Steris Harmonyair Utility Hub Operating instructions

Type
Operating instructions
11005535
Revision B
HarmonyAIR® Utility
Hub
Operator Manual
1 — A Word from STERIS
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11005535_B HarmonyAIR® Utility Hub Operator Manual
A Word from STERIS
1.1 Introduction
This manual contains important information on proper use and maintenance of the HarmonyAIR® Utility Hub. 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® Utility Hub and should be retained in a conveniently accessible area for quick
reference.
STERIS is able to provide Customer training. Contact STERIS 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 will make available on request circuit diagrams, component part lists, descriptions or other information that will
assist service personnel to repair those parts of ME equipment that are designated by STERIS as repairable by service
personnel.
STERIS carries a complete line of accessories for use with this 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® Utility Hub must comply with all applicable medical equipment standards.
1.2 Indications for Use
The HarmonyAIR® Utility Hub is designed as a customizable unit for the routing of electricity, video and data, and
limited medical gasses throughout an Operating Room, all while reducing the number of wall plates needed and the
routing of cords and wires on the floor. The 120 VAC receptacle is provided for external equipment (not supplied by
STERIS) and is for use in North America only. The HarmonyAIR® Utility Hub is for use in OR, trauma rooms, exam rooms
and critical care areas in major metropolitan hospitals, community hospitals, clinics and outpatient surgery centers. The
product can be a stand-alone mount solution, or mount in tandem with the HarmonyAIR® Surgical Lighting System M
Series and HarmonyAIR® Surgical Lighting System G Series.
1.3 Service Information
The Customer is 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 in Section
2, Safety Precautions. Do not operate or service the equipment until 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® Utility Hub 11005535_B
1.5 Associated Publications
Equipment Drawing Number Equipment Drawing Title
11005534 HarmonyAIR® Utility Hub Install Instructions
11005535 HarmonyAIR® Utility Hub Operator’s Manual
11046589 HarmonyAIR® Utility Hub Maintenance Manual
1.6 Contraindications
There are no known contraindications associated with the HarmonyAIR® Utility Hub.
1.7 Addresses
Manufactured by Ondal Medical Systems GmbH
Wellastraße 6, 36088 Hünfeld, Germany
for STERIS Corporation
2720 Gunter Park East
Montgomery, AL 36109 • USA
www.steris.com
Class 1 Equipment
Ordinary Equipment (enclosed equipment without protection from ingress of water)
The ceiling mount system must not be installed where flammable gases or anesthesia are or 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.
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.
1.8 Waste Disposal Guidelines
The following materials are contained within the HarmonyAIR® Utility Hub. When disposing of the equipment boom or
its parts, ensure proper disposal of hazardous and other regulated waste in compliance with national, state and local
WEEE/RoHS regulations.
Electronic and Electrical Parts — Not known to require special disposal methods at publication date of this manual.
Metal Parts — Made from aluminum (Al), steel (Fe), copper (Cu), and copper alloys (Cu/x), plastic, synthetic rubber,
plating (Cr, Ni, Zn, Au), and adhesives not known to require special disposal methods at publication date of this manual.
Polyvinyl Chloride (PVC) — The amount of PVC in an EMS system varies with configuration and options, with an upper
limit of approximately 23.9 lb (10.9 kg).
