PURCHASE OF MEDICAL DEVICES: INCUBATOR, SHAKER, AUTOMATIC PRESSES AND SEPARATOR

Platelet Cell Concentrate storage system, consisting of an incubator to maintain the desired temperature during storage of platelet preparations and an incubator-compatible shaker for mixing containers with platelet preparations. Incubator requirements:

1. A device that is a medical device.

2. Appliance bearing the CE mark.

3. External dimensions of the device - maximum: 1050 x 760 x 665 mm (width x height x depth).

4. Internal dimensions - maximum: 965 x 505 x 485 mm (width x height x depth).

5. Weight up to 80 kg.

6. Volume up to 50dB.

7. Power consumption: up to 1.5 kWh/day.

8. Operating temperature range from 20°C to 35°C

9. Required operating temperature of the device 22°C ± 2°C, with ambient temperature 15-25°C and relative humidity.

10. Power supply 230V, 50-60Hz.

11. The materials used in the manufacture of the appliance should be resistant to adhesion of bacteria, allowing easy cleaning and disinfection.

12. Temperature sensor made of stainless steel. Sensors should be calibrated – the Contractor will provide calibration certificates upon delivery.

13. Environmentally friendly foam insulation free of CFC, HFC and HCFC.

14. Gas-free cooling system – environmentally friendly forced air heat pump.

15. Glazed doors equipped with a lock, opening upwards and retractable in the compartment of the device.

16. Opening the door stops the shaker and closing the door resumes the process of shaking the preparation containers.

17. Internal power supply to the shaker.

18. Control panel located above the door of the machine.

19. The device should be equipped with an alarm – at least an audible one of adequate volume regarding the lack of power, exceeding the temperature (too high and too low).

20. Extensive microprocessor control system equipped with a colour touch screen, comprising:

a. displaying the current temperature in the chamber,

b. displaying the current alarm status,

c. displaying unapproved alarms,

d. password-protected settings,

e. power alarm,

f. open door alarm,

g. too low and too high temperature alarm,

h. graphical graph of the temperature in the chamber from the last 24 hours,

i. emergency battery power allowing the screen to work with alarm functions for up to 18 hours,

j. low battery alarm for uninterruptible power supply,

k. control and monitoring of the operation of the connected shaker in the range of its movement (speed and number of cycles) and the status of the connection,

l. the ability to download the collected data to a USB memory,

21. Temperature disc recorder:

a. without ink, using pressure-sensitive paper

b. Range 0° to 35°C

c. Electronic drive

d. Battery back up for continuous operation

e. Membrane buttons for changing the dial and calibration

f. Battery charge indicator

g. temperature sensor made of stainless steel

22. Possibility of connecting an external monitoring system by installing a temperature sensor inside the incubator. It is required that the Contractor, as part of the installation qualification, prepares the entrance for monitoring of the Contracting Authority.

23. The incubator must be compatible with the shaker offered.

B Requirements for the shaker:

1. Pull-out drawers/shelves with a capacity of not less than 32 plate containers (KKP) with a capacity of 1000/1300 ml.

2. Shelves/drawers for air circulation.

3. Containers arranged on a shelf/drawer, in a way that ensures air circulation with 2-3 cm spacing between containers.

4. Arrangement of containers only perpendicular to the door of the incubator.

5. The material from which the shelves/drawers are made, allowing washing and disinfection.

6. Power supply 230V, 50-60Hz.

7. Energy consumption: 0.27 kWh/day.

8. Volume up to 50dB.

9. The shaker should be equipped with an ON/OFF button.

10. The device shall have an audible and visual alarm of power failure and lack of movement.

11. Emergency battery power allowing the alarm system to work for up to 2 hours.

C Other device requirements – package I:

1. Brand new devices, manufactured not earlier than 2023.

2. Warranty for the devices for a minimum of 24 months from the moment of signing the delivery and acceptance protocol.

3. The Supplier shall provide free transport of the device to the place indicated by the Ordering Party.

4. The Supplier shall provide authorized service in the Polish.

5. During the warranty period, the supplier undertakes to perform free warranty inspections during the periods indicated by the ordering party or required by the manufacturer of the device.

6. Service with equipment (with current calibration certificates not older than 1 year) enabling repairs and service inspections with the qualification of the device.

7. The deadline for delivery of devices up to 12 weeks from the date of signing the contract.

8. Together with the device, the Contractor shall provide instructions for use in Polish.

9. The Contractor shall carry out the installation and operational qualification of the device – together with relevant documents confirming the correct execution of these processes.

10.The Contractor shall conduct the training for users and confirm with the relevant Training Protocol.

