Mizuho Osi 6875 User manual

hana

HIP AND KNEE ARTHROPLASTY

SURGERY TABLE

OWNERS MANUAL

Model 6875

This manual is written in five

languages in the following order:

 (en) English  (es) Spanish  (fr) French  (de) German  (it) Italian

MIZUHO OSI

30031 AHERN AVENUE  UNION CITY, CA 94587

Bus: 510-429-1500  Toll Free: 800-777-4674 Fax:  510-429- 85 00

WWW.MIZUHOSI.COM ·

 NEWHIPNEWS.COM · NEWSPINENEWS.COM

MIZUHOSI 2009 1 NW0508 Rev. D

TABLE OF CONTENTS

1.0 INTRODUCTION............................................................................................................................4

1.1 Important Notices ......................................................................................................................4

1.2 General Description...................................................................................................................6

1.3 Specifications ............................................................................................................................7

1.4 Shipping ....................................................................................................................................7

1.5 Storage......................................................................................................................................7

1.6 Glossary Of Terms ....................................................................................................................8

2.0 CONTROLS IDENTIFICATION...................................................................................................... 9

2.1 Table Orientation.......................................................................................................................9

2.2 Major Controls Location ............................................................................................................9

2.3 Control Panel Identification .....................................................................................................10

3.0 BASIC OPERATION ....................................................................................................................11

3.1 Control Operation ....................................................................................................................11

3.2 Caster Floor Locks ..................................................................................................................11

3.3 Moving The Table....................................................................................................................11

3.4 Hand Pendant/Control Panel Operation..................................................................................12

3.5 Leg Spars ................................................................................................................................13

4.0 INSPECTION ............................................................................................................................... 15

4.1 Acceptance And Transfer........................................................................................................15

4.2 Inspection And Transfer ........................................................................................................ 15

4.3 Pre-Procedure/Post-Procedure ...............................................................................................15

4.4 Semi-Annual............................................................................................................................15

5.0 FUNCTION CHECK ..................................................................................................................... 16

6.0 THE ELECTRICAL SYSTEM .......................................................................................................18

6.1 Description ..............................................................................................................................18

6.2 On/Off Power Switch ...............................................................................................................18

6.3 Component Circuit Breakers ...................................................................................................18

6.4 Power Cord .............................................................................................................................19

6.5 Battery System ........................................................................................................................19

6.6 Troubleshooting.......................................................................................................................20

7.0 CLEANING AND MAINTENANCE ...............................................................................................21

7.1 Cleaning And Disinfecting .......................................................................................................21

7.2 Preventative Maintenance.......................................................................................................22

8.0 SET-UP OF 6875 hana

SURGERY TABLE ...............................................................................23

8.1 Insertion And Removal Of Leg Spars – 6875-350 & 6875-360 ...............................................23

8.2 Removable Femur Jack Mount Assembly...............................................................................24

8.3 Attaching Femur Lift(s) And Femur Lift Foot Pedal 6875-600, 6875-601, 6875-19.................28

8.4 Femoral Hook Support And Femoral Hook(s) Sterilization Guidelines....................................29

8.5 Insertion Of Well Leg Support Adaptor 6875-200....................................................................32

8.6 Optional Patient Transfer Assembly Instructions For Use.......................................................33

8.7 Attaching hana

8.8 Knee Flexion Sterilization Guidelines......................................................................................35

8.9 IM Nailing Femur: Unilateral Skeletal Traction 6875 hana

8.10 IM Nailing Femur: Unilateral Skin Traction 6875 hana

8.11 IM Nailing Femur: Lateral Decubitus Position With Bilateral Skin Traction 6875 hana

Surgery Table Set-Up....................................................................................................................44

8.12 IM Nailing Tibia: Supine With Unilateral Skin Traction 6875 hana

8.13 Hip Pinning: Supine With Unilateral Skin Traction 6875 hana

8.14 Hip Pinning: Supine With Bilateral Skin Traction 6875 hana

8.15 Anterior Approach Total Hip Replacement 6875 hana

8.16 Total Knee Replacement 6875 hana

8.17 Total Knee Replacement 6875 hana

9.0 6875 hana

SURGERY TABLE COMPONENTS AND ACCESSORIES .....................................58

9.1 6875 hana

Knee Flexion System™ For TKA 6875-230..................................................34

