743306-9 Smartsigns Lite Plus User Guide
743306-9 Smartsigns Lite Plus User Guide
743306-9 Smartsigns Lite Plus User Guide
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except as allowed under the copyright laws.
Warranty
Revision History
The documentation part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the revision history of the
documentation. Minor corrections and updates which are incorporated at reprint do not cause
the revision number to change. The document part number changes when extensive technical
changes are incorporated.
2
Contents
Table of Contents
1. General Safety Information ................................................5
1.1 Warnings .................................................................................................. 5
1.2 Cautions ................................................................................................... 7
2. Introduction ........................................................................8
2.1 Features of the Smartsigns® Liteplus ....................................................... 8
2.2 Intended Use............................................................................................ 9
2.3 About This Manual ................................................................................... 9
3. Description of Controls, Indicators, Symbols and
Displays ..............................................................................10
3.1 Identification of Front Panel Controls and Symbols ................................. 10
3.2 Identification of Rear Panel Components and Symbols........................... 11
3.3 Description of Symbols/ Indicators........................................................... 12
3.4 Description of Controls............................................................................. 16
4. Setting up the Monitor........................................................17
4.1 Unpacking and Inspection........................................................................ 18
4.2 List of Components .................................................................................. 18
4.3 Power Cable Connections ....................................................................... 19
4.4 Measurement Cable Connections............................................................ 20
4.5 SpO2 Cables and Sensors ...................................................................... 20
4.6 Temperature Probes ................................................................................ 21
5. Battery Operation ...............................................................22
5.1 Operating on Battery Power..................................................................... 22
5.2 Charging a Low Battery ........................................................................... 23
5.3 Low Battery Indication.............................................................................. 23
6. Using the Monitor ...............................................................24
6.1 Turning on the Monitor ............................................................................. 24
6.2 Performing Power On and Self-Test (POST) ........................................... 25
6.3 Setting Date and Time ............................................................................. 26
6.4 Setting Patient Type ................................................................................. 28
6.5 Setting NIBP Units ................................................................................... 29
6.6 Setting Temperature Units and Modes..................................................... 30
6.7 Setting Pulse Tone Volume ...................................................................... 31
6.8 Setting Alarm Volume .............................................................................. 32
6.9 Resetting to Factory Defaults................................................................... 33
7. NIBP Monitoring..................................................................34
7.1 General .................................................................................................... 35
7.2 Setup Connections................................................................................... 36
7.3 NIBP Measurement Modes ...................................................................... 37
7.4 Description of NIBP Operation ................................................................. 37
8. SpO2/Pulse Rate Monitoring...............................................41
8.1 General .................................................................................................... 42
8.2 Setup Connections................................................................................... 43
8.3 Description of Pulse Rate Operation........................................................ 44
8.4 Description of SpO2 Operation ................................................................ 44
9. Temperature Monitoring .....................................................46
9.1 General .................................................................................................... 47
9.2 Setup Connections................................................................................... 47
9.3 Temperature Measurement Modes .......................................................... 48
9.4 Description of Temperature Operation ..................................................... 48
3
10. Alarms And Limits ............................................................54
Table of Contents
10.1 General .................................................................................................... 54
10.2 Setting Alarm Limits ................................................................................. 55
10.3 Alarm Silence ........................................................................................... 61
10.4 Verifying Visual and Audible Alarm Indication .......................................... 61
11. Reviewing Patient Data ....................................................62
11.1 General .................................................................................................... 62
11.2 Displaying Stored Patient Data ................................................................ 62
11.3 Printing Stored Patient Data (Optional Printer Installed).......................... 64
11.4 Erasing Patient Data ................................................................................ 64
12. Printing ..............................................................................65
12.1 General .................................................................................................... 65
12.2 Selecting Manual or Stream Printing type................................................ 65
12.3 Printing Patient Data (Manual Mode) ....................................................... 66
12.4 Print Out Configuration ............................................................................ 67
13. RS232 Interface ................................................................70
13.1 Overview .................................................................................................. 70
13.2 Cable Connection .................................................................................... 70
13.3 Nurse Call Interface ................................................................................. 71
14. Maintenance .....................................................................72
14.1 General .................................................................................................... 72
14.2 Returning the Smartsigns® Liteplus and System Components ................ 72
14.3 Service ..................................................................................................... 72
14.4 Periodic Safety Checks ............................................................................ 72
14.5 Cleaning ................................................................................................... 73
14.6 Battery maintenance ................................................................................ 73
14.7 Replacement of Printer Paper.................................................................. 74
15. Troubleshooting ................................................................75
15.1 General .................................................................................................... 75
15.2 Corrective Action ...................................................................................... 76
15.3 EMI (Electromagnetic Interference) ......................................................... 77
15.4 Obtaining Technical Assistance ............................................................... 78
16. Factory Defaults ...............................................................79
16.1 General .................................................................................................... 79
16.2 Parameter Ranges and Default Settings ................................................. 79
17. Specifications ...................................................................80
17.1 Physical.................................................................................................... 80
17.2 Electrical .................................................................................................. 80
17.3 Environmental .......................................................................................... 80
17.4 Measurement Parameters ....................................................................... 81
17.5 Compliance .............................................................................................. 83
17.6 Manufacturer’s Declaration ...................................................................... 86
.... Service Returns ....................................................................................... 90
4
1. General Safety Information
Important! Before using this equipment, please study this manual carefully and
familiarise yourself with the controls, display features and operating techniques.
Ensure each user fully understands the safety and operation of the unit, as
misuse may cause damage to the unit or injury to the user or patient.
1.1 Warnings
Warnings are identified by the WARNING symbol shown and alert you to potential
hazards.
WARNING: Do not disconnect a power cord before the system shuts down
as monitor settings may be lost.
WARNING: If the monitor does not shut down properly, the settings return to
factory defaults.
WARNING: Check the equipment prior to use and ensure its safe and proper
use.
WARNING: Before use, carefully read sensor or probe directions for use,
including all warnings, cautions, and instructions.
5
General Safety Information
WARNING: Do not use damaged cuffs, sensors and other cables. Do not
immerse cuffs, sensors and other cables completely in water, solvents, or
cleaning solutions as the connectors are not waterproof. Do not sterilize
cuffs, sensors and other cables by irradiation, steam, or ethylene oxide.
Refer to each cleaning instructions in the directions for use.
WARNING: To ensure patient safety, do not place the monitor in any position
that might cause it to fall on the patient.
WARNING: Do not lift the monitor by a sensor cable or a power cord because
the cable could disconnect from the monitor, causing the monitor to drop on
the patient.
WARNING: The unit may not operate effectively on patients who are
experiencing convulsions or tremors.
WARNING: To avoid burns, the temperature probe must remain in the probe
well when turning the monitor on or off.
WARNING: Do not connect more than one patient to the monitor. Do not
connect more than one monitor to a patient.
6
1.2 Cautions
CAUTION: Alert you to exercise care necessary for the safe and effective use of
Smartsigns® Liteplus monitor. Inaccurate data may be measured if operated or
stored at conditions outside the stated ranges, or subjected to excessive shock or
dropping.
CAUTION: The accuracy of the monitor may degrade if the monitor is connected to
secondary I/O devices when the monitor is not connected to earth reference.
CAUTION: Never place fluids on the monitor. In case of fluid spilling on the monitor,
disconnect power cord, wipe clean immediately and have the monitor serviced to
ensure that no hazard exists.
CAUTION: The monitor may display error codes when outside of the measurable
range occur.
7
2. Introduction
Introduction
This manual contains information about the Smartsigns® Liteplus vital signs monitor. The
Smartsigns® Liteplus is available in the following configurations:
Config. Features
Note: Refer to Specification Section for more information about each configuration.
