781301EN-3 Smartsigns Compact 300 IFU
781301EN-3 Smartsigns Compact 300 IFU
781301EN-3 Smartsigns Compact 300 IFU
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Warranty
Revision History
The documentation part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the revision history of the
documentation. Minor corrections and updates which are incorporated at reprint do not cause
the revision number to change. The document part number changes when extensive technical
changes are incorporated.
2
Contents
Table of Contents
1. General Safety Information ................................................5
1.1 Warnings / 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 SpO2 Plethysmography Parameter ............ 37
10.2 Identifying the SpO2 Module .......................................................................... 38
10.3 Setup Connections......................................................................................... 38
10.4 SpO2 and Pulse Rate Display ....................................................................... 39
3
11. Temperature Monitoring ...................................................40
Table of Contents
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
4
1. General Safety Information
Important! Before using this equipment, please study this manual carefully and
familiarise yourself with the controls, display features and operating techniques.
Ensure each user fully understands the safety and operation of the unit, as
misuse may cause damage to the unit or injury to the user or patient.
WARNING: Check the equipment prior to use and ensure its safe and
proper use.
5
General Safety Information
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: The unit may not operate effectively on patients who are
experiencing convulsions or tremors.
7
2. Introduction
Introduction
This manual contains information about the Smartsigns® Compact 300 vital signs monitor.
The Smartsigns® Compact 300 is available in the following configurations:
Config. Features
Note: Refer to Specification Section for more information about each configuration.
All information in this manual, including the illustrations, are based on a monitor
configured with the NIBP, SpO2 and Temperature options. If your monitor
configuration lacks any of these options, certain information in this manual does
not apply.
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.
8
2.2 Intended Use
Introduction
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:
Note: Hospital use typically covers such areas as general care floors, operating
rooms, special procedure areas, intensive and critical care areas, within the
hospital plus hospital-type facilities. Hospital-type facilities include physician
office based facilities, sleep labs, skilled nursing facilities, surgicenters, and
sub-acutecenters.
Note: The medically skilled and trained user can be clinicians like doctors and
nurses who know how to take and interpret a patient’s vital signs. These
clinicians must take direct responsibility for the patient’s life. This can include
care-givers or medically trained interpreters who are authorised under the
appropriate clinical facility procedures to support patient care. Any
inappropriate setting, 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.
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.
9
3. Description of Controls, Indicators,
Description of Controls, Indicators, Symbols and Displays
2 8
5
6
4
7
3
1 Carry handle
2 Display
3 ON / OFF
Battery Indicator
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
10
3.2 Identification of rear panel controls
2 Equipotential post
11
3.4 Identification of Underside
Description of Controls, Indicators, Symbols and Displays
2 1 Battery compartment
2 Adaptor plate fixing point
1
The internal battery is accessed
through the compartment located
on the underside of the unit.
Symbols Description
Equipotentiality
On/Off/Standby
12
Description of Controls, Indicators, Symbols and Displays
Symbols Description
AC power(AC)
Input/output
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
Keep dry
13
3.6 Description of Controls
Description of Controls, Indicators, Symbols and Displays
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
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
Patient selection
14
4. Setting up the Monitor
15
4.1 Unpacking and Inspection
Setting up the Monitor
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.
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.
16
4.3 Power Cable Connections
CAUTION: For the safety of patients, use only a Huntleigh Healthcare Ltd
supplied power cord. Using a non approved power cord can damage the
monitor, and will void the product warranty. If in doubt about the integrity
of the AC power source, the monitor must be operated from its internal
battery.
AC Power
Ensure that the AC outlet is properly grounded and that it is in the specified voltage and
frequent range (100 – 240 VAC, 50-60 Hz).
1
2 1 AC inlet
2 Equipotential point
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.
17
4.4 Connecting Accessories
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.
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.
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.
18
Wireless thermometer (Option)
2
4
3
5
1 Status indicator
2 Start measurement
3 Display
4 Infra red sensor
5 Lens ejector
6 Battery compartment
19
5. Battery Operation
Battery Operation
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.
20
5.2 Operating on Battery Power
Battery Operation
With NiBP measurements taken at 15 minute intervals, the operating time for a fully
charged battery pack is nominally 12 hours.
When connected to the AC power supply, the battery is automatically charged.
The battery icon shown on the screen will indicate the battery status:
If the battery symbol flashes, it indicates that the battery needs to be charged immediately.
The flashing symbol is also accompanied with an audible alert.
