MIR Spirodoc User manual

Spirodoc
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Rev.1.5
Service Guide
Service manual Rev. 1.5
Date issued 07.11.2014
Date of approval 07.11.2014

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Service Guide
INDEX
1. INTRODUCTION..................................................................................................................................................................................................................3
1.1. INTRODUCTORY REMARKS .............................................................................................................................................................................................3
1.1.1. General Aspects..................................................................................................................................................................................................................3
1.1.2. Safety Aspects.....................................................................................................................................................................................................................3
1.1.3. Legal Aspects .....................................................................................................................................................................................................................3
1.1.4. Environmental Aspects...................................................................................................................................................................................................... 3
1.2. DATA REGISTRATION........................................................................................................................................................................................................4
1.2.1. Equipment and customer registration / Service file ........................................................................................................................................................4
1.2.2. Configuration register........................................................................................................................................................................................................4
1.2.3. Product documentation .....................................................................................................................................................................................................4
1.2.4. Technical modifications ....................................................................................................................................................................................................4
1.2.5. Product evaluation .............................................................................................................................................................................................................4
1.2.6. Additional Information ......................................................................................................................................................................................................5
1.2.7. Installation..........................................................................................................................................................................................................................5
1.3. GENERAL...............................................................................................................................................................................................................................5
1.3.1. Technical Data...................................................................................................................................................................................................................5
1.3.1.1. spirodoc unit.......................................................................................................................................................................................................................5
1.3.1.2. Battery charger ...................................................................................................................................................................................................................6
1.4. STANDARDS APPLIED ........................................................................................................................................................................................................6
2. HARDWARE DESCRIPTION ..............................................................................................................................................................................................6
2.1. MAINBOARD MODULE ......................................................................................................................................................................................................7
2.1.1. Charging controller for battery pack (IC7 LTC 4067) ......................................................................................................................................................7
2.1.2. Room temperature sensor..................................................................................................................................................................................................8
2.1.3. USB communication port..................................................................................................................................................................................................8
2.1.4. Oximetry port .....................................................................................................................................................................................................................8
2.2. DISPLAY MODULE...............................................................................................................................................................................................................8
2.3. TURBINE FLOWMETER.....................................................................................................................................................................................................8
3. MAINTENANCE ...................................................................................................................................................................................................................9
3.1. GENERAL...............................................................................................................................................................................................................................9
3.2. TEST EQUIPMENT ..............................................................................................................................................................................................................9
3.3. CHECKLIST.......................................................................................................................................................................................................................... 10
3.3.1. Functional test.................................................................................................................................................................................................................. 10
3.3.1.1. Self test.............................................................................................................................................................................................................................. 10
3.3.1.2. Software version ............................................................................................................................................................................................................... 10
4. REPLACEMENT PROCEDURES ..................................................................................................................................................................................... 10
4.1. General ................................................................................................................................................................................................................................... 10
4.2. Cover........................................................................................................................................................................................................................................11
4.2.1. Opening the device ...........................................................................................................................................................................................................11
4.3. PCBs and components .......................................................................................................................................................................................................... 13
4.3.1. Removing and replacing the display............................................................................................................................................................................... 13
4.3.2. Touch screen calibration ................................................................................................................................................................................................. 14
4.3.3. Removing and replacing the internal battery pack ........................................................................................................................................................ 15
4.3.4. Turbine............................................................................................................................................................................................................................. 17
4.3.4.1. Cleaning the reusable turbine.......................................................................................................................................................................................... 18
4.3.4.2. Calibration of the reusable turbine.................................................................................................................................................................................. 19
4.3.5. Internal software upgrade procedure .............................................................................................................................................................................. 19
4.4. Oximeter module ................................................................................................................................................................................................................... 20
4.4.1. Replacing of the oximetry module.................................................................................................................................................................................. 20
4.5. Testing procedures ................................................................................................................................................................................................................ 21
4.5.1. Testing procedures for devices with oximeter................................................................................................................................................................ 21
4.5.2. Testing procedures for devices without oximeter .......................................................................................................................................................... 25
5. SPARE PARTS....................................................................................................................................................................................................................... 27
5.1. ORDERING .......................................................................................................................................................................................................................... 27
5.2. DELIVERY............................................................................................................................................................................................................................ 27
5.2.1. Ordering PCB's................................................................................................................................................................................................................ 27
5.2.2. Warranty claims................................................................................................................................................................................................................ 27
5.3. RETURN SHIPMENTS ...................................................................................................................................................................................................... 27
6. TROUBLESHOOTING....................................................................................................................................................................................................... 28
6.1. The device does not switch on .............................................................................................................................................................................................. 28
6.2. The LCD does not display..................................................................................................................................................................................................... 29
6.3. The battery pack is not working correctly ............................................................................................................................................................................ 29
6.4. The Bluetooth printer does not print .................................................................................................................................................................................... 29
6.5. The device does not measure spirometry at all .................................................................................................................................................................... 29
6.6. The device does not measure spirometry correctly.............................................................................................................................................................. 30
6.7. The device does not measure oximetry at all ....................................................................................................................................................................... 30
6.8. The device does not measure oximetry correctly ................................................................................................................................................................. 31
6.9. The data communication via USB does not function .......................................................................................................................................................... 31
6.10. Index of components ....................................................................................................................................................................................................... 31
APPENDIX A: SPARE PARTS LIST .............................................................................................................................................................................................. 32
APPENDIX B: SERVICE INFO'S (Product Change Notes) ........................................................................................................................................................ 35
APPENDIX C.................................................................................................................................................................................................................................... 36
ANNEX.............................................................................................................................................................................................................................................. 39

