WHO 2019 nCoV Clinical Oxygen 2023.1 Eng

1
medical oxygen
Foundations of
systems
FOUNDATIONS
17 FEBRUARY 2023
OF MEDICAL
OXYGEN SYSTEMS
Foundations of medical
oxygen systems
17 FEBRUARY 2023
WHO/2019-nCoV/Clinical/Oxygen/2023.1
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Figure 2.33 WHO / Hugues Gaertner; Figure 3.2 WHO / Alex Y. Sokemawu.
OXYGEN SYSTEMS
FOUNDATIONS OF MEDICAL
Contents
Acknowledgements v
Abbreviations vii
Introduction 1
Structure 1
Method 2
1. Oxygen history, ecosystem and related systems 3

1.1 An essential medicine 5
1.2 History of medical oxygen 5
1.3 Oxygen therapy and respiratory support: key concepts 7
1.4 Elements of the oxygen ecosystem 8
1.5 Oxygen systems 8
1.6 Oxygen production, storage and distribution 10
1.7 Delivery equipment and devices 14
1.8 Patient monitoring 18
1.9 Conditioning, regulation and testing devices 18
2. Health facility oxygen systems 19

2.1 Onsite production technologies: PSA, VSA and VPSA 21
2.2 Technical requirements for PSA oxygen generator plants 22
2.3 Sizing and configuring of PSA oxygen generator plants 26
2.4 PSA system costs 29
2.5 Cylinder filling station: booster compressor and filling ramp 30
2.6 Distribution ramp 31
2.7 Pneumatic changeover system: automatic/manual 31
2.8 High-pressure gas cylinders 33
2.9 Medical gas pipeline systems 39
2.10 Onsite liquid oxygen storage 42
3. Operationalization of oxygen systems 45

3.1 Estimation of oxygen demand 47
3.2 Calculation methods for estimating oxygen demand 48
3.3 Tips for rational use of oxygen 49
3.4 System implementation, operation and maintenance 50
3.5 Structural and electrical requirements for onsite oxygen systems 51
3.6 Safety and mitigation measures 56
iii
OXYGEN SYSTEMS
4. Offsite oxygen production 61
4.1 Value chain of liquid oxygen 63
4.2 Liquid oxygen availability 64
5. Tools and resources 67

5.1 WHO clinical treatment guidelines 69
5.2 WHO Emergency Response Framework 70
5.3 WHO COVID-19 Essential Supplies Forecasting Tool (ESFT) 70
5.4 Medical Equipment for COVID-19 Case Management Inventory Tool 70
5.5 WHO Global Clinical Platform for COVID-19 70
5.6 WHO technical consultation on oxygen access scale-up for COVID-19 70
5.7 O2CoV2 study 71
5.8 External resources 71
Glossary 75
References 78
Additional resources 80
Annexes
Web annex A. Technical considerations for the procurement of oxygen generator plants
https://apps.who.int/iris/bitstream/handle/10665/366134/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-A-
2023.1-eng.pdf
Web annex B. Site evaluation for oxygen generator plants
https://apps.who.int/iris/bitstream/handle/10665/366135/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-B-
2023.1-eng.pdf
Web annex C. Site readiness for oxygen generator plants
https://apps.who.int/iris/bitstream/handle/10665/366136/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-C-
2023.1-eng.pdf
Web annex D. Commissioning report for oxygen generator plants
https://apps.who.int/iris/bitstream/handle/10665/366137/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-D-
2023.1-eng.pdf
Web annex E. Oxygen supplier’s mapping
https://apps.who.int/iris/bitstream/handle/10665/366138/WHO-2019-nCoV-Clinical-Oxygen-Web-annex-E-
2023.1-eng.pdf
iv
OXYGEN SYSTEMS
Acknowledgements
The World Health Organization (WHO) would like to give special thanks to the Health Care Readiness
Department, Clinical Management Team, led by Dr Janet Diaz, for coordination of the Oxygen Access Scale Up
Initiative; and the technical team which developed the content, coordinated by Laura Alejandra Velez, with the
collaboration of Hugues Gaertner for the document, and Florestan Boualame, Edgardo Diaz and Ingrid Lara for
the annexes.
WHO would also like to thank all collaborators who contributed content and expert review, from the following
departments, regional and country offices and entities.
Access to Medicines and Health Products Division: Steve Estevão Cordeiro (Norms and Standards for
Pharmaceuticals); Benedikt Huttner (Model Lists of Essential Medicines); Herbert Schmidt (Norms and
Standards for Pharmaceuticals); Adriana Velazquez (Medical Devices).
Health Emergencies Programme (WHE): Sylvia Bertagnolio (Head, Control and Response Strategies Unit);
Vanessa Cramond (Clinical Management and Operations Unit); Michele Di Marco (Operations Support and
Logistics); Constance McDonough-Thayer (Operations Support and Logistics); Jia He (Clinical Management
and Operations Unit); Marta Lado Castro-Rial (Clinical Management and Operations Unit); Mahesh Madyagol
(Operations Support and Logistics); Pryanka Relan (Emergency Medical Teams); Jamie Rylance (Clinical
Management and Operations Unit); Ana Silenzi (Operations Support and Logistics).
Biomedical and oxygen focal points at regional and country level: Atalawoe Kossivi Kumedjro, Martha Mulerwa
(WHO Regional Office for Africa); Edgardo Diaz, Claudio Meirovich, Dmytro Osin, Ulian Rotari (WHO Regional
Office for Europe).
WHO would like to thank the following external reviewers from partner organizations for their support
in the preparation of this document: Beverly Bradley, Mansi Dalal, Florin Gheorghe, Katherine Kirsch, Ingrid
Lara, Helen Petach, Habtamu Seyoum Tolla (United Nations Children’s Fund [UNICEF]); Martha Gartley
(Clinton Health Access Initiative [CHAI]); Noah Hudelson (Build Health International); Antoine Maillard
(Alliance for International Medical Action [ALIMA]); Jim Stunkel (Assist International).
Developed with funding support of Unitaid.
v
OXYGEN SYSTEMS
vi
OXYGEN SYSTEMS
Abbreviations
AFNOR Association Française de Normalisation
AGA American Gas Association
ALIMA Alliance for International Medical Action
ASME American Society of Mechanical Engineers
ASU air separation unit
AVR automatic voltage regulator
BPAP bilevel positive airway pressure
BP British Pharmacopoeia
BS British Standard
CGE Compressed Gas Association (USA)
CHAI Clinton Health Access Initiative
COA certificate of analysis
CPAP continuous positive airway pressure
DIN Deutsche Industrial Norms
DISS Diameter Index Safety System
DOT Department of Transport (USA)
EBC Every Breath Counts Coalition (public-private partnership)
ESFT Essential Supplies Forecasting Tool (WHO)
Eur Ph European Pharmacopoeia
FiO2 fraction of inspired oxygen
FSC Free Sales Certificate
GB Guo Biao (national standards, People’s Republic of China)
GDP good distribution practices
GMP good manufacturing practices
GOX gaseous oxygen
HFNC high-flow nasal cannula
HFNO
high-flow nasal oxygen
HHHF heated humidified high flow
HTM Health Technical Memorandum (NHS)
HVAC heating, ventilation, air conditioning
ICU intensive care unit
IPC infection prevention and control
ISO International Organization for Standardization
JIS Japanese Institute of Standards
kPa kilopascal (unit of pressure, metric) (SI)
KPI key performance indicator
LCC life cycle cost
L/min litres per minute
vii
OXYGEN SYSTEMS
LMIC low- and middle-income countries
LOX liquid oxygen
MGPS medical gas pipeline system
NFPA National Fire Protection Association (USA)
NHS National Health Service (United Kingdom)
NIV Non-Invasive Ventilators
Nm3/hr normal cubic metres per hour
NTP normal temperature and pressure
OEM original equipment manufacturing
OSPT Oxygen System Planning Tool (UNICEF)
O2 oxygen (molecule)
PIC/S Pharmaceutical Inspection Co-operation Scheme
PMP preventive maintenance programme
PPE personal protective equipment
PPM planned preventive maintenance
PSA pressure swing adsorption
PSI pounds per square inch (unit of pressure, imperial)
PSIG PSI gauge
QA quality assurance
QC quality control
RPV residual pressure valve
SaO2 arterial oxygen saturation
SARI severe acute respiratory infection
SI International System of Units
SLA service level agreement
Sm3/hr standard cubic metres per hour
SPD surge protection device
SpO2 peripheral capillary oxygen saturation
STP standard temperature and pressure
TCO total cost of ownership
TPED Transportable Pressure Equipment Directive (European Union)
UNDSS United Nations Department for Safety and Security
UNICEF United Nations Children’s Fund
USP United States Pharmacopoeia
VIE vacuum-insulated evaporator
VPSA vacuum pressure swing adsorption
VSA vacuum swing adsorption
VSD variable speed drive
WFSA World Federation of Societies of Anaesthesiologists
WHO World Health Organization
% v/v percentage volume per volume
viii
OXYGEN SYSTEMS
Introduction
Oxygen – an element present in the atmosphere – is the second largest component after
nitrogen, comprising 20.8% of air by volume. It is the most common medicinal gas used
in health facilities.
Medical oxygen is lifesaving and an essential medicine Structure

used to ensure safe surgical, emergency and critical
care services. It is used at all levels of the health care The document has five main sections:
system and is crucial for the treatment of COVID-19 1. Oxygen history, ecosystem and related systems:
and other life-threatening conditions such as severe This section provides definitions, gives a history of
pneumonia, severe malaria, sepsis caused by a wide the use of medical oxygen, outlines the oxygen
variety of pathogens, trauma and complications of ecosystem and describes the different components
pregnancy or birth. Unlike many medicines, it has no of oxygen systems.
substitute. Although much work has been undertaken
in the oxygen ecosystem over the years, especially 2. Health facility oxygen systems: This section
in relation to its clinical use, access and availability presents an overview of the onsite technologies
remain limited in many countries. The COVID-19 for the production, distribution and storage of
pandemic has highlighted this gap. Only collaborative medical oxygen.
action can truly scale up access to and availability of
3. Operationalization of oxygen systems: Key
medical oxygen.
operational topics and main concerns related to the
Foundations of medical oxygen systems has design, implementation and use of oxygen systems
been compiled to capture definitions, technical are covered in this section.
requirements, tools and resources related to medical
4. Offsite oxygen production: This section provides
oxygen systems based on information available as of
a brief appraisal of general topics related to the value
January 2023. The purpose of this effort is to make
chain of offsite liquid oxygen (LOX) production.
relevant and practical material accessible for national
authorities, policy-makers, donors, implementing 5. Tools and resources: Here various WHO
partners, practitioners, biomedical engineers and practical tools, studies and platforms are outlined
anyone interested in medical oxygen systems. and links to external relevant resources, all related to
oxygen ecosystem.
This document references key WHO products,
which are the result of multidisciplinary efforts
related to medical oxygen; its safe use and quality
system’s implementation. A major gap regarding
medical oxygen systems concerns publicly available
technical guidance (1), and this document focuses
on providing definitions related to medical oxygen
systems and the technical and engineering aspects
requiring contextualized assessment, implementation
and operation. Relevant external resources are
outlined, acknowledging the recent enhanced global
collaboration made to close the identified gaps which
have started to be addressed since the beginning of
the COVID-19 pandemic.
1
OXYGEN SYSTEMS
Method Confidentiality and Declarations of Interest
The contents of this introduction document were The selection of internal WHO participants was based
developed by WHO collaborators from the Health Care on their involvement in oxygen-related work. The
Readiness Department, under the Clinical Pillar led selection of entities, which participated in the external
by Janet Diaz, and written by Laura Alejandra Velez review, was based on their technical expertise of the
with further contributions from Hugues Gaertner. subject matter. Each entity appointed representatives
The document is based on information available to undertake content review. The necessary measures
as of September 2022, and refers to available WHO to avoid conflicts of interest and to follow the
guidelines and guidance, and ongoing work related Framework of Engagement with Non-State Actors
to oxygen across a number of WHO units. The WHO rules were assessed by the WHO technical unit in
technical tools contained in the annexes were consultation with the legal unit, and no conflicts
developed together with consultants Florestan were identified. Appropriate WHO confidentiality
Boualame, Edgardo Diaz and Ingrid Lara. These tools undertakings were signed and submitted by all
have been tested via country and regional support in individual consultants of the participating entities.
collaboration with WHO biomedical engineers and
oxygen focal points. Appropriate WHO confidentiality A note on pressure units
undertakings were signed and submitted by all
individual consultants. This document refers to units derived from the
International System of Units (SI). Therefore,
This document contains links to multidisciplinary references to pressure are expressed in pascal
WHO oxygen-related resources, such as normative (Pa). However, the units most commonly used by
products, clinical guidelines, platforms, dashboards, manufacturers are bar or pounds per square inch
calculators and other publications. Relevant (psi). To facilitate understanding, pressure values
external resources produced by recognized partners are expressed in kPa with bar and psi conversions
belonging to the Oxygen Task Force are outlined. The provided in the present document. Additional
entities were consulted to approve inclusion of the conversion equivalences are shown in Table 1.
external resources. WHO is not responsible for the
development or use of those tools and simply refers to
Table 1. Pressure unit value equivalents
them as available resources.
kg/cm2 atm bar psi kPa mm hg
The draft document was sent for review to selected (libra/pulg2)
internationally recognized entities with technical 1 kg/cm2 0.968 0.980 14.2 98 736
expertise of the subject matter and which are part of
1 atm 1.033 1.013 14.7 101.3 760
the Oxygen Task Force. The content was reviewed for
readability, technical accuracy and usability. 1 bar 1.020 0.987 14.5 100 750
1 psi 0.070 0.068 0.069 6.894 51.7

Note: Further information about the Oxygen Task Force can be (libra/pulg2)
found at: https://www.who.int/news/item/25-02-2021-covid-
1 kPa 0.010 0.010 0.010 0.145 7.50
19-oxygen-emergency-impacting-more-than-half-a-million-
people-in-low--and-middle-income-countries-every-day-as- 1000 mm hg 1.360 1.316 1.333 19.33 133.3
demand-surges
2
OXYGEN SYSTEMS
1. Oxygen history,
ecosystem and
related systems
3
OXYGEN SYSTEMS
1. Oxygen history, ecosystem and related systems

1.1 An essential medicine 5
1.2 History of medical oxygen 5
1.3 Oxygen therapy and respiratory support: key concepts 7
1.4 Elements of the oxygen ecosystem 8
1.5 Oxygen systems 8
1.6 Oxygen production, storage and distribution 10
1.7 Delivery equipment and devices 14
1.8 Patient monitoring 18
1.9 Conditioning, regulation and testing devices 18
4
OXYGEN SYSTEMS
1. Oxygen history, ecosystem

and systems
This section provides definitions, gives a history of the use of medical oxygen, outlines
the oxygen ecosystem and describes the different components of oxygen systems.
1.1 An essential medicine 1.2 History of medical oxygen

Oxygen is an essential medicine – lifesaving for
The history of the use of oxygen in medicine began
many pathologies involving respiratory distress of
in the 1770s, when Swedish pharmacist Karl Scheele
the patient. Health care professionals use oxygen for
and British scientist Joseph Priestley independently
respiratory support [1.3] to treat illnesses such as
isolated oxygen gas. It was first administered to a
COVID-19, pneumonia, severe malaria and sepsis. It
patient in 1890, when Dr Alfred Blodgett used it to
is also essential in ensuring safe surgical, emergency
treat pneumonia (5). Over the years, clinical and
and critical care services.
technical guidance has been developed for use
in many different populations and settings, most
Access to medical oxygen must be ensured across recently in the treatment of COVID-19 patients.
all levels of care to treat diseases in all patient Key milestones (Fig. 1.1 and Fig. 1.2):
groups, especially the vulnerable such as older
people, pregnant women and newborns. · Inon1971 the first pharmacopoeia monograph
oxygen was published in the European
Unlike many medicines, oxygen has no substitute. Pharmacopoeia (6).
The International Pharmacopoeia (2) regional · InEssential

1979 oxygen was added to the WHO Model List of
Medicines, under sections 1. Anaesthetic
pharmacopoeias (e.g. European Pharmacopoeia
[Ph Eur]), and national pharmacopoeias (e.g. United and 1.1 General anaesthetics and oxygen – only
States Pharmacopeia [USP], British Pharmacopoeia considered for use in anaesthesia (4).
[BP]), establish the threshold values and requirements · InThe1979 the monograph on oxygen was included in
International Pharmacopoeia.
for testing concentration and impurities of oxygen
considered for medical applications. As with any other
medicine, oxygen production, distribution [1.6] and
· Ininstallation,
2006 technical guidance for system design,
validation and verification of oxygen
delivery must be strictly regulated. Recommendations as a medicinal gas was released by the United
to guarantee the identity, adequacy, continuity and Kingdom of Great Britain and Northern Ireland’s
quality of the oxygen for medical use can be found in National Health Service (NHS) (7).
WHO Good manufacturing practices for medicinal
gases (3). · Inof 2017 oxygen was added to the WHO Model List
Essential Medicines for treating hypoxaemia (8).
In 1979 oxygen was added to The Selection of · Inand2019 the WHO-UNICEF technical specifications
guidance for oxygen therapy devices was
Essential Drugs (4) and although much work has been
undertaken in the medical oxygen ecosystem [1.4] published (9).
since then, especially in its safe clinical use, access,
availability and the regulatory framework remain
· Infor2020 WHO published the Technical specifications
pressure swing adsorption (PSA) oxygen
limited in many countries (1). generator plants (10).
· InThe2021 WHO revised the monograph on oxygen in
International Pharmacopoeia (11) and on good
manufacturing practices (GMP) for medicinal gases (3).
Key resources
The International Pharmacopeia: https://www.who.int/teams/health-product-policy-and-standards/standards-and-
specifications/norms-and-standards-for-pharmaceuticals/pharmacopoeia
Good manufacturing practices for medicinal gases: https://www.who.int/publications/m/item/trs1044-annex5
WHO Model Lists of Essential Medicines: https://www.who.int/groups/expert-committee-on-selection-and-use-of-
essential-medicines/essential-medicines-lists
WHO Oxygen Access Scale Up Initiative: https://www.who.int/initiatives/oxygen-access-scale-up
WHO health topics – oxygen: https://www.who.int/health-topics/oxygen#tab=tab_1
WHO health topics – medical devices: https://www.who.int/health-topics/medical-devices#tab=tab_1
5
OXYGEN SYSTEMS
1770s 1970s 2006 2015 2017 2020

Discovery of PSA first used United Kingdom The international WHO Model List COVID-19
oxygen as an commercially NHS HTM 02-01: pharmacopoeia of Essential Medicines characterized
element and for medicinal use Medical gas (oxygen included) adds oxygen as a pandemic –
first pipeline systems Technical Nigeria: national strategy interim technical
publications guidance and for the scale-up of medical guidance
specifications oxygen in health facilities documents
for oxygen 2017–2022 published
concentrators Every Breath Counts
(WHO) Coalition launch
1902 1980 2012 2016 2019

First application Oxygen The clinical Oxygen therapy Technical
of an air separation included in use of oxygen for children (WHO) specifications
process by The European in hospitals Ethiopia: and guidance
fractional Pharmacopoeia with limited National medical for oxygen
distillation (2nd ed.) resources (WHO) oxygen and pulse therapy
(Carl Linde) oximetry scale up devices
road map (WHO-UNICEF)
2016–2020/21 First documented
(first LMIC to case of SARS-CoV-2
publish national
oxygen scale-up
roadmap)
Fig. 1.1 Oxygen history: identifying technical guidance for low- and middle-income countries
Biomedical
Consortium; inventory
Emergency tool
global supply
chain system
(COVID-19) catalogue
v1; ESFT WHO PSA Oxygen
plants technical
SARI treatment technical
centre guidance; consultation Therapeutics
specifications
Clinical care for and COVID-19
COVID-19
severe acute v3; living
characterized May September Clinical
respiratory guideline
as a pandemic November management
11 March 2020 infection: toolkit of COVID-19
June October guidance v4-v6
Living 2021
guideline on
2020 April Clinical
management
therapeutics v1
December
March (corticosteroids) PPE and
of COVID-19
guidance v3 specifications
for COVID-19 January - Public
November consultation
February for new
guidance
Priority medical devices on GMP
and specifications
for COVID-19
Rehabilitation SARI toolkit:
guidelines v5 clinical care
Clinical Care for
Severe Acute
Respiratory Infection Toolkit
of severe acute March -
Clinical
Update 2022
respiratory December
management infections,
of COVID-19 COVID-19 Therapeutics April
guidance v7 adaptation and COVID-19
2023 June
COVID-19 Adaptation
update v8-v12; living

guideline
Therapeutics
and
January updated COVID-19
September February
v4-7; living
April
NIV
guidelines
2022 October guideline
July
v4
January -
September December
Draft proposal
for revision of medicinal
Clinical management COVID-19 home care
oxygen monograph
guidelines bundle for health
in the international
care workers
pharmacopeia
Fig. 1.2 Oxygen history: clinical and technical guidance triggered by COVID-19
6
OXYGEN SYSTEMS
1.3 Oxygen therapy and respiratory The International Organization for Standardization
(ISO) 80601-2-69:2020 (13) covers the specific
support: key concepts
requirements for the safety and essential performance
Oxygen therapy is the administration of medical of bedside concentrators [1.6.1], and stipulates that
oxygen by any means that improves oxygen delivery to oxygen purity should typically be 82–96%. WHO-
the tissues by increasing oxygen content in the blood UNICEF technical specifications and guidance for
of hypoxaemic patients. Hypoxaemia is a clinical oxygen therapy devices (9) state the production of
condition which indicates low oxygen levels in the oxygen by bedside concentrator devices must attain
blood (12). a concentration of > 82% and trigger an alarm if the
level falls below this level.
Oxygen therapy is delivered either through an open
respiratory circuit (low-flow oxygen therapy such
as nasal cannula or a mask) where the fraction of
1.3.2 Fraction of inspired oxygen (% FiO2)
inspired oxygen (FiO2) is variable, or in a closed circuit The FiO2 is the percentage of oxygen concentration
(i.e. when on ventilatory support) where FiO2 is more participating in gas exchange in the alveoli.
accurately controlled.
FiO2 depends on:
As with any other medicine, delivering medical
oxygen to a patient must follow the prescription and · oxygen flow rate;
instructions of a health worker. These instructions · delivery interface;
involve providing a clear description outlining how,
when, for how long, how much, and the monitoring · patient’s minute ventilation (which is related to
respiratory rate and tidal volume); and
actions. Specific medical conditions require specific
delivery equipment and devices [1.7]. Further · entrainment of ambient gas by the patient during
each spontaneous inspiration (when applicable).
information on oxygen therapy can be found in various
WHO clinical treatment guidelines [5.1]. Moreover,
Regardless of the delivery device (non-invasive or
the clinical treatment guidelines are considered the
invasive) during respiratory support, the patient is
baseline information to estimate oxygen demand [3.1]
continuously receiving a mixture of medicinal air
for a given health facility.
and oxygen. The application of 100% oxygen for long
An overview of key terminology (Fig. 1.3) concerning periods of time could be toxic for the patient.
oxygen administration to the patient follows; however,
this is not intended as an in-depth exploration of 1.3.3 Measured oxygen levels in the
clinical practice and recommendations. blood (% SpO2)
Arterial blood oxygen saturation (SaO2) is usually
1.3.1 Oxygen concentration (% O2) determined by blood gas analysis. Peripheral capillary
Medical oxygen is acquired from ambient air by a blood oxygen saturation (SpO2) is measured non-
concentration method that varies depending on the invasively using pulse oximetry.
production source. Independent of the production
method, resulting in either gas or liquid oxygen (LOX),
· are
% SpO is used to determine whether patients
2
hypoxaemic (usually < 90%) and require
medical oxygen is always delivered to the patient in oxygen therapy.
gas form which is without colour, odour and taste.
Oxygen concentration (% O2) – or oxygen purity – is the

