Inow Cassette, select a preference le, and select a joint�

• Suspend a uid bag 1m/39in on its holder and connect the bag to the tubing according to the diagram�

• Discard the protective cap on the tubing (if needed), and place the end of the tubing into a container lled with water�

• Set the pressure to 150mmHg and ow to 50%�

• Remove air from the inow tubing according to the instructions in the “Prime the Inow Tubing” section of this manual�

• Clamp o the tubing in the measuring cup without stopping the pump�

Acceptable actual

pressure (mmHg)

EN-34

• Empty the measuring cup�

• Unclamp the tubing and place it in the cup� Start the stopwatch once the tubing is placed back in the cup�

• Once the measuring cup is lled with 1 liter of uid, press

• The test has been successfully completed if the time it takes to ll the measuring cup with 1 liter of uid is within the range specied in the table below�

Flow (%) Time (seconds)

50 70

to stop the pump�

Perform Preventive Maintenance and Calibration

Caution

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

• the pump or the accessories are improperly prepared and 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�

When the pump is 95% through the current maintenance period, a “Service Pump Soon” notication will appear on the screen� An authorized Stryker service technician must inspect and service the device according to the maintenance and calibration schedule below to maintain product functionality�

Component Maintenance/Calibration Period

Motors 2years Pinch valves 2years Pressure transducer 2years

DRAFT

Expected Life

Equipment Expected Life

Console Fiveyears Footswitch Threeyears Hand Control Oneyear Inow, outow, patient-use tubing Single-use Day-use cassette Tencases, eighthours of active use, or 24hours after point of rst

use

Disposal

This product contains electrical waste or electronic equipment� It must not be disposed of as unsorted municipal waste and must be collected separately in accordance with applicable national or institutional related policies relating to obsolete electronic equipment� Dispose of any system accessories and irrigation uid according to normal institutional practice relating to potentially contaminated items�

EN-35

Technical Specications

Equipment Information

Size Pump Dimensions:

• 12�528in� (318�2mm) width

• 7�025in� (178�4mm) height

• 16�990in� (431�6mm) depth

Pump Weight: 24lbs� (10�9kg) Hospital power cord: (p/n 0105-033-001) 2m Approved resection console power cord: (p/n P17275) 2m

Power Connection

Frequency 47–63Hz

Power/Current Consumption

Electrical Safety Classication

Environmental Specications

Safety and EMC Compliance

Pump Capacity 3�0L/min Pressure range 0-150mmHg

Max suction by pressure relief

Measuring accuracy

Display/Color Touch Screen

Volume Adjustment

Input Voltage: 80–275V Inlet Fuse: 10A, 250V

Maximum power consumption: 269W Maximum current consumption: 80V: 3�4A; 275V: 0�98A Motor output maximum speed: 650RPM RF output waveform: 13�56MHz (ISO15693)

Class I equipment Type BF Part Water ingress protection, IPX1 Continuous Operation

Operating Temperature: 5 – 40°C Operating Humidity: 30 – 95% RH (non-condensing) Shipping Temperature: -18° – 60°C Shipping Humidity: 15 – 90% RH

• UL 60601-1: 2006

• IEC 60601-1-2: 2007

• IEC 60601-1-4: 2000

• IEC 60601-1-6: 2010

• IEC 60601-1-8: 2006

• IEC 60601-1: 2005 + Corr 2006 + Corr 2007

• IEC 60601-1-1: 2005 + Corr 2006 + Corr 2007

• CAN/CSA-C 22�2 No� 60601-1-2: 2003 + A1: 2006

500mmHg

Pressure: ≤2% Flow: ±10%

160° viewing angle 6�5inch diagonal active LCD Resolution 800 (horizontal) x 480 (vertical) 12:8 aspect ratio 16-bit color Dimensions: 153mm (width) x 118mm (height)

0-85dBA

DRAFT

• IEC 62304: 2006

• IEC 62366: 2007

• CAN/CSA-C 22�2 No� 601�1-M90: 2003

• CAN/CSA 22�2 No� 60601-1: 2002

• AS/NZS 3200�1�0: 1998

EN-36

Connections Wired Hand Control

Wired Footswitch USB 1�1 port Stryker Firewire Backbone (SFB)

