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Arthrex DrillSaw Mini 300 System Скачать руководство пользователя страница 19

DrillSaw Mini 300™ System

User’s Guide

DFU-0223-2 Rev. 0

Page 13

3.3

Safety, EMC, and Regulatory Requirements

Table 8

Safety, EMC, and Regulatory Requirements

Parameter

Parameter Value

System Classification

IEC 60601-1

Class I
(protection against electric

shock)

FDA class

Class I

EU class

Class IIa

Health Canada Class

Class II

Safety Certifications

Domestic Certification

ANSI/AAMI ES60601-1

Canadian Certification

CSA C22.2 No 60601.1 (

EU Certification

EN/IEC 60601-1

EMC Certifications

EMC Certification

EN/IEC 60601-1-2

Safety Certification Marking

UL

CE Classification

MDD 93/42/EEC

Annex IX Rule 9

Class IIa

For all other accessories refer to accompanying DFUs for more information. Refer to Section

11.0 Electromagnetic Emissions for further details on EMC certification.

3.4 Electromagnetic Compatibility (EMC)

This device has passed testing for EMI/RFI radiation and susceptibility

and EMC compatibility. This device may cause interference with other

devices in the near vicinity if not set up and used as instructed by

Arthrex.

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Содержание DrillSaw Mini 300 System

Страница 1: ...g personnel must read this User s Guide thoroughly prior to using this system and follow all safety warnings cautions and precautions 0086 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA Toll Free 1 800 934 4404 www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 Fax 49 89 909005 280 www arthrex de DFU 0223 2 Revision 0 1 2019 Arthrex Inc All ri...

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Страница 3: ...nts 12 3 3 Safety EMC and Regulatory Requirements 13 3 4 Electromagnetic Compatibility EMC 13 3 5 Risks due to electromagnetic fields 14 4 4 0 0 Setup 15 4 1 How to Set Up the Handpiece 15 4 2 Setup Connecting and removing an attachment to the handpiece 15 4 3 Setup Connecting a battery housing to the handpiece 16 4 4 Setup Removing the battery housing from the handpiece 17 4 5 Setup Quick Connect...

Страница 4: ...Automated Cleaning and Thermal Disinfection 27 6 6 0 0 Sterilization 28 6 1 Approved Sterilization 28 6 1 Transmissible Spongiform Encephalopathy Agents 29 7 7 0 0 Maintenance 30 7 1 Periodic Maintenance 30 8 8 0 0 Technical Support 31 8 1 Additional Technical Information 31 9 9 0 0 Repair Policy 32 1 10 0 0 0 End of Life Environmental Directives 33 1 11 1 0 0 Electromagnetic Emissions 34 ...

Страница 5: ...chment 15 Figure 5 Connecting a battery housing 16 Figure 6 Removing the battery housing 17 Figure 7 Insert a drill bit 18 Figure 8 Insert a drill bit into a Jacobs Chuck 19 Figure 9 Insert a drill bit into a Keyless Chuck 20 Figure 10 Insert a sawblade 21 Figure 11 Insert a drill burr bit 22 Figure 12 Insert a pin wire 23 Figure 13 Insert drop in battery to the Battery Housing 24 ...

Страница 6: ...able 14 Insert a drill bit into a Keyless Chuck 20 Table 15 Insert a sawblade 21 Table 16 Insert a burr drill bit 22 Table 17 Insert a pin wire 23 Table 18 Drop in battery 24 Table 19 Guidance and Manufacturer s Declaration Electromagnetic Emissions 34 Table 20 Guidance and Manufacturer s Statement Electromagnetic Immunity 35 Table 21 Guidance and Manufacturer s Statement Electromagnetic Immunity ...

Страница 7: ...first time store it at room temperature for 24 hours 3 Charge batteries before every use Follow instructions for charging batteries before use 4 The device is intended to apply mechanical force rotational energy to the patient 5 Before each use check the handpiece and the attachments for damage and or loose parts Do not use any part that is damaged 6 Prior to each use press the trigger mechanism t...

