Coupler II Model 5873 Owners Manual Rev B 2011

IMPORTANT NOTICES Please READ THESE INSTRUCTIONS COMPLETELY and keep this manual readily available for future reference to ensure safe operation of the device. Carefully observe and comply with all warnings, cautions and instructions placed on the equipment or described in this manual. In this manual, the following symbols are used: Symbol

Meaning This symbol indicates an authorized representative in the European Community.

This symbol indicates the Manufacturer of the device.

NOTE

This symbol indicates a comment or instruction of importance.

This symbol is intended to alert the user of a WARNING to the presence of important operation, maintenance, or safety instructions.

This symbol indicates a catalog number.

THIS MANUAL IS NOT A SUBSTITUTE OR REPLACEMENT FOR THE 5943/5943AP JACKSON SPINAL SURGERY TOP OWNER’S MANUAL OR THE 5803 ADVANCED CONTROL BASE OWNER’S MANUAL. In this manual, the symbol WARNING is intended to alert the user to the presence of important operating and safety instructions. This device is intended for use by trained personnel only. To schedule an in-service, please contact your Mizuho OSI Sales Representative or call Mizuho OSI Customer Resource Group at 1-800-329-4674.

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NOTE: The application techniques outlined in these instructions are the manufacturer’s suggested techniques. The final disposition of each patient’s care as related to the use of this equipment rests with the attending surgeon. WARNING: When operating this device, it is imperative that the attending physician ensures that all components are properly secured and locked. Prior to patient transfer onto the table, the physician should ensure the Spinal Top Adaptor Brackets and Coupler II have been assembled, and secured to the Jackson Spinal Top (JST) Specifically, the Spinal Top Adaptor Brackets must be properly mounted and secured to the rail of the JST. The Coupler II Assembly locking joints may be loosened and adjusted as needed during patient transfer and positioning by the physician. The physician should ensure that the Coupler II is properly mounted and secured to the Adaptor Brackets by tightening the T-handles. Failure to properly secure the T-handles, brackets and locking joint may result in the device becoming inadvertently loosened and disengaged during surgery resulting in undesired head movement. NOTE: Perform a complete inspection before using this device. Inspect the device for possible damage, excessive wear, or non-functioning parts. Carefully inspect all critical, inaccessible areas, joints, and all moving parts for possible damage or non function. Refer to Section 5 Maintenance of the Coupler II in this manual. WARNING: Failure to complete the inspection may cause harm to the patient, health care professional, and/or device. If there is a problem with the device, please contact your local Mizuho OSI Sales Representative or the Mizuho OSI Customer Resource Group for further assistance. The use of this surgical device is contraindicated when, in the judgment of the surgeon, its use would be contrary to the best interest of the patient. THIS DEVICE IS TO BE USED BY MEDICAL PROFESSIONALS ONLY.

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TABLE OF CONTENTS Important Notices...2 1. General Description of the Coupler II... 5 1.1 Standard Component Identification 2. Assembly & Use of the Coupler II on MIZUHO OSI Jackson Spinal Table... 6 2.1 Prepare the Jackson Spinal Surgery Top for Mounting Coupler II 2.2 Mount Spinal Top Adaptor Brackets on Coupler II Assembly 2.3 Mounting the Coupler II on the Jackson Spinal Surgery Top 2.4 Attaching a Skull Clamp or Horseshoe Headrest to the Coupler II 2.5 Inspection of the Coupler II Assembly Prior to Use 3. Patient Transfer to the Jackson Spinal Surgery Top... 11 3.1 180 Degree Patient Rotation with the Coupler II 4. Cleaning of the Coupler II... 12 5. Maintenance of the Coupler II... 13 6. Replacement Parts for the Coupler II and Optional Accessories... 14 7. Product Lifetime... 15 8. MIZUHO OSI Customer Resource Group... 16 9. Product Warranty... 17

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1. General Description of Coupler II The Coupler II ( 5873) is designed for use specifically with the Jackson Spinal Table. It mounts on the Jackson Spinal Surgery Top (JSST) utilizing the Spinal Top Adaptor Brackets ( 5846). The Coupler II is required to allow positioning a patient on the spinal frame and utilize either a skull clamp or horseshoe headrest for cranial stabilization or support. The Coupler II can be utilized with either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences and referred to as a Mayfield® or the radiolucent or aluminum skull clamp referred to as the DORO® which is manufactured by pro med Inc. An optional adaptor is required to attach a radiolucent DORO® device. Refer to Section 5 Replacement Parts and Optional Accessories for more information including the part number and description. The Coupler II is shipped as pictured below with the Main Assembly assembled. 1.1 Standard Component Identification