Electromagnetic Compatibility

Like other electrical medical equipment, CROSSFLOW INTEGRATED ARTHROSCOPY PUMP requires special precautions to ensure electromagnetic compatibility with other electrical medical devices� To ensure electromagnetic compatibility (EMC), CROSSFLOW INTEGRATED ARTHROSCOPY PUMP must be installed and operated according to the EMC information provided in this manual�

The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices� Caution: Portable and mobile RF communications equipment may aect the normal function of the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP� Caution: Do not use cables or accessories other than those provided with the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP, as this may result in increased electromagnetic

emissions or decreased immunity to such emissions� Caution: If the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is used adjacent to or stacked with other equipment, observe and verify normal operation of the CROSSFLOW

INTEGRATED ARTHROSCOPY PUMP in the conguration in which it will be used prior to using it in a surgical procedure� Consult the tables below for guidance in placing the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP�

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is intended for use in the electromagnetic environment specied below� The customer or the user of CROSSFLOW INTEGRATED ARTHROSCOPY PUMP should ensure that it is used in such an environment�

Emissions test Compliance Elec tromagnetic Environment - guidance

RF emissions CISPR 11 Group 1

RF emissions CISPR 11 Class A

Harmonic emissions IEC61000-3-2 Not applicable

Voltage Fluctuations/ icker emissions IEC61000-3-3

Not applicable

CROSSFLOW INTEGRATED ARTHROSCOPY PUMP uses RF energy only for its internal function; therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment�

CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes�

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is intended for use in the electromagnetic environment specied below� The customer or the user of CROSSFLOW INTEGRATED ARTHROSCOPY PUMP should ensure that it is used in such an environment�

Immunity Test IEC 60601 test

Electrostatic Discharge (ESD) IEC61000-4-2

Electrical fast transient/burst IEC61000-4-4

Surge IEC61000-4-5 ±1kV dierential

Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11

Power frequency (50/60Hz) magnetic eld IEC 61000-4-8

NOTE UT is the a�c� mains voltage prior to application of the test level�

DRAFT

level

±6kV contact ±8kV air

±2kV for power supply lines

±1kV for input/ output lines

mode

±2kV common mode

<5% UT (>95% dip in UT) for 0�5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

3A/m 3A/m Power frequency magnetic elds should be at levels characteristic of a typical

Compliance Level Elec tromagnetic

±6kV contact ±8kV air

±2kV for power supply lines Mains power quality should be that of a typical commercial or hospital

±1kV for input/output lines

±1kV dierential mode Mains power quality should be that of a typical commercial or hospital

±2kV common mode

<5% UT (>95% dip in UT) for 0�5 cycle Mains power quality should be that of a typical commercial or hospital

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

Environment - guidance

Floors should be wood, concrete or ceramic tile� If oors are covered with synthetic material, the relative humidity should be at least 30%�

environment�

environment� If the user of CROSSFLOW INTEGRATED ARTHROSCOPY PUMP requires continued operation during power mains interruptions, it is recommended that CROSSFLOW INTEGRATED ARTHROSCOPY PUMP be powered from an uninterruptible power supply or a battery�

location in a typical commercial or hospital environment�

EN-37

Guidance and Manufacturer’s Declaration--Electromagnetic Immunity

The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system is intended for use in the electromagnetic environment specied below� The user of the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system should ensure that it is used in such an environment�

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTE 1: At 80MHz and 800MHz, the higher frequency range applies�

NOTE 2: These guidelines may not apply in all situations� Electromagnetic propagation is aected by absorption and reection from structures, objects, and people�

(a) Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered� If the measured eld strength in the location in which the CROSSFLOW INTEGRATED ARTHR OSCOPY PUMP system is used exceeds the applicable RF compliance level above, the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system should be observed to verify normal operation� If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CROSSFLOW INTEGRATED AR THROSCOPY PUMP unit�

(b) Over the frequency range 150kHz to 80MHz, eld strengths should be less than 3V/m�

IEC 60601 Test Level

3Vrms 150kHz to 80MHz

3V/m 80MHz to 2�5GHz

Compliance Level Electromagnetic Environment--Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter�

3Vrms

3V/m d = 1�2√P 80MHz to 800MHz

Recommended Separation Distance: d = 1�2√P

d = 2�3√P 800MHz to 2�5GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)�

Field strengths from xed RF transmitters, as determined by an electromagnetic site survey (a), should be less that the compliance level in each frequency range (b)�

Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP System

The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled� The user of the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system as recommended below, according to the maximum output power of the communications equipment�

