Model Ref 5803,5803I,5803J Advanced Control Base for Modular Table System Rev D Owners Manual 2014

Table of Contents 1

Important Notices... 1

2

Introduction... 5

1.1 Disposal of Electrical Components... 4

2.1 General Description... 2.2 Intended Use... 2.3 User Profile... 2.4 Training Requirements... 2.5 Conditions of Use... 2.6 Product Lifetime... 2.7 Specifications... 2.8 Shipping and Storage... 2.9 Glossary of Terms...

5 6 6 6 6 7 7 7 8

3

Component Identification... 10

4

Basic Operation... 17

5

3.1 Table Orientation... 10 3.2 Head-End Column of the Advanced Control Base... 11 3.2.1 Base of the Head-End Column... 12 3.2.2 Pivot Assembly... 13 3.3 Foot-End Column of the Advanced Control Base... 15 3.4 Model Number and Serial Number... 16

4.1 Control Operation... 4.2 Casters... 4.3 Moving the Advanced Control Base... 4.4 Hand Pendant... 4.5 Indicator Lights... 4.5.1 180 Degree Rotation Lock... 4.5.2 Rotation Safety Lock... 4.5.3 Tilt Drive Status... 4.6 Traction Pulley Assembly... 4.7 Retracting the Advanced Control Base for Storage... 4.8 Table Top Storage on the Base...

17 18 19 19 22 22 23 23 24 25 26

Inspection... 29 5.1 Acceptance and Transfer... 5.2 Pre-Procedure/Post-Procedure... 5.3 Semi-Annual Preventative Maintenance... 5.4 Product Lifetime...

ii

29 29 29 29

6

Installing a Table Top... 30

7

Function Check... 36 7.1 Table and Hand Pendant Functions... 7.2 Synchronizing the Lateral Tilt Function... 7.2.1 Evaluating Synchronization Status... 7.2.2 Synchronizing the Lateral Tilt Function with Table Top Coupled to the Base... 7.2.3 Synchronizing the Lateral Tilt Function Without a Table Top Coupled to the Base . .

36 39 39 39 40

8

Cleaning, Storage, and Maintenance... 42

9

Electrical System... 44

8.1 Cleaning and Disinfecting... 42 8.1.1 Advanced Control Base Exterior... 42 8.2 Storage... 42 8.3 Maintenance... 43 8.3.1 Battery Maintenance... 43 8.3.2 Preventative Maintenance... 43

9.1 Description... 44 9.2 Power Cord... 44 9.3 On/Off Circuit Breaker Power Switch... 44 9.4 Linear Actuators... 44 9.5 Battery System... 45

10 Troubleshooting... 46

10.1 Electrical System... 46 10.2 Base... 46 10.3 Hand Pendant... 47

11 Removal, Replacement, and Adjustment of Components... 48

11.1 Removal and Replacement of Components... 48 11.1.1 Base Cover, Foot-End... 48 11.1.2 Foot-End Cover... 49 11.1.3 Base Cover, Head-End... 50 11.1.4 Head-End Cover... 52 11.1.5 Hand Pendant Module... 55 11.1.6 Batteries... 56 11.1.7 Power Supply... 58 11.1.8 Control Circuit Board... 61 11.1.9 ON/OFF Power Switch... 62 11.1.10 Power Input Plate... 63 11.1.11 Head-End Assembly... 63 11.1.12 Foot-End Assembly... 67 11.1.13 Head-End Tilt Motor Assembly... 69 iii

11.1.14 Foot-End Rotation Safety Lock Motor... 72 11.1.15 Head-End Column... 73 11.1.16 Foot-End Column... 74 11.1.17 Retractable Center Beam... 75 11.1.18 Casters... 76 11.2 Adjustment of Components... 77 11.2.1 180 Degree Rotation Lock Sensor... 77 11.2.2 Home and Tilt Left/Right Sensors... 77 11.2.3 Head-End Slider Adjustment Procedure... 78 11.2.4 180 Degree Rotation Safety Lock... 79 11.2.5 Rotation Safety Lock (Brake) “ON” Sensor Setting... 80