Knob to secure crossbar in Yoke

Main Assembly Connection point for Swivel Adaptor Yoke Crossbar

Radiolucent Swivel Adaptor for the Mayfield

Aluminum Swivel Adaptor Figure 1:

5873 Coupler II Components Mounts on Spinal Frame T Handle

Attaches to Crossbar of Coupler II Figure 2: Mizuho OSI   2011

5846 Spinal Top Adaptor Brackets,1 pair 5

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NOTE: Before each use, ensure you have all components (Figure 1 and 2). Inspect each component for damage, excessive wear, or non-functioning parts. Carefully inspect all critical, inaccessible areas, joints, and all moveable parts for possible damage or nonfunction, damaged or defective products should not be used. Contact your local Mizuho OSI representative for replacement. (Refer to Section 5 for Replacement Parts and Optional Accessories for more information.) 2. Assemble & Use the Coupler II on Mizuho OSI Jackson Spinal Table 2.1 Prepare the Jackson Spinal Surgery Top for the Mounting the Coupler II 1.

Set-up the Advanced Control Modular Base. Lock the four caster locks.

2. Install the Jackson Spinal Surgery Top (JSST) (also referred to as the Jackson “frame”) on the Modular Base. (Refer to the 5943/5943AP Jackson Spinal Surgery Tops Owner’s Manual, Section 3.0 Table Top Coupling Procedures.) NOTE: For complete instructions on mounting the 5943/5943AP Jackson Spinal Surgery Top and the operation and functions of the 5892/5803 Advanced Control Base, please refer to the appropriate Owner’s Manual. A thorough understanding of the Advanced Control Base and use of the Jackson Spinal Surgery Top is required before continuing. This device is intended for use by trained personnel only. To schedule an in-service, please contact your Mizuho OSI sales representative or call 1-800-329-4674. WARNING: The Jackson Spinal Surgery Top must be coupled to the modular base such that the center of gravity of the patient will be at or below the centerline of the crossbars when the patient is prone. Failure to do so may make the patient unstable during lateral tilt. (Refer to the 5943/5943AP Jackson Spinal Surgery Tops Owner’s Manual, Section 3.6 Selecting the Mounting Holes for the Table Top.) 2.2 Assemble the Coupler II, prior to mounting on the Jackson Spinal Surgery Top 1.  Align the Crossbar with the opening in the Main Assembly and slide the Crossbar through the Yoke until is is centered. Ensure the knob which will secure the crossbar in place is loosened prior to advancing the Crossbar so the Crossbar advances freely. 2. Attach a Spinal Top Adaptor Bracket (Refer to Figure 2) to each end of the Crossbar. Orient the “C-shaped” openings on the brackets so they face the same direction. This will enable more easily mounting on the JSST frame. Tighten the oversized T-handle to secure the Bracket to the to the Crossbar. (Refer to Figure 3)

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Tighten T-Handle

Figure 3: Mounting Spinal Top Adaptor Bracket on Coupler II Crossbar 2.3 Mounting the Coupler II on the Jackson Spinal Surgery Top Ensure that the T-handles adjusting the “C-shaped” openings of the Adaptor Brackets are completely unscrewed. Support the Coupler II Main Assembly and approach the JSST initially from below the frame. Raise the assembly until the Spinal Top Adaptor Brackets can be slid into place on the frame. (Refer to Figure 4)

Slide Assembly into Place

Figure 4: Orienting Coupler II Assembly on Jackson Spinal Surgery Top 1. Tighten the T-handle on each Bracket securing the Spinal Top Adaptor Brackets to the JSST. (Refer to Figure 5)

Tighten T-Handle

Figure 5: Securing Coupler II Assembly on Jackson Spinal Surgery Top Mizuho OSI   2011

