Advanced Control Pad System with Tempur - Pedeic Medical Support Pads Owners Manual Rev F

Table of Contents 1

Important Notices... 1

2

Introduction... 4

3

Component Identification... 8

4

Set Up Instructions... 13

5

Basic Operation... 16

6

Troubleshooting... 18

1.1 Trademarks... 3 1.2 Disposal of Electrical Components... 3

2.1 General Description... 2.2 Intended Use / Indications... 2.3 Patient Population... 2.4 Identification of Type B Parts... 2.5 Specifications... 2.6 Shipping, Storage and Environmental Conditions... 2.7 Glossary of Terms...

4 5 5 5 6 6 7

3.1 Variable Cycle Controller... 8 3.1.1 Cycle Indicators... 8 3.2 On/Off Power Switch... 8 3.3 Power Cord and Ground Stud... 9 3.3.1 Power Cord... 9 3.3.2 External Ground Stud... 10 3.4 Model Number Identification Label and Voltage Requirements... 10 3.5 Snorkel Mounting Bracket... 10 3.6 Tempur-Pedic® Medical Patient Support Pads... 11 3.6.1 Hip Pads (Small, Medium/Regular, and Large)... 11 3.7 ACP Quick Connect Tubing Set... 12 3.7.1 Inspection and Transfer... 12

4.1 Controller Installation... 13 4.2 Pad Installation... 13 4.3 Tubing Attachment... 14

5.1 Power... 16 5.2 Cycle Selection... 16 5.3 Post Patient Removal... 17

6.1 In the event of a malfunction... 18

ii

7

Cleaning and Maintenance... 19

8

Parts List... 20

9

Mizuho OSI Customer Resource Group... 21

7.1 Cleaning and Disinfecting... 19

8.1 Replacement / Spare Parts List... 20

9.1 Contact for Parts and Service... 21 9.2 Instant Support Value Package... 21 9.3 Order Replacement Parts... 21 9.4 Return Damaged Parts... 21 9.5 Send a Part for Repair... 22 9.6 Warranty... 22 9.7 European Union EC Authorized Representative ... 22

10 Appendix... 23

10.1 Electromagnetic Emissions... 23 10.2 Electromagnetic Immunity... 24 10.3 Recommended Separation Distances... 26

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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 to be used by Trained Medical Professional only; Training consists of reading of this User Manual and of the NW0678 Spinal Surgery Top. If required, please contact Mizuho OSI Customer Resource Group to coordinate additional on-site training (refer to Customer Resource Group, section 9.0). 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 the MANUFACTURER of the device. This symbols 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 products’ REFERENCE NUMBER. This symbol indicates an AUTHORIZED REPRESENTATIVE in the EUROPEAN COMMUNITY. This symbol indicates that you need to READ THE MANUAL before use. This symbol indicates an EXTERNAL GROUND STUD that is required for use when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility. This symbol indicates PROTECTIVE EARTH (ground) to identify any terminal which is intended for connection to an external conductor for protection against electric shock.

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Advanced Control Pad System™ This symbol indicates this equipment is an applied part TYPE B in accordance with IEC 60601-1 and is generally suitable for applications involving external or internal contact with the patient, excluding the heart. The patient circuit is connected to protective earth and this equipment should be connected only to hospital grade AC outlets with a protective earth ground. This symbol indicates OUTPUT for the Tubing Port connection. This symbol indicates the switch to TURN POWER ON. This symbol indicates the switch to TURN POWER OFF.

This symbol indicates HIP PAD, SMALL PATIENT

This symbol indicates HIP PAD, REGULAR (MEDIUM) PATIENT

This symbol indicates HIP PAD, LARGE PATIENT

This symbol indicates THIGH PAD, LEFT

This symbol indicates THIGH PAD, RIGHT

This symbol indicates COMBINATION CONTOURED HIP/THIGH PAD, LEFT

This symbol indicates COMBINATION CONTOURED HIP/THIGH PAD, RIGHT

WARNING: To protect the patient and hospital staff from possible hazards, an external ground wire connection is required between the External Ground Stud and Protective Earth ground.

