Procurement Support to Ministry of Health, Ukraine Invitation to Bid for: PROGRAMME XIX: MEDICAL PRODUCTS FOR HEALTHCARE INSTITUTIONS FOR TREATMENT OF PATIENTS WITH CARDIOVASCULAR AND CEREBROVASCULAR DISEASES Part 2 Electrophysiology & Cardio Stimulation ITB No: CA/107403/0001/001 Clarification No 2 This is Clarification No 2 dated 6 th January 2017 to the ITB dated 28th December 2106, ITB No: CA/107403/0001/001 Please find attached the questions received from potential Suppliers and Crown Agents clarifications. Note that the deadline for seeking further clarifications is 19 th January 2017. Please acknowledge receipt of this clarification. Aysel Abasova Supply Chain Specialist Crown Agents 6 th January 2017 Page 1
CA/107403/0001/001 Clarification No 2 No 11. Attached you can also find the list of questions specifically related to Appendix C (STATEMENT OF COMPLIANCE and TECHNICAL OFFER) Answer Please see answers attached on the relevant bidding forms. Page 2
APPENDIX C STATEMENT OF COMPLIANCE and TECHNICAL OFFER STATEMENT OF COMPLIANCE Item Part 2 Electrophysiology and Cardio Stimulation 1 Single chamber pacemakers (SSI) with bipolar and monopolar electrode should correspond to the following medical-technical - Pacemaking regime single chamber (SSI) - AP rhythm intruding control option and automated amplitude control during ventricular pacing - Supply with bipolar steroid electrode with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (1 unit) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 2 Single chamber rate-responsive pacemaker with automatic amplitude control during ventricular pacing (SSIR) should correspond to the following medicaltechnical - Pacemaking regime single chamber (SSIR) Discrepancy of lot name and requirements (SSI vs. SSIR) SSIR is correct Page 3
- AP rhythm intruding control option and automated amplitude control during ventricular pacing - Supply with bipolar steroid electrode with active fixing (draw-out spiral) and possibility of implantation through the introducer in a kit/set (1 unit) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 3 Single chamber rate-responsive pacemaker (SSIR) should correspond to the following medical-technical - Pacemaking regime single chamber (SSIR) Discrepancy of lot name and requirements (SSI vs. SSIR) SSIR is correct episodes ATA/AF and pacemaking system status - Supply with bipolar steroid electrode with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (1 unit) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 4 Dual chamber pacemaker without autocapture function (DDD) should correspond to the following medical-technical - Pacemaking regime dual chamber (DDD) Page 4
episodes ATA/AF and pacemaking system status - Supply with two bipolar steroid electrodes with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a ket/set. (2 units) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 5 Dual chamber pacemaker with the autocapture function (DDD) should correspond to the following medical-technical?? with the autocapture function - Pacemaking regime dual chamber (DDD) - AP rhythm intruding control option and automated amplitude control during ventricular pacing Discrepancy of lot name and requirements (without autocapture vs. amplitude control during VP meaning autocapture) Lot name corrected episodes ATA/AF and pacemaking system status - Function allowing noninvasive pacing for the patient with artificial pacemaker implanted. - Automated tracing of intrinsic conduction to decrease ventricular pacing - Supply with two bipolar steroid electrodes with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (2 units) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 6 Dual chamber pacemaker (DDDR) which should correspond to the following medical-technical No longevity requirements while superior is mentioned in the lot name Page 5
Wording amended - Pacemaking regime dual chamber (DDDR) Discrepancy of lot name and requirements (DDD vs. DDDR) Should read DDDR - AP rhythm intruding control option and automated amplitude control during ventricular pacing episodes ATA/AF and pacemaking system status - Automated tracing of intrinsic conduction to decrease ventricular pacing - Supply with two bipolar steroid electrodes with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (2 units) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 7 Dual chamber rate-adaptive pacemaker (DDDR) for neonates should correspond to the following medicaltechnical - Pacemaking regime dual chamber (DDDR) Discrepancy of lot name and requirements (DDD vs. DDDR) Should read DDDR - Maximal possible pacemaking rate (not less than 200 BPM) - AP rhythm intruding control option and automated amplitude control during ventricular pacing Page 6
- Automated tracing of intrinsic conduction to decrease ventricular pacing episodes and pacemaking system status - The least weight and dimensions of device out of all introduced Not exact requirement Agreed - deleted 8 - Supply with two bipolar steroid electrodes with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (2 units) with a diameter not exceeding 6 Fr Dual chamber rate-responsive pacemaker (DDDR) for children and adolescents should correspond to the following medical-technical This row was missing in the original Appendix C - Pacemaking regime dual chamber (DDDR) Discrepancy of lot name and requirements (DDD vs. DDDR) Should read DDDR - Maximal possible pacemaking rate (not less than 180 BPM) - AP rhythm intruding control option and automated amplitude control during ventricular pacing - Automated tracing of intrinsic conduction to decrease ventricular pacing episodes and pacemaking system status - The least weight and dimensions of device out of all introduced Page 7
