Huntleigh Smartsigns MiniPulse User manual

2
Table of Contents
Contents
1. Quality, Reliability & Safety............................................. 3
2. Introduction ...................................................................... 4
2.1 Unpacking......................................................................... 4
2.2 Preliminary Checks........................................................... 4
2.3 Recommended Clinical Applications................................. 5
2.3.1 Intended Use...........................................................................5
2.3.2 Indications for Use...................................................................5
2.3.3 Contra Indications....................................................................6
2.4 Recommended Sensors.................................................... 6
2.5 Accessories....................................................................... 6
3. Controls, Indicators, Symbols & Displays..................... 7
3.1 Front panel........................................................................ 7
3.2 Keypad.............................................................................. 7
3.3 Displays and Audible Alarms............................................. 8
3.4 Rear panel......................................................................... 9
3.5 Desk Stand / Charger (MP1R Only).................................. 10
3.5.1 Connecting to Power Supply...................................................10
3.5.2 Battery charging LED status....................................................10
4. Set-Up................................................................................ 11
4.1 Battery Installation - MP1.................................................. 11
4.2 Battery Installation - MP1R ............................................... 12
4.3 Probe Installation and Use................................................ 13
5. Operation .......................................................................... 14
5.1 Switching the Unit ON....................................................... 14
5.2 System Operation ............................................................. 14
5.3 Setting the Alarms............................................................. 16
5.4 Setting the pulse tone ....................................................... 17
5.5 Pulse Strength................................................................... 17
5.6 Switching the Unit OFF..................................................... 17
6. Care of Your Equipment .................................................. 18
6.1 Storage.............................................................................. 18
6.2 Cleaning and Disinfecting ................................................ 18
6.2.1 Care of the Sensor ..................................................................18
6.2.2 Care of the Unit .......................................................................18
7. Specifications................................................................... 19
8. Trouble Shooting.............................................................. 21
9. Maintenance ..................................................................... 22
10.Warranty ........................................................................... 22
11.Service .............................................................................. 22
12.End of Life Disposal........................................................ 23
13.I.V. Pole Fixing ................................................................. 24

3
Quality Reliability & Safety
1. Quality, Reliability & Safety
This section contains important safety information related to the use of the
Smartsigns®MiniPulse pulse oximeter. Other important safety information
appears throughout the manual
Before using this equipment, please study this manual carefully and
familiarise yourself with the controls, displays and operating techniques.
All modifications and repairs must be carried out by a qualified service
engineer, agent or hospital technician authorised by Huntleigh Healthcare.
Atttention, consult accompanying documents / Instructions for
Use
Warning The Smartsigns®MiniPulse pulse oximeter should only be
operated by qualified personnel.
Warning Do not use the Smartsigns®MiniPulse pulse oximeter in the
presence of flammable anaesthetics.
Warning Apart from the batteries, there are no user-serviceable parts
inside the instrument.
Warning
To ensure accurate performance and prevent device failure,
do not expose the Smartsigns®MiniPulse pulse oximeter to
extreme moisture.
Caution
The Smartsigns®MiniPulse pulse oximeter is intended only
as an adjunct to patient assessment. It must be used in
conjunction with all clinical signs and symptoms
Warning Pulse oximetry readings and pulse signals can be affected by
certain ambient, environmental and certain patient conditions.
Warning Do not use the Smartsigns®MiniPulse during magnetic
resonance imaging (MRI) scanning
Caution
Do not autoclave, or use ethylene oxide sterilization process
on any part or accessory of the system.
Do not immerse the system in any liquid.
Caution
Electromagnetic Compatibility (EMC). This product complies
with the requirements of applicable EMC Standards. The use
of accessories not specified by the manufacturer may result
in increased emissions by, or decreased immunity of, the
equipment, affecting its performance.