WARNING: To avoid the risk of electric shock, this equipment must only be connected to supply mains with Protective Earth.

WARNING: Do not modify this equipment without the authorization of the manufacturer.

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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: Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

WARNING: The use of accessories, transducers and cables other than those specified by Mizuho OSI, may result in increased emissions or decreased immunity of the equipment.

WARNING: Operating environment is 10-30º C; relative humidity 30-60% non-condensing.

WARNING: This device is not suitable for use with flammable anesthetic gas mixtures and is not intended for use in an oxygen rich environment.

WARNING: This equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.

CONTRAINDICATION WARNING: The Advanced Control Pad System™ is designed to provide user selected massage action and periodic pressure point stimulation to the patient. The patient must be monitored for symptoms caused by pressure points per normal good operating room practice. Failure to monitor the patient adequately could result in injury to the patient.

1.1 Trademarks Advanced Control Pad System™ is a trademark of Mizuho OSI Tempur-Pedic® Medical is a registered trademark of Tempur-Pedic® Medical, Inc.

1.2 Disposal of Electrical Components In accordance to the WEEE directive, all electrical components, batteries and carbon composite components must be returned to Mizuho OSI for proper disposal. Please contact Mizuho OSI Technical Service Department at 1-800-777-4674 for further information regarding this requirement.

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Introduction

2.1 General Description The Advanced Control Pad System™ (ACP) with Tempur-Pedic® Medical is designed specifically for use with the Advanced Control Base and the Spinal Surgery Top (SST). Utilizing the ACP System, user selected massage action and periodic pressure point stimulation is provided to the patient at the site of the hip and thigh pads. The ACP System consists of three components (Figure 1) that work together: 5996-7 (5996 100/120 VAC) or 5996-8 (5996i 230 VAC), Variable Cycle Controller (Figure 2) 5996-200 Mizuho OSI Tempur-Pedic® Medical Patient Support Pads (Figure 6) 5996-12 ACP Quick Connect Tubing (Figure 7) The ACP System is an electronically controlled pneumatically actuated system, class I equipment with a rating of IPX4. It operates at either 100-120VAC, 50/60 Hz or at 230VAC, 50 Hz. NOTE: There are no other accessories that can or should be used with the ACP System. Other manufacturers’ products have not been tested for proper performance when used with the Advanced Control Pad System™ and therefore are not endorsed for use by Mizuho OSI. Use of other manufacturers’ product may void the warranty.

Figure 1: Advanced Control Pad System™ (ACP) Components

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2.2 Intended Use / Indications The intended use of the Advanced Control Pad System™ is as an electronically controlled, pneumatically actuated system. The ACP System is used to provide user selected massage action and periodic pressure point stimulation to the patient at the site of the hip and thigh pads, these support pads being defined as temporary use support and positioning of a prone patient during surgical procedures. NOTE: The ACP 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.

CONTRAINDICATION WARNING: The Advanced Control Pad System™ is designed to provide user selected massage action and periodic pressure point stimulation to the patient. The patient must be monitored for symptoms caused by pressure points per normal good operating room practice. Failure to monitor the patient adequately could result in injury to the patient.

2.3 Patient Population The Patient is an individual who is undergoing a surgical, diagnostic or imaging procedure. The Patient is positioned on the pads during the procedure. Patients may be of any age and size. Restrictions on the Pad’s use for Patient physical deformities, state of health and co-morbidities is per physician’s discretion.

