hana Hip and Knee Arthroplasty Surgery Table...hana® Hip and Knee Arthroplasty Surgery Table 6875,...

hana® Hip and Knee Arthroplasty Surgery

Table 6875, 6875I, 6875J

Owner’s Manual

NW0508 REV H MIZUHO OSI 2013

MIZUHO OSI 30031 Ahern Avenue Union City, CA 94587-1234 Business: 510-429-1500 International: 001-510-429-1500 Toll Free: 800-777-4674 Fax: 510-429-8500

WWW.MIZUHOSI.COM WWW.NEWHIPNEWS.COM

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Table of Contents

1 IMPORTANT NOTICES ........................................................................................... 1

1.1 Trademarks ................................................................................................................ 5

1.2 Disposal of Electrical Components ......................................................................... 5

2 INTRODUCTION ...................................................................................................... 6

2.1 General Description .................................................................................................. 6

2.2 Intended Use .............................................................................................................. 7

2.3 User Profile ................................................................................................................ 7

2.4 Training Requirements ............................................................................................. 7

2.5 Conditions of Use ..................................................................................................... 7

2.6 Product Lifetime ........................................................................................................ 7

2.7 Specifications ............................................................................................................ 8

2.8 Shipping ..................................................................................................................... 8

2.9 Storage ....................................................................................................................... 8

2.10 Glossary of Terms ................................................................................................... 9

3 CONTROLS IDENTIFICATION .............................................................................. 10

3.1 Table Orientation ..................................................................................................... 10

3.2 Major Controls Location ......................................................................................... 10

3.3 Control Panel Identification ................................................................................... 12

4 BASIC OPERATION .............................................................................................. 13

4.1 Control Operation ................................................................................................... 13

4.2 Casters ..................................................................................................................... 13

4.3 Moving the Table ..................................................................................................... 14

4.4 Hand Pendant/Control Panel Operation ................................................................ 14

4.5 Emergency Stop Button ......................................................................................... 16

4.6 Leg Spars ................................................................................................................. 17

5 INSPECTION .......................................................................................................... 19

5.1 Acceptance .............................................................................................................. 19

5.2 General Inspection .................................................................................................. 19

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5.3 Pre-Procedure/Post-Procedure .............................................................................. 19

5.4 Semi-Annual ............................................................................................................ 19

6 FUNCTION CHECK ............................................................................................... 20

7 SETUP OF HANA® SURGERY TABLE COMPONENTS ....................................... 22

7.1 Insertion and Removal of Leg Spars ..................................................................... 22

7.2 Femur Lifts and Coiled Hook Motor Cables ......................................................... 23 7.2.1 Installing the Coiled Hook Motor Cable ....................................................................... 24 7.2.2 Connecting Coiled Hook Motor Cable into Femur Lift ............................................... 25 7.2.3 Disconnecting Coiled Hook Motor Cable from the Femur Lift .................................. 26 7.2.4 Attaching Femur Lift Foot Pedal .................................................................................. 27

7.3 Removable Jack Mount Assembly ........................................................................ 27 7.3.1 Removable Jack Mount Assembly Parts Identification ............................................. 28 7.3.2 Installing the Jack Mount Assembly on the hana® Surgery Table........................... 29 7.3.3 Removing the Jack Mount Assembly from the hana® Surgery Table ....................... 29

7.4 Femoral Hook Support and Femoral Hook ........................................................... 30 7.4.1 Manual Operation of the Femur Lift ............................................................................. 30 7.4.2 How They are Supplied ................................................................................................. 31 7.4.3 Precautions .................................................................................................................... 31 7.4.4 Care and Handling: Inspection ..................................................................................... 31 7.4.5 Cleaning, Disinfection, Preparation for Sterilization.................................................. 31 7.4.6 Sterilization ..................................................................................................................... 32 7.4.7 Storage ............................................................................................................................ 32 7.4.8 Utilization ........................................................................................................................ 32

7.5 Insertion of Well Leg Support Adaptor ................................................................. 32

7.6 Optional Patient Transfer Assembly ..................................................................... 33 7.6.1 Installing the Transfer Board on the hana® Operating Table .................................... 34 7.6.2 Removing the Transfer Board from the hana® Operating Table ............................... 35

7.7 Attaching hana® Knee Flexion System™ For Total Knee Arthroplasty .............. 37 7.7.1 How They Are Supplied ................................................................................................. 40 7.7.2 Precautions .................................................................................................................... 40 7.7.3 Care and Handling: Inspection ..................................................................................... 40 7.7.4 Cleaning, Disinfection, Preparation for Sterilization.................................................. 40 7.7.5 Sterilization ..................................................................................................................... 41 7.7.6 Storage ............................................................................................................................ 41

8 SETUP OF THE HANA® SURGERY TABLE ......................................................... 42

8.1 IM Femur Nailing: Unilateral Skeletal Traction ..................................................... 42

8.2 IM Femur Nailing: Unilateral Skin Traction ........................................................... 45

8.3 IM Femur Nailing: Lateral Decubitus Position with Bilateral Skin Traction ....... 48

8.4 IM Tibia Nailing: Supine with Unilateral Skin Traction ........................................ 50

8.5 Hip Pinning: Supine With Unilateral Skin Traction .............................................. 52

8.6 Hip Pinning: Supine with Bilateral Skin Traction ................................................. 54

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8.7 Anterior Approach Total Hip Arthroplasty ............................................................ 57

8.8 Total Knee Arthroplasty ......................................................................................... 59

9 COMPONENTS AND ACCESSORIES .................................................................. 63

9.1 hana® Surgery Table Standard Components ........................................................ 63

9.2 hana® Surgery Table Optional Fracture Kit Components .................................. 64

9.3 hana® Surgery Table Recommended Optional Accessories .............................. 65

10 CLEANING AND MAINTENANCE ......................................................................... 66

10.1 Cleaning and Disinfecting .................................................................................... 66 10.1.1 Table Exterior ............................................................................................................... 66 10.1.2 Mizuho OSI® Tempur-Pedic® Medical Pads ............................................................. 66

10.2 Storage ................................................................................................................... 67

10.3 Maintenance .......................................................................................................... 67

11 ELECTRICAL SYSTEM ......................................................................................... 68

11.1 Description ............................................................................................................ 68

11.2 Power Cord ............................................................................................................ 69

11.3 On/Off Circuit Breaker Power Switch .................................................................. 69

11.4 Component Circuit Breakers ............................................................................... 70

11.5 Linear Actuators .................................................................................................... 70

11.6 Battery System ...................................................................................................... 70

12 TROUBLESHOOTING ........................................................................................... 72

13 REMOVAL AND REPLACEMENT OF COMPONENTS ........................................ 75

13.1 Motion Control Module ......................................................................................... 75

13.2 Internal Batteries ................................................................................................... 77

13.3 Caster(s) ................................................................................................................. 80

14 TECHNICAL DRAWINGS AND PARTS LIST ........................................................ 81

14.1 Replacement / Spare Parts List ........................................................................... 81

14.2 Interconnect Diagram, 100VAC, 120VAC, 230VAC Models ............................... 83

15 MIZUHO OSI CUSTOMER RESOURCE GROUP .................................................. 84

15.1 Contact for Parts and Service .............................................................................. 84

15.2 Instant Support Value Package ........................................................................... 84

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15.3 Order Replacement Parts ..................................................................................... 84

15.4 Return Damaged Parts ......................................................................................... 84

15.5 Send a Part for Repair .......................................................................................... 85

15.6 Warranty ................................................................................................................. 85

15.7 European Community Authorized Representative ............................ 85

16 APPENDIX ............................................................................................................. 86

16.1 Electromagnetic Emissions ................................................................................. 86

16.2 Electromagnetic Immunity ................................................................................... 87

16.3 Recommended Separation Distances ................................................................. 89

hana® Hip and Knee Arthroplasty Surgery Table Owner’s Manual

1 Mizuho OSI 2013 NW0508 Rev H

1 Important Notices

CAUTION: To ensure safe operation of the equipment, please READ THESE INSTRUCTIONS COMPLETELY and keep this manual readily available for future reference.

Carefully observe and comply with all warnings, cautions and instructions placed on the equipment or described in this manual.

NOTE: This device is intended for use by trained personnel only. To schedule an in-service, please contact your domestic Mizuho OSI sales representative or international distributor. You can also contact the Mizuho OSI Customer Resource Group at 1-800-777-4674 or (International) 001-510-429-1500.

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.

The following symbols are used in this manual and on the equipment:

Symbol Meaning

This symbol indicates an authorized representative in the European Community.

This symbol indicates this equipment is an applied part TYPE B in accordance with IEC 60601-1 and is generally suitable for applications involving external or internal contact with the patient, excluding the heart. The patient circuit is connected to protective earth and this equipment should be connected only to hospital grade AC outlets with a protective earth ground.

This symbol indicates the Manufacturer of the device.

NOTE: This symbol indicates a comment or instruction of importance.

This symbol is to signify CAUTION. It is intended to alert the user to consult the documentation for safety-related information such as warnings and precautions that cannot, for a variety of reasons, be presented on the device itself.

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

This symbol indicates proper disposal instructions.

This symbol indicates a product number.

This symbol indicates a serial number.

This symbol indicates that you need to consult instructions for use.


2 NW0508 Rev H Mizuho OSI 2013

Symbol Meaning

This symbol indicates that you need to read the manual before use.

This symbol indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility.

This symbol indicates a Pinch Point and danger to body extremities.

This symbol indicates the Emergency Stop.

This symbol indicates the Red Zone – See User Manual for set up.

This symbol indicates rotation in two directions.

This symbol indicates rotation in one direction.

This symbol indicates Alternating Current Indicator.

This symbol indicates Battery Charge Indicator.

This symbol indicates Battery OK Indicator.

This symbol indicates Battery Power Indicator.

This symbol indicates Power Connected Indicator.

This symbol indicates - To Change Battery, See the Maintenance Section of the Owner’s Manual.

This symbol indicates Lock.

This symbol indicates Unlock.

This symbol indicates Foot Rotation Lock.

This symbol indicates Foot Pedal.

This symbol indicates location of the Manual Femur Lift.

This symbol indicates the table weight limit.



Symbol Meaning

This symbol indicates Small Size.

This symbol indicates Large Size (regular).

This symbol indicates Extra Large Size.

This symbol indicates the Left Traction Boot.

This symbol indicates the Right Traction Boot.

This symbol indicates the Left Femur Lift Indicator.

This symbol indicates the Right Femur Lift Indicator.

This symbol indicates the Left Femur Lift.

This symbol indicates the Right Femur Lift.

This symbol indicates Femur Lift Control – Up and Down.

This symbol indicates that spar damage may occur when using extreme Trendelenburg.

This symbol indicates that the table shall not be used as a gurney to transport patients

WARNING: Proper preoperative and intra-operative procedures must be followed to prevent venous stasis and pooling, pressure sore development, neuropathy, improper electrosurgical tissue grounding, hypertension and hypothermia.

WARNING: This symbol indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility. To protect the patient, hospital staff and the table from possible electrical hazards, an external ground wire connection is required between the external ground stud and protective earth ground when the table is in use under battery power or not connected to a protective earth ground.



WARNING: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.

WARNING: Use of the hana® Surgery Table with patients weighing more than 450 lbs (205 kg) could result in damage to the table, possible injury to the patient, or harm to the healthcare workers.

WARNING: Before and after each use, inspect the table, components and accessories 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. Damaged or defective parts should not be used or processed. Contact the Mizuho OSI Customer Resource Group for repair or replacement (refer to Chapter 15).

WARNING: The hana® Surgery Table should not be operated in an oxygen-rich environment, or in the presence of flammable anesthetics, volatile substances, or other explosive gases, liquids, or atmospheres.