· by
% SpO is the ratio of red light not absorbed
2
deoxygenated haemoglobin (the coloured
amount on oxygen present in the final product, which substance in blood which carries oxygen)
can range depending on the source. The International to infrared light not absorbed by the
Pharmacopoeia (2) establishes that when produced oxygenated haemoglobin.
cryogenically, “oxygen contains not less than 99.5%
v/v of O2”. However, when produced by means of
oxygen generator plants through molecular sieves
(i.e. no liquification), then the minimum standard for
medical grade is 93% (90–96%).
7
OXYGEN SYSTEMS
1 1 % O2: Oxygen concentration at source
3 2 % FiO2: Fraction of inspired oxygen
3 % SpO2: Blood-oxygen saturation
Fig. 1.3 Key terminology: % O2, % FiO2 and % SpO2

Source: Technical specifications for oxygen concentrators (WHO, 2015) (14).
1.4 Elements of the oxygen ecosystem that are embedded into the dynamics of the oxygen
ecosystem [1.4]. It is important to contextualize
The oxygen ecosystem (Fig. 1.4) refers to holistic and regularly evaluate the implementation and
efforts, initiatives and resources across health systems, functioning of oxygen systems, together with re-
that are required for an optimal and sustainable assessing the environment in which they operate and
implementation of oxygen systems [1.5]. To accomplish ultimately impact the patient (Fig. 1.5). The long-term
this, stakeholders must have the ability to incorporate, sustainability of oxygen systems requires a holistic
adopt, operationalize and sustain investments into approach and a resource ecosystem focused not only
health systems at the country and facility level by on oxygen production but also on distribution and
providing policies and health system frameworks, delivery, ongoing maintenance and upkeep.
health financing, multidisciplinary guidelines,
country roadmaps, qualified and appropriately robust Oxygen systems are affected by both internal and
multidisciplinary teams, physician engagement external factors:
initiatives, patient safety and quality of care
programmes, biomedical engineering strengthening, · Internal factors include human and material
resources allocated to implement the oxygen
and other structural and non-structural actions. systems, from assessing the need, decision-making
All these aspects take part in the interdependent on solutions and their implementation, training
activities for ensuring a reliable and continuous cycle of staff in correct use and maintenance, up to
of provision of quality and safe medical oxygen, which allocation of financial resources for installation,
ultimately will reach the patient. running and maintenance costs.
1.5 Oxygen systems · External factors cover the environmental and

contextual conditions, such as geographical
The oxygen systems for medical use include, but location, product and service providers,
are not limited to, oxygen production, storage, technical and clinical availability and capacities,
distribution [1.6] and delivery supplies, as well as partnerships, financial and donor entities,
various items for flow regulation, conditioning [1.9], policy-makers, health systems planners and
quality assurance (QA), quality control (QC) and safety, technological upgrades.
8
OXYGEN SYSTEMS
NORMATIVE / STANDARDS
AND REGULATIONS
• Policy and country roadmaps
• National and/or international
regulatory frameworks
• Quality assurance and control
HUMAN RESOURCES:
HEALTH COVERAGE CLINICAL, NURSING,
PARAMEDICAL, BIOMEDICAL,
• Public health programme ENGINEERING, TECHNICIANS
• Epidemiological trends
• Referral system and pyramid • Availability of different levels
of health provision E of training programme
CL • Availability of staff
Y
EC
• Salaries and benefits
LIF
S
EM
ST
FINANCE SY INFRASTRUCTURE
E N
OXYG AND LOGISTICS
• Hospital budget
• Health ministry budget • Structural engineering
• Funds support • Electrical supply
• Water supply
• HVAC (heating – ventilation -
air conditioning)
MARKET LANDSCAPE
• Suppliers’ availability
• Service level capacities
• Maintenance and training
delivery
Fig. 1.4 Oxygen ecosystem
SEL
LITY APPROP ECTIO
IBI IS RIA
AS S TE N OF
FE NALY SO
A LU
TI
ON

X

EN E
$
FU RTNE
SSM LIZ
PA
T
ND
ASSE XTUA
ING SHIP
R
E
AND
CONT
ION
R E-A


TAT
SS
EN
ES
EM
SM
PL
IM
EN
T
E,
M
ON ANC
N
EV ITOR TE
AL I AIN G
UA NG AND ION, M ININ
TIO
N OPERAT D TRA
AN
Fig. 1.5 Life cycle of oxygen systems
9
OXYGEN SYSTEMS
To enable access to high-quality, safe and continuous Further to quality requirements, understanding
oxygen systems the following are required: the relation between pressure and flow depending
· sustained financial resources; on the product form is crucial to properly design

systems for storage, transport and distribution;
· appropriate policy and regulatory frameworks; namely high-pressure gas cylinders [2.8], bulk
· regular needs and feasibility assessment; tanks [2.10.1], cryogenic cylinder [2.10.2] and pipeline
networks [2.9]. Temperature and pressure will affect
· available, appropriate, trained clinical and
technical workforce;
the flow of concentrated oxygen depending on
whether it is in liquid or gas form.
· available, appropriate, affordable and well-
maintained source, storage, distribution and
In a health facility, there will normally be a primary
and secondary source and, it is important to
delivery systems; and
consider the preparation for backup supply [3.4.4],
· system monitoring: reporting and tracking key
performance indicators (KPI).
via redundancy (duplication of the system) or a
combination of different technologies, for example,
high-pressure gas cylinder stocking. If applicable,
The appropriate choice of oxygen systems is where there are existing medical gas pipeline
multifactorial. It is based on the need-gap assessment systems (MGPS) [2.9], each of the sources will be
and the absorptive capacity of the health facility, interconnected through a pneumatic changeover
which includes available technical workforce, system [2.7] to ensure uninterrupted supply.
infrastructure, reliability of power supply [3.5.3],
access to maintenance services and spare parts,
1.6.1 Bedside concentrators: oxygen
among others. Unfortunately, an important standard
production and delivery
procedure of preparing backup plans (15) to
ensure continuous access to oxygen, even in case A bedside oxygen concentrator (or oxygen extractor)
of emergency, is often disregarded due to budget is a self-contained medical device normally designed
availability and structural design. and manufactured for the sole purpose of home
care (9). However, WHO acknowledges this solution
1.6 Oxygen production, storage remains a vital resource for many outreach settings
in low- and middle-income countries (LMIC). Further
and distribution
information can be found in the WHO technical
The production of medical oxygen can either specifications for oxygen concentrators (14).
take place onsite in health facilities, or offsite at
manufacturing sites. Even if different standards apply This portable “plug and play” medical equipment uses
to each production method and site, the process to PSA technology to generate flow rates of, typically, 5, 8
concentrate, store and transport medical oxygen must or 10 L/min. Currently in the market, there are “oxygen
follow strict regulations for QA and verifications for QC concentrators” with higher production capacity (flow
conducted by certified specialized laboratories. rate capacity up to 30 L/min) intended to be used for
health care facilities with little or no access to medical
The concentration of medical oxygen is possible oxygen, especially those which have operating
because of air separation units (ASU), which separate theatres and intensive care units (ICUs), as they can
nitrogen and oxygen, and sometimes also argon and offer an output pressure of around 345 kPa (3.45 bar or
other rare inert gases, from atmospheric air. The 50 psi). To date, technical data on the quality and cost-
different separation methods to obtain concentrated effectiveness of this solution are still relatively poor.
oxygen are:
This equipment is situated onsite, generally at the
· cryogenic fractional distillation [1.6.3], which
generates a liquid oxygen (LOX);
bedside, and the oxygen generated is directly supplied
to patients through non-invasive delivery devices [1.7.1].
· pressure swing adsorption (PSA) [2.1], which
generates a gas oxygen product;
· vacuum swing adsorption (VSA) [2.1], which also

generates a gas product; and
· vacuum pressure swing absorption (VPSA) [2.1] – a

mixed technology, which combines engineering
systems of pressure variations from positive (PSA)
to negative (VSA) at different stages of the overall
process to concentrate oxygen.
10
OXYGEN SYSTEMS
1.6.2 Oxygen generator plants: oxygen The oxygen concentrated in gas form by these
production, storage and distribution plants will be distributed directly to the medical gas
pipeline system (MGPS)[2.9], or through
PSA, VSA or VPSA plants [2.1] are an assembly of
high-pressure gas cylinders [2.8] filled at a cylinder
different equipment often situated onsite, at facility
filling station [2.5] (composed of a booster compressor
level. The plants are sized to produce different
and filling ramp). The high-pressure cylinders serve to
flow rates ranging from 2–200 Nm3/hr depending
store the gas product, which is then transported
on the capacity of their air compressor. Further
to the patient’s bedside with proper conditioning and
information about PSA plants is described in technical
regulation devices [1.9] or connected to a distribution
requirements [2.2], sizing and configuring [2.3] and
ramp [2.6]. This distribution ramp is always connected
PSA system costs [2.4].
to a MGPS. In some countries bedside use of high-
pressure cylinders is prohibited for safety reasons.
O2 Analyzer
94% ppm
@ 3-6 BAR
OXYGEN
PIPING
PSA plant to pipe directly
DISTRIBUTION
MANIFOLD
OXYGEN
PIPING
TROLLEY
TROLLEY
PSA plant filling high-pressure gas cylinders
CYLINDER
Cylinder delivery
Cylinders distributed intra- or interfacility
Fig. 1.6 Distribution of oxygen produced by a primary line coming from a PSA plant
11
OXYGEN SYSTEMS
1.6.3 Cryogenic fractional distillation for industrial and medical sectors [4.1], in which
plants: liquid oxygen (LOX) production, the latter have more stringent requirements on the
storage and distribution compliance with GMP and good distribution practices
(GDP). The distribution sites where large bulk storage
Oxygen in liquid form is less bulky and less costly
tanks with specialized high-pressure vaporizer and
to transport than the equivalent capacity of high-
cryopump are installed to transform the LOX into gas
pressure gaseous storage. One litre of liquid oxygen
oxygen (GOX) before distribution to health facilities
is equivalent to 798 L gas at Normal Temperature and
are normally subsidiaries of the same third-party
Pressure (NTP), or 861 L at Standard Temperature
manufacturing company.
Pressure (STP). In Table 1.1 are shown the definitions
of normal and standard temperature and pressure The distribution pathway is very variable, as oxygen
conditions. can be supplied from the production or distribution
site to health facilities, either in liquid or gas form as
Table 1.1 Definitions of temperature and depicted in Fig. 1.7. The transportation of LOX must
pressure conditions (16) comply with strict international and/or national
regulations for handling of cryogenic pressure vessels.
NTP (normal STP (standard These containers can vary their capacity from litres
temperature and temperature and to many tonnes. Since heat leak (ingress) and surface
pressure) pressure)
evaporation are always present, vaporization is
Pressure 101.3 kPa 100 kPa continuously taking place, creating waste product.
(1.013 bar or (1 bar or 14.5 psi) The loss factor is sensitive to the size and isolation
14.7 psi)
technology of the tank and ambient conditions – it
Temperature 20 °C 0 °C can be as much as ~5% loss per day. This should be
reviewed on a case-by-case basis with manufacturers’
specifications at the design stage.
Air separation unit (ASU) plants for production and
bulk LOX storage are situated offsite and typically Table 1.2 depicts the main oxygen production sources
managed by private companies who are responsible with additional considerations.
for the entire value chain [4.1]. Such production serves
DIRECT
PIPING
OXYGEN
Bulk tank Vaporizer

PIPING
DISTRIBUTION
MANIFOLD (LIQUID)
OXYGEN
PIPING
Bulk liquid
trucking
DISTRIBUTION
MANIFOLD
OXYGEN
High-pressure gas PIPING

Cryogenic “liquid” oxygen production cylinder filling TROLLEY
CYLINDER
Cylinder delivery
Fig. 1.7 Distribution of cryogenically produced oxygen (liquid and gas)
12
OXYGEN SYSTEMS
Table 1.2 Oxygen production
Oxygen PSA bedside concentrator PSA, VSA, VPSA plant Cryogenic fractional
production (gas O2 generator) (gas O2 generator) distillation plant
sources (liquid O2 generator)
O2 Analyzer
94% ppm
• Continuous and reliable • Continuous and reliable • Typically, the recipient

electrical source is required electrical source is required facilities will engage with
during operations. during plant and booster contracts with the third party.
• Device-specific spare parts operations. • Detailed financial planning
need. • Device-specific spare parts for long-term operations
• Timely technical need. required (~20 years).
maintenance need. • Timely specialized technical • Need trained technicians to
• Need to follow infection maintenance need. ensure continuous operations
prevention control (IPC) • Detailed financial planning and regular maintenance.
measures as situated for long-term operations
bedside. required (~20 years).
Additional • Inefficient for large-scale • Various own/operate models.
considerations provision. • Need trained technicians to
• Flow could be split among ensure continuous operations
patients, depending on and regular maintenance.
oxygen therapy [1.3] needs
and available mandatory
ancillary devices (e.g. flow
splitter).
• Low-pressure output and
limited flow output. So, usually
not suitable for higher flow or
higher pressure needs (e.g.
patient ventilators.
Note: Complementary details about these sources can be found in WHO-UNICEF technical specifications and guidance for
oxygen therapy devices (9).
13
OXYGEN SYSTEMS
1.7 Delivery equipment and devices The technologies classified as medical devices must
follow specific regulations to guarantee safety,
The oxygen systems [1.5] also include medical efficiency and quality during design, manufacture,
devices for delivering oxygen to patients, as well operation and maintenance.
as patient monitoring devices [1.8], such as pulse
oximeters, which are also required for measuring The selection, adaptation and adoption of the
patient oxygen saturation levels (SpO2) [1.3.3] to technical specifications for procurement are always
detect hypoxaemia [1.3] (Fig. 1.8). context related and should consider the life cycle and
total cost of ownership (TCO) of the equipment.
Delivery equipment and devices serve as an interface
to provide oxygen to the patient. The appropriate Adequate installation, use and maintenance
selection of these devices depends on the specific of medical devices must be in accordance with
medical condition and treatment needs of the patient. manufacturers’ recommendations.
Refer to WHO clinical treatment guidelines [5.1] and
recommendations for the right selection and use of Infection prevention and control (IPC) measures,
medical devices for the administration of oxygen. such as cleaning, disinfection, and/or sterilization
methods for reusable medical devices, must be
The Priority medical devices list for the COVID-19 followed (18) (19). Likewise, IPC measures while using
response and associated technical specifications: reusable medical equipment and accessories, must
interim guidance (17) includes the minimum technical be implemented (20) (21). This includes adequate
specifications to ensure the safety and quality of the selection of personal protective equipment (PPE)
medical devices required for administering medical to minimize the risk of infections in health care
oxygen. Some of these specifications have been providers.
adapted from WHO-UNICEF technical specifications and
guidance for oxygen therapy devices (9). For more information about medical devices and
innovative technologies for LMIC see WHO Medical
devices (22) and WHO compendium of innovative health
technologies for low-resource settings (23).
1 Monitor: The screen displays

vital signs parameters such as
such as blood pressure
measurements and heart rate.
1 An alarm is activated when
abnormal vital signs develop.
2 Suction device: Excess secretions

are regularly removed from the
airways using suction.
2 3 Oxygen supply: Every bed area

should have an oxygen supply
3 available at all times.
I I II
IIII
I II I
III I I
I I I I I I I I I I II II
4 4 Pulse oximeter sensor: The level

I I II
II I
II I I
IIII
IIIII IIIIIII IIIIIII
of oxygen saturation in the

IIIII
IIIIII
III
IIII
IIIII
6
IIIIII
I II I
IIIIII
II
II I
I I I I I I I I III I
II I
blood (SpO2) is measured painlessly

IIIIIIII
II
I
IIIIIIIII
IIII I
II II
with probe on the finger or earlobe.

I II I
II I
IIIIIIIIIIIIII
I II I
II
5
II II
II I I
IIII
I I II I
IIIII
I II I I I I I I
IIIIII
I IIIIIII
I IIIIIIII
I I III
IIIIIIIII
II IIIIIIIIIII
III
II I
II IIIIIIIIIIIIIIIII
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII I
5 Ventilator tubing and face mask:

These consumables are the interface
between equipment and patient.
6 Ventilator: This equipment

provides respiratory support by
inflating the lungs with a mixture
of oxygen and air.
Fig. 1.8 Medical devices related to oxygen therapy used in an intensive care unit
14
OXYGEN SYSTEMS
1.7.1 Non-invasive delivery devices for single-patient use. However, more advanced non-
invasive devices (Fig. 1.10) are commonly connected
Non-invasive devices (Fig. 1.9) are connected directly
to patient ventilators and frequently designed to
to the output of a conditioning device [1.9], which
be reusable – following reutilization measures and
in turn is connected to either a bedside oxygen
lifespan recommended by the manufacturer.
concentrator [1.6.1], wall outlet [2.9.2] or to a high-
pressure gas cylinder [2.8]. Most of these are intended
Non-invasive O2 delivery devices

Nasal cannula Face mask Face mask reservoir bag Venturi face mask
O2 flow 1-5 L/min O2 flow 5-10 L/min O2 flow 10-15 L/min O2 flow 2-15 L/min
FiO2 0.23-0.35* FiO2 0.30-0.50* FiO2 0.24-0.60* FiO2 0.50-0.85*
* Delivered O2 concentration depends on multiple factors including the concentration of the oxygen source and the patient’s respiratory
pattern (e.g. peak inspiratory flow and minute ventilation).
O2 flow ranges differ for neonates, children and adults.
Fig. 1.9 Non-invasive delivery devices
Advanced non-invasive O2 delivery devices

High-flow nasal
BPAP/CPAP
oxygen
Oronasal Nasal Full face Helmet

O2 flow 10-60 L/min O2 flow ̴10-80** L/min
FiO2 0.23-1.00* FiO2 0.21-1.00*
* Delivered O2 concentration depends on multiple factors including the concentration of the oxygen source and the patient’s respiratory
pattern (e.g. peak inspiratory flow and minute ventilation).
** O2 consumption for BPAP/CPAP is widely variable depending on device used and the leak of the system.
O2 flow ranges differ for neonates, children and adults.
Fig. 1.10 Advanced non-invasive delivery devices
15
OXYGEN SYSTEMS
1.7.2 Patient ventilators: non-invasive Invasive ventilators are mainly used in ICUs for
and invasive long-term respiratory support. Certain modes of
operation require highly trained medical staff to
Non-invasive respiratory support is provided
perform intubation and to set the pressure and/or
by Non-Invasive Ventilators (NIV), high-flow nasal
volume settings, controls and alarms. The FiO2 [1.3.2]
cannula (HFNC), heated humidified high-flow (HHHF)
can be adjusted according to the concentration of
therapy or high-flow nasal oxygen (HFNO). This
oxygen prescribed by the physician up to 100% of
equipment is used in the escalation of respiratory
medical oxygen. Table 1.4 shows the equipment used
support [1.3] in adults and children during the
for invasive respiratory support.
titration of oxygen for pneumonia (12). Continuous
positive airway pressure (CPAP) is not considered
as non-invasive ventilator but is an equipment Table 1.4 Invasive respiratory equipment
sometimes used for respiratory support. Table 1.3 and intended use
shows the equipment used for advanced non-invasive Invasive respiratory
respiratory support. Intended use
equipment
ICU To provide temporary ventilatory
Table 1.3 Advanced non-invasive respiratory and respiratory assistance to
equipment and intended use adult and paediatric intensive
care patients.
Non-invasive Intended use
Transport To provide temporary
respiratory
equipment ventilatory assistance with a full
degree of portability (weight
NIV (e.g. BPAP) Allows clinicians to adjust and manageability).
pressures for inspiratory and
expiratory phases of a breath Subacute care To provide mainly non-invasive
to non-intubated adult or ventilation, but in case of an
paediatric patients. emergency, it can also provide
temporary invasive ventilation
HFNC, HHHF, HFNO Allows clinicians to deliver to patients who cannot
high flow rates with heated breathe on their own or who
humidification to non-intubated require assistance to maintain
adult or paediatric patients. ventilation.
The ICU ventilators require weekly calibration of

the integrated oxygen cell with the supply of ~100%
oxygen concentration. This can be achieved by using
a high-pressure cylinder with appropriate regulator
temporarily connected to the inlet to allow calibration
of the ventilator between 21–100% values.
Fig. 1.11 Non-invasive ventilator
Fig. 1.12 Patient ventilator for intensive care unit
16
OXYGEN SYSTEMS
1.7.3 Flow and pressure parameters per On the other hand, non-invasive ventilators mostly
delivery equipment and devices operate with air only, sometimes integrating an in-
built air compressor or turbine unit. However, certain
The delivery equipment (i.e. patient ventilators) may
equipment like the HFNC can generate a high flow of
require a source of medical air and/or medical oxygen
mixed air and medical oxygen, allowing the user to
to operate.
control the administration of oxygen in L/min but not
For instance, the most commonly used invasive the level of FiO2 [1.3.2].
ventilators require high-pressure medical oxygen
Regardless of the needs for high- or low-pressure
and air to operate. Some of them can have an in-built
medical gases at the inlet of the delivery equipment,
air compressor, and a few models can operate with
the oxygen will be delivered to the patient with
low-pressure oxygen coming from bedside oxygen
low pressure (regulated by a pressure regulator)
concentrators [1.6.1].
and variable flow by an independent or integrated
When required, the stream of high-pressure medical flowmeter (9).
oxygen could be supplied by an oxygen generator
Table 1.5 presents a variety of delivery equipment
plant [2.1], high-pressure gas cylinders [2.8], or
with the different user interfaces devices, showing
cryogenic vessels [2.10], as long as the source has
variable outputs of flow and pressure before reaching
been certified for medical use.
the patient.
Table 1.5 Oxygen delivery: flow and pressure considerations for various combinations of
delivery equipment and devices
Delivery device
Flow/pressure Bedside High-pressure Wall outlet Non-invasive HFNC Invasive Invasive
at the output concentrator cylinder ventilator ventilator ventilator
(21): non- (21): invasive
invasive mode mode
Non-invasive Low-flow Variable flow Variable flow Not applicable Not applicable Not applicable Not applicable
delivery (device (0–70 L/min (0–70 L/min
devices: nasal dependant) (22)) and (22)) and
cannula, face and low regulation to regulation to
mask, venturi pressure low pressure low pressure
face mask,
face mask
with reservoir
bag
Advanced Not applicable Not applicable Not applicable Not applicable Variable flow Variable flow Not applicable
non-invasive (from 10–60 (10–60 L/min)
devices: high- L/min) and and regulation
flow nasal regulation to to low
oxygen low pressure pressure by
User by the the ventilator
interface ventilator
Advanced Not applicable Not applicable Not applicable Variable flow Not applicable Variable flow Not applicable
non-invasive (from 10–80 (from 10–80
devices: L/min) and L/min) and
oronasal, regulation to regulation to
nasal, full low pressure low pressure
face, helmet by the by the
ventilator ventilator
Closed Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Variable flow
breathing (0–120 L/min)
circuits with and regulation
endotracheal to low
or pressure by
tracheostomy the ventilator
interface
17
OXYGEN SYSTEMS
1.8 Patient monitoring 1.9 Conditioning, regulation and
Equipment for vital sign patient monitoring (e.g., heart testing devices
rate, blood pressure, respiratory rate,temperature Across storage, distribution and delivery of oxygen,
and oxygen saturation) is used widely at all levels of different equipment is used to control pressure, flow,
the health system. Patient monitoring is essential humidity and concentration of the oxygen. Some
when providing oxygen therapy [1.3]. The research of these devices include pressure regulators,
community is continuously refining the regulation flowmeters, valves, flow splitters, humidifiers and
around qualified and accurate medical devices for this oxygen analysers (see Fig. 1.16).
purpose.
Pulse oximeter (Fig. 1.13): A pulse oximeter is a

medical device designed for non-invasive monitoring
of haemoglobin oxygen saturation (SpO2) [1.3.3],
by comparing the absorbance of light of different
wavelengths across a translucent part of the body.
Pulse oximetry is accepted globally as the most

reliable, accurate, affordable way for health care
workers to continuously and/or spot measure
blood SpO2.
97 Fig. 1.15 Oxygen outlet: conditioning and regulation

