Steris Harmonycare Equipment Boom Operating instructions

OPERATOR MANUAL

HarmonyCARE™ Equipment Boom

(Rev. A) 590103001

i

Introduction Operator Manual 590103001

A WORD FROM STERIS CORPORATION

This manual contains important information on proper use and

maintenance of the HarmonyCARE™ Equipment Boom. 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 a

HarmonyCARE Equipment Boom and should be retained in a

conveniently accessible area for quick reference.

STERIS is able to provide Customer training. Contact STERIS

Customer Service for more information.

Complete instructions for uncrating and connecting utilities, as well

as equipment drawings, have been furnished. If missing, contact

STERIS for replacement copies, giving the serial number and model

numbers of the unit.

STERIS carries a complete line of accessories for use with this

equipment management system. A STERIS representative will gladly

review these accessories with you. Any ancillary equipment (i.e.,

monitors, video recorders, etc.) that is to be used with the

HarmonyCARE Equipment Boom must comply with all applicable

medical equipment standards.

Application The HarmonyCARE Equipment Boom is for use by the direct and

indirect care givers of critically ill patients, in ICU/critical care rooms.

The equipment boom delivers low voltage and high voltage to

equipment/devices mounted on and around the equipment boom,

and medical gas to equipment/devices (such as respiratory and

ventilation equipment) mounted on and around the boom. The

equipment boom system allows for flexibility in the clinical space

through easy rearrangement, such as relocating boom systems in

conjunction with the patient bed and ancillary equipment for bedside

procedures, or to access life supporting equipment and devices.

HarmonyCARE Equipment Boom units help hospitals to improve

efficiency and safety, and to maximize total room workflow by

ergonomically centralizing all surgical support equipment:

• For communicating and exchanging data, e.g., telephone,

nurse's call button or computer networking.

• For the ergonomic positioning of medical equipment during use.

• For supplying medical equipment with electrical power and

medical gases.

• To provide additional instrument trays, shelves and supports.

ii

590103001 Operator Manual Introduction

Intended Users HarmonyCARE Equipment Boom should only be used by qualified

staff authorized to work in the ICU/critical care rooms (floor ICU

Nurse, Respiratory Therapist, Intensivist and other doctors,

Housekeeping, etc.).

This medical device shall be operated in a controlled environment by

a professional familiar with appropriate techniques with such

equipment.

Any use of this equipment not specified in the above conditions

violates the intended purposes. The user is responsible for any loss

or damage to the equipment due to misuse of the equipment.

Service Information You are encouraged to contact STERIS concerning our

comprehensive annual maintenance agreements. Under the terms of

these agreements, preventive maintenance, adjustments and

replacement of worn parts are done on a scheduled basis to help

ensure equipment performance at peak capability and to help avoid

untimely or costly interruptions. STERIS maintains a global staff of

well-equipped, factory-trained technicians to provide this service, as

well as repair services. Please contact STERIS for details.

Advisory A listing of the safety precautions to be observed when operating

and servicing this equipment can be found in SECTION 1, SAFETY

PRECAUTIONS of this manual. Do not operate or service the equipment

until you have become familiar with this information.

Any alteration of this equipment not authorized or performed by

STERIS that could affect its operation will void the warranty and

could violate national, state and local regulations.

iii

Introduction Operator Manual 590103001

STERIS Corporation

2720 Gunter Park East

Montgomery, AL 36109 • USA

Class 1 Equipment

Ordinary Equipment (enclosed equipment without protection

against ingress of water)

Equipment not suitable for use in the presence of a

flammable anesthetic mixture with air or with oxygen or

nitrous oxide. The HarmonyCARE Equipment Boom is not

designed to be installed and used in an oxygen-enriched

environment.

Suitable for continuous operation.

Canada Only:

Nonflammable medical gas pipeline systems shall comply

with CSA Z7396-1.

Electrical installations in healthcare facilities shall comply

with CSA C22.1 and CAN/CSA-Z32.

Anesthetic gas scavenging systems shall comply with CSA

Z7396.2.

The base language of this document is

ENGLISH. Any translations must be

made from the base language document.

