Instructions for Use
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STRYKER SYSTEM G™ Rotary Drill 7305-001-000
Rotary Drill Attachments 7307-XXX-XXX Series 4103-XXX-XXX Series Instructions For Use
ENGLISH (EN) ESPAÑOL (ES) ITALIANO (IT) PORTUGUÊS (PT) POLSKI (PL) ΕΛΛΗΝΙΚΑ (EL) TÜRKÇE (TR) РУССКИЙ (RU) 中文 (ZH) 한국어 (KO)
2021-07
7305-001-700 Rev-AC
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EN
7305-001-700 Rev-AC
Contents Introduction . . . . . . . . . . . . . . . . . . . . . 3 Audience . . . . . . . . . . . . . . . . . . . . 3 Conventions . . . . . . . . . . . . . . . . . . . 3 Contact Information . . . . . . . . . . . . . . . 3 Intellectual Property . . . . . . . . . . . . . . . 3 Indications For Use . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . 3 Safety Directives . . . . . . . . . . . . . . . . . . . 3 For Use With . . . . . . . . . . . . . . . . . . . . . 4 Power and Care Components . . . . . . . . . . . 4 Attachments and Cutting and Fixation Tools . . . . 4 Wire and Pin Collets . . . . . . . . . . . . . 4 Keyed Chucks . . . . . . . . . . . . . . . . 4 Keyless Chucks . . . . . . . . . . . . . . . 4 Drill Attachments . . . . . . . . . . . . . . . 4 Reamer Attachments . . . . . . . . . . . . . 5 Features . . . . . . . . . . . . . . . . . . . . . . . 5 Handpiece . . . . . . . . . . . . . . . . . . . . 5 Safety Switch . . . . . . . . . . . . . . . . . . 6 Attachments . . . . . . . . . . . . . . . . . . . 6 Wire and Pin Collets . . . . . . . . . . . . . 6 Keyed Chucks . . . . . . . . . . . . . . . . 6 Keyless Chucks . . . . . . . . . . . . . . . 6
To Install a Power Module . . . . . . . . . . . . 8 Sterile Assistant . . . . . . . . . . . . . . . 8 Circulating Assistant . . . . . . . . . . . . . 8 Sterile Assistant . . . . . . . . . . . . . . . 9 To Install an Attachment . . . . . . . . . . . . . 9 To Install and Remove a Cutting or Fixation Tool . . 10 Wire and Pin Collets . . . . . . . . . . . . . 10 Keyed Chucks . . . . . . . . . . . . . . . 11 Keyless Chucks . . . . . . . . . . . . . . . 11 Drill and Reamer Attachments . . . . . . . . 12 To Operate a Handpiece . . . . . . . . . . . . . 12 To Remove an Attachment . . . . . . . . . . . . 13 To Remove a Power Module . . . . . . . . . . . 13 Specifications . . . . . . . . . . . . . . . . . . . . 14 Handpiece . . . . . . . . . . . . . . . . . . . 14 Attachments . . . . . . . . . . . . . . . . . . 14 Wire and Pin Collets . . . . . . . . . . . . . 14 Keyed Chucks . . . . . . . . . . . . . . . 15 Keyless Chucks . . . . . . . . . . . . . . . 15 Drill Attachments . . . . . . . . . . . . . . 15 Reamer Attachments . . . . . . . . . . . . 16 Transfer Shield . . . . . . . . . . . . . . . . . 16 Product Safety Compliance . . . . . . . . . . . . . . 16 Electromagnetic Compatibility . . . . . . . . . . . . 17
Drill and Reamer Attachments . . . . . . . . 7 Definitions . . . . . . . . . . . . . . . . . . . . . . 7 Instructions . . . . . . . . . . . . . . . . . . . . . 7 To Process the Equipment . . . . . . . . . . . . 7 To Charge a Power Module . . . . . . . . . . . . 7
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7305-001-700 Rev-AC
EN
Introduction
Indications For Use
This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.