Sp02 (%) SI3
.9 3
100
90
99
FP (bpm
using a flowmeter
120 )
50
ID:99
OK
10:37
Shift
Fig. 1.13 Pulse oximeter
Patient monitor (Fig. 1.14): Patient monitors

are designed to measure vital signs and, in some
cases, other physiological parameters of a patient.
Depending on the number of parameters, monitors
are classified as basic, intermediary or advanced.
When used in oxygen therapy, patient monitors must
include the SpO2 [1.3.3] parameter and
sensor (16).
Fig. 1.16 Oxygen analyser
Note: Further specifications can be found in WHO-UNICEF
technical specifications and guidance for oxygen therapy
devices (9).
Fig. 1.14 Multiparameter monitor
18
19
2. Health facility
oxygen systems
OXYGEN SYSTEMS
OXYGEN SYSTEMS
2. Health facility oxygen systems

2.1 Onsite production technologies: PSA, VSA and VPSA 21
2.2 Technical requirements for PSA oxygen generator plants 22
2.3 Sizing and configuring of PSA oxygen generator plants 26
2.4 PSA system costs 29
2.5 Cylinder filling station: booster compressor and filling ramp 30
2.6 Distribution ramp 31
2.7 Pneumatic changeover system: automatic/manual 31
2.8 High-pressure gas cylinders 33
2.9 Medical gas pipeline systems 39
2.10 Onsite liquid oxygen storage 42
20
OXYGEN SYSTEMS
2. Health facility oxygen systems

This section presents an overview of the onsite technologies for the production,
distribution and storage of medical oxygen.
2.1 Onsite production technologies: It is useful to distinguish the key differences between
PSA and the newer VSA technologies, starting with the
PSA, VSA and VPSA technology used to create the gas flow:
Although there is extensive and detailed available
information on bedside oxygen concentrators [1.6.1], ·
PSA plants use a compressor to push the gas by
pressure through the sieve beds.
there are considerable gaps in publicly available
technical material related to at scale onsite production ·
VSA plants use a vacuum system to suck the gas
into the production equipment.
sources [1.6.2] (i.e. oxygen generator plants) (24).
The following informations cover at scale technologies
Additionally, for VSA the main operating differences
only.
from PSA are:
Oxygen generator plants are an assembly of different
equipment. The two existing technologies to perform ·
Oil-free blower – results in lower requirements for
filtration and eliminates the risk of oil carry over
this process are PSA and VSA (Fig. 2.1). Depending downstream of the oxygen system [1.5].
on the technology, PSA or VSA, the assembly will
comprise an air compressor or blower, always ·
Higher efficiency in humid environments due to
lack of need of the air dryer component.
followed by a dryer, filters, a compressed air tank, dual
separation chambers (sieve beds), a product tank/
reservoir and controls and alarms. Along the assembly
· Operation
level.
is less affected by altitude above the sea
there are copper pipes and hoses that are specific and
certified for high-pressure gases. The whole assembly · Inwater
certain cases, VSA minimizes the potential for
condensation, by cooling the feed gas for
should be certified for medical application.
the molecular sieve beds to within 10 °C of the
The process of oxygen concentration begins by prevailing ambient temperature.
compressing ambient air. This air then passes through
a filtration assembly to remove any particulate matter · VSA sieve beds have a longer projected lifespan
and require less maintenance than those for PSA.
and remaining moisture. Afterwards, it goes through
a molecular sieve containing zeolites that adsorb or · Lower output pressure, after the molecular
sieve beds, ranges from 130–420 kPa (1.3–4.2 bar
retain almost all the nitrogen molecules, while the
oxygen, along with a few other elements, passes or 18.85–60.89 psi). As this is below the common
through resulting in a concentrated oxygen product. requirements for pipeline networks, this
The purity of the concentrated oxygen should be generally adds the need for an oil-free booster
93% ±3% (2). The oxygen production capacity varies compressor [2.5] to attain 689 kPa (6.89 bar
depending on the model, typically ranging from or 100 psi).
2–200+ Nm3/hr, which has a reference condition of
temperature at 0°C for an absolute pressure 101.3 kPa
· Regarding electrical consumption and costs:
the absence of an air dryer may lower overall
[1.013 bar or 14.7 psi]. Sometimes the production consumption; however, the addition of a booster
capacity will be expressed in Sm3/hr which means may increase it.
that the flow rate is based on standard reference
conditions (temperature 20 °C and absolute pressure
101.3 kPa [1.013 bar or 14.7 psi]. Therefore, depending
on the measurement units used this will determine
the actual gas volume produced.
Key resources
WHO-UNICEF technical specifications and guidance for oxygen therapy devices: https://apps.who.int/iris/
handle/10665/329874
WHO technical specifications for oxygen concentrators: https://apps.who.int/iris/handle/10665/199326
Technical specifications for pressure swing adsorption (PSA) oxygen plants: https://apps.who.int/iris/
handle/10665/332313
21
OXYGEN SYSTEMS
In terms of capital expenditure, VSA plants are 2.2 Technical requirements for PSA
approximately 15% higher than PSA plants because
oxygen generator plants
of the additional booster compressor. Nevertheless,
when the units are generating > 100 Nm3/hr, this Currently, PSA technologies are more commonly
margin drops off and VSA affordability falls more in available in the market, thus the focus in this
line with PSA. document is on them. However, many of the technical
requirements apply to PSA, VSA and VPSA.
A hybrid system exists which consists of a
combination of the two technologies, called vacuum 2.2.1 General overview
pressure swing adsorption (VPSA). These systems
apply pressurized gas to the separation process · PSA plants (Fig. 2.2) should be designed according
to the oxygen need-gap assessment and the
as well as a vacuum to purge gas. This technology
is generally preferred when oxygen need is higher context in which they will be implemented. They
than normal and large-scale production is required, are typically manufactured to operate non-stop.
because it combines the benefits from VSA and PSA
systems. However, it involves some complexity in the
· PSA plants can be built onsite, skid-mounted or
containerized. They can be delivered as turn-key
configuration of the equipment which makes VPSA a units with all the necessary equipment to operate.
significant cost investment. A typical PSA configuration is shown in Fig. 2.2.
In general, VSA technology is restricted in availability
due to the low number of manufacturers and
· PSA plants must be compliant with the technical
specifications (10). These generic specifications
suppliers worldwide marketing the technology for provide comprehensive interim guidance;
medical application. However, several major PSA however, contextualized details for the goods
manufacturers offer VSA and PSA technologies, and and services acquired may prevail over the
some of them even include VPSA hybrid designs. generic specifications. Detailed guidance for
Regardless of the technology, training on these procurement is outlined in Web annex A. Technical
oxygen generation systems should be generic in considerations for the procurement of oxygen
nature, to empower the workforce to be appropriately generator plants.
skilled to operate and maintain any of the systems.
PSA
PSAschematic
PSA Product 02 Buffer
valves
schematic
schematic
Product
Product
valves
tank
02 Buffer
02 Buffer
tank
valves tank
Adsorber Adsorber
vessel vessel
PSA Inlet Adsorber Adsorber

Adsorber
vessel
Feed and Adsorber
vessel
schematic ventProduct
vessel valves
valves
02 Buffer
vessel
tank
Vent
Inlet Dryer
Inlet Adsorber
Feed and Adsorber
vessel vessel
Feed
ventandvalves x
vent valves
Compressor Feed buffer tan
Vent Valves and
Inlet Vent filters
Feed and
vent valves
Dryer Vent
VSA Dryer Adsorber
vessel
schematic Dryer
02
02
x x Adsorber Buffer x
Compressor Feed buffer tan Buffer vessel tank x
Compressor
Compressor
Feed
Feed buffer
buffer tan tan tank Valves x
and
Valves and Valves and
filters
Adsorber filters filters
vessel
Air filter Blower
VSA
VSAschematic
VSA
Adsorber
vessel Adsorber
Reversible
blower
02
Adsorber
Valves andvessel
02
schematic
schematic
x vesselBuffer
filters x
0
x Adsorber
vessel
Buffer
tank
0
02 2
Buffer
tank
02 2 x x Adsorber
Buffer Adsorber
vessel Buffer
x Inlet Ventx tank
Adsorber Buffer vessel tank
Vacuum pump vessel tank
Air filter Blower tank
Adsorber Reversible
Adsorber
vessel blower
vessel Valves and
Air filter Blower filters
Air filter x Blower
Reversible
Inlet Vent Reversible
blower
Vacuum pump blower
Valves and
Valves and
filters
x filters
x
Inlet Vent
Inlet Vent
Vacuum pump
Vacuum pump
Fig. 2.1 Main components of PSA and VSA plants
22
OXYGEN SYSTEMS
· The oxygen concentrator element must have a

regulatory certification for medical use that shows
· During the procurement phase, besides a proper
design of the PSA plant, the vendor is expected to
a risk classification (e.g. Class C [GHTF Rule 11]; provide information that will allow site preparation
FDA Class II [United States]; Class IIB [European (Web annex B: Site evaluation for oxygen generator
Union]; Class IIA [Australia]; Class II [Canada]). plants) and readiness (Web annex C: Site readiness
· For regulatory approval of PSA plants, there

are two main considerations: quality of design
for oxygen generator plants) to implement the
project. This includes but is not limited to:
and quality of the supplier. For design, the – Precise power requirements of the main
manufacturer should hold a design dossier or components and the whole system: acceptable
technical file that contains all the information mains capacity, appropriate electrical
about the design and development of the connections/adaptors, and compatibility
plant, verification test reports (e.g. mechanical, with primary power supply [3.5.3] (e.g. diesel
electrical), risk management files, post-market generator and electrical grid).
surveillance and monitoring procedures and
– Safety and structural requirements [3.5.1]
records. For supplier evaluation, generally the
needed to ensure that the building and
manufacturer needs to be ISO 13485 certified.
placement of equipment is to standard. This
ISO 13485 ensures the manufacturer’s company
includes appropriate room dimensions, door
operates consistently, and covers a wide range of
and window location and size, ventilation
topics from senior management, staff training,
(amount and specific location), air extractors
documentation control, production, internal audit,
and extra copper piping. The supplier should
post-market reporting and complaint handling.
provide a final drawing/layout indicating the
· During the design phase, site-specific
environmental considerations should be
placement of the components.
– Other tests and reports such as pre-shipment
addressed, such as elevation above sea level,
inspection report, running test to reach nominal
temperature, humidity, dust. Likewise, the system
performance (minimum time for continuously
output and configuration [2.3] should be specified.
running is 3 days), alarm testing, commissioning
report (Web annex D: Commissioning report
for oxygen generator plants), user and service
manual and training package.
10
O2 Analyzer
94% ppm
6 6
8
2 5 7
3
1
1 Air compressor 5 Compressed air tank

2 Water trap 6 PSA – O2 generator
3 Refrigeration or adsorption dryer 7 Control panel
4 Filtration assembly: 8 Product/buffer tank
• pre-filter (> 5 micron), 9 Bacteria/sterile filter
• coalescing filter (0.1 micron)
• coal filter or coal tower, alternatively activated carbon filter 10 Oxygen analyser
Fig. 2.2 Configuration of typical PSA plant
23
OXYGEN SYSTEMS
2.2.2 Maintenance service · The electrical requirements chart for the different
· Rigorous preventive maintenance programmes

(PMP) are needed to prevent malfunctions
components in the plant configuration should be
provided by the supplier (including the starting
current, minimum protection current and load
in accordance with manufacturer’s
curve) to determine total power needs and
recommendations. Some maintenance tasks
ability to configure the power source (e.g. diesel
should be performed periodically even if the
generator, voltage stabilizer, electrical grid with
plant is not continuously operational for external
transformer, circuit breaker and medium voltage
reasons (e.g. lower oxygen demand, lack of power
module). The power load differs depending on the
supply [3.5.3], scarce number of operators).
PSA plant configuration [2.3] (single/multiplex,
· Availability of spare part kits should be guaranteed
during the lifespan of the plant.
with or without cylinder filling station [2.5]).
· The primary and secondary power supply must

· Spare parts kits for preventive maintenance
service, as recommended by the PMP, should be
be connected to the power cabinet through a
transfer switch system. An automatic transfer
clearly defined in a list comprising part numbers switch is ideal as it reduces the transfer time delay.
and descriptions, quantity per kit and per However, a manual transfer switch requires less
maintenance activity, as well as indicating brand/ maintenance activities.
model specifics and expiration dates.
· Voltage fluctuation will cause damage to the unit.
· Maintenance toolkit with oxygen analyser, other
testing and mechanical tools, and complementary
Power should be supplied to the unit from an
armoured grounded electrical outlet with a three-
PPE (e.g. gloves, protective glasses, hearing prong plug and earth cable.
protectors) should be available for the operators of
the plant. · Electrical elements must be compatible with the
power source (frequency, voltage and plug type
· Ifis aavailable,
service level agreement (SLA) with the vendor
the corrective maintenance terms
need to be specified).
and conditions may specify estimated times for · Ifproperly

diesel generators are installed, they must be
chosen and provided with spare part
response, including: lead time for reception of any
kits and a maintenance service. Certain type
necessary spare parts; location of stockpiles and
of specifications and diesel consumption may
warehouses to access in case of distribution of
impact capital expenditure and operational costs.
spare parts; capabilities for remote support; and,
Preferably, the engine should be electronically
availability of local agent.
controlled and, if the diesel generator will be
used as a primary source (prime mode) instead
2.2.3 Electrical requirements
of backup source (standby mode), the preferred
· The PSA plant must be connected to a reliable and
continuous source of energy for all intended hours
specifications may comprise, for example, a shunt
excitation system (also called “self-excited”) and
of operations. Power supply [3.5.3] includes main an integrated automatic voltage regulator (AVR).
and backup sources.
· Ifbediesel generators are installed, they should
· The energy efficiency of PSA plants is largely
determined by the feed air compressor.
installed in a weatherproofed and sound-
attenuated enclosure. They should be positioned
· Peak power demand is determined by both

the inflow current and voltage of the feed air
so that air intake cannot be obstructed and the
exhaust points away from nearby oxygen sources
or pedestrian walkaways. The installation should
compressors. To minimize the requirement
be accessible to accommodate refuelling. The
for peak power, some brands offer feed air
access to this equipment should be restricted to
compressors fitted with variable speed drives
authorized personnel.
(VSDs). Careful assessment of the power supply
reliability must be done before choosing this
option.
· The plant must be supplied with electrical cables

for the power connection of each component as
applicable (e.g. air compressor, air dryer, desiccant
dryer, oxygen generator, booster compressor),
power cabinet with surge and earth protection,
and inbuilt phase controller for 3-phase devices.
24
OXYGEN SYSTEMS
2.2.4 Infrastructure requirements · The plant room should be equipped with
· During the project design phase, it is important to

properly define the location where the PSA plant
appropriate continuous lighting. LED lighting
reduces fire risks.
will be installed. Considerations include distance
to the MGPS [2.9] to prevent pressure drop in the
· The dimensions of the housing should match
manufacturer’s layout recommendations, should
wall outlets [2.9.2] and safety distance [3.5.2] to allow space for servicing the equipment and will
crowded areas and least polluted areas. be dependent on the plant configuration [2.3].
· Assystem
for all medical gases, the oxygen production
must be located under a covered structure,
In some cases, the plant room may be larger
than 6 x 6 x 5 m.
allowing protection from environmental factors
such as atmospheric precipitation, wind or dust;
· The colour the structure should be specified to
match the existing hospital colour.
protection from external mechanical damage; and
assuring noise reduction during operation. · Pipelines, pipe fittings and coupling connections
must be designed, manufactured, assembled and
· The structural elements [3.5.1] of housing should
be built considering the local environmental
tested in accordance with applicable national or
international regulations.
conditions and available isolation materials (for
heat management and fire prevention). If, for · Interconnecting pipelines with the existing
pipeline network should be made of stainless steel
example, a roofing system with a metallic structure
or reinforced rubber with a silicone coating on the
and corrugated sheets represents a potential
inner surface.
risk for room overheating, then adding a more
performant mechanical ventilation system will be · Ifa separate
high-pressure gas cylinders [2.8] are available,
cylinder storage room must be defined
needed.
with sufficient space to keep cylinders apart and
· The entrance doors should have external
protective shutters, which only authorized
for manoeuvring of full and empty cylinders. A
ramp (6–8% slope) should facilitate movement of
personnel can access; and appropriate signage for
cylinders in and out of the room.
medicinal gases and fire safety [3.6.2].
· Adequate ventilation should be provided to ensure

that oxygen-depleted air is rapidly replaced. To
Fig. 2.3 depicts the typical layout of an onsite oxygen
generation plant, showing the cross-ventilation and
monitor the oxygen-enriched atmosphere, items separation from the production room, with ambient
such as oxygen depletion sensors should be air enriched with nitrogen, from the cylinder’s storage
installed in the plant room. room, and separation of empty and full cylinders.
· The floor finish and material (e.g. concrete)

must be flat and smooth to facilitate movement
in the area and ease of cleaning, sustain the
heavy weight of the components and reduce
equipment vibration.
· The underground rooms, pits, vessels, ducts

and trenches may represent a risk for oxygen
accumulation.
· The plant room should have ducts for discharge

water coming from the water separator and
necessary openings for exhaust ventilation and the
introduction of cables and pipelines.
· The nitrogen discharge duct should be vented to

the atmosphere. It is suggested that the exhaust
should terminate at least 3 m clear of any door/
window that can be opened, or other ventilation/
air intake; it should have its end turned downward
to prevent the ingress of dirt and moisture.
25
OXYGEN SYSTEMS
SEC X
100
180
Filling Ramp
Air Air
Coal
Filter Tank Tank
Tower
Air Pack
Air
Dryer Product
Compressor Tank
PPSA
Generator
1032
1032
Air PPSA
Compressor Air Generator Air
Filter Tank Tank
Air Pack
Dryer Product
Tank
583 605
SEC X'
220
140
100
180
Fig. 2.3 Typical layout of an onsite oxygen generation plant
2.2.5 Human resources requirements 2.3 Sizing and configuring of PSA

· PSA plants require trained personnel [3.4.2] for
operation and maintenance. The training plan for
oxygen generator plants
The production capacity of an oxygen generator plant
local operators should indicate content, number
can range from 2–200 Nm3/hr. It’s important to note
of days and persons to be trained. The trainers
that not all plants existing in the market are certified
should be certified by the manufacturer.
for medical application, especially when they are
· The personnel (operators and drivers) dedicated
for cylinder management and handling, onsite
above 100 Nm3/hr.
and/or offsite, must be trained in safety and Plants must be sized and configured based on facility
mitigation measures [3.6] to prevent accidents needs and estimated oxygen demand [3.1]. Different
and fire. configurations can allow a combination of more than
one plant (e.g. single, duplex or multiplex plants) to
· When managing the cylinder’s fleet, consideration
should be given to the workload of personnel and
reach the expected oxygen output, or to alternate
usage and scheduled maintenance. While this has the
the distance for distribution (onsite and/or offsite). advantage of mitigating risk in case of malfunctioning
· Iftrained
diesel generators are installed, they also require
personnel for operation and maintenance.
of one of the plants, it will require higher maintenance
resources.
The configuration should also consider the

distribution system that will be implemented, either
direct connection to the MGPS [2.9], and/or to the
cylinder filling station [2.5] composed of a booster
compressor and filling ramp. In Figs 2.4 to 2.7 several
possible configurations for an identical estimated
oxygen demand of 30 Nm3/hr are shown.
26
OXYGEN SYSTEMS
O2 Analyzer
94% ppm
Primary oxygen Oxygen cylinder Cylinders to

source (15 Nm3/hr) O2 Analyzer
94%
filling station
ppm
be distributed
source (15 Nm3/hr) Fill up to 50 cylinders
O2 Analyzer
94% ppm
of 47.2 L
filling station be distributed
Primary oxygen Oxygen
(water capacity) cylinder
at 150 bar, in 24 hours Cylinders to
94%
filling station
Fill up to 50 cylinders
ppm
of 47.2 L be distributed
O2 Analyzer
94% ppm
Secondary oxygen (water capacity) Oxygen

at 150 bar,cylinder
in 24 hours Cylinders to
source (15 Nm3/hr) filling station
Fill up to 50 cylinders be distributed
source (15 Nm3/hr) filling of 47.2 L
station be distributed
(water capacity) at 150 bar, in 24 hours
O2 Analyzer
94% ppm
Secondary oxygen Oxygen

