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1. PURPOSE
A patient monitoring system is required for the intensive care unit of a hospital. The main
functions of the system are to display information on the patients’ vital signs, and to generate
alarms when unsafe conditions occur. In addition the system provides a number of auxiliary
functions, such as setting up monitoring parameters and alarm limits, patient admission and
discharge, alarm histories, event recording. The users of the system are nurses and doctors.
2. PHYSICAL STRUCTURE
2.1 BEDS
The system must be able to support a variable number of beds, up to a maximum of 16.
2.2 MONITOR
Each bed has a separate monitor that collects patient data, sends information to the display,
and responds to user commands and queries.
2.3 DISPLAY
Patient vital signs are displayed on a screen situated next to each bed.
2.6 PRINT
Each monitor is equipped with a strip-chart printing device on which waveforms and other
patient information can be printed.
The monitor must read, check, display and store the patient's vital signs at regular intervals.
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3.1.3 VITAL SIGNS SAMPLING RATE
A time interval between successive readings applies to each vital sign. The user must be able
to change this value. A default time interval applies to each vital sign and is reverted to when
the patient is discharged. A minimum and maximum value for the time interval applies to
each vital sign. The different vital signs are described below.
The user can select which of the three electrical signal s should appear as a waveform on the
monitor screen. Only one of the three signals can appear on the screen as a waveform at any
one time.
In addition, the system must display the current heart rate and the safe range in effect for
heart rate. The current heart rate can be determined from the ECG signal.
The safe range can be set by the user. A default value of 50-150 applies if no values are
entered for the patient.
The time interval for taking successive readings can be varied in one second steps, between a
minimum of 2 seconds and a maximum of 30 seconds. A default of 5 seconds applies.
The current temperature must be displayed on the monitor screen. It must be possible to
select either Celsius or Fahrenheit as the unit of measure. In addition, the current safe range
for the temperature must be displayed, and can be set by the user. A default value of 30-42
(C) applies.
The time interval for taking successive readings can be varied in one second steps, between a
minimum of 5 seconds and a maximum of 2 minutes. A default of 20 seconds applies.
Blood pressure is recorded as three values, the systolic pressure (when the heart is in
contraction), diastolic pressure (when the heart is in expansion), and the mean of the systolic
and diastolic pressures. All three values must be displayed on the screen. In addition, the
signal waveform must be displayed on the screen.
The safe ranges for the three values can be set separately. The default values are: SYS: 80-200;
DIA: 20-120; MEAN: 40-140.
The time interval for taking successive readings can be varied in one second steps, between a
minimum of 2 seconds and a maximum of 2 minutes. A default of 10 seconds applies.
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This method of measuring blood pressure uses a cuff around a patient limb, which is
periodically inflated (automatically, when requested by the patient monitoring system) so
that a reading can be taken. The signal is carried via a cable to the system. No waveform is
displayed as measurement is not continuous. The current value for the systolic pressure,
diastolic pressure and mean pressure must be displayed.
The time interval between successive readings can vary between 1 minute and 30 minutes.
The default value is ten minutes.
The safe ranges for the three values can be set separately. The default values are: SYS: 80-200;
DIA: 20-120; MEAN: 40-140.
3.2 ALARMS
If, during monitoring, a new vital sign is added, for example, invasive blood pressure, the
alarm processing for that vital sign will not be active until valid physiologic data is detected.
The monitor responds differently to each category. Patient Status Alarms always take
priority over System Status Alarms.
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When a critical alarm occurs, the following actions are taken: a high-pitch alarm tone is
sounded, the alarm is stored in the alarm history, and a flashing visual alert is displayed.
When a message alarm occurs, the following actions are taken: the alarm is stored in the
alarm history, and a flashing visual alert is displayed.
Each alarm associated with a vital sign exceeding its limit (low and high) can be assigned to
either of these two levels. The default assignment (see defaults) is reinstated upon discharge.
When a system status alarm occurs, a low-pitch alarm tone is sounded and a flashing visual
alert is displayed.
It must also be possible to change the upper and lower limit for any vital sign, and the level
they are assigned to.
The user must be able to input textual remarks on the patient condition. The name of the
doctor/nurse and the time and day of the remark, as well as its text, are retained by the
monitor, until the patient is discharged.
Turning a vital sign on will revert to normal display and alarm monitoring.
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3.4.3 SETTING MONITOR DEFAULTS
Monitor defaults can be changed only when the monitor is in a discharged state.
3.4.5 DEFAULTS
Vital Unit of Monitoring Safe range Physiologic Alarm level if Alarm level if
sign measure Interval limits sign too low sign too high
NBP mmHg 10 mins SYS 80-200 SYS -99 - 350 Message Message
DIA 20-120 DIA -99 - 350
MEAN 40-140 MEAN -99 - 350
IBP mmHg 10 secs SYS 80-200 Message Message
DIA 20-120
MEAN 40-140
It must be possible to view information concerning the 16 most recent patient status alarms.
The functions of the central station are similar to those of the monitor, except that the set up
functions are not available. The user must select a bed before patient information can be
displayed. Only one patient's information is displayed at any one time. Display of data on the
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central station is similar to the display on the monitor. For completeness, all the differences
are described below.
4.2 ALARMS
Alarms must be displayed and sounded on the central station. Alarms can be silenced and
their volume adjusted.
All patient history data must be available to the central station. The user must select a bed
number before data can be displayed.
Alarm history, vital signs and recorded events can be displayed or printed on request.
5 SYSTEM FAILURES
A failure in central station hardware or software must not affect the functioning of any
bedside monitor.
A software ot hardware failure of a bedside monitor must be reported as a system status
alarm on the central station.
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