Sibelmed DATOSPIR TOUCH Series User manual

DATOSPIR TOUCH
SPIROMETER
USER’S MANUAL
511-B00-MU2 • REV. 1.09 •2019-05

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SIBEL S.A.U., Rosellón 500 bajos, 08026 BARCELONA –(Spain)
National Sales: Tel. [phone] e-mail: [email protected]
International Sales: Tel. [phone] e-mail:[email protected]
Technical service: Tel. [phone] e-mail: [email protected]
Fax: [phone], Website: www.sibelmed.com

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1. SAFETY .......................................................................... 5
2. INSTRUCTIONS FOR USE AND INSTALLATION............. 10
2.1 INTRODUCTION ........................................................10
2.2 MODELS AND OPERATING MODES...............................10
2.3 LAYOUT OF CONTROLS AND CONNECTORS ..................15
2.4 INSTALLATION AND START-UP ...................................16
3. SPIROMETER CONFIGURATION ................................... 22
3.1 SETUP .....................................................................22
3.2 CUSTOMIZATION ......................................................22
3.3 INTERNAL DATABASE ................................................27
3.4 MAINTENANCE PROGRAM ..........................................28
3.5 QUALITY CONTROL: CALIBRATION CHECK ...................30
3.6 CALIBRATION PROCEDURE.........................................32
3.7 CALIBRATION RECORD ..............................................33
4. SPIROMETRIC TESTS PROCEDURES ............................. 35
4.1 FORCED VITAL CAPACITY «FVC» TEST.........................35
4.2 QUALITY OF FVC TEST ..............................................44
4.3 POST BRONCHODILATION TEST..................................47
4.4 SLOW VITAL CAPACITY «VC» TEST .............................49
4.5 MAXIMUM VOLUNTARY VENTILATION «MVV» TEST .......50
5. COMMUNICATIONS SYSTEM ........................................ 51
5.1 TRANSFERRING TESTS TO THE PC ..............................51
5.2 TRANSFERRING EQUIPMENT CHECK DATA ...................51
5.3 ADDING MODULES, OPTIONS AND/OR TRANSDUCER ....52
5.4 UPDATING FIRMWARE ...............................................53
6. TECHNICAL SPECIFICATIONS...................................... 55
6.1 GENERAL SPECIFICATIONS ........................................55
6.2 SYMBOLS.................................................................57
6.3 TESTS, FUNCTIONS AND PARAMETERS........................58
6.4 PREDICTED SETS......................................................60
6.5 FVC INTERPRETATION (Diagnosis) ..............................60
6.6 TRANSDUCERS .........................................................61
6.7 MANUFACTURER’S LIABILITY......................................61
7. CLEANING AND MAINTENANCE ................................... 62
7.1 CLEANING / DISINFECTION........................................62
7.2 PREVENTIVE MAINTENANCE .......................................64
7.3 CORRECTIVE MAINTENANCE ......................................66
Annex 1. ELECTROMAGNETIC COMPATIBILITY ................ 67
Annex 2. COMPLIANCE WITH THE DATA PROTECTION
ACT................................................................... 71

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The DATOSPIR TOUCH Spirometer has been designed by the
R+D+I Department of SIBEL S.A.U., with the collaboration of
the Pneumology Service of Hospital de la Santa Creu i Sant Pau
de Barcelona, in line with the standardization criteria of
International Institutions: ATS/ERS TASK FORCE 2005
(American Thoracic Society/ European Respiratory Society) and
National Institutions: SEPAR (Spanish Pneumology and Thoracic
Surgery Society).
COMPLIANT PRODUCT
93/42/EEC Medical Device Directive.
Class IIa
Revised Approved
Date: 2019-05 Date: 2019-05
Technical Director Sales Director