Fill up to 50 cylinders cylinder
of 47.2 L Cylinders to
Fill up to 50 cylinders
filling of 47.2 L
source (15 Nm3/hr) at 150station be distributed
O2 Analyzer
94% ppm
(water capacity) bar, in 24 hours

(water capacity) at 150 bar,cylinder
in 24 hours Cylinders to
94%
filling station
Fill up to 50 cylinders of 47.2 L
ppm
be distributed
Secondary oxygen Oxygen cylinder Cylinders to
Fig.
source2.4 Redundant
(15 Nm3/hr) production(water
source used
capacity) toinfill
at 150 bar,
filling
Fill up to 50 cylinders station
of 47.2 L
cylinders
24 hours
be distributed
O2 Analyzer
94% ppm

Primary oxygen
94% ppm
Primary oxygen
source (15 Nm3/hr)
O2 Analyzer
94% ppm
Primary oxygen MGPS

Pneumatic change
94% ppm
over system
NO.
Primary oxygen
Pneumatic change MGPS
source (15 Nm3/hr)
over system
NO.
O2 Analyzer
94% ppm
Cylinders to
Secondary oxygen Oxygen cylinder
distribution
over system
NO.
source (15 Nm3/hr) filling station Pneumatic change MGPS

ramp
Cylinders to
O2 Analyzer
94% ppm
Secondary oxygen Oxygen cylinder over system

NO.
Fill up to 50 cylinders of 47.2 L distribution

source (15 Nm3/hr) filling station Cylinders to
O2 Analyzer
94% ppm

(water capacity) cylinder
at 150 bar, in 24 hours ramp
distribution
94%
filling station
Fill up to 50 cylinders of 47.2 L Cylinders to
ramp
ppm

(water capacity) at 150 bar, in 24 hours distribution
source (15 Nm3/hr) filling station
ramp
Fig. 2.5 Primary source connected to50MGPS
Fill up to and
cylinders of 47.2 Lsecondary source used to fill cylinders
O2 Analyzer
94% ppm
Primary oxygen
94% ppm
Primary oxygen
source (15 Nm3/hr)
O2 Analyzer
94% ppm
Primary oxygen MGPS

94% ppm
Pneumatic change
Primary oxygen over system
source (15 Nm3/hr) Pneumatic change MGPS
O2 Analyzer
94% ppm
over system MGPS

Secondary oxygen Pneumatic change
source (15 Nm3/hr) over system
O2 Analyzer
94% ppm

Secondary oxygen
over system
source (15 Nm3/hr)
O2 Analyzer
94% ppm
Secondary oxygen
94% ppm
Secondary oxygen
source (15 Nm3/hr)
Fig. 2.6 Duplex system connected to MGPS

O2 Analyzer
94% ppm
PSA oxygen plant Pneumatic change MGPS

(30 Nm3/hr) O2 Analyzer
94% ppm
over system
(30 Nm3/hr) over system
O2 Analyzer
94% ppm

(30 Nm3/hr) O2 Analyzer
over system
Cylinders to change
94% ppm
PSA oxygen plant Oxygen cylinder Pneumatic MGPS

(30 Nm3/hr) distribution
filling station over system
ramp
Cylinders to
Oxygen cylinder
Optimal sizing to fill up cylinders of 47.2 L distribution
(water capacity)filling
Oxygen
station
at 200 bar, in 24 hours
cylinder Cylinders to
ramp
distribution
Optimal sizing tofilling station
fill up cylinders of 47.2 L Cylinders to
Oxygen cylinder
(water capacity) at 200 bar, in 24 hours ramp
distribution
Optimal sizing tofilling station
fill up cylinders of 47.2 L
Optimal sizing to fill up cylinders of 47.2 L
Fig. 2.7 Single system connected to MGPS and alternating to fill cylinders when oxygen demand is low
Primary oxygen Cylinders to
O2 Analyzer
94% ppm
Oxygen cylinder
source (30 Nm3/hr) Distribution
filling station ramp
Primary oxygen Cylinders to
O2 Analyzer
94% ppm
Oxygen cylinder
source (30 Nm3/hr) Fill up to 50 cylinders of 47.2 L Distribution
Primary oxygen filling station Cylinders to
O2 Analyzer
94% ppm

Oxygen cylinder
Primary oxygen
O2 Analyzer
94% ppm
fillingof station
Fill up to 50 cylinders 47.2 L Cylinders
ramp to
(water capacity)Oxygen
at 150 bar, cylinder
in 24 hours MGPS
source (30 Nm3/hr) Pneumatic change
Distribution
fillingof station
Fill up to 50 cylinders 47.2 L
ramp over system
(water capacity) at 150 bar, in 24 hours over system MGPS
Pneumatic change
over system
Cylinders to
O2 Analyzer
94% ppm
Secondary oxygen Oxygen cylinder Pneumatic change MGPS

filling station ramp
over system
Cylinders to
O2 Analyzer
94% ppm

source (30 Nm3/hr) Fill up to 50 cylinders of 47.2 L Distribution
filling station Cylinders to
O2 Analyzer
94% ppm
Secondary oxygen (water capacity) at 150 bar,

Oxygen in 24 hours
cylinder ramp
O2 Analyzer
94% ppm
fillingof station
Fill up to 50 cylinders 47.2 L Cylinders
ramp to
Secondary oxygen (water capacity)Oxygen
at 150 bar, cylinder
in 24 hours
fillingof station
Fill up to 50 cylinders 47.2 L
ramp
27
OXYGEN SYSTEMS
The sizing of the plant will also depend on An additional factor to consider is if the plant will be
whether the system will be used as main, secondary assembled onsite (Fig. 2.8), containerized (Fig. 2.9 and
or backup oxygen supply. At facility level, it is Fig. 2.10) or skid-mounted (Fig. 2.11). Though the last
important to consider the provision of a two solutions facilitate smoother installation, they are
backup supply [3.4.4], via a secondary supply not feasible for bigger sizes, typically above
source and/or cylinder stocking. 30 Nm3/hr production capacity.
Fig. 2.8 PSA oxygen generator plant Fig. 2.9 Containerized PSA plant
assembled onsite
Fig. 2.10 Containerized PSA plant
28
OXYGEN SYSTEMS
Fig. 2.11 “Skid-mounted” PSA generator
2.4 PSA system costs Implementing and scaling up oxygen solutions should
consider a project stepwise approach, starting with
The estimated cost for acquisition of a PSA system technical assessment, followed by procurement
varies significantly depending on: and operationalization. Technical experts should be
· size and configuration [2.3] of the assembly; involved throughout the entire process, from initial
· whether built onsite, skid-mounted or

containerized;
decision-making to final set up of contextualized
and holistic solutions that are also aligned to budget
availability for long-term operations.
· whether spare parts kits for PMP are included; Web annex A. Technical considerations for the
· interconnection
system;
to the selected distribution
procurement of oxygen generator plants, outlines best
procurement practices and how stakeholders can raise
· country of origin; awareness of the hidden costs and factors that need to
· shipping methods (type of transport), insurance
and trade terms (e.g. Incoterms); and
be considered for long-term operation of oxygen
systems [1.5] at scale. As far as possible, these high-
value investments should include long-term SLA to
· other associated costs for the implementation
and operation [3.4], such as housing and/or
ensure continued, safe and successful operation of the
oxygen systems.
shelter, ventilation, air conditioning and heating
equipment, diesel generator, high-pressure
cylinders, cylinder accessories and trolleys,
vehicles to transport cylinders offsite, SLA, staff
recruitment to operate and maintain the systems.
In 2020, the Respiratory care equipment market report

(25) produced information on different suppliers in
the United States, Europe and China. In 2021, UNICEF
offered in its supplies catalogue an “oxygen plant-in-a-
box” solution (26) with some reference costs. However,
since then, the market landscape and pricing continue
to change considerably.
29
OXYGEN SYSTEMS
2.5 Cylinder filling station: booster The filling capacity of the booster compressor is stated
in a range of Nm3/hr and must be optimal in relation to
compressor and filling ramp
the production capacity of the plant and the expected
The booster compressor (Fig. 2.12), also known as number and size of high-pressure gas cylinders [2.8]
a “high-pressure compressor”, must be an oil-free to be filled. Once, the specific flow rate is settled, the
compressor. Such compressors represent one of configuration must be kept unchanged.
the most expensive components of the PSA plant
assembly [2.1], due to their capital cost, electrical The booster compressor is connected to a filling
requirements and associated maintenance needs. cylinder ramp with flexible pigtails, regulators
and valves compatible with the existing cylinders
(Fig. 2.13). Additionally, a vacuum pump needs to
be located close to the filling ramps to be used for
purging cylinders before refilling.
In Fig 2.14, note that the flow of gas is from the plant
to the fill in cylinders, illustrating that the direction
of flow in a filling ramp is opposite to the flow in a
distribution ramp [2.6].
Output from PSA plant
Fig. 2.12 Booster compressor
1 Booster compressor
2 Cylinder filling ramp
3 Vacuum pump
Fig. 2.14 Gas flow from PSA plant to cylinder

filling station
Fig. 2.13 Booster compressor connected to the filling

ramp of eight high-pressure cylinders
30
OXYGEN SYSTEMS
Table 2.1 shows the approximate number of cylinders In Fig. 2.15, note that the flow of gas is from the
per day that can be filled by different booster cylinder bank to the MGPS, illustrating that the
compressor capacities, assuming that the PSA system direction of flow in a distribution ramp is opposite to
is running at full capacity, 24 hours a day and that the flow in a filling ramp [2.5].
~50 L (water capacity) cylinders are filled to 15 000 kPa
(150 bar or 2175.6 psi).
2.7 Pneumatic changeover system:
automatic/manual
Table 2.1 Booster compressor capacity
Pneumatic changeover systems (“manifold” or
Booster compressor No. of cylinders/day “pneumatic manifold”) are designed to ensure
capacity
continuous supply from two or more onsite oxygen
3 Nm3/hr (50 L/min) < 10 sources (Fig. 2.18). The onsite oxygen sources could be
6 Nm /hr (101 L/min)
3
< 20 an oxygen generator plant [1.6.2], VIE system [2.10.1],
cryogenic cylinder [2.10.2], high-pressure gas
12 Nm3/hr (200 L/min) < 35 cylinders [2.8], or a combination, as long as all
16 Nm3/hr (266 L/min) ~50 sources are certified for medical application.
32 Nm3/hr (533 L/min) ~100 Depending on the design, one source will be
considered primary and the other secondary.
A typical configuration will use two different
2.6 Distribution ramp production methods in case one fails or presents
constraints. For example, a combination of a LOX
A standalone distribution ramp consists of a ramp source with a cylinder bank; or two redundant
with flexible pigtails, regulators and valves compatible oxygen generator plants.
with the existing high-pressure gas cylinders [2.8].
The main and backup ramps are interconnected The changeover systems consist of multiple selection
through a pneumatic changeover system [2.7], valves which work manually (Fig. 2.16) or are
which in turn is connected to a MGPS [2.9] allowing programmed to automatically adjust and switch when
the continuous supply of medicinal gas at constant pressure and demands change in the pipeline network
pressure in the wall outlets [2.9.2]. The whole system (Fig. 2.17). These systems also include controls that
is also called the “cylinder bank”. serve to measure and regulate the pressure between
the entry point (higher pressure) and the output of
The cylinders are filled with medical grade the pipeline network (lower pressure). Additionally,
oxygen [1.3.1] produced by an oxygen generator alarms will activate when the working pressure
plant, or by a LOX source, after passing through the diminishes, for example when it reduces by more
vaporization stage. Having a mixture of cylinders filled than 25%. The whole system requires maintenance,
by different sources has not demonstrated any risk to cleaning, and testing of the specific medicinal
the patient, or to the MGPS, as long as the quality is gas following relevant national and international
ensured in the whole supply chain and GMP (3) and standards. The schematic in Fig. 2.18 illustrates the
GDP (27) are strictly followed. detailed components of changeover systems.
2 3
4
1 5
SECTION SHUTOFF VALVE

CLOSE ONLY IN EMERGENCY
MEDICAL OXYGEN
USE NO OIL
NO. CONTROLS SECTION
1 Cylinder distribution ramp

2 Vacuum pump
3 Pneumatic changeover system (manual or automatic)
4 Valve and line regulator
5 Wall outlet
Fig. 2.15 Gas flow from distribution ramp to MGPS
31
OXYGEN SYSTEMS
Fig. 2.16 Changeover system: manual Fig. 2.17 Changeover system: automatic
o a. inlet and outlet pressure gauges

b. high-pressure regulators
m c. high-pressure valves
d. connecting hoses (NF, DIN, BS, CGA etc.)
l e. cylinder ramps and safety valves
h
f. alarm panel with visual and audible alarm,
n connected to pressure switch (optional)
j g. line pressure gauge
h. exhaust vent
f g
i. inlet valve
j. regulator
Pneumatic
Low pressure change k. flexible pigtails with check valves
over system
l. pressure gauge
i
m. shut off valve
n. vent valve
b
o. gas outlet
High pressure
c
d
k
Main ramp Back-up ramp
Fig. 2.18 Schematic of a pneumatic changeover system
32
OXYGEN SYSTEMS
2.8 High-pressure gas cylinders These cylinders are typically regulated as pressure
vessels and not considered under the medical device
High-pressure gas cylinders are used to store regulatory framework. However, ascertaining the
compressed medical gases under varying pressures. quality of these “container closure systems” when
The main components of high-pressure cylinders are carrying a medicinal gas is vital; they should follow
depicted in Fig. 2.20. They are available in a variety GDP for medical products (27). The manufacturer
of sizes and most often made from molybdenum must be able to provide a technical data sheet for the
steel, but can also be made of aluminium or carbon production batch outlining relevant information (Fig.
fibre (28). Even though cylinders and the associated 2.19).
residual pressure valves (RPV) are not manufactured
by the gas supplier, the entity responsible for refilling Following best practices for procurement, refilling and
the medical gas must oversee proper maintenance management [3.6] may mitigate the risks associated
every 5 years. The maintenance involves, as a with pressurized contents and maintain the purity of
minimum, a hydrostatic test, weight loss test (> 5%) the gas contained.
and corrosion test. The cylinders must pass strict
There are several applicable quality and safety
verification procedures and be cleaned after every
standards for these devices, including the
use. Only cylinders tested following QA for medical
Transportable Pressure Equipment Directive (TPED)
application should be used for medical oxygen. At
in the European Union, which requires cylinders to
facility level, users must conduct frequent visual and
have a “π” mark stamped on their shoulder; and
leakage checks of the cylinders.
the Code of Federal Regulations of the Department
of Transportation (DOT) in the United States, which
requires them to have a “DOT3AA” stamp. Another
indicator of an appropriate vessel is if it bears a
United Nations packaging symbol stamp next
to ISO 9809-1.
Technical requirements
1. Manufacture standard: ISO 9809-1
2. Manufacture process
3. Working pressure
4. Hydraulic testing pressure
5. Minimum burst pressure
6. Material, including chemical composition (%)
7. Heat treatment process
8. Mechanical properties
9. Thread specification
10. Specification of the cylinder:

• Capacity (L) +5%
• Length (mm) ±10
• Weight (kg)
Fig. 2.19 Information outlined in a technical datasheet for cylinder conformity
33
OXYGEN SYSTEMS
2.8.1 Distinguishing different types of
high-pressure cylinders
It is crucial to distinguish between the different 8
high-pressure cylinders containing different

8
medicinal gases (e.g. oxygen, air, nitrous oxide) to
avoid a potentially lethal situation of administering 1a 1
the wrong gas to a patient. Different standards
for colour coding, labelling and connections are 1c
1b
applicable
1a in different countries. Also, each
1 type of
medicinal gas has a specific colour, nomenclature 3
and connection system across the national standards.

1b
1c
The following sections describe the characteristics 2
applicable to oxygen cylinders.

No. Description
3
2.8.2 Cylinder labelling 1
1a
Cylinder valve
Handwheel
1b Gas outlet / c
In absence to an existing national regulation, the 2 1c Security valve
labelling, including the content of the label (Fig. 2.21), 2 Security stopp
3 Thread for he
must respect the requirements for identification of 8 Security head
the content and warn of principal hazards stated on
ISO 7225 (29). Likewise, the ISO 13769 (30) indicates No. Description
the requirements for permanent marking applied to 1 Cylinder valve body
1a Handwheel
cylinders by hard metal stamping, engraving, casting
1b Gas outlet / connection (CGA 540)
or other method.
1c Security valve (pressure relief device)
2 Security stopple
3 Thread for head cover
8 Security head cover
Fig. 2.20 Cylinder components
OX
Y
CO GEN, E
MPR B TS
:
USP
s
EN er
ESS ti on
c i ta o u t
.
CO
NT Lit
ED
r
de
UN1
sus th 84
d re , wi lin 85
y an ration Cy e
enc
e fi ci lo ng d
u a ve F 22
MEDICAL G n d
yge over a wh o h Ty
p
63
072 AS or ox ents IF
nn el f f o xyge n pati DE T
Pro WARN
trained
perso
ions
o
to us
e on PLO 63
22
em er g e n cy u s e o nl y w he n adm i ni s t er e d b y p rop er l y e nt ra t
I NG : F o r
CA du h conc t atte
mpt AY
EX
S7 ce Fo r a l l
ot her med
ical applications, P only. Uninterrupted u
se o f hi g Do no URE re
;M H 72
78 db mo n i to X may b e h a rmful.
E S S o 31
2-4 y r i n g i t s e ff e
c ts on o x yge n con te nt of ar t e r ia l bl ood ,
e equi p
ment . NDE
R PR p and s .
e
t
l A K
4-7 st op p e d
bre a th i ng unl ess us ed in c on j uc ti on w it h r esu sc it a t iv AS U . Ke d oi
DO
NO G D ANG E
I DIZER .
CONTA
INS G
n d er s
an d u e fr o m g
tood as e an o
re to d
TR C HEATED.
R: MAY CAUSE
O R IN TENS IFY F I R E; OX
Do n ot h an d le u nt i l a ll saf et y pr e cau t io n s h
av e bee
n read s fre k if s
f it t i n g St o p le a o mp at i b
afe le M
OXYGE
EM es a n d
OV eep val v e of fi
re: fc for
f ro m cl oth i n
g and o th e r c o mb u st ib l e m a te r i al s . K e n t o le ane d ght e:
ET . I n c a s th e qu i pm unl i s
N
HIS Us e a nd s t o ed place i ent c t f rom s fore u
re o n l y o u t d o o rs or i n a w el l - ven t i la t g. U s e on l y w h eq ui pm e
PR so. U se a b pin it ro te c SDS ) b
OD a ck f l o w p re v e nn ti ve d evi c e in t he pi on ly w pty. P (
UC ma t e r i al s u re . Us e d w h en em t a Sh ee t
of const r u ct i on and r a t e d fo r c yl i nd er pr es s
G
2
TL c h u s e an f e t y Da d b y:
oxyg en se a Sa
ABE rvice. Open valve slowly. Close valve after e f o l l ow the ist r i b
ute
L. when a m
b ie nt t emp er a tu r e ex cee d 5 2 °C ( 12 5 ° F ). Rea d a n d D
G
0 11
LG D H
EC 231-956 1234353
-9 / 230 b ar at 15 °C 004177200
No. Description
A Hazards and precautions notice
B Name of the product
C Hazard diamond
D Filling pressure
E Gross weight
F Cylinder size
G Manufacturer brand name and contact
H Serial number
Fig. 2.21 Cylinder labelling
34
OXYGEN SYSTEMS
Colour
code Medical gas/medical gas mixture
Oxygen
Nitrous oxide
Entonox (50% N2O/50% O2)
Air
Carbon dioxide
Oxygen/carbon dioxide mixture (95% O2/5% CO2)
Helium
Helium/oxygen mixture (79% He/21% O2)
Lung function mixture type 1-4
Carbon dioxide/oxygen medical gas mixture
Carbon dioxide/air medical gas mixture (5% CO2/95% air)
Helium/oxygen/nitrogen medical gas mixture (56% N2/35% O2/9% He)
Fig. 2.22 ISO cylinder colour coding for different gases
2.8.3 Colour coding There are three main types of cylinder valves
(Fig. 2.23):
Currently, there are two predominant tank colouring
systems: ISO (Fig. 2.22) and that used in the United Bullnose valves: Cylinder valves with a bullnose
States. In ISO standards, the oxygen cylinder body connection have threaded outlets that use specific
is black, but the shoulders have different colours non-interchangeable screw thread systems
depending on the gases contained. In the case of for different medical gases to prevent a wrong
oxygen cylinders, they should have a white top or connection. These are the most common valves on
“white shoulder”. In contrast, in the United States, larger cylinders. When the regulator is fitted to a
oxygen cylinders should be completely green. cylinder with a bullnose valve, the nut allows for the
nipple to seal against the valve outlet, which then
2.8.4 Valve outlet connection allows the gas to pass through.
The primary valve of cylinders must be compatible Pin-index valves: Cylinder valves with a pin-index
with the fitting element, which is either the pressure connection prohibit interchanging cylinders for
regulator, filling ramp [2.5] output or distribution different medical or non-medical gases as only the
ramp [2.6] input. Valves are made of steel/plated correct pressure regulator (with the correct pin) fits
brass/aluminium casing and support the specified the associated cylinder.
nominal inlet pressure.
Integral valves: These are more common on smaller
The cylinder valves models will change according to cylinders. They have inbuilt pressure regulators and
the national standard applied and to the use type, flowmeters. While these are the most expensive, they
industrial vs medicinal (e.g. United States and Canada require the least amount of maintenance.
standard CGA 580 for industrial use vs standards CGA
540 and 810 for medical use).
Some cylinder valves require a metal protection

cap, also called a valve guard, to be used during the
transport of cylinders. This cap protects the valve from
tearing off if the cylinder falls over.
35
OXYGEN SYSTEMS
Bullnose connection Pin-index system – each medicinal gas Integral valves

has a different pin arrangement
Fig. 2.23 Cylinder valve types and depiction of the connection with pressure regulator and flowmeter
2.8.5 Size and denomination pressure to which a cylinder can be filled. This varies
according to manufacturer, but typically ranges from
There is no internationally harmonized standard,
13 700–15 000 kPa (137–150 bar or 1987–2175 psi) .
nevertheless there are two common systems used
to name and differentiate oxygen cylinder sizes. In When a booster compressor [2.5] is used to fill gas into
the United States, the naming system begins with a cylinder, the pressure inside the cylinder increases
the letter “M,” for “medical,” followed by a number proportionately with the volume of gas introduced.
signifying the volume (in cubic feet) of gas that can The following is a rule-of-thumb relationship,
be compressed into the cylinder. The British naming simplified formula which gives an approximate
system (letters) is more widely used (Fig. 2.24). estimation at STP to determine cylinder content:
Manufacturers typically offer a range of sizes from Pressure (bar) × Cylinder water volume (L)=
1.2 to 50 L water capacity (i.e. capacity to hold litres Total gas volume (L)
of water). However, it is the pressure to which the
Table 2.2 shows the example of a 47.2 L water capacity
gas is compressed that dictates the quantity of gas
cylinder contents at different filling pressures.
contained in a cylinder. Cylinders have rated working
or nominal pressure, which is defined as the maximum
Fig. 2.24 Cylinder dimensions and nominal content at a pressure of 150 bar
Source: Adapted from WHO-UNICEF technical specifications and guidance for oxygen therapy devices (9).
36
OXYGEN SYSTEMS
Table 2.2 Volume of gas in a 47.2 L water capacity cylinder at different pressures
Gauge pressure (kPa) Gauge pressure (bar) Gauge pressure (psi) Gas amount (approx. L)
100 1 14.5 47.2