12 Technical Drawings and Parts List... 82 12.1 Electrical Interconnect Diagram, 100/120/220-230V... 82 12.2 Replacement/Spare Parts List... 84 12.3 Replacement Parts... 85

13 Mizuho OSI Customer Resource Group... 86

13.1 Contact for Parts and Service... 86 13.2 Instant Support Value Package... 86 13.3 Order Replacement Parts... 86 13.4 Return Damaged Parts... 86 13.5 Send a Part for Repair... 87 13.6 Warranty... 87 13.7 European Union EC Representative ... 87

14 Appendix... 88 14.1 Electromagnetic Emissions... 88 14.2 Electromagnetic Immunity... 89 14.3 Recommended Separation Distances... 91

iv

Advanced Control Base Owner’s Manual

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 in the US or +1-510-429-1500 internationally. 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: Symbol

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

NOTE:

This symbol indicates a comment or instruction of importance. This symbol is 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 to important operation, maintenance, or safety instructions. This symbol indicates proper disposal instructions. This symbol indicates a product number. This symbol indicates a serial number. This symbol indicates that you need to read the owner’s manual for use. This symbol indicates that you need to refer to the operating instructions for use. This symbol indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility.

Mizuho OSI 2014

1

NW0646 Rev D

Advanced Control Base Owner’s Manual

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 a Fault Indicator. This symbol identifies the 180º Rotation Lock. This symbol identifies the Rotation Lock. This symbol indicates rotation in either of two directions. This symbol indicates rotation in one direction.

This symbol identifies the Tilt Drive Status.

This symbol identifies POWER OFF. This symbol identifies POWER ON. This symbol represents the Battery Status of the Advanced Control Base. This symbol represents a locked state. This symbol represents an unlocked state. This symbol informs the user that unlocking may cause movement.

This symbol informs the user that the Tilt Drive is centered when the light is on.

This symbol informs the user that the mechanism is locked when the light is on.

Mizuho OSI 2014

2

NW0646 Rev D

Advanced Control Base Owner’s Manual

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

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

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

WARNING: The weight capacity of the Advanced Control Base is table top specific. Use of the Modular Table System (Base with any of the five compatible table tops) with patients exceeding the table top specific weight capacity could result in damage to the table, possible injury to the patient or harm to the healthcare workers.

WARNING: A Spinal Surgery Top or Radiolucent Imaging Top used on the Advanced Control Base must have gimbals. Earlier versions of these table tops do not have gimbals. Use of table tops without gimbals on the Advanced Control Base may result in damage to the table top and the Base.

WARNING: Before and after each use, inspect the Advanced Control Base and its components for possible damage, excessive wear, or non-functioning parts. Carefully inspect all critical, inaccessible areas, joints, and all moving parts for possible damage or non-function. Damaged or defective parts should not be used or processed. Contact the Mizuho OSI Customer Resource Group for repair or replacement (refer to Section 13).

WARNING: The Advanced Control Base should not be operated in the presence of flammable anesthetics, volatile substances, or other explosive gases, liquids, or atmospheres.

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

CAUTION: No modification of the Advanced Control Base or its components is allowed. Any modification to the equipment may result in damage to the table, possible injury to the patient or harm to the healthcare workers. Mizuho OSI 2014

3

NW0646 Rev D

Advanced Control Base Owner’s Manual 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 Advanced Control Base, refer to the instructions for use provided by the manufacturer of those devices.

1.1 Disposal of Electrical Components

In accordance with the European Union Waste Electrical and Electronic Equipment (WEEE) Directive, all electrical components, batteries and carbon composite components must be returned to Mizuho OSI for proper disposal. Please contact Mizuho OSI Customer Resource Group Service Department at 1-800-7774674 in the US or +1-510-429-1500 internationally for further information regarding this requirement.