Surgery Table Set-Up.................38

Surgery Table Set-Up ....................41

Surgery Table Set-Up...47

Surgery Table Set-Up .........49

Surgery Table Set Up................................................55

Surgery Table Set Up................................................57

Standard Components........................................................................................58

Surgery Table Set-Up ...........51

Surgery Table Set-Up ....................53

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10.0 REMOVAL AND REPLACEMENT OF COMPONENTS ............................................................63

10.1 Hand Pendant Control...........................................................................................................63

10.2 Foot Pedal .............................................................................................................................63

10.3 Motion Control Module ..........................................................................................................64

10.4 Internal Batteries ...................................................................................................................65

10.5 Table Lift Assembly ...............................................................................................................67

10.6 Tilt/Trendelenburg Assembly.................................................................................................68

10.7 Femur Lift Assembly, Left/Right ............................................................................................69

10.8 Caster(s)................................................................................................................................69

11.1 Replacement/Spare Parts List...............................................................................................70

11.2 Interconnect Diagram, 100VAC, 120VAC, 230VAC..............................................................72

12.0 TROUBLESHOOTING ...............................................................................................................73

12.1 Table Malfunction ..................................................................................................................73

12.2 Diagnostics Tree ...................................................................................................................73

13.0 MIZUHO OSI CUSTOMER RESOURCE GROUP..................................................................... 76

13.1 Contact For Parts And Service..............................................................................................76

13.2 Instant Support Value Package.............................................................................................76

13.3 To Order Replacement Parts.................................................................................................76

13.4 To Return Damaged Parts ....................................................................................................76

13.5 To Send A Part For Repair....................................................................................................77

13.6 Warranty................................................................................................................................77

13.7 European Union EC Representative .....................................................................................77

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1.0 INTRODUCTION

1.1 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.

In this manual, the WARNING symbol is intended to alert the user to the presence of important operation, maintenance, or safety instructions.

Protection Against Electrical Shock Hazard:

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 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.

WARNING:

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

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

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 physician.

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

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Disposal of Electrical Components: In accordance to the 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 Service Department at 1-800-777-4674 for further information regarding this requirement.

THIS DEVICE IS TO BE USED BY TRAINED PROFESSIONAL PERSONNEL ONLY.

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1.2 General Description

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

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 TEMPUR® used in the manufacture of MIZUHO OSI 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, MR safe and latex free. The benefits of using MIZUHO OSI Tempur-Pedic® are improved pressure management, reduced shear forces and enhanced patient comfort.

The hana® Surgery Table has three primary electrically powered functions: height up/down, left/right lateral roll and trendelenburg/reverse trendelenburg. Electromechanical actuator motors perform these motions which 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.

HEAD END

FOOT END

Manual caster floor locks

Figure 1: Mizuho OSI 6875 hana® Surgery Table, right-side view

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1.3 Specifications

 The table is designed to hold a maximum patient load of 450-pound (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 patients leg in

up to 20 degrees of adduction, 45 degrees of abduction, raise the leg to 28 degrees above level and lower 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, 50Hz or 60Hz, 120 VAC, 60Hz or 230 VAC,

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.

WARNING:

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.

1.4 Shipping

The 6875 hana

Surgery Table must be shipped using the appropriate shipping carton.

During shipment the table is to be kept in an environment within the following limits:

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

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

3. Atmospheric pressure from 50 to 110 kPa.

1.5 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 should be utilized and serves as a dust cover.

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.

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1.6 Glossary Of Terms

This glossary of terms assumes the patient is supine with their head at the head end of table (toward control panel) and their feet at the foot end of table (toward leg spars). The hand pendant functions are oriented for this position only.

AUXILIARY CONTROL PANEL is a panel of buttons and lights located on the back of the pedestal.

FOOT END OF TABLE refers to the leg spar control end of the table.

HEAD END OF TABLE refers to the end of the table where the power cord, on/off power switch, and auxiliary control panel are located; otherwise referred to as the pedestal end.

HOSPITAL GRADE AC OUTLET refers to 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 refers to the side to the patient’s left in the supine position. This also corresponds to the hand pendant button labeled left lateral roll.

