BM 500
FINAL PROJECT
Topic: Anesthesia Unit
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1.
About Anesthesia Unit: .................................................................................................... 3
1.1. What is Anesthesia? ...................................................................................................... 3
1.2. What is Anesthesia Unit ................................................................................................ 5
2. Anesthesia Unit Manufacturers: ..................................................................................... 7
Nambuk Mednics Co., Ltd Osdm Co., Ltd ........................................................................ 8
Details of Some Machines .................................................................................................... 8
2. Equipment Management Coefficient ................................................................................ 16
3. Technical Specifications: ................................................................................................... 16
Tender requirement ........................................................................................................... 16
WARRANTY .................................................................................................................. 18
Installation, commissioning, Testing Maintenance and after Sales service .................. 18
4.Standards: ............................................................................................................................ 21
Preventing Accidents: The Safety Features of Modern Machines ................................ 21
Low Accident Rate ............................................................................................................. 24
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1. About Anesthesia Unit:
1.1. What is Anesthesia?
Anesthesia means that the condition of having sensation blocked or temporarily
taken away. This allows patients to undergo surgery and other procedures without
the distress and pain they would otherwise experience. In other words, Anesthesia is
a "reversible lack of awareness", whether this is a total lack of awareness (e.g. a
general anaesthetic) or a lack of awareness of a part of the body such as a spinal
anaesthetic or another nerve block would cause. Anesthesia is a pharmacologically
induced reversible state of amnesia, analgesia, loss of consciousness, loss of
skeletal muscle reflexes and decreased stress response.
The three components of anesthesia are analgesia (pain relief), amnesia (loss of
memory) and immobilization. The drugs used to achieve anesthesia usually have
varying effects in each of these areas. Some drugs may be used individually to
achieve all three. Others have only analgesic or sedative properties and may be used
individually for these purposes or in combination with other drugs to achieve full
anesthesia.
Curariform skeletal muscle relaxants or neuromuscular blockers (e.g. succinylcholine,
decamethonium, curare, gallamine, pancuronium) are not anesthetics and have no
analgesic effects. They may only be used in conjunction with general anesthetics.
Normally, artificial respiration must be provided. Physiologic monitoring methods
must also be used to assess anesthetic depth, as normal reflex methods will not be
reliable.
History of Anesthesia:
Ether synthesized in 1540 by Cordus
Ether used as anesthetic in 1842 by Dr. Crawford W. Long
Ether publicized as anesthetic in 1846 by Dr. William Morton
Chloroform used as anesthetic in 1853 by Dr. John Snow
Endotracheal tube discovered in 1878
Local anesthesia with cocaine in 1885
Thiopental first used in 1934
Curare first used in 1942 - opened the “Age of Anesthesia”
Anesthesia can be;
Inhalational anesthesia refers to the delivery of gases or vapors from the
respiratory system to produce anesthesia.
Pharmacokinetics uptake, distribution, and elimination from the body
Inhalational Anesthetic Agents are Nitrous Oxide, Halothane, Enflurane, Isoflurane,
Sevoflurane and Desflurane,.
Intravenous Anesthetic Agents are Thiopental, Etomidate, Ketamine, Propofol,
Benzodiazepines, Diazepam, Lorazepam and Midazolam.
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Patients undergoing anesthesia usually undergo preoperative evaluation. It includes
gathering history of previous anesthetics, and any other medical problems, physical
examination, ordering required blood work and consultations prior to surgery.
There are several forms of anesthesia. The following forms refer to states achieved
by anesthetics working on the brain:
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General anesthesia: "Drug-induced loss of consciousness during which
patients are not arousable, even by painful stimulation." Patients undergoing
general anesthesia can often neither maintain their own airway nor breathe on
their own. While usually administered with inhalational agents, general
anesthesia can be achieved with intravenous agents, such as propofol.
Deep sedation/analgesia: "Drug-induced depression of consciousness during
which patients cannot be easily aroused but respond purposefully following
repeated or painful stimulation." Patients may sometimes be unable to
maintain their airway and breathe on their own.
Moderate sedation/analgesia or conscious sedation: "Drug-induced
depression of consciousness during which patients respond purposefully to
verbal commands, either alone or accompanied by light tactile stimulation." In
this state, patients can breathe on their own and need no help maintaining an
airway.
Minimal sedation or anxiolysis: "Drug-induced state during which patients
respond normally to verbal commands." Though concentration, memory, and
coordination may be impaired, patients need no help breathing or maintaining
an airway.
The level of anesthesia achieved ranges on a continuum of depth of consciousness
from minimal sedation to general anesthesia. The depth of consciousness of a
patient may change from one minute to the next.
