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Anesthesia Machine Safety Standards Guide

The document outlines the safety standards and classifications of anesthesia machines, detailing the evolution of standards from 1979 to 2000 and the required monitoring parameters for compliance. It describes the components and functions of anesthesia gas machines, including pneumatic pressure classifications, gas supply systems, and safety devices for oxygen supply. Additionally, it covers the operation and hazards associated with vaporizers and ventilators used in anesthesia, emphasizing the importance of safety features and proper functioning to prevent complications during procedures.

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0% found this document useful (0 votes)
18 views67 pages

Anesthesia Machine Safety Standards Guide

The document outlines the safety standards and classifications of anesthesia machines, detailing the evolution of standards from 1979 to 2000 and the required monitoring parameters for compliance. It describes the components and functions of anesthesia gas machines, including pneumatic pressure classifications, gas supply systems, and safety devices for oxygen supply. Additionally, it covers the operation and hazards associated with vaporizers and ventilators used in anesthesia, emphasizing the importance of safety features and proper functioning to prevent complications during procedures.

Uploaded by

AleemHaider
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Anaesthesia Machine

Safety Standards
• During the past 2 decades, the progression of
anesthesia machine standards has been as
follows:
– 1979: American National Standards Institute (ANSI)
Z79.8-1979
– 1988: American Society for Testing and Materials
(ASTM) F1161-88
– 1994: ASTM F1161-94 (reapproved in 1994 and
discontinued in 2000)
– 2000: ASTM F1850-00
Safety Standards (con’t)
• To comply with the new 2000 ASTM F1850-00 standard, newly
manufactured workstations must have monitors that measure the
following parameters:
– continuous breathing system pressure,
– exhaled tidal volume,
– ventilatory carbon dioxide concentration,
– anesthetic vapor concentration,
– inspired oxygen concentration,
– oxygen supply pressure,
– arterial hemoglobin oxygen saturation,
– arterial blood pressure, and
– continuous electrocardiogram.
– prioritized alarm system that groups the alarms into three categories:
high, medium, and low priority.
Anaesthesia Gas Machine
Definition
Device to deliver
precisely known but variable gas
mixture
of
anaesthetizing & life sustaining
gases
•Convert supply gases from high pressure to low pressure
•Convert liquid agent to gas
•Deliver in a controlled manner
50-55 Psig

750-45
psig

2200-
45 psig

50-55 psig
Classification of Components
A- Pneumatic pressure classification

• High pressure circuit


– Hanger yoke
– Yoke block
– Pressure gauge
– Pressure regulator
• Cylinder Pressure
– oxygen: 2200-45 psig
– nitrous oxide: 750-45 psig.
Classification of Components

A- Pneumatic pressure classification

2- Intermediate pressure circuit


begins at the regulated cylinder supply sources at 45
psig (37-55psi) - Pipeline Pressure
1- Pipeline inlets & pressure gauges
2- Ventilator power inlet
3- O2 pressure failure device / Alarm
4- Flow meter valves
5- Second stage regulator 14 or 26 psig
6- O2 flush valve
Classification of Components

A- Pneumatic pressure classification

3- Low pressure circuit


Distal to flow meter
1- Valves one-way check valve
2- Flow meter tubes
3- Vapourizers
• 4- CGO The low-pressure circuit
B- Functional Components Classification

1- Gas supply
Cylinders
Pipeline
2- Means of metering &
vapourizing
Flow meters
Vapourizers
3- Gas delivery
Breathing circuits
Ventilator
4- Scavenging devices
O2 Task in AGM

