Huntleigh SC300 Instructions for use

SC300
Spot Check Vital
Signs Monitor
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
1. General Safety Information ................................................5
1.1 Warnings / Cautions ............................................................................................. 5
2. Introduction ........................................................................8
2.1
2.2
2.3
Features of the Smartsigns® Compact 300 .................................................... 8
Intended Use.................................................................................................. 9
About This Manual ......................................................................................... 9
3.1
3.2
3.3
3.4
3.5
3.6
Identification of Front Panel Controls and Symbols ....................................... 10
Identification of rear panel controls ............................................................... 11
Identification of Side panel controls .............................................................. 11
Identification of Underside ............................................................................ 12
Description of Symbols/ Indicators................................................................. 12
Description of Controls................................................................................... 14
4.1
4.2
4.3
4.4
Unpacking and Inspection.............................................................................. 16
List of Components ........................................................................................ 16
Power Cable Connections ............................................................................. 17
Connecting Accessories................................................................................. 18
5.1
5.2
5.3
5.4
Installing the Battery pack .............................................................................. 20
Operating on Battery Power........................................................................... 21
Charging a low battery ................................................................................... 21
Battery Using Guidance ................................................................................. 21
7.1
7.2
7.3
Turning the Monitor ON .................................................................................. 24
Performing Power On and Self-Test (POST) ................................................. 25
Turning the Monitor OFF ................................................................................ 25
8.1
8.2
8.3
8.4
8.5
8.6
Measuring Mode ............................................................................................ 26
Review Mode ................................................................................................. 26
Pulse Tone Setting ......................................................................................... 27
Standby Mode ................................................................................................ 27
Exiting Standby Mode .................................................................................... 27
Maintenance Mode ........................................................................................ 28
9.1
9.2
9.3
9.4
General .......................................................................................................... 32
Setup Connections......................................................................................... 32
Starting / Stopping Measurements................................................................. 34
Automatic Measurements .............................................................................. 34
10.1
10.2
10.3
10.4
General Principles of Measuring SpO2 Plethysmography Parameter ............ 37
Identifying the SpO2 Module .......................................................................... 38
Setup Connections......................................................................................... 38
SpO2 and Pulse Rate Display ....................................................................... 39
3. Description of Controls, Indicators,Symbols and
Displays ..............................................................................10
Table of Contents
Contents
4. Setting up the Monitor........................................................15
5. Battery Operation ...............................................................20
6. System Display ...................................................................22
7. Using the Monitor ...............................................................24
8. System Settings .................................................................26
9. NIBP Monitoring..................................................................31
10. SpO2/Pulse Rate Monitoring .............................................36
3
Table of Contents
11. Temperature Monitoring ...................................................40
11.1
11.2
11.3
11.4
11.5
Description of the Thermometer IRT10 .......................................................... 40
Thermometer Display..................................................................................... 41
Main Unit Display ........................................................................................... 41
Pairing the Thermometer and Main Unit ........................................................ 42
Temp Measurement ....................................................................................... 42
12.1
12.2
12.3
12.4
12.5
12.6
General .......................................................................................................... 43
Returning the Smartsigns® Compact 300 and System Components ............. 43
Service ........................................................................................................... 43
Periodic Safety Checks .................................................................................. 43
Cleaning ......................................................................................................... 44
Battery maintenance ...................................................................................... 44
13.1
13.2
13.3
General .......................................................................................................... 45
Corrective Action ............................................................................................ 48
Obtaining Technical Assistance ..................................................................... 48
15.1
15.2
15.3
15.4
15.5
15.6
Equipment Classification ............................................................................... 53
Standards....................................................................................................... 53
General .......................................................................................................... 53
Electrical ........................................................................................................ 54
Environmental ................................................................................................ 54
Measurement Parameters ............................................................................. 55
18.1
Service Returns ............................................................................................. 60
12. Maintenance .....................................................................43
13. Troubleshooting ................................................................45
14. Electromagnetic Compatibility ........................................49
15. Specifications ...................................................................53
16. Accessories ......................................................................57
17. End of Life Disposal ..........................................................59
18. Warranty & Service ..........................................................60
4
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
General Safety Information
1.
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.
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: 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.
6
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.
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 IEC606011-2. If in doubt, contact Huntleigh Healthcare Service Department.
General Safety Information
CAUTION: The monitor may display error codes when outside of the
measurable range occur.
