SDI Astra 300 User manual

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 1
The Spirometry Source
User’s Manual


1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
Table of Contents
2
The Spirometry Source
Distributed by:
SDI Diagnostics, Inc., 10 Hampden Drive, Easton, MA 02375
National Sales: 1-800-678-5782 1-508-238-7033
Email: [email protected]
Fax: [phone]

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
Table of Contents
3
The Spirometry Source
TABLE OF CONTENTS
SAFETY ............................................................................... 7
1. INSTRUCTIONS FOR USE AND INSTALLATION............ 9
1.1 INTRODUCTION........................................................ 10
1.2 LAYOUT OF CONTROLS, PILOT LIGHTS AND
CONNECTORS........................................................... 11
1.3 INSTALLATION AND START-UP.....................................12
1.4 OPERATING MODES .................................................. 15
CAUTION: Federal law restricts this device
to sale by or on the order of a physician!

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
Table of Contents
4
The Spirometry Source
2. ASTRA 300 FUNCTIONAL OPERATION .......................17
2.1 FUNCTION TREE ........................................................18
2.2 EQUIPMENT CUSTOMIZATION ...................................22
2.3 EQUIPMENT PROTECTION .........................................29
2.4 PERFORMING SPIROMETRY .......................................31
2.5 FORCED VITAL CAPACITY «FVC»
TEST PROCEDURE ......................................................33
QC GRADES ...............................................................46
2.6 SLOW VITAL CAPACITY «VC»
TEST PROCEDURE ......................................................53
2.7 MAXIMUM VOLUNTARY VENTILATION «MVV»
TEST PROCEDURE .....................................................55
2.8 POST BRONCHODILATOR SPIROMETRY
PROCEDURE ..............................................................57
2.9 OCCUPATIONAL HEALTH MODULE .............................61
3.0 CALIBRATION PROCEDURE........................................63
2.11 INTERNAL DATABASE ................................................68
2.12 MAINTENANCE PROGRAM ..........................................75

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
Table of Contents
5
The Spirometry Source
3. COMMUNICATIONS SYSTEM .................................... 81
3.1 PATIENT TEST MANAGEMENT IN THE PC .................. 82
3.2 EXPORTING TESTS TO OTHER SYSTEMS .................. 83
3.3 INSTALLING ASTRAPRO SPIROMETRY SOFTWARE
FOR PC .................................................................... 83
4. TECHNICAL SPECIFICATIONS .................................. 85
4.1 TYPES OF TEST, FUNCTIONS AND PARAMETERS ...... 86
4.2 MEASURING SYSTEM ............................................... 90
4.3 MICRO CONTROLLER ............................................... 91
4.4 PRESENTATION OF DATA......................................... 93
4.5 TEMPERATURE SENSOR ........................................... 93
5. OPERATING PRINCIPLES ......................................... 95
5.1 TURBINE.................................................................. 96
5.2 TURBINE ROTATION SENSOR .................................. 96
5.3 MICROPROCESSOR ................................................. 97

Table of Content
ss
ss
s
1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
6
The Spirometry Source
6.0 UPKEEP, PREVENTIVE AND CORRECTIVE
MAINTENANCE ........................................................ 100
6.1 UPKEEP .................................................................. 101
6.2 PREVENTIVE MAINTENANCE.................................... 103
7.0 LIMITED WARRANTY CONDITIONS......................... 105
8.0 SPIROMETRY INDICATIONS ................................... 106

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 7
The Spirometry Source
Safety
SAFETY
SPECIAL PRECAUTIONS
The ASTRA 300 spirometer has been designed for use
with safety in mind. All operating instructions must be
read before using the ASTRA 300. Failure to do so may
lead to injuries to the user or the patient and damage
to equipment and/or accessories.
INTENDED USE
The spirometer measures and calculates a series of
parameters related to human respiratory function. It is
intended to be used by or under the direction of a medical
professional
The spirometer is not designed for use outdoors or
under other conditions or using other power sources
not indicated in this manual.
EFFECTS ON PATIENTS USING THE SPIROMETER
The spirometry tests require patient cooperation.
Complete forced expiration is required to obtain meaningful
patient FVC values. The clinician administering the test
must assess the patient’s capacity to perform the
spirometry test.
LIMITATIONS OF USE. CONTRAINDICATIONS
An analysis of the results of spirometry tests is not
enough in of itself to give a correct diagnosis of the
patient’s clinical condition. The patient’s records and any
tests that the clinician believes necessary must therefore
also be considered. A doctor must interpret all data to
determine the course of treatment required.
The patient’s symptoms and capacity to perform a
spirometry test must be taken into account by medical
staff before any spirometric testing is undertaken.

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
8
The Spirometry Source
ELECTRICAL RISKS
Dot NOT disassemble the equipment casing. The device
must only be serviced and repaired by skilled personnel.
The contact with voltage inside the device may cause
serious injury.
Do NOT use damaged accessories.
Do NOT submerge the parts of the device in any liquid.
Consult the equipment cleaning method in Chapter 8,
Section 8.1. UPKEEP, PREVENTIVE AND CORRECTIVE
MAINTENANCE.
To ensure vital safety features under the EN 60601-1-1
standard, only equipment compliant with the electrical
safety standards in force may be connected to this device.
To connect ASTRA 300 to a non-medical device with a
ground conductor, you must install an additional ground
conductor to the non medical device.
The equipment must be stored and used within the
temperature, pressure and humidity ranges specified.
RISKS OF EXPLOSION
Do NOT use the equipment in the presence of volatile
anesthetics or inflammable gases.
RISKS OF CONTAMINATION
Turbine transducer: To avoid the risk of contamination or
cross infection, the turbine must be cleaned before use
or used with a protective barrier filter as indicated in this
manual.
Disposable mouthpieces must not be reused.
Pulse oximeter finger clip: The pulse oximeter finger clip
should be washed after each patient use using either
soapy water or using a medical equipment disinfectant of
choice.
Safety

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 9
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
1. INSTRUCTIONS
FOR USE AND
INSTALLATION

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
10
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
1.1 INTRODUCTION
The Astra 300 spirometer is a compact device with a
high-resolution graphic touch screen. It functions using
accurate and precise turbine transducers and may be
be connected to an external printer via USB.
The entire system is controlled by a microprocessor for
the acquisition, calculation and presentation of
alphanumeric and graphical data.
Part No. Qty. Description
29-5300 1SDI Astra 300
1 Stylus, Astra Series Spirometers
10 AstraGuard Bacteria/Viral Filters
10 The Klip Noseclips
1 Cable Mini USB B 5 Pins USB 1
2 AA 1.5 V Alkaline Battery
1 Turbine Transducer
1 Cable Mini USB(External Printer Option)
29-5310 1 Quick Reference Card, Astra 300
29-5002
29-7990
29-7966
29-5021
29-5023
29-5003
29-5022
ASTRA 300 LIST OF CONTENTS
PCP PROGRAM
Your Astra 300 comes to you preconfigured with a pre-
set program based on the recommendations of the Na-
tional Lung Health Education Program (NLHEP). It is con-
figured as the PCP mode. It meets all the recommended
guidelines of NLHEP for spirometry testing, including the
NHANES III predicted set and quality alerts to assist you
in producing high quality spirometry tests. The PCP mode
can be cancelled in the Spirometry Customization menu.
Cancelling the PCP mode will automatically set the Astra
300 in the full Customization mode to allow you to con-
figure the device based on your needs.

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 11
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
1.2 LAYOUT OF CONTROLS, PILOT LIGHTS AND
CONNECTORS
1
2
6
7
8
9
3
4
5
1- On/off button
2- Graphic LCD display
3- Turbine transducer
4- USB connection
5- RS·232
series connection
6- Specifications plate
7- Lithium
battery (CR1632)
8- Firmware loading
switch
9- Main batteries
(2xAA 1.5V)

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
12
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
1.3 INSTALLATION AND START-UP
Astra 300 INSTALLATION
The ASTRA 300 spirometer is CLASS IIa according to
the criteria of the 93/42/EEC European Medical Device
Directive and, in line with the type of protection against
electric shocks established by the EN60601.1 standard,
the equipment is rated as CLASS IP type B.
Batteries
The Astra 300 spirometer typically operates with two
AA 1.5 V alkaline batteries or optionally with two
rechargeable NiMh batteries (AA 1.2 V type).
WARNING:
Never try to recharge alkaline batteries. This would
cause damage to both the batteries and the charger.
In both cases, the battery charge will depend on the
quality of the batteries used. 1.5 V alkaline batteries or
2400 mAh rechargeable batteries will last for
approximately 40 hours. The charge may drop by 50%
when working via Bluetooth. USB Connection to the PC
will not use any battery power, given that the equipment
is powered through the PC’s USB port.
The charging time for rechargeable NiMh batteries will
depend on the charger used.
To conserve power, the equipment includes an auto switch
off system that turns the equipment off when the screen
is not accessed for 5 minutes, except in main spirometry
and pulse oximetry screens. In this case, you will be
prompted to save the data before powering off.
NOTE:
When inserting the batteries for the first time or when
replacing them, the equipment may switch on
automatically. This is normal and does not indicate
malfunction.

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 13
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
Atmospheric conditions
The atmospheric working conditions are:
•Ambient temperature between 10 and 40 ºC (50 and
104 ºF)
(The American Thoracic Society recommends 17 to
40 ºC)
•Relative humidity below 75% (without condensation)
•Atmospheric pressure from 430 to 800 mmHg

