Annex A – Anaesthesia Unit, Mobile, Full System
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Annex A
Technical Specifications for Anaesthesia Unit, Mobile, Full System ______
Technical Specifications for Anaesthetic Unit, Mobile, Full System
1.Functional Requirements
1.1The system is intended to provide means for administering an inspired gas mixture of Air, Oxygen, Nitrous Oxide and the vapour of a volatile liquid anaesthesia and for varying the proportions to control the patient's depth of anaesthesia during surgery.
1.2The system is intended for use in operating rooms, emergency rooms and any areas where anaesthetic gas/agents are used.
2.General Requirements
2.1The system is expected to include :
a)Anaesthetic unit;
b)Anaesthetic Ventilator;
c)Vaporisers;
d)Breathing circuits;
e)Scavenging system; and,
f)Mobile cart.
2.2The system shall comprise of three (3) basic sub-systems namely :
a)a gas supply and control circuit;
b) a breathing and ventilation circuit; and,
c) a scavenging system
2.3The system shall be mobile in design and equipped with heavy duty anti-static, swivel-type castors for ease of manoeuvring.
2.4The unit shall be equipped with a braking system to completely immobilize the system when necessary.
2.5The system shall be equipped with a stainless steel top instrument shelf for patient monitoring devices and drawer cabinet for accessories at the lower part of the trolley.
2.6The system shall be fully equipped with CO2 absorber, active gas scavenging system, mounting for ventilator and manifold for at least two vaporizers.
2.7The system shall be integrated with at least one oxygen power outlet to drive auxiliary devices and suction control.
2.8The system shall be equipped with a selectable valve (bag to ventilator) for providing either manual or mechanical ventilation.
2.9The system shall have low flow anaesthesia capability at fresh gas flow of 750 millilitre per minute.
2.10The system shall be equipped with a suitable interface port and capable of connecting, interfacing to any commercially available Patient monitoring System, Anaesthesia Information System (AIS), Clinical Information Systems (CIS) and other healthcare system connected in a hospital-wide network. The unit shall allow information to be transferred between the unit and other healthcare information system found in the hospital. The Tenderer shall compulsorily provide the detailed communication protocol of the unit as and when requested.
2.11The system shall be designed to permit extension or upgrades to more advanced systems and
capabilities. Documentary evidence in support of upgradeability shall be furnished during the
submission.
3.Electrical Requirements / Gas Requirements
3.1The unit shall be capable of operating :
a) on both a.c. power supply and its own internal rechargeable battery;
b) on its internal battery with full functional operation for at least thirty (30) minutes; and
c) on a.c. power supply even when its internal battery is completedly depleted. The system
shall fully conform to IEC 60601-1.
3.2The system shall be equipped with power outlet distribution box for connections of at least three auxiliary devices.
3.3The battery charger shall be built in to the system with total patient isolation.
3.4The unit shall be protected from transient power disruptions during use. The disruption shall not
affect the performance of the unit.
3.5Any loss of power shall not affect the retention of stored data.
3.6The system shall be capable of delivering the following gases :
a.Oxygen;
b. Nitrous Oxide; and,
c.Air.
3.7The system shall be capable of operating on either pipeline or cylinder gas.
3.8Pipeline input :
a.Oxygen: 200 - 700 kPa
b.Air:200 - 700 kPa
c.Nitrous Oxide: 200 - 700 kPa
d.Each input shall be equipped with filter and check valve.
e.The system shall use connections, compatible to existing TanTockSengHospital or NHG 1- Health(At Ang Mo Kio) gas outlets.
f.Each input shall be equipped with pressure gauge to indicate supply pressure.
3.9Cylinder input :
a.The system shall use CGA pin indexed yokes.
b.The system shall have facilities for :
i)one (1) size E, oxygen cylinders,
ii)one (1) size E, nitrous oxide cylinders; and,
iii)one (1) size E, compressed air cylinder.
Each facility shall be equipped with individual cylinder content pressure gauge.
c.Each input shall be equipped with filter and check valve.
d.Each input shall be equipped with pressure regulator, with diaphragm minimum burst pressure 1,750 kPa and preset regulated gas output at 414 kPa
3.10Regulated gas outlet pressure relief: 690 kPa
3.11Each gas outlet shall be equipped with a low pressure gauge to indicate supply pressure.
4.Safety Requirements
4.1The construction of the unit shall ensure a sufficient degree against safety hazards caused by overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilisation and disinfection.
4.2The enclosure shall be secure and provide adequate protection against moving and electrically energised parts.
