Instructions for Use
48 Pages
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Stryker F1® System Motors 1900-015-000 1900-031-000 1900-034-000 1900-037-000 1900-099-000 Attachments 1900-XXX-XXX Series SmartGrip® Battery Modules 1900-012-000 1900-013-000
Instructions For Use
ENGLISH (EN) 2021-11
1900-001-700 Rev-AC
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EN
1900-001-700 Rev-AC
Contents Introduction... 4 Audience... 4 Conventions... 4 Contact Information... 4 Intellectual Property... 4 Indications For Use... 5 Contraindications... 5 Safety Directives... 5 For Use With... 5 Motors, Attachments, and Battery Modules... 6 Cutting and Fixation Tools... 8 Battery Chargers... 10 Features... 10 Micro Drill... 10 Oscillating Saw... 11 Sagittal Saw... 11 Reciprocating Saw... 12 Universal Motor...12 Wire Collet... 13 AO Chuck... 14 T-Latch Attachment... 14 5/32 inch Keyed Chuck... 15 Pencil Battery Module... 16 Pistol Battery Module... 17 Definitions... 18 Symbols... 18 Colors... 19
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Instructions... 20 To Process the Equipment... 20 To Charge a Battery Module... 20 To Assemble a Handpiece... 20 To Install and Remove a Cutting or Fixation Tool... 23 Micro Drill... 23 Oscillating Saw... 24 Sagittal Saw... 25 Reciprocating Saw... 26 Universal Motor with Wire Collet... 27 Universal Motor with AO Chuck... 28 Universal Motor with T-Latch Attachment... 29 Universal Motor with 5/32 inch Keyed Chuck... 30 To Operate a Handpiece... 31 To Disassemble a Handpiece... 34 Specifications... 36 Motors... 36 Attachments... 41 Battery Modules... 42 Product Safety Certification... 43 Electromagnetic Compatibility... 44
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1900-001-700 Rev-AC
Introduction This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.
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 The following conventions are used in this manual: ▪
A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury.
▪
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, in-service 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. 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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Indications For Use The Stryker F1 System is a set of surgical battery-powered instruments and accessories designed to drill and cut bone and hard tissue, and drive wires and screws into bone and hard tissue. The system is designed for orthopedic surgical applications involving traumatology, hand/wrist, and foot/ ankle surgery where hard tissue and/or bone must be cut, drilled, shaped, and/or fixated with wires and/or screws.
Contraindications None known.
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.
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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.
For Use With This section identifies components intended to be used with the equipment to obtain a safe combination. 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.
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1900-001-700 Rev-AC
Motors, Attachments, and Battery Modules Stryker F1 motors, attachments, and battery modules may be assembled in various configurations as shown:
A
B
C D E F G
H I J K
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CAUTION: ALWAYS use the Pistol Battery Module with the Wire Collet attachment as shown: B
G
L
Item A B C D E F G H I J K L
Description Pencil Battery Module Pistol Battery Module Micro Drill Oscillating Saw Sagittal Saw Reciprocating Saw Universal Motor AO Chuck T-Latch Attachment 5/32 inch Keyed Chuck Chuck Key Wire Collet
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REF 1900-013-000 1900-012-000 1900-015-000 1900-031-000 1900-034-000 1900-037-000 1900-099-000 1900-110-000 1900-120-000 1900-132-000 1355-005-000 1900-062-000
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Cutting and Fixation Tools WARNINGS: ▪
All cutting and fixation tools are intended for single use only.
▪
Upon initial receipt and before use, visually inspect the package for damage to confirm the integrity of the sterile barrier. Do not use the product if damage is apparent, the sterile barrier is compromised, or the package is unintentionally opened.
NOTE: Cutting accessories are sterilized using irradiation. The following cutting and fixation tools may be installed into Stryker F1 motors: Motor Micro Drill
Tools Burs
Oscillating Saw
Blades
Sagittal Saw
Blades
Reciprocating Saw
Blades
Rasps
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REF 0277-010-XXX series 1607-002-XXX series 1608-002-XXX series 1608-006-XXX series 1900-010-XXX series 1900-015-XXX series 2296-003-XXX series 2296-023-XXX series 2296-033-XXX series 5400-003-XXX series 5400-031-17X series 5400-031-4XX series 2296-003-XXX series 2296-023-XXX series 2296-033-XXX series 5400-003-XXX series 5400-134-XXX series 5100-037-XXX series 5100-137-XXX series 5100-337-XXX series 5100-037-XXX series
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If the following symbol is on the device label, the device meets the stated criteria: This device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports the position that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. When using the Universal Motor, the following cutting and fixation tools may be installed into Stryker F1 attachments: Attachment Wire Collet AO Chuck
Tools Kirschner wires and Steinmann pins from 0.7 to 2.0 mm [0.028 to 0.08 inch] in diameter Cutting and fixation tools with AO (small quick couple) shanks of the following dimensions: 4.5 mm ≥ 22 mm
T-Latch
Cutting and fixation tools with T-Latch (mini quick couple) shanks of the following dimensions: 2.35 mm ≥ 13 mm
5/32 inch Keyed Chuck
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Cutting and fixation tools up to 4.0 mm [0.156 inch] in diameter
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Battery Chargers Battery modules may be charged with one of the following Stryker battery chargers: Description Stryker F1 Universal Battery Charger Universal Battery Charger*
REF 7110-190-000 7110-120-000
*Must be configured with a Stryker F1 Charger Module (REF 1900-125-000).
