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Stryker System 6 6203-000-000, Инструкция по эксплуатации

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6203-001-700 Rev-E

EN

www.stryker.com

3

 

▪

ALWAYS operate the equipment within the 
specified environmental condition values. See the 

Specifications 

section.

 

▪

ALWAYS follow the recommended duty cycle to 
prevent the equipment from overheating. See the 

Specifications

 section and/or the instructions for 

use supplied with the attachment.

 

▪

DO NOT use this equipment in areas in which 
flammable anesthetics or flammable agents are 
mixed with air, oxygen, or nitrous oxide.

 

▪

Take special precautions regarding 
electromagnetic compatibility (EMC) when 
using medical electrical equipment like the 
handpiece. Install and place the handpiece into 
service according to the EMC information in this 
manual. Portable and mobile RF communications 
equipment can affect the function of the 
handpiece.

Accessories

WARNINGS:

 

▪

Use only Stryker-approved system components 
and accessories, unless otherwise specified. 
Using other accessories may result in increased 
electromagnetic emissions or decreased 
electromagnetic immunity of the system. DO NOT 
modify any system component or accessory.

 

▪

DO NOT reuse, reprocess, or repackage single 
use cutting accessories. All cutting accessories 
are intended for a single use only. Reuse may 
create a serious risk of contamination and lead 
to infection or cross-infection. Reprocessing may 
compromise the structural integrity of the cutting 
accessory and result in fragmentation during use. 
Critical product information may be lost if the 
cutting accessory is repackaged.

NOTE: 

For a complete list of accessories, contact 

your Stryker sales representative or call Stryker 
customer service. Outside the US, contact your 
nearest Stryker subsidiary.

The following Stryker-approved accessories are sold 
separately:

DESCRIPTION

REF

Small Battery Pack

6212-000-000

Large Battery Pack

6215-000-000

Aseptic Battery Kit

6126-000-000

Small Aseptic Battery Kit

6127-000-000

Содержание System 6 6203-000-000

Страница 1: ...n of the document should not appear on produced Labels or IFUs Description Type Stryker Instruments 269 323 7700 800 253 3210 Print Location Suppliers Services Part Number Rev 6 inch width x 6 inch Booklet Print Center Color Graphics on White Background 20 Bond or Equivalent N A N A Instructions For Use 6203 001 700 E ...

Страница 2: ...2015 03 6203 001 700 Rev E www stryker com System 6 Single Trigger Rotary Handpiece 6203 000 000 Instructions For Use ENGLISH EN ...

Страница 3: ... used with a variety of attachments is intended for surgical procedures involving drilling reaming driving wire or pins cutting bone and hard tissue Contraindications None known User Patient Safety WARNINGS Only trained and experienced healthcare professionals should use this equipment Before using any system component or any component compatible with this system read and understand the instructio...

Страница 4: ...mponents and accessories unless otherwise specified Using other accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system DO NOT modify any system component or accessory DO NOT reuse reprocess or repackage single use cutting accessories All cutting accessories are intended for a single use only Reuse may create a serious risk of contamination...

Страница 5: ...achment slide the actuating collar Shifter Knob To select the handpiece mode of REAM slow or DRILL fast rotate the knob to the appropriate position as required Accessory Interface Connector provides power and communication for future accessories Attachment A variety of attachments are available for use with this handpiece Each attachment has a specialized retainer for wires pins tools and or cutti...

Страница 6: ...handpiece the handpiece cannot be operated Shifter Knob DRILL Mode For fast speed and low torque rotate shifter knob to DRILL REAM Mode For slow speed and high torque rotate shifter knob to REAM Definitions The symbols located on the equipment and or labeling are defined in this section or in the Symbol Definition Chart See the Symbol Definition Chart supplied with the equipment SYMBOL DEFINITION ...

Страница 7: ... with the appropriate battery charger modules See the instructions for use supplied with the battery charger and or battery pack for charging details and specifications Instructions To Install Attachment WARNING To prevent inadvertent running of the handpiece ALWAYS place the F R Safe control in the safe mode position before installing or removing any attachment NOTE Several attachments are availa...

Страница 8: ...hooting section DO NOT apply excessive pressure such as bending or prying with a cutting accessory to prevent fracturing the accessory Applying excessive pressure especially during high operating speeds may cause the cutting accessory to bend significantly and result in tissue damage loss of tactile control and the ejection of cutting accessory pieces at a high velocity CAUTIONS DO NOT stall the h...

Страница 9: ...e DRILL mode Failure to comply may cause wobble and result in patient and or healthcare staff injury 1 Ensure the handpiece is not running 2 Change the handpiece mode as follows For DRILL mode rotate the shifter knob counterclockwise until it clicks in place Troubleshooting WARNING DO NOT disassemble or service this equipment NOTE For service contact your Stryker sales representative or call Stryk...

Страница 10: ...piece with a small brush with stiff non metallic bristles Attachment is damaged Return the attachment for repair Handpiece is damaged Return the handpiece for repair Attachment and or cutting accessory wobbles in handpiece Cutting accessory or wire pin is bent extends too far from the distal end of attachment is the wrong size or is not properly centered in the attachment Reinsert the cutting acce...

Страница 11: ...Model System 6 Single Trigger Rotary Handpiece REF 6203 000 000 Dimensions 8 6 inch 219 mm height with large battery pack 1 5 inch 38 mm width 6 0 inch 153 mm length Mass 3 5 lb 1 6 kg with large battery pack Speed 1200 rpm drill 270 rpm ream Mode of Operation Duty Cycle Rest Between Cycles Non continuous Operation 1 minute on 4 minutes off 3 times 3 hours Equipment Type Type BF Applied Part Maxim...

Страница 12: ...ial Performance CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety American National Standards Institute Association for the Advancement of Medical Instrumentation ANSI AAMI ES60601 1 2005 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Consolidated Reprint 2009 Amendment 2 2010 Underwriters Laboratorie...

Страница 13: ... is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The System 6 Single Trigger Rotary Handpiece REF 6203 000 000 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 Class B The System 6 Single Trigger Ro...

Страница 14: ... tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines N A N A Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth N A N A Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 ...

Страница 15: ...tters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Non ionizing electromagnetic radiation 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 affe...

Страница 16: ...according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 For transmitters rated at a maximum output power not listed above the recom...

Страница 17: ...700 Rev E www stryker com ES DE FR IT NL 6203 001 710 JA ZH KO 6203 001 720 SV DA FI PT NO 6203 001 730 PL EL TR 6203 001 750 Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 ...

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