CardioTech GT-105 User manual

Attachment 3
Revised “Operation Manual”

C
Ca ar rd di io oT Te ec ch h
GT-105
Spirometry System
O
Op pe er ra at ti io on n M Ma an nu ua al l
REV. 1.4

-1- Rev.1.4
Warning Information
WARNING
The user should read and understand all product literature, labeling and
warnings prior to operation GT-105 spirometry system
Throughout this manual, the following indicators are used as follows;
WARNING
Warning alerts the user to potential serious outcomes (including injury or
adverse events) to the patient or user. It also alerts the user to potential serious
damages to the stored data or the unit.
NOTE
Important information for the safe, effective, and convenient use of GT-105
spirometer.

-2- Rev.1.4
Table of Contents
1.
Precautions ...…………………………………………………………………….
4
2.
Introduction ...………………………………………………...…………………
7
Spirometry / Intended use
3.
Configuration ...………………………………………………………………….
8
Standard accessories / Parts description
4.
System Preparation ...……………………………………………...……………
11
Hardware attachment
5.
Basic Operation ...…………………………………………………...…………..
14
Operational procedure
6.
Pre-measurement Settings …………………………………………...…………
17
General settings / Factory defaults setting
7.
Calibration ……………………………………………………………...……….
28
8.
Patient ID Input …………………………………………………………………
31
9.
Spirometry Tests ……………………………………………………………...…
33
SVC / FVC / MVV / MV
10.
BD [Bronchodilator] Test ……………………………………………………….
49
FVC
11.
Challenge Test ...…………………………………………………………………
53
12.
Interpretation ……………………………………………………………………
59
Spirometry / COPD / QC check
13.
Patient Database ……………………………………………...…………………
63
Database / Data batch processing

-3- Rev.1.4
14.
Description of the Measured Parameters ……………………………………...
66
SVC / FVC/ MVV/ MV
15.
Print-out …………………………………………………………………………
72
16.
Predicted Formula …...………………………………………………………….
73
Knudson / Morris / Polgar / ITS / ECCS / Crapo-Hsu / ASIA/ Predicted Curve
17.
Maintenance ……………………………………………………………………..
84
Cleaning /
18.
Troubleshooting Guide ………………………………………………………….
86
19.
Glossary of Spirometry Terms ………………………………………………….
88
20.
Technical References ……………………………………………………………
92
Product specifications
21.
Environment Protection ………………………………………………………...
93
22.
Accessories ……………………………………………………………………….
94
Accessories / Spirobank software
23.
Limited Warranty ……………………………………………………………….
96
24.
Contact Information …………………………………………………………….
97
EC representative / Manufacturer / Your local dealer

-4- Rev.1.4
1. Precautions
WARNING
Please read this operation manual carefully, and operate GT-105 spirometry
system properly and safely.
1. Precautions
1.1 Contraindication and prohibition
1.1.1 Precautions for use
Prepare the device for operation according to instructions in this operation manual.
Check to be sure that all the cords are connected correctly and firmly.
When the device is used with other equipment, check to be sure that they can be used safely without causing mutual
interference.
Observe the patient closely. If any abnormality is observed, proper action, which may include stopping the test,
should be taken immediately.
Do not allow the patient to touch the device directly.
When disconnecting the cords, do not apply excessive force.
Clean the accessories, cords, and flow sensor after use. Keep them in a clean environment.
A bacterial filter must be used to reduce the risk of patient cross contamination.
If any abnormality is found in the device, Turn off the power and plug off the Flow sensor cord.
In case of malfunction, mark the device with the notice, "FAILURE" or "DON'T USE". And contact our sales office, our
authorized representative, or medical dealer in your area as quickly as possible.
GT-105 should be used by trained healthcare professionals and is not intended for patient operation.
Equipments connected to Signal I/O ports, such as RS-232C and USB have to comply with IEC60601-1. If not,
IEC60950. In order to connect other equipments, use a separation transformer for the power supply, or connect it by
means of a separation device.
1.1.2 Precautions for handling
Strong electromagnetic waves in the surrounding may cause noise in the curve or malfunction. If any unexpected
malfunction occurs during operation, check the electromagnetic environment and take appropriate measures.
Examples:
1) Use of a cellular phone
・The electromagnetic wave may cause unexpected malfunction.
Turn off the power source of cellular phones and radio equipment in the room or building where electrical equipment for
medical equipment is installed.
2) When high-frequency noise generated by other equipment enters through the socket for power source
・Identify the source of noise, and take countermeasures such as installing a noise limiter in the circuit.
・If possible, stop the operation of the equipment that generates the noise.
・Connect the power cord to another power supply socket.
3) Electrostatic effect (caused by electrical discharge in the device or in the surrounding)
･Completely remove the electrostatic charge from the operator and patient.
・Humidify the room.
4) Effect of thunderbolt
・An excessive voltage may be induced in the device when a thunderbolt occurs in the neighborhood. In such a case, operate
the device using an uninterrupted power supply.