4.3Switches and controls should be protected against penetration of fluids.
4.4Switches and controls shall be protected against accidental setting changes.
4.5The controls (i.e. switches, knobs, etc.) should be visible and clearly identified, and their function should be self-evident. Device design should prevent misinterpretation of displays
and controls settings.
4.6The system should resist tipping over during use and transport.
4.7The breathing system shall be fully autoclavable and latex-free
5.Standards
5.1The system shall fully conform to the following standards :
a)IEC/EN 60601-1, general requirements for Safety for electromedical equipment;
b)IEC/EN 60601-1-2, Standard for Electromagnetic Compatibility;
c)IEC/EN 61000-4-x series requirements for Electromagnetic Compatibility;
d)IEC/EN 60601-2-13, (1989), Particular requirements for the safety of Anaesthetic machines;
e)ISO 5356-1 (1987), Standards for Anaesthetic and respiratory equipment - Conical connectors and sockets.
f)ISO 5356-2 (1987), Standards for Anaesthetic and respiratory equipment - Conical connectors and Screw-threaded weight-bearing connectors;
g)ISO 9396 (1992), Standards for Anaesthetic and respiratory equipment - Heat and moisture exchangers for use in humidifying respired gases in humans;
h)CAN3Z168.4-M83 (1983), Canadian Standards for keyed filling devices for Anaesthetic vaporisers;
i)ISO 5360 (1990), Standards for Agent-specific filling system in Anaesthetic vaporisers;
j)ISO 5352 (1986), Standards for Anaesthetic reservoir bags;
k)CAN3-Z16.3-M84 (1984), Canadian Standards for Continuous-flow inhalation Anaesthetic apparatus for medical use;
l)ISO 5358 (1992), Standards for Anaesthetic machines for use with humans;
m)CAN/CSA-Z305.2-M88 (1988), Canadian Standards for low-pressure connecting assemblies for medical gas systems;
n)Singapore Society of Anaesthesiologoists functional requirements and features of an Anaesthesia Unit;
o)BS 6834 (1987), scavenging system;
p)ISO 5358 (1980), continuous flow inhalation anaesthetic apparatus for use with humans;
q)BS4272 part 3 (1989), specifications for continuous flow anaesthetic machines.
r)IEEE 1073, Medical Information Bus (MIB) - tenderer must provide a IEEE 1073
standard data interface embedded within the device;
s)shall have FDA clearance.
5.2Contractors have to comply with Health Science Authority (HSA) Medical Device Regulation requirements for all classes of medical devices. A copy of the HSA registration certificate must be submitted together with the tender submission.
6.Technical Requirements
6.1Three-gas rotameter :
a.The system shall be designed such that any adjustment of ratios or rapid gross changes in flow rates will not induce system interactions that cause temporary delivery of undesirable mixtures.
b.The flow of each gas shall be controlled by a valve and indicated by glass-tube flowmeter. Small rotations of the control knob should not result in large flow changes
c.Flowmeter bobbins (if used) should be visible in any location from the top to the bottom of the tube. Bobbins should be of one-piece construction to prevent loss of weights or other part during disassembly or cleaning; they should bear markings that clearing indicate whether they are rotating rather than adhering to the tube wall.
d.Each flowmeter should be labeled with the name of the constituent gas it is intended
to measure and the units of indicated flow.
e.Each flowmeter shall be equipped back-lighting features for visibility in dim lighting
conditions. This shall be quoted as an option.
f.The control valve shall require turning thru' at least 90 to change flow rate
from 10 to 100 %.
g.The system shall have different size, shapes and color knobs for oxygen, air and nitrous
oxide. Oxygen, Air and Nitrous Oxide shall be coded white, white & black, and blue respectively.
h.The design shall be such that the oxygen valve is located on the left-hand of the rotameter. Oxygen should enter the common gas manifold closest to the common gas
outlet to minimise the loss of oxygen and the delivery of hypoxic mixtures in the event of a gas leak upstream.
i.The system shall be preferably equipped with a ratio controller for oxygen and nitrous oxide so that the oxygen concentration level cannot be reduced below a percentage of not less than 25%.
j.Flow delivery :
i)Oxygen, range, adjustable: 0.2 - 10 l/min
ii)Air, range, adjustable: 0 - 14 l/min
iii)Nitrous Oxide, range, adjustable : 0 - 10 l/min
iv)Accuracy: ± 10 %
k.The system shall be equipped with a fail-safe device to protect the patient against a fall in pressure of oxygen.
i)The device shall activate when oxygen pressure drops within the range of 138 - 207 kPa.
ii)The device shall either shut off flow of all gases or reduce all gas flows in proportion to the drop in oxygen pressure.
l.The system shall be equipped with an undefeatable audible low oxygen pressure alarm that will activate between range 193 - 221 kPa.
m.The system shall be equipped with a safety device that allow patient to breath ambient air spontaneously during an oxygen supply failure.
n.The system shall be equipped with pressure relief device at the common gas outlet.
