manualshive.com logo in svg

Arthrex AR-3200-0001T, Инструкция по эксплуатации, Страница: 1 / 55

Поделиться
Скачать
Arthrex AR-3200-0001T Скачать руководство пользователя страница 1

950-0027-01, Rev. B English 

950-0027-01B 

 

1 of 55

 

 

 

 

Synergy

HD3 

System 

Instructions for Use 

 

 
 
 
 
 
 
 
 
 
 
 

 

 

The Arthrex Synergy

HD3 

System Camera Controller and 

Camera Head User’s Guide provides important 
information for the safe operation of all components of the 
Synergy

HD3 

Camera System, including accessories.  Read 

this User’s Guide thoroughly prior to using this system 
and keep it in an easily accessible place for use by all 
operating personnel. Read and follow all safety warnings, 
cautions and precautions. 
 

 

 

 

  

 

 

Arthrex, Inc. 

1370 Creekside Blvd. 
Naples, FL 34108, USA 
+1 (800) 934-4404 
 
Technical Support  
1-800 391-8599  
 

 

EC 

REP 

 

Arthrex GmbH 

Erwin-Hielscher-Strasse 9 
81249 München, Germany 
+49 89 909005-0 

 

Содержание AR-3200-0001T

Страница 1: ... of the SynergyHD3 Camera System including accessories Read this User s Guide thoroughly prior to using this system and keep it in an easily accessible place for use by all operating personnel Read and follow all safety warnings cautions and precautions Arthrex Inc 1370 Creekside Blvd Naples FL 34108 USA 1 800 934 4404 Technical Support 1 800 391 8599 EC REP Arthrex GmbH Erwin Hielscher Strasse 9 ...

Страница 2: ...omer shall be free from defects in materials and workmanship for 1 year from date of purchase Arthrex s liability shall include replacing or repairing those Products shown to be defective either in materials or workmanship Claim of defect in materials or workmanship in any Product shall be considered when it is submitted to Arthrex in writing within thirty 30 days after discovery No claim shall be...

Страница 3: ...evice 18 2 1 Installation 18 2 2 Accessories for Intended Use 19 2 3 System Setup Facility and Surgeon Settings 20 2 4 Scheduling and Starting Cases 29 2 5 System Operation without Tablet Data Input Device 35 2 6 Picture in Picture Operation 37 3 0 Maintenance 39 3 1 Life Expectancy 39 3 2 Periodic Maintenance 39 3 3 Cleaning and Sterilizing 39 3 4 Troubleshooting 42 3 5 Recommended Annual Camera ...

Страница 4: ...s and Precautions The words WARNING PRECAUTION and NOTE carry special meanings and they should be read carefully WARNING The safety and or health of the patient user or a third party is at risk Comply with this warning to avoid injury to the patient user or third party PRECAUTION This contains information concerning the intended use of the device or accessory Damage to the equipment is possible if...

Страница 5: ...ual leakage currents may exceed the tolerated limits 12 The scope light guide tip can get extremely hot as result of high intensity light giving rise to high temperatures in front of the light emission window which may cause severe burns Always keep the light source in the STANDBY mode when not in use 13 Before each use the outer surface of the portions of the Endoscope and any Endoscopically Used...

Страница 6: ...hing the endoscope from the light guide cable Allow the endoscope and light guide cable to cool down after use 26 High Frequency HF electrical surgical instruments may lead to severe patient injuries and or damage to the endoscope Please take caution to insure that the working element is kept within field of view to prevent accidental burns A sufficient distance from the tip of the endoscope to ot...

Страница 7: ...easonable protection against harmful interference in a typical medical installation However if interference does occur with other equipment it may be corrected by one or more of the following measures Reorient or relocate this equipment the other equipment or both Increase the distance between the different pieces of equipment Consult a biomedical engineer 10 Do not expose the Camera Control Unit ...

Страница 8: ... occur in a particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures a Reorient or relocate the receiving device b Increase the separation between the equipment c Connect the equipment into an outlet on a ci...

Страница 9: ...sult Accompanying Documents Fragile Precaution of Warning Notice This Side Up Type BF Equipment Keep Dry Electrical Hazard Dangerous Voltages are Present Never attempt to repair the equipment Only Trained Service Personnel may remove the cover or obtain access to system components Temperature Limits for Storage and Transport Alternating Current Pressure Limits for Storage and Transport Protective ...

Страница 10: ...cs and Electrical Equipment Symbol Regarding European Union End of Life of Product RF Symbol Non ionizing Electromagnetic Radiation White Balance Symbol Color Video Camera Catalog Number Serial Number Manufacturer Authorized Representative in the European Community Do Not Use if Package is Damaged ...