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1. INTRODUCTION
1.1. INTRODUCTORY REMARKS
1.1.1. General Aspects
The spirometers from the product group MIR040 are marketed under the label spirodoc.
This manual has been written for technicians involved in the service of the spirodoc. Service can be carried out by the
service organization of the manufacturer or by any other technician authorized by MIR srl.
The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.
1.1.2. Safety Aspects
Safe execution of the procedures in this manual requires technical experience and general knowledge of safety precautions.
Before you start any operation on the unit, you must have first read both the User and this Service
Manual.
Warnings, Cautions and Notes are used throughout this manual to bring special matters to the immediate attention of the
reader.
Warning The Warning concerns danger to the safety of the technician or user.
Caution The Caution draws attention to an action which may damage the equipment.
Note The Note points out a statement deserving more emphasis than the general text, but which does not
deserve a Warning or Caution.
Warning
In order to prevent unforeseen incidents, keep away from sensitive electronical devices. Inside the spirodoc there
are low voltages and very low currents, so these represent no danger for persons with experience and with a
general knowledge of safety precautions.
The sequence of steps in a procedure may also be important from the point of view of personal safety and prevention of
damage, therefore never change the sequence of steps or alter any procedure.
Warning
Batteries may explode if defective or damaged or disposed of in fire. Do not short-circuit the batteries!
1.1.3. Legal Aspects
This manual and the information herein are property of MIR srl (Rome, Italy).
Copying this manual in whole or in part is strictly forbidden.
MIR srl disclaims any responsibility for personal injury and/or damage to equipment caused by:
negligence or disregard of a Warning or Caution
deviation from any of the prescribed procedures
execution of activities which are not prescribed
ignorance of the general safety precautions for handling tools and the use of electricity
incorrect or unreasonable use
1.1.4. Environmental Aspects
Please dispose properly of any items replaced, following all the local regulations.