7
Introduction
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:
Features
Config.
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.
8
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:
•
•
•
•
2.3
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.
Introduction
2.2
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.
9
Description of Controls, Indicators, Symbols and Displays
10
3.
Description of Controls, Indicators,
Symbols and Displays
3.1
Identification of Front Panel Controls and Symbols
1
2
8
5
6
4
7
3
1
Carry handle
2
Display
3
ON / OFF
Battery Indicator
4
•
•
•
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
Identification of rear panel controls
1
5
3
2
1
Loudspeaker
2
Equipotential post
3
RS232 Service port
4
AC Power connector
5
Product identification label
4
3.3
Identification of Side panel controls
Left
1
Right
2
1
2
1
NiBP connector
2
SpO2 connector
1
Wireless Infra red thermometer
IRT10 (option)
2
Thermometer lens (option)
Description of Controls, Indicators, Symbols and Displays
3.2
11
Description of Controls, Indicators, Symbols and Displays
3.4
Identification of Underside
2
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.
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
12
1
Description
Battery charging indicator lamp
AC power(AC)
Input/output
Refer to instructions for use
IPX1
SN
Protection against vertically falling water drops
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
Symbols
13
Description of Controls, Indicators, Symbols and Displays
14
3.6
Description of Controls
Description
Controls
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.
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.
Setting up the Monitor
4.
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.
15
Setting up the Monitor
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.
16
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
2
1.
2.
3.
4.
1
AC inlet
2
Equipotential point
Setting up the Monitor
4.3
Connect the female connector end of the AC power cord to the monitor rear
panel connector.
Plug the male connector end of the AC power cord into a suitably grounded
AC outlet.
Verify that the Charging/AC Indicator is lit.
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
Setting up the Monitor
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
18
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
Wireless thermometer (Option)
1
2
4
3
5
6
1
Status indicator
2
Start measurement
3
Display
4
Infra red sensor
5
Lens ejector
6
Battery compartment
19
Battery Operation
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.
20
Operating on Battery Power
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:
Battery indicator
Status
Battery is fully charged
&
Battery is charged but not at maximum level
Battery Operation
5.2
Battery requires recharging
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.
5.3 Charging a low battery
Connect the monitor to the local AC supply, charging is automatic.
During the charging process, the battery charging indicator lamp illuminates green.
On reaching full capacity the battery charging indicator lamp will extinguish.
The typical charging time of the lithium-ion battery is:
•
With the monitor switched OFF, the recharge time is less than 3 hours.
•
With the monitor switched ON, the recharge time is no longer than 5.5 hours.
5.4 Battery Using Guidance
Life expectancy of the battery depends on how frequent and how long it is used. For a
properly maintained and stored lithium-ion battery, its service life is approximately 3 years.
With more frequent and aggressive use, the life expectancy can be less.
We recommend replacing lithium-ion batteries every 3 years.
21
System Display
6.
System Display
The display is organised into a series of zones
18
19
1
17
2
3
16
4
15
5
6
14
7
8
13
9
10
22
11
12
Description
1
System time
Set the time - Year, Month, Date, Hour, Minute
2
Patient measurement data review
50 sets data can be stored in the monitor
3
NIBP measurement units
mmHg or kPa.
4
MAP - Mean arterial blood pressure reading
5
Pulse rate – derived from NiBP measurement
6
SpO2 sensor status:
Own brand SpO2:
• Icon flash: Poor finger connection, or sensor is disconnected
Nellcor SpO2
• Icon off: Probe is off
• Icon flash: Poor finger connection or sensor is disconnected
7
SpO2 measurement (Rotating digits is searching for a pulse).
8
Relative indication of signal strength
9
Temperature measurement
10
Temperature units (ºC or ºF)
11
Temperature reading
12
Wireless connection indicator – temperature sensor
ON: Temperature sensor paired
OFF: Temperature sensor NOT paired
13
Pulse rate – derived from the SpO2 sensor
14
Pulse rate symbol
15
Diastolic blood pressure measurement
16
Systolic blood pressure measurement
17
Battery indicator.
18
Patient type (neonate, paediatric, adult)
19
Error code
System Display
Item
23
Using the Monitor
7.
Using the Monitor
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® Compact 300 is intended only as an adjunct in
patient assessment. It must be used in conjunction with clinical signs and
symptoms.