Страница 8: ... truncated pyramid below the operating table which is tilted outwards at a 30 angle 17 Zone G also known as an enclosed medical gas system does not necessarily include areas enclosed around all sides in which explosive mixtures are continuously or temporarily generated directed or used in small quantities 18 Only fit an attachment accessory when the handpiece is at a complete stop and in safe posi...

Страница 9: ... that could scratch or damage the device 6 The battery packs are NOT to be cleaned and disinfected in a thermo washer disinfector 7 NEVER place the handpiece or accessories in Cidex or other aldehyde disinfectant solutions 8 After sterilization in the autoclave let the accessory device cool down slowly NEVER use cold water to cool the handpieces This will damage the electronic components and seals...

Страница 10: ...ature limits for storage and transport Electrical Hazard dangerous voltages are present Never attempt to repair the equipment Only trainer service personnel may remove the cover or obtain access to system components Atmospheric pressure limitation for storage and transport Type B Device Not suitable for intracardiac applications Humidity limits for storage and transport Authorized representative i...

Страница 11: ...ctromagnetic radiation 1 3 Shipping Unpacking and Warranty Information Carefully unpack and inspect all components for shipping damage Any damage could compromise patient safety and should be reported immediately to Arthrex or an authorized Arthrex distributor The warranty could be voided if shipping or first installation damage is not reported within seven business days of receiving the device Pl...

Страница 12: ...system consisting of a handpiece drive various accessories and a charging station for machining bones It can be used for small bone orthopedic and sports medicine applications to make osteotomies drill holes and drive pins and wires 2 3 Contraindications The DrillSaw Mini 300 System is contraindicated in any non orthopedic surgery procedure and procedure disregarding the intended use Specifically ...

Страница 13: ...osition Arthrex DrillSaw Mini 300 System parts and accessories Handpiece Attachments See Table 22 Battery pack Battery housing aseptic battery only Battery transfer plate aseptic battery only Battery Charger see DFU 0256 XX Instrument Tray s Elongation handle optional device ...

Страница 14: ...ct Functions 2 2 5 5 1 1 AR 300 Handpiece The handpiece functions are identified and defined below Figure 1 Handpiece Table 1 Handpiece 1 Chuck mechanism 2 Speed regulator 3 Battery housing 4 R S F Switch 5 Forward drive F 6 Safe position S 7 Reverse drive R 1 2 3 6 7 4 5 ...

Страница 15: ...er s Guide DFU 0223 2 Rev 0 Page 9 2 2 5 5 2 2 AR 300L Battery Pack Li Ion The main elements of the AR 300L battery pack are identified and defined below Figure 2 Battery Pack Table 2 Battery Pack 1 Battery contacts 2 Handle 1 2 ...

Страница 16: ...2 2 5 5 3 3 AR 3000LBH Battery Housing The main elements of the Battery Housing are identified and defined below Figure 3 Battery Housing Table 3 Battery Housing 1 Battery contacts 2 Battery housing door 3 Release tab to remove battery housing from handpiece 1 2 3 ...

Страница 17: ... average load using the Sagittal Saw attachment and at ambient air temperature of 25 C 77 F Operating the device above of these prescribed parameters can lead to user and patient injury as well as a shortened life span of the device itself The recommended environmental operating temperature is 25 C 77 F or lower Operating in environments above 25 C 77 F can shorten the above prescribed duty cycles...

Страница 18: ...23 2 Rev 0 Page 12 3 2 Attachments Table 7 Attachments Drill Speed 2 750 rpm 1 300 rpm Drill Torque 24 Ncm 2 12 inch pounds 45 Ncm 3 98 inch pounds Reamer Speed 500 rpm Reamer Torque 1 15 Nm 10 17 inch pounds Cutting 15 000 cpm Sterilization YES ...

Страница 19: ...A C22 2 No 60601 1 EU Certification EN IEC 60601 1 EMC Certifications EMC Certification EN IEC 60601 1 2 Safety Certification Marking UL CE Classification MDD 93 42 EEC Annex IX Rule 9 Class IIa For all other accessories refer to accompanying DFUs for more information Refer to Section 11 0 Electromagnetic Emissions for further details on EMC certification 3 4 Electromagnetic Compatibility EMC This...