STERIS Corporation,

Montgomery, Alabama is an

ISO 13485 certified facility.

iv

590103001 Operator Manual Introduction

Healthcare

Capital Equipment

v

Table of Contents Operator Manual 590103001

TABLE OF CONTENTS

Section

Number Title Page

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

2 Technical Specifications and Component Identification ..................................................2-1

2.1 HarmonyCARE Equipment Boom................................................................................................2-1

2.2 HarmonyCARE Equipment Boom with Supply Column...............................................................2-2

2.3 Environmental Conditions............................................................................................................2-2

2.4 Electrical Requirements...............................................................................................................2-3

2.5 Accessories..................................................................................................................................2-3

2.6 Component Identification (Single Fixed Arm System)..................................................................2-4

2.7 Component Identification (Dual Fixed Arm System)....................................................................2-5

3Operating Instructions..........................................................................................................3-1

3.1 Column Load Capacity.................................................................................................................3-1

3.2 Accessories Load Capacity..........................................................................................................3-1

3.3 Ambient Light (Located at Bottom of Column).............................................................................3-1

3.4 Preparing Unit for Initial Use (Column) ........................................................................................3-1

3.5 Preparing Unit for Initial Use (Shelf).............................................................................................3-2

3.6 Operating the Unit........................................................................................................................3-3

3.7 Gas Supply Connectors...............................................................................................................3-4

3.8 Hose Assembly Operating Instructions........................................................................................3-5

3.9 Means of Isolation – Disconnecting Power and Gas Connections...............................................3-6

3.10 Gas Data Plate Label and UDI Label...........................................................................................3-7

3.11 Gas Data Plate Label and UDI Label – Location on Lower Arm..................................................3-8

3.12 Column Load Capacity Label and Accessories Load Capacity Label Locations on Lower

Arm and Accessories...................................................................................................................3-9

4 Cleaning the Equipment.......................................................................................................4-1

4.1 Disinfecting/ Cleaning ..................................................................................................................4-1

4.2 Disinfect Surfaces........................................................................................................................4-2

5 Troubleshooting....................................................................................................................5-1

6 Routine Maintenance............................................................................................................6-1

6.1 Preventive Maintenance...............................................................................................................6-1

6.2 Stop Adjustment – Column and Bearing(s)..................................................................................6-2

6.3 Testing Requirements (Canada Only)..........................................................................................6-2

6.4 Replacement Parts.......................................................................................................................6-2

7Waste Management Guidelines...........................................................................................7-1

8Appendix – EMC Compliance Technical Data................................................................... A-1

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590103001 Operator Manual Table of Contents

Healthcare

Capital Equipment

vii

Table of Contents Operator Manual 590103001

LIST OF FIGURES

Figure Title Page

Figure 2-1. Component Identification (Single Fixed Arm System).........................................................................2-4

Figure 2-2. Component Identification (Dual Fixed Arm System)............................................................................2-5

Figure 3-1. Column ................................................................................................................................................3-1

Figure 3-2. Shelf ..................................................................................................................................................3-2

Figure 3-3. Types of Connectors Available............................................................................................................3-4

Figure 3-4. Example of UDI Label and Gas Data Plate Label ...............................................................................3-7

Figure 3-5. Gas Data Plate Label and UDI Label Location on Lower Arm.............................................................3-8

Figure 3-6. Column Load Capacity and Accessories Load Capacity Label Locations on Column ........................3-9

viii

590103001 Operator Manual Table of Contents

Healthcare

Capital Equipment

ix

Table of Contents Operator Manual 590103001

LIST OF TABLES

Table Title Page

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

Table 3-1. Color-coding of Gas Connections....................................................................................................3-4

Table 3-2. Circuits.............................................................................................................................................3-7

Table 5-1. Troubleshooting Guide ....................................................................................................................5-1

Table A-1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all Equipment and

Systems...........................................................................................................................................A-2

Table A-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for all Equipment and

Systems...........................................................................................................................................A-3

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

Systems that are not Life-Supporting..............................................................................................A-4

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

Equipment and the HarmonyCARE Equipment Boom....................................................................A-5

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590103001 Operator Manual Table of Contents

Healthcare

Capital Equipment

1-1

Safety Precautions Operator Manual 590103001

1

The following Safety Precautions must be observed when operating or servicing this HarmonyCARE™ Equipment

Boom. 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.