The following refer to the states achieved by anesthetics working outside of the brain:
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Regional anesthesia: Loss of pain sensation, with varying degrees of muscle
relaxation, in certain regions of the body. Administered with local anesthesia to
peripheral nerve bundles, such as the brachial plexus in the neck. Examples
include the interscalene block for shoulder surgery, axillary block for wrist
surgery, and femoral nerve block for leg surgery. While traditionally
administered as a single injection, newer techniques involve placement of
indwelling catheters for continuous or intermittent administration of local
anesthetics.
o Spinal anesthesia: also known as subarachnoid block. Refers to a
Regional block resulting from a small volume of local anesthetics being
injected into the spinal canal. The spinal canal is covered by the dura
mater, through which the spinal needle enters. The spinal canal
contains cerebrospinal fluid and the spinal cord. The sub arachnoid
block is usually injected between the 4th and 5th lumbar vertebrae,
because the spinal cord usually stops at the 1st lumbar vertebra, while
the canal continues to the sacral vertebrae. It results in a loss of pain
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sensation and muscle strength, usually up to the level of the chest
(nipple line or 4th thoracic dermatome).
o Epidural anesthesia: Regional block resulting from an injection of a
large volume of local anesthetic into the epidural space. The epidural
space is a potential space that lies underneath the ligamenta flava, and
outside the dura mater (outside layer of the spinal canal). This is
basically an injection around the spinal canal.
Local anesthesia is similar to regional anesthesia, but exerts its effect on a
smaller area of the body.
Anesthesia providers are: Anesthesiologists/Anaesthetists (medically-trained
physicians), Nurse anesthetists, Anaesthesiologist Assistants, Anesthesia
technicians and Operating Department Practitioners.
1.2. What is Anesthesia Unit
The anaesthetic machine is used by anesthesiologists to support the administration
of anaesthesia. The most common type of anaesthetic machine in use in the
developed world is the continuous-flow anaesthetic machine, which is designed to
provide an accurate and continuous supply of medical gases (such as oxygen and
nitrous oxide), mixed with an accurate concentration of anaesthetic vapour (such as
isoflurane), and deliver this to the patient at a safe pressure and flow. Modern
machines incorporate a ventilator, suction unit, and patient-monitoring devices.The
anaesthetic machine is usually mounted on anti-static wheels for convenient
transportation.
Simpler anaesthetic apparatus may be used in special circumstances, such as the
TriService Apparatus, a simplified anaesthesia delivery system invented for the
British armed forces, which is light and portable and may be used effectively even
when no medical gases are available. This device has unidirectional valves which
suck in ambient air which can be enriched with oxygen from a cylinder,with the help
of a set of bellows. A large number of draw-over type of anaesthesia devices are still
in use in India for administering an air-ether mixture to the patient, which can be
enriched with oxygen. But the advent of the cautery has sounded the death knell to
this contraption, due to the explosion hazard.
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A modern machine typically includes the following components:
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connections to piped hospital oxygen, medical air, and nitrous oxide. Pipeline
pressure from the hospital medical gas system (wall outlet) should be around
400 kPa (60 psi; 4 atmospheres).
reserve gas cylinders of oxygen, air, and nitrous oxide attached via a specific
yoke with a Bodok seal. Older machines may have cylinder yokes and flow
meters for carbon dioxide and cyclopropane. Many newer machines only have
oxygen reserve cylinders. The regulators for the cylinders are set at 300 kPa
(45 psi; 3 atmospheres). If the cylinders are left on and the machine is plugged
into the wall outlet, gas from the wall supply will be used preferentially, since it
is at a higher pressure. In situations where pipeline gases are not available,
machines may safely be used from cylinders alone, provided fresh cylinders
are available.
a high-flow oxygen flush which provides pure oxygen at 30 litres/minute
pressure gauges, regulators and 'pop-off' valves, to protect the machine
components and patient from high-pressure gases (referred to as
'barotrauma').
flow meters (rotameters) for oxygen, air, and nitrous oxide, which are used by
the anaesthesiologist to provide accurate mixtures of medical gases to the
patient. Flow meters are typically pneumatic, but increasingly electromagnetic
digital flow meters are being used.
one or more anaesthetic vaporisers to accurately add volatile anaesthetics to
the fresh gas flow
a ventilator
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physiological monitors to monitor the patient's heart rate, ECG, non-invasive
blood pressure and oxygen saturation (additional monitors are generally
available to monitor end-tidal CO2, temperature, arterial blood pressure
central venous pressure, etc.). In addition, the composition of the gases
delivered to the patient (and breathed out) is monitored continuously.
breathing circuits, most commonly a circle attachment, or a Bain's breathing
system, which are breathing hoses connected to a anaesthesia face mask
a heat and moisture exchanger (HME) with or without bacteria-viral filter
(HMEF).
scavenging system to remove expired anaesthetic gases from the operating
room. Scavenged gases are usually vented to the atmosphere.
suction apparatus
There is generally a small work bench built into the machine where airway
management equipment is kept within ready reach of the anaesthetist.
2. Anesthesia Unit Manufacturers:
In my research, I find nearly 30 manufacturers which provide anesthesia machines.
Most of them located in China and others are in Korea .
(http://www.ec21.com/companies/anesthesia_machine.html)
Manufacturers in China:
Shinova Systems Co., Ltd.
Perlong Medical Equipment Co,Ltd
Anjue Import & Export Co., Ltd.
Beijing Read Eagle Technology Co.,Ltd.
Perlong Medical Equipment Co., Ltd.
Martvi Medical & Hospital Supply
Medicalpoint
Anjue Import & Export Co., Ltd
Seeuco Electronics Technology Co.,Ltd.
Martvi Medical & Hospital Supply
Sunshine Medical Equipment Co., Ltd.
Perlong Medical Equipment Co,Ltd.
ZhendanTech Co., Ltd.