2.4 Identification of Type B Parts 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. Also noted, the Applied Parts as referenced in the General Description of this manual are the 5996-200 Mizuho OSI Tempur-Pedic® Medical Patient Support Pads as shown in Figure 6 and 5996-12 ACP Quick Connect Tubing as shown in Figure 7 (refer to section 3.0, Component Identification). Part Number

Description

5996-200

ACP Tempur-Pedic Medical Pads (set of 8 pads)

5996-205

Left ACP Tempur-Pedic® Medical Thigh Pad (1)

5996-206

Right ACP Tempur-Pedic® Medical Thigh Pad (1)

5996-207

Small Patient, ACP Tempur-Pedic® Medical Hip Pad (2)

5996-208

Regular Patient, (medium) ACP Tempur-Pedic® Medical Hip Pad (2)

5996-209

Large Patient, ACP Tempur-Pedic® Medical Hip Pad (2)

5996-12

Case of ACP Quick Connect Tubing (12 single use sets/case)

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2.5 Specifications Expected life of the electronic controller is 10 years. The pad assemblies are recommended to be assessed prior to and after each use for wear and misuse. The pads can be replaced without replacing the pad bases. The tubing sets are single use only. Failure to dispose of the tubing sets can cause cross contamination and harm the patient. NOTE: The tubing sets and replaced pad assemblies are expected to be disposed of in accordance with the hospitals waste materials procedures or policy. Controller dimensions: 9.5” x 8.7” x 7” Controller weight: 15 lbs. Pressure system output: 4.5 - 6.5 psig Voltage: 5996-7 (5996) 100/120 VAC 50/60 Hz 5996-8 (5996i) 230 VAC 50 Hz Current: 5996-7 (5996) 1.5 Amp 5996-8 (5996i) 1 Amp Load rating of pads max patient weight is 350 lbs (use of 4 hip pads allows for use with patients up to 500 lbs).

2.6 Shipping, Storage and Environmental Conditions The Advanced Control Pad System™ must be shipped using the appropriate shipping carton and in a manner that prevents damage to its structural elements, electronics, and operating controls. Contact with solid objects in the environment must be prevented during shipment and storage, except at the base. Banding for lateral constraint is to be limited to the base structure. During shipment, the equipment is to be kept in an environment within the following limits: • Temperature: 0-40º C • Relative Humidity: 5-95% non-condensation • Atmospheric Pressure: 75-105 kPa. When not in use, store the ACP System in a clean, dry environment within the following limits: • Temperature: 0-40º C • Relative Humidity: 5-95% non-condensation • Atmospheric Pressure: from 75-105 kPa.(corresponds to -1000 ft to 8000 ft altitude) The ACP System is to be used in operating conditions within the following limits: • Temperature: 0-40º C • Relative Humidity: 5-95% non-condensation • Atmospheric Pressure: 75-105 kPa.

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2.7 Glossary of Terms Term

Meaning

Cycle

A pre-programmed variation in frequency and duration of air flow (Figure 2)

Long Leg

The longer portion of the quick connect tubing having means of connection to the Support Pads on the far side of the frame (Figure 10)

Prone (Patient) Position

When the patient is positioned face down on the table

Quiver

Mounting tube on the Advanced Control Base used for inserting the snorkel for installation of the Advanced Control Pad System™ controller (Figure 5)

Short Leg

The shorter portion of the quick connect tubing having means of connection to the Support Pads on the near side of the frame (Figure 10)

Snorkel

Bracket on the Advanced Control Pad System™ for mounting to the Advanced Control Base quiver (Figure 5)

Supine (Patient) Position

When the patient is positioned face up on the table

Table Top

The patient support system attached to the base

Tail

The portion of the quick connect tubing connected into the Variable Cycle Controller (Figure 10)

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3

Component Identification

3.1 Variable Cycle Controller The Variable Cycle Controller (Controller or VCC), has 4 pre-programmed cycles which provide the desired frequency and duration of airflow which is delivered to the cells in the Mizuho OSI Tempur-Pedic® Medical Pads (refer to section 5.2, Cycle Selection). Located on the front of the Controller are a Cycle Selector, Tubing Port and On/Off Power Switch.

