Mizuho Osi ProAxis 6988 User manual

Download

Page 1

ProAxis

Spinal Surgery Table

6988, 6988I

Owner’s Manual

This manual is supplied in the following versions:

 English (EN)  Spanish (ES)  French (FR)  German (DE)  Italian (IT)  Portuguese (PT-BR)  Japanese (JA)  Multilingual (ML)

NW0725 Rev K

MIZUHO OSI 30031 Ahern Avenue Union City, CA 94587-1234 Telephone: 510-429-1500 Outside USA: +1-510-429-1500 Toll Free: 800-777-4674 Fax: 510-429-8500

WWW.MIZUHOSI.COM NEWHIPNEWS.COM

Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Telephone: (31) (0) 70 345-8570 Fax: (31) (0) 70 346-7299

Page 2

Table of Contents

1 Important Notices ................................................................................................................ 1

1.1 Trademarks and Patents ......................................................................................................... 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 and Storage .............................................................................................................. 9

2.9 Glossary of Terms.................................................................................................................. 10

3 Component Identification .................................................................................................12

3.1 Table Orientation .................................................................................................................... 12

3.1.1 IntelliPendant

3.1.2 Cord Wrap ....................................................................................................................................... 14

3.1.3 Emergency Stop ............................................................................................................................. 14

3.1.4 Auxiliary Control Panel ................................................................ .................................................. 15

3.1.5 Advanced Control Pad System™ .................................................................................................. 15

................................................................................................................................ 14

3.2 Storage Cart ............................................................................................................................ 16

3.3 Component Part Number ...................................................................................................... 17

3.4 Model Number and Serial Number ....................................................................................... 18

4 Basic Operation .................................................................................................................19

4.1 Control Operation .................................................................................................................. 19

4.2 Emergency Stop ..................................................................................................................... 20

4.3 Auxiliary Control Panel ......................................................................................................... 20

4.4 Floor Locks ............................................................................................................................. 21

4.4.1 IntelliPendant

4.4.2 Manual Floor Lock Override .......................................................................................................... 22

Activated Floor Lock Override ............................................................................ 22

4.5 Moving the Table .................................................................................................................... 22

4.6 Torso Trolley

4.7 IntelliPendant

......................................................................................................................... 23

........................................................................................................................ 23

Page 3

4.7.1 Table Functions .............................................................................................................................. 26

4.7.2 Defined Function and Setting Symbols ........................................................................................ 27

4.7.3 Return to Level ............................................................................................................................... 30

4.7.4 Soft Keys Functions and Settings ................................................................................................ 30

4.7.5 Configuration of Table for Transport or Storage ......................................................................... 38

4.7.6 Version Info ..................................................................................................................................... 47

4.8 Independent Monitoring System (IMS) ................................................................................ 47

5 Inspection ..........................................................................................................................49

5.1 Acceptance and Transfer ...................................................................................................... 49

5.2 Pre-Procedure/Post-Procedure ............................................................................................ 49

5.3 Semi-Annual Preventative Maintenance .............................................................................. 49

5.4 Product Lifetime ..................................................................................................................... 49

6 Function Check .................................................................................................................50

7 ProAxis® Spinal Surgery Table Standard Components ..................................................54

7.1 ProAxis

7.2 ProAxis

Standard Components .......................................................................................... 54

Patient Care Kits .................................................................................................... 56

8 Setup of ProAxis® Spinal Surgery Table for Surgical Procedures .................................57

8.1 ProAxis

8.1.1 Components Used for Prone Patient Positioning ........................................................................ 79

8.2 ProAxis

8.2.1 Prone Positioning with Cervical Management Base Unit ............................................................ 82

8.2.2 Prone Patient Positioning with Cervical Traction Vector Adjustor ............................................ 91

8.2.3 Components for Prone Patient Positioning with Cervical Accessories .................................... 93

8.3 ProAxis

8.3.1 Components Used for Supine Patient Positioning .................................................................... 102

8.3.2 Supine Patient Positioning with Cervical Traction Vector Adjustor ........................................ 103

8.3.3 Components for Supine Patient Positioning with Cervical Accessories ................................. 104

8.4 ProAxis

8.4.1 Components Used for Lateral Patient Positioning .................................................................... 109

Prone Patient Positioning ..................................................................................... 59

Prone Patient Positioning with Cervical Management ...................................... 82

Supine Patient Positioning ................................................................................... 95

Lateral Patient Positioning ................................................................................. 105

9 ProAxis® Optional Accessories ...................................................................................... 110

10 Cleaning, Storage, and Maintenance ............................................................................. 112

10.1 Cleaning and Disinfecting ................................................................................................. 112

10.1.1 Table Exterior .............................................................................................................................. 112

10.1.2 ProneView

Helmet and Mirror System .................................................................................... 112

Page 4

10.1.3 Mizuho OSI Tempur-Pedic

Medical Pads ................................................................................ 113

10.2 Storage ................................................................................................................................ 113

10.3 Maintenance ....................................................................................................................... 113

11 Software Troubleshooting .............................................................................................. 115

11.1 Software Release Notes .................................................................................................... 122

11.1.1 Software Version 1.105 .............................................................................................................. 122

11.1.2 Software Version 1.110 .............................................................................................................. 123

11.1.3 Software Version 1.111 .............................................................................................................. 124

11.2 Manual Floor Lock Override ............................................................................................. 125

12 Electrical System ............................................................................................................ 127

12.1 Description ......................................................................................................................... 127

12.2 Component Identification and Function .......................................................................... 127

12.2.1 Detachable Power Cord ............................................................................................................. 127

12.2.2 Power Switch .............................................................................................................................. 127

12.2.3 Power/Charging Indicator .......................................................................................................... 127

12.2.4 Circuit Breakers .......................................................................................................................... 128

12.2.5 The Emergency Stop Button ..................................................................................................... 128

12.2.6 IntelliPendant

............................................................................................................................ 128

12.3 Battery System ................................................................................................................... 128

12.3.1 Charging the Batteries ............................................................................................................... 129

12.3.2 Replacing the Batteries .............................................................................................................. 129

12.3.3 Lithium Battery ........................................................................................................................... 133

13 Technical Support ........................................................................................................... 134

13.1 Contact for Parts and Service ........................................................................................... 134

13.2 Further Technical Information .......................................................................................... 134

13.3 Order Replacement Parts .................................................................................................. 134

13.4 Return Damaged Parts ...................................................................................................... 134

13.5 Send a Part for Repair ....................................................................................................... 135

13.6 Warranty .............................................................................................................................. 135

13.7 European Union EC Representative ................................................................. 135

14 Appendix .......................................................................................................................... 136

14.1 Electromagnetic Emissions .............................................................................................. 136

14.2 Electromagnetic Immunity ................................................................................................ 137

14.3 Recommended Separation Distances.............................................................................. 139

iii

Page 5

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Symbol

Meaning

This symbol indicates an authorized representative in the European Community.

This symbol indicates the Manufacturer of the device.

This symbol indicates the Date of manufacture.

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 must read the owner’s manual before use. This symbol indicates that you are advised to refer to the owner’s manual before use.

This symbol directs the user to follow operating instructions (related to battery safety).

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.

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 call 1-800-777-4674 within the USA or +1-510-429-1500 outside the USA.

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.

In this manual, the following symbols are used:

Page 6

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

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 represents the visual alarm signal associated with the table being overloaded.

This symbol represents an Emergency Stop.

This symbol represents the table’s Weight Limit.

This symbol indicates that a Warning exists should the Torso Trolley® Chest Tray not be locked in place on the Rail Mounts.

This symbol indicates that a Warning exists related to actions to be taken, and the owner’s manual must be read before use.

This symbol represents a Pinch Hazard.

This symbol indicates Do not touch, housing energized (related to battery safety).

This symbol indicates Warning, dangerous voltage (related to battery safety).

This symbol indicates a medical device that needs to be protected from moisture.

This symbol indicates a medical device that can be broken or damaged if not handled carefully.

This symbol indicates “This End Up”, and identifies the correct orientation for safe handling.

This symbol indicates the temperature limits to which the medical device can be exposed safely.

This symbol indicates the range of humidity to which the medical device can be exposed safely.

This symbol indicates the range of atmospheric pressure to which the medical device can be exposed safely.

Page 7

Mizuho OSI 2016

NW0725 Rev K

This symbol indicates Do Not Stack. This symbol identifies POWER OFF.

This symbol identifies POWER ON.

ProAxis® Spinal Surgery Table Owner’s Manual

Page 8

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

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/hypotension, and hypothermia.

WARNING: To avoid the risk of electric shock, this equipment must only be connected to a

supply mains with protective earth.

WARNING: The ProAxis® Table is to be used by personnel that receive training from either Mizuho OSI or from someone qualified by the medical facility to provide this training. Failure to comply with this requirement may result in damage to the table, possible injury to the patient or harm to the healthcare workers.

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 device from possible electrical hazards, an external ground wire connection is required between the external ground stud and protective earth ground when the device 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 ProAxis® Spinal Surgery Table with patients weighing more than 500 lbs (227 kg) could result in damage to the table, possible injury to the patient, or harm to the healthcare professional.

WARNING: When unlatching the spars from the Head-End of the ProAxis® Spinal Surgery Table for either storage or cleaning, do not use excessive force to unlatch the spars. If after unlocking the spar lock, the spar does not unlatch with hand force, seek assistance from qualified service personnel. Failure to properly unlatch the spars may cause harm to the healthcare professional and/or the device.

WARNING: Before and after each use, inspect the table, components and accessories for possible damage, excessive wear, or non-functioning parts. Carefully inspect all accessible areas, joints, and all moving parts for possible damage or non-function. Damaged or defective parts should not be used or processed. Contact Mizuho OSI Services for repair or replacement (refer to Section 13).

WARNING: The ProAxis® Spinal Surgery Table should not be operated in an oxygen-rich environment nor in the presence of flammable anesthetics, volatile substances, or other explosive gases, liquids, or atmospheres.

WARNING: No modification of the ProAxis® Spinal Surgery Table or its components is

Page 9

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

allowed. Any modification to the equipment may result in damage to the table, possible injury to the patient or harm to the healthcare professionals.

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.

NOTE: If the integrity of the AC power source is in doubt, the equipment shall be operated from

its internal electrical power source (battery).

NOTE: If high-frequency surgical equipment, cardiac defibrillators or cardiac defibrillator monitors

are to be used with the ProAxis® Spinal Surgery Table, refer to the instructions for use provided by the manufacturer of those devices.

1.1 Trademarks and Patents

ProAxis®, IntelliPendant®, Torso Trolley®, GentleTouch®, ShearGuard®, and Orange Aid® are registered trademarks of Mizuho OSI.

Advanced Control Pad System™ is a trademark of Mizuho OSI. DORO® is a registered trademark of pro med instruments GmbH. Mayfield® is a registered trademark of Schaerer Mayfield USA, Inc. O-arm® is a registered trademark of Medtronic, Inc. ProneView® is a registered trademark of Dupaco, Inc. Tempur-Pedic® is a registered trademark of Tempur-Pedic North America, Inc. Velcro® is a registered trademark of Velcro Industries.

Product protected by:

 US Patent Number: 8,584,281

(Other patents pending)

1.2 Disposal of Electrical Components

In accordance with the European Union Waste Electrical and Electronic Equipment (WEEE) Directive, all electrical components and batteries must be disposed of in accordance with local regulations or returned to Mizuho OSI for proper disposal. Please contact Mizuho OSI Services at 1-800-777-4674 within the USA or +1-510-429-1500 outside the USA for further information regarding this requirement.

Page 10

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Foot-End

Head-End

2 Introduction

2.1 General Description

The ProAxis® Spinal Surgery Table (Figure 1) is designed to support and position a patient undergoing surgical procedures while allowing for the articulation of the patient’s spine intra-operatively through flexion and extension movements. These intra-operative movements allow the natural movement of the spine to be replicated during the surgical procedure. The table provides prone, supine, and lateral positioning capabilities, with enhanced user and patient benefits through key proprietary features. The table’s radiolucent hinge, spars, and two-piece supine top also allow for excellent intraoperative imaging using either a C-arm or O-arm®.

The ProAxis® table has electrically powered positioning and operating functions, which are controlled by means of the IntelliPendant®. The IntelliPendant® provides a visual status display for the Floor Locks, Hinge Mode, Advanced Control Pad System™ (ACP), Battery Status, Height Status, Trendelenburg/Reverse Trendelenburg Angle, Hinge Angle, and Lateral Tilt Angle. The table provides a further feature in providing the user with the option of selecting between two Hinge Mode settings – Fixed Surgical Site (FSS) or Fixed End (FE) mode.

The table includes Mizuho OSI Tempur-Pedic® medical pad technology. The material used in the manufacture of the Mizuho OSI pads has viscoelastic properties and is temperature sensitive, becoming softer where the patient’s body makes the most contact with the surface and remaining firm in the areas where less body contact is being made. Pressure is distributed evenly over the entire surface area. The pads are radiolucent and made without natural rubber latex. The benefits of using Mizuho OSI TempurPedic® Medical Pads are improved pressure management, reduced shear forces, and enhanced patient comfort when used in ambient temperatures. In accordance with AORN recommendations, it is important to limit skin exposures to lower ambient temperatures, protect the patient by initiating passive warming interventions (e.g. applied forced-air warming systems, blankets, drapes and reflective composites), and to maintain an ambient room temperature of 20° to 25°C.

The Advanced Control Pad System™ is utilized when the patient is positioned prone. The pad control system, which is built into the table, is electronically controlled and pneumatically actuated, providing massage action and periodic pressure point stimulation through the Contoured ACP Hip Pads.

Figure 1: ProAxis® Spinal Surgery Table – Prone Patient Setup, Fixed Surgical Site Hinge Mode

Page 11

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

2.2 Intended Use

The ProAxis® Spinal Surgery Table is a mobile, dual-column, carbon-fiber hinged frame surgery table designed for temporary support (<24 hours) and positioning of a patient in a prone, supine, or lateral position. The table is intended for use during surgical procedures, including radiographic imaging during such procedures. The table is not intended for use in patient transport.

ProAxis® provides a platform designed to support and position adult and pediatric patients with body weight less than 500 pounds (227 kg) that fall within the height range of 58-81 inches (147-206 cm).

The ProAxis® system, when used with the Torso Trolley® Chest Pad and the Contoured Hip Pads, shall support patients in a prone position with minimal iliac crest to iliac crest distances of 8.0 inches (20.3 cm).

2.3 User Profile

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

2.4 Training Requirements

Before using the ProAxis® Spinal Surgery Table, the user must read this ProAxis® Spinal Surgery Table Owner’s Manual ( NW0725).

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

WARNING: Failure to ensure training prior to use of this device may cause harm to the

patient, healthcare professional, or the device.

2.5 Conditions of Use

The ProAxis® Spinal Surgery Table may be used several times throughout the day and night in medical facilities; e.g. hospitals, and outpatient surgery/imaging centers. The ProAxis® Spinal Surgery Table will be used in an operating room or other treatment room, and may be rolled between rooms. It shall not be used for patient transport.

WARNING: To maximize patient safety, do not move the table with surgical equipment in

vivo that is not free to move with the patient.

2.6 Product Lifetime

The product’s service lifetime is defined as 10 years. At the time of delivery, your product fulfills existing regulations and standards. However, despite proper use, routine inspection, prescribed service, maintenance and repairs, the product is subject to aging and wear. Therefore, Mizuho OSI cannot guarantee the product’s safety after ten (10) years and recommends your product be taken out of service. For product warranty information, refer to Section 13 of this manual.

Page 12

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

2.7 Specifications

The ProAxis® Spinal Surgery Table has the following specifications:

 The maximum patient load is 500 pounds (227 kg) in a procedural position at any point within its

physical range.

 The patient height range supported by the table is 58-81 inches (147-206 cm).  Table top width:

o The open frame used for prone positioning is 19 inches (48 cm). o The Supine Tops used for supine and lateral positioning are 21 inches (53 cm).

 Table top length is 81 inches (206 cm).  When in use, the overall length of the table is 122-138 inches (310 - 351 cm) dependent on

where the table is in its range of movements.

 The table can be configured to a length of 80 inches (204 cm) for storage (Figure 55, page 46).  Defined Home position: Height of 32 inches (81 cm) top of hinged frame to floor with a level table

top (i.e. 0° Hinge, Tilt, and Trendelenburg/Reverse Trendelenburg).