1- Flow meter
2- Oxygen flush
3- Ventilator
4- Oxygen failure alarm (28 psig)
5- Oxygen pressure sensor
shut off valve (25 psig)
Medical Gas Supply
1- Storage
i- Liquid state
 Oxygen -165OC
a- Oxygen in VIE
(1 [Link] of liquid O2 at -270OF  10.5 Barr
yields 860 [Link] of gas O2at 70OF) 17 Barr - Safety valve
b- N2O, CO2 cylinders

ii- Compressed gas cylinders


a- Oxygen
 Molybdenum steel
b- Air etc
 Colour coding
• Pin index safety system  Pressures
Air 1-5  Safety systems
Oxygen 2-5
Nitrous oxide 3-5
 DISS
 PISS
 NIST
 Working pressure 4 Barr = 60psig
Medical Gas Supply
2- Physics & Cylinders
1- Critical pressure
2- Critical temperature
3- Boyle’s law
4- Charle’s law
5- Avogadroe’s law
6- Filling ratio
7- Poynting effect

3- Cylinder accessories
1- Cylinder valves
2- Pressure gauge
3- Pressure regulator
Gas Sources (con’t)

• Machine will use pipeline gas unless


supply pressure drops below 45 psig
Safety Devices for Oxygen Supply
Pressure Failure
• Pneumatic and Electronic Alarm Devices
• Low oxygen supply pressure; 30 psig, shall be
activated within 5 sec
• Fail-Safe Valves
• A fail-safe valve is present in the gas line
supplying each of the flow meters except that for
oxygen. Controlled by oxygen supply pressure,
the valve shuts off or proportionally decreases
the supply pressure of all other gases (e.g.,
nitrous oxide, air, carbon dioxide, helium,
nitrogen) as the oxygen supply pressure
decreases
• Datex-Ohmeda machines are equipped with a
fail-safe valve known as the pressure
sensor's shut-off valve
• threshold principle, and it is open or closed: a
nitrous oxide pressure sensor's shut-off valve
with a threshold pressure of 20 psig.[
• Dräger : oxygen failure protection device (OFPD);
proportioning principle
• The oxygen failure protection device (OFPD) responds
proportionally to changes in oxygen supply pressure. The
OFPD consists of a seat-nozzle assembly connected to a
spring-loaded piston
Flow meters
Definition
1- Controls
2- Measures Rate of flow of the gas passing
through it
3- Indicates
Components
1- Flow control valve
2- Control knob
3- Thorpe tube
4- Indicator
5- Stop valve
Arrangement
1- In series
2- Parallel
Nitrous oxide/oxygen proportioning
flowmeters
• Safety features
1- Touch coded knob
2- Colour coded knob
3- Propotioning devices
1- Link - 25
2- ORMC
4- Entrance of O2 in common manifold is always down
stream of other gases
5- Hypoxic guard (Fail-safe system)
Flow meters
• Physics
• Because the annular space is tubular at low flow rates,
laminar flow is present, and viscosity determines the gas
flow rate.
Poiseuilles law Q =II (P1 - P2) r4

8 l

• The annular space simulates an orifice at high flow rates, and


turbulent gas flow then depends predominantly on the density of the
gas
Grahams law Q = P1 - P2 d2
p •Orificial
•Density

• New technology
1- Electronic flow meters
2- Auxillary flow meters •Tubular
•Viscosity
Limitations of flow meters

1- Altitude effects high flows. (Flow at density)


2- Static electricity
3- Back pressure
4- DIRT
5- Improper assembly
6- Improper alignment
7- Leakage hypoxia
Leaks
• Cracked tubes
• Faulty connections
• May create hypoxic mixture
• Oxygen is always downstream from
other gases
Proportioning Systems
• Prevent delivery of less than 25% oxygen
• Either mechanical or pneumatic interface
Ohmeda Link-25
• Chain connects O2 and N2O flow control valves
• As N2O is increased, the chain will turn O2 control to
maintain at least 25% O2. Oxygen is increased
• Maintains 3:1 ratio with combination of mechanical and
pneumatic
Drager ORMC