In order to confirm that the offered devices meet the requirements specified by the Ordering Party, the Ordering Party requires the following documents:

1) Declaration of conformity confirming the marking of products with the CE mark,

2) Declaration confirming that the offered device is a medical device.

3) Technical specificity confirming compliance with the requirements of the Ordering Party.

Automatic presses for preparation of whole blood and blood components with necessary equipment and software – pieces 2.A. Requirements for the device:

1. Devices marked with CE mark, registered as a medical device.

2. External dimensions of the device - maximum: 60 x 50 x 55 cm (width x height x depth).

3. Maximum weight of the device with scales – 50 kg.

4. Electric presses.

5. Each press shall constitute an independent and independent workplace.

6. A device enabling the preparation of whole blood collected into various types of containers (up-up, up-down, also with integrated in-line filters) in triple and quadruple configurations, of all manufacturers offering containers in Poland.

7. Possibility of preparation based on basic blood components, i.e. e.g. poured KKP.

8. Device software in Polish.

9. Short separation time of whole blood after centrifugation, collected into all types of containers, including an in-line filter for KCz (no more than 5 minutes).

10. The device is equipped with a system of automatic opening of the connectors (mother container, container for KKCz and container with enrichment liquid).

11. Equipped with an in-line filter holder ensuring the correct position of the filter during venting and preparation.

12. Function of adding enrichment solution to KCz in automatic mode in a controlled manner (not by gravity).

13. Equipped with automatically (without operator intervention) closed and opening door allowing easy hanging of the container with centrifuged blood without the risk of shaking.

14. The device is equipped with 6 welding heads, enabling welding in automatic mode. Five heads are placed above the whole blood container and one below. Wide welds with perforation for easy separation of drains without tools.

15. All heads equipped with optical sensors

16. A device equipped with scales (three separate) for measuring the mass of blood components obtained with the function of transferring the net or gross weight to the computer system.

17. Equipment equipped with four independent moving parts (presses) responsible for separation processes.

18. Device equipped with a barcode reader that scans ISBT 128 compliant codes.

19. Automatic test of press components, when it is switched on. The press has a daily weight control program, enabling visualization of the obtained results, generating reports and printing them (in cooperation with a computer system).

20. Plasma weight with plasma container venting function

21. Automatic checking of the correct placement of the set drains in the individual head terminals according to the selected program, before starting the separation procedure.

22. Colour LCD display informing about the current stage of the separation process and indicating any irregularity (e.g. failure to place the drain in the head).

23. Control of the course of separation of whole blood by a set of optical sensors placed in upper and lower presses (8 sensors in total) and heads (6 sensors).

24. Equipped with a durable memory that allows storing data from min. The last 500 procedures for blood division in the absence of communication with the computer.

25. The set contains all components necessary to start wireless transmission from the device to the computer.

26. Possibility to enter 50 separation programs that will not be lost when the device is disconnected from the power source.

27. The ability to independently create or customize separation programs (regulation of the volume of leukocyte-plate sheepskin) depending on the needs of the user, without the intervention of the service.

B. Software requirements:

1. Barcode scanning capability turned off when the machine does not perform separation process.

2. Visual confirmation of the correctness of the read bar codes (on the control panel).

3. Separation lock if all required barcodes are not read.

4. Entering specific operator codes into the system.

5. Ability to display currently read barcodes on the control panel

6. Possibility of recording and archiving separation parameters such as:

a. data

B. Start time

c. End time

D. Total Process Time

E. Identification number

f. Process result / status

G. Programme number

h. Operator code

I. Results of checks on the indications of instruments

J. plasma weight

k. the weight of KKCz,

l. Donation numbers

7. The device has the function of wireless data transfer to the computer system that supports it. In the event of a temporary loss of communication with the system, the device automatically enters data collection mode and automatically transmits data when the connection is resumed.

8. The Supplier shall ensure full transmission of data from the presses to the "Blood Bank" system – currently in the future E-blood, i.e.:

A. Donation number

b. time and minute of the start and end of the process

c. Operator code

D. Date

E. Identification number

f. Total separation time

g. the weight of the individual blood components.

9. The Contractor shall ensure proper transmission (In technical matters regarding data transmission to the "Blood Bank" system, please contact Asseco Poland with its registered office in Katowice). The launch of data transmission to the Blood Bank system is on the side of the Contractor, while the final license for transmission must be transferred to the Ordering Party.

10. Ability to create ready-to-print separation reports from a given day, including: date, time and minute of start and end, total time, device number, program number, donation numbers, operator code, weights of individual blood components, separation status.

