Steris Ot 1000 Series Orthopedic Surgical Table Operating instructions

OPERATOR MANUAL

OT1000 Series

Orthopedic Surgical Tables

(Rev G) 10008511

i

Introduction Operator Manual 10008511

A WORD FROM STERIS CORPORATION

IMPORTANT: Read this entire manual before attempting to

install or operate your OT1000 Series Orthopedic Surgical

Tables. Ensure all appropriate personnel understand the

contents of this manual.

This Operating Manual contains important information on proper use

and maintenance of the OT1000 Series Orthopedic Surgical Tables.

All personnel involved in the use and maintenance of this

equipment must carefully review and comply with the warnings,

cautions and instructions contained in this manual.

These

instructions are important to protect the health and safety of personnel

operating the table and should be retained in a conveniently

accessible area for quick reference.

Complete instructions for uncrating have been furnished. If missing,

contact STERIS for a replacement copy, giving the serial, equipment

and model numbers of the unit.

STERIS carries a complete line of accessories for use with this table.

STERIS representatives will gladly review these with you.

Advisory

A listing of the

SAFETY PRECAUTIONS

to be observed when operating

and servicing these OT1000 Series Orthopedic Surgical Tables is

found in

SECTION 1

of this manual. Do not operate or service the

equipment until you have become familiar with this information.

Any alteration of the table not authorized or performed by STERIS

voids the warranty. Alteration of the equipment which could jeopardize

operator and patient safety may violate national, state or local laws or

regulations.

Serious incidents that have occurred in relation to this medical device

should be reported to the manufacturer and competent authority in the

country where the incident occurred.

Indications for Use

The OT1000 Series Orthopedic Surgical Tables are mobile, power

operated orthopedic tables. They provide flexible, easy-to-use,

articulated posturing of the patient for reconstructive and reparative

orthopedic procedures.

The OT1000 Series Orthopedic Surgical Tables are designed primarily

for hip and lower extremity procedures: hip pinning, ender nailing,

intramedullary nailing of the femur, tibia and fibula surgery.

The OT1000 Series Orthopedic Surgical Tables are to be operated by

fully trained personnel who have successfully completed the Operator

Training Course.

Service Information

A thorough preventive maintenance program is essential for safe and

proper unit operation. This manual contains maintenance schedules

and procedures which should be followed for satisfactory equipment

performance. Comprehensive instructions for monthly, quarterly and

semi-annual preventive maintenance can be found in the Maintenance

Manual (available from STERIS).

ii

10008511 Operator Manual Introduction

Only STERIS-trained personnel should attempt to perform maintenance on the

OT1000 Series Orthopedic Surgical Tables. Improper maintenance may result

in personal injury, improper equipment performance, damage to the

equipment and invalidation of the equipment warranty.

Customers are encouraged to contact STERIS concerning our comprehensive

preventive maintenance program. Under the terms of this program, preventive

maintenance, adjustments and replacement of worn parts are provided on a

scheduled basis to help ensure optimal equipment performance and help

avoid untimely or costly interruptions. STERIS maintains a global staff of well

equipped, factory-trained technicians to provide these services, as well as

expert repair services. Please contact STERIS for details.

STERIS Ireland Limited

IDA Business and Technology Park

Tullamore

County Offaly

R35 X865  Ireland

STERIS Corporation

2720 Gunter Park East

Montgomery AL 36109 USA

334-277-6660 • 800-444-9009

www.

s

t

e

r

is

.

com

Class 1 Equipment

Type B Equipment

Splash-Proof Equipment (enclosed equipment protected against splashing

water, IPX4)

Equipment not suitable for use in the presence of a flammable

anesthetic mixture with air or oxygen or nitrous oxide.