- Supply with two bipolar steroid electrode with active fixing (draw-out spiral) and possibility of implantation through the introducer in a kit/set (2 units) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 9 Dual chamber rate-responsive pacemaker with regime (DDDR) should correspond to the following medicaltechnical No leads/introducers in the kit?? If leads/introducers are supposed to be in the kit, please add this to requirements. Amended - Pacemaking regime dual chamber rate adaptive (DDDR) episodes and pacemaking system status - Automated tracing of intrinsic conduction to decrease ventricular pacing 10 - Supply with two bipolar steroid electrodes with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (2 units) with a diameter not exceeding 7 Fr Dual chamber rate-adaptive pacemaker with preventive pacing algorithms (DDDRP) for bradycardia patients with atrial fibrillation should correspond to the following medical-technical This row was missing in the original Appendix C - Pacemaking regime dual chamber rate adaptive (DDDR) - AP rhythm intruding control option and automated amplitude control during ventricular pacing episodes ATA/AF and pacemaking system status - Automated tracing of intrinsic conduction to decrease ventricular pacing Page 8
- Atrial pacing self-regulation algorithm to prevent and treat atrial arrhythmia - Supply with two bipolar steroid electrodes with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (2 units) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended 11 Cardiac resynchronization therapy pacemaker with the function of intrathoracic impedance measurement should correspond to the following medical-technical Discrepancy of lot name and requirements (intrathoracic impedance measurement vs. no in requirements) See below - Pacemaking regime - triple chamber biventricular - Cardiac resynchronization therapy option - Sensor for rate adaptation before physical activity - Interventricular break regulation option episodes ATA/AF and pacemaking system status - Supply with two bipolar steroid electrodes for right atrium and right ventricule with active fixing (draw-out spiral) and possibility of implantation through the introducer sheath in a kit/set (2 units) with a diameter not exceeding 7 Fr - Electrode for left ventricle (LV) pacemaking should be supplied with the system of delivery to the cardiac veins What are the parts of the system of delivery? Name each part in requirements exactly, please. Page 9
The electrode should have the capability (additional system) which enables the delivery of the electrode to the cardiac veins. - Electrode for left ventricle (LV) pacemaking should have the option of delivery on the conductor - Option of recording and memorizing of intracardial tracing, adjustment of duration and number of intracardial tracing recordings 12 Single chamber implantable cardioverter-defibrillator should correspond to the following medical-technical - Pacemaking regime - triple chamber biventricular (VVIR) episodes AT/AF/VT/VF and pacemaking system status - Maximal power of defibrillating impulse not less than 30.0 J - Directed discharge inversion option - Ventricular and supraventricular tachyarrhythmia differencing algorithm - Supply with single spiral defibrillating electrode not less than 9 Fr thick with active fixing and introducer sheath not more than 10 Fr thick with connector DF-1 or DF-4. Where we can have clients requirements? Deleted - Function of ventricular tachycardia elimination by defibrilator antitachycardic pacemaking 13 Dual chamber implantable cardioverter-defibrillator should correspond to the following medical-technical Discrepancy of lot name and requirements (Single chamber vs. dual Page 10
requirements chamber rate adaptive) Corrected should be dual chamber - Pacemaking regime dual chamber rate adaptive (DDDR) - Maximal power of defibrillating impulse not less than 30.0 J - Directed discharge inversion option DDDR is correct - Ventricular and supraventricular tachyarrhythmia differencing algorithm episodes AT/AF/VT/VF and pacemaking system status - Function to decrease the extensive stimulation of right ventricle - Function of ventricular tachycardia elimination by defibrillator antitachycardic stimulation - Supply with bipolar steroid electrode with active fixing (draw-out spiral) and possibility of implantation through the introducer in a kit/set (2 units) with a diameter not exceeding 7 Fr What does stand CPL. For. Complete wording amended - Supply with single spiral defibrillating electrode not more than 9 Fr thick with active fixing and introducer sheath not more than 10 Fr thick with connector DF-1 or DF-4 Where we can have clients requirements? Should be "more" and not "less" Client requirement deleted. Page 11