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All components (housing, PCBs, batteries, electronic and disposable parts, etc.) must be disposed of according to the
relevant local regulations.
1.2. DATA REGISTRATION
1.2.1. Equipment and customer registration / Service file
From the point of view of safety and product liability the following data must be registered for each unit:
Equipment data
Model, REF code and serial number
Customer data
date of purchase
name and full address of the customer
Service data
log of all service activities
Configuration data
the actual configuration of the equipment (hardware and software versions)
The distributor (through their dealer and/or service organization, if any) is responsible for maintaining these records and
they must be able to provide these data when requested.
1.2.2. Configuration register
A configuration file gives the serial numbers and/or batch numbers of main sub-assemblies and/or important parts of
each unit. The parts listed in a configuration file are defined as registered parts. For example parts as mainboards, display,
batteries and internal software.
Note
MIR srl has the original configuration file of each unit sold. Any possible changes in the original configuration of
the supplied units must be filed and the distributor must be able to provide this data.
1.2.3. Product documentation
The documentation set for the spirodoc includes a User Manual. The User Manual is a recommended item for all service
engineers. The user manual is available in the following languages:
English
Spanish
German
French
Italian
Polish
1.2.4. Technical modifications
This publication could include technical inaccuracies or typographical errors. Changes are periodically made to the
information herein; these changes will be published as Service Info in appendix B of this Service Manual.
Note
Some functions described in this manual may not be activated in the present software or hardware version. For
detailed information, please refer to the User Manual.
1.2.5. Product evaluation
In order continuously to improve the quality of our products, MIR srl requests that the service organizations should report
any device issue which may be discovered. When the same issue regularly occurs or when a safety issue occurs, MIR srl
would like you to send us a product complaint report. The report must contain the name, the type of product, a detailed

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description of the problem, the frequency of the same problems, the quantity of sold equipment and your solution to the
problem (if any).
1.2.6. Additional Information
Please do not hesitate to contact MIR if you require additional information.
Manufacturer’s address:
MIR srl
Medical International Research
Via del Maggiolino, 125
00155 Rome
Italy
Tel.: [phone]
Fax.: [phone]
Email: [email protected]
1.2.7. Installation
Warning:
Before using spirodoc check internal battery pack charge level.
turn on the SPIRODOC by pressing and release the
power key placed in the middle on the side of the
device
Check battery level on the upper right of the display
as shown in the image.
1.3. GENERAL
spirodoc is an “open circuit system” for the measurement of inspiratory and expiratory lung function parameters and
oximetry values, such as pulse rate and SpO2. It is suitable for basic lung function analysis of the mechanical respiratory
tract parameters. Three different respiratory tests can be performed:
the forced vital capacity test (FVC),
the slow Vital Capacity test (VC/IVC)
the Maximum Voluntary Ventilation test (MVV)
spirodoc has been designed and manufactured to ensure the highest level of safety and the unit fully complies with the
stringent international EN 60601-1 and EN 60601-1-2 standards.
1.3.1. Technical Data
1.3.1.1. spirodoc unit
Max. current inside the unit
90 mA (with LCD at the maximum lightness)
Internal batteries
Rechargeable Battery pack Li-ion 3.7 V 1100mAh
Approval
CE 0476 EC mark for Medical Devices
FDA
Dimensions
101x48x16 mm;
turbine housing 46x47x24 mm