Nanjing Tops and Trading Industrial Co., Ltd.
Honkon Science and Technology Development Co.,ltd
Martvi Medical & Hospital Supply .
Perlong Medcial Equipment Co Ltd
Nison Shanghai
Beijing Aerospace ChangFeng Co., Ltd
Perlong Medical Equipment Co., Ltd
Medical Instruments Factory No.5 of Shanghai Medical Instruments Co.,Ltd
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Perlong Medical Equipment Co.,Ltd.
Beijing Aerospace Changfeng Co. Ltd Medical Devices Branch
Manufacturers in Korea
Nambuk Mednics Co., Ltd
Osdm Co., Ltd
Distributors Located in US
Hi Grant International
Tenko International Group
Details of Some Machines
Anjue Import & Export Co., Ltd.
AJ-2102 Anesthesia Machine (Model Number : AJ-2102 )
Main Specification:
* Working Mode: Closed system, half-closed system and half-open system
* Application: adult ，child（options）
* Gas supplies: O2: 0.3MPa~0.5MPa, N2O: 0.3MPa~0.5MPa
* Oxygen flush: 35L/min~75L/min
* Alarms Parameters: Upper and Lower Airway Pressure Alarm; Upper and Lower Tidal Volume
Alarm; Lack of Oxygen Alarm; Apnea; Power Outage
* High precise vaporizer: Enflurane or Isoflurane
* Power: 220V±10％、50Hz±1％
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Anesthesia Ventilator:
* One Adult Bellows, （optional: Child's）
* Gas Driven and Electrically Controlled
* Digital LED Display; and Keys Conditioning Means
* Monitoring Parameters: Tidal Volume, the Respiratory Rate; I/E Ratio; the Peak
Airway Pressure; Airway Pressure Waveform
* Working Mode: Manual Control or Automatic Control
* Breathing Modes: IPPV , SIGH
，SIMV/F/2、(optional：PEEP（＋0.5kPa～＋2kPa）、SIPPV)
* Tidal volume: 30~1500ml
* Respiratory Rate: 4~60bpm
* I/E Ratio: 3: 1~1:4 Adjustable
* Upper Airway pressure: 2~6KPa
* Lower Airway pressure: 0.6~2KPa
Flow Meter:
* O2/N2O Four-Tube Flow Meter (0-10L/Min)
* Interlock of O2 and N2O; Keep Oxygen Concentration Over 25%
Loop:
* Integrated Design, Orderliness Respiratory Loop
Vaporizer:
* High Precise Vaporizer: Enflurane or Isoflurane
* Scope of Concentration Regulation: 0.2~5%VOL
* Automatic Compensation of Flow, Temperature and Pressure
* Self-Lock
* Volume: 140ml
Perlong Medical Equipment Co., Ltd.
Adopts a two stage regulator and a hight precision three-gas flowmeter with ORC
system,ensures oxygen concentration not less than 25%
· Automatic N2O cut off and an unique O2 deficiency alarm divice.
· With Enflurane or lsoflurane vaporizer,or both.
· Attachable cylinder bracket.
· Pneumatic-driven and electic-controlled anesthesia ventilator(Optional)
· With constant volume for adults and children(With Ventilator).
· Real time airway measurement
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· Exhaled tidal volume and Minute vlulme measurement(Optional).
· Stainless steel ansesthesia writing surface
Nanjing Sunshine Medical Equipment Co., Ltd.
MHJ-III B1 is a univeral multi-functional anaesthesia machine incorporating
anaesthesia, respiratory and monitorings. In design, it improves the reliability, safety
and combination. Also consideration has been taken to the connection between
anesthesia machine and all kinds of monitors, extending its functions. This machine
is equipped with Model SC-M3A1 pneumatic-driven and pneumatic controlled
anesthesia ventilator, suitable for closed, semi-closed and semi-opened inhalation
anesthesia and non-inhalation anesthesia in all levels hospitals.
Feathers:
Flow meter with ORC system to ensure oxygen concentration not less than 25%.
N2O cut-off device
O2 deficiency alarm
SC-M3A1 anesthesia ventilator,with easy operation and low air consumption
Top plate intended for all kinds of monitors
Main technical specifications:
1.Supply pressure:0.27~0.55MPa
2.Adjustment rang of flow: O2　 0.1~10L/min N2O 0.1~10L/min
3.ORC system: Oxygen concentration no less than 25% (O2+N2O)
4.N2O cut-off device :Active when oxygen pressure less than 0.1MPa
5.O2 flush:50±10L/min (O2 pressure 0.45Mpa)
6.Adjustment concentartion of Enflurane Vaporizer:0~5Vol%
7.Adjustment range of APL: 0.5~7kpa
8.Control mode of SC-M3A1 anaesthesia ventilator
9.Pneumatic-controlled and pneumatic-driven,time-cycled,volume constant
10 Ventilation frequency:6~40bpm, adjustable
11. O2 deficiency alarm: audible alarm occurs when O2 pressure less than 0.2MPa
12. Minute volume:3~18L/min, adjustable
13. I:E ration:1:1.5 (fixed)
14. Air consumption:less than 0.8L/min( pneumatic-controlled part)
15. Dimensions:516×600×1370(L×W×H)
16. Weight:60kg
17. No need of power supply. Only compressed oxygen for pneumatic driving and
pneumatic control.
