743306-9 Smartsigns Lite Plus User Guide

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Notice

This document contains proprietary information that is protected by copyright. All Rights
Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited,
except as allowed under the copyright laws.

Warranty

The information contained in this document is subject to change without notice.


Huntleigh Healthcare Ltd makes no warranty of any kind with regard to this material, including,
but not limited to, the implied warranties or merchantability and fitness for a particular purpose.
Huntleigh Healthcare Ltd shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of this material.

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

General Safety Information


This section contains important safety information related to general use of the
Smartsigns® Liteplus vital signs monitor. Other important safety information appears
throughout the manual

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: In the USA, do not connect to an electrical outlet controlled by a


wall switch as the device may be accidentally turned off.

WARNING: If in doubt about the integrity of the AC power source, the


monitor must be operated from its internal battery.

WARNING: Do not disconnect a power cord before the system shuts down
as monitor settings may be lost.

WARNING: As with any medical equipment, carefully route patient cabling to


reduce the possibility of patient entanglement or strangulation.

WARNING: Do not touch the monitor when a defibrillator is being discharged


(electrified), as doing so may cause electric shock. NIBP monitoring only in
this monitor is protected against the discharge of a defibrillator. The other
functions (SPO2, TEMP) are not protected. Please be sure of no other patient
connections, except NIPB, before using the defibrillator.

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: Do not autoclave the monitor.

WARNING: Explosion hazard. Do not use the unit in the presence of


flammable anesthetics or gases. Do not operate in a hyperbaric chamber,
in oxygen-enriched environments, or in any other potentially explosive
environment.

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: 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.

WARNING: The monitor is intended only as an adjunct in patient assessment.


It must be used in conjunction with clinical signs and symptoms.

WARNING: The measurement of vital signs can be affected by patient


conditions, motions, sensors, environmental condition and electromagnetic
external condition.

WARNING: It is possible that any radio frequency transmitting equipment


and other sources of electrical noise such as cellular phones, due to close
proximity or strength of a source, may result in disruption of performance.

WARNING: To ensure patient safety, do not place the monitor in any position
that might cause it to fall on the patient.

WARNING: Disconnect the monitor and sensors during magnetic resonance


imaging (MRI) scanning. Use during MRI could cause burns or adversely
affect the MRI image or the monitor’s accuracy. Also, to avoid burns, remove
the sensors from the patient before conducting MRI.

WARNING: During prolonged and continuous SpO2 monitoring, check the


sensor site at least once every 4 hours. Inspect the patient’s skin integrity
and circulation, and relocate the sensor if necessary. Tissue damage can
result from improper or prolonged sensor attachment.

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

General Safety Information


CAUTION: U.S. Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.

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: Grounding reliability can only be achieved when equipment is connected


to an equivalent receptacle marked ‘Hospital Only’ or ‘Hospital Grade’.

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.

CAUTION: Accessory equipment connected to the monitor’s data interface must be


certified according to IEC60950 for data processing equipment or IEC60601-1 for
electromedical equipment. All combinations of equipment must be in compliance
with IEC60601-1-1 system requirements. Anyone who connects additional
equipment to the signal input or signal output port configures a medical system and
is therefore responsible that the system complies with the requirements of
IEC60601-1-1 and the electromagnetic compatibility standard IEC60601-1-2. If in
doubt, contact Huntleigh Healthcare Technical Services Department.

7
2. Introduction
Introduction

WARNING: The Smartsigns® Liteplus is intended only as an adjunct in


patient assessment. It must be used in conjunction with clinical signs and
symptoms.

This manual contains information about the Smartsigns® Liteplus vital signs monitor. The
Smartsigns® Liteplus is available in the following configurations:

Config. Features

NB Standard (NIBP + Pulse Rate + Ni-MH Battery)

NSB Standard + SpO2

NTB Standard + Temperature

NSTB Standard + SpO2 + Temperature

NPB Standard + Printer

NSPB Standard + SpO2 + Printer

NTPB Standard + Temperature+ Printer

NSTPB Standard + SpO2 + Temperature + Printer

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.

2.1 Features of the Smartsigns® Liteplus


Physical
The Smartsigns® Liteplus vital signs monitor is a lightweight and compact vital signs
monitor measuring 130×180×284 (mm) (H×D×W) and weighing 2.7 kg. Its carrying handle
is designed for instrument transport while battery-powered monitoring.

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.

2.2 Intended Use


The purpose and function of the Huntleigh Healthcare Smartsigns® Liteplus vital signs
monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial
pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and
neonate patients and temperature for adult and pediatric patients in all hospital areas
and hospital-type facilities. It may be used during hospital transport and in mobile, land-
based environments, such as ambulances, within the specification of the environmental
characteristics.

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: Intra-hospital transport includes transport of a patient within the hospital or


hospital-type facility.

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.

2.3 About This Manual


This manual explains how to set up and use the Smartsigns® Liteplus vital signs monitor.
Important safety information relating to general use of the monitors appears before this
introduction. Other important safety information is located throughout the text where
applicable.

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

Symbols and Displays


3.1 Identification of Front Panel Controls and
Symbols

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

1 Blood Pressure Unit Indicators 15 %SpO2 Display


2 Systolic Blood Pressure Display 16 Mode Button
3 Patient Type Indicators 17 Pulse Amplitude Indicator
4 Diastolic Blood Pressure Display 18 Alarm Silence Indicator
5 Pulse Rate Display 19 Up/Down Selection Button
6 MAP (Mean Arterial Pressure) Display 20 Alarm silence button
7 Print Setting Indicators 21 NIBP start/stop button
8 Print Button 22 Temperature Unit/Mode Indicators
9 Alarm Button 23 Temperature Display
10 Auto Indicator 24 Power Button
11 Auto Cycle Display 25 Battery Indicator
12 Auto Button 26 Charging/AC in Indicator
13 Pulse Tone/Alarm Volume Setting Indicators 27 Time Display
14 Review Button 28 Review Indicator

Figure 1. Front Panel Controls and Symbols

10
3.2 Identification of Rear Panel Components and

Description of Controls, Indicators, Symbols and Displays


Symbols

2
NiMH

3 4 5 6 7

1 Handle 4 Equipotential (Ground)

2 Air Ventilator 5 Battery Cover (Replacement)


3 AC Power Connector 6 Battery Label
7 RS-232 Data Interface

Figure 2. Rear Panel Components and Symbols

11
3.3 Description of Symbols/ Indicators
Description of Controls, Indicators, Symbols and Displays

The symbols and Indicators are described as follows:

Table 1. Display Symbols/Indicators

Symbols Description

Attention, consult accompanying documents.

Type BF applied part

Type BF – Defibrillator proof

Equipotentiality

Data interface

Review Indicator

is lit when the user select the Review button to see the patient history.

Auto Indicator

is on whenever NIBP automatic timed cycles are enabled.

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.

Alarm Silence Indicator

is on continuously whenever the unit is in Alarm Silence mode.

Temperature in degrees Fahrenheit

is configured to display temperature in degrees Fahrenheit.

Temperature in degrees Celsius

is configured to display temperature in degrees Celsius.

Temperature in Monitor mode

is configured to take temperature in the monitor mode. This indicator is off


when the temperature is being taken using the predictive method.

Patient type: Adult

is on when the Patient type is adult.

Patient type: Paediatric

is on when the Patient type is paediatric.

Patient type: Neonatal

is on when the Patient type is neonatal.

NIBP unit: mmHg

is on when the NIBP unit setting is mmHg.

NIBP unit: kPa

is on when the NIBP unit setting is kPa.

13
Description of Controls, Indicators, Symbols and Displays
Symbols Description

Target Pressure Setting Indicator

is flashing when the NIBP target inflation pressure is under the setting for
NIBP measurement.

