Stryker 1288HD Video Camera - User manual
Contents
1. Analog video output Digital video output Digital video output Digital video output Connects to seperable power cord which can be used for mains isolation Contains two 0 63 A fuses DVI output for connection to Lucent connector fibers optional 1288010001 The Camera Head The camera head connects to the camera console and captures video and photographic images which it relays to the camera console It features several controls that are accessible through a button keypad located on the top of the camera head see the Operation Instructions section of this manual 1 Soaking Cap 2 Cable Connector 3 Camera Cable 4 Camera Head Protects the cable connector during cleaning and sterilization Connects the camera head to the camera console Captures photographic and video images provides camera controls and connects with a focusing coupler The C Mount Coupler The C Mount coupler threads onto the face of the camera head enabling a scope to be attached to the camera It provides a focusing ring to adjust image sharpness The features of the coupler are listed in Figure 3 below Additional instructions are available in the 1288 C Mount Coupler User Guide P N 1000401152 1 Rear Adapter Threads onto the camera head 2 Focusing Ring Adjusts the coupler focus 3 Endobody Clamp Secures the scope to the coupler 4 Scope End Receives the endoscope Setup and Interconnection Note Stryker Endosc2. connect the SIDNE interface as well See Wiring Diagram 2 11 Wiring Diagram 1 Camera and Flat Panel Monitor 12 WiSe 26 HDTV Surgical Display DVI I VGA Adapter BSB E000 1288 HD Video Camera Wiring Diagram 2 Camera SDC SIDNE5 and Flat Panel Monitor WiSe 26 HDTV Surgical Display SIDNE USB CI 1288 HD Video Camera 13 Wiring Diagram 3 Camera Flat Panel Monitor and CRT Monitor WiSe 26 HDTV Surgical Display r y x S oe usiuasa Io o DVI I VGA Adapter DVI DVI 1288 HD Video Camera S VHS CRT Monitor 14 Note If you are using any device with unterminated analog video inputs you must connect a cable from the VIDEO OUT of that device to the VIDEO IN on the monitor Note An additional monitor may be connected using an open camera output Note The camera console is shipped from the factory in NTSC video format If necessary the video format can be changed to PAL by using the Options submenu in the configuration men
3. Type BF Applied Part Water Ingress Protection IPX0 Ordinary Equipment Continuous Operation IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 2 18 1996 A1 2000 CAN CSA C22 2 No 601 1 M90 UL 60601 1 2003 AS NZS 3200 1 0 1998 CSA 22 2 601 1 1 2002 CAN CSA C22 2 No 601 2 18 1990 IEC 60601 1 2 2001 A1 2004 Class 1 Laser Product Contains four 850 nm laser diodes This product complies with IEC 60825 1 1993 A1 1997 A2 2001 This product complies with 21CFR Subchapter J Parts 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated July 26 2001 Please contact your local Stryker Endoscopy sales representative for information on changes and new products 38 Electromagnetic Compatibility Like other electrical medical equipment the 1288 HD Camera requires special precautions to ensure electromagnetic compatibility with other electrical medical devices To ensure electromagnetic compatibility EMC the 1288 HD Camera must be installed and operated according to the EMC information provided in this manual Note The 1288HD Camera has been designed and tested to comply with IEC 60601 1 2 2001 requirements for EMC with other devices Do not use cables or accessories other than those provided with the 1288 HD Camera as this may result in increased electromagnetic emissions or decreased immunity to such emissions If the 1288 HD Camera is used adjacent to or stacked with other equipment
4. follow its instructions carefully The words warning caution and note carry special meaning 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 An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual A lightning bolt within a triangle is intended to warn of the A presence of hazardous voltage Refer all service to authorized personnel IMPORTANT SAFETY NOTICE Before operating this device please read this operating manual thoroughly and carefully When using this device with a light source fire and or severe injury may result to the patient user or inanimate objects if the instructions in this manual are not followed All light sources can generate significant amounts of heat at the scope tip the scope light post the light cable tip and or near the light cable adapter Higher levels of brightness from the light source result in higher levels of heat Always adjust the brightness level of the camera and the monitor before adjusting the brightness level of the light source Adjust the brightness level of the light source to the
5. for cleanliness 33 Disinfection optional 1 Disinfect the device by submerging it in a disinfection agent Follow the disinfection agent manufacturer s recommended concentrations temperatures and exposure times Acceptable disinfection agents contain 22 4 glutaraldehyde or 20 55 ortho phthalaldehyde 2 Thoroughly rinse and flush all parts and lumens with running demineralized water to remove the disinfectant 3 Dry all parts with a lint free towel immediately after rinsing Drying For automated drying use the drying cycle provided with the washer disinfector For manual drying use a lint free cloth Dry any lumens with compressed air Maintenance Inspection and Testing Inspect the device on a continual basis If a problem is observed or suspected the device should be returned for repair Inspect all components for cleanliness If fluid or tissue buildup is present repeat the above cleaning and disinfection procedures Inspect the camera cable for cuts and breaks Return any damaged camera to Stryker for service Packaging N A Sterilization After performing the cleaning instructions specified above perform one of the following sterilization cycles 34 Ethylene Oxide EtO Preconditioning parameters Temperature 55 2 C 131 5 F Exposure Concentration 100 EtO 725 mg L Temperature 55 2 C 131 5 F Time 1 hour Chamber Humidity 70 RH 50 80 5 Aeration
6. observe and verify normal operation of the 1288 HD Camera in the configuration in which it will be used prior to using it in a surgical procedure Consult the tables below for guidance in placing the 1288 HD Camera Caution Equipment which employs RF communications may affect the normal function of the 1288 HD Camera Guidance and Manufacturer s Declaration Electromagnetic Emissions 1288 HD Camera is intended for use in the electromagnetic environment specified below The customer or the user of 1288 HD Camera should ensure that it is used in such an environment Emissions test Compliance Electromagnetic Environment guidance RF emissions CISPR 11 Group 1 1288 HD Camera 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 RF emissions CISPR 11 Class B The 1288 HD Camera is suitable for use in all establishments other than domestic establishments and those IEC61000 3 2 directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Harmonic emissions Class B Voltage Fluctuations flicker Complies emissions IEC61000 3 3 Warning This system is intended for use by health care professionals only This system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take