Separation distance (m) according to frequency of transmitter

Rated maximum output power (W) of transmitter

0�01 0�12 0�12 0�23

0�1 0�38 0�38 0�73

1 1�2 1�2 2�3

10 3�8 3�8 7�3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer�

NOTE 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies�

NOTE 2: These guidelines may not apply in all situations� Electromagnetic propagation is aected by absorption and reection from structures, objects, and people�

150kHz to 80MHz d = 1�2√P

DRAFT

80kHz to 800MHz d = 1�2√P

800kHz to 2�5GHz d = 2�3√P

Regulatory Information

Federal Communications Commission (FCC)

FCC ID: SSH-XFLOW Trade Name: CrossFlow Integrated Arthroscopy Pump Type or Model: 0450000000

This device complies with Part 15 of the FCC rules� Operation is subject to the following two conditions:

• this device may not cause harmful interference, and

• this device must accept any interference received, including interference that may cause undesired operation�

Note: FCC regulations provide that changes or modications not expressly approved by Stryker Endoscopy could void your authority to operate this equipment�

EN-38

Frequency of transmission: 13�56MHz Type of frequency / characteristics of the modulation: 10%ASK Subcarrier: 423�75kHz, Manchester coding Eective radiated power: 50µW

Industry Canada (IC)

IC: 4919C-XFLOW Trade Name: CrossFlow Integrated Arthroscopy Pump Type or Model: 0450000000

This device complies with Industy Canada license-exempt RSS standard(s)� Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device�

The term “IC” before the radio certication number only signies that Industry Canada technical specications were met�

R&TTE Declaration of Conformity

We, Name of company: Stryker Endoscopy

Address: 5900Optical Court, San Jose, CA 95138 Authorized representative: Jean-Yves Carentz Contact detail of authorized representative: Stryker France, ZAC Satolas Green Pusignan, Av� de

Satolas Green, 69881 MEYZIEU Cedex, France

Declare under our sole responsibility that the product:

Product Name: CrossFlow Integrated Arthroscopy Pump Trade Name: CrossFlow Integrated Arthroscopy Pump Type or Model: 0450000000 Relevant Supplementary Information: None

to which this declaration relates is in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC).

The product is compliant with the following standards and/or other normative documents:

Safety: EN 60601-1 EMC: EN 60601-1-2 Radio Spectrum: EN 300 330-1 V1�5�1 Supplementary information: none Notied body involved: TÜV Rheinland Product Safety (GmbH) Technical le held by: Stryker Endoscopy Place and date of issue (of this DoC): San Jose, CA USA, DATE

Signed by or for the manufacturer:

Name: Mike Hilldoerfer Title: Associate Director, Regulatory Aairs

Hereby, Stryker Endoscopy declares that this Short Range Device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC�

DRAFT

EN-39

Symbols and Terminology

This device and its labeling contain symbols that provide important information for the safe and proper use of the device� These symbols are dened below�

Warning

Warning/Caution: See Instructions for Use

Front Console

Power USB port

Auxiliary receptacle Footswitch receptacle

Hand control receptacle

Rear Console

Complies with CSA C22�2 No� 601�1, UL 60601-1 Emits RF radiation

Equipotential ground plug- connects to potential equalization conductor� The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements�

General warning sign, Multiple socket-outlet, maximum allowed continuous output

DRAFT

Stryker Firewire- enables rewire connection with Stryker rewire devices (Crossre, iSwitch, SDC3)

Fuse rating Type BF Applied Part

Probe Shaver

Alternating Current RoHS 50years

IPX1

Protection against vertically falling objects Follow instructions for use

This product contains electrical waste or electronic equipment� It must not be disposed of as unsorted municipal waste and must be collected separately�

Packaging/Labeling

Manufacturer

Authorized representative in the European community

Date of manufacture

Consult instructions for use

EN-40

SN

XF

DAY-USE

Serial Number

Catalog number

Fullls requirements of the European Medical Device Directive 93/42/EEC

Made in USA

Interface

Icon Name/Term Description

OPEN MAIN MENU Accesses the Main Menu

CLOSE MAIN MENU Closes the Main Menu

CROSSFIRE Indicates the Crossre is attached

FOOTSWITCH Indicates the footswitch is attached

HAND CONTROL Indicates the hand control is attached

AUXILIARY DEVICE Indicates the auxiliary device is attached

(currently there are no approved auxiliary devices for use)