WARNING: If high-frequency surgical equipment, cardiac defibrillators or cardiac defibrillator monitors are to be used with the hana® Surgery Table, refer to the instructions for use provided by the manufacturer of those devices.

WARNING: The 6875 hana® Surgery Table should not be transported with a patient on it. The table can tip over and cause injury to the patient.

WARNING: Use of components not manufactured by Mizuho OSI may result in harm to the patient, the table top, the device or the healthcare professional.

WARNING: Tipping Hazard – Do not use on surface inclined greater than 5°.

WARNING: Tipping Hazard – Exercise caution when transporting device over uneven surfaces.

CAUTION: If the integrity of the AC power source is in doubt, the equipment shall be operated from its internal electrical power source (battery).

CAUTION: As outlined in the AORN Recommended Practices for Positioning a Patient in the Perioperative Setting, following the positioning of the patient, an assessment of the patient’s alignment, tissue perfusion and skin integrity should be completed. All contact points of the patient with the table pads should be monitored during the procedure.

CAUTION: No modification of the hana® Surgery Table or its components is allowed. Any modification to the equipment may result in damage to the table, possible injury to the patient or harm to the healthcare workers.



1.1 Trademarks

GentleTouch® and Orange Aid® are registered trademarks of Mizuho OSI.

ShearGuard® and hana® are registered trademarks of Mizuho OSI.

Knee Flexion System™ is a trademark of Mizuho OSI.

ProneView® is a registered trademark of Dupaco, Inc.

Tempur-Pedic® is a registered trademark of Tempur-Pedic® Medical, Inc.

1.2 Disposal of Electrical Components

In accordance to the European Union Waste Electrical and Electronic Equipment (WEEE) Directive, all electrical components, batteries and carbon composite components must be returned to Mizuho OSI for proper disposal. Please contact Mizuho OSI Customer Resource Group at 1-800-777-4674 or 001-510-429-1500 (International) for further information regarding this requirement.



2 Introduction

2.1 General Description

The Mizuho OSI 6875 hana® Surgery Table is designed to safely hold in proper position a patient undergoing orthopedic surgical procedures including the Anterior Approach Total Hip Arthroplasty, Total Knee Arthroplasty, IM Nailing of the Femur or Tibia and Hip Pinning.

It is a stand-alone, single-pedestal, AC-powered or internal battery powered table designed to position a patient in a supine or lateral position during surgical procedures.

The table has a 2” (5 cm) Mizuho OSI Tempur-Pedic® pad. The material used in the manufacture of the pads has viscoelastic properties and is a temperature sensitive material, becoming softer where the patient’s body is making the most contact with the surface and remaining firm in areas where less body contact is being made. Pressure is distributed evenly over the entire surface area. The pad is radiolucent and latex-free. The benefits of using Mizuho OSI Tempur-Pedic® pads are improved pressure management, reduced shear forces, and enhanced patient comfort.

The hana® Surgery Table has three primary electrically powered functions: Height (up/down), Lateral Roll (left/right), and Trendelenburg/reverse Trendelenburg. Electromechanical actuator motors perform these motions that are controlled by means of a Hand Pendant or onboard Auxiliary Control Panel with functions clearly labeled. The table is also equipped with powered left and right Femur Lifts that are controlled by a Foot Pedal providing the surgeon the ability to raise and lower the Femoral Hook during the Anterior Approach Total Hip Arthroplasty.

Four (4) independent, manual Caster Floor Locks are utilized to stabilize the table in the operating location.

Figure 1: Mizuho OSI hana® Surgery Table, right-side view



2.2 Intended Use

The Mizuho OSI hana® Orthopedic Surgical Tables are intended for and suitable for use in the hospital operating room, sub-acute surgical environments, and hospital trauma centers. The Mizuho OSI hana® Orthopedic Surgical Tables are designed for adult and pediatric patients with body weight less than 450 lbs (205 kg), needing hip or knee orthopedic surgical procedure as prescribed by a trained physician.

This device is intended for and designed to provide patient comfort and enhanced patient positioning for surgery.

Due to the design of the table top, the operating table is suitable for Hip and Knee Orthopedic surgical disciplines, as described in the Directions for Use.

Movements are initiated manually; they are executed manually or electro-mechanically. Side rails are provided for securing accessories in accordance with the manufacturer's specifications.

The radiolucent table top and leg spars of the hana® Surgery Table permit intra-operative use of X-ray equipment.

2.3 User Profile

The System is suitable for use by health care professionals, including but not limited to surgeons, radiologists, anesthesiologists, circulating nurses, surgical technicians, biomedical and radiology technicians.

2.4 Training Requirements

Before using the hana® Surgery Table, the user must read the NW0508 hana® Hip and Knee Arthroplasty Surgery Table Owner’s Manual.

It is recommended that personnel using the hana® Surgery Table receive training by either Mizuho OSI or by someone qualified by the medical facility to provide this training.

NOTE: To schedule an in-service, please contact your domestic Mizuho OSI sales representative or call the Customer Resource Group at 1-800-777-4674 in the US or 001-510-429-1500 internationally.

2.5 Conditions of Use

The hana® Surgery Table may be used several times throughout the day and night in medical facilities; e.g. hospitals and outpatient surgery/imaging centers. The hana® Surgery Table will be used in an operating room or other treatment room, and may be rolled between rooms.

2.6 Product Lifetime

The device’s service lifetime is defined as 10 years.

NOTE: For optimum performance, ensure that Preventive Maintenance is performed regularly, damaged and worn out parts are replaced, and batteries replaced as necessary.



2.7 Specifications

The hana® Surgery Table has the following specifications:

The table is designed to hold a maximum patient load of 450 pounds (205 kg) in a procedural position at any point within its physical range.

The table has a height range of 29 to 49 inches (74 cm – 124 cm).

The width of the tabletop is 21.5 inches (55 cm) and narrows to 10 inches (25 cm) toward the Foot-End and 5 inches (13 cm) at the Perineal Post.

The length of the tabletop is 48.5 inches (123 cm). The overall length with leg spars attached is 124 inches (315 cm).

The lateral roll range is +/- 12 degrees and the Trendelenburg/Reverse Trendelenburg range is +/- 12 degrees.

The leg spars rotate on a spherical joint and are capable of positioning the patient’s leg in up to 20 degrees of adduction, 45 degrees of abduction, raising the leg to 28 degrees above level and lowering the leg to 35 degrees below level.

The tabletop has a radiolucent equivalency of less than 1 millimeter of aluminum.

The input power requirement is 100 VAC/ 4 A/ 50-60Hz, 120 VAC/ 60Hz or 230 VAC/ 4 A/ 50Hz as indicated on the table label.

The table may also be operated under battery power. The expected working life of a fully charged battery is approximately 12 hours at a 10% duty cycle.

The table is IPX4 rated per IEC 60529.

The Foot Pedal is rated IP68.

Operating Environment is 68° F (20°C), relative humidity 50%, atmospheric pressure 75-105kPa.

Class 1 Equipment; Type B per IEC 60601-1.

The table is not suitable for use with flammable anesthetic gas mixtures.

2.8 Shipping

The hana® Surgery Table must be shipped using the appropriate shipping crate. During shipment the table is to be kept in an environment within the following limits:

Ambient temperature -4 °F (-20 °C) to +122 °F (50 °C).

Relative humidity from 10% to 100%, including condensation.

Atmospheric pressure from 50 to 110 kPa.

2.9 Storage

When not in use, the hana® Surgery Table should be stored in a clean, dry environment with temperature between 32 °F (0°C) and 120°F (49°C). The table cover provided serves as a dust cover and should be utilized.



To ensure the battery is always fully charged and ready for use, the table should be stored with the Power Cord inserted on the Head-End Control Panel and attached to an appropriate, Hospital-grade AC Outlet (100VAC, 120VAC, or 230VAC) and the Power Switch turned ON.

2.10 Glossary of Terms

Term Description

Foot-End of Table The end of the table where the leg spar is controlled.

Head-End of Table The end of the table where the Power Cord, ON/OFF Power Switch, and Auxiliary Control Panel are located; also referred to as the pedestal end.

Hospital Grade AC Outlet Specially designated outlets (receptacles) that include additional grounding reliability, assembly integrity, strength and durability. Hospital Grade is indicated by a Green Colored Dot on the face of the outlet.

Left Side of the Table The side to the patient’s left in the supine position. This corresponds to the Hand Pendant button labeled LEFT LATERAL ROLL.

Lower the Table Lowering the height of the table. This corresponds to the Hand Pendant button labeled HEIGHT DOWN.

Pedestal Main column structure that supports the tabletop.

Raise the Table Raising the height of the table. This corresponds to the Hand Pendant button labeled HEIGHT UP.

Return to Level, or Level the Table

Returning the tabletop to a state of level regardless of its position. This corresponds to the Hand Pendant button labeled RETURN TO LEVEL. Holding the RETURN TO LEVEL button longer than approximately three seconds will also lower the tabletop to its lowest position.

Reverse Trendelenburg Raising the height of the Head-End of the table. This corresponds to the Hand Pendant button labeled REV TREN.

Right Side of the Table The side to the patient’s right in the supine position. This corresponds to the Hand Pendant button labeled RIGHT LATERAL ROLL.

Trendelenburg Lowering the height of the Head-End of the table. This corresponds to the Hand Pendant button labeled TREN.



3 Controls Identification

3.1 Table Orientation

The major components of the hana® Surgery Table are identified in this chapter. The table is described as having a Head-End and a Foot-End. The Control Panel, ON/OFF Switch, and the Power Cord Receptacle are located at the Head-End of the table.

Figure 2: Right-side view with patient in supine position

3.2 Major Controls Location

The Control Panel, ON/OFF Power Switch, Power Cord Receptacle, and Model Number/Serial Number Identification Label are located at the base of the Head-End of the table.

The Hand Pendant Controller also connects at the Head-End of the table. To learn about the Hand Pendant and its functions, see Section 4.4.



Figure 3: Head-End Motion Control Box and Control Panel

Input power requirement for the hana® Surgery Table Models 6875, 6875I, and 6875J as indicated on the manufacturer’s label:

100 VAC 50/60Hz, 4 Amp

120 VAC, 60Hz, 4 Amp

230 VAC, 50Hz, 2 Amp

On/Off Power Switch

Hand Pendant Connector

Model/ Serial Number Model

Power Cord Receptacle



3.3 Control Panel Identification

Figure 4: Control Panel

Term Description

Femur Lift Control Selection switch changes between right and left Femur Lift operation. Indicators display status of Femur Lift connection (left, right) and the status of Foot Pedal connection. (If the indicator is illuminated, the parts are connected; if the indicator is not illuminated, the parts are not connected)

Control Pad The Control Pad and the Hand Pendant Control the table’s up/down movements, lateral tilt, and Trendelenburg; see Section 4.4 for operation of the Hand Pendant and Control Pad.

Power indicators LED indicators notify user of the following conditions when illuminated:

BATTERY CHARGE: Battery power low or no battery installed.

BATTERY OK: Battery has sufficient power to operate the table.

AC POWER: Indicates the table is running on AC power (100, 120, 230 VAC) from the wall receptacle.

BATTERY POWER: Indicates the table is running from internal battery power.

Femur Lift Control Control Pad Power Indicators



4 Basic Operation

4.1 Control Operation

Refer to the model/serial number label on the Head-End of the table for input voltage requirements. Plug the Power Cord into the Power Cord Receptacle located at the Head-End of the table and into a properly grounded receptacle. Turn on the ON/OFF Power Switch. The green light in the Power Switch illuminates, indicating that AC power is applied to the table. This switch functions as a combination ON/OFF Power Switch, Circuit Breaker, and pilot light.