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
14
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
EQUIPMENT PROTECTION
To insure the security of patient data, the ASTRA 300
has an equipment protection option accessed by PIN.This
option can be customized, enabled or disabled as required.
Where enabled, a screen will appear requesting the PIN
(user-configured) when the equipment is turned on.
If an erroneous PIN is entered three times, the equipment
will lock and will switch off. On restarting it, a screen will
appear requesting the unlock code. Call SDI’s technical
service department for the unlock code at 1-800-678-
5782.
START-UP
To start the ASTRA 300 spirometer,
press the key for 2 seconds .
The equipment will then make a beeping sound and will
check itself. The <SDI> logo, the name of the equipment,
the program version and the address of SDI Diagnostics
will appear on screen for two seconds.
If equipment protection is enabled, the PIN entry
screen will appear. Ifequipment protection is not enabled
or if the correct PIN has been entered, the MAIN MENU
will then be displayed, which varies according to the
model.
SpO2
Astra300
Setup
Post

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 15
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
NOTE:
The first time the equipment is started, the
protection is disabled and the PIN is set to 0000.
See Section 2.2/3.2 EQUIPMENT CUSTOMIZATION
to enable it and configure the PIN.
HANDLING THE EQUIPMENT
The spirometer has been designed to be simple to operate.
Although it allows a number of functions, its unique
navigation properties will quickly demonstrate that it is
truly intuitive for any clinician
All functions are accessed using the icons on the screen
using the supplied stylus.
The spirometer may be connected to an external printer
when this has been previously selected in the
Customization option and the appropriate printer is
selected
1.4 OPERATING MODES
•Spirometry
. Patient Details (Reference, Age, Weight, Height, Sex,
Smoker Index)
. Atmospheric Conditions (Temperature, Pressure,
Humidity)
. Tests (FVC, VC, MVV , Bronchodilation)
. Report
•Customization (selectable options)
. Spirometry (Predicteds/Parameters/Graphs/
Interpretation/Bronchodilation Modes/Warnings)
. Printers
. Standard curves (Retrieve standard / Modify standard)
. Battery
. Language
. Set clock (Time / Date)
. Pulse oximetry

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
16
Chapter 1: Instructions for Use and Installaton
The Spirometry Source
•Calibration
•Internal Database to save tests with alphanumeric
and graphical data (depending on model).
•Maintenance
. Warnings
. LCD contrast
. Equipment check
. Equipment configuration
. ATS curves

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 17
Chapter 2: Astra 300 Functional Operation
The Spirometry Source
2. ASTRA 300
FUNCTIONAL
OPERATION

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
18
Chapter 2: Astra 300 Functional Operation
The Spirometry Source
2.1 FUNCTION TREE
The ASTRA300 spirometer function tree (following) is
displayed to allow the user a better understanding of its
structure.
To move around the different equipment menus, ASTRA300
utilizes a stylus to select the functions appearing on
screen.
The character (number or letter) must also be selected
for insertion in the numeric or alphanumeric fields using
the stylus.
WARNING
It is recommended to use only the stylus included
with your ASTRA300 spirometer. SDI Diagnostics is
not responsible for any damage caused where other
styli are used.
Pointed objects must not be used under any
circumstances.
The following can be accessed from the Main Menu,
depending on the options included:
SPIROMETRY
CALIBRATION
DATABASE
CUSTOMIZATION
MAINTENANCE
OPERATING MODE
PULSE OXIMETRY
DILATION REPORT
BLUETOOTH

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 19
Chapter 2: Astra 300 Functional Operation
The Spirometry Source
SPIROMETRY
•Forced Vital Capacity «FVC» Test
Test data
PatientCode
Full name
Age, height, weight and sex
Smoker index
Ethnic factor
Barometric Pressure
Temperature
Start of the spirometric maneuver
Graph presentation
Flow/Volume Loop or Curve (only in FVC)
Volume/Time Curve
Maneuver selection
Select the best maneuver
Maneuver data selected
Memory for five maneuvers
Deleting a maneuver
Interpretation
Saving test for Post-Bronchodilation
Saving test in the Database
Test printout
•Slow Vital Capacity «VC» Test
Similar ro the FVC criteria above
•Maximum Voluntary Ventilation «MVV» Test
Similar to the FVC criteria above
CALIBRATION
•Calibration using a syringe
•Report on the latest calibrations
DATABASE
•Search by patient code or register number
•Summarized display of the tests saved
•Printing and displaying a test

1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
20
Chapter 2: Astra 300 Functional Operation
The Spirometry Source
•Deleting a test
•Summarized printing of the tests saved
CUSTOMIZATION
•Standard Configuration
Retrieving the configuration
Saving the configuration
•Database customization
Number of registers
•Common customization
Setting the clock
Patient code and others
Numeric
Alphanumeric
Battery type
Operating language
Entering a heading in the report
Selecting the printer type
•Spirometry customization
Parameters of reference and ethnic factor
Observed parameters (FVC, VC, MVV)
Graph selection
Saving graphs on the database
Printing FVC Flow/Volume graph
Printing FVC Flow/Time graph
Printing VC Flow/Time graph
Printing MVV Flow/Time graph
Interpretation selection
Comparison mode in POST bronchodilation
Weighted % between PRE and POST
% between REF and POST
% between PRE and POST
Difference between PRE and POST
Display of alerts for maneuvers not in
compliance with ATS/ERS or NLHEPcriteria
•SpO2Pulse oximetry customization
•Equipment protection customization
Modifying the PIN