1000 10 145 472
10 000 100 1450.4 4720
13 700 137 1987 6466.4
15 000 150 2175.6 7080
Larger cylinders are typically suited for use in A pressure regulator can have a single gauge with a set
distribution ramps [2.6] but can also be brought to pressure, showing the pressure of the contents. This
the bedside of patients. The smallest cylinders is generally used in direct delivery to a patient using a
(i.e. type D or E) are typically used for anaesthesia flowmeter and, optionally, a humidifier.
machines, for ambulances and for patient
intrahospital transportation. There are also regulators with two gauges (Fig. 2.25),
one showing the contents’ pressure – the inlet gauge
Regardless of the size of the cylinder, they are often (which corresponds to the amount of gas in the
filled at 15 000 kPa (150 bar or 2175 psi) and removed cylinder) and the other showing the reduced outlet
from use with a retained minimum pressure of 200 kPa pressure, which can be adjustable with a knob or
(2 bar or 29 psi). This pressure remains in the cylinder screw. These are used to provide oxygen to specific
to prevent the ingress of any contaminants, including medical equipment (e.g. invasive ventilator).
moisture.
When purchasing a new regulator, ensure:
2.8.6 Cylinder accessories · The outlet pressure is within the required range,
i.e. sized for achievable flow rate, clearly indicating
All cylinder accessories, pressure regulators,
flowmeters and humidifiers are described in detail in half-full and maximum values.
the WHO-UNICEF technical specifications and guidance
for oxygen therapy devices (9). The key cylinder
· The connection thread fits to the cylinder.
accessories are outlined below. · Itmedicinal
is suitable for use with the specified
gas.
Pressure regulator: A pressure regulator reduces
When the cylinder is directly connected to a patient
the pressure of highly compressed gas in an oxygen
ventilator, an additional adaptor is needed to fit
cylinder to lower usable pressure for medical
the connection requirements between the pressure
application. The regulator allows the outlet pressure
regulator outlet and patient ventilator inlet. This
to be kept stable, regardless of the fill-level of the
connection is illustrated in Fig. 2.26.
cylinder and the flow demanded.
Outlet gauge
Inlet gauge
Safety valve
Cylinder stop
valve
Stop
valve
Diaphragm
GAS CYLINDER
Outlet
Pressure
adjustment
Fig. 2.25 Depiction of a two-gauge pressure regulator connected to a cylinder
37
OXYGEN SYSTEMS
Regulator type
Regulator Barbed type
Barbed Fitting
Diss Connector
Ohmeda Connectors
DIN 13260 mentioned in the
FRENCH AFNOR previous slide
SS
Many More
UNI 111 44
EN 850
NF-E-29-650
BS 341-3
DIN 477-1 No connector
ISO 5154 When barbed fitting
terminal unit regulator
Fig. 2.26 Oxygen cylinder in direct supply to patient ventilator
Flowmeter (flow regulator): Flow regulators are A pressure-compensated flowmeter has a float that is
connected between the patient and gas supply to upstream from the valve so that the float is in contact
deliver controlled flow rates according to the therapy with the source pressure rather than atmospheric
(Fig. 2.27). There are three types of flowmeters: pressure. This offers the advantage that if pressure
Thorpe tube, dial-click and Bourdon gauge. is applied distally to the tube, e.g. flow-restricting
equipment or kinked tubing, it will have no effect on
the flowmeter’s performance. The flow displayed is
accurate in the face of an obstruction downstream. As
the flow is restricted, the flowmeter will display lower
and lower flows, down to zero if there is a complete
blockage. If the resistance is removed, the flow will
increase.
Non-heated bubble humidifier: Humidifier

bottles are fitted to the outlet end of flowmeters.
They are used, when prescribed by the clinician, in
administrating oxygen to the patient. The oxygen
passes through distilled water to prevent dryness of
the upper respiratory track reducing discomfort of the
patient.
2.8.7 Key considerations for storage, transport

and handling of high-pressure cylinders
To prevent accidents when managing these
Fig. 2.27 Cylinder with flowmeter (dial-click left; pressurized vessels containing oxygen, which is an
Thorpe tube right) and attached humidifier oxidating agent, safety and mitigations measures [3.6]
must be followed, including:
The most common type of flowmeter used in oxygen
therapy [1.3] is a Thorpe tube a transparent plastic
· Amust
dedicated, well-ventilated and sizable space
be designated to store cylinders (“cylinders
tube with a scale. Inside this tube there is a small storage station”).
floating ball. The height of the ball indicates the flow
of the oxygen to the patient. The flow of oxygen can · Separated areas to differentiate full and empty
cylinders must be clearly identified.
be adjusted using the knob at the bottom of the tube.
It is important to know if the Thorpe tube is pressure · Only trained personnel should transfer and
transport cylinders, with an appropriate trolley,
compensated.
and keeping cylinders chained.
· Appropriate vehicles to transport cylinders should

be considered if distribution offsite is required.
· Never change a cylinder’s contents from that

intended.
38
OXYGEN SYSTEMS
· Never repaint a cylinder. Considering the physical laws of fluid dynamics, the
· Never change a cylinder’s markings or

identification.
initial pressure provided by the source of medical
oxygen will drop along the distribution system
depending on various factors such as the section of
· Never refill a cylinder from another one; especially
big containers to smaller ones.
the tube, the length of the network, the number of
branches to wall outlets [2.9.2].
· Tighten
spanner.
the regulator inlet nut securely with a Dual-line regulators (Fig. 2.28) control the oxygen
pressure, allowing it to be supplied at the average
· Use appropriate wrench. value defined during the design phase. This assembly
includes a relief pressure valve. The maximum flow
2.9 Medical gas pipeline and relief pressure settings are manufacturer set.
systems
The MGPS consists of a network of pipelines, fittings
for connections, line valve assemblies and isolation
valves, regulators, alarms and control panels and
wall outlets (bedside terminal units) (Fig. 2.29). The
design, installation and upkeep of MGPS are complex
undertakings and require expert consultation and
overview. All MGPS designs are facility-specific; there
is no one-size-fits-all solution. For design alone,
there is no straightforward methodology or approach
because each facility’s configuration will differ. A
design engineer will follow a logical approach, apply
theories of fluid dynamics, and draw from previous
experience for each situation to find the “best Fig. 2.28 Dual-line regulator assembly
fit” solution. The length and number of branches
of the network, and/or manufacturers’ technical 2.9.2 Wall outlet
requirements for specific medical equipment which
need oxygen provision, will typically require the gas Wall outlet terminals are the endpoint of the MGPS
output pressure from the source to be between and are placed at each patient bed. They must clearly
300–600 kPa (3–6 bar or 43.5–87 psi). distinguish between the different medical gases
(e.g. oxygen, air, nitrous oxide) and vacuum line,
There are three reference standards widely used to avoid life-threatening situations. To ensure this
in the design MGPS, namely ISO 7396-1 (31), the differentiation, there are two combined methods,
Health Technical Memorandum (HTM 02-01) (7) and colour coding and shape/fitting of the connectors.
National Fire Protection Association (NFPA) 99 (32).
Still, national authorities will indicate the applicable Colour code: Using the same colour code [2.8.3] as for
local standard (e.g. Guo Biao [GB] standards for the high-pressure cylinders, the front cover of the terminal
People’s Republic of China). There are also certified displays the colours of the medical gas distributed.
agencies that will establish testing procedures for Local and international standards may vary.
some components of the MGPS, e.g. American Society
Shape/fitting of the connectors: Wall outlet [2.9.2]
of Mechanical Engineers (ASME) B31.3 (33) and
terminals used for health purposes must have a
Compressed Gas Association (CGA) (34).
“foolproof” system, which makes it impossible to
connect a hose from one medical gas or for a vacuum,
2.9.1 Dual-line regulators assembly with a wall outlet terminal of another medical gases
An important aspect to be considered when designing or vacuum.
the MGPS is the gas working pressure. It is essential
There are several styles of connector patterns,
to guarantee a minimum pressure at every wall
including the DISS (Diameter Index Safety System),
outlet [2.9.2] terminal, from the one closest to the
Ohmeda, Puritan, Chemetron (NCG), AFNOR
central source, to the farthest one at the other side
(Association Française de Normalisation), DIN
of the health facility site. For example, NFPA 99 (32)
(Deutsche Industrial Norms), BS (British Standard),
standards recommend a gas working pressure at the
JIS (Japanese Institute of Standards), AS (Australian
wall outlets of 345–380 kPa (3.45–3.8 bar or 50–55 psi).
Standard) or AGA (American Gas Association). Each
Today, medical equipment is designed to operate at
of these styles establishes a standard for non-
lower pressures than in the past and this may impact
interchangeable indexing which acts in a key-like
their oxygen usage.
fashion, so that the fittings within the gas service
39
OXYGEN SYSTEMS
group will connect only with their own type. 2.9.3 Safety (isolation) valves
Fig. 2.29 illustrates some examples of these types
Safety valves aim to stop the flow of medical gases
of wall outlets.
in the MGPS when necessary and in pre-defined
A “foolproof” system supplements but does not areas or wards. The reasons for this can range from
replace: simple maintenance procedures to a first responder
needing to stop the flow of gas during an emergency
· any of the means for medical gas identification
currently in use;
situation. The two use types are defined according to
their purpose, distinguishing between main and zone
· pin-index safety system; isolation valves.
· existing threaded outlet standards for cylinder

valves; or,
The main isolation valve is located directly
downstream of the source system. This single valve
· automatic quick coupler valves that also provide

non-interchangeable connections for medical
effectively isolates the source of supply from the rest
of the pipeline network. This valve is rarely closed.
gases and suction equipment. This valve would only be closed in a major emergency
or if the entire system was compromised and deemed
Medical Gas Outlet not to be used.
Ohmeda, DIN, JIS, BS styles

Medical Gas Outlet
Ohmeda, DIN, JIS, BS styles
DISS style AFNOR style
DISS style AFNOR style
OXYGEN
OXYGEN OXYGEN
OXYGEN OXYGEN
OXYGEN
OXYGEN
OXYGEN OXYGEN
OXYGEN OXYGEN
USE NO OIL USE NO OIL OXYGEN
USE NO OIL USE NO OIL
MG-DS-10 MG-DS-12 MG-AF-10

Side View thread type barb type
O2 O2 O2
MG-DS-10 MG-DS-12 MG-AF-10
Chemetron style Side DIN
Viewstyle thread type barb type
O2 O2 O2
OXYGEN OXYGEN
Chemetron style
O2 O2
DIN style
O2 VAC
OXYGEN OXYGEN
MG-CT-11 MG-CT-10 MG-DN-10 Domed cover N2O O2 AIR O2
Side View
O2 O2 O2
O2 VAC
Ohmeda style JIS style
OXYGEN OXYGEN O2 O2
O2 VAC
MG-CT-11 MG-CT-10 MG-DN-10 Domed cover N 2O AIR
Side View
O2 O2 O2
N 2O AIR
MG-OA-14 MG-OA-13 MG-JP-10 Domed cover
Side View
O2 O2
Ohmeda style O 2
JIS style
BS style
OXYGEN OXYGEN O2 O2
O2 O2
O2 VAC
USE NO OIL USE NO OIL O2 N 2O AIR VAC
MG-BS-13 MG-BS-10 Domed cover
O2 O2
N 2O AIR
MG-OA-14 MG-OA-13 MG-JP-10 Domed cover
Side View O2
O2 O2
BS style
O2 O2
O2 N 2O AIR VAC
MG-BS-13 MG-BS-10 Domed cover
O2 O2
Fig. 2.29 Examples of medical gas wall outlet types
40
OXYGEN SYSTEMS
The MGPS also contains zone isolation valves 2.9.4 Alarms and sensors system
installed in a number of locations. Strategic locations
The pressure of oxygen gas in the pipeline network
are decided during the design phase of the network,
between the source system and the patient must be
as a common agreement between the key manager
monitored. Specific alarm sensors and displays are
of the health facility and providers. In most cases, they
located along the MGPS to detect if the pressure drops
are close to the ceiling line, with the objective of being
or rises. The alarm panels are constantly monitored
operated only by authorized personnel. However,
by authorized personnel (Fig. 2.31). The two types –
some may be accessible to other medical staff. These
master and zone alarms – are defined according to
valves are meant to assist if medical gas needs to be
their purpose.
shut off immediately. They may have a safety feature
which makes it extremely visible to nearby staff if a Master alarm: While the source systems have their
valve is open or closed. own alarms, which are a combination of pressure
sensing, electrical failure, device failure, or other
For both types, the only acceptable isolation valve
specific functions; to monitor pressure in the pipeline
style is a quarter turn ball valve (Fig. 2.30) (7). It
network, the most common alarm device is a pressure
consists of a ball assembly inside the body of the valve
switch, which sends a low-voltage signal to the supply
which has a hole from one side to the other, lined up
system panel if the level in the pipeline exceeds or
with the inlet and outlet part of the body. When the
drops below set values. This master alarm is normally
handle is turned a quarter rotation, the ball moves
located in the operator’s room.
and effectively closes the direction in which the gas
travels. This is an easy-to-use configuration and Zone alarms: Zone alarms are installed downstream
allows for quick opening and closing. of the zone valve box. These panels not only sense
pressure but also display the actual pressure
For MGPS, valves are used fully open or fully closed,
contained in the pipeline. Should the level drop below
i.e. they are not meant to act as a flow control
or rise above the set point, an audible and visual
mechanism. Valves should be installed in such a
alarm is initiated. They are all hardwired, via low-
way as they are secured during normal use, i.e.
voltage wiring, to the master alarm.
it should take a specific act to move the handle
beyond how it is orientated. Securing the assembly
in the proper position prevents the valve from being
mistakenly closed by accident. On the other hand,
the operationality of the valve must be facilitated,
with clear access to the valve and no obstacle to 48 54 37 56
performing the full quarter turn movement of the
valve.
SECTION SHUTOFF VALVE

CLOSE ONLY IN EMERGENCY
MEDICAL OXYGEN
USE NO OIL
NO. CONTROLS SECTION
Fig. 2.30 Quarter turn isolation valve for

medical oxygen
The combination of valves allocated to different

medical gases in an enclosure is referred to as the
zone valve box (Fig. 2.31). In a valve box, butterfly
style valves are not appropriate, regardless of the
medical gas piped. Each valve in the box has a label
to identify the medical gas and the locations it serves. Fig. 2.31 Zone valve box and alarm panels
A gauge is usually present to indicate the pressure
downstream of the valve. In an emergency (e.g. fire
outbreak), first responders can open the glass-door
and close the valve, providing there is a gauge that can
identify how much pressure is left in the line.
41
OXYGEN SYSTEMS
1. DISS [Oxygen]
2. Ohmeda [Oxygen]
3. Puritan [Oxygen]
4. Chemetron (NCG)
5. French (NF S90-116)
6. German (DIN 13260-2)
7. British (BS5682-1998)
8. Japanese Style (JIS)
9. Australian (AS2896)
10. American (AGA) [Oxygen]
Fig. 2.32 Connection between oxygen wall outlet and patient ventilator
2.9.5 Other accessories at delivery level Selecting the adequate size for the LOX storage must
In connecting medical equipment (such as a patient consider various factors such as:
ventilator [1.7.2] to the pipeline network, it is
necessary to adjust fitting connectors (adaptors)
· Maximum and average oxygen demand,
anticipating potential surges.
between the wall outlet terminal and the specific
hoses used in the medical equipment (as illustrated in · Pipeline network diversification.
Fig. 2.32). · Distance of the health facility from source of LOX
(either distribution hub or point of production).
It is highly recommended to follow a colour-coded
system in accordance with the colour code used for · Logistics to establish a regular refiling schedule; for
instance, trucking capacity, both size of and total
the high-pressure cylinders based on national or
international regulations. number of trucks in circulation; and environmental
constraints (e.g. snow or rainy season) that may
affect roads, are critical factors.
2.10 Onsite liquid oxygen storage
As outlined in cryogenic fractional distillation plants · Financial resources.
producing liquid oxygen (LOX) [1.6.3], bulk LOX is The sizing of the source will also depend on if the
produced by specialized and certified companies system will be used as a main, secondary or backup
outside health facility premises. After production oxygen supply. At facility level, it is important to
it follows a strict supply chain [4.1] to reach health consider the backup supply [3.4.4], via a secondary
facilities in liquid or gas form. This section describes source of supply, and/or cylinder stocking.
the LOX storage [1.6.3] set up and conditions at facility
level. In the facility, LOX is always transformed by 2.10.1 Vacuum-insulated evaporator systems
passive means to gas before entering the MGPS [2.9]. for bulk LOX storage
The key advantage of LOX bulk storage over other
systems is more evident when high demand exists.
The pre-installed vacuum-insulated evaporator (VIE)
system consists of a cylindrical cryogenic pressure
vessel (bulk tank) with a pressure regulation assembly
connected to an external vaporizer (Fig. 2.33).
Bulk tanks vary in size, typical volumes being 2, 3, 5,

10 and 20 m3 (Fig. 2.34, Fig. 2.35). The size selection
should consider the average oxygen demand in the
facility (unlike PSA plants, which are sized based on
peak flows) to allow oxygen flow at working pressure
and prevent excessive icing in the external vaporizer.
Over-sizing the bulk tank can result in future excess
pressure build-up and off-gassing (wastage).
Whereas under-sizing can result in the need for
greater frequency of refills and could run the risk of
LOX stock out.
Fig. 2.33 External vaporizer in a VIE system
42
OXYGEN SYSTEMS
In addition, the shape, design and sizing of the
external vaporizer, which conditions the oxygen from
liquid to gaseous form, is also relevant. The external
vaporization is a passive process. The maximum
quantified flow rates should determine vaporizer size.
An undersized vaporizer would mean that the demand
would exceed the possible output flow rates of the
vaporizer, and this would result in icing up, eventually
damaging material and parts. While there are
measures to thaw pipes, if not noticed early, system
blockages could occur. When in doubt, safe practice
for a vaporizer would be to oversize, not undersize.
The pressure control manifold manages and monitors

the product fill, pressure build-up, pressure relief,
product withdrawal and tank vacuum. The pressure
is reduced from 1050 to 420 kPag (10.5 to 4.2 barg or
152.3 to 60.9 psig) to enter the pipeline network.
The pressure is expressed as gauge pressure, meaning
it is measured against the local site atmospheric
pressure instead of 1 standard atmosphere. The whole
system should incorporate an alarm mechanism.
Fig. 2.35 Installation of LOX bulk tank [20 m3]
2.10.2 Cryogenic LOX cylinders

with in-built vaporization
These cylinders are insulated, vacuum-jacketed
pressure vessels, equipped with pressure relief valves
and bursting discs to protect the cylinders from
pressure build-up (Fig. 2.36). The working pressure is
up to 2413.2 kPag (2.4 barg or 350 psig). The typical
volumes are 185, 260, 300 and 500 L of LOX, although
there are other sizes on the market.
Cryogenic LOX cylinders are more sensitive to small

shocks and inertia, which occur during transportation,
leading to small escapes of gas. Moreover, as a result
Fig. 2.34 VIE system [2 m3] mounted on a skid of static losses, only around two thirds of the volume
is ever usable. Thus it is crucial to reinforce proper
sizing that considers estimation of volume usability
and secondary sources available at the facility (e.g.
cylinder bank).
43
OXYGEN SYSTEMS
Secondly, prior to installation and physical anchoring,
a slab is needed. A full tank bears a significant tonnage
(dependent on size of tank but can be up to 30
tonnes). A formal geotechnical assessment is essential
to ensure appropriate slab design, which should be
cast accord to specifications (this will require a water
supply). A crane is needed for installation.
Fig. 2.36 Cryogenic LOX cylinder
2.10.3 Key implementation, managerial

and operational considerations for LOX
implementation
Acquiring this type of hardware can be done through
lease agreements with LOX providers, where the
provider will be the ultimate owner of the asset Fig. 2.37 Installation with cranes of onsite LOX
and responsible for all preventive and curative bulk tank
maintenance. An alternative, is third-party ownership,
including by the client themselves. However, in this Finally, operations of the VIE system will entail limited
case it is imperative that the tank intended for use electrical supply for instrumentation and alarms (e.g.
adheres to both the operational and safety directives 12 V) , and the availability of 63 A industrial plug.
of the intended LOX supplier. Ongoing maintenance and upkeep are imperative to
ensure both continued operations and safety, and
Regardless of the ownership model, installation
this will require regular checks, as well as third-party
of LOX equipment should be sited away from
inspection at predetermined intervals to ensure that
boilers and other sources of naked lights, fuel stores,
the unit is and will continue
paint stores and other volatile flammable materials.
to operate safely.
Warning notices prohibiting smoking and naked
lights must be posted clearly in the vessel storage For cryogenic cylinders [2.10.2], key considerations
area. The emergency services should be advised include:
of the location of the vessel store and this location
must have appropriate signs for medicinal gases · Stored in a covered, dry and clean, well-ventilated
area not subjected to extremes of heat, and away
and fire safety [3.6.2].
from stocks of combustible material.
Installing VIE systems [2.10.1] requires some
specialized civil engineering works to ensure safe, · Stored separately from other medical cylinders and
other non-medical cylinders.
secure, lasting placement (Fig. 2.37). This is high-
pressure equipment with many associated risks, and · Stored to maintain separation between full and
empty cylinders.
ownership comes with high responsibility.
Firstly, a site must be dedicated for siting a VIE system. · Stored in a secure and upright position to avoid
spilling of the liquid.
At a minimum, a 5 x 5 m footprint will be required,
sited at least 8 m away from the facility. This area
must be fenced, unobstructed and accessible by
· Stored without a cover or material over the vessel.
the LOX tanker truck for refilling and safely turning · Used in strict rotation so that cylinders with the
earliest filling date are used first.
around. Preferably, no parking or user area should be
in the nearby area.
44
OXYGEN SYSTEMS
3. Operationalization
of oxygen systems
45
OXYGEN SYSTEMS
3. Operationalization of oxygen systems

