Technical Specifications of Anesthesia Machine With Workstation.

Following are the minimum requirements. Products offered must meet these parameters herein.

Technical specifications/ composition of tender enquiry Compliance on each

parameter with detailed
substantiation how the
offered product meets
Sr. Remarks,
the requirement.
No if any
(Simply writing as YES/
Complied/ As per
BIS/CE/ISO terms is not
allowed)
A. Basic Unit:
General description:-
The unit should be a cost-effective, flexible anaesthesia
workstation for performing and monitoring inhalation
1 anaesthesia, suitable for Adult as well Child upto
neonatal age.
It should be capable of providing low-flow techniques to
minimize gas and anaesthetic agent consumption for
economical day-to-day operation
Integrated systems:-
The Anaesthesia Workstation should have
a. In-built Ventilator with Coloured TFT display.
b. Integrated CO2 Absorber.
c. In-built & Integrated Anaesthesia Gas Monitoring
Facility
2
d. Multi parameter monitor
e. All these components should be of the same
manufacturer or brand with their label on each
component. Both anaesthesia delivery system &
multipara monitor must be US FDA approved &
European CE Marked (Should be from notified
body).
Gas supply:-
The unit should be able to connect to Central pipeline &
3 there should be provision of One PIN Index Yoke to
connect to One Emergency Gas Cylinder of O2 & N2O
each.
4 Trolley:-
 The unit should have Powder Coated Steel Trolley with 4
Wheels & 1 or more Drawers & the front wheels should
have locking device.
The unit should have mounting facility to mount other
equipments.
Flow meters:-
5 Machine should provide electronic gas mixing with
digital control for O2, N2O and Air.
Hypoxia guard:-
It should have proven hypoxia guard design using the
Pin-valve Mechanism or equivalent mechanism. The unit
6 should equipped with Integrated Ratio System to
maintain 25 Vol% O2 in Fresh Gas & on accidental
opening of only N2O flow with O2 valve closed, the
Ratio system should automatically Open O2 Valve to
maintain 25 Vol% O2 in Fresh Gas.
Water & Particle Trap:-
7 The unit should have Water & Particle trap to the inlet
Central Gas Pipe-line connections of O2, N2O & AIR.
Patient Module:-
It should have fully autoclavable patient module having
anodized metallic casing.
It should have 34°C Heated Patient Module to deliver
8 Warm Fresh Gas to Patient & to prevent condensation.
The Patient Module should have Pressure Graduated
Metallic APL Valve, Inspiratory Valve, Expiratory Valve
,a Controlled Room Air Valve & Active Gas Scavenging
Port.
CO2 absorber:-
Patient Module should be integrated to the CO2 absorber
9 of 1.4 Kg & CO2 absorber should be Single/Double
chamber design having screw type threading for easy
removal & re-fitting during the operation.
O2 Flush:-
10 The unit should have O2 Flush facility to give
approximately 50Ltr/min flow.
Common gas outlet:-
11 The unit should have Common Gas Outlet for using open
circuit & the unit should have easy change over from
open circuit to closed circuit or vice-versa.
Vaporizers:-
12
It should have provision to connect Two Selectatec
 mount vaporizers & the unit should be provided with
Two vaporizers equivalent to TEC-7 type ,One of
Isoflurane& One of Sevoflurane.
B. Inbuilt Anesthesia Ventilator:
Ventilator:-
It should have Integrated Microprocessor Controlled &
1 Pneumatically Driven Ventilator with bellows and the
same bellows should be useful for Pediatric& Adult
Application, thus avoiding change of bellows
Modes:-
2 It should offer Ventilation Modes such as Manual,
Spontaneous, CMV Adult & CMV Child & PCV Adult
& PCV Child , SIMV & PSV
I:E ratio:-
The unit should offer I/E Ratios : 1:1, 1:1.5, 1:2, 1:2.5,
3 1:3, 1:4, 1:5 with I/E Inverse Ratios: 2:1, 3:1 & 4:1
(PCV); PEEP: 0-15mbar ± 2mbar, Tidal Volume: 20-
1400 ml
Display:-
4
It should have a high contrast color TFT Display.
Self test:-
5 It should be equipped with self test routines and
automatic calibration of all sensors
Display:-
Display should indicate measured values: O2
(Paramagnetic), real time capnograph, anesthetic agents
6 (HALOTHENE
/ISOFLURANE/SEVOFLURANE/ENFLURANE/DESF
LURANE), Tidal Volume, Minute Volume, Frequency,
PEEP, Mean pressure-in graphic form with numerical
display.
Gas Monitioring:-
The In-built Anesthesia Gas Monitoring Facility should
based on side-stream technology, using Infra Red
Photometry Principal & also it offer Automatice
Anesthetic Agent Identification
7 The unit should offer In-built Anasthesia Gas Monitoring
with following specifications:
CO2 Et. & In: Display: 0-10%, 0-76 mmHg
Accuracy: +/-0.5 Vol% or +/-12% rel.
Reaction time: <500 ms 150 ml/min
 N2O In & Et.: Display: 0-100
Accuracy: +/-2 Vol% Or +8% rel.
Reaction time: <500 ms 150 ml/min
O2 (paramagnetic) In & Et.: Display: 0-100%
Accuracy: +/-0.1%
Reaction time: <500 ms
150ml/min
Anesthetic agent:
Halothane, Isoflurane : Display: 0-8.5 Vol%
Enflurane, Sevoflurane : Display: 0-10 Vol%
Desflurane : Display: 0-22%
Accuracy : 0-1.15% or +15% rel.
MAC:-
8 It should have a display of MAC (Minimum Alveolar
Concentration).
Alarms:-
It should have clear alarms and user information as text
9 messages. It is essential that unit should prompt user for
corrective action rather than giving only alarm with no
diagnostic message