Strictly following these Safety Precautions enhances the Customer’s ability to use the unit safely and effectively

and helps avoid improper maintenance methods which may damage the unit or render it unsafe. It is important to

understand that these Safety Precautions are not exhaustive; Customers are encouraged to develop their own

safety policies and procedures to enhance and complement these Safety Precautions.

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

Repairs and adjustments to the unit should be made only by STERIS or STERIS-trained, fully qualified

personnel. Work by inexperienced or unqualified persons or the installation of unauthorized parts could

cause personal injury, invalidate the warranty or result in costly damage.

When installing equipment on the boom, securely attach the equipment to platform and support shelves/

accessories. Equipment could fall off platform and shelves during unit positioning if not fastened securely.

In the event of a regular audible sound such as hissing being heard, stop using the device and isolate the

part of the gas supply network concerned. Contact STERIS Service department immediately.

In the event of accessories from other manufacturers being used, users are responsible for ensuring that

these accessories are fully compatible and that they offer no danger to patients and to the medical team.

Before connecting accessories to the HarmonyCARE Equipment Boom, check the general state of the

accessories to ensure they are not degraded and that the connection system is not damaged.

Never pull on the cables and connection hoses. Hold the wall supply point with one hand and disconnect

or release the equipment connector with the other hand. Avoid handling the cables and the hoses

roughly when connecting or disconnecting them.

Avoid handling HarmonyCARE Equipment Boom and accessories roughly during the operation. Do not

exert lateral loads on them. Do not pull or push on the utility panels or on the accessories to move the

boom.

Do not use the arm of the HarmonyCARE Equipment Boom to carry or lift objects. Do not hang from the

column or from the arm. Do not use the arms to store any object.

Avoid handling the equipment boom roughly, particularly excessive shocks against the stops. The stops

are only end of travel components. Take care of the risks of collisions with surrounded equipment when

moving the arms.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could

result in improper operation. If such use is necessary, this equipment and the other equipment should be

observed to verify that they are operating normally.

Use of accessories, transducers and cables other than those specified or provided by the manufacturer

of this equipment could result in increased electromagnetic emissions or decreased electromagnetic

immunity of this equipment and result in improper operation.

!

SAFETY PRECAUTIONS 1

1-2

590103001 Operator Manual Safety Precautions

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD

(CONTINUED):

WARNING – PERSONAL INJURY HAZARD:

Portable RF communications equipment (including peripherals such as antenna cables and external

antennas) should be used no closer than 12" (30 cm) to any part of the HarmonyCARE Equipment

Boom, including cables specified by the manufacturer. Otherwise, degradation of the performance of this

equipment could result. Before connecting any equipment, the user should make sure that they respect

the applicable regulations and that their connections comply with the manufacturers’ recommendations.

HarmonyCARE Equipment Boom needs special precautions regarding electromagnetic compatibility and

needs to be installed and put into service according to EMC information provided in this instruction of

use.

HarmonyCARE Equipment Boom shall only be installed in ICU/critical care rooms, and does not claim

any compatibility with high frequency surgical equipment. Such equipment shall not be used near

HarmonyCARE Equipment Boom.

Before using on a patient, check for proper equipment operation and acceptable gas flows.

Do not position equipment boom over patient.

Connecting electrical equipment to the multiple socket outlet (MSO) effectively leads to creating a

medical electrical (ME) system, and the result can be a reduced level of safety.

Before connecting any electrical equipment to the HarmonyCARE Equipment Boom, it is the

responsibility of the healthcare professional to ensure the electrical compatibility (amperage, voltage,

frequency, etc.) matches the information provided in the data plate label. See SECTION 3.10, GAS DATA

PLATE LABEL AND UDI LABEL, PAGE 3-7.