The STRYKER SYSTEM G Rotary Drill (handpiece) is a surgical battery-powered instrument intended for use during a variety of orthopedic and trauma procedures to provide power to operate various accessories or attachments, which may include a pin/wire driver, a driver bit, and/or a drill bit.
Audience This manual is intended for in-service trainers, physicians, nurses, and surgical technologists. Keep and consult this reference manual during the life of the product.
Conventions
This handpiece is designed for surgical procedures where hard tissue and/or bone must be reamed, drilled and/or fixated with screws, including, but not limited to, the hand wrist, elbow, shoulder, foot, ankle, knee, and hip.
The following conventions are used in this manual:
Contraindications
▪
A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury.
None known.
▪
A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.
▪
A NOTE supplements and/or clarifies procedural information.
Contact Information For additional information, including safety information, inservice training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-269-323-7700 or 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.
Safety Directives WARNINGS: ▪
Before using this equipment, read and understand the instructions for use. Pay particular attention to safety information.
▪
Only trained and experienced healthcare professionals should use this equipment.
▪
The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker does not recommend surgical procedure or technique.
NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.
Intellectual Property Trademarks not the property of Stryker Corporation are the property of their respective owners.
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7305-001-700 Rev-AC
For Use With
Keyed Chucks
This section identifies components intended to be used with the equipment to obtain a safe combination.
NOTE: Each chuck is supplied with a chuck key (REF 1331-001-009)
WARNINGS: ▪
Use only Stryker-approved equipment, unless otherwise specified.
▪
Use of unapproved electrical equipment may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system.
NOTE: For a complete list of components or ordering information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.
Attachment 1:1 1/4 inch (6.4 mm) Keyed Chuck High Torque 1/4 inch (6.35 mm) Drill with Chuck 2:1 with Key 3.25:1 1/4 inch (6.4 mm) Keyed Chuck
REF 4103-131-000
4103-180-000
4103-231-000
Tools Wires, pins, drill bits, and tools up to 6.4 mm in diameter Wires, pins, drill bits, and tools up to 6.4 mm in diameter Wires, pins, drill bits, and tools up to 6.4 mm in diameter
Keyless Chucks
Power and Care Components Description STRYKER SYSTEM G Transfer Shield STRYKER SYSTEM G Power Module STRYKER SYSTEM G Charger, 2-Bay STRYKER SYSTEM G Sterilization Cases
REF 7304-120-000 7309-120-000 7310-120-000 7302-120-000 7302-130-000
Attachments and Cutting and Fixation Tools
NOTE: The Keyless Chuck Adaptor (REF 4103-082-131) is intended for use with standard Trinkle attachments. Attachment Keyless Chuck Adaptor
REF 4103-082-131
Keyless Drill Attachment
4103-133-000
Drill Attachments Attachment 1:1 AO Small Drill
REF 4103-110-000
1:1 Hudson
4103-113-000
WARNING: All cutting and fixation tools are intended for single use only.
Wire and Pin Collets NOTE: Wire and pin collets REF 4103-063-000, 4103126-000S3, and 4103-126-000 are not compatible with STRYKER SYSTEM G. Attachment STRYKER SYSTEM G Wire Collet
REF 7307-001-000
STRYKER SYSTEM G Pin Collet, Small
7307-002-000
STRYKER SYSTEM G Pin Collet, Large
7307-003-000
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Tools Kirschner wires and Steinmann pins from 0.7 to 1.8 mm in diameter Kirschner wires and Steinmann pins from 2.0 to 3.2 mm in diameter Kirschner wires and Steinmann pins from 3.0 to 4.2 mm in diameter
Tools Wires, pins, drill bits, and tools up to 6.4 mm in diameter Wires, pins, drill bits, and tools up to 6.4 mm in diameter
1:1 Hudson/ 4103-135-000 Modified Trinkle
1:1 Trinkle
4103-160-000
Tools Drill bits, taps, automatic screwdrivers, and tools with AO snaplock shanks Drill bits, reamers, taps, automatic screwdrivers, and tools with Hudson fittings Drill bits, reamers, automatic screwdrivers, and tools with Hudson or modified Trinkle fittings Drill bits, reamers, automatic screwdrivers, and tools with standard Trinkle fittings