• Pneumatic N2O
interlock
• Mobile shaft
• Slave control
valve
• Pressure
moves shaft
and opens or
closes slave
valve
Drager ORMC (con’t)
• N2O flow is reduced to maintain 25% O2
• Electrical contact provides alarm
– Functional only in the O2 / N2O mode (not
in the “all gases” mode)
Limitations of
Proportioning Systems
• Wrong gas supply
• Defective operation
• Leaks downstream
• Inert gas administration
Vaporizers
• Convert liquid anesthetic into a volatile
inhalation agent
• Based on laws of physics
• You must memorize the chemical properties of
the volatile agents
Basic Design
• Gas enters vaporizer
• Flow is split
– Majority is bypassed
– Some enters vaporizing chamber
• Saturated gas leaves chamber
• Diluted by bypass gas
• Delivered to patient
Types of Vaporizers
• Historic
– Copper kettle
• Modern
– Ohmeda Tec 4
– Drager Vapor 19.1
Applied Physics
• Vapor pressure
– Dalton’s law
– Based on characteristics of agent
– Varies with temperature
Applied Physics (con’t)

• Boiling point
– Vapor pressure equals atmospheric
pressure
• Latent heat of vaporization
– Heat required to change liquid into a
vapor
– Comes from liquid and environment
Vapourizers

 Classification
1- Plenum
2- Draw over
 Important features
1- Agent specific / multiple agent
2- Efficient / non efficient
3- Variable bypass / measured flow
4- Flow over / bubble thru
5- VOC / VIC
6- Effects of back pressure
1- IPPV 2- Oxygen flush
1- Pumping effect
2- Pressurizing effect
Factors that Effect Output
• Flow rate
– Accurate at most flows
– Lower than dial setting at both extremes of flow
• Temperature
– Vapor pressure varies with temp
– Accurate at 20 - 35o C
Factors Effecting Output (con’t)

• Intermittent back pressure


– Retrograde flow
– Higher than dial setting
• especially at low flows and high
ventilator pressures
• Carrier gas composition
– N2O causes transient drop
Changes in temperature
[Link] temperature fluctuations by a heavy copper construction, which acts as heat sink.
[Link] for temperature changes by a valve

• a bimetallic strip ↓ flow through the • a bellows and thimble valve increases flow
vaporising chamber when temperature ↑ through the bypass chamber when
temperature increases.

• a bimetallic strip increases flow through • an annular valve constructed of dissimilar


the bypass chamber when temperature metals increases flow through the bypass
increases. chamber when temperature increases.
Multiple vaporisers
• flexible hose and 23 mm adapters,
pole-mount anaesthesia
machines.

• A switch on the back bar may be


used to direct gas flow through
only one vaporiser at a time

• A mechanical locking system may


be used that only allows one
vaporiser to be switched on, e.g.
Ohio selector manifolds and
Dräger 19.3 vaporisers
• A mechanical inter-
connector may be used to
prevent more than one
vaporiser being switched
on at a time, e.g. the
Ohmeda Selectatec
system and Dräger 19.2
vaporisers.
• If none of the above is possible, mounting the vaporiser for
the most volatile agent downstream will prevent release of
high concentrations of a volatile agent owing to
contamination of a vaporiser designed for an agent with a
low saturated vapour pressure. Vaporisers should be
arranged in the order:
Vapor Pressures:
Isoflurane
Enflurane
Halothane
• Isoflurane - 238
• Enflurane - 175
• Halothane - 241
Vaporizer Hazards
• Misfilling
• Tipping
• Dual vaporizers on
• Leaks
• Free standing vaporizers
Misfilling
• Vaporizers are calibrated according to the
vapor pressure of the agent
– If you fill with an agent with a higher v.p. --
overdose
– If you fill with an agent with a lower v.p. --
underdose
Vapourizers

 Differences between TEC. 3-4-5

 New technology

1- TEC. - 6 vapourizer

2- Aladin Cassette Vapourizer System


Desflurane
• Requires special vaporizer
– Vapor pressure 664
– Pressurized, heated chamber
• 1550 mm / Hg prevents boiling
TEC - 6 (Not a variable bypass)

