The document provides specifications for a neonatal monitor called the Gamma XL. It lists the required technical specifications including the ability to measure and display waveforms for ECG, respiratory rate, blood pressure, temperature, oxygen saturation, CO2, and other parameters. It specifies that the monitor must have an 8.4" or larger screen, soft keys for control, and be able to operate between 0-45 degrees Celsius. The specifications also list requirements for modules to measure ECG, arrhythmias, pulse oximetry, blood pressure, respiration, end-tidal CO2, temperature, and include a dual-channel recorder. Alarms and controls are also outlined.
The document provides specifications for a neonatal monitor called the Gamma XL. It lists the required technical specifications including the ability to measure and display waveforms for ECG, respiratory rate, blood pressure, temperature, oxygen saturation, CO2, and other parameters. It specifies that the monitor must have an 8.4" or larger screen, soft keys for control, and be able to operate between 0-45 degrees Celsius. The specifications also list requirements for modules to measure ECG, arrhythmias, pulse oximetry, blood pressure, respiration, end-tidal CO2, temperature, and include a dual-channel recorder. Alarms and controls are also outlined.
The document provides specifications for a neonatal monitor called the Gamma XL. It lists the required technical specifications including the ability to measure and display waveforms for ECG, respiratory rate, blood pressure, temperature, oxygen saturation, CO2, and other parameters. It specifies that the monitor must have an 8.4" or larger screen, soft keys for control, and be able to operate between 0-45 degrees Celsius. The specifications also list requirements for modules to measure ECG, arrhythmias, pulse oximetry, blood pressure, respiration, end-tidal CO2, temperature, and include a dual-channel recorder. Alarms and controls are also outlined.
The document provides specifications for a neonatal monitor called the Gamma XL. It lists the required technical specifications including the ability to measure and display waveforms for ECG, respiratory rate, blood pressure, temperature, oxygen saturation, CO2, and other parameters. It specifies that the monitor must have an 8.4" or larger screen, soft keys for control, and be able to operate between 0-45 degrees Celsius. The specifications also list requirements for modules to measure ECG, arrhythmias, pulse oximetry, blood pressure, respiration, end-tidal CO2, temperature, and include a dual-channel recorder. Alarms and controls are also outlined.
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ITEM SPECIFICATION
ITEM No. : DESCRIPTION:
Gamma XL Monitor for Neonatal Dept.
Specification: 1 TECHNICAL SPECIFICATIONS OF Neonatal MONITOR, 4 waveforms
1-1 Transfer monitor shall be capable of measuring and displaying
Waveforms for the following monitored parameters: 1-1-1 ECG 1-1-2 Respiratory rate 1-1-3 Blood pressure (systolic, diastolic, and mean) 1-1-4 Body temperature 1-1-5 Arterial haemoglobin oxygen saturation (SpO2) 1-1-6 CO2 module (upgradeability) 1-1-7 Oxy-Cardio respire Gram (OCRG) 1-1-7 Soft keys & Rotary knob control, and not touch screen or any external control device Alphanumeric data shall be displayed for each parameter. 1-1-8 All patient inputs shall be defibrillator protected. 1-1-9 All patient inputs to comply with IEC and UL standards. 1-1-10 All equipment shall be capable of operating under normal ambient environmental conditions of 0 to 45 C, 10% to 95% relative humidity. 1-1-10 Screen size not less than 8.4” TFT screen 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 Display section 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 no latching. Pressure channels are to have selectable display of individual or common scale. 1-3 Each monitor shall be supplied with a patient cable and lead set. 1-4 Single-channel or multichannel strip-chart recorders must include the following features and characteristics: 1-4-1 Annotation of date, time, bed number, alarm status, and vital signs.
1-4-2 Automatic trace calibration and centering.
1-5 Trending of all parameters shall be for up to 24 hours .
