Steris Harmonyair Equipment Boom Operating instructions

10038023

Revision G

HarmonyAIR®

Equipment Boom

Operator Manual

2

10038023_G HarmonyAIR®Equipment Boom Operator Manual

TABLE OF CONTENTS

Section Number Description Page

1 A Word from STERIS...................................................................................................................................... 4

1.1 Introduction - A word from STERIS Corporation...................................................................... 4

1.2 Indications for Use...................................................................................................................... 4

1.3 Service Informaton ..................................................................................................................... 4

1.4 Advisory....................................................................................................................................... 4

1.5 Addresses.................................................................................................................................... 5

2 Safety Precautions ........................................................................................................................................ 6

3 Symbols ........................................................................................................................................................ 11

4 Technical Specifications.............................................................................................................................. 13

4.1 Application Specific................................................................................................................... 13

4.2 HarmonyAir Equipment Boom................................................................................................. 15

4.3 HarmonyAIR Equipment Boom with Supply Column/Supply Head ...................................... 20

4.4 Essential Performance ............................................................................................................. 20

4.5 Environmental Conditions........................................................................................................ 20

4.6 Electrical Requirements ........................................................................................................... 21

4.7 Accessories ............................................................................................................................... 21

5 Component Identification ........................................................................................................................... 22

5.1 Component Identification (Single Fixed Arm System)............................................................ 22

5.2 Component Identification (Dual Fixed Arm System) .............................................................. 23

5.3 Component Identification (Spring Arm System) ..................................................................... 24

5.4 Component Identification (Motorized Arm System)............................................................... 25

5.5 Component Identification (Central Tandem Fixed Arm System) ........................................... 26

5.6 Component Identification (Central Tandem Motorized Arm System)................................... 27

5.7 Component Identification (Central Tandem Spring Arm System) ......................................... 28

6 Operating Instructions ................................................................................................................................ 29

6.1 Introduction-Operating Instructions ....................................................................................... 29

6.2 Supply Column Load Capacity.................................................................................................. 29

6.3 Small Shelf Load Capacity ........................................................................................................ 29

6.4 Large Shelf Load Capacity ........................................................................................................ 29

6.5 Preparing Unit for Initial Use (Column) for Fixed Arm System.............................................. 30

6.6 Preparing Unit for Initial Use (Column) for Motorized Arm System...................................... 32

6.7 Preparing Unit for Initial Use (Shelf) for Fixed Arm System .................................................. 34

6.8 Preparing Unit for Initial Use (Shelf) for Motorized Arm System.......................................... 36

6.9 Supply Head Load Capacity...................................................................................................... 37

6.10 Preparing Unit for Initial Use (Supply Head for Fixed Arm System)...................................... 38

6.11 Preparing Unit for Initial Use (Supply Head for Spring Arm/Fixed Arm System) ................. 40

6.12 Preparing Unit for Initial Use (Supply Head for Motorized Arm System) ............................. 42

6.13 Operating the Unit .................................................................................................................... 44

6.14 Gas Supply Connectors............................................................................................................. 46

6.15 Hose Assembly Operating Instructions................................................................................... 48

6.16 Means of Isolation - Disconnecting Power and Gas Connections ........................................ 49

6.17 Data Plate Label........................................................................................................................ 50

6.18 Label Location on Supply Column............................................................................................ 51

6.19 Label Location on Supply Head................................................................................................ 52

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

7 Cleaning the Equipment.............................................................................................................................. 53

7.1 Disinfecting/Cleaning ............................................................................................................... 53

7.2 Disinfect Surfaces..................................................................................................................... 54

8 Troubleshooting........................................................................................................................................... 55

8.1 Troubleshooting........................................................................................................................ 55

8.2 Insufficient Gas Supply or Audible Hissing Sound.................................................................. 56

8.3 Arm Only Moves with Difficulty or Drifts................................................................................ 56