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4 5

2

3

4

1 5

Figure 6: Coupler II Assembly Mounted on Jackson Spinal Surgery Top 2. With the Coupler II Assembly mounted on the JSST, adjustments can be made to the location of the Assembly on the Top and to the position of the Adaptor to which the skull clamp or horseshoe headrest is connected. (Refer to Figure 6) Each of the Black Knobs (# 1, 2 and 3 in Figure 6) on the Main Assembly provides for making adjustments to the position of the assembly until the desired position is achieved. 3. Loosen the Black Knob securing the Main Assembly on the Crossbar and slide the Assembly laterally to the desired position and tighten the Black Knob. (Refer to Figure 6 Black Knob #1) 4. Loosen the Black Knobs controlling the position of the Transitional Arms holding the Adaptor. (Refer to Figure 6 Black Knobs #2 and #3) You can adjust the height and angle of the Assembly utilizing the Black Knobs. Tighten the Black Knobs when the desired position is achieved. 5. To re-locate the Coupler II Assembly along the Top, loosen the T handles securing the Brackets and slide the Assembly on the frame toward the head-end or the footend of the modular base until the desired location is reached. Tighten the T handles securing the Brackets on the JSST. (Refer to Figure 6 T-Handle #4) 6. Loosening the oversized T-handles securing the Spinal Top Adaptor Brackets to the Crossbar, allows you to rotate the Crossbar in place should that assist in reaching the final desired position of the device. Ensure you tighten the oversized T- handles after the desired position is achieved. (Refer to Figure 6 T-Handle #5) NOTE: The components of the Coupler II have a starburst locking mechanism. Ensure that all teeth of the starburst are aligned and the corresponding knob is properly tightened when assembling or repositioning the device. All knobs should be tightened by hand, do not use a wrench of any kind. WARNING: Failure to ensure that all teeth of the starbursts are aligned and the knobs are properly tightened may cause harm to the patient, healthcare professional or the device. Mizuho OSI   2011

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2.4 Attaching a Skull Clamp or Horseshoe Headrest to Coupler II 1. Confirm which manufacturer’s device will be utilized and attach the appropriate Adaptor. The Radiolucent Adaptor which is a standard component of the Coupler II, is utilized for mounting a Radiolucent Mayfield® skull clamp or horseshoe headrest. If a Radiolucent DORO® skull clamp or horseshoe 5873-300) is headrest will be utilized, the Radiolucent DORO® Adaptor ( required. (Refer to Section 7 for more information) 2. If an aluminum skull clamp or horseshoe headrest will be utilized, the device is attached to the Aluminum Adaptor. Confirm the Aluminum Adaptor is attached. To attach, align the starburst of the device with the opening and starburst of the Adaptor and tighten in place with the Silver Knob. Ensure the teeth of the starburst on both the device and the adaptor are not misaligned so they can tightened securely. 3.  If a radiolucent skull clamp or horseshoe headrest will be utilized, the appropriate Radiolucent Adaptor must be utilized. To remove the Aluminum Adaptor, hold the Adaptor and the Black Knob to which it is mounted. Loosen the Black Knob and remove the Aluminum Adaptor (Refer to Figure 7).

Loosen Black Knob Aluminum Adaptor

Figure 7: Removing the Aluminum Adaptor from the Coupler II Main Assembly

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4. To attach a Radiolucent Adaptor, align the opening and starburst with the yellow bolt. Tighten in place with the Black Knob. (Refer to Figure 8) Tighten the Black Knob Radiolucent Adaptor

Figure 8: Attaching the Radiolucent Adaptor for the Coupler II Main Assembly 5. The Coupler II is ready for a radiolucent skull clamp or radiolucent horseshoe headrest to be attached. Align the starbursts and tighten into place by turning the Black Knob of the Radiolucent Adaptor (Refer to Figure 9) Align starbursts and tighten Black Knob of Radiolucent Adaptor

Figure 9: Attaching the Radiolucent Skull Clamp to the Coupler II Main Assembly 2.5 Inspection of the Coupler II Assembly Prior to Use Prior to use, ensure the following: The Coupler II is assembled properly and correctly mounted on the Jackson Spinal Surgery Frame with the Spinal Top Adaptor Brackets, the teeth of all the starbursts are aligned and fully engaged and the corresponding knob is properly tightened. NOTE: The Coupler II is temporarily destablized when you loosen any of the joints or the adapter brackets to which it is mounted. Therefore: Ensure all knobs and T-handles on the device and brackets are fully engaged and tightened prior to each clinical use. WARNING: Failure to ensure all knobs and T-handles on the device and adaptor brackets are fully engaged and tightened prior to each use, may cause harm to the patient, healthcare professional or device. Refer to the specific manufacturer’s instructions for use of the Skull Clamp or Horseshoe Headrest to be attached to the Coupler II. Mizuho OSI   2011