 Height Range: 20 inches – 47 inches (51 cm – 119 cm) when table top is Level.  Lateral Tilt (left/right) is 0 – 15 degrees.  Trendelenburg is 0 – 15 degrees from the Home position  Reverse Trendelenburg is 0 – 20 degrees from the Home position  Two Hinge Modes: Fixed Surgical Site (FSS), Fixed End (FE)  Hinge Angle Range: -20 to +35 degrees

o Some height adjustments may be required to achieve the maximum hinge up angle in

FSS only.

o Some height adjustments may be required to achieve the minimum hinge down angle.

 The table trapezoidal rail frame and Supine Tops are made of radiolucent carbon-fiber

construction.

 Input power requirement is 100/120V, 50/60 Hz ( 6988) or 220/240V, 50/60 Hz ( 6988I) as

indicated on the manufacturer’s label.

 As a back-up power source, the table may be operated under battery power. The expected

working life of a fully charged battery is approximately eight (8) hours with two procedures averaging six (6) minutes of motion time.

 The table is IPX4 rated per IEC 60529.  Operating environment: +50 to +86 degrees F (+10 to +30 degrees C), relative humidity 40%-70%.  Class 1 Equipment, Type B per IEC 60601-1.  The table is not suitable for use with flammable anesthetic gas mixtures.

Page 13

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

2.8 Shipping and Storage

If required to be transported, the ProAxis® Spinal Surgery Table must be transported using the appropriate shipping crate. Unpacking instructions are included with the original shipping crate.

When not in use, the ProAxis® Spinal Surgery Table should be stored in a clean, dry environment. The following conditions are required of the shipping and or storage environment:

 Ambient temperature -4°F (-20°C) to 122°F (50°C)  Relative humidity from 10% to 95%, non-condensing  Atmospheric pressure from 75 to 105 kPa

To prepare the table to be shipped or stored in a more compact configuration, utilize the IntelliPendant® and complete the steps outlined (Section 4.7.5). Transporting or storing the table in the stored configuration reduces the length of the table from 122 inches (310 cm) to 80 inches (204 cm).

When in storage, the table cover provided serves as a dust cover and should be used. The table cover can be adjusted with the Velcro® closures so it will fit the ProAxis® in the standard use table position (fully extended) or stored configuration (reduced length). Also, to ensure that the battery is always fully charged and ready for use, store the table connected to AC power that matches the ratings on the manufacturer’s label, located on the Foot-End column (Figure 10, page 18).

Page 14

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Head-End Column

The Head-End Column consists of one set of linkage arms and the base. The Power Switch, Emergency Stop Button, Auxiliary Control Panel, and port for the IntelliPendant® are located on the Head-End Column.

Head-End Frame

The Head-End Frame of the ProAxis® is the patient support structure comprised of the head board, rails and hinge components extending from the Head-End Column. The Head-End Frame is intended to support the patient’s upper torso, and therefore, the Head-End Frame Rails are shorter than the Foot-End Frame Rails.

Foot-End Column

The Foot-End Column consists of one set of linkage arms and the base. The

manufacturer’s label and the port for connecting the Advanced Control Pad System™ Tubing are located on the Foot-End Column.

Foot-End Frame

The Foot-End Frame of the ProAxis® is the patient support structure comprised of the rails extending from the hinge to the Foot-End Column. When the patient is positioned on the table, his/her lower torso and feet are oriented toward the FootEnd Column.

Retractable Center Beam

The Retractable Center Beam connects the Head-End and Foot-End Columns. The Beam retracts, allowing the table to be transported or stored in smaller configuration.

Floor Locks Unlocked

Refers to the Floor Locks being fully retracted. The button on the IntelliPendant® and the Auxiliary Control Panel used to unlock the Floor Locks is labeled .

Floor Locks Locked

Refers to the Floor Locks being fully deployed. The button on the IntelliPendant® and the Auxiliary Control Panel used to lock the Floor Locks is labeled .

Left Side of the Table

Refers to the left side of the table (as you stand at the Head-End Column and look to the Foot-End Column). The button on the IntelliPendant® and the Auxiliary Control Panel used to laterally roll (tilt) the table top to the left is labeled

Right Side of the Table

Refers to the right side of the table (as you stand at the Head-End Column and look to the Foot-End Column). The button on the IntelliPendant® and the Auxiliary

Control Panel used to laterally roll (tilt) the table top to the right is labeled .

Lower the Table

Refers to lowering the Height of the table top. The button on the IntelliPendant® and the Auxiliary Control Panel used to lower the table top is labeled .

Raise the Table

Refers to raising the Height of the table top. The button on the IntelliPendant® and the Auxiliary Control Panel used to raise the table top is labeled .

Trendelenburg

Refers to lowering the height of the Head-End of the table top relative to the FootEnd of the table top. The button on the IntelliPendant® and the Auxiliary Control

Panel used to lower the Head-End is labeled . The height of the hinge is maintained during this motion.

Reverse Trendelenburg

Refers to lowering the height of the Foot-End of the table top relative to the HeadEnd of the table top. The button on the IntelliPendant® and the Auxiliary Control

Panel used to lower the Foot-End is labeled . The height of the hinge is maintained during this motion.

Hinge Up

Refers to the frame hinging such that the table is flexed upwards. The button on

2.9 Glossary of Terms

This glossary of terms assumes that the patient is positioned prone with his or her head oriented towards Head-End Column of the table and his or her feet towards the Foot-End Column. The functions of the IntelliPendant® and Auxiliary Control Panel are oriented for this position.

Page 15

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

the IntelliPendant® and the Auxiliary Control Panel used to Hinge Up the frame is labeled .

Hinge Down

Refers to the frame hinging such that the table is flexed downwards. The button on the IntelliPendant® and the Auxiliary Control Panel used to hinge down the

table is labeled .

Advanced Control Pad System™ (ACP)

The Advanced Control Pad System™ provides user-selectable, pressure point

stimulation to the patient’s hips, thighs and chest when positioned prone. The

Contoured Hip Pads have built in cells that alternate between inflating and deflating with air.

Return to Level

Refers to the motion of the table required to return the table top to the neutral position. When the Return to Level function is activated, the Lateral Tilt Angle returns to 0 degrees; Trendelenburg / Reverse Trendelenburg Angle returns to 0 degrees and the Hinge Angle returns to 0 degrees. Following a one (1) second pause, if the button continues to be depressed, the table top will return to a height of 32 inches (81 cm) above the floor, which is defined as its Home position.

NOTE: The complete functionality of the Return to Level feature

requires either the Rail Mounts or the Supine Tops to be installed on the open frame to be operational. If either of these components is not installed, the Return to Level feature will only return the Lateral Tilt Angle to 0 degrees and the table top height to 32 inches (81 cm) above the floor.

The IntelliPendant® button used to return the table to level is labeled .

Home Position

The position of the ProAxis® when the table top is level head-to-foot and side-to side, the hinge is neutral and the height of the table top is 32 inches (81 cm) above the floor.

Fixed Surgical Site (FSS) Hinge Mode

The hinge mode of the Frame that raises and lowers the Head-End and Foot-End while maintaining the height of the hinge as it is raised or lowered. This motion approximates “fixing” the surgical site at a constant position.

When FSS Hinge Mode is selected and the Hinge Angle is positive, the symbol is visible on the display of the IntelliPendant®.

When FSS Hinge Mode is selected and the Hinge Angle is negative, the symbol is visible on the display of the IntelliPendant®.

Fixed End (FE) Hinge Mode

The hinge mode of the Frame that maintains the Head-End and Foot-End at a constant height as the hinge is raised and lowered.

When FE Hinge Mode is selected and the Hinge Angle is positive, the symbol is visible on the display of the IntelliPendant®.

When FE Hinge Mode is selected and the Hinge Angle is negative, the symbol is visible on the display of the IntelliPendant®.

Hospital Grade AC Outlet

Refers to specially designated outlets (receptacles) that include additional grounding reliability, assembly integrity, strength, and durability. A hospital grade outlet in the United States may be indicated by a green colored dot on the face of the outlet.

Page 16

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Head-End

Foot-End

Base

3 Component Identification

3.1 Table Orientation

The ProAxis® Spinal Surgery Table is described as having a Head-End and a Foot-End (Figure 2). When the components are set up and the patient is positioned, the patient’s head is oriented towards the

Head-End of the device and his/her feet are oriented towards the Foot-End of the device.

Figure 2: ProAxis® Spinal Surgery Table

The linkage arms of the columns raise, lower, and rotate when the table is in use, and may come in contact with items located on or near the table, potentially causing damage to the table or item. The base surfaces at the Head-End and Foot-End columns are not intended to be used for storage.

CAUTION: Do not place any items on the base of the Head-End or Foot-End columns or below the table. Storing or placing anything in these areas may result in damage to the device or the item being stored.

An important safety label regarding Patient Weight Capacity is also located at the Head-End of the table top (Figure 3).

Figure 3: Patient Weight Capacity Label at Head-End

Page 17

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Power Switch

Reset Button Circuit Breakers

External Ground Stud

Power Receptacle

AC Power Indicator LED

Battery Indicator LED

WARNING: Use of the ProAxis® Spinal Surgery Table with patients weighing more than 500 pounds (227 kg) could result in damage to the table, possible injury to the patient, or harm to the healthcare professionals.

The Power Switch, Battery, and AC Power Indicator LEDs, Power Receptacle, and Circuit Breakers are located on the Head-End table base.

Figure 4: ProAxis® Table Base, Head-End

The Hand Pendant, called the IntelliPendant®, the Auxiliary Control Panel, the Emergency Stop, and Cord Wrap are located on the Head-End column.

Page 18

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

IntelliPendant®

Emergency Stop

Auxiliary Control Panel

Connection Port for IntelliPendant®

Cord Wrap

Figure 5: ProAxis® Head-End Column

3.1.1 IntelliPendant

The ProAxis® Spinal Surgery Table functions are controlled by the single hand pendant referred to as the IntelliPendant® (Figure 5).

The graphical display of the IntelliPendant® provides real time information about the table’s position: Height, Trendelenburg / Reverse Trendelenburg angle, Lateral Tilt angle and Hinge angle. The IntelliPendant® also informs the user of the table’s status for Power, Hinge Motion, ACP Setting, and Floor Locks. The table’s functions and settings, which include Hinge Mode, Memory Position, Advanced Control Pad System™ Cycles, Floor Lock Override, and Storage Configuration, are managed through the use of the IntelliPendant®.

When the table is in use, the current Height is identified on the display screen in inches/centimeters. The angle of Trendelenburg/Reverse Trendelenburg, Lateral Tilt, and the Hinge is displayed in degrees. The Hinge angle displayed when the hinge is raised or lowered will range from -20 to +35 degrees as the hinge angle changes.

Detailed instructions for utilizing the IntelliPendant® are provided in Section 4.

3.1.2 Cord Wrap

A Cord Wrap is provided on the inside of the Head-End column for convenient storage of the Power Cord when not in use (Figure 5).

3.1.3 Emergency Stop

An Emergency Stop is provided on the Head-End column above the connection port for the IntelliPendant® (Figure 5). Pressing this button will immediately stop any motion of the ProAxis® Spinal Surgery Table.

Detailed instructions for utilizing the Emergency Stop are provided in Section 4.

Page 19

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Connection Port for the Advanced Control Pad System™ Tubing

Foot-End Base Not Intended for Storage

3.1.4 Auxiliary Control Panel

The Auxiliary Control Panel (Figure 5) is intended to provide a second option for controlling primary table motions and Floor Lock function. The Auxiliary Control Panel may be utilized to control table Height, Trendelenburg/Reverse Trendelenburg, Lateral Tilt, Hinge motion, and Floor Lock operation.

NOTE: Should the IntelliPendant

stop functioning, the Auxiliary Control Panel will allow the user to

execute the basic motions of the table and lock/unlock the Floor Locks.

Detailed instructions for utilizing the Auxiliary Control Panel are provided in Section 4, Basic Operation.

3.1.5 Advanced Control Pad System™

The Advanced Control Pad System™ Connection Port is located on the Foot-End column (Figure 6). Detailed instructions for utilizing the Advanced Control Pad System™ are provided in Section 4.

Figure 6: ProAxis® Foot-End Column

Page 20

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Chest Pad

Cervical Management Base Unit and Adaptor

5-Way Articulating Arm Boards (2) Chest Tray

Cervical Traction Adjustor Vector

Rail Mounts (2)

2-inch Tempur-Pedic® Supine Top Pad

3.2 Storage Cart

A Storage Cart is provided for ease of storing the table’s standard components and optional accessories when not in use. The silhouettes on the Cart provide guidance on where each component or accessory should be stored. The front side of the Cart is primarily dedicated to the storage of standard components (Figure 7), while the back side of the Cart is designed for the storage of most optional accessories (Figure 8).

Figure 7: Front Side of Storage Cart

NOTE: Ensure the Chest Tray is stored as shown within the ledge of the Cart to prevent damage to

the pieces of the component when removing or handling.

Page 21

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

ProneView® Mirror and Helmet

Lateral Positioners

Lateral Arm Board

Pivoting Arm Boards (2)

Supine Tops

Cervical Chest Tray Hip Pads (2)

Cross Arm Support

Safety Straps and Adaptors

3.3 Component Part Number

Each standard component of the ProAxis® Spinal Surgery Table is identified and labeled with its respective part number.

Figure 8: Back Side of Storage Cart

Figure 9: ProAxis® Component Label

Page 22

Mizuho OSI 2016

NW0725 Rev K

3.4 Model Number and Serial Number

Manufacturer’s

Label

ProAxis® Spinal Surgery Table Owner’s Manual

Figure 10: ProAxis® Foot-End Column

In addition to the product number and serial number, the following information is provided on the manufacturer’s label:

Figure 11: Manufacturer’s Label, Examples

NOTE: Additional product information may also be found on the label.

Page 23

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

4 Basic Operation

4.1 Control Operation

For use with AC power:

1. Plug the Power Cord into a properly grounded receptacle. Refer to the manufacturer’s label at the Foot-End column for input voltage requirements (Figure 10, page 18).

NOTE: Only use the Power Cord supplied by Mizuho OSI with the table or if necessary, one of

equivalent rating.

2. Depress the Power Switch and observe that the switch illuminates with a green ring indicating that power is applied to the table.

3. If the AC power cable is not connected to an outlet with a protective earth ground, then the external ground stud should be connected to a protective earth ground (Figure 4, page 13).

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 or when the table is in use under battery power. Failure to ensure ground may cause harm to the patient, healthcare professionals, or the device.

NOTE: If the integrity of the AC power source is in doubt, the equipment shall be operated from its

internal electrical power source (battery).

Should the table be operated on battery power:

1. Ensure that the battery has been properly charged as outlined in Section 12.3. Depress the Power Switch and observe that the switch illuminates with a green ring indicating that power is applied to the table. The battery LED at the base of the Head-End column will not be illuminated, indicating that the table is being used on battery power (Figure 4, page 13).

2. The battery status symbol on the screen of the IntelliPendant® indicates the level of charge in the batteries. If the battery status symbol with one green bar appears , the

battery is not charged and the table should only be used with AC power.

WARNING: Failure to ensure the table is properly charged when used on battery power may

cause the table to malfunction and may harm the patient, healthcare professional and the table.

3. To protect the patient, hospital staff, and the table from possible electrical hazards, an external ground cable connection is required between the external ground stud and protective earth ground when the table is in use under battery power (Figure 4, page 13).

The expected working life of a fully charged battery is approximately eight (8) hours with two procedures averaging a total of six (6) minutes of motion time. While in storage, it is recommended that the table be plugged in to charge the battery. A fully depleted battery will take 24 hours to fully charge. This can be accomplished when using the table under AC power.

If during use, the battery symbol on the IntelliPendant® appears , the table should be connected to AC power, and it can continue to be utilized while the battery is charging.

Page 24

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Graphical Display of Emergency Stop

4.2 Emergency Stop

To immediately interrupt the motion of the ProAxis® Spinal Surgery Table, press the Emergency Stop button located on the side of the Head-End column (Figure 12). The IntelliPendant® will display if the

Emergency Stop is engaged (Figure 14), and the IntelliPendant® will vibrate. No further table functions will be allowed until the Emergency Stop is reset. To reset the table, turn the Emergency Stop button in the direction of the arrows until it returns to the original position (Figure 13).