8.4 LED Brake Indicators do not Light ........................................................................................... 56

8.5 Brakes do not Release or are Continually Disengaged .......................................................... 56

9 Routine Maintenance .................................................................................................................................. 57

9.1 Preventive Maintenance .......................................................................................................... 57

9.2 Stop Adjustment Column and Bearing(s)............................................................................... 58

9.3 Testing Requirements (Canada Only)...................................................................................... 58

9.4 Replacement Parts ................................................................................................................... 58

10 Waste Management Guidelines................................................................................................................. 59

11 Appendix EMC Compliance Technical Data............................................................................................... 60

1 — A Word from STERIS

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

A Word from STERIS

1.1 Introduction - A word from STERIS Corporation

This manual contains important information on proper use and maintenance of the HarmonyAIR 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 HarmonyAIR 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 HarmonyAIR Equipment Boom must comply with all applicable medical equipment

standards.

1.2 Indications for Use

For use in hospital facilities where there is a need for ready access to medical gases, electrical power and audio/visual

data services. HarmonyAIR Equipment Boom organize surgical equipment such as endoscopy equipment, laparoscopic

equipment, cautery devices, insufflators, etc. HarmonyAIR Equipment Boom units help hospitals to improve efficiency

and safety, and to maximize total room workflow by ergonomically centralizing all surgical support equipment:

• As individual unit or in combination with the ceiling supply units of the HarmonyAIR Equipment Management

System.

• 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.

• The intended user for this equipment includes OR, ER/Trauma Room, Ambulatory Surgery Center and ICU staff.

NOTE:

There are no known contradictions to using this unit.

1.3 Service Informaton

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.

1.4 Advisory

A listing of the safety precautions to be observed when operating and servicing this equipment can be found inSection

2, 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.

1 — A Word from STERIS

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

1.5 Addresses

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.

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.

STERIS Corporation, Montgomery, Alabama is an ISO 13485 certified facility.

The base language of this document is ENGLISH. Any translations must be made from the base language

document.

2 — Safety Precautions

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

Safety Precautions

The following Safety Precautions must be observed when operating or servicing this HarmonyAIR 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 clinical instrumentation, securely attach instrumentation to platform

and support shelves/accessories. Instrumentation could fall off platform and shelves

during unit positioning if not fastened securely.

Avoid patient injury and anesthesia head damage. Do not place objects on top of

anesthesia head.

Use of this equipment adjacent to other equipment should be avoided due to risk of

improper operation of the powered device. Observe equipment used adjacent to this

equipment for proper operation prior to use.

This equipment is intended for use by healthcare professionals only. This equipment

may cause radio interference or may disrupt the operation of nearby equipment. It may

be necessary to take mitigation measures, such as re-orienting the equipment or

shielding the location.

2 — Safety Precautions

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

WARNING

PERSONAL INJURY HAZARD

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

flows.

Do not position equipment boom over patient.

Nitrogen regulator is intended as a means of supplying power to pneumatic surgical

tools only. Nitrogen regulator is not to be used for medical purposes (e.g., anesthesia).

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.

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.

WARNING

FIRE HAZARD

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

disinfecting the HarmonyAIR 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.

2 — Safety Precautions

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

WARNING

EXPLOSION HAZARD

The HarmonyAIR 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.

WARNING

ELECTRIC SHOCK AND BURN HAZARD

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

mains protective earth.

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

service the equipment management system unless all utilites have been properly locked

out. Always follow lockout-tagout and electrical safety-related work practice standards.

CAUTION

POSSIBLE EQUIPMENT DAMAGE

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 (P764335-769). 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 Maintenance Intervals

section.

No modification allowed to this equipment other than as performed or approved by

STERIS.