21
6. System Display
System Display
19 18
1 17
2
3
16
15
5
6 14
7 13
8
10 11 12
22
System Display
Item Description
System time
1
Set the time - Year, Month, Date, Hour, Minute
Patient measurement data review
2
50 sets data can be stored in the monitor
NIBP measurement units
3
mmHg or kPa.
4 MAP - Mean arterial blood pressure reading
17 Battery indicator.
19 Error code
23
7. Using the Monitor
Using the Monitor
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
7.2 Performing Power On and Self-Test (POST)
4. Should the system detect an internal problem, the system will display an error code
on the display. Contact a qualified service person
5. Upon completion of the POST, the monitor will enter the MEASUREMENT MODE.
The Smartsigns Compact 300 Series provides multiple working modes for its users
• Measurement mode – Take measurements
• Review mode – View saved measurements
• Parameter setting mode – Set pulse tone ON or OFF
• Maintenance mode – Adjust system settings
• Standby mode - Sleep
2. Apply the SpO2 sensor to the patient, after a short period, the SpO2 measurement
will be displayed on the screen.
3. Apply a new infrared lens cover to the tip of the Thermometer, temperature
measurements can now be made
4. After making a measurement, data will be displayed in the corresponding area on the
display.
6. After measuring one or multiple parameters, data will be automatically saved if there
is no additional measurement made within 2 minutes.
In the measuring mode, press for 2s to enter review mode; in this mode, up to 50
sets measurement data can be reviewed. Measurements are stored in date and time
order.
System Settings
1. In the measuring mode, press and hold for 4s to enter the pulse tone setting.
The monitor will automatically enter the standby mode if there is no activity for 10 minutes.
The monitor will automatically shut down if it remains in standby mode for more than 30
minutes
When the unit is in standby mode, the display will be switched off and the
ON/OFF/STANDBY key backlight will be illuminated amber.
27
8.6 Maintenance Mode
System Settings
To enter the maintenance mode, press the key within 10s of switching the system
ON.
The system will display the firmware revision in each of the corresponding sections of the
display.
f) Display brightness
Having made a change, Press and hold to shut the monitor down. The new settings
will take effect when the monitor is restarted.
28
System Date & Time Setting
System Settings
Enter the maintenance mode;
Year
1. Press twice to enter the ” year” setting area;
2. Press to increase the value
3. Press to decrease the value
Month/Day
Hour/Minute
Having made the selection, press to exit the date and time setting.
30
9. NIBP Monitoring
NIBP Monitoring
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 Service Department. Using other cuffs
or hoses may result in inaccuracies.
The Smartsigns® Compact 300 is not intended for diagnostic treatment. To ensure
patient safety, use other diagnosis equipment.
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.
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.
Check the patient’s limb on which the cuff is applied to assure that circulation is
not constricted. Constriction of circulation is indicated by discolouration of the
extremity. This check should be performed at the clinician’s discretion at regular
intervals based on the circumstances of the specific situation.
In some cases, rapid, prolonged cycling of a blood pressure monitor cuff
has been associated with any or all of the following: ischemia, purpura, or
neuropathy. Apply the cuff appropriately, according to instructions, and check
the cuff site and extremity regularly when blood pressure is measured at frequent
intervals or over extended periods of time.
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.
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.
Never use an adult or paediatric monitor setting or cuff for an NIBP measurement
on a neonatal patient. Adult and paediatric inflation limits can be excessive for
neonatal patients, even if a neonatal cuff is used.
Note: A patient’s vital signs may vary during administration of agents affecting the
cardiovascular system, such as those used to raise or lower blood pressure
or raise or lower heart rate.
Note: Blood pressure measurements can be affected by the position of the patient,
the patient’s physiological condition, and other factors.
9.1 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.
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 Service Department.
32
1. Measure the patient’s limb and select the proper size cuff. As a general rule,
NIBP Monitoring
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. Push until you
hear a click, indicating that the connection is secure.
3. Connect a cuff to the 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.
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.
33
9.3 Starting / Stopping Measurements
NIBP Monitoring
From the main application screen, press and hold the NiBP START / STOP button for 2s
to enter the AUTO NiBP mode.
The CLOCK will change from the current time (Hours & minutes) and display the AUTO
interval setting (00:02 default setting).
As soon as the interval is displayed, release the button.
Press the NIBP START / STOP button to cycle through the interval options.
2 → 3 → 4 → 5→ 10 → 15 → 20 → 25 → 30 → 60 → CO (STAT mode)
From here the user will be able to set the time interval (minutes) : 2, 3, 4, 5, 10, 15, 20, 25,
30, 60 and CO (CO = continuous sequential measurements for 5 minute period equivalent
to STAT mode).