3.1 Estimation of oxygen demand 47
3.2 Calculation methods for estimating oxygen demand 48
3.3 Tips for rational use of oxygen 49
3.4 System implementation, operation and maintenance 50
3.5 Structural and electrical requirements for onsite oxygen systems 51
3.6 Safety and mitigation measures 56
46
OXYGEN SYSTEMS
3. Operationalization of
oxygen systems
This section covers key operational topics and main concerns related to the design,
implementation and use of oxygen systems.
3.1 Estimation of oxygen demand With the above information, the calculation method
will apply assorted usage factors. Common usage
There are different methods for estimating oxygen factors are: annual inpatient admissions, facility
demand at facility level, or to capture needs across bed occupancy rate, estimated hypoxaemia [1.3] rate
a broader catchment when the intention is to per type of ward, and average flow rates per ward.
establish oxygen distribution hubs. Regardless of the It is suggested not to use more than two usage
methodology applied, oxygen demand estimation factors together to prevent undersizing the oxygen
and procurement planning are key first steps for system [1.5]. Likewise, not using any of them could
sustaining a long-term oxygen ecosystem [1.4]. lead to oversizing the system, which could also
Spreading the required costs over time to meet the represent technical and financial risks.
required demand can ensure the financial means for
long-term maintenance and may impact government Once the oxygen demand is calculated, the
and donor cost estimations. Depending on the context following must be considered in order to arrive at an
– emergency or long-term oxygen needs – scenarios appropriate contextualized technical solution:
may need to be evaluated repeatedly over time to
model changes in clinical need. · Existing and planned oxygen production, storage
and distribution systems [1.6]: location, distance
It is important to point out, oxygen demand and accessibility of those sites.
estimation may not always be equal to oxygen usage;
particularly where there are other ecosystem barriers,
· The ability to incorporate, adopt, assimilate
and operationalize investments at country and
e.g. weak value chain, poorly maintained equipment, facility level. This includes but is not limited to the
or lack of clinical staff trained on provision of oxygen actual operating conditions, available operators,
therapy [1.3] on the subject matter. For instance, if available medical staff to provide oxygen therapy,
the overall availability of oxygen increases but there working hours and power supply [3.5.3].
is not enough medical equipment to diagnose and/or
treat hypoxaemia, there will be a discrepancy between · Financial sustainability to pay local vendors for
oxygen delivery, provision and maintenance.
oxygen forecasted and consumed.
Three most used methods to calculate estimated need · Other project risks that may affect the
sustainability of the different technical solutions,
are based on:
such as political or environmental factors.
· number of beds per type of wards/per health
facility;
· number of gas wall outlets [2.9.2] per bed in each

type of ward, if any; or
· historical consumption, e.g. additional cylinders

consumed per day (indicating size), if any.
Key resources
Good practices in the rational and effective use of oxygen (PAHO): https://iris.paho.org/handle/10665.2/55735
Medical oxygen fire risk – mitigation measures: https://www.who.int/publications/m/item/medical-oxygen-fire-risk-
mitigation-measures
Medical gas piping systems safety: https://www.who.int/publications/m/item/medical-gas-piping-systems-safety
Oxygen cylinder safety: https://www.who.int/publications/m/item/oxygen-cylinder-safety
47
OXYGEN SYSTEMS
2. Usage factors 4. Simulate scenarios
Collect information Select the usage factors Prevent oversizing or • Simulate scenarios
available on the facility or to be used with the undersizing the oxygen with the combination
facilities to be served by calculation method source. Consider the of oxygen systems
the supply system: (use a maximum of two ability to incorporate, and including all
• Number of beds together): adopt, assimilate ancillary requirements
per type of wards • Bed occupancy rate. and operationalize to complement
per facility. the different types the particular
• Hypoxaemia rate per
of oxygen systems at oxygen source, e.g.
• Number of gas wall type of ward.
country and facility infrastructure, power
outlets per bed per • Average flow rate per level. Important factors and human resources
type of ward. type of ward. include: requirements.
• Historical
• Number of operators • Select a scenario and
consumption, e.g.
and working hours. develop a technical
cylinders consumed
• Surge and financial proposal.
per day (indicating
size). capacity.
• Other existing supply
systems.
• Distance from the
source.
1. Define calculation 3. Evaluate context
method situation and risks
Fig. 3.1 Estimation of oxygen demand
3.2 Calculation methods for Table 3.1 Pros and drawbacks of calculations
estimating oxygen demand based on bed capacity
Depending on the calculation method used (Fig.3.1),
Pros Drawbacks
there are various caveats to consider in arriving at the
final estimation. Below are the pros and cons related Quantity of beds for each Bed type definitions can
to each of the three calculation methods. purpose is obtained quickly vary according to each
in hospitals. context.
3.2.1 Considerations when assessing Use of bed is defined. Surge capacity is limited by
by number of beds per type of wards/ the defined type of bed.
per health facility Calculation is not affected If MGPS is installed, it is
Once the clinical wards and number of beds per ward by distribution system possible that two or more
have been identified, this method analyses each type (i.e. pipeline network or wall terminal outlets per
cylinders). bed are available. In case
of bed to suggest how many patients will be treated
of surged need, all wall
with oxygen therapy [1.3]. The flow rates and beds in
terminal outlets could be
need of oxygen therapy vary according to the type of used suddenly increasing
ward, as well as for each patient along their treatment the oxygen usage and
course. Flow and hypoxaemia rates are usage factors surpassing the estimated
that have reference values based on literature (35–40). production.
See Table 3.1 for pros and drawbacks of this method.
Average hypoxaemia and Average hypoxaemia
flow rates are based on and flow rates may not
clinical guidelines. represent the real clinical
practice in the facility.
48
OXYGEN SYSTEMS
3.2.2 Considerations when assessing by Table 3.3 Pros and drawbacks of calculations
number of wall outlets per bed/per type based on historical consumption
of ward
Pros Drawbacks
This method only applies when there is an existing
When information is clear, Historical records can be
pipeline network. Based on the total number of wall legible and complete, it unrealistic due to several
terminal outlets in each ward, the calculation is done is easy to aggregate the external factors.
considering either an average or a maximum flow historical consumption of
rate per ward. Prior to the calculation, it must be cylinders per size per period
ensured the pipeline network design has been of time, or LOX bulk tank
properly planned. See Table 3.2 for the pros and refilling per period of time.
drawbacks of this method. Appropriate for modular Surge capacity is limited by
facilities and/or without historical consumption and
Table 3.2 Pros and drawbacks of calculations piped distribution systems. existent storage space.
based on wall outlets
Pros Drawbacks 3.3 Tips for rational use of oxygen

Defined maximum or Is limited to facilities with The gap in oxygen access is multifactorial. It should
average flow rates of each pipeline network. not only be focused on one topic like production
outlet station. capacity, availability of supply or needs assessment.
As it considers 100% of By considering 100% of Improving access to oxygen also means using the
stations, when there are the stations in use and oxygen available efficiently. Rational use of oxygen
two or more stations per maximum flow, the source can be addressed through different strategies:
bed, it allows preparation can be easily oversized.
for surge demand. 3.3.1 Management
Calculation considers It is complex to simulate
different flow rates allowing and analyse the different
· Periodically monitor and register the consumption
of oxygen at the health facility to detect critical
more versatile scenarios. scenarios because it needs changes timely.
detailed consumption
per medical equipment · Monitor and, when possible, diminish the working
pressure of pipeline network.
or historical averages of
consumption per outlet,
that are commonly 3.3.2 Medical equipment usage
unknown.
· Ifpatient
possible, use bedside concentrators [1.6.1] when
needs lower flow (< 10 L/min) oxygen
therapy.
3.2.3 Considerations when assessing by using
historical consumption · Disconnect patient ventilator [1.7.2] from the
oxygen source when not in use.
This method can be used only when there are existing
oxygen systems [1.4] implemented in the health · Close valves and pressure regulators when high-
pressure gas cylinders [2.8] are not in use.
facility from which historical consumption has been
recorded. In general, to prevent underestimating the
demand, careful understanding of potential external
· Make sure that flowmeters are of good quality
supplied by approved manufacturers.
factors that have affected the registered consumption
should be considered. For example, lack of funds · Check for leakages along the MGPS [2.9], from the
source downstream to the medical wards.
to refill LOX or high-pressure gas cylinders [2.8],
uncertainty of the size of cylinders, scarce suppliers
in the area, difficult road access, lack of trained staff
· Be aware of any alarm activated on the MGPS or
medical equipment in use.
to provide oxygen therapy [1.3], deficient system to
keep records, are common restrictions that can affect · Select appropriate conditioning, regulation [1.9]
and delivery devices [1.7].
the baseline information. Consequently, this method
is best used as complementary to the two previous · Enable effective monitoring with properly fitted
pulse oximeters [1.8] probe. Remove nail polish if
methods. See Table 3.3 for pros and drawbacks of
this method. applicable and if possible.
· Make sure that pulse oximeters comply with

quality and safety standards for medical
devices and properly selected for the patient’s
demographic.
49
OXYGEN SYSTEMS
3.3.3 Health care worker: provision of
oxygen therapy
· ensuring available financial resources for
operational costs (e.g. staffing, training, spares
· Provide continued and repeated training in oxygen

therapy [1.3] for clinical staff, on delivering and
and repairs, SLA, power supply [3.5.3] and offsite
distribution);
weaning at different levels of care. · ifaccess
cylinders are transported offsite, appropriate
· Ensure that patients are properly diagnosed with

hypoxaemia [1.3] before administering oxygen.
for dedicated and appropriate vehicles
must be guaranteed, along with fuel and resources
to maintain said vehicle.
· Periodically monitor patient [1.8] status and
adjust flow rates as needed for treating 3.4.2 Human resources
hypoxaemia to avoid under- or overuse of oxygen
(12). For HFNC, HHHF, HFNO [1.7.1], the additional Besides the clinical staff, skilled and dedicated
benefit at flow rates of < 30 L/min is minimal. staff are necessary for successful operation and
Consider stepping down to face mask. maintenance of oxygen systems.
· Weaning (12) during the phase of “continuous

monitoring and reassess” to reduce flow as
Oxygen generator plants [1.6.2] (depending on
facility/catchment area):
tolerated, if patient is on nasal prongs, face mask
or non-rebreathing mask.
· operator(s) required onsite 24/7;
· qualified technician(s), required on call 24/7;
3.4 System implementation, operation · manager of operations, dayshift (if operations are
and maintenance large).
This section outlines basic considerations for the Note: Repurposing guards or otherwise allocated staff
operationalization and maintenance of health facility is not appropriate.
oxygen systems [1.5].
Bedside oxygen concentrators [1.6.1] (depending on
3.4.1 Implementation level of facility):
Depending on the system, the installation tasks may · dedicated technical staff may not be
necessary 24/7, but on-call technician allows
include but are not limited to:
for quick support.
· use of equipment for positioning the system
onsite, e.g. forklifts, cranes, slings, rigging gear; Note: Otherwise, having functional replacement
concentrators available so that users can easily swap
· connecting
power;
reliable and continuous source of with non-functioning units during non-working hours
can avoid treatment interruptions.
· interconnecting primary and/or secondary supply

with the available distribution system [2.6];
Note: Clinical staff must carry out basic weekly
tasks to ensure proper functioning and to clean and
· designing and installing the MGPS [2.9] (including

pipeline, wall terminal outlets, alarms and valves);
disinfect the equipment.
LOX storage [1.6.3] (depending on facility/

· building or improving the existing housing; catchment size):
· increasing the number of technical workers

dedicated to operate and maintain the oxygen
· operator(s) required onsite 24/7, even if not
dedicated only for the medicinal gases station,
systems; to communicate with service provider when
· training on safety management of oxygen; something is amiss.
· operator training by the supplier’s certified High-pressure gas cylinders [2.8]:

trainers;
· minimum team, to be scaled to accommodate
· handover of documentation, tests and reports

from the supplier;
operations, comprising:
– order management staff,
· verification by third parties (e.g. auditors, certified

laboratories, technical experts);
– book-keeping,
– trained manoeuvring for loading/offloading;
· establishment of long-term SLA to ensure

continued, safe, successful operation of the
· trained personnel for onsite distribution (at
distribution ramp and/or in medical wards)
oxygen systems; required on call 24/7;
· drivers, if offsite distribution available.

50
OXYGEN SYSTEMS
3.4.3 Equipment management (designed to improve preparedness for emergency
and disaster situations) recommends having a backup
Proper management of capital equipment, including
supply [3.4.4] for continued oxygen delivery of at least
a functional inventory and forecasting of spare parts
72 hours (42).
and consumables, is crucial for sustainability of the
oxygen systems [1.5]. The procurement and storing Unfortunately, budgetary implications mean that this
of spare parts and consumables must consider the safety net is often deprioritized.
shelf life of the parts (even if they don’t expire, dust
and other environmental conditions can damage their
useful life). The warehouses and/or workshops for
storing parts should be secured and covered to reduce
environmental damage.
Proper maintenance tasks are related to inspection,

and preventive and corrective servicing of the oxygen
systems (41). Tasks are executed with the aim that
the systems should operate safely, performing as
specified by manufacturers’ standards of quality
and continuously for the sake of patient needs. Such
maintenance tasks can be performed by dedicated
and qualified staff at the facility, and/or they can be
outsourced via an SLA. If an SLA with the vendor is Fig. 3.2 Building for housing an oxygen plant
available, logbooks to keep records of maintenance
and parts exchanged should be in place. The SLA
should specify: warranty terms and conditions;
3.5 Structural and electrical
response times; time schedules for reception of any requirements for onsite
necessary spare parts; location of stockpiles and oxygen systems
warehouses; capabilities for remote support;
and availability of local agent. Currently, some 3.5.1 Structural elements and general
technologies, such as PSA oxygen generator considerations
plants [2.1], allow vendors to do remote monitoring. The structural elements of health facilities such
Where feasible, this hardware feature enables live as location, design and buildings (Fig. 3.2), are
reporting and tracking of systems’ dysfunctions. context related and oxygen system dependent.
The following structural considerations are not
The PMP must be diligently performed according
applicable to all designs and implementation. For
to manufacturers’ specifications. For instance, the
example, for most VIE systems, it is endorsed to rely
equipment maintenance schedule may relate to the
on natural ventilation and install the hardware in an
number of hours operated. For example, air
open-air space. In contrast, PSA oxygen generator
and booster compressors [2.5] may need servicing
plants require a dedicated housing conditioned to
after 2000 hours or 6 months of operations. In general,
maintain the inside ambient temperature between an
daily or very frequent, visual and audible inspections
operational range of 5–35 °C. In this case, the decision
are recommended to be followed by operators or final
of adding mechanical ventilation will also take into
users, as applicable.
consideration the capacity to deplete the oxygen-
enriched atmosphere inside the room. Therefore, the
3.4.4 Backup supply
considerations below are intended as guidance only,
A backup strategy is a safety net that should be further consultation with civil engineers, architects
considered essential to guarantee continuity of and other experts must be performed.
distribution of medical oxygen to patients. A backup
plan should include comprehensive risk analysis · Asbe aprotected
general rule, the medicinal gas room must
from environmental factors such as
and mitigation measures, emergency response time,
atmospheric precipitation, wind or dust; external
resource availability, among other contextualized
mechanical damage; unauthorized personnel; and
factors, to allow preparation for security of supply.
must ensure noise reduction during operation and
System security means that the primary source
appropriate signage for medicinal gases and fire
has two additional fallbacks at any time to ensure
safety [3.6.2].
continuity of supply: the secondary system and the
reserve supply. The secondary system and reserve
supply could be redundant systems, or a combination
· Itassess
is the responsibility of the implementor to
all the different information for the setup
of different technologies. The Hospital Safety Index of new oxygen systems, and to refer to vendor’s
recommendations.
51
OXYGEN SYSTEMS
· The implementor should consider: – Concrete main entry ramps that should
meet local accessibility requirements or 1:12
– Hospital ground conditions (e.g. flood during
maximum slope, whichever is more stringent.
high tide, storm surges).
Doors that should be wide enough to allow the
– Other context-important requirements (e.g. passage of equipment.
strong winds or earthquakes).
– Prime and paint all steel with a high-
– Infrastructure requirements for operation (e.g. performance coating or acceptable marine
roofing, flooring, ventilation, air conditioning, grade paint.
ducting, water drains, room requirements
– Finishes that should be easy to clean and kept
without oil, grease and petroleum-based or
dust free. In order to keep the room as clean as
other flammable products).
possible installing grids/nets in the openings
– Compatibility with existing structure (e.g. (i.e. windows) is suggested.
container or tent field hospital).
– Provision of a concrete pad for the heavy
– Locally available construction materials. equipment such as generators. Consult size
– Colour context sensitivities. and anchoraging recommendations from the
equipment manufacturer; engineer the depth
– Truck pathway and parking (e.g. for based on the equipment load.
transportation of high-pressure cylinders [2.8],
LOX refilling). – Anchorage systems to the foundations that
should resist sliding or overturning as a result
– Storage area for fuel/diesel tanks. of cyclones or earthquakes and be located as
– Power supply [3.5.3] in the facility: location prescribed by the vendor.
and distance.
· For systems that will require roofing and/or an
enclosed building structure, the design should
– Distance and requirements for interconnection
with existing MGPS [2.9]. consider the indoor temperature to be maintained
in the specific environmental conditions. These
– In general, no water service is required for conditions should include worst case outdoor
the operations of onsite oxygen systems [1.5]. conditions, including maximum expected
However, a VIE system requires a water point to temperature and maximum expected enthalpy.
perform de-icing maintenance. Temperature control influences architectural
– In general, no sanitary sewer or storm sewer strategies, roofing shape and building materials.
systems are needed in relation to oxygen If local climate conditions do not allow the
systems. temperature to be kept within the required
operational range, mechanical ventilation
– Local regulations for civil works related to new
(air conditioning and/or heating) should be
and refurbishing health facilities.
considered. The ventilation system should be
· As required, some architectural elements include: designed in an efficient manner, locating the
air inlet opposite to the air outlet. In addition,
– A security wire mesh to enclose the perimeter
adequate ducting systems should be designed to
of the canopy. The enclosure should be painted
maintain acceptable indoor conditions.
and galvanized to prevent rusting; and of gauge
16 wire or thicker. · The medicinal gases station should have proper
exterior and interior lighting during the whole
– Structural steel trusses that are efficient and
day. As applicable, provide exterior lights on the
simple to erect. Spacing should be sufficient
underside of new awning structures; exterior LED
and uniform. All steel framing should be hot
flood lights at three corners of the new structure
dipped galvanized or coated with a high-
to provide site lighting near the secured entrance;
performing paint to reduce potential corrosion.
control exterior lights with photocells to illuminate
– A secure sliding gate on a roller system located from dusk to dawn; and install surface-mounted
above the gate. The gate should be made of a interior LED lights, controlled with manual
tubular steel frame and security mesh, with a switches at the entrance to each enclosed building
locking mechanism provided. and equipped with a timer switch.
– Concrete slabs that should be designed
considering the load of the equipment (in kg/
m2) and be broom finished with non-slip finish.
52
OXYGEN SYSTEMS
3.5.2 Safety distances to implement a Local regulations must be consulted to determine
medical gas room the safety distances recommended regarding the
location of the medical gas room, including
The location of the onsite oxygen system [1.5] must
VIE systems [2.10.1] (Fig. 3.3) and the distribution
consider:
ramps [2.6] (Fig. 3.4). Table 3.4 charts the safety
· Firstly, due to fire risk, a minimum safe distance
from flammable and combustible sources must be
distances established by the British Compressed
Gases Association (BCGA) CP36 for VIE systems (43).
respected. The distance will depend on the type of
materials nearby. In contrast, the Table 3.5 list the safety distance from
exposure to VIE systems available in another standard
· Secondly, due to the close source of contaminated
air (e.g. gas exhaust from a diesel generator, or
named NFPA 99 (32).
waste zone incinerator) performance of onsite

production technologies [2.1] may be affected.
Thus, the distances endorsed by the manufacturer
to aid good quality of oxygen production and to
reduce degrading of parts (e.g. filters, sieve beds
etc.) should be followed.
Table 3.4 Safety distance from exposure to VIE systems (BCGA CP36)
Safety distances from: Oxygen vessel Oxygen vessel Oxygen vessel

up to 2000 litres 2000–20 000 litres above 20 000 litres
water capacity (m) water capacity (m) water capacity (m)
Large wooden structures, timber yards, etc. 5 15 15
Areas where open flames/smoking permitted 3 5 8
Small stocks of combustible materials, site huts, etc. 3 5 8
Non-flammable gas cylinder storage 1 1 1
Liquefied petroleum gas storage vessels 7.5 7.5 7.5
(up to 4 tonnes)
Bulk flammable liquid storage vessels (up to 4 tonnes) 7.5 7.5 7.5
Flammable gas cylinder storage (up to 4 tonnes) 5 8 8
Flanges, unions in flammable gas pipelines 6 6 6
Continuous sections of flammable gas pipelines 1 5 6
Pits, ducts, surface water drains 4 5 8
Vehicle parking areas (other than authorized) 3 5 8
Property boundaries 3 5 8
Public roads 3 5 8
Railways 3 10 15
Places of public assembly 5 10 15
Openings, windows and escape routes from buildings 5 7 8
medium voltage and high voltage sub-stations 4 5 8
Process equipment and machinery which is not part of 4 5 8
the storage installation
Fuel gas vent pipes 5 5 8
Compressor, ventilator and air conditioning intakes 5 7 8
Offices, canteens and areas of occupancy 5 7 8
53
OXYGEN SYSTEMS
Table 3.5 NFPA 99 recommendations for location of LOX cylinders – safety distances
Exposure Minimum Minimum

distance (m) distance (ft)
Building exits 3.1 10
Wall openings 0.3 1
Air intakes 3.1 10
Property lines 1.5 5
Room or area exits 0.9 3
Combustible materials (e.g. paper, leaves, weeds, dry grass, debris) 4.5 15
Incompatible hazardous materials 6.1 20
Source: NFPA 99 (NFPA, 2021:126) (32).
Medium-voltage
or high-voltage Liquefied
electrical petroleum
substations gas storage
Public vessels
meeting point Wooden
structure
5–8 m 7,5 m
10–15 m
15 m
Small stocks of
combustible
materials
Vehicle 5–8 m 5–8 m
parking
5–8 m
1.5 m
Open flame/smoke
free zone
5–8 m
Public
3m 5–8 m
sidewalk
Nearest area
Opening in wall or of stationary
some other structure occupancy
Fig. 3.3 Location of VIE system: safety distances
54
OXYGEN SYSTEMS
Areas where
open
Liquefied flames/smoking
petroleum gas permitted
Bulk flammable
liquid storage storage vessels
vessels
Flammable gas
Large wooden cylinder storage
structures,
Flanges, unions
timber yards, etc
in flammable gas
5m
pipelines
3m
Compressor,
ventilator and air 3m Continuous
conditioning intakes 3m 3m sections of
flammable gas
3m
pipelines
5m
3m
Places of public Non-flammable
assembly (including gas cylinder
offices, canteens,…) Small stocks of
storage
5m combustible
materials, site
Vehicle N/A huts, etc
parking areas 5m 3m
(other than
authorized)
Pits, ducts,
3m surface water
1.5 m drains
3m
Property
boundaries
3m
3m
Public roads
N/A 5–8 m
and Fuel gas
railways N/A N/A vent pipes
Process equipment and MV and HV Nearest area

machinery which is not sub-stations Openings, windows of stationary
part of the storage and escape routes occupancy
installation from buildings
Fig. 3.4 Location of main and backup distribution ramps: safety distances
3.5.3 Power supply diesel generator, voltage stabilizer, electrical grid

with transformer, circuit breaker and medium
The following considerations are intended to give
voltage module. Electrical elements must be
guidance, but further consultation with electrical
compatible with the power source (frequency,
engineers, electricians and other experts must be
voltage and plug type need to be specified).
performed.
· The power supply in health facilities must be · Ideally, an automatic transfer switch between the
main and backup sources allows the transfer time
continuous, reliable and stable. Voltage fluctuation
delay to be minimized. However, a manual transfer
causes equipment damage. If needed, additional
switch can be less maintenance dependent.
to the electrical grid, voltage stabilizers and/
or diesel generators with stable voltage can be
installed.
· Ifmust
diesel generators (Fig. 3.5) are installed, they
be properly chosen and provided with
spare part kits and a maintenance service. The
· The supplier of the oxygen system [1.5] should
specify the total power needs for the system,
specifications and diesel consumption may impact
the capital expenditure and operational costs.
including the starting current, minimum protection
Preferably, the engine of the diesel generator
current, and load curve to determine power supply
should be electronically controlled and, if it is to be
needed.
used as primary source (prime mode) rather than
· Power should be supplied to the unit from an
armoured grounded electrical outlet with a three-
a backup source (standby mode), the preferred
specifications may comprise, for example, a shunt
prong plug and earth cable. excitation system (also called “self-excited”) and
· The configuration of the power supply must an integrated AVR.

