LRE Medical Esterline 8066000 Laboratory Equipment with RFID User Manual

LRE Medical GmbH Esterline Corporation Laboratory Equipment with RFID

User Manual

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Philips Electronics Nederland B.V.
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Philips minicare analyzer
INSTRUCTIONS FOR USE
Release 1.0
English
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Published by Philips Electronics Nederland B.V.
Philips Electronics Nederland B.V. reserves the right to make
changes to both this document and to the product it describes.
Product specifications are subject to change without notice.
Nothing contained within this document is intended as any
offer, warranty, promise or contractual condition, and must not
be taken as such.
© Koninklijke Philips Electronics N.V. 2011
All Rights are reserved. Reproduction in whole or in part in any
form or by any means, electrical, mechanical or otherwise is
prohibited without the written consent of the copyright holder.
Issue Number [12nc xxxx xxx xxxx] [Draft version 0.2 This
label will be removed]
Philips Electronics Nederland B.V.
acting through Healtcare Incubator
High Tech Campus 5
5656 AE Eindhoven
The Netherlands
Philips Electronics Nederland B.V.
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Unauthorized copying of this publication may not only infringe
copyright but also reduce the ability of Philips Electronics
Nederland B.V. to provide accurate and up-to-date information
to users.
Non-Philips product names may be trademarks of their
respective owners.
Published in The Netherlands.
Philips minicare analyzer
Release 1.0
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Philips Electronics Nederland B.V.
Introduction..............................................................................................
1.1
About the Philips minicare system............................................. 1-1
1.2
About these Instructions for Use................................................ 1-2
1.3
Intended use.............................................................................. 1-3
1.4
Compatibility............................................................................ 1-3
1.5
Compliance............................................................................... 1-4
1.6
European authorized representative........................................... 1-4
1.7
Training.................................................................................... 1-5
Safety.........................................................................................................
Release 1.0
2-1
2.1
Important safety directions........................................................ 2-1
2.2
Emergency procedures............................................................... 2-2
2.3
Explosion safety......................................................................... 2-2
2.4
Electromagnetic Compatibility (EMC)...................................... 2-3
2.5
Labels and symbols....................................................................
2.5.1 minicare analyzer label.................................................
2.5.2 minicare docking station label......................................
2.5.3 Symbols.......................................................................
2-4
2-4
2-5
2-6
Installation................................................................................................
3-1
3.1
Philips minicare analyzer
1-1
3.2
Equipment overview.................................................................. 3-1
3.1.1 Equipment connections............................................... 3-2
Action upon delivery.................................................................. 3-4
3.3
Site preparation......................................................................... 3-4
Contents
0-3
4
Storage and handling.................................................................
3.4.1 Environmental conditions............................................
3.4.2 Battery care..................................................................
3.4.3 Dust.............................................................................
3-5
3-5
3-6
3-6
System overview......................................................................................
4-1
4.1
Theory of operation................................................................... 4-1
4.2
4.3
Performance and limitations......................................................
4.2.1 Performance characteristics..........................................
4.2.2 Limitations of use........................................................
Preparation prior to use.............................................................
4.4
Installing the data manager software.......................................... 4-4
4.5
4.7
Docking and undocking the minicare analyzer..........................
4.5.1 Docking the minicare analyzer.....................................
4.5.2 Undocking the minicare analyzer.................................
Configuring analyzer connectivity..............................................
4.6.1 Configuring the minicare analyzer with a static IP
address.........................................................................
4.6.2 Configuring the minicare analyzer with a DHCP server
....................................................................................
4.6.3 Configuring the minicare analyzer on the data
manager software.........................................................
Configuring LIS connectivity.....................................................
4.8
Configuring analyzer settings..................................................... 4-12
4.6
4-5
4-5
4-6
4-7
4-7
4-8
4-9
4-9
Operation - minicare analyzer................................................................
5-1
5.1
5-1
5-1
5-2
5-3
5-3
5.2
Contents
4-3
4-3
4-4
4-4
minicare analyzer overview.........................................................
5.1.1 Main screen.................................................................
5.1.2 Blood analysis workflow...............................................
Starting up and shutting down...................................................
5.2.1 Starting the minicare analyzer......................................
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3.4
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5.2.2 Shutting down the minicare analyzer...........................
Identifying the user....................................................................
5.3.1 Logging on...................................................................
5.3.2 Logging out.................................................................
Starting analysis.........................................................................
5-6
5-6
5-6
5-9
5-9
5.6
Identifying the patient...............................................................
5.5.1 Identifying the patient by barcode scanning.................
5.5.2 Identifying the patient from a list.................................
5.5.3 Performing an anonymous test.....................................
Inserting a cartridge...................................................................
5-10
5-10
5-11
5-12
5-13
5.7
Adding a blood sample and performing a test............................ 5-14
5.8
Removing a cartridge................................................................. 5-16
5.9
Performing multiple tests........................................................... 5-16
5.3
5.4
5.5
5.10 Finishing a test or analysis.......................................................... 5-16
Operation - minicare data manager......................................................
Philips Electronics Nederland B.V.
6.1
6.2
6.3
Philips minicare analyzer
Release 1.0
Starting and stopping the data manager software.......................
6.1.1 Starting the data manager software...............................
6.1.2 Logging on...................................................................
6.1.3 Logging off..................................................................
6.1.4 Exiting the data manager software................................
System overview.........................................................................
6.2.1 Common elements.......................................................
Analysis orders...........................................................................
6.3.1 Patient List...................................................................
6.3.2 Details area..................................................................
6.3.3 Creating a new analysis order.......................................
6.3.4 Transferring an analysis order to the minicare analyzer
....................................................................................
6.3.5 Deleting an analysis order............................................
Contents
0-5
6-1
6-1
6-1
6-1
6-2
6-3
6-3
6-7
6-11
6-11
6-13
6-14
6-15
6-15
Analysis results...........................................................................
6.4.1 Patient List...................................................................
6.4.2 Details area..................................................................
6.4.3 Transferring analysis results from the minicare analyzer
....................................................................................
6.4.4 Editing analysis results.................................................
6.4.5 Printing analysis results................................................
6.4.6 Transferring analysis results to the LIS.........................
QC results.................................................................................
6.5.1 QC results list..............................................................
6.5.2 Additional QC results options......................................
6-16
6-16
6-18
System messages and troubleshooting..................................................
7-1
6.5
7.1
System and error messages.........................................................
7.1.1 Philips minicare analyzer..............................................
7.1.2 Data manager software.................................................
Contacting Service.....................................................................
7-1
7-1
7-3
7-10
Maintenance..............................................................................................
8-1
8.1
8-1
8-2
8-3
8-4
8-4
8-4
8-5
8-5
8-6
8-8
8-9
7.2
8.4
Cleaning and disinfection..........................................................
8.1.1 Cleaning the minicare analyzer.....................................
8.1.2 Disinfecting the minicare analyzer...............................
8.1.3 Cleaning the battery in the battery compartment.........
Planned maintenance and user routine checks...........................
8.2.1 Planned maintenance program.....................................
8.2.2 User routine checks program........................................
Quality control..........................................................................
8.3.1 QC test workflow........................................................
8.3.2 Performing a QC test...................................................
Antivirus protection...................................................................
8.5
After-sales support..................................................................... 8-10
8.2
8.3
Contents
6-19
6-20
6-21
6-22
6-23
6-23
6-24
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Release 1.0
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6.4
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10
Product disposal.......................................................................................
9-1
9.1
Passing this product on to another user...................................... 9-1
9.2
Final disposal of this product..................................................... 9-2
9.3
Fitting, removing and disposing of batteries............................... 9-2
9.3.1 Replacing the minicare analyzer battery....................... 9-3
Technical data.......................................................................................... 10-1
10.1 Specifications............................................................................. 10-1
10.2 System requirements.................................................................. 10-1
11
Glossary..................................................................................................... 11-1
11.1 Definitions................................................................................ 11-1
11.2 Abbreviations............................................................................. 11-1
12
Appendices................................................................................................ 12-1
Philips Electronics Nederland B.V.
12.1 Special functions........................................................................ 12-1
12.1.1 Additional host software options for Administrators.... 12-1
12.1.2 Analyzer menu and options.......................................... 12-9
12.2 Security and privacy requirements..............................................12-10
12.3 References..................................................................................12-10
Index..........................................................................................................
Philips minicare analyzer
Release 1.0
Contents
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Contents
Philips minicare analyzer
Release 1.0
1
1.1
Introduction
About the Philips minicare system
The Philips minicare system comprises a handheld analyzer, its docking
station, and data manager software for the quantitative determination of the
concentration of biomarkers in blood.
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Figure 1.1
Philips minicare analyzer, with docking station (right)
Figure 1.2
Philips minicare analyzer, with cartridge loaded (right)
Philips minicare analyzer
The minicare analyzer receives blood cartridges and performs tests on the
blood sample. It is intended for use in medical care settings, for example,
operating theaters.
To perform a test with the minicare analyzer, a cartridge sample for a
specific application is also required. These cartridges can be used only once.
Philips minicare analyzer
Release 1.0
Introduction
1-1
Philips minicare data manager
The minicare data manager software allows you to configure the minicare
analyzer, and to exchange data from the minicare analyzer with an external
information system, for example, LIS.
1.2
About these Instructions for Use
These Instructions for Use are intended to assist users in the safe and
effective operation of the product described.
Before attempting to operate the product, you must read these Instructions
for Use, noting and strictly observing all WARNINGS and CAUTION
notices.
Pay special attention to all the information given and procedures described
in the SAFETY section.
A WARNING alerts you to a potential serious outcome, adverse event or
safety hazard. Failure to observe a warning may result in death or serious
injury to the user or patient.
A CAUTION alerts you to where special care is necessary for the safe and
effective use of the product. Failure to observe a caution may result in minor
or moderate personal injury or damage to the product or other property,
and possibly in a remote risk of more serious injury, and/or cause
environmental pollution.
Notes highlight unusual points as an aid to a user.
[NOTE TO REVIEWERS: If there are no options on the system, the
following paragraph is can be removed. Please confirm.] These Instructions
for Use describe the most extensive configuration of the product, with the
maximum number of options and accessories. Not every function described
may be available on your product.
Introduction
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Release 1.0
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About these Instructions for Use
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Intended use
1.3
1.3
Intended use
This Philips product is intended to be installed, used and operated only in
accordance with the safety procedures and operating instructions given in
this Instructions for Use for the purposes for which it is designed. The
purposes for which this product is intended are given below. However,
nothing stated in this Instructions for Use reduces user’s responsibilities for
sound clinical judgment and best clinical procedure.
The intended use of the Philips minicare system is as a point of care device
to measure the concentration of biomarkers in blood using Magnotech
blood cartridges.
Installation, use, and operation of this product is subject to the law in the
jurisdictions in which this product is being used. Operators must only
install, use, and operate this product in such ways as do not conflict with
applicable laws, or regulations, which have the force of law.
Uses of this product for purposes other than those intended and expressly
stated by the manufacturer, as well as incorrect use or operation, may relieve
the manufacturer (or his agent) from all or some responsibility for resultant
non-compliance, damage, or injury.
Intended users
The intended users of the Philips minicare system are laboratory and nonlaboratory medical professionals (for example, nurses).
Intended use environment
The Philips minicare system is used to perform tests in different care
settings, for example, an emergency room or an operating theater.
1.4
Compatibility
The product described in this manual should not be used in combination
with other products or components unless such other products or
components are expressly recognized as compatible by Philips Electronics
Nederland B.V. A list of such products and components is available from
the manufacturer.
Philips minicare analyzer
Release 1.0
Introduction
1-3
Philips minicare analyzer identification
Module no.
[To be defined]
Software version
[To be defined]
Changes and/or additions to the product should only be carried out by
Philips Electronics Nederland B.V. or by third parties expressly authorized
by Philips Electronics Nederland B.V. to do so. Such changes and/or
additions must comply with all applicable laws and regulations that have the
force of law within the jurisdiction(s) concerned, and with best engineering
practice.
WARNING
1.5
Changes and/or additions to the product that are carried out by persons without the
appropriate training and/or using unapproved spare parts may lead to the Philips
Electronics Nederland B.V. warranty being voided. As with all complex technical
products, maintenance by persons not appropriately qualified and/or using
unapproved spare parts carries serious risks of damage to the product and of personal
injury.
Compliance
The Philips minicare analyzer complies with relevant international and
national standards and laws. Information on compliance will be supplied on
request by your local Philips Electronics Nederland B.V. representative, or
by the manufacturer.
1.6
European authorized representative
The European authorized representative is located at the following address:
Philips Electronics Nederland B.V, acting through Healthcare Incubator
High Tech Campus 5
5656AE, Eindhoven
The Netherlands.
Introduction
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Release 1.0
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Compliance
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Training
1.7
1.7
Training
Users of this product must have received adequate training on its safe and
effective use before attempting to operate the product described in these
Instructions for Use. Training requirements for this type of device will vary
from country to country. Users must make sure they receive adequate
training in accordance with local laws or regulations.
If you require further information about training in the use of this product,
please contact your local Philips Electronics Nederland B.V. representative.
Alternatively, contact the manufacturer.
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Introduction
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Training
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Introduction
Philips minicare analyzer
Release 1.0
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Safety
Important safety directions
2.1
WARNING
Maintenance and faults
• Do not use the product for any application until you are sure that the user routinechecks have been satisfactorily completed, and that the periodic maintenance of
the product is up to date. If any part of the product is known (or suspected) to be
defective or wrongly adjusted, DO NOT USE the product until a repair has been
made. Operation of the product with defective or wrongly adjusted components
could expose the user or the patient to safety hazards. This could lead to fatal or
other serious personal injury, or to clinical misdiagnosis.
WARNING
Safety awareness
• Do not use the product for any application until you have read, understood and
know all the safety information, safety procedures and emergency procedures
contained in this SAFETY section. Operation of the product without a proper
awareness of how to use it safely could lead to fatal or other serious personal
injury. It could also lead to clinical misdiagnosis.