Suitable for Intermittent Use (3 minute articulations/hour)

The base language of this document is

ENGLISH. Any translations must be

made from the base language document.

iii

Table of Contents Operator Manual 10008511

TABLE OF CONTENTS

Section

Number Description Page

1 Safety Precautions ........................................................................................................................1-1

1.1 Symbols on Table .................................................................................................................................. 1-5

1.2 Symbols on Hand Control...................................................................................................................... 1-7

1.3 Screen Graphics on LCD Display .......................................................................................................... 1-9

2 Operating Instructions ..................................................................................................................2-1

2.1 Table Preparation .................................................................................................................................. 2-1

2.2 Floor Locks ............................................................................................................................................ 2-3

2.3 Level All Table Function ........................................................................................................................ 2-4

2.4 Lateral Slide Function ............................................................................................................................ 2-5

2.5 Femur Positioner Control....................................................................................................................... 2-6

2.6 Leg Spar Usage..................................................................................................................................... 2-7

2.7 Table Power Drive Feature.................................................................................................................... 2-8

3 Troubleshooting ............................................................................................................................3-1

4 Routine Maintenance.....................................................................................................................4-1

4.1 Read Before Performing Routine Maintenance ..................................................................................... 4-1

4.2 Cleaning Table....................................................................................................................................... 4-2

4.2.1 General ........................................................................................................................................ 4-2

4.2.2 After Each Usage......................................................................................................................... 4-4

4.2.3 End-of-Day Cleaning Procedure .................................................................................................. 4-5

4.2.4 Weekly Cleaning Procedure......................................................................................................... 4-5

4.3 Daily Maintenance ................................................................................................................................. 4-5

4.4 Bi-Weekly Maintenance ......................................................................................................................... 4-6

4.5 Monthly Maintenance............................................................................................................................. 4-6

4.6 Battery Charging Procedure .................................................................................................................. 4-6

4.7 Preventive Maintenance Schedule ........................................................................................................ 4-8

4.8 Replacement Parts ................................................................................................................................ 4-9

4.9 LEVEL Check ...................................................................................................................................... 4-10

4.10 Override Hand Control Check.............................................................................................................. 4-10

5 Supplemental Information ............................................................................................................5-1

5.1 Pinch Point Warnings ............................................................................................................................ 5-1

5.2 Patient Positioning and Weight Limitation ............................................................................................. 5-1

5.3 Patient Safety Straps ............................................................................................................................ 5-2

5.4 General Description .............................................................................................................................. 5-2

iv

10008511 Operator Manual Table of Contents

Section

Number Description Page

TABLE OF CONTENTS (CONT’D)

5.5 Technical Specifications ........................................................................................................................ 5-2

5.5.1 Overall Size (W x L x H)............................................................................................................... 5-2

5.5.2 Range of Motion........................................................................................................................... 5-2

5.5.3 EMC ............................................................................................................................................. 5-3

5.5.4 High-Frequency Interference ...................................................................................................... 5-3

5.5.5 Weight.......................................................................................................................................... 5-4

5.5.6 Power Requirements.................................................................................................................... 5-4

5.5.7 Environmental Conditions ............................................................................................................ 5-4

5.5.8 Transportation and Storage Conditions ....................................................................................... 5-4

5.5.9 Drive Feature Table Limits ........................................................................................................... 5-4

5.5.10 Image Amplification Coverage .................................................................................................... 5-4

5.5.11 Essential Performance................................................................................................................ 5-7

5.6 Installation Instructions .......................................................................................................................... 5-8

5.7 Primary Hand Control .......................................................................................................................... 5-10

5.7.1 Hand Control Function Buttons Description ............................................................................... 5-10

5.7.2 Hand Control LCD Display Description ...................................................................................... 5-12

5.8 Override Hand Control......................................................................................................................... 5-13

5.8.1 System Operation ...................................................................................................................... 5-13

5.8.2 Override Hand Control Description ............................................................................................ 5-14

5.8.3 Return Backup Control System.................................................................................................. 5-16

5.9 Table Pads.......................................................................................................................................... 5-16

5.10 Accessories/Side Rails ........................................................................................................................ 5-16

5.11 Disposal Hazards................................................................................................................................. 5-17

EMC COMPLIANCE TECHNICAL DATA ..............................................................................................A-1

6 Appendix ....................................................................................................................................... A-1

v

Table of Contents Operator Manual 10008511

LIST OF FIGURES

Description Page

Figure 2-1. Table Floor Lock Operation ..........................................................................................................2-3