Desflurane (Boiling point = 23OC)


Micro-processor based
Electrically heated to 39OC
Thermostatically controlled
Pressurized
Electromechanically coupled
Dual circuit
Gas vapour blender
Aladin Cassette Vapourizer System
A Novel system
Single vapourizer capable of
delivering
5 different anaesthetic agents
Components - 2 major
1- Vapourizer with its control electronics
2- Liquid anaesthetic agent cassettes coded with a
magnetic signature recognized by the vapourizer
on insertion of cassette
Principle
Combination of
Conventional variable bypass system + TEC - 6
Simplified schematic of Datex-Ohmeda Aladin Cassette Vaporizer. The arrows represent flow
from the flow meters, and the open circles represent anesthetic vapor. The heart of the vaporizer
is the electronically controlled flow control valve located in the outlet of the vaporizing chamber.
CPU, central processing unit, FBC , flow-measurement unit that measures flow through the bypass
chamber, FVC , flow-measurement unit that measures flow through the vaporizing chamber, P,
pressure sensor, T, temperature sensor.
Aladin Cassette Vapourizer System

Working
1- Cassette inserted
2- Agent identified
3- Sump temperature + pressure sensors
4- 2 flow sensors
5- C.P.U.
6- Thermal compensations
a- CPU alters flow
b- Warming fan
For desflurane
Ventilators Classified by:
• Power source
– pneumatic
– electric
– both
• Drive mechanism
– double circuit
– driven by oxygen
Ventilator Classification (con’t)
• Cycling mechanism
– time cycled
– pressure cycled
• Bellows classification
– ascending / descending
• related to expiratory phase
– Ascending is safer
Ventilator Problems
• Circuit disconnect
– Redundant alarms in place
– Check APL valve
• Occlusion
• Barotrauma
Ventilator Problems (con’t)
• Leak in bellows assembly
• Mechanical problems
• Electrical problems
Humidification
The Artificial Nose (HME)

• Provides external heat and humidity


• More effective
Heated Humidifier
• More dangerous
– Larger circuit volume
– Increased circuit compliance
– Thermal injuries
Safety Features in Anaesthesia Machine

1- Colour coded pipeline inlets


2- Colour coded cylinders & connection
tubings
3- DISS, PISS, NIST
4- Non return valves in cylinders
5- Oxygen failure alarms
6- Oxygen pressure sensor shut off valve
7- Oxygen flush
8- Second stage pressure regulator
Safety Features in Anaesthesia Machine
9- Flow restrictors
10- Arrangement of flow meters + coded control
knobs
11- Link 25, ORMC - Propotioning devices
12- Arrangement of vapourizers
13- Non return valves in back bar
14- 35 kpa pressure relief valve
15- 7 kpa pressure relief valve
16- Reservoir bag
• Minimum test under life-threatening conditions
• While there is no universally accepted machine checklist less than the full
FDA Checklist, situations do arise in anesthesia for trauma or emergency
cesarean section where there is neither time nor opportunity to fully
check the anesthesia gas machine. The following checklist is suggested for
these situations. It requires little if any additional time, and can add
greatly to safety, and hence, peace of mind.
• High pressure test of the breathing circuit
– Ensures there are no leaks distal to common gas outlet
• Check suction
• Observe and/or palpate breathing bag during preoxygenation
– Ensures Adequate flow of oxygen
– Good mask fit (very important)
– The patient is breathing
– The Bag/Vent switch is on "Bag" not "Vent"
Detection of Leaks in the Low Pressure System
UNPLT
Universal Negative Pressure Leak
Test
Applicable to all machines
1- Put off
1- Master switch
2- Flow control valves
3- Vapourizers
2- Attach suction bulb to CGO
3- Squeeze till fully collapsed
4- Should not fill with in 10secs
5- Repeated with each vapourizer in “ON” position
Assignment

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