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1. SAFETY
SPECIAL PRECAUTIONS
The DATOSPIR TOUCH spirometer has been designed for use with
the safety in mind. All operating instructions must be read before
using it. Failure to do so could cause injury to the user or patient
and damage to the equipment and/or accessories.
INTENDED USE
a) Measurement of lung flows and volumes for the diagnostic and
control of respiratory diseases (Asthma, COPD, etc.).
b) Measurement of peripheral blood oxygen saturation and cardiac
pulse for the respiratory diagnostic.
c) Measurement of inspiratory and expiratory maxima pressures
for the respiratory diagnostic.
Use in a health center or similar and indoor use (not for outdoor use).
Not intended for home use or for use in moving transport vehicles.
INDICATIONS FOR USE
The spirometer should NOT be used under high ambient
noise levels to ensure that the patient may hear the acoustic
signal of the device.
The equipment should be placed in a safe position to
avoid falling that may result in equipment damage or harm
to the patient and/or user.
The spirometer is NOT designed for use under other
conditions or using other power sources not indicated in this
manual. Use only accessories specified in this manual.
The spirometer is intended to be used in the following patient
population:
a) Age: more than 4 years until elderly
b) Weight: > 15 Kg
c) Height: > 50 cm
d) Health status: physical and mental condition that allows the
performance of the forced maneuver.

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USER PROFILE
The spirometer is intended to be used by or under the direction of a
medical professional. Specific training on the Spirometry technique
is recommended.
Bronchoconstriction test must be supervised by a
qualified technician in the art.
Before using the spirometer on patients, you should be
familiar with the operation of equipment. All information
necessary for its operation is available in this Manual.
For additional training on the technique or on the product, contact
SIBEL S.A.U. or your dealer.
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. Special attention must be paid to children,
the elderly and the disabled.
LIMITATIONS FOR USE. CONTRAINDICATIONS
An analysis of the results of spirometry tests is not enough 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. Acceptability of
a test is the responsibility of the medical professionals.
The spirometer should not be used when it is likely that the validity
of the results could be compromised by external factors.

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Take care NOT to place the equipment where it could be
splashed by water or other liquids or cover it with objects
that prevent air from circulating around it while it is running.
The device should NOT be used stacked or adjacent to
other equipment.
The equipment must be stored and used within the temperature,
pressure and humidity ranges specified in the section 6.1.
WATER INGRESS PROTECTION LEVEL
IPX2. Equipment Protected against falling water equivalent
to 3-5mm rainfall per minute during 10 minutes. Unit placed
tilted 15 degrees, in each direction, from normal operating
position. In compliance with EN ISO 80601-2-61:2011.
ELECTRICAL RISKS
To avoid the risk of electric shock, this equipment must be
connected to a power supply with protective earth only.
DO NOT tamper with the integrity of the system's electric earth
connection. Protection against electrical discharge is provided by the
connection of the chassis to an electrical earth connection.
The earth connection is only effective when the three-wire power
cable supplied with the equipment is connected to a suitably
earthed electrical socket.
DO NOT use multiple mains sockets to NOT degrade the electrical
safety.
DO NOT disassemble the equipment or accessories 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 connect a line phone to the MIP-MEP connector.
DO NOT use damaged accessories. DO NOT use the equipment if
the power cable is in poor condition or cracked.
According to EN 60601-1 the device is classified as continuous
operating mode.

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It is considered essential performance the measurement of
parameters related with spirometry (flow and volume), maximal
pressures and pulse oximetry (fulfilling the specified accuracy
and/or indicating that the maneuver is not correct), the display of
results, saving and integrity of data in memory. It is not considered
essential performance the communication with the computer nor
the printing of the results.
ELECTRICAL DISCHARGE
To ensure vital safety features under the EN 60601-1 standard, only
equipment compliant with the electrical safety standards in force
may be connected to this device. To connect DATOSPIR TOUCH to
a non-medical device as a printer or PC, they must be compliant
with EN60950 and the installation must provide an additional
safeguard. This safeguard could be an additional ground conductor
connected to the metallic enclosure of the non-medical device
(contact to Technical Support to see if it is practicable) or a USB
separation device provided by the manufacturer SIBEL S.A.U.
NEVER immerse any part of the equipment in liquid. THIS COULD
CAUSE AN ELECTRIC SHOCK. Consult the section 7.1.
RISKS OF EXPLOSION
NOT suitable for use in the presence of volatile anesthetics,
flammable gases or in oxygen-rich environments. THIS MAY CAUSE
AN EXPLOSION.
RISKS OF CONTAMINATION
To avoid the risk of contamination or cross infection, the Turbine
and Fleisch transducers and some of the optional modules must
be disinfected before use in a new patient or must be used with
an adequate protective barrier filter compatible with the
equipment (see section 7.1).
Reusable mouthpieces must also be disinfected. Disposable
transducers and disposable mouthpieces must NOT be reused.
DO NOT use mouthpieces or other supplies from manufacturers
that have not tested their biocompatibility, since it could endanger

