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.
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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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