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.
7.1
Turning the Monitor ON
Before using the Smartsigns® Compact 300, 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.
24
Note:
Physiological conditions, medical procedures, or external agents that
may interfere with the monitor’s ability to detect and display measurements,
include dysfunctional haemoglobin, arterial dyes, low perfusion, dark pigment,
and externally applied colouring 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.
Performing Power On and Self-Test (POST)
CAUTION: The Smartsigns® Compact 300 automatically starts the PowerOn-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 Service Department.
1.
Turn the monitor ON by pressing the ON/OFF/STAND BY button.
2.
The monitor automatically starts the Power On Self Test (POST), which tests
the system integrity.
3.
Verify that the monitor sounds a confirmation tone during power up and each section
of the display is illuminated.
Using the Monitor
7.2
Power On Self Test
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.
7.3
Turning the Monitor OFF
To switch the system OFF, follow the steps blow,
1.
Ensure the monitoring session has finished.
2.
Disconnect all accessories from the patient.
3.
Press and hold the ON/OFF/STAND BY key for 2s, the system will shut down.
25
System Settings
8.
System Settings
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
Each mode offers different facilities and access to different settings.
8.1
Measuring Mode
After the initial startup, the system defaults to the measurement mode.
From here the user can undertake a series of measurements.
1.
Press
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.
5.
Press
6.
After measuring one or multiple parameters, data will be automatically saved if there
is no additional measurement made within 2 minutes.
8.2
to start the NIBP measurement.
to save the measurement to memory.
Review Mode
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.
1.
Press
to cycle through the stored measurements, the oldest measurement
will be displayed first.
2.
Press
to return to the measurement mode.
This monitor saves up to 50 measurements.
26
Pulse Tone Setting
1.
In the measuring mode, press and hold
2.
The PR value will flash
3.
Press
to switch pulse sound on or off.
4.
Press
to save the setting and return to the measurement mode.
8.4
for 4s to enter the pulse tone setting.
Standby Mode
Press
System Settings
8.3
to enter the standby mode.
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.
8.5
Exiting Standby Mode
To exit the standby mode, press any key. Additionally, the system will automatically exit
standby if:
1.
The monitor receives an input from the SpO2 sensor.
2.
The power is too low (
3.
Receives a temperature measurement
)
27
System Settings
8.6
Maintenance Mode
The maintenance mode is intended for use of a biomedical technician or
suitably qualified person. It is unlikely that healthcare professionals or
clinicians would need to access this mode.
To enter the maintenance mode, press the
ON.
key within 10s of switching the system
The system will display the firmware revision in each of the corresponding sections of the
display.
In this mode, the user can access the flowing settings:
a)
NIBP units of measure
b)
Temp units of measure
c)
System date & time
d)
NIBP leak test
e)
NIBP pressure test
f)
Display brightness
g)
Restoration of the factory default settings.
Having made a change, Press and hold
will take effect when the monitor is restarted.
to shut the monitor down. The new settings
NIBP Units Setting
Enter the maintenance mode;
or
to alternate between mmHg or kPa.
1.
Press
2.
Make the selection and press and hold
move to the next setting.
to shut the monitor down or
to
Temp Units Setting
Enter the maintenance mode;
28
1.
Press
and switch to the TEMP unit setting area
2.
Press
or
3.
Make the selection and press and hold
move to the next setting.
to switch between ºC or ºF
to shut the monitor down or
to
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
1.
Press
to enter the ”Month” setting
2.
Press
to increase the value
3.
Press
to decrease the value
4.
Press
to enter the ”Day” setting
5.
Press
to increase the value
3.
Press
to decrease the value
System Settings
System Date & Time Setting
Hour/Minute
1.
Press
to enter the ”Hour” setting
2.
Press
to increase the value
3.
Press
to decrease the value
4.
Press
to enter the ”Minute” setting
5.
Press
to increase the value
3.
Press
to decrease the value
Having made the selection, press
to exit the date and time setting.
NIBP Module Testing
This adjustment is reserved for service personnel
Enter the maintenance mode.
1.
Press
until the PR bpm display begins to flash
2.
Press
to switch between the leak test or pressure test
“150” selects the NIBP leak test;
“250” selects the NIBP pressure testing.
3.
Press
to start each test.
29
System Settings
Brightness Adjust
This adjustment is reserved for service personnel
Enter the maintenance mode
repeatedly until the brightness adjustment setting begins to flash.
