Astra 300 Manual
Astra 300 Manual
Astra 300 Manual
User’s Manual
1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 1
The Spirometry Source
Table of Conten ts
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: 1-508-230-2752
1-800-678-5782 1-508-238-7033
2 www.sdidiagnostics.com
The Spirometry Source
TABLE OF CONTENTS
SAFETY ............................................................................... 7
1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 3
The Spirometry Source
QC GRADES ............................................................... 46
1-800-678-5782 1-508-238-7033
4 www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com 5
The Spirometry Source
6.0 UPKEEP, PREVENTIVE AND CORRECTIVE
MAINTENANCE ........................................................ 100
6 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
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.
Safety
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
1-800-678-5782 1-508-238-7033 7
www.sdidiagnostics.com
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.
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.
1-800-678-5782 1-508-238-7033
8 www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 9
www.sdidiagnostics.com
The Spirometry Source
1.1 INTRODUCTION
Chapter 1: Instructions for Use and Installaton
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.
10 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1.2 LAYOUT OF CONTROLS, PILOT LIGHTS AND
CONNECTORS
5
2
1- On/off button
2- Graphic LCD display
3- Turbine transducer
6 4- USB connection
5- RS·232
series connection
7 6- Specifications plate
7- Lithium
8 battery (CR1632)
8- Firmware loading
9
switch
9- Main batteries
(2xAA 1.5V)
1-800-678-5782 1-508-238-7033 11
www.sdidiagnostics.com
The Spirometry Source
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.
12 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
Atmospheric conditions
The atmospheric working conditions are:
1-800-678-5782 1-508-238-7033 13
www.sdidiagnostics.com
The Spirometry Source
EQUIPMENT PROTECTION
Chapter 1: Instructions for Use and Installaton
START-UP
To start the ASTRA 300 spirometer,
Post
Setup SpO2
14 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
NOTE:
The first time the equipment is started, the
1-800-678-5782 1-508-238-7033 15
www.sdidiagnostics.com
The Spirometry Source
•Calibration
Chapter 1: Instructions for Use and Installaton
•Maintenance
. Warnings
. LCD contrast
. Equipment check
. Equipment configuration
. ATS curves
16 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 17
www.sdidiagnostics.com
The Spirometry Source
2.1 FUNCTION TREE
The ASTRA300 spirometer function tree (following) is
Chapter 2: Astra 300 Functional Operation
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.
SPIROMETRY
CALIBRATION
DATABASE
CUSTOMIZATION
MAINTENANCE
OPERATING MODE
PULSE OXIMETRY
DILATION REPORT
BLUETOOTH
18 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
SPIROMETRY
CALIBRATION
DATABASE
1-800-678-5782 1-508-238-7033 19
www.sdidiagnostics.com
The Spirometry Source
•Deleting a test
•Summarized printing of the tests saved
Chapter 2: Astra 300 Functional Operation
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
•SpO2 Pulse oximetry customization
20 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
MAINTENANCE
•Alerts selection
PULSE OXIMETRY
•Test data
Patient
Code
Full name
Age, height, weight and sex
•Configuration
Average in the SpO2
•Saving Trends
•Displaying Trends
Configuration
Signal forwards and backwards
Test Parameters
Parameter printout
Saving parameters in the database
BRONCHODILATION
REPORT
•Printing a report
1-800-678-5782 1-508-238-7033 21
www.sdidiagnostics.com
The Spirometry Source
Setup
Standard Configuration
Database customization
Setup
Common customization
Spirometry customization
22 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
SPIROMETRY CUSTOMIZATION
Pred
Actual Post
Predicted Values
Pred
Allows selecting among several authors
for children and adults
Prioritizes the age range selected for adults
if a different table is chosen for children.
Extrapolates the values for the ages outside
the selected table range.
Actual
Observed Parameters
Allows for the observed parameters or
measured parameters you want to use to be
selected. This is only at display level or for the
report. All the parameters are saved on the
database and can be enabled at any time.
1-800-678-5782 1-508-238-7033 23
www.sdidiagnostics.com
The Spirometry Source
Alerts
Select Alerts displayed for maneuvers not
compliant with ATS/ERS or NLHEP criteria
Date of latest calibration
STANDARD CONFIGURATION
Restore
Save
24 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
Follow the instructions below to save the Standard
configuration:
1-800-678-5782 1-508-238-7033 25
www.sdidiagnostics.com
The Spirometry Source
ABC
Printer type
26 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
*As with any data entry, in order to save the changes be sure to
1-800-678-5782 1-508-238-7033 27
www.sdidiagnostics.com
The Spirometry Source
DATABASE CUSTOMIZATION
28 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
2.3 EQUIPMENT PROTECTION
If equipment protection has been enabled, the following
1-800-678-5782 1-508-238-7033 29
www.sdidiagnostics.com
The Spirometry Source
30 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
2.4 PERFORMING SPIROMETRY
Before testing patients, it is important to keep in mind that
1-800-678-5782 1-508-238-7033 31
www.sdidiagnostics.com
The Spirometry Source
see and hear a forced expiration, they are more apt to
perform well. Body language is the key to good performance.
Instruct the patient to put the AstraGuard filter between his/
Chapter 2: Astra 300 Functional Operation
her teeth and make a good, tight seal with his lips. After the
patient slowly makes a maximal inspiration, the first phase of
the test, loudly exhort the patient to BLAST out. This
element of surprise will help the patient to realize the
maximum peak flow, which is the second phase of the test.
1
European Respiratory Journal. Standardisation of Spirometry. Eur Resp J 2005; 26:319-338 .
2
Enright, Paul L., MD. How to Make Sure Your Spirometry Tests Are of Good Quality. Respiratory Care
August 2003; 48:774.
32 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
ID ID Race
CAUCASIAN
First
Age In Lb Smk I
Last
Tech C/d
Del
1-800-678-5782 1-508-238-7033 33
www.sdidiagnostics.com
The Spirometry Source
Yrs (Age): Number corresponding to the age, between 4 and
100.
in (Height): Height in inches between 20 and 90.
Chapter 2: Astra 300 Functional Operation
34 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
There are other areas of the screen that also have certain
functions:
1-800-678-5782 1-508-238-7033 35
www.sdidiagnostics.com
The Spirometry Source
•Pressing on the parameters displays the screen
containing the data on the selected maneuver.
Chapter 2: Astra 300 Functional Operation
36 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
When testing a patient, consider the following:
INSERT
FIRMLY
1-800-678-5782 1-508-238-7033 37
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
Mod
Pat
38 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
40 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
DISPLAYING RESULTS
ACT PRED
1-800-678-5782 1-508-238-7033 41
www.sdidiagnostics.com
The Spirometry Source
WARNING:
As indicated, the BEST maneuver is set at M1.
Therefore, use M1 to display the interpretation, to
print the report or to save the maneuver for the POST
bronchodilation test or for the Internal Database. The
technician has the option to override this selection.
NOTE:
If you do not agree with the interpretation criteria,
do not use them as a reference or diagnosis
•ATS Interpretation
This presents the following information:NORMAL,
RESTRICTIVE, or OBSTRUCTIVE, according to the criteria
of the following table:
42 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
Bronchodilation
Test
T
FEV1 and/or FVC >
12% of baseline
and > 200 mL
Yes No
T T
Significant Response No Interpretation
1-800-678-5782 1-508-238-7033 43
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
44 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
•Miller Diagnosis
This presents the following information: NORMAL,
1-800-678-5782 1-508-238-7033 45
www.sdidiagnostics.com
The Spirometry Source
FVC < 35% Very Intense
QC GRADES
46 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
SAVING FVC TESTS
Mod
Pat
Mod
Pat
1-800-678-5782 1-508-238-7033 47
www.sdidiagnostics.com
The Spirometry Source
Saving a test to compare in POST bronchodilator mode
Mod
Pat
Mod
Pat
48 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
PRINTING THE FVC
1-800-678-5782 1-508-238-7033 49
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
50 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
DELETING AN EXISTING MANEUVER
1-800-678-5782 1-508-238-7033 51
www.sdidiagnostics.com
The Spirometry Source
OTHER TESTS ON THE SAME PATIENT
You can do the following after carrying out the FVC test
Chapter 2: Astra 300 Functional Operation
on a patient:
NOTE:
When details of an existing patient have been
modified (age, height,sex), the patient’s parameters
will be recalculated accordingly.
52 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
2.6 SLOW VITAL CAPACITY «VC»
TEST PROCEDURE
Mod Del
Pat
1-800-678-5782 1-508-238-7033 53
www.sdidiagnostics.com
The Spirometry Source
54 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
2.7 MAXIMUM VOLUNTARY
VENTILATION «MVV TEST
1-800-678-5782 1-508-238-7033 55
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
56 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 57
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
The screen then shows the two graphs (PRE and POST)
for comparison purposes:
POST
58 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 59
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
60 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
2.9 OCCUPATIONAL HEALTH (OHM)
MODULE (if equipped)
F/V Report
V/T Report
Print large curves
Print curves 3 PRE
Print Data 3 PRE
1-800-678-5782 1-508-238-7033 61
www.sdidiagnostics.com
The Spirometry Source
CALIBRATION CHECK
instructions
2 Power up the Astra 300 using the (On) button and at the
Startup menu, press (Setup) to bring you to the SETUP
UTILITIES menu: Press the (CAL) button
4 Push to empty the syringe then pull out the plunger fully.
do this maneuver two more cycles If the Astra 300 is in precise
calibration, you will get the message:
CAL PASSED!
MEAN F.(l/s) = XX
62 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
2.10 CALIBRATION PROCEDURE
CALIBRATION PROCESS
1-800-678-5782 1-508-238-7033 63
www.sdidiagnostics.com
The Spirometry Source
64 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
If it is different, enter the number of turbine pulses. In
this case, the factors will be recalculated and the
calibration process completed.
1-800-678-5782 1-508-238-7033 65
www.sdidiagnostics.com
The Spirometry Source
4 Press and start the calibration process.
Note:
If, upon entering the calibration parameters in point
2, “Calibration Volume (l): 0” is allocated, the system
takes the calibration factors “EXP F. and INS F.:1.00”,
corresponding to original factory calibration. This
calibration should only be used as a guideline and in
the event of a syringe not being available.
66 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
CALIBRATION REGISTERING
Del
1-800-678-5782 1-508-238-7033 67
www.sdidiagnostics.com
The Spirometry Source
2.11 INTERNAL DATABASE
The Astra 300 has an Internal Database as standard
Chapter 2: Astra 300 Functional Operation
68 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
ASTRA
Post
Setup SP O2
Search
DB
Reg
Del
1-800-678-5782 1-508-238-7033 69
www.sdidiagnostics.com
The Spirometry Source
Chapter 2: Astra 300 Functional Operation
Summarized report
DATABASE SEARCH
Search
Select DB option to display the tests saved on the
database
Del
70 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 71
www.sdidiagnostics.com
The Spirometry Source
Volume or Volume/Time).
PATIENT SEARCH
Reg
Select the option to search for a patient in the
database. The following screen will appear:
72 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
SUMMARIZED REPORT
1-800-678-5782 1-508-238-7033 73
www.sdidiagnostics.com
The Spirometry Source
DELETE DATABASE
deleting it.
74 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
CAL
Cont
Touch
Recalibrate Screen
CAL
Touch
Check equipment
Equipment configuration
1-800-678-5782 1-508-238-7033 75
www.sdidiagnostics.com
The Spirometry Source
WARNINGS
Press .
ALERTS
76 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
LCD CONTRAST
Validate choice
EQUIPMENT CHECK
Sp02 TOUCH
1-800-678-5782 1-508-238-7033 77
www.sdidiagnostics.com
The Spirometry Source
Distributor details
Sp02
Pulse oximetry module
Del
78 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
STANDARD CURVES
1-800-678-5782 1-508-238-7033 79
www.sdidiagnostics.com
The Spirometry Source
EQUIPMENT CONFIGURATION
the equipment.
WARNING
This option should be carried out by a qualified
technician!
80 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 81
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033 85
www.sdidiagnostics.com
The Spirometry Source
Parameters:
86 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
• MIF50% (l/s)
Maximum Inspiratory flow with
50% of FVC inspired
• FIVC (l) Forced Inspiratory Vital Capacity
•ATS
Patient’s ID details
1-800-678-5782 1-508-238-7033 87
www.sdidiagnostics.com
The Spirometry Source
Graphs in FLOW/VOLUME and VOLUME/TIME
Parameters:
Patient’s ID details
88 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
Parameters:
Patient’s ID details
CALIBRATION
Spirometry customization
Chapter 4: Technical Specifications
Parameters of reference
Observed parameters
Graph selection
Interpretation selection
Report customization
INTERNAL DATABASE
CLOCK-CALENDAR
Hour-Minute-Second
Month-Day-Year
90 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
RANGES AND MEASUREMENTS
Turbine
•Hitachi H8S2144
1-800-678-5782 1-508-238-7033 91
www.sdidiagnostics.com
The Spirometry Source
Volume accumulation time:
Parameter selection:
•FVC and FEV1, the two with the highest value of the
tests saved. Remaining parameters of the selected test,
with the highest sum being recommended.
Keypad:
92 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
Communications channel:
•RS 232C
By external printer
Relative humidity:
Barometric pressure:
1-800-678-5782 1-508-238-7033 93
www.sdidiagnostics.com
The Spirometry Source
Temperature:
•Storage, between 32 and 94 °F
•Working, between 42 and 72 °F
Chapter 4: Technical Specifications
Applicable standards:
•Spirometry (ATS/ERS, SEPAR)
•Safety (EN 60601.1, EN 60601.1.1)
•Electro-magnetic Compatibility (EN 60601.1.2). See
Appendix 1
•Quality (EN 13485, ISO 9001:2000)
•Spirometers for peak expiratory flow (UNE EN
13826:2004)
•Bluetooth Module
- Compliance with Standard 2.0
- Class II
- CE and FCC Certificate.
Power supply:
•1.2 NiMh battery
Power:
•Below 400 mW
Size:
•153.5 x 80 x 52 mm
Weight:
•250 g
Equipment lifetime:
•10 years
94 1-800-678-5782 1-508-238-7033
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033
95
www.sdidiagnostics.com
The Spirometry Source
The Astra 300 spirometer is an instrument that acquires
mechanical signals and processes the information provided
by the signal related to the pulmonary function. For
processing purposes, mechanical must be changed to
electrical. The devices responsible for this change are
Chapter 5: Operating Principles
5.1 TURBINE
The turbine is axial with two stators in the form of a
propeller and a rotor made up of a flat, rectangular blade.
The shape of the stators means that the air flow passing
turns, which makes the blade turn. The turbine operates
based on the Fluid Mechanics theory and, more
specifically, the Machine Turbo theory. Applied to this
case, the angle at which the rotor turns is directly
proportional to the fluid volume crossing the turbine and
the proportionality constant depends on its shape.
1-800-678-5782 1-508-238-7033
96
www.sdidiagnostics.com
The Spirometry Source
5.3 MICROPROCESSOR
PHYSICAL DESCRIPTION
PROGRAM
MEMORY
1-800-678-5782 1-508-238-7033
97
www.sdidiagnostics.com
The Spirometry Source
CPU
This device manages and runs the process that is coded
into the data that forms the program. The Renesas
H8S2144 micro controller is used as a CPU.
Chapter 5: Operating Principles
CONTROLLERS
QUALITATIVE DESCRIPTION
- Calibration program
1-800-678-5782 1-508-238-7033
98
www.sdidiagnostics.com
The Spirometry Source
1-800-678-5782 1-508-238-7033
99
www.sdidiagnostics.com
The Spirometry Source
Chapter 6: Upkeep, Preventive & Corrective Maintenance
6. UPKEEP,
PREVENTIVE AND
CORRECTIVE
MAINTENANCE
6.1 UPKEEP
Upkeep is aimed at ensuring the correct working order of
the equipment. The person undertaking it requires no
special technical skills except knowledge of the functions
and handling of the equipment. The equipment user
normally performs this. The operations to be completed
are as follows:
PRECAUTION
DO NOT EXPOSE THE TURBINE TO TEMPERATURES
OF OVER 60ºC OR BELOW 0ºC. DO NOT USE
SOLVENTS OR OTHER SIMILAR SUBSTANCES FOR
CLEANING AS THEY MAY DAMAGE IT.
SPIROMETER
WARNING
See Inside Back Cover for CPT and ICD-9 Codes for Spirometry