Fukuda Sangyo ST-95 User Manual
SPIROANALYZER ST-95
Version 1.2
INSTRUCTION MANUAL
FUKUDA SANGYO
December 1999
This Manual must be read carefully before using the
PAGE REVISION LIST
Clause Page
All
All
All
No.
All
All
All
Rev.
No.
1.0 First Issue
1.1 Re-issued
1.2 Re-issued
Amendments
Date
mm/dd/yy
02/18/99
04/23/99
12/13/99
Geraldo S. Sadian
Geraldo S. Sadian
Geraldo S. Sadian
Authorized
By
If you have any questions, please call the local FUKUDA SANGYO products'
distributor or our office listed below:
Manufacturer:
FUKUDA SANGYO INC.
Address: 2/L Kingsville Comm’l Arcade
Marcos Highway, Antipolo City
PHILIPPINES
Phone: +(632) 645-8276
Fax: +(632) 645-8276
Marketing / Sales Coordinator:
FUKUDA SANGYO CO., LTD.
Address: 996 Nazukari, Nagareyama-City,
Chiba 270-0145
JAPAN
Phone: +81 471 46 9734
Fax: +81 471 47 2193
Responsible for placing the devices on the EC Market under MDD 93/42/EEC:
FUKUDA SANGYO EUROPE s.r.l.
Address: Via Germania, 12/14, 35127 Camin (Padova)
ITALY
Phone: +39 49 870 3344
Fax: +39 49 870 3388
Your local FUKUDA SANGYO product distributor:
(please fill-in your distributor details here)
Company:
Address:
Phone:
Fax:
0123
EQUIPMENT SYMBOLS
Reference: EN 60 601-1 Appendix D
Table DI (IEC ISO 417) and Table D II (IEC ISO 417-878)
Direct Current (DC)
Alternating Current (AC)
Equipotential Ground
OFF (Power is disconnected from the mains)
ON (Power is connected to the mains)
Type B applied part
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CONTENTS
Chapter 1. CONTENTS
CHAPTER 1. CONTENTS......................................................................................................................................... 5
CHAPTER 2. INTRODUCTION............................................................................................................................... 7
2.1. OUTLINE........................................................................................................................................................... 7
2.2. INTENDED MEASURING METHOD ............................................................................................................. 7
2.3. MEASUREMENT PRINCIPLE......................................................................................................................... 7
2.4. BLOCK DIAGRAM........................................................................................................................................... 8
CHAPTER 3. SPECIFICATIONS............................................................................................................................. 9
3.1. CLASSIFICATION............................................................................................................................................ 9
3.2. MEASUREMENT SPECIFICATION................................................................................................................ 9
3.3. OTHER SPECIFICATION .............................................................................................................................. 10
CHAPTER 4. PARTS IDENTIFICATION............................................................................................................. 11
4.1. MAIN UNIT..................................................................................................................................................... 11
4.2. INTERNAL STRUCTURE.............................................................................................................................. 12
4.3. FLOW SENSOR............................................................................................................................................... 13
4.4. ACCESSORIES................................................................................................................................................ 13
4.5. OPERATIONAL KEYS................................................................................................................................... 14
CHAPTER 5. CAUTIONS........................................................................................................................................ 15
5.1. GENERAL CARE............................................................................................................................................ 15
5.2. INSTALLATION ............................................................................................................................................. 15
5.3. ELECTROMAGNETIC COMPATIBILITY ................................................................................................... 15
5.4. FUSES REPLACEMENT ................................................................................................................................ 15
5.5. THERMAL PAPER.......................................................................................................................................... 16
5.6. PAPER MOUTHPIECE................................................................................................................................... 16
CHAPTER 6. DISPLAY ........................................................................................................................................... 17
6.1. PARAMETER DEFINITION........................................................................................................................... 17
6.2. LCD SCREEN.................................................................................................................................................. 18
6.3. OTHER ABBREVIATION USED................................................................................................................... 19
CHAPTER 7. SETTINGS......................................................................................................................................... 20
7.1. CONFIGURATION ......................................................................................................................................... 20
CHAPTER 8. OPERATION..................................................................................................................................... 21
8.1. PREPARATION............................................................................................................................................... 21