7. 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 affected by absorption and reflection from structures objects and people 42 Warranty and Return Policy Product Warranty Stryker Endoscopy warrants all products subject to the exceptions provided herein to be free from defects in design materials and workmanship and to substantially conform to the product specifications contained in the documentation provided by Stryker Endoscopy with the products for a period of one year from the date of purchase the Warranty Period This warranty shall apply only to the original end user purchaser of products directly from Stryker Endoscopy or a Stryker Endoscopy authorized distributor This warranty may not be transferred or assigned without the express written consent of Stryker Endoscopy If a valid warranty claim is received within the Warranty Period Stryker will in its sole discretion 1 repair the product at no charge 2 replace the product at no charge with a product that is at least functionally equivalent to the original product or 3 refund the purchase price of the product In any event Stryker s liability for breach of warranty shall be limited to the replacement value of the defective or non confor
8. should be connected to the camera console in the labeled order RGBC e The fibers should be connected to the monitor in one of two configurations CBGR reverse order or BGRC R B switched 3 Ensure the fiberoptic output is enabled on via the Options Submenu in the Configuration Menu See the section Using the Configuration Menu Note The 1288 HD Camera model 1288010001 is a Class 1 laser product per IEC 60825 1 and 21CFR 25 Operating the Camera with a Light Source A 26 IMPORTANT SAFETY NOTICE Before operating this device please read this operating manual thoroughly and carefully When using this device with a light source fire and or severe injury may result to the patient user or inanimate objects if the instructions in this manual are not followed All light sources can generate significant amounts of heat at the scope tip the scope light post the light cable tip and or near the light cable adapter Higher levels of brightness from the light source result in higher levels of heat Always adjust the brightness level of the camera and the monitor before adjusting the brightness level of the light source Adjust the brightness level of the light source to the minimum brightness necessary to adequately illuminate the surgical site In addition adjust the internal shutter of the camera higher in order to run the light source at a lower intensity Avoid touching the scope tip or the light cable tip to the patient a
9. the Using the Camera Buttons section of this manual 1 Connect the video accessory to one of the remote outputs on the rear console panel Use the provided remote cables See Wiring Diagram 2 in the Setting Up the Console section of this manual 2 Press the P button for less than one second to select Remote 1 One beep will sound 3 Press the P button for more than one second to select Remote 2 Two beeps will sound Using the SFB Serial Interface The SFB serial connection on the console rear panel enables FireWire connection to the Stryker Endoscopy Software Management Site SMS Connect to the L9000 Light Source for Run Standby controls from the Camera Head Note This system feature is not necessary for regular camera system operation This system feature requires an additional device that is a computer to connect to SMS Using the DVI Fiber Outputs Using controls or adjustments or performing procedures A differently than specified in this manual may result in hazardous radiation exposure The 1288 HD Camera has the optional upgrade the fiber output for model 1288010001 This upgrade contains four laser diodes to transmit a DVI output over fiberoptic cables 1 Connect four individual fibers terminated in Lucent connectors to the red R green G blue B and clock C laser diodes on the console rear panel 2 Connect the four fibers to a compatible fiberoptic DVI receiver e The four fibers
10. the floor The warranty is void if any of these warnings are disregarded Symbol Definitions In addition to the cautionary symbols already listed other symbols found on the 1288 HD Camera and in this manual have specific meanings that clarify the proper use and storage of the 1288 HD Camera The following list defines the symbols associated with this product FA Operating humidity ratings S b Z Operating pressure ratings Operating temperature ratings Denotes compliance to CAN CSA C22 2 No 601 1 M90 UL60601 1 Type BF applied part Equipotentiality Protective Ground Earth FireWire Fuse rating This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact the manufacturer or other authorized disposal company to decommission your equipment Product Description and Intended Use By oN Sf Z RO SY SS The Stryker Endoscopy 1288 HD Medical Video Camera is a high definition camera used to capture still and video images of endoscopic surgical applications The 1288 HD Medical Video Camera consists of three main components Component Stryker Part Number Camera console 1288010000 1288010001 Camera head 1288210105 1288710105 C mount coupler 1288020122 The 1288 HD also comes with various connection cables which like the other components can be purchased
11. use of this equipment Test this equipment prior to a surgical procedure This unit was fully tested at the factory before shipment Never use this equipment in the presence of flammable or explosive gases Avoid dissembling any part of the camera head as doing so may break the seals causing leakage and or electric shock Avoid removing covers on the control unit as doing so may cause damage to electronics and or electric shock Attempt no internal repairs or adjustments not specifically detailed in this operating manual Pay close attention to the care and cleaning instructions in this manual Any deviation may cause damage Never sterilize the camera console because the delicate electronics cannot withstand this procedure Disconnect the control unit from the electrical outlet when inspecting the fuses Before each use check the outer surface of the endoscope to ensure that there are no rough surfaces sharp edges or protrusions Avoid dropping the camera system The camera system contains sensitive parts that are precisely aligned Ensure that readjustments modifications and or repairs are carried out by persons authorized by Stryker Endoscopy Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Multiple portable socket outlets shall not be placed on
