Public procurement notice: Contract Notice
Published: 2024-08-14
Region: MK008
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33100000
Estimated value: 12000000 MKD
Submission deadline: 2024-08-29
Award criteria: price

Technical requirements: 1 Mechanical ventilation system for children and adults
2 Mechanical ventilation system for children and adults with an automatic weaning protocol
3 Bronchial aspirator for intensive care
- Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered. 
– Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
- Certificate for at least 2 trained service engineers who have attended service training at the equipment manufacturer for the same or related device (mechanical ventilation device). The person to whom the certificate refers is employed by the bidding company
-Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered
- Submission of an Authorization from the manufacturer of the offered device for participation in the procurement and further
servicing 
- Decision for placing medical device on the market, with correctly marked positions that are subject to procurement, in accordance with the Law on Medicines and Medical Devices.
- statement of the economic operator that no effective verdict has been pronounced against the economic operator within the past five years for a committed crime stated in Art. 88, paragraph 1 of the LPP;
- certificate stating that no bankruptcy procedure has been initiated by a competent body;
- certificate stating that no liquidation procedure has been initiated by a competent body;
- certificate of paid taxes, contributions and other public duties issued by a competent body in the country where the economic operator is registered;
- certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - ban on participating in open call procedures, awarding public procurement contracts and contracts on public - private partnership has been pronounced;
- certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - temporary or permanent ban on performing particular activity has been pronounced;
- certificate stating that no misdemeanour sanction - ban on the performance of the profession, activity or duty, i.e. temporary ban on the performance of a particular activity has been pronounced with an effective verdict.
1	The device can be used in intensive care both for children and adults
2	The device must be mobile and placed on a trolley with lockable wheels
3	The supply of medical gases should be centralized through a compressed air and oxygen system
4	The device should also have an external source for compressed air with an electric drive mounted on the trolley of the device, which should be independent of the central gas system
5	The device must have a battery of at least 30 minutes of operation
6	The device must be powered by 220V electricity and have a display of the battery status on the device's display
7	It should have a color screen of at least 18 inches, be touch-sensitive and have a resolution of at least 1360 x 760 pixels, and to have input and output ports with a minimum of 3 external RS232 connectors, a LAN port, as well as a minimum of 4 USB connections for data transfer.
8	At least 3 ventilation curves can be displayed on the screen simultaneously
9	The device must be able to deliver a set tidal volume under the minimum possible pressures - PRVC, Autoflow, ASV or equivalent
10	Different screen views possibilities showing curves, parameters, loops or trends, with a minimum of 6 different screen views
11	The ventilator should use a permanent method for measuring oxygen concentration without the need to replace the sensor - ultrasonic or paramagnetic probe
12	The device should have the following ventilation modes:
	Volume-controlled: VC-CMV, VC-SIMV, VC-AC, VC-MMV or ASV or equivalent
	Pressure-controlled: PC-BIPAP, PC-SIMV, PC-AC, PC-APRV, PC-PSV
	Spontaneous: SPN-CPAP, SPN-CPAP/VS, SPN-CPAP/PS
13	The device should have O2 therapy – application of a continuous flow of oxygen through masks or nasal cannulas, with an oxygen concentration setting of 21-100%, and a flow setting of 2-50l/min
14	The device should have a mode with variable pressure support - VPS
15	The device has special maneuvers to hold inhalation and exhalation (inspirium and expirium)
16	It has pressure support mode which commensurates with the patient’s effort PAV/PPS/NAVA or equivalent
17	The device should have a mode for non-invasive ventilation in all ventilation modes
18	The ventilator should have a capnography measurement using a sensor
19	Possibility of automatic calibration of the flow sensors, which can also be performed during ventilation
20	Upgradable software for graphic display of lungs with the ability to track changes in patient compliance and resistance
21	The ventilator should be able to display loops, and have the ability to record a minimum of 10 loops
22	The ventilator should have automatic tube compensation with the possibility of setting compensation from 0-100% (possibility of turning off compensation for mandatory breaths)
23	-	Tidal volume of 2ml-3l
24	-	Ventilation frequency from 0.5-150 per minute
25	-	PEEP adjustable 0-50 mbar
26	-	Inspirium time from 0.1 to 10 seconds
27	-	Pressure support (Psupp) from 0 to 95 mbar
28	-	Oxygen concentration adjustment from 21-100%
29	-	Trigger sensitivity setting from 0.2-15l/min
30	-	Inspiratory pressure rise time adjustable from 0-2 seconds
31	Monitoring parameters on the fan screen:
	-	Pressure (superficial, plateau, medium)
	-	Total MV, MV of spontaneous breathing
	-	Tidal volume VT
	-	Frequency of breathing (total, spontaneous)
	-	FiO2
	Capnography with measurement and display of parameters:
    * VCO2 – amount of exhaled CO2 per minute
    * VTCO2- amount of exhaled CO2 in expiration
	-	compliance
	-	resistance
	-	RSBi
	-	NIF
	-	Po.1
	-	trend minimum 30 days for patients who are on ventilation for a longer time
32	Consumables necessary for the operations should be delivered with the device, namely: 2 sets of reusable hoses for adult and pediatric patients, 50 filters, gas supply hoses, patient hose holder
33	A medication nebulizer and an active humidifier placed on the mechanical ventilation device should be delivered with the device.