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7305-001-700 Rev-AC
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Features
Reamer Attachments Attachment 3.25:1 AO Large Reamer
3.25:1 Hudson
REF 4103-210-000
4103-213-000
3.25:1 Hudson/ 4103-235-000 Modified Trinkle
3.25:1 Trinkle
4103-260-000
4:1 Hudson
4103-413-000
4:1 Hudson/ 4103-435-000 Modified Trinkle
Tools Drill bits, flexible reamers, automatic screwdrivers, and tools with AO snaplock shanks Drill bits, reamers, taps, automatic screwdrivers, and tools with Hudson fittings Drill bits, reamers, automatic screwdrivers, and tools with Hudson or modified Trinkle fittings Drill bits, reamers, automatic screwdrivers, and tools with standard Trinkle fittings Drill bits, reamers, taps, automatic screwdrivers, and tools with Hudson fittings Drill bits, reamers, automatic screwdrivers, and tools with Hudson or modified Trinkle fittings
Handpiece B
A C D E
A B C
D
E F
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F
Safety Switch – Locks one or both of the triggers. Release Lever – Push to release an attachment from the handpiece. Reverse Trigger – Controls the variable speed operation of the handpiece in a counterclockwise direction. Forward Trigger – Controls the variable speed operation of the handpiece in a clockwise direction. Door – Opens to allow installation of a power module. Latch – Secures the door.
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7305-001-700 Rev-AC
Safety Switch
Keyed Chucks
Forward Mode – Only the forward trigger is functional. The reverse trigger is locked to prevent inadvertent operation of the handpiece in a counterclockwise direction. Forward/Reverse Mode – Both triggers are functional.
A
C B A
Safe Mode – Both triggers are locked to prevent inadvertent operation of the handpiece.
B C
Attachments
Jaws – Secure the cutting tool in the attachment. Chuck Key – A tool used to open and close the jaws. J-Notch – Secures the attachment in the handpiece.
Keyless Chucks
Wire and Pin Collets
A
B C
C B
A D A
B C D
A B C
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Lock Switch – Locks the collar to prevent inadvertent operation of the attachment (REF 4103-133-000 only). Chuck – Rotates to open and close the jaws. Jaws – Secure the cutting tool in the attachment. J-Notch – Secures the attachment in the handpiece.
Clamping Lever – Secures and releases the wire or pin from the attachment. Pre-adjust Knob – Allows the collet to receive wires and pins of various diameters. J-Notch – Secures the attachment in the handpiece.
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7305-001-700 Rev-AC
EN
Instructions
Drill and Reamer Attachments A
To Process the Equipment WARNING: Upon initial receipt and before each use, process the equipment as indicated in the care instructions manual supplied with the equipment.
To Charge a Power Module
B
Fully charge the power module before first and every use. A B
Retaining Collar – Slide to allow installation of a cutting tool. J-Notch – Secures the attachment in the handpiece.
Definitions
NOTES: ▪
For charging instructions, see the instructions for use supplied with the battery charger.
▪
For additional information, including safety information, see the instructions for use supplied with the power module.
The symbols located on the equipment and/or labeling are defined in this section and/or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. Symbol
Definition General Warning Sign
F/R 1 min/ 4 min X 3
Forward/Reverse Trigger (Action is in the direction of the arrow.) Forward/Reverse Trigger (Action is in the direction of the arrow.) Duty Cycle (See the Specifications section.) Lock Unlock Direction of Rotation Alignment Mark
USE ONLY STRYKER POWER MODULE STERILIZE WITH DOOR FULLY OPEN S L
Use only Stryker power module.
Sterilize with door fully open. Small Diameter Large Diameter Run Load
SERIAL
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Serial Number
7
EN
To Install a Power Module Sterile Assistant 1. Set the safety switch to the safe mode position.
7305-001-700 Rev-AC
Circulating Assistant WARNING: DO NOT contaminate the handpiece. The transfer shield guards the sterile handpiece from contamination during power module installation. 1. Hold the power module by the handle. 2. Insert the power module through the transfer shield into the open compartment.