Time Indicator

is on when the actual time is displayed on the time/date numeric display


area. It is flashing when it is selected to set the time in configuration mode.

Date Indicator

is on when the actual date is displayed on the time/date numeric display


area. It is flashing when it is selected to set the date in configuration mode.

Manual Print Indicator

is on when the print setting is set to Manual Print.

Stream Print Indicator

is on when the print setting is set to Stream Print.

Pulse Tone Volume Setting indicator

is flashing when the pulse tone volume setting is selected in setting mode.

Alarm Volume Setting Indicator

is flashing when the alarm volume setting is selected in setting mode.

Network Indicator

is flashing when the monitor is set to software upgrade mode.

AC Power Rating Input

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

IPX2 Dust and Water Resistance

REF Reference Number

SN Serial Number

500-1060 hPa

Environmental shipping / storage temperature limitations

o
50 C

o
-20 C

Fragile - Handle with Care

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.

NIBP start/stop button


initiates NIBP measurement when pressed. If the NIBP start/stop button is
pressed again during the measurement, it will cancel the current reading.

Alarm Silence Button


allows you to silence a patient alarm temporarily and also is used to
acknowledge (cancel) other non-patient alarms.

Up/Down Selection Buttons


allows you to select items within a particular settable feature in several
different modes. If the Up or Down selection button is pressed and held,
the unit will scroll through the available selections as if the button is being
pressed repeatedly while the button is held in.

Print Button (Option)


sends the data to the printer and prints current onscreen readings if a
printer is installed in the monitor. Pressing the Print button during print-out
stops printing.

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

Setting up the Monitor


WARNING: The Smartsigns® Liteplus is a prescription device and is to be
operated by qualified personnel only. It is designed for use by medical
clinicians. Although this document might illustrate medical monitoring
techniques, the monitor must be used only by trained clinicians who know
how to take and interpret a patient’s vital signs.

WARNING: In the USA, do not connect to an electrical outlet controlled by a


wall switch because the device may be accidentally turned off.

WARNING: As with all medical equipment, carefully route patient cabling to


reduce the possibility of patient entanglement or strangulation.
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 the sensor cables or power cord
because the cable could disconnect from the monitor, causing the monitor to
drop on the patient.

WARNING: Disconnect the monitor and sensors/cables during magnetic


resonance imaging (MRI) scanning. Using the monitor during MRI may cause
burns or adversely affect the MRI image or the monitor’s accuracy.

WARNING: To ensure accurate performance or prevent device failure do not


subject the monitor to extreme moisture, such as direct exposure to rain.
Such exposure may cause inaccurate performance or device failure

WARNING: Do not use the Smartsigns® Liteplus vital signs monitor, SpO2
sensors, temperature probes or connectors that appear damaged.

WARNING: Discarded battery may explode during incineration. Follow local


government ordinances and recycle instructions regarding disposal or
recycling of device components, including batteries.

WARNING: Do not touch the monitor when a defibrillator is being discharged


(electrified), as doing so may cause electric shock. NIBP monitoring only in
this monitor is protected against the discharge of a defibrillator. The other
functions (SPO2, TEMP) are not protected. Please be sure of no other patient
connections, except NIPB, before using the defibrillator.

WARNING: Ensure that the speaker is clear of any obstruction. Failure to do


so could result in an inaudible alarm tone.

CAUTION: If the Smartsigns® Liteplus is to be stored for a period of 2 months or longer, it


is recommended to notify service personnel to remove the battery from the monitor prior to
storage. Recharging the battery is strongly recommended when the battery has not been
recharged for 2 or more months.

CAUTION: Recycle used batteries properly. Do not dispose of batteries in refuse


containers.

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.

4.2 List of Components

Quantity Item
1 Smartsigns Liteplus Vital signs monitor
®

1 NIBP Cuff adult (23 - 33 cm)


1 NIBP Cuff small adult (17 - 25 cm)
1 NIBP Cuff child (12 - 19 cm)
1 NIBP Hose adult/paediatric
1 Temperature Probe with Temperature option configured
1 Temperature Probe Cover with Temperature option configured
1 SpO2 Sensor with SpO2 option configured
1 Pulse Oximetry Cable with SpO2 option configured
1 Operator’s Manual
1 Power Cord (applicable to country of sale)
1 pack Printer Paper with Printer option configured

A range of additional accessories are available for the Smartsigns® Liteplus.


Please contact the Customer Services Department for more information.

18
4.3 Power Cable Connections

Setting up the Monitor


WARNING: In the USA, do not connect to an electrical outlet controlled by a
wall switch because the device may be accidentally turned off.

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

Figure 3. AC Power Connection

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.

Note: If the Charging/AC in Indicator is not lit, check:

• the power cord


• the AC power inlet

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.

NIBP Hoses and Cuffs

SYS
mmHg
NIBP Cuff Hose Connector kPa
BP
1

°F
M
DIA °C
/min

%SpO2

MAP

smartsignsLitePlus
®

Figure 4. NIBP Cable Connections

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.

4.5 SpO2 Cables and Sensors

SpO2 Sensor/ Cable Connector

Figure 5. SpO2 Sensor/Cable Connections

1. Select an appropriate sensor for the patient and desired application.


2. Apply the sensor to the selected site.
3. Connect the sensor to the cable.
4. Connect the cable to the right panel SpO2 connector (see Figure 5).
20
Setting up the Monitor
Note: For the safety of patients, and to ensure the best product performance and
accuracy, use only Huntleigh Healthcare Ltd provided tsensor pulse oximetry
cables and SpO2 sensors.

4.6 Temperature Probes

Temperature Probe
SYS
mmHg
kPa 1
Temperature Probe Well
BP
°F
DIA
/min
°C
M
Temperature Probe Cover
%SpO2

MAP
Temperature Probe
Connector

smartsignsLitePlus
®

Figure 6. Temperature Probe Connections

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

WARNING: Dispose of Battery in accordance with local requirements and


regulation. Follow local instructions regarding disposal or recycling of
batteries.

CAUTION: If the Smartsigns® Liteplus is to be stored for a period of 2 months or


longer, it is recommended to notify service personnel to remove the battery from
the monitor prior to storage. Recharging the battery is strongly recommended
when it has not been recharged for 2 or more months.

CAUTION: Measured or displayed data may not be assured in the low battery or
the critical low battery condition.

CAUTION: Discarded battery may explode during incineration. Recycle used


batteries properly. Do not dispose of batteries in refuse containers.

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.

5.1 Operating on Battery Power


The monitor has an internal battery that can be used to power the monitor during transport
or when AC power source is not available.

Table 3. Front Panel Indications in accordance with power operation

Condition
Indicators
Monitor AC Power Battery

No operation Connected Full charged ‘Charging/AC in’ on

No operation Connected Charging ‘Charging/AC in’ flashing

Operation Connected Full charged ‘Charging/AC in’ on

Operation Connected Charging ‘Charging/AC in’ flashing

Operation Disconnected Normal battery status ‘Battery’ on

Operation Disconnected Low battery status ‘Battery’ flashing

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:

Table 4. Operating time in accordance with battery conditions

Type Conditions Operating Time


NI-MH without any measurement and printing at 25°C 10 hours

with an NIBP measurement per 15 minutes, 8 hours


continuous SpO2 measurement and no printing

5.2 Charging a Low Battery


1. Connect the monitor to AC power in order to charge a low or dead battery.
(see ‘Setting up the Monitor’ section)

Note: A full charge of a depleted Ni-MH battery takes approximately 8 hours while the
monitor is turned off.

5.3 Low Battery Indication


The Battery Indicator flashes when the remaining battery power is only enough for about
10 minutes of operation. The monitor will also sound an audible alarm. This will inhibit the
monitor from printing. This audible alarm can be silenced by pressing the Alarm silence
button. Connecting the monitor to AC power will terminate the alarm.