Cycle Indicators (2)

On/Off Power Switch

Cycle Selection Indicators (4)

Cycle Selector – Depress to select desired cycle

Figure 2: Variable Cycle Controller

3.1.1 Cycle Indicators The Cycle Selection Indicators (Figure 2) is a green LED that is illuminated when a specific cycle is chosen. The LED Cycle Indicators on the top of the Controller alternate illuminating green identifying air is circulating to the Mizuho OSI Tempur-Pedic® Medical Pads.

3.2 On/Off Power Switch This switch functions as a combination On/Off Power Switch, Circuit Breaker and Pilot Light (Figure 2). When in the ON position, the green light in the Power Switch illuminates indicating that AC power is applied to the Controller. The switch will trip to the OFF position in an overloaded or short is detected. If failure is noted, determine the source of the overload prior to resetting this switch (refer to section 6.0, Troubleshooting Guide). To reset, push to the OFF position and then the ON position. If failure continues, contact Mizuho OSI’s Customer Resources Group for technical support (refer to section 9.0, Customer Resource Group).

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3.3 Power Cord and Ground Stud The attached Power Cord and External Ground Stud are located on the left side of the unit. When the AC power cable is not connected to a protective earth ground outlet in your operating room or facility, an external ground wire connection is required between the External Ground Stud and Protective Earth Ground to protect the patient or hospital staff from possible hazards. The means of isolation of mains supply is through the power supply cord.

Ground Stud

Power Cord Socket with Cord Retainer Clip

Figure 3: Ground Stud and Power Cord Socket

3.3.1 Power Cord The

5996 100/120VAC Controller is supplied with a North American Hospital Grade Power Cord. The 5996i 230VAC Controller is supplied with a medical grade plug that is specific to that country.

WARNING: It is important for the user to position the controller snorkel into the table base’s quiver to ensure it is not difficult to disconnect the power supply cord. Placement of the ACP controller’s snorkel into the Advanced Control Base’s quiver as shown (Figure 8) ensures full access to the molded power supply cord.

WARNING: Use only approved power cord supplied with the Advanced Control Pad System™. NOTE: Maximum length of Power Cord external to the Box must not exceed 10 feet.

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3.3.2 External Ground Stud The External Ground Stud is provided for use if the Power Cord will be connected to a non-grounded outlet (Figure 3). Model Number Identification Label and Voltage Requirements are located on the back of the unit (Figure 4). Snorkel Mounting Bracket

Model Number Identification Label

Read Manual Caution Label

Figure 4: Identification Label and Snorkel Mounting Bracket

3.4

Model Number Identification Label and Voltage Requirements

The Model Number Identification Label identifies Model Number and voltage requirements for the Controller (Figure 4). The input power requirement is 100/120 VAC, 50/60Hz, or 230 VAC, 50Hz as indicated on the label.

3.5 Snorkel Mounting Bracket The Snorkel Mounting Bracket secures the Controller to Quiver on the Advanced Control Base (Figure 5).

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Quiver on the Advanced Control Base

Snorkel Mounting Bracket on ACP Controller

Figure 5: Quiver and Snorkel for mounting ACP Controller on Advanced Control Base

WARNING: Remove the Controller from the Advanced Contol Base when not in use. It can interfere with using other modular tops and accessories. Example: Orthopedic Trauma Top with Traction Arc. The Traction Arc Cart cannot be positioned properly for mounting of the Traction Arc with the Controller on the base.

3.6 Tempur-Pedic® Medical Patient Support Pads Patient Support Pads (Figure 6) are designed specifically with Tempur-Pedic® Medical material for use with the Mizuho OSI Spinal Surgery Top and Mizuho OSI Advanced Control Pad System™. Air cells within the pads inflate and deflate with varying degrees of frequency and duration providing massage action and periodic pressure point stimulation to the patient’s hips and thighs. NOTE: At the discretion of the physician, the pads can be used for patient support on the Spinal Surgery Top without the Controller being utilized.

WARNING: The patient must be monitored with or without the Controller being utilized. Failure to do so could result in injury to the patient.