Relief pressure : 27 - 38 kPa at 200 ml/minute.
o.The common gas outlet shall be of non-swivel type with dimensions to fit standard
22/15 mm conical connectors.
p.The system shall be equipped with separate oxygen flush circuit.
i)The oxygen flush flow shall bypass the flowmeters and vaporizers and shall not cause change in the gas flow thru' them when activated.
ii)The oxygen valve shall not be lockable.
iii)Oxygen flush flow rate: 35 - 75 l/min
iv)Oxygen flowmeter drop: ≤ 0.2 l/min at 2 l/min flow
v)Recovery time : ≤ 2 s
q.The system shall have a separate Oxygen flowmeter to provide oxygen to patients under
regional anaesthesia.
6.2Vaporizers
a.The vaporisers shall be for Sevoflurane.
b.The vaporisers shall be temperature, flow and pressure compensated so that the output will be constant.
c.A safety feature shall be incorporated on the control dial of vaporizer to prevent accidental displacement of the dial from OFF position.
d.The design shall be such that the setting can be performed using only one hand.
e.The concentration scale shall be in % of the anesthetic agent vapour per total volume (v/v).
Range, adjustable: OFF, 0 - 18%
Accuracy: ± 0.3 % vapour at oxygen flow of 4 l/min
f.The vaporizers shall be equipped with a safety interlock system which will ensure the following :
i)the vaporizers must be locked onto the manifold before it can be turned on;
ii)gas flow will only enter the vaporizer when turned on;
iii)minimum unwanted anesthetic trace vapour after vaporizer is off; and,
iv)only one vaporizer can be turned ON at any time if more than one vaporizers are mounted.
g.Identification label, containing information regarding vaporizer type, vaporizer name, identification code and agent name, must be affixed on vaporizer.
h.Resistance to gas flow at oxygen flow rate of 5 l/min :
With control dial at OFF position: 5 cmH2O
Delivering vapour: 21 - 29 cmH2O
i.The vaporisers shall have safety features to ensure filling of correct agent with keyed
adaptor filling or agent specific bottle filling.
j.The minimum volume of anesthetic agent to fully fill the vaporiser shall be not less than 125ml.
6.3Breathing Circuit
a.The unit shall be capable of using a Paediatric T-piece system, circle system, Bain
circuit or universal F circuit.
b. The breathing circuit shall complete with adjustable mounting post.
c.Airway pressure gauge be incoporated to indicate pressure with the circuit during IPPV.
6.4CO2 Absorber
a.The absorber shall be equipped with a valve switch which will provide the feature of bypassing the soda lime canister assembly without physically removing.
b.The absorber shall be equipped with one inspiratory and one expiratory non-return valves.
c.The absorber shall have a minimum capacity for CO2 absorption for 6 hours under normal circumstances with Fresh Gas Flow of 1000 millilitre per minute.
d.The soda lime canister of the absorber shall be constructed of transparent material.
e.The absorber shall preferably utilize self-indicating high activity soda lime.
f.The absorber shall be designed such that the soda lime canister may be removed for replenishing while the absorber is in use without affecting the functioning of the circuit and ventilation.
g.The absorber shall have drainage facility for condensing moisture.
h.The absorber shall be equipped with an adjustable pressure-limiting valve.
Operating range: 0.1 - 7.5 kPa
i.The absorber and the gas delivery block including the valve housing shall be autoclavable.
j. The absorber shall be equipped with a selectable valve for providing ventilation mode selection of either ventilator or manual bag.
k.The absorber shall preferable be able to be mounted and rotated through an angle of at
least 90degrees.
l.The absorber shall preferably be capable of mounting on either the left side or right side of the system.