2 — Safety Precautions

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

Use of any disinfectant solution OTHER than those listed here may cause discoloration

or deformation on system components:

●Coverage® Plus Germicidal Surface Wipes Disinfecting/Deodorizing/Cleaning Wipes

●Quaternary Ammonium Compound (Quats) with Ethanol solvent

●Quaternary Ammonium Compound (Quats) with Isopropyl Alcohol (IPA) solvent

●Quaternary Ammonium Compound (Quats) with IPA + 2-Butoxyethanol solvent

●Quaternary Ammonium Compound (Quats) + Biguanide

●H2O2 (Hydrogen Peroxide)

●Neutral Cleaners

●Hypochlorite (3 to 6% solution diluted 1:10 in water)

The use of H2O2 + PAA (Hydrogen Peroxide + Peracetic Acid) is strongly discouraged for

use on all STERIS products.

Always follow manufacturer instructions for concentrations and use of cleaning

products.

Do not use STERIS Stainless Steel Cleaner to clean the surface of the label found on the

nitrogen and/or instrument air regulator panel assemblies. Using this cleaner will result

in the label lifting at the edges.

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/head.

2 — Safety Precautions

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

Cables or accessories other than those supplied by STERIS may affect EMC

performance.

Portable RF communications equipment, including peripherals such as antenna cables

and external antennas, should be used no closer than 12" (305 mm) to any part of the

equipment boom, including cables specified by STERIS. Degradation of equipment

performance could result.

●For standard EMS units the total weight capacity on supply column (consisting of

shelves, equipment, and accessories) not to exceed 450 lb. (204 kg.). DO NOT

OVERLOAD.

●For Central Tandem EMS units, total weight capacity on supply column (consisting of

shelves, equipment, and accessories) not to exceed 285 lb. (129 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.

●Total weight capacity of supply head (consisting of accessories mounted to the

distance tube above the supply head) not to exceed 70 lb. (32 kg). DO NOT

OVERLOAD.

For equipment booms with electromechanical brakes, avoid brake pad and internal

bearing damage:

●Do not articulate the suspension arm(s) without first depressing the brake release

button(s).

●After depressing brake release button(s), the suspension arms, supply column, or

supply head can be repositioned in the room.

●Bring the system to a complete stop before releasing the brake button(s).

NOTE:

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 normally 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.

3 — Symbols

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

Symbols

The following symbols may appear on the HarmonyAIR Equipment Boom:

Table 3-1. Definition of Symbols

Symbol Definition

Protective Earth (Ground)

Consult manual for further instructions

General Warning

Consult instructions before use

Serial Number of Unit

Equipment or Reorder Number

Symbol indicating the legal manufacturer name and address

Symbol indicating the date of manufacture (yyyy/mm)

Symbol indicating This Way Up

3 — Symbols

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

Table 3-1 Definition of Symbols (Continued)

Symbol Definition

Symbol indicating high voltage.

Maximum Load Hazard (maximum load limit given on label)

V~ Voltage Rating of Unit, Alternating Current

AAmperage Rating of Unit

Hz Frequency Rating of Unit

Table 3-2. Warning Labels

Warning Label - Disconnect Supply Before Servicing

Warning Label - Brake Control System Power Switch

4 — Technical Specifications

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

Technical Specifications

4.1 Application Specific

The HarmonyAIR®Equipment Boom’s minimal footprint enables it to be easily placed at various locations in OR or ICU

rooms without monopolizing valuable space. The HarmonyAIR®Equipment Boom supplies gases, electrical power, and

acts as a shelving unit for various types of medical equipment. Surgical staff in operating rooms, trauma centers, critical

care rooms, clinics, and outpatient surgery centers will be the primary users.

Intended Medical Indication:

The HarmonyAIR Equipment Boom can be used in a variety of applications, including diagnostic procedures performed

in outpatient surgery centers, operating rooms, intensive care units, and major acute care suites.

Intended Patient Population:

There are no restrictions on patient populations.

Intended part of the body or type of tissue applied to or interacted with:

This device will not directly interact with the patient but will interact with the caregiver. The hands, arms, and torso

may be used to interact with the device.