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11005535_B HarmonyAIR® Utility Hub Operator Manual
TABLE OF CONTENTS
Section Number Description Page
1 A Word from STERIS...................................................................................................................................... 2
1.1 Introduction................................................................................................................................. 2
1.2 Indications for Use...................................................................................................................... 2
1.3 Service Information .................................................................................................................... 2
1.4 Advisory....................................................................................................................................... 2
1.5 Associated Publications ............................................................................................................. 3
1.6 Contraindications........................................................................................................................ 3
1.7 Addresses.................................................................................................................................... 3
1.8 Waste Disposal Guidelines......................................................................................................... 3
2 Safety Precautions ........................................................................................................................................ 5
3 Symbols .......................................................................................................................................................... 7
4 Technical Specifications................................................................................................................................ 9
4.1 Travel and Articulation Range.................................................................................................... 9
4.2 Ceiling Mounting and Rotation Range....................................................................................... 9
4.3 Environmental Conditions........................................................................................................ 10
4.4 Electrical Requirements ........................................................................................................... 10
4.5 Accessories ............................................................................................................................... 10
5 Operating Instructions ................................................................................................................................ 11
5.1 Supply Head Load Capacity...................................................................................................... 11
5.2 Preparing Unit for Initial Use ................................................................................................... 11
5.3 Operation................................................................................................................................... 11
5.4 Gas Supply Connectors............................................................................................................. 12
5.5 Gas Connection ......................................................................................................................... 13
5.6 Hose Assembly ......................................................................................................................... 15
5.7 Electrical Connection ................................................................................................................ 15
5.8 Means of Isolation — Disconnecting Power and Gas Connections...................................... 16
5.9 Data Plate Label........................................................................................................................ 17
5.10 Data Plate Label Location for Supply Head ............................................................................ 17
5.11 Maximum Payload Label Location for Supply Head............................................................... 18
6 Routine Maintenance .................................................................................................................................. 19
6.1 Preventative Maintenance ....................................................................................................... 19
6.2 Testing Requirements (Canada Only)...................................................................................... 20
7 Troubleshooting........................................................................................................................................... 21
7.1 Introduction............................................................................................................................... 21
7.2 Insufficient Gas Supply or Audible Hiss .................................................................................. 21
7.3 Arm Moves with Difficulty or Drifts ........................................................................................ 21
8 Appendix EMC Compliance Technical Data.............................................................................................. 22
2 — Safety Precautions
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
Safety Precautions
The following Safety Precautions must be observed when operating or servicing the HarmonyAIR® Utility Hub.
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
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.
WARNING
PERSONAL INJURY
Before using on a patient, check for proper equipment operation and acceptable gas
flows.
WARNING
FIRE HAZARD
Avoid any risk of fire. Do not use flammable cleaning agents when cleaning or
disinfecting the HarmonyAIR® Utility Hub.
WARNING
EXPLOSION HAZARD
The HarmonyAIR® Utility Hub 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.
2 — Safety Precautions
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11005535_B HarmonyAIR® Utility Hub Operator Manual
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.
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.
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® Utility Hub 11005535_B
Symbols
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
Symbol indicating high voltage.
Maximum Load Hazard (maximum load limit given on label)
Voltage Rating of Unit, Alternating Current
Amperage Rating of Unit
Frequency Rating of Unit, Alternating Current
Warning Label – Disconnect Supply Before Servicing
3 — Symbols
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11005535_B HarmonyAIR® Utility Hub Operator Manual
Table 3-1 Definition of Symbols (Continued)
Symbol Definition
Warning Label – Brake Control System Power Switch
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE
AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES
60601-1 (2005) + AMD1 (2012) and CAN/CSA-C22.2 No. 60601-1:14
E346486
4 — Technical Specifications
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
Technical Specifications
4.1 Travel and Articulation Range
See Figure 4-1.
Figure 4-1. Travel and Articulation Range
4.2 Ceiling Mounting and Rotation Range
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® Utility Hub
4 — Technical Specifications
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11005535_B HarmonyAIR® Utility Hub Operator Manual
Rotation Range of Joints
Gradually adjustable of up to max. 330°
4.3 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 ceiling mount system must not be installed where flammable gases or anesthesia are or 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 ambient temperature during operation must be kept between 20 and 25°C (68 and 77°F).
Relative humidity should stay within a range of 20 to 75%.
Atmospheric pressure should stay within a range of 0.7 to 1.05 atm STP atmospheric pressure (700 to 1060 hPa).
4.4 Electrical Requirements
Outlet for North America: 120V, 20A.
Low voltage wiring can be routed through suspension arms and boom cavities without additional protection.
The HarmonyAIR® Utility Hub is approved for use with high frequency surgical equipment subject to the following
conditions:
1. The Customer is responsible for ensuring that no equipment powered from the utility hub is affected by the use
of ESU or HF surgical devices.
2. If the Customer discovers that equipment powered from the utility hub can be affected, the Customer is
responsible for repositioning equipment as necessary, or taking other precautionary measures.
4.5 Accessories
Use only authorized accessories. Contact STERIS for further details.
5 — Operating Instructions
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
Operating Instructions
5.1 Supply Head Load Capacity
Total weight of supply head accessories not to exceed 23.6 lb (11 kg.). DO NOT OVERLOAD.