Figure 2-2. Level All Table Function (Typical) ................................................................................................2-4

Figure 2-3. Tabletop Lateral Slide Function (Typical) .....................................................................................2-5

Figure 2-4. Femur Positioner Function (Typical).............................................................................................2-6

Figure 2-5. Leg Spar Operation ......................................................................................................................2-7

Figure 2-6. Table Power Drive Feature...........................................................................................................2-8

Figure 2-7. Leg Spars in Storage Position ......................................................................................................2-9

Figure 4-1. INTELLIPOWER Panel LED Display (Typical) .............................................................................4-8

Figure 5-1. The OT1000 Series Orthopedic Surgical Tables Components (Typical)......................................5-5

Figure 5-2. The OT1000 Series Orthopedic Surgical Tables Range of Motion (Typical)................................5-6

Figure 5-3. The OT1000 Series Orthopedic Surgical Tables Tabletop Dimensions (Typical) ........................5-7

Figure 5-4. The OT1000 Series Orthopedic Surgical Tables Image Amplification Coverage (Typical) ..........5-7

Figure 5-5. Install/Remove Battery Fuse (Typical)..........................................................................................5-9

Figure 5-6. Connect Facility Power and Primary Hand Control to

OT1000 Series Orthopedic Surgical Table.................................................................................5-10

Figure 5-7. OT1000 Series Orthopedic Surgical Tables Primary Hand Control ...........................................5-11

Figure 5-8. Primary Hand Control LCD Display Areas..................................................................................5-12

Figure 5-9. Typical Backup System (Override Control) ................................................................................5-14

Figure 5-10. Override Hand Control................................................................................................................5-15

vi

10008511 Operator Manual Table of Contents

Healthcare

Capital Equipment

vii

Table of Contents Operator Manual 10008511

LIST OF TABLES

Table Title Page

Table 1-1 Definition of Symbols on Surgical Table.......................................................................................... 1-5

Table 1-2 Definition of Symbols on Hand Control ........................................................................................... 1-7

Table 1-3 Definition of Hand Control LCD Display Screen Icons ....................................................................1-9

Table 3-1 Troubleshooting Chart..................................................................................................................... 3-2

Table 3-2 LCD Display Screen Alarm Chart.................................................................................................... 3-3

Table 4-1 Replacement Parts.......................................................................................................................... 4-9

Table 5-1 OT1000 Series Orthopedic Surgical Tables Accessories*............................................................ 5-16

Table A-1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions –

For All Equipment and Systems (per IEC 60601-1-2 Clause 5.2.2.1 c) Table 1.............................A-2

Table A-2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity For All Equipment

and Systems (per IEC 60601-1-2 Clause 5.2.2.1 f) Table 2 ...........................................................A-3

Table A-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity For Equipment

and Systems That Are Not Life-Supporting (per IEC 60601-1-2 Clause 5.2.2.2) Table 4 ..............A-4

Table A-4 Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and OT1000 Series Orthopedic Surgical Table

(per IEC 60601-1-2 Clause 5.2.2.2) Table 6 ...................................................................................A-5

viii

10008511 Operator Manual Table of Contents

Healthcare

Capital Equipment

1-1

Safety Precautions Operator Manual 10008511

1

The following Safety Precautions must be observed when operating or servicing the

OT1000 Series Orthopedic

Surgical Tables

. WARNING indicates the potential for personal injury and CAUTION indicates the potential for

damage to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual. It is

important to review ALL Safety Precautions before operating or servicing the unit.

NOTE: Disregarding the presented safety information is considered ABNORMAL USE of this product.

WARNING – PINCHING HAZARD:

WARNING – TIPPING HAZARD:

WARNING – EXPLOSION HAZARD:

WARNING – TRIPPING HAZARD:

To avoid serious injury, keep limbs, fingers and other body areas clear of all pinch points when

positioning the table.

Do not transfer patient onto or off of the table unless floor locks are engaged.

Do not release floor locks while patient is on table.

Do not use this table for patients exceeding the maximum patient weight of 500 lb (227 kg) or length of

7 ft (2 m).

Center tabletop over column before applying chest compressions.