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patient health.
RISKS OF INTERFERENCE
This is an electronic medical device; therefore requires special
precautions regarding electromagnetic compatibility (EMC): it must
be installed and put in service according to the information
attached in Annex 1. ELECTROMAGNETIC COMPATIBILITY.
As this is an electronic product, high frequency emissions may
interfere with its correct use. Thus, keep the spirometer away from
products that may generate interference (radios, cell phones, etc).
All accessories, transducers, cables and spare parts must be
original and must be requested from the manufacturer or dealer, to
ensure patient safety and ensuring the proper operation of the
spirometer. Failure to do so may increase the emissions or
decrease the immunity of the equipment.
DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY
DOMESTIC USERS IN THE EUROPEAN UNION
Never dispose of the DATOSPIR TOUCH,
its accessories and its batteries in the household trash. It
must be disposed of properly and may need to be recycled in
accordance with the statutory requirements in your country.
Devices commercialized before July 22nd, 2014:
The device contains lead for the electric soldering.
It uses a lithium battery and could use an optional NiMh battery.
Information on proper disposal is available from your dealer or from
Technical Support at SIBEL S.A.U.

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2. INSTRUCTIONS FOR USE AND INSTALLATION
2.1 INTRODUCTION
The DATOSPIR TOUCH spirometer is a compact device based on
different types of transducers: Fleisch, Turbine or Lilly
disposable, awide high-resolution color touch screen and an
internal thermal printer. Has an internal database to store the
performed tests and also allows connection to an external printer
via USB. In addition, it may incorporate a Weather Station to
measure pressure and humidity (it includes a temperature
sensor); a MIP-MEP module to measure Maximal Inspiratory and
Expiratory Pressures, an electronic Pulse oximetry module,
exclusively for taking Oxygen Saturation and Pulse Rate samples
(SpO2) and an Ethernet module.
Furthermore, the spirometer may be connected in real or deferred
time to a PC via USB, Bluetooth or Ethernet, using the W20s
Spirometry software to perform tests, download tests results
from the device to permanent records, print hard copies of selected
data or transfer test to telemedicine platforms or clinical information
systems. Thus, it allows carrying out interactive real-time testing on
your PC and transfer status device data
2.2 MODELS AND OPERATING MODES
2.2.1. MODELS
The DATOSPIR TOUCH series is available in 6 different models:
DATOSPIR TOUCH EASY - T
DATOSPIR TOUCH DIAGNOSTIC - T
DATOSPIR TOUCH EASY - F
DATOSPIR TOUCH DIAGNOSTIC - F
DATOSPIR TOUCH EASY - D
DATOSPIR TOUCH DIAGNOSTIC - D
This manual is intended for all models and options of the
DATOSPIR TOUCH spirometer. Therefore, only specific options and
functions of the model available will be applicable in each case.
The following table shows the standard features and optional
functions for each model.

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The spirometer has three possible different transducers:
Turbine Transducer
Fleisch Transducer
Disposable Transducer (Lilly type)
And two software configuration choices:
Easy –for occupational and primary care
Diagnostic –for lung function laboratories (occupational and
primary care also included).
Easy
Diagnostic
D
T
F
D
T
F
TRANSDUCERS
Disposable
Turbine
Fleisch
SETTINGS
Occupational Medicine Mode
Primary care Mode
Diagnostic mode
1.000 test internal database with graphics
3.000 test internal database with graphics
Bronchoconstriction module
W20s Spirometry software
CONNECTIVITY
USB to extern printer connection
USB to PC
Ethernet module
Bluetooth module
Included
Optional
Not included
2.2.2. OPERATING MODES
There are 3operating modes available. Choose the settings that
best fit your needs:

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Diagnostic Mode (DG): Orientated to Lung Function
Laboratories. This is the most complete mode. Practically all
the functionalities of the device are available and it allows you to
use whatever operating mode.
Primary care Mode (PC): Orientated to Primary Care.
It includes quality alerts to assist you in producing high quality
spirometry tests. Direct access to FVC, Bronchodilatation,
VC and MVV tests.
Occupational Medicine Mode (OC): Orientated to Prevention
Centers and Mutual. Ideal for "screening", it is easy to use
and allows you to perform FVC and Bronchodilatation tests.
OC
PC
DIAG
FUNCTIONALITIES
FVC
VC
MVV
Bronchodilation (Post)
Bronchoconstriction
Alternated V-T & F-V plots
Simultaneous V-T & F-V plots
Superposed curves
Acoustic signal for begin and end of maneuver
Time-based progress bar (adult incentive)
Volume-based progress bar (adult incentive)
Parameter and plot selection (customization)
Calibration program
Cal-check
Large graphs on reports
Print/save 3 maneuvers
Print 3 PRE maneuvers (data and graphs)
Time-audit module
Miller Interpretation
Snider, Kory&Lyons, NLHEP (Ferguson) Interpretation
ATS/ERS (McKay) Interpretation
Quality of the FVC test (NLHEP: QC prompts, QC grades)
Help screen in all menus
Pediatric incentives
Device auto-check program
Import external patient data
Export data to Health Information Systems
Included
Optional
Not included

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A model can be upgraded at any time by adding the corresponding
parts. To do so, please contact the SIBEL S.A.U. Sales
Department or your dealer.
2.2.3 PACKING LIST
Easy
Diagnostic
D
T
F
D
T
F
TRANSDUCERS
1. Disposable
2. Turbine
3. Fleisch
ACCESSORIES STANDARD
4. Thermal paper 110x50
5. USB and printer cable connection
6. Nose clip
7. Plastic Mouthpiece
8. Disposable mouthpiece pack (25 u)
9. Disposable transducers pack (25 u)
10. External power supply
11. Transducer holder
12. User’s manual
Included
Optional
Not included

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2.2.4 ACCESSORIES, OPTIONS AND
SPARE PARTS
Easy
Diagnostic
D
T
F
D
T
F
REF.
OPTIONAL ACCESSORIES
TRANSDUCERS KITS
07046
Disposable
07053
Turbine
07052
Fleisch
OPTIONS
07272
Pulse oximetry module
07144
MIP-MEP module
07146
Sniff module
FIRMWARE OPTIONS
07060
Bronchoconstriction module
07061
Concurrent display of V/t & F/V
07062
Database upgrade to 3000 records
07068
Diagnostic model Upgrade. Includes weather
station and Bluetooh modules
ACCESORIES
08290
Calibration syringe (3 L)
09160
Nose clip (1 u)
09152
Plastic Mouthpiece (1u)
09037
Disposable mouthpiece pack (25 u)
03169
Disposable transducers (50 u)
06391
SpO2soft sensor adult (M50E)
07725
SpO2soft sensor children (M50B)
03175
Turbine transducer
07828
Software W20s CD
SPARE PARTS AND COMPONENTS
07233
Weather station module
07193
Bluetooth module
06610
Ethernet module
02634
Thermal paper 110x50 (5 u)
07238
Rechargeable battery
07283
Carrying Bag
01145
Bluetooth adapter for PC
03658
USB 2.0 and printer cable connection
08165
Galvanic isolator for USB 2.0
06611
Ethernet cable
03052
MIP-MEP Shutter probe
07147
Sniff probe (for MIP-MEP module)
05602
MIP-MEP mouthpiece
01149
Paediatric Mouthpiece adapter
06186
Fleisch Transducer
06187
Fleisch filter (3u.)
Included
Optional
Not included

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2.3 LAYOUT OF CONTROLS AND CONNECTORS
1- Internal printer (thermal paper roll).
2- Lever to lock/unlock the paper roll.
3- ON/OFF button
4- Color graphic touch screen
(640 x480 pixels).
5- Printer casing
6-Transducer Connection:
Fleisch, turbine or Lilly disposable
7- MIP-MEP Connection
8- Pulse oximetry sensor connection
9- Power supply connection
10- USB connector for PC
11- USB connector for external printer
12- Ethernet Connection
13- Rechargeable battery location
14- Pulse oximetry board connection
15- Electronic Weather Station board
connection
16- Bluetooth board connection
17- Lithium battery CR1815
18- Specifications plate
13
14
15
16
17
18
REAR PANNEL
FRONT PANNEL
BASE
Do not connect
accessories not supplied by
SIBEL,S.A.U.