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2. Introduction
2.1 Unpacking
Carefully remove the Smartsigns®MiniPulse and its accessories from the
shipping carton. Save the packing materials in case the device must be
shipped or stored.
2.2 Preliminary Checks
Huntleigh Healthcare takes every precaution to ensure that their products reach
you in perfect condition. We recommend that a thorough visual inspection is
made prior to installation.
Should any damage be evident or any part missing, please ensure that
Huntleigh Healthcare, Diagnostic Products Division are informed at once.
Each system is supplied with the following accessories:
Item MP1 MP1R
1 x Smartsigns®MiniPulse 1 pulse oximeter •
1 x Smartsigns®MiniPulse 1R pulse oximeter •
1 x SpO2Sensor • •
4 x AA high capacity alkaline batteries •
4 x Rechargeable AA NiMH batteries •
1 x Desk stand with integrated charger •
1 x Charger wall cube •
1 x Instructions for Use • •
Introduction

5
Introduction
2.3 Recommended Clinical Applications
The Smartsigns®MiniPulse handheld pulse oximeter is intended for non-
invasive continuous or spot check monitoring of functional arterial oxygen
saturation (SpO2%), and pulse rate.
2.3.1 Intended Use
The Smartsigns®MiniPulse pulse oximeter is intended for use by healthcare
professionals for monitoring adult, paediatric and neonatal patients in hospitals
and hospital-type facilities. A range of sensors are available for use with the
MP1/MP1R. These are listed in section 2.4 along with details of each application
site.
Under low perfusion or patient motion conditions, the displayed pulse rate and
SpO2may become erratic or intermittent. In these circumstances, reposition the
sensor and ensure the patient remains still.
2.3.2 Indications for Use
The specific medical indications for the use of this device are:
• This device is a prescription device.
• This device is reusable and is intended for spot or continuous
measurement.
• This device is intended to display oxygen saturation, heart rate and
pulse strength or pulsatile signal.
• This device is intended to indicate an alarm if the measured
saturation or heart rate are outside user-set alarm limits.
Warning
The Smartsigns®MiniPulse pulse oximeter is designed for
attended monitoring only and must be used under the direct
observation of a qualified health care provider.
Warning The MP1R must not be charged when connected to a patient.
The MP1R cannot be used while being charged.
Warning Any doubt concerning the accuracy of any measurement, an
alternative method should be used.
Warning
In extreme situations, tissue damage can be caused by
incorrect application or duration of use of the SpO2probe.
Regularly inspect the probe site.

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Introduction
Caution
Ambient light, movement, low patient perfusion,
electromagnetic interference, artefacts, dysfunctional
haemoglobin, and certain dyes, may interfere with the pulse
oximeter’s function.
Caution
Do not autoclave, or use ethylene oxide sterilization process
on any part or accessory of the system.
Do not immerse the system in any liquid.
2.3.3 Contra Indications
Inaccurate measurements may be caused by:
• Excessive patient movement
• Venous pulsations
• Intravascular dyes, such as indocyanine green or methylene blue
• Significant levels of dysfunctional haemoglobin
• Defibrillation
2.4 Recommended Sensors
Description Application Site Part No.
Adult Sensor Finger ACC-VSM-171M
3178 Paediatric Sensor Finger ACC-VSM-170
3043 Universal Y Sensor
Finger/Toe - Adult/
Paediatric
Hand/Foot - Infant
ACC-VSM-169
3025 Infant Wrap Sensor Toe ACC-VSM-167
3026 Neonatal Wrap Sensor Foot ACC-VSM-168
2.5 Accessories
Item Part No.
Pole Clamp ACC47
Carry Case ACC-VSM-172
Desk Stand (MP1) ACC-VSM-173
Desk Stand with Integrated charger (MP1R) ACC-VSM-174

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Controls, Indicators, Symbols and Displays
3. Controls, Indicators, Symbols &
Displays
3.1 Front panel
Item Description
1Sensor
connection
2 Loudspeaker
3 Protective grip
4 Display
5 Front Panel
6 Keypad
3.2 Keypad
Button Description Button Description
Power - ON / OFF Key Up Key
MENU – Alarm limits and
Pulse tone setting Down Key
Alarm suspend - turns the alarms ON or OFF. Press and hold
for 2 seconds to permanently disable the alarms; the system will
sound a confirmation tone.
1
2
3
4
5
6