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: If the POST (power on self-test) is not completed successfully, do


not use the monitor.

WARNING: Ensure that the speaker is clear of any obstructions. Failure to do


so could result in an inaudible alarm tone.

WARNING: Disconnect the monitor and sensors/cables during magnetic


resonance imaging (MRI) scanning. Using the monitor during MRI may cause
burns or adversely affect the MRI image or the monitor’s accuracy.

WARNING: The Smartsigns® Liteplus is intended only as an adjunct in patient


assessment. It must be used in conjunction with clinical signs and symptoms.

WARNING: The Smartsigns® Liteplus is a prescription device and is to be


operated by qualified personnel only. It is designed for use by medical
clinicians. Although this document might illustrate medical monitoring
techniques, the monitor must be used only by trained clinicians who know
how to take and interpret a patient’s vital signs.

WARNING: Each time the monitor is used, check alarm limits to ensure that
they are appropriate for the patient being monitored.

6.1 Turning on the Monitor


Before using the Smartsigns® Liteplus, verify that the monitor is working properly and is
safe to use. Proper working condition will be verified each time the monitor is turned on as
described in the following procedure.

Note: Physiological conditions, medical procedures, or external agents that


may interfere with the monitor’s ability to detect and display measurements,
include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment,
and externally applied coloring agents such as nail polish, dye, or pigmented
cream.

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)

Using the Monitor


CAUTION: The Smartsigns® Liteplus automatically starts the Power-On-Self-Test,
which tests the monitor circuitry and functions. During POST (immediately after
power-up), confirm that all display segments and indicators are illuminated and the
power on beep tone sounds.

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.

1. Turn on the monitor ON by pressing the Power button.

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

Figure 7. Power On Self Test

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

Figure 8. Normal Mode Before Measurement

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.

6.3 Setting Date and Time


This procedure will enable you to set current date and time of the monitor.

Note: The date format may be selected either ’year/month/day’ or ’day/ month/
year’ via Service mode.

With the monitor in the normal monitoring 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.

Using the Monitor


Set current month, using the Up/Down (+/-) selection buttons.

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

Figure 9. Date and Time Setting

27
6.4 Setting Patient Type
Using the Monitor

This procedure will allow you to select Patient Type: Adult, Pediatric or Neonatal.

With the monitor in the normal monitoring mode:

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

Figure 10. Patient Type Setting

28
6.5 Setting NIBP Units

Using the Monitor


This procedure will allow you to select a NIBP measurement unit either mmHg or kPa.

With the monitor in the normal monitoring mode:

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

Figure 11. NIBP Units Setting

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.

With the monitor in the normal monitoring 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.

Fahrenheit Predictive (°F) Fahrenheit Monitored (°F M)

Celsius Predictive (°C) Celsius Monitored (°C M)

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

Figure 12. Temperature Units and Modes Setting

30
6.7 Setting Pulse Tone Volume

Using the Monitor


This procedure will enable you to set Pulse Tone Volume.

With the monitor in the normal monitoring mode:

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

Figure 13. Pulse Tone Volume Setting

31
6.8 Setting Alarm Volume
Using the Monitor

This procedure will enable you to set audible Alarm Volume.

With the monitor in the normal monitoring mode:

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

Figure 14. Alarm Volume Setting

32
6.9 Resetting to Factory Defaults

Using the Monitor


Following procedure will allow you to reset the monitor operating parameters to the factory
default settings.

With the monitor powered off:

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.

3. Press the Mode button until “ DEFAULT RESET=NO” is displayed.

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.

5. To return to normal operation, turn the monitor off; then restart.

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 15. Factory Defaults Setting

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: Inaccurate measurements may be caused by incorrect cuff


application or use, such as placing the cuff too loosely on the patient, using
the incorrect cuff size, or not placing the cuff at the same level as the heart,
leaky cuff or hose, and excessive patient motion.

WARNING: Keep patients under close surveillance when monitoring.


It is possible, although unlikely, that radiated electromagnetic signals
from sources external to the patient and monitor can cause inaccurate
measurement readings. Do not rely entirely on the Smartsigns® Liteplus
readings for patient assessment.

WARNING: The Smartsigns® Liteplus is not intended for diagnostic treatment.


To ensure patient safety, use other diagnosis equipments.

WARNING: The monitor displays results of the last blood pressure


measurement until another measurement starts. If a patient’s condition
changes during the time interval between measurements, the monitor will not
detect the change or indicate an alarm condition.
WARNING: Any excessive patient motion may cause inaccurate
measurements of non-invasive blood pressure. Make sure there is no patient
motion affected to blood pressure measurements.

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: In some cases, rapid, prolonged cycling of an oscillometric,


noninvasive blood pressure monitor cuff has been associated with any or all
of the following: ischemia, purpura, or neuropathy. Apply the oscillometric
cuff appropriately, according to instructions, and check the cuff site and
cuffed extremity regularly when blood pressure is measured at frequent
intervals or over extended periods of time.

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.

WARNING: NIBP readings may be inaccurate for patients experiencing


moderate to severe arrhythmia.

WARNING: Do not touch the monitor when a defibrillator is being discharged


(electrified), as doing so may cause electric shock. NIBP monitoring only in
this monitor is protected against the discharge of a defibrillator. The other
functions (SPO2, TEMP) are not protected. Please be sure of no other patient
connections, except NIPB, before using the defibrillator.

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.

Note: This equipment is suitable for use in the presence of electrosurgery

35
7.2 Setup Connections
NIBP Monitoring

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

smartsignsLitePlus
®

NIBP Cuff Hose Connector


Figure 16. NIBP Setup Connections

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

7.3 NIBP Measurement Modes


Blood pressure measurements can be made in three modes:

• MANUAL mode - One measurement of each systolic/diastolic/mean arterial


pressure.
• Automatic (AUTO) mode - Measurements at preset intervals.
• STAT mode - As many measurements as possible within a 5-minute period.

7.4 Description of NIBP Operation


Setting Initial Inflation Pressure
With the monitor in the normal monitoring mode:

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

Initiating MANUAL mode of NIBP operation

1. Press the NIBP start/stop button.

A single blood pressure measurement will be made. As soon as an NIBP measurement


begins, the SYS display shows the current cuff 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

Figure 18. Manual mode of NIBP operation


38
NIBP Monitoring
Initiating AUTO mode of NIBP operation

1. Press the Auto button. The latest selected interval is displayed.

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.

Figure 19. Indication of Auto Mode Turn-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:

• The monitor reaches the 5-minute limit for a STAT measurement.


• The monitor halts because the NIBP start/stop button is pressed.
• The monitor halts because the Auto button is pressed.
• The monitor halts because of an alarm, alert, or error condition.
• The AUTO cycle is changed to ‘-’.

Note: During Auto mode, if an NIBP limit violation alarm occurs, this alarm
disables any automatic NIBP measurement until the alarm is released.

Figure 20. Auto Mode Setting (i.e.) – 15 minute Period

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

Figure 21. Auto Mode of Measurement

Initiating STAT mode of NIBP operation


1. Press the Auto button. The latest selected interval is displayed.

2. Press the Up/Down (+/-) selection buttons to set STAT.


Upon selection, automatic measurement is activated and the initial
measurement will be made in 3 seconds after you select an interval.

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 22. STAT Mode Setting

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.

Stopping Blood Pressure Measurements


1. Press the NIBP start/stop button at any time that you wish to stop the current
measurement and deflate the cuff. If AUTO or Stat mode is underway, the
mode including interval time will be reset.

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

SpO2/Pulse Rate Monitoring


WARNING: Tissue damage can be caused by incorrect application or use
of an SpO2 sensor, for example by wrapping the sensor too tightly or by
applying supplemental tape. Inspect the sensor site as directed in the
sensor directions for use to ensure skin integrity and correct positioning
and adhesion of the sensor.

