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Speaker : Dr Omar Kamal
 To safeguard human life from unknown
human errors.
 Safety devices are to prevent delivery of
hypoxic mixture
 Regulation to prevent excessive pressure which
is traumatic to patient
 1979: American National Standards Institute
(ANSI)
 1988: American Society for Testing and
Materials (ASTM) F1161-883
 1994: ASTM F1161-944 (reapproved in 1994 and
discontinued in 2000)
 2000: ASTM F1850-005
2000 ASTM F1850-00 standard, newly
 continuous breathing system pressure,
 exhaled tidal volume, ventilatory CO2
concentration,
 anesthetic vapor concentration, inspired
oxygen concentration,
 oxygen supply pressure, arterial oxygen
saturation of hemoglobin,
 arterial blood pressure, and continuous
electrocardiogram
 Master Switch
 Power Failure Indicator
 Reserve Power
 Electrical Outlets
 Circuit Breakers
 Data Communication Ports
 High pressure division
 Intermediate pressure division
 Low pressure division
 Gas cylinder
Color coding
Cylinder labels
Symbol of gas
Pin index safety system
Safety relief device
Filling within service pressure
Oxygen black body,white shoulders
Nitrous oxide blue
Air white and black
Carbon dioxide gray
Helium brown
Entonox black with blue/white shoulders
 The safety relief device is composed of atleast
one of
- Frangible disc [bursts under extreme
pressure]
- Fusible plug [wood’s metal which has
a low melting Point ]
- Safety relief valve [ opens at extreme
pressure ]
 Check valves at the cylinder inlet and pipeline
inlet
 Cylinder pressure indicator [ bourdon’ s
pressure gauge]
 Pressure regulator
 Pressure relief valves
 Washer [ bodok seal ] – rubber made of
neoprene
 Gauge is usually color coded.
 Name and symbol of gas are written over dial.
 If bourdon tube ruptures gas is vented from
back side
 Gauges are angled and placed in such a way
that it can be easily read by anesthetist.
 Instructions like “use no oil’’ “open the valve
slowly’’ are written on the gauge
 Pressure regulators have safety relief valves
 Safety valve blow off at a set pressure of 525 k
pa(70psi)
 Pipeline
• wall outlet : labelled and colour coded
• primary valve or automatic shut off valve
• secondary valve or isolation valve
• schraeders probes, quick connectors or
diameter index safety system to prevent
interchangeability
• pipeline hoses – colour coded
The 2000 ASTM F1850-00 standard states that
“The anesthesia gas supply device shall be
designed so that whenever oxygen supply
pressure is reduced to below the manufacturer
specified minimum, the delivered oxygen
concentration shall not decrease below 19% at the
common gas outlet.”
fail-safe valve
 is located downstream from the nitrous oxide
supply source.
 This valve shuts off or proportionally
decreases the supply of nitrous oxide (and
other gases) if the oxygen supply pressure
declines
 Datex-Ohmeda machines
 Threshold principle
 This valve operates in a threshold manner and
is either open or closed.
 Oxygen supply pressure opens the valve, and
the valve return spring closes the valve
 OFPD is based on a proportioning principle
 The pressure of all gases controlled by the
OFPD will decrease proportionally with the
oxygen pressure.
 consists of a seat nozzle assembly connected to
a spring-loaded piston
 The oxygen flow control knob is distinctively
fluted, projects beyond the control knobs of the
other gases, and is larger in diameter
 All knobs are color-coded for the appropriate
gas,
 the chemical formula or name of the gas is
permanently marked on each.
 If a single gas has two flow tubes, the tubes are
arranged in series and controlled by a single
flow control valve.
- Bobbin rotates on flow which prevents it
from sticking.