8.2. POWERING ON .............................................................................................................................................. 21
8.3. LOADING THERMAL PAPER ...................................................................................................................... 22
8.4. ENTRY OF PATIENT'S INFORMATION...................................................................................................... 22
8.5. CORRECTION OF PATIENT INFORMATION ENTRY.............................................................................. 23
8.6. CANCELLING OF PATIENT'S INFORMATION ENTRY ........................................................................... 24
8.7. VC MEASUREMENT ..................................................................................................................................... 24
8.8. FVC MEASUREMENT ................................................................................................................................... 25
8.9. MVV MEASUREMENT.................................................................................................................................. 26
8.10. POST-BRONCHODILATOR TESTING....................................................................................................... 27
8.11. BRONCHIAL CHALLENGE TESTING....................................................................................................... 29
8.12. DATA PROTECTION FROM OPERATIONAL
ERROR ............................................................................ 32
8.13. SELECTION AND DISPLAY OF DATA..................................................................................................... 32
8.14. EXPANDED WAVEFORM SCALE............................................................................................................. 33
8.15. RECORD FILING IN MEMORY.................................................................................................................. 33
8.16. PRINTING OF DATA ................................................................................................................................... 34
8.17. OTHER FUNCTIONS.................................................................................................................................... 34
CHAPTER 9. SAFEKEEPING ................................................................................................................................ 45
9.1. S
TOWING ........................................................................................................................................................... 45
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CONTENTS
CHAPTER 10. CLEANING AND STERILIZING ................................................................................................ 46
10.1. CLEANING THE EXTERNAL OF THE INSTRUMENT............................................................................ 46
10.2. TAPERED RUBBER TUBE.......................................................................................................................... 46
10.3. LAMINAR FLOW TUBE (METAL)............................................................................................................. 46
10.4. NOSECLIP CLEANING................................................................................................................................ 47
CHAPTER 11. PREDICTED EQUATIONS .......................................................................................................... 48
11.1. ITS (I
NTERMOUNTAIN THORACIC SOCIETY) ................................................................................................... 48
11.2. KNUDSON ........................................................................................................................................................ 51
11.3. MORRIS/POLGAR........................................................................................................................................ 54
11.4. ECCS (EUROPEAN COMMUNITY FOR COAL AND STEEL)................................................................................. 56
11.5. SPAIN............................................................................................................................................................. 58
11.6. OSLO(NORWAY) ......................................................................................................................................... 60
11.7. CHILENA....................................................................................................................................................... 62
11.8. AUSTRIAN.................................................................................................................................................... 63
11.9. JAPAN............................................................................................................................................................ 64
CHAPTER 12. ERROR MESSAGES...................................................................................................................... 66
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INTRODUCTION
Chapter 2. INTRODUCTION
2.1.OUTLINE
The ST-95 SPIROANALYZER, belonging to Fukuda Sangyo’s family of Spirometer products, is a
pulmonary function testing instrument intended for performing patho-physiological breathing tests to
evaluate human respiratory functionality. The instrument is used by general physicians; respiratory
practitioners; or, qualified personnel in medical hospitals, medical centers, clinics, or near the patient
during domiciliary visit.
The instrument carries out measurements of a patient’s pulmonary Vital Capacity (VC), Forced Vital
Capacity (FVC), and, Maximum Voluntary Ventilation (MVV) by capturing instantaneous air flow data at
discreet intervals of time while the patient does a prescribed breathing maneuver. The flow data pattern
being displayed graphically on a LCD screen display. Its capability also extends to the storage and
analysis per patient for three (3) series of VC and FVC data respectively; and, two (2) series of MVV data
that maybe displayed in tabulated data-form on the same LCD screen. The acquired and analyzed data
may then be compared against various spirometric indices as determined from user-selectable predicted
equations.