2. Turn the latch to the unlock position and open the door.
3. Push the handle down. 3. Place the sterile transfer shield over the open compartment.
4. Present the compartment to the Circulating Assistant.
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7305-001-700 Rev-AC
WARNING: ALWAYS sterilize the contaminated transfer shield before using it again. 4. Remove the contaminated transfer shield.
Sterile Assistant WARNINGS: ▪
▪
When closing the door, hold the door by the latch. DO NOT touch the edges of the door or the internal surface of the door that faces the power module. ALWAYS verify the door is securely closed to prevent exposing the power module to the sterile field.
EN
2. Close the door and turn the latch to the lock position. Verify the mark on the latch aligns with the lock symbol and the door is securely closed.
NOTE: Although one power module is usually sufficient for one operation, Stryker recommends preparing a second handpiece with power module to ensure quick intraoperative exchange of handpieces under sterile conditions.
To Install an Attachment 1. Align the J-notch with the handpiece and insert the attachment until it snaps securely into place.
1. Holding the door by the latch, use the door to push the power module handle down until it locks into position against the power module.
2. Gently pull on the attachment to verify it is secure.
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EN
7305-001-700 Rev-AC
To Install and Remove a Cutting or Fixation Tool
3. Insert the wire or pin through the front of the collet or the back of the handpiece until the desired length extends from the collet.
Wire and Pin Collets 1. Select the appropriate collet for the desired wire or pin diameter. NOTE: All collets have a pre-adjust knob with small and large diameter settings. Wire Collet (REF 7307-001-000) Setting Small (S) Large (L)
Wire or Pin Diameter 0.7 to 1.2 mm 1.3 to 1.8 mm
Pin Collet, Small (REF 7307-002-000) Setting Small (S) Large (L)
4. Pull the clamping lever back to grasp the wire or pin.
Wire or Pin Diameter 2.0 to 2.6 mm 2.7 to 3.2 mm
Pin Collet, Large (REF 7307-003-000) Setting Small (S) Large (L)
Wire or Pin Diameter 3.0 to 3.6 mm 3.7 to 4.2 mm
2. Pull and rotate the pre-adjust knob to align the symbols for the desired wire or pin diameter. After alignment, snap the knob back into place.
S
L
5. To remove the wire or pin, or to adjust the wire length, release the clamping lever.
L
S
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7305-001-700 Rev-AC
EN
Keyed Chucks
Keyless Chucks
1. Use the chuck key to open the jaws.
1. Hold the attachment and manually rotate the chuck to open the jaws.
2. Insert the tool into the center of the jaws. 2. Insert the tool into the center of the jaws.
3. Use the chuck key to close the jaws. 4. Visually inspect the tool to make sure it is centered in the jaws. WARNING: DO NOT operate the handpiece to close the jaws on the cutting tool. 3. Hold the attachment and manually rotate the chuck to close the jaws. 4. Visually inspect the tool to make sure it is centered in the jaws.
5. Gently pull on the tool to verify it is secure. 6. To remove the tool, use the chuck key to open the jaws again.
5. Gently pull on the tool to verify it is secure. 6. To remove the tool, hold the attachment and manually rotate the chuck to open the jaws again.
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EN
Drill and Reamer Attachments
7305-001-700 Rev-AC
To Operate a Handpiece
1. Slide the retaining collar back.
2. Hold the retaining collar in position and insert the tool into the attachment.
3. Release the retaining collar.
WARNINGS: ▪
DO NOT open the handpiece housing during surgery as the inside of the device is not sterile.
▪
ALWAYS follow the specified duty cycle to prevent the equipment from overheating. See the Specifications section.
▪
ALWAYS consult attachment and tool labeling for product-specific duty cycles and instructions for use.
▪
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 this equipment. Place the equipment into service according to the EMC information contained in this manual.
▪
Portable and mobile radio frequency (RF) communications equipment can affect the function of this equipment.
▪
This equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, ALWAYS verify normal operation in the configuration in which it will be used.