LOWER THE TABLE refers to lowering the height of the table. This corresponds to the hand pendant button labeled height down.

PEDESTAL refers to the main column structure that supports the tabletop.

RAISE THE TABLE refers to raising the height of the table. This corresponds to the hand pendant button labeled height up.

RETURN TO LEVEL, OR LEVEL THE TABLE, refers to 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 refers to raising the height of the head end of the table tilting. This corresponds to the hand pendant button labeled rev.tren.

RIGHT SIDE OF THE TABLE refers to the side to the patient’s right in the supine position. This also corresponds to the hand pendant button labeled right lateral roll.

TRENDELENBURG refers to lowering the height of the head end of the table. This corresponds to the hand pendant button is labeled tren.

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2.0 CONTROLS IDENTIFICATION

2.1 Table Orientation

The major components of the 6875 hana® Surgery Table are identified below. 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.

HEAD END

FOOT END

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

2.2 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.

On/off power switch

Number/serial model

Power cord receptacle

Hand pendant

Figure 3: Head end power supply box and control panel

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2.3 Control Panel Identification

The control panel is divided into 3 sections: Section 1: Femur lift control section. Selection switch changes between right and left femur

lift operation. Indicator displays status of femur lift connection (left, right). Indicator displays status of foot pedal connection. (Indicator illuminated: Parts are connected, Indicator not illuminated: Parts not connected)

Section 2: Control pad section. The control pad and the hand pendant control table up/down, lateral tilt and trendelenburg; see section 3.4 for operation of the hand pendant and control pad.

Section 3: Power indicator section. LED indicators notify user of the following conditions when illuminated:

1. Battery condition

a. BATTERY CHARGE: Battery power low or no battery installed. b. BATTERY OK: Battery has sufficient power to operate table c. AC POWER: Indicates table is running on line (100, 120, 230 VAC) power from

wall receptacle.

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

Femur lift control

section

Control pad

section

Figure 4: Control panel

Release button

Power indicator

section

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3.0 BASIC OPERATION

3.1 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.

3.2 Caster Floor Locks

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

LOCK

Figure 5: Floor lock in the unlocked position Figure 6: Floor lock in the locked position

Location of external ground stud

UNLOCK

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.

3.3 Moving The Table

After all four (4) floor locks 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. The 6875 hana® Surgery Table is heavy and a minimum of two people should move it, one at the head end, one at the foot end, and care should be taken to control it 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 section 5.0 of this manual). If damage is discovered or the table does not pass the Function Check call your Mizuho OSI service representative.

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3.4 Hand Pendant/Control Panel Operation

The 6875 hana® Surgery Table is controlled by means of a hand pendant, alternate control, via control panel built into power supply. The hand pendant is plugged into the receptacle labeled hand pendant on the control panel (see figure 3). To activate a desired function, press and hold the appropriate button on the hand pendant until the desired position is achieved.

The hand pendant is equipped with a return to level button. This button functions to first level the lateral roll, second level the trendelenburg, third re-level lateral roll and fourth brings the table to its lowest position. A delay of 3 seconds is programmed after the leveling functions are completed before returning 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.

Height Up

Trendelenburg

Left Lateral Roll

Figure 7: hana

Height Down

Reverse Trendelenburg

Right Lateral Roll

Surgery Table 6807-4 hand pendant

Height Up

Trendelenburg

Left Lateral Roll

Height Down

Reverse Trendelenburg

Right Lateral Roll

Figure 8: Head end control panel

WARNING: When installing a hand pendant, turn the power switch off, then plug in hand pendant connector and rotate locking collar clockwise until 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.

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3.5 Leg Spars

The 6875 hana® Surgery Table is equipped with two adjustable leg spars. Each leg spar is designed to support the foot in the traction boot and allow for traction, abduction, adduction, 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.

Rotation lock

Foot rotation

Fine traction

Spar lock handle

Internal/external rotation dial

Gross traction

Figure 9: 6875 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 picture below). 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 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.

Figure 10: Spar ball joint lock/unlock loop handle of leg spar

Unlock

Lock

Loop handle

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 area of any obstructions or obstacles during table movement.