NOTE: A startup self-diagnostic routine is initiated each time the table is plugged in and turned on. Wait 20 seconds before operating controls on the table after powering the table on.

4.2 Casters

Prior to transferring a patient onto the table and at all times when the table is in use, ensure all four (4) independent, manual Casters are in the locked position. To engage the Lock, step on the foot pad and depress to the floor. To unlock, slide foot under pad and lift to disengage lock.

Figure 5: Caster Lock in the unlocked position



Figure 6: Caster in the locked position

NOTE: The casters and locks installed on your hana® Surgery Table may look different than those depicted above but they will operate in the same manner that is described.

4.3 Moving the Table

CAUTION: The casters are designed to roll smoothly on level surfaces. If it is necessary to negotiate a high threshold or other uneven surface, a slightly higher speed and/or more people may be required. Take care to control the table’s motion.

After all four (4) Casters are unlocked; the table can be rolled for relocation. It is best that the table be rolled with the Foot-End pointed in the direction of travel, with the table lowered to its minimum height, and without the leg spars attached to the table. The hana® Surgery Table is heavy and a minimum of two people should move it, one at the Head-End, and one at the Foot-End. Care should be taken to control the table when rolling.

WARNING: If the table is allowed to roll too fast, it may be difficult to stop or turn. Impact of the table top with a stationary object may cause serious damage to the table top. If an impact occurs, the table must be visually inspected for visible damage, and a Function Check must be performed (see Chapter 6 of this manual). If damage is discovered or the table does not pass the Function Check, contact Mizuho OSI Customer Resource Group (see Chapter 15).

4.4 Hand Pendant/Control Panel Operation

The hana® Surgery Table is controlled by means of a Hand Pendant or the Control Panel. The Hand Pendant is plugged into the receptacle labeled Hand Pendant on the Control Box (see Figure 3). To activate a desired function, press and hold the appropriate button on the Hand Pendant until the desired position is achieved.

CAUTION: Ensure the leg spars have sufficient clearance before adjusting table position.

The Hand Pendant is equipped with Return to Level button. This button functions as follows:



First level - lateral roll

Second level - Trendelenburg

Third re-level - lateral roll

Fourth level - brings the level table to its lowest position

A delay of 3 seconds is programmed after the leveling functions are completed before the table returns to its lowest position. To achieve the final position, this button must be held continuously until motion stops. The controller considers the table to be level if it is within +/- 2 degrees of horizontal. If the Return to Level button is pressed while the table is within this range, it may not move. If it is required to adjust the table to a position closer to zero degrees, press the appropriate function button on the Hand Pendant until the desired position is achieved.

Figure 7: Hand Pendant

Height Up

Trendelenburg

Left Lateral Roll

Height Down

Reverse Trendelenburg

Right Lateral Roll



Figure 8: Head-End Control Panel

NOTE: When installing a Hand Pendant, turn the Power Switch off, then plug in the Hand Pendant connector and rotate the locking collar clockwise until the collar is hand tight. To operate any of the desired functions, turn the Power Switch on and wait for 20 seconds for the table to power up and run its self-diagnostics.

4.5 Emergency Stop Button

To immediately interrupt power to the hana® Surgery Table, press the Emergency Stop button. To reset the system, turn the Emergency Stop button in the direction of the arrows until it returns to the original position.

Figure 9: The Emergency Stop button

Height Up

Trendelenburg

Left Lateral Roll

Height Down

Reverse Trendelenburg

Right Lateral Roll

The Emergency Stop button



4.6 Leg Spars

The hana® Surgery Table is equipped with two adjustable leg spars. Each leg spar is designed to support the foot in the Traction Boot or with skeletal traction devices and allow for traction, abduction, adduction, and raising or lowering of the leg. When the leg is in a desired position, the spar can be locked to maintain that position. A dial is provided to gauge the degree of internal and external rotation and should be zeroed out and locked in place utilizing the thumb screw when the foot is in the neutral position. Gross and fine traction are also controlled near the Foot-End of the spar.

Gross Traction is adjusted by releasing the knob at the base of the Traction Slider and sliding the entire assembly to the desired position. The fine traction mechanism should be positioned near its center of travel. Fine Traction is applied using the crank handle at the end of the spar.

Figure 10: hana® Surgery Table Spar controls

To unlock the spar for abduction, adduction or height adjustment, hold the spar with one hand by the loop handle and move the Spar Lock Handle (knobbed lever) from the locked to unlocked position (refer to Figure 11). When you have positioned the leg where needed, lock the spar by rotating the Spar Lock Handle clockwise to the locked position. If the spar will not hold position, rotate the lock handle further toward the locked position. The spar should be held securely by the looped handle at all times when it is not locked.

WARNING: Adjusting spar position can affect traction. Release the Gross Traction Knob while adjusting the spar position.

NOTE: If the patient is short in stature and the gross traction locking device enters the red zone, the installation and use of the Traction Hook Extension is required.

Gross Traction Knob

Spar Lock Handle

Fine Traction Handle

Foot Rotation Locking Knob

Internal/External Rotation Dial

Boot Operation Locking Handle



Figure 11: Spar ball joint lock/unlock loop handle of leg spar

WARNING: Failure to lock the Spar Lock Handle can cause the spar to drop when not held in place.

WARNING: Leg spars can be damaged if allowed to contact the floor during table operation. Clear the area of any obstructions or obstacles during table movement.

Figure 12: hana® Surgery Table with leg spars attached and set up for bilateral anterior approach total hip replacement

Lock Unlock

Loop Handle



5 Inspection

5.1 Acceptance

Upon receipt of your hana® Surgery Table, remove it from the shipping carton by following the provided instructions. Remove any protective wrapping or packaging. Visually inspect all surfaces for freight damage. Check each caster for proper rolling operation.

NOTE: Any freight damage must be reported to the freight carrier immediately upon delivery. It is the responsibility of the recipient to make freight damage claims.

Read the Model/Serial Number Identification Label found at the Head-End of the table to confirm the serial number and the input power requirements.

Plug the Power Cord into an appropriate AC receptacle and into the Power Cord Receptacle (located on table-base panel). Power on the table to charge the batteries for at least 3 hours.

Place the table in an area with at least 4 feet of clearance on all sides.

Perform Function Check; see Chapter 6.

5.2 General Inspection

Before use, inspect the device for possible damage, excessive wear or non-functioning parts. Visually inspect all accessible areas, electrical cords, and all movable parts for possible damage that may adversely affect the proper operation of the hana® Surgical Table. Damaged or defective products should not be used or processed. Contact your Mizuho OSI Customer Resource Group for repair or replacement of parts (see Chapter 15).

5.3 Pre-Procedure/Post-Procedure

Inspect and test the table as described in Chapter 6, Function Check.

Inspect pad material for wear or damage.

Thoroughly clean the table as described in Chapter 10. Pay special attention to the cleanliness of the controls as excessive soil can affect function.

Inspect the Power Cord for cuts in the insulation or damage to the connector.

On a smooth surface with the Caster Locks engaged, push the table. The table should not move.

5.4 Semi-Annual

It is recommended to perform a Preventive Maintenance (PM) check on your hana® Surgery Table. A PM checklist is available from Mizuho OSI Customer Resource Group (Chapter 15).



6 Function Check Perform all steps in this procedure before using the table. For a complete definition of terms used in this procedure, please refer to the Glossary of Terms in Section 2.10 of this manual.

1. Turn the Power Switch off. Plug in the connector of the Hand Pendant into the Hand Pendant Receptacle on the Control Panel.

2. If the table is to be used under battery power, put the Power Switch in the ON position and wait for 20 seconds for the table to power up and run its self diagnostics. The battery power lamp on the Control Panel should illuminate.

WARNING: This symbol indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility. To protect the patient, hospital staff, and the table from possible electrical hazards, an external ground wire connection is required between the external ground stud and protective earth ground.

3. Battery operation check:

4. Observe the Battery Status Light in the power indicator Section of the Control Panel or on the Hand Pendant. A green light indicates the table is set on battery power operation.

If green battery OK light is on, the table is ready to operate normally.

If the red battery Charge light is on, the battery must be charged prior to using the table. To charge the battery, make sure the Power Cord is plugged into a live receptacle and then turn on the Power Switch. This switch will illuminate indicating that appropriate power is applied to the table. The table must remain plugged in and switched on for a minimum of 3 hours to ensure sufficient charging of the battery to operate the table.

If the red “check battery” light remains on after 3 hours, continue to charge battery for up to 18 hours.

If the green “battery ok” light does not illuminate after 18 hours, refer to Section 11.5 of this manual.

NOTE: The table may be used with AC power even if the battery status light is red, indicating batteries need charging.

5. If the table is to be used under line power, plug the Power Cord into an appropriate hospital grade AC outlet and turn on the Power Switch. Note that the Power Switch illuminates indicating the AC power is on. The AC power lamps on the Control Panel and Hand Pendant should illuminate.

6. Hand Pendant check:

7. Press and hold the HEIGHT UP button. Observe the tabletop move up.

8. Press and hold the HEIGHT DOWN button. Observe the tabletop move down.

9. Press and hold the REVERSE TRENDELENBURG button. Foot-End of the tabletop becomes lower than the Head-End.

10. Press and hold the TRENDELENBURG button. Head-End of the tabletop becomes lower than the Foot-End.

11. Press and hold LEFT LATERAL ROLL button. Observe that the tabletop tilts to the left.

12. Press and hold RIGHT LATERAL ROLL button. Observe that the tabletop tilts to the right.

13. Move the tabletop out of level in both tilt and Trendelenburg by 5 degrees and raise the table at least 2 inches from its lowest position. Press and hold the RETURN TO LEVEL button. The



tabletop first levels roll and Trendelenburg and then after a 3-second delay, the tabletop moves down to its lowest height position. Observe that the table top is level and in its lowest height position.

14. Control Panel check:

15. Repeat steps 7 through 13 using the Control Panel buttons.

16. Femur Lift Control and Foot Pedal check:

17. With Femur Lift connected to electricity, the corresponding light on the Control Panel should illuminate indicating a good connection. See Section 7.2 for proper installation of Femur Lift and Foot Pedal.

18. With Femur Lifts and Foot Pedal connected and connectivity indicator lights green, position the Control Knob located on the Control Panel (see Figure 4) to either the left Femur Lift or right Femur Lift. Test the Femur Lift Foot Pedal function for operation of the indicated Femur Lift. Repeat for opposite side.



7 Setup of hana® Surgery Table Components

NOTE: Only Mizuho OSI supplied accessories have been tested and approved for use with the hana®

surgery Table. Other manufacturers’ products have not been tested for proper performance when used with the Base, and therefore are not endorsed for use by Mizuho OSI.

Instructions are provided for the following components of the hana® Surgery Table:

Leg Spars

Femur Lift(s) and Coiled Hook Motor Cable(s)

Femur Lift Foot Pedal

Jack Mount Assembly

Femoral Support and Femoral Hook(s)

Well Leg Support Adaptor

Patient Transfer Assembly

hana® Knee Flexion System™ for Total Knee Arthroplasty

7.1 Insertion and Removal of Leg Spars

Before you begin:

Lock the Casters.

Raise the height of the table to be able to easily access the spar mount.

Ensure the Spar Locking Knob is in the unlocked position by turning the knob counterclockwise.

Ensure the Spar Lock Handle is in the locked position.

NOTE: Two people are needed for this procedure. One person supports the distal (foot) end of the spar holding the loop handle, while another person supports the spar as it slides into the spar mount on the table.

1. Slide the end of the spar forward until it is fully engaged. A defined click should be heard when the spar post is inserted past the safety latch.

2. Lock in place by turning the Spar Locking Knob clockwise until tight.

3. Move the spar up and down slightly while tightening the knob to ensure a tighter lock.

4. While continuing to support the distal (foot) end of the spar, holding the loop handle, move the Spar Lock Handle to the unlocked position.