14 Cardiac resynchronization therapy implantable dual chamber cardioverter- defibrillator should correspond to the following medical-technical - Pacemaking regime triple chamber rate adaptive. - VV break programming option - Ventricular and supraventricular tachyarrhythmia differencing algorithm - Supply with bipolar steroid electrodes for atrium and right ventricle not more than 7 Fr thick. Electrode should have active fixing - Electrode for left ventricle (LV) pacemaking should be bipolar and supplied with the system of its delivery to the cardiac veins on the conductor If that the Right Ventricle lead (asked in the req below), please remove it. What are the parts of the system? Do we need to provide catheter? Or balloon as well? There is no further information. Each bidder should offer their product that gives the solution required by MOH Ukraine. - Maximal power of defibrillating impulse not less than 30.0 J - Directed discharge inversion option - Ventricular and supraventricular tachyarrhythmia differencing algorithm episodes AT/AF/VT/VF and pacemaking system status - Supply with single spiral defibrillating electrode not less than 9 Fr thick with active fixing and introducer sheath not more than 9 Fr thick with connector DF-1 or DF-4. Where we can have clients requirements? Because DF1/DF4 connectors are the different types of devices Each bidder should offer their product that gives the solution required by Page 12
MOH Ukraine - Function of ventricular tachycardia elimination by defibrillator antitachycardic pacemaking 15 Epicardial chronic steroid eluting electrode should correspond to the following medical-technical - Bipolar with ventricle or atrium pacemaking option - Active fixation with stitching option - Electrode length from 35 to 80 cm Will the length of 35, 50 and 60 be accepted The length should be within the range specified - Connector type IS-1 Were these items lost from the ITB appendix C?. Our source copy is correct. 16 Conventional electrodes for ablation catheters should correspond to the following medical-technical - 4 poles of electrode with the length of distal pole 4 mm - Electrode thickness not more than 7 Fr - Temperature indicator - Curve dimensions according to the Client s requirements - Electrode spacing : 2-5-2mm 17 Irrigated electrodes for ablation catheters should correspond to the following medical-technical Page 13
- 4 poles of electrode with the length of distal pole 4 mm - Electrode thickness not more than 7 Fr - Temperature indicator - Should have external cooling contour - Curve dimensions according to the Client s requirements - Electrode spacing : 2-5-2мм 18 Steerable double-curved ablation catheter with bidirectional tip should correspond to the following medical-technical 18.1 Distal electrode length 4 mm - 4 poles of electrode with the length of distal pole 4 mm - Electrode thickness not more than 7 Fr - Temperature indicator - Proximal and distal curve. Bi-directional distal tip - Electrode spacing : 2-5-2 mm - Curve dimensions according to the Client s requirements 18.2 Distal electrode length 8 mm - 4 poles of electrode with the length of distal pole 8 mm - Electrode thickness not more than 7 Fr - Temperature indicator - Proximal and distal curve. Bi-directional distal tip - Electrode spacing : 2-5-2 mm Page 14
- Curve dimensions according to the Client s requirements 19 Navigation irrigated diagnostic ablation catheter should correspond to the following medical-technical Purpose For electrophysiological mapping (pacing and recording) and for cardiac ablation, if used together with RF generator Compatibility Should be compatible with Carto navigation system and RF generator Stockert EP-Shuttle Possibilities Electrode cooling (irrigation) technology should be available during the ablation procedure Electrode spacing 2-5-2 mm Insertion depth Not less than 115 cm Curve dimensions according to the Client s requirements 20 Navigation system reference electrodes should correspond to the following medical-technical Temporarily removed from tender whilst specification is checked. It may be re-introduced through an amendment to this ITB 21 Temporary cardiac pacing wire should correspond to the following medical-technical 21.1 Length 0.65 m - Temporary cardiac pacing wire with length not less than 65 cm and not more than 75sm - Micro wire bladed or twisted, insulated - 2 needles at the end of the wire Page 15
21.1 Length 0.90 m - One needle is straight, with length not less than 60 mm, with notch for easier breakage - Second needle is bladed ½ circle, with length 17 to 26 mm - Temporary cardiac pacing wire with length not less than 90 cm and not more than 100cm - Micro wire bladed or twisted, insulated - 2 needles at the end of the wire 21.3 Length 1.20 m - One needle is straight, with length not less than 60 mm, with notch for easier breakage - Second needle is bladed ½ circle, with length 17 to 26 mm - Temporary cardiac pacing wire with length not less than 120 cm and not more than 130 cm - Micro wire bladed or twisted, insulated - 2 needles at the end of the wire - One needle is straight, with length not less than 60 mm, with notch for easier breakage - Second needle is bladed ½ circle, with length 17 to 26 mm Page 16
TECHNICAL OFFER Crown Agents Reference: CA/107403/0001/001 Bidders Reference: Bid Closing Date: 26 January 2017 Currency: USD To:- Crown Agents Limited St Nicholas House, St Nicholas Road Sutton, Surrey SM1 1EL United Kingdom Details of item offered Item INN Form of presentation Shelf Life (expiry date of product dd/mm/yy) Manufacturer Brand Name Country of Manufacture & Certified Country of Origin Delivery lead time from contract signature* Can we put item description as the lot (kit)? Or it shall be item by item:it should be item by item based on the list provided in ITB 1 Single chamber AP (SSI) with bipolar lead Kit with lead and introducer that includes: 1. 2. 3. Not less than 75% of total UBD (without dd/mm/yy) 1. 2. 3. We have several manufacturi ng facilities for one type of device and it could come from all of them) The origin should comply with the product documents registered in Ukraine 4. Page 17
Or? 1 Single chamber AP (SSI) with bipolar lead pcs Not less than 75% of total UBD (without dd/mm/yy) NO Page 18