Huntleigh SC300 User manual

Spot Check Vital
Signs Monitor
SC300

2
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.

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Table of Contents
Contents
1. General Safety Information................................................5
1.1 Warnings / Cautions ............................................................................................. 5
2. Introduction ........................................................................8
2.1 Features of the Smartsigns®Compact 300.................................................... 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 controls ............................................................... 11
3.3 Identification of Side panel controls .............................................................. 11
3.4 Identification of Underside ............................................................................ 12
3.5 Description of Symbols/ Indicators................................................................. 12
3.6 Description of Controls................................................................................... 14
4. Setting up the Monitor........................................................15
4.1 Unpacking and Inspection.............................................................................. 16
4.2 List of Components ........................................................................................ 16
4.3 Power Cable Connections ............................................................................. 17
4.4 Connecting Accessories................................................................................. 18
5. Battery Operation...............................................................20
5.1 Installing the Battery pack.............................................................................. 20
5.2 Operating on Battery Power........................................................................... 21
5.3 Charging a low battery ................................................................................... 21
5.4 Battery Using Guidance ................................................................................. 21
6. System Display ...................................................................22
7. Using the Monitor ...............................................................24
7.1 Turning the Monitor ON.................................................................................. 24
7.2 Performing Power On and Self-Test (POST) ................................................. 25
7.3 Turning the Monitor OFF................................................................................ 25
8. System Settings .................................................................26
8.1 Measuring Mode ............................................................................................ 26
8.2 Review Mode ................................................................................................. 26
8.3 Pulse Tone Setting......................................................................................... 27
8.4 Standby Mode................................................................................................ 27
8.5 Exiting Standby Mode .................................................................................... 27
8.6 Maintenance Mode ........................................................................................ 28
9. NIBP Monitoring..................................................................31
9.1 General .......................................................................................................... 32
9.2 Setup Connections......................................................................................... 32
9.3 Starting / Stopping Measurements................................................................. 34
9.4 Automatic Measurements .............................................................................. 34
10. SpO2/Pulse Rate Monitoring.............................................36
10.1 General Principles of Measuring SpO2Plethysmography Parameter............ 37
10.2 Identifying the SpO2Module .......................................................................... 38
10.3 Setup Connections......................................................................................... 38
10.4 SpO2 and Pulse Rate Display ....................................................................... 39

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Table of Contents
11. Temperature Monitoring ...................................................40
11.1 Description of the Thermometer IRT10.......................................................... 40
11.2 Thermometer Display..................................................................................... 41
11.3 Main Unit Display ........................................................................................... 41
11.4 Pairing the Thermometer and Main Unit ........................................................ 42
11.5 Temp Measurement ....................................................................................... 42
12. Maintenance .....................................................................43
12.1 General .......................................................................................................... 43
12.2 Returning the Smartsigns®Compact 300 and System Components ............. 43
12.3 Service ........................................................................................................... 43
12.4 Periodic Safety Checks.................................................................................. 43
12.5 Cleaning......................................................................................................... 44
12.6 Battery maintenance ...................................................................................... 44
13. Troubleshooting ................................................................45
13.1 General .......................................................................................................... 45
13.2 Corrective Action............................................................................................ 48
13.3 Obtaining Technical Assistance ..................................................................... 48
14. Electromagnetic Compatibility ........................................49
15. Specifications ...................................................................53
15.1 Equipment Classification ............................................................................... 53
15.2 Standards....................................................................................................... 53
15.3 General .......................................................................................................... 53
15.4 Electrical ........................................................................................................ 54
15.5 Environmental ................................................................................................ 54
15.6 Measurement Parameters ............................................................................. 55
16. Accessories ......................................................................57
17. End of Life Disposal..........................................................59
18. Warranty & Service ..........................................................60
18.1 Service Returns ............................................................................................. 60

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1. General Safety Information
This section contains important safety information related to general use of the
Smartsigns®Compact 300 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 / Cautions
General warning / caution
Refer to Instructions for Use
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: As with any medical equipment, carefully route patient
cabling to reduce the possibility of patient entanglement or
strangulation.
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 anaesthetics 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 the accessories instructions for
use, including all warnings, cautions, and instructions.
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.
General Safety Information