11. Possibility to check the indications of scales for plasma and KKCz using calibration weights of 200 g or 500 g. The result of the check must be visible on the printout of the daily separation.

12. Press software allows you to interrupt the separation program, pause the separation program, select the appropriate separation program, assign parameters to a given separation program, password protect access to the software and direct selection of the separation program, calibration of press and slide scales, press cleaning, selection of software language, alarming problems and errors during operation.

13. Possibility to create collective reports on the total time of performed processes, the number of separation processes divided into individual devices.

14. Data archiving – computer files, printouts.

15. Determining the scope of access divided into service/administration; supervisor/manager and user.

16. The Contractor shall ensure that the software managing the transmission from devices to the computer and data archiving is updated along with validation throughout the duration of the contract and after its completion.

C. Requirements for qualification of the device for use:

1. When installing and commissioning the equipment by an authorized service, installation, operational and process qualification must be carried out in accordance with the current GMP requirements. Procedural qualification in cooperation with the Ordering Party. Documentation confirming the execution of these processes should be prepared in Polish.

2. Staff training: Certificates of personnel training in the operation, operation and maintenance of the equipment.

D. Other requirements for the device:

1. Brand new devices, manufactured not earlier than 2023.

2. Warranty for the devices for a minimum of 24 months from the moment of signing the delivery and acceptance protocol.

3. The Supplier shall provide free transport of the device to the place indicated by the Ordering Party.

4. The Supplier shall provide authorized service in the Polish.

5. During the warranty period, the supplier undertakes to perform free warranty inspections during the periods indicated by the ordering party or required by the manufacturer of the device.

6. Service with equipment (with current calibration certificates not older than 1 year) enabling repairs and service inspections with the qualification of the device.

7. The deadline for delivery of devices up to 12 weeks from the date of signing the contract.

8. Together with the device, the Contractor shall provide instructions for use in Polish.

In order to confirm that the offered devices meet the requirements specified by the Ordering Party, the Ordering Party requires the following documents:

1) Declaration of conformity confirming the marking of products with the CE mark,

2) Declaration confirming that the offered device is a medical device.

3) Technical specificity confirming compliance with the requirements of the Ordering Party.

Separator for plasma collection by automatic plasmapheresis compatible with sets currently used in the Department of Donors and Collection for plasma collection – Plasmacell C – 1 pc.1. Device new year of manufacture 2023

2. Being a medical device.

3. Bearing the CE mark.

4. Powered by 230V.

5. Maximum power consumption 350W

6. The device is equipped with locking wheels, which are an integral part of the camera.

7. Weight maximum 43kg.

8. Camera height at least 150 cm – the control panel is at eye level.

9. Used for plasma collection by automatic plasmapheresis.

10. Possibility of obtaining 600 – 800 ml of plasma from one donor.

11. Separator guaranteeing continuous flow of donor blood providing an extracorporeal volume of less than 200 ml.

12. Uses saline solution to prefill the kit and provides the possibility of compensating for the collected plasma with salt during or at the end of the procedure.

13. Number of red blood cells remaining in the set at the end of the procedure:

a. less than 10 ml for the procedure without reinfusion of salt,

b. less than 3,5 ml for the saline reinfusion procedure.

14. Parameters to be met by the collected plasma:

a. Less than 50 × 109/l platelet cells,

b. Less than 0,1 x 109/l white blood cells,

c. Less than 6 x 109/l red blood cells.

15. Control the camera using the touch panel. Understandable for the camera interface – messages in Polish and/or in a graphic way (e.g. icons) allowing intuitive identification of functions by the operator.

16. Device equipped with a system of automatic control of flow from the donor vein (automatic reduction of flow velocity in case of problems with pressure in the vein).

17. Display for the donor on both sides of the apparatus, indicating the status of the procedure and the need to work with the hand.

18. Optical and audible alarm system. An optical signal on the top of the device that allows you to identify the alarming device from a greater distance.

19. Possibility to change the entered donor parameters and procedure during the procedure.

20. Plasma collection container cover to ensure correct weighing of the product during the procedure.

21. Equipped with a bar code reader compliant with ISBT 128 and EAN 128 standards.

22. Device with the possibility of starting data transmission to the ICT system.

23. Separator software and displayed messages in Polish.

24. Device manual (in Polish) – provided during installation.

25. Authorized service in Polish.

26. Warranty required 24 months and free technical inspections during this period.

27. The Contractor shall provide free of charge activities related to the installation and operational qualification of the device and training of employees. The contractor shall provide documentation of the installation and operational qualification process, staff training and a handover protocol.