WARNING: Do not use damaged SpO2 sensors. Do not use an SpO2


sensor with exposed optical components. Do not immerse sensor
completely in water, solvents, or cleaning solutions because the sensor
and connectors are not waterproof. Do not sterilize SpO2 sensors by
irradiation, steam, or ethylene oxide. Refer to the cleaning instructions in
the directions for use for reusable SpO2 sensors.

WARNING: Pulse oximetry readings and pulse signal can be affected by


certain ambient environmental conditions, sensor application errors, and
certain patient conditions.

WARNING: The monitor is intended only as an adjunct in patient


assessment. It must be used in conjunction with clinical signs and
symptoms.
WARNING: Inaccurate measurements may be caused by:
• incorrect sensor application or use
• significant levels of dysfunctional hemoglobin
(such as carboxyhemoglobin or methemoglobin)
• intravascular dyes such as indocyanine green or
methylene blue
• exposure to excessive illumination, such as surgical
lamps (especially ones with a xenon light source), bilirubin
lamps, fluorescent lights, infrared heating lamps, or direct
sunlight
• excessive patient movement
• high-frequency electrosurgical interference and
defibrillators
• venous pulsations
• placement of a sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line
• the patient has hypotension, severe vasoconstriction,
severe anemia, or hypothermia
• there is arterial occlusion proximal to the sensor the
patient is in cardiac arrest or is in shock
WARNING: Loss of pulse signal can occur in any of the following
situations:
• the sensor is too tight
• there is excessive illumination from light sources such as
a surgical lamp, a bilirubin lamp, or sunlight
• a blood pressure cuff is inflated on the same extremity as
the one to which an SpO2 sensor is attached

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: Inaccurate readings could result if a sensor is used incorrectly. Before


using a sensor, carefully read and understand the sensor directions for use.
Periodically check to see the sensor remains properly positioned on the patient
and that skin integrity is acceptable. Refer to sensor directions for use.

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

SpO2/Pulse Rate Monitoring


Use only provided sensor pulse oximetry cables and SpO2 sensors with the monitor.

Biocompatibility testing has been conducted on sensors in compliance with ISO10993-1,


Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The sensors
have passed the recommended biocompatibility testing and are therefore in compliance
with ISO10993-1.

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.

SpO2 Sensor/ Cable


Connector

Figure 23. SpO2 Setup Connections

1. Observe all warnings and cautions in the directions for use.

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.

Table 6. SpO2 Sensors

Sensor Model Patient Size

OXIMAX Durasensor ® Oxygen transducer


DS-100A >40 kg
(Reusable, non-sterile)

OXIMAX oxygen transducer (Sterile, single-use only) MAX-N <3 or >40 kg

OXIMAX oxygen transducer (Sterile, single-use only) MAX-A >30 kg

OXIMAX Oxyband ®
Oxygen transducer (Reusable, non-
OXI-P/I 3 kg to 30 kg
sterile)

OXIMAX adhesive reflectance oxygen transducer MAX-FAST >40 kg

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

Pulse Rate MAP

Figure 24. Pulse Rate Operation

8.4 Description of SpO2 Operation

SpO2 Operation

SYS
mmHg
%SpO2 kPa 1

BP
°F
M
DIA °C
/min

SpO2 & %SpO2


Pulse
MAP
Amplitude
Indicator

Figure 25. SpO2 Operation

44
SpO2/Pulse Rate Monitoring
Functional versus Fractional Saturation

This monitor measures functional saturation — oxygenated hemoglobin expressed as


a percentage of the hemoglobin that can transport oxygen. It does not detect significant
amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin.
In contrast, hemoximeters such as the IL482 report fractional saturation — oxygenated
hemoglobin expressed as a percentage of all measured hemoglobin, including measured
dysfunctional hemoglobin. To compare functional saturation measurements to those from
an instrument that measures fractional saturation, fractional measurements must be
converted as follows:

functional saturation = fractional saturation x100


100 – (%carboxyhemoglobin + %methemoglobin)

Measured versus Calculated 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.

Adjusting Pulse Tone Volume from SpO2 signal

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: The monitor is intended only as an adjunct in patient


assessment. It must be used in conjunction with clinical signs and
symptoms.

WARNING: To ensure patient safety and to obtain accurate and reliable


temperature results, read this section thoroughly before using the
temperature instrument.

WARNING: To limit patient cross-contamination, use only manufacturer’s


recommended single-use disposable probe covers. The use of any other
probe cover, or the failure to use a probe cover, can endanger patients
in the electrical risk point of view and produce inaccurate temperature
measurements.

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: Use of a probe at the wrong site produces inaccurate


measurements and can cause patient injury.

WARNING: Use extreme caution when taking rectal temperatures on


children. Insert the probe tip only 3/8-inch (~1 cm) to avoid risk of bowel
perforation.

WARNING: The thermometer consists of high-quality precision parts.


Protect it from severe impact or shock. Do not use the thermometer if you
notice any signs of damage to the probe or the instrument.

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.

Measurement of patient temperature is accomplished by processing the signal from a


probe containing a resistance element whose impedance is temperature dependent.
These devices are called thermistors. The signal from the probe is conditioned by the
monitor input circuitry, processed, and the measured values are shown in the numeric
frame.

9.2 Setup Connections

WARNING: To limit patient cross-contamination, use only manufacturer’s


recommended single-use disposable probe covers. The use of any other
probe cover, or the failure to use a probe cover, can endanger patients
in the electrical risk point of view and produce inaccurate temperature
measurements.

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Temperature Probe
Connector
smartsignsLitePlus
®

Figure 26. Temperature Setup Connections

Follow the directions for use accompanying the temperature probe.

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

Temperature measurements can be made in two modes:

• PREDICTIVE mode

is a one-time measurement that takes only a few seconds. It results in a single


temperature reading which is displayed at the end of the brief measurement period.

• MONITORED mode

is a continuous measurement over an indefinite period. The current temperature displayed


dynamically throughout the measurement period.

9.4 Description of Temperature Operation

Setting the Temperature Measurement Mode


For the setting the Temperature measurement mode, refer to section 6.6 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.

Note: If there is no activity for 3 seconds, the monitor will return to normal operation.

Table 7. Indication of Temperature Measurement Mode

Indication Temperature Mode

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)

Figure 27. Temperature – Predictive Mode

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.

4. Hold the probe in place until the measurement is complete.


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: Use only a blue-capped probe for oral temperatures.

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.

6. Return the probe into the probe well.


49
If the monitor cannot make a predicted measurement, it takes a monitored temperature.
Temperature Monitoring
(See “Taking a Monitored Measurement” on page 52.)

Possible reasons for a failure to predict are the following:

• The measured temperature is too high or


• The ambient temperature too low or
• The temperature measurement varies too much during the prediction period.

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: Use only a blue-capped probe for axillary temperatures.

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.

3. Lift the patient’s arm to fully expose the axilla.

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.

6. Return the probe into the probe well.

If the monitor cannot make a predicted measurement, it takes a monitored temperature.


(See “Taking a Monitored Measurement” section.)

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

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, the monitor clears the temperature display. “rEC”
appears in the temperature display.

2. Load a probe cover onto the probe.

3. Apply a thin coat of water-based lubricant to the probe tip.

4. Separate the patient’s buttocks with one hand.

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: Use only a red-capped probe for rectal temperatures.

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.

6. Remove the probe.

7. Eject the probe cover by pressing the ejection button, and hygienically
dispose of it.

8. Return the probe into the probe well.

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:

For monitored measurements:

• The monitor must be set to take a monitored temperature.


• The monitor displays the temperature continuously.
• The measurement continues until the probe is replaced in the probe well.

Note: Verify that the temperature measurement type is set to monitored.

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

Figure 28. Temperature – Monitored Mode

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

Figure 29. Example display of over 43°C or under 26°C

52
Temperature Monitoring
Probe Decontamination Procedure

1. Turn the monitor off.

2. Unplug the latching probe connector from the monitor.

3. Remove the probe from the probe well.

4. Remove the probe well from the monitor.

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 immerse or soak the probe in any type of fluid.

Note: Do not autoclave the probe or probe well.

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.

6. Thoroughly dry all surfaces before reassembling the instrument.

7. Re-install the probe well into the monitor.

8. Insert the probe into the probe well.

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

Table 8. Alarm Indication

Alarm Condition Alarm 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

Flashing the violating value in the appropriate display and


Limit violation
sounding audible alarms.
Other system or Presenting appropriate error codes and sounding audible alarms
measurement error if available.

54
10.2 Setting Alarm Limits

Alarms and Limits


CAUTION: Do not set the alarm limit to extreme values that can cause the alarm to
become useless.
During patient monitoring, an alarm occurs when a measurement falls outside the
programmed alarm limit. Alarms can be set or turned off for the following vital signs:

• Systolic high and Systolic low alarm limits


• Diastolic high and Diastolic low alarm limits
• MAP high and MAP low alarm limits
• Pulse rate high and Pulse rate low alarm limits
• SpO2 high and SpO2 low alarm limits

The range of high and low alarm limits for each vital sign is shown here:

Table 9. Range of Alarm Limits (Defaults)


Parameter Low Limit, Default High Limit, Default Resolution
Systolic (mmHg)

Neonatal 40 to 115, 50 45 to 120, 100 5 mmHg (0.7 kPa)

Pediatric 60 to 155, 75 65 to 160, 145 5 mmHg (0.7 kPa)

Adult 60 to 245, 75 65 to 250, 220 5 mmHg (0.7 kPa)

Diastolic (mmHg)

Neonatal 20 to 85, 30 25 to 90, 70 5 mmHg (0.7 kPa)

Pediatric 40 to 125, 50 45 to 130, 100 5 mmHg (0.7 kPa)

Adult 40 to 195, 50 45 to 200, 110 5 mmHg (0.7 kPa)

MAP (mmHg)

Neonatal 30 to 95, 40 35 to 100, 80 5 mmHg (0.7 kPa)

Pediatric 45 to 135, 60 50 to 140, 110 5 mmHg (0.7 kPa)

Adult 45 to 230, 60 50 to 235, 120 5 mmHg (0.7 kPa)

PR (bpm)
Neonatal 25 to 295, 100 30 to 300, 200 5 bpm

Pediatric 25 to 295, 50 30 to 300, 150 5 bpm


Adult 25 to 295, 50 30 to 300, 120 5 bpm
SpO2 %
Neonatal 50 to 98, 85 52 to 100, 98 1%
Pediatric 50 to 98, 90 52 to 100, 100 1%
Adult 50 to 98, 90 52 to 100, 100 1%
55
Alarms and Limits
NIBP Alarm Limits

Alarm Limits determine the high and low points of patient data at which the monitor will
sound an alarm.

Systolic high and low alarm limits


With the monitor in the normal monitoring mode:

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

Figure 30. Systolic High Alarm Limit Setting

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 31. Systolic Low Alarm Limit Setting

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

Figure 32. Diastolic High Alarm Limit Setting

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 33. Diastolic Low Alarm Limit Setting

57
Alarms and Limits
MAP high and low alarm limits

With the monitor in the normal monitoring mode:

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

Figure 34. MAP High Alarm Limit Setting

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 35. MAP Low Alarm Limit Setting

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.

With the monitor in the normal monitoring mode:

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

Figure 36. Pulse Rate High Alarm Limit Setting

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 37. Pulse Rate Low Alarm Limit Setting

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.

With the monitor in the normal monitoring mode:

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

Figure 38. SpO2 High Alarm Limit Setting

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Figure 39. SpO2 Low Alarm Limit Setting

60
10.3 Alarm Silence

Alarms and Limits


WARNING: Do not silence the audible alarm or decrease its volume if
patient safety could be compromised.

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.)

2. Check the patient and provide appropriate care.

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.

10.4 Verifying Visual and Audible Alarm Indication


If the monitor fails to perform as specified in this test, contact qualified service personnel
for assistance.

You can verify the alarm operation for all parameters like NIBP, SpO2 and Temp, by
following the procedures below.

1. Connect the monitor to an AC power source.


2. Press the Power Button to turn on the monitor.
3. Connect the simulator to the sensor input cable and connect cable to monitor.
4. Set the simulator to a smaller value than the lower alarm limit on the monitor.
5. Verify the following reaction:
a. The monitor begins to track the physiological signal from the simulator.
b. After about 10 to 20 seconds, the monitor displays the value measured
as specified by the simulator. Verify values are within the tolerances
specified in the Specification section for each parameter (NIBP, SpO2, Temp).
c. The violating value in the appropriate display flashes and the audible alarm
sounds.

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.

11.2 Displaying Stored Patient Data

1. Press the Review button to display the newest stored set of patient vital-signs
data.

• The monitor interrupts the dynamic display of any current vital-sign


measurement.

• 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

Data #1 Display: Data stored


at an error occurred 2 minutes ago

SYS
mmHg
1
kPa
BP
°F
M
DIA °C
/min

%SpO2

MAP

Data #2 Display: Data stored


at the measurement completed 18 minutes ago

Figure 40. Stored Patient Data Display

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”.

Follow the instructions to print stored data if an optional printer is installed.

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.

 • If the monitor is printing, press the Print button to stop printing.

Note: The print button is not enabled during an NIBP cycle.

11.4 Erasing Patient Data


All patient vital-signs data is stored even the monitor is powered off, however 24-hour old
data will be removed. You can also erase patient data when you change the time and date
settings and at any time during normal monitor operation.

Erasing Data During Normal Operation

To erase patient data during normal operation;

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.

12.2 Selecting Manual or Stream Printing type


This procedure will allow you to select Print mode either Manual or Stream.

With the monitor in the normal monitoring mode:

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

Figure 41. Printing Type Setting

12.3 Printing Patient Data (Manual Mode)


You can print vital-signs measurement data each time you press the Print button (Manual
printing), or you can store patient data and print all of it at one time (Batch printing).

Follow the instructions to print stored data if an optional printer is installed.

1. Press Print button when the monitor is in Normal or Review mode.

• If the monitor is not printing, press the Print button to start printing.

• If the monitor is printing, press the Print button to stop printing.

Note: The print button is not enabled during an NIBP cycle.

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:

• Header: Time, Date, Measurement Parameters and Parameter units

• Measurement data and/or error codes

Real Time Print Out at Manual and Stream Modes

Patient Name:
Patient ID:
Physician:
Comments:

TIME SYS DIA MAP HR O2 TEMP


- - mmHg - - BPM % °C
17:26 26-Mar-2004
17:26 127 84 98 68 98 36.1

Figure 42. Real-Time Printing

Stored Data Print Out

Patient Name:
Patient ID:
Physician:
Comments:

TIME SYS DIA MAP HR O2 TEMP


- - mmHg - - BPM % °C
17:20 26-Mar-2004
17:19 126 83 98 60 98 36.5
17:15 123 82 97 62 98 36.5
17:14 E22 - - - - -

Figure 43. Stored Data Printing (Batch Printing)

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:

TIME SYS DIA MAP HR O2 TEMP


- - mmHg - - BPM % °C
17:52 26-Mar-2004
17:52 127 84 98 200 l 75 36.1

Figure 44. Stream Printing at Alarm Condition

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

Patient type: Adult


NIBP target press (mmHg): 160
NIBP auto interval: 15
NIBP units: mmHg
NIBP Smart Inflation Off
Temperature mode: Predict
Temperature units: °F
Print mode: Manual
Night panel: Off
Nurse call state Normal open
Date format Y-M-D
Sound mode Full
Pulse tone volume: 4
Alarm tone volume: 4

Alarm limit settings


High Sys (mmHg) 220
Low Sys (mmHg) 75
High Dia (mmHg) 110
Low Dia (mmHg) 35
High MAP (mmHg) 120
Low MAP (mmHg) 50
High HR (BPM) 120
Low HR (BPM) 50
High SpO2 (%) 100
Low SpO2 (%) 90

Total cycles: 6
Total runtime: 2

Software versions:
Units: 3.00
NIBP: 1.01
SpO2: 1.90
Temp: 1.2

Figure 45. System Information Printing

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.