6.5Anaesthetic Scavenger System
a.The scavenger system compatible to the hospital centralised scavenging system and shall be designed to extract waste and excess gases from the patient circuit into the hospital central scavenging disposal vacuum system.
b.The scavenger shall be equipped with a flow indicator.
c.The scavenger shall be equipped with filter and filter condition indicator.
d.Maximum vacuum: -0.5 - 0 cmH2O
Vacuum at 10 l/min O2 flow rate: near ambient
Maximum pressure with vacuum hose occluded: < 10 cmH2O
6.6Central Alarm Control/Display for the following :
a.Low/high Airway pressure;
b.Low/high Inspiratory pressure ;
c.Low Minute volume; and,
d.Low/high Oxygen concentration as an option.
6.7Oxygen Monitor (If Optional,please state)
a.Minimum measuring range: 0 - 100 %
b.Accuracy: ≤ ± 2 %
c.Alarm limits, adjustable- high: 25 - 100 %
- low: 18 - 90 %
6.8Airway Pressure Monitor (If Optional, please state)
a.Range:-20 to 120 cmH2O
b.Accuracy: 3 cmH2O
cDisplay resolution:1 cmH2O
d.Alarm pressure limit:+ 20 to 100 cmH2O
6.9Respiratory Volume Monitor (If Optional, please state)
a.Tidal volume range:0 to 999 ml
b.Minute volume range:0 to 99.9 Litres
c.Breathing rate:0 to 100 breath/min
d.Accuracy:5%
7.Standard Accessories
7.1All standard accessories and consumables shall be listed with itemized prices and included in the base price.
7.2The standard accessories shall included the following items :
a.cylinder wrench x 2;
b.Sevoflurane vaporiser complete with specific key-filler and all necessary accessories must be included as standard item;
- Absorber complete with absorber mounting post and all necessary accessories;
d.APL and ventilator/bag valve;
e. Gas scavenging system and all necessary accessories;
f.Test lung;
g.Airway pressure gauge;
hThree (3) nos. of 6-meter length color code high-pressure hoses with non-interchangeable quick-coupling probes for coupling the unit to pipeline medical gas outlets on the medical gas service pendant; the quick-coupling probe to be supplied shall match the medical gas outlets in the existing TanTockSengHospital. The color for the high-pressure hoses should be White for Oxygen,White&Black for Air and Blue for Nitrous Oxide.
i.all necessary accessories, cables and connectors necessary for safe and smooth operation of the system.
7.3Please note that failure to include all the a/m standard accessories in the base price or inability to supply all the a/m standard accessories will result in disqualification of the tender.
8.Optional Accessories
8.1All optional features shall be listed.
8.2All optional accessories shall be listed with itemized prices.
8.3The optional accessories shall include :
a)Isoflurane vaporiser;
b)Halothane vaporiser;
c)Desflurane vaporiser;
d)Bain circuit connector.
e)Disposable CO2 Absorber;
f)Oxygen sensor;
g)PEEP valve;
h)Spirometer; and
I)Electronic pressure monitor.
9.Installation / Commissioning Requirements
9.1The Contractor shall inspect the site and fully acquaint himself with the nature of the work and the local conditions and facilities available, including water, drainage, ventilation and air-conditioning, where the Article is to be installed, before submitting his tender. He should also utilise other means he may prefer or consider necessary in order to fully ascertain other matters, site accessibility to equipment, conditions or constructions that may have a bearing on, or in any way affect the preparation of his tender. No claim for extra payment will be entertained by the Hospital owing to the Contractor’s neglect in this regard and any unforeseen difficulties for which provision is not made. This will in no way relieve the Contractor from the full execution of all works necessary to complete the installation. A Contractor, by the fact of submission of a tender, shall be deemed to have accepted all conditions and stipulations of this clause, which shall be binding on the Contractor.
9.2For the testing & commissioning and thereafter for the warranty preventive maintenance & corrective maintenance or on service contract preventive maintenance & corrective maintenance, the contractor shall be represented by competent staff, suitably equipped with all necessary calibrated test and measuring instruments including electrical safety analyser with printout, who shall test and commission or performing the preventive maintenance the Articles in the presence of and to the satisfaction of the Company’s authorised representatives. The Contractor must perform the electrical leakage safety test for the equipment during commissioning and for every preventive maintenance servicing during warranty preventive maintenance & corrective maintenance or on service contract preventive maintenance & corrective maintenance with no cost to the hospital.( Please refer SCC.3, Clause 11 for details )
9.3The testing and commissioning of the Article shall be in accordance with clause 11 of *SCC.3 called under Material Management Department. No payment shall be made if any of the stated requirements under this clause were not met. Notwithstanding the incomplete acceptance of the Article, the Company has the right to utilise the Article while waiting for any incomplete supply , measurements , testing and training to be delivered.