1.
Press
2.
Press
or
brightness.
to adjust the display brightness – 05 being maximum
Restoring Factory Default settings
This adjustment is reserved for service personnel
Enter the maintenance mode;
1.
2.
repeatedly until 00 is displayed in the PR bpm area.
Press
Although the factory default settings cannot be changed, the user can assign a
different configuration to the local default settings.
3.
To restore the configuration to the default factory settings, press
The factory default settings are:
30
Unit
Default setting
NiBP units
mmHg
Temperature Units
ºC
Patient Type
Beep Tone
Adult
ON
to select 00.
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.
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.
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® Compact 300 readings for patient assessment.
NIBP Monitoring
9.
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 noninvasive 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.
As with all automatically inflatable blood pressure devices, continual cuff
measurements can cause injury to the patient being monitored.
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.
NIBP readings may be inaccurate for patients experiencing moderate to severe
arrhythmia.
31
NIBP Monitoring
Do not touch the monitor when a defibrillator is being discharged (electrified), as
doing so may cause electric shock.
Continual cycling of the BP cuff may in extreme situations cause harm to the
patient. Assess the advantages of frequent measurements in particular the use of
CO mode against the potential risk of injury.
9.1
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.
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:
9.2
This equipment is suitable for use in the presence of electrosurgery
Setup Connections
NIBP Hose Connector
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
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. 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.
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.
NIBP Monitoring
1.
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.
Size
Limb Circumference
Cuff width
Neonate 1
3.1 - 5.7 cm
2.5 cm
Neonate 2
4.3 - 8.0 cm
3.2 cm
Neonate 3
5.8 - 10.9 cm
4.3 cm
Neonate 4
7.1 - 13.1 cm
5.1 cm
Infant
10 - 19 cm
8 cm
Paediatric
18 - 26 cm
10.6 cm
Adult
25 - 35 cm
14 cm
Adult
33 - 47 cm
17 cm
Adult
46 - 66 cm
21 cm
Hose length
3m
33
NIBP Monitoring
9.3 Starting / Stopping Measurements
Press the
key on the monitor’s front panel to initiate a measurement.
As soon as the measurement has started, the MAP area of the display will show the cuff
pressure.
The system will inflate the cuff to the appropriate default target pressure.
The default target pressure of this monitor is:
•
Adult: 160mmHg
•
Child: 120mmHg
•
Neonate: 100mmHg
After a short period, the measurement will be displayed on the screen.
The pulse rate will be shown below the NiBP measurement.
If there is any doubt concerning the NIBP measurement, an alternative
method should be used.
9.4 Automatic Measurements
Using the front panel keypad, users can set the unit to deliver automatic cyclic NiBP
measurements – this interval can be set to 2, 3, 4, 5, 10, 15, 20, 25, 30, 60 or CO
(continuous STAT measurements).
Setting the Auto NiBP time interval
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.
When the system is set to CO mode, the system will take
sequential measurements in a 5 minute period. After the 5
minute STAT period has elapsed, the system will automatically
revert back to manual mode.
Saving the Auto NiBP time interval
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.
Starting the AUTOMATIC NiBP Measurement
Press the NIBP START / STOP button
NIBP Monitoring
NOTE:
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.
Stopping the AUTOMATIC NiBP Measurement
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.
Recalling SAVED measurements
Press and HOLD the SAVE button
Use the patient group selection
Use the NIBP START / STOP
for 2s.
to cycle up through the saved measurements.
to cycle down through the saved measurements.
35
SpO2/Pulse Rate Monitoring
10. SpO2/Pulse Rate Monitoring
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.
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.
The monitor is intended only as an adjunct in patient assessment. It must be
used in conjunction with clinical signs and symptoms.
Inaccurate measurements may be caused by:
•
incorrect sensor application or use
•
significant levels of dysfunctional haemoglobin
(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 anaemia, or hypothermia
•
there is arterial occlusion proximal to the sensor the
patient is in cardiac arrest or is in shock
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
Do not attach any cable to the sensor port (sensor connector) that is intended
for computer use.
36
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.
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.
10.1
General Principles of Measuring SpO2
Plethysmography Parameter
Oxygen saturation in capillary blood is measured by a method called pulse oximetry
(SpO2). It is a continuous, non-invasive method of determining the amount of oxygen
attached to the haemoglobin in red blood cells (oxyhaemoglobin). It is an estimation of
arterial oxygen saturation.
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.
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.
The Smartisgns Compact 300 series uses technologies from two different providers:
Technology
Red wavelength (nm)
Infra Red wavelength (nm)
Own brand
660
905
Nellcor
660
890
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
SpO2/Pulse Rate Monitoring
10.2
Identifying the SpO2 Module
To identify which SpO2 module is incorporated into your product, refer to the identification
on the side of the unit:
Own brand SpO2 module
NIBP
SpO2
Nellcor Oximax SpO2
NIBP
NOTE:
10.3
SpO2
Nellcor
The SpO2 sensors are NOT interchangeable between the
different techn ologies.
Setup Connections
Carefully apply the sensor to the patient’s finger as described in the sensor directions for
use.
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
SpO2 (Arterial oxygen saturation):
The percentage of oxyhaemoglobin to total
haemoglobin.
Bar graph:
Relative strength of the pulse.
PR - Pulse rate:
Pulse or heart rate derived from SpO2
signal source.
PR symbol:
Heart beat
SpO2/Pulse Rate Monitoring
10.4 SpO2 and Pulse Rate Display
39
Temperature Monitoring
11. Temperature Monitoring
The calibration of the Thermometer should be checked at least once every two
years.
Use only specified protective lens covers
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.
During the monitoring process, the temperature measuring instrument will
automatically check itself once per hour. Self-checking will last 2 seconds, and
will not affect the normal working of the temperature monitor.
Temperature measurements are obtained from a wireless infrared ear thermometer.
Measurements are sent via a wireless connection established between the thermometer
and the main unit.
Both items (Thermometer and unit) must be paired to enable wireless data transfer.
11.1
Description of the Thermometer IRT10
1
2
4
3
40
5
1
Status indicator
2
Start measurement
3
Display
4
Infra red sensor
5
Lens ejector
6
Battery compartment
6
Thermometer Display
Key
Function / Display
Battery status
Lens filter status
Temperature Monitoring
11.2
Wireless status
Scale ºC or ºF
Measurement
11.3
Main Unit Display
Key
Function / Display
Temperature logo
Scale ºC or ºF
Measurement
Wireless status
41
Temperature Monitoring
42
11.4
Pairing the Thermometer and Main Unit
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
6.
If pairing has failed, no
11.5
icon is displayed on the host unit.
icon will be displayed.
Temp Measurement
1.
Install a new protective lens cover to the thermometer.
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.
4.
Remove the thermometer.
5.
The measurement will be shown on the thermometer’s screen, it will be automatically
transferred to the monitor.
6.
Press the eject key to remove the disposable lens cover.
7.
Place the lens cover in the appropriate waste collection point and replace the
thermometer onto the unit
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
Maintenance
12. Maintenance
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.
12.2
Returning the Smartsigns® Compact 300 and
System Components
Contact Huntleigh Healthcare Ltd Service Department for shipping instructions including
a Returned Goods Authorization (RGA) number. Pack the Smartsigns® Compact 300
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® Compact 300 by any
shipping method that provides proof of delivery.
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.
12.4
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.
43
Maintenance
12.5
Cleaning
For surface-cleaning, follow your institution’s procedures or:
•
The Smartsigns® Compact 300 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.
12.6
Battery maintenance
If the Smartsigns® Compact 300 vital signs monitor has not been used 2 months, the
battery will need charging. To charge the battery, connect the Smartsigns® Compact 300
to an AC power source as described in the Battery Operation section.
Note: Storing the Smartsigns® Compact 300 for a long period without charging the battery
may degrade the battery capacity.
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: 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.
44
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
Troubleshooting
13. Troubleshooting
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
Code
Description
Cause
Solution
01
The communication
of SpO2 module
has stopped
There is a problem
with SpO2 module
Contact service personnel or
biomedical engineer.
02
Unrecognised
probe
The sensor can’t be
recognized by SpO2
module
03
Weak signal
04
Too much light
05
SpO2 board fault
06
PI too low
07
Sensor fault
08
Interference
09
No pulse detected
10
Loose cuff
11
Air leak
The signal is too
weak
SpO2 sensor is too
loose
There is a problem
with the module
The SpO2 signal is
too weak.