All information in this manual, including the illustrations, are based on a monitor
configured with the NIBP, Temperature, SpO2, and Printer options. If your monitor
configuration lacks any of these options, certain information in this manual does
not apply.
Electrical
The monitor is powered by a Ni-MH type of internal battery pack. The batteries are
continuously recharged when AC power (100-240 VAC, 50-60 Hz) is connected to the
monitor. Details are described in the Battery Operation section.
8
Introduction
Display
The monitor has an LED display which shows numeric patient information as well as
alphanumeric status conditions and error codes.
Auxiliary Outputs
The monitor provides RS-232 I/O port for software upgrade or nurse call system. Refer to
the RS-232 Interface section for additional information.
Note: Hospital use typically covers such areas as general care floors, operating
rooms, special procedure areas, intensive and critical care areas, within the
hospital plus hospital-type facilities. Hospital-type facilities include physician
office based facilities, sleep labs, skilled nursing facilities, surgicenters, and
sub-acutecenters.
Note: The medically skilled and trained user can be clinicians like doctors and
nurses who know how to take and interpret a patient’s vital signs. These
clinicians must take direct responsibility for the patient’s life. This can include
care-givers or medically trained interpreters who are authorised under the
appropriate clinical facility procedures to support patient care. Any
inappropriate setting, especially the alarm limit or alarm notification settings,
can lead to a hazardous situation that injures, harms or threatens the patient’s
life. This equipment should only be operated by trained users who can adjust
the settings of the patient monitor.
All users should read this manual thoroughly. More experienced users of the
Smartsigns® Liteplus will be able to go to the topics for the information they require.
Read the entire manual including the Safety Information section, before you operate the
monitor. 9
3. Description of Controls, Indicators,
Description of Controls, Indicators, Symbols and Displays
28
27
26
25
SYS
1 mmHg
kPa 1 24
2
BP 23
°F 22
3 M
DIA °C 21
/min
4
%SpO2
20
5
MAP
6
smartsignsLitePlus
®
8 9 10 11 12 13 14 15 16 17 18 19
10
3.2 Identification of Rear Panel Components and
2
NiMH
3 4 5 6 7
11
3.3 Description of Symbols/ Indicators
Description of Controls, Indicators, Symbols and Displays
Symbols Description
Equipotentiality
Data interface
Review Indicator
is lit when the user select the Review button to see the patient history.
Auto Indicator
Charging/AC in Indicator
is on whenever AC power is present from the wall (even if the monitor is off
and is not under battery charging).
The Charging/AC in indicator flashes while the battery is charging, and then
remains illuminated once the battery is maintained with a trickle charge.
12
Description of Controls, Indicators, Symbols and Displays
Symbols Description
Battery Indicator
indicates the state of the battery. This indicator is on when the monitor
uses battery power. This indicator will be flashing when the battery needs
charging. It is not reset unless AC power cord has been plugged in for
battery charging.
13
Description of Controls, Indicators, Symbols and Displays
Symbols Description
is flashing when the NIBP target inflation pressure is under the setting for
NIBP measurement.
Time Indicator
Date Indicator
is flashing when the pulse tone volume setting is selected in setting mode.
Network Indicator
Disposal Instructions
14
Description of Controls, Indicators, Symbols and Displays
Symbols Description
Manufacturer
Date of Manufacture
CE Mark
PATIENT MONITOR
32MX
UL Mark
E252514
UL60601-1
CAN/CSA C22.2 No.601.1
SN Serial Number
500-1060 hPa
o
50 C
o
-20 C
This Way Up
Keep Dry
15
3.4 Description of Controls
Description of Controls, Indicators, Symbols and Displays
Table 2. Controls
Controls Description
Power Button
turns the monitor on or off when pressed for over 1 second.
Review Button
allows the user to review or to erase measurement data in the memory.
If pressed and held for more than 3 seconds, the monitor will erase the
data.
Auto Button
puts the monitor in Auto interval selection mode, allowing the user to take
automatic blood pressures at a selected increment.
Alarm Button
puts the monitor into Alarm Set mode, allowing the user to set alarm limits
for Systolic, Diastolic, MAP, Pulse rate and SpO2.
Mode Button
puts the monitor into the Settings or Configuration mode. Once the
monitor is in one of these modes, the Mode button will be used to cycle
through the configuration options of the specific menu mode.
16
4. Setting up the Monitor
WARNING: Do not lift the monitor by the sensor cables or power cord
because the cable could disconnect from the monitor, causing the monitor to
drop on the patient.
WARNING: Do not use the Smartsigns® Liteplus vital signs monitor, SpO2
sensors, temperature probes or connectors that appear damaged.
17
4.1 Unpacking and Inspection
Setting up the Monitor
The Smartsigns® Liteplus vital signs monitor is shipped in one carton. Examine the carton
carefully for evidence of damage. Contact Huntleigh Healthcare Ltd Technical Services
Department immediately if any damage is discovered. Return all packing material and
monitor. Refer to the Maintenance section for instructions on returning damaged items.
Set the monitor to the user’s intended position where the user can easily recognise the
visual and audible monitoring conditions. Normally it is recommended to set at a distance
of 1 metre from the user. Also, the viewpoint is at any point within the base of a cone by
an angle of 30° to the centre of the monitoring display.
Quantity Item
1 Smartsigns Liteplus Vital signs monitor
®
18
4.3 Power Cable Connections
CAUTION: For the safety of patients, use only a Huntleigh Healthcare Ltd supplied
power cord. Using a non approved power cord can damage the monitor, and will
void the product warranty. If in doubt about the integrity of the AC power source,
the monitor must be operated from its internal battery.
AC Power
Ensure that the AC outlet is properly grounded and that it is the specified voltage
and frequency (100-240 VAC, 50-60 Hz).
AC Power Connector
1. Connect the female connector end of the AC power cord to the monitor rear
panel connector.
2. Plug the male connector end of the AC power cord into a properly grounded
AC outlet.
3. Verify that the Charging/AC in Indicator is lit. This indicator will be flashing if
the battery needs charging.
4. If necessary, connect the grounding wire. Connect the grounding wire
connector to the equipotential terminal on the rear panel. Attach the clip end
of the grounding wire to the medical equipment grounding terminal on the wall.
19
4.4 Measurement Cable Connections
Setting up the Monitor
WARNING: Do not lift the monitor by the sensor cables, or power cord
because the cable could disconnect from the monitor, causing the monitor
to drop on the patient.
SYS
mmHg
NIBP Cuff Hose Connector kPa
BP
1
°F
M
DIA °C
/min
%SpO2
MAP
smartsignsLitePlus
®
1. Select the appropriate size cuff for the patient (Refer to the NIBP Monitoring
section) and apply the cuff to the selected site.
2. Connect the hose to the right panel NIBP connector (see Figure 4).
Note: For the safety of patients, and to ensure the best product performance
and accuracy, use only a cuff and a hose provided with the Smartsigns®
Liteplus, or a cuff and hose recommended by Huntleigh Healthcare Ltd
Technical Services.
Temperature Probe
SYS
mmHg
kPa 1
Temperature Probe Well
BP
°F
DIA
/min
°C
M
Temperature Probe Cover
%SpO2
MAP
Temperature Probe
Connector
smartsignsLitePlus
®
1. Insert the plug into the compatible jack on the monitor right panel.
Note: For the safety of patients, and to ensure the best product performance and
accuracy, use only Huntleigh Healthcare Ltd provided temperature probes (see
Figure 6).
Note: The temperature probes are available from Huntleigh Healthcare Ltd sales
department. For the safety of patients, and to ensure the best product
performance and accuracy, use only temperature probes that have passed the
recommended biocompatibility testing in compliance with ISO10993-1.
21
5. Battery Operation
Battery Operation
CAUTION: Measured or displayed data may not be assured in the low battery or
the critical low battery condition.
Note: It is recommended that the monitor remain connected to AC power source when not
in use. This will ensure a fully charged battery whenever it is needed.
Note: As the battery is used and recharged over a period of time, the amount of
time between the onset of the low battery alarm and the instrument shut-off may
become shorter. It is recommended for service personnel to check periodically
or replace of internal battery if necessary.
Condition
Indicators
Monitor AC Power Battery
22
The monitor cannot operate with a fully discharged battery. Before turning on a monitor
Battery Operation
whose battery has been completely discharged, first plug the monitor into an AC outlet to
charge the battery for a few minutes. The monitor may then be powered on.
A new, fully charged battery will provide the following operating times under each
condition:
Note: A full charge of a depleted Ni-MH battery takes approximately 8 hours while the
monitor is turned off.
A battery status of approximately 3-minutes operation will inhibit the monitor from taking
NIBP inflation.
After a critical low battery alarm sounds for about 5 seconds, the monitor will automatically
shut down. You should connect the monitor to an AC power source to avoid any loss of
monitor settings and trend data.
23
6. Using the Monitor
Using the Monitor
WARNING: To avoid burns, the probe must remain in the probe well when
turning the monitor on or off.
WARNING: Each time the monitor is used, check alarm limits to ensure that
they are appropriate for the patient being monitored.
Note: The parameters may be set on an individual basis, by the clinician, and these
settings will remain in effect until the monitor is turned off.
24
6.2 Performing Power On and Self-Test (POST)
CAUTION: If any indicator or display element does not light, or the speaker does
not sound, do not use the monitor. Contact qualified service personnel or
Huntleigh Healthcare Ltd Technical Service Department.
2. The monitor automatically starts the Power On Self Test (POST), which tests
monitor circuitry and functions.
3. Ensure the monitor sounds the power-on beep tones, and all displays and
indicators are illuminated for 3 seconds.
CAUTION: The power-on beep tones will not be heard if Sound mode is set to 3
(Mute) via Service mode. It may cause the hazard that speaker failure cannot be
detected during the POST. This hazard must be ackknowledged to the operator
before sound mode is set to 3 (Mute) in risk control point of view
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
4. If the Smartsigns® Liteplus detects an internal problem during POST, the monitor
will display an error code. Contact qualified service personnel or Huntleigh
Healthcare Ltd Technical Services Department.
5. Upon successful completion of the POST, the monitor enters Normal mode.
25
Using the Monitor
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
Note: If the segment of ‘SYS’, ‘DIA’ and ‘MAP’ displays is blinking, do not use the
monitor and contact qualified service personnel or Huntleigh Healthcare Ltd
Technical Services Department because this symptom indicates that an
internal problem may occur.
Note: The date format may be selected either ’year/month/day’ or ’day/ month/
year’ via Service mode.
1. Press and hold the Mode button for 3 seconds until the monitor enters
Configuration mode.
2. Press the Mode button twice until the Time indicator and Hour set are flashing.
Set current time to increment Hour up and down between 0 and 23, using the
Up/Down (+/-) selection buttons.
3. Press the Mode button until the Time indicator and Minute set are flashing.
Set current minute between 00 and 59, using the Up/Down (+/-) selection
buttons.
4. Press the Mode button until the Time indicator and Second set are flashing.
Set current second between 00 and 59, using the Up/Down (+/-) selection
buttons.
5. Press the Mode button until the Date indicator and Year set are flashing.
Set current year, using the Up/Down (+/-) selection buttons.
26
6. Press the Mode button until the Date indicator and Month set are flashing.
7. Press the Mode button until the Date indicator and Day set are flashing.
Set current day, using the Up/Down (+/-) selection buttons.
8. Pressing buttons other than the Mode button also returns to normal operation.
If there is no activity for 5 seconds, the monitor will return to normal operation.
SYS Hour
1
mmHg
1
kPa Minute
BP 1
°F
M
DIA °C Second
/min 1
%SpO2 Year 1
MAP
Month
1
Day
1
27
6.4 Setting Patient Type
Using the Monitor
This procedure will allow you to select Patient Type: Adult, Pediatric or Neonatal.
1. Press the Mode button until the Patient type indicators are on (a selected
Patient type indicator is shown flashing).
2. Select a desired patient type, using the Up/Down (+/-) selection buttons.
3. Press any other button to return to normal operation. If there is no activity for
3 seconds, the monitor will return to normal operation.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
28
6.5 Setting NIBP Units
1. Press and hold the Mode button for 3 seconds or more until the monitor enters
Configuration mode. Once the monitor is in the Configuration mode, current
NIBP unit is flashing on the display.
2. Select a NIBP unit either mmHg or kPa, using the Up/Down (+/-) selection
buttons.
3. Press any other button to return to normal operation. If there is no activity for
3 seconds, the monitor will return to normal operation.
mmHg
kPa
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
29
6.6 Setting Temperature Units and Modes
Using the Monitor
This procedure will allow you to set temperature type and measurement units, providing
the monitor has the temperature option. You can display the temperature measurement in
either Celsius (°C) or Fahrenheit (°F). Also you may select whether to use Monitor mode
or Predictive mode for taking temperatures. For more information, refer to Temperature
Monitoring section of this manual.
1. Press the Mode button until the Temperature units and modes are on (a
selected unit/mode is shown flashing).
2. Select desired temperature unit and mode, using the Up/Down (+/-) selection
buttons.
3. Press any other button to return to normal operation. If there is no activity for
3 seconds, the monitor will return to normal operation.
SYS
mmHg
1
kPa
BP
°F
M
°F
DIA
/min
°C
M
%SpO2 °C
MAP
30
6.7 Setting Pulse Tone Volume
1. Press the Mode button until the Pulse Tone Volume setting indicator and current
pulse tone volume are displayed.
2. Select a level of pulse tone volume between 0 and 8, using the Up/Down (+/-)
selection buttons.
3. Press any other button to return to normal operation. If there is no activity for
3 seconds, the monitor will return to normal operation.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
31
6.8 Setting Alarm Volume
Using the Monitor
1. Press the Mode button until the Alarm Volume setting indicator and current alarm
volume are displayed.
2. Select a level of alarm volume between 1 and 8, using the Up/Down (+/-) selection
buttons.
3. Press any other button to return to normal operation. If there is no activity for 3
seconds, the monitor will return to normal operation.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
32
6.9 Resetting to Factory Defaults
1. Simultaneously press the Power button and the NIBP start/stop button.
2. The monitor runs a self-test and then displays the current monitor software
version.
4. To leave the settings unchanged, select ‘NO’ using only the Down (-)
selection button.
To reset the operating parameters to the factory default values, select ‘YES’
using only the Up (+) selection button. The monitor immediately resets to the
defaults and the confirmation tone sounds.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
33
7. NIBP Monitoring
NIBP Monitoring
WARNINGS: For the safety of patients, and to ensure the best product
performance and accuracy, use only the cuffs and the hose provided with the
monitor, or recommended by Huntleigh Healthcare Ltd Technical Services.
Using other cuffs or hoses may result in inaccuracies.
WARNING: The blood pressure cuff should not be applied to the same
extremity as the one to which an SpO2 sensor is attached, since cuff inflation
will disrupt SpO2 monitoring and lead to nuisance alarms.
WARNING: Check the patient’s limb on which the cuff is applied to assure
that circulation is not constricted. Constriction of circulation is indicated
by discoloration of the extremity. This check should be performed at the
clinician’s discretion at regular intervals based on the circumstances of the
specific situation.
WARNING: Never place the cuff on extremity being used for intravenous
infusion or any area where circulation is compromised or has the potential to
be compromised. Never fit NIBP system with Luer Lock adapters that can be
connected to IBP or injection systems.
34
NIBP Monitoring
WARNING: As with all automatically inflatable blood pressure devices,
continual cuff measurements can cause injury to the patient being
monitored. Weigh the advantages of frequent measurement and/or use of
STAT mode against the risk of injury.
WARNING: During use on patients, ensure that heavy objects are not placed
on the hose. Avoid crimping or undue bending, twisting, or entanglement of
the hose.
WARNING: Never use an adult or pediatric monitor setting or cuff for an NIBP
measurement on a neonatal patient. Adult and pediatric inflation limits can be
excessive for neonatal patients, even if a neonatal cuff is used.
Note: A patient’s vital signs may vary during administration of agents affecting the
cardiovascular system, such as those used to raise or lower blood pressure
or raise or lower heart rate.
Note: Blood pressure measurements can be affected by the position of the patient,
the patient’s physiological condition, and other factors.
7.1 General
NIBP processing by the monitor uses the oscillometric measuring technique. A motorized
pump inflates the cuff to initially block the flow of blood in the extremity. Then, under
monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer
detects air pressure and transmits a signal to the NIBP circuitry.
When the cuff pressure is still above systolic pressure, small pulses or oscillations in
the cuff pressure begin to be sensed by the transducer. As the cuff continues to deflate,
oscillation amplitude increases to a maximum and then decreases. When maximum
oscillation amplitude occurs, the cuff pressure at that time is measured as mean arterial
pressure (MAP). The systolic and diastolic pressures are calculated based on analysis of
the oscillation amplitude profile.
35
7.2 Setup Connections
NIBP Monitoring
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
smartsignsLitePlus
®
For the safety of patients, and to ensure the best product performance and accuracy,
use only the cuffs and the hose provided with the monitor or recommended by Huntleigh
Healthcare Ltd Technical Services.
1. Measure the patient’s limb and select the proper size cuff. As a general rule,
cuff width should span approximately two-thirds of the distance between the
patient’s elbow and shoulder.
2. Connect the hose to the bottom of left corner of the monitor as shown Figure
16. Push until you hear a click, indicating that the connection is secure.
3. Connect a cuff to the cuff hose and push until you hear a click, indicating that
the connection is secure.
4. Wrap the cuff around a bare arm or around an arm covered in thin clothing.
Thick clothing or a rolled up sleeve will cause a major discrepancy in the blood
pressure reading.
5. Wrap the cuff around the patient’s arm so that the centre of the cuff’s rubber
bladder sits on the artery of the upper arm. The hose should be brought out
from the peripheral side without bending. (The Brachial artery is located on the
inside of the patient’s upper arm.) At this time, check that the index line on the
edge of the cuff sits inside the range. Use a different size cuff if the index line is
outside of the range, as this will cause a major discrepancy in blood pressure
readings.
CAUTION: The adult cuff should be wrapped around the arm tightly enough so
that only two fingers can be inserted under it, above and below the cuff.
6. Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s
right ventricle during measurement.
7. Follow the cuff directions for use when applying the cuff to the arm.
36
NIBP Monitoring
Table 5. Cuff Size
Patient Group
Cuff Hose Circumference Range
Setting
3 - 6cm
4 - 8cm
Neonatal
Neonate Neonate (single use) 6 - 11cm
Hose
7 - 13cm
8 - 15cm
Infant APC 8 - 13cm
Paediatric
Child APC 12 - 19cm
Small Adult APC 19 - 25cm
Adult Hose
Adult APC 23 - 33cm
Adult
Large Adult APC 31 - 40cm
Thigh APC 38 - 50cm
1. Press the Mode button twice until current NIBP target inflation is displayed.
2. Change NIBP target inflation to be desired, using the Up/Down (+/-) selection
buttons.
3. Press any other button to return to normal operation. If there is no activity for
3 seconds, the monitor will return to normal operation.
The numeric display in the lower right corner of the NIBP frame indicates the setting of the
initial inflation pressure. The initial inflation pressure can be set from 120 to 260 mmHg
for adult (120 to 170 mmHg for pediatric, 80 to 140 mmHg for neonatal), in intervals of 10
or 20mmHg. You may select an initial cuff inflation pressure. This is particularly important
with children, since an initial cuff inflation pressure of factory default, 160 mmHg for adult
(120 mmHg for pediatric, 90 mmHg for neonatal) may be uncomfortable, and is typically
higher than it needs to be.
37
When NIBP Smart Inflation is set to OFF via Service Mode: in MANUAL mode the cuff
NIBP Monitoring
pressure is inflated until the inflation value selected by user, In AUTO/STAT Mode, the
cuff pressure is inflated until the inflation value selected by user in initial measurement
and, from the next measurement, the inflation value for Adult and Pediatric patients will be
last Systolic BP value + 50mmHg and the inflation value for Neonatal patients will be last
systolic BP value + 30mmHg.
When NIBP Smart Inflation is set to ON via Service Mode: in MANUAL mode, the suitable
inflation value for the Adult and Pediatric patient is automatically calculated during the
inflation, and the inflation value for the Neonatal patient is initial inflation value selected by
the user. In AUTO/STAT mode, the suitable inflation value for the Adult and Pediatric
patient is automatically calculated during the inflation in initial measurement and, from the
next measurement, the inflation value will be last systolic BP value +50mmHg. Also, the
inflation value for the Neonatal patient is initial inflation value selected by user in initial
measurement and, from the next measurement, the inflation value for Neonatal patient will
be last systolic value +30mmHg.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
Figure 17. Initial Inflation
Pressure
Systolic, diastolic, and MAP values are presented when the measurement is completed.
The measurements remain in the numeric display for 2 minutes or until another NIBP
cycle begins.
SYS
mmHg SYS
Systolic kPa mmHg
1
BP kPa
BP
°F
M
DIA DIA °C
/min
Diastolic %SpO2
MAP
MAP
MAP
2. Press the Up/Down (+/- ) selection buttons to cycle through the options, which
include (- ), STAT, and a range of intervals:1, 2, 3, 4, 5, 10, 15, 30, 45, 60, 90,
120, and 240 minutes for taking automatic blood pressures. The dash (-)
indicate that automatic measurement is turned off.
Upon selection, automatic measurement is activated and the initial measurement will be
made immediately after you select an interval.
The AUTO indicator is flashing when s selected for the automatic mode interval. After the
first cycle, the cuff target pressure is not used; rather, the cuff inflates to a pressure level
20~30 mmHg above the previous systolic reading.
The automatic NIBP cycles continue until one of the following occurs:
Note: During Auto mode, if an NIBP limit violation alarm occurs, this alarm
disables any automatic NIBP measurement until the alarm is released.
Note: The interval is the time from the beginning of one measurement cycle to the
beginning of the next measurement cycle.
Note: The selected interval is displayed on the Auto cycle display. The countdown
timer for initiating next measurement is displayed on the Time display.
39
NIBP Monitoring
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
With the selected interval STAT, the monitor takes repeated NIBP measurements for 5
minutes. Current cuff pressures are not dynamically displayed during a STAT reading. The
measurement displays the NIBP reading from the previous cycle until the current cycle
finishes. (Before the first cycle finishes, the display appears blank.)
Note: During STAT mode, if an alarm, alert, or error condition occurs, the STAT
measurement will be terminated.
Note: During AUTO mode, pressing the NIBP start/stop button at the time before
the next auto measurement starts will cancel the AUTO mode and will be
made a single blood pressure measurement (MANUAL mode).
40
8. SpO2/Pulse Rate Monitoring
WARNING: Do not attach any cable to the sensor port (sensor connector)
that is intended for computer use.
41
SpO2/Pulse Rate Monitoring
CAUTION: The sensor disconnect error and associated alarm indicate the sensor
is either disconnected or the wiring is faulty. Check the sensor connection and, if
necessary, replace the sensor, pulse oximetry cable, or both.
CAUTION: To ensure the best product performance and accuracy, use only
Huntleigh Healthcare Ltd provided SpO2 sensors for SpO2 measurements. Other
SpO2 sensors may cause improper performance.
8.1 General
The Smartsigns® Liteplus uses pulse oximetry to measure functional oxygen saturation in
the blood. Pulse oximetry works by applying an OXIMAX sensor to a pulsating arteriolar
vascular bed. SpO2 and Pulse rate is updated every second. The OXIMAX sensor
contains a dual light source and photodetector. Bone, tissue, pigmentation, and venous
vessels normally absorb a constant amount of light over time. The arteriolar bed normally
pulsates and absorbs variable amounts of light during the pulsations. The ratio of light
absorbed is translated into a measurement of functional oxygen saturation (SpO2).
Because a measurement of SpO2 is dependent upon light from the OXIMAX sensor,
excessive ambient light can interfere with this measurement.
42
8.2 Setup Connections
When selecting a sensor, consider patient’s weight and activity, adequacy of perfusion,
availability of sensor sites, need for sterility, and anticipated duration of monitoring.
For more information, refer to Table 6, or contact to Huntleigh Healthcare Ltd sales
department.
2. Carefully apply the sensor to the patient, as described in the sensor directions
for use. The sensor may be connected directly to the connector. Typically,
however, it is more convenient to connect the sensor to the monitor by using
an SpO2 pulse oximetry cable.
OXIMAX Oxyband ®
Oxygen transducer (Reusable, non-
OXI-P/I 3 kg to 30 kg
sterile)
43
8.3 Description of Pulse Rate Operation
SpO2/Pulse Rate Monitoring
The monitor displays the pulse rate during SpO2 measurements. It displays NIBP pulse
information only if no SpO2 reading is available.
During the measurement period, the pulse amplitude indicator rises and falls in rhythm
with the monitored pulse rate. The pulse amplitude indicator is a segmented display
showing the relative strength of the detected pulse. As the detected pulse becomes
stronger, more bars light with each pulse.
SYS
mmHg
1
kPa
BP
/min °F
M
DIA °C
/min
%SpO2
SpO2 Operation
SYS
mmHg
%SpO2 kPa 1
BP
°F
M
DIA °C
/min
44
SpO2/Pulse Rate Monitoring
Functional versus Fractional Saturation
When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the
calculated value may differ from the SpO2 measurement of the monitor. This usually
occurs because the calculated saturation was not appropriately corrected for the effects of
variables that shift the relationship between PO2 and pH, temperature, the partial pressure
of carbon dioxide (PCO2), 2, 3-DPG, and fetal hemoglobin.
Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent and because the mean
wavelength of LEDs varies, an oximeter must know the mean wavelength of the OXIMAX
sensor’s red LED to accurately measure SpO2. The wavelength range of the light emitted
are near 660nm and 890nm with the energy not exceeding 15 mW. During monitoring, the
instrument’s software selects coefficients that are appropriate for the wavelength of that
individual sensor’s red LED; these coefficients are then used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the light intensity of the
sensor’s LEDs is adjusted automatically.
For the setting the pulse tone volume, refer to section 6.7, of this manual.
1. Press the Mode button until the Pulse Tone Volume setting indicator and
current pulse tone volume are displayed.
2. Select a level of pulse tone volume between 0 and 8, using the Up/Down (+/-)
selection buttons.
45
9. Temperature Monitoring
Temperature Monitoring
WARNING: To avoid burns, the probe must remain in the probe well when
turning the monitor on or off.
WARNING: Never re-use a probe cover. Discard, without using it, any
probe cover that makes contact with any heat source (including hands and
fingers) prior to use.
WARNING: Do not use the temperature instrument for any purpose other
than those described in this document. Doing so will invalidate the product
warranty.
WARNING: The probe must remain in steady contact with the sublingual
pocket throughout the measurement period; otherwise, the monitor fails to
accurately predict the temperature.
WARNING: Never insert the probe, without disregarding a used probe cover,
into the probe well to keep the probe well clean (decontaminated). Remove a
used probe cover or replace a probe cover whenever the probe needs to be
returned to the probe well.
WARNING: Never wipe the inside of the probe well with water-damped cloth
during the cleaning. It may cause any electrical risks.
46
9.1 General
Temperature Monitoring
This section applies if the monitor is configured with the temperature option.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
Temperature Probe
Connector
smartsignsLitePlus
®
Note: Use only provided temperature probes which have passed the recommended
biocompatibility testing in compliance with ISO10993-1.
Note: If temperature probes are not readily available, contact Huntleigh Healthcare
Ltd sales department. To avoid nuisance limit alarms,the probe should be
affixed to the patient before connecting to the monitor’s right panel connector.
47
9.3 Temperature Measurement Modes
Temperature Monitoring
• PREDICTIVE mode
• MONITORED mode
1. Press the Mode button until the Temperature units and modes are on (a
selected unit/mode is shown flashing).
2. Select desired temperature unit and mode, using the Up/Down (+/-) selection
buttons.
Note: If there is no activity for 3 seconds, the monitor will return to normal operation.
Celsius Predictive
Celsius Monitored
Fahrenheit Predictive
Fahrenheit Monitored
48
Temperature Monitoring
Taking a Predictive Measurement
To take a predictive temperature (Celsius Predictive or Fahrenheit Predictive indicator
shall be on), follow these steps:
Note: Verify that the temperature measurement type is set to predictive. (Indicator ‘M’ is
not illuminated.)
SYS
mmHg
1
kPa
BP
°F °F
M
M DIA °C
°C /min
Temperature %SpO2
- Predictive Mode MAP
(i.e. Celsius)
Oral Measurement
1. Remove the temperature probe from the probe well. The temperature probe
runs a self-test, displaying ‘888.8’ for a few seconds. When it is ready for use,
verify “OrL” appears in the temperature display. If not, press the Up/Down (+/-)
selection buttons to select Oral or Axillary.
2. Put a new probe cover on the probe tip. Verify that the cover locks into position.
3. Insert the tip of the probe into the mouth—under the tongue and against a
sublingual pocket.
Note: The probe must remain in steady contact with the sublingual pocket
throughout the measurement period; otherwise, the monitor fails to accurately
predict the temperature.
Note: During the measurement period, the temperature window displays a “walking
box”—a box with the sides illuminated sequentially. When the measurement
is complete, the monitor sounds a tone and displays the measurement in the
temperature window.
5. Eject the probe cover by pressing the ejection button, and hygienically dispose
of it.
If a probe position error occurs during the temperature determination, the temperature
displays “P”.
Axillary Measurement
1. Remove the temperature probe from the probe well. The temperature probe
runs a self-test, displaying ‘888.8’ for a few seconds. When it is ready for use,
verify “ALY” appears in the temperature display. If not, press the Up/Down
(+/-) selection buttons to select Oral or Axillary.
2. Put a new probe cover on the probe tip. Verify that the cover locks into
position.
Note: During the measurement period, the temperature window displays a “walking
box”—a box with the sides illuminated sequentially. When the measurement
is complete, the monitor sounds a tone and displays the measurement in the
temperature window.
Note: Be sure that nothing touches the probe tip before you place it in the axillary
measurement site. If the probe tip is moved after it first makes contact, the
measurement is unreliable.
4. Place the probe tip as high as possible in the axilla, and then bring the
patient’s arm down to make maximum contact with the probe tip. Hold the
patient’s arm in this position, keeping the patient as still as possible, for the
duration of the measurement.