13.2 Cable Connection

RS-232 I/O connector

Figure 46. RS-232 I/O connector

The Pin layouts (as viewed from the rear panel of the monitor) are illustrated below.

6 7 8 9
1 2 3 4 5

Figure 47. Data Port Pin Layout

Table 10. RS-232 Serial Interface Connections

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.

The Nurse Call function specification is as follows:

• Switch current: 1 A maximum

• Switch voltage: 30 Vac/dc maximum

• Isolation: 1500 Vrms

• Alarm relay: Normal open (default)

Note: The alarm relay may be selected either ’Normal Open’ or ’Normal Close’ via
Service mode.

71
14. Maintenance
Maintenance

WARNING: Only qualified service personnel should remove the cover.


There are no internal user-serviceable parts.

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.

14.2 Returning the Smartsigns® Liteplus and


System Components
Contact Huntleigh Healthcare Ltd Technical Services Department for shipping instructions
including a Returned Goods Authorization (RGA) number. Pack the Smartsigns® Liteplus
monitor with sensors, cables or other accessory items in its original shipping carton. If the
original carton is not available, use a suitable carton with appropriate packing material
to protect the monitor during shipping. Return the Smartsigns® Liteplus by any shipping
method that provides proof of delivery.

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.

14.4 Periodic Safety Checks


It is recommended that the following checks be performed every 24 months.

• Inspect the equipment for mechanical and functional damage.


• Inspect the safety relevant labels for legibility.

72
14.5 Cleaning

Maintenance
For surface-cleaning, follow your institution’s procedures or:

• The Smartsigns® Liteplus may be surface-cleaned by using a soft cloth


dampened with either a commercial or nonabrasive cleaner, and lightly wiping
the top, bottom, and front surfaces of the monitor lightly.

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.

14.6 Battery maintenance


If the Smartsigns® Liteplus vital signs monitor has not been used 2 months, the battery
will need charging. To charge the battery, connect the Smartsigns® Liteplus to an AC
power source as described in the Battery Operation section.

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 Smartsigns® Liteplus is to be stored for a period of 2 months or


longer, it is recommended to notify service personnel to remove the battery from
the monitor prior to storage. Recharging the battery is strongly recommended
when the battery has not been recharged for 2 or more months.

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.

CAUTION: Discarded battery may explode during incineration. Follow local


government ordinances and recycle instructions regarding disposal or recycling of
device components, including batteries.

CAUTION: Recycle used batteries properly. Do not dispose of batteries in refuse


containers.

73
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.

3. Place a new paper roll. Orient the paper roll.

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.

6. Close 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.

74
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.

WARNING: Only qualified service personnel should remove the cover.


There are no user-serviceable parts inside.

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.

Table 11. Error Codes

Error Codes Description


E01 Battery failure
E02 Abnormally shutdown last time
E09 System error (malfunction)
E21 Air leakage
E22 Cuff not detected
E23 Kinked or neonate hose
E24 Cuff too large for neonate
E25 Overpressure condition
E26 Motion artifact
E27 Weak pulse or no pulse detected
E28 Valid BP not found
E29 NIBP module error (malfunction)
E41 Sensor off
E42 Sensor disconnected
E43 Bad sensor
E44 Loss of pulse
E49 SpO2 module error (malfunction)
“P” Loss of tissue contact
E62 Probe disconnected
E63 Probe error
E64 Probe heated too high
E65 Ambient temperature out of range
E69 Temperature module error (malfunction)
75
Serviceable error codes and other error codes are listed in the Smartsigns® Liteplus
Troubelshooting
service manual. If the monitor continues to present an error code, call the Huntleigh
Healthcare Ltd technical representative and report the error code number. You will be
advised of the remedial action to be taken. Before calling the Huntleigh Healthcare Ltd
Technical Services Department, make sure that the battery is charged, and that all power
connections are correctly made.

15.2 Corrective Action


If you experience a problem while using the Smartsigns® Liteplus and are unable to
correct it, contact qualified service personnel or Huntleigh Healthcare Ltd Technical
Services Department.

The Smartsigns® Liteplus service manual, which is for user by qualified service personnel,
provides additional troubleshooting information.

Following is a list of possible errors and suggestions for correcting them.

1. There is no response to the Power On/Off switch.

• A fuse may be blown. Notify service personnel to check and, if necessary,


replace the fuse.

• If operating on battery power, the battery may be missing or discharged.


If the battery is discharged, charge the battery, see Battery Operation
section.

2. The monitor display does not function properly and the power- on beep
tones do not sound during the power-on self-test.

• Do not use the Smartsigns® Liteplus; contact qualified service personnel


or Huntleigh Healthcare Ltd Technical Services Department.

3. The monitor is operating on battery power, even though it is connected to


AC.

• Make sure that the power cord is properly connected to the Smartsigns®
Liteplus.

• Check to see if power is available to other equipment on the same AC


circuit.

• The monitor will be operated from its internal battery if in doubt about the
integrity of the AC power source,

76
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.

WARNING: It is possible that any radio frequency transmitting equipment


and other sources of electrical noise such as cellular phones, due to close
proximity or strength of a source, may result in disruption of performance
of the Smartsigns® Liteplus.

WARNING: It is possible, although unlikely, that large equipment using a


switching relay for its power on/off may result in disruption of performance
of the Smartsigns® Liteplus when the large equipment powers on or off. Do
not place the Smartsigns® Liteplus to monitor in such environments.

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.

However, because of the proliferation of electromagnetic noise in health care


environments (for example; electrosurgical unit, cellular phones, mobile two-way radios,
electrical appliances, and high-definition television), it is possible that high levels of such
interference due to close proximity or strength of a source may result in disruption of
performance of this device.

CAUTION: The Smartsigns® Liteplus is designed for use in environments in which


the signal can be obscured by electromagnetic interference. During such
interference, measurements may seem inappropriate or the monitor may not seem
to operate correctly.

CAUTION: Disruption may be evidenced by erratic readings, cessation of


operation, or other incorrect functioning.

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.

• Reorient or relocate the interfering equipment.

• Increase the separation between the interfering equipment and this


equipment.

If assistance is required, contact Huntleigh Healthcare Ltd Technical Services Department.

77
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.

