DanMedical D-MAS HyperSat 2540 User manual

DM DOC 040 Rev 1.0
DanMedical Analysis System
D-MAS HyperSat
2540
Instructions for use
© 2013 DanMedical Ltd 1

DM DOC 040 Rev 1.0
Notice
The DanMedical logo is a registered trademark of DanMedical Ltd.
D-MAS™, D-MAS Remote™, D-MAS HyperSat™ and Battery Bade™ are trademarks of
DanMedical Ltd.
DanMedical Ltd. is protected under patents and patents pending.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the
device with unauthorized sensors or cables which would, alone, or in combination with this
device, fall within the scope of one or more of the patents relating to this device.
The software in this product is copyright © 2013 by DanMedical Ltd.
DanMedical Ltd. shall not be liable for errors contained herein, or for damages in connection with
the performance or use of this material.
DanMedical Ltd. will not be responsible for any injury to the user or other person(s) that may
result from accidents during operation or use of any DanMedical D-MAS System.
DanMedical Ltd. assumes no responsibility for use of D-MAS not in accordance with this manual.
Before using a D-MAS please read this guide and become familiar with the contents.
The information in this user manual is subject to change without notice. Please check for latest
revision.
For further information concerning this user manual please contact your supplier or sales
representative. Alternatively, please contact:
DanMedical Ltd
12 Threshers Yard
Kingham,
Oxon
OX7 6YF
UK
[email protected]
www.DanMedical.com
DM DOC 040 Instructions for use
© 2013, DanMedical Limited
www.DanMedical.com
ALL RIGHTS RESERVED. This report contains material protected under International and Federal Copyright Laws and
Treaties. Any unauthorized reprint or use of this material is prohibited. No part of this report may be reproduced or
transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any
information storage and retrieval system without express written permission from DanMedical Limited.
© 2013 DanMedical Ltd 2

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Contents
C apter Heading Page
1General Information 4
Indications For Use Statement 4
Intended use 5
Symbols, warnings and cautions 6
2List of components 11
Product overview 12
Battery Blades 13
Features 16
General description
Principle of operation
Pulse CO-Oximeter 17
Resting ECG 23
Blood pressure 36
Spirometry 38
Monitor mode 41
3Set up 42
Basic operation 43
Software overview 45
Using the D-MAS System 45
Pulse CO-OXIMETER 47
Alarms 54
Sensors, cleaning & reuse 64
Resting ECG 71
Blood pressure 74
Spirometry 77
Monitor mode 78
Alarms and limits 80
4Retrieving patient data 81
Printing reports 81
5Maintenance 82
Storage & cleaning 82
Battery 83
Device function check 84
Troubleshooting 87
Replacement parts and accessories 91
Specifications & factory defaults 92
6Guidance and Manufacturer’s Declarations 98
Warranty & returns 102
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General Information
The DanMedical Analysis System will be referred to as D-MAS throughout this manual.
Important! Read this manual before use.
About t is manual
This user manual relates to the DanMedical Analysis System (D-MAS).
This manual explains how to set up and use D-MAS and includes important safety information.
All information in this manual is based on D-MAS and the standard factory default configuration.
Indications For Use Statement
Under the supervision of a qualified Healthcare Professional and for prescription use only, D-MAS
can be used as a personal computer in hospitals, Healthcare Professional's offices, laboratories
and occupational health testing or healthcare environments for an initial screening evaluation of a
patient to:
•Display non invasive measurements of functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation, methemoglobin saturation
and total hemoglobin concentration with a sensor.
•Display, record and analyze ECG signals for an initial evaluation of the electrical activity
of the heart
•Measure and display systolic and diastolic blood pressures and pulse rate of an adult
•Measure and display the maximal volume and flow of air that can be moved in and out of
a patient's lungs
•Measurement and display of images acquired using a digital examination camera.
This equipment is not designed to produce definitive interpretations for direct treatment or
therapy.
Statements given with this interpretation program do not replace a detailed report by the
Healthcare Professional and a clinical diagnosis is the responsibility of the Healthcare
Professional.
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Intended use
D-MAS HyperSat 2540 is intended for use in a HyperBaric or Diving Saturation chamber.
D-MAS is intended for use by medical clinicians on adult patients.