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3. Patient Transfer to the Jackson Spinal Surgery Top NOTE: The surgeon decides the best approach to secure the patient to the Skull Clamp. The patient’s head may be secured first to the Skull Clamp with Skull Pins according to the manufacturer’s recommendation and then connected to the Coupler II already mounted on the Jackson Spinal Surgery Top. Alternatively, the Coupler II with Skull Clamp attached can be mounted on the Jackson Spinal Surgery Top and the patient’s head brought to the Skull Clamp. After mounting the Coupler II, for instructions on preparing the JSST for patient transfer refer to the 5943/5943AP Jackson Spinal Surgery Tops Owner’s Manual, Section Section 7.0 Prone Positioning for Posterior Spine Surgery and Procedures and Section 7.8 Transferring the Patient. WARNING: Failure to follow the instructions in Section 7.0 Prone Positioning and Section 7.8 Transferring the Patient in the 5943/5943AP Jackson Spinal Surgery Top Owner’s Manual, may cause harm to the patient, healthcare professional or device. 3.1 180 Degree Patient Rotation with the Coupler II NOTE: The surgeon decides if the patient is to be rotated from supine to prone while positioned with the Coupler II Assembly. To complete a rotation: 1. The Coupler II is mounted on the Jackson Spinal Surgery Top during the set-up of the table system for rotation. 2. The patient is positioned on the Radiolucent Imaging Top and the Jackson Spinal Surgery Top with the Coupler II positioned over the patient. 3. The Skull Clamp is attached to the patient and to the Coupler II Assembly. 4. The 180 degree rotation is completed as instructed in the 5943/5943AP Jackson Spinal Surgery Owner’s Manual, Section 8.0 Rotation Procedures. WARNING: Failure to follow the instructions in Section 8.0 Rotation Procedures in the 5943/5943AP Jackson Spinal Surgery Top Owner’s Manual, may result in harm to the patient, the healthcare professional or the device.

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4. Cleaning of the Coupler II After each use, clean the entire unit with a quaternary disinfectant (ammonium chloride). NOTE: There are numerous quaternary disinfectants labeled for use as a surface disinfectant for medical equipment. It is the responsibility of the user to determine which specific cleaner is appropriate. It is the responsibility of the user to use per manufacturer’s label instructions. Ensure the cleaning solution is labeled for use as a surface disinfectant for medical equipment and utilize per the manufacture’s label instructions. Wipe dry with a lint free cloth. The Coupler II does not require complete disassembly to be cleaned. Should it be necessary to access the surfaces of the starbursts, loosen the Black Knobs until the area can be accessed for surface cleaning. Following cleaning, ensure the surfaces are dry, align all the teeth of the starbursts and tighten the corresponding Black Knob. WARNING: Failure to thoroughly dry the surface after cleaning and disinfecting may result in changes in the integrity of the material and may cause harm to the patient, healthcare professional or the device Do not use of alcohol, bleach or other highly concentrated chemicals. Do not allow any liquid to enter the joints or moving parts. Do not pour or spray any liquid on the assembly or the components. Do not soak or place the device in a washer or flood with water or cleaning solutions. Do not steam sterilize. The heat will damage the components. Do not use iodophors. Iodophors will cause staining. WARNING: Damage to the device due to improper care, handling and cleaning may cause harm to the patient, healthcare professional and the device. It may decrease the product life and void the warranty.

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5. Maintenance of the Coupler II Inspection and ensuring the device remains in working order is the required maintenance for the Coupler II prior to each use. The Coupler II does not require any lubrication. Prior to use ensure the following: Inspect the Main Assembly, Crossbar and Swivel Adaptors for damage, excessive wear, or non functioning parts. Carefully inspect all critical joints and all moveable parts for possible damage or non-function. Damaged components should not be used. Contact your local Mizuho OSI Sales Representative for replacement. Refer to Section 6.0 for Replacement Part information. Confirm the Coupler II Main Assembly, Crossbar and Swivel Adaptors are complete. Confirm the teeth of the starbursts are intact and remain aligned. Confirm the Black Knobs which allow for adjustments to the position of the Transitional Arms, Yoke and Swivel Adaptors turn freely. WARNING: Failure to inspect the device before and after each use and replace damaged components may cause harm to the patient, healthcare professional and the device.