There is a problem
with the sensor
The signal has been
interfered by motion
or noise
SpO2 sensor cannot
detect pulse signal
The NIBP cuff is not
properly connected
The NIBP cuff is not
properly connected or
there is a leak in the
airway
Check the connection between probe
and host, if the alarm still can’t be
cancelled, contact service personnel or
biomedical engineer.
Check patient’s vital signs, and change
the measurement site.
Reposition SpO2 sensor.
Do not use and contact service
personnel.
Check the patient’s condition and
change the application site.
Do not use the sensor and contact
service personnel
Check for any possible sources of
signal noise from the area around
the sensor and check the patient for
excess motion
Probe loose or faulty
Check and connect the cuff again.
Check the connection or use a new
cuff, if the problem persists, contact
service personnel.
45
Troubleshooting
46
Code
Description
Cause
Solution
12
Air pressure Err
The pressure is not
stable, such as hose
entanglement
13
NIBP weak signal
The cuff is loose or
the signal is weak
Check the connection or use a new
cuff. If the problem persists, contact
service personnel.
Check the patient type setting and the
connection or replace a cuff. If the error
persists, contact service personnel
14
NIBP over range
The measured value
is not within the
specified range
15
NIBP excessive
motion
Arm motion
16
NIBP over voltage
protective
the airway may be
occluded
17
NIBP air leak
There is a leak in
airway
18
NIBP system error
19
NIBP time-out
20
NIBP signal
saturated
21
NIBP self-test error
22
NIBP
communication
error
23
NIBP cuff type
wrong
27
Systolic pressure
out of range
28
Mean pressure out
of range
29
Diastolic pressure
out of range
30
Ear thermometer
communication
error
Contact service personnel
Check the patient’s condition and
reduce the motion
Check the airway and the patient’s
condition. If the error persists, contact
service personnel
Check and replace the parts that cause
the leak. If the error persists, contact
service personnel
There is a problem
with the system of
pressure pump
The measurement
time exceeds 120s in
adult/child mode or
90s in neonate mode
Check the patient type setting and
connection. If needed, replace a cuff,
if the error persists, contact service
personnel
Excess motion
Reduce the motion and measure again
There is a problem
with the sensor or
other hardware
There is a problem
with the NIBP module
or host
The cuff doesn’t
match the patient
type
The measured
value is outside the
specified range
The measured
value is outside the
specified range
The measured
value is outside the
specified range
The battery is too
low or there is a
problem with the
communication
module
Do not use the NIBP module and
contact service personnel
Do not use the NIBP module and
contact service personnel
Restart the monitor, if the error
persists, contact service personnel
Replace a cuff and measure
Incorrect patient group set or wrong
size cuff
Incorrect patient group set or wrong
size cuff
Incorrect patient group set or wrong
size cuff
Replace a battery, and restart the
monitor,if the error persists, contact
service personnel
Description
Cause
Solution
46
Low battery
The battery terminal
voltage is too low
Connect the monitor to an AC power
source and allow the batteries to
charge.
47
12V too high
48
12V too low
49
5V too high
There is a problem
with the system
power supply
Restart the monitor. If the error
persists, contact service personnel
50
5V too low
51
52
Unable to obtain
SpO2 data
Unable to obtain
PR data
Sp02 module can not
calculate SpO2 value
Sp02 module can not
calculate PR value
Faulty SpO2 module
Troubleshooting
Code
Faulty SpO2 module
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
Problem
Possible Cause
Servicing Method
Er0
Wireless module failure
Contact service personnel
Keep ear thermometer within 10M
of main unit.
Wireless
transmission
failure
Thermometer is far away from the
receiving device
Thermometer does not connect to
the main unit
or
Main unit is switched OFF
Wireless transmission function is
damaged
Pair again and ensure the
receiving device is on.
Contact service personnel
47
Troubleshooting
13.2
Corrective Action
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.
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® Compact 300; contact qualified service
personnel or Huntleigh Healthcare Ltd Service Department.
3. The monitor is operating on battery power, even though it is connected to
AC.
13.3
•
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,
Obtaining Technical Assistance
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
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 EN606011-2, 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:
•
•
•
•
Reorienting the equipment
Relocating the equipment with respect to the source of interference
Moving the equipment away from the device with which it is interfering
Plugging the equipment into a different outlet so that the devices are
on different branch circuits
WARNING: The use of accessories, transducers and cables other than
those specified, with the exception of transducers and cables sold by the
manufacturer of the Smartsigns® Compact 300 as replacement parts for
internal components, may result in increased emissions or decreased
immunity of the Smartsigns® Compact 300.