Figure 12: Activating Emergency Stop Figure 13: Reset Emergency Stop

Figure 14: Emergency Stop Display on the IntelliPendant®

4.3 Auxiliary Control Panel

The Auxiliary Control Panel provides function and motion buttons labeled with symbols identifying what function or motion can be achieved (Figure 15, page 21). The motion buttons control the Height, Trendelenburg/Reverse Trendelenburg, Lateral Tilt Right/Left, Hinge Up/Down, and Return to Level. The two (2) function buttons control the table’s Floor Lock/Unlock capabilities.

A green Light Emitting Diode (LED) illuminates on the face of the Auxiliary Control Panel when the Floor Locks are fully deployed and locked, when the table frame has returned to a level position, and when the table is prepared for storage.

In order for the motion buttons on the Auxiliary Control Panel to function, the Floor Locks must be fully deployed. To lock the Floor Locks, press the Floor Lock button on the Auxiliary Control Panel or the IntelliPendant®. Confirm the Floor Locks are engaged by observing that the Floor Lock LED illuminates green and the Floor Lock symbol is visible on the IntelliPendant®.

Page 25

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Return to Level

Height Down Reverse Trendelenburg Lateral Tilt, Right Hinge Down

Unlock Floor Locks

Level LED

Height Up Trendelenburg Lateral Tilt, Left

Hinge Up Floor Locks

Locked LED

Lock Floor Locks

Storage Status LED

To utilize the Auxiliary Control Panel, press and hold a button until the desired motion is achieved. A display on the IntelliPendant® will show the symbol of the motion button when it is activated (Figure 23, page 26).

4.4 Floor Locks

When the ProAxis® Spinal Surgery Table is powered on, the Floor Locks will automatically return to their previous state of being either fully deployed (locked) or fully retracted (unlocked).

To lock the Floor Locks via the IntelliPendant® or the Auxiliary Control Panel, press the Floor Lock button once and release to deploy the Locks (Figure 16). The IntelliPendant® will display when the Floor Locks are fully deployed and locked (Figure 22, page 25). On the Auxiliary Control Panel, the Floor Lock LED will illuminate (Figure 15). To unlock the Floor Locks via the IntelliPendant® or the Auxiliary Control Panel, press

the Floor Unlock button once to completely retract the Floor Locks (Figure 17). The IntelliPendant® will display when the Floor Locks are fully retracted and unlocked (Figure 21, page 25). It will take

approximately 10 to 15 seconds for the Floor Locks to change position.

Figure 16: Floor Lock Deployed (Locked) Figure 17: Floor Lock Retracted (Unlocked)

NOTE: The ProAxis

symbol is visible on the IntelliPendant® display.

Figure 15: Auxiliary Control Panel

table will not function until the Floor Locks are completely deployed and the

Page 26

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

4.4.1 IntelliPendant

Activated Floor Lock Override

If the Floor Lock systems fail during table use such that powered table motion is prevented, the IntelliPendant® can be used to activate the Floor Lock Override function (see Section 4.7.4.4, page 35). Use of the Floor Lock Override function will allow for 60 seconds of activity during which multiple actions can be taken.

NOTE: Should a particular motion take longer than 60 seconds, the action will be completed as

long as the function button continues to be depressed.

NOTE: The Floor Lock Override function allows for changes to Height, Trendelenburg/Reverse

Trendelenburg, Lateral Roll, Hinge, and Return to Level functions via the Hand Pendant and is intended for use in emergency situations only.

4.4.2 Manual Floor Lock Override

In the event the table’s floor locks do not retract properly to allow for table transport, the Floor Locks can be manually raised or lowered (see Section 0).

NOTE: The manual floor lock override is intended only as a means of transporting the table should

the Floor Lock systems fail. Use of this override will not allow the user to activate any of the table functions.

4.5 Moving the Table

Before moving the ProAxis® Spinal Surgery Table or preparing it for its storage sequence of movements, ensure the table is returned to its Home position such that it is neutral and at a maximum height of 32 inches (81 cm).

CAUTION: When moving the ProAxis® Spinal Surgery Table in its normal configuration,

ensure that the table is at a height no greater than its home position of 32 inches (81 cm) and in a neutral state with the IntelliPendant® reading 0º for Lateral Roll, Trendelenburg/Reverse

Trendelenburg and Hinge to prevent the table from being unstable during relocation.

After all four (4) Floor Locks are unlocked, the table can be rolled for relocation. The ProAxis® Spinal Surgery Table is heavy, and a minimum of two people is required to move it. Position one person at the Head-End of the table and one person at the Foot-End. Care should be taken to control the ProAxis® when rolling it.

CAUTION: If the ProAxis® Spinal Surgery Table is allowed to roll too fast, it may be difficult to stop or turn. Impact of the table with a stationary object may cause serious damage to the table or the other object. If an impact does occur the table must be visually inspected for damage, and a Function Check must be performed (refer to Section 6). If damage is discovered or the table does not successfully complete the Function Check, call Mizuho OSI Services (refer to Section 13).

NOTE: For easier moving and storage, the ProAxis

to its retracted position of 80 inches (203 cm) (see Section 4.7.5).

Spinal Surgery Table may also be configured

Page 27

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Motion Buttons:

Return to Level (Home)

Height Up/Height Down

Trendelenburg / Reverse Trendelenburg

Lateral Tilt Left / Right

Hinge Up/Hinge Down

Graphical Display

Dynamic Soft Keys

Function Buttons:

Floor Lock Floor Unlock

Soft Key Function Display

4.6 Torso Trolley

The Torso Trolley® is designed to support the patient and simultaneously move the prone patient’s upper torso in conjunction with the hinge angle being changed, preventing any spinal compression or distraction.

The Torso Trolley® is formed by utilizing the Chest Tray to which the chest pad is mounted. The 5-Way Adjustable Arm Boards are also mounted to the Chest Tray utilizing the Arm Board Brackets provided. Refer to Section 8 for detailed instructions on the setup and use of the Torso Trolley®.

4.7 IntelliPendant

The ProAxis® Spinal Surgery Table functions are controlled by the IntelliPendant®. When the table is in use, the display screen provides the user with detailed real time information as to the status of each motion or function. This includes specific data on the table’s position including Height, Trendelenburg/Reverse Trendelenburg Angles, Lateral Tilt Angle, and Hinge Angle. To activate a function or motion, a button must be pressed and held until the function is complete or the desired position is achieved. The IntelliPendant

also provides important information about the system’s operational state, including Power status, Hinge Motion, Advanced Control Pad setting, and Floor Lock status (Figure 18).

Utilizing the Soft Keys allows the user to access and select the following functions and settings: Hinge Mode, Memory Position, Advanced Control Pad System™ Cycles, and Floor Lock Override (Figure 18).

Figure 18: IntelliPendant®

Page 28

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

The IntelliPendant® also provides haptic feedback to the user when a requested action is not possible. This may occur under the following conditions:

 Floor Locks are Unlocked and must be engaged before continuing.  The maximum range of a particular motion has been reached.  A system error has occurred.

A visual indication of the constrained movement will also be displayed on the IntelliPendant® screen informing the user of the table’s state. For instances where a particular table function has reached its limit, the image depicted on the screen will show the location of the error or limit through the use of an orange circle (see Section 4.7.2).

To connect:

1. Align the pins with the port located at the Head-End column of the table (Figure 19). Insert until the locking collar clicks, securing the pins in the port.

Figure 19: Connecting the IntelliPendant®

NOTE: Only connect the IntelliPendant

supplied with the ProAxis® Spinal Surgery Table to the

IntelliPendant® port.

2. The IntelliPendant® should remain connected and be stored on the hand pendant clip on the Head-End column when not in use (Figure 5, page 14).

Press the Power Switch on the Head-End base once the IntelliPendant® has been connected. A green ring will illuminate around the switch confirming power is applied to the table (Figure 4, page 13). The Graphical Display that appears when the ProAxis® table is turned on is identified as the IntelliPendant® screen (Figure 20).

Page 29

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Floor Lock Status Icon

Figure 20: IntelliPendant® Screen at Start-Up

The Floor Locks must be fully deployed for the IntelliPendant® or Auxiliary Control Panel motion buttons to function. To lock the Floor Locks, press the Floor Lock button once on the IntelliPendant® or the Auxiliary Control Panel and confirm the Floor Lock symbol is visible on the IntelliPendant®, indicating the Floor Locks have been engaged (Figure 22).

Figure 21: Unlocked Floor Locks Symbol Figure 22: Locked Floor Locks Symbol

Page 30

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Graphical Display of Function

4.7.1 Table Functions

When in use, the table’s position at any given time is identified on the IntelliPendant® (Figure 18, page 23) as follows:

 Height reported in inches/centimeters  Angle of Trendelenburg/Reverse Trendelenburg reported in degrees  Angle of Lateral Tilt reported in degrees  Angle of the Hinge reported in degrees

The function being executed is also reflected on the IntelliPendant® screen, informing the user of the action taking place (Figures 23 and 24).

Figure 23: Hinge Up Action Displayed Figure 24: Hinge Down Action Displayed

Page 31

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Symbol

Meaning

Height Up

Height Down

Trendelenburg

Reverse Trendelenburg

Lateral Tilt, Right

Lateral Tilt, Left

Hinge Up

Hinge Down

Lock (Floor Locks) and Locked Position

Unlock (Floor Locks) and Unlocked Position

Half-lock Position; indicates the transitional stage of the Floor Locks while they are in the process of being either locked or unlocked

Lock Error; indicates the Floor Locks must be locked before executing any table function

Represents Return to Level on function button, also appears on the screen display to indicate height position

ACP ON/OFF Function

Save to Memory Position

Go to Memory Position

Cancel

Accept / Select

4.7.2 Defined Function and Setting Symbols

The following symbols are utilized on the function buttons of the IntelliPendant®, the Auxiliary Control Panel, or on the display screen itself when in use.

Page 32

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Advanced Control Pad Cycle, Fast

Advanced Control Pad Cycle, Slow

Fixed End Hinge Mode, Hinge Up

Fixed End Hinge Mode, Hinge Down

Fixed Surgical Site Hinge Mode, Hinge Up

Fixed Surgical Site Hinge Mode, Hinge Down

Home (Return to Level) Position Achieved

Floor Lock Override

Indicates the system is running on battery power or AC power, and the battery voltage meets or exceeds the 100% charged threshold

Indicates the system is running on battery power, and the battery voltage exceeds the 75% threshold but not the 100% threshold

Indicates the system is running on battery power, and the battery voltage exceeds the 50% threshold but not the 75% threshold

Indicates the system is running on battery power, and the battery voltage is below the 50% threshold. Requires Charging and AC Power Connection

Battery Charging

AC Power Connected

Displayed when user has saved the current position as M1, or when the table has arrived at the stored position M1

Displayed when user has saved the current position as M2, or when the table has arrived at the stored position M2

Indicates that the requested motion would exceed a boundary for height up, hinge angle increase, or Trendelenburg angle increase

Indicates that the requested motion would exceed a boundary for height down, hinge angle decrease, or Trendelenburg angle decrease

Indicates that the requested left tilt motion would exceed a boundary

Indicates that the requested right tilt motion would exceed a boundary

Appears when a “hinge up” button is held, and the maximum hinge angle has been reached

Appears when a “hinge up” button is held, and a boundary has been reached

Page 33

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Appears when a “hinge down” button is held, and a boundary has been reached

Appears when a “height up” button is held, and a boundary has been reached

Appears when a “height down” or “home” button is held, and a boundary has been reached

Appears when a “Trendelenburg” button is held, and a boundary has been reached

Appears when a “Reverse Trendelenburg” button is held, and a boundary has been reached

Appears when a “Lateral Roll Right” button is held, and a boundary has been reached

Appears when a “Lateral Roll Left” button is held, and a boundary has been reached

Appears when an upward hinge motion is requested, and hinge lockout is in effect (due to the hinge enable cables on Torso Trolley® or supine top not being plugged in)

Note that hinge and memory buttons can do this.

Appears when a downward hinge motion is requested, and hinge lockout is in effect (due to the hinge enable cables on Torso Trolley® or supine top not being plugged in)

Note that hinge and memory buttons can do this.

Appears when the Emergency Stop is enabled

Page 34

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Menu Function

ACP On/Off

Save To Memory Position

Go To Memory Position

Graphical Display of Function

4.7.3 Return to Level

The IntelliPendant® is equipped with a Return to Level button that allows the table to be returned to a neutral position from any current state. When the Return to Level function is activated, the Lateral Tilt Angle returns to 0 degrees, Trendelenburg/Reverse Trendelenburg Angle returns to 0 degrees, and the Hinge Angle returns to 0 degrees. Following a one (1) second pause, if the button continues to be depressed, the table top will return to a height of 32 inches (81 cm) above the floor, which is defined as its Home position.

NOTE: The complete functionality of the Return to Level feature requires either the Rail Mounts or

the Supine Tops to be installed on the open frame to be operational. If neither of these components is installed, the Return to Level feature will only return the Lateral Tilt Angle to 0 degrees and the table top height to 32 inches (81 cm) above the floor. This is intended to prevent unintentional traction via the automatic return of Trendelenburg/Reverse Trendelenburg to neutral when using Cervical Management. The Hinge capability is not enabled when neither Rail Mounts nor the Supine Tops are installed.

Figure 25: Display when Return to Level Function is Completed

4.7.4 Soft Keys Functions and Settings

To control system functions and settings, the Soft Keys corresponding to the icons at the bottom of the screen are utilized (Figure 26).

Figure 26: Soft Key Selections

Page 35

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Pressing the Menu Key provides the user with a list of setting choices for the table, which may be selected and customized as needed for each procedure (Figure 27).

Figure 27: Menu Key Selections

4.7.4.1 Memory Positioning

The ProAxis® Spinal Surgery Table has the ability to store two specified table positions in memory for ease of returning to the desired position at a later time. The table positions can be stored to either Memory Position 1 or Memory Position 2.

Assignment of the table position to memory is completed through the use of the IntelliPendant®.

To assign the table’s current position to a memory position:

1. From the Home Screen, select the Save to Memory Position using the corresponding Soft Key (Figure 26).

2. Assign the table position to either the Memory Position 1 or Memory Position 2 location (Figure 28).

Figure 28: Memory Position Selection

3. The table position is now saved.

Page 36

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Up / Down Arrows

Check Mark

Hinge Mode Options

To move the table from its current position to a saved memory position:

1. From the Home Screen, select the Go To Memory Position using the corresponding Soft Key (Figure 26).

2. Press and hold the Soft Key corresponding to either Memory Position 1 or Memory Position 2 to move to the desired location.

NOTE: If the hinge capability is not enabled (see Section 8 for setup instructions) and the desired

Memory Position requires a change in hinge angle, the selection of Memory Positions will not provide the desired motion to the stored position requested.

4.7.4.2 Hinge Mode

The ProAxis® Spinal Surgery Table has two operating modes for the hinged frame, Fixed Surgical Site (FSS) or Fixed End (FE), which can be selected depending on the surgeon’s preference for positioning the patient.

FSS mode is designed to ensure the height of the top at the hinge remains constant when the hinge is flexed or extended. This is accomplished through the simultaneous motions of the Head-End and FootEnd of the table. This mode is utilized primarily for prone patient positioning.

FE mode is designed to ensure the height of the Head-End and Foot-End of the table top remains at a constant height when the hinge is flexed or extended. This mode is utilized primarily for lateral patient positioning.

NOTE: For the hinge of the frame to be operational, the Rail Mounts or the Supine Top, Head-End

needs to be installed and the cables connected. Refer to Section 8 for setup instructions.

Selection of the hinge mode is completed through the use of the IntelliPendant®.

To activate the desired Hinge Mode:

1. Press the Menu Soft Key on the IntelliPendant® and observe that the Set Hinge Mode setting is selected (Figure 27).

2. Upon confirming that Set Hinge Mode is highlighted, press the Soft Key that corresponds to the check mark.

3. Utilize the arrow Soft Keys to highlight the FSS or FE mode, and press the check mark Soft Key to select the desired hinge mode (Figure 29).

Figure 29: Hinge Mode Selection

Page 37

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

FE Mode Icon

FSS Mode Icon

4. Selection of the desired hinge mode can be visually confirmed through the corresponding symbol depicted on the IntelliPendant® display (Figures 30 and 31).