78
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’)

16.2 Parameter Ranges and Default Settings


Table 12. Parameter Ranges and Factory Defaults

Parameter Ranges Defaults


Neonatal Low: 40 to 115 High: 45 to 120 50, 100
Systolic (mmHg)
Pediatric Low: 60 to 155 High: 65 to 160 75, 145
Alarm Limits
Adult Low: 60 to 245 High: 65 to 250 75, 220
Neonatal Low: 20 to 85 High: 25 to 90 30, 70
Diastolic (mmHg)
Pediatric Low: 40 to 125 High: 45 to 130 50, 100
Alarm Limits
Adult Low: 40 to 195 High: 45 to 200 50, 110
Neonatal Low: 30 to 95 High: 35 to 100 40, 80
MAP (mmHg)
Pediatric Low: 45 to 135 High: 50 to 140 60, 110
Alarm Limits
Adult Low: 45 to 230 High: 50 to 235 60, 120
Neonatal Low: 25 to 295 High: 30 to 300 100, 200
PR (bpm)
Pediatric Low: 25 to 295 High: 30 to 300 50, 150
Alarm Limits
Adult Low: 25 to 295 High: 30 to 300 50, 120
Neonatal Low: 50 to 98 High: 52 to 100 85, 98
SpO2 %
Pediatric Low: 50 to 98 High: 52 to 100 90, 100
Alarm Limits
Adult Low: 50 to 98 High: 52 to 100 90, 100
Patient Type Adult, Pediatric, Neonatal Adult
NIBP Units mmHg, kPa mmHg
Off, STAT, 1, 2, 3, 4, 5, 10, 15, 30, 45,
NIBP Auto Interval 15
60, 90, 120, 240
Temperature Units/Modes °C, °F, °C M, °F M °F
Pulse Tone Volume 0 to 8 4
Alarm Volume 1 to 8 4
Night Panel On, Off Off
Normal
Nurse call state Normal Open, Normal Close
Open
Date format Y-M-D, D-M-Y Y-M-D
Sound mode Full, Mid, Mute Full
Print Control Manual, Stream Manual
NIBP Smart Inflation On/Off Off

79
Specifications
17. Specifications
17.1 Physical

Instrument
Dimensions 130×180×284 (mm)
Weight 2.7 (kg)

17.2 Electrical

AC Power

Power 100Vac to 240Vac, 50 Hz/60 Hz,60 VA

Battery

Type Ni-MH

Voltage/Capacity Ni-MH : 8.4 V/ 7.6 Ampere-Hours

Charging Time Ni-MH : 8 Hours

Shelf Life 2 years, new fully charged battery

Complies with 91/157/EEC, 93/86/EEC and 2006/66/EC

17.3 Environmental

Operation

Temperature 10 °C (50 °F) to 40 °C (104 °F)

Humidity 15 % RH to 95% RH, non-condensing


Altitude 700 hPa to 1060hPa

Transport and Storage


Temperature –20 °C (-4 °F) to 50 °C (122 °F)
Humidity 15 % RH to 95% RH, non-condensing

Altitude 500 hPa to 1060 hPa

Note: The system may not meet its performance specifications if stored or used outside the
manufacturer’s specified temperature and humidity range.

80
17.4 Measurement Parameters

Specifications
NIBP

Pulse Rate

Adult/Pediatric 40 BPM to 200 BPM


Pulse Rate Range
Neonatal 40 BPM to 240 BPM

Pulse Rate Accuracy ±2 BPM or ±2%, whichever is greater

NIBP (Non-Invasive Blood Pressure)

Technique Oscillometric Measurement

Measurement modes AUTO, MANUAL and STAT

Automatic NIBP measurements at intervals of 1, 2, 3, 4, 5, 10,


AUTO Mode
15, 30, 45, 60, 90, 120, and 240 minutes

MANUAL Mode Single measurement initiated by NIBP Start/Stop switch

STAT Mode Series of consecutive measurements for 5 minutes

NIBP pressure measurement range

Adult: 60 mmHg to 250 mmHg (8 kPa to 33.3 kPa)


Systolic pressure range Pediatric: 60 mmHg to 250 mmHg (8 kPa to 33.3 kPa)
Neonatal: 40 mmHg to 120 mmHg (5.3 kPa to 16.0 kPa)

Adult: 40 mmHg to 200 mmHg (5.3 kPa to 26.7 kPa)


Diastolic pressure range Pediatric: 40 mmHg to 200 mmHg (5.3 kPa to 26.7 kPa)
Neonatal: 20mmHg to 90 mmHg (2.7 kPa to 12.0 kPa)

Adult: 45 mmHg to 235 mmHg (6 kPa to 31.3 kPa)


Mean pressure range Pediatric: 45 mmHg to 235 mmHg (6 kPa to 31.3 kPa)
Neonatal: 30 mmHg to 100 mmHg (4 kPa to 13.3 kPa)

Pressure Display Accuracy Meets ANSI/AAMI SP10:2002+A1:2003

Cuff Pressure Range 0 to 300 mmHg (0 to 40 kPa)

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)

Pediatric: - 120 (default), 130, 140, 150, 160, 170mmHg


Initial Cuff Inflation
(15.9 (default), 17.2, 18.6, 19.9, 21.2, 22.6 kPa)

Neonatal: - 80, 90 (default), 100, 110, 120, 130, 140 mmHg


(10.6, 11.9 (default), 13.3, 14.6, 15.9, 17.5, 18.6 kPa)

Adult/Pediatric 300 mmHg (N.C.), 330 mmHg (S.F.C.)


Overpressure protector
Neonatal 150 mmHg (N.C.), 165 mmHg (S.F.C.)

ANSI/AAMI SP10:2002+A1:2003, IEC60601-2-30:1999


Standards
EN1060-1:1995, EN1060-3:1997 and EN1060-4:2004.
81
Note: Systolic and diastolic blood pressure measurements determined with this
Specifications
device are equivalent to those obtained by a trained observer using the cuff/
stethoscope auscultation method, within the limits prescribed by the American
National Standard, Electronic or automated sphygmomanometers.

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

Probe Type Thermistor probe


Range 26° C to 43° C (80° F to 110°F)

Display Accuracy ±0.1° C (±0.2° F)

Measurement units ° C, ° F

Measurement modes Predictive, Monitored

One-time measurement in a single temperature reading which


Predictive Mode
is displayed at the end of the brief measurement period

Monitored Mode Continuous measurement over an indefinite period.


Standards ASTM E1112-00:2000, EN12470-3 and EN12470-4

82
Specifications
Printer

Type Thermal
Resolution 8 (dots/mm)
Printing speed 45 (mm/s)
Paper width 57 (mm)

17.5 Compliance

Item Compliant with


Class I (on AC power) and Internally powered (on battery power)
Classification Equipment not suitable for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
Mode of operation Continuous
Type of protection Type BF – Applied parts (NIBP Defibrillation-proof applied parts)
93/42/EEC Medical Device Directive
US FDA 21 CFR 820 Code of federal regulations, Quality system
regulation
91/157/EEC Battery Declaration Directive
93/86/EEC Battery Disposal Directive
General Safety 2006/66/EC Battery directive

2002/96/EC waste electrical and electronic equipment (WEEE)


ISO13485:2003 Quality Systems - Medical devices - Requirements for
regulating purposes
IEC60601-1:1998+A1:1991+A2:1995
General requirements for safety of medical electrical equipment

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

AAMI HE48:1993 Human factors engineering guidelines and preferred


practices for the design of medical devices
IEC60601-2-49:2001 - Particular requirements for the safety of
Multifunction patient monitoring equipment
General Safety
IEC60601-1-1:2000 Collateral standard for medical electrical systems

IEC60601-1-4:2000 Collateral standard for Programable medical systems

IEC60601-1-6:2004 Collateral standard for Usability


ISO14971:2000+A1:2003
Application of risk management to Medical devices
ISO10993-1:2003 Biological evaluation of medical devices-Part 1:
Evaluation and testing

IEC60601-1-8:2003 Alarm systems requirements, tests and guidances in


Alarms
medical electrical equipments systems
AAMI SP10:2002+A1:2003
Electronic or Automated Sphygmomanometers
EN1060-1:1995 Non-invasive sphygmomanometers