D-MAS is not intended for use in environments that are not supervised by a health care
practitioner.
D-MAS is not intended for continuous monitoring.
D-MAS is designed with defibrillator protection, but it is recommended that the D-MAS ECG
electrodes be removed from the patient before a defibrillator is used.
D-MAS is not intended for use on patients under critical care and the system is not intended for
use within an intensive care environment.
D-MAS is not intended for use on neonatal patients.
D-MAS will provide Non Invasive Blood Pressure measurements when using the appropriate
blood pressure cuff.
D-MAS is intended to provide an interpretation of a resting ECG in all situations.
D-MAS is not intended for use in conjunction with any high frequency generator, diathermy
machine or exposure to other strong radio frequency interference. Under such circumstances,
degradations in performance of D-MAS may be observed.
D-MAS is not intended for use in conjunction with pacemakers. Under such circumstances,
degradations in performance of D-MAS may be observed.
D-MAS is not intended for use in the presence of flammable anaesthetics or other explosive
atmosphere.
D-MAS will operate accurately over an ambient temperature range of 5 to 50 degrees Celsius.
Contraindications
The D-MAS is not designed to provide alarms and is not for arrhythmia detection. The device is
not suitable for intra cardiac application.
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Symbols
These symbols appear on D-MAS:
Symbols Description
The CE Mark and notified body registration
number signify that the device meets all
essential requirements of the European
Medical Device Directive 93/42/EEC
General warning sign.
Defib. protection is within patient cable.
Type CF
Defibrillator proof
Address of manufacture
These symbols appear in this user manual:
Symbols Description
Warning symbol
Caution symbol
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Warnings and cautions
WARNING! Explosion hazard. Do not use D-MAS in the presence of flammable
anaesthetics or other flammable environments.
WARNING! D-MAS is designed for use by healthcare professionals who have completed
user training.
WARNING! During defibrillation, it is recommended that the D-MAS ECG electrodes are
first removed from the patient.
WARNING! Do not touch the patient, patient cable or D-MAS during defibrillation. Death
or injury may occur from the electrical shock delivered by the defibrillator.
WARNING! For the safety of patients and to ensure best product performance and
accuracy, use only supplies and accessories recommended or supplied by DanMedical
Ltd.
WARNING! Do not place containers with liquids on or near D-MAS. Liquids spilled on D-
MAS may cause it to perform inaccurately or fail.
WARNING! The patient cables supplied with the D-MAS, or approved replacements, are
an integral part of the D-MAS safety feature.
WARNING! High intensity extreme lights (such as pulsating strobe lights) directed on the
sensor, may not allow D-MAS to obtain vital sign readings.
WARNING! D-MAS is NOT intended for use as an apnea monitor.
WARNING! D-MAS should be considered an early warning device. As a trend towards
patient hypoxemia is indicated, blood samples should be analyzed by laboratory
instruments to completely understand the patient’s condition.
WARNING! Electric shock hazard. Do not open D-MAS. Only qualified personnel may
perform maintenance procedures specifically described in this manual. Refer servicing to
DanMedical for repair of this equipment.
WARNING! The D-MAS Pulse CO-Oximeter function should not be used as a
replacement or substitute for ECG based arrythmia analysis.
WARNING! The use of ACCESSORIES, transducers and cables other than those
specified, may result in increased EMISSIONS or decreased IMMUNITY of the D-MAS.
WARNING! The D-MAS should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the D-MAS should be observed to verify normal
operation in the configuration in which it will be used.
WARNING! Always use the accessories with adherence to the manufacturer’s instructions
for use.
WARNING! The use of multiple instruments connected to the same patient may pose a
safety hazard due to the summation of leakage currents from each instrument. Any
combination of instruments should be evaluated by local safety personnel before being
put into service.
WARNING! As with all medical equipment, carefully route NIBP hose and ECG cables to
reduce the possibility of patient entanglement or strangulation.
WARNING! Ensure that the Non Invasive Blood Pressure hose is routed carefully. Be
sure that the hose cannot become trapped or kinked.
WARNING! Do not place the D-MAS in any position that may cause it to fall on the
patient. Do not lift D-MAS by the power cord or any other cable.
WARNING! Do not block any ventilation slots of the D-MAS as this may cause failure of
internal electronic devices.