12. 1288 HD Camera system is used exceeds the applicable RF compliance level above the 1288 HD Camera system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the 1288 HD Camera unit b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the 1288 HD Camera System The 1288 HD Camera system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the 1288 HD Camera system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the 1288 HD Camera system as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance m according to frequency of transmitter power W of transmitter 450 kHz to 80 MHz 80MHZ to 800 MHz 800 MHz to d 1 17 P d 1 17 P 25 GHz d 2 33 VP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 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
13. AROSCOPY _ 208 me e _ Language OSD 1 s E s Gi sss ia oH Go Scroll through preset camera settings designed for surgical specialties Choose from e Arthroscopy e Laparoscopy e Cystoscopy e Laser ENT Neuro e Microscope e Flexi Scope e Standard Hysteroscopy Capture photo Press and hold button for two seconds before it activates Capture video Press and hold button for two seconds before it begins recording Press again to stop _ Activate white balance WB Press and hold button for two seconds before it activates e Press once to proceed to the Menu screen e Hold for 5 seconds to proceed to the Main Menu on screen display 21 Menu Screen The Menu screen provides options for adjusting the camera picture nn E ai JEE td Press once to return to the Home screen Hold for 5 seconds to proceed to the Language screen Increase or decrease Enhance picture sharpness a e Light automatic shutter light level Zoom magnification Enhance Light Zoom Meter Appears on the monitor indicating the selection level 22 Language Screen The Language screen allows you to choose the default language for the user interface 3 I LAPAROSCOPY 5 noo TL non MENU LANGUAGE ENGLISH 2 OSD Scroll through available interface languages lt q Choose from e Danish Simplified Chinese German Finnish
14. Continue pointing the scope at the white surface until the video monitor indicates that white balance is WHITE BALANCE COMPLETE The video picture may change color If you cannot achieve an acceptable white balance refer to the Troubleshooting section of this manual 19 Up and Down Buttons The up and down buttons work together to increase or decrease the light zoom level The camera console can be set to light mode or zoom mode using the Buttons submenu of the Configuration Menu In light mode pressing the arrow buttons will raise or lower the automatic shutter light level setting in 8 steps In zoom mode pressing the arrow buttons will raise or lower the zoom level in 8 steps Press the arrow button once to adjust the light level by one step or hold down the button for a quicker transition Using the Touchscreen Interface SPECIALTY LAPAROSCOPY LJ The touchscreen interface on the console provides controls for operating the camera and selecting system settings Controls are located in a series of menus shown below and described hereafter Home Menu SPECIALTY p Ei LAPAROSCOPY G i pe ENHANCE a LIGHT ZOOM Language LANGUAGE a ENGLISH 2 20 Home Screen The Home screen is the default screen Use the buttons below to choose surgical specialties operate the camera head and navigate to other menus SPECIALTY Menu LAP
15. If dust particles lie between the coupler and camera remove the coupler and clean the coupler and camera windows Ensure all components are completely dry before reassembling them or fogging may result Ensure the coupler or C Mount scope is in focus Increase the enhancement Ensure the specialty switch is not set to FLEXI SCOPE unless you are using a flexible scope Note If this troubleshooting guide does not resolve the problem call Stryker Technical Support at 1 877 478 7953 inside the U S or refer to the Warranty and Return Policy section of this manual 29 Cleaning Reprocessing and Maintenance The camera console is not intended to come into contact with the patient It may be cleaned but not sterilized The camera head and coupler may contact the patient and should both be cleaned and sterilized prior to every use Cleaning the Camera Console Disconnect the console from the AC power source before cleaning Caution Never immerse or sterilize the camera console as this will damage the camera and void the warranty Should the camera console need cleaning wipe it down with a sterile cloth and mild cleaning solution Reprocessing the Camera Head These reprocessing instructions are provided in accordance with ISO 17664 While they have been validated by the manufacturer of the medical device as being capable of preparing the device for re use it remains the responsibility of the processor to ensure that the
16. Setting Up the Console UU aaausasassssssasa 10 Setting Up the Camera Head 15 Setting Up the Coupler l UU nnana niaan naa 16 Operation 18 Powering the Camera On Off 18 Using the Camera Head Buttons 1 a 18 Using the Touchscreen Interface 20 Controlling Remote Video Accessories 25 Using the SFB Serial Interface 25 Using the DVI Fiber OUtpUtS 2000 UU eeeeeeeeeeeeeaeeeeeeeeaaes 25 Operating the Camera with a Light Source 26 Troubleshooting 27 Cleaning Reprocessing and Maintenance 30 Cleaning the Camera Console a 30 Reprocessing the Camera Head u a 30 Using Sterile Drapes_ U ua asas ssassasasssaasaaswiasasa 35 Replacing the FIjSes_ LIU IILI aaa asasasasha ka Gpasa sas 36 Periodic Maintenance Schedule 36 Electromagnetic Compatibility 39 Warranty and Return Policy 43 Warnings and Cautions Please read this manual and
17. Stryker Stryker Endoscopy 5900 Optical Court San Jose CA 95138 APPROVALS DATE TITLE DRAWN BY S Livaskani 01 26 09 User Manual 1288HD Video Camera ORIGINATOR J Henley 01 26 09 SIZE REV DOCUMENT NO SHEET OF A C 1000 401 140 1 53 REVISIONS REVISIONS LTR ECN NO DATE APPROVED LTR ECN NO DATE APPROVED ECO 114767 11 12 08 J Henley ECO 115358 12 08 08 J Henley Poning ee ECO 116299 01 26 09 J Henley SE EAN CSS lt lt c a D uz zr x lt I O ml mM o o w gt 3 Select binding and paper weight based on cost 4 Source files are available from Engineering Services Global Source Archive this document as a user guide manual This document contains the following languages 1 English 1288010000 1288010001 1288210105 1288710105 Contents Warnings and Cautions 1 Product Description and Intended Use 4 Indications Contraindications 5 The Camera Console 6 The Camera Fleagdiu sg you u u nn u Susa Sam ug 8 The C Mount Coupler 9 Setup and Interconnection 10