▪
ALWAYS operate the equipment within the specified environmental condition values: Temperature Limitation
Humidity Limitation
Atmospheric Pressure Limitation
4. Gently pull on the tool to verify it is secure. 5. To remove the tool, slide the retaining collar back again. 1. Before operating the equipment, verify the following: ▪ You are using Stryker-approved equipment. ▪ The equipment is not damaged. ▪ The equipment is clean and sterile. ▪ You have properly assembled the equipment. ▪ You have installed a fully-charged power module. NOTE: If you experience difficulty during operation, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.
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7305-001-700 Rev-AC
2. Set the safety switch to the forward or forward/reverse mode position. NOTE: Set the safety switch back to the safe mode position when the handpiece is idle or when passing the handpiece to another person. CAUTION: DO NOT apply excessive pressure or restrict the motion of the cutting or fixation tool during operation. An excessive load on the system may cause the power module to temporarily shut down. If this happens, release the trigger to resume operation or allow the power module to cool for 20 to 40 minutes.
EN
To Remove a Power Module NOTE: Keep the power module as clean as possible because it cannot be sterilized. 1. Wipe all debris from the external surfaces of the handpiece. 2. Turn the latch to the unlock position and open the door. 3. Use the handle to remove the power module from the handpiece.
3. Pull the triggers to control the variable speed operation of the handpiece. NOTE: Typical power module run time is 5 minutes or longer, depending on surgical procedure and technique.
To Remove an Attachment 1. Push the release lever down and pull the attachment from the handpiece.
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7305-001-700 Rev-AC
Specifications Handpiece Model: Catalog Number: Dimensions: Length: Width: Height: Mass: Nominal Speed: Drill: Ream: Mode of Operation: Duty Cycle: Rest Between Cycles: Applied Part: Maximum Temperature of Applied Part: Power Supply: Ingress Protection (IP): Equipment Type:
STRYKER SYSTEM G Rotary Drill 7305-001-000 168.15 mm 83.82 mm 226.10 mm 1.043 kg 825 revolutions per minute 250 revolutions per minute Non-continuous 1 minute on/4 minutes off, 3 times 4 hours The handpiece, attachment, and cutting or fixation tool as defined by the manufacturer Less than 43 °C, as tested to the Product Safety Compliance standards at a maximum ambient temperature of 30 °C. Internally Powered IPX0 Type BF Applied Part
European Conformity:
Attachments Wire and Pin Collets Model: Catalog Number: Dimensions: Length: Diameter: Mass: Gear Ratio: Ingress Protection (IP): European Conformity:
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STRYKER SYSTEM G Wire Collet 7307-001-000
STRYKER SYSTEM G Pin Collet, Small 7307-002-000
STRYKER SYSTEM G Pin Collet, Large 7307-003-000
88 mm 26 mm 0.27 kg 1:1 IPX0
88 mm 26 mm 0.27 kg 1:1
88 mm 26 mm 0.27 kg 1:1
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7305-001-700 Rev-AC
EN
Keyed Chucks Model: Catalog Number: Dimensions: Length: Diameter: Mass: Gear Ratio: Ingress Protection (IP): European Conformity:
1:1 1/4 inch (6.4 mm) Keyed Chuck 4103-131-000
High Torque 1/4 inch (6.35 mm) Drill with Chuck 2:1 with Key 4103-180-000
3.25:1 1/4 inch (6.4 mm) Keyed Chuck 4103-231-000
105.90 mm 28.60 mm 0.313 kg 1:1 IPX0
111.25 mm 33.80 mm 0.198 kg 2:1
118.62 mm 28.60 mm 0.182 kg 3.25:1
Keyless Chucks Model: Catalog Number: Dimensions: Length: Diameter: Mass: Gear Ratio: Ingress Protection (IP): European Conformity:
Keyless Chuck Adaptor 4103-082-131
Keyless Drill Attachment 4103-133-000