- Antistatic spray in flowmeter
- master and slave safety mechanism for gas delivery
between N2O and O2
- Downstream placement of oxygen flowmeter
- Radio florescent plastic sheet behind flow meter
- Float stop
- Auxiliary oxygen flowmeter
 An oxygen leak from the flow tube can
produce a hypoxic mixture, regardless of the
arrangement of the flow tubes
 Proportionating devices –
• link 25 in datex
ohmeda[mechanical,pneumatic
and electronic linkage]
• S-ORC( sensitive oxygen ratio controller)
ORMC( oxygen ratio monitor controller) in
draeger,
• Mandatory minimum oxygen flow :
150 to 250 ml/min
 It allows independent adjustment of either
valve, automatically intercedes to maintain a
minimum 25% oxygen concentration with a
maximum N2O– oxygen flow ratio of 3 : 1
 increases oxygen flow to prevent delivery of a
hypoxic mixture.
 14-tooth sprocket (nitrous oxide flow control
valve) , 28-tooth sprocket (oxygen flow control
valve)
 2 : 1 gear ratio
 Pneumatic oxygen–nitrous oxide interlock
systems designed to maintain a fresh gas
oxygen concentration of at least 25%
 ORMC and S-ORC limit nitrous oxide flow to
prevent delivery of a hypoxic mixture
 Movement of the shaft regulates the nitrous
oxide slave control valve, which feeds the
nitrous oxide flow control valve.
 If the oxygen pressure > N2O , the nitrous
oxide slave control valve opens wider to allow
more nitrous oxide to flow.
 As the N2O flow is increased manually, this
pressure forces the shaft toward the oxygen
chamber limiting the flow of N2O
 whenever the oxygen supply pressure falls
below a manufacturer-specified threshold
(usually 30 psig (205 kPa)
 at least a medium priority alarm shall be
enunciated within 5 seconds
Limitations
 Depend on pressure and not flow
 Do not prevent anesthetic gas from flowing if
there is no flow of oxygen
 Crossovers in the pipeline system or a cylinder
containing the wrong gas
 Leaks downstream
Ritchie whistle
 Present in older machines – ohmeda
 When the oxygen pressure drops below 260
kpa( 38 psi ), oxygen failure whistle valve
opens
 Whistle sounds continuously, until oxygen
pressure has fallen to approx 40.5 kpa ( 6 psi )
 At 30 psi ( 200 kpa ) , it cuts off the supply of
anesthetic gases to the patient
Criteria required for oxygen failure warning
devices :
 Alarm should be auditory(60 dB), for atleast 7
s duration measured at 1 m..
 alarm gets activated when oxygen supply
pressure falls to approx 200 kpa
 Alarm linked to gas shut off device
 Vaporizers - Interlocking Selectatec
mechanism, low filling port..
 Unidirectional [check ] valve
 Back pressure relief valve [opens when the
pressure exceeds 200 cm H2O]
 Common gas outlet
 Receives oxygen from the pipeline inlet or cylinder
pressure regulator and directs a high unmetered
flow directly to the common gas outlet
 labeled “O2+.”
 activated regardless of whether the master switch is
turned ON or OFF.
 flow between 35 and 75 L/minute delivered
 The button is commonly recessed or placed in a
collar to prevent accidental activation
 activation does not increase or decrease the pressure
at the vaporizer outlet > 10 kPa or increase the vapor
output > 20%
Limitations
 Accidental activation and internal leakage
 The flush valve may stick in the ON position
 Oxygen flush activation during inspiration -
barotrauma
 Its purpose is to prevent backflow into the
vaporizer during positive-pressure ventilation,
thereby minimizing the effects of intermittent
fluctuations in downstream pressure on the
concentration of inhaled anesthetic
 APL valve open when pressure exceeds 60 cm
H2O
 Pressure in reservoir bag shouldn’t exceed 60
cm H2O.
 Oxygen analyser
 Canister – Dessicated absorbents without KOH
or ba(OH)2 and with lesser amounts of NaOH
produce less heat and no fires
 VENTILATORS – Pressure sensors to detect
excessive airway pressure due to ventilator
malfunction
 Alternative oxygen control
 Scavenging system
 Wheels in anesthetic workstation is made of
antistatic low friction rubber.