18. a e Polish Japanese e Dutch Spanish Greek French Portuguese e Korean English Swedish Italian e Norwegian Press the Home button to exit the language screen Power cycle the unit for the change to take effect e To initiate black balance hold for 5 seconds until BLACK BALANCE begins flashing on the video monitor 23 Main Menu Screen for On Screen Display The Main Menu screen works in conjunction with the on screen display OSD to provide options for adjusting system settings Home SPECIALTY LAPAROSCOPY Language LANGUAGE Ey mas gt Press once to return to the Home screen and exit OSD e Hold for 5 seconds to reset global system settings to defaults and return to the Home screen Power cycle the unit for global settings to take effect MAIN MENU Select up or down in the OSD Choose from Shutter OPTIONS Options e Buttons BUTTONS Proceed to the next or previous OSD screen Choose from e OSD Main Menu e Shutter to adjust camera shutter settings Options to adjust camera control unit options Buttons to program functions of the camera head buttons 2 4 Controlling Remote Video Accessories The 1288HD Camera can remotely control up to two video accessories such as the SDC Ultra a VCR or a photo printer enabling the user to capture images or start and stop video recording by pressing the P button See also
19. amera cable from the electrocautery cable Reposition the electrocautery grounding pad on the patient Reduce Enhancement Check for and replace faulty video cables Check to ensure that all devices in the video system are plugged in and powered on Check the connector on the camera head cable for broken pins Detach the camera head from console and reconnect Turn off the console wait 3 seconds and turn it back on Release the scope from the coupler and then reconnect it Make sure the scope is seated correctly in the coupler Perform the white balance procedure See the W Button section of this manual Check the settings on video peripherals Ensure the light source has a proper infrared filter check with manufacturer specifications Refocus the camera Refocus the coupler Clean and dry both the scope and the coupler windows Remove the coupler from the camera head and remove any moisture that has built up between the two components Problem Possible Solution Optics are dirty Blurry picture Rotate the scope If dust particles in the picture rotate the dust is located on the scope itself Follow the manufacturer s instructions for cleaning the eyepiece and negative lens If particles in the picture do not move when you rotate the scope the particles are located on the coupler or camera Remove the scope and clean the window on the front of the coupler with a dry or alcohol tipped cotton swab
20. are powered on Ensure that the camera head is not connected to the console Turn off the console wait 3 seconds and turn it back on Same as above See the Using the DVI Fiber Outputs section of this manual Perform the white balance procedure See the W Button section of this manual Check the color settings on the monitor See the solution for Picture is too dark See the solution for Picture is too bright Perform the white balance procedure with the light source connected to the scope Use metal halide xenon or LED lighting no fluorescent lighting Increase the camera light level with the camera head Increase the light source output Check the fiber optic light cable for excessive broken fibers Decrease the camera light level Decrease the light source output Ensure that Shutter submenu in the Configuration menu has the following settings BRT CNTRL AUTO Shutter On 27 Noise or snow on picture when using electrocautery probes Noise or snow on picture when not using electrocautery probes No video picture when the camera head is plugged in Image is not well centered Variability in color reproduction between different light sources or peripherals Foggy picture loss of definition and clarity 28 Plug the electrocautery generator into a separate electrical outlet and separate the 1288 HD power cord from the electrocautery power cord Separate the c
21. ause the console to overheat and shut down 10 To set up the console make the following connections 1 Connect the AC power Connect the AC power cord to the AC inlet on the rear console panel Connect the other end to a hospital grade outlet 2 Connect the video output e The rear panel provides one analog and three or four with the optional fiber digital video outputs which can be used together or DVI I2 Displayport independently Output Type Output Analog S VHS 1 Digital DVI I1 Optional DVI over optical Fiber Connector 4 pin Mini Din push only connectors 29 pin push only connectors with two tightening knobs 29 pin push only connectors with two tightening knobs 20 pin Displayport auto locking connector Lucent connector fiber x 4 push only On some monitors S VHS inputs may be labeled Y C The DVI connectors can also output analog SXGA signals through a DVI I to VGA adapter Use the cables and outputs described above to connect the 1288 HD to other operating room equipment Wiring Diagrams 1 3 describe typical set ups Ifdesired connect any remote outputs using the remote cables supplied with the 1288 HD Camera See Wiring Diagram 2 Devices connected to the remote outputs of the 1288 HD Camera can be operated using the P buttons on the camera head and or console See the Operation Instructions section of this manual for details If desired
22. cloth 4 Immerse the device in the detergent Inject any inside regions of the device with 50mL of the detergent solution to remove loose debris 5 Soak the device in the detergent for at least 15 minutes Cleaning Manual 1 Brush e Thoroughly brush the exterior of the device with a soft bristled brush focusing on any mated or rough surfaces Inject any lumen or mated surface a minimum of five times with at least 50mL of the detergent e Brush any lumens a minimum of five times from each end using an appropriate bottle brush Brush any movable parts in their extreme open and closed positions 2 Rinse Rinse the device with treated water at ambient temperature to remove all detergent residue Flush any lumens or mated surfaces a minimum of 5 times Once all detergent residues have been removed continue to rinse for a minimum of 30 seconds Drain excess water from the device and dry it using a clean cloth or pressurized air e Visually inspect the device for cleanliness paying close attention to hard to reach areas If visible soil remains repeat steps 1 and 2 3 Soak Prepare a non enzymatic detergent according to the manufacturer s recommendations of 0 25 ounces gallon tap water at 35 40 C Fully immerse the device and inject any lumens and mated surfaces with at least 50mL of the detergent Soak the device for a minimum of 15 minutes 32 4 Brush Thoroughly brush the exterior of the d