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Nambuk Mednics.
SAFER-100
Product Features Anesthesia Machine Specifications - Flowmeters
O :0.1-10 L/min. overall-length 254mm X 1
N O:0.1-10 L/min. overall-length 254mm X 1
- Oxygen Flush Valve
Auto-return system with min. flow rate of 35 L/min.
- Safeguards
N2O Shut-Off Mechanism
In the event that oxygen flowate to 1.5L/min. or oxyzgen supply pressure faas to
1.1kgf/cm2, the delivery of nitrous oxide gas will be shut off.
- Alarms
-Oxygen Concentration
In caseof falling below the sest lower oxygen concentration.(audible & visible)
-Oxygen Pressure
In case of oxygen pressure falls to 2kgf/cm2 or lower.(audible only)
-Low Battery Indicator
Lights up when the battery capacity lowered.
- Airway Pressure Gauge
Range:-20-+80cmH2O(-20-+80 X 100pa)
- Canister
Capacity:2,000ml(Double chamber)
Adjustable height:30cm
- Scavenging System
It consists of extra gas evacuting valve, a corrugated tube and suction hose.
- Vaporizer Mount
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Two AIKA TCV Vaporizers can be mounted.
- Premary Pressure gauge
O2:Bourdon tube, range 0-250kgf/cm2
N2O:Bourdon tube, range 0-150kgf/cm2
- Gas Connections
Yoke:O2 small pin-index type cylinder X 1
Pipping connector:
O2 DISS Connecting port X 1
N2O DISS Connecting port X 1
- Power Requirement
6VDC(for oxyzen moniter, R6P X 4)
- Size
870W X 555D X 1285H(mm)
- Weight
50kg.approx., net Model No. Safer-100
Optional Accessories
1.AIKA Anasthetic Ventilator EVA 1200
2.AIKA Anasthetic Ventilator EVA 900N
3.AIKA Enfluramatic TCV-3 Vaporizer
4.AIKA Isoflumatic TCV-5 Vaporizer
5.AIKA Sevoflumatic TCV-7 Vaporizer
6.PAT Selector (bag/ventilator change-over valve)
7.Additional Drawer
Hefei Lanrui Science and Technology Development Co.,
Ltd.
Battery backup: More than 30 minutes Vaporizer: Single(position), GE DatexOhmeda TEC7 easy -filled Vaporizer. Power supply: 220-240VAC, 50/60Hz, 3A
Technical Specification Alarm settings: Upper & lower limit for Tidal volume, O2
concentration, minute volume, airway Ventilator: Pneumatic driven, mocrocontroller.
Volume control, pressure limited Tidal Volume: 45-1500ml I: E ratio: 2: 1-1: 6
Monitoring parameter: Tidal Volume, Breathing frequency, oxygen concentration,
Minute volume, O2 Flush: 35~75 L/min Inspriratory pause: 5%T1-60% T1 increment
of 5% T1 Breathing Frequency: 4-65 bpm Airway pressure: -20~100cm H2O
Ventilator mode: VCV +PLV Tidal Volume Monitor with TV Compensation O2 Volume
monitoring O2/N2O safe-guard interlink device: Provide a nominal minimum 25%
concentration of O2 in.
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Datex Ohmeda Excel 210 SE
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Accommodates 3 gases and 2 vaporizers
Tek 5 vaporizers
Powerful ventilation and monitoring capabilities
Options 7800 Electronic Ventilator 7900 Smart Ventilator
Specifications:
Weight: 116 KG
Height: 158.1 CM
Width: 69.2 CM
Top Shelf: Max Shelf load: 56 KG
Size: 55.2 x 31.1 cm
Table top: Height from floor: 87.6
Size: 55.2 x 31.1
Lower Cabinet: Fixed Shelf: 47.6 X 36.8
Sliding Shelf: 47.6 x 34.3 x 14
Drawer: 47.6 x 34.3 x 14
Drawer Cabinet: Contains two 26.7 cm x 38 cm x 10.2 cm drawers.
Absorber Post: Arm length: 30.5 cm
Ht Adjustment: 36.8 – 78.2 cm
Casters: Number Size 127 cm
Brake: Rear
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Dräger Narkomed 2A Anesthesia Machine
Narkomed 2A Introduces the Following Options:
• Oxymed Oxygen Analyzer
• Spiromed and Centralert (Central Alarm Unit)
• Three Vaporizers : 19.1 or 19.3 Vaporizers (Isoflurane, Halothane, Enflurane)
• Interlock System and Capability to Store up to Four Gases
• CO2 Absorber, Oxygen Monitor, Volume Monitor
• Standard Configuration includes AVE Electronic Ventilator with Ascending or Descending Bellows
• Battery-Pack and 4 Electrical Outlets
• Refurbishing Available - Includes Painting, New Casters, CRTs, Hoses, Batteries, and O2 Cells
• O2 and N2O (Standard)
• Air (Optional)
• ORM (Standard), ORMC (Optional)(Hypoxic Guard)
• Can be Configured with Ascending (A- or F-Style) or Descending Bellows
• E-Cylinder and Central Gas Connections (Standard)
• Drawer Pack Configurations May Vary
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Battery
Voltage / Capacity : 12 Volt / 7.0Ah
Dimensions / Specifications
Weight : Approximately 330 lb (147 kg) (Depending on Drawer Configurations)
Height : Approximately 68 inches (173 cm)
Width : Approximately 40 inches (102 cm)
Depth : Approximately 25 inches (63.5 cm)
Shelving : 200 square inches (1,290 cm2) (May Vary)
Price: 16,000 USD
Improved low flow/reduced life cycle costs
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Fresh gas flow compensation—automatically
Smooth, faster acting fresh gas flow control
Minimum O2 flow of 50 mL
Dual air flow tube for low flow
Two scheduled maintenance checks per year
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2. Equipment Management Coefficient
Equipment management number of anesthesia unit is determined by considering function, risk
and required maintenance.