Figure 30: FSS Mode, Positive Hinge Angle Figure 31: FE Mode, Negative Hinge Angle

4.7.4.3 Advanced Control Pad System™ (ACP)

The ProAxis® provides the Advanced Control Pad System™ (ACP) for use when the patient is positioned prone. The ProAxis® Contoured ACP Hip Pads, the Bilateral Winged ACP Chest Pad, and the Flat ACP Chest Pad are designed specifically with Tempur-Pedic® medical material and air cells within the pads. The cells inflate and deflate at selectable intervals providing massage action and periodic pressure point stimulation to the patient’s chest, hips, and thighs when positioned prone. At the discretion of the surgeon, the pads can also be used for patient support on the ProAxis® without the massage action being activated.

The ProAxis® Spinal Surgery Table has two speed settings, Fast and Slow, for the ACP System.

 The Fast Cycle, alternates inflation and deflation of the air cells every four (4) seconds. The

Fast Cycle is represented with the symbol.

 The Slow Cycle, alternates inflation and deflation of the air cells every six (6) seconds. The

Slow Cycle is represented with the symbol.

NOTE: Selection of the ACP System cycle is at the discretion of the surgeon.

Selection of the ACP System cycle is completed through the use of the IntelliPendant®.

To activate the ACP System:

1. Press the Menu Soft Key on the IntelliPendant®.

2. Utilize the Down arrow Soft Key to select Set ACP Mode (Figure 32). Press the Soft Key that corresponds to the check mark.

Page 38

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Up / Down Arrows

ACP Cycle Options

Check Mark

Figure 32: Set ACP Mode Selection

3. Utilize the Up or Down arrow Soft Keys to highlight either the Fast Cycle or Slow Cycle, and press the check mark Soft Key to select the desired speed (Figure 33).

4. Return to the Main IntelliPendant® Screen (Figure 26, page 30) and press the ACP Soft Key to activate.

NOTE: The ACP system will not function if the ACP function is not selected on the main screen of

the IntelliPendant®.

5. Selection of the desired ACP setting can be visually confirmed through the corresponding symbol depicted on the IntelliPendant® display (Figures 34 and 35).

a. The Fast Cycle is represented with the symbol (1 cycle every four (4) seconds). b. The Slow Cycle is represented with the symbol (1 cycle every six (6) seconds).

NOTE: If the ACP system has not been selected, no symbol will appear on the screen, indicating

the ACP function is not in use.

Figure 33: ACP Cycle Selection

Page 39

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Slow ACP Icon

Fast ACP Icon

Figure 34: Fast ACP Cycle Selected Figure 35: Slow ACP Cycle Selected

4.7.4.4 Floor Lock Override

To allow for the use of the Floor Lock Override functionality:

1. Press the Menu Soft Key on the IntelliPendant®.

2. Utilize the Down arrow Soft Key to select the Override Floor Locks option (Figure 36).

3. Upon confirming that Override Floor Lock is highlighted, press the Soft Key that corresponds to the check mark.

Figure 36: Override Floor Locks Selection

4. Utilize the Down arrow Soft Key to select the Override mode (Figure 37).

5. Upon confirming that the Override Floor Lock mode Override is highlighted, press the check mark Soft Key (Figure 37). The Override functionality will now be enabled.

Page 40

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 37: Floor Lock Override Screen

6. Press the appropriate motion button on the IntelliPendant® to achieve the desired table motion. The Floor Lock Override capability will allow for 60 seconds of activity during which multiple actions can be taken. Should a desired motion take longer than 60 seconds, the action will be completed as long as the motion button continues to be depressed.

7. Should additional time be required beyond the 60 seconds to complete an additional function or if the motion button has been released once the 60 seconds have elapsed, the Floor Lock Override capability will have to be activated starting with Step 1 above.

NOTE: The Floor Lock Override function allows for changes to Height, Trendelenburg/Reverse

Trendelenburg, Lateral Roll, Hinge, and Return to Level motions via the Hand Pendant and is intended for use in emergency situations only.

4.7.4.5 Language Selection

To select the preferred language display for the IntelliPendant®:

1. Press the Menu Soft Key on the IntelliPendant®.

2. Utilize the Down arrow Soft Key to select Set Language (Figure 38). Press the Soft Key that corresponds to the check mark.

Figure 38: Set Language Selection

Page 41

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

3. Utilize the arrow Soft Keys to highlight the desired language, and press the check mark Soft Key to set the language mode (Figure 39).

Figure 39: Language Selection Menu

NOTE: The language setting is preserved when the table is powered off.

4.7.4.6 Display Units Selection

To select the preferred units display for the IntelliPendant®:

1. Press the Menu Soft Key on the IntelliPendant®.

2. Utilize the Down arrow Soft Key to select Set Units (Figure 40). Press the Soft Key that corresponds to the check mark.

Figure 40: Set Units Selection

3. Utilize the arrow Soft Keys to highlight the desired units, and press the check mark Soft Key to set the units mode (Figure 41).

Page 42

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 41: Units Selection Menu

NOTE: The units setting is preserved when the table is powered off.

4.7.5 Configuration of Table for Transport or Storage

The ProAxis® table can be configured to a smaller footprint for transport or storage. To prepare the table to be shipped or stored in a more compact configuration, utilize the IntelliPendant® and complete the steps outlined. Transporting or storing the table in the stored configuration reduces the length of the table from 122 inches (310 cm) to 80 inches (204 cm).

NOTE: Do not attempt to disconnect the spars from their connection point without performing the

exact procedure described below.

WARNING: Failure to properly disconnect the spars using the process below may cause

injury to the healthcare professional and/or damage to the table.

To configure the table to its stored position:

1. Press the Menu Soft Key on the IntelliPendant®.

2. Utilize the Down arrow Soft Key to select Store Table (Figure 42). Press the Soft Key that corresponds to the check mark.

Figure 42: Store Table Screen

Page 43

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

NOTE: If the ProAxis

Table is under too much load such that it is unsafe to disconnect the spars, a blue warning screen identifying an “ERROR” will appear on the IntelliPendant® and the user will not be able to proceed with the storage sequence (Figure 43).

Figure 43: Store Table Screen

WARNING: Attempting to disconnect the spars when this “ERROR” message appears may

cause injury to the healthcare professional and/or damage to the table.

3. Following the instructions depicted on the IntelliPendant®, complete the following steps to configure the table to its stored position.

a. STEP 1: Remove any components and accessories attached to the table (Figure 44).

If the Supine Top or Chest Tray is detected, the user will be notified via the IntelliPendant® screen.

Figure 44: ProAxis® with All Components Removed in Preparation for Storage

b. STEP 2: Confirm the next step to allow the table to move to its storage position.

Continue to hold down the Soft Key until the configuration is completed (Figure 45).

Page 44

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Spar Lock

Figure 45: ProAxis® Configured for Release of Spars

c. STEP 3: Confirm selection of storage position using the Soft Key that corresponds to

the check mark. After continuing with this selection, confirm the Storage LED light on the Control Panel is illuminated green.

NOTE: Upon confirmation, the remaining steps must be completed to store the table.

d. STEP 4: Disconnect the Spars by:

i. Loosening the Spar Lock on either side of the spars by turning the knob counter-

clockwise (Figure 46).

Figure 46: Loosening the Spar Lock on Spar

WARNING: Do not use excessive force when disconnecting the Spars. If after loosening the Spar Lock, the Spar does not disconnect with hand force, seek assistance from qualified service personnel. Failure to do so may cause harm to the healthcare professional or device.

Page 45

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Black Tab

ii. Simultaneously pressing down on the black tabs on each side of the table to

disconnect the spars from their locked position (Figure 47) and raise them out of the latches.

Figure 47: Pressing down on the black tab to disconnect the Spar

iii. Remove the spars by lifting up and shifting the pair of spars to either side such that

they can drop down for storage (Figure 48).

Figure 48: Disconnecting the Spars

Page 46

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Cervical Receptacle Posts

Hinge Pinch Points

iv. Move spars to the side such that one is positioned on the outside of the Head-End

column while the other is positioned between the posts of the cervical receptacle (Figure 49).

of the spar hinges and healthcare professionals position themselves away from the linkage arms when moving the table to a storage position. Failure to do so may cause injury to the healthcare professional or possible damage to the table.

Figure 49: Spars in process of being lowered to their storage position

WARNING: Take note of the pinch points at the spar hinges. Ensure no items are in the path

Page 47

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 50: Spars Positioned Down for Storage

e. STEP 5: Install the protective Spar Cover on each Spar (Figure 51).

Figure 51: Spar Covers Being Installed

Page 48

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 52: Spars in Position for Storage with Spar Covers Applied

f. STEP 6: Loosen the Beam Lock (Figure 53).

Figure 53: Beam Lock Loosened

g. Using the IntelliPendant®, continue to the next step, which allows the table to configure

the Floor Locks such that those at the Head-End are unlocked while those at the FootEnd remain locked.

Page 49

Mizuho OSI 2016

NW0725 Rev K

h. STEP 7: Retract the table (Figure 54).

Head-End

Foot-End

PUSH HERE TO COLLAPSE TABLE

ProAxis® Spinal Surgery Table Owner’s Manual

Figure 54: Collapsing the ProAxis® Table for Storage

i. STEP 8: Secure the Beam Lock. j. Using the IntelliPendant® or the Auxiliary Panel, unlock the Floor Locks. With the

assistance of two people, the ProAxis® table may now be moved to its storage location.

Page 50

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 55: ProAxis® Configured for Storage or Transport

To expand the table from its retracted position:

1. With the assistance of two people, move the table to the desired location.

2. Press the Power Switch on the Head-End base, and observe that a green ring illuminates around the switch, confirming power is applied to the table.

3. The IntelliPendant® will now provide step-by-step instructions on how to configure the table to its full position.

4. Complete the following steps in order as directed on the Hand Pendant: a. Loosen the Beam Lock. b. Continue to the next step, which allows the table to configure the Floor Locks such that

those at the Head-End are unlocked while those at the Foot-End remain locked. c. Expand the table. d. Tighten the Beam Lock. e. Remove the protective Spar Cover from each Spar. f. Attach the Spars by:

i. Raising the spars such that one is positioned on the outside of the Head-End

column while the other is positioned between the posts of the cervical receptacle (Figure 49, page 42).

ii. Lifting the spars above the latch position. iii. Lowering the spars into the respective latches. iv. Tightening the Spar Locks to secure the spars in place.

Page 51

Mizuho OSI 2016

NW0725 Rev K

5. Using the IntelliPendant®, lock the Floor Locks. Complete the Function Check (see Section

6).

6. Confirm Storage LED is no longer illuminated on the Auxiliary Control Panel.

NOTE: Upon expanding the table, the table will still be in the hinged state required for storage. To

level the table top, install the Head-End Supine Top or the two rail mounts to activate the table’s hinge functionality. Then, press either the Hinge Down button or the Return to Level button until the Hinge Angle reads 0°.

4.7.6 Version Info

To access information on the table’s software version:

1. Press the Menu Soft Key on the IntelliPendant®.

2. Utilize the Down arrow Soft Key to select Version Info (Figure 56). Press the Soft Key that corresponds to the check mark.

3. Information on the table’s current software version will be displayed.

NOTE: Software version information will be primarily used by a service technician should it need to

be accessed.

ProAxis® Spinal Surgery Table Owner’s Manual

Figure 56: Version Info Menu Selection

4.8 Independent Monitoring System (IMS)

The ProAxis® Spinal Surgery Table includes an Independent Monitoring System that monitors the load on the table and notifies the user in the event the table is overloaded. The system works by monitoring the load on the Head-End plate to which the spars are attached. If the load exceeds the allowable amount for the maximum-weight patient, the system will notify the user through the use of an error message and table motion will be interrupted.

The table can be overloaded for three (3) reasons, any of which will be detected by the IMS and prevent motion of the table. No other conditions are monitored that will trigger the alarm system.

1. A patient whose weight is over the maximum weight limit is placed on the table.

2. Extreme external forces.

3. A loss of coordination between the Head-End and Foot-End, which can place additional load or tension on the table.

Page 52

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Should the table be overloaded due to any of these three conditions, the overload notification of the IMS will be triggered and the user will be notified via the Overload screen (Figure 57). In this state, the user has the opportunity to reverse the table’s overloaded state by removing the load.

Figure 57: IntelliPendant® Display when the Overload Notification of the IMS is Triggered

If the load on the table increases beyond the overload notification level, the IMS will trigger an overload alarm to notify the user and prevent any further motion of the table (Figure 58).

Figure 58: IntelliPendant® Display when the IMS Overload Alarm is Triggered

For the user, there is no detectable delay from the time the alarm system detects the table is overloaded to when a warning is displayed on the IntelliPendant®.

The specific load on the table that triggers the alarm system is preset at the factory and is not adjustable. The functionality of the alarm system should be verified as part of the periodic maintenance of the table.

Page 53

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

5 Inspection

5.1 Acceptance and Transfer

1. Upon receipt of your ProAxis® Spinal Surgery Table, remove it from the shipping crate. Remove any protective wrapping or packaging. Visually inspect all surfaces for freight damage.

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 number, serial number and confirm the power requirements on the manufacturer’s label located on the Foot-End column of the table.

3. Perform Function Check (refer to Section 6).

5.2 Pre-Procedure/Post-Procedure

Before and after each use of the ProAxis® Spinal Surgery Table, visually inspect all accessible areas, electrical cords, the table and all movable parts and components for possible damage that may adversely affect the proper operation of the table. Verify Beam Lock and Silver Spar Knobs are tightened. Examine the patient safety straps for any sign of wear or damage. Examine the covers of all pads for tears or other damage that might cause the pads to trap fluids or other contaminants. Damaged or defective products should not be used or processed. Contact Mizuho OSI Services for repair or replacement (refer to Section

13).

5.3 Semi-Annual Preventative Maintenance

A Semi-Annual Preventative Maintenance (PM) check (refer to Section 10.3) on your ProAxis® Spinal Surgery Table is required at least once every six (6) months.

To obtain the PM checklist call Mizuho OSI Services at 1-800-777-4674 within the USA or +1-510-429-1500 outside the USA.

5.4 Product Lifetime

At the time of delivery, your product fulfills existing regulations and standards; however, in spite of proper use, routine inspection, prescribed service, maintenance and repairs, the product is subject to aging and

wear. Therefore, Mizuho OSI cannot guarantee the product’s safety after ten (10) years and recommends

your product be taken out of service. For product warranty information, refer to Section 13.6 of this manual.

Page 54

Mizuho OSI 2016

NW0725 Rev K

6 Function Check

ProAxis® Spinal Surgery Table Owner’s Manual

NOTE: Perform all steps of the Function Check before every use of the ProAxis

For a complete definition of terms used in this procedure, please refer to the Glossary of Terms in Section 2.9.

1. Confirm the Beam Lock is tightened.

2. Confirm the silver Spar Locks at the Head-End of the table are tightened, securing the spars in place.

3. Connect the IntelliPendant® cable to the IntelliPendant® port on the Head-End column (Figure 5, page 14).

4. Plug the Power Cord into a properly grounded receptacle to use with AC power. Refer to the manufacturer’s label on the Foot-End column for input voltage requirements (Figure 10, page 18).

5. Press the Power Switch on the Head-End base, and observe that a green ring illuminates around the switch, confirming power is applied to the table.

6. If the AC power cable is not connected to an outlet with a protective earth ground, then the external ground stud should be connected to a protective earth ground (Figure 4, page 13).

7. If the table needs to be used under battery power due to AC outage, ensure that the battery has been properly charged as outlined in Section 12.3. Press the Power Switch on the Head-End base, and observe that a green ring illuminates around the switch confirming

power is applied to the table. The battery status symbol on the IntelliPendant® should be visible indicating a charged battery. If the battery status symbol on the IntelliPendant® is

the battery is not adequately charged and the table should only be used with AC power. To protect the patient, hospital staff, and the table from possible electrical hazards, an external ground cable connection is required between the external ground stud and protective earth ground when the table is in use under battery power (Figure 4, page 13).

Surgery Table.

8. Lockout mode: The ProAxis® Surgery Table motions are only operational if the Floor Locks are locked. The green indicator located on the Auxiliary Control Panel is illuminated and the Floor Lock symbol is visible on the IntelliPendant® display screen when the Floor Locks are completely engaged. Unlock the Floor Locks and verify that neither the IntelliPendant® nor the Auxiliary Control Panel functions operate except to activate the Floor Locks.