23. e or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of 1288 HD Camera requires continued operation during power mains interruptions it is recommended that 1288 HD Camera be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance and Manufacturer s Declaration Electromagnetic Immunity 1288 HD Camera is intended for use in the electromagnetic environment specified below The customer or the user of 1288 HD Camera should ensure that it is used in such an environment Immunity Test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz 3 V m 80MHz to 2 5 GHz Compliance Level 3V 3 V m Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the 1288 HD Camera system including its cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter R
24. ecommended Separation Distance d 1 17 VP d 1 17VP 80 MHz to 800 MHz d 2 23 VP 800 MHzto2 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 fixed RF transmitters as determined by an electromagnetic site survey 8 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following e gt l 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 affected by absorption and reflection from structures objects and people 41 Guidance and Manufacturer s Declaration Electromagnetic Immunity 1288 HD Camera is intended for use in the electromagnetic environment specified below The customer or the user of 1288 HD Camera should ensure that it is used in such an environment a Field strengths from fixed 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 fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the
25. ep will sound Press the P button for more than two seconds to select Remote 2 Two beeps will sound W White Balance Button The W button activates the white balance function or the light zoom function The white balance function is used to correct slight color differences that exist between different light sources or endoscopes Press the W button for less than two seconds to activate the white balance function Press the W button for more than two seconds to increase the light or zoom level The camera console can be set to light mode or zoom mode using the Buttons submenu of the Configuration Menu In zoom mode each W button press will raise the light level in four steps In light mode each press will raise the zoom level in four steps When either mode has reached its maximum pressing the W button again will cycle the level back to the lowest setting Perform the white balance procedure before every surgical procedure Note Ensure that a scope and light source are attached to the camera and that the camera light source and monitor are powered on before adjusting the white balance 1 Point the scope at several stacked 4 x 4 white gauze pads a white laparoscopic sponge or any clean white surface Look at the monitor and make sure that no glare is visible off of the white surface Press and hold the W button until WHITE BALANCE IN PROGRESS begins flashing on the video monitor
26. evice using a soft bristled brush Inject the prepared detergent into any cannulae lumens or mated surfaces a minimum of 5 times e Brush any lumens a minimum of 5 times from each end using an appropriate bottle brush e Actuate the device brushing around any movable parts in all extreme positions 5 Rinse e Thoroughly rinse the device with treated water until all detergent residue is removed Flush any lumens or crevices 5 times After the detergent residue is removed continue rinsing for a minimum of 30 seconds e Drain the excess water from the device and dry it with a clean cloth or pressurized air Cleaning Automated 1 Brush e Brush both ends of any lumens a minimum of five times using an appropriate bottle brush 2 Rinse Rinse the device with treated water at ambient temperature until there is no visible detergent residue Continue to rinse for a minimum of 30 seconds after all detergent residue has been removed e Place the device in the washer on an incline to facilitate drainage 3 Automated wash Program the washer using the following parameters Phase Recirculation Water Detergent Type and Time Temperature Concentration if applicable Pre Wash 2 minutes Cold N A Enzyme 2 minutes Hot Enzymatic Detergent Wash Wash 1 2 minutes Set point Regular Detergent 66 C Rinse 1 2 minutes Hot N A Dry Phase 7 minutes 115 C N A If necessary use pressurized air to aid in drying Visually inspect each device
27. irect coupled C mount scope as this may damage the front window of the camera Note For direct coupled C mount scopes scopes that require no coupler thread the endoscope directly into the camera head until it forms a tight seal 16 2 Attach an endoscope to the coupler e Remove the red dust cap if it is present e Push down on the endobody clamp a and insert the scope into the scope end of the coupler b Release the endobody clamp 3 Attach a light cable from the light source to the light post on the endoscope c 17 Operation Warning Before using the 1288 HD Camera in a surgical A procedure test all components to ensure proper function Ensure that a video image appears on all video monitors before beginning any procedure Note Before operating the 1288 HD Camera ensure all components have been set up according to the instructions in the Setup and Interconnection section of this manual Powering the Camera On Off Ciba rap gt ewovcugza Press the power switch on the console to power the camera on or off Using the Camera Head Buttons The camera head features a cross shaped four button keypad for controlling the 1288 camera Shown below these buttons are labeled P W Up and Down 18 P Picture Button The P button controls up to two remote video accessories Press the P button for less than two seconds to select Remote 1 One be
28. is replaced the item provided in replacement will be the customer s property and the replaced item will be Stryker s property If a refund is provided by Stryker the product for which the refund is provided must be returned to Stryker and will become Stryker s property The inspection testing acceptance or use of the products and services furnished 43 hereunder shall not affect Stryker s obligation under this warranty and such warranty shall survive inspection test acceptance and use Notwithstanding the above the following products are warranted for a period of ninety 90 days from the date of purchase Scopes Associated Scope Hardware Fiber Optic Cables Laparoscopic Instruments VCRs Monitors and Printers replacement light bulbs are warranted for a period of sixty 60 days from the date of purchase TO THE FULLEST EXTENT PERMITTED BY LAW THE EXPRESS WARRANTY SET FORTH HEREIN IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY BY STRYKER EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE EXCEPT AS SPECIFICALLY PROVIDED IN THIS WARRANTY AND TO THE EXTENT PERMITTED BY LAW STRYKER IS NOT RESPONSIBLE FOR INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY OTHER LEGAL THEORY Return Policy Stryker Endoscopy values customer relationships and s