consider the primary and secondary sources and
could have a combination of elements, such as
· Alternative sources of energy could be assessed for
cost-effectiveness (e.g. solar power plant).
55
OXYGEN SYSTEMS
Oxygen, contained at high pressure, such as inside
high-pressure gas cylinders [2.8], can react violently
with flammable materials such as oil and grease.
Leakages from damaged hoses, flexible pigtails, pipes,
valves and poor connections are common causes of
oxygen fires and explosions in health facilities (44). A
gas leakage in a poorly ventilated room or confined
space can quickly increase the oxygen concentration
in the ambient atmosphere to a dangerous level. Even
a small increase in the oxygen level in the air (from
21% to 24%) can be hazardous as some materials
become self-combustible. Oxygen-enriched air in
combination with a fuel source (i.e. combustible
materials such as paper, clothing, flammable liquids)
and heat source (i.e. an item that emits a spark or
flame such as torches, matchbox) can cause a fire.
3.6.1 Fire risk mitigation essentials

Fig. 3.5 Diesel generator 1. Medical gases should be handled by qualified
personnel.
3.6 Safety and mitigation measures 2. Oxygen systems [1.5] should be maintained in
Pure oxygen does not burn itself, but it is an oxidizing good condition, well secured and protected, with a
agent and therefore, it facilitates combustion (i.e. good quality anchorage system to withstand major
it makes fires burn faster and hotter than in normal hazards (32).
air) (44) (45). Fig. 3.6 depicts the three elements fires 3. Careless operation, misuse and unnecessary
require to start and expand – heat, or an ignition storage of oxygen must be always avoided.
source; fuel; and oxygen. This is typically referred to
4. Oxygen, where stored or used, must be in a
as the “fire triangle” (Fig. 3.6) (45) (46).
well-ventilated area, away from any source of
heat or fuel.
5. Adequate ventilation should ensure that oxygen-
depleted air is rapidly replaced. To monitor the
oxygen-enriched atmosphere, items such as
oxygen depletion sensors are installed in the room.
6. Ventilation can be provided with a natural or
mechanical exhaust. To define the ventilation
requirement, the volume of stored oxygen in
the largest single vessel or the entire volume
of connected vessels on a common manifold,
· Fuel is any combustible material that can be used as the

source of ignition of the fire, as well as to keep it burning.
whichever is greater, needs to be considered.
If natural ventilation, this must consist of two
· Oxygen is an oxidizing agent which reacts with the fuel
to start and continue the fire. Lower concentrations of
non-closable louvred openings (to allow “cross
ventilation”). These openings have the
oxygen result in slower fuel combustion. following requirements:
· Heat: Fires require oxygen and fuel reacting

with each other at a temperature exceeding a threshold
– each opening must have an open area of at
least 155 cm2 per 28 m3 of stored oxygen. The
temperature, referred to as the “flash point.” Different total surface of cumulative openings should not
materials and chemicals have different flash points. The be less than 464 cm2;
lower the flash point temperature of a compound, the – one opening must be located within 30 cm
more easily the compound ignites. of the floor, and one must be within 30 cm of
the ceiling;
Fig. 3.6 The fire triangle
– openings need to be located to ensure
cross ventilation; and
– openings have to be direct to the outside
atmosphere without ductwork.
56
OXYGEN SYSTEMS
7. Newly assembled equipment should be leak 14. Consider prohibiting the use of combustible
checked. All related equipment and hose structural (e.g. floors, walls, roofs, stairwells, fire
connections must be properly fitted. escapes) and non-structural (e.g. doors, windows,
ceilings, fixtures, façades, insulation, mechanical
8. High-pressure gas cylinders should be handled
and electrical conduits) components in the
and transported with care, securing with racks
medical gas room. Some examples of materials
or chains, and protecting them against being
that emit toxic fumes during a fire and should be
knocked or dropped. Requirements for the storage
avoided: polystyrene (for example, polystyrene
of medical high-pressure gas cylinders depend on
decorative mouldings), insulation spray foams,
the total volume of gas contained: the greater the
polyurethane and isocyanate foams in newly built
volume, the more stringent the requirements for
facilities. Design engineers should account for the
the cylinder storage station.
required fire rating of the structural components
9. Cylinder valves must be turned off when not in use. of the building, guided by Building Code
10. Where oxygen systems [1.5] require maintenance, Standards. Building codes differ depending on
only tools and substances recommended by the the country.
manufacturer should be used. Oil and grease can 15. Materials used in the design and construction
ignite and burn in oxygen-enriched air and must of hospitals must be non-combustible/non-
not be used on oxygen equipment. Only lubricants flammable, must have adequate fire-resistance
and tapes made specifically for oxygen service ratings, and should not emit toxic gases/smoke
should be used. during a fire. Fire-resistance ratings are usually
11. Fire brigades should be constituted at hospital dependent on the layout, occupancy and usage
level, and fire extinguishing equipment should of the facility. For example, walls and floors with
be available in strategic places. Local regulations 1-hour fire-resistance rating, and other openings
may specify extinguishers available for enriched- with 45-minutes fire protection rating (if indoors).
oxygen areas. 16. Appropriate safety signage (Figs 3.7, 3.8 and 3.9)
12. New facilities should be designed using building must be in the medical gas room (47).
codes and guidelines for fire prevention, and
the materials used should have adequate fire
resistance ratings. These ratings refer to the
duration, usually in hours, that a given material
can withstand a fire at a specific maximum
temperature before losing its integrity, including
its strength and insulation capabilities. In the case
of both structural and non-structural components,
fire resistance ratings/durations can vary from
30 minutes to over 4 hours.
13. As-built drawings or plans for existing facilities
are required to determine the fire-retardant
retrofitting needs of the facility. As-built drawings
should also be produced for new facilities for
future reference, for example in the case of
renovation or refurbishment. These drawings
should be submitted to the fire service so that, in
the event of an emergency at the medical facility,
first responders will have a good knowledge of
the layout and location of emergency exits, fire
compartments, and so forth, allowing for a more
efficient response in saving lives.
57
OXYGEN SYSTEMS
3.6.2 Signage for mitigation measures
Medical Oxygen Fire Risk

Mitigation Measures
Intended for health workers and all personnel managing medical oxygen
Prepare Actions Response Actions

DO REGULAR EQUIPMENT CHECKS SOUND ALARM AND CALL
FIRE BRIGADE
• Check regularly the fire extinguisher
and all the detection and alarm
systems. • Have easy access to emergency
contact numbers and fire alarms.
TRAIN AND CERTIFY ON FIRE

DETECTION, ALARM SYSTEMS
AND EXTINGUISHER SKILLS
• Staff should know how to activate

the alarm and where the safety
equipment is located. Do staff
training on extinguisher types ACTIVATE EVACUATION PLAN
and use. EXIT
• Prioritize evacuation with those

who are most exposed to danger.
KNOW THE FACILITY EMERGENCY

BRIGADE PROCEDURES AND
EVACUATION PLAN EXIT
• Know the patient triage

classification for evacuation
process.
• Learn and practice evacuation
processes considering the
different types of medical gases.
KEEP OXYGEN SUPPLY AND TURN OFF ELECTRICAL

USE AREAS CLEAN AND SUPPLY LINKED TO –
VENTILATED OR CLOSE TO – THE OXYGEN
SYSTEMS
• Ensure that clinical use spaces and
all surrounding areas of the oxygen
sources (e.g., PSA, bulk tank) are
kept clean and well ventilated. OXYGEN
17 February 2023
© World Health Organization 2023. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.
WHO/2019-nCoV/Clinical/Oxygen/Poster_A/2023.1.
Fig. 3.7 Signage for medical oxygen fire risk

https://apps.who.int/iris/bitstream/handle/10665/366139/WHO-2019-nCoV-Clinical-Oxygen-Poster-A-2023.1-
eng.pdf
58
OXYGEN SYSTEMS
Oxygen Cylinder Safety

Intended for health workers and all personnel managing medical oxygen
Do Do not
DO LEARN PROPER MEDICAL CYLINDER DO NOT ALTER, TRANSPORT OR HANDLE
SAFETY HANDLING CYLINDERS INCORRECTLY
• Read and follow the cylinder • Do not change the labelling or
labelling instructions. repaint a cylinder.
• Do not transport gas cylinders in
the passenger compartment of
a vehicle.
• Do not handle more than one
cylinder at a time, or roll cylinders
along the ground, except on carts
designed for handling gas cylinder.
DO TRANSPORT CYLINDERS CORRECTLY DO NOT USE UNCERTIFIED MEDICAL

• Use personal protective equipment and OXYGEN CYLINDERS
mechanical assistance when handling
cylinders (e.g. trolleys). • Do not refill cylinders that are not
meant for medical oxygen
• Ensure cylinder (regardless of size) is (e.g. cylinders used for other
firmly secured by a strong chain or industrial gases) and that have
strap, capable of preventing the not passed a quality test by
cylinder from falling or being
knocked over.
a specialist. O
• Ensure valve guards or caps are fitted
when cylinders are not in use or when
being transported for delivery.
DO SET UP CYLINDERS FOR CLINICAL DO NOT USE OIL, LUBRICANTS OR

USE AT A SAFE DISTANCE ALCOHOL-BASED HAND
FROM THE PATIENT SANITIZER ON
• Ensure that the gas is only turned on when CYLINDER’S FITTINGS
it is required. Adequate valves, pressure
regulators and flowmeters should be
placed to control the desired rates.
• Oxygen cylinder valves should be opened
smoothly to avoid (adiabatic) compression
and heat generation and associated fire risks.
• Ensure adequate ventilation on the wards to
reduce the risk of fire.
DO STORE CYLINDERS CORRECTLY DO NOT ATTEMPT TO REPAIR

• Always physically separate full and empty A CYLINDER OR A VALVE IF
medical cylinders. LEAKAGE IS DETECTED
• Store all oxygen cylinders in upright
position and nesting, with three points • Replacement of damaged components
of contact. is suggested.
• Ensure that the storage room is well
ventilated, clean and not exposed to
extremes of temperature and humidity.
• Keep oxygen sources several metres from FULL EMPTY
ignition sources (for example, acetylene
used in maintenance).
• Ensure appropriate fire extinguishers are kept
nearby and are regularly inspected.
Sources: WHO-UNICEF Technical Specifications and Guidance for oxygen therapy devices. https://www.who.int/medical_devices/publications/tech_specs_oxygen_therapy_devices/en/
GOV.UK Department of Health, Medical gases – Health Technical Memorandum 02-01: Medical gas pipeline
systems. Part B: Operational Management. Department of Health libraries, House of Commons library, 2006. https://www.cganet.com/resources/safety-posters/
17 February 2023
WHO/2019-nCoV/Clinical/Oxygen/Poster_B/2023.1.
Fig. 3.8 Signage for medical oxygen cylinder safety

https://apps.who.int/iris/bitstream/handle/10665/366140/WHO-2019-nCoV-Clinical-Oxygen-Poster-B-2023.1-
eng.pdf
59
OXYGEN SYSTEMS
17 February 2023
WHO/2019-nCoV/Clinical/Oxygen/Poster_C/2023.1
Fig. 3.9 Signage for medical gas piping systems safety

https://apps.who.int/iris/bitstream/handle/10665/366141/WHO-2019-nCoV-Clinical-Oxygen-Poster-C-2023.1-
eng.pdf
60
61
4. Offsite oxygen
production
OXYGEN SYSTEMS
OXYGEN SYSTEMS
4. Offsite oxygen production

4.1 Value chain of liquid oxygen 63
4.2 Liquid oxygen availability 64
62
OXYGEN SYSTEMS
4. Offsite oxygen production

This section provides a brief appraisal of general topics related to
the value chain of offsite liquid oxygen (LOX) production.
4.1 Value chain of liquid oxygen Table 4.1 Oxygen products and purity levels
The value chain is the model describing the full range Products % purity Purity level
of activities needed to bring a product or service from
Oxygen gas 99.5 2.5
its production site through the subsequent supply
chain until it reaches the user. In this case, the focus is Liquid oxygen (LOX) 99.95 3.5
production of medical oxygen and its distribution for Extra-dry oxygen 99.5 2.5
the health sector.
Ultra-high purity zero oxygen 99.8 2.8
Typically, industrial plants manufacture different Ultra-pure carry oxygen 99.98 3.8
gases at the same site (e.g. oxygen, nitrogen, argon,
Oxygen research 99.999 5.0
helium, carbon dioxide, hydrogen). Depending on
the site location and distribution network, the gases
are transported using cryogenic vessels or, in some LOX produced at industrial scale in fractional
cases, through industrial pipelines. The industrial distillation plants can serve either industrial or
applications of these gases are diverse, including medicinal purposes, depending on whether or not
the energy sector, mining, production of metals, GMP (3) and GDP (27) have been applied during
aerospace, petrochemicals, food preservation, and production. Manufacturers and distributors of medical
ripening of fruits and vegetables. The main medical oxygen, as for any other medicine, must comply with
applications include use in hyperbaric chambers local regulations and standards, and, when applicable,
and cryopreservation, oxygen therapy [1.3] and with international regulations. Two publicly available
mechanical ventilation, diagnosis and treatment and relevant reference guides are GDP (27) and the
of obstructive sleep apnoea, aerosol therapy, laser Pharmaceutical Inspection Co-operation Scheme
surgery and cryosurgery. (PIC/S) (48). These guidelines establish specific steps
for testing medical gas along the value chain.
Oxygen is produced in liquid form by an ASU through
Fig. 4.1 depicts an extended LOX value chain.
a method of cryogenic fractional distillation. It can
have different purity levels (Table 4.1). It is pale blue
in colour and has a boiling point of -183 °C (-297 °F).
Its production, handling and storage require special
technologies to keep it insulated from the surrounding
environmental heat. These technologies can be capital
intensive. Cryogenic fractional distillation plants
produce LOX in large quantities: 300–5500 tonnes/day
(equivalent to 8750–160 370 Nm3/hr of gas at NTP).
Production requires significant energy input; at
scale cost-effective LOX production consumes around
~0.3 kW per m3 produced.
Key resources
The International Pharmacopoeia: https://www.who.int/teams/health-product-policy-and-standards/standards-and-
specifications/norms-and-standards-for-pharmaceuticals/pharmacopoeia
GMP – Good manufacturing practices for medicinal gases: https://www.who.int/publications/m/item/trs1044-annex5
GDP – Good storage and distribution practices for medical products (TRS 1025 Annex 7): https://www.who.int/
publications/m/item/trs-1025-annex-7-gdp-medical-products
Oxygen Task Force: https://www.who.int/news/item/25-02-2021-covid-19-oxygen-emergency-impacting-more-than-half-a-
million-people-in-low--and-middle-income-countries-every-day-as-demand-surges
63
OXYGEN SYSTEMS
Decentralized
warehouse
Cryogenic air
separation plant Distribution to
suppliers
Cylinder filling
central
Distribution to
regional hub
Electricity
supply system
Cryogenic supply
transport
Distribution to Health facility
health facility
Fig. 4.1 LOX production and distribution value chain
A proper assessment for oxygen suppliers ensures: Only medical oxygen that has been tested to meet
· Production capacity of medical oxygen is

guaranteed to cope with the oxygen demand of
authorized specifications for its identity, purity and
content and that was produced, stored and distributed
following appropriate practices for medicinal use
the targeted health facilities (Web annex E: Oxygen
should reach the patient. Uncertainties regarding the
supplier’s mapping).
content of oxygen intended for industrial purpose,
· Chain of custody of bulk tanks and/or high-
pressure cylinders is always maintained.
due to the possible occurrence of particulate and
microbial contamination, can result in unacceptable
· That there is no cross-over with equipment

intended for industrial application (e.g. welding)
risks for patients.
as this could result in cross-contamination. For 4.2 Liquid oxygen availability

instance, before unloading the LOX from the LOX availability is extensive, though not in all LMIC.
cryogenic supply transporter truck into storage Understanding where LOX is produced, and whether
tanks of the central cylinder filling station, the it is accessible and affordable, as well as whether it
contents of each pipe should be analysed and is an option for medical applications are important
approved for compliance with quality standards. considerations. There are a few global multinational
· That before filling bulk tanks [2.10.1], cryogenic
cylinders [2.10.2] and/or high-pressure gas
producers of LOX with a handful of subsidiaries, often
regionally or nationally branded – at least two of these
cylinders [2.8], product sampling should be do not claim to produce medical grade oxygen.
performed once more and sent to a laboratory.
Historical barriers to additional companies entering
The resulting analysis must again fulfil reference
the sector are the perceived high costs for the medical
pharmacopoeia requirements for both purity
LOX value chain, operational costs related to common
levels and remaining impurities. Details found
business models (needing deposits and/or leases
on the certificate of analysis (COA) (Fig. 4.2)
for expensive requisite hardware), and no sense of
should align with a reference pharmacopoeia:
ownership by the end user. Since the onset of the
International Pharmacopoeia (WHO), United States
COVID-19 pandemic, global partnerships have been
Pharmacopeia (USP), British Pharmacopoeia
established to reduce these costs and strategically
(BP) and European Pharmacopoeia (Ph Eur)
increase LOX availability, especially for LMIC (49).
and/or national regulations. Only then should
the production batch be made available for
distribution to health facilities.
· Labelling must also comply with standards

applicable for medicines.
64
OXYGEN SYSTEMS
Certificate of Analysis
Product: Oxygen [gas]
Date
Facility Name
Facility Address
Lot # Batch #
Sampling method
Final analysis results
Component Unit (V/V) Ph. Eur. Method Analytical Device Measured Requirement Ph. Eur
O2 % Ph Eur IX 2.5.27 LH-02-45-1 99.86 > 99.5
2017
CO2 ppm Ph Eur IX 2.5.24 LH-02-26-1 0.1 < 300
2017
CO ppm Ph Eur IX 2.5.25 LH-02-26-2 0.1 <5
2017
H2O ppm Ph Eur IX 2.5.28 LH-02-37 1.22 < 67
2017
Odour – None N/A – N/A
· This product was manufactured by air liquification.