WARNING
Adequate training
• Do not use the product for any application until you have received adequate and
proper training in its safe and effective operation. If you are unsure of your ability
to operate this product safely and effectively DO NOT USE IT. Operation of this
product without proper and adequate training could lead to fatal or other serious
personal injury. It could also lead to clinical misdiagnosis.
• Do not operate the product with patients unless you have an adequate
understanding of its capabilities and functions. Using this product without such an
understanding may compromise its effectiveness and/or reduce the safety of the
patient, you and others.
Philips minicare analyzer
Release 1.0
Safety
2-1
2.2
WARNING
Safety devices
• Never attempt to remove, modify, or over-ride or frustrate any safety device on
the product. Interfering with safety devices could lead to fatal or other serious
personal injury.
• [NOTE TO REVIEWERS — during review 1, a defect was raised indicating this
warning (above) is too vague. In your review, please indicate one of the following:
(A) that there are no safety devices on the analyzer (not required through good
design), in which case we can remove this warning altogether, or (B) there are
specific safety devices on the analyzer that require more in-depth explanation, in
which case we need to expand this warning with more detail. Thank you.]
WARNING
Intended use and compatibility
• Do not use the product for any purpose other than those for which it is intended.
Do not use the product with any product other than that which Philips Medical
Systems recognizes as compatible. Operation of the product for unintended
purposes, or with incompatible product, could lead to fatal or other serious injury.
It could also lead to clinical misdiagnosis.
Emergency procedures
There are no emergency procedures for the minicare analyzer.
2.3
Explosion safety
WARNING
Safety
[NOTE TO REVIEWERS - During review 1, the following defect was raised: “Do we
need a 'battery exploding warning' ? These types of batteries (used in remote
controled cars e.g., sometimes self combust. Are our batteries safeguarded againat
that?” In your review, please could you indicate whether or not there is a risk of the
battery exploding that requires mitigation in the IfU. Normally, this will be driven by
the Risk Management Report (not available at the time of writing).
Philips minicare analyzer
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Emergency procedures
Philips Electronics Nederland B.V.
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Electromagnetic Compatibility (EMC)
2.4
Electromagnetic Compatibility (EMC)
2.4
This Philips product complies with relevant international and national law
and standards on EMC (electro-magnetic compatibility) for this type of
product when used as intended. Such laws and standards define both the
permissible electromagnetic emission levels from product and its required
immunity to electromagnetic interference from external sources.
Other electronic products exceeding the limits defined in such EMC
standards could, under unusual circumstances, affect the operation of the
product.
Medical electrical products needs special precautions regarding EMC, and
needs to be installed and put into service according to EMC information
provided in the accompanying documents.
The use of accessories and cables other than those specified, may result in
increased emission or decreased immunity levels.
The product should not be used adjacent to or stacked with other products
and that if adjacent or stacked use is necessary, it should be observed to
verify normal operation.
Portable and Mobile Phones
CAUTION
Portable and mobile RF communications can affect medical electrical equipment. Use
caution when using such communication devices within the specified range of medical
electrical devices.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment.
This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s).
Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may cause undesired operation.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de
licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de
brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage
est susceptible d'en compromettre le fonctionnement.
Philips minicare analyzer
Release 1.0
Safety
2-3
2.5
2.5.1
Labels and symbols
minicare analyzer label
The following label is located on the rear side of the minicare analyzer.
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Labels and symbols
Philips Electronics Nederland B.V.
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Figure 2.1
Safety
minicare analyzer label
Philips minicare analyzer
Release 1.0
Labels and symbols
2.5.2
2.5
minicare docking station label
The following label is located on the rear side of the minicare docking station.
Philips Electronics Nederland B.V.
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Figure 2.2
Philips minicare analyzer
Release 1.0
minicare docking station
Safety
2-5
2.5.3
Symbols
The following symbols are used on the equipment and on equipment labels.
Authorized Representative in the European Community
Batch code
Catalogue number
Caution, consult accompanying documents
CE mark
Consult Instructions for Use
Contains sufficient for (specified number of) tests
Contents
• The contents of the package are listed below this symbol
Do not use if package damaged
Docking status
• Illuminated: docked
• Not illuminated: undocked
In Vitro Diagnostic Medical Device
Mains connection status
• White: connected
• Red: not connected
Manufacturer
Network connection port
Safety
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Philips minicare analyzer
Release 1.0
Labels and symbols
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2.5
On / Off button
Polarity
Power supply adapter connection port
Printer connection port
Product disposal
This symbol indicates that the equipment contains materials that are
harmful to the environment if disposed of incorrectly. See section
“Product disposal” on page 9-1 for details.
Serial number
Temperature limitation
This symbol indicates the lower and upper limit of the acceptable
temperature range for storage or transportation.
Philips Electronics Nederland B.V.
Use By
Philips minicare analyzer
Release 1.0
Safety
2-7
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Safety
Philips minicare analyzer
Release 1.0
3
3.1
Installation
Equipment overview
Figure 3.1
Equipment inventory
Legend
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Philips minicare analyzer
Release 1.0
minicare analyzer
Docking station
Docking station AC adapter
AC adapter power cord
Ethernet cable
Data manager installation CD
[Other items as appropriate]
Installation
3-1
Equipment overview
Equipment connections
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3.1.1
minicare analyzer
Figure 3.2
Network connection port
• Specification: Ethernet
• An Ethernet cable is supplied with the minicare analyzer
Philips Electronics Nederland B.V.
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Figure 3.3
Installation
Docking station connector
Philips minicare analyzer
Release 1.0
Equipment overview
3.1
Docking station
Philips Electronics Nederland B.V.
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Figure 3.4
Docking station connection ports
Symbol
Description
Specification
Printer connection port
•
•
Specification: Mini USB
[To be confirmed — Cable
supplied?]
Network connection port
•
•
Specification: Ethernet
An Ethernet cable is supplied with
the minicare analyzer
•
Input: 100–240 V AC, 47–63 Hz,
700 mA
Output: 24 V DC, 1250 mA
A power supply adapter and power
cord are supplied with the
minicare analyzer
Philips minicare analyzer
Release 1.0
Power supply adapter
connection port
•
•
Installation
3-3
Figure 3.5
3.2
Docking station connector for the minicare analyzer
Action upon delivery
The minicare analyzer is installed and configured by a Philips Service
engineer as part of delivery. If you require information about suitable
location, preparation, and connection of the system, contact your local
Philips Service organization.
3.3
Site preparation
Conditions
• A PC is required for installation of the data manager software.
• The docking station requires a power connection.
• To transfer data to the data manager PC, the docking station requires a
connection to the local network or directly to the PC.
Installation
Philips minicare analyzer
Release 1.0
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Action upon delivery
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Storage and handling
3.4
Unpack the minicare start pack.
Connect one end of the Ethernet cable to the docking station, and the other
end either to a port on the local network or directly to the PC.
[NOTE TO REVIEWERS: Does direct connection to the PC require an
Ethernet crossover cable? If so, is this also provided?]
Connect the AC power adapter to the docking station and connect the AC
power adapter to the power source using the power cord.
Place the battery in the minicare analyzer.
For details, see section “Fitting, removing and disposing of batteries” on
page 9-2.
Put the analyzer in docking station to charge the battery.
For details, see section “Docking the minicare analyzer” on page 4-5.
3.4
3.4.1
Storage and handling
Environmental conditions
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Storage
The minicare analyzer can be stored and transported in the following
conditions. These conditions are valid while the minicare analyzer is still in
its original packaging.
Condition
Range
Ambient temperature
-25°C–70°C
Relative humidity (non-condensing)
5%–95%
Air pressure
70–110 kPa
Handling
The minicare analyzer can be used in the following conditions.
Philips minicare analyzer
Release 1.0
Condition
Range
Ambient temperature
2°C–27°C
Relative humidity
20%–80%
Installation
3-5
3.4.2
Battery care
During long periods of storage, you should remove the battery from the
minicare analyzer. If the battery is left in the analyzer during storage, it will
discharge slowly over time. Damage to the battery may result if it is allowed
to completely discharge while in storage.
3.4.3
Dust
The minicare analyzer cap should be closed while not in use to avoid dust
entering the device at the cartridge entrance.
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Storage and handling
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Installation
Philips minicare analyzer
Release 1.0
4
System overview
Philips Electronics Nederland B.V.
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This product allows you to quickly and easily analyze the levels of certain
bio markers in small blood samples taken from a patient. The system is
designed for medical applications in various point of care settings, such as
operation theatres and hospital emergency rooms. The system allows you to
see and upload results to your information system for further analysis.
The system consists of the following main parts.
Cartridges
Blood samples are dispensed into cartridges for analysis.
The minicare analyzer
A handheld device in which you insert the cartridge containing the blood
sample. The minicare analyzer executes the test and displays test results.
Docking station
The minicare analyzer can be docked in the docking station to charge the
battery and to transfer test result data to the data manager software.
Data manager software
The data manager software allows you to configure the system and to
exchange information with a hospital information system, for example, an LIS.
This section provides an overview of the system functions. The following
sections provide details of the specific functions you use and the tasks you
perform when operating the minicare analyzer and data manager software.
4.1
Theory of operation
The minicare analyzer uses Philips Magnotech technology. Magnotech is a
type of biosensor technology that uses magnetic nanoparticles to measure
picomolar concentrations of target substances in blood or saliva in a matter
of minutes.
Philips minicare analyzer
Release 1.0
System overview
4-1
Integrated into a disposable biosensor cartridge that inserts into a handheld
analyzer, it automatically fills itself from a single drop of blood or saliva.
Once filled, no other fluid movement is required. The entire assay process
within the cartridge is executed by controlled movement of the magnetic
nanoparticles within the cartridge using external magnetic fields.
The cartridge, constructed entirely from plastic components, has no moving
parts or embedded electronics, and is disposable. The analyzer unit contains
the electromagnets, optical detection system, control electronics, software
and the read-out display.
Magnotech process
Figure 4.1
Magnotech process
Coated with appropriate ligand molecules, the magnetic nanoparticles bind
to the target protein molecules in the sample blood or saliva.
The target molecules end up locked between the active surface (binding
magnet [1]) and attached nanoparticles.
A second magnetic field is then generated (washing magnet [2]) to pull
unbound magnetic nanoparticles away from the active surface. A very fast
and accurately controlled separation between bound and unbound magnetic
nanoparticles is thereby achieved.
System overview
Philips minicare analyzer
Release 1.0
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Theory of operation
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Performance and limitations
Figure 4.2
4.2
Magnotech process - final phase
In the final phase, the number of bound nanoparticles is measured using an
optical technique based on frustrated total internal reflection.
4.2
4.2.1
Performance and limitations
Performance characteristics
Philips minicare analyzer
The analyzer can perform 10 typical tests on a partial battery charge.
The analyzer goes into sleep mode after 20 minutes of inactivity if it is not in the minicare
docking station.
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The analyzer takes 10 seconds to resume from sleep mode and be ready for testing.
The analyzer goes into deep sleep mode when it has been in sleep mode for 5 hours and is
not in the minicare docking station.
The analyzer takes 40 seconds to resume from deep sleep mode and be ready for testing.
The analyzer is designed to perform correctly at an ambient temperature between 2° C
and 27° C, at a relative humidity between 20% and 80%.
The analyzer measurement stability is ≤ 0.03% over a period of 8 minutes, starting after
the sample has filled the chambers.
The analyzer is ready to perform a test 30 seconds after the previous test.
Philips minicare analyzer
Release 1.0
System overview
4-3
4.2.2
Limitations of use
Depending on the application (duration and strength of measurement) and
the conditions (ambient temperature), the number of measurements in a
row is limited.
In case a limitation is needed, the system will detect this and will give a warning.
Refer to the Instructions for Use of the specific application cartridges for
further limitations.
[NOTE TO REVIEWERS — the information above taken from defect
sheet responses after review 1. No further information at this time. More
information about limitations of use to be provided during the verification
phase and further reviews.]
4.3
Preparation prior to use
First, ensure that the minicare analyzer docking station is properly
connected to the mains supply.
Prior to use, you must charge the minicare analyzer battery to ensure that
the minicare analyzer can function correctly when it is not docked in the
minicare docking station. A partial battery charge takes one hour; a full
battery charge takes 12 hours. For instructions on docking the minicare
analyzer to charge the battery, see section “Docking the minicare analyzer”
on page 4-5.
The system is capable of performing at least one test after one hour of
battery charging, but it is preferable to fully charge the battery before use.
4.4
Installing the data manager software
The system requires an available PC for data manager software installation.
Installation from CD
Insert the installation CD in the drive on the host PC. Follow the on-screen
instructions as the CD guides you through the installation process.
System overview
Philips minicare analyzer
Release 1.0
[12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]
Preparation prior to use
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Docking and undocking the minicare analyzer
4.5
Installation from file
Double-click the “setup.exe” installation file on the host PC. Follow the onscreen instructions as the program guides you through the installation process.
4.5
4.5.1
Docking and undocking the minicare analyzer
Docking the minicare analyzer
To establish data transfer between the minicare analyzer and data manager
software, as well as to charge the analyzer battery, the minicare analyzer
must be docked in the minicare docking station. Follow the procedure
below to dock the minicare analyzer.
• To dock the minicare analyzer, put the analyzer in the minicare docking
station so that the docking station connectors are engaged.
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Figure 4.3
Docked minicare analyzer
See section “Equipment connections” on page 3-2 for details of the connectors.
The minicare analyzer screen displays the confirmation messages “Analyzer
Docked” and “Connected”.
Philips minicare analyzer
Release 1.0
System overview
4-5
Data automatically transfers between the minicare analyzer and the data
manager software as indicated on the minicare analyzer screen. Do not
disconnect the minicare analyzer from the minicare docking station during
data transfer.
The docking station has the following status indicators.
Status light
Status
Docked/Undocked
status
White
•
The minicare analyzer is correctly docked.
Red
•
•
Mains connection status
The minicare analyzer is not correctly docked.
Please try docking the analyzer again.