Страница 11: ... Requirement Lithium Batteries contain Perchlorate Material special handling may apply See www dtsc ca gov HazardousWaste Perchlorate In the US a list of recyclers in your area can be found at www eiae org 1 6 Initial Use of the Device WARNINGS 1 The device is only completely isolated from the mains if the power plug is disconnected from the device s power inlet module 2 The electrical installatio...

Страница 12: ...acking and Inspecting the Device Upon receipt carefully unpack the SynergyHD3 Controller Unit CCU and accessories Ensure contents are complete and are free from damage If any damage is noted contact your Arthrex Customer Service Contact the Manufacturer for Return Authorization PRIOR to shipping your device for service Save ALL packaging materials they may be needed to verify any claims of damage ...

Страница 13: ...Call Arthrex for a RMA Number for the device return for service Owner s Name Owner s Address Owner s Daytime Telephone Number Device type and model Serial Number Detailed explanation of the damage NOTE 1 The CCU shall be cleaned per section Cleaning and Sterilization prior to returning for service 2 The Camera Head shall be cleaned and Sterilized per Cleaning and Sterilization prior to returning f...

Страница 14: ...ra head from being improperly connected Ensure that the UP label on the camera head connector is facing upwards when the camera head connector is inserted PRECAUTION Ensure camera head contacts are clean and dry and cool 15 minutes prior to insertion 6 Light Source On Standby Switch The Light Source On Standby Switch toggles the Light Source between ON Operational Mode and STANDBY PRECAUTION 1 Use...

Страница 15: ...he purpose of the Potential Equalization Connector is to equalize the potentials between different metal parts of the various Medical Electrical ME equipment which make up a Medical Electrical system or to reduce differences of potential which can occur during operation between the bodies of the Medical Electrical devices and conductive parts of other objects The Potential Equalization Connector m...

Страница 16: ...s of the camera See Optional Tablet Data Input Device for programming information 2 Button 2 A programmable button that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 3 Focus Ring Used to sharpen or bring into focus the image detail 4 Grasping Mechanism Accepts and locks into place the compatible scope DIN 58105 compliant endoscope in...

Страница 17: ... 1 A programmable button that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 2 Button 2 A programmable button that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 3 C Mount Threads Accepts standard C Mount Optical Couplers ...

Страница 18: ...lay monitor An HD SDI cable may be used instead of DVI 5 If using a printer connect printer cable to USB connector on the rear panel of the SynergyHD3 console Connect other end of printer cable to the printer 6 Plug the AC power cord into the SynergyHD3 power inlet module and a standard grounded AC Mains outlet 100 240 V 50 60Hz 7 Insert the card edge connector the SynergyHD3 camera head into the ...

Страница 19: ...nergyHD3 Digital Documentation Tablet 12 SynergyHD3 Digital Documentation Tablet SONY UP PR80MD SONY UP PR80MD with upDR80MD NKIT Medical Grade Printers AR 3250 2601 AR 3250 2602 AR 3250 2603 AR 3250 3201 AR 3250 3203 AR 3250 3204 Medical Grade Surgical Monitor 26 Medical Grade Surgical Monitor 25 Medical Grade Surgical Monitor 26 Medical Grade Surgical Monitor 32 Medical Grade Surgical Monitor 32...

Страница 20: ...reless Microphone AR 3210 0005 C Mount Optical Zoom Coupler AR 3210 1005 Video Input Output Converter 2 3 System Setup Facility and Surgeon Settings NOTE Facility surgeon and procedural settings are made from the SynergyHD3 s tablet Data Input Device Figure 7 System Maintenance 2 3 1 System Set Up can be accessed by pressing the Maintenance Icon on the SynergyHD3 Tablet Data Input Device and then ...

Страница 21: ...erences to be setup Remote Entry enables users that have networked the SynergyHD3 system to add patients from a networked computer Password Access can be set to on or off On will require a password in order to enter add patients remotely Users can also select language time format Date format the number of cases saved ...

Страница 22: ...e fields that will be included on a print Available Fields are Facility Name Surgeon Name Patient Name Patient I D Procedure Type Date Notes Note It should be noted that Print Fields are also selectable as surgeon preferences although any conflict between facility preference and surgeon preference would be reconciled to facility preference ...

Страница 23: ...ure 10 System Maintenance Network 2 3 4 Selecting Network allows for connecting the SynergyHD3 system to a facility network Fields are Ethernet IP Mode Host Name Ethernet IP Address Ethernet Subnet Mask Ethernet Default Gateway ...