Страница 20: ...ld service technician for the receiving device for guidance 3 5 Risks due to electromagnetic fields The functionality of implantable systems such as cardiac pacemakers and ICD implantable cardioverter defibrillator can be affected by electric magnetic and electromagnetic fields 1 Consider the application and find out if patient or user has any of these devices before using the product 2 Weigh the ...

Страница 21: ...hment to the handpiece These instructions describe the procedure for connecting an attachment to the AR 300 handpiece Figure 4 Connecting and removing an attachment Table 9 Connecting and removing an attachment 1 To Insert the attachment Turn the handpiece drive chuck mechanism Push the adaptor into the locking mechanism and release the chuck mechanism 2 To remove the attachment Turn the handpiece...

Страница 22: ... housing to the handpiece These instructions describe the procedure for connecting a battery to the AR 300 handpiece Figure 5 Connecting a battery housing Table 10 Connecting a battery housing 1 Pressing the locking dive and push the battery housing into the handpiece drive as far as it will go 2 You will hear an audible click once the retaining tab mechanism is engaged to the handpiece 3 Battery ...

Страница 23: ...ng from the handpiece These instructions describe the procedure for removing the battery housing assembly from the AR 300 handpiece Figure 6 Removing the battery housing Table 11 Removing the battery housing 1 Pressing the locking device and hold 2 Move the battery housing away from the handpiece 2 1 ...

Страница 24: ...be the procedure to inserting a drill bit into the AR 300 quick connect attachments Figure 7 Insert a drill bit Table 12 Insert a drill bit 1 Pull back on the quick connect collar and hold it in place 2 Insert the drill bit into the end of the attachment 3 Release the collar and check to make sure the drill bit is secured in the attachment 1 3 2 1 ...

Страница 25: ...r inserting a drill bit to the AR 300 keyed chucks Figure 8 Insert a drill bit into a Jacobs Chuck Table 13 Insert a drill bit into a Jacobs Chuck 1 Open the collar of the Jacobs Chuck enough for the drill bit to fit into the attachment 2 Insert the drill bit Use the chuck key to tighten down the collar Make sure to tighten using all three holes on the Jacobs Chuck 1 2 ...

Страница 26: ...bit to the AR 300 keyless attachments Figure 9 Insert a drill bit into a Keyless Chuck Table 14 Insert a drill bit into a Keyless Chuck 1 Open the collar of the Chuck enough for the drill bit to fit into the attachment 2 Insert the drill bit Hold the locking collar with one hand and twist the distal end of the chuck with your other hand until the drill bit is firmly held in place 1 2 ...

Страница 27: ...ing a sawblade to the AR 300 sagittal saw attachments and reciprocating saw attachment Figure 10 Insert a sawblade Table 15 Insert a sawblade 1 Operate the twist chuck or the push button and push the saw in as far as it will go 2 Release the twist chuck or the push button Pull on the blade to ensure it is fully seated in the attachment 1 2 ...

Страница 28: ...procedure for connecting the burr to the burr drill attachment Figure 11 Insert a drill burr bit Table 16 Insert a burr drill bit 1 Operate the twist chuck 2 Push the rotary instrument in and turn it until you hear it engage 3 Release the twist chuck and check that the connection is secure by pulling in an axial direction 1 2 3 ...

Страница 29: ...e AR 300 pin driver attachment Figure 12 Insert a pin wire Table 17 Insert a pin wire 1 Pull the lever of the pin or wire driver back and insert the pin or wire 2 Slide the pin or wire into the driver until the desired length is reached Do not insert the wire up to the limit stop in the handpiece drive 3 Release the lever in order to fix the pin or wire in place 1 3 2 ...

Страница 30: ...an B Non sterile Circulating Nurse 1 The Sterile Technician holds sterile battery housing upright and places the sterile transfer plate on top 2 The Non sterile Circulating Nurse places the unsterile battery down into the housing through the sterile transfer plate until it is fully seated 3 The Non sterile Circulating Nurse then removes the sterile transfer plate and the Sterile Technician closes ...