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Figure 11: 6875 hana® Surgery Table with leg spars attached & set up for bilateral anterior approach total hip replacement

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4.0 INSPECTION

4.1 Acceptance And Transfer

1. Upon receipt of your Mizuho OSI 6875 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.

2. 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.

3. Place the 6875 hana® Surgery Table in an area with at least 4 feet of clearance on all

sides.

4. Perform Function Check; see section 5.0.

4.2 Inspection And Transfer

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 local Mizuho OSI sales representative for repair or replacement.

4.3 Pre-Procedure/Post-Procedure

 Inspect and test the table as described in Function Check section 5.0.

 Thoroughly clean the table as described in the Cleaning and Maintenance section 7.0.

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.

4.4 Semi-Annual

It is recommended to perform a Preventative Maintenance (PM) check on your 6875 hana

Surgery Table (see section 7.0 Cleaning and Maintenance).

A PM checklist is available from Mizuho OSI Customer Resource Group (800-777-4674).

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5.0 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 1.6 of the manual.

1. Turn the power switch off. Plug in the hand pendant cable connector 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:

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:

3.1 Observe table battery power status light in the power indicator section of the control panel or on the hand pendant. A green light indicates the table is set for battery power operation.

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

3.1.2 If 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 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 insure sufficient charging of the battery to operate the table.

3.1.3 If red check battery light remains on after 3 hours, continue to charge battery for

up to 18 hours.

3.1.4 If green battery ok light does not illuminate after 18 hours, refer to section 6.5 of

this manual.

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

4. If the table is to be used under line power, plug 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 on. The AC power lamps on the control panel and hand pendant should illuminate.

5. Hand pendant check:

5.1 Press and hold HEIGHT UP button. Observe that the tabletop moves up.

5.2 Press and hold HEIGHT DOWN button. Observe that the tabletop moves down.

5.3 Press and hold REVERSE.TRENDELENBURG button. Foot end of tabletop becomes

lower than the head end

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5.4 Press and hold TRENDELENBURG button. Head end of tabletop becomes lower

than the foot end

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

left.

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

right.

5.7 Move tabletop out of level in both tilt and trendelenburg by 5 degrees and raise table

at least 2 inches from lowest position. Press and hold RETURN TO LEVEL button. The tabletop first levels roll and trendelenburg and then after a three-second delay, the tabletop moves down to its lowest height position. Observe that the table top is level and in its lowest height position.

6. Control panel check:

6.1 Repeat steps 5.1 through 5.7 using the control panel buttons.

7. Femur lift control and foot pedal check:

7.1 With femur lift connected with electrical connectivity, the corresponding light on the

control panel should illuminate indicating a good connection. See section 8.3 for proper installation of femur lift and foot pedal.

7.2 With femur lifts and foot pedal connected and connectivity indicator lights green,

position the control knob located in section 1 of the control panel (see figure 4) to either the left femur lift or right femur lift. Test femur lift foot pedal function for operation of the indicated femur lift. Repeat for opposite side.

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6.0 THE ELECTRICAL SYSTEM

6.1 Description

The electrical system provides control of all table functions and is comprised of a power cord, an on/off circuit-breaker switch, wire harnesses, a power supply, a controller circuit, a hand pendant, floor lock jackscrew-actuators, and various electromechanical actuators. Electric motor-driven lead-screw actuators manipulate the table height, lateral roll and trendelenburg functions. 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 11.2 for details of the electrical system.

The primary components of the electrical control system are contained in the power supply box at the head end of the table.

6.2 On/Off 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 Hospital Grade AC outlet and the power is on. (When the table is turned on using 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.

6.3 Component Circuit Breakers

The electrical system includes individual component 24-VDC 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.

WARNING: 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.

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6.4 Power Cord

The table is equipped with a detachable standard IEC power cord connector. The power cord is connected to the table at the IEC power entry socket located below the on/off switch, at the head end control panel.

On/off power switch

Power cord receptacle

Figure 12: Head end power supply box and control panel

6.5 Battery System

The 6875 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 6875 hana® Surgery Table, the table can be used on battery power for up to 12 hours at 10% duty cycle.

WARNING:

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.

On the hand pendant:

 If illuminated green = OK.  If 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.