White
•
•
The docking station is connected to the main
supply.
The docking station automatically charges the
minicare analyzer battery when the analyzer is
docked.
Data automatically transfers between the minicare analyzer and the data
manager software as indicated on the minicare analyzer screen. Do not
disconnect the minicare analyzer from the minicare docking station during
data transfer.
4.5.2
Undocking the minicare analyzer
• Lift the minicare analyzer out of the minicare docking station.
NOTE
System overview
When the minicare analyzer is undocked, it:
• does not receive data from the data manager software.
• does not transfer data to the data manager software.
• performs a self test.
Philips minicare analyzer
Release 1.0
[12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]
Docking and undocking the minicare analyzer
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Configuring analyzer connectivity
4.6
4.6
Configuring analyzer connectivity
Conditions:
• You must have information from your network administrator about
whether the IP address used for the analyzer is a static address or assigned
dynamically by a DHCP server.
• You must have Administrator rights for the minicare analyzer and data
manager software.
• The minicare analyzer displays “Analyzer docked”.
You must configure analyzer connectivity before you can transfer data to
and from the data manager software. You must perform configuration tasks
on both the minicare analyzer and the data manager software.
4.6.1
Configuring the minicare analyzer with a static IP address
This is the proceudre to follow on the minicare analyzer if you are assigning
a static IP address.
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Philips minicare analyzer
Release 1.0
On the minicare analyzer screen, press Menu.
If required, log on to the system.
Press Network settings.
Press Change.
To clear the warning screen, press OK.
To enter the static IP address details,
• Select Static.
• Press Next.
• Enter the IP address, using the displayed numeric pad, and then
press Next.
• Enter the Subnet mask, using the displayed numeric pad, and then
press Next.
• Enter the default gateway, using the displayed numeric pad, and then
press Next.
System overview
4-7
7
On the restart screen, press Yes.
The minicare analyzer restarts.
You can now proceed to the configuration procedure for the data manager
software, to complete the configuration.
4.6.2
Configuring the minicare analyzer with a DHCP server
This is the procedure to follow on the minicare analyzer if your network
uses a DHCP server.
On the minicare analyzer screen, press Menu.
If required, log on to the system.
Press Network settings.
Press Change.
To clear the warning screen, press OK.
Select DHCP.
Press Next.
On the restart screen, press Yes.
The minicare analyzer restarts.
Press Menu.
10
Press Network settings.
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Write down the IP address.
You can now proceed to the configuration procedure for the data manager
software, to complete the configuration.
System overview
Philips minicare analyzer
Release 1.0
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Configuring analyzer connectivity
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Configuring LIS connectivity
4.6.3
4.7
Configuring the minicare analyzer on the data manager software
After you have changed the configuration settings on the minicare analyzer,
you must ensure that the data manager software has the correct IP address
for the minicare analyzer.
Start the data manager software, and log on as an administrator.
From the System menu, select Host configuration.
Enter the minicare analyzer IP address in the Analyzer address text box.
Press OK.
The minicare analyzer is now configured to exchange data with the data
manager software.
4.7
Configuring LIS connectivity
NOTE
LIS connectivity is a complex task. Contact your local sales organization if you
require further information.
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Philips minicare analyzer
Release 1.0
System overview
4-9
The data manager software contains an LIS Configuration screen that can
be used to specify a limited number of options. You can access the LIS
Configuration screen from the data manager software, by
selecting LIS configuration from the System menu.
Figure 4.4
[1]
LIS Configuration screen
LIS enabled
Select this check box to enable communication between the data manager
software and the LIS.
[2]
Server address
The host name, IPv4 or IPv6 address of the LIS server.
[3]
Port number
The TCP port to which the LIS server should connect.
[4]
IHE/HL7 MSH parameters
These values correspond to parameters of the same name (message header)
in the IHE/HL7 MSH segment.
• Sending application
• Sending facility
System overview
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Configuring LIS connectivity
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Release 1.0
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Configuring LIS connectivity
4.7
• Receiving application
• Receiving facility
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[5]
Assigning authority
Used in the Patient ID field of the IHE/HL7 PID (patient identification)
segment.
[6]
Secure
Select this check box to enable node authentication, which means that the
data manager software and the LIS verify that they are communicating to
the correct machine.
When this box is not selected, no node authentication takes place and data
is transferred unencrypted, making it possible to intercept all sent data.
[7]
Certificate
Node authentication uses certificates to verify the identity of computers.
These certificates need to be installed on the PC, but the data manager
software needs to be told which certificate to send to the LIS when asked for
it.
[8]
Encrypt data transfer
Philips Electronics Nederland B.V.
Besides node authentication, data transfer can be made more secure by
encrypting, which happens when this box is checked. When it is not
checked, communication will happen unencrypted.
[9]
Data mapper
The data manager software uses the Symphonia library in its
implementation and as such leaves the possibility to map messages to and
from the LIS to any desired format, using a message mapping configuration.
[10]
Location
The path to the Symphonia message mapping configuration. The
configuration file must be created with Orion Health’s Map Designer tool.
[11]
Automatic transfer to LIS
When this check box is selected, any incoming analysis result that is received
from an analyzer, is automatically transferred to the LIS on the condition
that the result is complete, in other words, that there is no missing data that
must be filled in by an operator of the data manager software
Philips minicare analyzer
Release 1.0
System overview
4-11
[12]
LIS identifier mapping
This button opens a dialog box that enables editing of the cartridge and
target IDs of any installed cartridge file. These parameters manipulate the
Universal Service Identifier field in the IHE/HL7 OBR (Observation
Order) segment and the Observation Identifier in the IHE/HL7 OBX
(Observation Result) segment for cartridge and target results.
4.8
Configuring analyzer settings
Conditions:
• The minicare analyzer must be connected to the data manager software.
• You must have administrator privileges for the data manager software.
The minicare analyzer configuration settings show the analyzer currently
connected, control the language used, how the user and patient
identification process is handled, and treatment of results. The screen also
shows hardware and software information about the analyzer. For further
details, see section “Configuring the minicare analyzer” on page 12-4
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Configuring analyzer settings
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Figure 4.5
System overview
Analyzer Configuration screen
Philips minicare analyzer
Release 1.0
5
5.1
5.1.1
Operation - minicare analyzer
minicare analyzer overview
Main screen
The main screen of the minicare analyzer displays the following items.
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Figure 5.1
Main screen of the minicare analyzer
Legend
Philips minicare analyzer
Release 1.0
Date and time
Battery charge level
Current user
Main display area
Operation - minicare analyzer
5-1
5.1.2
Blood analysis workflow
Depending on your needs and available resources, you can perform tests
using the minicare analyzer in several different ways. The information below
describes the most common workflow.
Workflow step
Analyzer user interface
Identify the patient by scanning a barcode.
See section “Identifying the patient by
barcode scanning” on page 5-10 for
details.
You can also choose a patient from a list
of analysis orders that have been
transferred from the data manager
software. See section “Identifying the
patient from a list” on page 5-11 for details
Operation - minicare analyzer
Insert the cartridge.
The analyzer validates the cartridge.
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minicare analyzer overview
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Philips minicare analyzer
Release 1.0
Starting up and shutting down
Workflow step
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Add the sample and close the analyzer cap.
Wait for analysis.
View the result.
5.2
Analyzer user interface
Starting up and shutting down
5.2
Starting the minicare analyzer
5.2.1
WARNING
Philips minicare analyzer
Release 1.0
Safety awareness: do not start up the product unless you and all other users present
have read, fully understood and know all the safety information and emergency
procedures given in the SAFETY section of this Instructions for Use. Operation of the
Operation - minicare analyzer
5-3
product without having read, understood and knowing ALL the safety information and
procedures in the SAFETY section could lead to fatal or other serious personal injury.
It could also lead to clinical misdiagnosis.
Press the Power button located on the side of the minicare analyzer shown
in the figure below.
Figure 5.2
Power button
The minicare analyzer starts and performs a self-test to ensure correct
operation.
Details of the self-test are displayed on the minicare analyzer screen. During
the test, the system performs a sound check. You should hear an audible tone.
NOTE
Operation - minicare analyzer
Watch the minicare analyzer screen carefully during startup to ensure that all
elements on the screen display properly.
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Release 1.0
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Starting up and shutting down
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Starting up and shutting down
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Figure 5.3
5.2
minicare analyzer self-test screen
Wait for the minicare analyzer to finish the self-test before continuing to
operate it.
The analyzer screen indicates when the self-test is finished.
Philips Electronics Nederland B.V.
NOTE
Philips minicare analyzer
Release 1.0
The minicare analyzer performs a self-test each time that you:
• Start up the analyzer after it has been shut down (turned off).
• Undock the analyzer.
• Restart the analyzer after it has entered “sleep” or “deep sleep” mode to conserve
battery power during periods of inactivity.
Operation - minicare analyzer
5-5
5.2.2
Shutting down the minicare analyzer
The minicare analyzer can be shut down (powered off) or put into standby
mode using the Power button.
NOTE
5.3
5.3.1
The minicare analyzer cannot be shut down during certain workflow steps. [Project
team to provide details after Review 2 - not available at time of writing]
To shut down the minicare analyzer, press the Power button for a long
duration (several seconds).
To put the minicare analyzer into standby mode, press the Power button
for a short duration.
Identifying the user
Logging on
If your minicare analyzer is configured to require user logon, the Log on
screen appears after starting the system.
Operation - minicare analyzer
There are two different ways you log on and begin using the analyzer:
• To identify yourself by scanning your personal identification barcode,
press Scan.
• To identify yourself by entering your user PIN, press Manual.
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Release 1.0
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Identifying the user
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Identifying the user
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Figure 5.4
5.3
User log on screen
If you select Scan, the minicare analyzer displays “Scan Barcode.”
Philips Electronics Nederland B.V.
If you select Manual, the analyzer displays “User log on” with a numeric
keypad.
Philips minicare analyzer
Release 1.0
Log in with your personal identification barcode or your user PIN,
depending on your selection in step 1.
• Scan your personal identification barcode with the barcode reader located
on the front of the minicare analyzer, OR
• Enter your user PIN using the numeric keypad on the minicare analyzer
screen and press OK.
Operation - minicare analyzer
5-7
Figure 5.5
Log on with your user PIN
The system displays your user information on the screen after you have
successfully logged on.
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Identifying the user
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Figure 5.6
Operation - minicare analyzer
User identification on analyzer
Philips minicare analyzer
Release 1.0
Starting analysis
5.3.2
5.4
Logging out
When you are logged on and finish using the minicare analyzer, follow the
instructions below to logout:
From the minicare analyzer home screen, press Menu.
Press Logout
The analyzer screen displays “Are you sure you want to Logout?”
Press Yes.
The “User log on” screen appears.
5.4
Starting analysis
Conditions
• The minicare analyzer is docked. The analyzer screen displays “Analyzer
docked”.
The minicare analyzer may remain in docked position on the docking
station during an analysis, but it must be disconnected from the data
manager software to perform a test. Follow the steps below to terminate the
connection between the minicare analyzer and data manager software for a
docked analysis.
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Press Start to terminate the connection between the docked minicare
analyzer and the data manager software.
Press Yes to disconnect from the data manager software.
The “Identify patient” screen is displayed. See section “Identifying the
patient” on page 5-10.
Philips minicare analyzer
Release 1.0
Operation - minicare analyzer
5-9
5.5
Identifying the patient
You can identify the patient before testing by either barcode scanning or by
locating patient data in a list that has been loaded by the data manager
software. If necessary, you can also perform an anonymous test and enter
patient data later using the data manager software or using the HIS/LIS.
NOTE
5.5.1
You can cancel a test at any time by pressing Abort on the minicare analyzer screen.
By confirming cancellation, the minicare analyzer settings will be reset to Identifying
the patient. If Abort is not on the minicare analyzer screen, you can cancel the test by
removing the cartridge.
Identifying the patient by barcode scanning
Conditions
• The analyzer screen displays “Identify Patient” and the patient has a
patient identification barcode available for scanning.
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Identifying the patient
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Figure 5.7
Operation - minicare analyzer
Identify Patient screen
Philips minicare analyzer
Release 1.0
Identifying the patient
5.5
Press Scan.
The minicare analyzer displays “Scan Barcode”.
Scan the patient barcode using the scanner on the front of the minicare
analyzer.
The minicare analyzer displays the patient ID at the top of the “Ready for
use” screen.
5.5.2
Identifying the patient from a list
Conditions
• The minicare analyzer screen displays the “Identify Patient” and relevant
patient data has been transferred to the minicare analyzer from the data
manager software. See section “Transferring an analysis order to the
minicare analyzer” on page 6-15.
Press Manual on the “Identify Patient” screen.
The “Select Patient” screen appears.
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Figure 5.8
Philips minicare analyzer
Release 1.0
Select Patient screen
Operation - minicare analyzer
5-11
2
Touch the correct patient name on the list.
The selected patient name is highlighted.
Press OK.
The minicare analyzer displays the patient ID and name at the top of the
“Ready for use” screen.
If you selected the incorrect patient, press Abort and confirm your decision
by pressing Yes on the “Abort Analysis” screen to return to the “Identify
Patient” screen.
5.5.3
Performing an anonymous test
Conditions
• The minicare analyzer screen displays “Identify Patient”.
• No patient barcode is available for scanning, and the patient data has not
been transferred to the minicare analyzer from the data manager software.
Press Manual.
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Identifying the patient
The “Select Patient” screen appears.
Touch .
Press OK.
The minicare analyzer displays “Anonymous” as the patient name on the
“Ready for use” screen. The Patient ID field is left blank.
Operation - minicare analyzer
Philips minicare analyzer
Release 1.0
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Inserting a cartridge
5.6
5.6
Inserting a cartridge
Conditions
• The minicare analyzer displays the message “Ready for Use” and “Insert
Cartridge.”
NOTE
Read the assay Instructions for Use supplied with the cartridge for adding a blood
sample to the cartridge. Each assay type has specific procedures that you must follow
when collecting and handling blood samples.