EN1060-3:1997 Supplementary requirements for electrical-mechanical


Non-invasive blood pressure measuring systems
blood pressure
EN1060-4:2004
Non-invasive sphygmomanometers - Test procedures to determine the
overall system accuracy of automated non-invasive sphygmomanometers
IEC60601-2-30:1999
Particular requirements for the Safety, including essential performance, of
automatic cycling indirect blood pressure monitoring equipment
Oxygen saturation ISO9919:2005 Pulse oximeters, Particular requirements
ASTM E1112-00:2000 - Electronic thermometer for intermittent
determination of patient temperature
Temperature EN12470-3 Clinical thermometers - Part 3: Performance of compact
monitoring electrical thermometers (non predictive/predictive) with maximum device
EN12470-4 Clinical thermometers - Part 4: Performance of electrical
thermometers for continuous measurement
IEC 60601-1, sub clause 36, and IEC60601-1-2:2001+ A1:2004
Electromagnetic Electromagnetic compatibility-requirements & test
Compatibility
IEC61000-3-2:2005 Harmonic Emission

84
Specifications
Item Compliant with

IEC61000-3-3:2005 Voltage Fluctuations/Flicker Emission

IEC61000-4-2:2001 Electrostatic Discharge (ESD)

IEC61000-4-3:2006 Radiated RF electromagnetic field

IEC61000-4-4:2004 Electrical fast Transient/Burst (EFT)

IEC61000-4-5:2005 Surge current


Electromagnetic
Compatibility IEC61000-4-6:2006 Conducted disturbances, induced by RF field

IEC61000-4-8:2001 Power frequency (50/60H) Magnetic field

IEC61000-4-11:2004 Voltage dips, short interruptions, and voltage


variation on power supply input lines

CISPR 11, EN55011 RF emissions Group 1, Class B


Limits and methods of measurement of radio disturbance characteristics
of industrial scientific and medical (ISM) radio-frequency equipment.
EN1041:1998 Information supplied by the manufacturer with medical
Labeling
devices
IEC /TR60878:2003 Graphical symbols for electrical equipment in
medical practice

EN980:2003 Graphical symbols for use in the labeling of medical devices


ISO7000:2004 Graphical symbols for use on equipment-index and
synopsis
Marking EN60417-1:1999 Graphical symbols for use on equipment-overview and
application
EN60417-2:1999 Graphical symbols for use on equipment-symbol
originals
EN50419:2005 Marking of electrical and electronic equipment in
accordance with article II (2) of directive 2002/96/EC (WEEE)

ISTA: Pre-Shipment Test Procedures (Procedure 1A, 2001 Rev.)

Package ASTM D4169:2005 Standard practice for performance testing of shipping


containers and system

IEC 60068-1:1988 Environmental testing, Part 1: General guidelines

IEC60068-2-27 Environmental testing - Shock

Reliability IEC60068-2-6:1995 Environmental testing –Vibration (sinusoidal)

IEC60068-2-64:1993, Broadband random (Digital Control) and Guidance

85
17.6 Manufacturer’s Declaration
Manufacturer’s Declaration

WARNING: The use of accessories, transducers, and cables other


than those specified may result in increased emission and/or
decreased immunity of the Smartsigns® Liteplus monitor.

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)

Emission Test Compliance Electromagnetic Environment

The Smartsigns® Liteplus must emit


RF emission electromagnetic energy in order to
Group 1
CISPR 11 perform its intended function. Nearby
electronic equipment may be affected.

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

Table 14. Electromagnetic Immunity (IEC60601-1-2)

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 %.

Electric fast ±2 kV for ±2 kV for Mains power quality


transient/burst IEC power supply lines power supply lines should be that of a
61000-4-4 ±1 kV for ±1 kV for typical commercial and/
input/output lines input/output lines or hospital environment

86
Manufacturer’s Declaration
Electromagnetic
IEC60601-1-2 Test Compliance
Immunity Test Environment
Level Level
Guidance

±1 kV differential ±1 kV differential Mains power quality


Surge
mode mode should be that of a
IEC 61000-4-5
±2 kV ±2 kV typical commercial and/
common mode common mode or hospital environment

Voltage dips, short Mains power quality


<5 % U T <5 % U T
interruptions and should be that of a
(>95 % dip in UT ) for (>95 % dip in U T)
voltage variations typical commercial and/
0.5 cycle for 0.5 cycle
on power supply or hospital environment.
If the user of the
40 % U T 40 % U T Smartsigns® Liteplus
IEC 61000-4-11 (60 % dip in UT ) for (60 % dip in U T) for requires continued
5 cycles 5 cycles operation during power
mains interruption, it is
70 % U T 70 % U T recommended that the
(30 % dip in UT ) for (30 % dip in UT) for Smartsigns® Liteplus
25 cycles 25 cycles be powered from an
uninterruptible power
<5 % U T <5 % U T supply or battery.
(95 % dip in UT ) for (95 % dip in UT) for
5 sec. 5 sec.

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.

Note: UT is the AC mains voltage prior to application of the test level.

87
Manufacturer’s Declaration
Table 15. Electromagnetic Immunity (IEC60601-1-2)

IEC60601-1-2 Test Electromagnetic


Immunity Test Compliance Level
Level Environment Guidance

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.

Radiated RF 3 V/m distance = 1.2 √Power


3 V/m
IEC 61000-4-3 80 MHz ~ 800 MHz 80 MHz ~ 800 MHz

3 V/m distance = 2.3 √Power


3 V/m
800 MHz ~ 2.5 GHz 800 MHz to 2.5 GHz

Conducted RF 3 Vrms distance = 1.2 √Power


3 Vrms
IEC 61000-4-6 150 kHz ~ 80 MHz 150 kHz to 80 MHz

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

Rated Maximum Output


Separation Distance Separation Distance Separation Distance
Power of Transmitter in
in Meters in Meters in Meters
Watts
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

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.

Recommended Separation Distances between Portable and Mobile RF


Communications Equipment and the Smartsigns® Liteplus.
(IEC60601-1-2)

Table 17. Cables (IEC60601-1-2)

Maximum
Cables and Sensors Complies with
Length

Pulse oximetry cable 10 ft. (3 m) -RF emissions, CISPR 11, Class B/


Group 1
Software download cable, RS-232 -Harmonic emissions, IEC 61000-3-2
10 ft. (3 m)
serial, 9 pin “D” -Voltage fluctuations/flicker emission,
Non-terminated cable, RS-232, 9 IEC 61000-3-3
10 ft. (3 m) -Electrostatic discharge (ESD), IEC
pin “D”
61000-4-2
-Electric fast transient/burst,
IEC61000-4-4
Reusable SpO2 sensor 3 ft (0.91 m) -Surge, IE 61000-4-5
-Conducted RF IEC 61000-4-6
-Radiated RF, IEC 61000-4-3

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:

• Clean the product following the instructions in this manual.

• Pack it in suitable packing.

• Attach a decontamination certificate (or other statement declaring that the


product has been cleaned) to the outside of the package.

• Mark the package ‘Service Department ‘

For further details, refer to NHS document HSG(93)26 (UK only).

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:-

Customer Care Department.


Huntleigh Healthcare, Diagnostic Products Division,
35, Portmanmoor Rd.,
Cardiff. CF24 5HN
United Kingdom.

Tel: +44 (0)29 20496793 - Service (24hr answer machine)


Tel: +44 (0)29 20485885
Fax: +44 (0)29 20492520
Email: [email protected]
[email protected]

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.

Manufactured in the UK by Huntleigh Healthcare Ltd.


As part of the ongoing development programme the company reserves the right
to modify specifications and materials without notice.

Smartsigns® and Huntleigh are registered trademarks of Huntleigh Technology


Ltd.

© Huntleigh Healthcare Ltd. 2006, 2011


...with people in mind
Huntleigh Healthcare Ltd. - Diagnostic Products Division
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: +44 (0)29 20485885 F: +44 (0)29 20492520
E: [email protected]
W: www.huntleigh-diagnostics.com

Registered No: 942245 England & Wales. Registered Office: ArjoHuntleigh


House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF

© Huntleigh Healthcare Limited 2006, 2011

AN COMPANY, MEMBER OF THE GETINGE GROUP

®
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

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