Electromagnetic Compatibility
14. Electromagnetic Compatibility
WARNING: The Smartsigns® Compact 300 should not be used adjacent
to or stacked with other equipment and that if adjacent or stacked use is
necessary, the Smartsigns® Compact 300 should be observed to verify
normal operation in the configuration in which it will be used
WARNING: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the Smartsigns® Compact 300
including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
Guidance and Manufacturer’s declaration - electromagnetic emissions
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.
Emissions Test
Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
Electromagnetic Environment - guidance
The Smartsigns® Compact 300 uses RF energy only for
its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
The Smartsigns® Compact 300 is suitable for use in all
establishments, other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
49
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
Test
IEC 60601 test level
Compliance
level
Electromagnetic Environment - guidance
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
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
6 Vrms
150 kHz to 80 MHz
in ISM and amateur
radio bands
3 V/m
80MHz to 2.5GHz
3V
3V/m
d = 1.2 √ P
d = 1.2 √ P
d = 2.3 √ P
80MHz to 800MHz
800MHz to 2.5GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m). b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, c
should be less than the compliance level in each
frequency range d.
Interference may occur in the vicinity of the
equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, 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.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz, to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these
frequency ranges.
c
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 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® Compact 300 is used exceeds the applicable RF compliance level above, the Smartsigns®
Compact 300 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® Compact 300.
d
Over the frequency range 150kHz to 80kHz, field strengths should be less than 3V/m.
a
50
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.
Immunity Test
Electrostatic
discharge (ESD)
IEC 60601 test
level
Compliance
level
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
Electrical fast
transient burst
± 2 kV for power
supply lines
± 2 kV for power
supply lines
IEC 61000-4-4
± 1 kV for input/
output lines
± 1 kV for input/
output lines
Surge
± 1 kV line(s) to
line(s)
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 2 kV line(s) to
earth
<5 % Ur
(>95 % dip in Ur )
for 0,5 cycles
<5 % Ur
(>95 % dip in Ur )
for 0,5 cycles
40 % Ur
(60 % dip in Ur )
for 5 cycles
40 % Ur
(60 % dip in Ur )
for 5 cycles
70 % Ur
(30 % dip in Ur )
for 25 cycles
70 % Ur
(30 % dip in Ur )
for 25 cycles
<5 % Ur
(>95 % dip in Ur )
for 5 s
<5 % Ur
(>95 % dip in Ur )
for 5 s
3 A/m
3 A/m
IEC 61000-4-2
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50/60Hz) magnetic
field
IEC 61000-4-8
Electromagnetic Environment guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial of
hospital environment. If the user
of the Smartsigns® Compact
300 requires continued operation
during power mains interruptions,
it is recommended that the
Smartsigns® Compact 300 is
powered from an uninterruptible
power supply or battery.
Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic immunity
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
NOTE Ur is the a.c. mains voltage prior to the application of the test level.
51
Electromagnetic Compatibility
52
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.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150kHz to 80MHz
d = 1.2 √ P
80MHz to 800MHz
d = 1.2 √ P
800MHz to 2.5GHz
d = 2.3 √ P
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 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.
15.1
15.2
15.3
Equipment Classification
Type of protection against
electric shock.
Class 1 with internal power
Degree of protection against
electric shock
BF
Mode of operation.
Continuous
Degree of protection against
harmful ingress of particles
and/or water.
IPX1
Degree of safety of
application in the presence of
a flammable anaesthetic
Equipment not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR,
OXYGEN OR NITROUS OXIDE
Specifications
15. Specifications
Standards
MDD 93/42/EEC
EN ISO13485:2012+AC2012
EN ISO14971: 2012
EN 60601-1: 2006/ AC:2013
EN 60601-1-2: 2007/AC:2010
EN60601-1-6:2010
EN 980:2008
EN 1041: 2008
EN ISO10993-1:2009
EN ISO10993-5:2009
EN ISO 10993-10:2010
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 1060-4:2004
EN ISO 80601-2-30:2009+A1:2013
EN ISO 80601-2-61:2011
EN 62366:2008
EN62304:2006
General
Display
100mm x 120mm
RS-232
Equipotential socket
Loudspeaker
Size
Width 125mm, Height 219mm, Depth 130mm
Weight
1.25Kg including battery (weight of battery:0.25Kg)
Service Life
7 years
53
Specifications
15.4
Electrical
AC Power
Voltage
100-240 VAC
Frequency
50Hz/60Hz
Rated Input power
35VA
Battery
Type
Charging Time
Endurance time
Battery Specifications
(IRT10 ear thermometer)
15.5
2200 mAh, 11.1V Lithium Ion
When monitor is OFF, the charging time will be no longer
than 3 hours
When monitor is ON, the charging time will be no longer
than 5.5 hours.