SHAVER Indicates an approved resection shaver console is attached

RF PROBE Indicates an approved resection RF console is attached

DRAFT

Non-Sterile

— OUTFLOW Indicates the Outow Cassette is inserted

DAY-USE CASSETTE Indicates the Day-Use Cassette is inserted UP Scrolls up

DOWN Scrolls down

FORWARD Advances to the next screen

BACK Returns to the previous screen

SHOULDER JOINT Selects the shoulder joint

KNEE JOINT Selects the knee joint

HIP JOINT Selects the hip joint

SMALL JOINT Selects the small joint

HARDWARE COMBINATION SELECTION

Hardware combination selection (3 and 4 are only available if the hip joint is selected)

EN-41

Icon Name/Term Description

PRESSURE Displays the current pressure setting

45

mmHg

FLOW/SUCTION Displays the current ow/suction setting

START/STOP Starts/stops the pump

IN PROGRESS Indicates the pump is operating

HOT SWAP Toggles between hardware combination selections

WASH FUNCTION Increases the set pressure and ow limit by a user-specied

percentage over a user-specied duration (for Inow-only mode)

Increases the set pressure and suction by a user-specied percentage over a user-specied duration (for Inow/Outow mode)

DRAIN FUNCTION Removes excess uid from the joint at the end of a case

(Outow mode only)

HOME Retuns to the user preference le selection screen

DELETE Deletes a le CANCEL Rejects an action CONFIRM Accepts an action

HELP Accesses task-oriented help related to screen and button

WASH MENU Navigates to the Wash menu to adjust the Wash and Clear

CLEAR FUNCTION Increases the ow limit by a user-specied percentage over a

RESECTION INTEGRATION Navigates to resection integration settings menu

RF PROBE Selects an approved resection RF console

SHAVER Selects an approved resection shaver console

CROSSFIRE Selects the Stryker Crossre console

APPROVED RESECTION CONSOLE

NONE Indicates no RF/shaver console is selected

DRAFT

functionality

function settings

user-specied duration (for Inow-only mode) Increases the suction by a user-specied percentage over a

user-specied duration (for Inow/Outow mode)

Selects an approved resection console

FOOTSWITCH/FORMULA SHAVER OPTIONS

EN-42

Programs footswitch and hand control options for Crossow, iSwitch, Crossre, and Formula shaver

Icon Name/Term Description

CROSSFLOW FOOTSWITCH Programs the settings for the CrossFlow footswitch

iSWITCH FOOTSWITCH Programs the settings for the iSwitch footswitch

CROSSFIRE FOOTSWITCH Programs the settings for the Crossre footswitch

FORMULA SHAVER� Programs the settings for the Formula Shaver

USER PREFERENCE Loads User Preference les

USB UPLOAD Uploads/saves user preference settings from/to USB drive

RIGHT ARROW Moves a le to the right screen

LEFT ARROW Moves a le to the left screen

SEND PREFERENCE FILE TO CROSSFIRE

SETTINGS Navigates to the Settings screens

GENERAL SETTINGS Adjusts the volume, brightness, and language

VOLUME Adjusts the volume of pump

BRIGHTNESS Adjusts the monitor brightness

SOFTWARE UPGRADE Loads new software upgrades from a USB drive

ACTUAL PRESSURE DISPLAY ICON SELECTION

STRYKER SETTINGS Password-protected settings, for Stryker use only

— FLOW The uid entering and exiting the joint; keeps the joint space

— FLOW LIMIT The maximum ow rate� — FLOW RATE The speed at which uid enters and exits the joint; measured

— PRIME To remove air from the inow tubing prior to pumping uid

— SUCTION The force required to pull loose tissue, debris, and uid from

DRAFT

Sends a preference le to the Crossre system

Selects the Actual Pressure Display icon

clear by removing loose tissue, debris, and uid from the joint�

as volume over time, or liters per minute (L/min)�

through the tubing�

the joint�

EN-43

DRAFT

EN-44

DRAFT

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www�stryker�com

European Representative Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av� De Satolas Green 69881 MEYZIEU Cedex, France

Stryker Corporation or its divisions or other corporate aliated entities own, use or have applied for the following trademarks or service marks: CrossFlow and the Stryker logo. All other trademarks are trademarks of their respective owners or holders�

DRAFT

P17330 A 2012/06

Stryker CrossFlow Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual