This document provides item specifications for a patient monitor for an ICU department. It lists technical requirements for a 5-channel monitor that is upgradeable to 8 channels. The monitor must be capable of measuring and displaying waveforms for parameters like ECG, blood pressure, temperature, oxygen saturation. It must have alarms, integrated software, and be modular and upgradeable to accept additional modules like EEG and respiratory mechanics. The monitor must comply with safety and environmental standards.
This document provides item specifications for a patient monitor for an ICU department. It lists technical requirements for a 5-channel monitor that is upgradeable to 8 channels. The monitor must be capable of measuring and displaying waveforms for parameters like ECG, blood pressure, temperature, oxygen saturation. It must have alarms, integrated software, and be modular and upgradeable to accept additional modules like EEG and respiratory mechanics. The monitor must comply with safety and environmental standards.
This document provides item specifications for a patient monitor for an ICU department. It lists technical requirements for a 5-channel monitor that is upgradeable to 8 channels. The monitor must be capable of measuring and displaying waveforms for parameters like ECG, blood pressure, temperature, oxygen saturation. It must have alarms, integrated software, and be modular and upgradeable to accept additional modules like EEG and respiratory mechanics. The monitor must comply with safety and environmental standards.
Specification: 1 TECHNICAL SPECIFICATIONS OF ICU MONITOR,5 CHANNELS upgradeable to 8 Channels )
1-1 All equipment shall be capable of measuring and displaying
waveforms for the following hospital desired monitored parameters: 1-1-1 ECG 1-1-1-1 EEG ( Upgradeability of the monitor to monitor EEG ) 1-1-1-2 Respiratory rate 1-1-1-3 Blood pressure (systolic, diastolic, and mean) 1-1-1-4 Body temperature 1-1-1-5 Arterial hemoglobin oxygen saturation (SpO2) 1-1-1-6 Cardiac output ( Upgradeability of the monitor to monitor COP ) 1-1-1-7 Airway gas concentrations 1-1-1-8 Arrhythmia 1-1-2 Waveforms shall be displayed at a selectable sweep speed of 25 or 50 mm/sec for a display of at least eight seconds of each waveform. Alphanumeric data shall be displayed for each parameter. 1-1-3 All patient inputs shall be defibrillator protected. 1-1-4 All patient inputs to comply with IEC and UL standards. 1-1-5 All equipment shall be capable of operating under normal ambient environmental conditions of 0 to 45oC, 10% to 95% relative humidity. 1-2 The display section shall be capable of the digital display of alarm limits for each parameter and the alarm status for each parameter (i.e., standby or suspend mode). 1-2-1 Control panel shall incorporate programmed softkeys for control of monitor functions and display modes, remote record initiation control for all waveforms, controls for waveform, visual and audible alarms, and standard Alarm/acknowledge/reset controls. Alarms are to be configured by the hospital as either latching or non latching. Pressure channels are to have selectable display of individual or common scale. 1-3 Monitors must be modular for at least the advanced parameters other than the basic functions (i.e. other than ECG, NIBP, SPO2, & Temp), and screen size should not be less than 10.4”. 1-4 screen will have a split screen capability to permanently view the mini –trend without obstructing live waveforms. . 1-4-1 Each monitor shall be supplied with a monitor bracket and necessary hardware for mounting and a patient cable and lead set. 1-5 Trending of all parameters shall be for up to 24 hours of Graphic and tabular displays of derived numeric variables shall be for selectable sample intervals of one minute up to one hour. 1-6 All bedside monitors should be able to be interfaced with the hospital's existing information system. Access to individual bedsides can be obtained through the monitoring system LAN. then direct connections to each bedside will be required. Specify the best methodology for your system. 1-7 The following modules should be used in configuring an appropriate acute care physiologic monitoring system: 1-7-1 ECG 1-7-1-1 All equipment shall comply with the following criteria or requirements: isolated input ECG/respiration module(s) with 12- lead selection, 1 mV calibration, monitor/diagnostic selection, QRS beeper with adjustable volume control, digital heart rate display, adjustable heart rate alarm, lead-fault alarm, and trace size/position controls. 1-7-1-2 Monitor(s) shall be able to display 12 leads of ECG simultaneously using 6 leads cable ( not 10 leads Cable ). 1-7-1-3 Module(s) must come complete with patient safety cables and patient-lead set (5&6 leads). 1-7-1-4 Equipment should include an apnea alarm, which is triggered if no breaths are detected over a predetermined period of time. 1-7-2 Arrhythmia 1-7-2-1 The arrhythmia monitoring system shall be a computer-based system(using either a centralizer on the network or built into each bedside monitor or bedside module for the detection and classification of arrhythmias and paced beats). 