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Open the cartridge chamber cap on the minicare analyzer.
Figure 5.9
Philips minicare analyzer
Release 1.0
Opening the minicare analyzer cap
Operation - minicare analyzer
5-13
2
NOTE
Insert the cartridge in the cartridge chamber as shown in the figure below.
Always be sure to insert the correct cartridge for the intended test.
Figure 5.10 Inserting a cartridge
The minicare analyzer automatically validates the cartridge, using the
information stored in the RFID tag.
If the cartridge is validated, the minicare analyzer displays “Cartridge ready”
and “Add blood sample”.
5.7
Adding a blood sample and performing a test
Conditions
• The cartridge has been inserted in and validated by the minicare analyzer.
The minicare analyzer displays “Cartridge ready” and “Add blood sample.”
NOTE
Operation - minicare analyzer
Read the assay Instructions for Use supplied with the cartridge for adding a blood
sample to the cartridge. Each assay type has specific procedures that you must follow
when collecting and handling blood samples.
Philips minicare analyzer
Release 1.0
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Adding a blood sample and performing a test
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Adding a blood sample and performing a test
5.7
The minicare analyzer can be either docked or undocked for this procedure.
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Add the blood sample to the cartridge as specified in the assay instructions.
Figure 5.11 Cartridge underfilled (left), overfilled (middle), and correctly filled (right)
The blood sample must be added to the cartridge and read by the minicare
analyzer within the time limit for the assay, otherwise the system times out
and the cartridge is no longer valid.
Close the cartridge chamber cap as soon as the blood sample is added.
The analyzer will show instructions for closing the analyzer cap and
cartridge lid
Philips Electronics Nederland B.V.
If the minicare analyzer cannot read the blood sample after a short period,
the system times out and the cartridge is no longer valid.
The cartridge registers the blood sample. There is a short waiting period
during analysis.
When the cartridge registers the blood sample, the minicare analyzer
automatically begins blood analysis.
The minicare analyzer displays “Analyzing” and the remaining time needed
for analysis.
Philips minicare analyzer
Release 1.0
The minicare analyzer completes the test and displays the analysis results.
Press Continue if you want to perform additional tests for the same analysis,
or press Finish if you do not want to perform additional tests.
Operation - minicare analyzer
5-15
5.8
Removing a cartridge
Conditions
• The minicare analyzer displays “Remove cartridge” .
Open the cartridge chamber cap on the minicare analyzer.
Pull the cartridge out of the minicare analyzer.
Dispose of the cartridge immediately as described in the assay Instructions
for Use supplied with the cartridge.
Close the minicare analyzer cap.
CAUTION
5.9
Close the cap after each use to prevent dust and other foreign particles and
substances from entering the cartridge chamber on the minicare analyzer.
Performing multiple tests
Conditions
• The Continue button has been pressed after a previous test.
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Removing a cartridge
• Certain assays require multiple tests before completing the entire analysis.
5.10
Follow the procedures described in the previous sections for inserting a
cartridge (section “Inserting a cartridge” on page 5-13), performing analysis
(section “Adding a blood sample and performing a test” on page 5-14), and
removing a cartridge (section “Removing a cartridge” on page 5-16).
Press Continue to perform additional tests.
Press Finish to complete all tests in the analysis.
Finishing a test or analysis
Conditions
• You have finished a test or multiple tests in an analysis.
• The minicare analyzer displays test results.
Operation - minicare analyzer
Philips minicare analyzer
Release 1.0
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5.10
Press Finish.
The minicare analyzer displays a confirmation message.
Press Accept to accept the results and finish the analysis. The minicare
analyzer automatically transfers the results to the data manager software.
Press Reject to reject the entire analysis.
Press Cancel to return to the previous screen and continue with the current
analysis (run additional tests).
The minicare analyzer displays “Remove cartridge.”
Remove the cartridge. See section “Removing a cartridge” on page 5-16.
Philips Electronics Nederland B.V.
If the minicare analyzer is currently docked and connected, it automatically
transfers the results to the data manager software. If the minicare analyzer is
not currently docked and connected, the results will transfer automatically
the next time it is docked and connected.
Philips minicare analyzer
Release 1.0
Operation - minicare analyzer
5-17
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Finishing a test or analysis
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Operation - minicare analyzer
Philips minicare analyzer
Release 1.0
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Operation - minicare data manager
The data manager software connects to your minicare analyzer through the
minicare docking station. It enables you to load patient data, transfer the
patient data to the minicare analyzer, transfer test results from the minicare
analyzer to the software, and then transfer analysis results to the hospital
LIS. The data manager software also provides areas for you to configure
your minicare analyzer and manage user accounts.
Security
The data manager software provides the facility for user names and
passwords to protect patient data from unauthorized access. The system also
automatically logs the user off after a period of inactivity.
For further details contact your Hospital Administrator.
6.1
6.1.1
Starting and stopping the data manager software
Starting the data manager software
Click the Windows Start menu.
Select Programs.
Select Philips Magnotech Host Software.
Click Philips Magnotech Host Software.
The Philips Magnotech Host Software logon screen appears.
6.1.2
Logging on
It is recommended that each user of the system is identifiable via a unique
user name, and that each user name is protected with a password known
only to the user. User names and passwords are usually created by your
Point of Care Coordinator or Hospital Administrator whenever a new user
name is required.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-1
Figure 6.1
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Starting and stopping the data manager software
The Data Manager Software Logon panel
Type your user name in the User Name field.
Type your password in the Password field.
Click OK.
The system opens to the Analysis orders tab.
6.1.3
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Logging off
Figure 6.2
Log off button
• Click Log off.
Your work is saved and the Logon screen is displayed for the next user.
NOTE
Operation - minicare data manager
An automatic logoff feature terminates the current user session after 15 minutes of
inactivity.
Philips minicare analyzer
Release 1.0
System overview
6.1.4
6.2
Exiting the data manager software
Follow the steps below to close the data manager software application
completely.
Figure 6.3
Exiting the data manager software
Click System
Click Exit.
The entire data manager software application closes.
6.2
System overview
The data manager software provides an environment for creating analysis
orders, transferring analyses, and managing patient analyses. There are two
main areas for managing patient data. In addition, there is an area to
manage Quality Control (QC) test results from the analyzer.
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For details on configuring data manager software settings, see section
“Configuring the data manager software” on page 12-2.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-3
Analysis orders
The Analysis orders tab displays the list of active patient orders for analysis.
Figure 6.4
Analysis orders tab
Use this area to:
• Enter and edit patient data.
• Create new orders for analysis.
• Transfer orders to the minicare analyzer.
Operation - minicare data manager
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System overview
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Philips minicare analyzer
Release 1.0
System overview
6.2
Analysis results
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The Analysis results tab displays the results of patient analyses.
Figure 6.5
Analysis results tab
Philips Electronics Nederland B.V.
Use this area to:
• View analysis results.
• Transfer analyses to the LIS.
• Edit, delete, and print analysis results.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-5
QC results tab
The QC results tab displays the results of Quality Control (QC) tests.
Figure 6.6
QC results tab
Use this area to:
• View QC test results.
• Edit, delete and export QC test results.
Operation - minicare data manager
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System overview
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Philips minicare analyzer
Release 1.0
System overview
6.2.1
6.2
Common elements
The following controls are available in all activities.
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Figure 6.7
Data manager software common elements
Legend
Navigation tabs
System menu
Help menu
Patient List
Details area
Analyzer information
Analyzer connection
User Identification
Log off button
Navigation tabs
The navigation tabs allow you to switch between the two main screens. The
navigation tabs are described in more detail later in this Instructions for Use.
See section “Analysis orders” on page 6-11 and section “Analysis results”
on page 6-16 and .
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-7
System menu
You can use the system menu to change your password or exit the system.
For additional system menu options for Hospital Administrators, see section
“Additional host software options for Administrators” on page 12-1.
Changing your password
Your first password will be configured by your Hospital Administrator. It is
advised that you change your password initially and at regular intervals as
recommended by your institution’s security guidelines.
Click System.
Select and click Change password.
The Change Password dialog appears.
NOTE
Operation - minicare data manager
Type your old password in the Old password field.
Enter your new password in the New password field.
Reenter your new password in the Reenter password field.
Click OK to confirm your password change. If you do not want to change
your password, click Cancel and your changes will not be saved.
If you forget your user name or password, contact your Hospital Administrator. If the
Hospital Administrator cannot reset the user name or password, contact Service.
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Release 1.0
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System overview
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6.2
Help menu
The help menu provides options for online assistance as well as system
information.
Help
Clicking Help opens this Instructions for Use, where you can search for
guidance on functions and features.
Online help
Clicking Online Help opens the Philips web site, where you can search for
information within the larger context of Philips.
About Magnotech Host software
Clicking About Magnotech Host software displays a window containing
the following system information:
• Version number
• Build ID
• Philips Electronics name and address
• Copyright information and date
Click Close to exit the window and return to the main screen.
Philips Electronics Nederland B.V.
Patient List
Depending on the selected tab, the Patient List displays either current orders
or analysis results. The Patient Lists are described in more detail later in this
Instructions for Use. See section “Patient List” on page 6-11 and section
“Patient List” on page 6-16.
Details area
The Details area displays more information on the patient order selected
from the Patient List. The Details areas are described in more detail later in
this Instructions for Use. See
section “Details area” on page 6-13 and section “Details area” on page
6-18.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-9
Analyzer area
The Analyzer area provides information about the minicare analyzer
connected to the data manager software. It also displays a status bar during
data transfer between the minicare analyzer and data manager software.
The message “No analyzer connected” is displayed when there is no
minicare analyzer connected to the data manager software via the minicare
docking station. When an analyzer is not connected, all options to transfer
orders to an analyzer are disabled until the connection is established.
LIS connection
The LIS connection area displays whether the data manager software is
connected to the LIS.
The message “Not available” is displayed when there is no active LIS
connection. When the LIS is not connected, all options to transfer results to
the LIS are disabled until the connection is established.
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Operation - minicare data manager
Philips minicare analyzer
Release 1.0
Analysis orders
6.3
User information
The User area displays the user name currently logged on. The User area
also contains the Log off button.
6.3
Analysis orders
The Analysis orders screen provides an overview of patient orders awaiting
or undergoing analysis.
You use the Analysis orders screen to create a new order, transfer an order
to the minicare analyzer, view and edit order details, and delete orders.
6.3.1
Patient List
The Patient List shows patient orders waiting for analysis.
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Figure 6.8
[1]
Patient List entry attributes on the Analysis orders tab
Patient ID
The unique number assigned to the patient upon admission.
[2]
Patient name
The patient’s name, in (lastname, firstname) format.
[3]
Cartridge
The type of cartridge assigned to the particular test the patient requires.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-11
[4]
Order ID
The unique ID generated by the data manager software when the order was
created.
[5]
Order date
The date the order was created.
[6]
Transferred to
The minicare analyzer the order was transferred to. If the order has not been
transferred to an analyzer, the field remains blank.
Patient List basic actions
Operation - minicare data manager
To
Do this
Sort the Patient List on an attribute in
ascending order
Click a Patient entry attribute
Sort the Patient List on an attribute in
descending order
Click a Patient entry attribute
Change the width of an attribute column
Move the pointer over the split bar. When
the pointer becomes a doubleheaded
arrow, drag the pointer to move the split bar.
Reorder Patient List attributes
Drag the attribute to a new position.
Delete patient entry
Select the patient entry and click Delete.
You must confirm your action before it is
completed. All series and associated objects
contained in the patient entry are deleted.
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Release 1.0
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Analysis orders
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Analysis orders
6.3.2
6.3
Details area
Analysis orders Details area
The Details area displays additional information on a specific order selected
from the Patient List.
Figure 6.9
[1]
Analysis orders Details area
Cartridge
The type of cartridge assigned to the particular test the patient requires.
[2]
Order ID
The unique ID generated by the data manager software when the order was
created.
[3]
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Order date
The date the order was created.
[4]
Requester
The user who created the order.
[5]
Transferred to
The name of the minicare analyzer to which the order was transferred.
[6]
Patient ID
The unique number assigned to the patient upon admission.
[7]
Last name
The patient’s last name.
[8]
First name
The patient’s first name.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-13
[9]
Date of birth
The patient’s birth date.
[10]
Gender
The patient’s sex (male or female).
6.3.3
Creating a new analysis order
Click the Analysis orders tab.
Click the New order button.
The New Order dialog box appears.
Enter the patient information for each field in the New Order dialog box.
Fields marked with an asterisk (*) are mandatory.
Figure 6.10 New Order dialog box
When all fields are complete, do one of the following:
• Click Save to save the new order in the data manager software without
transferring it to the minicare analyzer immediately.
• Click Save and transfer to transfer the order to the minicare analyzer
immediately. This option is only available when an analyzer is connected.
• Click Cancel to cancel the order. The information is deleted.
Operation - minicare data manager
Philips minicare analyzer
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Analysis orders
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Release 1.0
Analysis orders
6.3
The new order appears in the Analysis orders Patient List.
6.3.4
Transferring an analysis order to the minicare analyzer
Conditions
• An analyzer is connected.
• The analysis order saved in the Analysis orders Patient List has not
already been transferred.
If the order has not yet been created, see section “Creating a new analysis
order” on page 6-14.
• Click the Transfer button next to the patient order in the Analysis orders
Patient List.
The order transfers to the minicare analyzer and the status changes to the
minicare analyzer name. You can now select the patient for analysis from the
Patient List on the minicare analyzer.
6.3.5
Deleting an analysis order
Conditions
• An analysis order is saved in the Analysis orders Patient List.
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Click the Delete button.
A confirmation dialog appears. Click OK to complete the deletion
or Cancel to keep the order in the Analysis orders Patient List.
If the analysis order has already been transferred to the minicare analyzer, a
dialog appears advising that deleting the order from the data manager
software will not delete the order from the minicare analyzer, even if the
minicare analyzer is connected.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-15
6.4
Analysis results
The Analysis results screen provides an overview of patient analyses that
have been transferred from the minicare analyzer.
You use the Analysis results screen to view analysis results, transfer analysis
results to the LIS, as well as edit, print, and delete results.
6.4.1
Patient List
The Patient List shows results of patient analysis before being transferred to
the LIS.
Figure 6.11 Patient List entry attributes on the Analysis results tab
[1]
Patient ID
The unique number assigned to the patient upon admission.
[2]
Patient name
The patient’s name, in (lastname, firstname) format.
[3]
Cartridge
The type of cartridge assigned to the particular test the patient requires.
[4]
Order ID
The unique ID generated by the data manager software when the order was
created.
Operation - minicare data manager
Philips minicare analyzer
Release 1.0
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Analysis results
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Analysis results
[5]
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6.4
Analysis date
The date the analysis was completed on the minicare analyzer.
[6]
Status
Information whether the analysis is complete, incomplete, or rejected.
[7]
Analyzer
The name of the minicare analyzer on which the test was performed and
registered.
Philips Electronics Nederland B.V.
Patient List basic actions
Philips minicare analyzer
Release 1.0
To
Do this
Sort the Patient List on an attribute in
ascending order
Click a Patient entry attribute
Sort the Patient List on an attribute in
descending order
Click a Patient entry attribute
Change the width of an attribute column
Move the pointer over the split bar. When
the pointer becomes a doubleheaded
arrow, drag the pointer to move the split bar.
Reorder Patient List attributes
Drag the attribute to a new position.
Delete patient entry
Select the patient entry and click Delete.
You must confirm your action before it is
completed. All series and associated objects
contained in the patient entry are deleted.
Filter the results list
Click the Show field and choose the filter
method that you want to use.
Operation - minicare data manager
6-17
6.4.2
Details area
Analysis results Details area
The Details area displays additional information on a specific patient result
selected from the Patient List.
Figure 6.12 Analysis results Details area
[1]
Cartridge
The type of cartridge assigned to the particular test the patient requires.
[2]
Order ID
The unique ID generated by the data manager software when the order was
created.
[3]
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Analysis results
Order date
The date the order was created.
[4]
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Requester
The user who created the order.
[5]
Analysis date
The date the analysis was completed on the minicare analyzer.
[6]
Operator
The name of the current operator.
[7]
Patient ID
The unique number assigned to the patient upon admission.
[8]
Last name
The patient’s last name.
[9]
First name
The patient’s first name.
Operation - minicare data manager
Philips minicare analyzer
Release 1.0
Analysis results
[10]
6.4
Date of birth
The patient’s birth date.
[11]
Gender
The patient’s sex (male/female).
[12]
Remarks
Shows any remarks entered for the patient using the Edit function.
[13]
Results
Click the Details button for analysis results, including the time of each test
in the analysis as well as the result of each test.
6.4.3
Transferring analysis results from the minicare analyzer
• Dock the minicare analyzer on the minicare docking station.
Any completed test results that have not already transferred to the minicare
analyzer transfer automatically. The transfer progress appears in the Analyzer
area on the data manager software.
When the transfer is complete, all new results appear in the Analysis results
Patient List. The patient data is automatically deleted from the minicare
analyzer after it is transferred to the data manager software.
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Release 1.0
Operation - minicare data manager
6-19
Analysis results
Editing analysis results
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6.4.4
Click on a patient row in the Analysis results Patient List.
The selected result is highlighted.
Click the Edit button
The Edit Result dialog appears.
Figure 6.13 Edit Result dialog
Edit any of the patient information or add comments in the Remarks area.
Click Save to save your changes.
If you click Cancel, your changes will not be saved.
Operation - minicare data manager
Philips minicare analyzer
Release 1.0
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Analysis results
6.4.5
6.4
Printing analysis results
Condition: a printer is configured for your workstation.
Click on a patient row in the Analysis results Patient List.
The selected result is highlighted.
Click the Print button
The Windows Print dialog appears.
Select the printer from the list and click Print.
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Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-21
Analysis results
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Transferring analysis results to the LIS
6.4.6
You can transfer results to a LIS using the Transfer button.
Condition: LIS connectivity must be enabled.
Figure 6.14 Transfer button on the Analysis results tab
• On the Analysis results tab, press the Transfer button next to the result that
you want to transfer.
Operation - minicare data manager
Philips minicare analyzer
Release 1.0
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QC results
6.5
6.5
QC results
The QC results screen provides an overview of QC tests that have been
transferred from the minicare analyzer.
You use the QC results screen to view QC test analysis results, export
analysis results, as well as edit remarks and delete results.
6.5.1
QC results list
The QC results list shows results of QC tests before being exported or deleted.
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Figure 6.15 QC results entry attributes on the QC results tab
[1]
Reagent ID
The number assigned to the reagent.
[2]
Cartridge
The type of cartridge assigned to the particular test.
[3]
Order ID
The unique ID generated by the data manager software when the order was
created.
[4]
Analysis date
The date the QC test analysis was completed on the minicare analyzer.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-23
[5]
Analyzer
The name of the minicare analyzer on which the test was performed and
registered.
QC results list basic actions
6.5.2
To
Do this
Sort the QC results list on an attribute in
ascending order
Click QC entry attribute
Sort the QC results list on an attribute in
descending order
Click a QC entry attribute
Change the width of an attribute column
Move the pointer over the split bar. When
the pointer becomes a doubleheaded
arrow, drag the pointer to move the split bar.
Reorder QC results list attributes
Drag the attribute to a new position.
Delete QC test entry
Select the QC result entry and click Delete.
You must confirm your action before it is
completed. All series and associated objects
contained in the entry are deleted.
Filter the results list
Click the Show field and choose the filter
method that you want to use.
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QC results
Additional QC results options
Details area
The Details area shows any remarks that have been written when you
highlight a specific QC result selected from the list.
Transferring results from the minicare analyzer
Dock the minicare analyzer on the minicare docking station as you would
when transferring analysis results. See section “Transferring analysis results
from the minicare analyzer” on page 6-19.
Any completed QC test results that have not already transferred to the
minicare analyzer transfer automatically. The transfer progress appears in
the Analyzer area on the data manager software.
When the transfer is complete, all new results appear in the QC test results
list.
Operation - minicare data manager
Philips minicare analyzer
Release 1.0
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QC results
6.5
Editing QC results remarks
Click the Edit Remarks button below the results list. Click Save to save
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your changes and return to the patient list.
Exporting QC results
Click the Export button. You can then select where you would like to save
Philips Electronics Nederland B.V.
your results in Microsoft Excel format.
Philips minicare analyzer
Release 1.0
Operation - minicare data manager
6-25
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QC results
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Operation - minicare data manager
Philips minicare analyzer
Release 1.0
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7.1
7.1.1
System messages and troubleshooting
System and error messages
Philips minicare analyzer
Message number
Category
Description
Action
1000
Analyzer Failure
Measuring unit power off failed.
Please try again. If the problem persists
contact your local representative.
1001
Analyzer Failure
Measuring unit power on failed with code
'{0}'.
Please try again. If the problem persists
contact your local representative.
1100
Analyzer Failure
Failure during cartridge detection.
Please try again. If the problem persists
contact your local representative.
1101
Cartridge Failure
Cartridge expired on '{0}'.
Please use another cartridge
1102
Workflow Failure
Cartridge has been used before.
Please use another cartridge.
1103
Workflow Failure
Cartridge '{0}' is not supported by analyzer.
Install the cartridge using host software or
use a supported cartridge type.
1104
Workflow Failure
The selected patient requires cartridge '{0}'.
Inserted cartridge is '{1}'.
Use cartridge '{0}'.
1105
Workflow Failure
Cartridge was removed during analysis. The
analysis has been aborted.
Please try again.
1106
Cartridge Failure
Cartridge is invalid.
Use another cartridge.
1107
Analyzer Failure
Access to protocol for cartridge '{0}' failed.
Please try again. If the problem persists
contact your local representative.
1108
Cartridge Failure
Cartridge is invalid.
Use another cartridge.
1109
Analyzer Failure
Cartridge configuration is invalid.
Please contact your local representative.
1110
Power Failure
Battery level too low for cartridge
measurement. The analyzer has stopped
operation.
Please charge the analyzer and then retry
the cartridge measurement.
1200
Analyzer Failure
RFID hardware failed.
Please try again. If the problem persists
contact your local representative.
1201
Cartridge Failure
Invalid RFID format.
Use another cartridge.
1202
Cartridge Failure
RFID version '{0}' is not supported.
Use another cartridge.
1203
Cartridge Failure
Cartridge RFID could not be read.
Remove cartridge and try again.
Philips minicare analyzer
Release 1.0
System messages and troubleshooting
7-1
Action
Temperature hardware failed.
Please try again. If the problem persists
contact your local representative.
Sample detection hardware failed.
Please try again. If the problem persists
contact your local representative.
Sample timeout.
Please apply sample within '{0}' seconds and
apply sufficient volume of sample.
A sample was added before target
temperature was reached.
Please add sample after analyzer reaches
target temperature.
Target temperature '{0}' out of analyzer
range.
Cartridge '{1}' cannot be measured on this
analyzer. Contact your local representative.
Frame capturing hardware failed.
Please try again. If the problem persists
contact your local representative.
Update of firmware failed. The analyzer has
stopped operation.
Please reset the analyzer to retry the
firmware update.
Update of firmware failed. The previous
Please retry the firmware update using the
version is running and the upgrade is aborted. host software.
Battery level too low for firmware upgrade.
The analyzer has stopped operation.
Please charge the analyzer and then retry
the firmware update.
Self test failed with code '{0}'. The analyzer
will not allow to perform an analysis.
Try to reset the analyzer. If the problem
persists contact your local representative.
Result calculation failed.
Contact your local representative.
Image of the cartridge is invalid.
Please try another cartridge.
Sample did not reach the measurement
chamber within the maximum '{0}' seconds.
Please try another cartridge. Make sure
sufficient blood is applied.
Measurement hardware failed.
Please try again. If the problem persists
contact your local representative.
Temperature was too low during
measurement.
Please try another cartridge.
Temperature was too high during
measurement.
Please try another cartridge.
Data processing has failed.
Please try another cartridge.
Measurement failed.
Please try again. If the problem persists
contact your local representative.
Storage of new measurement results is full.
Synchronize the analyzer with the Host
software to free storage.
Philips minicare analyzer
Release 1.0
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Description
Philips Electronics Nederland B.V.
7.1
System and error messages
Category
10Message number
111300
Analyzer Failure
12
13
1302
Analyzer Failure
14
15
Workflow Failure
161303
17
181304
Workflow Failure
19
20
1305
Cartridge Failure
21
22
Analyzer Failure
231350
24
251400
Update Failure
26
271401
Update Failure
28
29
Update Failure
301402
31
321410
Analyzer Failure
33
341500
Analyzer Failure
35
Analyzer Failure
361600
371601
Cartridge Failure
38
391602
Analyzer Failure
40
41
Analyzer Failure
421603
43
441604
Analyzer Failure
45
461605
Analyzer Failure
47
Analyzer Failure
481606
49
501700
Workflow Failure
51
52
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System and error messages
7.1
Message number
Category
Description
Action
1800
Analyzer Failure
Cap hardware failed.
Please try again. If the problem persists
contact your local representative.
1801
Workflow Failure
Cap not closed on time.
Please try again. Make sure to close the cap
when prompted.
1900
Analyzer Failure
Power button hardware failed.
Please try again. If the problem persists
contact your local representative.
2000
Barcode Failure
Unable to scan barcode.
Please try again. If the problem persists
contact your local representative.
2100
Analyzer Failure
Battery hardware failed.
Please try again. If the problem persists
contact your local representative.
2200
Hardware failure
Unable to detect docking station.
Try to reset the analyzer. If the problem
persists contact your local representative.
9000
Critical Error
Critical error '{0}' occurred. The analyzer
has stopped.
Try to reset the analyzer. If the problem
persists contact your local representative.
9001
Critical Error
Data access failed. The analyzer has stopped. Try to reset the analyzer. If the problem
persists contact your local representative.
7.1.2
Data manager software
Error messages
Number
Category
Description
Action
TBD
Analyzer Cartridge
Not Compatible
Cartridge file '{0}' is not compatible with
the current analyzer.
Contact the POC administrator to check
the software version of the analyzer and to
provide compatible cartridge file.
TBD
Analyzer
Communication
Incompatibility
Analyzer and Magnotech Host Software
incompatibility detected.
Contact the POC Administrator to check
the versions of the analyzer and Magnotech
Host Software.
TBD
Analyzer
Connection
Exception
Connection with analyzer lost during
communication.
Try docking the analyzer to reestablish the
connection.
TBD
Analyzer Firmware
File Not Found
The analyzer firmware update pack '{0}'
could not be found.
Contact the POC administrator to make
sure the firmware update pack exists and
sufficient permissions to access the file are
available.
Philips minicare analyzer
Release 1.0
System messages and troubleshooting
7-3
Action
An unexpected problem with the analyzer
has occurred. The analyzer cannot perform
the requested action.
Try to reset the analyzer and/or the
Magnotech Host Software. If the problem
persists contact the POC administrator.
The analyzer language pack '{0}' could not
be found.
Contact the POC Administrator to make
sure that the selected analyzer language
pack is installed in the Magnotech Host
Software.
Unable to install this language on the
analyzer. This language is currently active.
To update the active language, change the
active language to another language and
back again.
Invalid analyzer language pack '{0}'.
Contact the POC Administrator to reinstall
the analyzer language pack.
Failed to transfer order '{0}' to the analyzer.
Try to restart the analyzer and retransmit
the order. If the problem persists contact
the POC administrator.
Order '{0}' cannot be transferred to the
analyzer due to missing cartridge '{1}' on
the analyzer.
Contact the POC Administrator to add
cartridge '{1}' to the analyzer. This can be
done in the Analyzer Configuration screen.
Failed to transfer result '{0}' from the
analyzer.
Try to restart the analyzer. Docking the
analyzer automatically retries the result
transmission. If the problem persists
contact the POC administrator.
