Specification builder · Tier B
Multi-parameter bedside patient monitor (basic 5-parameter, standard, and advanced modular high-acuity configurations)
A bedside monitor that continuously shows and alarms on a patient's vital signs: ECG and heart rate, oxygen saturation (SpO2), blood pressure, temperature and breathing, with optional invasive pressures, CO2, cardiac output, anaesthesia depth and gases. Hospitals buy them for ICU, CCU, operating theatres, emergency, high-dependency and general wards. Choosing the right class (basic, standard or modular high-acuity) and keeping the specification brand-neutral are the main tender decisions.
Loading the builder...
Standards this specification draws on
- IEC 60601-1 General electrical and mechanical safety of medical equipment.
- IEC 60601-1-2 Electromagnetic compatibility, so the monitor works near diathermy, phones and other equipment.
- IEC 60601-1-8 Alarm system design: priorities, sounds and visual signals.
- IEC 60601-2-27 Particular requirements for ECG monitoring equipment.
- IEC 80601-2-49 Particular requirements for multifunction patient monitors (replaced IEC 60601-2-49).
- ISO 80601-2-61 Safety and accuracy of pulse oximeters.
- IEC 80601-2-30 Safety and performance of automated non-invasive blood pressure monitors.
- ISO 81060-2 Clinical validation of NIBP accuracy.
- IEC 60601-2-34 Invasive blood pressure monitoring equipment.
- ISO 80601-2-55 Respiratory gas monitors (CO2, anaesthetic agents, O2).
- ISO 80601-2-56 Clinical thermometers for body temperature measurement.
- IEC 80601-2-26 Electroencephalographs, applies to processed-EEG depth-of-anaesthesia modules.
- IEC 60601-2-25 Diagnostic 12-lead ECG acquisition and interpretation, where offered.
- ANSI/AAMI EC57 Standard test method for arrhythmia and ST algorithm performance.
- IEC 62304 Medical device software life-cycle.
- ISO 14971 Risk management for medical devices.
- ISO 13485 Quality management system of the manufacturer.
- IEC 62353 Electrical safety testing after installation and repair.
- HL7 v2.x Standard messaging for sending vital signs to the HIS/EMR.
- DRAP Medical Devices Rules 2017 Registration/enlistment required to import and sell medical devices in Pakistan.
Common mistakes in tenders for this equipment
- Copying one brand's brochure: naming proprietary SpO2 technologies, algorithm names, screen sizes to the decimal (e.g. 15.6 inch) or exact module counts that only one model has. Use 'not less than' values and accept any validated technology.
- Asking for 12-lead diagnostic interpretation, transpulmonary thermodilution or cerebral oximetry on every bed when only a few beds need it; this cuts competition and doubles price.
- Buying monitors from one brand and a central station from another: they will not connect. Monitors, central station and network licences must be specified together.
- Accepting 'battery up to 4 hours' measured in standby. Specify run time with ECG, SpO2 and NIBP every 15 minutes.
- Forgetting neonatal and paediatric accessories (cuffs, SpO2 wraps, electrodes), so monitors in NICU/PICU cannot be used on delivery.
- Not asking for consumable and sensor prices: a cheap monitor may need costly single-source sensors and CO2 lines for 10 years.
- Accepting DRAP registration of a different model or of the brand only; the exact offered model and modules must be covered.
- Paid 'software activation' of parameters that the hardware already has (e.g. ST, arrhythmia, network). Require all specified functions to be fully licensed in the bid price.