3.6.1 Hip Pads (Small, Medium/Regular, and Large) Three sizes of Hip Pads are provided with the Advanced Control Pad System™. These include Small, Medium/Regular and Large (Figure 6). The appropriate Hip Pad should be chosen such that they support the patient while allowing abdominal fallout. For individuals weighing 350 pounds (159 kg) or less, take into consideration the patient’s girth and weight when selecting the Pad size. For individuals weighing more than 350 pounds (159 kg), it may be necessary to purchase an additional set of Large Hip Pads so that two sets can be used together to support the patient properly.

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CAUTION: The choice of the proper pads used for any particular patient is the responsibility of the surgeon.

Small Patient

Regular Patient (Medium) Large Patient

Figure 6: Tempur-Pedic® Medical Patient Support Pads

3.7 ACP Quick Connect Tubing Set The tubing set (Figure 7) is single use only and is not indicated for reuse. Please dispose of this tubing set in accordance with your hospital’s contaminated waste policy. The pads are non-electrical and when determined for disposal, the pads can be disposed of in accordance with your hospital’s contaminated waste policy. The electronic controller is not to be disposed and should be returned to Mizuho OSI.

Figure 7: ACP Quick Connect Tubing NOTE: The ACP Tubing is non-sterile and packaged in single-use sets.

3.7.1 Inspection and Transfer Before each use, inspect the device for possible damage, excessive wear or non-functioning parts. Carefully inspect all critical, inaccessible areas, joints, electrical cords and all movable parts for possible damage or non-function. Damaged or defective products should not be used or processed. Contact your local Mizuho OSI Sales Representative or the Mizuho OSI Customer Resource Group (refer to section 9.0, Customer Resource Group) for repair or replacement.

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4

Set Up Instructions

4.1 Controller Installation The Controller is designed to sit on the foot-end of the Base with the Snorkel slipping into the Quiver, allowing for further stability. 1. Place the Controller on the foot end of Mizuho OSI Advanced Control Base and slide the end of the Snorkel Mounting Bracket over the quiver (Figure 5). 2. Insure that nothing is blocking the air intake or exhaust ports on the bottom (Figure 8). 3. Plug the power cord into a properly grounded receptacle. Refer to the Model Number Identification Label on the back of the Controller for input voltage requirements.

Figure 8: Controller mounted on the Advanced Control Base

WARNING: It is important for the user to position the controller snorkel into the table base’s quiver to ensure it is not difficult to disconnect the power supply cord. Placement of the ACP controller’s snorkel into the base’s quiver as shown (Figure 8) ensures full access to the molded power supply cord.

4.2 Pad Installation Place the appropriate Mizuho OSI Tempur-Pedic® Medical Hip and Thigh Pads on the table in accordance with Mizuho OSI NW0678 Spinal Surgery Top Owner’s Manual.

CAUTION: The choice of the proper pads used for any particular patient is the responsibility of the surgeon. Before use, inspect the pads for possible damage, excessive wear or non-functioning parts. Damaged or defective products should not be used (refer to section 3.7.1, Inspection and Transfer).

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WARNING: Pad lock levers must be properly engaged prior to patient population. Refer to Mizuho OSI Spinal Surgery Top Owner’s Manual for complete installation instructions.

Figure 9: Pads mounted on the Spinal Surgery Top Frame When rotating the patient from supine on the Mizuho OSI Imaging Top to prone on the Mizuho OSI Spinal Surgery Top, do not connect the ACP tubing to the pads and Controller until the rotation sequence is completed.

WARNING: Verify that pad lock levers are properly engaged before rotation of the table.