 More accurate and corrected tidal volume
through compliance and fresh gas
compensation
 Fresh gas decoupling prevent hyperinflation of
the lung
 Electronic PEEP
 Electronic selection of ventilation parameters
 Reduced external connections
 It is the only machine safety device that
evaluates the integrity of the low-pressure
circuit
 Oxygen concentration–sensing element must
be exposed to room air for calibration to 21%.
Absolute criteria:
1. Lack of essential safety features such as:
A. O2/N2O proportioning system
B. O2 failure safety device (‘‘fail--safe’’ system)
C. O2 supply failure alarm
D. vaporizer interlock device
E. noninterchangeable, gas-specific pin indexed and
diameter-indexed safety systems for gas supplies.
1. Presence of unacceptable features such as:
A. measured flow vaporizers (e.g., Copper Kettle)
B. more than one flow control knob for a single gas
delivered to the common gas outlet
C. vaporizer with a dial such that the concentration
increases when the dial is turned clockwise
D. connections in the scavenging system that are the
same (15 or 22mm diameter) as in the breathing
system.
2. Adequate maintenance no longer possible
1. Lack of certain safety features such as
A. a manual/automatic bag/ventilator selector switch
B. a fluted O2 flow-control knob that is larger than the
other gas flow-control knobs
C. an O2 flush control that is protected from unintentional
activation
D. an antidisconnection device at the common gas outlet
E. an airway pressure alarm.
2. Problems with maintenance.
3. Potential for human error.
4. Inability to meet practice needs such as
A. accepting vaporizers for newer agents
B. ability to deliver low fresh gas flows (FGFs)
C. a ventilator that is not capable of safely ventilating the
lungs of the target patient population
THANK YOU

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Anesthesia Machine Safety Standards Over the Years

  • 1. Speaker : Dr Omar Kamal
  • 2.  To safeguard human life from unknown human errors.  Safety devices are to prevent delivery of hypoxic mixture  Regulation to prevent excessive pressure which is traumatic to patient
  • 3.  1979: American National Standards Institute (ANSI)  1988: American Society for Testing and Materials (ASTM) F1161-883  1994: ASTM F1161-944 (reapproved in 1994 and discontinued in 2000)  2000: ASTM F1850-005
  • 4. 2000 ASTM F1850-00 standard, newly  continuous breathing system pressure,  exhaled tidal volume, ventilatory CO2 concentration,  anesthetic vapor concentration, inspired oxygen concentration,  oxygen supply pressure, arterial oxygen saturation of hemoglobin,  arterial blood pressure, and continuous electrocardiogram
  • 5.  Master Switch  Power Failure Indicator  Reserve Power  Electrical Outlets  Circuit Breakers  Data Communication Ports
  • 6.  High pressure division  Intermediate pressure division  Low pressure division
  • 7.
  • 8.  Gas cylinder Color coding Cylinder labels Symbol of gas Pin index safety system Safety relief device Filling within service pressure
  • 9. Oxygen black body,white shoulders Nitrous oxide blue Air white and black Carbon dioxide gray Helium brown Entonox black with blue/white shoulders
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.  The safety relief device is composed of atleast one of - Frangible disc [bursts under extreme pressure] - Fusible plug [wood’s metal which has a low melting Point ] - Safety relief valve [ opens at extreme pressure ]
  • 15.  Check valves at the cylinder inlet and pipeline inlet  Cylinder pressure indicator [ bourdon’ s pressure gauge]  Pressure regulator  Pressure relief valves  Washer [ bodok seal ] – rubber made of neoprene
  • 16.  Gauge is usually color coded.  Name and symbol of gas are written over dial.  If bourdon tube ruptures gas is vented from back side  Gauges are angled and placed in such a way that it can be easily read by anesthetist.  Instructions like “use no oil’’ “open the valve slowly’’ are written on the gauge
  • 17.