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WARNING: Life of the batteries can be shortened if the table remains unplugged and turned on for 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.

Both batteries should be replaced every five (5) years or when they fail to hold a charge.

6.6 Troubleshooting

In the event of a table malfunction:

 Check input power, verify the power cord is plugged into a live hospital grade AC

electrical outlet.

 Verify the power switch is on; the switch illuminates green.  Check hand pendant is plugged in and lights illuminated.  Switch main power to off, wait 30 seconds and turn to on position.  Contact Mizuho OSI Customer Resource Group if table function is not restored, please

note what functions are working as well as those not working when you call (see section

13.0 of this manual for more information on Customer Resource Group).

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7.0 CLEANING AND MAINTENANCE

7.1 Cleaning And Disinfecting

NOTE: Never pour any liquid directly onto the table. Never subject the 6875 hana® Surgery Table to an equipment washing machine.

Use of iodophors will cause staining.

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.

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.

Clean with a good commercial cleaning compound, such as Stainless Steel Magic or Acme White Finish, and then buff the surface by hand to correct staining and discoloration of plated or stainless steel surfaces only.

To disinfect exterior surfaces, use a quaternary ammonium compound or similar type disinfectant 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.

Table Pad:

MIZUHO OSI

Tempur-med® Pad

IMPORTANT: The MIZUHO OSI Tempur-Pedic

pad should always be stored in a flat position. It can actually get stiff in cold temperatures and can crack and break if in a rolled position. It is important that you allow the pad to warm to room temperature before attempting to utilize or handle it.

When handling always grasp by the entire thickness of the pad.

Do not lift, slide or carry MIZUHO OSI Tempur-med

pads by grabbing the fabric. The cover

may tear or rip.

The pad is intended to be cleaned in place. It does not need to be rotated or flipped.

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

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autoclave pads. The continued use of bleach or highly concentrated chemicals will void the warranty on the cover.

When cleaning the bottom of the pad or the table top, simply lift one end of the pad, and fold it over onto the other end. Clean the pad or the table top then return to pad to flat on the table top.

7.2 Preventative Maintenance

Routine table care will assure many years of trouble-free service.

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

Preventative Maintenance: Contact OSI Technical Service for a complete preventative maintenance checklist.

For detailed repair information or to order replacement parts, call or contact via the web the OSI technical services department:

1-800-777-4674 Extension 2

techsvcs@mizuhosi.com www.mizuhosi.com

Technical services is available from 7am – 5pm PST Monday – Friday. Please leave a message at the extension after normal business hours.

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8.0 SET-UP OF 6875 hana® SURGERY TABLE

Instructions are provided for the following components to the 6875 hana® Surgery Table:

Leg spars 6875-350 Femur lift(s) and foot pedal assembly 6875-600, 6875-601, 6875-19 Femoral support and femoral hook(s) 6850-110.6850-919, 6850-918 Well leg support adaptor 6875-201 hana® Knee Flexion System™ for TKA 6875-230

8.1 Insertion And Removal Of Leg Spars – 6875-350 & 6875-360

Raise the height of the table to be able to easily access the spar mount. Insure the spar locking knob is in the unlocked position by turning counterclockwise. Prior to mounting the spar, ensure the spar ball joint handle is in the locked position. One person needs to support 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. Slide the end of the spar forward until it is fully engaged, and a defined click should be heard when spar post is inserted past the safety latch. Lock in place by turning the spar locking knob clockwise until tight. Slight movement of spar up and down while tightening knob will insure a tighter lock. While continuing to support the distal (foot) end of the spar holding the loop handle, move the spar lock handle to the unlocked position. Reposition the spar as needed and then return the spar ball joint handle to the locked position.

Spar mount

Spar

Figure 13: Mounting the leg spar

Spar locking knob

Unlock

Lock

Safety latch

Figure 14: Locking and unlocking the leg spar

To remove the spar from the table, one person should support the distal (foot) end of the spar with the loop handle and one person should turn the spar locking knob counterclockwise

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to unlock the spar. Release the safety latch by lifting it to allow the spar to be removed. Slide the spar out of the spar mount.