5. Reposition the spar as needed and then return the Spar Lock Handle to the locked position.



Figure 13: Mounting the leg spar

Figure 14: Locking and unlocking the leg spar

To remove the spar from the table:

NOTE: Two people are needed for this procedure. One person supports the distal (foot) end of the spar holding the loop handle, while another person turns the Spar Locking Knob counterclockwise to unlock the spar.

Unlock the Spar Locking Knob.

Release the safety latch by lifting it to allow the spar to be removed.

Slide the spar out of the spar mount.

7.2 Femur Lifts and Coiled Hook Motor Cables

Two Femur Lift Expansion Junction Boxes (left and right) are located underneath the table top at the Foot-End. If the Circuit Breaker trips on either of the boxes, the corresponding Femur Lift is powered OFF.

Spar

Spar Mount

Safety Latch

Spar Locking Knob



WARNING: If the Circuit Breaker trips on the Left/Right Expansion Junction Box during surgery, the Femur Lift Emergency Handle should be used to move the Femur Lift. It is not recommended that the Circuit Breaker is reset during surgery or the Foot Switch and Femur Lifts are reused. The table should be properly checked by a trained technician prior to reusing the Foot Switch and Femur Lifts.

There are two Coiled Hook Motor Cables.

Figure 15: Expansion Junction Box, left

Figure 16: Coiled Hook Motor Cables

7.2.1 Installing the Coiled Hook Motor Cable

CAUTION: Before use, inspect the Coiled Hook Motor Cables for possible damage, excessive stretch, or damaged electrical quick-disconnect plugs. Carefully inspect all electrical quick-disconnect receptacles and Circuit Breakers for possible damage or non-function. Damaged or defective products should not be used or processed. Contact the Mizuho OSI Customer Resource Group (Chapter 15).

1. Locate the red dot on the Expansion Junction Box’s electrical quick-disconnect receptacle.

2. Plug in the Coiled Hook Motor Cable’s plug into the Expansion Junction Box’s receptacle by matching the red dots.



3. Push the Coiled Hook Motor Cable’s plug into the Expansion Junction Box’s receptacle until it clicks.

4. Repeat procedure for the other Expansion Junction Box.

Figure 17: Connecting Coiled Hook Motor Cable into Expansion Junction Boxes

7.2.2 Connecting Coiled Hook Motor Cable into Femur Lift

1. Place Femur Lift on a flat surface with the red dot of the electrical quick-disconnect receptacle visible.

2. Plug in Coiled Hook Motor Cable’s plug into the Femur Lift’s receptacle by matching the red dots.

3. Push the Coiled Hook Motor cable’s plug into the Femur Lift’s receptacle until it clicks.

4. Mount the Femur Lift into hana® Surgery Table’s Jack Mount Assembly and tighten the Femur Lift Lock.

5. Repeat procedure for the other side Femur Lift.

Figure 18: Connecting Coiled Hook Motor Cable into Femur Lift

Match the red dots

Expansion Junction Box

Electrical Quick Disconnect Receptacle

Electrical Quick Disconnect plug

Match the red dots

Femur Lift



7.2.3 Disconnecting Coiled Hook Motor Cable from the Femur Lift

1. Hold the grooved part of the electrical quick-disconnect plug, pull down and pull the electrical quick-disconnect plug out from the Femur Lift.

Figure 19: Disconnecting the Coiled Hook Cable from Femur Lift

2. Stow the electrical quick-disconnect plug of the Coiled Hook Motor Cable into the clip behind the Jack Mount Assembly.

Figure 20: Clips for electrical quick-disconnect Plugs

3. Unlock the Femur Lift Lock and remove the Femur Lift from the Jack Mount Assembly.

4. Repeat procedure for the Femur Lift on the other side.

If a complete removal of the Coiled Hook Motor Cable from the table is desired, repeat step 1 for the other side of electrical quick-disconnect plug on the Expansion Junction Box. Remove Coiled Hook Motor Cable from Clip.

Jack Mount Assembly

Grooves

Clips for Electrical Quick Disconnect plugs



CAUTION: Do not attempt to remove Femur Lift if Coiled Hook Motor Cable is connected to it, this can cause damage to the Coiled Hook Motor Cable and electrical quick-disconnect connectors. Always unplug the Femur Lift first.

7.2.4 Attaching Femur Lift Foot Pedal

A single Foot Pedal is used to operate both left and right Femur Lifts. Switching operation from one to the other is accomplished by rotating the Femur Lift Control on the Control Panel in the desired direction (see Figure 4).

Plug the Foot Pedal into the port at the Foot-End of the table base. (The flange should be flush or below surface of receptacle).

Figure 21: Plugging in the Foot Pedal

Ensure the Foot Pedal and Femur Lift function correctly. On the Control Panel, (see Figure 4) verify the Femur Lift is connected by the corresponding LED illuminating when the appropriate lift is selected. Press the Foot Pedal towards the left, and observe the lift rise to its fullest height and then depress towards the right and observe the lift lower to its lowest position. Complete this process for both the right and left Femur Lifts.

7.3 Removable Jack Mount Assembly

The Removable Jack Mount Assembly is used to support the Femur Lift(s) and/or the Patient Transfer Assembly. Before use, inspect the device for possible damage, excessive wear, or non-functioning parts. Visually inspect all accessible areas for possible damage that may adversely affect the proper operation of the hana® Surgical Table. Damaged or defective products should not be used or processed. Contact your Mizuho OSI Customer Resource Group (Chapter 15) for repair or replacement.

The Removable Jack Mount Assembly is designed to allow for removal and reinstallation as needed, depending on the type of surgical procedures being performed. Removing the Removable Jack Mount allows for C-arm access during Hip Arthroscopy and certain fracture procedures. If C-arm access is not required, or your C-arm can be positioned with the Removable Jack Mount in place, the Removable Jack Mount may remain on the table.

The Removable Jack Mount is located directly underneath the Foot-End of the table between the removable leg spars.

Foot Pedal Port Below this surface

Flange



Figure 22: Leg Spars and Femur Lift shown removed

7.3.1 Removable Jack Mount Assembly Parts Identification

Figure 23: Jack Mount Assembly 1

Femur Lift Mounting Location

Transfer Board Mounting Location

Mounting Slide

Black Knob

Transfer Board Attachment Guided fins

Safety Latch Locked position

Coiled Hook Motor Cables Stowed in clips



Figure 24: Jack Mount Assembly 2

7.3.2 Installing the Jack Mount Assembly on the hana® Surgery Table

1. Slide the Removable Jack Mount Assembly into the mounting slide located underneath the table top. The safety latch will fall into the locked position. The assembly will move in and out but should be unable to be removed from the slide without lifting the safety latch.

2. Tighten the black knob to secure the Removable Jack Mount assembly to the table.

3. When the handle is firmly tight, the Removable Jack Mount Assembly should have minimum movement (less than 1/4” at the Jack Mount location).

7.3.3 Removing the Jack Mount Assembly from the hana® Surgery Table

1. If the Femur Lifts are attached to the Removable Jack Mount assembly, unplug the Coiled Hook Motor cables from the Femur Lifts and secure in the clips behind the Jack Mount Assembly.

2. Remove the Femur Lifts.

3. To remove the Removable Jack Mount Assembly, loosen the black knob to fully disengage the threads. Lift the safety latch to the unlocked position as shown above and pull forward on the Removable Jack Mount Assembly.

4. The Removable Jack Mount Assembly should slide off freely without excessive force.

WARNING: Do not attempt to install or remove the Removable Jack Mount from the hana®

table with the Femur Lifts attached to the Jack Mount.

Safety Latch unlocked position



Before every use, visually inspect that the safety latch lever is fully engaged and hanging in a downward direction. Make sure that the black knob is fully tightened and that the Removable Jack Mount is secured to the table.

7.4 Femoral Hook Support and Femoral Hook

The Femoral Hook and Femoral Hook Support are designed for use with only the Mizuho OSI PROfx®

Orthopedic Surgery Table or the Mizuho OSI hana® Surgery Table. They are utilized during the Single Incision Tissue Sparing (SITS) Anterior Approach Total Hip Arthroplasty. The hooks are imprinted with L and R to designate left and right.

Figure 25: The Femur Lift is in place for use with the Femoral Hook Support

Proper cleaning, handling, and sterilization will ensure that the Femoral Hook(s) and Femoral Hook Support perform as intended.

7.4.1 Manual Operation of the Femur Lift

The Femur Lift Emergency Handle is attached on the rear of the Femur Lift Assembly. To operate the Femur Lift manually, insert the Emergency Handle into the opening and rotate the handle to move the Femoral Lift up and down.

Femoral Hook

Lift



Figure 26: Emergency Handle inserted in the Femur Lift

7.4.2 How They are Supplied

Mizuho OSI's Femoral Hooks and Femoral Hook Support are supplied non-sterile. Cleaning and sterilizing of the instrument(s) are required before each use according to your hospital’s washing, decontamination, and sterilization procedures.

7.4.3 Precautions

The Mizuho OSI Femoral Hooks and Femoral Hook Support are surgical instruments that require special handling to prevent damage. Misuse can cause excessive stress or strain that can result in damage that can adversely affect their intended use. Use caution during cleaning and sterilization. The Femoral Hooks are approved for use only in combination with the Femoral Hook Support in conjunction with the Mizuho OSI 6850 PROfx® Table or Mizuho OSI hana® Surgery Table.

7.4.4 Care and Handling: Inspection

Before each use, inspect the Femoral Hook(s) and Femoral Hook Support for damage, wear, and functionality (check for nicks, burrs, or bent parts).

Damaged or nonfunctioning instruments should not be used or processed. Contact your local Mizuho OSI sales representative or the Mizuho OSI Customer Resource Group for repair or replacement.

WARNING: Use of damaged instruments may increase the risk of tissue trauma, infection and length of operative procedures.

7.4.5 Cleaning, Disinfection, Preparation for Sterilization

Prior to each patient use - inspect, clean, disinfect and sterilize the Femoral Hook(s) and Femoral Hook Support per hospital protocol for reprocessing surgical instruments.

Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents. Use of anything other than high quality brushes designed for surgical instrument cleaning may result in damage.

Disassembly of the Femoral Hook Support before cleaning is generally not necessary unless severely soiled or dictated by hospital policy.

Do not use high acid (pH 4 or lower) or high alkaline (pH 10 or higher) products for disinfectants, such as bleach and bi-chloride of mercury.



7.4.6 Sterilization

NOTE: Mizuho OSI does not recommend the Femoral Hooks or Femoral Hook Support to be sterilized by flash or chemical sterilization.

Sterilization of the Femoral Hook(s) and Femoral Hook Support is accomplished by steam. To achieve a sterility assurance level of 10-6, Mizuho OSI recommends the sterilization parameters listed below:

Sterilization Method Temperature Containment Type Minimum Exposure

Time Range

Gravity Steam 270°F/132°C Wrapped 10 Minutes

Pre-Vacuum Steam 270°F/132°C Wrapped 4 Minutes

Gravity Steam 254°F/ 123°C Wrapped 30 Minutes

Other sterilization cycles may also be suitable. However, individuals or hospitals not using the recommended methods are advised to validate any alternative methods using current good laboratory practices (cGLP).

7.4.7 Storage

Store the Mizuho OSI Femoral Hooks and Femoral Hook Support with care to prevent damage.

Keep stored instruments on carts or shelving in a storage area free of dust, insects, chemical vapors and extreme changes in temperature and humidity.