WARNING! Do not use the D-MAS or its accessories if it appears damaged. If dropped or
damaged, it must be thoroughly tested by qualified service personnel before it is returned
to service.
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WARNING! Do not subject the D-MAS to extreme moisture.
WARNING! Do not use the D-MAS in an MRI environment.
WARNING! D-MAS is not intended for use on patients under critical care.
WARNING! To avoid the risk of electric shock, this equipment must only be connected to
a supply mains with protective earth
WARNING! For Adult use only. The D-MAS is not intended for use with neonates.
WARNING! It is the user’s responsibility to set alarm limits.
WARNING! Be sure that the electrodes or lead wire tips do not come into contact with any
other conductive materials, including earth grounded materials, especially when
connecting or disconnecting electrodes to or from the patient.
WARNING! Periodically check and replace all components of the
D-MAS that appear damaged, worn or frayed.
WARNING! The D-MAS contains no user serviceable parts other than the accessories.
WARNING! Do not use the D-MAS on patients who are also connected to a heart or lung
machine.
WARNING! Do not use the D-MAS on patients who appear to be experiencing
convulsions or tremors.
WARNING! Protection against the effects of discharge of cardiac defibrillator is dependent
upon the use of appropriate cables.
WARNING! Do not modify D-MAS. No modification or unauthorized repair is allowed.
WARNING! Patient Safety - If a sensor is damaged in any way, discontinue use
immediately.
WARNING! D-MAS can be used during defibrillation, but the readings may be inaccurate
for up to 20 seconds.
WARNING! Failure of Operation - If D-MAS fails any part of the setup procedures or
leakage tests, remove D-MAS from operation until qualified service personnel have
corrected the situation.
WARNING! Refer servicing to authorized and qualified personnel.
Important Notice
All maintenance, repairs and other technical adjustments to be performed by DanMedical
or authorised provider only. Warranties and any maintenance cover will lapse/end if
unauthorised providers are used.
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CAUTION! Interfering Substances: SpO2 is a functional calculation of arterial oxygen saturation.
Carboxyhemoglobin and Methemoglobin may erroneously increase SpO2 readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin and/or methemoglobin that is
present. Dyes, or any substance containing dyes, that change usual blood pigmentation may cause
erroneous readings. If the accuracy of the D-MAS is in doubt, verify the measurement concerned by
another method, and then have the D-MAS inspected by qualified service personnel.
CAUTION! Severe anemia may cause erroneous SpO2 readings.
CAUTION! Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 and SpCO
measurements.
CAUTION! Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2
measurements.
CAUTION! Elevated levels of Total Bilirubin may lead to inaccurate Sp02, SpMet. SpCO, SpHb and
SpOC
CAUTION! Very Low arterial Oxygen Saturation (Sp02) levels may cause inaccurate SpCO and
SpMet measurements.
CAUTION! Hemoglobin synthesis disorders may cause erroneous SpHb readings
CAUTION! If the sensor is wrapped too tightly or supplementary tape is used, congestion/pulsations
may occur causing erroneous readings.
CAUTION! Exercise caution when applying a sensor to a site with compromised skin integrity.
Applying tape or pressure to such a site may reduce circulation and/or cause further skin
deterioration.
CAUTION! With very low perfusion at the monitored site, the readings may read lower than core
arterial oxygen saturation.
CAUTION! Misapplied sensors or sensors that become partially dislodged may cause either over or
under reading of actual arterial oxygen.
CAUTION! Do not modify or alter the sensor in any way. Alterations or modification may affect
performance accuracy.
CAUTION! Venous congestion may cause under reading of actual arterial oxygen saturation.
Therefore assure proper venous outflow from monitored site. Sensor should be not below heart level
(e.g. sensor on hand of patient in a bed with arm dangling to the floor).
CAUTION! Circulation distal to the sensor site should be checked routinely
CAUTION! To avoid cross contamination only use single use sensors on the same patient.
CAUTION! Sensors applied too tightly may cause erroneous readings. Inaccurate measurements or
loss of signal may be caused by:
excessive patient movement
venous pulsations
placement of the Pulse CO-Oximeter sensor on an extremity with a blood pressure cuff,
arterial catheter or intravascular line.
CAUTION! Loss of pulse signal can occur when:
the sensor is too tight
the patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia
there is arterial occlusion proximal to the sensor
the patient is in cardiac arrest or in shock
CAUTION! Read sensor directions for use prior to usage.
CAUTION! If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the
irradiation field. If the sensor is exposed to the irradiation, the reading might be inaccurate or the unit
might read zero for the duration of the active irradiation period.
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CAUTION! For home use, ensure that the Pulse CO-Oximeter’s alarm can be heard from other
rooms in the house especially when noisy appliances such as vacuum cleaners, dishwashers,
clothes dryers, televisions, or radios are operating.
CAUTION! Always remove the sensor from the patient and completely disconnect the patient from
the Pulse CO-Oximeter before bathing the patient.
CAUTION! Do not place the Pulse CO-Oximeter where the controls can be changed by the patient.
CAUTION! Alarms are provided for indication only.
CAUTION! If the user saves inappropriate alarm limits, they will be retained, even when the unit is
switched off.
CAUTION. The user should wait 30 seconds between NIBP measurements to allow venous return
to the arm.
CAUTION! Ensure that D-MAS is placed on a secure, flat surface.
CAUTION! Do not use tape to secure the sensor to the site. This can restrict blood flow and cause
inaccurate readings. Use of additional tape can cause skin damage or damage to the sensor.
CAUTION! Do not autoclave.
CAUTION! Keep all ventilation slots clear to enable free air flow.
CAUTION! Dispose of waste and equipment in accordance with local regulations, or contact
DanMedical.
CAUTION! D-MAS accessories are not interchangeable. If operating/owning more than 1 D-MAS
unit, don't interchange accessories between units.
CAUTION! A functional tester cannot be utilized to assess the accuracy of D-MAS or any sensors.
CAUTION! This equipment has been tested and found to comply with the limits for medical devices
to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits are designed to
provide reasonable protection against harmful interference in a typical medical installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to other devices, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
■ Reorient or relocate the receiving device.
■ Increase the separation between the equipment.
■ Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
CAUTION! DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR
FROM THE POWER PLUG. THE POWER CORD AND PLUG MUST BE INTACT AND
UNDAMAGED. IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE
EARTH CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY
POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY FUNCTIONAL.
DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR
DIMMER. TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER
EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS.
CAUTION! To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not
attempt to sterilize by irradiation, steam, autoclave, or any method other than ethylene oxide as
indicated.
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CAUTION! Intravascular dyes or externally applied colouring (such as nail polish) may lead to
inaccurate SpO2 measurements.
CAUTION! The pulsations from intra-aortic ballon support can be additive to the oximeter pulse rate.
Verify patients pulse rate against the ECG heart rate.
CAUTION! Do not use damaged sensors or patient cables. Do not use a sensor or patient cable
with exposed optical or electrical components.
CAUTION! Do not immerse the sensor or patient cable in water, solvents, or cleaning solutions (the
sensor and connectors are not waterproof).
CAUTION! Do not attempt to reprocess, recondition, or recycle any D-MAS sensors or patient
cables as these processes may damage the electrical components, potentially leading to harm.
CAUTION! Inaccurate measurements may be caused by incorrect application or use.
CAUTION! All D-MAS sensor and accessories listed are to be available for the device.
List of components
Quantity Item
1 D-MAS HyperSat
1 Power supply unit
1 Power cord
4 Battery Blades
2 Battery Blade chargers
1 WiFi LAN Router (option)
1 SPO2 finger probe
1 SpO2, SpHb finger probe (option)
1 SpO2, SpCO, SpMet finger probe (option)
1 ECG patient cable
10 ECG electrode clips
1 BP cuff (Large adult , Standard adult & Small adult)
1 NIBP hose
1 USB Spirometer
1 General Examination Camera
1 Backpack (option)
Protective case (option)
1 User manual (electronic)
Unpacking and inspection
Inspect packaging for signs of damage in transit. Contact DanMedical Ltd. immediately if any
damage is discovered. If possible retain packaging for future use.
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Product overview
D-MAS HyperSat has been designed for use in Hyperbaric and Diving Saturation chambers. It
incorporates a personal computer with a Pulse CO-Oximeter, arterial oxygen saturation and pulse
rate monitor, an electrocardiogram amplifier (10 Applied Parts), a blood pressure monitor, USB
Spirometry, and digital image capture hardware and software.