87.12 mm 30.07 mm 0.185 kg 1:1 IPX0
126.50 mm 31.95 mm 0.157 kg 1:1
Drill Attachments Model:
1:1 AO Small Drill
1:1 Hudson
Catalog Number: Dimensions: Length: Diameter: Mass: Gear Ratio: Ingress Protection (IP): European Conformity:
4103-110-000 89.50 mm 26.04 mm 0.185 kg 1:1 IPX0
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1:1 Trinkle
4103-113-000
1:1 Hudson/Modified Trinkle 4103-135-000
84.33 mm 26.04 mm 0.183 kg 1:1
78.25 mm 26.04 mm 0.157 kg 1:1
79.85 mm 26.04 mm 0.154 kg 1:1
4103-160-000
N/A
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7305-001-700 Rev-AC
Reamer Attachments Model:
Catalog Number: Dimensions: Length: Diameter: Mass: Gear Ratio: Ingress Protection (IP): European Conformity:
3.25:1 AO 3.25:1 Hudson 3.25:1 Large Reamer Hudson/ Modified Trinkle 4103-210-000 4103-213-000 4103-235-000 95.45 mm 27.95 mm 0.198 kg 3.25:1 IPX0
100.46 mm 27.95 mm 0.256 kg 3.25:1
94.00 mm 27.95 mm 0.182 kg 3.25:1
3.25:1 Trinkle
4:1 Hudson
4:1 Hudson/ Modified Trinkle
4103-260-000
4103-413-000
4103-435-000
97.30 mm 27.70 mm 0.180 kg 3.25:1
100.46 mm 32.40 mm 0.225 kg 4:1
94.00 mm 32.40 mm 0.208 kg 4:1
Transfer Shield Model: Catalog Number: Dimensions: Length: Width: Height: Mass: European Conformity:
STRYKER SYSTEM G Transfer Shield 7304-120-000 150.9 mm 103.5 mm 37.0 mm 77 g
Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1 A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint. IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1 Consolidated Reprint. IEC 60601-1-2: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and essential performance – Incorporates Amendment A12: 2014
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7305-001-700 Rev-AC
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Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic emissions The STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) should assure that it is used in such an environment. Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) 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.
Class A
The STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:
CISPR 11 RF emissions CISPR 11 N/A
Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions
N/A
WARNING: This equipment/system is intended for use in a professional healthcare facility environment. 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 reorienting or relocating the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) or shielding the location.
IEC 61000-3-3
Guidance and manufacturer’s declaration - electromagnetic immunity NOTE: The STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electrostatic discharge (ESD)
±2 kV, ±4 kV, ±6 kV, ±8 kV contact
±2 kV, ±4 kV, ±6 kV, ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV at 100 kHz repetition frequency for power supply lines
N/A
±1 kV at 100 kHz repetition frequency for input/output lines
N/A
Surge
±0.5, ±1 kV line(s) to line(s)
N/A
IEC 61000-4-5
±0.5, ±1, ±2 kV line(s) to earth
N/A
Voltage dips, short interruptions and voltage variations on power supply input lines
<5% UT (>95% dip in UT) for 0.5 cycle
N/A
0% UT (100% dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°
N/A
0% UT (100% dip in UT) for 1 cycle at 0°
N/A
40% UT (60% dip in UT) for 5 cycles
N/A
70% UT (30% dip in UT) for 25 & 30 cycles at 0°
N/A
<5% UT (>95% dip in UT) for 5 s
N/A
IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4
IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 20%.
N/A
N/A
N/A
0% UT (100% dip in UT) for 5 s
N/A
30 A/m at 50 and 60 Hz
30 A/m at 50 and 60 Hz
IEC 61000-4-8
Electromagnetic environment guidance
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the alternating current mains voltage prior to application of the test level.