Страница 31: ...facturer s instructions regarding use concentration and temperature Use only freshly prepared solutions as well as only purified critical water at least for final rinse Caution Low acid or high alkaline solutions are not recommended as they corrode metal and anodized aluminum and can cause damage to polymers Remove any attachments and the battery housing from the handpiece prior to cleaning Remove...

Страница 32: ...s areas are clean 5 5 2 2 1 1 Handpieces and Battery Housings 1 Prepare a detergent solution using cool utility tap water according to the manufacturer s recommended concentration 2 Using a soft bristled brush that has been dampened with the detergent solution remove visible gross soil from the surface of the device For handpieces use an appropriately sized lumen brush that has been dampened with ...

Страница 33: ...ing minimum recommended wash cycle parameters were utilized by Arthrex during the validation of these instructions If your washer disinfector has an ULTRASONIC cleaning stage you must deactivate it prior to cleaning the DrillSaw Mini 300 System handpieces Ultrasonic cleaning of the handpiece is NOT approved and can cause damage to the handpiece RECOMMENDED WASHING CYCLE PARAMETERS Phase Recirculat...

Страница 34: ...erning body Only Arthrex devices should be included in the trays These validated instructions are not applicable to trays that include devices not intended to be used with Arthrex trays 6 1 Approved Sterilization Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below Sterilizers vary in desig...

Страница 35: ...function at all W A R N I N G After autoclaving the accessory devices are VERY HOT Handle with care to avoid burns 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 res...

Страница 36: ...ortant to visually inspect the DrillSaw Mini 300 System before each use Your authorized Arthrex service department is extremely knowledgeable about the Arthrex DrillSaw Mini 300 System and will provide professional service Any services and or repairs carried out by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure 7 1 Periodic Maintenance T...

Страница 37: ...t the Arthrex Technical Support Hotline at 1 888 420 9393 Monday through Friday from 9 00 AM to 5 00 PM EST or at 49 89 90 90 05 8800 or techsupport arthrex de from 8 00 AM to 5 00 PM CET 8 1 Additional Technical Information Contact your Arthrex representative if you require more comprehensive technical information Other information will be provided upon request by Arthrex Approved Service Personn...

Страница 38: ...DrillSaw Mini 300 System User s Guide DFU 0223 2 Rev 0 Page 32 9 9 0 0 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device ...

Страница 39: ...oduct or its packaging indicates that this product must not be disposed of with other waste Instead it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources a...

Страница 40: ...ce Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The DrillSaw Mini 300 System uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference with nearby electronic equipment RF emissions CISPR 11 Class A The DrillSaw Mini 300 System is suitable for use in all establishments other than domestic and those directly c...

Страница 41: ...vironment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m 50 60 Hz...

Страница 42: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than 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 propagat...

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Страница 44: ... Jacobs Chuck 0 0 4 mm AR 300DK30 Drill Keyless Chuck 0 3 0 mm AR 300DK45 Drill Keyless Chuck 2 0 4 5 mm AR 300DJH Drill Jacobs Chuck Hybrid 0 5 0 mm AR 300RAO Reamer Attachment Style AO AR 300RJ Reamer Jacobs Chuck 0 4 0 mm AR 300SAG Saw Attachment Sagittal AR 300SR Saw Attachment Reciprocating AR 300WD16 Wire Driver Attachment 0 6 1 6 mm AR 300PD24 Pin Driver Attachment 1 6 2 4 mm AR 300L Batter...

Страница 45: ...ongation Handle AR 300C G Tray for AR 300 AR 300C Instrument Case AR 300KEY Replacement Key for Jacobs Chuck for AR 300 AR 300HKEY Replacement Key for Hybrid Chuck for AR 300 AR 400UBC Universal Battery Charger AR 400UBC 3 Charging Bay for AR 300L and AR 600L Aseptic Battery ...

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Страница 47: ...DrillSaw Mini 300 System User s Guide DFU 0223 2 Rev 0 Page 41 This page intentionally left blank ...

Страница 48: ... 2 Rev 0 Page 42 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 www arthrex de All rights reserved 0086 ...

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