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2.4 INSTALLATION AND START-UP
This spirometer has been manufactured using solid-state
professional components under strict quality controls. However,
accidents may occur during the transportation or storage of the
equipment and it is therefore wise to initially check its condition
and that of its accessories before installing them.
If you detect any damage to the packaging, contact the
haulier agency and distributor immediately before starting
the installation. Packaging must not be disposed of until the
correct working order of the device has been fully verified.
2.4.1 START-UP
1 Connect the external power supply to the socket no.9,
located on the rear of the device, and to the mains.
The power supply shoud be placed to allow an easy
disconnection for any emergency situation. The disconnection
from electrical main is performed through the plug of the power
supply.
2Insert the plug of the transducer cord into the socket no.6
3 Connect the other optional modules that you have acquired.
Consult the specific user’s manuals.
4Press the ON/OFF button (no.3).
5Choose the language
6Enter the PIN number, if equipment protection is enabled.
See the chapter 3.3 EQUIPMENT PROTECTION.
The first time the equipment is started, the protection is
disabled and the PIN is set to 0000.
7 If equipment 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:

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Access to the FVC test
Access to the Post Bronchodilation test
Access to the VC test
Access to the MVV test
Access to the Bronchoconstriction test
Access to the Pulse oximetry test
Access to the MIP-MEP test
Quality control procedure: Calibration check
Access to the Internal database/ Database customization
Printing a report
Access to the Setup options: Calibration, Customization
and Maintenance.

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Pressing on the black area of the screen you may enable / disable
the main menu buttons.
2.4.2 RECHARGEABLE BATTERY: INSTALLATION AND LOAD
The DATOSPIR TOUCH spirometer operates optionally with
rechargeable Ni-Mh battery (9.6V ≥2000mAh) with an
autonomy of 1.5 hours approx.
Installation must be carried out by qualified technical
personnel accustomed to handling electronic devices.
To install the battery, remove
the base cover and insert it
where indicated in the figure.
The battery is recharged by
connecting the spirometer to the
power supply, even though the
device is turned off.
The charging time is about
20 hours.
DO NOT charge other
type of batteries, they could EXPLODE. Remove old batteries
to avoid they could spill its substances.
2.4.3 POWER SAVING
To save power, when working with battery, the device includes an
auto switch off system that turns the equipment off when the screen
is not accessed for one minute, except in tests screens. In this case,
you will be prompted to save the data before powering off.
The state of the battery shoud be checked periodically and extracted
from the device if it is not going to be used for a long time.
When the spirometer is connected to the power supply, the
backlight turns off after not accessing the screen for two minutes.
The device will sleep until one key is pressed, recovering the
information previously displayed.
Connect

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2.4.4 PLACEMENT OF THE PAPER INTO THE INTERNAL PRINTER
Lift the printer cover and press the tab
located on the right-hand side of the
printer to unlock the cylinder. Place the
paper roll into its housing and pull out
about 20 cm of paper towards the unit
screen, ensuring that it is properly
aligned. Reinsert the cylinder into the
printer, on top of the paper, with the
cogwheel on the left-hand side, press
until it clicks. Pass the paper through
the slot in the cover and close it.
A screen will appear to pull the paper
forwards/backwards. Pull out the
amount of paper that you deem
necessary. To cut the paper, pull it
sideways.
2.4.5 CONNECTION TO AN EXTERNAL PRINTER
Select the external printer option in the COMMON
CUSTOMIZATION menu. Connect the USB cable into the socket
n.11 (PRINT) and the other end to the printer.
Contact the manufacturer or dealer for a list of compatible printers.

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2.4.6 USB CONNECTION TO PC
To connect the device to a PC, install the USB driver and the
W20s Spirometry Software in the PC. Consult the W20s
Spirometry Software User’s Manual.Then, connect the correct
end of the USB cable to the socket n.10 , and the other end to
the computer.
2.4.7 BLUETOOTH CONNECTION TO PC
If you have purchased this module with the spirometer, it will be
already installed. Otherwise, you must remove the cover from the
base of the spirometer and insert the bluetooth board where is
shown in Figure.
The following steps must only be carried out by
technical personeel used to dealing with electronic devices.
Then, in both cases, connect the
Bluetooth adapter to the PC and
simply install the software
included. To do so, consult the
Bluetooth adapter user’s
manual.
Install the W20s Spirometry
Software to the PC and choose
the Bluetooth link option, consult
the W20s Spirometry Software
User’s Manual, included in the
CD.