  • 18.  Pressure regulators have safety relief valves  Safety valve blow off at a set pressure of 525 k pa(70psi)
  • 19.  Pipeline • wall outlet : labelled and colour coded • primary valve or automatic shut off valve • secondary valve or isolation valve • schraeders probes, quick connectors or diameter index safety system to prevent interchangeability • pipeline hoses – colour coded
  • 20. The 2000 ASTM F1850-00 standard states that “The anesthesia gas supply device shall be designed so that whenever oxygen supply pressure is reduced to below the manufacturer specified minimum, the delivered oxygen concentration shall not decrease below 19% at the common gas outlet.”
  • 21. fail-safe valve  is located downstream from the nitrous oxide supply source.  This valve shuts off or proportionally decreases the supply of nitrous oxide (and other gases) if the oxygen supply pressure declines
  • 22.
  • 23.  Datex-Ohmeda machines  Threshold principle  This valve operates in a threshold manner and is either open or closed.  Oxygen supply pressure opens the valve, and the valve return spring closes the valve
  • 24.
  • 25.  OFPD is based on a proportioning principle  The pressure of all gases controlled by the OFPD will decrease proportionally with the oxygen pressure.  consists of a seat nozzle assembly connected to a spring-loaded piston
  • 26.  The oxygen flow control knob is distinctively fluted, projects beyond the control knobs of the other gases, and is larger in diameter  All knobs are color-coded for the appropriate gas,  the chemical formula or name of the gas is permanently marked on each.  If a single gas has two flow tubes, the tubes are arranged in series and controlled by a single flow control valve.
  • 27. - Bobbin rotates on flow which prevents it from sticking. - Antistatic spray in flowmeter - master and slave safety mechanism for gas delivery between N2O and O2 - Downstream placement of oxygen flowmeter - Radio florescent plastic sheet behind flow meter - Float stop - Auxiliary oxygen flowmeter
  • 28.
  • 29.
  • 30.  An oxygen leak from the flow tube can produce a hypoxic mixture, regardless of the arrangement of the flow tubes
  • 31.  Proportionating devices – • link 25 in datex ohmeda[mechanical,pneumatic and electronic linkage] • S-ORC( sensitive oxygen ratio controller) ORMC( oxygen ratio monitor controller) in draeger, • Mandatory minimum oxygen flow : 150 to 250 ml/min
  • 32.
  • 33.  It allows independent adjustment of either valve, automatically intercedes to maintain a minimum 25% oxygen concentration with a maximum N2O– oxygen flow ratio of 3 : 1  increases oxygen flow to prevent delivery of a hypoxic mixture.  14-tooth sprocket (nitrous oxide flow control valve) , 28-tooth sprocket (oxygen flow control valve)  2 : 1 gear ratio
  • 34.