Load settings failed because of the following
reason : {0}
Save settings failed because of the following
reason : {0}
Failed to synchronize date and time with
the analyzer.
Try to restart the analyzer. Docking the
analyzer automatically synchronizes the date
and time. If the problem persists contact
the POC administrator.
Failed to synchronize time zone with the
analyzer.
Try to restart the analyzer. Docking the
analyzer automatically synchronizes the
time zone if needed. If the problem persists
contact the POC administrator.
Failed to synchronize users list with the
analyzer.
Try to restart the analyzer. Docking the
analyzer automatically synchronizes the
users list. If the problem persists contact
the POC administrator.
–
No action is necessary.
Philips minicare analyzer
Release 1.0
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Description
Philips Electronics Nederland B.V.
7.1
System and error messages
Category
10Number
11TBD
Analyzer General
12
13
14
TBD
Analyzer Language
15
File Not Found
16
17
18
Analyzer Language In
19TBD
Use
20
21
Analyzer Language
22TBD
Invalid File
23
24TBD
Analyzer Order
25
Adding Failed
26
27
TBD
Analyzer Order
28
Cartridge Not
29
Supported
30
Analyzer Results
31TBD
Receiving Failed
32
33
34
Analyzer Settings
35TBD
Cannot Be Saved
36
37TBD
Analyzer Time Date
38
Synchronization
39
Failed
40
41TBD
Analyzer Time Zone
42
Synchronization
43
Failed
44
45
Analyzer Users
46TBD
Synchronization
47
Failed
48
49
Cartridge Already
50TBD
Exists
51
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System messages and troubleshooting
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System and error messages
7.1
Number
Category
Description
TBD
Cartridge Already In
Use
Cannot remove Cartridge '{0}'. Orders have First process the orders on the analyzer to
been sent to an analyzer.
generate results or delete the orders from
the analyzer, before removing the cartridge.
TBD
Cartridge Invalid
The selected cartridge file '{0}' is not valid.
TBD
Cartridge Not Found The analyzer cartridge '{0}' could not be
found.
TBD
Cartridge Not
Installed In HS
Cartridge "{0}-{1}" is not installed on HS.
TBD
Cartridge Xml
Problem
Cartridge '{0}' could not be transferred to
the analyzer, due to internal XML problem.
Contact the POC administrator to inspect
the log files.
TBD
Configuration
Setting Key Does
Not Exist
Failed to read/write setting '{0}' from/to the
configuration.
Please contact the POC administrator. The
log file contains further details. An uninstall
and install of the Magnotech Host Software
will repair the configuration file.
TBD
Configuration
Setting Save Failed
Saving configuration setting '{0}' failed.
Contact the POC administrator.
TBD
Database Cartridges
Problem
Failed to store or retrieve cartridge
information.
Contact the POC administrator and inspect
the logs for further details.
TBD
Database Orders
Problem
Failed to store or retrieve order information. Contact the POC administrator and inspect
the logs for further details.
TBD
Database Results
Problem
Failed to store or retrieve result information. Contact the POC administrator and inspect
the logs for further details.
TBD
Database Settings
Problem
Failed to store or retrieve setting
information.
Contact the POC administrator and inspect
the logs for further details.
TBD
Database Users
Problem
Failed to store or retrieve user information.
Contact the POC administrator and inspect
the logs for further details.
TBD
General Unhandled
Analyzer
Unexpected problem in background
communication with analyzer.
Try restarting the computer. If the problem
persists contact the POC Administrator.
The log file contains further details.
TBD
General Unhandled
Application
An unexpected problem occurred. The
Magnotech Host Software will now close.
Try restarting the computer. Please contact
the POC administrator to inspect the log
files for further analysis.
Philips minicare analyzer
Release 1.0
Action
Contact the POC Administrator to obtain a
valid cartridge file.
Contact the POC administrator to make
sure that the cartridge file still exists and
sufficient permissions to access the file are
available.
System messages and troubleshooting
7-5
Action
Unexpected problem in background
communication with the LIS.
Try restarting the computer. If the problem
persists contact the POC Administrator.
The log file contains further details.
The help file cannot be opened.
Contact the POC administrator to reinstall
the Magnotech Host Software installation.
This will repair the help file.
An unexpected message from the LIS was
received. Message for order {0} received
while waiting for a message for order {1}
Contact the POC administrator to inform
something is wrong with the LIS
communication.
An acknowledge from the LIS was not
received for analysis result '{0}'.
Try to resend the result. If the problem
persists, contact the POC administrator to
check LIS availability.
Invalid certificate '{0}' for secure LIS
communication.
Contact the POC administrator to make
sure the certificate is a valid X509 certificate.
A 'secure' connection with the LIS could
not be established. The Magnotech Host
Software will keep trying to connect.
Contact the POC administrator to check
the certificate in the LIS settings.
Connection with the LIS could not be
established. The Magnotech Host Software
will keep trying to connect until the set
amount of retries is reached.
Contact the POC administrator to check
the LIS settings.
An invalid message received from the LIS.
The message is not a valid HL7 message.
Contact the POC administrator to inform
something is wrong with the LIS
communication. The log file contain more
details.
Result '{0}' could not be transferred to the
LIS. An internal HL7 message parsing error
occurred.
Contact the POC administrator to inspect
the details in the log file.
Failed to tranfer result '{0}' to the LIS. The
data mapper could not map the result
message.
Contact the POC administrator to inspect
the logs for futher details.
Invalid HL7 message: {0}
Contact the POC administrator.
The data mapper configuration file '{0}'
could not be found.
Contact the POC administrator to make
sure the data mapper configuration file
exists and sufficient permissions to access
the file are available.
Philips minicare analyzer
Release 1.0
[12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]
Description
Philips Electronics Nederland B.V.
7.1
System and error messages
Category
10Number
11TBD
General Unhandled
12
Lis
13
14
TBD
Help File Not Found
15
16
17
Lis Ack Does Not
18TBD
Match
19
20
Lis Ack Time Out
21TBD
22
23
24TBD
Lis Certificate Invalid
25
26
TBD
LisConnectionAuthe
27
ntication
28
29
Lis Connection
30TBD
31
32
33
Lis Could Not Parse
34TBD
Lis Message
35
36
37
38TBD
Lis Hl7 Conversion
39
40
41TBD
Lis Hl7 Mapping
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Error
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Lis Invalid HL7
45TBD
Message Error
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Lis Mapper
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Configuration File
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Not Found
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System and error messages
7.1
Number
Category
Description
Action
TBD
Lis Mapper
Configuration Invalid
Invalid data mapper configuration file '{0}'.
Contact the POC administrator to make
sure a valid OrionHealth Symphonia HL7
mapper configuration file is selected.
TBD
Lis No Symphonia
License
No valid Symphonia runtime license is
available
Contact the POC administrator to install a
valid Symphonia runtime license.
TBD
Lis No Symphonia
Mapper License
No valid Symphonia Mapper runtime license
is available
Contact the POC administrator to install a
valid Symphonia Mapper runtime license.
TBD
Login Incorrect
User name or password invalid.
Please enter a valid combination of user
name and password.
TBD
Login User Blocked
User '{0}' is blocked.
Please contact an administrator to unblock
your account.
TBD
Order Xml Problem
Order '{0}' could not be transferred to the
analyzer, due to internal XML problem.
Contact the POC administrator to inspect
the log files.
TBD
Result Xml Problem
Result '{0}' could not be transferred from
the analyzer, due to internal XML problem.
Contact the POC administrator to inspect
the log files.
TBD
Service Data Too
Large
The service data could not be retrieved,
because it is too large.
Retrieve the service data via the file system
of the analyzer (only possible when access is
granted).
TBD
Start Up
Configuration Not
Found
The Magnotech Host Software
configuration is missing or broken. The
application will now close.
Contact the POC administrator to reinstall
the software. The configuration will be
repaired.
TBD
Start Up
Configuration
Setting Wrong
Version
The Magnotech Host Software
configuration has an incompatible version.
The application will now close. Current
version = {0} Expected version = {1}
Contact the POC administrator to reinstall
the software. The configuration will be
repaired.
TBD
Start Up Error App
Already Running
The user interface is already running.
Please use the user interface that is already
running.
TBD
Start Up Error Back
End Connect
Connection to the Magnotech Host
Software Service could not be made. The
user interface will now close.
Try restarting the computer. If the problem
persists, please contact the POC
administrator.
TBD
Start Up Error No
Database Access
The Magnotech Host Software Service
Contact the POC administrator to make
could not initialize the database. The service sure that the Windows service 'SQL Server
will now close.
(HIP)' is running or try restarting the
computer. The log file may contain more
detailed information.
TBD
Start Up Error No
Database Space
Insufficient database space. The Magnotech
Host Software will now close.
Philips minicare analyzer
Release 1.0
Contact the POC administrator to free
database space.
System messages and troubleshooting
7-7
Contact the POC administrator to free disk
space.
Contact the POC administrator to reinstall
the Magnotech Host Software installation.
Contact the POC administrator.
Contact the POC administrator.
Contact the POC administrator to check
the logs for details. Restart the computer
and restart Magnotech Host Software.
Contact the POC administrator to inspect
the log files.
Please select an existing directory with
write access.
Contact the POC administrator. A
customized 'Decimal symbol' and 'Digit
grouping symbol' for US English in the
Regional Settings of the Control Panel is not
supported. Use a dot for the 'Decimal
symbol' and a comma for 'Digit grouping
symbol'. The user interface should now start.
Action
It may take a few minutes for the analyzer
to become available again. The analyzer will
reconnect automatically.
Contact the POC administrator to obtain a
valid firmware update pack.
Philips minicare analyzer
Release 1.0
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Action
Philips Electronics Nederland B.V.
7.1
System and error messages
Category
Description
10Number
11TBD
Start Up Error No
Insufficient disk space on drive '{0}'. The
12
Disk Space
minimum disk space level is '{1}' bytes. The
13
Magnotech Host Software will now close.
14
TBD
Start Up Error No
15
Host Languages
16
Start Up Error
Could not retrieve security keys required to
17TBD
Security Keys Missing communicate with the analyzer. The
18
software will now close.
19
20TBD
Start Up Error
Incompatible database version detected.
Wrong Database
Current version = {0} Expected version =
21
Scheme
{1} The Magnotech Host Software will now
22
close.
23
24TBD
Unhandled Exception The Magnotech Host Software user
25
interface caught an unexpected exception
26
and will now shutdown.
27
TBD
User Xml Problem
User '{0}' could not be transferred to or
28
from the analyzer, due to internal XML
29
problem.
30
Write To Selected
Failed to write to selected directory '{0}'.
31TBD
Directory
Not
The directory does not exist or writing is
32
Successful
not permitted.
33
Xml Parse Exception Failed to load the views of the user interface.
34TBD
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Warning messages
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Category
Description
44Number
45TBD
Analyzer Expected
The analyzer performed a reboot to
46
Reboot
effectuate analyzer setting changes. Changes
that require a reboot are installation of
47
analyzer languages, firmware updates and
48
time zone synchronization.
49
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Analyzer Firmware
The firmware update pack '{0}' is invalid and
51
Invalid
cannot be used.
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System and error messages
7.1
Number
Category
Description
Action
TBD
Analyzer Firmware
Upgrade Not
Compatible
The firmware update pack '{0}' is not
compatible with the connected analyzer.
Contact the POC administrator to check
the compatibility of the firmware update
pack.
TBD
Analyzer Firmware
Upgrade Not
Possible
It is not safe to perform an analyzer
firmware update at this moment.
Retry the firmware update when the
battery is not empty and the analyzer is not
executing a measurement, booting or
performing a self test.
TBD
Analyzer Language
Invalid Language
The selected language '{0}' is not a valid
language code supported by the analyzer.
Contact the POC administrator.
TBD
Analyzer Language
Not Compatible
Language Pack '{0}' is not compatible with
current analyzer.
Contact the POC administrator to provide
compatible language packs for the analyzer.
TBD
Analyzer No Service
Data
No service data is available on the analyzer.
This is normal behavior when no
measurements are performed.
TBD
Analyzer Order
Already Exists
Order '{0}' already exists on analyzer '{1}'.
The order was already transferred to this
analyzer.
TBD
Analyzer Result
Already Exists
Result for order '{0}' already available.
A result cannot be overwritten.
TBD
Analyzer Start
Failed to communicate with the analyzer on
address '{0}'.
Contact the POC Administrator to
configure the IP address in the Host
Configuration menu.
TBD
Language Changed
Restart Needed
Restart the User Interface to make the
language change visible.
Please restart the user interface.
TBD
Number Of Users
With Access Code
Zero
The last user with an access code has been
removed. If User Logon is enabled for your
analyzers, it will not be possible anymore to
logon the analyzer.
Add access codes to the users who need to
operate the analyzer or disable 'User logon'
for the analyzer.
TBD
StartUp Warning No No cartridges found. Creating orders is not
Cartridges
possible.
Contact the POC administrator to install
one or more cartridges in the Magnotech
Host Software.
TBD
Start Up Warning
No Database Space
Database space is low.
Contact the POC administrator to free
database space.
TBD
Start Up Warning
No Disk Space
Low disk space on drive '{0}'. Warning disk
space level is '{1}' bytes. The Magnotech
Host Software will continue.
Contact the POC administrator to free disk
space.
TBD
Warning Max Idle
The configuration contains an incorrect
Time Incorrect Value value for the automatic logoff function.
Key='{0}'
Philips minicare analyzer
Release 1.0
Contact the POC administrator. Use value
0 to disable automatic logout or specify the
number of seconds.
System messages and troubleshooting
7-9
7.2
Contacting Service
When assistance is needed with your minicare analyzer, contact your local
Philips Electronics representative.
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Contacting Service
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System messages and troubleshooting
Philips minicare analyzer
Release 1.0
8
8.1
Maintenance
Cleaning and disinfection
Use only the Philips-approved substances and methods listed in this chapter
to clean or disinfect your equipment. Warranty does not cover damage
caused by using unapproved substances or methods. Philips makes no claims
regarding the efficacy of the listed chemicals or methods as a means for
controlling infection. Consult your hospital’s Infection Control Officer or
Epidemiologist.
