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Technical Specifications  

NanoScope Manual 

DFU-0298-1, Revision 0 

Page 18 of 38

 

 

 

3.5 

Safety, EMC, and Regulatory Requirements  

Table 9 

Safety, EMC, and Regulatory Requirements 

Parameter 

Parameter Value 

System 

Classification 

IEC 60601-1 

Class I (protection against electric 

shock) 

FDA Class 

Class II 

EU Class 

Class I Console/ Class IIa Handpiece 

Health Canada Class 

Class 2 

Safety Certifications 

Domestic Certification 

IEC60601-1:2005/A1:2012 

Canadian Certification 

CAN/CSA C22.2 No. 60601-1-08 

EU Certification 

EN 60601-1:2006/A1:2013 

EMC Certifications 

CISPR 11 EMC Class 

Class A 

CISPR 11 EMC Group 

Group 1 

EMC Certification 

IEC 60601-1-2:2014   

Safety Certification 

Marking 

Per IEC 60601-1 3

rd

 Ed.  

UL 

cUL 

FCC 

Safety 

Classifications 

According to protection 

against electric shock 

Class 1 (grounded) 

According to degree of 

protection against 

electrical shock 

Applied part is Type BF Isolated 

According to degree of 

protection against 

harmful ingress of water 

NanoScope Console is IP20 
NanoScope Handpiece is IPX4 
(protected against water splash) 

According to the degree of 

safety in the presence 

Flammable Anesthetics 

Equipment is NOT suitable for use in 

the presence of flammable 

anesthetics 

Содержание NanoScope

Страница 1: ... All operating personnel must read this Manual thoroughly prior to using this system and follow all safety warnings precautions and notes Console Disposable Handpieces 0086 Arthrex Inc Arthrex GmbH 1370 Creekside Blvd Erwin Hielscher Straße 9 Naples FL 34108 1945 USA 81249 München Germany Toll free 1 800 934 4404 Tel 49 89 90 90 05 0 www arthrex com www arthrex de DFU 0298 1 Revision 0 07 2019 201...

Страница 2: ...anty information including disclaimers exclusions terms conditions and related provisions refer to the Arthrex U S Product Warranty section of the Arthrex Inc website found at www arthrex com whose provisions are incorporated herein by reference ...

Страница 3: ...ng packaging 16 3 4 NanoScope Handpiece 17 3 5 Safety EMC and Regulatory Requirements 18 4 0 Setup Use 20 4 1 Set up the NanoScope Console Non Sterile 20 4 2 Prepare the NanoScope Handpiece Kit Sterile 22 4 3 Performing a NanoScope Procedure 23 4 4 Ending a NanoScope Procedure 25 5 0 Cleaning and Disinfecting 26 5 1 NanoScope Console 26 6 0 Sterilization 27 6 1 Transmissible Spongiform Encephalopa...

Страница 4: ...PONENTS 10 TABLE 2 HANDPIECE CONNECTION ELEMENTS 11 TABLE 3 KIT COMPONENT DESCRIPTION 12 TABLE 4 ELEMENTS OF THE NANOSCOPE CONSOLE 13 TABLE 5 NANOSCOPE CONSOLE SPECIFICATIONS 15 TABLE 6 NANOSCOPE SYSTEM AMBIENT CONDITIONS FOR OPERATION 16 TABLE 7 NANOSCOPE SYSTEM AMBIENT CONDITIONS FOR STORAGE 16 TABLE 8 NANOSCOPE HANDPIECE SPECIFICATIONS 17 TABLE 9 SAFETY EMC AND REGULATORY REQUIREMENTS 18 TABLE ...

Страница 5: ...t Prior to using the device read and follow all warning and precautionary notices and instructions marked on the product and included in this manual Become familiar with the operation and function of the NanoScope Console and the associated NanoScope disposable Handpiece and accessories Failure to follow these instructions may lead to Serious injuries to the patient Potential injuries to the surgi...

Страница 6: ...g is vital for safe operation Plug the power cord into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual 10 This equipment should not share an electrical outlet or grounding with life supporting or life sustaining equipment 11 If one or more mains powered units are connected simultaneously to one socket...