4.3 Tubing Attachment After the patient is appropriately positioned on the Mizuho OSI Tempur-Pedic® Medical Pads, remove the ACP Quick Connect Tubing (Figure 7) from its package and align with the sides of the Spinal Surgery Frame. Orient the Advanced Control Pad or ACP Tubing so that the longer length of the tubing will connect to the Pads furthest from the Controller and the shorter length of tubing runs down the rail on the same side as the Controller. 1. The tail connects to the frame at the corner directly above the Controller. 2. The long leg is attached along the bottom of the frame and down the side of the frame furthest away from the Controller. 3. The short leg travels down the side directly above the Controller (Figure 10). 4. Attach the ACP Tubing to the Mizuho OSI Tempur-Pedic® Medical Pads by inserting the nipple into the Port on the Pad Tubing. Secure the Tubing with the Velcro® straps. 5. Adjust the tubing to ensure there are no kinks in the tubing. 6. Confirm the Clamps on the Tubing are in an open position to ensure air reaches each Pad.

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Tubing Ports to pads

Short Leg – near side of frame

Velcro Straps

Pinch Tight tube clamp

Tail Section of tubing to controller at the foot end

Long Leg – far side of frame

Figure 10: Schematic for attaching the ACP Quick Connect Tubing Set 7. Secure the tubing along the sides of the frame with the Velcro ties. 8. Insert the tail section of the tubing into the Tubing Port (Figure 11). NOTE: The only time the Clamps should be closed is when only one pair of Pads is in use.

Tubing Port

Figure 11: Tubing Port

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5

Basic Operation

5.1 Power Toggle ON the ON/Off Power switch. The green light in the power switch illuminates indicating that AC power is applied to the Controller (refer to section 3.1, Variable Cycle Controller).

WARNING: Ensure that Mizuho OSI Tempur-Pedic® Medical Support Pads are properly positioned before use. Refer to Mizuho OSI Spinal Surgery Top Owner’s Manual for complete instructions.

CAUTION: The choice of the proper pads used for any particular patient is the responsibility of the surgeon.

5.2 Cycle Selection The Controller has 4 pre-programmed cycles. Refer to the Cycle Selection area of the Controller and choose a cycle. Select the Cycle by depressing the Cycle Selector until the desired cycle is chosen. Figure 12 demonstrates the frequency and duration of the air cells’ movement.

Cycles at 5 sec intervals Cycles at 10 sec intervals Cycles at 60 sec intervals Cycles at 5 sec intervals for 25 sec, rest for 30 sec Selector Button

Figure 12: Cycle Selector Legend

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Advanced Control Pad System™ Pressing the Cycle Selector Button changes the frequency at which the cells in the pads inflate and deflate. Pressing the Button once moves the selected mode from 1 to 2, once more from 2 to 3, next from 3 to 4; the next press changes the cycle from 4 to 1.

CAUTION: Selection of the ACP System Cycles is at the discretion of the surgeon. The green LED illuminates the chosen cycle. The LED Cycle Indicators on the top of the Controller alternate illuminating green; identifying air is circulating to the Mizuho OSI Tempur-Pedic® Medical Pads. Before use, disconnect the tubing at the Tubing Port of the Controller, you should feel light air flowing, then reconnect. Disconnect at each pad tubing connector, feel light air flowing then re-connect. If air flow cannot be detected from the Controller, confirm the Controller On/Off Power Switch is toggled ON. If air flow cannot be detected from the end of the tubing, ensure the tubing is connected properly and is not clamped off. NOTE: The clamps on the tubing should only be closed if the pad is not being used, as the closed clamp pinches off the tubing and restricts airflow.

5.3 Post Patient Removal After the patient has been removed from the Mizuho OSI Spinal Surgery Top, turn the Power Switch to OFF. Disconnect the tubing from the Tubing Port of the Controller and at each pad tubing connector. Remove the Velcro ties from around the tubing and frame. Dispose of the ACP tubing. NOTE: The ACP pads can be used without the Controller (VCC) turned on. No massage action will occur with the Controller off. Clean the frame, Mizuho OSI Tempur-Pedic® Medical Pads, and tubing connections before and after each use (refer to section 7.0, Cleaning and Maintenance).

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