For comprehensive details on cleaning agents and their efficacy refer to
“Guidelines for Prevention of Transmission of Human Immunodeficiency
Virus and Hepatitis B Virus to Health Care and Public-Safety Workers”
issued by the U.S. Department of Health and Human Services, Public
Health Service, Centers for Disease Control, Atlanta, Georgia, February
1989. See also any local policies that apply within your hospital, and country.
General points
Keep your minicare analyzer, docking station, associated cables, and any
accessories free of dust and dirt. After cleaning and disinfection, check the
equipment carefully. Do not use if you see signs of deterioration or damage.
If you need to return any equipment to Philips, decontaminate it first.
Observe the following general precautions:
• Always dilute according to the manufacturer’s instructions or use lowest
possible concentration.
• Do not allow liquid to enter the minicare analyzer or docking station case.
• Do not immerse any part of the equipment or any accessories in liquid.
• Do not pour liquid onto the system.
• Never use abrasive material (such as steel wool or silver polish).
• Never use bleach.
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Philips minicare analyzer
Release 1.0
Maintenance
8-1
Sterilization
Sterilization is not recommended for this analyzer, docking station, related
products, accessories, or supplies unless otherwise indicated in the
Instructions for Use that accompany the accessories and supplies.
WARNINGS
•
•
•
•
CAUTION
8.1.1
If you spill liquid on the equipment, battery, or accessories, or they are
accidentally immersed in liquid, contact your service personnel or Philips service
engineer. Do not operate the equipment before it has been tested and approved
for further use.
Always isolate the product from the mains electrical supply before cleaning,
disinfecting, or sterilizing to prevent electric shocks.
Strictly follow cleaning and disinfection guidelines to ensure that patient is not
exposed to infections.
Cleaning and disinfection techniques for the product must comply with all
applicable local laws and regulations.
Never allow water or other liquids to enter the product, since these may cause
electrical short-circuits or metal corrosion.
Cleaning the minicare analyzer
Clean with a lint-free cloth, moistened with warm water (40°C/104°F
maximum) and soap, a diluted non-caustic detergent, tenside, ammonia- or
alcohol-based cleaning agent. Do not use strong solvents such as acetone or
trichloroethylene.
Take extra care when cleaning the minicare analyzer screen because it is
more sensitive to rough cleaning methods than the housing.
Do not permit any liquid to enter the analyzer housing case and avoid
pouring it on the minicare analyzer while cleaning. Do not allow water or
cleaning solution to enter the measurement connectors. Wipe around, not
over, connector sockets.
Maintenance
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Cleaning and disinfection
Philips minicare analyzer
Release 1.0
Philips Electronics Nederland B.V.
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Cleaning and disinfection
8.1
The minicare analyzer/cartridge interface should only be cleaned by an
approved tool.
CAUTION
To clean the touch-enabled display, disable the touch operation by switching off the
analyzer.
Recommended cleaning agents
• Tensides (dishwasher detergents) Edisonite Schnellreiniger®, Alconox®
• Ammonias Dilution of Ammonia <3%, Window cleaner
• Alcohol Ethanol 70%, Isopropanol 70%, Window cleaner
8.1.2
Disinfecting the minicare analyzer
Those parts of the minicare analyzer that are suitable for such treatment,
including accessories and connecting cables, can be disinfected by wiping
with a cloth dampened with a suitable agent. Never use corrosive or solvent
disinfectants or sterilizing agents. If you are not sure about the properties of
a disinfectant or sterilizing agent, do not use it.
Hospital policy
Disinfect the product as determined by your hospital’s policy, to avoid long
term damage to the product.
Base approved agents
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Clean equipment before disinfecting. Recommended types of disinfecting
agents are:
• Alcohol Ethanol up to 70%
• 1- and 2- Propanol up to 70%
• Aldehyde Glutaraldehyde up to 3.6%
Philips minicare analyzer
Release 1.0
Maintenance
8-3
WARNING
CAUTIONS
Do not use flammable or potentially explosive disinfecting sprays. Such sprays create
vapors, which can ignite, causing fatal or other serious personal injury.
•
•
8.1.3
Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases
may result.
Disinfecting a medical equipment room by means of sprays is not recommended
since the vapor can penetrate the equipment causing electrical short-circuits or
corrosion.
Cleaning the battery in the battery compartment
Wipe with a lint-free cloth, moistened with warm water (40°C/104°F
maximum) and soap. Do not use strong solvents.
Do not soak the battery.
8.2
Planned maintenance and user routine checks
This product requires proper operation, planned maintenance, and checks
the user must perform routinely, which are essential to keep the product
operating safely, effectively and reliably.
8.2.1
Planned maintenance program
Planned maintenance may only be carried out by qualified and authorized
personnel, and is comprehensively described in the service documentation.
Philips provides a full planned maintenance and repair service on both a call
basis and a contract basis. Full details are available from your Philips Service
Organization.
A summary of the preventive maintenance program appears in the table below.
Where the user carries out planned maintenance, he or she should always
take all practical steps to make sure that the Planned Maintenance Program
is fully up to date before using the product with a patient.
Maintenance
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Release 1.0
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Planned maintenance and user routine checks
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8.2
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Quality control
8.3
Preventive maintenance is to be performed on a regular basis.
Check
Actions
Frequency
[NOTE TO REVIEWERS: Project team to provide details after Review 2]
8.2.2
User routine checks program
The user of the product must institute a User Routine Checks Program as
detailed in the table below. The user of the product shall make sure that all
checks and actions have been satisfactorily completed before using the
product for its intended purpose
Check
Actions
Frequency
[NOTE TO REVIEWERS: Project team to provide details after Review 2]
NOTE
8.3
Perform visual and/or audible checks during routine use.
Quality control
You can perform a Quality control (QC) test to ensure that the minicare
analyzer results are as accurate as possible. The test procedure is described
below.
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QC test results are transferred to the data manager when the minicare
analyzer is docked. For details of viewing and exporting stored QC test
results, see section “QC results” on page 6-23.
Philips minicare analyzer
Release 1.0
Maintenance
8-5
8.3.1
QC test workflow
The information below describes the QC test workflow.
Workflow step
Maintenance
Analyzer user interface
Identify the reagent by either scanning or entering the
reagent identification manually.
Scan the barcode on the reagent sample label (or
enter identification number manually).
Insert the cartridge.
The analyzer validates the cartridge.
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Quality control
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Philips minicare analyzer
Release 1.0
Quality control
Workflow step
Philips Electronics Nederland B.V.
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Philips minicare analyzer
Release 1.0
Insert test reagent sample.
Close the analyzer cap.
Wait for analysis.
View result.
8.3
Analyzer user interface
Maintenance
8-7
8.3.2
Performing a QC test
The QC test is performed in a similar manner to the blood analysis test.
Log on to the analyzer by scanning your user ID barcode or entering your PIN.
See section “Logging on” on page 5-6.
Press Menu from the “Identify Patient” screen.
Press Perform QC Test.
Select the method for identifying the test reagent.
• Press Scan if you want to scan the test reagent barcode.
• Press Manual if you want to enter the test reagent identification number
manually.
Identify the test reagent.
• Scan the test reagent identification barcode on the test reagent packaging
or label.
• Enter the test reagent identification number using the numeric keypad.
The analyzer will confirm the test reagent identification number.
When the “Ready for use” screen appears, insert a new cartridge.
See section “Inserting a cartridge” on page 5-13.
The “Cartridge ready” screen appears.
Add the test reagent sample to the cartridge, close the cartridge cap, and
press Proceed to start the analysis.
The analyzer begins the analysis. The screen displays “Analyzing” and
estimated analysis time remaining.
Maintenance
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Quality control
The analyzer displays test results. Press Finish.
Philips minicare analyzer
Release 1.0
Philips Electronics Nederland B.V.
8.3
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Antivirus protection
10
8.4
8.4
The analyzer asks if you want to finish the current measurement. Select one
of the following options:
• Press Cancel to go back to the “Test result” screen.
• Press Reject to delete the QC test you just performed. Your results are
not saved.
• Press Accept to save the QC test results. When the analyzer is docked the
results will transfer to the QC results area of data manager software.
Remove the cartridge and close the analyzer cap.
Antivirus protection
We recommend that the data manager software system is equipped with
antivirus software, which is designed to detect viruses on your system, and
to deny access to infected files before they can do any damage.
Antivirus definitions should be updated on a regular basis. The majority of
antivirus software automatically checks for updated virus definition files at
system startup and implements them, if available.
NOTE
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For optimal protection, it is advisable to restart the system as soon as new virus
definitions are loaded onto the system.
Malware
Although the system incorporates protection mechanisms to protect it
against the intrusion of malware, a remote possibility remains that a system
could become infected. If you notice that unfamiliar system behavior or
performance occurs repeatedly, including after the system has been switched
off and on again, you are advised to call Service to have the system checked
and, if needed, cleaned of malware.
Philips minicare analyzer
Release 1.0
Maintenance
8-9
8.5
After-sales support
For the following services, please contact your local Philips Electronics
representative.
• List of uses and applications
• Possibility of extension
• Service and assistance
• Warranty
• Replacement battery
NOTE
The minicare analyzer and docking station have no replaceable parts apart from the
minicare analyzer battery.
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After-sales support
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Maintenance
Philips minicare analyzer
Release 1.0
9
Product disposal
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Philips Electronics is concerned to help protect the natural environment and
to help ensure continued safe and effective use of the this product through
proper support, maintenance and training. Therefore Philips products are
designed and manufactured to comply with relevant guidelines for
environmental protection. As long as the product is properly operated and
maintained it presents no environmental risks. However, the product may
contain material[s] which could be harmful to the environment if disposed
of incorrectly. Use of such material[s] is essential to performing the
functions of the product, and for meeting statutory and other requirements.
This section of this Instructions for Use is directed mainly at the user of the
equipment or system, the body with legal authority over the equipment.
Operators are not usually involved in disposal, except in the case of certain
batteries (see section section “Fitting, removing and disposing of batteries”
on page 9-2).
Passing this product on to another user
Philips Electronics Nederland B.V.
9.1
If this product passes to another user, it must be in its complete state,
including all product support documentation.
Make the new user aware of the support services that Philips Medical
Systems provides for installing, commissioning and maintaining the product.
Before passing on the product or taking it out of service, all patient data
must be backed up elsewhere if necessary, and then be deleted on the product.
It must be remembered by all existing users that passing on medical
electrical products to new users may create serious technical, medical and
legal (for example, privacy) risks. Such risks can arise even if the product is
given away. Existing users are strongly advised to seek advice from their local
Philips Medical Systems representative before committing themselves to
passing on any product. Alternatively, contact the manufacturer.
Philips minicare analyzer
Release 1.0
Product disposal
9-1
Once the product has been passed on to a new user, a previous user may still
receive important safety-related information, such as bulletins and field
change orders. In many jurisdictions there is a clear duty on the previous
user to communicate such safety-related information to new users. Previous
users who are not able or prepared to do this should inform Philips Medical
Systems about the new user, so that Philips Medical Systems can provide the
new user with safety-related information.
9.2
Final disposal of this product
Final disposal is when the user disposes of the equipment or system in such
a way that it can no longer be used for its intended purposes.
The minicare analyzer and minicare docking station comply with the EU
directive 2002/96/EC, Waste electrical and electronic equipment.
WARNING
Do not dispose any parts of this product with industrial or domestic waste. The
product contains hazardous substances, such as lithium, which require special
disposal. Incorrect disposal of any hazardous materials may lead to serious
environmental pollution.
Philips supports users in:
• Recovering reusable parts
• Recycling of useful materials by competent disposal companies
• Safe and effective disposal of the product.
For advice and information, contact your Philips Service Organization.
9.3
Fitting, removing and disposing of batteries
For continued optimal operation, the batteries must be replaced when their
capacity is reduced. To replace the batteries, refer to the instructions in
section “Replacing the minicare analyzer battery” on page 9-3.
Product disposal
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Release 1.0
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Final disposal of this product
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Fitting, removing and disposing of batteries
9.3
Battery type: Philips XXX (BATTERY TYPE/NAME NEEDED)
NOTE
REACH requires Philips Medical Systems to provide chemical content information for
substances of very high concern (SVHC) if they are present above 0.1% of the product
weight. Components within electric and electronic equipment may contain phthalates
above the threshold (for example, bis(2–ethyl(hexyl)phthalate), CAS nr.: 117–81–7).
The SVHC list is updated on a regular basis. Therefore, refer to the following Philips
REACH web site for the most up-to-date list of products containing SVHC above the
threshold:
• http://www.philips.com/about/sustainability/reach.page
CAUTION
9.3.1
Always remove the batteries if the product will not be used for some time.
Replacing the minicare analyzer battery
Conditions
• A small flathead screwdriver is required to perform this procedure.
On the back of the minicare analyzer, locate the small screw holding the
battery cover in place. Using the screwdriver, remove the screw completely
and set it aside.
Slide the cover upward to remove it from the minicare analyzer as shown
below.
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Figure 9.1
Philips minicare analyzer
Release 1.0
Removing the battery cover
Gently pull the battery from the battery compartment. Wires still connect
the battery and the minicare analyzer.
Product disposal
9-3
4
Using the screwdriver, gently press the wire connector as shown below to
release it from the minicare analyzer.
Figure 9.2
Product disposal
Disconnecting the battery wires from the minicare analyzer
Remove the new battery from any packaging and insert the plastic wire
connector into the minicare analyzer. You should hear or feel it snap into place.
Fit the new battery into the battery compartment. Ensure that the wires are
not crimped and will not interfere with reattaching the battery cover.
Slide the battery cover back in place on the minicare analyzer.
Screw the small screw back in to secure the battery cover.