12 hours fully charged
Low battery alarm is sounded 5 minutes before shut down.
2 x Type LR03 AAA1.5VDC
Environmental
Operation
Temperature
Humidity
Altitude
5 °C to 40 °C without ear thermometer)
15 °C to 38 °C (with ear thermometer)
93% non-condensing (without thermometer)
≤85% non-condensing (with thermometer)
700 hPa to 1060hPa
Transport and Storage
Temperature
–20 °C to 60 °C (Packed)
Humidity
≤93% 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.
54
Measurement Parameters
NIBP
Measurement method
Oscillometric
Parameter display
Systolic pressure, diastolic blood, mean pressure and
pulse
Range of measurement for
adult
Range of measurement for
child
Range of measurement for
neonate
systolic pressure
40-270mmHg (5.3-36kPa)
diastolic pressure
10-215mmHg (1.3-28.7kPa)
mean pressure
20-235mmHg (2.7-31.3kPa)
systolic pressure
40-200mmHg (5.3-26.7kPa)
diastolic pressure
10-150mmHg (1.3-20kPa)
mean pressure
20-165mmHg (2.7-22kPa)
systolic pressure
40-135mmHg (5.3-18kPa)
diastolic pressure
10-100mmHg (1.3-13.3kPa)
mean pressure
20-110mmHg (2.7-14.7kPa)
Resolution
1mmHg (0.1kPa)
The measurement range and
accuracy of static pressure
0 mmHg (0 kPa) to 300 mmHg (40.0 kPa) to ±3 mmHg
(±0.4 kPa)
Accuracy
±5mmHg
Automatic Intervals
2, 3, 4, 5, 10, 15, 20, 25, 30, 60 or CO measurement
intervals
Note:
Specifications
15.6
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
Range and accuracy (70% to 100%*)
Own Brand
0% to 100%
±2% (measured without motion in adult/child mode)
±3% (measured without motion in adult/child mode)
Nellcor Module
0% to 100%
±2% (measured without motion in adult/child mode)
±3% (measured without motion in neonate mode)
Resolution
1%
* Accuracy 0% to 69% - not specified
55
Specifications
Temperature
Probe Type
Tympanic Infrared
Range
34° C to 42.2° C (93.2° F to 108°F)
Accuracy
35° C to 42° C : ±0.2° C (±0.4° F)
Other range : ±0.3° C (±0.5° F)
Resolution
0.1°C (0.1° F)
Standards
ASTM E1112-00:2000, EN12470-3 and EN12470-4
Pulse Rate
Range and accuracy
56
Own Brand
20bpm -250bpm
1bpm
±2bmp
Nellcor Module
25bpm-250bpm
1bpm
±3bpm
NIBP Module
40bpm-240bpm
1bpm
±3bpm or ±3%(MAX)
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
Accessories
16. Accessories
Disposing of single use accessories shall be handled in accordance with
the local protocol after use.
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
58
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
End of Life Disposal
17. End of Life Disposal
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.
59
Warranty & Service
18. 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.
18.1 Service Returns
If for any reason the Smartsigns Compact 300 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:Service Department.
Huntleigh Healthcare, Diagnostic Products Division,
35, Portmanmoor Rd.,
Cardiff. CF24 5HN
United Kingdom.
Tel:
Fax:
Email:
60
+44 (0)29 20485885
+44 (0)29 20492520
[email protected]
[email protected]
www.huntleigh-diagnostics.com
© 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.
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. 2017
Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: +44 (0)29 20485885 F: +44 (0)29 20492520 [email protected]
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 2017
A Member of the Arjo Family
® and ™ are trademarks of Huntleigh Technology Limited
As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.
AW:1001008-3
781301EN-3