Graphic and tabular displays of derived numeric variables shall be for selectable sample intervals of one minute up to one hour. 1-6 The following modules should be used in configuring an appropriate acute care physiologic monitoring system: 1-6-1 ECG 1-6-1-1 All equipment shall comply with the following criteria or requirements: isolated input ECG/respiration module(s) , 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. 1-6-1-2 Monitor(s) shall be able to display multiple leads of ECG simultaneously. 1-6-1-3 Module(s) must come complete with patient safety cables and patient-lead set. 1-6-1-4 Equipment should include an apnea alarm, which is triggered if no breaths are detected over a predetermined period of time. 1-6-2 Arrhythmia detection (Recognition & display of all kinds of Arrhythmia) 1-6-2-1 The arrhythmia monitoring system shall be a computer-based system (built into each bedside monitor or bedside module for the detection and classification of arrhythmias and paced beats). 1-6-2-2 Each unit shall provide trending,tabular display of arrhythmia parameters. 1-6-2-3 All waveform sampling shall be at a rate of at least 250 samples/second. 1-6-2-4 Each unit shall be capable of displaying the following information without loss on the central station or bedside display of any continuous patient waveforms: 1-6-2-5 Display of each patient's alarm and rhythm status, heart rate, and alarm limits for arrhythmia-related criteria (e.g., ventricular tachycardia, PVC runs). 1-6-2-6 Tabular trend display of arrhythmia data for each patient. 1-6-2-7 Unit status display. 1-6-2-8 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.
1-6-3 Pulse Oximeter
1-6-3-1 Pulse oximetry module(s) 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. 1-6-4 Noninvasive Blood Pressure (NIBP) 1-6-4-1 NIBP module(s) shall have Neonatal blood pressure capabilities. At a minimum, they should be able to measure systolic pressures up to 250 mm Hg. 1-6-4-2 Module(s) must come complete with one set of Neonatalcuffs. 1-6-5 Respiration 1-6-5-1 All equipment shall have the capability to measure respiratory rate through at least one of the following methods: 1-6-5-2 Impedance pneumography, which passes a low-current, high-frequency carrier signal between two ECG electrodes on either side of the chest wall. 1-6-5-3 Pressure-sensitive capsule, which is placed on the abdomen to detect body surface movements caused by breathing. 1-6-5-4 Thermistor, which is placed near the mouth or nose to detect the temperature changes between inhaled and exhaled air. 1-6-5-5 An apnea alarm, which is triggered if no breaths are detected over a predetermined period of time, should be included. 1-6-6 End-tidal CO2 1-6-6-1 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. 1-6-7 Temperature 1-6-7-1 Temperature module(s) shall include digital temperature display for 0 to 50 C with the ability to use standard YSI 400 or 700 probes. 1-6-7-2 Thermistor probe (a semiconductor whose resistance changes with temperature) shall be included. 1-6-8 Recorder 1-6-8-1 Dual-channel recorder(s): 1-6-8-2 Equipment shall be capable of automatic write-out of ECG, pressure, respiration, and/or other waveforms following bedside unit alarm initiation. 1-6-8-3 Equipment shall be capable of hard-copy output trend data. 1-6-8-4 Docking station for secured fixation on the wall mount & on trolley during transportation. 1-6-8-5 Equipment shall have a minimum 20-second solid state memory for write-out of past events. 1-7 Alarms 1-7-1 The physiologic monitoring system should have visual or audible alarms to warn operators of any system fault that may cause unsafe or erroneous results. 1-7-2 Audible and/or visual indicators should activate when the display reading reaches and remains at the alarm limit. 1-7-3 All alarms should be fully explained in the operator's manual. 1-8 Audible Alarms 1-8-1 Audible alarms should be distinct and easily identified. 1-8-2 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. 1-8-3 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. 1-8-4 Although an audible-alarm silence is acceptable, the alarm must recur automatically if the condition is not corrected. 1-8-5 If an alarm is silenced, a visual display should clearly indicate which alarm is disabled. 1-9 Visual Alarms End of specification