6
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 SpO2monitoring, 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: Do not connect more than one patient to the monitor.
CAUTION: U.S. Federal law restricts this device to sale by or on the
order of a licensed healthcare practitioner.
CAUTION: Exercise care for the safe and effective use of Smartsigns®
Compact 300 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.
General Safety Information

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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 Service Department.
General Safety Information

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2. Introduction
WARNING: The Smartsigns®Compact 300 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®Compact 300 vital signs monitor.
The Smartsigns®Compact 300 is available in the following configurations:
Config. Features
SC300 NiBP, Pulse & SpO2
SC300T NiBP, Pulse, SpO2 & Temperature
SC300N NiBP, Pulse & SpO2 (NELLCOR)
SC300NT NiBP, Pulse, SpO2 (NELLCOR) & Temperature
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, SpO2 and Temperature options. If your monitor
configuration lacks any of these options, certain information in this manual does
not apply.
2.1 Features of the Smartsigns®Compact 300
Physical
The Smartsigns Compact 300 series is a small lightweight SPOT check vital signs
monitor. It measures 130mm x 125mm x 219 mm and weighs 1.25 Kg. The integrated
carry handle allows the unit to be hand carried between locations.
Electrical
The monitor is powered either by the local mains supply (100 – 240 VAC 50/60Hz) or an
internal 2200 mAh lithium Ion battery.
The internal batteries are charged whenever the SC300 is connected to the local supply.
Display
The monitor uses a 6” LED type of numerical display to display patient and system status.
Auxiliary Outputs
The monitor provides an RS-232 I/O facility on the rear of the unit, this is used for
software upgrades.
Introduction

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2.2 Intended Use
The Smartsigns Compact 300 Series is intended for use by trained healthcare
professional in healthcare settings to monitor physiologic status of Adult, Paediatric and
Neonatal patients.
Physiologic measurements include:
• Non invasive blood pressure (NiBP)
• Pulse oximetry
• Pulse rate
• Temperature
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, 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 monitor.
2.3 About This Manual
This manual explains how to set up and use the Smartsigns®Compact 300 vital signs
monitor. Important safety information relating to general use of the monitor appears before
this introduction. Other important safety information is located throughout the text where
applicable.
Read the entire manual including the Safety Information section, before you operate the
monitor.
This manual is compatible with units fitted with Version 3.0 software and above.
Introduction

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3. Description of Controls, Indicators,
Symbols and Displays
3.1 Identification of Front Panel Controls and Symbols
4
2
1
3
8
5
6
7
1 Carry handle
2 Display
3 ON / OFF
4
Battery Indicator
• ON: Battery is being charged, or fully charged
• OFF: Battery is not fitted or faulty
• FLASHING: The battery is supplying power to the monitor.
AC Power Indicator
• ON: Monitor is connected to AC power
• OFF: Monitor is not connected to AC power
5 Return
6 Patient group selection
7 Start / Stop NiBP
8 Wireless infrared thermometer
Description of Controls, Indicators, Symbols and Displays

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3.2 Identification of rear panel controls
1 Loudspeaker
2 Equipotential post
3 RS232 Service port
4 AC Power connector
5 Product identification label
4
2
1
3
5
3.3 Identification of Side panel controls
1 NiBP connector
2 SpO2 connector
1Wireless Infra red thermometer
IRT10 (option)
2 Thermometer lens (option)
Left Right
2
1
2
1
Description of Controls, Indicators, Symbols and Displays

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3.4 Identification of Underside
1 Battery compartment
2 Adaptor plate fixing point
The internal battery is accessed
through the compartment located
on the underside of the unit.
A fixing kit is available for the unit.
It is attached using a single point
fixing.
2
1
3.5 Description of Symbols/ Indicators
The symbols and Indicators are described as follows:
Symbols Description
Attention, consult accompanying documents.
Patient type: Adult
Patient type: Paediatric
Patient type: Neonatal
Start / Stop Non-invasive blood pressure measurement
Type BF – Defibrillator proof
Equipotentiality
On/Off/Standby
Description of Controls, Indicators, Symbols and Displays