The unit is powered by Battery Blades. Battery Blades are intrinsically safe dedicated battery
power packs designed for use in pressurized environments.
D-MAS has been designed to be used within the patient environment as detailed in EN 60601-1-
1:2001 (Medical Electrical Equipment - General requirements for safety).
D-MAS will accurately measure and store:
Pulse CO-Oximeter with continuous display of numeric values for SpO2, SpCO *,
SpMet™*,pulse rate, Perfusion Index (PI) and Pleth Variability Index (PVI)
graphical displays for plethysmographic waveform and Signal Identification and Quality
Indicator (Signal IQ )
10 lead Resting ECG recordings with interpretation
Non-invasive blood pressure with pulse rate for adult patients
Spirometry (Lung function)
Audiometry HSE & OSHA hearing thresholds
USB scope and general examination digital camera images
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Battery Blade General Description
Twin Battery Blades are intended
to provide DC supply to the
D-MAS HyperSat device when it
is used within a Hyperbaric or
Diving Saturation chamber.
To fit a Battery Blade to a
HyperSat, orientate the Battery
Blade following the instruction
labels and slide into the housing
tray.
D-MAS HyperSat wit twin Battery Blades
Ensure the battery locking button locates into tray when inserting the battery.
A positive click signals the Battery Blade is inserted correctly.
Battery Blade On/Off switc Switch on the D-MAS HyperSat
Switch ON both Battery Blades using the ON/OFF switch on each Battery Blade then switch on the D-MAS
HyperSat
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Battery Blade removal
With the Battery Blade stud located in the tray, the battery cannot be removed.
To remove the Battery Blade from the HyperSat, push the battery locking button in and withdraw
the battery.
Battery Blade Housing
The end panel has the On/Off switch, the battery capacity gauge and a 10 Amp fuse
Battery Blade end panel
With both fully charged twin battery blades inserted, turning each of the blades on with the on/off
switch will result in power appearing at the jack connector and the output gauge on each blade
will illuminate Green.
The twin battery blades will provide power to the HyperSat for approximately 3 hours, as the
batteries becomes depleted the number of green segments on the capacity gauge will slowly
reduce until the indicator will illuminate Red, an audible beep will occur every 10 seconds to
provide a visual and audible indication that the battery is becoming flat, at this point the battery
should be swapped out for a fully charged battery.
W en new, eac battery will last for approximately 15 minutes after t e Low Battery alert
first occurs.
Note
It is recommended that each battery is replaced with a fully charged battery once the low battery
point is reached. The twin batteries should be replaced sequentially to prevent power loss from
the D-MAS HyperSat.
Removing both batteries will result in complete power loss to the D-MAS HyperSat and it will
require re-booting once fully charged batteries are inserted.
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C arging t e twin battery blades
A depleted battery will continue to indicate Lo.Batt after the battery output has turned off. The
battery blade should then be switched off after its has been swapped out and then recharged.
The charger consists of two intelligent battery chargers, at power up, without batteries connected,
the charger LED will initially illuminate Green and then Red for about 5 seconds, reverting to
Green LED illumination.
Connect the Battery Blade to the charger, the Charger LED will turn RED to indicate charging is
occurring, the charger LED will remain RED until the battery is fully charged at which point it
illuminates Green (2 hours approx.)
The Battery Blade is provided with a 10Amp Auto fuse, it is a “when it blows it glows” type and will
illuminate if blown.
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FEATURES
Some D-MAS features may not be enabled depending on region or only available as optional
extras.
Pulse CO-Oximetry
D-MAS is a fully featured Pulse CO-Oximeter. All pulse oximetry measurement information, as
well as device status data is displayed on the screen. All user input is performed through the
keyboard and touch pad. The sensor cable connector is located on the rear of the D-MAS
instrument. These features are common to D-MAS:
Clinically proven to be the highest sensitivity and specificity pulse oximeter in the world.
Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively
measure carboxyhemoglobin (*SpCO ) and methemoglobin (*SpMetTM), as well as
providing a more reliable probe-off detection.
Perfusion Index (PI) with trending capability indicates arterial pulse signal strength and
may be used as a diagnostic tool during low perfusion.
Pleth Variability Index (PVI): captures vital thoracic pressure changes that may
compromise normal cardiac function affecting systemic circulation.
Accurate on cyanotic patients when used with an LNOP Blue Sensor.
Signal IQ waveform provides signal identification and quality indication during excessive
motion and low signal to noise situations.
FastSat tracks rapid changes in arterial O2 with high fidelity unlike any other pulse
oximeter.
Variable pitch provides tonal variance for every 1% change in saturation.
3D Alarm System Option:
Desat Index AlarmTM enables clinicians to detect an increasing quantity of smaller
desaturations that may precede declining respiratory status.
PI Delta AlarmTM alerts clinicians to specified changes in perfusion, often a reliable
indicator of illness severity.
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Pulse CO-Oximetry General description
Pulse CO-Oximetry is a continuous and non-invasive method of measuring the level of arterial
oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually
on the fingertip for adults and the hand or foot for neonates. The sensor is connected to the Pulse
CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient and
sends it to the instrument.
D-MAS displays the calculated
data in three ways:
As a percent value for
arterial oxygen
saturation (SpO2)
As a pulse rate (BPM)
As a plethysmographic
waveform
SpCO GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of carbon
monoxide concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse
oximetry (spectrophotometry) to make its SpCO measurement. The measurement is obtained by
placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants.
The sensor connects either directly to the Pulse CO-Oximetry instrument or through an
instrument patient cable. The sensor collects signal data from the patient and sends it to the
instrument. The instrument displays the calculated data as percentage value for the SpCO, which
reflect blood levels of carbon monoxide bound to hemoglobin.
SpMet GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of
methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles of
pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is
obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot
for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through
an instrument patient cable. The sensor collects signal data from the patient and sends it to the
instrument. The instrument displays the calculated data as percentage value for the SpMet.
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PRINCIPLE OF OPERATION
Pulse CO-Oximetry is governed by the following principles:
Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood)
carboxyhemoglobin (blood with carbon monoxide content) and methemoglobin species
differ in their absorption of visible and infrared light (using spectrophotometry, see figure
below).
The amount of arterial blood in tissue changes with the pulse (photoplethysography).
Therefore, the amount of light absorbed by the varying quantities of arterial blood also
changes.
The D-MAS Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between
oxygenated blood, deoxygenated blood, blood with carbon monoxide content and blood with
oxidized hemoglobin. The D-MAS utilizes a sensor with various lightemitting diodes (LEDs) that
pass light through the site to a photodiode (photodetector). Signal data is obtained by passing
various visible and infrared lights (LED’s, 500 to 1000nm) through a capillary bed (for example, a
fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile
cycle. The maximum radiant power of the strongest light is rated at 22mW. The photodetector
receives the light which is converted into an electronic signal and is sent to D-MAS for calculation.
Once the D-MAS receives the signal from the sensor, it utilizes Rainbow SET signal extraction
technology to calculate the patient’s functional oxygen saturation, blood levels of
carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pulse rate. The SpCO and SpMet
measurements rely on a multiwavelength calibration equation to quantify the percentage of
carbon monoxide and methemoglobin in arterial blood. The maximum of the skin surface
temperature is measured at an ambient temperature of less than 106º F (41º C). This is verified
by sensor skin temperature test procedures
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FUNCTIONAL SATURATION
The D-MAS is calibrated to measure and display functional saturation (SpO2): the amount of
oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport
oxygen. Note that carboxyhemoglobin and methemoglobin are not capable of transporting
oxygen, but is recognized as oxygenated hemoglobin by conventional pulse oximetry.
MEASURED VS. CALCULATED SATURATION
SpO2, SpMet and SpCO measurements that can be obtained from D-MAS are commonly
compared to invasive measurements obtained from blood gas samples. When comparing
invasive and noninvasive measurements and interpreting values, caution should be used, as the
calculated values obtained from the blood gas sample may differ from the SpO2, SpMet and
SpCO measurements of the Pulse CO-Oximeter. In the case of SpO2, different results are usually
obtained from the arterial blood gas sample if the calculated measurement is not appropriately
corrected for the effects of variables that shift the relationship between the partial pressure of
oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide
(PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpMet and SpCO, in addition to the
effects of temperature and pH, different results are also expected if concentration of
methemoglobin in the blood gas sample are abnormal (less than 90% for arterial oxygen
saturation, and greater than 2% for methemoglobin concentration). As blood gas samples are
usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful
comparison can only be achieved if the oxygen saturation, carboxyhemoglobin and
methemoglobin concentration of the patient are stable and not changing over the period of time
that the blood gas sample is taken.