Features Micro Drill C B D A
A B C D
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Bur Mount – Retains the cutting tool in the motor. Lock Collar – Secures and releases the cutting tool from the motor. Tab – Interfaces with the slot on the battery module to ensure proper alignment during assembly. Connector – Interfaces with the battery module.
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Oscillating Saw C
D
B A
A B C D
Blade Mount – Retains the cutting tool in the motor. Release Collar – Secures and releases the cutting tool from the motor. Tab – Interfaces with the slot on the battery module to ensure proper alignment during assembly. Connector – Interfaces with the battery module.
Sagittal Saw C
B
D
A A B C D
Release Button – Secures and releases the cutting tool from the motor. Blade Mount – Retains the cutting tool in the motor. Tab – Interfaces with the slot on the battery module to ensure proper alignment during assembly. Connector – Interfaces with the battery module.
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Reciprocating Saw C
D B
A A B C D
Release Button – Secures and releases the cutting tool from the motor. Blade Mount – Retains the cutting tool in the motor. Tab – Interfaces with the slot on the battery module to ensure proper alignment during assembly. Connector – Interfaces with the battery module.
Universal Motor B A C
A B C
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Attachment Mount – Interfaces with the attachment. Tab – Interfaces with the slot on the battery module to ensure proper alignment during assembly. Connector – Interfaces with the battery module.
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Wire Collet A
B
A B
Lock Collar – Secures and releases the attachment from the motor. Clamping Lever – Secures and releases the wire or pin from the attachment.
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AO Chuck B A
A B
Retaining Collar – Secures and releases the cutting or fixation tool from the attachment. Lock Collar – Secures and releases the attachment from the motor.
T-Latch Attachment B A
A B
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Retaining Collar – Secures and releases the cutting or fixation tool from the attachment. Lock Collar – Secures and releases the attachment from the motor.
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5/32 inch Keyed Chuck B
A
A B C
C
Jaws – Secure and release the cutting or fixation tool from the attachment. Lock Collar – Secures and releases the attachment from the motor. Chuck Key – Opens and closes the jaws to allow installation of a cutting or fixation tool.
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Pencil Battery Module
C B A
D E A
B C D E
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Handswitch – Controls the variable speed operation of the handpiece. The Micro Drill and Universal Motor will operate in a clockwise direction. Safety Switch – Locks the handswitch to prevent inadvertent operation of the handpiece. Ready Light – Displays status information for the battery module. See the Definitions section. Release Button – Releases the motor from the battery module during disassembly. Slot – Interfaces with the tab on the motor to ensure proper alignment during assembly.
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Pistol Battery Module C
D
E B F
A
A
B
C D E F
Forward Trigger – Controls the variable speed operation of the handpiece. The Micro Drill and Universal Motor will operate in a clockwise direction. Reverse Trigger – For Universal Motor only: ▪ Controls the variable speed operation of the handpiece in a counterclockwise direction. ▪ When pressed simultaneously with the forward trigger, operates the handpiece in oscillate mode. Variable speed of the motor in oscillate mode is determined by the trigger that is pressed the farthest. For all other motors, the reverse trigger functions the same as the forward trigger. Slot – Interfaces with the tab on the motor to ensure proper alignment during assembly. Release Button – Releases the motor from the battery module during disassembly. Ready Light – Displays status information for the battery module. See the Definitions section. Safety Switch – Locks the trigger to prevent inadvertent operation of the handpiece.
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Definitions Symbols 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
SAG OSC RECIP MICRODRILL U-DRIVER SEE IFU FOR DUTY CYCLE
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Location
Definition
Labeling
General Warning Sign
Labeling Reciprocating Saw
Direct Current (DC) Alignment Mark
Attachments
Direction of Rotation
Attachments
Alignment Mark
Micro Drill
Alignment mark; Direction of Rotation
Micro Drill; Battery Modules Micro Drill; Attachments; Battery Modules Sagittal Saw Oscillating Saw Reciprocating Saw Micro Drill Universal Driver Motors
Lock Unlock Sagittal Saw Oscillating Saw Reciprocating Saw Micro Drill Universal Driver For duty cycle information, see the instructions for use.
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Symbol
EN
Location
WARNING ADVERTISSEMENT
Battery Modules
Battery Modules Pistol Battery Module Pistol Battery Module
Definition WARNING: Battery modules contain Lithium-ion material. Risk of fire, burns, and explosion. DO NOT short circuit, open, crush or incinerate. Sterilize only per instructions. Consult instructions for use. Battery Module Status (See the Definitions, Colors section.) Forward Trigger Reverse Trigger
Colors The battery module ready light uses colors to display battery module status information. These colors are defined as follows: Color Green
State Solid (10 seconds)
Amber
Solid Blinking
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Definition The battery module is charged, the motor is connected, and the handpiece is ready for operation. The battery module charge is low. Prepare a backup battery module for use. The battery module is expended and about to shut down.
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Instructions 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 Battery Module Fully charge the battery module before each use. For charging instructions, see the instructions for use supplied with the battery charger. NOTES: ▪
For maximum capacity, charge the battery module before sterilization, even if the battery module has not been used.
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A typical charging sequence will take up to 20 minutes. Charging a fully expended battery module may take up to 50 minutes.
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For maximum capacity, store the battery module on the battery charger to maintain a full charge. DO NOT store the battery module with a motor installed. Discharge will occur even though the handpiece is not operating.
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Stryker recommends using battery modules that have been charged within the last 30 days.
To Assemble a Handpiece 1. Set the safety switch to the lock position.
Pencil Battery Module
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Pistol Battery Module
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