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7305-001-700 Rev-AC
Guidance and manufacturer’s declaration - electromagnetic immunity NOTE: The STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) should assure that it is used in such an environment. IEC 60601 test level
Immunity test
3 Vrms 150 kHz to 80 MHz outside ISM bands 80% AM at 1 kHz
Conducted RF IEC 61000-4-6
Compliance level
Electromagnetic environment - guidance IEC 60601-1-2 3rd Edition: Portable and mobile RF equipment should be used no closer to any part of the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
N/A
6 Vrms 150 kHz to 80 MHz in ISM bands 80% AM at 1 kHz
Recommended separation distance d=1.2√P d=1.2√P 80 MHz to 800 MHz d=2.3√P 800 MHz to 2.5 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). IEC 60601-1-2 4th Edition:
3 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz
WARNING: Portable RF equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the STRYKER SYSTEM G Rotary Drill (REF 7305001-000) specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 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: (Non-ionizing electromagnetic radiation)
NOTE 1: At 80 MHz and 800MHz 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. 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 STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) is used exceeds the applicable RF compliance level above, the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000).
a
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
IEC 60601-1-2 3rd Edition: Recommended separation distances between portable and mobile RF equipment and the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) The STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF equipment (transmitters) and the STRYKER SYSTEM G Rotary Drill (REF 7305-001-000) as recommended below, according to the maximum output power of the 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
800 MHz to 2.5 GHz d=2.3√P
d=1.2√P
d=1.2√P
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 1: At 80 MHz and 800MHz, 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.
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IT
7305-001-700 Rev-AC
Terminali per fresa Modello:
Fresa 3,25:1 AO grande
3,25:1 Trinkle
4:1 Hudson
4:1 Hudson/ Trinkle modificato
4103-210-000
3.25:1 Hudson 3,25:1 Hudson/ Trinkle modificato 4103-213-000 4103-235-000
Numero di catalogo: Dimensioni: Lunghezza: Diametro: Peso: Rapporti di cambio: Protezione dalle infiltrazioni (IP): Conformità alle norme europee:
4103-260-000
4103-413-000
4103-435-000
95,45 mm 27,95 mm 0,198 kg 3,25:1
100,46 mm 27,95 mm 0,256 kg 3,25:1
97,30 mm 27,70 mm 0,180 kg 3,25:1
100,46 mm 32,40 mm 0,225 kg 4:1
94,00 mm 32,40 mm 0,208 kg 4:1
94,00 mm 27,95 mm 0,182 kg 3,25:1
IPX0
Riparo mobile Modello: Numero di catalogo: Dimensioni: Lunghezza: Larghezza: Altezza: Peso: Conformità alle norme europee:
Riparo mobile STRYKER SYSTEM G 7304-120-000 150,9 mm 103,5 mm 37,0 mm 77 g
Conformità di sicurezza del prodotto International Electrotechnical Commission (IEC) IEC 60601-1 A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint. IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1 Consolidated Reprint. IEC 60601-1-2: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and essential performance – Incorporates Amendment A12: 2014
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PT
7305-001-700 Rev-AC
Dispositivos de fixação do escareador Modelo:
Escareador AO grande 3,25:1
Trinkle 3,25:1
Hudson 4:1
4103-210-000
Hudson 3,25:1 Dispositivo de fixação Hudson/ Trinkle modificado 3,25:1 4103-213-000 4103-235-000
4103-260-000
4103-413-000
Dispositivo de fixação Hudson/ Trinkle modificado 4:1 4103-435-000
Número de catálogo: Dimensões: Comprimento: Diâmetro: Massa: Razão de engrenagem: Protecção contra entrada (IP): Conformidade europeia:
95,45 mm 27,95 mm 0,198 kg 3,25:1
100,46 mm 27,95 mm 0,256 kg 3,25:1
97,30 mm 27,70 mm 0,180 kg 3,25:1
100,46 mm 32,40 mm 0,225 kg 4:1
94,00 mm 32,40 mm 0,208 kg 4:1
94,00 mm 27,95 mm 0,182 kg 3,25:1
IPX0
Escudo protector de transferência Modelo: Número de catálogo: Dimensões: Comprimento: Largura: Altura: Massa: Conformidade europeia:
Escudo protector de transferência SYSTEM G da STRYKER 7304-120-000 150,9 mm 103,5 mm 37,0 mm 77 g
Conformidade da segurança do produto International Electrotechnical Commission (IEC) IEC 60601-1 A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint. IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1 Consolidated Reprint. IEC 60601-1-2: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and essential performance – Incorporates Amendment A12: 2014
16
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