SIGNAL EXTRACTION TECHNOLOGY FOR SpO2 MEASUREMENTS
Signal Extraction Technology’s signal processing differs from conventional pulse oximeters.
Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in
the measurement site. During patient motion, however, the non-arterial blood also moves,
causing conventional pulse oximeters to read low values, because they cannot distinguish
between the arterial and venous blood movement (sometimes referred to as noise). Pulse
oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful
because they are able to adapt to the varying physiologic signals and/or noise and separate them
by looking at the whole signal and breaking it down to its fundamental components. The signal
processing algorithm, Discrete Saturation Transform (DST ) reliably identifies the noise,
isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation
for display on the monitor.
SpMet AND SpCO MEASUREMENTS DURING PATIENT MOTION
The D-MAS displays measurements of SpMet and SpCO during patient motion. However,
because of the changes in the physiological parameters such as blood volume, arterial-venous
coupling, etc. that occur during patient motion, the accuracy of such measurements may not be
readable during excessive motion.
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NUMERIC DISPLAY – SpO2
Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a
relative term, experience will provide a good feeling for changes that are artifactual or
physiological and the speed, timing, and behaviour of each. The stability of the readings over time
is affected by the averaging mode being used. The longer the averaging time, the more stable the
readings tend to become. This is due to a dampened response as the signal is averaged over a
longer period of time than during shorter averaging times. However, longer averaging times delay
the response of the oximeter and reduce the measured variations of SpO2 and pulse rate.
NUMERIC DISPLAY - PULSE RATE
The Pulse Rate display may differ slightly from the heart rate displayed on ECG monitors due to
differences in averaging times. There may also be a discrepancy between cardiac electrical
activity and peripheral arterial pulsation. Significant differences may indicate a problem with the
signal quality due to physiological changes in the patient or one of the instruments or application
of the sensor or patient cable. The pulsations from intra-aortic balloon support can cause the
pulse rate displayed on the Pulse CO-Oximeter to be significantly different than the ECG heart
rate.
NUMERIC DISPLAY – SpCO
A stable SpCO reading is associated with correct sensor placement, small physiological changes
during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip
(measurement site). Physiological changes at the measurement site are mainly caused by
fluctuations in the oxygen saturation, blood concentration and perfusion.
Inaccurate measurements may be caused by:
■ Significant levels of methemoglobin.
■ Intravascular dyes such as indocyanine green or methylene blue.
■ Abnormal hemoglobin levels.
■ Abnormally low arterial perfusion.
NUMERIC DISPLAY – SpMet
A stable SpMet reading is associated with correct sensor placement, small physiological changes
during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip
(measurement site). Physiological changes at the measurement site are mainly caused by
fluctuations in the oxygen saturation, blood concentration and perfusion.
Inaccurate measurements may be caused by:
Intravascular dyes such as indocyanine green or methylene blue.
Abnormal arterial perfusion
NUMERIC DISPLAY – PI
The Perfusion Index (PI) display provides a relative numeric indication of the pulse strength at the
monitoring site. It is a calculated percentage between the pulsatile signal and nonpulsatile signal
of arterial blood moving through the site. PI may be used to find the best perfused site and to
monitor physiological changes in the patient. It displays an operating range of 0.02 to 20.00%. A
percentage greater than 1.00% is desired. Extreme changes in the display number are due to
changes in physiology and blood flow.
SIGNAL IQ
The D-MAS display provides a visual indicator of the plethysmogram signal quality and an alert
when the displayed SpO2 values are not based on adequate signal quality. The signal quality
indicator displayed is called the Signal IQ and can be used to identify the occurrence of a
patient’s pulse and the associated signal quality of the measurement. With motion, the
plethysmographic waveform is often distorted and may be obscured by artifact. The Signal IQ,
shown as a vertical line, coincides with the peak of an arterial pulsation.
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