9. Complete a Floor Lock check using the Auxiliary Control Panel (Figure 15, page 21). a. Press the Floor Lock button and observe the LED indicator is illuminated on the

Auxiliary Panel and the Floor Lock symbol is visible on the IntelliPendant® display. The table is locked if it cannot be moved on its wheels.

b. Press the Floor Unlock button and observe the LED is no longer illuminated on the

Auxiliary Panel and the Floor Unlock symbol is visible on the IntelliPendant® display. The table is unlocked if it can move on its wheels.

Page 55

Mizuho OSI 2016

NW0725 Rev K

c. Floor Lock Override Check:

i. With the Floor Locks unlocked, utilize the IntelliPendant® and select the Override

Floor Locks setting.

ii. With the Override function active, utilize the Height Up, Height Down, Lateral Tilt

Right and Left, or Trendelenburg/Reverse Trendelenburg buttons. These buttons should function without the Floor Locks being locked while the Override function is utilized.

10. IntelliPendant® Check: a. Utilizing the IntelliPendant®, press the Floor Lock button. Observe on the Auxiliary

Control Panel that the LED illuminates and that the Floor Lock symbol displays on the IntelliPendant® display after the floor locks are completely deployed and locked. Look under the Head-End and Foot-End base, and observe that all four feet have moved down and are in direct contact with the floor (Figure 16, page 21).

b. Press the Floor Unlock button. Observe that all four locking feet move up. Confirm

the LED is not illuminated on the Auxiliary Control Panel and the Floor Unlock symbol displays on the IntelliPendant® display after the floor locks are completely retracted and unlocked. Look under the Head-End and Foot-End base and observe that all four feet have moved up and are not contacting the floor (Figure 16, page 21).

c. Repeat Step (a) to ensure the Floor Locks are fully engaged such that the rest of the

table’s functionality may be tested.

ProAxis® Spinal Surgery Table Owner’s Manual

d. Press and hold the Height Up button. Observe that the table top raises through its

entire range. Observe the IntelliPendant® display, and confirm that the Height Up symbol is visible in the action display area of the screen. The number beside the Height Up symbol in the motion status area of the screen should be changing, corresponding to where the table top is within the height range.

e. Press and hold the Height Down button. Observe that the table top lowers through its

entire range. Observe the IntelliPendant® display, and confirm that the Height Down symbol is visible in the action display area of the screen. The number beside the Height Down symbol in the motion status area of the screen should be changing, corresponding to where the table top is within the height range.

f. Press and hold the Reverse Trendelenburg button. Observe that the Foot-End of the

table top moves down through its entire range. Observe the IntelliPendant® display, and confirm the Reverse Trendelenburg symbol is visible in the action display area of the screen. The number beside the Reverse Trendelenburg symbol in the motion status area of the screen should be changing, corresponding to where the table top is within the Reverse Trendelenburg range.

g. Press and hold the Trendelenburg button. Observe that the Head-End of the table top

moves down through its entire range. Observe the IntelliPendant® display, and confirm that the Trendelenburg symbol is visible in the action display area of the screen. The number beside the Trendelenburg symbol in the motion status area of the screen should be changing, corresponding to where the table top is within the Trendelenburg range.

h. Press and hold the Lateral Tilt, Left button. Observe that the table top tilts to the left

through its entire range. Observe the IntelliPendant® display, and confirm that the Lateral Tilt, Left symbol is visible in the action display area of the screen. The number beside the Lateral Tilt, Left symbol in the motion status area of the screen should be changing, corresponding to where the table top is within the Lateral Tilt range.

Page 56

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

i. Press and hold the Lateral Tilt, Right button. Observe that the table top tilts to the

right through its entire range. Observe the IntelliPendant® display, and confirm that the Lateral Tilt, Right symbol is visible in the action display area of the screen. The number beside the Lateral Tilt, Right symbol in the motion status area of the screen should be changing, corresponding to where the table top is within the Lateral Tilt range.

j. Install the Two-Piece Supine Top on the frame (refer to Section 8) and test the table’s

hinge functionality:

1. Select the FSS Hinge Mode Setting using the IntelliPendant®.

2. Press and hold the Hinge Up button. Observe that the table top hinge angle increases through its entire range. Observe the IntelliPendant® display, and confirm

the FSS Hinge Up symbol is visible on the screen. The number beside the Hinge Up symbol in the motion status area of the screen should be changing, corresponding to where the hinge is within the range of travel.

3. Press and hold the Hinge Down button. Observe that the table top hinge angle decreases through its entire range. Observe the IntelliPendant® display, and

confirm that the FSS Hinge Down symbol is visible on the screen. The number beside the Hinge Down symbol in the motion status area of the screen should be changing, corresponding to where the hinge is within the range of travel.

4. Select the FE Hinge Mode Setting using the IntelliPendant®.

5. Press and hold the Hinge Up button. Observe that the table top hinge raises through its entire range. Observe the IntelliPendant® display, and confirm the FE

Hinge Up symbol is visible on the screen. The number beside the Hinge Up symbol in the motion status area of the screen should be changing, corresponding to where the hinge is within the range of travel.

6. Press and hold the Hinge Down button. Observe that the table top hinge lowers through its entire range. Observe the IntelliPendant® display, and confirm that the

FE Hinge Down symbol is visible on the screen. The number beside the Hinge Down symbol in the motion status area of the screen should be changing, corresponding to where the hinge is within the range of travel.

7. Return to the FSS Hinge Mode Setting using the IntelliPendant® if desired.

k. With the Two-Piece Supine Top installed on the frame, re-position the table top by

raising the Height to 36 inches (91 cm); laterally Tilt the table top left or right six (6) degrees; raise or lower the Hinge 10 degrees; and place the table top in five (5) degrees of Trendelenburg. Confirm this position by reading the display on the IntelliPendant® screen. Press and hold the Return to Level button. Observe that the table top levels side to side and head to foot. Continue to depress the button, and after a one-second delay, the table top will move down to its Home height. Observe that the table top is level and at the Home height position of 32 inches (81 cm) off the floor when movement stops. Observe the IntelliPendant® display, and confirm the Height display reads 32 inches (81 cm), the Hinge angle reads 0 degrees, the Tilt angle reads 0 degrees, and the Trendelenburg/Reverse Trendelenburg angle reads 0 degrees.

l. Using the Menu key, navigate to the ACP setting and select the Fast setting. Using the

ACP Soft Key on the Main Screen, activate the ACP function. Observe the Fast ACP symbol is present on the IntelliPendant® display screen. Repeat the process, this time selecting the Slow setting. Observe that the Slow ACP symbol is now present on the IntelliPendant® display screen.

Page 57

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

11. Battery operation check: a. Observe the Battery Status on the base of the Head-End column. If the LED is

illuminated green - OK, then the battery is properly charged. Confirm that the Battery Status icon on the IntelliPendant® is indicating the battery is fully charged and the

table is ready to operate on battery power.

b. If the LED is illuminated red or the Battery Status icon on the IntelliPendant® is , the

battery must be charged prior to using the table. To charge the battery, ensure the Power Cord is plugged into a functioning receptacle. The AC LED at the base of the Head-End column will illuminate green indicating that appropriate AC power is applied to the table. The table must remain plugged in for a minimum of three (3) hours to ensure sufficient charging of the battery to operate the table.

c. If the LED remains red and the Battery Status icon is still after three (3) hours,

continue to charge the battery for up to 24 hours.

d. If the LED does not illuminate green-OK and the Battery Status icon does not reflect

after 24 hours, refer to Section 12.3 for servicing instructions.

NOTE: The table may be used with AC power even when the Battery Status icon is indicating

the battery needs charging. Confirm the green AC power LED at the base of the Head-End column is illuminated.

Page 58

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

6988-899

Rail Mount, Left

The Rail Mount, Left slides on the left side of the Head-End hinged, open frame

and works in conjunction with the Chest Tray to translate the patient’s upper

torso when the hinge of the frame is raised or lowered.

6988-887

Rail Mount, Right

The Rail Mount, Right slides on the right side of the Head-End hinged, open frame and works in conjunction with the Chest Tray to translate the patient’s upper torso when the hinge of the frame is raised or lowered.

6988-950

Chest Tray

The Chest Tray sits on the Rail Mounts and provides the platform to which to attach one of the three available Chest Pads used to support the patient. The Chest Tray has a numeric scale to allow for ease in patient positioning.

6988-530 ProAxis® 5-Way Articulating Arm

Board (2)

- includes 6988-526 Arm Board Bracket (2)

The 5-Way Articulating Arm Boards provide support for the patient’s arms when positioned prone on the ProAxis®. When in place, the Arm Board can be translated, articulated, raised, lowered, and laterally adjusted depending on the positioning needs of the patient. The Ball Joint controls the articulating motion of the Arm Board, which may be required for positioning a patient with decreased shoulder or arm range of motion. The 1-inch (2.5 cm) pad provided is of Mizuho OSI Tempur-Pedic® medical construction. The bracket required to attach the Arm Board on the Chest Tray is provided with the Arm Board assembly.

6988-758 ProAxis® Chest Pad

The ProAxis® Chest Pad is of Mizuho OSI Tempur-Pedic® medical construction. When properly positioned, the top edge of the pad should rest at the bottom of the patient’s supra-sternal notch.

D28502CE Re-usable ProneView®

Adjustable Protective Helmet

The re-usable ProneView® Adjustable Protective Helmet is part of the ProneView® system and supports the one-time use disposable cushion insert provided in the Patient Care Kit. The ProneView® Adjustable Protective Helmet has four posts with 2.2 inches (5.6 cm) of height adjustment.

D28580CE Re-usable ProneView®

Mirror Platform with Post Holes

The re-usable Mirror Platform with Post Holes provides support for the ProneView® Adjustable Protective Helmet and allows the patient’s eyes to be viewed from three sides when positioned prone. The ProneView® Adjustable Protective Helmet posts seat in the post holes of the mirror.

6988-969 Cervical Chest Tray

The Cervical Chest Tray sits directly on the rails of the open frame and the ProAxis® Chest Pad attaches to the tray to support the patient. The Chest Tray has Velcro® straps for securing it to the frame.

6988-725 Cervical Traction

Vector Adjustor

The Cervical Traction Vector Adjustor mounts on the Head-End of the table and maintains alignment of the traction rope when cervical traction is utilized.

7 ProAxis

Spinal Surgery Table

Standard Components

7.1 ProAxis® Standard Components

In addition to the IntelliPendant® and the Power Cord, the following standard patient positioning components are shipped with the ProAxis® Spinal Surgery Table. Pictures of the individual components

and instructions for use are provided in Section 8.

NOTE: Use proper lifting and carrying techniques when moving components and accessories due

to their weight and size.

Page 59

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

6988-209 Cervical Management Mounting Bracket

The Cervical Management Mounting Bracket installs in the Head Board and allows the Mizuho OSI optional accessory, the Cervical Management Base Unit, to be utilized with an aluminum or radiolucent DORO® or Mayfield® skull clamp.

6988-387 Contoured ACP Hip Pad,

Left

The Contoured ACP Hip Pad, Left is of Mizuho OSI Tempur-Pedic® medical construction and provides support for the patient when positioned prone on the

open frame. When positioned correctly, the patient’s left iliac crest should be

positioned in the top third of the pad labeled Left.

6988-388 Contoured ACP Hip Pad,

Right

The Contoured ACP Hip Pad, Right is of Mizuho OSI Tempur-Pedic® medical construction and provides support for the patient when positioned prone on the

open frame. When positioned correctly, the patient’s right iliac crest should be

positioned in the top third of the pad labeled Right.

6977-739 Buttocks Strap

The Buttocks Strap rests across the patient’s lower gluteal area when positioned prone to secure the patient in place on the Contoured ACP Hip Pads and open frame.

6844-148

Leg Board with Pad (2)

The two (2) Leg Boards, when used together, provide support for the patient’s

legs when positioned prone on the open frame. The 1-inch (2.5 cm) pad is made of Mizuho OSI Tempur-Pedic® medical construction.

5840-450 Leg Sling

The Leg Sling is placed over the Foot-End section of the hinged, open frame and is secured in place with Velcro® straps. Positioning pillows should be utilized in the sling to achieve the desired positioning and support of the patient’s legs when positioned prone.

6988-880 Retractor Adaptor

The Retractor Adaptor provides six (6) inches (15 cm) of side rail and is required for mounting ancillary equipment onto the carbon fiber open frame.

6946 Tempur-Pedic® Medical

Pillow, Standard Size

A standard size pillow of Tempur-Pedic® medical construction is provided for patient positioning. A cleanable, zippered cover encases the pillow.

6947 Tempur-Pedic® Medical

Pillow, Queen Size (2)

A queen size pillow of Tempur-Pedic® medical construction is provided for patient positioning. A cleanable, zippered cover encases the pillow.

6988-623 Supine Top, Head-End

Assembly

The Supine Top, Head-End is of carbon fiber construction and mounts on the Head-End section of the hinged, open frame. It is secured to the frame with locking brackets and accommodates supine and lateral patient positioning.

6988-621 Supine Top, Foot-End

Assembly

The Supine Top, Foot-End is of carbon fiber construction and mounts on the Foot-End section of the hinged, open frame. It is secured to the frame with locking brackets and accommodates supine and lateral patient positioning.

6988-442 Tempur-Pedic® Medical

2-inch (5 cm) Supine Top Pad (one piece)

The one piece Tempur-Pedic® Medical 2-inch (5 cm) Pad mounts on the Supine Tops. The pad is of viscoelastic foam construction and has a built-in translation slide on the bottom of the pad that interfaces with the surface of the Supine Top, Foot-End, allowing for support and movement when the hinge is raised or lowered.

6977-959 Universal Side Rail

Adaptor (4)

Utilized on the Supine Top, the Universal Side Rail Adaptor is designed to protect the carbon fiber and provide 6-in. (15 cm) of side rail for mounting ancillary equipment.

5840-43 Safety Strap, 60 inches (152 cm) (2)

The Safety Straps are provided to secure the patient when positioned prone on the ProAxis®.

Page 60

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

5855-550 Safety Strap for

Supine Top (2)

The Safety Strap slides on the carbon fiber rails of the Supine Top and is provided to secure the patient when positioned supine or lateral on the ProAxis®.

6988A-PV-1-ACP ProAxis® Spinal Surgery

Table ProneView® Patient Care Kit (3)

The Patient Care Kits are single-use pad covers intended to prevent crosscontamination and protect the equipment. Three (3) ProneView® Patient Care Kits are included with the ProAxis® table.

6988-900 ProAxis® Component Cart

The ProAxis® Component Cart is provided to safely store all the standard components of the table. It is also designed to store optional accessories which may be acquired for use with the ProAxis®. A cover is provided with the cart and serves as a dust cover when the cart is not in use.

6988-70 ProAxis® Table Cover

The ProAxis® Table Cover is provided to serve as a dust cover when the table is not in use. The cover fits the table when set up (fully extended) or it can be adjusted with the Velcro® closures to cover the table when it is configured for transport or storage.

6988-90 Spar Cover (2)

The Spar Covers are provided to serve as a protective cover for the spars when the table is not in use and configured for transport or storage.

7.2 ProAxis

Patient Care Kits

The ProAxis® Surgery Table ships with three (3) individual ProAxis® ProneView® Patient Care Kits. A case of six (6) individual kits is provided when ordering 6988A-PV-ACP.

Each individual ProAxis® ProneView® Patient Care Kit includes the following:

 ProneView® Cushion Insert  Chest Pad Cover for ProAxis® Chest Pad  Pair of Hip Pad Covers with Aprons  Pair of Foam Arm Cradles  1 Set of Single-Use, Disposable Advanced Control Pad System™ Tubing

WARNING: Patient Care Kits are single use-only. Discard after use. Re-use of any component

in the Patient Care Kit may result in cross contamination.

The components should be used as described in the Patient Care Kit instructions included in each kit. The ProneView® Patient Care Kit works with the provided ProneView® Adjustable Protective Helmet

System. The system is designed by the manufacturer to support the patient’s head while in a prone

position. Additionally, the position of the patient’s facial alignment in the ProneView® Adjustable Protective

Helmet can be readily viewed while in the prone position.

NOTE: Remove the Patient Care Kit components from the packaging and visually inspect the

components. The ProneView® Cushion Insert should be opened sixty (60) minutes prior to use and the Arm Cradles should be opened twenty (20) minutes prior to use for complete expansion of the foam.