· The equipment used for analysis has been calibrated. Validation certificates can be requested to
the oxygen supplier.
Conclusion
The analysed gas complies with the requirements of current version of the European Pharmacopoeia for
oxygen for medical use.
Analyst Date
Quality Reviewer Date
Fig. 4.2 Certificate of analysis of gas stored in high-pressure cylinder
65
66
OXYGEN SYSTEMS
67
5. Tools and
resources
OXYGEN SYSTEMS
OXYGEN SYSTEMS
5. Tools and resources

5.1 WHO clinical treatment guidelines 69
5.2 WHO Emergency Response Framework 70
5.3 WHO COVID-19 Essential Supplies Forecasting Tool (ESFT) 70
5.4 Medical Equipment for COVID-19 Case Management Inventory Tool 70
5.5 WHO Global Clinical Platform for COVID-19 70
5.6 WHO technical consultation on oxygen access scale-up for COVID-19 70
5.7 O2CoV2 study 71
5.8 External resources 71
68
OXYGEN SYSTEMS
5. Tools and resources

Various WHO practical tools, studies, and platforms are outlined here together with links to
external relevant resources, all related to oxygen ecosystem.
5.1 WHO clinical treatment guidelines

The following list of WHO clinical treatment guidelines, concerning delivery of oxygen to a patient, is not
exhaustive – further and up-to-date references can be found on the WHO website
(https://www.who.int/publications/who-guidelines, https://www.who.int/teams/health-care-readiness/covid-19).
Clinical management of COVID-19: WHO guidelines for safe surgery 2009:

living guideline 2023. safe surgery saves lives.
https://apps.who.int/iris/ https://apps.who.int/iris/
handle/10665/365580 handle/10665/44185
Clinical care for severe acute Guidelines for essential

respiratory infection: toolkit trauma care, 2004.
(COVID-19 adaptation, update 2022). https://apps.who.int/iris/
https://apps.who.int/iris/ handle/10665/42565
handle/10665/352851
Oxygen therapy for children: Paediatric emergency triage,

a manual for health workers, 2016. assessment and treatment:
https://apps.who.int/iris/ care of critically ill children
handle/10665/204584 (updated version), 2016.
https://apps.who.int/iris/bitstream/
handle/10665/204463/9789241510219_
eng.pdf
Therapeutics and COVID-19:

living guideline, January 2023.
https://www.who.int/
publications/i/item/WHO-2019-
nCoV-therapeutics-2023.1
69
OXYGEN SYSTEMS
5.2 WHO Emergency 5.4 Medical Equipment for COVID-19
Response Framework Case Management Inventory Tool
At the onset of the COVID-19 pandemic, the WHO The Biomedical Equipment for COVID-19 Case
Emergency Response Framework established Management Inventory Tool was developed rapidly
a multidisciplinary team to integrate the clinical in response to the pandemic to determine medical
management and operations emergency response equipment availability and management, and
regarding medical oxygen. The team comprised facility and operational readiness. With this resource,
expertise in supply chain, markets, clinical countries can assess the existing functional capacity
management, biomedical engineering, architecture, at facility level regarding equipment and forecast
logistics, data management and pharmaceuticals, procurement needs.
with the objective of scaling up access and availability
of medical oxygen across the globe, especially in · Biomedical Equipment for COVID-19 Case
Management Inventory Tool. Geneva: World Health
LMIC. Initial tools developed to establish the need-
Organization; 2020 (https://apps.who.int/iris/
gap at national or subnational level include the WHO
handle/10665/332777).
COVID-19 Essential Supplies Forecasting Tool
(ESFT) and the Medical Equipment for COVID-19
Case Management Inventory Tool.
5.5 WHO Global Clinical Platform
for COVID-19
· Emergency Response Framework (ERF), 2nd
edition. Geneva: World Health Organization; 2017 To characterize the clinical presentation of COVID-19
(https://apps.who.int/iris/handle/10665/258604). among hospitalized individuals globally, including
the need for oxygen therapy and respiratory support,
5.3 WHO COVID-19 Essential Supplies in April 2020 WHO launched the WHO Global Clinical
Platform for COVID-19. Anonymized individual
Forecasting Tool (ESFT) patient level data contributed to the platform are
There are various case method estimations within pooled and regularly analysed to inform public health
the ESFT, which provide a forecast of anticipated interventions and clinical management guidelines.
cases over time. Considerations when choosing a
case estimation method include the length of the · WHO Global Clinical Platform for COVID-19.
Geneva: World Health Organization; 2021
forecast and availability of country-level data. The
(https://www.who.int/teams/health-care-
estimated cases are applied to a variety of inputs and
readiness/covid-19/data-platform).
ratios to estimate the equipment needed to manage
the anticipated cases. This tool includes capital
equipment, as well as accessories and consumables,
5.6 WHO technical consultation on
and covers PPE, IPC, diagnostics and therapeutics in oxygen access scale-up for COVID-19
addition to medical equipment and oxygen estimation At the end of 2020, WHO convened a consultation,
in cubic metres per day at national level. The tool has held over four meetings, with groups with proven
been updated as more data became available to better experience in implementing oxygen scale-up
reflect evolution of the understanding of treatment, activities. This consultation identified gaps and further
for example, through changing ratios needed for actions needed to scale up access to medical oxygen.
invasive or non-invasive ventilation for ICU patients. The consultation facilitated the understanding of the
These ratios impact the equipment, infrastructure and critical challenges of oxygen systems and highlighted
market-shaping requirements of what needs to be the need for operational guidance to scale up, in an
mobilized to allow scale-up access to respiratory care. efficient, transparent and sustainable manner in the
· WHO COVID-19 Essential Supplies Forecasting
Tool (COVID-ESFT), v 4.1. Geneva: World Health
short term, for the COVID-19 surge, but with a long-
term vision beyond the current emergency response.
Organization; 2022 (https://apps.who.int/iris/
handle/10665/352028).
· WHO technical consultation on oxygen access
scale-up for COVID-19; 2021 (https://apps.who.int/
iris/handle/10665/342817).
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OXYGEN SYSTEMS
5.7 O2CoV2 study Rapid oxygen and respiratory care equipment
gap assessment for designated, planned and/or
Due to the need to understand the requirements potential COVID-19 treatment centres:
for oxygen at both the patient and facility level,
the WHO Clinical Characterization and Management · World Federation of Societies of Anaesthesiologists
(WFSA) Oxygen Supply & Demand Calculator
Working Group developed a protocol for the
observational study O2CoV2: Oxygen requirements
and approaches to respiratory support in patients
· UNICEF Oxygen System Planning Tool
(https://www.unicef.org/innovation/oxygen-
with COVID-19 in LMIC. system-planning-tool)
The study’s primary objective is to inform an · EBC Oxygen Plant Find & Fix Map
upcoming multidomain randomized clinical trial to
test the ability of a variety of non-invasive respiratory · Open Critical Care – The hub for critical care
education tools (https://opencriticalcare.org/)
approaches to reduce mortality and the need for
intubation and mechanical ventilation. In mid- Develop high-level supply landscape overview:
2021, LMIC sites with a diverse range of resources
and experience were encouraged to participate · PATH/CHAI distributor data collector
in O2CoV2. Over 175 expressions of interest from
principal investigators from over 50 LMIC were
· PATH/CHAI
report
Respiratory care equipment market
received, of which 40 principal investigators from

30 countries were invited to implement the study, · EBC coalition members matrix
across all WHO regions. Develop robust procurement requests:
· O2CoV2 terms of reference (International Study

Steering Committee).
· UNICEF Supply Division procurement services
Develop targeted training plans:
· WHO respiratory support research
(https://www.who.int/news-room/articles-detail/ · Project ECHO webinar series from Assist
who-respiratory-support-research-group). International
Build Health International: training and repair
5.8 External resources packages https://buildhealthinternational.org/
Partners of the Oxygen Task Force have made oxygen/
collective efforts to enhance the resources available in
relation to the oxygen ecosystem.
Country coordinating mechanisms:
· Assessing the medical oxygen ecosystem: tools

from national to primary health care levels
(a compilation of resources). USAID and EpiC;
March 2022 (https://pdf.usaid.gov/pdf_docs/
PA00Z9ZB.pdf).
· Every Breath Counts (EBC):

(https://stoppneumonia.org/about-us/).
· Improving oxygen delivery: country progress in

the time of COVID-19. PATH; 2022 (https://www.
path.org/programs/market-dynamics/improving-
oxygen-delivery-country-progress-time-covid-19/).
· Operational recommendations resource package

(C19RM). Partners in Health; 2021 (https://www.
pih.org/sites/default/files/2021-04/GF_C19RM_
MASTER_V8.pdf).
· Oxygen delivery toolkit: resources to plan and scale

medical oxygen. PATH; 2022 (https://www.path.
org/programs/market-dynamics/oxygen-delivery-
toolkit/).
71
72
OXYGEN SYSTEMS
Glossary
OXYGEN SYSTEMS
References
Additional resources
73
OXYGEN SYSTEMS
Glossary 75
References 78
Additional resources 80
74
OXYGEN SYSTEMS
Glossary
Air separation unit (ASU): Through different separation Filling ramp: A cylinder ramp with pressure regulators,
methods, this system separates mainly nitrogen and oxygen one-way valves and flexible pigtails. This assembly allows
from atmospheric air; sometimes also argon and other rare the supply of high-pressure gas coming from the booster
inert gases. compressor to fill the high-pressure cylinders at constant
pressure. The length of the ramp is variable, typically has
Bilevel positive airway pressure (BPAP): Medical device
space for 4, 8 or 10 cylinders.
for the delivery of a two levels airway pressure providing a
constant flow of air/oxygen to the patient at a preselected Flexible pigtails: Pigtails are hoses used to connect to a
pressure, thereby imposing a small positive pressure within cylinder ramp with high-pressure gas cylinders.
the lungs which assists with gas exchange. This function is
Flow: Steady and continuous movement in a stream
typically found in advanced patient ventilators; however,
commonly used for liquid, air or gas.
it can also be a standalone device and used in several
treatment settings. Health facilities: Includes facilities at different levels of
care. Primary level refers to health centres, rural, community
Booster compressor or high-pressure booster: Device
and general hospitals. Secondary level refers to regional
connected to the output of an oxygen generator plant
and provincial hospitals, and some general hospitals
enabling the pressure of the gas to be increased – from
with above five clinical specialties. Tertiary level refers to
3 to 6 bars – before filling high-pressure gas cylinders
highly specialized facilities with above 300 beds, including
(up to 200 bars).
national, central and university or teaching hospitals.
Cryogenic fractional distillation: Process of air separation
Hypoxaemia: Low oxygen in the blood.
into its constituents. The separation method involves first
liquifying the air at low temperature and high pressure, Hypoxia: Low oxygen at cellular level.
and then increasing the temperature at different degrees,
International Organization for Standardization (ISO):
which correspond to the boiling points of the various
An independent, nongovernmental standard-setting body
desired constituents.
to facilitate the international coordination and unification
Cylinder bank, or cylinder row: Arrangement of high- of proprietary, industrial and commercial standards. ISO
pressure cylinders in a line. standards are of relevance to manufacturers, sellers, buyers,
customers, trade associations, users and regulators.
Cylinder filling station: Assembly of a booster compressor
and a cylinder filling ramp. Maintenance: Includes tasks related to inspection,
preventive maintenance and corrective maintenance (i.e.
Cylinder storage station: The main area where all cylinders
troubleshooting and repairs).
(segregated into full, empty or faulty) on a site are stored,
excluding those cylinders in, or for immediate use in, the Medical device: An article, instrument, apparatus or
medical gas room, at the patient bedside or for transport machine used in the prevention, diagnosis or treatment of
(ambulances or stretchers). illness or disease, or for detecting, measuring, restoring,
correcting or modifying the structure or function of the body
Dewpoint: Temperature to which air must be cooled in
for some health purpose. Typically, the purpose of a medical
order to reach saturation with respect to water vapour at
device is not achieved by pharmacological, immunological
its instant pressure. In medical air compressors, dewpoints
or metabolic means.
are quoted as if the air were at atmospheric pressure;
even though the air comes out from the dryer columns Medical equipment: Medical devices requiring calibration,
with high pressure. maintenance, repair, user training and decommissioning −
activities usually managed by biomedical engineers. Medical
Diesel generator: A standalone, diesel-fuelled, power
equipment is used for the specific purposes of diagnosis and
generator, or electricity generator, which converts
treatment of disease or rehabilitation following disease or
mechanical energy into electricity. The electrical output
injury; it can be used either alone or in combination with any
is alternating current (AC) and can typically range from
accessory, consumable or other piece of medical equipment.
7 to 7000 kVA.
Medical equipment excludes implantable, disposable or
Distribution ramp: A cylinder ramp with pressure single-use medical devices.
regulators, one-way valves and flexible pigtails. This
Medical gas pipeline system (MGPS): Assembly of different
assembly allows the supply from high-pressure gas cylinders
elements (fixed medical gases pipeline networks, warning
connected into the rack to feed into the pipeline network at
and alarm systems, sets of valves and pressure regulators,
constant pressure. Before entering the medical gas pipeline
and wall outlets) to safely bring a medical gas from the
system, the gas will typically pass through a pneumatic
generator or bulk storage system to the patient bedside.
changeover system which itself is connected to a gas source.
Medical gases can include provision of medicinal oxygen,
The length of the ramp is variable and typically has space for
medical compressed air, anaesthetic gas scavenging systems
4, 8 or 10 cylinders.
(AGSS) and medical vacuum installations.
75
OXYGEN SYSTEMS
Medical gas room or medical gas central station: Oxygen storage and distribution: Includes, but is not
Structural element hosting the medical gases (e.g. oxygen, limited to, high-pressure gas cylinders, vessels, pipeline
air, vacuum) and comprising generator plants, compressors networks and other supplies for storage and distribution of
and/or pumps and/or storage systems. medical oxygen.
Molecular sieve beds: Components of PSA systems Oxygen system: Includes, but is not limited to,
containing zeolite crystals, which separate gases as air oxygen production sources, storage, distribution and
moves in and out. For oxygen production, the zeolites in the delivery supplies.
sieve beds are designed particularly for nitrogen adsorption
Oxygen therapy: Administration of medical oxygen by
so that oxygen can pass through for use, whilst the nitrogen
any means that improves oxygen delivery to the tissues,
is selectively adsorbed.
increasing oxygen content in the blood.
Monograph: In this context – a detailed written study of
Pipeline network: Interconnected tubes of typically
a single medicine, its composition, allowable impurities,
non-arsenical copper that is treated for medical use,
methods of analysis and other relevant information
with potentially several branches, allowing to connect
contained in a pharmacopoeia; detailing essential standards
the medical gas to the wall outlets that reach the patient
to ensure the quality of medicines, thus contributing to their
bedside. It is part of the MGPS.
safe and efficacious use.
Pharmacopoeia: Reference book providing specifications,
Non-structural: Non-structural elements of a health facility
test methods and a scientific basis for quality control during
include architectural elements (such as ceilings, windows
the entire life cycle of medicines. It supports building trust in
and doors), medical and laboratory equipment, lifelines
the supply of safe, quality medicines people rely on
(mechanical, electrical and plumbing installations) and
for health.
safety and security issues. These elements are necessary for
the daily operation of health facilities. Pneumatic changeover system, or manifold: A device that
allows interconnection and alternation between different
Oxygen (O2): O2 molecule. Oxygen is critical to sustain
medical gas supply systems (e.g. distribution ramp, oxygen
human life (and other animals). Oxygen is used by cells to
generator plant, VIE system) within a medical gas pipeline
release energy from food. The primary role of the respiratory
network. It comprises a control panel which regulate
system is to take in oxygen from the air into the blood, and
the working pressure and has alarm indicators. It can be
to expel carbon dioxide from blood into the air. If there is
automatized, semi-automatized or mechanical.
insufficient oxygen in the cells they die. This is especially
important in vital organs such as the brain. Power supply, or electrical supply: Refers to the provision
of electrical energy from an electricity source.
Oxygen analyser: An oxygen analyser (also known
as an oxygen meter) is a device used to determine the Pressure: The pressure is the force exerted by molecules in
percentage or concentration of oxygen being delivered. a specific area.
There are different types of oxygen analysers: hand-held
Pulse oximetry: Non-invasive method to measure the
devices with a digital display and external oxygen sensor;
oxygen saturation (SpO2) of the blood cells.
or sensors installed inside a source of oxygen (e.g. bedside
concentrator or oxygen generator plant). Quality assurance and quality control (QA & QC):
Quality assurance focuses on systemic activities
Oxygen delivery: Includes reusable and single-use medical
implemented within a quality system; quality control
devices used to administer oxygen to the patient; covers the
focuses on the testing of a product to ensure it meets the
capital equipment as well as accessories and consumables
specifications required. QA and QC are complementary
related to it (e.g. invasive and non-invasive patient
activities; strong QA and QC programmes are critical in
ventilators, breathing circuits, nasal cannulas, face masks).
manufacturing high-quality products.
Oxygen ecosystem: Refers to the multisystemic efforts,
Relative humidity (RH): Ratio of the current absolute
initiatives and resources required for an optimal and
humidity to the highest possible absolute humidity, which is
sustainable implementation of oxygen systems, including
the mass of water vapour divided by the mass of dry air in a
policy, guidelines and roadmaps, physician engagement
volume of air at a given temperature.
initiatives, patient safety and quality of care programmes,
structural and non-structural investments. Service level agreement (SLA): A contract between a
service provider and its customers which defines the
Oxygen generator plant: An assembly of different
services (e.g. maintenance activities) and goods (e.g. spares
equipment, consisting, at minimum, of an air compressor,
parts) that the provider is required to offer in accordance
air dryer, filtration unit, air tank (or vessel), control panel,
with the terms, standards and duration established.
oxygen generator (element that separates the oxygen from
atmospheric air through molecular absorption) and product Structural: Construction and building elements of
tank (or vessel). health facilities.
Oxygen production sources: Includes bedside oxygen Vacuum-insulated evaporator (VIE): A pressure vessel
concentrators, oxygen generator plants (PSA, VSA, PSA/VSA) that allows the bulk storage of cryogenic liquids including
and cryogenic liquid plants. oxygen, nitrogen and argon for industrial processes and
medical applications. The purpose of the vacuum insulation
is to prevent heat transfer between the inner shell, which
holds the liquid, and the surrounding atmosphere.
76
OXYGEN SYSTEMS
Value chain: A term used relating to the supply chain Wall outlets: Terminals at the endpoint of the medical
to describe the series of processes involved to deliver a gas pipeline network and placed at the patient bedside to
service or create a product. It involves the full life cycle from deliver a given medical gas.
production to delivery the customer.
Zeolite: Microporous crystalline aluminosilicate materials
Valve: Device for controlling the passage of fluid or air commonly used as commercial adsorbents and catalysts.
through a pipe, duct, etc., and allowing movement in one Because of its unique porous properties, its main use is in
direction only. the separation and removal of gases and solvents.
77
OXYGEN SYSTEMS
References
1. WHO technical consultation on oxygen access scale-up 12. Clinical care for severe acute respiratory infections:
for COVID-19. Geneva: World Health Organization; 2021 toolkit: COVID-19 adaptation, 2022 update Geneva:
(https://apps.who.int/iris/handle/10665/342817, accessed World Health Organization; 2022 (https://apps.who.int/iris/
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digicollections.net/phint/2020/index.html#p/home, performance of oxygen concentrator equipment. Geneva:
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Boston Med Surg. 1890;123:481-485.
17. Priority medical devices list for the COVID-19 response
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Directorate for the Quality of Medicines & HealthCare; 2022 Geneva: World Health Organization; 2020 (https://apps.who.
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18. Medical equipment related to oxygen therapy –
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(https://www.england.nhs.uk/publication/nhs-estates- item/medical-equipment-related-to-oxygen-therapy---
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19. Decontamination and reprocessing of medical devices
8. WHO Model Lists of Essential Medicines. Geneva: World for health-care facilities. Geneva: World Health Organization;
Health Organization; 2022 (https://www.who.int/groups/ 2016 (https://apps.who.int/iris/handle/10665/250232,
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Interim version for submission to Expert Committee on
for low-resource settings 2022. Geneva: World
Specifications for Pharmaceutical Preparations. Geneva:
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media/docs/default-source/2021-dha-docs/qas20-867rev4_
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25. Respiratory care equipment market report. PATH & CHAI; 39. Junge S, Palmer A, Greenwood BM, Mulholland EK,
2020 (https://www.path.org/resources/respiratory-care- Weber MW. The spectrum of hypoxaemia in children
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children under 5 years of age in Nigeria: the need for
27. Good storage and distribution practices for medical
pulse oximetry in case management. Afr Health Sci.
products. Geneva: World Health Organization, 2019
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28. ISO 11114-1:2020 Gas cylinders – Compatibility of
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Geneva: International Organization for Standardization;
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Additional resources
CGA V-5: Standard for diameter index safety system (noninterchangeable low pressure connections for medical gas
applications). McLean, Virginia, USA: Compressed Gas Association; 2019.
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field study. Health. 2014;6:1978-1983.
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(https://iris.paho.org/handle/10665.2/55735, accessed 5 December 2022).
Guidelines on core components of infection prevention and control programmes at the national and acute health
care facility level. Geneva: World Health Organization, 2016 (https://apps.who.int/iris/handle/10665/251730, accessed
5 December 2022).
Open Oximetry. 2022 (https://openoximetry.org/about/, accessed 5 December 2022).
Oxygen sources and distribution for COVID-19 treatment centres; interim guidance. Geneva: World Health Organization;
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Technical specifications for invasive and non-invasive ventilators for COVID-19: interim guidance. Geneva: World Health
Organization; 2020 (https://apps.who.int/iris/handle/10665/331792, accessed 5 December 2022).
Trainings for medical devices. Geneva: World Health Organization; 2022 (https://www.who.int/teams/health-product-policy-
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WHO and ESICM developed the C19_SPACE interactive programme C19 Skills Preparation Course (C19_SPACE) to orientate
and supplement clinical learning for nurses and doctors not regularly or newly engaged in intensive care units (ICUs).
C19_SPACE provides the most recent evidence-based information, video lectures and clinical case videos delivered
by critical care experts to continue supporting the healthcare community worldwide. (https://www.esicm.org/who-covid-
19-skills-preparation-course, accessed 5 January 2023).
80
81
OXYGEN SYSTEMS
OXYGEN SYSTEMS
For more information, please contact:

Clinical Management and Operations
Health Emergencies Programme
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27
Switzerland
Email:
[email protected]
Oxygen Access Scale Up (who.int)
Oxygen – Global (who.int)
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Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.

1. Oxygen history, ecosystem and related systems 3

2. Health facility oxygen systems 19

3. Operationalization of oxygen systems 45

5. Tools and resources 67

Developed with funding support of Unitaid.

Medical oxygen is lifesaving and an essential medicine Structure

1 psi 0.070 0.068 0.069 6.894 51.7

1. Oxygen history, ecosystem and related systems

1. Oxygen history, ecosystem

1.1 An essential medicine 1.2 History of medical oxygen

The International Pharmacopoeia (2) regional · InEssential

1770s 1970s 2006 2015 2017 2020

1902 1980 2012 2016 2019

update v8-v12; living

Oxygen concentration (% O2) – or oxygen purity – is the

1 1 % O2: Oxygen concentration at source

3 2 % FiO2: Fraction of inspired oxygen

3 % SpO2: Blood-oxygen saturation

Fig. 1.3 Key terminology: % O2, % FiO2 and % SpO2

1.5 Oxygen systems · External factors cover the environmental and

Fig. 1.4 Oxygen ecosystem

Fig. 1.5 Life cycle of oxygen systems

· sustained financial resources; on the product form is crucial to properly design

· vacuum swing adsorption (VSA) [2.1], which also

· vacuum pressure swing absorption (VPSA) [2.1] – a

PSA plant to pipe directly

PSA plant filling high-pressure gas cylinders

Cylinders distributed intra- or interfacility

Bulk tank Vaporizer

High-pressure gas PIPING

Fig. 1.7 Distribution of cryogenically produced oxygen (liquid and gas)

• Continuous and reliable • Continuous and reliable • Typically, the recipient

1 Monitor: The screen displays

2 Suction device: Excess secretions

2 3 Oxygen supply: Every bed area

4 4 Pulse oximeter sensor: The level

of oxygen saturation in the

blood (SpO2) is measured painlessly

with probe on the finger or earlobe.

5 Ventilator tubing and face mask:

6 Ventilator: This equipment

Non-invasive O2 delivery devices

Fig. 1.9 Non-invasive delivery devices

Advanced non-invasive O2 delivery devices

Oronasal Nasal Full face Helmet

Fig. 1.10 Advanced non-invasive delivery devices

The ICU ventilators require weekly calibration of

Fig. 1.11 Non-invasive ventilator

Fig. 1.12 Patient ventilator for intensive care unit

Pulse oximeter (Fig. 1.13): A pulse oximeter is a

Pulse oximetry is accepted globally as the most

97 Fig. 1.15 Oxygen outlet: conditioning and regulation

Fig. 1.13 Pulse oximeter

Patient monitor (Fig. 1.14): Patient monitors

Fig. 1.14 Multiparameter monitor

2. Health facility oxygen systems

2. Health facility oxygen systems