29. ls in close proximity Only camera heads marked AUTOCLAVABLE can withstand steam sterilization Autoclaving camera heads that do not bear this marking will result in product damage Allow the camera head to cool before connecting it to the console Connecting the camera head while it is still hot may result in system error Limitations on Reprocessing Do not cross sterilize the device Using multiple sterilization methods may significantly reduce the performance of the device Do not leave the device in solutions longer than necessary This may accelerate normal product aging Proper processing has a minimal effect on this device End of life is normally determined by wear and damage due to use Damage incurred by improper processing will not be covered by the warranty Instructions Point of Use Wipe excess soil from the device using disposable paper towels If an automated reprocessing method will be used rinse any channels in the device with 50mL of sterile distilled water immediately after use Containment and Transportation Reprocess the device as soon as reasonably practical following use Transport the device in a tray to avoid damage 31 Preparation for Cleaning 1 Disassemble the coupler from the scope and camera head 2 Prepare an enzymatic detergent according to the manufacturer s recommendations one ounce per gallon of tap water at 35 40 C 3 Wipe the entire device with the detergent using a clean
30. mber if applicable Please carefully package the product being returned Credit will not be given for items that are damaged in return shipment due to inadequate packaging Stryker Endoscopy does not accept any COD returns Return shipping costs are borne by the customer unless Stryker Endoscopy specifically agrees otherwise Please clean and sterilize all potentially contaminated products prior to returning them to Stryker Endoscopy It is unlawful to transport bio contaminated products through interstate commerce unless they are properly packaged and labeled as such Stryker Endoscopy reserves the right to destroy contaminated product at the customers expense and charge the customer for a replacement unit If a return does not comply with these terms Stryker Endoscopy reserves the right to destroy the product at the customer s expense Any replacement would be at the customers expense 45 stryker Stryker Endoscopy 5900 Optical Court San Jose CA 95138 USA 1 408 754 2000 1 800 624 4422 wwwsstryker com European Representative Regulatory Manager Stryker France ZAC Satolas Green Pusignan Av De Satolas Green 69881 MEYZIEU Cedex France 1000401140 C 2008 12
31. ming part or component This warranty does not apply to 1 products that have been misused neglected modified altered adjusted tampered with improperly installed or refurbished 2 products that have been repaired by any person other than Stryker Endoscopy personnel without the prior written consent of Stryker Endoscopy 3 products that have been subjected to unusual stress or have not been maintained in accordance with the instructions in the user manual or as demonstrated by a Stryker Endoscopy representative 4 products on which any original serial numbers or other identification marks have been removed or destroyed or 5 products that have been repaired with any unauthorized or non Stryker components including replacement lamps If Stryker determines in its reasonable discretion that the claimed defect or non conformance in the product is excluded from warranty coverage as described hereunder it will notify the customer of such determination and will provide an estimate of the cost of repair of the product In such an event any repair would be performed at Stryker s standard rates Products and product components repaired or replaced under this warranty continue to be warranted as described herein during the initial Warranty Period or if the initial Warranty Period has expired by the time the product is repaired or replaced for thirty 30 days after delivery of the repaired or replaced product When a product or component
32. minimum brightness necessary to adequately illuminate the surgical site In addition adjust the internal shutter of the camera higher in order to run the light source at a lower intensity Avoid touching the scope tip or the light cable tip to the patient and never place them on top of the patient as doing so may result in burns to the patient or user In addition never place the scope tip the scope light post the light cable adapter or the light cable tip on the surgical drapes or other flammable material as doing so may result in fire Always place the light source in standby mode whenever the scope is removed from the light cable or the device is unattended The scope tip scope light post light cable adapter and light cable tip will take several minutes to cool off after being placed in standby mode and therefore may still result in fire or burns to the patient user or inanimate objects Warnings To avoid potential serious injury to the user and the patient and or damage to this device please note the following warnings 1 10 11 12 13 14 15 16 Carefully unpack this unit and check if any damage occurred during shipment If damage is detected refer to the Warranty and Return Policy section of this manual Read this operating manual thoroughly especially the warnings and be familiar with its contents before connecting and using this equipment Beaqualified physician having complete knowledge of the
33. mitigation measures such as reorienting or relocating the system or shielding the location 39 Guidance and Manufacturer s Declaration Electromagnetic Immunity 1288 HD Camera is intended for use in the electromagnetic environment specified below The customer or the user of 1288HD Camera should ensure that it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC61000 4 2 Electrical fast transient burst IEC61000 4 4 Surge IEC61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines 1EC61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6kV contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode lt 5 Ut gt 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 lt 5 Ut gt 95 dip in Ut for 5 sec 3 A m Compliance Level 2 4 6kV contact 2 4 8kV air 2kV line to ground 1kvV line to line 0 5 1kV differential mode 0 5 1 2kV common mode lt 5 Ut gt 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 lt 5 Ut gt 95 dip in Ut for 5 sec N A NOTE Ut is the AC mains voltage prior to application of the test level 40 Electromagnetic Environment Guidance Floors should be wood concret