NOTE: The Mirror Platform with Post Holes is a rectangular shaped mirror with four holes

patterned to accept the adjustable posts on the helmet. The mirror can be seated on the Face Plate with the longer side oriented either parallel or perpendicular to the overall length of the table.

Page 61

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

8 Setup of ProAxis

Spinal Surgery

Table for Surgical Procedures

NOTE: This device is intended for use by trained personnel. Prior to setup and use of the ProAxis

Spinal Surgery Table, ensure personnel have been trained. To schedule an in-service, please contact your domestic Mizuho OSI sales representative or call 1-800-777-4674 within the USA or +1-510-429-1500 outside the USA.

To prepare the ProAxis® Spinal Surgery Table for patient positioning, complete the following steps:

1. Connect the IntelliPendant® to the port on the Head-End column (Figure 19, page 24).

2. Press the Power Switch and observe that the switch illuminates with a green ring indicating that power is applied to the table.

3. Utilizing the IntelliPendant®, press the Floor Unlock button. Observe that the Floor Locks are completely retracted and the Floor Unlock symbol is visible on the display of the hand pendant (Figure 21, page 25).

4. With the assistance of a second person, move the table to where it will be used. One person should be located at the Head-End and the other person at the Foot-End of the table. Care should be taken to control the table when rolling.

WARNING: If the ProAxis® Spinal Surgery 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 does occur, the table must be visually inspected for damage and a Function Check must be performed (refer to Section 6). If damage is discovered or the table does not successfully complete the Function Check, call Mizuho OSI Services (refer to Section 13).

5. Orient the Head-End of the table in the room where the anesthesiologist work station is located.

6. Plug the Power Cord into a properly grounded receptacle. Refer to the manufacturer’s label on the Foot-End column for input voltage requirements (Figure 10, page 18). If the AC power cable is not connected to an outlet with a protective earth ground, then the external ground stud should be connected to a protective earth ground (Figure 10, page

18).

7. Using the IntelliPendant®, press the Floor Lock button. Observe that the Floor Lock symbol is visible on the hand pendant display (Figure 22, page 25).

8. Complete a Function Check with the IntelliPendant® (refer to Section 6).

NOTE: Perform all steps of the Function Check before every use of the ProAxis

Table.

NOTE: The ProAxis

components prior to patient transfer. Components have been designed to specifically mount on the carbon-fiber, trapezoidal frame or the Supine Top, while safely supporting the patient and not damaging the frame.

Spinal Surgery Table is now ready for completing the setup of the patient

Spinal Surgery

Page 62

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 59: ProAxis® Spinal Surgery Table Open Frame Ready for Setup

Page 63

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Torso Trolley®

Flat ACP Chest

ProneView

Helmet System

Hinged Open Frame

Contoured ACP Hip Pads

Built-in ACP System

Built-in Foot Board

5-Way Articulating Arm Boards

Adjustable Leg Sling

IntelliPendant®

8.1 ProAxis

NOTE: Only Mizuho OSI components and accessories have been tested and approved for use

Prone Patient Positioning

with the ProAxis® Spinal Surgery Table. Other manufacturers’ products have not been tested for proper performance when used with the ProAxis® Spinal Surgery Table, and therefore are not endorsed for use by Mizuho OSI. Use of other manufacturers’ products may void the warranty.

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.

The following instructions provide the recommended steps for setup. Final determination of patient positioning and setup is at the discretion of the surgeon and surgical team.

Figure 60: ProAxis® Prone Setup – Fixed Surgical Site Hinge Mode

1. Confirm the ProAxis® Spinal Surgery Table is prepared for setup (refer to Section 8). When the patient is positioned prone, their head is oriented to the Head-End of the table (Figure 1, page 6).

2. Confirm that the Floor Locks are locked. Ensure the Floor Lock symbol is visible on the IntelliPendant® display.

3. Open the following: the Patient Care Kit, the ProneView® Cushion Insert or the GentleTouch® Face Pillow, and the package of Arm Cradles and set aside.

NOTE: The surgeon may decide to use the ProneView

Cushion or the GentleTouch® Face Pillow

depending on which option allows for the achievement of proper cervical spine position.

Page 64

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Rail Mount, Slides into Bracket

Hinged Frame Bracket

4. Slide the Rail Mount, Right and Rail Mount, Left onto the corresponding Head-End sections of the Hinged Frame. The nipple will engage the bracket, locking the Rail Mount in place. To confirm, pull back on the Rail Mount; it should remain secure in the Hinged Frame bracket (Figure 61).

Figure 61: Installing the Rail Mount

5. Connect the cable connector extending from the Rail Mount, Right/Left to the port on the corresponding side of the Head-End Assembly. Align the pins of the cable connector with the port, insert and turn the locking collar to the right securing the pins in the port (Figure 62).

NOTE: To remove the Rail Mount, turn the locking collar to the left and pull the cable connector out

of the port, disconnecting it from the Head-End Assembly. With the cable connector disconnected, depress the Black Tab on the frame while sliding the Rail Mount towards the hinge.

NOTE: When both rail mounts are connected, the Torso Trolley

drive pins may reposition to align

properly.

Page 65

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Depress Black Tab to Remove Rail Mount

Port for Cable Connector of Rail Mount

Figure 62: Attaching the Cable to the Port

6. The Torso Trolley® consists of a Chest Tray to which the Flat ACP or non-ACP Chest Pad or optional Bilateral Winged ACP Chest Pad and 5-way Adjustable Arm Boards are mounted (Figure 69, page 66).

a. Prior to installing the Chest Tray, ensure the Rail Mounts are correctly installed and the

Hinged Frame is in the neutral position.

Figure 63: Rail Mount Installed

Page 66

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Yellow Strip

b. Confirm the display on the IntelliPendant® shows the Hinge, Trendelenburg, and

Lateral Tilt angles are all 0° (Figure 22, page 25). If necessary, utilize the IntelliPendant® and press the Return to Level button to return the Hinged Frame to the neutral position.

Figure 64: Left and Right Rail Mounts Attached

7. To install the Chest Tray: a. Orient the Chest Tray over the posts of the Rail Mounts and lower into place. The

Chest Slide can be placed anywhere on the Rail Mounts that allows the posts to sit between the teeth of the Chest Slide (Figure 65).

b. Confirm the Chest Tray is not placed on the rails at a point lower than Position 1 on the

Rail Mounts in order to ensure the Chest Tray is properly engaged.

NOTE: When mounting the Chest Tray onto the rails, ensure the yellow strip on each of the Rail

Mounts is not visible. Appearance of the yellow strips indicates that the Chest Tray is not properly engaged with Rail Mounts.

WARNING: Visibility of the yellow strips on the Rail Mounts indicate that Chest Tray is not properly engaged with the Rail Mounts, which will prevent it from sliding correctly during hinge motion. Failure to ensure the Chest Tray is correctly mounted may result in harm to the patient or the device.

c. The Chest Tray may be moved up or down the length of the Rail Mounts by

simultaneously squeezing the grips of the Chest Tray and moving it to the desired location. Release both grips to lock the Chest Tray into place.

Page 67

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Chest Slide Grip

Pad Indentation

Tab of Flat Chest Pad Secures Pad to Chest Tray

Depress Tab to Remove Pad

Figure 65: Chest Slide Mounted on the Rail Mounts

8. To attach the ProAxis® Chest Pad, orient the opening of the pad bracket so it surrounds the lower surface of the Chest Tray. Slide onto the Chest Tray until the tab of the bracket is secure on the tray. The indentation in the pad for the supra-sternal notch should be oriented towards the Head-End of the table (Figure 66). Confirm the tab of the bracket is secure on the tray. To remove, press the tab of the bracket and slide the pad towards the Foot-End of the table.

Figure 66: ProAxis® Chest Pad Mounted on the Chest Tray

Page 68

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

NOTE: Also at the discretion of the physician, additional foam or padding can be placed between

the patient and the pad as needed to accommodate varying sizes of patients.

NOTE: With ideal positioning, the Chest Pad should support the patient such that the load is borne

predominantly by the sternum. When the patient is positioned correctly, the top edge of the pad should rest below the patient’s anatomical landmark, the supra-sternal notch.

WARNING: Positioning the Chest Pad superior to the supra-sternal notch may apply pressure

to the throat and the patient’s airway. Failure to ensure the patient is positioned correctly on the

Chest Pad may result in harm to the patient or the device.

9. Install the 5-Way Adjustable Arm Boards. a. Slide the Arm Board Mounting Brackets into each opening of the bracket on the

underside of the Chest Slide (Figure 67). Advance the brackets fully and tighten the THandles.

b. Attach the Articulating Arm Board to the non-patient transfer side of the table. Insert the

arm board assembly into the Arm Board Bracket and tighten the T-Handle on the Arm Board Mounting Bracket.

c. Attach the Articulating Arm Board to the patient transfer side of the table. Insert the arm

board assembly into the Arm Board Bracket and tighten the T-Handle on the Arm Board Mounting Bracket.

d. Adjust the arm boards as needed in preparation for patient transfer (Figure 68). The

Height, Translation, and Angle of the arm board surface can be adjusted. To adjust the Height, loosen the Black Knob and raise or lower the assembly, or raise or lower the assembly on the mounting bracket. Tighten the Black Knob and or the T-Handle when the desired Height is achieved. To translate the arm board towards the Head-End or Foot-End of the table, pull the pin on the underside of the arm board, translate and then re-position and release the pin to lock in place. To articulate the arm board, loosen the drop handle, pivot in the ball joint to the desired position, and tighten T-Handle.

CAUTION: Use care when positioning the arm board to ensure that it does not come in contact with the floor or surrounding equipment positioned near the table. Failure to allow for proper clearance of the arm board with its surroundings may result in damage to the arm board or other equipment.

e. Pivot the Articulating Arm Board on the patient transfer side out of the way by turning

the Black Knob and moving the arm board. Secure in place by re-tightening the Black Knob (Figure 68).

Page 69

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Pull knob to Release and Translate Arm Board North/South.

Bracket on the bottom of the Chest Tray includes T- Handles to secure the Arm Board Mounting Bracket.

T-Handle Allows Lateral Adjustment of Arm Board in Place

T-Handle Allows Height Adjustment of Arm Board

Arm Board Mounting Bracket Height Adjustments

Articulating Ball Joint

Pivot & Lateral Adjustment

Figure 67: Arm Board Mounting Bracket Installed

Figure 68: 5-Way Adjustable Arm Board Installed

Page 70

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 69: Torso Trolley® with Chest Pad and Arm Board Mounted

10. Confirm the Torso Trolley® slides properly. Simultaneously squeeze the grips of the Chest Tray (Figure 70). This releases the post in the Rail Mount from the teeth of the Chest Tray and allows for the Chest Tray with Arm Boards to be moved easily toward the Head-End or Foot-End of the table. The 1-8 scale on the Chest Tray assists in identifying where the Chest Tray is in its range of movement.

Figure 70: Manually Moving the Torso Trolley®

Page 71

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Slide on Rail Frame Pad Stop Here

Locking Bracket, Open

White tab

Lip of black component of clamp

11. Attach the Contoured ACP Hip Pads. The pads are labeled right and left specific to be oriented to the patient’s iliac crest when lying prone. Open the Locking Bracket, orient the Pad with Locking Bracket over the rail of the open frame on the Foot-End section of the frame, lower into place and slide towards the Hinge until it rests against the Pad Stop (Figure 71).

Figure 71: Mounting the Contoured ACP Hip Pad on the Frame

12. Press up on the white tab until the black component of the clamp fits into the open notch of the white tab. Press down on the lip of the black component of the clamp to lock the pad in place (Figure 72).

Figure 72: Locking the Contoured ACP Hip Pad Bracket

13. When installed correctly, the pad should rest against the Pad Stop and the arrow on the side of the Bracket should be pointed toward the Foot-End of the table (Figure 73). To remove the Contoured Hip Pad, lift up on the lip of the Bracket so that it disconnects, and lift the pad off the rail of the frame.

Page 72

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Loop for Buttocks Strap

Oriented Correctly, Arrow Points to Foot-End

Positioned at Hinge, Pad Rests against Stop

Locking Bracket, Locked

ACP Tubing Hangs Freely

NOTE: Depending on desired area of flexion and patient’s anatomy, the hip pads may be moved

towards the Foot-End of the table at the surgeon’s discretion to achieve proper positioning.

Figure 73: Contoured ACP Hip Pad Locked in Place

14. To install the Adjustable Leg Sling, place the sling over the Foot-End section of the open frame (Figure 74). Feed the four straps through their respective buckles on the opposite side of the sling and secure. The sling should be adjusted for each patient. The straps on the sling consist of a double–sided hook and loop closure that allows for infinite adjustment along the length of the strap. The hook end of the strap may be folded over onto the loop portion of the strap to allow for greater adjustability. The strap may be folded over itself again to shorten, thereby raising the sling and decreasing the degree to which the patient’s hips are flexed. If the double-sided hook and loop closure is worn from repetitive use or misuse, replacement of the sling is required.

Figure 74: Sling Attached to ProAxis® Spinal Frame

15. Place two (2) or three (3) 6946 or 6947 Tempur-Pedic® Medical Pillows in the

sling approximately where the patient’s lower legs will rest to achieve the desired amount of knee flexion and support (Figure 75).

Page 73

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 75: Sling with Pillow Placement

16. The Leg Boards may be used in place of the Leg Sling to support the legs. Attach the Leg Boards with the 1-inch (2.5 cm) Tempur-Pedic® Medical Pad. Release the Velcro® Straps on the sides of the Leg Board. Place one Leg Board over the rails of the open frame and slide into place. Secure with the Velcro® Straps. Repeat this process with the second Leg Board. Ensure that the two Leg Boards abut each other (Figure 76).

Figure 76: Leg Boards Installed on the ProAxis® Spinal Frame

17. If using the ProneView® Mirror and Helmet System, place the Mirror Platform with the ProneView® Adjustable Helmet on the Chest Tray (Figure 77). Ensure that the adjustable posts are in their lowest position in preparation for patient transfer. Fit the ProneView® Cushion Insert into the ProneView® Helmet and within the tabs provided at the chin end of the ProneView® Helmet. Adjust the Cushion Insert openings to be centered relative to the ProneView® Helmet openings.

Page 74

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 77: ProneView® Mirror and Helmet System Properly Positioned

18. If using the GentleTouch® Face Pillow, place the Pillow on the Chest Tray (Figure 78).

Figure 78: GentleTouch® Face Pillow Properly Positioned

NOTE: In some cases if use of tongs or a head halter is desired in conjunction with the use of the

Torso Trolley®, an optional short Cervical Traction Vector ( 6988-720) is available.

Page 75

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

19. After the desired prone components are in place on the frame, the tubing can be connected to the Contoured ACP Hip Pads.

a. Secure the ACP tubing with the Velcro® wraps along the frame and by routing it

through the underside of the Leg Sling. Ensure the tubing is secure and out of the way such that the tubing will be able to move when the Hinged Frame is moved.

b. Ensure the third port that does not connect to the Hip Pads is cinched to prevent air

from escaping the system. c. Connect the tubing to the port at the Foot-End of the table. d. Utilize the IntelliPendant® and raise and lower the Hinge to the extent of its travel. Re-

adjust the ACP tubing as may be required.

NOTE: Verify the ACP tubing will not be stretched or pinched during hinge movement, which may

interrupt or obstruct air flow to the pads. Failure to do so may result in ACP malfunction.

20. Place the Patient Kit Covers on the Chest and Hip Pads (Figure 79).

Figure 79: ProAxis® Spinal Surgery Table Prone Setup with Patient Care Kits Applied

21. Trial position the imaging equipment if it will be used. If necessary, re-locate the ProAxis® Surgery Table in the room. Unlock the Floor Locks by using the IntelliPendant® and with the assistance of a second person move the ProAxis® Surgery Table. When the table is located where it will be used, lock the Floor Locks.

CAUTION: The ProAxis® Surgery Table is not for patient transport. The location of the table relative to any imaging equipment that may be used needs to be confirmed prior to transferring the patient to the table.

Page 76

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

22. Position the patient bed or stretcher so the patient’s anatomical landmarks are aligned with the support pads on the hinged frame of the ProAxis® Surgery Table. It may be necessary to re-position the Chest Pad by manually moving the Torso Trolley®. The top edge of the Chest Pad should align with the patient’s anatomical landmark, the bottom of supra-sternal notch, and the top third of the Contoured ACP Hip Pad should align with the patient’s anatomical landmark, the iliac crest.