Страница 24: ... preferences 2 3 6 To add surgeons and their preferences press the maintenance icon on the SynergyHD3 Tablet Data Input Device and then select Surgeon Management A list of surgeons will appear 2 3 7 To add a surgeon press the Add New Surgeon button enter the first and last name of a surgeon then press the Preferences button ...

Страница 25: ...950 0027 01B 25 of 55 Figure 12 Surgeon Management Preferences ...

Страница 26: ... 55 Figure 13 Surgeon Preferences Settings 2 3 8 Surgeon preferences can be defined for the following Camera Settings including camera head button setup Printer Settings Print Fields Multimedia Web Server Access Display ...

Страница 27: ...idual surgeon preferences On the surgeon management list select a surgeon and a list of procedures will appear 2 3 10 Select the appropriate Procedure for the Surgeon If the procedure is not currently in the list select the Create New Procedure from the Procedures drop down list and enter the name of the new procedure ...

Страница 28: ...r entering Procedure Name select Camera Settings Surgeon preferences may be entered for Brightness Zoom Scene Gain Auto Exposure Window Enhancement NOTE If a surgeon performs multiple types of procedures and it is necessary to add additional procedures press the Add Procedure icon ...

Страница 29: ...950 0027 01B 29 of 55 2 4 Scheduling and Starting Cases Figure 16 Scheduling a case 2 4 1 To schedule a case press the Add New Case icon ...

Страница 30: ...27 01B 30 of 55 Figure 17 Scheduling a Case 2 4 2 Select the Surgeon and or Procedure and enter data in the following required fields Patient First Name Patient Last Name Patient I D 2 4 3 Press the Save icon ...

Страница 31: ...re 18 Starting a Case 2 4 4 To start a case select the case patient from the Case List and press the Start icon NOTE Cases may also be started from the Add Case screen by entering the required fields and pressing the Start icon ...

Страница 32: ... 19 Camera Head Button Change During Case 2 4 5 Changes to SETTINGS may be made during the procedure by pressing the Maintenance Icon Changes may be made to the following Camera Head Button Functions Camera Settings Print Settings ...

Страница 33: ...950 0027 01B 33 of 55 Figure 20 Camera Change During Case Figure 21 Print Changes During Case ...

Страница 34: ...ding a case 2 4 6 Ending a Case to end a case press the End Case Icon NOTE An End Case confirmation message will appear If confirmed the case will end and the SynergyHD3 Tablet Data Input Device will transition to the case review screen ...

Страница 35: ...After a LONG press on the LEFT BUTTON pressing the Left Button will DECREASE Brightness 6 Long Press on the RIGHT BUTTON will control Digital Zoom After a LONG PRESS on the RIGHT BUTTON pressing the RIGHT Button will INCREASE ZOOM After a LONG PRESS on the RIGHT BUTTON pressing the LEFT Button will DECREASE ZOOM 7 The SynergyHD3 Initial Screen will also indicate that the Printer is Active and that...

Страница 36: ...be shown on screen Figure 25 White Balance Fail 13 If the White Balance Operation has been successful the camera will enter the Surgical Ready Mode and be ready for surgical operation 14 If the White Balance Operation has not been successful you must move the Tip of the Endoscope closer or farther from the White Gauze until the operation can be completed successfully 15 Once the White Balance Oper...

Страница 37: ...950 0027 01B 37 of 55 2 6 Picture in Picture Operation Figure 26 Picture in Picture System Set Up Figure 27 Tablet PIP Control ...

Страница 38: ...ting a DVI 1080P 60 VIDEO SOURCE directly to the Camera Control Unit s DVI Input or by using the optional AR 3210 1005 Video Input Output Converter 2 6 3 2 The AR 3210 1005 Video Input Output Converter is connected to the Camera Control Unit DVI Input and the NON 1080P 60 video source is connected to the AR 3210 1005 which will convert the source to the needed 1080P 60 video format for PIP 2 6 4 T...

Страница 39: ... for this product is twelve months Life expectancy for the product is expected to meet and exceed this period for approximately 5 years under normal use and standard of care 3 2 Periodic Maintenance The product should be inspected prior to and after each use to ensure that the camera head cable strain relief overmold or connector contacts are not damaged or worn If it becomes necessary to return t...

Страница 40: ... the camera heads immediately after the automatic procedure has stopped 5 Set up washer for the wash cycle listed below Automatic Washer Cycle Definition Phase Recirculation Time Minutes Temperature Detergent Type and Concentration Pre Wash 1 02 00 Cold Tap Water NA Enzyme Wash 03 00 Hot tap water Enzol 1oz gallon Rinse 1 00 15 Hot tap Water 60oC NA Drying 06 00 90oC NA 3 3 2 2 Manual Cleaning CAU...