Test:-
The unit should perform the Leak Test & Sensor Test on
10 Start of the unit to know the leak volume or dead space
volume of tubings etc. & thus deliver exact Tidal Volume
to the Patient.
Fresh Gas De-coupling:-
11 The unit should have Fresh Gas De-coupling or
equivalent mechanism.
InternationalStandards:-
The unit should comply with International Standards &
12 should have CE Marking, DIN EN ISO 9001: 2000
Certification & EN ISO 13485: 2003 Quality Systems-
should have European CE Marking (should be from
notified body) and US FDA approved
C. Specifications for Multi Parameter Patient Monitor
Parameters:-
1 Should be capable of Monitoring Heart rate, SPO2 ,
NIBP, ECG, Temp, RR and IBP2(Upgradable to 4),
NMT,BIS/ENTROPY
 Display:-
2 Should have a Display of 15 inch and above diagonal
colour TFT display.
Operating system:-
3 Should operate through Rotary knob & Membrane
keyboard.
Fields:-
4
Should have 8 waveform fields.
ECG:-
5 Should have provisions to connect 3 or 5 Lead ECG
cables
NIBP:-
Should have NIBP measurement by Osillometric method.
6 - Should have Manual / Automatic modes of
measurement.
- Should have a measurement range of 20 to 250 mm Hg.
Invasive BP:-
-Should have 2 channel Invasive Blood pressure (IBP)
7
measurement.
- Should have waveform IBP1 and IBP2.
Temperature:-
8 Should have provision for Two temperatures with display
of T1 and T2.
Respiration:-
9
Should have Respiration by Impedance method
SPO2:-
It must use Nellcor /Masimo technology to measure
oxygen saturation for accuracy during motion artifacts,
low
10 perfusion states like shock, bradycardia and hypothermia
Should have SPO2 measurement with plethysmograph ,
digital value & perfusion index and SPO2 values with
range 50% to 100% .
and SPO2 values with range 50% to 100% .
Alarm facility:-
11 Should have Alarm facility for HR limits, Arrythmia, ST
Segment Limit, and all other parameter limits.
12 Graphs & Trends:-
 Should have 24 hr of Graphical and Tabular Trend for
NIBP, HR, SPO2, RR, IBP, IBP2, T1, T2, AWRR, ST.
Segment and CSI %.
NMT Monitoring:-
13 Integrated Neuromuscular Transmission Monitoring in
the primary monitor with all accessories. Display should
be in the primary monitor
BIS/Entropy:-
Depth of Anaesthesia Monitoring module -- BIS/Entropy
with BIS/Entropy all accessories &50 sensors
Should include inbuilt Anaesthesia record keeping
software facility in monitor to document anaesthesia
14 event using standardized menu based entries
Facility to store snapshots during critical events for
waveform review at a later stage.
Audio visual and graded alarming system.
It should provide slave display of 15 inches and above
with cable.
System ConfigurationAccessories,spares and
consumables:-
Should be supplied with the following Standard
Accessories.
15 1. 3 Lead ECG cable with cords- 02nos. & 5
Lead ECG cable with cords- 02nos.
2. SPO2 finger probe for Adult and Paedicatric
application.-2 each along with 2 connecting cable.
3. SpO2 Neonatal Probe.-2
4. NIBP cuff for conventional Adult, extra
large for adult and for Paediatric application – 2 each.
5. IBP Reusable Transducers with cable – 2
each.
6. Disposable IBP pressure transducers - 50
7. 2 Temperature Probes
8. Depth of Anaesthesia Sensors-50
9. Accessories for neuromuscular transmission
monitor-01 set
10. Disposable domes-50
11. Disposable Adult & Paediatric circuits-50
each.
11. HME filters-50
16 Environmental Factors:-
 - The unit shall be capable of operating continuously in
ambient temperature of 10 –40 deg C and relative
humidity of 15-90%.
- The unit shall be capable of being stored continuously
in ambient temperature of 0 –50 deg C and relative
humidity of 15-90%.
- Shall meet IEC-60601-1-2: 2001(Or Equivalent BIS)
General Requirements of Safety for Electromagnetic
Compatibility or should comply with 89/366/EEC;
EMCdirective.
Power Supply:-
Power input to be 220-240VAC, 50Hz fitted with Indian
plug
Voltage corrector/stabilizer of appropriate ratings
17 meeting ISI Specifications.
(Input 160-260 V and output 220-240 V and 50 Hz)
Should provide Suitable Isolation Transformer with true
online UPS with maintenance free batteries for minimum
one-hour back up should be supplied with the system.
Standards, Safety & Training:-
Should be US FDA and European CE approved
(Should be from Notified body) product
Shall meet the safety requirements as per IEC 60601-2-
27:1994—Medical electrical equipment—Part 2:
Particular requirements for the safety of
electrocardiographic monitoring equipment.
Manufacturer/Supplier should have ISO certification for
quality standards.
Should have local service facility .The service provider
should have the necessary equipments recommended by
the manufacturer to carry out preventive maintenance test
as per guidelines provided in the service/maintenance
manual
Back to back warranty to be taken by the supplier from
the principal to supply spares for a minimum period 10
years
Comprehensive warranty for 5 years after warranty for 2
yrs.
Documentation:-
Log book with instruction for daily, weekly, monthly and
quarterly maintenance checklist. The job description of
19 the hospital technician and company service engineer
should be clearly spelt out
The job description of the hospital technician and
company service engineer should be clearly spelt out.