23. The height of the patient bed or stretcher should be level with the top of the Contoured ACP Hip Pad. To assist the patient transfer process, you may choose to use the IntelliPendant® and laterally tilt the table toward the patient bed or stretcher by pressing the appropriate tilt button.

NOTE: When the patient is correctly positioned prone on the ProAxis

, the hinge will flex or extend

the patient’s spine at L3.

24. Lock the patient stretcher or bed. Confirm by observing on the IntelliPendant® display that the table Floor Locks are locked. The Floor Locks Locked symbol should be visible (Figure 22, page 25).

25. Ensure that the ProneView® Adjustable Protective Helmet legs are set to the lowest position.

26. Place the ProneView® Adjustable Protective Helmet with Cushion Insert on the patient’s face. Ensure the patient’s eyes are visible. With the assistance of others, log-roll the patient onto the ProAxis® Spinal Surgery Table supporting the patient’s head, torso and legs.

27. After log-rolling the patient to a prone position and onto the Mirror Platform on the Chest

Tray, verify there is adequate clearance between the patient’s nose and the mirror, and

verify the endotracheal tube is not kinked.

WARNING: Failure to confirm the positioning of the patient and patient tubes may cause harm

to the patient.

28. Continue to support the patient on the table until the safety straps are in place. DO NOT leave the patient unattended on the table.

WARNING: Patient must be restrained at all time by a safety strap(s) when positioned on the

table.

29. Remove the patient bed or stretcher while supporting the patient on the table.

30. Install and secure the Articulating Arm Board on the patient transfer side of the table (Figure 68, page 65). Position the patient’s arms in the Arm Cradles and on the Arm Boards. Final positioning of the patient’s arms should be completed after confirming the patient’s orientation on the Chest Pad and the Contoured ACP Hip Pads.

31. Confirm that the patient’s face is seated in the Cushion Insert; the eyes should be visible in the mirror; the neck should be in a neutral position (Figure 80). Raise the height of the ProneView® Adjustable Protective Helmet until a neutral neck position is achieved by turning the posts of the helmet. There is a 2.3-inch (5.6 cm) height adjustment range available.

Page 77

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

WARNING: Frequently monitor the patient’s neck, head, eyes, nose, and mouth to ensure that a safe position is maintained and the ET tube has not been kinked or displaced. Failure to do so can lead to serious adverse consequences including blindness and failure to ventilate.

WARNING: Failure to maintain neutral neck position can result in neck damage and/or chin abrasions. Some erythema may result from skin contact with the materials in this product or from compression during prolonged cases.

Figure 80: Patient Positioned Properly in ProneView® Helmet

32. Visually confirm the placement of the Contoured ACP Hip Pads. The pad should be mounted abutting the Pad Stop (Figure 71, page 68). When positioned correctly, the patient’s anatomical landmark, the iliac crest, should rest in the top one-third of the pad. The Patient Kit Hip Pad Cover should be smooth against the patient’s skin. Ensure that the patient’s skin is smooth and flat against the Patient Kit Hip Pad Cover. To re-position the patient on the Pad, the patient should be lifted and moved such that the iliac crest contacts the top third of the pad. Ensure the Hip Pad Cover is smoothed and lower the patient back onto the Pad. Confirm correct placement of the Pads such that the each of the patient’s iliac crests rest in the top one-third of each respective Hip Pad (Figure 81).

CAUTION: Failure to ensure that the patient is positioned correctly on the Contoured ACP Hip

Pad, may result in harm to the patient or the device.

Page 78

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Supra-sternal Notch

Figure 81: Proper Lower Body Patient Positioning

33. Visually confirm the placement of the Chest Pad. When positioned correctly, the edge of the Pad should rest below the patient’s anatomical landmark, the supra-sternal notch (Figure 82). Breasts should be down and lying flat with the nipples oriented towards the Foot-End of the table. The Patient Kit Chest Pad Cover should be smooth against the

patient’s skin. Ensure that the patient’s skin is smooth and positioned flat against the

cover. If necessary, re-position the Chest Pad. While lifting and supporting the patient, move the Torso Trolley® with the attached Chest Pad to the desired location and smooth the Chest Pad Cover. The patient should then be lowered back onto the Chest Pad (Figure 83).

NOTE: With ideal positioning, the Chest Pad should contact the patient such that the load is borne

predominantly by the sternum.

WARNING: Positioning the Chest Pad superior to the supra-sternal notch may apply pressure

to the throat and patient’s airway. Failure to ensure the patient is positioned correctly on the Chest

Pad may result in harm to the patient or the device.

Figure 82: Example of Patient’s Supra-sternal Notch

Page 79

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 83: Proper Upper Body Patient Positioning

34. Visually confirm that the Leg Sling or Leg Boards provide support to the patient’s knees, with legs supported on pillows. If using the Leg Sling, the patient’s knees should be flexed and legs supported on the pillows. Re-position the legs and add pillows as required under

the patient’s tibias to ensure that the ankles are not hyper-extended and there is no pressure on the patient’s feet (Figure 81, page 74).

CAUTION: Failure to ensure that the patient is positioned correctly with the Leg Sling or Leg

Boards may result in harm to the patient or the device.

CAUTION: When the table is positioned at a low height, take care in positioning the patient in

the Leg Sling such that the Sling does not come in contact with the center beam. Failure to properly

monitor the position of the Leg Sling with the patient’s legs positioned in it may result in harm to

the patient or the device.

35. Place the Buttocks Strap across the lower gluteal area of the patient. A blanket may be used under the Buttocks Strap to protect the patient from direct contact with the strap. The strap can be fed through the buckle on the sides of the Contoured ACP Hip Pads and then back on itself, securing the Velcro®. Confirm that the Buttocks Strap is positioned low on the gluteal area, and that it surrounds both Contoured ACP Hip Pads, and is secured snugly around the buttocks. Ensure that the patient does not directly contact the frame of the table. Use foam or gel padding as needed to pad the area between the patient and the rails of the frame.

36. Apply a Safety Strap over the patient’s lower legs. Secure the Safety Strap in place with use of the buckle.

NOTE: The placement and location of the Straps are at the discretion of the surgeon and vary by

procedure.

Page 80

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Pull to Release and Translate Arm Board North/South

Black Knob to Control Pivoting of Arm Board

Drop Handle Releases Ball Joint so that Arm Board can be angled

T-Handle Allows Height Adjustment on Post

NOTE: Due to the open nature of the ProAxis

frame and the long duration of many spinal procedures, the use of forced air warmers, fluid warmers, and blankets should be considered to help prevent hypothermia. Blankets may be placed over the feet up to the gluteal area and across the shoulders and arms out of the surgical field to aid in

maintaining the patient’s body temperature. These devices should be used according to

the manufacturer’s directions and at the discretion of the surgeon.

37. Position the patient’s arms and adjust the Articulating Arm Boards as needed. Support the arms in the foam Arm Cradles. The V of the cradle should rest against the inside of the patient’s elbow. Translate, raise, lower, or articulate the Arm Board as needed and then secure in place (Figure 84). Confirm that all the T-Handles and the Drop Handle are tightened. Confirm that the patient’s arms are positioned so there is no more than 90 degrees flexion at the shoulder and no more than 90 degrees flexion at the elbow. Use the Velcro® Arm Board Straps provided to secure the arms.

Figure 84: Articulating Arm Board Functionality

WARNING: Hyperextension of the shoulder may cause compression of the brachial plexus resulting in a potential nerve or vascular injury. Failure to ensure proper arm positioning may result in harm to the patient.

Figure 85: Final Neutral Prone Positioning

Page 81

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Retractor Adaptor

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

CAUTION: Use care and monitor the patient when changing the position of the ProAxis® Surgery Table (Height Up/Down, Hinge Up/Down, Trendelenburg/Reverse Trendelenburg, and Lateral Roll) to ensure that the patient or table does not interfere with other equipment and the components and accessories have proper clearance in relation to the surrounding areas. Failure to do so may cause harm to the patient or device.

38. Confirm that the patient is properly positioned. If a Retractor Adaptor is required to mount auxiliary equipment, mount it on the rail frame. Open the Adaptor by turning the black knob and releasing the bottom of the Adaptor. Place the Adaptor around the frame, align the black knob, turn to tighten and secure the Adaptor in place (Figure 86). Ensure that the patient does not directly contact the Retractor Adaptor. Use foam or gel padding as needed to pad the area between the patient and the Adaptor.

Figure 86: Retractor Adaptor Mounted on Carbon Fiber Rail

WARNING: Only the metal Retractor Adaptor may be positioned in the area above the hinge and below the rail mounts. Use of the optional Radiolucent Retractor Adaptor at this location results in a pinch point when using the hinge capabilities of the table, which may cause harm to the patient or the device.

NOTE: Use of the Radiolucent Retractor Adaptor at any location below the Hip Pads is allowed

when the hinge functionality of the table is engaged. The Radiolucent Retractor Adaptor can also be used above the hinge when the table is configured for cervical and the hinge functionality is deactivated.

39. Refer to Section 4 for instructions on how to utilize the IntelliPendant® and operate the table.

Page 82

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

CAUTION: The linkage arms of the columns raise, lower, and rotate when the table is in use. Ensure no items are in the path of the moving arms and healthcare professionals position themselves away from the linkage arms when the table is in motion. Failure to do so may cause injury to the healthcare professional or possible damage to the table.

Figure 87: Prone Positioning with Fixed Surgical Site Mode, Hinge Up

Page 83

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Rail Mount

Chest Tray

5 Way Articulating Arm Board

6988-899, Left 6988-887, Right

6988-950

6988-530, Arm Board

Assembly with Bracket & Pad (2)

5379-7722 1-inch (2.5)

Tempur-Pedic® Medical Arm Board Pad

Flat Chest Pad

Contoured ACP

Hip Pad, Right

Contoured ACP

Hip Pad, Left

6988-758 ProAxis®

Chest Pad

6988-388

6988-387

Leg Board

Leg Sling

Buttocks Strap

6844-148 (2)

5840-450

6977-739

Left

Right

8.1.1 Components Used for Prone Patient Positioning

Page 84

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Safety Strap, 60 in (152 cm)

Retractor Adaptor

ProAxis® ProneView®

Patient Care Kit

5840-43 (2)

6988-880

6988A-PV-ACP 6/case

Re-usable ProneView®

Adjustable Protective Helmet

System

Tempur-Pedic® Medical

Positioning Pillows (3)

ProAxis® Component Cart

D28502CE ProneView®

Adjustable Protective Helmet

D28580CE Mirror Platform

with Post Holes

6946 Standard Pillow (1) 6947 Queen Pillow (2)

6988-900

Includes a Cart Cover

ProAxis® Table Cover

Optional Accessory

6988-70

6988A-GT-ACP

ProAxis® GentleTouch® Patient Care Kit

6988-449

Radiolucent Retractor Adaptor

Front - Prone

Component Storage

Back - Optional Accessory Storage

Page 85

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Optional Accessory

6988-720

Cervical Traction Vector, Short

Page 86

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

8.2 ProAxis

Prone Patient Positioning with Cervical Management

Figure 88: ProAxis® Prone Positioning with Cervical Management Base Unit

The following instructions provide the recommended steps for setup. Final determination of patient positioning and setup is at the discretion of the surgeon and surgical team.

NOTE: When setting up the ProAxis

Table for prone patient positioning with cervical

management, the hinge capability of the table should not be enabled.

8.2.1 Prone Positioning with Cervical Management Base Unit

1. Confirm that the ProAxis® Spinal Surgery Table is prepared for setup (refer to Section 8).

8.1) to temporarily enable the hinge functionality. Utilizing the IntelliPendant®, press the Return to Level button to return the Hinged Frame to a neutral position. Remove the Rail Mounts and return them to their storage location on the ProAxis® Component Cart.

NOTE: DO NOT install the Left and Right Rail Mounts and the Torso Trolley

absence of these components will allow the hinge capabilities of the table to be disabled and the cervical components to be properly mounted.

Chest Tray. The

3. Install the ProAxis® Cervical Management Mounting Bracket on the Head-End Assembly (Figure 90).

Page 87

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Posts - Slide into Head-End Assembly

Horizontal Slide Locking Lever

Traction Rope Pulley

T-Handle Tightens Securing the Bracket in Place

Traction Pulley Faces Up

Open Rail Frame

Horizontal Slide Locking Lever

Figure 89: ProAxis® Cervical Management Base Unit Mounting Bracket

4. Orient the posts of the Bracket over the Head-End Assembly receptacle. Ensure the T-Handles of the receptacle are unscrewed. Slide the posts into the receptacle. The Bracket will rest on the top of the receptacle. Tighten both T-Handles (Figure 90).

Figure 90: ProAxis® Cervical Management Mounting Bracket Installed

5. To use the optional Mizuho OSI Cervical Management Base Unit on the ProAxis® Spinal Surgery Table:

a. Remove the Cervical Management Base Unit Sub-Assembly from the Table Adaptor

Assembly by:

i. First, loosening the Horizontal Slide Locking Lever on the Table Adaptor

Assembly.

ii. Aligning the Stop Cap of the Horizontal Slide so it can pass through and out of

the Table Adapter Assembly. Pull the Sub-Assembly away from the Table Adaptor Assembly to remove (Figure 91).

Page 88

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Table Adapter Assembly

Stop Cap

Horizontal Slide Locking Lever

Cervical Management Base Unit SubAssembly

Stop Cap

Horizontal Slide Locking Lever

Figure 91: Removal of Cervical Management Base Unit Sub-Assembly

b. Attach the Cervical Management Base Unit Sub-Assembly into the ProAxis® Cervical

Management Mounting Bracket. To attach:

i. Ensure the Horizontal Slide Locking Lever on the ProAxis® Cervical

Management Mounting Bracket is loosened and ready to receive the Cervical Management Base Unit Sub-Assembly.

ii. Align the Stop Cap and insert the posts of the Base Unit into the ProAxis®

Bracket (Figure 92).

iii. Tighten the Horizontal Slide Locking Lever when the desired position of the

Horizontal Slide is achieved.

Figure 92: Inserting Cervical Management Base Unit Sub-Assembly into the

ProAxis® Cervical Management Mounting Bracket

Page 89

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Transitional Arm Knobs #2 and #3

Horizontal Slide Locking Lever

#1 Black Knob Yoke Height Adjustment

Aluminum Adaptor

6. In preparation for attaching a Skull Clamp, attach the appropriate adaptor to the end of the Cervical Management Base Unit. The Cervical Management Base Unit includes the aluminum Swivel Adaptor used to mount an aluminum DORO® or Mayfield® Skull Clamp. A specific Radiolucent Adaptor is required to mount a radiolucent DORO® or a radiolucent Mayfield® device. Refer to the Cervical Management Base Unit Owner’s Manual for ordering information and detailed instructions on the use of the Radiolucent Adaptors.

7. With the Cervical Management Base Unit mounted on the ProAxis®, adjustments can be made to the position of the Adaptor to which the Skull Clamp is connected (Figure 93).

a. Refer to the Mizuho OSI Owner’s Manual NW0658 provided with the Cervical

Management Base Unit for detailed information on the functionality of the Cervical Management Base Unit Sub-Assembly and its various adjustment options.

b. Each of the Black Knobs (# 1, 2, and 3 in Figure 93) on the Sub-Assembly allow for

making adjustments to the position of the assembly until the desired position is achieved.

WARNING: Failure to ensure that all teeth of the starbursts are aligned and the knobs are

properly tightened may cause harm to the patient, healthcare professional or the device.

Figure 93: Cervical Management Components

c. To raise the height of the Yoke and Transitional Arms, turn the Black Knob #1 until the

desired height of the assembly is achieved. Loosen the Black Knobs, #2 and #3, controlling the position of the Transitional Arms holding the Adaptor. Adjustments can be made to the position and angle of the Assembly utilizing the Black Knobs. Tighten the Black Knobs when the desired position is achieved.

8. The components of the Cervical Management Base Unit Sub-Assembly have a starburst locking mechanism. Ensure that all teeth of the starburst are aligned and the corresponding knob is properly tightened when assembling or repositioning the device. All knobs should be tightened by hand; DO NOT use a wrench of any kind.