5.2 Preparing Unit for Initial Use
WARNING
PERSONAL INJURY
Do not position HarmonyAIR® Utility Hub over patient.
Ensure that supply head is level, secure and adequately supported.
5.3 Operation
WARNING
PERSONAL INJURY
Before using on a patient, check for proper equipment operation and acceptable gas
flows.
Do not position equipment boom over patient.
WARNING
PERSONAL INJURY AND/OR POSSIBLE EQUIPMENT 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.
5 — Operating Instructions
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11005535_B HarmonyAIR® Utility Hub Operator Manual
CAUTION
POSSIBLE EQUIPMENT DAMAGE
For equipment booms with pneumatic brakes, avoid brake bladder damage:
After pressing the brake release button(s), wait about two seconds before positioning
the column.
Bring the system to a complete stop before releasing the brake buttons.
CAUTION
POSSIBLE EQUIPMENT DAMAGE
Avoid damage to pneumatic brakes. Release brake buttons only after system has come
to a complete standstill.
1. Ensure that monitor (optional) is secured and adequately supported.
2. Connect other desired equipment to the proper electrical or gas outlet. Check for proper operation.
3. If required, securely attach accessories to platform railing.
NOTE:
Ranges of rotation are limited by adjustable or fixed rotational stops to prevent damage of internal hoses and
wires. These stops must be adjusted to prevent unit from striking walls, equipment or other obstructions.
5.4 Gas Supply Connectors
WARNING
EXPLOSION
The HarmonyAIR® Utility Hub 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
PERSONAL INJURY
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).
Each gas connection is marked and color-coded as indicated in Table 5-1.
5 — Operating Instructions
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
Table 5-1. Color-Coding of Gas Connections
Connection U.S.A. Color Canadian Color
Vacuum White Yellow
Oxygen Green White
Nitrous Oxide Blue Blue
Medical Air Yellow Black/White
WAGD (Evac.) Purple Purple
Nitrogen Black Black
Carbon Dioxide Gray Gray
NOTE:
Four types of gas connections are available: DISS, Chemetron compatible, Ohio Medical compatible and Puritan-Bennett
(see Figure 5-1). Refer to manufacturer's instructions for guidance in proper operation of gas connectors supplied with
the HarmonyAIR® Utility Hub.
Figure 5-1. Types of Connectors Available
5.5 Gas Connection
Follow the safety instructions in Section 2, Safety Precautions.
Gas connections are identified at gas interface piece.
Connection of gas interface pieces are marked with the codes mentioned in Table 5-2 and Table 5-3.
Consider local rules and regulations.
5 — Operating Instructions
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11005535_B HarmonyAIR® Utility Hub Operator Manual
Color Code for Gas Connectors According to NFPA 99 Identification Marking of Connecting Tube via Hose Color
Table 5-2. Color Code for Gas Connectors According to NFPA 99 Identification Marking of Connecting Tube via Hose
Color
Gas Connector Color Code
AIR Yellow
O2 Green
N2O Blue
VAC White
N2 Black
CO2 Gray
INA Red
WAGD Purple
Color Code for Gas Connectors According to ISO 5359 Identification Marking of Connecting Tube via Hose Color
Table 5-3. Color Code for Gas Connectors According to ISO 539 Identification Marking of Connecting Tube via Hose
Color
Gas Connector Color Code
AIR Black/White
O2 White
N2O Blue
VAC Yellow
N2 Gray
CO2 Black
INA Black/White
WAGD Violet/Purple
5 — Operating Instructions
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
5.6 Hose Assembly
CAUTION
POSSIBLE EQUIPMENT DAMAGE
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 pendant.
1. Inspect mating hose assembly for damage. If any is found, do not use hose assembly.
2. Connect hose assembly to correct mating gas-specific outlet. Gas-specific fittings are permanently crimped to
each end of hose assembly.
NOTE:
Gas flow may be affected by the attachment of multiple hoses.
Normal Settings
Nitrogen: Supply gauge 160 psi ± 2% accuracy.
Instrument Air: 125 psi ± 2% accuracy.
Gauge Information
• Range:
1-300 psi.
• Accuracy:
0-100 ± 3%.
100-200 ± 2%.
200-300 ± 3%.
5.7 Electrical Connection
See Figure 5-2.