34 Select the desired interval.
NOTE: When the system is set to CO mode, the system will take
NIBP Monitoring
sequential measurements in a 5 minute period. After the 5
minute STAT period has elapsed, the system will automatically
revert back to manual mode.
To SAVE the NiBP interval setting, press the RETURN button once.
The interval is “locked” into the system and displayed in the clock area of the display.
Press the NIBP START / STOP button to begin the sequence of measurements.
The cuff will begin to inflate and the interval time will change to a countdown timer
counting down to the start of the next measurement.
When the timer reaches 00:00, the next measurement begins automatically.
The SC300 will remain in this mode until the user forces a STOP or switches the unit OFF.
PRESS and HOLD the NIBP START / STOP button to stop the automatic interval.
The SC300 will automatically return to manual mode.
Or
Switch the system OFF.
The next time the system is powered up, it will be in MANUAL mode.
Use the patient group selection to cycle up through the saved measurements.
Use the NIBP START / STOP to cycle down through the saved measurements.
35
10. SpO2/Pulse Rate Monitoring
SpO2/Pulse Rate Monitoring
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.
Pulse oximetry readings and pulse signal can be affected by certain ambient
environmental conditions, sensor application errors, and certain patient
conditions.
Do not attach any cable to the sensor port (sensor connector) that is intended
for computer use.
The sensor disconnect error indicates 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.
36
SpO2/Pulse Rate Monitoring
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.
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.
The traditional method relies on the concept of passing red and infra-red light into the
capillary bed and measuring the changes due to the absorption during the pulsatile cycle.
Both red and infra red sensors with specific wave lengths serve as the light source for the
light transfer, whereas a photodiode serves are the receptor.
The Smartisgns Compact 300 series uses technologies from two different providers:
Sensors are designed for specific patient groups and sites, therefore, when considering
the sensor, consider the patients weight, activity, expected levels of perfusion and
environment.
To optimise the SpO2 measurement, apply it as directed and pay particular attention to all
warnings and cautions
37
10.2 Identifying the SpO2 Module
SpO2/Pulse Rate Monitoring
To identify which SpO2 module is incorporated into your product, refer to the identification
on the side of the unit:
NIBP SpO2
NIBP
SpO2 Nellcor
Insert the interface cable into the socket marked SpO2 on the monitor.
Turn the monitor ON, the measurements will appear on the SpO2 and PR area of the
display after a short period.
38
10.4 SpO2 and Pulse Rate Display
39
11. Temperature Monitoring
Temperature Monitoring
The calibration of the Thermometer should be checked at least once every two
years.
The protective lens cover is single-use. Repeated use might give rise to cross
infection.
The protective lens cover must be used when measuring, if not, it might cause
cross infection or inaccurate readings.
Before use, check whether the cover is free from damage, if not, don’t use.
Handle the thermometer with care, it should be stored in the cradle when not in
use.
Discard the protective lens cover in accordance with the local regulations.
2
4
3
5
1 Status indicator
2 Start measurement
3 Display
4 Infra red sensor
5 Lens ejector
6
6 Battery compartment
40
11.2 Thermometer Display
Temperature Monitoring
Key Function / Display
Battery status
Wireless status
Scale ºC or ºF
Measurement
Temperature logo
Scale ºC or ºF
Measurement
Wireless status
41
11.4 Pairing the Thermometer and Main Unit
Temperature Monitoring
1. Make sure the main unit and ear thermometer are both switched OFF.
2. Press and hold the “ejector key” on the thermometer and switch it ON.
3. The thermometer display will alternate between ºC and ºF and then display “SE”.
4. When “SE” is displayed, release the ejector button and switch the main unit ON.
5. Pairing will be established when the icon is displayed on the host unit.
2. Place the ear thermometer in the correct position and press the measurement key.
3. After approximately two seconds, the sensor emits a short “tone” indicating that the
measurement is complete.
7. Place the lens cover in the appropriate waste collection point and replace the
thermometer onto the unit
42
12. 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.
12.1 General
Follow local governing ordinance and recycling instructions regarding the disposal or
recycling of end of life use of Smartsigns® Compact 300 and accessories. Otherwise
environment or people may be harmed from improper disposal of battery or accessories.
12.3 Service
The Smartsigns® Compact 300 requires no routine service other than cleaning or battery
maintenance that is mandated by the user’s institution. For more information, refer to
Smartsigns® Compact 300 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 Service Department.
If the institution’s service personnel cannot correct problems, the Smartsigns® Compact
300 should be returned to Huntleigh Healthcare Ltd for service. Contact Huntleigh
Healthcare Ltd Service Department for return instructions.
43
12.5 Cleaning
Maintenance
For sensors and probes follow cleaning, disinfecting and/or sterilizing instructions in the
directions for use shipped with those components.
Never allow any liquid substance to enter any monitor connector. If a connector does
come in contact with a liquid substance accidentally, clean and dry thoroughly before
reuse. If in doubt about monitor safety, refer the unit to qualified service personnel.
Note: Storing the Smartsigns® Compact 300 for a long period without charging the battery
may degrade the battery capacity.
44
13. Troubleshooting
Troubleshooting
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®
Compact 300, its accessories, connectors, switches, or openings in the
chassis.
13.1 General
If the Smartsigns® Compact 300 is unable to perform any of its monitoring functions
because of the loss of software control or a hardware malfunction, an error code is
presented.
In the unlikely event of the unit developing a fault, fault codes will be shown in the
corresponding area and the related parameters will flash on the screen
Serviceable error codes and other error codes are listed in the Smartsigns® Compact
300 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 Service Department, make sure that the battery is charged, and that all power
connections are correctly made.
Temperature Module
47
13.2 Corrective Action
Troubleshooting
If you experience a problem while using the Smartsigns® Compact 300 and are unable
to correct it, contact qualified service personnel or Huntleigh Healthcare Ltd Service
Department.
The Smartsigns® Compact 300 service manual, which is for user by qualified service
personnel, provides additional troubleshooting information.
2. The monitor display does not function properly and the power- on beep
tones do not sound during the power-on self-test.
• Make sure that the power cord is properly connected to the Smartsigns®
Liteplus.
• The monitor will be operated from its internal battery if in doubt about the
integrity of the AC power source,
For technical information and assistance, or to order a service manual, call Huntleigh
Healthcare Ltd Service Department. The service manual includes information required by
qualified service personnel when servicing the Smartsigns® Compact 300.
When calling the Huntleigh Healthcare Ltd Service Department, you may be asked to
tell the representative the software version number of your Smartsigns® Compact 300.
Qualified service personnel or Huntleigh Healthcare Ltd Service Department may help you
check the software version installed in your monitor.
48
14. Electromagnetic Compatibility
Electromagnetic Compatibility
Make sure the environment in which Smartsigns® Compact 300 is installed is not subject
to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones).
This equipment generates and uses radio frequency energy. If not installed and used
properly, in strict accordance with the manufacturer’s instructions, it may cause or be
subject to interference. Type-tested in a fully configured system, complies with EN60601-
1-2, the standard intended to provide reasonable protection against such interference.
Whether the equipment causes interference may be determined by turning the equipment
off and on. If it does cause or is affected by interference, one or more of the following
measures may correct the interference:
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Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Smartsigns® Compact 300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Smartsigns® Compact 300 should assure that it is used in such an environment.
Immunity Compliance
IEC 60601 test level Electromagnetic Environment - guidance
Test level
Portable and mobile RF communications
equipment should be used no closer to any part of
the Smartsigns® Compact 300, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
3 Vrms
150kHz to 80MHz
outside ISM bandsa
Conducted RF
3V d = 1.2 √ P
IEC 61000-4-6 6 Vrms
150 kHz to 80 MHz
in ISM and amateur
radio bands
50
Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Smartsigns® Compact 300 intended for use in the electromagnetic environment specified
below. The customer or the user of the Smartsigns® Compact 300 should assure that it is used in
such an environment.
IEC 60601 test Compliance Electromagnetic Environment -
Immunity Test
level level guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete
discharge (ESD) or ceramic tile. If floors are
± 8 kV air ± 8 kV air covered with synthetic material,
IEC 61000-4-2 the relative humidity should be at
least 30%.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient burst supply lines supply lines that of a typical commercial or
hospital environment.
IEC 61000-4-4 ± 1 kV for input/ ± 1 kV for input/
output lines output lines
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be
line(s) line(s) that of a typical commercial or
IEC 61000-4-5 hospital environment.
± 2 kV line(s) to ± 2 kV line(s) to
earth earth
Voltage dips, short <5 % Ur <5 % Ur Mains power quality should be
interruptions and (>95 % dip in Ur ) (>95 % dip in Ur ) that of a typical commercial of
voltage variations on for 0,5 cycles for 0,5 cycles hospital environment. If the user
power supply input of the Smartsigns® Compact
lines 40 % Ur 40 % Ur 300 requires continued operation
(60 % dip in Ur ) (60 % dip in Ur ) during power mains interruptions,
IEC 61000-4-11 for 5 cycles for 5 cycles it is recommended that the
Smartsigns® Compact 300 is
70 % Ur 70 % Ur powered from an uninterruptible
(30 % dip in Ur ) (30 % dip in Ur ) power supply or battery.
for 25 cycles for 25 cycles
<5 % Ur <5 % Ur
(>95 % dip in Ur ) (>95 % dip in Ur )
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60Hz) magnetic should be at levels characteristic
field of a typical location in a
typical commercial or hospital
IEC 61000-4-8 environment.