Ensure table is positioned on a flat (less than 5° incline) surface before transfering patient onto table or

performing any procedures.

Table must not be used in the presence of flammable anesthetics.

Route the power cord to the receptacle to minimize being tripped over by personnel in the area.

SAFETY PRECAUTIONS 1

1-2

10008511 Operator Manual Safety Precautions

WARNING – PERSONAL INJURY HAZARD:

Failure to keep the patient properly secured with the patient safety straps at all times could result in

death or serious injury.

Failure to engage the floor locks before placing a patient on or removing from the table or disengaging

the floor locks while a patient is on the table during a surgical procedure could result in the table rolling

unexpectedly during the procedure.

SECTION 2.1, TABLE PREPARATION, Steps 1-7 must be executed before patient transfer to the table.

Execution of Steps 1-7 with the patient on the table could result in injury to both the patient and the

operating room staff.

Healthcare professionals must ensure patients are positioned and monitored to prevent compromising

respiration, nerve pathways or circulation.

When installing any table accessory, check for correct attachment and tighten securely (if appropriate).

Do not use a worn or damaged accessory. Check installation before using any accessory.

Unanticipated table movement could cause patient injury. Patient must be secured to the table in

accordance with recommended positioning practices.

When using table, ensure notice of leg spars locations to avoid inadvertent collision.

When cleaning/disinfecting table, do not use phenolics which may cause patient skin burns if

inadequately rinsed off, or alcohol, which does not have sufficient cleaning/disinfecting properties.

If the integrity of the external protective ground installation or arrangement is in doubt, operate the table

from its internal power source.

If an antistatic path is necessary, STERIS recommends antistatic pads in direct contact with the patient.

Table must also be positioned on antistatic floor or connected to equalization device (equipotential

connector).

Keep hands and feet clear of the unloading platform and the table base when uncrating the table.

Serious personal injury could result.

Following leg spar articulation, ensure spar is locked before moving tabletop.

This table is not intended for patient transport. Do not attempt to engage drive feature while patient is on

table.

Table weighs approximately 1000 lb (454 kg), ensure adequate precaution when moving.

Must level TILT first before pressing LATERAL SLIDE touch pad.

Appropriate components of this surgical table have been tested and found in compliance with IEC

60601-2-46. There is, however, a potential that high frequency surgical equipment, cardiac defibrillators

or cardiac defibrillator-monitors could interfere with this equipment and cause unanticipated table

movement producing possible patient and/or staff injury. Should user experience any interference,

relocate this device or minimize the use of the interfering equipment while this device is in operation.

1-3

Safety Precautions Operator Manual 10008511

WARNING – INSTABILITY HAZARD:

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

Possible patient or user injury, as well as table or accessory failure, may result from using STERIS table

accessories for other than their stated purpose – or from using, on STERIS tables, accessories

manufactured and sold by other companies.

Patient or operator injury may result if the operator of this table is not completely familiar with the

controls for patient positioning and table operation.

Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service

personnel. Maintenance performed by unqualified personnel or installation of unauthorized parts could

cause personal injury, result in improper equipment performance, invalidate the warranty or result in

costly damage. Contact STERIS regarding service options.

Regularly scheduled preventive maintenance is required for safe and reliable operation of this

equipment. Contact STERIS to schedule preventive maintenance.

Table is factory set to operate at a certain voltage. Use of any other power supply could result in serious

personal injury or table damage.

Placing a patient on this table whose weight exceeds maximum patient weight limit of 500 lb (227 kg)

could result in injury to the patient and the operating room staff, and serious equipment damage.

If the integrity of the external protective ground installation or arrangement is in doubt, operate the table

from its internal power source.

Failure to perform periodic inspections of the table could result in serious personal injury or equipment

damage.

During backup control, tabletop functions are available even if table floor locks are NOT engaged.

LOCK table before moving tabletop or transferring patient.

Hand Control must be attached to table at all times to enable Safety Stop and all modes of

operation.

Do not store items or step on table base. Doing so may result in equipment damage or inadvertent

tabletop movement that could place the patient and/or user at risk of injury.