Function of anesthesia unit is Life Support (10/10).
Physical risk associated with clinical application is patient or operator injury (4/5).
Maintenance requirements number is (4/5).
Total of 10 + 4 + 4= 18 is the Equipment management coefficient number of anesthesia unit.
Anesthesia Machine Consideration
3. Technical Specifications:
The Anaesthesia Machine should have the following essential components. The quote for
optional accessories should be submitted.
Tender requirement
1) Anaesthesia machine complete with
a) Anaesthesia gas delivery system.
b) Circle absorber system.
c) Precision vaporiser for halothane, isoflurane
d) Anaesthesia ventilator.
e) Monitoring system to monitor Anaesthetic gases, EtCO2, Pulse Oximeter
and airway pressure & temperature.
2) Essential accessories to make the system complete
Detailed specifications:
1. Anaesthesia gas delivery system.
 Should have provision for delivery of oxygen, nitrous oxide and medical air with
pressure gauges.
 Should have independent attachments for connecting central gas supply and pin
indexed cylinders. Should have provision for attaching 1 cylinder of(O 2 and N2O).
 Oxygen and Nitrous oxide should be linked either mechanically or pneumatically
to ensure a minimum of 25% oxygen delivery at all times to avoid delivery of
hypoxic mixture.
 Should have audio-visual oxygen Failure warning System with Nitrous oxide cut
off.
 Should have back bar which is ISO pin type to attach vaporiser easily.
 Should be supplied with necessary attachments to use of the breathing circuits
(Bains, Jackson-Rees and closed circuit etc.,)
 Should have top shelf to keep monitors and a tabletop to keep anaesthetic drugs,
equipments etc.
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The machine should possess battery back up if any electrical components are
present
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Castor wheels should be durable and moisture resistance & Smooth.
The Anaesthesia machine frame should be made of rust proof material/Stainless
steel.
2. Standard Circle Absorber System
 Should have adjustable pressure limiting valve, breathing circuit pressure
measuring device.
 Should have a bag/ventilator selecting valve integrated onto the absorber.
 Should be suitable to use low flow techniques involving total flow of 500 ml/min
 Facility to attach oxygen sensor.
 Should have dual absorbent chamber canister. Arranged vertically one above the
other.
3. Precision Vaporisers (Temperature and flow compensated) for Halothane,
Isoflurane.
 Should be easy to attach and dismount from the back bar.
 Vaporisers should have ISO pin type (Selectatec) mounting and vaporiser
interlocking facility..
 Should have a standard filling port with keyed filling device.
 Should be designed for transport with liquid in vaporiser chamber with protection
against tipping and shaking
 Maintenance free vaporiser (desirable)
4. Ventilator
 Should be a bag in bottle anaesthesia ventilator with standing (ascending)
bellows.
 Should be supplied with adult and paediatric bellows.
 Should be able to set tidal volume, respiratory rate and I:E ratio
 Ventilator should have audible alarms for ventilator failure, low oxygen supply
pressure, inadequate volume delivery, disconnection alarm, and power supply
failure.
5. Monitoring system
Should provide facility to monitor
a) Oxygen and Nitrous oxide and anaesthetic agent in the inspired mixture
b) Inspired and end tidal carbon di-oxide through side stream
c) Oxygen saturation of the blood with both adult & paediatric probes & sensors
d) Monitoring of ECG, NIBP (inclusive of adult, paediatric & neonatal NIBP cuffs),
IBP and CVP should be present
e) Airway Pressure monitoring should be present
f) Temperature Monitoring with 2 probes oesophageal and skin probe.
g) Glare free monitors with large screen for easy visibility.
h) Monitor should be accurate, prcise and standard monitoring modes in modular
type.
i) Trolley should be provided for the monitors.
6. Back-up power supply:
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1 KV UPS systems suitable for Anaesthesia Machine for a minimum one hour
7. Power requirements: 220-240 V, 50/60 Hz
Price quote for any other essential items with justifications, which are
necessary for trouble free functioning of Anaesthesia Machine
Quote for total CIF value at Chennai airport. The break up of cost of the equipment,
agency commission, Airfreight and insurance charge should be given.
Demonstration of the equipment before price bid evaluation is must. Otherwise
it will not be taken into consideration.
WARRANTY
1. The equipment and all accessories should be under WARRANTY for a
period of THREE YEARS after successful commissioning.
2. If the WARRANTY period ends before the start of the Financial Year then
the WARRANTY should be extended till the beginning of the next financial
year. For example, if the warranty period ends in December then the
warranty should be extended up to 31st March of the next financial year so
that the Annual Maintenance Contract can commence from 1st April.
