Supply of pacemakers and cardioverters for cardiac electrotherapy laboratory

Package 1 – Dual-cavity stimulator – DDDR MRI with electrodes adapted to work in an MRI environment with wireless interrogation

Package no. 2 – Single-cavity stimulator PM-VVIR/AAIR adapted for MRI environment with wireless interrogation

Package No. 3 – DDD MRI two-cavity stimulator (replaced) with wireless interrogation

Package no. 4 – Single-cavity stimulator PM-VVI/AAI MRI with wireless interrogation

Package No. 5 – Cardioverter – single-cavity defibrillator with an electrode adapted to work in an MRI environment, enabling a view of the vestibule IEGM with MRI after implantation with wireless interrogation with accessories and telemonitoring

L.P. DETAILED ASSORTMENT UNIT. MEASURES QUANTITY 36 MONTHS

1.Dual-cavity stimulator adapted to work in MRI environment with wireless interrogation pcs. 300

2.Chamber electrodes active simple MRI pcs. 300

3.Atrial electrodes active simple MRI pcs. 300

4.Electrode implantation troductors 7-9 F pcs. 300

5.Cables in sterile packages of 1 pc. for intraoperative control compatible with the St. Jude Medical programmer used by the hospital pcs. 300

In consignment composition 10 devices

L.P. Required parameters Meet parameters

1.Stimulator life min 10 years (nominal settings) YES

2.Weight max. 28 g YES

3. Year of equipment production not earlier than the year preceding delivery to the recipient and the latest offer for the Polish market. YES

4.Pulse amplitude min.plot 0,2 - 7,5 [ V ] SO

5.Pulse width (A/V) min. range 0.1 - 1.5 [ms] YES

6.Cellular sensitivity - at least in the range of 0.5 - 7.5 [ mV] YES

7.Vestibular sensitivity - at least in the range of 0.1 - 7.5 [ mV] YES

8.AV spacing, programmable in min. 20 - 300 [ms] YES

9.Automatic polarity switching capability when electrode impedance range is exceeded YES

10.The device with electrodes certified for testing in MRI environment 1.5T without exclusion zones and 3T with exclusion zone YES

11.Refractive period A / V min. range 225 - 400 [ms] YES

12.Algorithm promoting own atrioventricular conduction YES

13.Program night YES

14.Hysteresis in both channels of the stimulator min 3 types YES

15.Has a function of adjusting the frequency of stimulation to the patient's metabolic needs YES

16.2:1 type conduction protection algorithm for atrial flutter YES

17.Algorithm automatically detects electrode polarity and automatically activates basic stimulator functions YES

18.Automatic change of stimulation mode in the presence of rapid atrial rhythms YES

19.Has automatic ventricular stimulation threshold and automatically adjusts ventricular stimulation parameters to measured stimulation threshold YES

20.Record electrode resistance trends throughout the life of the device YES

21.Ability to automatically switch polarity when the programmed impedance range is exceeded YES

22.Electrodes A and V active YES

23.Electrodes A i V sterydowe TAK

24.Introducery 7-9 F YES

25.Total IEGM record min.70 s YES

26.Has wireless telemetry YES

27.Atricular/ventricular electrodes passing through introducers ≤ 6F YES

28.Stimulator thickness ≤ 7mm YES

29.Ability to supply hardware with programmable MRI YES

30.Min. 2 programmers for the entire duration of the contract YES

31.Cables in sterile packages of 1 pc. for intraoperative control compatible with St. Jude Medical programmer used by TAK hospital

L.P. DETAILED ASSORTMENT UNIT. MEASURES QUANTITY 36 MONTHS

1.Single-cavity stimulator adapted for MRI operation with wireless interrogation pcs. 400

2.Active electrodes straight 52-63 cm MRI pcs. 400

3.Electrode implantation troductors 7-8 F pcs. 400

4.Cables in sterile packages of 1 pc. for intraoperative control compatible with the St. Jude Medical programmer used by the hospital pcs. 400

In consignment composition 10 devices

L.P. Required parameters Meet parameters

1.Stimulator life min 10 years (nominal settings) YES

2.Weight max. 28 g YES

3. Year of equipment production not earlier than the year preceding delivery to the recipient and the latest offer for the Polish market. YES

4.Pulse amplitude min.plot 0,2 - 7,5 [ V ] SO

5.Pulse width (A/V) min. range 0.1 - 1.5 [ms] YES

6.Sensitivity at least in the range of 0.5 - 7.5 [ mV] YES

7.The device with electrodes certified for testing in an MRI environment with parameters not worse than: 1.5T without exclusion zones and 3T with exclusion zone YES

8.Program night YES

9.Function of adjusting the frequency of stimulation to the patient's metabolic demand YES

10.Algorithm automatically detects electrode polarity and automatically activates basic stimulator functions YES

11.Has an automatic ventricular stimulation threshold and automatically adjusts ventricular stimulation parameters to the measured stimulation threshold YES

12.Record electrode resistance trends throughout the life of the device YES

13.Ability to automatically switch polarity when the programmed electrode impedance range is exceeded YES

14.Electrodes A and V active YES

15.Introducery 7-8 F YES

16.Total IEGM record min.70 s YES

17.Has wireless telemetry YES

18.Atri/ventricular electrodes passing through ≤ 7F introducers YES

19.Stimulator thickness ≤ 7mm YES

20.Min. 2 programmers for the entire duration of the contract YES

21.Cables in sterile packages of 1 pc. for intraoperative control compatible with St. Jude Medical programmer used by TAK hospital