Mizuho OSI 2014

4

NW0646 Rev D

Advanced Control Base Owner’s Manual

2

Introduction

2.1 General Description The Advanced Control Base is the primary component of the Modular Table System and is designed to be used with multiple interchangeable table tops. The Modular Table System provides the flexibility to position patients for a variety of surgical or radiographic imaging procedures. The Advanced Control Base provides the foundation on which a table top may be mounted, creating a surgical platform free of any obstructions when used with a fluoroscopic C-arm or the O-arm®. The Base is designed for use with the following procedurespecific table-tops currently offered: Spinal Surgery Top, Radiolucent Imaging Top, and Orthopedic Trauma Top. The Base may also be used with two discontinued tops, the Axis System and the Maximum Access™ Top. The Advanced Control Base has three primary electrically powered functions. Electromechanical actuator motors perform these motions which are controlled by means of the Hand Pendant. The three functions are: Height (up/down), Lateral Roll (left/right), and Trendelenburg/reverse Trendelenburg. The Base may also be retracted for storage (refer to Section 4.7). The Base can be operated under AC power or internal batteries. The product life of the Advanced Control Base is ten (10) years when used and maintained as outlined in this manual. Head-End Foot-End

Figure 1: Advanced Control Base

Mizuho OSI 2014

5

NW0646 Rev D

Advanced Control Base Owner’s Manual

2.2 Intended Use With a table top mounted on the Advanced Control Base, an electrically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized. The Base with a table top is intended for use during surgical procedures, including radiographic imaging during such procedures. The Base with a table top mounted should not be used for patient transport. The modular tops when mounted on the Advanced Control Base provide a platform designed to support and position adult and pediatric patients falling within the maximum weight limit allowed for each top as listed below: • Spinal Surgery Top:

500 lbs (227 kg)

• Radiolucent Imaging Top:

500 lbs (227 kg)

• Orthopedic Trauma Top:

500 lbs (227 kg)

• Axis System (discontinued):

500 lbs (227 kg)

• Maximum Access™ Lateral Top (discontinued):

350 lbs (159 kg)

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

2.4 Training Requirements Before using the Modular Table System, the user must read the NW0646 Advanced Control Base Owner’s Manual. Depending on the table top(s) used, the user must also read the corresponding Owner’s Manual listed below: NW0677 Radiolucent Imaging Top Owner’s Manual NW0678 Spinal Surgery Top Owner’s Manual NW0648 Orthopedic Trauma Top Owner’s Manual It is recommended that personnel using the Modular Table System receive training by either Mizuho OSI or by someone qualified by the medical facility to provide this training.

2.5 Conditions of Use The Advanced Control Base may be used several times throughout the day and night in medical facilities; e.g. hospitals, and outpatient surgery/imaging centers. The Advanced Control Base 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.

Mizuho OSI 2014

6

NW0646 Rev D

Advanced Control Base Owner’s Manual

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.

2.7 Specifications The Advanced Control Base has the following specifications. • The Base is compatible with all Modular Table System tops equipped with gimbals. • When used with each of the procedure-specific, modular table tops, the Advanced Control Base provides the platform on which these table tops are designed to mount. The maximum patient load is table top specific (Refer to appropriate Owner’s Manual). • Height range of the Base is 34 to 48 inches (86.4 cm – 122 cm). • Width of the Base is 32 inches (81.3 cm). • Maximum length of the Base is 102 inches (259.1 cm), with a retracted length of 64 inches (162.6 cm) for storage. • Lateral Roll (left/right) is 0-25 degrees (± 3 degrees), and the Trendelenburg/reverse Trendelenburg is 0-10 degrees (± 3 degrees), • Input power requirement is 100V, 50/60Hz; 120V, 60Hz; or 220-230V, 50/60Hz as indicated on the table label. • The table may also be operated under battery power. The expected working life of a fully charged battery is approximately eight (8) hours. • The Base is IPX4 rated per IEC 60529. • Operating environment – 68 degrees F (20 degrees C), relative humidity 50%, atmospheric pressure 75-105 kPa. • Class 1 Equipment; Type B per IEC 60601-1. • The Base is not suitable for use with flammable anesthetic gas mixtures.

2.8 Shipping and Storage If required to be transported, the Advanced Control Base must be transported using the appropriate shipping crate. Unpacking instructions were included with the original shipping crate and should be included on the outside of the crate if the Advanced Control Base must be transported. When not in use, the Advanced Control Base 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 When in storage, the table cover provided with each respective table top serves as a dust cover and should be used. Also, to ensure that the battery is always fully charged and ready for use, store the Base connected to the AC power which matches the ratings on the manufacturer’s label located on the Head-End of the Base (Figure 8, Page 16).