3. All essential spare parts, PC boards and service manuals should be
available with the local service centre during WARRANTY Period and all
steps should be taken for immediate servicing to prevent the down time.
Annual Maintenance contract:
1. The Annual Maintenance contracts rates for a period of 5 years after
warranty period should be quoted separately and this would be
taken into consideration in comparing the price bids.
2. Annual Maintenance contract should include preventive
maintenance and breakdown calls. A copy of service manual
should be available with local service centre.
Installation, commissioning, Testing Maintenance and after Sales
service
1. The equipment and all accessories should be installed and tested and
commissioned in the Department of Anaesthesiology, JIPMER,
Pondicherry-6 free of cost.
2. All electric connections, plug points, wiring etc should be provided free of
cost.
3. All spare parts and consumables should be available with the supplier or
principals for the period of 10 years.
Tender conditions:
1. The company should quote/send their technical and price bids in separate
sealed envelops
2. Companies to indicate separately and clearly in their technical bids
whether their products conforms/does not conform to each parameter in
the specification and also to extent it deviates from the specifications as
per enclosed proforma
3. Quotation should be valid for 1 year
4. Details of Agency commission should be given. This will be paid in Indian
Currency
5. The user list from reputed Institutions should be provided.
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Proforma for Technical Specifications of Anaesthesia Machine.
(To be filled by the company and submitted along with Technical bid)
Company name:
Model
Component
Tender Specification
1. Anaesthesia
Gas delivery
system
a) Should have provision for
delivery of oxygen, nitrous oxide
and medical air with pressure
gauges.
b) Should have independent
attachments for connecting central
gas supply and pin indexed
cylinders.
c) Should have provision for
attaching 1 cylinder of N2O & O2.
d) Oxygen and Nitrous oxide
should be linked either
mechanically or pneumatically to
ensure a minimum of 25% oxygen
delivery at all times to avoid
delivery of hypoxic mixture.
e) Should have audio-visual
oxygen Failure warning System
with Nitrous oxide cut off.
e) Should have back bar which is
ISO pin type to attach vaporiser
easily.
f) Should be supplied with
necessary attachments to use of
the breathing circuits (Bains,
Jackson-Rees & Closed Circuit
etc.)
g) Should have top shelf to keep
monitors and a tabletop to keep
anaesthetic drugs, equipments etc.
h) Castor (wheels should be
durable and moisture resistant &
smooth.
i) The Anaesthesia machine frame
should be made of Rust proof
material/stainless steel.
2. Standard
Circle Absorber
a) Should have adjustable
pressure limiting valve, breathing
Model’s
Specification
(write Yes or
No
Additional
feature ,if any
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System
3. Precision
Vaporisers
(Temperature
and flow
compensation)
for Halothane,
Isoflurane
circuit pressure measuring device.
b) Should have a bag/ventilator
selecting valve integrated onto the
absorber.
c) Should be suitable to use low
flow techniques involving total flow
of 500 ml/min
d) Facility to attach oxygen sensor.
f) Should have Dual Absorbent
Chamber Canister arranged
vertically one above the other.
a) Should be easy to attach and
dismount from the back bar.
b) Vaporisers should have ISO pin
type (Selectatec) mounting and
vaporiser interlocking facility.
c) Should have a standard filling
port with keyed filing device
d) Maintenance free vaporiser is
desirable
e) should be designed for transport
with liquid in the vaporiser
chamber with protection against
tipping and shaking.
4.Ventilator
a) Should be a bag in bottle
anaesthesia ventilator with
standing, ascending bellows.
2) Should be supplied with adult
and paediatric bellows.
3) Should be able to set tidal
volume, respiratory rate and I:E
ratio.
4)Ventilator should have audible
alarms for ventilator failure, low
oxygen supply pressure,
inadequate volume delivery,
disconnection alarm, and power
supply failure
5. Monitoring
Systems
Should provide facility to monitor
 Oxygen and Nitrous oxide and
anaesthetic agent in the inspired
mixture
 Inspired and end tidal carbon
dioxide (side stream)
 Oxygen saturation of the blood
with both adult & paediatric
probes & sensors
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






Monitoring of ECG, NIBP, IBP
and CVP should be present
Airway pressure monitoring
should be present.
NIBP with Adult, Paediatric &
Neonatal NIBP cuffs
Temperature Monitoring with
oesophaeal Probe and skin
Probes.
Glare free monitors with large
screen for easy visibility
Monitor should be
accurate,Precise and standard
monitoring mode in modular
type
Trolley should be provided for
the monitor.
4.Standards:
ISO standards related with anesthetic machines for use with humans is ISO
5358:1992
The European Standard for anaesthetic machines (EN740) requires them to have
means to prevent the delivery of a gas mixture with an oxygen concentration below
20%. Some of the respondents to Saunders and Meek's survey probably regarded
compliance with this standard as synonymous with the presence of an anti-hypoxia
device on their anaesthetic machine.1-1
The European Standard refers to machines in the workshop. I have to attach these
machines to patients via a patient circuit, and thus my interest is whether the
machine in this configuration will prevent the inadvertent delivery of a hypoxic
inspired gas mixture. In machines with a simple (ratio) oxygen/nitrous oxide linkage,
a combination of 300 ml oxygen/min and 900 ml nitrous oxide/min into a circle
absorber circuit is permissible and the machine will conform to EN740 but a hypoxic
inspiratory mix will develop in adults and in children as young as 8. This machine will
prevent the administration of an anoxic mix, and probably of a severely hypoxic mix,
but not the administration of a hypoxic mix.