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Release 1.0
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Fitting, removing and disposing of batteries
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10
10.1
Technical data
Specifications
Property
Value
Dimensions
25 x 8 x 5 cm (approx)
Weight
750 g including battery pack (approx)
Power supply adapter
Input: 100–240 V AC, 47–63 Hz, 700 mA
Output: 24 V DC, 1250 mA
Tests per battery cycle
10.2
15 tests on a fully charged battery (approx)
System requirements
The minicare analyzer has no special requirements.
The computer system requirements for the Data Manager software are
shown in the following table.
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Philips minicare analyzer
Release 1.0
Item
Requirement
Operating system
Windows Vista, Windows XP
RAM
2 GB
Disk space
15 GB
Technical data
10-1
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System requirements
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Technical data
Philips minicare analyzer
Release 1.0
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11
Glossary
11.1
Definitions
Term
Explanation
analyzer
The minicare analyzer receives blood cartridges and performs tests
on the blood sample. It is intended for use in medical care settings,
for example, operating theaters.
application
assay
blood
cartridge
data manager
The minicare data manager software allows you to configure the
minicare analyzer, and to exchange data from the minicare analyzer
with an external information system, for example, LIS.
docking station
Magnotech
minicare
operator
self test
system
whole blood
user
11.2
Philips minicare analyzer
The intended users of the Philips minicare system are laboratory
and non-laboratory medical professionals (for example, nurses).
Abbreviations
Release 1.0
Abbreviation
Explanation
EMC
Electromagnetic compatibility
EMF
Electromagnetic fields
ESD
Electromagnetic discharge
HIS
Hospital information system
Glossary
11-1
Abbreviation
Explanation
IfU
Instructions for Use
IP
Internet protocol
IVD
In vitro diagnostic
LIS
Laboratory information system
OS
Operating system
PC
Personal computer
PIN
Personal identification number
POC
Point of care
QRC
Quick reference card
RF
Radio frequency
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Abbreviations
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Glossary
Philips minicare analyzer
Release 1.0
12
Appendices
12.1
Special functions
12.1.1
Additional host software options for Administrators
There are certain functions for the data manager software that can only be
performed by a Point of Care Coordinator, including:
• minicare analyzer configuration, see section “Configuring the minicare
analyzer” on page 12-4.
• Data manager software configuration, see section “Configuring the data
manager software” on page 12-2.
• User accounts, see section “Managing user accounts” on page 12-6.
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Philips minicare analyzer
Release 1.0
Appendices
12-1
Configuring the data manager software
As a Hospital Administrator, you can configure the data manager software
ID and language, which minicare analyzer is connected to the data manager
software, and which cartridges are supported.
Click the System menu.
Roll the mouse pointer to Host Configuration, and click.
The Host Configuration dialog box appears.
Figure 12.1 Host Configuration dialog box
Appendices
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Special functions
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12.1
Change your host configuration as desired.
To
Do this
Change the data manager software ID Enter the new ID in the Host software ID field.
The data manager software ID is used to ensure
that generated orders have a unique ID. If you have
multiple installations of the data manager software,
you must give each data manager software
installation a unique ID to avoid duplicate order IDs.
Change the data manager software
language
Select the desired language from the Language dropdown menu.
Change the minicare analyzer
currently connected
Enter the IP address for the new minicare analyzer.
See section “Configuring analyzer connectivity” on
page 4-7.
Add a new supported cartridge type
Click the Add button next to
the Supported Cartridges field and select the new
cartridge type (with extension ‘.crt’) from the
appropriate local or network location.
After importing a new cartridge type, you can
enable and disable the supported cartridges by
selecting and clearing the check boxes.
Philips Electronics Nederland B.V.
Note that the selected cartridge must also be
activated on the minicare analyzer being used. See
section “Configuring the minicare analyzer” on page
12-4
Delete a currently supported
cartridge type
Click the Delete button next to
the Supported Cartridges field.
Ensure that only results with user
Click the check box so the checkmark appears.
name specified can be transferred to
When the check box is cleared, all results (with or
LIS
without username specified), can be transferred to
the LIS.
Click OK to save your changes and close the dialog box.
If you click Cancel, the dialog box closes and your changes are not saved.
Philips minicare analyzer
Release 1.0
Appendices
12-3
Configuring the minicare analyzer
Conditions
• An analyzer must be connected to view this menu.
As the Hospital Administrator, you can use the Analyzer Configuration
menu to view and change minicare analyzer settings including the minicare
analyzer name, software, language, user logon, print settings, and results
overwriting.
Click the System menu.
Roll the mouse pointer to Analyzer Configuration, and click.
The Analyzer Configuration dialog box appears.
Figure 12.2 Analyzer Configuration dialog box
Appendices
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Special functions
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12.1
Change the configuration for the connected minicare analyzer as desired.
To
Do this
Change the name of the minicare
analyzer currently connected.
Enter the new minicare analyzer name in
the Analyzer name field section “Analyzer menu
and options” on page 12-9.
View the Serial ID of the minicare
analyzer currently connected.
The Serial ID is displayed in the Serial ID field.
View the current minicare analyzer
software.
The current software version number is displayed
in the Software field.
Update the current minicare
analyzer software.
Click the Update button and select the new
software update from the appropriate local or
network location.
Note that this is not an automatic search function.
Updates are communicated and provided through
the Service organization.
View the current Firmware.
The current firmware number is displayed in
the Firmware field
Change the minicare analyzer
language.
Select the desired language from the Language dropdown menu
Philips Electronics Nederland B.V.
Change the identification options for Selecting Barcode requires users to scan an
the user logon screen or eliminate
identification barcode before using the minicare
the requirement for a user to log on analyzer.
before performing a test.
Selecting Manual requires users to enter a numeric
PIN before using the minicare analyzer.
Selecting None disables user identification. Users
then do not have to enter any identification to use
the minicare analyzer.
Change the identification options for
the patient identification screen or
eliminate the requirement for a
patient identification before
performing a test.
Selecting Barcode requires users to scan a patient
identification barcode before performing a test.
Selecting Manual requires users to enter a numeric
PIN to identify the patient before performing a test.
Selecting None disables user identification. Users
then do not have to enter any patient identification
before performing a test.
Philips minicare analyzer
Release 1.0
Appendices
12-5
To
Do this
Overwrite the oldest results on the
analyzer if memory is full.
There is a limited amount of memory on the
minicare analyzer for storing results.
Select Automatic from the Overwrite oldest results
drop-down menu if the oldest results on the
minicare analyzer should automatically be
overwritten by the newest results.
Select Ask user from the Overwrite oldest results
drop-down menu if results should only be
overwritten after confirmation from the user.
Select Never from the Overwrite oldest results
drop-down menu if results should never be
overwritten.
Note that once results are transferred to the data
manager software they are automatically marked
for deletion on the minicare analyzer.
Turn the analyzer sound on or off.
Check the box next to Enable Sound to turn on
the sound. Uncheck the box to turn the sound off.
Use the Windows date/time format.
Check the box next to Use Windows date/
time format to automatically synchronize the date
and time with the host PC. The date/time format is
synchronized between the data manager software
and the minicare analyzer.
Specify the timeout period
Enter a value in Autologout timeout.
Select the supported cartridge type
You can enable and disable the supported
cartridges for the minicare analyzer by selecting or
clearing the check boxes next to the cartridge
name in the Supported Cartridges area.
Click OK to save your changes and close the dialog box.
If you click Cancel, the dialog box closes and your changes are not saved.
Managing user accounts
As the Hospital Administrator, you can allow additional users to access the
data manager software. You can also disable user accounts.
Appendices
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Release 1.0
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Special functions
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Click the System menu.
Roll the mouse pointer to User Accounts, and click.
12.1
The User Accounts dialog box appears.
Figure 12.3 User Accounts dialog box
Philips Electronics Nederland B.V.
Configure the user accounts as desired.
To
Do this
View existing user name, role, and
analyzer access code
Click the User name from the list.
Add a new user
The user information appears in the User details
area to the right.
Click the Add user button and add the new user
account details in the Add User Account dialog box.
Select the new user name, role, analyzer access
code, and password.
Activate the user account by clicking the check box.
Click Save to save changes and return to the User
Accounts dialog box.
Philips minicare analyzer
Release 1.0
Appendices
12-7
To
Do this
Activate or deactivate a user account. Click the user name from the list and click the Edit
button.
Click the check box until the check mark appears
to activate the user account.
When the check box is cleared, the user account is
inactive.
Click Save to save changes and return to the User
Accounts dialog box.
Edit an existing user name, role
assignment, analyzer access code, or
password.
Click the user name from the list and click the Edit
button.
Change the user information in the corresponding
fields as desired.
Click Save to save changes and return to the User
Accounts dialog box.
Delete an existing user
Click the user name from the list and click
the Delete button.
A confirmation dialog box appears, click Yes to
confirm deletion.
If you click No, the user account will not be deleted.
Click Save to save changes and return to the User
Accounts dialog box.
Appendices
Click Close to save any changes and close the dialog box.
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Release 1.0
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Special functions
12.1.2
12.1
Analyzer menu and options
When you press Menu on the minicare analyzer main screen, you can view
analyzer information, view results, change IP address, and logout.
Figure 12.4 Analyzer menu
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To
Do this
Find analyzer name, Serial ID,
Software, Firmware, and OS
Press Analyzer information
View results
Press View results
Change the analyzer IP address
Press Network settings and change
You can then enter the IP address. See section
“Configuring analyzer settings” on page 4-12
Logout as the current user
Press Logout
Perform a Quality Control (QC) test Press Perform QC Test. See section “Performing a
QC test” on page 8-8.
Philips minicare analyzer
Release 1.0
Appendices
12-9
12.2
Security and privacy requirements
Antivirus
The PC on which the data manager is installed should be protected from
attack or damage by computer viruses or malware. See section “Antivirus
protection” on page 8-9 for details.
[NOTE TO REVIEWERS: Details about the following items will be
provided by the Project team after Review 2]
Network ports
Encryption
12.3
References
Magnotech
Information about the Magnotech process can be found at the following
web site.
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Security and privacy requirements
www.philips.com/magnotech
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Appendices
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Release 1.0
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Index
Abbreviations 11-1
After-sales support 8-10
Analyzer
– Adding blood sample 5-14
– Anonymous test 5-12
– Cartridge insertion 5-13
– Cartridge removal 5-16
– Configuring 12-4
– Configuring connectivity 4-7
– Configuring settings 4-12
– Docking 4-5
– Finishing a test 5-16
– Identifying the patient 5-10
– Logging on 5-6
– Logging out 5-9
– Performance characteristics 4-3
– Performing multiple tests 5-16
– Quality Control (QC) test 8-8
– Self test 5-4
– Shutting down 5-6
– Starting 5-3
– Starting analysis when docked 5-9
– Undocking 4-6
Antivirus protection 8-9
Data manager software
– Configuring 12-2
– Installing 4-4
Definitions 11-1
Disinfection 8-3
Disposal
– Final 9-2
Environmental conditions
– Handling 3-5
– Storage 3-5
Equipment connections 3-2, 3-3
Error messages
– Data manager 7-3
– Philips minicare analyzer 7-1
European authorized representative 1-4
Batteries 9-2, 9-3
– Replacing 9-3
Cleaning and disinfection 8-1–8-3
– Cleaning 8-2
– Disinfection 8-3
Philips minicare analyzer
Compatibility 1-3
Compliance 1-4
Contacting Service 7-10
Release 1.0
Handling requirements 3-5
Host software
– Analysis orders tab 6-11
– Analysis results tab 6-16
– Changing password 6-8
– Creating a new order 6-14
Index
I-1
[12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]
30
31
I 32
33
Intended
use 1-3
34
35
L36
37
38
Limitations
of use 4-4
39
LIS
–40Configuring connectivity 4-9
41
42
M43
44
45
Magnotech
technology 4-1, 4-2
46
Maintenance
8-4
47
48
P49
50
Passing
51 this product to another user 9-1
52
Performance
characteristics 4-3
53
54
I-2
Index
55
56
57
Performing a blood test 5-14
Preparation prior to use 4-4
Quality control 8-5, 8-8
– QC test 8-8
References 12-10
Routine checks 8-5
Safety
– Explosion safety 2-2
– Important safety directions 2-1
– Safety awareness 5-3
Safety directions 2-1
Security and privacy requirements
– Computer viruses and malware 12-10
– Encryption 12-10
– Network ports 12-10
Service 7-10
Spare parts 8-10
Specifications 10-1
Sterilization 8-2
Storage requirements 3-5
Symbols 2-6
System and error messages
– Data manager 7-3
– Philips minicare analyzer 7-1
System components 4-1
System identification 1-3
System requirements 10-1
Philips minicare analyzer
Philips Electronics Nederland B.V.
Index
–10Deleting an order 6-15
–11Deleting a patient entry 6-12, 6-17
–12Deleting a QC test entry 6-24
–13Deleting a user 12-8
14
– Editing analysis results 6-20
15
–16Exiting 6-3
–17Filtering the patient list 6-17
–18Filtering the QC result list 6-24
–19Help menu 6-9
–20Logging off 6-2
21
– Logging on 6-1
22
–23Log off button 6-11
–24Managing user accounts 12-6
–25Printing analysis results 6-21
–26Starting 6-1
–27Transferring orders to the analyzer 6-15
28
– Transferring results to the LIS 6-22
29
Release 1.0
Index
Technical specifications 10-1
Terminology 11-1
Theory, operation 4-1
Training 1-5
Transferring results from analyzer to data manager
software 6-19
Warnings and cautions (general) 2-1
Warranty 8-10
Workflow 5-2, 8-6
– Blood analysis workflow 5-2
– Quality control (QC) test workflow 8-6
User routine checks 8-5
Philips Electronics Nederland B.V.
[12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed]
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
Philips minicare analyzer
Release 1.0
Index
I-3

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EXIF Metadata provided by EXIF.tools

LRE Medical Esterline 8066000 Laboratory Equipment with RFID User Manual

LRE Medical GmbH Esterline Corporation Laboratory Equipment with RFID

User Manual

FCC ID Filing: YMQ-8066000

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