Страница 7: ...esult in device failure render the device unsuitable for its intended use or compromise the procedure 22 The Console is not an applied part and is not intended to contact the patient 23 Prevent contact between the patient and any peripherals attached to the Console not including the NanoScope Handpiece 24 Never contact the Console or remove the applied NanoScope Handpiece while the distal portion ...

Страница 8: ...andpiece for an arthroscopy procedure without the cannula in place The Handpiece tube can easily be bent or broken if leveraged against bone or other anatomy 13 Store the NanoScope Handpiece and all disposable accessories in the original protective packaging to prevent sterile package damage during storage 14 Do not store the NanoScope Console where it will be exposed to temperatures in excess of ...

Страница 9: ...devices in the environment are causing interference turn the equipment off and on and identify the cause Correct the interference by using one or more of the following measures Reorient or relocate the receiving device Increase the separation between devices Connect the equipment into an outlet on a separate electrical circuit Consult the manufacturer or field service technician for help 22 This u...

Страница 10: ...irements of Medical Device Directive 93 42 EEC Authorized representative in the European Community The product meets the essential requirements of Medical Device Directive 93 42 EEC Fragile handle with care Precaution of Warning Notice This side up Keep dry Alternating current Electrical hazard dangerous voltages are present Never attempt to repair the equipment Only trained service personnel may ...

Страница 11: ...Manufacturer Humidity Limits for storage and transport WEEE Waste Electronics and Electrical Equipment Symbol Regarding European Union End of Life of Product Type BF Equipment Quantity RF symbol Non ionizing electromagnetic radiation Universal Serial Bus For use ONLY with thumb drive SN Serial Number Non Sterile Do Not Reuse Catalog Number Expiration Date Ethernet iPad compatible USB Port ...

Страница 12: ...e warranty could be voided if shipping or first installation damage is not reported within seven 7 business days of receiving the device Refer also to our General Terms of Business All defective products will be repaired or replaced at the discretion of Arthrex at no charge The warranty does not cover damage caused by unlawful use or improper handling of a product The warranty is not valid if modi...

Страница 13: ...s storage of procedure still images and videos Additional output ports include USB HDMI video and Ethernet for network capability The NanoScope Handpiece provides distal LED illumination to the surgical site using a fiber optic bundle surrounding a high resolution camera sensor The disposable NanoScope Handpiece Kit is packaged sterile and includes the Handpiece two 2 cannulas a conical obturator ...

Страница 14: ...Use NanoScope Manual DFU 0298 1 Revision 0 Page 10 of 38 2 2 Product Features Figure 1 NanoScope Handpiece Kit Table 1 Handpiece Kit Components 1 Trocar 2 Obturator 3 Calibration Cap 4 Handpiece 5 Cannulas 2 6 Stopcocks 2 7 Handpiece Cable ...

Страница 15: ...s Intended Use NanoScope Manual DFU 0298 1 Revision 0 Page 11 of 38 Figure 2 NanoScope Handpiece Table 2 Handpiece Connection Elements 1 Rear Handpiece button 2 Front Handpiece button 3 Calibration cap 4 Handpiece cable connector ...

Страница 16: ... Page 12 of 38 Figure 3 Additional Handpiece Kit Components Table 3 Kit component Description 1 Cannula quantity 2 2 Sharp trocar 3 Conical obturator 4 Stopcock quantity 2 Note Irrigation fluid and luer compatible devices e g saline filled 30 CC syringe are not included in the kit ...

Страница 17: ...0298 1 Revision 0 Page 13 of 38 Figure 4 NanoScope Console Table 4 Elements of the NanoScope Console 1 Power button 2 Handpiece connector 3 Microphone 4 Ethernet port 5 USB port 6 HDMI output 7 Power cable connector 8 Display touch screen 9 Power adapter not shown ...