The instrument has likewise the ability to do comparative analysis required in Pre-post Medication and
Bronchial Challenge Testing Regimens and a summary generation of hard-copy reports for all the tests in
a manner useful for clinical analysis.
The device has multiple patient-data storage of up to fifty (50) patients' that can be selectively stored into
its built-in memory. With selected measurement results, data and their corresponding waveforms may be
electronically uploaded via the RS-232 port to a waiting Personal Computer (PC). Data Management
Software, FS/PC-95, for the PC is available at an option. Conventional fleish-type pneumotach flow
sensor is provided as a standard accessory and an optional disposal flow sensor may be used at your
requisite.
Contraindication in the use of this instrument lies solely in the skill of the clinical technician to exact and
be able to recognize a good patient effort and cooperation for optimal measurement results. The multipletesting function of the instrument thus insures that a “maximum training effect” is achieved by the patient
for measurement accuracy.
2.2.INTENDED MEASURING METHOD
Under room condition, the patient is made to breathe air through the tubular-portion of the flow sensor
following a prearranged breathing maneuver. Because the flow sensor is a low-resistance free-flow tube,
no real energy transfer between the instrument and the patient is required to effect measurement. Only
differential pressure in the airflow path is used to capture the needed flow data.
2.3.MEASUREMENT PRINCIPLE
Tracking the patient’s breathing effort, the differential pressure generated in the flow sensor is transposed
into an electrical signal by a piezo-electric resistance-type transducer. The resulting analog waveform is
then digitally traced by an Analog-Digital Converter (ADC) and therewith recorded by the instrument’s
onboard microprocessor. The microprocessor processes the digital data and memorizes the measurement
data into the instrument’s memory. The requisite respiratory parametric readings are collated from the
aforesaid digital measurement data and next displayed on the LCD, printed on the built-in printer, or
may be transferred into a PC. All the foregoing operations controlled by the essential switches on the
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INTRODUCTION
g
front panel. A heater is fitted in the flow sensor to avoid water condensation and to keep the respiration
flow at simulated body temperature.
2.4.BLOCK DIAGRAM
KEY BOARD A/D Converter
CPU 16bit
ROM 256KB
RAM 384KB
LCD
PRINTER
SERIAL COMM.
(RS-232)
Warning:
The compliance to the standards may be nullified by the following actions:
• Improper use of components not approved by the manufacturer;
• Modifications or patches not expressly authorized by the manufacturer;
• Interconnection to outside equipment not explicitly sanctioned by the manufacturer.
The manufacturer is not responsible for any accident or damage occurring as a consequence of nonobservance of this warnin
.
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SPECIFICATIONS
Chapter 3. SPECIFICATIONS
3.1.CLASSIFICATION
1) Type of protection against electric shock : Class I equipment
2) Degree of protection against electric shock : Type B applied part
3) Degree of protection against water penetration : Ordinary equipment
4) Degree of safety of application in the presence of
flammable anaesthetic mixture with air or with
oxygen or nitrous oxide : Not suitable equipment
5) Mode of operation : Continuous operation
3.2.MEASUREMENT SPECIFICATION
1) Measurement Method
Flow detection : Pneumotach Flow Sensor
Volume detection : Flow Integration
2) Measurement range
Flow range : 0 to ± 14 liters/second (l/s)
Volume range : 0 to 8 liters (l)
3) Measurement accuracy
Flow : ±5% indication or 0.2 l/s whichever is greater
Volume : ±3% indication or 50 ml whichever is greater
4) Measurements duration and times
Vital Capacity : three (3) sets of 50-sec test
Forced Vital Capacity : three (3) sets of 25-sec test
Max. Voluntary Ventilation : two (2) sets of 12-sec test
5) Display (LCD) : 15 characters x 8 lines (text), 120 x 64 pixels (graphics)
6) Printer : 32 characters/line, 46 characters/second, 58mm/width
7) Data memory : 50 pre-test data or 25 pre/post test data
8) Output (RS-232C) : 1 channel for data transmission
(This instrument may only be connected to PC
devices
meeting EN60950 Standard)
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SPECIFICATIONS
3.3.OTHER SPECIFICATION
1) Power supply
Voltage : 100-240 V ~
Frequency : 50/60Hz
Power input : 25 VA (max)
Fuse : T 2Ax2 250V (IEC 127-2-III)
2) Operating conditions
Temperature : 10 to 40°C
Humidity : Under 80% (no condensation)
3) Transport/Stocking conditions
Temperature : -25 to 70°C
Humidity : Under 95% (no condensation)
4) Dimensions
Size : (W) 220mm × (D) 230mm × (H) 86mm
Weight : 1,300g (Main Unit)
500g (Flow Sensor)
5) Casing material : ABS (Formaldehyde free)
6) PC connection (via RS 232C) : This instrument may only be connected to PC devices
meeting EN60950 Standard
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Chapter 4. PARTS IDENTIFICATION
4.1.MAIN UNIT
PARTS IDENTIFICATION
Number Description
1 Power Switch
2 AC Inlet
3 Fuse Holder
4 Potential Equalization Terminal
5 Serial Communication (RS-232) Port
6 Liquid Crystal Display
7 Operational Keys
8 Printer Cover
9 Paper Outlet
10 Flow Sensor Holder
11 Heater Plug (female)
12 Sensor Tube Couplers (male)
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4.2.INTERNAL STRUCTURE
PARTS IDENTIFICATION
Number Description
13 Keyboard Assembly
14 Switching Power Supply
15 Pressure Transducer
16 Main Board
17 ROM (Read Only Memory)
18 Printer
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4.3.FLOW SENSOR
Number Description
19 Complete Sensor Tube
20 Tube Couplers (female)
21 Heater Plug (Male)
22 Flowhead
23 Laminar Flow Tube
PARTS IDENTIFICATION
4.4.ACCESSORIES
Number Description
24 Printer Paper (Thermal-type)
25 Nose Clip
26 Tapered Rubber Tube
NOTE: Disposable paper mouthpieces are not included as a standard accessory to this instrument.
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4.5.OPERATIONAL KEYS
Key Description
PARTS IDENTIFICATION
[0] ~ [9]
[ENT]
[CLR]
[ID]
[VC]
[FVC]
[MVV]
[POST]
[START]
[STOP]
[UTILITY]
[PRINT]
[FEED]
[ ▲ ], [ ▼ ]
Type-in keys for detail information entry
Delimiter for key entry confirmation
Cancellation of key entry detail
Patient information entry
Launch VC measurement and display
Launch FVC measurement and display
Launch MVV measurement and display
Initiation of post bronchodilator test mode
Action key to begin function
Action key to halt terminate function
Launch support function routines
Print measurement results
Advance / feed the printer paper
Scroll display screen
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Chapter 5. CAUTIONS
5.1.GENERAL CARE
1) Read and understand the instruction manual before operating the instrument.
2) Handle the instrument with care especially during transport.
3) Do not alter or repair this instrument by yourself.
4) No user-serviceable parts are included in this instrument. Repairs must be done by
authorized FUKUDA SANGYO service personnel only.
5.2.INSTALLATION
1) Locate the instrument atop a sturdy and level surface with a minimum 10cm clearing at both
sides and rear.
2) Locate the instrument in a stable environment where no abrupt temperature, humidity or
pressure change occurs.
3) Locate the instrument in clean surroundings where no ambient dusts, salts or ions are found.
4) Do not operate the instrument where the ambient temperature is over 40°C or under 10°C.
5) Do not immerse the instrument in water.
6) Do not expose the instrument to direct sunlight or excessive vibration.
CAUTIONS
5.3.ELECTROMAGNETIC COMPATIBILITY
This device has been proven to comply with EN60601-1-2 for Medical Electrical Equipment (under the
Collateral Standard for Electromagnetic Compatibility – Requirement and Tests) in the Harmonized
Standards. In order to further warrant a good level of electromagnetic immunity, it is suggested that the
instrument be kept away from devices generating electromagnetic fields or interference, such as:
loudspeakers; television sets; cellular telephones; other telephonic apparatus; or any similar devices.
5.4.FUSES REPLACEMENT
To replace the power fuses, perform the following procedures:
1) Turn the power switch of the Main Unit to OFF;
2) Disconnect the instrument from the ac mains;
3) On the rear side of the Main Unit, unscrew the two fuse holders clockwise using a suitable
tool;
4) Remove both fuses from their receptacles;
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CAUTIONS
5) Substitute the blown fuse with a known good fuse of an identical characteristic with that of
the replaced fuse;
6) Restore the fuses into their receptacles and screw the fuse holder clockwise using a suitable
tool;
7) Connect the instrument to the ac mains;
8) Turn the power switch to ON;
5.5.THERMAL PAPER
This instrument includes a printer device that uses thermal paper. The proper handling of new and
unused thermal paper are observe by the following actions:
1) Keep away from direct sunlight or placed in a high temperature environment where the
paper may discolor at about 70° C;
2) Keep away from prolonged exposure to fluorescent lighting;
3) Not to be press stored alongside a PVC film;
4) Contamination may occur on prolonged contact with a used thermal paper;
5) Used thermal paper sheets should not be carelessly thrown away in the environment but
should be subjected to disposal compliance of the present normative.
5.6.PAPER MOUTHPIECE
The rubber mouthpiece of this instrument will fit any commercially available paper mouthpiece used for
this purpose. Preference however may be limited to the following conditions:
1) Not less than 23.6 mm in outer diameter;
2) Not less than 72 mm in length;
3) Not less than 1.6 mm paper thickness;
4) Steady and long-term availability.
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Chapter 6. DISPLAY
6.1.PARAMETER DEFINITION
Description of Parameter Unit LCD Printer Standard
Vital Capacity l VC VC
Expiratory Reserved Volume l ERV ERV
Inspiratory Reserved Volume l IRV IRV
Tidal Volume l TV TV
Functional Residual Capacity l FRC FRC
Residual Volume l RV RV
Total Lung Capacity l TLC TLC
Ratio of RV divided by TLC % RV/TLC RV/TLC
Forced Vital Capacity l FVC FVC
Forced Expiratory Volume at 0.5 l FEV.5 FEV.5
Forced Expiratory Volume at 1.0 l FEV1 FEV1
Forced Expiratory Volume at 3.0 l FEV3
Ratio of FEV1 divided by FVC % (FEV1%G) (FEV1%G)
Ratio of FEV1 divided by VC % (FEV1%T) (FEV1%T)
Ratio of FEV3 divided by FVC % (FEV3%G)
Ratio of FEV3 divided by VC % (FEV3%T)
Maximal Mid-Expiratory Flow l/s MMEF MMEF
Expiratory Time s EX TIME EX TIME
Extrapolated Volume l V ext V ext
Forced Inspiratory Vital Capacity l FIVC FIVC
Forced Inspiratory Volume at 0.5 sec l FIV.5
Forced Inspiratory Volume at 1.0 sec l FIV1
Ratio of FIV1 divided by FVC % FIV1/FVC
Ratio of FIV1 divided by FIVC % FIV1/FIVC
Peak Expiratory Flow l/s PEF PEF
Mid (Forced)-Expiratory Flow at 75%(25%) l/s MEF75 (FEF25) MEF75% (FEF25%)
Mid (Forced)-Expiratory Flow at 50%(50%) l/s MEF50 (FEF50) MEF50% (FEF50%)
Mid (Forced)-Expiratory Flow at 25%(75%) l/s MEF25 (FEF75) MEF25% (FEF75%)
Peak Inspiratory Flow l/s PIF PIF
Inspiratory flow at 50% l/s MIF50% (FIF50%)
Maximum Voluntary Ventilation l/min MVV MVV
Respiration Rate Resp/min RR RR
Tidal Volume l TV TV
Parameters bracketed by () can be switched according to the utility setting.
Parameters marked by √ are printed on the standard print format.
DISPLAY
√
√
√
√
√
√
√
√
√
√
√
√
√
√
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6.2.LCD SCREEN
1) ID screen
DATE Jun/12/95
TEMP 22 ℃
ID.# 1234567890
AGE 30 yrs
Ht 171 cm
Wt 56 kg
SEX MALE
RACE WHITE
2) Comparison data screen
VC DATA
No VC
~ 1 4.70
{ 2 4.66
_ 3 4.62
Pr 4.84
3) Selected data screen
FVC DATA [1]
MEAS %PR
FVC 4.58 97
FEV.5 3.16
FEV1 3.84 96
FEV1% 87.4 99
MMEF 4.66 99
TIME 7.69
Auto calendar
Temperature (0 to 50°C)
ID number (maximum 10 digits)
Age (1 to 99 years)
Height (90 to 220cm)
Weight (10 to 220Kg)
Sex (MALE or FEMALE)
Race (WHITE, BLACK or OTHERS)
Measurement
Measurement number and Data
~ : Best data
{ : Second data
_ :Last measurement data
Predicted value
Measurement number
Data and Predicted value
DISPLAY
4) Selected data screen (Pre-Post)
[1] MEAS %CH
V ext 0.12 -1
FIVC 4.39 9
PEF 9.85 12
MEF75 9.69 8
MEF50 5.85 6
MEF25 2.17 2
PIF 9.05 2
Measurement number
Data and percentage improvement
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6.3.OTHER ABBREVIATION USED
Abbreviation Meaning
%BL Percentage (Measured Value divided by the Baseline Value)
%PR Percentage (Measured Value divided by Predicted Value)
BSA Body Surface Area
ENT Enter key
Exp Expiration
Fact Factor
Ht Height
ID Identification (or Identification number)
ins Inches
INTER Interpretation
Insp Inspiration
LANG Language
lbs Pounds
MEAS Measured Value
p Post Bronchodilator
PARA Parameter
PRED Predicted Value
Post Post Bronchodilator
SENS Sensor
TEMP Temperature
TX Transmission of data
WTX Transmission of data with waveform
Wt Weight
Yrs Years
DISPLAY
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Chapter 7. SETTINGS
7.1.CONFIGURATION
Prediction equations, and interpretation algorithms are user-selectable and set as follows.
Item Description
Predicted Equation ITS
Knudson
Morris-Polgar
ECCS
Spain
Oslo (Norway)
Chilena
Austrian
Japan
Interpretation Algorithm ITS
NIOSH/OSHA
Ellis
Diagnosis
Unit of Height and Weight cm/kg
ins/lbs
Unit of Temperature °C
°F
Expression of Expiratory Flow MEFx
FEFx
Language English
German
French
Spanish
Flow Sensor Fleish
Disposable
Display and print formats are executed according to the above settings. Most recent settings are
backed up by battery and kept in the memory until the next setting change. Setting operation is
described in 8.16. OTHER OPERATIONS.
ITS prediction equation will be automatically selected by the instrument in cases where ITS or ITS
(NIOSH/OSHA) interpretation is selected. No other prediction equation may be selected with the ITS or
ITS (NIOSH/OSHA) interpretation setting.
SETTINGS
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