When the temperature prediction is complete (usually about 10 seconds later),
the monitor briefly sounds a tone and displays the temperature reading, which
persists for one minute.
5. Eject the probe cover by pressing the ejection button, and hygienically dispose
of it.
50
Possible reasons for a failure to predict are the following:
Temperature Monitoring
• The measured temperature is too high or
• The ambient temperature too low or
• The temperature measurement varies too much during the prediction period.
Be sure that the probe tip is fully covered by the axilla and the arm, and that it is not
touching any clothing.
If a probe position error occurs during the temperature determination, the temperature
displays “P”.
Rectal Measurement
5. Insert the probe tip 1 centimeter (3/8-inch) inside the rectal sphincter. Tilt the
probe slightly to ensure good tissue contact, and keep the buttocks separated
throughout the duration of the measurement.
When the temperature prediction is complete (usually about 10 seconds later),
the monitor briefly sounds a tone and displays the temperature reading, which
persists for one minute.
Note: During the measurement period, the temperature window displays a “walking
box”—a box with the sides illuminated sequentially. When the measurement
is complete, the monitor sounds a tone and displays the measurement in the
temperature window.
7. Eject the probe cover by pressing the ejection button, and hygienically
dispose of it.
If a probe position error occurs during the temperature determination, the temperature
displays “P”.
51
Temperature Monitoring
Taking a Monitored Measurement
To take a monitored temperature (Celsius Monitored or Fahrenheit Monitored indicator
shall be on), the procedures for monitored and predictive temperature measurements are
the same, with the following exceptions:
If the measured temperature remains below the minimum measurable temperature for 5
minutes, the temperature cycle is terminated and the temperature display goes blank. To
reactivate the probe, insert it into the probe well, discarding the used probe cover, and
extract it again, loading a new probe cover.
SYS
mmHg
1
kPa
BP
°F °F
M
M DIA °C
°C /min
%SpO2
MAP
Note: The monitor only displays 26°C to 43°C (80°F to 110°F). If the reading is over
43°C (110°F) or under 26°C (80°F), the monitor will display as follows.
°F °F
M M
°C °C
52
Temperature Monitoring
Probe Decontamination Procedure
5. Clean the probe and the inner and outer surface of the probe well by swabbing
with a cloth dampened with 70% isopropyl alcohol or a 10% solution of chlorine
bleach.
Note: Do not use steam, heat, or gas sterilisation of the probe or probe well.
Note: Do not use hard or sharp objects to clean the probe well. These can damage
the probe well, which could cause the unit to fail.
9. Reconnect the probe latching connector to the monitor, making sure that the
connector snaps into place.
53
10. Alarms And Limits
Alarms and Limits
WARNING: Do not silence the audible alarm or decrease its volume if patient
safety could be compromised.
WARNING: Each time the monitor is used, check alarm limits to ensure that
they are appropriate for the patient being monitored.
WARNING: The audible and visual alarms on the monitor, used in conjunction
with clinical signs and symptoms, are the primary source for notifying
medical personnel that an alarm condition exists.
WARNING: If different alarm presets are used for the same or similar
equipment in any single area, e.g. an intensive care unit or cardiac operating
theatre, a potential hazard can exist.
CAUTION: For patient safety, all alarms are reset to the factory default levels
whenever the patient type is changed. This means that you must either accept the
default alarm limits or set new limits every time you change patient type.
CAUTION: The high alarm limit for any vital sign is always higher than the low
alarm limit for the same vital sign. For example, the alarm limit for systolic high is
always higher than the alarm limit for systolic low.
Note: For adjusting alarm volume, you may refer to section 6.8, of this manual.
Alarm volume is set to ‘4’ as a factory default.
10.1 General
When the monitor detects certain conditions that require user attention, such as out-of-
limit vital signs, the monitor enters an alarm state. The monitor response is indicated by
visual and audible indication
Battery Failure Presenting appropriate error codes and sounding audible alarms.
Loss of Pulse Note: In case of loss of pulse alarm, error code (E44) is flashing
54
10.2 Setting Alarm Limits
The range of high and low alarm limits for each vital sign is shown here:
Diastolic (mmHg)
MAP (mmHg)
PR (bpm)
Neonatal 25 to 295, 100 30 to 300, 200 5 bpm
Alarm Limits determine the high and low points of patient data at which the monitor will
sound an alarm.
1. Press the Alarm button until Systolic high alarm limit is displayed.
2. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
3. Press the Alarm button once again until Systolic low alarm limit is displayed.
4. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
56
Alarms and Limits
Diastolic high and low alarm limits
With the monitor in the normal monitoring mode:
1. Press the Alarm button until Diastolic high alarm limit is displayed.
2. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
3. Press the Alarm button once again until Diastolic low alarm limit is displayed.
4. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
57
Alarms and Limits
MAP high and low alarm limits
1. Press the Alarm button until MAP high alarm limit is displayed.
2. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
3. Press the Alarm button once again until MAP low alarm limit is displayed.
4. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
58
Alarms and Limits
Pulse Rate Alarm Limits
Alarm Limits determine the high and low points of patient data at which the monitor will
sound an alarm.
1. Press the Alarm button until Pulse rate high alarm limit is displayed.
2. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
3. Press the Alarm button once again until Pulse rate low alarm limit is
displayed.
4. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
59
Alarms and Limits
SpO2 Alarm Limits
Alarm Limits determine the high and low points of patient data at which the monitor will
sound an alarm.
1. Press the Alarm button until SpO2 high alarm limit is displayed.
2. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
3. Press the Alarm button once again until SpO2 low alarm limit is displayed.
4. Leave the limit unchanged or press the Up/Down (+/-) selection buttons as
needed to change the limit to another value.
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
60
10.3 Alarm Silence
Press the Alarm Silence Button on the front panel. This action temporarily silences all
audible alarms for 90 seconds. Alarm Silence Indicator lights during a temporary silence
period.
1. Press the Alarm Silence Button to immediately silence the alarm tone. (Alarm
silence period default-90 seconds later, the alarm resumes if the alarm
condition has not been corrected.)
If the Alarm Silence Button is pressed during the alarm silence, the alarm silence is ended
and the audible alarms are re-enabled.
Note: Visual indications of an alarm condition cannot be turned off. For example, if
the %SpO2 low alarm limit is exceeded, the audible alarm can be silenced for
the alarm silence period, but the %SpO2 value will continue to flash.
Note: Low Battery alarm cannot be silenced while running on battery power.
Connecting the monitor to AC power will silence the alarm. If a sensor
disconnect alarm is occurred, the alarm can be released by pressing the
Alarm Silence Button.
Note: The alarms can be cancelled by pressing the Alarm silence button, but battery
failure, loss of pulse and limit violation alarms cannot be released until the
alarm condition is terminated.
You can verify the alarm operation for all parameters like NIBP, SpO2 and Temp, by
following the procedures below.
Note: The maximum mean time of the alarm delay is less than 10 seconds unless
otherwise specified in this manual. 61
11. Reviewing Patient Data
Reviewing Patient Data
11.1 General
You can review stored patient data either by viewing it on the monitor or by printing it.
The monitor stores 200 measurements. After 200 measurements are reached, the oldest
stored measurement will be deleted and replaced with a new measurement. 24-hour
old measurements will also be automatically deleted. Data is recorded when patient
measurement completes or an alarm condition occurs.
Pressing the Review button while the monitor is in Normal mode or Auto mode will enter
Review mode. This will cause the monitor to display the most recent data set. If SpO2
data or temperature data is available when the NIBP cycle completes, that information will
be included in the record and will display in Review mode.
1. Press the Review button to display the newest stored set of patient vital-signs
data.
• The most current set of stored data including NIBP, SpO2, Pulse rate and
Temperature with a data-set sequence number and the time and date of the
displayed reading during a patient data review, if available, displays on entry
into Review mode.