Страница 18: ...ing but not limited to orthopedic laparoscopic urologic sinuscopic and plastic surgical procedures The device is also intended to be used as an accessory for microscopic surgery W A R N I N G Use this device only under the supervision of a trained and licensed physician This device should not be used by untrained personnel or used for indications other than those described in this manual and the N...

Страница 19: ...ly Universal input 110 240V medical grade 19 V 110 W AC input 100 240V 50 60Hz 8 0A Class I Applied part type BF Isolation Time to full charge 3 hours Battery usage A minimum of 100 minutes of use when new Data storage Non volatile memory 600 single frame images 60 minutes video and 1500 minutes of audio Display size 29 3 cm horizontal by 16 5 cm vertical 11 5 in horizontal by 6 5 in vertical Vide...

Страница 20: ...hPa to 1060 hPa 21 in Hg to 31 3 in Hg 3 3 Ambient Conditions for Storage in shipping packaging Table 7 NanoScope System Ambient Conditions for Storage Temperature Console 20 C to 50 C 4 F to 122 F up to 1 month 20 C to 45 C 4 F to 113 F up to 3 months 20 C to 20 C 4 F to 68 F up to 12 months Temperature Handpiece 40 C to 50 C 40 F to 122 F up to 1 year Relative humidity 10 to 90 non condensing Ai...

Страница 21: ... Handpiece width 4 1 cm 1 6 in Handpiece length 25 4 cm 10 in Handpiece height 6 4 cm 2 5 in Handpiece weight 150 gr 5 3 oz Water protection IPX4 Functions 1 MOS sensor Image resolution 400 X 400 pixels Frame rate 30 fps Field of view 120 degrees Illumination 2 lumens Insertion length 95 mm 3 7 in with cannula Diameter 2 2 mm 09 in with cannula ...

Страница 22: ...ertification EN 60601 1 2006 A1 2013 EMC Certifications CISPR 11 EMC Class Class A CISPR 11 EMC Group Group 1 EMC Certification IEC 60601 1 2 2014 Safety Certification Marking Per IEC 60601 1 3rd Ed UL cUL FCC Safety Classifications According to protection against electric shock Class 1 grounded According to degree of protection against electrical shock Applied part is Type BF Isolated According t...

Страница 23: ...operation CAUTION changes or modifications not expressly approved by Arthrex will void the user s authority to operate this equipment Industry Canada Information Contains IC 451I WL18DBMOD IC Model WL18MODGI This device complies with Industry Canada license exempt Radio Standard Specification RSS standard s Operation is subject to the following two conditions 1 this device may not cause harmful in...

Страница 24: ... a flat stable and skid free surface or Mount the Console to a stable mounting system with the VESA mount on the rear of the Console 2 Supply power to the Console Connect the power adapter from the mains power to the Console or Power the Console using battery power WARNING If you are using battery power once the Console is turned on view the battery icon on the Console interface to ensure the batt...

Страница 25: ...sion 0 Page 21 of 38 Figure 5 NanoScope Console login screen and keyboard 6 Follow the on screen instructions Note The patient demographics can be entered before the case begins after the case is complete or by accessing the case history later ...

Страница 26: ... sterile field The Handpiece Kit tray may act as a sterile field itself if space permits Inspect each component of the NanoScope Handpiece Kit and ensure there is no damage 4 When instructed on the Console insert the Handpiece cable into the Console connector table 4 item 2 until fully seated Note The Console is not sterile Figure 6 NanoScope Console on screen instructions 5 When instructed on the...

Страница 27: ...e anesthetized 3 Insert the sharp trocar or the conical obturator fully into cannula 4 Optional Attach a closed stopcock to the cannula Figure 7 Fully insert trocar or obturator into cannula as shown 5 Administer an incision if needed and insert the assembled trocar obturator and cannula into the patient insertion site using enough force to enter the joint cavity 6 Remove the trocar obturator leav...

Страница 28: ... cannula as shown 10 Visualize the cavity joint 11 Administer fluid as needed to aid in visualization 12 If needed use the additional cannula provided in the kit Then repeat the steps above to establish a second portal 13 Use the NanoScope Handpiece buttons to capture images or video 14 The NanoScope Console display can be used to capture images videos etc Note The Console is not sterile and shoul...

