DRAFT DRAFT CrossFlow™ Integrated Arthroscopy Pump 0450000000
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Table of Contents Warnings............................................................................................................................................
Electromagnetic Compatibility �������������������������������������������������������������������������������������������������������������37 Regulatory Information ���������������������������������������������������������������������������������������������������������������������������38 Symbols and Terminology............................................................................................................
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.
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 fluid to distend the joint carries the possibility of fluid extravasation into surrounding tissue.
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.
About Your Product Product Description/Intended Use The Stryker CrossFlow Integrated Arthroscopy 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. DRAFT 1.
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.
Front Panel 1. 3. 5. 7. 9. LCD Touchscreen Outflow Cassette Holder Footswitch Receptacle USB Port Inflow Cassette Holder Rear Panel 2. Outflow Cassette Ejection Button 4. Hand Control Receptacle 6. Auxiliary Receptacle 8. Power Button 10. Inflow Cassette Ejection Button DRAFT T10A 250V T3A 250V FCC ID: SSH-XFLOW This device complies with part 15 of the FCC Rules.
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.
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.
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 specific components that are connected when the device is powered on. Caution DRAFT • 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.
Operation Note: Refer to the “Symbols and Terminology” section in this manual for button and icon definitions and commonly used terms. Starting a Procedure To start a procedure, perform the following steps: 1. Power the Pump On and Off 2. Insert the Inflow/Outflow Cassette 3. Select the User Preference File 4. Select the Joint 5. Prime the Inflow Tubing and Operate the Pump Power the Pump On and Off 1. Press located at the bottom left corner of the front panel to power on the pump.
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 cassette, and the screen will advance to the User Preference File Selection screen. • When the Outflow Cassette is inserted, “Outflow” will appear at the bottom of the screen.
1. To scroll up and down the user preference file list, press and . 2. Press the name of the desired user preference file to highlight it. In this scenario, “Doctor 1” is highlighted. 3. When the desired user preference file is highlighted, press to confirm the selection and advance to the next screen. Select the Joint 1. Select the joint: • Press to select the shoulder; • Press to select the knee; • Press to select the hip; • Press to select the small joint. 2.
1. Press to remove air from the inflow tubing. The icon indicates that the pump is operating. Note: This step must be performed each time a new Inflow Cassette is inserted into the pump. 2. Once the air has been removed and tubing is completely filled with fluid, close the pinch clamps or stopcock. 3. Open the pinch clamps or stopcock to proceed with pump operation. 4. Press to start/stop the pump.
Changing the User Preference File or Joint Selections 1. If the pump is running, press to stop the pump. 2. Press in the lower left-hand corner of the screen. 3. Press to return to the user preference file selection menu. Press to return to the Run Screen. 4. Follow the instructions in the “Select the User Preference File” and “Select the Joint” section to change the user preference file and/or joint.
3. Select the scope/cannula combination for option ; to scroll up and down the hardware combination list, press and . 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.
1. Press to change to option . A green box will briefly 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 to change to hardware combination .
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.
Menu Features Opening and Closing the Main Menu 1. If the pump is running, press stop the pump. 2. Press to open the Main Menu. 3. Press to close the Main Menu. to DRAFT Programming the Wash and Clear Functions Settings Note: Adjusting the settings will override the default and user preference file settings. 1. Press 2. Press to open the Main Menu. to open the Wash and Clear Settings Menu.
Wash 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 flow will increase by 100% for 30 seconds. Clear Function Settings 1. Press to program the settings for the Clear function. 2. Press and to adjust the Flow or Duration. In this scenario, the flow will increase by 100% for 30 seconds.
Shaver Console Settings 1. Press to specify the shaver console: • Press to select the CrossFire console; • Press to select an approved resection console; • Press if no shaver console is in use. In this scenario, the CrossFire console is selected. 2. Press and to increase or decrease the Suction (adjust in increments of 10% from 0–100%). In this scenario, the Suction is set at 50%. RF Console Settings DRAFT 1.
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 • • Inflow-only mode: Increases/decreases the flow limit. Inflow/Outflow mode: Increases/decreases suction. None • No function. CrossFlow Footswitch 1. Press the CrossFlow button to program settings for the CrossFlow Footswitch. 2. Press the black foot pedal (highlighted with green border) to select its function. 3.