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Symbols Description
Battery charging indicator lamp
AC power(AC)
Input/output
Refer to instructions for use
IPX1 Protection against vertically falling water drops
SN Serial number (Date of manufacture is included in SN)
This symbol signifies that this product complies with the essential
requirements of the Medical Devices Directive
93/42/EEC as amended by 2007/47/EC
This symbol signifies that this product, including its accessories and
consumables is subject to the WEEE (Waste Electrical and Electronic
Equipment) regulations and should be disposed of responsibly in
accordance with local procedures.
Manufacturer
This way Up
Fragile – Handle with care
Limit of stacking layers
Keep dry
Description of Controls, Indicators, Symbols and Displays

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3.6 Description of Controls
Controls Description
ON/OFF/STANDBY Key
• Press this button to start the system – the system status indicator will
illuminate green.
• When in measurement mode, press this button to enter standby
mode – the system indicator changes to amber.
• To switch OFF, press and hold this button for 2s.
Return key
Error code clearance
• Press this key to clear any error code which may be displayed when
in measurement mode.
Save measurement
• Press this key to save measurement to memory
Memory re-call
• Press and hold this key for 2s to access stored measurements in the
memory
Pulse tone enable / disable
• Press and hold this key for 4s to enable the pulse tone setting (on / off)
Maintenance mode selection
• Press this key within 10s of power up to enter the maintenance mode.
Patient Group select key
Patient selection
• Press this key to select the relevant patient group.
Start/Stop NIBP Measurement
• Press this key to initiate a blood pressure measurement, If the button
is pressed during a measurement, the measurement will stop.
Description of Controls, Indicators, Symbols and Displays

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4. Setting up the Monitor
WARNING: The Smartsigns®Compact 300 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®Compact 300 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.
WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so
could result in an inaudible tone.
CAUTION: If the Smartsigns®Compact 300 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.
Setting up the Monitor

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4.1 Unpacking and Inspection
The Smartsigns®Compact 300 vital signs monitor is shipped in one carton. Examine
the carton carefully for evidence of damage. Contact Huntleigh Healthcare Ltd Service
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.
4.2 List of Components
Quantity Item
1 Smartsigns Compact 300 Spot Check Vital Signs Monitor
1 NiBP Cuff Adult ( 25 – 35 cm)
1 NiBP hose
1 SpO2 sensor
1 Wireless thermometer (Optional)
1 Thermometer lens - pack 20 pcs (Optional)
1 Operator’s manual
1 Power cord (country specific)
1 Grounding wire
A range of accessories are available for the Smartsigns Compact 300 series, please
contact your distributor or the customer services Department for more information.
Setting up the Monitor

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4.3 Power Cable Connections
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 in the specified voltage and
frequent range (100 – 240 VAC, 50-60 Hz).
1 AC inlet
2 Equipotential point
2
1
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 suitably grounded
AC outlet.
3. Verify that the Charging/AC Indicator is lit.
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.
Setting up the Monitor

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4.4 Connecting Accessories
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.
Note: For the safety of patients, and to ensure the best product
performance and accuracy, use accessories provided with the
Smartsigns®Compact 300 only, or accessories recommended by
Huntleigh Healthcare Ltd Service Department.
NIBP Hoses and Cuffs
NIBP Hose Connector
1. Select the appropriate size cuff for the patient and apply the cuff to the selected
site.
2. Connect the hose to the NiBP connector on the side of the unit.
SpO2 Cables and Sensors
SpO2 Interface cable connector
1. Select an appropriate sensor for the patient and desired application.
2. Apply the sensor to the selected site.
3. Connect the SpO2 sensor to the side of the unit.
Setting up the Monitor

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Wireless thermometer (Option)
1
2
3
4
5
6
1 Status indicator
2 Start measurement
3 Display
4 Infra red sensor
5 Lens ejector
6 Battery compartment
Setting up the Monitor

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5. 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®Compact 300 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: 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.
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.
5.1 Installing the Battery pack
The monitor has an internal Lithium Ion rechargeable battery which can power the unit
when an AC power source is not available.
Turn the monitor OFF, disconnect the power cord and any accessory.
Place the monitor on a surface and place upright with the base exposed.
Unscrew the battery cover, offer the battery into the battery compartment making sure the
positive and negative terminals are connected correctly.
Replace the battery cover and secure, turn the monitor upright.
Battery Operation