8.2 Removable Femur Jack Mount Assembly

WARNING: To ensure safe operation of the equipment, READ THESE INSTRUCTIONS COMPLETELY and keep this instruction sheet readily available to operating room personnel for future reference. Carefully observe and comply with all warnings, cautions and instructions placed on the equipment or described in this manual.

The 6875-730, 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 and certain fracture procedures are not required, the removable jack mount may remain on the table.

The removable jack mount is located directly underneath the foot end of the hana® Surgical Table top between the removable leg spars (figure 20).

Figure 15: Spars are not shown for clarification purposes

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Removal:

Step 1: Unplug both femur lift cables and click the plugs into its holders (figure 16). Step 2: Remove both femur lifts from the removable jack mount (figure 17).

Figure 16: Locking and unlocking the removable jack mount

NOTE: Steps 1 and 2 must be completed before moving to step 3 (figure 18).

Figure 17: Locking and unlocking the removable jack mount

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Step 3: Locate and loosen the ratchet black lever handle by rotating it counter-clockwise until loose (figure 18). The ratchet black lever handle operates by rotating it within its full range of motion, depressing the center button, pulling the lever back the opposite direction then releasing the button and rotating it within its full range of motion once again.

Figure 18: Locking and unlocking the removable jack mount

Step 4: Push the silver lock lever up towards the table top (figures 18 & 19)

Figure 19: Locking and unlocking the removable jack mount

While holding the silver lock handle, slide the entire bracket assembly to the left until the dove tail disengages (figure 20).

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Figure 20: Locking and unlocking the removable jack mount

Installation:

To reinstall the removable jack mount, place the assembly to the left of the attachment point, align the dove tail then slide the assembly from left to right until the silver lock lever drops into place (figure 18). Tighten the ratchet black lever handle by clockwise rotation until fully tightened. Do not attempt to reinstall the removable jack mount with the femur lifts attached.

WARNING: Before every use, visually inspect that the silver lock lever is fully engaged by noting the handle is pointing downwards and the ratchet black lever handle is tight (figure

18). Failure to perform these actions can result in the removable jack mount falling off while the table is being tilted and cause injury to the patient.

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8.3 Attaching Femur Lift(s) And Femur Lift Foot Pedal 6875-600, 6875-601, 6875-19

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).

Attach the right or left femur lift to the corresponding mounting bracket by sliding into the bracket and secure by turning the locking knob clockwise until hand tight.

Pull down and then pull connector out of socket

Locking knob

Power cord connector

Figure 21: Removing the power cord connector

Attach the power cord connector extending from the mounting bracket to the port on the bottom of the femur lift. Align the red dot on the power cord connector with the red dot on the receptacle, and it will snap in place when properly aligned.

To remove power connector, pull down on the metal checkered jacket of connector.

WARNING:

Failure to properly disconnect connector can damage device.

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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).

Flange

Foot pedal port

Figure 22: Plugging in the foot pedal

Below this surface

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. Depress the foot pedal, up side and observe the lift rise to its fullest height and then depress down side and observe the lift lower to its lowest position. Complete this process for both the right and left femur lifts.

8.4 Femoral Hook Support And Femoral Hook(s) Sterilization Guidelines

The femoral hook(s) (6850-919, 6850-918) and femoral hook support (6850-110) are designed for use with only the Mizuho OSI 6850 PROfx® Orthopedic Surgery Table or the Mizuho OSI 6875 hana® Surgery Table. They are utilized during the Single Incision Tissue Sparing (SITS) Anterior Approach Total Hip Arthroplasty. The hooks are imprinted with an L and R to designate left and right.

6850-918/919 Femoral hook

6850-110 Hook support

Lift

Figure 23: The femur lift is in place for use with the femoral hook support 6850-110

Proper cleaning, handling and sterilization will ensure that the femoral hook(s) and femoral hook support perform as intended.

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How supplied:

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

Contraindications:

The use of these surgical instruments is contraindicated when, in the judgment of the physician, their use would be contrary to the best interest of the patient.

Precautions:

The Mizuho OSI's femoral hook(s) 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 hook(s) are approved for use only in combination with the femoral hook support in conjunction with the Mizuho OSI 6850 PROfx® Table or Mizuho OSI 6875 hana® Surgery Table .

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 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.

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.

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