• The next most recent stored data sets display wrapping from the first stored
data set to the last by pressing the Review button subsequently.
• In Review mode, the readings show time of reading in minus time, for
example, (-0:05) is 5 minutes ago, (-2:45) is 2 hour 45 minutes ago
2. Press the Up/Down (+/-) selection button to cycle forward or backward (scroll)
through the stored measurement data sets. (The monitor stores 200
measurement cycles.)
3. To stop reviewing data and return to normal operation, press any button other
than the Review button or the Up/Down (+/-) selection button.
62
Reviewing Patient Data
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
Note: 5 seconds of operator inactivity will exit Review mode and return to Normal
mode.
63
11.3 Printing Stored Patient Data (Optional
Reviewing Patient Data
Printer Installed)
You can print vital-signs measurement data each time the monitor completes a
measurement cycle (stream printing), or you can store patient data and print all of it at
one time (batch printing). For information on setting the printer for stream printing or batch
printing, see section 12 “Printing”.
1. Press Print button when the monitor is in Review mode to display stored data on
the screen.
• If the monitor is not printing, press the Print button to start printing.
1. Press and hold the Review button for 3 seconds to erase data in the memory.
After data cleared, the monitor returns to normal operation.
64
12. Printing
Printing
12.1 General
This section applies if the monitor is configured with the printer option.
When the optional printer is installed, the monitor allows the user to print in Manual mode
or Stream mode. The type is determined by the Print setting in Configuration mode.
Manual Mode
The monitor prints out current measurement data (Real-time printing) or stored patient
data on the screen (Batch printing). Manual print indicator is on.
Stream Mode
The monitor automatically prints out patient measurement data: as NIBP measurement
or Temperature predictive measurement completes. Also in Stream mode, the monitor
automatically prints out the measurement data when an alarm condition occurs. When the
Print button is pressed at Stream mode, the monitor prints out current measurement data.
Stream print indicator is on.
1. Press and hold the Mode button for 3 seconds or more until the monitor enters
Configuration mode.
2. Press the Mode button once again until either Manual Print or Stream Print
indicator is flashing on the display.
3. Press the Up/Down (+/-) selection button to alternate between Manual Print and
Stream Print and display. A selected type indicator will be flashing on the display.
4. To set the displayed printing method and return to normal operation, press any
other key. If there is no activity for 5 seconds, the monitor will return to normal
operation.
65
Printing
SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min
%SpO2
MAP
• If the monitor is not printing, press the Print button to start printing.
Note: The monitor sounds an invalid button tone when the printer door opens or when
paper runs out.
66
12.4 Print Out Configuration
Printing
Print Out includes information as follows:
Patient Name:
Patient ID:
Physician:
Comments:
Patient Name:
Patient ID:
Physician:
Comments:
Note: The date format shown in the printout may be selected either ’year/month/day’
or ’day/month/year’ via Service mode.
67
Printing
Stream Print Out at Alarm Condition
Patient Name:
Patient ID:
Physician:
Comments:
68
Printing
System Information Print out
If the Print button is pressed while the monitor is in Service mode, (accessed by
authorized personnel only), the monitor prints out the internal settings of the monitor as
shown in Figure 45.
17:52 26-Mar-2004
Total cycles: 6
Total runtime: 2
Software versions:
Units: 3.00
NIBP: 1.01
SpO2: 1.90
Temp: 1.2
69
13. RS232 Interface
RS232 Interface
13.1 Overview
The Smartsigns® Liteplus monitor provides RS-232 I/O port for software upgrade or nurse
call system. The 9-pin connector mounted on the rear panel provides an access port for a
serial interface. RS-232 I/O port is intended only for connection to specified equipment in
accordance with compliance requirements.
The Pin layouts (as viewed from the rear panel of the monitor) are illustrated below.
6 7 8 9
1 2 3 4 5
Pin # Signal
1 +5V (Use for Software Upgrade)
2 RxD_232 (RS-232 Input)
3 TxD_232 (RS-232 Output)
4 DTR (Use for Software Upgrade)
5 Signal ground (Isolated from Earth ground)
6 DSR (Use for Software Upgrade)
7 Nurse call A
8 Nurse call B
9 SMODE (Use for Software Upgrade)
70
13.3 Nurse Call Interface
RS232 Interface
WARNING: Although the Nurse Call option enables remote notification of
an alarm condition, it is not intended to replace appropriate bedside patient
surveillance by trained clinicians.
The monitor can be connected to a Nurse Call system through a customized cable that
connects to the Nurse Call connector. When the cable is connected and operational, the
monitor immediately notifies the Nurse Call system when a patient alarm occurs.
Note: The alarm relay may be selected either ’Normal Open’ or ’Normal Close’ via
Service mode.
71
14. Maintenance
Maintenance
WARNING: Do not spray, pour, or spill any liquid on the monitor, its
accessories, connectors, switches, or openings in the chassis.
CAUTION: Unplug the power cord from the monitor before cleaning the monitor.
14.1 General
Follow local governing ordinance and recycling instructions regarding the disposal
or recycling of end of life use of Smartsigns® Liteplus and accessories. Otherwise
environment or people may be harmed from improper disposal of battery or accessories.
14.3 Service
The Smartsigns® Liteplus requires no routine service other than cleaning or battery
maintenance that is mandated by the user’s institution. For more information, refer to
Smartsigns® Liteplus service manual. Qualified service personnel in the user’s institution
should perform periodic inspections of the monitor. If service is necessary, contact
qualified service personnel or Huntleigh Healthcare Ltd Technical Services Department.
If the institution’s service personnel cannot correct problems, the Smartsigns® Liteplus
should be returned to Huntleigh Healthcare Ltd for service. Contact Huntleigh Healthcare
Ltd Technical Services Department for return instructions.
72
14.5 Cleaning
Maintenance
For surface-cleaning, follow your institution’s procedures or:
For sensors and probes follow cleaning, disinfecting and/or sterilizing instructions in the
directions for use shipped with those components.
Never allow any liquid substance to enter any monitor connector. If a connector does
come in contact with a liquid substance accidentally, clean and dry thoroughly before
reuse. If in doubt about monitor safety, refer the unit to qualified service personnel.
Note: Storing the Smartsigns® Liteplus for a long period without charging the battery
may degrade the battery capacity. A full charge of a depleted Ni-MH battery takes
approximately 8 hours while the monitor is switched off.
CAUTION: If the battery shows any signs of damage, leakage, or cracking, it must
be replaced immediately, by a qualified service person, and only with a battery
approved by the manufacturer.
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14.7 Replacement of Printer Paper
Maintenance
1. Open the door by pulling the latch on the printer slightly. The door should tilt
open.
2. Reach in and remove the spent paper core by pulling it over gently with your
thumb and index finger.
4. Pull the paper towards you until approximately 2 inches (5.08 cm) of paper have
been unrolled.
5. Align the paper with the pinch roller attached to the printer door.
Note: To ensure that the paper is aligned in the slot and has not been pinched in the
door, pull the loose edge until a few inches of paper is showing. If the paper will
not move, open the door and return to alignment step 5.
Note: The monitor sounds an invalid button tone when the printer door opens or when
paper runs out.
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15. Troubleshooting
Troubelshooting
WARNING: If you are uncertain about the accuracy of any
measurement, check the patient’s vital signs by alternate means;
then make sure the monitor is functioning correctly.
CAUTION: Do not spray, pour, or spill any liquid on the Smartsigns® Liteplus,
its accessories, connectors, switches, or openings in the chassis.
15.1 General
If the Smartsigns® Liteplus is unable to perform any of its monitoring functions because
of the loss of software control or a detected hardware malfunction, an error code is
presented.