7.4.8 Utilization

Prior to the Anterior Approach Total Hip Arthroplasty procedure, the appropriate right or left Femoral Hook and Femoral Hook Support should be cleaned, disinfected, and sterilized according to the hospital’s recommended guidelines. During the surgical procedure, the surgeon will drape the Femur Lift and place the sterile Femoral Hook Support and sterile Femoral Hook in the desired position. The height of the Femoral Hook Support is raised and lowered by depressing the Foot Pedal.

7.5 Insertion of Well Leg Support Adaptor

The Well Leg Support Adaptor attaches to the spar mount and works in conjunction with the Articulating Bracket and Well Leg Support for positioning the non-operative leg. Align end of Well Leg Support Adaptor with the appropriate spar mount on table (left or right). Slide forward until fully engaged and locked in place.



Figure 27: Well Leg Support Adaptor locked in place

Figure 28: Well Leg Support mounted on the table

7.6 Optional Patient Transfer Assembly

The hana® Patient Transfer Board is designed to work with the Removable Jack Mount Assembly to provide a large surface to aid in transferring a patient to and from the hana® Surgery Table.

Well Leg Support




CAUTION: The Patient Transfer Board is not intended to work as a surgical platform. It should be removed prior to surgery to avoid interference with operation of the spars and other equipment used during the surgery.

7.6.1 Installing the Transfer Board on the hana® Operating Table

Make sure the Removable Jack Mount Assembly is securely attached to the table (see Section 7.3).

Hold the Transfer Board by the hard plastic top and guide the long arms into the guide fins on the Removable Jack Mount Assembly.

Figure 29: Transfer Board fully installed

The Small Stop Bolt contacts the Guide Fin when the Transfer Board is fully installed

Small Stop Bolt contacts Guide Fin when Transfer Board is fully installed



Note the following:

The Transfer Board will stop when a small bolt on the bottom of the long arms contacts the front of the guide fin.

There should be a slight gap between the Transfer Board and the table top.

The pads may be slightly out of alignment when the Transfer Board is installed.

This operation may be easier if the 3-inch Tempur-Pedic® pad is temporarily removed from the Transfer Board.

7.6.2 Removing the Transfer Board from the hana® Operating Table

To remove the Transfer Board, grasp the Transfer Board by the hard plastic top and pull distally and slightly upward.

Figure 30: Grasping and pulling the Transfer Board

NOTE: This operation may be easier if the 3-inch Tempur-Pedic® pad is temporarily removed from the Transfer Board.



Figure 31: Removing the Transfer Board

The hana® Patient Transfer Board may be installed and removed with the following:

The spars on the table or off the table.

With one spar and Well Leg Support Assembly.

With or without the Femur Lift installed.

With the lateral board and Lateral Perineal Post installed.

With or without a patient on the table in any of the above setup situations.

NOTE: With a patient on the table using two spars, the spars may need to be abducted 10° to 20° each so the Transfer Board can be removed from between the spars and patient’s legs.

Small Stop Bolt



Figure 32: Patient on the table and Transfer Board ready for removal

7.7 Attaching hana® Knee Flexion System™ For Total Knee Arthroplasty

The hana® Knee Flexion System™ is designed to mount on the operative leg spar to support and position the leg as needed during Total Knee Arthroplasty (TKA). It allows for full flexion/extension of the leg and knee as well as internal/external rotation and plantar/dorsal flexion of the foot.

This device is intended to be used above the drapes in the sterile field.

To attach the Knee Flexion System™:

1. Rotate the Clamp Knob to loosen the Attachment Brackets on the Knee Flexion System™.

2. Insert the system in the Fine Traction Upright and tighten the Attachment Brackets.



Figure 33: Knee Flexion System™ being inserted in the Fine Traction

3. Place the Foot Plate on the Foot Plate Holder.

Figure 34: Foot Plate placed on the Foot Plate Holder

NOTE: Mizuho OSI's Knee Flexion System™ is supplied non-sterile. Cleaning and sterilizing of the instrument(s) are required before each use according to your hospital’s washing, decontamination, and sterilization procedures.



Figure 35: hana® Knee Flexion System™ attachment detail, spar un-draped

NOTE: Prior to draping, the fine traction must be adjusted fully towards the Foot-End of the leg spar by rotating the Traction Handle clockwise until it stops.

Figure 36: hana® Hip and Knee Arthroplasty Table set up for right TKA, spar draped

Prior to use, drape the operative side leg spar prior to attachment of the sterile Knee Flexion System™ device. Maintaining sterile technique, position the distal end base onto the post above the Gross Traction Adjustment with the clamp around the Fine Traction Upright and tighten clamp knob until secure (refer to Figure 35).

Clamp Knob

Gross Traction Adjustment Fine Traction

Upright



Figure 37: hana® Knee Flexion System™ attachment detail, spar-draped

7.7.1 How They Are Supplied

Mizuho OSI's Knee Flexion System is supplied non-sterile. Cleaning and sterilizing of the instrument(s) are required before each use according to your hospital’s washing, decontamination, and sterilization procedures.

7.7.2 Precautions

The Mizuho OSI's Knee Flexion System™ is a surgical instrument that requires special handling to prevent damage. Do not apply excessive stress or strain at the joints; misuse will result in damage. Use caution during cleaning and sterilization. The Knee Flexion System is approved for use only in combination with the Mizuho OSI hana® Surgery Table.

7.7.3 Care and Handling: Inspection

Before each use, inspect the Knee Flexion System for damage, wear, and functionality (check for nicks, burrs or bent parts).

Damaged or nonfunctioning instruments should not be used or processed. Contact your local Mizuho OSI sales representative or the Mizuho OSI Customer Resource Group for repair or replacement.

WARNING: Use of damaged instruments may increase the risk of tissue trauma, infection, and length of operative procedures.

7.7.4 Cleaning, Disinfection, Preparation for Sterilization

Prior to each patient use, inspect, clean, disinfect, and sterilize the Knee Flexion System according to the hospital’s protocol for reprocessing surgical instruments.

Do not use steel wool, wire brushes, pipe cleaners, or abrasive detergents. Use of anything other than high quality brushes designed for surgical instrument cleaning may result in damage.



Disassembly of the Knee Flexion System before cleaning is generally not necessary unless severely soiled or dictated by hospital policy.

Do not use high acid (pH 4 or lower) or high alkaline (pH 10 or higher) products for disinfectants, such as bleach and bi-chloride of mercury.

7.7.5 Sterilization

NOTE: Mizuho OSI does not recommend the Knee Flexion to be sterilized by flash or chemical sterilization.

Sterilization of the Knee Flexion is accomplished by steam. To achieve a sterility assurance level of 10-6, Mizuho OSI recommends the sterilization parameters listed below:

Sterilization Method Temperature Containment Type Minimum Exposure

Time Range

Pre-Vacuum Steam 270°F/132°C Wrapped 4 Minutes



NOTE: Other sterilization cycles may also be suitable. However, individuals or hospitals not using the recommended methods are advised to validate any alternative methods using Current Good Laboratory Practices (cGLP).

7.7.6 Storage

Store the Mizuho OSI Knee Flexion System with care to prevent damage.

Keep stored instruments on carts or shelving in a storage area free of dust, insects, chemical vapors, and extreme changes in temperature and humidity.



8 Setup of the hana® Surgery Table

CAUTION: Inspect all accessories for signs of wear or damage before installation on the table.

CAUTION: When applying safety straps, monitor patient contact points for pressure points that could cause circulatory or other impairment.

8.1 IM Femur Nailing: Unilateral Skeletal Traction

Figure 38: Patient positioned for Right IM Femur Nailing, supine, with Skeletal Traction and well leg retained in Traction Boot

Instructions provided are for suggested set-ups. Final determination of patient positioning and set-up is at the discretion of the surgeon and surgical team.

1. Ensure all four (4) Casters are in the locked position.

2. If the Patient Transfer Board is to be used, ensure the Removable Jack Mount Assembly is installed. Refer to Section 7.3.

3. Attach Radiolucent Leg Spars left & right to the table and lock in place. Refer to Section 7.1.

4. Place the Pelvic Pad onto the table. Attach Lower Leg Support to non-operative leg spar with accessory clamp and lock in place.



5. Attach optional Patient Transfer Board. Refer to Section 7.6.

6. Slide the Patient Safety Strap into place.

7. Adjust table height to appropriate position to transfer patient from the stretcher.

8. Attach appropriate Traction Boot small or large, to the patient’s non-operative foot while the patient is on the stretcher.

9. Transfer patient to the table in supine position, insert well Padded Perineal Post, move the patient to establish firm contact with the Perineal Post, and secure with Patient Safety Strap.

10. Place non-operative leg Traction Boot into traction mount on the non-operative leg spar.

11. Install Arm Board with Pad to each side of the table and position patient’s arms out to the side or attach arm board with pad to the non operative side of the table and optional cross arm support using Clark Socket to the non-operative side of the table and secure the patient’s arms.

12. Attach a pin holder (not provided) to the traction mount on the operative leg spar using the Traction Device Hook and Traction Hook Extension. Position the patient’s leg.

13. Remove Patient Transfer Assembly, sliding it out from underneath the fully positioned patient.

14. If desired, attach the Lower Leg Support to the non-operative leg spar with the accessory clamp and lock it into place.

15. Trial position the C-arm unit on the non-operative side.

16. Install the Head-End Drape Rod Assembly at the Head-End of the table and the Foot-End Drape Rod Assembly on the operative leg spar at the Foot-End of the table with hole on the outside. Adjust to the appropriate height and lock.

Figure 39: Table set up for Right IM Femur Nailing supine with skeletal traction and well leg retained in Traction Boot



Components for Femur Nailing Supine with Skeletal Traction

Radiolucent Leg Spars,

Left and Right

Pelvic Pad

Lower Leg Support

Accessory Clamp

Patient Transfer Board

Traction Boot (pair),

Large and Small

Perineal Post and Pad

Patient Safety Strap

Arm Boards with pad (2)

Cross Arm Support

Clark Socket

Traction Device Hook

Traction Hook Extender

Head-End Drape Rod

Assembly

Foot-End Drape Rod

Assembly



8.2 IM Femur Nailing: Unilateral Skin Traction

Figure 40: Patient positioned for a right IM Femur Nailing, supine, with Unilateral Skin Traction and well leg supported in leg holder


1. Ensure all (4) Casters are in the locked position.


3. Attach appropriate Radiolucent Leg Spar left or right to the table on the operative side and lock in place. Refer to Section 7.1.

4. Place Pelvic Pad onto table.


6. Slide the Patient Safety Strap into place.


8. Attach appropriate Traction Boot small or large to the patient’s operative foot while the patient is on the stretcher.

9. Transfer patient to the table in supine position, insert Padded Perineal Post, move the patient to establish firm contact with the Perineal Post and secure with Patient Safety Strap. Place boot into traction mount on leg spar,

10. Attach Well Leg Support Adaptor (refer to Section 7.5) into the Spar Mount on the non-operative side of the table and lock into position.



11. Attach Well Leg Support Assembly to the Well Leg Support Arm using Articulating Bracket and secure the patient’s leg.

12. Install Arm Board with Pad to each side of the table and position patient’s arms out to the side, or attach Arm Boards with Pad to the non-operative side of the table and optional Cross Arm Support using Clark Socket to the non-operative side of the table and secure the patient’s arms.

13. Remove Patient Transfer Board by sliding it out from underneath the fully positioned patient.

14. If desired, attach the Lower Leg Support to the leg spar with the accessory clamp and lock it into place.

15. Trial-position the C-arm unit on the non-operative side.

16. Install the Head-End Drape Rod Assembly at the Head-End of the table and the Foot-End Drape Rod Assembly on the appropriate leg spar at the Foot-End of the table with hole on the outside. Adjust to the appropriate height and lock.