Mizuho OSI 2014

7

NW0646 Rev D

Advanced Control Base Owner’s Manual NOTE: The Power Switch must be toggled to the ON position for the battery to charge.

2.9 Glossary of Terms This glossary of terms assumes that the patient is oriented with his or her head at the Head-End of the table and his or her feet at the Foot-End of the table. The Hand Pendant functions are oriented for this position only. Term

Description

Head-End

Refers to the end of the Base where the Power Cord, ON/OFF Power Switch and Control Panel are located.

Foot-End

Refers to the end of the Base opposite the Head-End.

Column

Refers to each of the two main column structures of the Base used to support the table top.

Left Side of the Base Refers to the left side of the Base (as you stand at the Head-End and look towards the Foot-End). The Hand Pendant button used to laterally roll (tilt) the table top to the left is labeled LEFT LATERAL ROLL. Right Side of the Base

Refers to the right side of the Base (as you stand at the Head-End and look towards the Foot-End). The Hand Pendant button used to laterally roll (tilt) the table top to the right is labeled RIGHT LATERAL ROLL.

Raise the Column

Refers to raising the Height of the Base. The Hand Pendant button used to raise the Base is labeled HEIGHT UP.

Lower the Column

Refers to lowering the Height of the Base. The Hand Pendant button used to lower the Base is labeled HEIGHT DOWN.

Trendelenburg

Refers to lowering the height of the Head-End of the column relative to the FootEnd of the Column. The Hand Pendant button used to lower the Head-End below the Food-End is labeled TREN.

Reverse Trendelenburg

Refers to lowering the height of the Foot-End of the column relative to the HeadEnd of the Column. The Hand Pendant button used to lower the Foot-End below the Head-End is labeled REV TREN.

Table Motion

Any one of the three motions: Height , Tilt, or Trendelenburg.

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.

Caster Locks

Swivel wheels mounted at the bottom of the frame with rotational lock.

Hand Pendant

A wired hand-held device that can control specific motions of the table (e.g. Height, Tilt, or Trendelenburg).

Quiver

A Quiver is located at both the Head-End and Foot-End of the Base and provides a storage location for the T-Pins when not in use.

H-Frame Storage Bracket

The H-Frame Storage Brackets, located at each end of the Base, provide a storage location for H-Frames when not in use.

Slide Assembly

The Slide Assembly at the Head-End Column adjusts superiorly or inferiorly to accommodate for the length adjustments needed when using Trendelenburg and reverse Trendelenburg.

Traction Pulley Assembly

The Traction Pulley Assembly allows for weighted traction to be pulled by guiding the use of a traction rope.

Mizuho OSI 2014

8

NW0646 Rev D

Advanced Control Base Owner’s Manual Table Top

The patient support surface or frame on which patient support accessories are attached. The Advanced Control Base is designed for use with three (3) table tops: Spinal Surgery Top, Radiolucent Imaging Top, and Orthopedic Trauma Top.

Gimbal

Gimbals allow for the rotation of a table top when positioned in extreme lateral tilt. The Spinal Surgery Top and the Radiolucent Imaging Top must be equipped with gimbals in order to be used with the Advanced Control Base.

Prone (Patient) Position

A body position in which the patient lies face down on a table top

Supine (Patient) Position

A position in which the patient lies face-up on a table top.

Mizuho OSI 2014

9

NW0646 Rev D

Advanced Control Base Owner’s Manual

3

Component Identification

3.1 Table Orientation The Advanced Control Base is described as having a Head-End and a Foot-End. The Head-End of the Base provides the port to which the Hand Pendant is connected, and the end opposite to it is identified as the FootEnd (Figure 2). Each end also contains a Crossbar with mounting posts that allows for the attachment of a table top. With a table top installed, the patient should be positioned with his or her head oriented towards the Head-End of the Base. Head-End Foot-End Crossbar Crossbar Quiver

Center Beam Retracting Lock Knob

H-Frame Storage Brackets

Figure 2: Advanced Control Base NOTE: The maximum weight capacity for this table system is specific to each table top as noted in the respective Owner’s Manuals and on the safety labels found on the table tops themselves.

