Specification builder · Tier B
Manual biphasic defibrillator/monitor with AED mode, synchronised cardioversion, optional transcutaneous pacing and SpO2/NIBP/EtCO2 monitoring
A portable defibrillator that shows the heart rhythm and lets a doctor give a manual shock, a timed (synchronised) shock for fast irregular rhythms, or follow voice prompts in AED mode; most units can also pace a slow heart through skin pads and monitor SpO2, blood pressure and CO2. Hospitals buy them for emergency, ICU, CCU, wards and theatres, and ambulance services for transfers. The key tender decisions are energy and modes, pads and paddles, battery and ruggedness, and keeping the specification open to several makers.
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Standards this specification draws on
- IEC 60601-1 General basic safety and essential performance of medical electrical equipment.
- IEC 60601-2-4 Particular requirements for cardiac defibrillators: energy accuracy, charge time, synchronisation, AED rhythm recognition and operator/patient protection.
- IEC 60601-1-2 Electromagnetic compatibility so the unit works near diathermy, radios and phones and does not disturb other equipment.
- IEC 60601-1-8 Alarm system design: priorities, sounds and visual signals.
- IEC 60601-1-12 Additional requirements for equipment used in the emergency medical services (ambulance) environment.
- IEC 60601-2-27 Particular requirements for ECG monitoring, including defibrillation protection and pacemaker pulse handling.
- ISO 80601-2-61 Safety and accuracy of the pulse oximeter (SpO2).
- IEC 80601-2-30 Safety and performance of the automated non-invasive blood pressure function.
- IEC 62304 Software life-cycle for the rhythm analysis, synchronisation and control software.
- ISO 14971 Risk management for medical devices.
- ISO 13485 Quality management system of the manufacturer.
- DRAP Medical Devices Rules 2017 Registration/enlistment required to import and sell medical devices in Pakistan.
Common mistakes in tenders for this equipment
- Requiring 360 J or a specific waveform name: this copies one brand and excludes equally effective 200 J biphasic units. Ask for not less than 200 J biphasic with impedance compensation and a validated escalating protocol.
- Naming proprietary CPR feedback, rhythm analysis or SpO2 technologies instead of measurable functions (compression depth and rate feedback, validated accuracy).
- Forgetting multifunction pads, paediatric pads and their 5-year price: pads are single-use and expire, and some units only accept costly single-source pads.
- Accepting battery claims in standby or at low energy. Specify shocks at 200 J and monitoring hours with SpO2/NIBP running.
- No delivered-energy acceptance test: without a calibrated defibrillator analyser at installation and PM, a unit delivering the wrong energy is never detected.
- Accepting refurbished, monophasic or end-of-life models; require new, current-production biphasic units with 10-year parts support.
- Accepting DRAP registration of a different model or brand family only; the exact model and options must be covered.
- Paid software activation of pacing, 12-lead or AED functions after delivery; require every specified function fully licensed in the bid price.