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6. Replacement Parts and Optional Accessories Coupler II components are not repairable. To order replacement parts contact the Mizuho OSI Customer Resource Group as outlined in Section 8 of this manual. 5873 Coupler II Replacement Parts Swivel Adapter Assembly 5873-30 (Aluminum Adaptor) Swivel Adapter Assembly 5873-31 (Radiolucent Adapter) Crossbar Assembly 5873-27 Yoke Assembly

5873-37

Sleeve Swivel Adapter Assembly

5873-53

Knob Assembly, Sleeve Swivel Adapter Assembly Knob Assembly, Yoke

5873-34 5873-47

Left Transitional Knob Assembly

5873-52

Right Transitional Assembly

5873-36

1

5873-30 Swivel adapter assy

2

5873-52 Left transitional knob assy

12

5873-31 Swivel adapter assy

10

5873-53 Sleeve swivel adapter assy 5

4

3

5873-37 yoke assy

5873-27 Crossbar assy

9

5873-34 knob assy sleeve sw adapter 8 5873-36 Right transitional assy 11

15

5873-47 Knob assy yoke

Figure 10: Coupler II Replacement Components Identification Mizuho OSI   2011

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The Swivel Adapter Assembly ( 5873-31) Radiolucent is a standard component of the Coupler II. It is utilized for mounting a Radiolucent Mayfield® Skull Clamp or Horseshoe Headrest. If a Radiolucent DORO® Skull Clamp or Horseshoe Headrest will be utilized, the Radiolucent DORO® Adaptor ( 5873-300) is required. (Refer to Figure 11)

Figure 11: Optional Accessory,

5873-300 Radiolucent DORO® Adaptor

7. Product Lifetime: Upon receipt of your new product and under normal use conditions, Mizuho OSI has defined the product to have a technical lifetime of ten (10) years. At the time of delivery, your product fulfills existing regulations and standards; however, through proper use, routine inspection, prescribed service, maintenance and repairs, the product is subject to aging, and wear. Therefore, Mizuho OSI cannot guarantee the product’s safety after ten (10) years and recommends your product be taken out of service. For product warranty information, refer to Section 8 of this manual.

WARNING: Damage to the device due to improper care, handling and cleaning may cause harm to the patient, healthcare professional and the device. It may decrease the product life and void the warranty.

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8. Mizuho OSI Customer Resource Group

Contact Information: In USA: Mizuho OSI 30031 Ahern Avenue Union City, CA USA 94587 Inside USA Tel: 1-800-777-4674 Fax: 1-510-429-8324 Outside USA Tel: 00+1-510-476-8199 Fax: 00+1-510-429-8324 European Union EC Representative Emergo Europe Molenstraat 15 2513 BH The Hague, The Netherlands Tel: (31) (0) 70 346-8570 Fax: (31) (0) 70 346-7299 Customer Resource Group (CRG) For detailed repair information or to order parts, call the Mizuho OSI Customer Resource Group Department: 1-800-777-4674 A Mizuho OSI Customer Resource Group line is available from 7am-5pm PST, Monday through Friday. Please leave a message after business hours. Be sure to state slowly your name, phone number, your facility name and city, and affected equipment model number. An email message may be left anytime at [email protected] or by clicking the Mizuho OSI Customer Resource Group icon on our website: www.mizuhosi.com. To order Replacement Parts (RP) 1. If unable to identify part please telephone, fax or E-mail to Technical Service. 2. If part is known please telephone, fax or E-mail part number and description to Customer Service for price and availability. 3. To place Replacement Parts (RP) order please telephone, fax or E-mail part number, description, price, customer number and method of shipment to Customer Service with purchase order. Indicate that order is for Replacement Parts (RP). Mizuho OSI   2011

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To return damaged parts (RGA) 1. Identify parts to be returned. 2. Telephone, fax or E-mail part number and description of parts for return to Customer Service for Return Goods Authorization (RGA) number. 3. Return ship parts with RGA number clearly marked on outside of package. 4. Complete Certificate of Disinfected Parts Document #40204-17. To send a part for repair (RA) 1. If unable to identify part please call, fax or E-mail to Technical Service. 2. If part is known please telephone, fax or E-mail part number and description to Technical Service for Repair Authorization (RA) number. 3. Clean (disinfect) parts prior to shipping; complete Certificate of Disinfected Parts Document #40204-17. 4. Ship part with RA number clearly marked on outside of package. 5. Part will be evaluated and customer will be contacted with the cost of repair. 6. After customer approval of repair cost, part will be repaired and return shipped to customer. 9. Warranty Mizuho OSI guarantees all of its products for a period not to exceed one (1) year from date of invoice for defects in material and workmanship with the exception of products which are misused, altered, or damaged. Defective merchandise will be credited or replaced.

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