NOTE Ur is the a.c. mains voltage prior to the application of the test level.
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Electromagnetic Compatibility
Recommended separation distances between portable and mobile RF communications
equipment and the Smartsigns® Compact 300
The Smartsigns® Compact 300 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. the customer or user of the Smartsigns® Compact 300
can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the Smartsigns® Compact 300 as
recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum m
output power of
transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
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15. Specifications
Specifications
15.1 Equipment Classification
15.2 Standards
15.3 General
AC Power
Frequency 50Hz/60Hz
Battery
15.5 Environmental
Operation
5 °C to 40 °C without ear thermometer)
Temperature
15 °C to 38 °C (with ear thermometer)
93% non-condensing (without thermometer)
Humidity
≤85% non-condensing (with thermometer)
Altitude 700 hPa to 1060hPa
Note: The system may not meet its performance specifications if stored or used outside
the manufacturer’s specified temperature and humidity range.
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15.6 Measurement Parameters
Specifications
NIBP
Note: Systolic and diastolic blood pressure measurements determined with this
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
Resolution 1%
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Temperature
Specifications
Pulse Rate
56
16. Accessories
Accessories
Please use accessory models designated by the manufacturer. Using
accessories of other models may cause damage to this monitor
Disposable accessories can be used only once; their repeated using may
result in performance deterioration or cross infection
Check the accessories and their packages for any signs of damage. Do not
use them if any damage is observed
Item Part No
Own brand SpO2
12 Pin Adult re-useable SpO2 sensor 10ft ACC VSM 289
12 Pin to DB9F Extension cable 8ft ACC VSM 290
Adult reusable SpO2 sensor (DB9F) 3ft ACC VSM 291
Neonate / Paediatric Wrap sensor (DB9F) 3ft ACC VSM 292
NELLCOR OXIMAX SpO2
NELLCOR Reusable Extension cable/DOC-10,10ft ACC VSM 251
Adult Nellcor Reusable SpO2 Sensor/DS-100A,3ft ACC VSM 252
NELLCOR Reusable Type Y SpO2 Sensor/Dura-Y D-YS,3ft ACC VSM 255
Neo Disposable Nellcor SPO2 Probe(MAX-N),3ft ACC VSM 256
Ped Disposable Nellcor SPO2 Probe(MAX-P),3ft ACC VSM 257
NiBP
Infant NIBP Cuff 6-11cm ACC VSM 273
Infant NIBP Cuff 10-19cm ACC VSM 274
Paediatric NIBP Cuff 18-26cm ACC VSM 275
Adult NIBP Cuff 20-38cm ACC VSM 276
Adult NIBP Cuff 25-35cm ACC VSM 277
Adult NIBP Cuff 33-47cm ACC VSM 278
Adult NIBP Cuff 46-66cm ACC VSM 279
Neo Disposable NIBP Cuff #1 / 3.0-5.5cm ACC VSM 280
Neo Disposable NIBP Cuff #2 / 4.0-7.6cm ACC VSM 281
Neo Disposable NIBP Cuff #3 / 5.6-10.6cm ACC VSM 282
Neo Disposable NIBP Cuff #4 / 7.0-12.8cm ACC VSM 283
NIBP hose /3M ACC VSM 284
57
Accessories
Temperature
Lens filter 200 pcs (10 boxes) ACC VSM 293
Lens filter 800 pcs (40 boxes) ACC VSM 286
Lens filter 8,000 pcs (400 boxes) ACC VSM 287
Hardware
Mobile stand ACC VSM 153
Wall mount ACC VSM 157
Utility hook ACC VSM 187
Utility basket ACC VSM 189
Fixing / mounting kit ACC VSM 288
IV Pole clamp ACC VSM 294
58
17. End of Life Disposal
59
18. Warranty & Service
Warranty & Service
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.
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:-
Service Department.
Huntleigh Healthcare, Diagnostic Products Division,
35, Portmanmoor Rd.,
Cardiff. CF24 5HN
United Kingdom.
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© Huntleigh Healthcare Ltd
All rights reserved
The Smartsigns® Compact 300 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.
AW:1001008-3
781301EN-3