Preventing Accidents: The Safety Features of Modern Machines
Prior to the mid-late 1980s the prototypical intraoperative anesthesia catastrophe was
an unrecognized accidental esophageal intubation during the induction of general
anesthesia with muscle relaxation. In such a case, the first indication of trouble often
was an expanding stomach and transient tachycardia and hypertension from the
sympathetic response to hypoxemia and hypercarbia followed soon by the surgeon
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making an incision and commenting with distress: “Hey! The blood looks really dark
down here!” Ventricular ectopy leading quickly to fibrillation ensued, creating an
immediate life-threatening crisis. The necessity was to get help, make the initial
diagnosis by recognizing the cause of the problem, replace the endotracheal tube
correctly in the trachea, successfully resuscitate the patient, verify that the incident
had ended, institute care to minimize hypoxemic damage, and administratively
manage the situation, including with investigation and teaching to reduce the
probability of it happening again to another patient. Other examples also usually
involving some type of failure of ventilation (such as from an unrecognized breathing
circuit disconnection) or even a disruption of the oxygen supply are possible, but the
point is clear regarding the need to organize the response to such a major event.
By the end of the 1980s the nature of intraoperative anesthesia accidents changed
with the creation and universal application of the strategies of intraoperative
anesthesia safety monitoring. Specifically the change of behavior and mindset from
intermittent to genuinely continuous patient and anesthesia delivery system
monitoring coupled with the use of then-new electronic monitors as extensions of the
anesthesia provider's senses allowed extremely sensitive real-time monitoring of
patient oxygenation and ventilation. This resulted in much earlier warning of the
potentially dangerous mishaps (that continue to occur still today) that previously
would have evolved to patient injury. The information in the warning, in turn, directed
and facilitated diagnosis and correction of the problems well before the onset of
injury. As a result, the frequency and severity of intraoperative patient-injury
accidents decreased dramatically. Thus, a significant component of the previously
traditional training and experience of anesthesia practitioners was functionally
eliminated.
While overt unrecognized simple failures of ventilation are much less likely, they can
still occur. Also, other, more modern, intraoperative accidents may be more complex
and more subtle. Human error theory suggests analogies to other types of major
accidents: airliner or train crashes and nuclear plant or electric power grid disasters.
These usually involve 2 or more abnormalities or variances in conditions or
procedures coincident in time that cause unusual interaction and results, making the
operator (or anesthesia practitioner) face an unfamiliar situation. A listing of actual or
potential situations is not possible in this setting, but they do happen—very rarely, but
they do. Today, applying population statistics, a new practitioner could expect to be
involved in a patient-injury accident once in an average career. This means, by
definition, that the practitioner will have no direct experience in managing such a
situation. The “Adverse Event Protocol” is specifically intended to fill that gap and arm
every anesthesia practitioner with a detailed, carefully thought out plan to respond to
a patient-injury intraoperative accident. Laminated copies of the printed protocol were
attached to anesthesia machines in some operating rooms (ORs) in the 1990s.
Today, a great many OR rooms and virtually all OR suites have immediate Internet
access. The original “Adverse Event Protocol” is in the APSF website:
www.apsf.org, “Clinical Safety Tools” under “Resource Center” at the top of any
page on the site. When the urgent overhead page in an OR suite comes,
“ANESTHESIA STAT! to OR X,” almost always several people respond, usually more
than can physically get to the head of the involved patient at one time. One of the
helpers later to arrive profitably could either be assigned or take their own initiative to
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go immediately to an on-line computer and print or even simply read out loud the
protocol from the APSF site.
Based on experience gained from analysis of mishaps, the modern anaesthetic
machine incorporates several safety devices, including:









an oxygen failure alarm (also known as 'Oxygen Failure Warning Device' or
OFWD). In older machines this was a pneumatic device called a Ritchie
whistle. Newer machines have an electronic sensor.
nitrous cut-off: the flow of medical nitrous-oxide is dependent on oxygen
pressure. This is done at the regulator level. In essence, the nitrous-oxide
regulator is a 'slave' of the oxygen regulator.
hypoxic-mixture alarms (hypoxy guards or ratio controllers) to prevent gas
mixtures which contain less than 21% oxygen being delivered to the patient. In
modern machines it is impossible to deliver 100% nitrous oxide (or any
hypoxic mixture) to the patient to breathe. Oxygen is automatically added to
the fresh gas flow even if the anaesthetist should attempt to deliver 100%
nitrous oxide. Ratio controllers usually operate on the penumatic principle or
are chain linked. Both are located on the rotameter assembly, unless
electronically controlled.
ventilator alarms, which warn of disconnection or high airway pressures
interlocks between the vaporisers preventing inadvertent administration of
more than one volatile agent concurrently
alarms on all the above physiological monitors
the Pin Index Safety System prevents cylinders being accidentally connected
to the wrong yoke
the NIST (Non-Interchangeable Screw Thread) system for pipeline gases,
which prevents piped gases from the wall being accidentally connected to the
wrong inlet on the machine
pipeline gas hoses have non-interchangeable Schrader valve connectors,
which prevents hoses being accidentally plugged into the wrong wall socket
The functions of the machine should be checked at the beginning of every operating
list in a "cockpit-drill". Machines and associated equipment must be maintained and
serviced regularly.
