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