  • 35.  Pneumatic oxygen–nitrous oxide interlock systems designed to maintain a fresh gas oxygen concentration of at least 25%  ORMC and S-ORC limit nitrous oxide flow to prevent delivery of a hypoxic mixture
  • 36.  Movement of the shaft regulates the nitrous oxide slave control valve, which feeds the nitrous oxide flow control valve.  If the oxygen pressure > N2O , the nitrous oxide slave control valve opens wider to allow more nitrous oxide to flow.  As the N2O flow is increased manually, this pressure forces the shaft toward the oxygen chamber limiting the flow of N2O
  • 37.  whenever the oxygen supply pressure falls below a manufacturer-specified threshold (usually 30 psig (205 kPa)  at least a medium priority alarm shall be enunciated within 5 seconds Limitations  Depend on pressure and not flow  Do not prevent anesthetic gas from flowing if there is no flow of oxygen  Crossovers in the pipeline system or a cylinder containing the wrong gas  Leaks downstream
  • 38. Ritchie whistle  Present in older machines – ohmeda  When the oxygen pressure drops below 260 kpa( 38 psi ), oxygen failure whistle valve opens  Whistle sounds continuously, until oxygen pressure has fallen to approx 40.5 kpa ( 6 psi )  At 30 psi ( 200 kpa ) , it cuts off the supply of anesthetic gases to the patient
  • 39. Criteria required for oxygen failure warning devices :  Alarm should be auditory(60 dB), for atleast 7 s duration measured at 1 m..  alarm gets activated when oxygen supply pressure falls to approx 200 kpa  Alarm linked to gas shut off device
  • 40.  Vaporizers - Interlocking Selectatec mechanism, low filling port..  Unidirectional [check ] valve  Back pressure relief valve [opens when the pressure exceeds 200 cm H2O]  Common gas outlet
  • 41.  Receives oxygen from the pipeline inlet or cylinder pressure regulator and directs a high unmetered flow directly to the common gas outlet  labeled “O2+.”  activated regardless of whether the master switch is turned ON or OFF.  flow between 35 and 75 L/minute delivered  The button is commonly recessed or placed in a collar to prevent accidental activation  activation does not increase or decrease the pressure at the vaporizer outlet > 10 kPa or increase the vapor output > 20%
  • 42.
  • 43. Limitations  Accidental activation and internal leakage  The flush valve may stick in the ON position  Oxygen flush activation during inspiration - barotrauma
  • 44.  Its purpose is to prevent backflow into the vaporizer during positive-pressure ventilation, thereby minimizing the effects of intermittent fluctuations in downstream pressure on the concentration of inhaled anesthetic
  • 45.  APL valve open when pressure exceeds 60 cm H2O  Pressure in reservoir bag shouldn’t exceed 60 cm H2O.  Oxygen analyser  Canister – Dessicated absorbents without KOH or ba(OH)2 and with lesser amounts of NaOH produce less heat and no fires
  • 46.  VENTILATORS – Pressure sensors to detect excessive airway pressure due to ventilator malfunction  Alternative oxygen control  Scavenging system  Wheels in anesthetic workstation is made of antistatic low friction rubber.
  • 47.  More accurate and corrected tidal volume through compliance and fresh gas compensation  Fresh gas decoupling prevent hyperinflation of the lung  Electronic PEEP  Electronic selection of ventilation parameters  Reduced external connections
  • 48.  It is the only machine safety device that evaluates the integrity of the low-pressure circuit  Oxygen concentration–sensing element must be exposed to room air for calibration to 21%.
  • 49. Absolute criteria: 1. Lack of essential safety features such as: A. O2/N2O proportioning system B. O2 failure safety device (‘‘fail--safe’’ system) C. O2 supply failure alarm D. vaporizer interlock device E. noninterchangeable, gas-specific pin indexed and diameter-indexed safety systems for gas supplies.
  • 50. 1. Presence of unacceptable features such as: A. measured flow vaporizers (e.g., Copper Kettle) B. more than one flow control knob for a single gas delivered to the common gas outlet C. vaporizer with a dial such that the concentration increases when the dial is turned clockwise D. connections in the scavenging system that are the same (15 or 22mm diameter) as in the breathing system. 2. Adequate maintenance no longer possible
  • 51. 1. Lack of certain safety features such as A. a manual/automatic bag/ventilator selector switch B. a fluted O2 flow-control knob that is larger than the other gas flow-control knobs C. an O2 flush control that is protected from unintentional activation D. an antidisconnection device at the common gas outlet E. an airway pressure alarm. 2. Problems with maintenance. 3. Potential for human error. 4. Inability to meet practice needs such as A. accepting vaporizers for newer agents B. ability to deliver low fresh gas flows (FGFs) C. a ventilator that is not capable of safely ventilating the lungs of the target patient population
  • 52.
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  • 56.