Страница 29: ...ing a NanoScope Procedure 1 Aspirate the fluid from the joint cavity and remove the cannula s from patient 2 Follow the on screen Console instructions to end the case 3 Discard the NanoScope Handpiece Kit and accessories in appropriate biohazard containers single use only ...

Страница 30: ...ing and disinfecting to evaporate before using Always turn the power off and disconnect the external power adapter before cleaning the Console Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration exposure times temperature and material compatibility NEVER allow the Console receptacles to have any contact with liquids If there is dust o...

Страница 31: ...ur local Arthrex Representative 6 1 Transmissible Spongiform Encephalopathy Agents It is outside the scope of this document to describe in detail the precautions that should be taken for Transmissible Spongiform Encephalopathy TSE Agents The agents for transmission of Creutzfeldt Jakob disease are believed to be resistant to normal processes of disinfection and sterilization Therefore the normal p...

Страница 32: ...r facility may result in reduced performance or instrument failure 7 1 Periodic Maintenance The product should be inspected prior to and after each use to ensure that the there is no damage If it becomes necessary to return the Console or accessory devices to Arthrex for service please clean them before shipping If fluid or particles splash on the display clean it with a micro fiber cloth by gentl...

Страница 33: ...port For assistance in using the products identified in this Manual contact an Arthrex representative or call the Arthrex Technical Support Hotline at 1 800 391 8599 Monday through Friday from 9 00 AM to 5 00 PM EST at 49 89 909005 8800 or techsupport arthrex de from 8 00 AM to 5 00 PM CET ...

Страница 34: ...nal power failure Return to Arthrex for repair Poor image quality or poor color reproduction Failed calibration Perform calibration again Dirty front window Clean the distal tip of the handpiece with sterile gauze and or fluid Defective Handpiece Use a new NanoScope Handpiece Console communication error failure with Handpiece Power down the Console Wait three minutes and restart the system Recalib...

Страница 35: ... correctly Banners do not display or do not display properly Improper shut down of Console Power down device Wait three minutes and restart system Interference with other devices Image disruption or noise on display 1 Turn off the suspect device to verify interference 2 Reorient or relocate the receiving device 3 Increase the distance between devices 4 Connect the device to an outlet on a differen...

Страница 36: ... problems persist disinfect the NanoScope Console and send it to Arthrex using the original packaging Always send the corresponding accessory device with the Console Please enclose a brief explanation of the malfunction Contact Arthrex for a Return Authorization Number and instructions prior to returning the device ...

Страница 37: ...n Waste Electrical and Electronic Equipment obliges manufacturers importers and or distributors of electronic equipment to provide for recycling of the electronic equipment at the end of its useful life Do not dispose of WEEE in unsorted municipal waste The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste Instead it is your responsibi...

Страница 38: ... guidance RF emissions CISPR 11 Group1 The NanoScope System is suitable for use in all residential environments and in establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emissions CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Table 12 System ...

Страница 39: ...power supply lines 100kHz 1 kV for input output lines 100 kHz Mains power quality should be that of a doctor s office typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a doctor s office typical commercial or hospital environment Voltage dips short interruptions a...

Страница 40: ...ectromagnetic environment guidance Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m 50 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a doctor s office typical commercial or hospital environment Note Uτ is the AC mains voltage prior to application of the test level ...

Страница 41: ...cables than the recommended separation calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P V d 1 5 3 1 2 P P V d 1 5 3 1 2 P 80 MHz to 800 MHz P E d 1 7 2 3 P 800 MHz to 2 7 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 m...

Страница 42: ... 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE...

Страница 43: ...This page intentionally left blank ...

Страница 44: ... 34108 1945 USA 81249 München Germany www arthrex com www arthrex de Customer Service 1 800 934 4404 Tel 49 89 909005 0 Toll Free Technical Support 1 800 391 8599 Monday through Friday 9 00 AM 5 00 PM EST Console Disposable Handpieces 0086 DFU 0298 1 Revision 0 All rights reserved ...

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