-5- Rev.1.4
5) Noise generation
・If noise is caused to a receiver of radio or television by the device, move the receiver to a distant place from the device.
1.1.3 Precautions for installation
Avoid placing the device in the following places.
1) A place likely to be splashed with water.
2) A place with the direct sun light, high temperature, high humidity, dust, and air containing salt or sulfur.
3) A place with inclination, vibration, or shock (same during transportation.)
4) A place where chemical substances are stored or gasses are generated.
1.1.4 Precautions for maintenance and inspection
Do not make any modifications to the devices; any modifications made will void the warranty.
Do not disassemble the device, anytime.
Perform routine maintenance and inspection on the device.
1.2 Standards and Compliance
1.2.1 Electrical Safety Standards
IEC60601-1: IEC60601-1-1 (Electrical Safety), IEC60601-1-2: 2000 (EMC)
1.2.2 EMC COMPLIANCE
Guidance and manufacturer's declaration - electromagnetic emissions
GT-105 is intended for use in the electromagnetic environment specified below.
The customer or the user of the GT-105 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR11
Group 1
GT-105 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
CISPR11
CISPR11
Class B
GT-105 is suitable for use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC61000-3-2
Class B
Voltage fluctuations/
flicker emissions
IEC61000-3-3
Complies
Guidance and manufacturer's declaration - electromagnetic immunity
The GT-105 is intended for use in the electromagnetic environment specified below.
The customer or the user of the GT-105 should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC61000-4-2
±6kV Contact
±8kV air
±6kV Contact
±8kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material,
the relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC61000-4-5
±2kV for power
supply lines
±2kV for power
supply lines
Main power quality should be that of a typical
commercial or hospital environment.
Surge
IEC61000-4-5
±1kV differential
mode
±2kV common mode
±1kV differential
mode
±2kV common mode
Main power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
<5% UT
(>95% dip in UT )
for 0.5 cycle
<40% UT
(>60% dip in UT)
for 5 cycle
<5% UT
(>95% dip in UT )
for 0.5 cycle
<40% UT
(>60% dip in UT)
for 5 cycle
Main power quality should be that of a typical
commercial or hospital environment. If the user
of GT-105 requires continued operation during
power mains interruptions, it is recommended
that GT-105 be powered from an
uninterruptible power supply or a battery.