L.P. DETAILED ASSORTMENT UNIT. MEASURES CAPACITY: 36 MONTHS

1.Two-cavity MRI swap stimulator with wireless interrogation pcs. 120

2.Cables in sterile packages of 1 pc. for intraoperative control compatible with the St. Jude Medical programmer used by the hospital pcs. 120

No. Required parameters Meet parameters

1. Year of equipment production not earlier than the year preceding delivery to the recipient and the latest offer for the Polish market. YES

2.Stymulator DDD TAK

3. Stimulation modes - DDD(R);DD I(R);D OO(R) YES

4.Vestibular sensitivity (mV) - at least in the range of: 0.4 – 4.0 mV YES

5.Cellular sensitivity (mV) – at least in the range:1.0-6.0 mV YES

6.Pulse amplitude - min. Range: 0.5-7.0V YES

7.Atrioventricular delay YES

8.Algorithm promoting own atrioventricular conduction YES

9.Automatic PVARP YES

10.Auto sensitivity in vestibule and chamber YES

11.Weight of stimulator (g) ≤ 28 YES

12.Mode of operation promoting own atrioventricular conduction nominally enabled with automatic change of AAI stimulation mode – DDD as protection in case of conduction disorders A-V YES

13. Algorithm adjusting the pulse energy to the individual needs of the patient (automatically or after prior programming) YES

14.Algorithm automatically adjusts the pulse energy to the individual needs of the patient in the vestibule YES

15.Automatic polarity switching capability when electrode impedance range is exceeded YES

16.Battery life min. 8 years (founded ampl. RV 2.5v) YES

17.In consignment warehouse 3 devices YES

18.Min. 2 programmers for the entire duration of the contract YES

19.Cables in sterile packages of 1 pc. for intraoperative control compatible with St. Jude Medical programmer used by TAK hospital

L.P. DETAILED ASSORTMENT UNIT. MEASURES CAPACITY: 36 MONTHS

1.Swap MRI single-cavity stimulator with wireless interrogation pcs. 120

2.Cables in sterile packages of 1 pc. for intraoperative control compatible with the St. Jude Medical programmer used by the hospital pcs. 120

No.Required parameters Parameters met

1.Basal frequency min <= 40ppm max >=120ppm YES

2.Pulse amplitude min <= 0.5V max >= 6.5V SO

3.Szerokość impulsu min <= 0,3ms max >= 1,0ms TAK

4.Czułość :

Przedsionek min <= 0,5mV max >= 4,0mV

Komora min <= 1,0mV max >= 10mV

Yeah

5.Refractive period :

Przedsionek min <= 250ms

Komora max >= 500ms

Yeah

6.Hysteresis YES

7.Night program adapted to the patient's activity (programmable) YES

8.Polarity of electrodes Unipolar and bipolar YES

9.Przyłącze elektrod : IS-1 TAK

10.Battery life min. 9 years (founded ampl. RV 2.5v) YES

11. Year of equipment production not earlier than the year preceding delivery to the recipient and the latest offer for the Polish market. YES

12.In consignment 3 devices YES

13.Min. 2 programmers for the entire duration of the contract YES

14.Cables in sterile packages of 1 pc. for intraoperative control compatible with St. Jude Medical programmer used by TAK hospital

L.P. DETAILED ASSORTMENT UNIT. MEASURES CAPACITY: 36 MONTHS

1.Cardioverter-defibrillator single-cavity with electrode adapted to work in MRI environment, enabling viewing of the vestibule IEGM with MRI after implantation with wireless interrogation pcs. 20

2.Hardware pcs. 20

3.Telemonitoring pcs. 20

4.Single-koyl defibrillating chamber electrodes active simple MRI pcs. 20

5.Adapters 8-9 F pcs. 20

6.Cables in sterile packages of 1 pc. for intraoperative control compatible with the St. Jude Medical programmer used by the hospital pcs. 20

In the consignment composition of 3 devices: one with DF1 link and two with DF4 link.

L.P. Required parameters Meet parameters

1.Cardioverter defibrillator weight less than 82g YES

2.Working modes: VVIR, VDD, VVI, V00, OFF YES

3. Year of equipment production not earlier than the year preceding delivery to the recipient and the latest offer for the Polish market. YES

4.Cardioverter defibrillator thickness max 11mm YES

5.Automatic stimulation threshold measurement and automatic adjustment of stimulation pulse value to measured YES value

6.Min 3 discriminators of arrhythmia YES

7.Low voltage therapies min 2 YES

8.Optimization of ATP Therapy, selection of the last effective ATP therapy YES

9.ATP therapies in VF zone before charging capacitors YES

10.IEGM recording time in both channels in total more than 40 min YES

11.Possibility to change the shape of the high-energy pulse YES

12.Automatyczny follow up TAK

13.Bezprzewodowa telemetry (RF) TAK

14.Chamber electrode passing through Introducer ≤ 8F YES

15.ICD with electrode certified to conduct MRI examination in a field of intensity not worse than 1.5T without exclusion zones YES

16.Min. 8 shocks of high-energy therapy, in each of the therapy zones YES

17.Arrhythmia discrimination based on comparison of atrial and ventricular intervals YES

18.Continuous VOO stimulation in 1.5T MRI mode without exclusion zones YES

19.Defibrillating electrode with sensing dipole placed at the height of the vestibule DF1 or DF4 to be chosen by the implanter YES

20.Chamber electrode with dipoles type TrueBipolar YES

21.Min. 2 programmers for the entire duration of the contract YES

22.Cables in sterile packages of 1 pc. for intraoperative control compatible with St. Jude Medical programmer used by TAK hospital