Страница 41: ...ged cables to Arthrex for repair 10 Before sterilization and or disinfection coil the camera head cable into loops at least six inches in diameter Do not kink or twist the cable 3 3 3 Sterilization of the AR 3210 Camera Heads Sterilization Protocols Validated PRECAUTION After sterilization set the AR 3210 Camera Heads aside for 15 minutes to allow equipment to cool before connecting to the CCU or ...

Страница 42: ...ttent picture Verify camera head connector card edge is fully inserted into the CCU camera receptacle Suspect video and or power cables Suspect camera head or cable Reinsert camera head connector card edge Flex video and power cables If picture is affected inspect cables and replace as necessary Flex camera cable If picture is affected return to factory for repair or replacement Camera will not wh...

Страница 43: ...y per interconnect diagram Check video cables for damage replace as necessary Replace the camera head with a working unit and verify image on monitor If image is now viewed the original camera head and or cable were faulty return them to Arthrex for repair Insert camera head cable connector completely into the console s camera head receptacle on the front panel Check monitor using color bars from ...

Страница 44: ...no breakdown See IEC 60601 1 for test methods 3 6 Replacement of the Lithium Battery The Camera Control Unit CCU main circuit board contains a Lithium Battery for use in the Real Time Clock Circuit This battery should have a service life of 8 years 1 If you need to replace the Lithium Battery a Use any UL recognized CR2032 Lithium Coin Cell Eveready CR2032 for example b Remove the old Lithium Batt...

Страница 45: ...No 60601 2 18 01 CAN CSA C22 2 No 60601 1 2008 CAN CSA C22 2 No 60601 2 18 2011 EU Certification CAN CSA C22 2 No 601 1 M90 IEC 60601 1 2nd Edition with Canadian Deviations CAN CSA C22 2 No 60601 2 18 01 IEC 60601 2 18 2nd Edition with Canadian Deviations CAN CSA C22 2 No 60601 1 2008 IEC 60601 1 3rd Edition with Canadian Deviations CAN CSA C22 2 No 60601 2 18 2011 IEC 60601 2 18 3rd Edition with ...

Страница 46: ... Value Power Requirements Rated Voltage 100 240 V Supply Frequency 50 60 Hz Power Input 140 VA Fuses No user serviceable fuses Video Outputs 3G SDI 1080P Video 59 94 Hz Progressive SMPTE 425 Standard DVI 1080P 1920 X 1080 Pixels Progressive Scan 1080P Vertical Scanning Frequency 59 94 Hz Signal to Noise Ratio 50 dB White Balance Range Integrated Optics Head 2000 to 10 000 K White Balance Range C M...

Страница 47: ...ting Conditions Ambient Temperature 50 F to 95 F 10 C to 35 C Relative Humidity 30 to 75 non condensing Atmospheric Pressure Altitudes 3000 m Table 6 Light Source Specifications Parameter Parameter Value LED Light Source Specifications Light output 1350 Lumens Color Temp 7000 K Nominal LED Life 30 000 hours Light Guide Port Wolf Standard Light Guide Port Turret ACMI Standard Storz Wolf and Olympus...

Страница 48: ...provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electro magnetic Environment of use and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non medical electrical equipment NOTE Medical Electrical Equipment ne...

Страница 49: ...ose directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as...

Страница 50: ...al environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 UT 0 0 5 cycle 0 45 90 135 180 225 270 and 3150 UT 0 1 cycle UT 70 25 30 cycles 0 degrees UT 70 250 300 cycles ...

Страница 51: ...gths from fixed 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 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 abs...

Страница 52: ...maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 7 GHz P E d 1 7 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 14 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimat...

Страница 53: ...ergy HD3 1 Login to the Android application Figure 28 Logging on to Android 2 Tap and hold the date field to bring up the Admin Options Figure 29 Tap and Hold DATE FIELD 3 Tap About Figure 30 Tap ABOUT 4 Tablet and CCU software version are displayed Figure 31 SW Version Information ...

Страница 54: ...950 0027 01B 54 of 55 THIS PAGE INTENTIONALLY LEFT BLANK ...

Страница 55: ...tomer Service 1 800 934 4404 Arthrex Inc Toll Free Technical Support 1 800 391 8599 Monday through Friday 8 00 AM 8 00 PM ET www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany 49 89 909005 0 All rights reserved Printed in USA ...

Отзывы:

Нет отзывов