34. nd never place them on top of the patient as doing so may result in burns to the patient or user In addition never place the scope tip the scope light post the light cable adapter or the light cable tip on the surgical drapes or other flammable material as doing so may result in fire Always place the light source in standby mode whenever the scope is removed from the light cable or the device is unattended The scope tip scope light post light cable adapter and light cable tip will take several minutes to cool off after being placed in standby mode and therefore may still result in fire or burns to the patient user or inanimate objects Troubleshooting Problem Restart Camera Console message Color bar background System Error message Light blue background No color bar No color bar Optical DVI only Incorrect picture color White balance WB quality not good Picture is too dark Picture is too bright Possible Solution Camera head temporarily shut down due to overcurrent Turn off the console wait 3 seconds and turn it back on After sterilization ensure the camera head has cooled down before connecting it to the console No video detected After sterilization ensure the camera head has cooled down before connecting it to the console Return the system for repair Ensure the video out from the console is connected to the video in on the monitor Ensure all video systems
35. ons Transport and Storage Conditions Input Electrical Ratings 1 3 Progressive Scan CCDs High Definition Horizontal 64 00 kHz 60 00 kHz Vertical 60 02 Hz 50 00 Hz Digital Two Digital Video Interface Analog DVI RGBHV 1280 x 1024 HD 720p 1080p HDTV format Connector 29 pin DVI I Y C One S VHS Connector 4 pin mini DIN Digital Fiber HD HDTV R G B Clk Connector Four Lucent fiber connectors with 1 25 mm ferrules Digital One Displayport 1280 x 1024 HD 720p 1080p HDTV format Connector 20 pin Displayport Endoscope eyepiece used with C mount coupler C mount camera head used with C mount scopes C mount coupler scope thread 1 32 UN 2A 1 60 1 50 1 50 000 second Temperature 5 40 C Relative Humidity 30 95 Temperature 10 60 C Relative Humidity 10 75 Atmospheric Pressure 700 1060 hPa 100 240VAC 10 0 6A 47 63Hz 37 Total Shipping Weight Dimensions Enhancement Classification Complies with Medical Safety Standards Complies with Medical EMC Standard Complies with Laser Product Standards 13 lbs 6 0 kg Camera console 0 5 lbs 0 226 kg Coupler 1 5 lbs 0 680 kg Camera head Camera Console 12 5 w x 4 0 h x 15 25 d 31 8 cm w x 10 2 cm h x 38 7 cm d Camera Head Cable to Camera Console 10 3 ft 3 15 m sealed cable 20 7 ft 6 30 m cable extension available 16 levels switchable Class I Equipment
36. opy considers instructional training or inservice an integral part of the 1288 HD Medical Video Camera Your local Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your staff on its operation and maintenance To schedule an inservice contact your local Stryker Endoscopy representative after your equipment has arrived Setting Up the 1288 HD Camera involves three steps 1 Setting up the console 2 Setting up the camera head 3 Setting up the coupler Setting Up the Console Always connect the camera to an appropriate power source using a hospital grade power cord Loss of AC power will cause the camera to shut down and the surgical image to be lost Only connect items to the camera that have been specified for use with the camera Connecting incompatible equipment may cause unexpected results When the 1288 HD Camera is used with other equipment leakage currents may be additive Ensure that all systems are installed according to the requirements of IEC 60601 1 1 Caution Equipment which employs RF communications may affect the normal function of the 1288 HD Camera When choosing a location for the 1288 HD Camera consult the Electromagnetic Compatibility section of this manual to ensure proper function Always set up the console in a location that allows adequate ventilation airflow to the console Insufficient ventilation may c
37. parameters Aeration Time 12 hours Temperature 35 54 C 95 130 F Steris System 1 1 Clean and prepare the camera head and cable as recommended in the Cleaning and Disinfection sections Ensure the soaking cap is installed 2 Sterilize the camera head and cable using Steris System 1 with Steris Sterilant 20 3 Allow the camera head cable coupler and scope to completely dry before reassembly Any moisture on the threads will cause the camera and coupler windows to fog during use Sterrad 1 Clean and prepare the camera head and cable as recommended in the Cleaning and Sterilization section Ensure the soaking cap is installed 2 Sterilize the camera head and cable using the Sterrad NX or 100s Sterilization System 3 Allow the camera head cable coupler and scope to completely dry before reassembly Any moisture on the threads will cause the camera and coupler windows to fog during use Storage N A Using Sterile Drapes Using sterile drapes will ensure maximum longevity of your 1288 HD Camera Head For best results follow the instructions provided by the drape manufacturer Sterile camera drapes for use with the 1288 HD Camera Head can be ordered under Stryker product number 240 010 200 35 User Maintenance Replacing the Fuses To avoid the risk of fire use only fuses of the value specified on the fuse label located on the rear panel of the transmitter p Unplug the power cord from the wall ou
38. reprocessing as actually performed using equipment materials and personnel in the reprocessing facility achieves the desired result This normally requires validation and routine monitoring of the process Warnings This device must be cleaned and sterilized prior to the first use and after every subsequent use Use only the sterilization cycles outlined in this document Using unspecified sterilization cycles may damage the device or result in incomplete sterilization Separate the camera head coupler and scope prior to cleaning disinfection or sterilization If the coupler and camera head are cleaned disinfected or sterilized as a single unit disconnecting the coupler during use will compromise the sterility of the two products Refer to the coupler and scope product manuals for reprocessing instructions e Wear appropriate protective equipment gloves eye protection etc 30 Cautions Always install the soaking cap prior to processing the camera Failure to properly tighten the soaking cap will corrode the connector pins and void the warranty Inspect the camera cable for cuts and breaks before soaking in any fluid Return any damaged camera to Stryker for service Never soak the camera in the same tray with sharp instruments Do not use brushes or pads with metal or abrasive tips during manual cleaning as permanent scoring or damage could result To minimize galvanic corrosion avoid soaking dissimilar meta