WARNING: Use of the Advanced Control Base and a procedure-specific table top with a patient exceeding the maximum patient weight capacity noted could result in damage to the table, possible injury to the patient or harm to the healthcare workers.

Mizuho OSI 2014

10

NW0646 Rev D

Advanced Control Base Owner’s Manual

3.2 Head-End Column of the Advanced Control Base The Head-End Column of the Advanced Control Base contains several key controls necessary to operate the Base correctly as well as important indicator lights and product identification information. Features found on Head-End Column include the Cord Wrap, the Traction Pulley, a Quiver for T-Pin Storage and two locking casters (Figure 3).

Traction Pulley

Hand Pendant

Cord Wrap

Quiver

ON/OFF Switch

Locking Caster

Locking Caster

Manufacturer’s Label Indicator Lights

Figure 3: Head-End Column of the Advanced Control Base

Mizuho OSI 2014

11

NW0646 Rev D

Advanced Control Base Owner’s Manual

3.2.1 Base of the Head-End Column The outside base of the Head-End Column is equipped with the following four (4) indicator lights (Figure 4): • • • •

ON/OFF Power Switch Light Power Light Battery Status Light Fault Light

Under normal operation, the ON/OFF Power Switch Light, the Power Light, and the Battery Status Light should be illuminated green, and the Fault Light should be dark. NOTE: If the Battery Status Light is illuminated red, the battery requires charging, and the table should only be used under AC Power. NOTE: If the Fault Light is illuminated red, there is an electrical fault that must be addressed and resolved prior to using the Base.

CAUTION: Failure to address and resolve the electrical fault prior to using the Base may result in damage to the table, possible injury to the patient or harm to the healthcare workers.

On/Off Power Switch Battery Status Light

Power Light

Fault Light

Figure 4: Head-End Column, Outside Base

Mizuho OSI 2014

12

NW0646 Rev D

Advanced Control Base Owner’s Manual The inside base of the Head-End Column is equipped with the following electrical features (Figure 5): • Power Cord Receptacle • Reset Button/Circuit Breaker • External Ground Stud

External Ground Stud Reset Button/Circuit Breaker

Power Cord Receptacle

Figure 5: Head-End Column, Inside Base

3.2.2 Pivot Assembly The Head-End Pivot Assembly is equipped with three indicator lights, which consist of the following (Figure 6): • 180 Degree Rotation Lock indicator light • Rotation Safety Lock indicator light • Tilt Drive Status indicator light

Mizuho OSI 2014

13

NW0646 Rev D

Advanced Control Base Owner’s Manual Rotation Safety Lock Indicator Light

180 Degree Rotation Lock Indicator Light

Hand Pendant Storage Bracket

Tilt Drive Status Indicator Light

180 Degree Rotation Lock Blue Handle

Figure 6: Pivot Assembly of the Head-End Column The Head-End Pivot Assembly also features the 180 Degree Rotation Lock blue handle, the Traction Pulley, and the Hand Pendant Storage Bracket.

Mizuho OSI 2014

14

NW0646 Rev D

Advanced Control Base Owner’s Manual

3.3 Foot-End Column of the Advanced Control Base The Foot-End Column of the Advanced Control Base contains the Traction Arc Interlocking Switch and a second Quiver for T-Pin Storage as well as one steering caster and one locking caster (Figure 7).

Traction Arc Interlocking Switch

Quiver

Locking Caster Steering Caster

Figure 7: Foot-End Column of the Advanced Control Base

Mizuho OSI 2014

15

NW0646 Rev D

Advanced Control Base Owner’s Manual

3.4 Model Number and Serial Number

Manufacturer’s Label

Figure 8: Manufacturer’s Label, Outside Base of Head-End Column product number and In addition to the manufacturer’s label:

serial number, the following information is provided on the

Duty Cycle: 4% / 2.5 min. per 60 min. Voltage: varies with product number: 5803 (120V 60Hz) 5803I (220-230V 50/60Hz) 5803J (100V 50/60Hz)

Mizuho OSI 2014

16

NW0646 Rev D