Intended user profiles:

Surgical staff members are the intended operators of this device. The Operator Manual is written at a level consistent

with this intended user.

Intended conditions of use:

This equipment is designed to be used in operating rooms, trauma rooms, exam rooms, and critical care areas of

hospitals, clinics, physician offices and outpatient surgery centers that meets the environment requirements of the

operator manual. This equipment is suitable for continuous operation.

Operating principle:

• Electromechanical brake operation for lateral movement:

– Column/head lateral movement control is accomplished releasing either of two electromechanical brakes.

– The brakes are controlled by two pushbuttons on the column handle, accessory shelf handle, or on the supply

head handle. The green button is for the upper arm brake, and the blue button for the lower arm brake.

• Motorized Arm operation for vertical movement:

– The motorized arm allows the head/column to be adjusted up or down by activating a motor. The motor is

activated to move the head up by pressing and holding the up arrow button on the handle. Conversely, the

motor is activated to move the head down by pressing and holding the down arrow button on the handle. In

either case, releasing the button will stop movement of the head.

– The available range of travel can be adjusted by repositioning two limit switched installed along the drive

screw. The adjustment can be accessed under the covers at the second bearing.

• Gas Lines:

– Each gas hose line has a special marked hose and fitting for each gas outlet based on the DISS system.

– The gas outlets will not allow crossing of lines.

– Each outlet is marked with type of gas.

– Nitrogen and instrument air have pressure regulation and a pressure meter for control of these gases.

– The pressure meter is ranged so that the readings are in the middle third of the meter range. The accuracy is

±2%.

4 — Technical Specifications

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

• Electrical Power:

– Medical equipment power is divided for multiple outlets on different electrical panel circuit breakers (customer

supplied).

– Each circuit number is identified on the main label and the rating for that breaker.

– A special circuit is provided for Laser equipment when so configured — normally 230 VAC and is restricted to

one receptacle.

• Ambient Light:

– Supply Heads that have brakes will also be equipped with a light on the bottom surface of the unit for user

convenience. The light can be set to off, low, medium, or high illumination.

– The light is controlled by two pushbuttons on the head handles. The + turns the light on or increases its

illumination, while the – button decreases illumination or turns the light off.

4 — Technical Specifications

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

4.2 HarmonyAir Equipment Boom

Figure 4-1. HarmonyAIR Equipment Boom

4 — Technical Specifications

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

Figure 4-2. HarmonyAIR Equipment Boom

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

Figure 4-3. HarmonyAIR Equipment Boom

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

Figure 4-4. HarmonyAIR Equipment Boom

4 — Technical Specifications

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Operator Manual HarmonyAIR®Equipment Boom 10038023_G

Figure 4-5. HarmonyAIR Equipment Boom

4 — Technical Specifications

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10038023_G HarmonyAIR®Equipment Boom Operator Manual

4.3 HarmonyAIR Equipment Boom with Supply Column/Supply Head

HarmonyAIR Equipment Boom Single Arm or Double Arm

with Supply Column/Supply Head

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 HarmonyAIR Equipment Boom

• 6417 ft-lb (8700 N•m) for double arm HarmonyAIR Equipment Boom

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

4.4 Essential Performance

A. Uninterrupted delivery of power to receptacles as supplied to the device input with less than 3% voltage loss within

the system.

B. Uninterrupted deliver of gas flow to the gas outlets with gas flow rate at least 5 cfm when gas line is pressurized at

160 psi.

NOTE: For extreme cases of EM disturbance, the user may see increased noise on the ac receptacles.

4.5 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 HarmonyAIR Equipment Boom is not suitable for use in the presence of a flammable anesthetic mixture with

air or with oxygen or nitrous oxide.

• 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 Harmonyair Equipment Boom Operating instructions

Steris Harmonyair Equipment Boom Operating instructions

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