The Smartsigns® Liteplus service manual, which is for user by qualified service personnel,
provides additional troubleshooting information.
2. The monitor display does not function properly and the power- on beep
tones do not sound during the power-on self-test.
• Make sure that the power cord is properly connected to the Smartsigns®
Liteplus.
• The monitor will be operated from its internal battery if in doubt about the
integrity of the AC power source,
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15.3 EMI (Electromagnetic Interference)
Troubelshooting
WARNING: Keep patients under close surveillance when monitoring. It is
possible, although unlikely, that radiated electromagnetic signals from
sources external to the patient and the Smartsigns® Liteplus can cause
inaccurate measurement readings. Do not rely entirely on the Smartsigns®
Liteplus readings for patient assessment.
CAUTION: This device has been tested and found to comply with the limits for medical
devices to the IEC60601-1-2, and the Medical Device Directive 93/42/EEC. These limits
are designed to provide reasonable protection against harmful interference in a typical
medical installation.
If this occurs, the site of use should be surveyed to determine the source of this
disruption, and the following actions taken to eliminate the source:
• Turn equipment in the vicinity off and on to isolate the offending equipment.
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15.4 Obtaining Technical Assistance
Troubelshooting
For technical information and assistance, or to order a service manual, call Huntleigh
Healthcare Ltd Technical Services Department. The service manual includes information
required by qualified service personnel when servicing the Smartsigns® Liteplus.
When calling the Huntleigh Healthcare Ltd Technical Services Department, you may be
asked to tell the representative the software version number of your Smartsigns® Liteplus.
Qualified service personnel or Huntleigh Healthcare Ltd Technical Services Department
may help you check the software version installed in your monitor.
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16. Factory Defaults
Factory Defaults
16.1 General
The Smartsigns® Liteplus is shipped with factory default settings. You may change the
default settings to desired values as described in ‘Using the Monitor’ and ‘Alarm and
Limits’ sections of this manual. When you turn the monitor off properly with the change of
the default setting, the changed settings will be saved and they will be power-on default
settings for next power-on. If you want the power-on setting back to factory defaults, refer
to section 6 of this manual (‘Using the Monitor’)
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Specifications
17. Specifications
17.1 Physical
Instrument
Dimensions 130×180×284 (mm)
Weight 2.7 (kg)
17.2 Electrical
AC Power
Battery
Type Ni-MH
17.3 Environmental
Operation
Note: The system may not meet its performance specifications if stored or used outside the
manufacturer’s specified temperature and humidity range.
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17.4 Measurement Parameters
Specifications
NIBP
Pulse Rate
Adult: - 120, 140, 160 (default), 180, 200, 220, 240, 260 mmHg
(15.9, 18.6, 21.2 (default), 23.9, 26.6, 29.2, 31.9, 34.5 kPa)
SpO2/Pulse Rate
%Saturation
Range 1% to 100%
Low Perfusion 0.03% to 20%
Without Interference -Adults 70% to 100% ±2 digits
1% to 69% unspecified
Without Interference-Neonate1 70% to 100% ±3 digits
Accuracy
1% to 69% unspecified
Low Perfusion2 70% to 100% ±2 digits
1% to 69% unspecified
Pulse Rate
Range 20 BPM to 300 BPM
Without Interference2 20 BPM to 300 BPM ±3 digits
Accuracy
Low Perfusion2 20 BPM to 300 BPM ±3 digits
Standards ISO9919:2005
1
Neonate specifications are shown for neonate sensors with the Smartsigns® Liteplus.
Saturation accuracy will vary by sensor type recommended by the manufacturer.
2
Specification applies to monitor performance and was validated with Biotek and Nellcor
simulators
Temperature
Measurement units ° C, ° F
82
Specifications
Printer
Type Thermal
Resolution 8 (dots/mm)
Printing speed 45 (mm/s)
Paper width 57 (mm)
17.5 Compliance
83
Specifications
Item Compliant with
IEC60529 Degree of protection provided by enclosures
water ingress testing (IPX2)
EN ISO14155-1:2003 Clinical Investigation of Medical Devices for Human
Subjects-part 1: General Requirement
84
Specifications
Item Compliant with
85
17.6 Manufacturer’s Declaration
Manufacturer’s Declaration
The Smartsigns® Liteplus is suitable for use in the specified electromagnetic environment.
The customer and/or user of the Smartsigns® Liteplus should assure that it is used in an
electromagnetic environment as described below;
Table 13. Electromagnetic Emissions (IEC60601-1-2)
RF emissions
Class B
CISPR 11
Harmonic emissions
Complies The Smartsigns® Liteplus is suitable for
IEC 61000-3-2
use in all establishments.
Voltage fluctuations/flicker
emission Complies
IEC 61000-3-3
Electromagnetic
IEC60601-1-2 Test Compliance
Immunity Test Environment
Level Level
Guidance
Floor should be wood,
concrete, or ceramic tile.
Electrostatic
±6 kV contact ±6 kV contact If floors are covered with
discharge (ESD)
±8 kV air ±8 kV air synthetic material, the
IEC 61000-4-2
relative humidity should
be at least 30 %.
86
Manufacturer’s Declaration
Electromagnetic
IEC60601-1-2 Test Compliance
Immunity Test Environment
Level Level
Guidance
It may be necessary to
position the Smartsigns®
Liteplus further from
the sources of power
Power frequency frequency magnetic
(50/ 60 Hz) fields or to install
magnetic field 3 A/m 3 A/m magnetic shielding.
The power frequency
IEC 61000-4-8 magnetic field should
be measured in the
intended installation
location to assure that it
is sufficiently low.
87
Manufacturer’s Declaration
Table 15. Electromagnetic Immunity (IEC60601-1-2)
Potable and mobile RF communications equipment should be used no closer to any part of the
Smartsigns® Liteplus , including cables, than the recommended separation distance calculated
from the equation appropriate for the frequency of the transmitter.
Note: Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast,
and TV broadcast cannot be predicted theoretically with survey accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Smartsigns®
Liteplus is used exceeds the applicable RF compliance level above, the Smartsigns® Liteplus
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Smartsigns® Liteplus.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
Interference may occur in the vicinity of equipment marked with the following
symbol:
88
Manufacturer’s Declaration
Table 16. Recommended Separation Distances
Frequency of
150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
Transmitter
Equation d = 1.2 √P d = 1.2 √P d = 2.3 √P
For transmitters rated at a maximum output power not listed above, the separation
distance can be estimated using the equation in the corresponding column, where P is the
maximum output [power rating of the transmitter in watts (W)] according to the transmitter
manufacturer.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Maximum
Cables and Sensors Complies with
Length
89
18. Warranty & Service
Warranty
Huntleigh Healthcare Diagnostic Products Division standard terms and conditions apply to
all sales. A copy is available on request. These contain full details of warranty terms and
do not limit the statutory rights of the consumer.
Service Returns
If for any reason the Smartsigns Liteplus® has to be returned, please:
Huntleigh Diagnostics reserve the right to return product that does not contain a
decontamination certificate.
A service manual is available for the Smartsigns® series. It contains service information,
parts lists and fault finding guidelines. The service manual can be obtained by contacting
your local supplier or:-
90
© Huntleigh Healthcare Ltd
All rights reserved
PATIENT MONITOR
32MX
E252514
UL60601-1
CAN/CSA C22.2 No.601.1
The Smartsigns® LitePlus is in conformity with the Medical Devices Directive 93/42/
EEC as amended by 2007/47/EC and has been subject to the conformity
assurance procedures laid down by the Council Directive.
®
and ™ are trademarks of Huntleigh Technology Limited
As our policy is one of continuous improvement, we reserve the right to modify A7096-3
designs without prior notice. 743306-9