The compressed air supply to the ceiling supply unit must be turned off for the repair procedure. Inform

the user in advance before turning off the compressed air supply.

The incoming ac power supply must be interrupted temporarily during repair. To avoid endangering the

patients, including those on life support mechanisms, it is critical that all users connected to the same

mains power supply be informed so that appropriate precautions can be taken.

Install shelf according to the instructions provided in this manual. Improperly installed shelf can cause a

pinching hazard.

Ambient light is an energy that can potentially dry out tissue. The ambient light must light only the floor.

Do not look directly at the light source of the ambient light.

!

1-3

Safety Precautions Operator Manual 590103001

WARNING – FIRE HAZARD:

WARNING – EXPLOSION HAZARD:

WARNING – ELECTRIC SHOCK AND BURN HAZARD:

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

Avoid any risk of fire. Do not use flammable cleaning agents when cleaning or disinfecting the

HarmonyCARE Equipment Management System.

Avoid dust/lint buildup that could start a fire in the system. Contact STERIS or STERIS-trained technician

to remove dust/lint as necessary.

Oxygen promotes combustion. The use of any equipment that might produce flames or of any type of

equipment which includes heated winding (motors, transformers, etc.) is prohibited in the vicinity of

terminals and pipework which contain this gas (O2, N2O etc).

The HarmonyCARE Equipment Boom must not be installed where flammable gases or anesthesia will be

used. This equipment is not designed for use in a hazardous location as defined in National Fire

Protection Association (NFPA) Flammable Anesthetics Code.

The HarmonyCARE Equipment Boom is not designed to be installed and used in an oxygen rich

environment.

Oxygen can promote the formation of explosive mixtures in the presence of oil, grease or lubricants.

Cleaning products which may contain such substances are therefore strictly prohibited.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains protective

earth.

Disconnect all utilities to the HarmonyCARE Equipment Boom before servicing. Do not service the

equipment management system unless all utilities have been properly locked out. Always follow lockout-

tagout and electrical safety-related work practice standards.

Any use of the apparatus requires full understanding and strict observation of these instructions. The

apparatus is only to be used for purposes specified here.

The apparatus must be inspected and serviced at six month intervals by trained service personnel to

maintain basic safety, essential performance and EMC at acceptable levels. Refer to maintenance

manual (590103003). Maintain complete service records.

Repair and general overhaul of the apparatus may only be carried out by STERIS or STERIS-trained

service personnel. STERIS recommends that a service contract be obtained with STERIS and that all

repairs also be carried out by STERIS. Only authentic STERIS spare parts may be used for

maintenance. Observe SECTION 6, PREVENTIVE MAINTENANCE.

!

1-4

590103001 Operator Manual Safety Precautions

WARNING – POSSIBLE EQUIPMENT DAMAGE (CONTINUED):

Use of any disinfectant solution OTHER than those listed below may cause discoloration or deformation:

Coverage Plus® Germicidal Surface Wipes, Coverage® Spray HB Plus Ready-To-Use One-Step

Disinfectant, Surfa Safe Premium, CaviWipes™ Hard Surface Cleaner and Disinfectant Wipe, Staphene®

Spray Environment Disinfectant, LpH® se Non-sterile Disinfectant Cleaner, Vesphene® IIse Non-sterile

Disinfectant Cleaner. Cleaning solutions other than those listed have NOT been tested for compatibility or

effectiveness. Always follow manufacturer instructions for concentrations and use of cleaning products.

Do not spray cleaners directly onto terminal points. No cleaning products must be allowed to enter the

interior of the equipment boom. After cleaning procedures, ensure no residual water remains near the

electrical socket.

Only personnel authorized to operate the equipment and properly trained in the use of the hose

assembly should use this product.

• Keep the hose assembly in a clean area when not being used.

• Verify all connections are tightened and free of leaks prior to use.

• Use only an oxygen-safe leak detector when testing for leaks.

• DO NOT gas sterilize with ethylene oxide (EO).

• DO NOT clean with pungent hydrocarbons.

Connection to the gas source must be done with fittings appropriately indexed to the latch assembly on

the supply column.