5 — Operating Instructions
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11005535_B HarmonyAIR® Utility Hub Operator Manual
Figure 5-2. Junction Box Label
Follow safety instructions in Section 2, Safety Precautions.
Electrical connection is identified via a junction box/connection terminal that is placed outside HarmonyAIR®
Utility Hub, usually in free space between ceiling and intermediate ceiling.
Cable clips are marked with:
»Grounding symbol for the protective earth connection,
»“N” for the neutral conductor,
»Based on that there is only one more option to connect the remaining cable “L” (not marked separately).
Permitted electrical supply data is mentioned on type label of junction box (see Figure 5-2).
Appearance of junction box can vary depending on configuration of HarmonyAIR® Utility Hub and therefore has to
be connected individually.
5.8 Means of Isolation — Disconnecting Power and Gas Connections
WARNING
PERSONAL INJURY
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.
5 — Operating Instructions
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
WARNING
ELECTRIC SHOCK AND BURN
Disconnect all utilities to the HarmonyAIR® Utility Hub 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.
Disconnect HarmonyAIR® Utility Hub System power from electrical mains power panel for the room. Power for the
receptacles and equipment boom brake and motor controls are all located on separate breakers within the power
panel.
Turn OFF gas at ceiling if system develops a leak or to disconnect a leaking hose.
Turn OFF nitrogen by using shut off switch located on the nitrogen panel.
Turn OFF air by using shut off switch located on air panel.
External Isolation of Mains Power
Customer is responsible for supplying an isolation transformer to each OR power panel.
5.9 Data Plate Label
See Figure 5-3.
The HarmonyAIR® Utility Hub is permanently installed medical equipment. Customer supplied circuit protection must
be in compliance with local codes and protect circuits for configured voltage and amperage.
Figure 5-3. Example of Data Plate Label
5.10 Data Plate Label Location for Supply Head
The supply head is equipped with a data plate label. See Figure 5-4.
5 — Operating Instructions
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11005535_B HarmonyAIR® Utility Hub Operator Manual
Figure 5-4. Data Plate Label Location
5.11 Maximum Payload Label Location for Supply Head
See Figure 5-5.
Figure 5-5. Maximum Payload Label Location for Supply Head
6 — Routine Maintenance
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Operator Manual HarmonyAIR® Utility Hub 11005535_B
Routine Maintenance
6.1 Preventative Maintenance
WARNING
PERSONAL INJURY
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.
The compressed air supply to the ceiling supply unit must be turned off for the repair
procedure. Inform the Customer 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 Customers connected to the same mains power supply be informed so
that appropriate precautions can be taken.
WARNING
ELECTRIC SHOCK AND BURN
Disconnect all utilities to the HarmonyAIR® Utility Hub 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.
CAUTION
POSSIBLE EQUIPMENT DAMAGE
The apparatus must be inspected and serviced regularly by trained service personnel at
six monthly intervals. Maintain complete service records.
Equipment Inspection
Regular service and maintenance MUST be performed only by STERIS or a STERIS-trained technician. Any work
performed by inexperienced or unqualified persons or the installation of unauthorized parts could cause personal injury,
invalidate the warranty or result in costly damage. If any issues arise during the following procedures, contact STERIS.
6 — Routine Maintenance
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11005535_B HarmonyAIR® Utility Hub Operator Manual
NOTE:
Use only authorized STERIS replacement parts when conducting any maintenance on the equipment.
Inspect system and arm wiring for deterioration or loose connections.
Inspect arm assembly for ease of movement.
Inspect gas hoses and outlets for chafing or damage.
Verify similar forces required to raise and lower arm.
Verify suspension system does not drift.
Verify suspended components move through entire range of articulation without binding or drifting.
Check electrical outlet insertion forces
Engage a professional testing service to check all pressure hoses and cables on a yearly basis (not provided by
STERIS).
6.2 Testing Requirements (Canada Only)
Following any modifications or repairs, the tests listed below must be conducted in compliance with the specifications
given in CSA Z5359:
Leakage test.
Obstruction/restriction test.
Particulate contamination test.
Gas identity test.
In addition, the following tests are to be conducted in compliance with CSA Z5359 following any repairs to the unit:
Leakage test.
Flow/pressure drop test.
Refer to applicable NFPA/CSA standard(s) for additional information.
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Steris Harmonyair Utility Hub Operating instructions

Type
Operating instructions

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