Figure 41: Table set up for right IM Femur Nailing, supine, with Unilateral Skin Traction and well leg supported in Leg Holder



Components for Femur Nailing Supine with Skin Traction


Left and Right

Pelvic Pad




Large and Small




Well Leg Support Assembly

Articulating Bracket


Cross Arm Support

Clark Socket

Head-End Drape Rod

Assembly

Well Leg Support Arm



8.3 IM Femur Nailing: Lateral Decubitus Position with Bilateral Skin Traction

Figure 42: hana® Surgery Table set-up for IM Femur Nailing, patient in Lateral Decubitus position with Bilateral Skin Traction




3. Attach Radiolucent Leg Spars left & right to the table and lock in place. Refer to Section 7.1.

4. Attach the Lateral Perineal Post and Pad Assembly to the table top by sliding into position and inserting the plug into the standard Perineal Post hole on the table top.

5. Position the Patient Safety Strap in place.


7. Adjust table height to appropriate level to transfer patient from Patient Stretcher.

8. Place Traction Boots small, or large onto patient and secure while still on the Patient Stretcher.

9. Transfer patient to the table in the supine position.

10. Reposition patient into lateral decubitus position. At this time an attendant should be assigned to support the patient until patient is safely positioned.

11. Install the Lateral Perineal Post. Slide the patient toward the Foot-End of the table until firmly positioned against the Perineal Post and secure with a Patient Safety Strap.

12. Attach Well Leg Traction Boot to the Traction Mount on the operative side’s leg spar.

13. Attach the Operative Leg Traction Boot to the Traction Mount on the well side’s leg spar.



14. Install the Arm Board with Pad and optional Cross Arm Support using a Clark Socket to the side of the table and secure the patient’s arms.

15. Remove Patient Transfer Board by sliding it out from underneath the fully positioned patient.

16. Attach Lower Leg Support to the lower leg spar using an Accessory Clamp.


Figure 43: Table set-up for IM Femur Nailing, Lateral Decubitus position with Bilateral Skin Traction

Components for IM Femur Nailing, Lateral Decubitus Position with Bilateral Skin Traction


Left and Right

Lateral Perineal Post and Pad

Assembly



Lower Leg Support


Large and Small

Clark Socket

Cross Arm Support

Arm Boards with Pad (2)



Foot-End Drape Rod

Head-End Drape Rod Assembly

8.4 IM Tibia Nailing: Supine with Unilateral Skin Traction

Figure 44: Patient positioned for Right IM Tibia Nailing in supine position with Unilateral Skin Traction (optional Lateral Perineal Post and Mounting Bracket are required for this setup)



2. Ensure that the Removable Jack Mount Assembly (refer to Section 7.3) is installed. Insert the appropriate Femur Lift (right or left) to the operative side of the table. Refer to Section 7.2.

3. Plug the Femur Lift Foot Pedal into the front of the base of the table. Ensure that the Femur Lift is in its lowest position.

4. Attach appropriate Radiolucent Leg Spar (left or right) to the table and lock in place. Refer to Section 7.1.

5. Place the Pelvic Pad onto the table. Slide the Patient Safety Strap in place.


7. Adjust table height to appropriate position to transfer patient from Patient Stretcher.

8. Transfer patient to the table in a supine position and secure with Patient Safety Strap.

9. Attach Lateral Perineal Post to the traction lifter with the Lateral Perineal Post Adaptor and position patient’s leg over the Lateral Perineal Post.



10. Attach Well Leg Support Adaptor (refer to Section 7.5) into the Leg Spar Mount on the non-operative side of the table and lock into position. See section 9.2 for optional components shown in figure 45.

11. Attach Well Leg Support Assembly to the Well Leg Support Adaptor using the Articulating Bracket and secure patient’s leg.

12. Install Arm Board with Pad to each side of the table and position patient’s arms out to the side, or attach Arm Boards with Pad to the non-operative side of the table and optional Cross Arm Support using Clark Socket to the non-operative side of the table and secure the patient’s arms.

13. Remove the Patient Transfer Board by sliding it out from underneath the fully positioned patient.

14. Trial position the C-arm unit.

Figure 46: Table set up for Right IM Tibia Nailing in supine position with Unilateral Skin Traction

Components for IM Tibia Nailing, in Supine Position with Unilateral Skin Traction


Left and Right

Lateral Perineal Post and Pad

Assembly






Cross Arm Support

Clark Socket




Lateral Perineal Post Adaptor

8.5 Hip Pinning: Supine With Unilateral Skin Traction

Figure 47: Patient positioned for Right Hip Pinning, supine position with Unilateral Skin Traction and Well Leg Supported in leg holder




3. Attach appropriate Radiolucent Leg Spar (left or right) to the table and lock in place. Refer to Section 7.1.

4. Place Pelvic Pad on the table. Slide the Safety Strap in place.

5. Attach Well Leg Support Adaptor (refer to Section 7.5) into the Leg Spar Mount on the non-operative side of the table and lock into position.


7. Adjust the table height to appropriate position to transfer the patient from the stretcher.



8. Attach the appropriate Traction Boot, (small or large), to patient’s operative foot while on stretcher.

9. Transfer patient to the table in supine position, insert Padded Perineal Post, move the patient to establish firm contact with the perineal post and secure patient with Patient Safety Strap.

10. Place Operative Leg Traction Boot into traction mount on the operative leg spar.

11. Attach Well Leg Support Assembly to the Well Leg Support Adaptor using the Articulating Bracket and secure the patient’s leg.

12. Install Arm Boards with Pad to each side of the table and position patient’s arms out to the side, or attach Arm Boards with Pad to the non operative side of the table and optional Cross Arm Support using Clark Socket to the non-operative side of the table and secure the patient’s arms.

13. Remove Patient Transfer Board, sliding it out from underneath the fully positioned patient.


Figure 48: Table set up for Right Hip Pinning, supine position with Unilateral Skin Traction and well leg supported in Leg Holder

Components for Hip Pinning, supine position with Unilateral Skin Traction


Left and Right



Large and Small






Clark Socket


Foot-End Drape Rod

8.6 Hip Pinning: Supine with Bilateral Skin Traction

Figure 49: Patient positioned for Hip Pinning with Bilateral Skin Traction, supine position


1. Ensure all Casters are completely deployed.


3. Attach Radiolucent Leg Spars to the table and lock in place. Refer to Section 7.1.






7. Adjust table height to the appropriate position to transfer patient from the stretcher.

8. Attach appropriate Traction Boots small, or large to patient’s feet while on the stretcher.

9. Transfer patient to the table in supine position, insert Padded Perineal Post, move the patient to establish firm contact with perineal post and secure with Patient Safety Strap.

10. Attach Traction Boots to Leg Spar Traction Mounts and lock in place.

11. Install Arm Board with Pad to each side of the table and position the patient’s arms out to the side, or attach Arm Board with Pad to the non operative side of the table and optional Cross Arm Support using Clark Socket to the non-operative side of the table and secure the patient’s arms.


13. If desired, attach Lower Leg Support to non-operative leg spar using Accessory Clamp and lock in place.

14. Trial position the C-Arm.


Figure 50: Table set up for Hip Pinning, Supine, with Bilateral Skin Traction



Components for Hip Pinning, Supine, with Bilateral Skin Traction


Left and Right Pelvic Pad

Clark Socket

Accessory Clamp


Large and Small




Cross Arm Support


Foot-End Drape Rod




8.7 Anterior Approach Total Hip Arthroplasty

Figure 51: Patient positioned for Anterior Approach Right Total Hip Arthroplasty


NOTE: Femoral Hook Support Assembly and appropriate Femoral Hook need to be sterilized as they will be needed during the surgery. These items attach to the top of the appropriate Femur Lift. Refer to Section 7.4.


2. Ensure the Removable Jack Mount Assembly is installed. Refer to Section 7.3.

3. Ensure that the Radiolucent Leg Spars are attached to the table and locked in place. Refer to Section 7.1.


5. Plug the Femur Lift Foot Pedal into the front of the base of the table.

6. Insert the appropriate Femur Lift on the operative side of the table and attach the Coiled Hook Motor Cable. Refer to Section 7.2. Using the Foot Pedal, adjust the Femur Lift to its lowest position.




10. Attach Traction Boot (large or small) to patient’s feet while the patient is on the stretcher.

11. Transfer patient to the table in supine position.

12. Insert Padded Perineal Post. Move the patient to establish firm contact with the Perineal Post and secure with Patient Safety Strap.

13. Attach boots to the appropriate Traction Mount on the leg spars.

14. Pivot the Arm Board Bracket to the appropriate position, insert Arm Support and secure the patient’s arms.




16. If desired, attach Lower Leg Support to non-operative leg spar using Accessory Clamp and lock in place.

17. Trial position C-arm unit on non-operative side of table.

Figure 52: Using a Traction Hook Extension for patients short in stature

NOTE: If the patient is short in stature and the gross traction locking device enters the red zone, the installation and use of the Traction Hook Extension is required.

Figure 53: Table set up for Anterior Approach Right Total Hip Replacement

Traction Hook Extension

Table



Components for Anterior Approach Total Hip Replacement


Left and Right

Femur Lift Foot Pedal

Femur Lift

Traction Boots (pair)



Femoral Hooks

Femur Hook Support


Pelvic Pad

Lower Leg Support

8.8 Total Knee Arthroplasty

Figure 54: Patient positioned for Total Knee Arthroplasty




NOTE: The Knee Flexion System™ needs to be sterilized before use in surgery, (reference Section 7.7).


2. If not already in place, attach the Radiolucent Leg Spar to the operative side of the table and lock in place. Refer to Section 7.1.

3. Attach the Well Leg Support Adaptor to the non-operative side of the table and lock in place.

4. Attach the Articulating Bracket to the Well Leg Support Adaptor and tighten securely.

5. Insert the Well Leg Support Assembly into the Articulating Bracket and tighten securely.

6. Install the Lateral Perineal Post and Pad Assembly and Perineal Post and Pad for extra support if desired or use the standard pad and Perineal Post and Pad.

7. Adjust the table height to appropriate position to transfer patient from the stretcher.

8. Transfer patient to the table in supine position and place well leg in Well Leg Support Assembly. Then secure patient with Patient Safety Strap.

9. Insert Perineal Post and Pad if used.

10. Pivot the Arm Board Bracket into the appropriate position, insert Arm Support and secure the patient’s arms.

11. Drape Operative Side Radiolucent Leg Spar and attach Knee Flexion System™. Refer to Section 7.7.

12. Place operative side foot into Knee Flexion System™ and secure according to surgeon protocol.

Components for Total Knee Arthroplasty


Left and Right






Lateral Perineal Post &

Pad Assembly

hana® Knee Flexion System™ for

TKA



Figure 55: hana® Surgery Table set up for Total Knee Arthroplasty with Knee Flexion System™ foot plate located in position 2, knee 100% flexion

Figure 56: hana® Surgery Table set up for Total Knee Arthroplasty with Knee Flexion System™ foot plate located in position 1, knee at 50% flexion



Figure 57: hana® Surgery Table set up for Total Knee Arthroplasty with Knee Flexion System™ foot plate located in position 1, knee at 100% extension, by adjusting gross traction



9 Components and Accessories

9.1 hana® Surgery Table Standard Components

Standard Components

5840-44 Patient Safety Strap

6300-92 Articulating Bracket

6807-4 Hand Pendant

6850-110 Femoral Hook Support

6850-140 Classic (Left) 6850-144 Classic (Right) 6850-918 (Right) 6850-919 (Left)

Femoral Hooks (1 each)

6875-326 Table base, column and top

6875-5003 Femur Lift Foot Pedal

6875-20 hana® table cover

6875-200 Well Leg Support Adaptor

6875-230 hana® Knee Flexion System™ for TKA

6875-250 Lateral Perineal Post and Pad Assembly

6875-399 Traction Hook Extension

6875-600 Right

6875-601 Left Femur Lift

6875-264 Femur Lift Extension (2)

5855-838 Well Leg Support Assembly



6875-602 Femur Lift Emergency Handle

6875-2730

Removable Jack Mount Assembly

6875-7129 Pelvic Pad

6850-413 Perineal Post and Pad

Left: 6875-360

Right: 6875-350 Radiolucent Leg Spars (2)

6850-486 (Large)

6850-485 (Small) Traction Boot (pair)

6875-292 Arm Boards with pad (2)

6875-7120 Table pad (torso)

9.2 hana® Surgery Table Optional Fracture Kit Components

Optional Fracture Kit Components

6875-2740 Patient Transfer Board

6875-747 Head-End Drape Rod Assembly

6875-750 Foot-End Drape Rod Assembly

6850-180 Mounting Bracket Lateral Perineal Post

6850-400 Lateral Perineal Post

6850-114 Traction Device Hook



9.3 hana® Surgery Table Recommended Optional Accessories

Recommended Optional Accessories

6850-170

Lower Leg Support

5855-61

Accessory Clamp

6875-500

Equipment Cart

6850-487

Traction Boot X-large (pair)

5393

Clark Socket

5857

Cross Arm Support

5855-411

Tibial Traction Upright

6850-25

Tibial Traction Boot Adaptor

5855-345

Traction Unit

.



