medical device s for the laboratory of heart electrophysiology and electrostimulation

University Clinic of Cardiology

Рок

Рокот за прием на понудите беше 2022-05-30. Набавката беше објавена на 2022-04-29.

Кој?

• University Clinic of Cardiology

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега

Каде?

• Северна Македонија › Скопски

Историја на набавките

Датум	Документ
2022-04-29	Оглас за договор

Оглас за договор (2022-04-29)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Краток опис:

medical device s for the laboratory of heart electrophysiology and electrostimulation

Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема, фармацевтски производи и производи за лична нега 📦
Дополнителен CPV: Медицинска опрема, фармацевтски производи и производи за лична нега 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Друго
Име на органот кој доделува: University Clinic of Cardiology
Поштенска адреса: University Clinic of Cardiology, Vodnjanska 17, Meri Mandalova, 1000, Skopje, Republic of Macedonia; +389 2 3147181, +389 2 3164134,
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: https://e-nabavki.gov.mk 🌏
Е-пошта: sonjajanakieva1@gmail.com 📧
Телефон: +389 023147576 📞
Факс: +389 023211662 📠
URL за документи: https://e-nabavki.gov.mk 🌏

Референца
Датуми
Датум на испраќање: 2022-04-29 📅
Рок за поднесување: 2022-05-30 📅
Датум на објавување: 2022-05-04 📅
Идентификатори
Број на огласот: 2022/S 087-238211
OJ-S издание: 87

Предмет
Опсег на набавката
Проценета вкупна вредност: 71 986 450 MKD 💰
Наслов на делот: Single-lead pacemaker VVIR, with normal optimal time of 10 years, with an electrode with active fixation for right chamber
Број на дел: 1
Краток опис:

IS-1 connector or equivalent

automatic adjustment of the stimulation voltage and sensitivity

Possibility for MRI imaging of the whole body with intensity of 1,5-3Т

imaging and memorizing of IEGM

possibility of independent programming of frequency adaptability in at least two zones

transfer from bipolar to unipolar stimulation in the event of electrode damage

automatic recognition of electrode polarity during implantation

electrode with active fixation for the right chamber with the possibility to choose the electrode length

Времетраење: 12 месеци
Наслов на делот: Biventricular implantable cardioverter defibrillator (CRT-ICD) with minimal voltage of 3,2V before implantation, with electrodes- atrium electrode with active fixation, chamber defibrillation electrod
Број на дел: 2
Краток опис:

with min. 40J delivered energy

DF-1 or DF-4, IS-1 or IS-4 connector of the device or equivalent

vibration alarm in the event of electrode damage or battery deterioration

possibility for MRI imaging of the whole body with intensity of 1.5T regardless of body size with isocenter in every body position, without any time limitation of the imaging

wireless programming

automatic algorithm for AV optimization

possibility for simultaneous stimulation from several poles of electrodes for coronary sinus

possibility for ATP treatment during charging and before charging

possibility for software turn on and turn off of the active case and the high-voltage thread of the SVC

minimum stimulation voltage of 5V in all channels

automatic reprogramming of the parameters for VT/ VF detection

algorithm for electrode integrity monitoring

set introducer for coronary sinus that will include: two catheters, dilator, guide wire, hemostasis valve, small blade

electrode for coronary sinus IS-1 or IS-4 or equivalent, bipolar or quadripolar with minimum length of 85 cm

chamber defibrillation electrode DF-1 or DF-4 connector or equivalent, with one or two threads with active or passive fixation, with minimum length of 65 cm

atrium electrode with active fixation

Наслов на делот: Single-lead pacemaker VVIR with normal optimal time of 14 years, with electrode with active fixation for right chamber
Број на дел: 3
Краток опис:

Programming basic rhythm when the patient is at rest or sleeps

Possibility for MRI imaging of the whole body with intensity of 1,5T

imaging and memorizing of EGM, min. 14 minutes

automatic beat-to-beat adjustment of stimulation voltage in ventricle in the event of unipolar and bipolar configuration of the electrode

transfer of bipolar to unipolar stimulation in the event of electrode damage

Наслов на делот: Self-adhesive electrode for pacing
Број на дел: 4
Краток опис: compatible with the external defibrillator "LIFEPACK 12" or equivalent
Наслов на делот: Dual-chamber pacemaker DDR, with normal optimal time of 10 years, two electrodes with active fixation for the right atrium and right chamber
Број на дел: 5
Краток опис:

automatic adjustment of stimulation voltage and sensitivity in atrium and ventricle

imaging and memorizing IEGM

algorithm for extension of the AV interval up to 450 ms for the promotion of own rhythm,

trend for resistance and transfer from bipolar to unipolar stimulation in the event of electrode damage

possibility of independent programming of frequent adaptability in at least two zones

with two electrodes with active fixation for the right atrium and right chamber with the possibility to choose the electrode length

Наслов на делот: Dual-chamber pacemaker with frequency adaptation (DDDR) and protection from magnetic resonance +2 bipolar electrodes, IS-1 connection, passive or active fixation, straight or “J” curve with magnetic r
Број на дел: 6
Краток опис:

beat-to-beat measurement of threshold and adjustment of the stimulus amplitude in the chamber

Algorithm for automatic measurement of the threshold and adjustment of the amplitude for stimulation of the atria

Physical activity sensor for regulation of pacing speed

Physiological sensor for rhythm adjustment in the event of physical and mental stress

Automatic adjustment of sensitivity in atria and chambers

Algorithm for automatic extension of AV interval to reduce unnecessary chamber pacing.

Possibility for adjustment of unipolar or bipolar regime of work of the electrode as well as automatic algorithm for the change from bipolar to unipolar regime in the event of impedance deviation beyond the interval determined

Automatic measuring of parameters (threshold, sensing, impedance) in the one step follow-up without previous settings and adjustments

System (two electrodes + pacemaker) with protection from magnetic resonance for the whole body when permanent magnetic field of 1.5 T and 3.0 T is applied

Possibility for activating the magnetic field sensors for automatic transfer of the device in MRI regime of work with the objective to reduce the time of asynchronous regime of pacing

Weight of the device < 24 g

Volume of the device < 13 cm3

Battery life > 11 years (DDD 50% pacing, A/V : 2.5 V at 0.4 ms, 60 bpm, 500 Ω)

bipolar electrode with steroid, minimum length 52 cm for atrium and 59 cm for chamber

Наслов на делот: Implantable device for detection of rhythm disorders and continuous EKG monitoring
Број на дел: 7
Краток опис:

with algorithms for detection of АТ/АF

battery life of minimum 3 years

cardiac function monitor with the possibility of implantation with injector, maximum volume 1,5cm3 and maximum weight 3g

external patient- monitor for wireless data transfer from the injectable monitor of the cardiac function

possibility for manual activation of the imaging with additional presentation of the continuous EKG for at least 10 minutes before the activation moment

Наслов на делот: Dual-chamber pacemaker DDDR with IS-1 connector or equivalent, compatible with GSM receiving unit for automatic, continuous telemonitoring with clinically proved benefit
Број на дел: 8
Краток опис:

Automatic adjustment of sensitivity

imaging and memorizing IEGM, frequent adjustability

algorithm for extension of the AV interval up to 400ms

pacemaker with protection from magnetic resonance for the whole body when permanent magnetic field of 1.5 T and 3.0 T is applied

automatic possibility for data export into electronic format that can be printed via external printer

Наслов на делот: Dual-chamber pacemaker DDDR with IS-1 connector or equivalent,compatible with GSM receiving unit for automatic,continuous telemonitoring with clinically proved benefit +2 bipolar electrodes, IS-1 co
Број на дел: 9
Краток опис:

Algorithm for automatic measurement of the threshold and adjustment of the stimulus amplitude in atria

imaging and memorizing IEGM, frequent adaptability

Наслов на делот: Single-lead implantable cardioverter defibrillator with sensing option in atrium (ICD-DX) + 1 HV electrode with active fixation with floating dipole and one defibrillation thread
Број на дел: 10
Краток опис:

Possibility to adjust different automatic thresholds in the chamber

Possibility to measure the amplitude signal in the atrium with the assistance of floating dipole

Possibility to measure the stimulation threshold in the chamber and electrode impedance

Possibility for programing of two VT and one VF with the selection of treatment in the form of antitachycardia pacing, maximum shock strength of at least 35 J

selection of different discriminatory algorithms for tachycardia detection

Option for programming of specific antibradycardia pacing after shock

Algorithm for automatic extension of AV interval due to the reduction of unnecessary ventricular pacing

Diagnostic possibility in the form of imaging episodes with marked markers of iEGM

device weight < 85 g

Volume of the device < 35 cm3

Battery life >9 years (VVI 15% pacing, 2.5 V at 0.4 ms, 60 bpm, 500 Ω, 4 shocks maximum energy per year)

HV electrode with steroid, minimum length of 59 cm and different distances of the atrium dipole from the tip of the electrode

Наслов на делот: Dual-chamber implantable cardioverter defibrillator (ICD), with minimum voltage of 3,2 V before implantation, in a set with electrodes- atrium electrode with active fixation, chamber defibrillation el
Број на дел: 11
Краток опис:

min. 35 J delivered energy

sound alarm in the event of electrode damage or battery deterioration

DF-1 or DF-4 connector of the device or equivalent

possibility for MRI imaging of the whole body with intensity of 1,5T regardless of body size with isocenter in every body position, without any time limitation of the imaging

automatic reprogramming of the parameters for detection of VT/VF

minimum voltage of stimulation of 5V (in both channels)

shape of the device that follows the anatomy of the pectoral region

chamber defibrillation electrode with DF-1 or DF-4 connector or equivalent, with one or two threads, with active or passive fixation, with minimum length of the electrode of 65 cm

Наслов на делот: Single-lead implantable cardioverter defibrillator (ICD) with minimum voltage of 3,2V before implantation
Број на дел: 12
Краток опис:

Possibility for MRI imaging for the whole body with intensity of 1,5-3T, regardless of body size, with isocenter in each body position, without time limitation of the imaging

possibility for ATP treatment during and before charging

automatic programming of the parameters for detection of VT/VF

Наслов на делот: Implantable loop recorder
Број на дел: 13
Краток опис:

Possibility for recording episodes of atrial fibrillation, high ventricular rate (HVR), bradycardia, asystole and sustained rate duration (SRD)

Possibility for activating recording from outside

Possibility for inversion of the EKG records on the device in the event of negative QRS complex

Smart system for recording episodes

Daily monitoring via external unit

Enabling section smaller than 1,5cm for device implantation

device weight lower than 5g and volume of the device lower than 3 cm3

Lifetime and duration longer than 3,5 years, with activated telemonitoring that includes sending one superficial EKG per day and 2 episodes per months that are activated by the patient

MRI compatible at а 3.0 T

Наслов на делот: Biventricular pacemaker CRT-P with protection from magnetic resonance, compatible with GSM receiving unit for automatic, continuous telemonitoring with clinically proved benefit, +2 bipolar electrodes
Број на дел: 14
Краток опис:

Algorithm for automatic measuring of the threshold and adjustment of the stimulus amplitudes in atria, right and left chamber

Physical and mental activity sensor for regulation of pacing speed

Automatic sensitivity adjustment in chambers and atria

Algorithm for automatic reduction of the AV interval to prevent intrinsic rhythm in the chambers

Programmed VV interval as a possibility to choose initial pacing of chambers

Possibility to adjust unipolar and bipolar regime of work of the electrode and automatic algorithm for the change from bipolar to unipolar regime in the event of impedance deviation beyond the interval determined

System (three electrodes + pacemaker) with protection from magnetic resonance for the whole body when permanent magnetic field of 1.5 T and 3.0 T is applied

Possibility for activating the magnetic field sensors for automatic transfer of the device in MRI regime of work with the objective to reduce the time of asynchronous regime of pacing

GSM receiving unit, compatible with CRT-P device for automatic, continuous telemonitoring with clinically proved benefit

device weight < 33 g

Volume of the device < 16 cm3

Battery life > 9 years (DDD-BiV 10% pacing, A : 2.5 V at 0.4 ms, 100% pacing, RV/LV: 2.5 V at 0.4 ms, 60 bpm, 500 Ω)

quadripolar electrode for coronary sinus with steroids, different lengths and shapes

Introductory system for coronary sinus with appropriate diameter, different lengths and forms, composed of external and internal (subselective catheter with possibility for different curves) lead, guide wire, syringe and blade

Наслов на делот: Biventricular pacemaker CRT-P with normal optimal time of 5 years, with two electrodes with active fixation for right atrium and right chamber, unipolar, bipolar and quadripolar electrode for coronary
Број на дел: 15
Краток опис:

IS-1 connetor or IS-4 or equivalent

Possibility for MRI imaging with intensity of 1,5-3T regardless of body size, with isocenter in every body position, without time limitation of the imaging

possibility for presentation of at least two EKG leads

possibility for programming at least 15 vectors for stimulation of LV,

independent programming of frequent adaptability in at least two zones

algorithm for the reduction of symptoms in the event of AT/AF

automatic adjustment of the LV stimulation voltage according to the threshold measured

measuring thoracic impedance/ resistance as indicator of the level of fluid in the lungs

shape of the device that follows the anatomy of the pectoral region

two electrodes with active fixation for the right atrium and right chamber with the possibility to choose the length of the electrode

unipolar, bipolar or quadripolar electrode for coronary sinus, IS-1 or IS-4, active or passive fixation, with min. lengths of 85 cm.

set introducer for coronary sinus (two catheters, dilatator, guide wire, blade and hemostasis valve)

catheter for subselection of tortuous branches of the coronary sinus with possibility for selection of the curvature of the distal part (tip) of the catheter from 90 to 130 degrees, possibility for implantation of electrode for coronary sinus though the catheter, internal diameter 4.0-5.5 Fr, hemostasis valve

Наслов на делот: Biventricular implantable cardioverter defibrillator (CRT-DX) with protection from magnetic resonance, compatible with GSM self-receiving unit for automatic, continuous telemonitoring, with clinically
Број на дел: 16
Краток опис:

Possibility to adjust different automatic sensing thresholds in right chamber

Possibility to measure the signal amplitude in the atrium with the help of floating dipole

Possibility to measure the stimulation threshold in right and left chamber and electrode impedance

Possibility for programming of two VT and one VF zone with selection of treatment in the type of antitachycardia pacing, maximum power at least 35J

Algorithm for automatic reduction of the AV interval to prevent intrinsinc rhythm in the chamber

GSM receiving unit, compatible with CRT-DX device for automatic, continuous telemonitoring with clinically proved benefit

Device weight < 89 g

Volume of the device < 38 cm3

Battery life >6.5 years (DDD-BiV 15% pacing, A : 2.5 V at 0.4 ms, 100% pacing, RV/LV: 2.5 V at 0.4 ms, 60 bpm, 500 Ω, 4 shocks, maximum energy per year

HV electrode with steroid, minimum length of 59 cm and different distances of the atrium dipole from the tip of the electrode- quadripole electrode for coronary sinus with steroids, different lengths and shapes

Наслов на делот: Biventricular implantable cardioverter defibrillator (CRT-ICD) with minimum voltage of 3,2V before implantation, with electrodes- atrium electrode with active fixation, chamber defibrillation electrod
Број на дел: 17
Краток опис:

with min. 35 J delivered energy

DF-1 or DF-4, IS-1 or IS-4 connector of the device or equivalent

possibility for MRI imaging of the whole body with intensity of 1.5-3T regardless of body size with isocenter in every body position, without any time limitation of the imaging

automatic algorithm for optimization of AV and VV time

possibility for ATP treatment during and after charging

automatic reprogramming of parameters for detection of VT/VF

minimum voltage for stimulation of 5V (in all channels)

shape of the device that follows the anatomy of pectoral region

chamber defibrillation electrode with DF-1 or DF-4 connector or equivalent, with one or two threads with active or passive fixation, with minimum length of 65 cm

coronary sinus electrode, IS-1 or IS-4 or equivalent, bipolar or quadripolar, active or passive fixation, with minimum length of 85 cm

set introducer for coronary sinus (two catheters, dilatator, guide wire, blade and hemostatic valve)

Наслов на делот: Soft tissue dissection devices (“plazma” blades)
Број на дел: 18
Краток опис:

Monopolar instrument for precise dissection that uses low energy and low temperatures ( 40-170 С), for reduced thermal and deep damaging

Наслов на делот: Cable for external heart stimulation
Број на дел: 19
Краток опис:

possibility to be connected to programmer- tester Medtronic or possible compatible equivalent to the programmer-Medtronic

