Poland - Cardiovascular diagnostic devices

Description

1. aspiration cathetersCutting off limit values: - catheter interior coated with PTFE for easy extraction, distal part of the catheter impregnated with hydrophilic coating,- catheter reinforced with stainless steel braided wire,- flow rate 115.2 cc/min,- total length of the catheter 140 cm,- entry profile 0.017'',- crossing profile 0.059'',- compatible with 6F and 7F guide catheters; guide 0.014'',- distal ray: 5.1 F, length: 16.5 cm, proximal ray: 4.2 F, length: 123.5 cm,- catheter lumen: distal 0.947 mm2, proximal 1.040 mm2,- proximal outer diameter: 1.40 mm (0.055''),- distal outer diameter: 1.7-1.6 mm (0.066''-0.063''),- aspiration strength: 13.5 mN,- the catheter is included in the set with 2 30cc aspiration syringes, a faucet extension, a basket - 20 pieces. Diagnostic catheters for coronarography Cut-off parameters: - Full-length reinforced catheter, clearly visible in the coping,- for good maneuvering and rotation,- soft tip (atraumatic),- large internal diameters (min.0.044" for 4F; 0.050" for 5F; 0.057" for 6F),- Required TIG curvature dedicated to radial access and 3DS curvature - Internal hydrophilic covering allowing good flow - Catheter with Hydro-dynamic surface reducing the risk of radial vessels spasm (for 6F)- Available lengths 130 cm for JL4 and JR4 and PIGTAIL curvatures - 3000 pcs. 1. Endovascular ultrasound catheters Cut-off limit values:- compatibility with 0.014" guides in the Rx monorail system - compatibility with 5F guide catheters - electronic catheters - system length ≥150 cm - possibility to visualize distal changes - distance of the transmitter from the catheter end < 11 mm - pulse frequency ≥ 20 MHz - allowing to visualize blood flow (meaning in colour) andAutomatic analysis of the plate composition (virtual histology) - construction eliminating artifacts: Guide artifact and NURD effect - catheter-assisted automatic catheter ejection system with adjustable speeds of 0.5 mm/sec and 1 mm/sec - 10 pcs.2Pressure guides for measuring the partial flow reserve (portable measuring device included in the price of the kit) Cut-off parameters: - Measuring guide based on an angioplastic Ballance Middle Weight type (BMW),- PTFE on a rigid part,- hydrophilic coating on a flexible part: 31cm,- distal, platinum end clearly visible in the X-ray image.For manual shaping: 3cm,- hydrophobic proximal end (3 pins) pre-mounted in the instrument connector (possibility of disassembling and using the measuring guide as an Angioplastic 0,014"),- length of the guide 175cm,- guide adapted for FFR, CFR and endovascular temperature measurements - wireless guides - data sent from the guide to the measuring instrument in radio technology - 10 pcs.3Object of lease - One apparatus for intracoronary ultrasonography and partial flow reserve measurement. Due to the limited number of characters in this section, a detailed description of the subject matter of the contract (lease) is included in Annex No. 2B to the Terms of Reference, entitled "Technical and Functional Parameters Form" on the Contracting Authority's website. Cladding to close the femoral artery puncture siteCut-off parameters: - mechanical closure - soluble components - set consisting of 4 components: T-shirt, expander, closure device, guide - size range allowing to close the vessel for the puncture from 6F to 8F- 30 pcs. Intra-aortic counterpulsation balloonsSize ≤ 7.5F- required balloon size 34 cm3, 40 cm3, a wider range is allowed - compatible with Datascope console system 98- sterile induction set with an angiographic needle, expander.Vascular T-shirt with haemostatic valve, catheter extension, pressure drain, syringe and one-way valve - sets for attaching the catheters to the skin without the use of stitches (for the sticker) - 10 pcs. 1. coronary artery perforation stent graftsCoronary artery cut-off parameters: - range of available lengths 9-26 mm - range of available diameters from 3.0 to 5 mm - balloon-mounted - Rx monorail-compatible introducer system 0.014"- made of PTFE material - 5 pieces 1. Drapes for procedures with access through the femoral and radial arteries Cut-off parameters:1) Angiographic 4-hole angiographical serviette made of non-woven SMS measuring 240 x 380 cm with 2 transparent edges 60 cm x 380 cm2 holes for tt. femur surrounded by a 12 cm diameter clear opening and 2 elliptical radial elliptical tt. holes with a 12 x 7 cm clear opening. 140 x 150 cm.2) Surgical apron made of non-woven SMS type, sleeves made of cotton. Size XL - 2 pieces3) Surgical powder-free gloves, size 7 - 1 pair4) Surgical powder-free gloves, size 7 - 1 pair4) Surgical powder-free gloves, size 7 - 1 pair4) Surgical powder-free gloves, size 7 - 1 pair4) Surgical powder-free gloves, size 7 - 1 pair4) Surgical powder-free gloves, size 7 - 1 pair4) Surgical powder-free gloves, size 7 - 2 pieces 8 - 1 pair5) Protective coating with a rubber band in the shape of a bag 85 x 90 cm - 1 piece6) Highly absorbent towel 56 x 80 cm - 2 pieces7) Compresses 10 x 10 cm 8-layer - 10 pieces8) Serviettes made of 2-layer 75 x 75 cm laminate - 2 pieces9) 250 ml bowl with scale, transparent - 2 pieces 10) Operating field cleaning tongs plastic length 20 cm - 1 piece11) Syringe luer lock 10 ml with white piston for contrast injection - 1 piece12) Rampa 2 - faucet tested up to 35 BAR, faucets set in OFF version - 1 piece13) Pressure drain 30 cm long, light diameter 1.5 x 2.7mm - 1 piece14) Scalpel size. 11 with a button for one-handed operation and a locking mechanism to lock the blade securely in a position that prevents stabbing. The blade must be permanently locked in a safe position to prevent reuse. The design of the scalpel must comply with EU Directive 2010/32/EU - 1 piece15)Complete set with a single blood pressure transmitter, compatible with the hospital's monitor. Connection to the interface cable pin, waterproof16) Contrast-saving drain with non-returnable 180 cm long non-returnable valve with male connectors - 1 pc17) Liquids transfer set 150 cm18) 2-ply serviette for instrument table and to wrap the set 100 x 150 cm19) Self-adhesive label with the name of the set, catalogue number and expiry date to be pasted into the medical documentation - 1 pc.Note: The Contractor is obliged to equip the Orderer, for the duration of the contract, with cables, plates and brackets suitable for connecting the offered transducers with a monitor owned by the Orderer. - 2000 pieces2. Angiographic slingCutting off parameters: Angiographic sling for the patient's clothing made of nonwoven SMS cloth 208x330cm with 2 round holes of 12cm diameter glued with a delicate adhesive foil entering 2.5cm into the hole surrounded by an absorbent layer of 81X122cm. To the right of the patient's long side, a transparent 69X330cm film is used to secure the desktop. Weight: 47 g/m2 weight of reinforcement: 99 g/m2 - 50 pieces3. Low-profile balloon catheters semicompliantThe cut-off parameters: - monorail system - 8 atm and RBP-min required pressures. 14atm- diameter of balloons from 1.5mm to 5.5mm- length of balloon 10-40mm- profile maximum - 0.026" for balloon diameter 3.0mm- type of balloon "semi-compliant" - good visibility in the sky- two markers- material durable and resistant to damage- small diameter of catheter tip- possibility to pass through very winding, calcified and narrow vessels- compatibility with the guide 0.014". - 200 pieces. (...)Due to the limited number of characters in this item, a detailed description of the subject matter of the contract is included in Attachment No. 2 to the Terms of Reference entitled Assortment and Price Form on the Contracting Authority's website. 1) Electrodes for Temporary Cardiac Pacing Cut-off parameters: - ES- group of electrodes- distal end type: soft, rigid- FG/CH scale size: 4F,5F,6F,7F- distal end configuration; straight, bent, bent J- number of rings/fields: two (bipolar)- field spacing: 2 to 10 mm- ring material: acid resistant steel- length of working part: 110 cm - 100 pieces. 1. Inflators for balloon catheters Cut-off limit values: - graduated to a minimum of 30 atm - volume 25 ml- with a 30 cm long reinforced high pressure drain - with a 1000-pressure three-way valve. 1. angioplasty guides 0,014 "Cut-off parameters: - with working tip made of steel and other metal alloys, - diameter 0,014",- length 190 and 300 cm,- straight and J-shaped tip, - min 32 types (regardless of the length and shape of the tip),- availability of hydrophilic and hydrophobic coating over the entire length,- available angioplasty guides for use in pavements with different types of "working" part stiffness (11 types regardless of the length and shape of the tip),- available with tapered tip diameters of 0.009", 0.010" and 0.0105" and 0.012" - available with minimum4 tip diameters (regardless of the length and shape of the tip),- available with steel and alloy core - 200 pieces 2Cobalt chrome coronary stents releasing the antiproliferative drug rapamycin derivative Cut-off parameters: - Cobalt chrome alloy stent based on more than 50 % cobalt and iron not more than 3 %, slotted tube stent coated with rapamycin analogue (everolimus) - 0,0032" stent wall thickness for all sizes - 145 cm supply system length - diameter range: 2.0-4.0mm (2.0; 2.25; 2.5; 2.75; 3.0; 3.25, 3.5; 4.0) - required lengths for diameter 3.0: 8, 12, 15, 18, 23, 28, 33, 38 and 48 mm - nominal pressure max. 11 atm for all sizes - RBP: 18 atm for all sizes - good access to sidings (maximum opening diameter of a single stent cell for 3.0 mm is 4.0 mm)- length of stent - to - shoulder (STS) - 0.65 mm - shortening of stent after implantation: 0,3 % for 3,0mm - 200 pieces 3. Non-compliant high-pressure balloon catheters for stenting the cut-off parameters:- nominal pressure minimum 12 atm, RBP - minimum 18 atm, balloon diameter increase between nominal pressure and RBP below 5.5 % - balloon diameters from 2.0 to 5.0 mm - length range from 8 to 30 mm - system length at least 140 cm - low profile of balloon 0,027"-0.028" for 3.0 mm diameter - lesion entry profile 0.017"-0.018"- compatibility with the guide 0.014""- two markers indicating the beginning and the end - in the 6F guide catheter the possibility of using the balloon kissing technique -300 pieces. PTCAParameters: Large internal diameter -0.058"-5F;0.071"-6F;0.081"-7F;0.090"-8Offered diameters: 5F, 6F, 7F, 8F,- metal reinforcement that keeps the light inside constant over the entire length of the catheter - soft atraumatic tip + marker visible in the coping,- curvature stability at temp. 37 oC throughout the entire procedure - resistance to torsion and refraction - good shape memory - good manoeuvrability - high catheter durability - full range of typical and unusual curves - 89 in each diameter: Judkins L&R, Amplatz J&R, Femoral J&R, Multipurpose, Bypass, Extra Back Up L&R, MAC - Multi Aortic Curve, Champ - allowing access from the femoral, radial and shoulder artery puncture, access to bypasses as well as other unusual vessel departures - Possibility to order catheters with side openings and modified endings - 1200 pieces.2. Cobalt chrome coronary stents releasing an antiproliferative drug - rapamycin derivative Cut-off parameters:- - Coronary stent system releasing an antiproliferative drug from polymer - -Biocompatible polymer consisting of two layers: Hydrophilic and hydrophobic, controlling the release of the drug - - Active substance - Zotarolimus (Sirolimus derivative)- - Cobalt chromium-cobalt stent plateau made in sinusoidal technique from one piece of wire connected by laser with Platinum Iridium core to improve visibility during the procedure (Core Wire technology)- - Open-cell stent housing - available stent diameters: 2.0.2.25; 2.5; 2.75; 3.0; 3.5; 4.0 mm- available stent lengths: 8; 12; 15; 18; 22; 26; 30; 34; 38 mm-max. extension of the stent to approx. 4.75 mm-transition profile 0.037 for size 2.5 mm- thickness of the elements of which the stent is made - 0.0032"- nominal pressure - 12 atm- RBP pressure 18 atm- safety and effectiveness of the use of stents confirmed by results of multi-centre clinical trials with a minimum of three years' observation of patients - 100 pcs.3Coronary coronary catheters of the non-compliant typeThe "rapid exchange" type is a type of balloon diameter (mm): 2.0; 2.25; 2.5; 2.75; 3.0; 3.25; 3.5; 3.75; 4.0; 4.5; 5.0 mm- different balloon lengths: 6; 9, 12, 15, 21, 27 mm- type of balloon "non-compliant" - new balloon material - "Soft Fulcrum Plus" - flexible and flexible - allows to pass narrow changes in winding vessels - material very durable and resistant to damage - shape durability - does not deform after the first filling - nominal pressure 10 atm,- rated burst pressure 18 atm,- distal shaft 2,4F/2,6F, proximal shaft 1,9F (for catheters with diameter of 1.5 mm). 2.0-3.75 mm)- distal shaft 3.0F, proximal shaft 1.9F (for catheters of diameter 2.0-3.75 mm) 4,0-5,0 mm)- catheter's useful length 142 cm- crossing profile (for balloon 3,0 mm) - 0,026" for size 2,0 mm - 0,024"- Selective Dura - Trac™ - prevents movement during inflation - entry profile 0,016"- balloon catheter designed to tighten stents - 100 pieces.4. Semi-compliant balloon cathetersShut-off limit values:- rapid exchange type and OTW- pressure NP and RBP=12- balloon profile ≤0.20'' with a diameter of 1.25 mm- zerofold balloon providing an ultra low transition profile for difficult changes- for 1.25 mm diameter balloon the presence of one marker- balloon tip entry profile ≤0,016''- the end piece in combination with a low profile ensures easy passage through tight, winding and calcified changes in the dishes - for OTW version extended to 152 cm cabinet length - required lengths from 6.0 to 20 mm including 10 mm-50 pcs. 1. Hydrophilic angiographic guides Cut-off parameters: - diameter 0.035"- various lengths of cut-off core (taper) short=1 cm, regular=3 cm and long=5 cm- straight tip, bent 45 degrees, type J, curvature Bolia- nitinol core sunk in polyurethane, made of one piece, with very good traction control 1:1, deformation- and fracture-resistant longitudinal structure - in polyurethane additionally sunken tungsten threads - durable full length hydrophilic coating - atraumatic, soft tip, with shape memory - available in standard stiffness, semi-rigid and rigid versions - available in option with shapeable tip - length 180 cm - 200pcs. 1. Angioplasty guides 0,014 "Cut-off parameters: - Diameter 0,014"- Guide made of steel 316L- Distal part of the guide made of 15 wires providing high resistance and excellent manoeuvrability and feel of the guide - Guide core made of one piece of wire- Stiffness of the tip 0,5 g; 0,7g; 0,8g- Shading tip 3cm (platinum)- Shape of the tip: simple with the possibility of shaping the distal 3cm and J- SLIPCOAT® hydrophilic braided cover, available with polymer-hydrophilic cover- PTFE-coated guide cabinet- Available lengths: 180cm, 190cm and 300cm- Universal guide for simple and curvilinear anatomical procedures and for tightly-aligned procedures - 700 pcs.2. System for removing foreign bodies from blood vesselsShut-off limit values:- Includes: loop, shotcrecker, introducer and catheter - Size 3,2 F, 6F - 7F- Range of operation: 2 - 45 mm- Loop length 120 and 175 cm- Catheter length 100 and 150 cm- A system consisting of three interconnected nitinol loops- A system that also allows repositioning of venous catheters and purification of fibrin coating venous catheters- High flexibility, transfer of rotation 1:1- Loops with embedded platinum fibers for excellent visibility in the coping - Catheter made of FEP (Teflon) resistant to kinks and bends with the tip bent by 15 degrees to control the system - 5 pcs.3Cobalt chrome coronary stents releasing an antiproliferative drug - rapamycin derivative Cut-off parameters: - cobalt chrome stent made of L-605 alloy - laser cut-out "slotted tube" stent - compatible with 0.014" guide - compatible with 5 F (0.058") guide catheter - available stent diameters: 2.25mm; 2.5mm; 2.75mm; 3.0mm; 3.5mm; 4.0mm; 4.5mm- available stent lengths: 8mm; 12mm; 16mm; 20mm; 25mm; 31mm; 38mm; 46mm - Sirolimus release stent; the drug is suspended in a carrier which is an organic acid ensuring uniform and controlled distribution of the drug over the length of the lesion and in the wall of the vessel - 0.9μg/mm2- drug release system without polymer: The drug is released from special channels in the stent bays in direct contact with the vessel wall (the drug is not released into the blood) - Bio Inducer Surface coating to prevent release of metal ions into the blood and to speed up the endothelialisation of the stent - no shortening of the stent during expansion - elastic recoil 2 - 7 % - stent wall thickness 80μm (0,0031")- nominal pressure 9atm- pressure RBP 18atm- pressure ABP 24atm- catheter working length 142cm- 4 markers: 2 integrated with the stent at its ends and 2 on the balloon catheter - special balloon construction preventing the "dog bone" effect - crossing profile 0.039" for the stent diameter of 3.0mm - radial force 18.37psi - different number of cells on the perimeter of the stent depending on the diameter: 4 cells for diameters 2.5mm - 2.75mm; 5 cells for diameters 3.0mm - 3.5mm and 6 cells for diameters 4.0mm - 4.5mm - excellent access to the siding: the surface of the cell with a nominal diameter of 3.0mm stent is 1.3mm2 - 200 pieces 4Pressure guides for measuring the partial flow reserve (portable measuring device included in the price of the set)Cut-off parameters: - Hydrophilic pressure guide with a diameter of 0.014''- Distal pressure signal transmitted via a fibre-optic cable - Guide length 175 cm- Guide construction with a nitinol core placed in a stainless steel tube - 3.5 cm visible in the coping and flexible tip - 40 pcs.5Radial artery puncture kit - 50pcs(...) Due to the limited number of characters in this item, a detailed description of the subject matter of the contract is included in Attachment No. 2 to the Specification of Material Terms of Contract entitled "Assortment and Price Form" on the Contracting Authority's website. 1. semicompliant balloon cathetersSemicompliant limit values: - type, rapid exchange" monorail- RBP min. 14 atm for sizes 2.5 - 4.0 mm - profile maximum 0.026" for 3.0 mm - diameters from 1.5 to 5.5 mm, wider range is allowed - balloons up to 5.5 mm in diameter compatible with 6F guide catheters - length from 10 to 40 mm - possibility to pass through very winding, calcified and narrow vessels -300 pieces 2Stents releasing the antiproliferative agentCutting off limits: - Stent diameters 2 - 4.50 mm- Stent lengths 8 - 40 mm (for diameters from 2.5 to 4.5 mm) (8,10,12,15,18,22,25,29,34,36,38,40)- Loss of length at expansion < 0.5 %- Nominal pressure for stent 3.0 8 atm- RBP pressure for stent 3.0.16atm, available versions 14 and 18 atm,- Stent wall thickness 0.07 mm- Transition profile (stent 3.0mm) 0.034"- System diameter in the distal part 2.5F- System diameter in the proximal part 1.8F- Available version coated with biodegradable polymer releasing paclitaxel - 200 pcs.3Diagnostic guides long hydrophilicAluminum stoppers; - diameter - 0,032", 0,035", 0,038'- J-tip or straight - length from 150 to 260 cm - 2000 pcs.4Sets: Blunt metal needles + torquerParameters: - Stainless metal needles with blunt tip - compatible with 0,014" - Torquers for handling the guideCompatible with 0,014" guides Y-type connectorParameters cut-off valves:- light with a diameter of up to 9 F- rubber gasket- adapter enabling rotation without loss of tightness - 1000 pcs.6. Long vascular shirts with a valve, needle and guide includedLength min. 20 cm for diameters ≥ 6F - compatible with 0.038 guide"- valve ensuring tightness - diameters 5F, 6F, 7F, 8F - 800 pcs.7. Short vascular shirts with valve, needle and guide includedLimit stoppers: - length 11 cm - compatible with 0.038 guide"- valve ensuring tightness - diameters 5F, 6F, 7F, 8F - 800 pcs.8. Radial inductor with a valve included in the set with a pressure band, needle and guideCutting off parameters: - valve ensuring tightness - diameters 5F,6F - length 7-10 cm-1700 pcs9. High-pressure extender - length 150 cm, maximum permissible pressure 8 MPa-50 pcs. 1.Platinum-chromium stents releasing antimitotic drugShut-off limit values: - diameters 2.25 -4.00mm (2.25, 2.50, 2.75, 3.00, 3.50, 4.00)- lengths 8-38mm (8, 12, 16, 20, 24, 28, 32, 38mm) excluding size 2.25 x 38mm - platinum-chromium alloy (PtCr) - platinum content 33 % by weight,- rapamycin derivative (everolimus) released from durable acrylic-fluoride polymer - nominal pressure 11 atm - pressure RBP 18atm for diameters 2.25- 2.75 and 16atm for 3.0 - 4.0mm - stent to vessel ratio 12.5-15.1 %,- lesion entry profile - 0.018" for all sizes - stent profile with balloon for 3.0 mm diameter max. 0.040",- balloon length outside the stent ("balloon overhang") 0.4mm- recoil max. 3 %- high radial force min. 0.26 N/mm- possibility to increase the stent diameter over the nominal RBP (same balloon) by more than 5 % for all sizes (for 3.00 - 3.17mm) - possibility to strain the stent (other balloon) without damaging the structure2.25 to 2.75;2.50-2.75 to 3.50;3.00-3.50 to 4.25;4.00 to 5.75; - 200 pcs.2High-pressure, noncompliant balloon catheters for stent loadingThe cut-off parameters are: - diameters 2.00 -5.00mm (2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.50, 5.0)- length 6-20mm (6, 8, 12, 15, 20) and 30mm for diameters 2.00 - 4.00mm - two-segment internal shaft construction - nominal pressure 12atm, - pressure RBP 20atm for 2.00-4.00 18atm for 4.50-5.00 (RBP for 3.00 - 20atm)- lesion entry profile - 0.017" for all sizes - high non-susceptibility (precision stent tension), increase in balloon diameter over nominal within RBP of less than 5.5 % for all sizes (3.00 - 3.16mm) - 300 pcs.3Low-profile predisposition balloon catheters: Cut-off limits: - diameters 1.20 -4.00mm (1.20, 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00) - diameter 1.20 and 1.50mm - two cabinet stiffnesses available for twist and CTO (Push) - length 8-20mm (8, 12, 15, 20) and 30mm for diameters 2.0 - 4.0mm - two types of balloons available: Monorail and OTW in all sizes - hydrophilic shaft covering - nominal pressure 6atm, - RBP 18 atm for 1.20mm, 14atm for 1.50-3.25 and 12atm for 3.50-4.00 - lesion entry profile - 0.017" for all sizes - possibility to increase the diameter of the balloon above the nominal one within RBP by more than 6 % for all sizes - 300 pcs.4. IVUS catheter + Pullback Galaxy Pullback Emergency stopper:- mechanical drive, imaging core revolutions-30 revolutions per second - frequency-40 MHz ultrasonic transducer - axial resolution-38 μm - length from distal end to transducer-20 mm - position of the radio shading marker-5 mm from distal end - maximum penetration depth-6 mm - catheter-135 cm - catheter compatible with the 0 guide,014" and a 5F guiding catheter - telescopic design enabling examination of the vessel over a length of 150 mm without changing the original position of the catheter - catheter telescope with external markers enabling assessment of the head position - 10 pcs.5Corner guide FFR Cut-Off Limits: - optical sensor - guide working length-185 cm - guide diameter-0.014" (≤0.36 mm)-Length of the tip visible in the copier-3 cm-distance markers-90 cm radial, 100 cm thigh- length of the optical cable -2 m- operating range-45 mmHg up to 300 mm Hg- 10 pcs.Condition up to point 4 point 5 - free of charge lend 1. Chromium-cobalt stent releasing Sirolimus drug from biodegradable polymer, TESParameters cut-off limits:- The Sirolimus drug is released from laser cut-out tubules on the abluminal surface of the stent. This allows the application of a reduced drug dose so that the stent quickly covers the epithelium,- The stent platform: L605 Co-Cr-polymer: 100 % biodegradable PLA, abluminous coating - Stent bay thickness: 0.0034'' for diameters 2.25mm-3.0mm0.0038'' for diameters 3.5mm-4.0mm-length: 13, 18, 23, 29, 33, 38mm- Diameter: 2.25, 2.5, 2.75, 3.0, 3.5, 4.0mm- Nominal pressure: 10 atm - 150 pieces.

Opportunity closing date

04 February 2020

Value of contract

to be confirmed