Crossfire Footswitch 1. Press the Crossfire icon to program settings for the Crossfire 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 and 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, the “Wash” function is selected for Button I. Formula Shaver DRAFT 1. Press the Formula icon to program settings for the hand control.
Transferring Files to/from a USB drive 1. Press to upload/download files to/from a USB drive. 2. Connect the USB drive according to the instructions in the “Setup and Device Configuration” section. 3. Press and 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. 5. Press and to transfer files to/from the USB drive to/from the pump. 6. Press below the USB or pump list to delete the selected file. 7.
Adjusting the Volume, Brightness, and Language, and Upgrade Software 1. Press to open the General Settings Menu. 2. Adjust the Volume . 3. Adjust the Brightness . 4. Press and 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 appears in the box. In this scenario, version 00.02.10 is installed. • Press to upgrade the software.
Navigating to the Help Menu 1. Press to open the Help Menu on any screen.
Error Message Cause Possible Solution FAULT Instrument recognition error: The stopcock • on the cannula is closed, the lower clamp on inflow tubeset is closed, or no hardware is attached to the tubing. • • Check the inflow tubing from the bags to the joint and ensure the hardware is properly attached. Open any closed clamps or stopcocks. Repeat the priming step. FAULT Inflow and/or Outflow Cassette not fully inserted. • Remove and reinsert the cassette until it clicks into place.
Troubleshooting Problem Cause Possible Solution The pump does not The pump is not plugged in, or the power on (no approved global or main fuses are out. resection console(s) are attached to the pump). • The pump does not turn on (approved resection console(s) are attached and turn on). There is a power supply failure, or the main fuses are out. • The pump turns on, but approved resection console(s) do not. There is a problem with the approved resection console(s).
There are abnormal pressure or flow rate fluctuations. There is a pressure sensor error. • • Reboot the system. If the problem persists, contact your Stryker representative, or return the console for repair. The pump stops pumping fluid, and the pressure indicator continues to blink. The pressure is too high. The actual pressure exceeds 200 mmHg for 15 seconds or greater than 250 mmHg for five seconds.
Sporadic electrical Electrical, RF, and/or mobile interference is affecting communications equipment is the pump. affecting the normal function of the pump. • • • The touch screen is unresponsive or inaccurate. 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 different outlets. Reboot the system.
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.
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 affects device performance.
• • 1 m / 39 in • h • • • • • Gather the following equipment: • disposable Inflow Cassette tube set • container filled with water • fluid bag (3 L) Follow the instructions in this manual to power on the pump, insert the Inflow Cassette, select a preference file, and select a joint. Suspend a fluid bag 1 m/39 in on its holder and connect the bag to the tubing according to the diagram.
• • • • 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 filled with 1 liter of fluid, press to stop the pump. The test has been successfully completed if the time it takes to fill the measuring cup with 1 liter of fluid is within the range specified in the table below.
Technical Specifications 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 Input Voltage: 80–275 V Inlet Fuse: 10 A, 250 V Frequency 47–63 Hz Power/Current Consumption Maximum power consumption: 269 W Maximum current consumption: 80 V: 3.4 A; 275 V: 0.
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.
Guidance and Manufacturer’s Declaration--Electromagnetic Immunity The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system is intended for use in the electromagnetic environment specified below. The user of the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system should ensure that it is used in such an environment.
Frequency of transmission: 13.56 MHz Type of frequency / characteristics of the modulation: 10% ASK Subcarrier: 423.75 kHz, Manchester coding Effective 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).
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 defined below. Warning Warning/Caution: See Instructions for Use General warning sign, Multiple socket-outlet, maximum allowed continuous output Front Console Power USB port Auxiliary receptacle Footswitch receptacle Hand control receptacle Rear Console IPX1 DRAFT Complies with CSA C22.2 No. 601.
SN Serial Number Catalog number Fulfills requirements of the European Medical Device Directive 93/42/EEC Non-Sterile Made in USA Interface Icon XF — DAY-USE Name/Term Description OPEN MAIN MENU Accesses the Main Menu CLOSE MAIN MENU Closes the Main Menu CROSSFIRE Indicates the Crossfire 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 approv
Icon 45 Name/Term Description PRESSURE Displays the current pressure setting FLOW/SUCTION Displays the current flow/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 flow limit by a user-specified percentage over a user-specified duration (for Inflow-only mode) mmHg Increases the set pressure and suction by a user-specified percentage over a user-s
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 Crossfire footswitch FORMULA SHAVER.
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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 affiliated 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.