Page 90

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Chest Tray

9. Attach the Contoured ACP Hip Pads. The pads are labeled right and left specific to be

oriented to the patient’s iliac crest when lying prone. Open the Locking Bracket, orient the

Pad with Locking Bracket over the rail of the open frame on the Foot-End section of the frame, lower into place and slide towards the Hinge until it rests against the Pad Stop (Figure 71, page 67). Press up on the white tab until the black component of the clamp fits into the open notch of the white tab. Press down on the lip of the black component of the clamp to lock the pad in place. (Figure 72, page 67). When installed correctly, the pad should rest against the Pad Stop and the arrow on the side of the Bracket should be pointed toward the Foot-End of the table. To remove the Contoured Hip Pad, lift up on the lip of the Bracket so that it disconnects and lift the pad off the rail of the frame.

NOTE: Depending on the patient’s anatomy, the hip pads may be moved towards the Foot-End of

the table at the surgeon’s discretion to achieve proper positioning.

10. Attach the Cervical Chest Tray by releasing the Velcro® Straps on both sides and orienting the Cervical Chest Tray above the rails of the frame in the desired location. Slide the Chest Tray over the Frame until it sits on the Frame, and secure with the Velcro® Straps (Figure 94).

Figure 94: Cervical Chest Tray Installed on ProAxis® Frame

11. To attach the Flat ACP or Non-ACP Chest Pad, orient the opening of the pad bracket so it surrounds the edge of the Cervical Chest Tray. Slide onto the Cervical Chest Tray until the tab of the bracket is secure on the tray (Figure 95). To remove, press the tab of the bracket and slide the pad towards the Foot-End of the table.

NOTE: With ideal positioning, the Chest Pad should support the patient such that the load is borne

predominantly by the sternum. When the patient is positioned correctly, the top edge of the pad should rest below the patient’s anatomical landmark, the supra-sternal notch.

WARNING: Positioning the Chest Pad superior to the supra-sternal notch may apply pressure

to the throat and the patient’s airway. Failure to ensure the patient is positioned correctly on the

Chest Pad may result in harm to the patient or the device.

Page 91

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Tab of Chest Pad bracket

Chest Pad

Figure 95: Cervical Chest Tray with Chest Pad Installed

12. To install the Adjustable Leg Sling, place the sling over the Foot-End section of the open frame (Figure 74, page 68). Feed the four straps through their respective buckles on the opposite side of the sling and secure. The sling should be adjusted for each patient. The straps on the sling consist of a double–sided hook and loop closure that allows for infinite adjustment along the length of the strap. The hook end of the strap may be folded over onto the loop portion of the strap to allow for greater adjustability. The strap may be folded over itself again to shorten, thereby raising the sling and decreasing the degree to which the patient’s hips are flexed. Place two (2) or three (3) 6946 or 6947 TempurPedic® Medical Pillows in the sling approximately where the patient’s lower legs will rest to achieve the desired amount of knee flexion and support (Figure 75, page 69).

13. The Leg Boards may be used in place of the Leg Sling to support the legs. Attach the Leg Boards with the 1-inch (2.5 cm) Tempur-Pedic® Medical Pad. Release the Velcro® Straps on the sides of the Leg Board. Place one Leg Board over the rails of the open frame and slide into place. Secure with the Velcro® Straps. Repeat this process with the second Leg Board. Ensure that the two Leg Boards abut each other (Figure 76).

14. After the desired Flat Chest Pad and Contoured ACP Hip Pads are in place on the frame, the tubing can be connected to the pads.

a. Align the tubing with the long end directed to the pad furthest away from the port at the

Foot-End column (Figure 6, page 15).

b. Secure the ACP tubing with the Velcro® wraps along the frame and by routing it

through the underside of the Leg Sling. Ensure the tubing is secure and out of the way. c. Connect to the tubing to the port at the Foot-End of the table. d. Re-adjust the ACP tubing as may be required.

15. Place the Patient Kit Covers on the Chest and Hip Pads.

Page 92

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

16. Trial position the imaging equipment if it will be used. If necessary, re-locate the ProAxis® Spinal Surgery Table in the room. Unlock the Floor Locks by using the IntelliPendant® and with the assistance of a second person move the ProAxis® Spinal Surgery Table. When the table is located where it will be used, lock the Floor Locks.

CAUTION: The ProAxis® Surgery Table is not for patient transport. The location of the table relative to any imaging equipment that may be used needs to be confirmed prior to the patient being transferred to the table.

17. Refer to the specific manufacturer’s instructions for use regarding the Skull Clamp being attached to the Cervical Management Base Unit. The surgeon determines the best approach to secure the patient to the Skull Clamp.

18. Confirm the Black Knobs of the Cervical Management Base Unit are loosened so that the Transitional Arms and Adaptor can be readily positioned when connecting the Skull Clamp.

19. Position the patient bed or stretcher so the patient’s anatomical landmarks are aligned with the support pads on the hinged frame of the ProAxis® Spinal Surgery Table. It may be necessary to re-position the Chest Pad. The top edge of the Chest Pad should align with the patient’s anatomical landmark, the bottom of supra-sternal notch, and the top third of the Contoured ACP Hip Pad should align with the patient’s anatomical landmark, the iliac crest.

20. The height of the patient’s bed or stretcher should be level with the top of the Contoured ACP Hip Pad. To assist the patient transfer process, you may choose to use the IntelliPendant® and laterally tilt the table toward the patient bed or stretcher.

21. Lock the patient stretcher or bed. Confirm by observing the IntelliPendant® display that the table Floor Locks are locked. The Floor Locks Locked symbol should be visible (Figure 22, page 25).

22. The surgeon supports the patient’s head in the Skull Clamp while others assist to log-roll the patient onto the ProAxis® Spinal Surgery Table. The surgeon continues to support the patient’s head and Skull Clamp until final positioning is achieved with the Cervical Management Base Unit.

WARNING: After log-rolling the patient to a prone position, confirm that the endotracheal tube

is not kinked. Failure to confirm may cause harm to the patient.

23. Continue to support the patient on the table until the safety straps are in place. DO NOT leave the patient unattended on the table.

WARNING: Patient must be restrained at all times by a safety strap(s) when positioned on the

table.

24. Remove the patient bed or stretcher while supporting the patient on the table.

Page 93

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

25. Visually confirm the placement of the Contoured ACP Hip Pads. The pad should be mounted abutting the Pad Stop (Figure 73, page 68). When positioned correctly, the

patient’s anatomical landmark, the iliac crest, should rest in the top one-third of the pad.

The Patient Kit Hip Pad Cover should be smooth against the patient’s skin. Ensure that the

patient’s skin is smooth and flat against the Patient Kit Hip Pad Cover. To re-position the

patient on the Pad, the patient should be lifted and moved such that the iliac crest contacts the top third of the pad. Ensure the Hip Pad Cover is smoothed and lower the patient back onto the Pad. Confirm correct placement of the Pads such that each of the patient’s iliac crests rest in the top one-third of each respective Hip Pad (Figure 81, page 74).

CAUTION: Failure to ensure that the patient is positioned correctly on the Contoured ACP Hip

Pad may result in harm to the patient or the device.

26. Visually confirm the placement of the Chest Pad. When positioned correctly, the edge of the Pad should rest at the patient’s anatomical landmark, the supra-sternal notch (Figure 82, page 74). Breasts should be down and lying flat, with the nipples oriented towards the Foot-End of the table. The Patient Kit Chest Pad Cover should be smooth against the patient’s skin. Ensure that the patient’s skin is smooth and positioned flat against the cover. If necessary, re-position the Chest Tray. While lifting and supporting the patient, move the Chest Tray to the desired location and smooth the Chest Pad Cover. The patient should then be lowered back onto the Chest Pad.

NOTE: With ideal positioning, the Chest Pad should contact the patient such that the load is borne

predominantly by the sternum.

WARNING: Positioning the Chest Pad superior to the supra-sternal notch may apply pressure

to the throat and patient’s airway. Failure to ensure the patient is positioned correctly on the Chest

Pad may result in harm to the patient or the device.

27. Visually confirm that the Leg Sling or Leg Boards provide support to the patient’s knees, and the legs are supported on the pillows. If the Leg Sling is being used, the patient’s knees should be flexed and legs supported on the pillows. Re-position the legs and add

pillows as required under the patient’s tibias to ensure that the ankles are not hyper- extended and there is no pressure on the patient’s feet (Figure 81, page 74).

CAUTION: Failure to ensure that the patient is positioned correctly with the Leg Sling or Leg

Boards may result in harm to the patient or the device.

28. Position the patient’s arms back to his/her sides and secure. The disposable Positioning Straps may be used to assist in final positioning. The Arm Cradles may be used to provide padding.

29. Place the Buttocks Strap across the lower gluteal area of the patient. A blanket may be used under the Buttocks Strap to protect the patient from direct contact with the strap. The strap can be fed through the buckle on the sides of the Contoured ACP Hip Pads and then back on itself, securing the Velcro®. Confirm that the Buttocks Strap is positioned low on the gluteal area, and that it surrounds both Contoured ACP Hip Pads, and is secured snugly around the buttocks. Ensure that the patient does not directly contact the frame of the table. Use foam or gel padding as needed to pad the area between the patient and the rails of the frame.

30. Apply a Safety Strap over the patient’s lower legs. Secure the Safety Strap in place with use of the buckle.

Page 94

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Figure 96: Final Prone Positioning with Cervical Management Base Unit

NOTE: The placement and location of the Straps are at the discretion of the surgeon and vary by

procedure.

31. Due to the open nature of the ProAxis® frame and the long duration of many spinal procedures, the use of forced air warmers, fluid warmers, and blankets should be considered to help prevent hypothermia. Blankets may be placed over the feet up to the gluteal area and across the shoulders and arms out of the surgical field to aid in

maintaining the patient’s body temperature. These devices should be used according to the manufacturer’s directions and at the discretion of the surgeon.

WARNING: Use care and monitor the patient when changing the position of the ProAxis® Surgery Table (Height Up/Down, Trendelenburg/Reverse Trendelenburg, and Lateral Roll) to ensure that the patient or table does not interfere with other equipment, and the components and accessories have proper clearance in relation to the surrounding areas. Failure to do so may cause harm to the patient or device.

32. Confirm that the patient is in their final position. If a Retractor Adaptor is required to mount auxiliary equipment, mount it on the rail frame. Open the Adaptor by turning the black knob and releasing the bottom of the Adaptor. Place the Adaptor around the frame, align the black knob, turn to tighten and secure the Adaptor in place. Ensure that the patient does not directly contact the Retractor Adaptor. Use foam or gel padding as needed to pad the area between the patient and the Adaptor.

33. Refer to Section 4, Basic Operation, for instructions on how to utilize the IntelliPendant® and operate the table.

Page 95

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Cervical Traction Vector Adjustor

8.2.2 Prone Patient Positioning with Cervical Traction Vector Adjustor

The Cervical Traction Vector Adjustor is designed to provide adjustability of the angle of pull of cervical traction as well as to maintain alignment of the traction rope when skull tongs or a head halter is used.

Figure 97: Cervical Traction Vector Adjustor Properly Installed on ProAxis®

1. Confirm that the ProAxis® Surgery Table is prepared for setup (refer to Section 8).

2. Confirm that the Floor Lock symbol is visible on the display of the IntelliPendant® (Figure 22, page 25). Observe the display on the IntelliPendant® and confirm the frame is level and the hinge neutral. The Hinge, Trendelenburg, and Lateral Tilt angles should read 0° (Figure 22, page 25). If necessary, temporarily install the Right and Left Rail Mounts (refer to Section 8.1) in order to enable the hinge functionality. Utilizing the IntelliPendant®, press the Return to Level button to return the Hinged Frame to the neutral position. Remove the Rail Mounts and return them to their storage location on the ProAxis® Component Cart.

3. Install the ProAxis® Cervical Traction Vector Adjustor. Extend the Drop Lock on the post of the Cervical Traction Vector Adjustor, align the posts with the Head-End Assembly receptacle, and lower the Vector into place (Figure 98). Position the Vector at the desired height and tighten both T-Handles on the Head-End Assembly (Figure 99).

Page 96

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Notch to Guide Traction Rope

Drop Lock

Tighten T-Handle to Secure Traction Vector Adjustor at Desired Height

Figure 98: Installation of Cervical Traction Vector Adjustor

NOTE: DO NOT install the Left and Right Rail Mounts and the Torso Trolley

Chest Tray. The absence of these components will allow the hinge capabilities of the table to be disabled and the cervical components to be properly mounted.

Figure 99: Cervical Traction Vector Adjustor Properly Installed on ProAxis®

4. A traction rope can be directed over the Traction Vector Adjustor, with the length of rope adjusted so the attached weight(s) can hang freely. While monitoring the position of the weights, utilize the IntelliPendant® to raise and lower the table through its full range of motion. Ensure the weight(s) continues to hang freely in all table positions. Adjust the length of traction rope if necessary.

5. Install the remaining prone positioning components as instructed in Section 8.2.2.

Page 97

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

ProAxis® Cervical Management

Base Unit Mounting Bracket

Cervical Chest Tray

Flat Chest Pad

6988-209

6988-969

6988-758 ProAxis® Chest

Pad

Contoured ACP

Hip Pad, Left

Contoured ACP

Hip Pad, Right

Leg Sling

6988-387

6988-388

5840-450

Leg Board

Buttocks Strap

Safety Strap, 60 in. (152 cm)

6844-148 (2)

6977-739

5840-43 (2)

8.2.3 Components for Prone Patient Positioning with Cervical Accessories

Page 98

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Tempur-Pedic® Medical Pillow

Retractor Adaptor

Cervical Traction Vector Adjustor

6946 Standard Pillow (1) 6947 Queen Pillow (2)

6988-880

6988-725

Optional Accessory

5979-1 Cervical

Management Base Unit

6910-3034 DORO®

Radiolucent Skull Clamp (pictured)

6910-1001 DORO® QR3

Aluminum Skull Clamp

6910-3006-2 Titanium, Adult

Skull Pins for DORO®

6910-3006-5 Stainless, Adult

Skull Pins for DORO®

Optional Accessory

5979-300 Radiolucent

DORO® Adaptor for Cervical Management Base Unit (pictured)

5979-200 Radiolucent

Mayfield® Adaptor for Cervical Management Base Unit

6988-449

Radiolucent Retractor Adaptor

Page 99

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Hinge Angle -20º

Tempur-Pedic® Medical 2-inch Supine Table Pad with Translation Slide

Carbon Fiber Removable Two-Piece Supine Top

8.3 ProAxis

Supine Patient Positioning

Figure 100: ProAxis® Supine Setup, Fixed Surgical Site Mode

The following instructions provide the recommended steps for setup. Final determination of patient positioning and setup is at the discretion of the surgeon and surgical team.

1. Confirm the ProAxis® Surgery Table is prepared for setup (refer to Section 8).

2. Confirm that the Floor Lock symbol is visible on the display of the IntelliPendant® (Figure 22, page 25). Observe the display on the IntelliPendant® and confirm the frame is level and the hinge neutral. The Hinge, Trendelenburg, and Lateral Tilt angles should read 0° (Figure 22, page 25). If necessary, temporarily install the Right and Left Rail Mounts (refer to Section 8.1) in order to enable the hinge functionality. Utilizing the IntelliPendant®, press the Return to Level button to return the Hinged Frame to a neutral position. Remove the Rail Mounts and return them to their storage location on the ProAxis® Component Cart.

3. Confirm that there are no accessories mounted to the rails before attempting to mount the Two-Piece Supine Top.

4. The ProAxis® Two-Piece Supine Top is made of carbon fiber construction and mounts on the open rail frame. Each section (Head-End and Foot-End) has a set of Locking Brackets that secure the top to the frame. The Head-End section also has a Cable Connector that plugs into the Head-End port, allowing the hinge to function (Figure 104, page 97).

a. To install the Head-End section on the frame, open the Locking Brackets, align the

Locking Brackets over the rails, and lower into place (Figure 101). The top should rest flat on the frame. Slide the Top toward the Head-End Column until it rests against the Brackets of the rail frame on both sides (Figure 107, page 99).

Page 100

ProAxis® Spinal Surgery Table Owner’s Manual

Mizuho OSI 2016

NW0725 Rev K

Locking Bracket Aligned over Rail Frame

Figure 101: Supine Top Locking Bracket Placed over Rail in Open Position

b. To engage the Locking Brackets on each side, first press up on the white tab until the

black portion of the clamp fits into the open notch of the white tab. Press down on the lip of the black component of the clamp to lock it into place (Figure 102).

Figure 102: Latching of Locking Bracket

Mizuho Osi ProAxis 6988 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual