Medical devices for electrophysiology and heart electrostimulation laboratory

University Clinic of Cardiology

Рок

Рокот за прием на понудите беше 2023-05-02. Набавката беше објавена на 2023-03-31.

Кој?

• University Clinic of Cardiology

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега

Каде?

• Северна Македонија › Скопски

Историја на набавките

Датум	Документ
2023-03-31	Оглас за договор

Оглас за договор (2023-03-31)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Краток опис: Medical devices for electrophysiology and heart electrostimulation laboratory
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: 2023-03-31 📅
Рок за поднесување: 2023-05-02 📅
Датум на објавување: 2023-04-05 📅
Идентификатори
Број на огласот: 2023/S 068-201927
OJ-S издание: 68

Предмет
Опсег на набавката
Проценета вкупна вредност: 75 000 900 MKD 💰
Наслов на делот: "Single-chamber VVIR pacemaker, with a ""normal optimal time"" of 10 years, with an electrode with active fixation for the right "
Број на дел: 1
Краток опис:

IS-1 connector or equivalent

"automatic adjustment of stimulation voltage and sensitivity

MRI possibility of the whole body with a strength of 1.5-3T

scanning and memorization of IEGM

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

switching from bipolar to unipolar stimulation during electrode damage

automatic recognition of electrode polarity during implantation

electrode with active fixation for the right ventricle with the possibility of choosing the length of the electrode

Времетраење: 12 месеци
Наслов на делот: Biventricular implantable cardioverter defibrillator (CRT-ICD) with a minimum pre-implantation voltage of 3.2V, with electrodes - atrial electrode with active fixation, ventricular defibrillation elec
Број на дел: 2
Краток опис:

with min. 40J delivered energy

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

vibration alarm in case of electrode damage or battery weakness

"MRI possibility of the whole body with a strength of 1.5T regardless of the size of the body, with an isocenter in every position of the body, without a time limit on the scanning

wireless programming

automatic algorithm for AV optimization

possibility of simultaneous stimulation from multiple poles of coronary sinus electrodes

possibility of ATP therapy during charging and before charging

possibility of software turn on and off the active case and SVC high voltage lead

minimum stimulation voltage of 5V in all channels

automatic reprogramming of VT/VF detection parameters

electrode integrity monitoring algorithm

set introducer for coronary sinus which will include: two catheters, dilator, guide wire, hemostatic valve, knife

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

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

atrial electrode with active fixation

Наслов на делот: VVIR single-chamber pacemaker, with a "normal optimal time" of 14 years, with an electrode with active fixation for the right ventricle
Број на дел: 3
Краток опис:

"IS-1 connector or equivalent

Programming a basic rhythm during rest or sleep of the patient

MRI possibility of the whole body with a strength of 1.5T

scanning and memorization of IEGM, min 14 minutes

automatic 'beat-to-beat' voltage adjustment for ventricular stimulation in uni- and bipolar electrode configuration

Наслов на делот: VVIR pacemaker for transcatheter implantation with introducer
Број на дел: 4
Краток опис:

"VVIR mode of operation

Total mass of the device < 2g

Volume of the device < 1cm3

Bipolar sensing

MRI compatible

Battery life > 7 years (100% pacing for 1.5 V at 0.24ms pulse width)

in set with a suitable introducer""

Наслов на делот: Two-chamber pacemaker DDDR, with a "normal optimal time" of 10 years with two electrodes with active fixation for the right atrium and right ventricle
Број на дел: 5
Краток опис:

automatic voltage adjustment for stimulation and sensitivity in atrium and ventricle

"Full body MRI imaging capability with 1.5-3T strength

"scanning and memorization of IEGM

algorithm for extending the AV interval up to 450ms to promote own rhythm

"trend for electrode resistance and switching from bipolar to unipolar stimulation during electrode damage

"automatic recognition of electrode polarity during implantation

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

with two electrodes with active fixation, for the right atrium and right ventricle with the possibility of choosing the length of the electrode

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

"""Beat-to-beat"" threshold measurement and adjustment of the stimulation amplitude in the chamber

"Algorithm for automatic threshold measurement and amplitude adjustment for atrial stimulation

"Physical activity sensor to regulate pacing speed

"Physiological sensor for rhythm adaptation during episodes of physical and mental stress

Automatic adjustment of the sensitivity in chambers and atria

Algorithm for automatic extension of AV interval in order to reduce unnecessary ventricular pacing.

Possibility to set unipolar or bipolar mode of operation of the electrode as well as an automatic algorithm for changing from bipolar to unipolar mode in case of deviation of the impedance outside the specified interval

Automatic measurement of parameters (threshold, sensing, impedance) during "follow-up" in one step without previous settings and adjustments.

System (two electrodes + pacemaker) with protection against magnetic resonance for the whole body when applying a permanent magnetic field of 1.5 T and 3.0 T

Possibility to activate the magnetic field sensors to automatically switch the device to MRI mode of operation in order to reduce the time in asynchronous pacing mode

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 ventricle

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

with AT/AF detection algorithms

battery life of at least 3 years

cardiac function monitor with the possibility of implantation with an injector, maximum volume 1.5cm3 and maximum weight 3g

external patient monitor for wireless data transmission from the injectable heart function monitor

possibility of manual activation of recording with additional display of continuous ECG at least 10 minutes before the moment of activation

"Beat-to-beat" threshold measurement and adjustment of the stimulation amplitude in the chamber

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

Algorithm for automatic threshold measurement and amplitude adjustment for atrial stimulation

"Automatic sensitivity adjustment,

recording and memorization of IEGM, frequency adaptability

algorithm for extending the AV interval up to 400ms

pacemaker with protection against magnetic resonance for the whole body when applying a constant magnetic field of 1.5 T and 3.0 T

possibility to activate the magnetic field sensors to automatically switch the device to MRI mode of operation in order to reduce the time in asynchronous pacing mode

trend for electrode resistance and switching from bipolar to unipolar stimulation during electrode damage

automatic recognition of electrode polarity during implantation.

automatic possibility to export the data in an electronic format that can be printed through an external printer

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

Dual-chamber DDDR pacemaker with IS-1 connector or equivalent, GSM-compatible transceiver unit for automatic, continuous telemonitoring with clinically proven benefit +2 bipolar electrodes, IS-1 connection passive or active fixation, straight or “J” curve

-"Beat-to-beat" threshold measurement and adjustment of the stimulation amplitude in the chamber

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

Possibility to set different automatic sensing thresholds in the chamber

Possibility of measuring the amplitude of the signal in the atrium using a floating dipole

Possibility to measure stimulation threshold in the chamber as well as electrode impedance

Possibility to program two VT and one VF zone with the choice of therapy in the form of antitachycardia pacing, maximum shock strength of at least 35 J

choice of different discriminating algorithms for tachycardia detection

Option to program special anti-bradycaric pacing after shock

Diagnostic possibility in the form of episode recording with marked iEGM markers

Weight of the device < 85 g

Volume of the device < 35 cm3

Battery life >9 years (VVI 15% pejsing, 2.5 V na 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 supraventricular dipole from the tip of the electrode

Наслов на делот: Dual-chamber implantable cardioverter defibrillator (ICD), with a minimum pre-implantation voltage of 3.2V, in Set with electrodes - atrial with active fixation, ventricular defibrillation electrode w
Број на дел: 11
Краток опис:

Dual-chamber implantable cardioverter defibrillator (ICD), with a minimum pre-implantation voltage of 3.2V, in Set with electrodes - atrial with active fixation, ventricular defibrillation electrode with two leads and active or passive fixation with a minimum length of 70 cm

-min. 35 J of delivered energy

sound alarm in case of electrode damage or battery weakness

DF-1 or DF-4 device connector or equivalent

possibility of recording a full-body MRI with a strength of 1.5-3T, regardless of body size, with an isocenter in any position of the body, without a time limit on the recording

possibility to software enable and disable active case and high voltage lead in SVC

algorithm for monitoring the integrity of the electrode

minimum stimulation voltage of 5V (in both channels)

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

a ventricular defibrillation lead with a DF-1 or DF-4 connector or equivalent, with one or two leads with active or passive fixation with a minimum lead length of 65 cm

Наслов на делот: Single-chamber implantable cardioverter defibrillator (ICD) with a minimum pre-implantation voltage of 3.2V
Број на дел: 12
Краток опис: min. 35 J of delivered energy
Наслов на делот: Implantable heart monitor
Број на дел: 13
Краток опис:

Ability to record episodes of atrial fibrillation, rapid ventricular rate (HVR), bradycardia, asystole and rapid deceleration (SRD)

Ability to activate recording from outside

- Possibility of inversion of the device's ECG records in case of a negative QRS complex

Smart episode recording system

- Daily monitoring through an external unit

- Enabling an incision smaller than 1.5cm for device implantation

- Device weight less than 5g and device volume less than 3 cm3

- Lifespan and duration greater than 3.5 years, with activated telemonitoring that includes sending one surface ECG per day and 2 patient-activated episodes per month

- MRI compatible at 3.0 T

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

Biventricular pacemaker CRT-P with magnetic resonance protection GSM compatible transceiver unit for automatic, continuous telemonitoring with clinically proven benefit +2 bipolar electrodes, IS connection -1 passive or active fixation, straight or “J” curve with magnetic resonance protection + 1 IS-4 Connection Quadripolar Coronary Sinus Electrode with Magnetic Resonance Protection + Coronary Sinus System

-Algorithm for automatic measurement of the threshold and adjustment of the amplitude for stimulation in atria, right and left ventricle

Sensor for physical and mental activity to regulate pacing speed

Algorithm for automatic reduction of AV interval in order to prevent intrising rhythm in ventricles.

Programmed VV interval as option to select initial ventricular pacing

System (three electrodes + pacemaker) with protection against magnetic resonance for the whole body when applying a constant magnetic field from 1.5 T to 3.0 T

GSM transceiver unit, compatible with CRT-P device for automatic, continuous telemonitoring with clinically proven benefit

Weight of the device < 33 g

Volume of the device < 16 cm3

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

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

-steroid coronary sinus quadripolar electrode, various lengths and shapes

-Introduction system for coronary sinus with suitable diameter, different lengths and shapes consisting of external and internal (subselective catheter with the possibility of different curves) introducer, introducer 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 ventricle, unipolar, bipolar or quadripolar electrode
Број на дел: 15
Краток опис:

Biventricular pacemaker CRT-P, with "normal optimal time" of 5 years, with two electrodes with active fixation for right atrium and right ventricle, unipolar, bipolar or quadripolar electrode for coronary sinus.

-IS-1 connector or IS-4 or equivalent

Ability to record whole body MRI with 1.5-3T strength, independent of body size, with isocenter in any position of the body, without recording time limit

"recording and memorization of IEGM

trend and automatic measurement of electrode resistance and switching from bi- to unipolar stimulation in case of its damage

possibility to display at least two ECG leads

possibility to program at least 15 vectors for LV stimulation,

independent programming of frequency adaptability in at least two zones

an algorithm to reduce symptoms in AT/AF

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

measurement of thoracic impedance/resistance as an indicator of lung fluid level

two electrodes with active fixation for the right atrium and right ventricle with the possibility of choosing the length of the electrode

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

coronary sinus introducer set (two catheters, dilator, guide wire, sheath and hemostatic valve)

catheter for subselection of tortuous branches of the coronary sinus with the ability to select the curvature of the distal part (tip) of the catheter from 90 to 130 degrees, the possibility of introducing the electrode for the coronary sinus through the catheter, internal diameter of 4.0-5.5 Fr, hemostatic valve

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

Biventricular implantable cardioverter defibrillator (CRT-DX) with magnetic resonance protection GSM compatible transceiver unit for automatic, continuous telemonitoring with clinically proven benefit + 1 HV electrode for active fixation with a floating dipole and one defibrillation lead + 1 quadripolar electrode for coronary sinus connection IS-4 with magnetic resonance shielding + 1 Coronary Sinus System

-Possibility to set different automatic sensing thresholds in the right ventricle

Possibility to measure stimulation threshold in left and right ventricle as well as electrode impedance

Possibility to program two VT and one VF zone with the choice of therapy in the type of antitachycardia pacing, maximum shock strength of at least 35 J

Algorithm for automatic prolongation of AV interval in order to prevent the inducing rhythm in the ventricle

GSM transceiver unit, compatible with CRT-DX device for automatic, continuous telemonitoring with clinically proven benefit.

"Weight of the device < 89 g

Volume of the device < 38 cm3

Battery life >6.5 years (DDD-BiV 15% pacing, A : 2.5 V na 0.4 ms, 100% pacing, RV/LV: 2.5 V na 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 supraventricular dipole from the tip of the electrode - quadripolar coronary sinus electrode with steroids, different lengths and shapes

Introducer system for coronary sinus with suitable diameter, different lengths and shapes consisting of external and internal (subselective catheter with the possibility of different curves) introducer, introducer wire, syringe and blade.

Број на дел: 17
Краток опис:

Biventricular implantable cardioverter defibrillator (CRT-ICD) with a minimum pre-implantation voltage of 3.2V, with electrodes - atrial electrode with active fixation, ventricular defibrillation electrode and coronary sinus electrode

-with min. 35 J of delivered energy

possibility of a full-body MRI with a strength of 1.5-3T, regardless of body size, with an isocenter in any position of the body, without a time limit on the recording

automatic AV and VV time optimization algorithm

the possibility of simultaneous stimulation from multiple poles of coronary sinus electrodes

ability to software enable and disable active case and high voltage lead in SVC

minimum stimulation voltage of 5V (in all channels)

Atrial electrode with active fixation

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

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

Наслов на делот: Knives for dissection of soft tissues ("plazma" knives)
Број на дел: 18
Краток опис:

A monopolar instrument for precise dissection that uses low energy and low temperatures (from 40-170 C), for reduced thermal and depth damage

Наслов на делот: VDDR pacemaker for transcatheter implantation with introducers
Број на дел: 19
Краток опис:

"VDDR mode of operation (AV), total device mass < 2g, device volume < 1cm3, bipolar sensing, MRI compatible Battery life > 7 years (100% pacing for 1.5 V at 0.24ms pulse width)

in set with two suitable introducers"

Наслов на делот: Resorbable antibacterial coating to prevent infections
Број на дел: 20
Краток опис:

which contains minocycline and rifampicin

intended for implantable devices – pacemakers, defibrillators and CRT devices

size M and L

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

Bipolar electrode with active fixation and length < = 60 cm, MRI compatible with strength 3.0 T FBS, with retractable length of minimum 1.8 mm, with steroid of 0.85 mg, with recommended diameter 6 F

External catheter 32 cm and 39 cm long, made of PEBAX and PA with an inner hydrophilic coating, with inner diameter < 8 F and outer diameter < 9 F

Dilator with edge length < 47 cm

59 cm and 69 cm length PEBAX and PA internal catheter with hydrophilic inner coating, < 6F inner diameter and < 7F outer diameter, 50⁰ and 90⁰ catheter tip, compatible with 0.014" - 0.035" guide wire. compatible with electrode < 6F and female luer-lock connection

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

Наслов на делот: A long introducer to electrophysiology
Број на дел: 22
Краток опис:

length from 63 to 81 cm

8F and 8.5 F inner diameter

at least 5 different curves

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

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

"possibility to choose dimensions when ordering from

6-10 F, with mandatory representation of all dimensions

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

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

possibility to choose dimensions when ordering from

6-12 F, with mandatory representation of all dimensions

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

possibility of deflection min 180 degrees

different curves and temperature control

distal electrode for ablation min 4 mm,

catheter length min 110 cm

distance between electrodes 2-5-2 mm.

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

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

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

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

length of 90-115 cm

thickness no greater than 7F

D-F curve

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

tip with a length of 3.2 mm

4F, 5F or 6F

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

the option of choosing an atraumatic soft tip

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

Наслов на делот: " Electrode Extraction Set"
Број на дел: 29
Краток опис:

One long dilator for controlled manual rotary extraction, with an internal diameter of 9-13 F and a length of 40 cm

One short dilator for controlled manual rotary extraction, with an internal diameter of 9-11 F and a length of 13 cm

One femoral catheter with the possibility of ""snare"" i.e. ""grabbing"" electrodes, with an internal diameter of 12 F and a length of 90 cm; ""locking stylet"" ie. ""locking stylet"" for the electrodes; electrode extender i.e. ""lead extender"" with a length of 70 cm, which aims to insert the electrode through the dilator (3 pieces); wires for tensioning and stabilization of the ""locking stylet"" with the proximal end of the electrode - set of 5 (five)"

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

Introducer 8F and 8.5F, with hemostatic valve length from 63 to 81 cm and needle with extremely sharp tip, 18 Gauge with length from 71 to 98 cm, guide wire

Наслов на делот: Long introducer with a deflectable tip
Број на дел: 31
Краток опис:

Catheter with a diameter of 8.5F with variable curvature in two directions, opposite each other, asymmetrical bending, in one direction 90° and in the other direction 180°

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: 2023-05-02 📅
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 2023/S 068-201927 (2023-03-31)

Нови набавки во поврзани категории 🆕

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