Cardiology services or pulmonary specialists services

Tender description

Pacemakers, CRTP's and Loop Recorders. Brady pacemaker systems: — P1. Dual Chamber, — P2. Single Chamber, — P3. Leads, — P4. Generators only. Lot 2 Cardiac Resynchronisation Pacemakers Systems: While functioning like a normal pacemaker to treat slow heart rhythms, a CRT-P device also delivers small electrical impulses to the left ventricle to improve the coordination of ventricular contraction. A CRT-P system consists of the pulse generator (device) and pacing leads that are in contact with the inner wall of the right atrium, the right ventricle and an additional lead positioned within the coronary sinus. C.1 CRT-P systems: Systems offered must be MRI conditional to at least 1.5 Tesla, ideally full body. Devices should offer a rate response option (dual sensor or physiological response sensor), with a maximal programmable sensor rate and ability to adjust sensitivity of response. Devices must have options that allow minimised ventricular pacing via algorithms that allow an extension of AV delays/ability to switch from atrial based to ventricular based pacing upon detection of AV block. Automatic self-lead checks with viewable trends and alerts for measurements outside programmed ranges. EGM storage for events. Rate hysteresis/Night rate. Fully programmable parameter options including range of lower/upper rates from 30-180 bpm. Full range of pacing modes including DDD, VVI, DDI as well as those needed to meet the requirements already stated above. Ergonomically shaped and sized, max. volume 20CC. Ideally offer AF therapy to include rate regulation, pause suppression and overdrive pacing. Diagnostics: must include HR graph, % pacing and HF information (e.g. rate variation, activity levels, thoracic impedance). Estimated battery longevity > 6 years. Must have wireless telemetry. Ideally compatible with home monitoring Multiple options for output to include automatic selection in line with daily lead checks. Manual options to allow for output and pulse width changes ideally from <1V up to max output in increments of up to 0,5 V (increment doesn’t have to cover entire output range, but ideally up to at least 5 V). Must be an IS-1 connection for RA and RV lead and IS-4 connection for LV lead. Must offer all available configurations for LV pacing. Ideally offer automatic programming suggestions feature e.g. for AV/VV delays. Programmable VV offset. Ideally offer a threshold test feature that allows quick assessment of all programmable LV configurations. C.2 Generators only: There will be a requirement for standalone generators to be purchased for box change procedures. These will need to be a mix of full body MRI conditional devices to maintain currently MRI compatibility and non MRI for those patients with non MRI leads. Generators must fulfil all of the other criteria above (C. 1). CRT-P generators used for box change will need to cover all combinations of lead connectors, including IS-4 and IS-1 connections for LV leads. C.3 Leads only: Must be IS-4 connection for LV lead. Available in a range of shapes and lengths. See Lot 5.1 for RA and RV leads. Lot 3 Implantable loop recorder: An insertable Cardiac monitor that allows home ECG monitoring of patients with suspected cardiac arrhythmias or unexplained syncope. Must be injectable. No greater than 2CC. Record an EGM for both automatic events and patient activated episodes. Must be able to be activated by the patient at time of symptom. Must be supplied with remote monitoring that enables both patient activated and automatic download on detection of events. Battery longevity of approximately 2 years. Programmable options to allow for EGM storage pre and post activation/detection. Programmable event criteria. Ergonomic design. Must be full body MRI-conditional. 5.4 Implant Accessories The following must be provided: — peel-able Introducer sheaths in a range of sizes from 6Fr — 9Fr, — testing cables, — LV Introducer sheaths (outer and inner), — lead end caps, — pin port plugs, — stylets, — wrench kit, — rotation Tool, — LV guide wire, — IS-4 connector tool (where applicable), — LV sheath slitter, — balloon occlusion catheter, — ID card holders ideally.