1-7-2-2 Each unit shall provided trending, graphic display editing, and tabular display of arrhythmia parameters. 1-7-2-3 Each unit shall be capable of displaying the following information without loss on the central station or bedside display of any continuous patient waveforms: 1-7-2-4 Display of each patient's alarm and rhythm status, heart rate,and alarm limits for arrhythmia-related criteria . 1-7-2-6 Tabular trend display of arrhythmia data for each patient. 1-7-2-7 Unit status display. 1-7-2-8 Each unit shall be fully integrated with both bedside monitors and the central station system; that is, all alarms generated by the arrhythmia monitoring system shall be displayed on the bedside monitor for the patient, as well as the central station. 1-7-2-9 Capability for S-T segment analysis, including trending and curser control, for user-selectable point of analysis determination should be included. 1-7-3 Pulse Oximeter 1-7-3-1 Pulse oximetry shall include capabilities for measurement of oxygen saturation with percent digital display, automatic calibration, low O2 saturation and low signal alarms, and adjustable heart rate and saturation alarms with visual display, and probe. 1-7-4 Invasive Blood Pressure (IBP) 1-7-4-1 IBP module shall be suitable for arterial, venous, pulmonary artery, wedge, intracranial, and cerebrospinal fluid pressures with pressure range selection, auto-zero calibration, dual-digital display for systolic/diastolic and/or mean pressures, pressure alarm, and trace size/position controls. To be supplied 2x IBP module with 1 reusable IBP kit including the transducer. 1-7-5 Non invasive Blood Pressure (NIBP) 1-7-5-1 NIBP shall have adult and pediatric blood pressure capabilities. At a minimum, they should be able to measure systolic pressures up to 250 mm Hg. 1-7-5-2 Module(s) must come complete with one set of adult, large, thigh, and paediatric cuffs. 1-7-6 Respiration 1-7-6-1 All equipment shall have the capability to measure respiratory rate through at least one of the following methods: 1-7-6-2 Impedance pneumography, which passes a low-current, high-frequency carrier signal between two ECG electrodes on either side of the chest wall. 1-7-6-3 Pressure-sensitive capsule, which is placed on the abdomen to detect body surface movements caused by breathing. 1-7-6-4 Thermistor, which is placed near the mouth or nose to detect the temperature changes between inhaled and exhaled air. 1-7-6-5 An apnea alarm, which is triggered if no breaths are detected over a predetermined period of time, should be included. 1-7-7 End-tidal CO2 ( Option ) 1-7-7-1 End-tidal CO2 module(s) shall have capabilities for measurement of expired gas concentrations of CO2 with digital percent CO2 and respiratory rate display, calibration controls, adjustable alarms, trace size/position controls, and probe. 1-7-8 Temperature 1-7-8-1 Temperature module(s) shall include digital temperature display for 0E to 50EC with the ability to use standard YSI 400 or 700 probes. 1-7-8-2 Thermistor probe (a semiconductor whose resistance changes with temperature) shall be included. 1-7-9 Cardiac Output ( Option ) 1-7-9-1 Cardiac output module(s) utilizing the thermodilution principle shall include digital display of injectate and blood temperatures and CO consumption constant with injectate volume/temperature controls, trace size/position controls, and hemodynamic calculations (stroke volume, systemic vascular resistance, left ventricular stroke work index).
1-8 Alarms ( 3 levels )
1-8-1 The physiologic monitoring system should have visual or audible alarms to warn operators of any system fault that may cause
unsafe or erroneous results.
1-8-2 Audible and/or visual indicators should activate when the display reading reaches and remains at the alarm limit. 1-8-3 All alarms should be fully explained in the operator's manual. 1-9 Audible Alarms ( 3 levels ) 1-9-1 Audible alarms should be distinct and easily identified. 1-9-2 Audible alarms should be enabled when the physiologic monitoring system is turned on (i.e., the default volume should not be set to OFF) and should be clearly audible at any volume setting. 1-9-3 If the alarm volume is adjustable, it should not be possible to turn the volume down so low that it is not likely to be heard. 1-9-4 Although an audible-alarm silence is acceptable, the alarm must recur automatically if the condition is not corrected. 1-9-5 If an alarm is silenced, a visual display should clearly indicate which alarm is disabled. 1-10 Visual Alarms 1-11 Monitor Upgradeability & open Plateform Technology for future parameters 1-11-1 The monitor should be upgradeable to accept and operate neuromuscular transmission module to be used during Mechanical ventilation. 1-11-2 The monitor should be upgradeable to accept and operate Respiratory Mechanics module. 1-11-3 The monitor should be upgradeable to accept and operate EEG module at least 4 channels. 1-11-4 Rechargeable battery for at least 3 hours operating time End of specification