Inspect carbon fiber spars, sacral rests and perineal posts for possible damage and wear prior to each

use. Cracked or splintered surfaces may cause injury and/or not work properly.

Use of this table in the presence of flammable anesthetics could result in serious personal injury or table

damage.

Following tabletop lateral slide, ensure tabletop is latched before transferring patient or moving

tabletop.

Prior to articulating Leg Spar, ensure Traction Unit (if equipped) Gross Traction Lock/Release Lever is in

proper position (lock/unlock) for procedure.

1-4

10008511 Operator Manual Safety Precautions

WARNING – INFECTION HAZARD:

WARNING – DISPOSAL HAZARD:

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

To protect against aerosols being reflected from potentially contaminated surfaces, wear rubber or

plastic gloves, masks and eye protection, and follow OSHA blood-borne pathogens standards when

cleaning.

When cleaning/disinfecting table, do not use alcohol which does not have sufficient

cleaning/disinfection properties.

This product contains materials which may require disposal through appropriately licensed and

permitted hazardous waste management firms.

Failure to keep all personnel and equipment clear of the table before articulation could result in table

damage.

When moving the table to or from point of use, roll it carefully at moderate speed and only over level

hard floors. Maximum floor clearance is 1/2" (13 mm). Avoid door and elevator jambs (or any

obstructions) greater than 1/2" (13 mm). If necessary, lift table over obstructions, onto trucks, etc. Lift

table evenly and only by the table base. If transporting articles (including accessories) on top of the

table, ensure all articles are properly secured to prevent falling off tabletop. DO NOT use a forklift to

move the uncrated table.

Hang the hand control from tabletop side rail when not in use or head section end rail when moving

table to avoid possible damage to the control.

When cleaning/disinfecting table, thoroughly read the cleaning fluid directions for use and follow all

directions and cautions as shown.

Do not spray cleaning fluid into electric receptacles and avoid spraying directly on emergency backup

buttons or into clearance space. Spray or drippage may settle onto electric circuits inside table causing

corrosion, loss of function or erratic table movement.

Cleaning procedures requiring articulation of the table should be performed only by persons familiar

with table operation.

Route the hand control cord clear of any pinch points where cord could be damaged.

Use of incorrect hydraulic oil may severely damage the table and/or cause malfunction. Contact STERIS

for proper hydraulic oil.

After performing cleaning procedures, ensure pads and tabletop are completely dry before reinstalling.

Appropriate components of this surgical table have been tested and found in compliance with the

specifications listed in

Table A-1

through

Table A-4

. There is, however, a potential for electromagnetic

or other interference between this equipment and other devices. Should user experience interference,

relocate this device or minimize the use of the affected equipment while this device is in operation.

Cracked or splintered carbon fiber leg spars or perineal accessories may be weakened and splinters

can cause injuries if touched. Frequent inspections should be made.

1-5

Safety Precautions Operator Manual 10008511

CAUTION – POSSIBLE EQUIPMENT DAMAGE (CONT’D):

1.1 Symbols on Table

Table 1-1

is a key to the symbols appearing on the

OT1000 Series

Orthopedic Surgical Tables

.

Surgical table operation may be temporarily affected if portable or mobile RF communications

equipment is used in close proximity.

Medical Electrical Equipment needs special precautions regarding EMC. Put table into service

according to the EMC information provided in this manual.

Possible EMC increased EMISSIONS or decreased IMMUNITY. Do not use accessories or replacement

parts not listed in the Operator or Maintenance Manuals.

The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals

(CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class B is required)

this equipment might not offer adequate protection to radio frequency communication services. The

user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Surgical table operation may be affected if used adjacent to or stacked with other equipment. If

adjacent or stacked use is needed, ensure table operates properly in this configuration.

Do not apply floor locks to a wet floor. Damage to floor lock and/or floor may occur.

If Leg Spar is lowered from storage position, return spar to storage position before lowering tabletop or

damage to spar may occur.

Table operation may still occur with orange wrench displayed.