10 Cleaning and Maintenance

10.1 Cleaning and Disinfecting

10.1.1 Table Exterior

The exterior surface should be regularly wiped clean with a mild detergent solution and wiped dry with a soft lint-free cloth. This includes the table pad and table top.

Care should be taken to avoid exposing the table to excessive moisture. Flooding, fogging, or steam cleaning is not recommended.

CAUTION: Never pour any liquid directly onto the table. Never subject the hana® Surgery Table to an equipment washing machine.

Blood or other fluids, etc., if allowed to remain on the table for a long period of time, will require special cleaning to remove. A 5% acetic acid solution or white vinegar and water solution is especially good for this purpose.

NOTE: Use of iodophors will cause staining.

To remove staining or discoloration of plated or stainless steel surfaces, clean with a good commercial cleaning compound labeled for stainless steel and then buff the surface by hand.

To disinfect exterior surfaces, use a quaternary ammonium compound according to manufacturer's directions for use. Wipe dry with a soft lint-free cloth.

NOTE: Failure to thoroughly dry the surface after cleaning and disinfecting may result in rust.

10.1.2 Mizuho OSI® Tempur-Pedic® Medical Pads

NOTE: The Mizuho OSI Tempur-Pedic® Medical Pads should always be stored in a flat position. The pads can become stiff in cold temperatures and can crack and break if in a rolled position. It is important that you allow the pads to warm to room temperature before attempting to use or handle.

When handling a Tempur-Pedic® Medical Pad, always grasp by the entire thickness of the pad.

CAUTION: DO NOT lift, slide, or carry MIZUHO OSI Tempur-Pedic® Medical Pads by grabbing the fabric cover. The cover may tear or rip.

The pads are intended to be cleaned in place. They do not need to be rotated or removed.

Clean with standard hospital disinfectants labeled for use on table pads. Always dilute and rinse per manufacturer’s label instructions. Wipe dry with a lint-free cloth. DO NOT soak or autoclave the pads. Clean the pad on the table top and wipe dry with a lint free cloth, then reposition the pad to flat on the tabletop.

NOTE: The use of bleach or highly concentrated chemicals may discolor the cover and will void the warranty on the pad.



When cleaning the bottom of the pad or the tabletop, simply lift one end of the pad, and fold it over onto the other end. Clean the pad or the tabletop, wipe dry with a lint-free cloth, then reposition the pad to lay flat on the tabletop.

10.2 Storage

When not in use, the hana® Surgery Table should be stored in a clean, dry environment.

For information on shipping and/or storage conditions, refer to 2.8 and 2.9.

10.3 Maintenance

CAUTION: Whenever servicing the table, personnel are required to wear personal protective equipment (work jackets, leather gloves and safety glasses) whenever moving, removing, parts, components or replacing sheet metal covers.

Cleaning the table surfaces and table pad after each use will assure many years of trouble-free service.

All components are lubricated for life at the factory and no other lubrication for the table is required.

Preventative Maintenance:

Contact the Mizuho OSI Customer Group for a complete preventative maintenance checklist.

For detailed repair information or to order replacement parts, call or contact via the web the Mizuho OSI Customer Resource Group:

1-800-777-4674 (Extension 2)

Or

001-510-429-1500 (International calls)

001-510-429-8324 (Fax, Domestic and International)

[email protected]

www.mizuhosi.com

Mizuho OSI Customer Resource Group is available from 5am – 5pm Pacific Standard Time, Monday – Friday. Please leave a message at the extension after normal business hours.



11 Electrical System

11.1 Description

The electrical system provides control of all table functions and includes the following:

Power Cord

On/off Circuit Breaker Power Switch

Component Circuit Breakers

Linear Actuators

Battery System

Hand Pendant

Motion Control Module

Electric Motors

Electric motor driven lead screw-type actuators

Manipulate the Height, Lateral Roll and Trendelenburg functions are controlled by the Hand Pendant.

Input power requirement for the hana® Surgery Table

As indicated on the manufacturer’s label: 100 VAC 50/60Hz, 4 Amp 120 VAC, 60Hz, 4 Amp 230 VAC, 50Hz, 2 Amps

The input power requirement is 100 VAC 50/60Hz, 4 Amp, 120 VAC 60Hz, 4 Amp or 230 VAC 50Hz, 2 Amp, 10%/6 minute duty cycle as indicated on the serial number label. Refer to 6875 hana® Surgery Table Electrical Interconnect Diagram in Section 14.2 for details of the electrical system.

The primary components of the electrical control system are contained in the Motion Control Box at the Head-End of the table.



11.2 Power Cord

The table is equipped with a detachable Power Cord. The Power Cord is connected to the table at the power entry socket located below the ON/OFF switch, on the Motion Control Box.

Figure 58: Head-End Motion Control Box and Control Panel

WARNING: Use only Mizuho OSI supplied Power Cord.

NOTE: Country-specific Power Cords are available. Please contact your Mizuho OSI representative for proper selection.

11.3 On/Off Circuit Breaker Power Switch

An illuminated ON/OFF Power Switch and Circuit Breaker is located on the Head-End of the table. When illuminated, it indicates that the table is plugged into a live electrical AC outlet and the power is on.

NOTE: When the Power Switch is toggled ON and the table is operating under battery power, this switch will not illuminate.

This switch also serves as a Circuit Breaker. In the event of an overload condition this switch will trip off. To reset, push to the off position and then the on position.

NOTE: Determine the source of the overload prior to resetting this switch.

On/Off Power Switch Power Cord Receptacle



11.4 Component Circuit Breakers

The electrical system includes individual component 24-V DC Circuit Breakers located at the Head-End of the table. If a short circuit occurs in the low voltage circuit, the breaker will trip as indicated by a button protruding from the access hole. To reset, press the button in and release.

CAUTION: Determine the source of the overload prior to resetting this switch. If unable to determine and fix the source of failure, contact Mizuho OSI for additional support.

11.5 Linear Actuators

There are four linear actuators in the Base:

Two of the actuators are 24V motion system actuators, located in the left and right Tilt/Trendelenburg motor assembly.

The other two actuators are 24V motion system actuators, located in the height up/down motor assembly.

11.6 Battery System

The hana® Surgery Table is equipped with a battery system that provides power to all functions, and consists of two batteries ( NV0801). Due to the relatively low power consumption of the hana® Surgery Table, the table can be used on battery power for up to 12 hours at 10% duty cycle.


WARNING: This symbol indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground hospital-grade AC outlet in your operating room or facility. To protect the patient, hospital staff, and the table from possible electrical hazards, an external ground wire connection is required between the external ground stud and protective earth ground.

Battery charge status is shown via a LED on the Hand Pendant labeled “Battery Status” and in the power indicator Section of the Control Panel.

If LED illuminated green = OK.

If LED illuminated red = charge required

If a recharge is required, charging the batteries is necessary for a minimum of 3 hours. Fully discharged batteries will require 18 hours for a complete charge. To charge the batteries, simply plug the Power Cord into an appropriate hospital grade AC outlet and turn the Power Switch on. It is important to plug in the table as soon as possible after the battery status LED is illuminated red.

If the battery fails to hold a charge it should be replaced. Replace only with an identical type and size battery.



Replace both batteries at the same time.

At a minimum, the batteries should be replaced once every five (5) years.

Whenever the battery cover is opened, check the battery for signs of corrosion. The battery terminals should be clean and free from corrosion, oil, grease, dirt, or other contaminants.

Battery ordering number: NV0801.

NOTE: Failure to use an approved Mizuho OSI battery voids the warranty and can cause harm to the table.

CAUTION: Life of the batteries can be shortened if the table remains unplugged and turned on for an extended period of time with the red battery charge light illuminated. While in storage it is desirable that the table be plugged in and the Power Switch turned on so that the batteries remain charged. If this is not possible, the batteries must be charged for at least three hours per week under normal use conditions. This can be accomplished when using the table under AC power since the system batteries are automatically charged while the table is plugged in and turned on.



12 Troubleshooting


NOTE: The Power Switch must be turned off before disconnecting or connecting Hand Pendant.

Problem Solution

Table is “dead”; no functions are operational

1. Verify the Power Cord is plugged into an appropriate AC receptacle and into the Power Cord receptacle (located on table-base panel).

2. Verify the Power Switch is ON and illuminated. If the Power Switch is not illuminated, the table may still operate on internal battery power (Hand Pendant control buttons and light will be illuminated).

3. Verify the Circuit Breaker (that is part of the Power Switch located on table-base panel) is not tripped (indicating table power overload). To reset the Circuit Breaker, toggle the Power Switch OFF, and then ON.

4. Verify the Component Circuit Breakers (located on table-base panel) are not tripped (indicating component power-overload condition). Observe if the three Component Circuit Breaker buttons are protruding from Circuit Breaker access holes. Find the source of overload prior to resetting the buttons.

5. If the problem persists, call the Mizuho OSI Customer Resource Group.

1-800-777-4674, Extension 2

001-510-429-1500 (International)



Problem Solution

The table does not make any movement when Height (Up/Down), Lateral Tilt (Right/left), Tren/Reverse Tren, buttons are pressed


2. Verify the Power Switch is ON and illuminated. If the Power Switch is not illuminated, the table may still operate on internal battery power (Hand Pendant control buttons and light will be illuminated).

3. Verify that the Hand Pendant is properly connected to the Hand Pendant Receptacle. Ensure that the Hand Pendant control buttons illuminate green.

4. Press and hold the corresponding Hand Pendant buttons (Height Up/Height Down, Tren/Reverse Tren, or Lateral Tilt). Observe tabletop movement. If the table does not move when any button is pressed, try the manual control at the Control Box. If it moves, the Hand Pendant is damaged and needs to be replaced.

5. If the table is on battery power, verify that the battery is adequately charged and the green battery light illuminates.


1-800-777-4674, Extension 2


The Return to Level function is not operational


2. Press and hold the Return to Level button on the Hand Pendant. Observe tabletop movement.

3. Disorient the tabletop by doing the following:

Raise the height approximately 2 inches.

Tilt the tabletop.

Activate Trendelenburg approximately 5s.

4. Press and hold the Return to Level button on the Hand Pendant. Observe the Trendelenburg functions level first, then lateral roll functions level, and after a three-second delay, tabletop moves down to its lowest height position and is level.