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Controls, Indicators, Symbols & Displays
3.3 Displays and Audible Alarms
Item Description
1%SpO2• Patient’s saturation
• ‘Flashing’ alarm threshold exceeded
2♥/min • Patient’s pulse rate
• ‘Flashing’ alarm threshold exceeded
3 Pulse Strength • 8-segment bar graph pulse indicator (PI) and
pulse strength
4 Alarm suspend • Illuminated - Alarm OFF
1
2
3
4

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Controls, Indicators, Symbols & Displays
3.4 Rear panel
Item Description
1 Probe socket
2 Probe storage
3 Belt Clip
4 Rear panel
5 Battery cover
Symbol Description
Attention, consult accompanying
documents / Instructions for Use.
Type BF applied part
1
2
3
4
5

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Controls, Indicators, Symbols & Displays
3.5 Desk Stand / Charger (MP1R Only)
3.5.1 Connecting to Power Supply
Connect the power supply to the desk stand and connect to mains supply.
3.5.2 Battery charging LED status
• Red Battery conditioning
• Amber Charging
• Green Charged
Symbol Description
Only use the PSU provided
with the product.
Class II Electrical Equipment
XXXXXXXXXXXX
Diagnostic Products Division
Huntleigh Healthcare
35 Portmanmoor Rd,
Cardiff CF24 5HN, UK
Tel [phone]
Fax [phone]
Email: [e-mail]
INPUT RATING:
9V 1A
SERIAL No.
Made in the U.K.
750316-2
DSR
MODEL No.

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Set-Up
4. Set-Up
4.1 Battery Installation - MP1
1. Slide the battery compartment latch
across to remove the battery cover.
2. Install four “AA” size
batteries, ensuring correct
polarity.
3. Replace the Battery cover
before use.

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Set-Up
4.2 Battery Installation - MP1R
Caution: Use only the prescribed batteries with the system.
Note: Do not mix alkaline “AA” batteries with rechargeable batteries.
When replacing batteries, replace with four fresh batteries. Do not
mix new and used batteries.
1. Remove the securing screw and the battery cover.
2. Install four “AA” size rechargeable
batteries, ensuring correct polarity.
3. Replace the Battery cover
before use.

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Set-Up
4.3 Probe Installation and Use
Warning
Before use, carefully read the probe manufacturers
directions for use, including all warnings, cautions, and
instructions.
Warning Do not use a damaged probe. Do not use a probe with
exposed optical components.
Warning Use only BCI sensors for SpO2measurements. Other
sensors may cause damage.
Warning Incorrectly applied sensors may give inaccurate readings.
2. Insert the patient’s finger into
the tip of the oximeter probe.
3. Ensure the cable extends
along the top of the patient’s
hand.
1. Connect the probe to the pulse oximeter.

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Operation
5. Operation
5.1 Switching the Unit ON
Warning Do not lift the unit by the probe cable.
Press the ON/OFF button .
During power up, the system will perform a self test, illuminate the displays for 2
seconds and enter the measurement mode.
5.2 System Operation
With the system connected to a patient, the oximeter will search for a pulse.
After a short period the system will display the patient’s saturation level and
pulse rate. The pulse indicator will be synchronised with the audible pulse tone
(If enabled).
The frequency of the pulse tone is closely related with saturation level; lower
tones indicate lower saturation levels.
After 2 mins, the display will reduce to a level which is equivalent to 50% output
intensity; press any key to re-establish the normal display intensity setting.
The display will automatically brighten in the event of an alarm condition.

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Operation
If there is no finger connected to the sensor, the %SpO2and Pulse Rate (♥/min)
will display:
If no probe is connected to the system, the unit will turn off automatically after 3
minutes.
Warning Reposition the probe at least once every 4 hours to allow
the patient’s skin to respire.

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Operation
5.3 Setting the Alarms
The default setting for the alarms are:-
• SpO2Low 92%
• SpO2High 99%
• HR Low 50BPM
• HR High 150BPM
Press the MENU button to enter the Alarm Setup mode.
The display will change to :
Press the UP or DOWN button to adjust the SpO2low setting.
Press the MENU button to select the SpO2high setting.
Press the UP or DOWN button to adjust the SpO2High setting.
Press the MENU button to select the HR Low setting.
Press UP or DOWN button to adjust the setting.
Press the MENU button to select the HR High setting.
Press the UP or DOWN button to adjust the setting.
Press the MENU button to save the settings.

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Operation
5.4 Setting the pulse tone
Press the MENU button five times to display the Pulse Tone set-up option.
Press the UP or DOWN key to set the pulse tone
Setting Display
• OFF PB OFF
• ON PB ON
Press the MENU button to save the settings.
5.5 Pulse Strength
Press and hold the UP button to display the Pulse Strength. The bar graph will
illuminate according to the strength of the pulse signal.
Good Quality Poor Quality
5.6 Switching the Unit OFF
Press the ON/OFF button to switch the unit OFF.

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Care of your Equipment
6. Care of Your Equipment
It is recommended that the unit and accessories are inspected and tested on a
regular basis.
If any part of the system appears to be damaged, the system should be
returned to your service centre for repair.
6.1 Storage
Remove the batteries from the unit before long-term storage.
6.2 Cleaning and Disinfecting
Warning Turn the Pulse Oximeter OFF before cleaning.
6.2.1 Care of the Sensor
Clean the probe after each use.
Clean the surface of the sensor and cable with a soft gauze pad by saturating it
with a solution of 70% isopropyl alcohol. If low level disinfection is required, use
a 1:10 bleach solution.
6.2.2 Care of the Unit
If cleaning is required, wipe the Pulse Oximeter’s surfaces with a soft cloth
moistened with a non-abrasive cleaner.
Do not allow any liquid to enter any of the system.

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Specifications
7. Specifications
Electrical
Power requirements
MP1 4 x AA High Capacity Alkaline cells
MP1R 4 x AA rechargeable NiMH ≥2500mAH cells
Battery life MP1 60 hours typical
Battery life MP1R 60 hours typical before recharge is required
Charger MP1R only
Type Desk top stand with wall mount power supply
Charge time 6.5 Hours to full charge
Built in protection for under / over charge
Wall cube Input voltage 100 – 240 VAC 60Hz
Output 9V @ 6VA
General
Dimensions 75 x 140 x 25mm (excluding desk stand, sensor and
wall cube)
Weight 300gm (excluding desk stand, sensor and wall
cube)
Display indicators
• SpO2
• Pulse rate
• Pulse Strength
• Alarm status
• Charge status (desk stand only)
Alarms
Audible and visual alarms for high and low
saturation and pulse rate. Synchronized saturation
tone

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Specifications
Environmental
Operating temperature 5°C to 40°C
Storage temperature -40°C to +70°C
Humidity 5% to 95% non condensing
Pressure 600mbar – 1080mbar
SpO2 /Pulse Rate
%Saturation
Range 0 – 99% Functional SpO2(1% increments)
Accuracy Adults +/-2% @ 70 – 99%
SpO2< 70% undefined
Averaging 8 beats
Pulse Rate
Range 30 – 254 BPM (1 BPM increments)
Accuracy Better than +/-2 BPM or +/-2%
Averaging 8 seconds
Bargraph 0 – 8 segments providing pulsatile signal or pulse
strength
Calibration Factory calibrated over range 70% to 100%
Compliance
Equipment classification
Medical
Electrical
Equipment
25EA
IEC60601-1, WITH RESPECT TO ELECTRIC
SHOCK, FIRE AND MECHANICAL HAZARDS
ONLY, IN ACCORDANCE WITH UL60601-1,
CAN/CSA C22.2 No 601.1 and ISO 9919.
EMC compliance EN55011 Group 1 Class B, EN60601-1-2,
EN61000-3-2, EN61000-3-3
Degree of protection Type BF
Degree of protection
against ingress of water IPX1