Table 1-1. Definition of Symbols on Surgical Table

Symbol Definition

Type B Equipment

Protective Earth Ground

Equipotentiality

Electric Shock Hazard

1-6

10008511 Operator Manual Safety Precautions

Control Power ON

Control Power OFF

Powered By AC

Attention, Consult Manual for Further Instructions

AAmperage Rating of the Unit

VVoltage Rating of Unit

~Alternating Current

Hz Frequency Rating of Unit

WPower Rating

SN Serial Number of the Unit

IPX4 Splash-Proof Equipment

INTELLIPOWER® Dual Power System Power Panel

(Battery Charge/Discharge Status)

Powered By Battery

REF Equipment or Reorder Number

Medical Device

Unique Device Identifier

General Mandatory Action Sign (Blue Circle, White Symbol)

Table 1-1. Definition of Symbols on Surgical Table (Cont’d)

Symbol Definition

0

CHARGE BATTERY

INTELLI POWER

1-7

Safety Precautions Operator Manual 10008511

1.2 Symbols on Hand

Control

Table 1-2

is a key to the symbols appearing on the

OT1000 Series

Orthopedic Surgical Tables

Primary Hand Control.

Leg Spar Control

Enable Drive

Femur Positioner Foot Control

Table 1-1. Definition of Symbols on Surgical Table (Cont’d)

Symbol Definition



Table 1-2. Definition of Symbols on Hand Control

Symbol Definition

Move Tabletop to Level

Interrupts Power to Control System and Stops All Table Articulation

Tilt Tabletop Left

Tilt Tabletop Right

Tabletop Up (Height Up; Raise)

LEVEL ALL

STOP

TILT LEFT

TILT RIGHT

HEIGHT UP

1-8

10008511 Operator Manual Safety Precautions

Tabletop Down (Height Dn; Lower)

Move Tabletop into Trendelenburg

Move Tabletop into Reverse Trendelenburg

Floor Lock Function

Floor Unlock Function

Lateral Slide Unlock

Lateral Slide, Level Tilt

Femur Control, Lift Connected

Femur Control, Foot Pedal Connected

Femur Control, Femur Up

Femur Control, Femur Down

Table 1-2. Definition of Symbols on Hand Control (Cont’d)

Symbol Definition

HEIGHT DN

TREND

REVERSE

TREND

FLOOR

LOCK

FLOOR

UNLOCK

UNLATCH

LEVEL TILT

LIFT

CONNECTED

FOOT PEDAL

CONNECTED

FEMUR UP

FEMUR DN

1-9

Safety Precautions Operator Manual 10008511

1.3 Screen Graphics

on LCD Display

Table 1-3

is a key to the graphics appearing in the

OT1000 Series

Orthopedic Surgical Tables

Hand Control LCD Display.

NOTE: Refer to SECTION 5.7.2, HAND CONTROL LCD DISPLAY

DESCRIPTION, for table operation using hand control LCD display.

Table 1-3. Definition of Hand Control LCD Display Screen Icons

Symbol Definition

Table Powered by Facility Power.

Green = Normal Condition; Red = Fault Condition.

Table Powered by Battery Power.

Green (Solid Icon) = Battery Fully Charged;

Orange/Yellow (Half-Filled/-Solid Icon) = Battery at Half Charge (between

23.1 and 23.95 Vdc);

Red/Yellow (Solid Icon With Yellow !) = Battery at Low Charge (between

21 and 23.1 Vdc);

Red (Outline Icon, flashing) = Battery Empty (Table Will Soon Stop

Functioning).

Floor Locks Engaged (Green).

Floor Locks Unlocked (Orange).

Maintenance Notification (Orange).

Table Controlled by Primary Hand Control.

Table Controlled by Service Diagnostic Utility on PC.

Keypress (Green).

Table Height Position.

CM = Height Displayed in Centimeters;

" = Height Displayed in Inches.

1-10

10008511 Operator Manual Safety Precautions

Table Trendelenburg and Tilt Position.

° = Angles Displayed in Degrees.

See Operator Manual for More Information.

Table 1-3. Definition of Hand Control LCD Display Screen Icons (Cont’d)

Symbol Definition

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Steris Ot 1000 Series Orthopedic Surgical Table Operating instructions

Steris Ot 1000 Series Orthopedic Surgical Table Operating instructions

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