1-800-777-4674, Extension 2




Problem Solution

Battery status LED illuminates red 1. The battery system requires charging. Charge batteries for minimum three (3) hours; plug Power Cord into appropriate hospital-grade AC outlet.

NOTE: Power Switch must be toggled to ON.


1-800-777-4674, Extension 2


Leg spar is loose (not securely attached to the table)

1. Verify if the Spar Lock Handle is stripped.

2. If the Spar Lock Handle needs to be replaced, call the Mizuho OSI Customer Resource Group.

1-800-777-4674, Extension 2


Leg spar is not holding vertical position (drifting downward)

1. Verify the Spar Ball Joint Lock Handle is rotated clockwise to the locked position.

2. Verify the leg spar is securely attached (fully seated and locked) to table.

3. With wear, the Spar Ball Joint Lock Handle may require adjustment to allow adequate movement to the lock position to hold the leg spar. Adjust the Spar Ball Joint Lock position as needed.


1-800-777-4674, Extension 2




13 Removal and Replacement of Components


13.1 Motion Control Module

Figure 59: The Control Panel of the Motion Control Module

1. Disconnect the Hand Pendant’s bayonet-type connector from the front panel.

2. Remove the cover of the Motion Control Module by removing four #10 screws.



Figure 60: Removing the cover of the Motion Control Module

3. Remove the two ¼-inch screws.

4. Slide the Motion Control Module away from the base about six inches.

Figure 61: Bayonet connectors

5. Disconnect the six bayonet-type electrical connectors.

CAUTION: The control box weighs between 25-40 pounds. Use proper lifting technique when removing the box.

Bayonet Connectors



6. Remove the box by lifting the handles.

Figure 62: Lift by handles to remove box

7. Remove the protective covering from bayonet electrical connectors prior to reinstallation of new unit.

13.2 Internal Batteries

WARNING: Improperly installed batteries can leak, causing equipment damage or injury. See the procedures in Section 13.2 to confirm correct installation and replacement of batteries.

WARNING: Incorrectly connected batteries can cause damage to equipment or injury. Bridging (shorting) of battery terminals can cause explosion of the battery or fire.

CAUTION: Rechargeable lead-acid batteries contain toxic materials. Batteries should be fully discharged prior to handling, or the terminals should be isolated to prevent accidental discharge.

CAUTION: Batteries should only be replaced with Mizuho OSI approved parts. Contact Mizuho OSI to obtain correct replacement batteries. Refer to Section 15 Mizuho OSI Customer Resource Group.

CAUTION: Do not attempt to connect AC power to the hana® Surgery Table until correct battery connection is confirmed.

CAUTION: Remove metal jewelry and wristwatches when in proximity to batteries.

CAUTION: Always cover at least one terminal of each battery with insulating material if connectors are removed.



CAUTION: Use caution when employing metal tools in proximity to batteries. Metal tools create circuit bridges (electrical shorts) upon contact. When possible, use tools with insulated handles and ends.

CAUTION: Never place anything on top of batteries, whether batteries are mounted or removed from the product.

NOTE: Batteries contain sulfuric acid. In the event of a leak in the battery or fire, dilute spilled fluid with water. In case of skin contact, wash areas with water. In the event of eye contact, flush eyes with water for 15 minutes and consult a physician immediately.

NOTE: Always dispose of batteries properly. Do not incinerate batteries. Do not place rechargeable 12V batteries into a metal trashcan, toolbox, drawer or parts bin.

To replace the batteries:

1. Lower the metal shrouds about half way down.

2. Raise the table up to the maximum height to access the batteries. There are two batteries, one on each side of the column.

3. Power off the table and disconnect the Power Cord.

4. Remove the covers of the batteries on both sides.

Figure 63: Removing battery covers

5. Remove the positive terminal from each battery.

Remove the screws to remove the battery covers



6. Remove the negative terminal from each battery.

7. Remove the hex nuts from battery securing bolts (on each side of each battery).

Figure 64: Removing battery securing bolt

8. Remove the hex nuts from battery securing bolts (on each side of each battery).

9. Carefully lift out each battery.

10. Clean the battery area of any corrosion, grease oil, or other contaminants.

11. Install the batteries in reverse order. When connecting the wires, connect the red wire to the positive terminal of each battery prior to installing the black wire to the negative terminal.

12. Confirm proper installation by performing the following test:

13. Verify that the Power Cord is unplugged from the power source.

14. Turn ON the main Power Switch (utilizing battery power).

15. Observe all LED lights on the Hand Pendant turn on and off sequentially.

NOTE: If the test fails, turn off the main Power Switch immediately and check if connection of battery is correct and the Hand Pendant is fully connected to the receptacle on the table. Then repeat the above test. If this does not solve the problem, contact Mizuho OSI Customer Resource Group at 1-800-777-4674 0r 001-510-429-1500 (International) for further assistance.

With batteries correctly connected, the Power Cord unplugged from the power source and the main ON/OFF Power Switch turned on, the Hand Pendant Battery Status Indicator Light will illuminate green or red.

Green battery status indicator light - Batteries are charged and installed correctly.

Red battery status indicator light - Batteries are connected correctly but are in need of charging. Charge for at least three (3) hours by plugging the Power Cord into the grounded, hospital-grade, AC outlet. Toggle the main ON/OFF Power Switch to on; the switch illuminates green, indicating power is supplied to the table. Full charge should be available after 18 hours.

Remove the hex nuts



13.3 Caster(s)

Lock all the casters.

Support the base of the table with a hydraulic lift (position the lift in the middle of the base for optimum support).

Figure 65: Placing hydraulic lift to support the base

Ensure the caster is raised half-an-inch from the ground.

Remove the four screws holding the caster and replace the damaged caster.

Figure 66: Removing the caster



14 Technical Drawings and Parts List

14.1 Replacement / Spare Parts List

DESCRIPTION PART NUMBER

Arm Board, left 6875-700

Arm Board, right 6875-701

Arm Board Pad Assembly 6875-292

Arm Board Contoured Pad (left and right) 6850-7600

Arm Board Pivot (small silver knob) 914-424

Arm Board Pivot (silver knob) 914-516

Batteries, (2 required) NV0801

Caster (4 Required) ND0451

Column Cover Base 6875-79

Column Cover Mid-low 6875-80

Column Cover Mid-high 6875-81

Column Cover Spacer Slide (16 required) 6875-87

Femur Lift Assembly, right 6875-600

Femur Lift Assembly, left 6875-601

Femur Lift Emergency Handle 6875-602

Coiled Hook Motor Cable 6875-5019

Foot Pedal 6875-5003

Hand Pendant Control 6807-4

Motion-control Module, 120VAC (per model) 6875-4007



On/off Power Switch (Circuit Breaker, 115VAC) NV0946

AC Power Receptacle NV0585

Push Button Assembly 6875-4013

Patient Leg Spar Mount Detent Housing (2 required) 6875-310

Patient Leg Spar Lock Knob Assembly (2 required) 6875-325

Traction Unit Assembly (2 required) 6875-2370



Rotation Lock Knob (traction unit) 6875-378

Traction Handle (fine traction) 6850-313

Power Cord, 120VAC NOTE: Country specific Power Cords are available. Please contact your Mizuho OSI representative for proper selection.

NV0956

Table Lift Motor (2 required)

6875-5034

Table Pad (torso) 6875-7120

Table Pad (at perineal post) 6875-7129

Table Protective Cover 6875-20

Tilt/Trendelenburg Motor (2 required) 6875-5036

Limit Switch (4 required) 6875-5042



14.2 Interconnect Diagram, 100VAC, 120VAC, 230VAC Models



15 Mizuho OSI Customer Resource Group

15.1 Contact for Parts and Service

For detailed repair information or to order replacement parts, call the Mizuho OSI Customer Resource Group: 1-800-777-4674 (Extension 2) or 001-510-429-1500 (International).

A Customer Resource Group line is available from 5 AM-5 PM Pacific Standard Time, Monday through Friday. Please leave a message after business hours.

Please state slowly your name, phone number, your facility name and city, affected equipment model number, and serial number.

An e-mail message may be left anytime at [email protected] or through the Customer Resource Group link on the web site: www.mizuhosi.com.

15.2 Instant Support Value Package

Additional technical information and documentation is available via Mizuho OSI’s subscription based instant support. Instant support is a web-based virtual support agent accessible from Mizuho OSI’s web page: www.mizuhosi.com. Instant support provides immediate and actionable answers to problems and questions on a 24/7 basis.

The Instant Support Value Package (ISVP) is a comprehensive support package designed to enhance the hospital’s internal equipment support efforts. Contact your local Mizuho OSI sales representative for subscription information and additional details of the program.

15.3 Order Replacement Parts

If unable to identify a part please call, fax or e-mail to the Customer Resource Group before placing an order. Once the part number is obtained, follow the instructions below to order replacement part.

If part is known, please telephone, fax or e-mail part number and description to Customer Resource Group for price and availability.

To place Replacement Parts (RP) order please telephone, fax or e-mail part number, description, price, customer number and method of shipment to the Customer Resource Group with purchase order. Indicate that order is for Replacement Parts (RP).

15.4 Return Damaged Parts

Identify part or part number to be returned.

Telephone, fax or e-mail the part number and description of the part for return to Customer Resource Group for Return Goods Authorization (RGA) number.

Return part with RGA number clearly marked on outside of package.

Complete the Certificate of Decontamination provided by the Mizuho OSI Customer Resource Group.



15.5 Send a Part for Repair

If unable to identify part please call, fax or e-mail to Customer Resource Group for assistance.

If part number is known, please call, fax or e-mail part number and description of problem to the Customer Resource Group for Repair Authorization (RA) number.

Clean/disinfect parts prior to shipping and complete the Certificate of Decontamination provided by the Mizuho OSI Customer Resource Group.

Ship part with RA number clearly marked on outside of package.

Part will be evaluated and customer will be contacted with the cost of repair, if not covered under table warranty.

After customer approval of repair cost, part will be repaired and returned to customer.

15.6 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.

15.7 European Community Authorized Representative

Emergo Europe

Molenstraat 15

2513 BH The Hague

The Netherlands

Tel: (31) (0) 70 345-8570

Fax: (31) (0) 70 346-7299



16 Appendix

16.1 Electromagnetic Emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The hana® Surgery Table is intended for use in the electromagnetic environment specified below. The customer or the user of the hana® Surgery Table should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The hana® Surgery Table 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

CISPR 11

Class A The hana® Surgery Table is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A (230 V)

Not applicable (100 V)

Voltage fluctuations / flicker emissions

IEC 61000-3-3

Complies (230 V)

Not applicable (100 V)



16.2 Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8kV air

± 6 kV contact

± 8kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst

IEC 61000-4-4

± 2kV for power supply lines

± 1kV for input / output lines

± 2kV for power supply lines

± 1kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles


<5% UT (>95% dip in UT) for 5 s

<5% UT (>95% dip in UT) for 0.5 cycle



<5% UT (>95% dip in UT) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the hana® Surgery Table requires continued operation during power mains interruptions, it is recommended that the hana® Surgery Table be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.



Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the hana®

Surgery Table including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=1.2

d=1.2 80 MHz to 800 MHz

d=2.3 800 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).

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 propagation is affected by absorption and

reflection from structures, objects and people.

a 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 hana® Surgery Table is used exceeds the applicable RF compliance level above, the hana® Surgery Table should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the hana® Surgery Table.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.



16.3 Recommended Separation Distances

Recommended separation distances between portable and mobile RF communications equipment and the hana® Surgery Table

The hana® Surgery Table is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the hana® Surgery Table can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the hana® Surgery Table as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency transmitter

m

150 kHz to 80 MHz

d=1.2

80 MHz to 800 MHz

d=1.2

800MHz to 2.5 GHz

d=2.3

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

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 in the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, 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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