Before moving HarmonyCARE Equipment Boom, always check that there are no obstacles in its path

and move the boom with caution. Avoid any impact with other equipment.

Total weight of shelves, pole bracket and accessories not to exceed 165 lb (75 kg). DO NOT

OVERLOAD.

Small shelf weighs 5.7 lb. (2.6 kg.). Maximum load capacity of small shelf is 44 lb (20 kg) DO NOT

OVERLOAD.

Large shelf weighs 18 lb. (8.2 kg.). Maximum load capacity of large shelf is 110 lb (50 kg). DO NOT

OVERLOAD.

!

1-5

Safety Precautions Operator Manual 590103001

The following symbols may appear on the HarmonyCARE Equipment Boom:

Table 1-1. Definition of Symbols

Symbol Definition

Protective Earth (Ground)

or

Consult manual for further instructions

Refer to instruction manual/booklet

Serial Number of Unit

Equipment or Reorder Number

Symbol indicating the legal manufacturer name and address

Symbol indicating the date of manufacture (yyyy/mm/dd)

Symbol indicating This Way Up

Symbol indicating information about electrical circuits

Symbol indicating high voltage.

1-6

590103001 Operator Manual Safety Precautions

Maximum Load Hazard (maximum load limit given on label)

V~ Voltage Rating of Unit, Alternating Current

A Amperage Rating of Unit

Hz Frequency Rating of Unit

Table 1-1. Definition of Symbols (Continued)

Symbol Definition

2-1

Technical Specifications and Component Identification Operator Manual 590103001

2.1 HarmonyCARE

Equipment Boom

HarmonyCARE Equipment Boom

Single Arm Fixed System HarmonyCARE Equipment Boom

Dual Arm Fixed System

Plan view

Typical rotation Ranges

330°

Plan view

Typical rotation Ranges

330°

Elevation view

Typical configuration

Elevation view

Typical configuration

TECHNICAL SPECIFICATIONS AND

COMPONENT IDENTIFICATION 2

2-2

590103001 Operator Manual Technical Specifications and Component Identification

2.2 HarmonyCARE

Equipment Boom with

Supply Column

HarmonyCARE™ Equipment Boom Single Arm or Double Arm

with Supply Column

Ceiling mounting:

• Suspended ceiling depth up to 47" (1200 mm) mounting on

concrete ceiling with heavy-duty anchor

• Maximum moment on structural ceiling 3024 ft•lb (4100 N•m) for

single arm HarmonyCARE Equipment Boom

• 6417 ft•lb (8700 N•m) for double arm HarmonyCARE Equipment

Boom

Rotation range of joints: Gradually adjustable of up to max. 330°

Ambient light: Location at the bottom of column. Color temperature

4100°K. Light output; 820 lm.

2.3 Environmental

Conditions

Transport and Storage

NOTE: The following storage conditions apply for up to 15 weeks.

• Temperature: 13 to 158°F (–11 to +70°C)

• Relative Humidity: 10 to 75%

• Barometric Pressure: 0.5 to 1.05 atm STP atmospheric pressure

(500 to 1060 hPa)

• Store only in closed or covered spaces. After 15 weeks, the

values for the Operational Location Requirements (below) apply.

Operational Location Requirements

• The equipment is not suitable for operation in areas where there is

an explosion hazard.

• The equipment is not suitable for operation in the vicinity of strong

magnetic fields (MRI environment)

• The HarmonyCARE Equipment Boom is not suitable for use in the

presence of a flammable anesthetic mixture with air or with

oxygen or nitrous oxide.

• The HarmonyCARE Equipment Boom is not designed to be

installed and used in an oxygen-enriched environment

• The ambient temperature during operation must be kept between

20 and 25°C (68 and 77°F)

• Relative humidity should stay within a range of 30 to 75%.

• Atmospheric pressure should stay within a range of 0.7 to 1.05

atm STP atmospheric pressure (700 to 1060 hPa).

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Steris Harmonycare Equipment Boom Operating instructions

Steris Harmonycare Equipment Boom Operating instructions

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