Наслов на делот: Resorptive antibacterial sheath for preventing infections
Број на дел: 20
Краток опис:

contains minocycline and rifampicin

intended for implantable devices- pacemakers, defibrillators and CRT device

size M and L

Наслов на делот: Electrode and introduction system with accompanying material for His bundle pacing
Број на дел: 21
Краток опис:

Bipolar electrode with active fixation and length < = 60 cm, MRI compatible with intensity of 3.0 T FBS, with retractable length of minimum 1,8mm, with steroid of 0.85 mg, with diameter of 6 F

External catheter with length of 32 cm and 39 cm, made of PEBAX and PA with internal hydrophilic strip, with internal diameter < 8 F and external diameter < 9 F

Dilator with working length of < 47 cm

Internal catheter with length of 59 cm and 69 cm, made of PEBAX and PA with internal hydrophilic strip, with internal diameter of < 6F and external diameter of < 7F, with catheter tip of 50⁰ and 90⁰, compatible with guide wire 0.014" - 0.035", compatible with electrode < 6F and female luer-lock connection

Additional set including 12 cm3 syringe with luer-lock, tool for transvalvular regurgitation with guide wire, internal diameter < 8F, Seldinger guiding wire 150 cm, screwdriver, blade, bidirectional control valve, TBA adapter with internal diameter < 4F, safety valve

Наслов на делот: Long introducer for electrophysiology
Број на дел: 22
Краток опис:

length from 63 to 81 cm

internal diameter 8F and 8.5 F

at least 5 different curvatures

Наслов на делот: Side port introducers
Број на дел: 23
Краток опис:

introducer (side-port) -set with wire and needle

possibility to choose the dimensions when ordering from

6-10 F, with obligatory availability of all dimensions

Наслов на делот: Peel away introducers
Број на дел: 24
Краток опис:

introducer (peel-away) - set with wire and needle

6-12 F, with obligatory availability of all dimensions

Наслов на делот: Ablation catheter with golden tip for ablation 4 mm
Број на дел: 25
Краток опис:

possibility for deflection min 180 degrees

and temperature control

distal electrode for ablatio min 4 mm,

catheter length min 110 cm

distance between electrodes 2-5-2 mm.

Наслов на делот: Ablation catheter with golden tip for ablation 8mm
Број на дел: 26
Краток опис:

different curvatures and temperature control

distal electrode for ablation 8 mm, catheter length min 95 cm ,distance between electrodes 2-5-2 mm

Наслов на делот: deflectable decapolar catheter
Број на дел: 27
Краток опис:

distance between electrodes 2-6-2 mm or 2-8-2mm

length of 90-115 cm

no thicker than 7F

D-F curve

Наслов на делот: Quadripolar catheter
Број на дел: 28
Краток опис:

tip with length of 3.2 мм

4F, 5F or 6F

length from 80 to 110 cm, fixed curve Josephson, Josephson special, Damato, Cournand and HIS or equivalent

possibility for choice with atraumatic soft tip

distance between electrodes: 2mm, 5mm, 2-5-2mm

Наслов на делот: Decapolar catheter for coronary sinus
Број на дел: 29
Краток опис:

minimum length of 84 cm

with G curve(type of curve)

distance between electrodes 2-5-2mm.

Наслов на делот: Transseptal introducer (set+long needle)
Број на дел: 30
Краток опис:

Introducer 8F and 8,5F, with hemostasis valve, with length of 63 to 81 cm and needle with exceptionally sharp tip, 18 Gauge with length from 71 to 98 cm, guide wire

Наслов на делот: Solution for intra and postoperative cleaning of wounds and body cavities
Број на дел: 31
Краток опис:

made of basis of hypochlorous acid with concentration of minimum (50mg/L) and potassium hypochlorite with concentration of minimum (50mg/L), without presence of heavy metals in a bottle of 500 ml and 1 L, waterproof to sunlight

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 12:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Датум на отворање на понудите: 2022-05-30 📅
Време на отворање на понудите: 12:00

Договорен орган
Идентитет
Национален регистарски број: 17851/2021
Друг вид договорен орган: University hospital
Контакт
URL на документи: https://e-nabavki.gov.mk 🌏

Дополнителни информации
Тело за преглед
Име: University Clinic of Cardiology
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Извор: OJS 2022/S 087-238211 (2022-04-29)

Нови набавки во поврзани категории 🆕

Медицинска опрема, фармацевтски производи и производи за лична нега (19 нови набавки)