-6- Rev.1.4
IEC61000-4-11
<70% UT
(>30% dip in UT)
for 25 cycle"
<70% UT
(>30% dip in UT)
for 25 cycle"
Power frequency
(50/60Hz)
magnetic field
IEC61000-4-8
3 A/m
3 A/m
If image distortion occurs, it may be necessary
to position GT-105 further from sources of
power frequency magnetic fields or to install
magnetic shielding. The power frequency
magnetic field should be measured in the
intended installation location to
assure that it is sufficiently low.
Guidance and manufacturer's declaration - electromagnetic immunity
The GT-105 is intended for use in the electromagnetic environment specified below.
The customer or the user of the GT-105 should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150kHz to 80MHz
3 V/m
80MHz to 2.5GHz
3 Vrms
[V1]
3 V/m
[V1]
Portable and mobile RF communications
equipment should be used no closer to any part
of GT-105, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter. Recommended separation
distance
d=[3.5/V1]√P
150kHz to 80MHz
d=[3.5/E1]√P
80MHz to 800MHz
d=[7/E1]√P
800MHz to 2.5GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compliance level
in each frequency range
interference may occur in the vicinity of
equipment marked with the following symbol:
Guidance and manufacturer's declaration - electromagnetic immunity
GT-105 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the GT-105 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment(transmitters) and GT-105 as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150kHz to 80MHz
d=[3.5/V1]√P
80MHz to 800MHz
d=[3.5/E1]√P
800MHz to 2.5GHz
d=[7/E1]√P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.2
1.2
2.3
10
3.7
3.7
7.4
100
12
12
23
Name of cable
Manufacturer
Length
Shielding
Ferrite Core
AC power cable for
220V
Kawasaki Electric Wire
3.0m
None
Provided
AC power cable for
100V
Kawasaki Electric Wire
3.0m
None
Provided
The EMC of GT-105 had been tested based on the criteria described above.

-7- Rev.1.4
2. Introduction
Thank you for purchasing the CardioTech, GT-105. GT-105 provides you SVC, FVC, MVV, MV,
and bronchodilator inhalation & broncho-constrictor challenge tests. Patient data can be
saved in the internal memory, also be downloaded to a computer for database creation and A4
printing with optional Spirobank software. It also provides the useful information to help
physicians to diagnose patients’lung function as well as COPD. GT-105 features the large full
color LCD, high-speed in-line thermal printer, highly accurate pneumotacho flow sensor, and
RS-232C/USB interfaces for data transfer. GT-105 is suitable in early detection of respiratory
impairments such as Asthma and COPD. We trust our product will enable you to use
office-based Spirometry tests to diagnose and enhance your patient’s pulmonary health.
Caution: Federal (U.S.A.) restricts this device to sale by or on the order of a physician.
Spirometry testing
Spirometry is used to measure the rate at which the lung changes volume during forced
breathing maneuvers. The most commonly performed test procedure uses the forced
expiratory vital capacity (FVC) maneuver, in which the subject inhales maximally and then
exhales as rapidly and completely as possible. The FVC test is the most important. Generally,
it provides most of the information that is to be obtained from pulmonary function testing.
(“Interpretation of Pulmonary Function Tests”by Robert Hyatt et al) The FVC test shows how fast he
can blow (flow) and how much he can blow (volume). These parameters are compared to
normal values derived from “Predicted formula”based upon the patient’s age, height and sex.
Depending on the results, it is decided whether the patient is normal, or has an obstructive or
a restrictive lung disease.
Scope of this manual
This manual will show you how to use the CardioTech, GT-105 Spirometry system. Read and
understand the entire manual before trying to use this device.
Intended use
CardioTech, GT-105 Spirometry system is an electrical medical device designed to perform
pulmonary function tests. It is to be used by physicians or by trained personnel on a
physician’s responsibility. It is intended for use with pediatric and adult patients in hospitals,
physicians’ offices, and occupational health testing environments.
Indications for use
The CardioTech Spirometry System, Model GT-105 is a diagnostic tool to measure the
maximal volume and flow of air that can be moved in and out of a patient’s lungs. The system
is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in
hospitals, physician’s offices, laboratories, and occupational health environments.

-8- Rev.1.4
3. Configuration
Standard Accessories
When you get your CardioTech GT-105, carefully open the box and unpack the system. Make
sure that you have all the parts listed below and that nothing looks damaged. Included with
this system are the following:
#
Description
Q’ty
1.
Cardboard mouthpiece (50pcs/box) *
1 box
2.
Nose clip (Plastic)
1 pcs
3.
Printer paper (112mm width, thermal)
1 roll
4.
Flow sensor head
2 pcs
5.
Flow sensor body
1 pc
6.
Power cord & AC adapter
1 pc
7.
Operation manual
1 copy
A bacterial filter*, purchased separately, must be used with the CardioTech GT-105 Spirometer.
* single patient use
(1)
(2)
(3)
(4)
(5)
(6)
(7)