39. tlet and remove the cord from the transmitter console 2 Unlatch the fuse holder above the AC inlet and remove it You may need to press the tab on the fuse holder with a slender screwdriver to release the latch Replace the fuse with the same value and rating W 4 Reinstall the fuse holder until the tab snaps in place Periodic Maintenance Schedule To ensure safe operation of the Model 1288 HD Video Camera you should periodically perform the following procedure Every 12 months check the earth leakage current to lt 500uA lt 300uA in U S A ground protective earth impedance to lt 0 1 ohms and power consumption less than or equal to rated power Use a true RMS digital multimeter and safety analyzer to perform this test Note Refer calibration and operating difficulties not detailed in this manual to your Stryker Endoscopy sales representative Disposal It must not be disposed of as unsorted municipal waste and 4 must be collected separately in accordance with applicable national or institutional related policies relating to obsolete electronic equipment x This product contains electrical waste or electronic equipment The 1288 HD must be disposed of according to local laws and hospital practices 36 Technical Specifications 60Hz settings are displayed first 50Hz settings follow in parentheses Imaging System Scanning System Video Outputs Mounting Auto Shutter Range Operating Conditi
40. together or separately Federal law United States of America restricts this device to use by or on the order of a physician Indications Contraindications The 1288 HD Camera is indicated for use in general laparoscopy nasopharyngoscopy ear endoscopy sinuscopy and plastic surgery wherever a laparoscope endoscope arthroscope is indicated for use A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy laparoscopic hernia repair laparoscopic appendectomy laparoscopic pelvic lymph node dissection laparoscopically assisted hysterectomy laparoscopic and thorascopic anterior spinal fusion anterior cruciate ligament reconstruction knee arthroscopy shoulder arthroscopy small joint arthroscopy decompression fixation wedge resection lung biopsy pleural biopsy dorsal sympathectomy pleurodesis internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement The users of the camera are general surgeons gynecologists cardiac surgeons thoracic surgeons plastic surgeons orthopedic surgeons ENT surgeons and urologists There are no known contraindications The Camera Console The camera console or Camera Control Unit CCU is the control center for the 1288 HD Medical Video Camera and processes the video and photographic images captured d
41. trives for satisfaction in purchases made by our customers Therefore we offer a return policy for most products Under this policy customers may return purchased products to Stryker Endoscopy within 90 days of customer s receipt of the product for a credit or a refund of the purchase price paid less shipping and handling and applicable restocking fees Products that fail after the first 90 days may be covered by and are subject to the terms of applicable product warranty Sterile products may not be returned for credit or refund unless they are in their original unopened packaging or unless they are in breach of the applicable warranty Restocking Fees Unless the product is defective or the return is the direct result of a Stryker Endoscopy error a restocking fee of 10 may be charged on all returned products A Returned Merchandise Authorization RMA number must be obtained from Stryker Endoscopy before returning product To obtain an RMA number please contact Stryker Endoscopy Customer Service at 1 800 624 4422 Please send any returned products to Stryker Endoscopy Attn Returns 5900 Optical Court San Jose CA 95138 With the return please include the following 1 RMA number 2 Purchase order number 44 3 Original invoice number 4 Name address and account number of the organization returning the product 5 Itemized list of the items being returned 6 Reason for the return 7 Product Experience Report Complaint nu
42. u See the Using the Configuration Menu section of this manual 1 Power on the monitor 2 Power on the camera Note A color bar pattern will appear on the monitor when the camera head is not connected to the camera console Follow the instructions in the Setting Up the Camera Head section of this manual to connect the camera head to the console Setting Up the Camera Head Caution Do not severely bend the camera cable or damage may result Note To unplug the camera from the control unit grasp the knobbed portion of the connector and pull straight out 1 Connect the camera head to the console e Unscrew the soaking cap from the cable connector if necessary e Align the blue arrow on the cable connector with the blue arrow on the camera connector port on the front console panel e Push in the connector until it locks in place 15 Setting Up the Coupler 1 Attach the coupler to the camera head e Grasping the rear adapter screw the coupler onto the camera head clockwise until it forms a tight seal Before each use check the outer surface of the endoscope to ensure there are no rough surfaces sharp edges or protrusions Caution When attaching or removing the coupler grip only the rear adapter as twisting other parts of the coupler may result in mechanical damage Do not overtighten the coupler as this may damage the front window of the camera Do not overtighten a d
43. uring the surgical procedure The console front panel features a touch screen where different menus can be accessed including the controls for adjusting the enhancement level light level zoom and white balance as well as allows the selection of surgical specialty settings that optimize camera performance for various specific surgical procedures The front panel also allows activation of remote outputs The rear panel provides ports for connecting the 1288 HD Camera to viewing and recording equipment such as video monitors the SDC Ultra or photo printers Front Panel Gabe rap ssivemoucmess __ a T 1 Power Switch Powers the camera ON and OFF 2 Touch Screen Allows navigation through different menus for controlling the camera and adjusting the system settings 3 Camera Connector Port Connects to the 1288 HD Camera Head Rear Panel 1 SFB Connectors 2 SIDNE Port 3 Remote Out 1 4 Remote Out 2 5 S Video Out 6 DVI Out 1 7 DVI Out 2 8 Display Port 9 AC Power Inlet 10 Fuse Panel 11 Equipotential Ground Plug 12 Fiber Outputs optical aUL amp 234567 8 910 11 Enables FireWire connection with Stryker FireWire devices provides connection for remote diagnoses and future software upgrades Connects to the SIDNE Console to enable voice operation and or graphic tablet control Connects to a video accessory remote switch Connects to a video accessory remote switch
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