Older machines may lack some of the safety features and refinements present on
newer machines. However, they were designed to be operated without mains
electricity, using compressed gas power for the ventilator and suction apparatus.
Modern machines often have battery backup, but may fail when this becomes
depleted.
The modern anaesthetic machine still retains all the key working principles of the
Boyle's machine (a British Oxygen Company trade name) in honour of the British
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anaesthetist H.E.G. Boyle (1875-1941). In India, however, the trade name 'Boyle' is
registered with Boyle HealthCare Pvt. Ltd., Indore MP.
A two-person (Operating Theatre Practitioner and anaesthetist) pre-use check of the
anaesthetic machine is recommended before every single case and has been shown
to decrease the risk of 24-hour severe postoperative morbidity and mortality (Arbous
et al. Anesthesiology 2005). Various regulatory and professional bodies have
formulated checklists for different countries - see
http://vam.anest.ufl.edu/guidelines.html. A free transparent reality simulation of the
checklist recommended by the United States Food & Drug Administration is available
from the Virtual Anesthesia Machine web site ( see below) after registration which is
also free.
Low Accident Rate
There is no more supervised and monitored time during a patient’s stay in the
hospital than in the operating room (OR).
An OR is the most densely populated area of the hospital, in terms of staff and
equipment. There are always one or two anesthesia personnel, a surgeon or two, a
scrub nurse or two, a couple of circulating nurses, equipment operators, and several
other assorted personnel in the room. The number of staff in an OR can often
number eight or more. It is very difficult for anesthesia machine-related accidents to
occur during surgery for several reasons, including the following:
• There is a full-time, specially trained person dedicated to keeping the patient at just
the right level of anesthesia—not too deep and not too light.
• Vital-sign monitors, oxygen analyzers, anesthetic gas monitors, and pulse
oximeters all are monitoring the patient’s parameters. The anesthesia machine, the
ventilator, and all of the associated patient monitors feature alarms, which provide a
level of safety and redundant security beyond that of the anesthesia staff. And in
case the electronic equipment isn’t enough, there is always a stethoscope monitoring
the heartbeat and breathing sounds directly.
• The anesthesia machine itself has several built-in safety devices. Flow meters
cannot deliver less than 21% oxygen. Nitrous oxide is shut off if the oxygen pressure
fails. Vaporizers are linked so that no more than a single agent can be delivered at
any time. An assortment of gauges and dials give the anesthesia personnel ready
information about the state of the machine and the gases that it administers.
• Each of these machines, monitors, and systems has its own preuse checkout
procedure, which, if followed regularly and often, will virtually ensure that no
equipment fails during a case.
It would be logical that most incidents would occur at the start of a case, since the
patient is being put to sleep, intubated, and hooked up to all of the equipment. But
surprisingly, researchers1 found that most incidents occurred during the middle of a
case, which also is the time when the anesthesia personnel have the least to do and
can be less diligent in their attention to the patient. Indeed, only 2% of the failures (6
out of 359) documented in the study were due to machine failure of some sort. It
seems an anesthesia machine is as safe as the person using it.
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No Room for Error
A certain type of repair person is needed for anesthesia service. The machines are
straightforward, but the consequences of failure can be devastating—they are among
only four or five items in the entire hospital that are truly “life support” (others include
ventilators, heart–lung bypass pumps, and pacemakers). The person who works on
anesthesia machines must, above all, be someone who always follows procedures.
Diligently following all checkout procedures and postrepair tests is the final critical
step every time you touch a machine. These checkouts are designed to determine
whether a repair is done correctly or not. Life-support equipment is no place to cut
corners or rush through a repair or preventive maintenance check.
It doesn’t require a senior-level BMET to service anesthesia machines, though. I
have taken recent graduates from a BMET school and sent them to a manufacturer’s
school, and they have been very successful when working under the guidance of a
seasoned BMET. It is the personality and attention to detail that determines their
success. There is no room for error in anesthesia service.
References:
http://www.tradekey.com/ks-anesthesia-unit/
http://www.pjr.com/china/ISO_13485.htm
http://www.pjr.com/china/ISO_13485.htm
http://mohfw.nic.in/Anesthesia%20Machines.pdf
http://209.85.129.132/search?q=cache:ovks5VBrjwJ:www.iso.org/iso/catalogue_detail.htm%3Fcsnumber%3D11385+Anaesthetic+mac
hine+ISO+standards&cd=2&hl=tr&ct=clnk&gl=tr&client=firefox-a
http://www.springerlink.com/content/64454u7172746685/fulltext.pdf
http://www.somatechnology.com/MedicalProducts/Ohmeda%20Excel%20210%20SE
.asp
http://www.medikalborsa.com/index.php?blm=urunler&is=goster&urunno=991
http://en.wikipedia.org/wiki/Anaesthetic_machine
http://www.tradekey.com/ks-anesthesia-machine/
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