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Weight
Central unit 99g (including batteries)
Turbine housing 17g
Volume range
10 L
Flow range
± 16 L/s
Volume accuracy
± 3% or 100 mL
Flow accuracy
± 5% or 250 mL/s
Dynamic resistance at 12 L/s
< 0,5 cmH2O/L/s
Type of electrical protection
Class II device
Level of protection against direct or indirect contact
Category BF apparatus
Level of water ingress protection
IPX1 device, protected against water drops
Level of assurance of use in the presence of an anaesthetic
mix flammable with air or oxygen or protoxide of nitrogen
Apparatus not suitable
Conditions of use
Apparatus for repeated use
Storage conditions
Temperature: MIN -20 °C, MAX +60 °C
Humidity: MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN +10 °C, MAX +40 °C
Humidity: MIN 10% RH; MAX 95%RH
1.3.1.2. Battery charger
Battery charger supply: Voltage = 5VDC, Current = 1300 mA
Permissible mains voltage var.: 100 V-240 V
Mains frequency: 50 –60 Hz
Max. current: 1300 mA at 5 VDC
1.4. STANDARDS APPLIED
According to rule 10 of the European directive 93/42/CEE the device is classified as Class IIa
EN 60601-1 Electronic medical apparatus. Part 1: General safety standards
EN 60601-1-1 Electronic Medical apparatus. Part 1: General safety standards 1. Collateral standard: Safety requirements
for medical electronic systems
EN 60601-1-2 Electronic medical apparatus. Part 1: General safety standards 2. Collateral standard: Electromagnetic
compatibility –Requirements and tests
EN 60601-1-4 Electronic medical apparatus. Part 1: General safety standards 4. Collateral standards: Programmable
medical electronic systems
UNI CEI EN ISO 14971 Medical devices: application of risk management to medical devices
ATS/ERS TASK FORCE: Standardisation of lung function testing (volume 26/numbers 1-5/2005)
Health Canada Medical Device Regulation: P.C. 1998-783 del 7 /5/1998
SANS 451:2008 Spirometry —Generation of acceptable and repeatable spirograms FDA Regulations
Japanese MHLW Ministerial Ordinance 169: 2004
2. HARDWARE DESCRIPTION
Because of the modular design of the spirodoc, the description is on a block diagram level.
BLOCK DIAGRAM

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2.1. MAINBOARD MODULE
The mainboard module translates the input signal from the turbine flowmeter into spirometry values and compares them
with the predicted values calculated with the parameters age, sex, height, weight and ethnic group. Test results are
displayed on a LCD and can be printed on paper with an external printer. Spirometry test data are stored into memory and
are available for later use.
The mainboard module also makes a calculation using the oximetry input signal; from this signal collected at a 16
msec/frequency the percentage value of oxygen saturation in the blood and the heart beat values are obtained, which are
oximetry parameters.
The mainboard module includes:
-Main Microcontroller
-FLASH memory with device configuration and spirometry data
-FRAM IC with non volatile memory and real time clock
-Measuring controller for flow, volume and ambient temperature
-Ambient temperature sensor (to enable conversion from ATP to BTPS conditions).
-USB port
-Oximetry port
-Bluetooth module
2.1.1. Charging controller for battery pack (IC7 LTC 4067)
The charging controlling circuit used in the Spirodoc ensures a charge and optimum condition of the battery pack
providing that the battery temperature and voltage are within the preset limits. Temperature, voltage and time are all
monitored throughout the charge process.
The charging process itself is automatically initiated in two situations:
1. After connecting the battery charger to the unit.
2. When the unit is switched on, the battery charger is connected and the voltage level of the battery is below a preset
limit. In this situation the LCD indicates the low battery status with one line in the battery indicator.
The fast charging process is terminated by any of the following:
-Battery voltage out of range (Maximum/Minimum)
-Battery temperature out of range (Maximum/Minimum)
-Maximum charging time (timeout = 2h after the voltage arrives at the maximum value, 4.2 V)
Charging phases:

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1. If everything is in order (battery temperature, temperature rising, battery voltage etc.) then the charging process starts
and the display shows the following image in the upper right
2. At the end of the regular charging process, the display shows the following message:
Battery full
3. If after completing the charging process the battery charger is still connected, a so-called Pulse-Trickle-Function is
activated that gives a very low charge to compensate the self-discharging of the battery while it is idle connected to the
charger.
2.1.2. Room temperature sensor
(IC6) DALLAS DS 18B20 to measure the ambient (room) temperature to enable the calculation of the BTPS conversion
factor.
2.1.3. USB communication port
Version 2.0.
2.1.4. Oximetry port
The connector beside the USB ports is used to connect the oximetry sensor, where this function is enabled on the device.
Many sensors can be used on spirodoc based on the type of test to be performed and on the patient characteristics.
The manufacturer provides the most frequently used sensor with the device, which has the following features:
mechanical part
finger
electrical part
two light emitting diodes (LEDs), one emits in the visible spectre and one infrared
Both lights then pass through the finger and are “read” by the receiver. As these lights pass through the finger, a
proportion of the light is absorbed by the blood and by the soft tissue, in function of the concentration of heamoglobin.
The quantity of light absorbed, at each frequency, depends on the degree of oxygenation of the haemoglobin inside the
soft tissue.
2.2. DISPLAY MODULE
The display module shows patient data, user set parameters and test results. The display has the touch screen function.
It is connected with:
20-pin flat-cable for digital connection (CON 12)
4 spring contacts for the display lamp (CON 7 and CON 8)
4 pin flat cable for touch controller (CON 2)
The touch controller (IC17) MAX 11800
The lamp controller (IC12) MAX 8822
2.3. TURBINE FLOWMETER
The sensor for measuring flow and volume is similar to the model already used in other spirometers produced by MIR
(Series MIR 020 rev 5 Mod. Spirobank II, MIR024_REV2 Mod. Spirobank G USB).
The turbine flowmeter consists of one mechanical and two electrical parts:
Mechanical parts:

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-turbine
Electrical parts:
-Two pairs of infrared transmitters/receivers positioned as shown below.
-A signal conditioning circuit to rectify the output signal from the two infrared light receivers.
The rotation of the rotor causes the interruption of the infrared beam, thus creating a pulse signal which has a frequency
directly proportional to the flow.
The measurement of the air flow which passes through the tube is therefore proportional to the number of interruptions
of the infrared beam.
The phase difference  (positive or negative)
between the signals from each of the two infrared
receivers (RX1 and RX2) depends upon the direction
of rotation of the moving rotor and therefore supply
the information of the direction of the air flow
(expiration or inspiration).
In detail,  > 0 for expiratory flow,  < 0 for
inspiratory flow.
The two pulse trains are squared by a Schmitt trigger
(LMV932MM on MiniFlowmeter) and then sent to
two input ports of the microprocessor (IC17
CP3BT26, pins 38 and 36).
The main microprocessor has the possibility to switch
all the peripheral ports on or off, including the
turbine.
3. MAINTENANCE
3.1. GENERAL
We recommend checking the spirodoc on an annual basis.
For cleaning of the spirodoc and the accessories please see the User Manual.
3.2. TEST EQUIPMENT
For the repair and maintenance procedures of the spirodoc the following test equipment and accessories are required:
-Complete set of precision engineering tools (including 2.5 mm allen key and cross-screwdriver)
-Calibration syringe (3L is recommended)
-Case opener

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-Digital multimeter, at least 3½ digits, accuracy better than 1%.
-Oscilloscope
-Digital Thermometer
-PC
-winspiroPRO Software Installation CD
-USB port connection cable
-Oximeter sensor (MIR code 919024_INV)
-Hot Glue Gun
-3 mm double-sided adhesive tape
-Welder
-Signal cable (MIR code ZC017).
If a problem cannot be solved with the present equipment and suitable instruments are not available, please send the
spirodoc to the manufacturer to carry out the service.
3.3. CHECKLIST
The following procedures must be carried out during an inspection and/or after every repair:
Modifications, if any, must be noted on the “Service Info” sheets. See Appendix B of this manual for further
information.
Visual inspection. Check the electrical connection for safety and check that all components are properly fastened.
Check that all accessories do not present any visible damage.
Functional test (see Paragraph 3.3.1)
File a copy of all service activities.
3.3.1. Functional test
3.3.1.1. Self test
Switch on the equipment. spirodoc will carry out the so-called self-test for approx 3 seconds. It is assumed that when the
self-test is passed all functions of spirodoc are okay.
Any severe malfunction (if any) will be reported on the display.
Switch off spirodoc.
3.3.1.2. Software version
To check the software version installed on the device, switch on
spirodoc pressing and releasing the power key placed in the
middle on the side of the device, wait for the first screen to
appear; the software version is found as indicated in the image
alongside.
4. REPLACEMENT PROCEDURES
4.1. General
When handling sensitive static devices such as the mainboard of the spirodoc the following precautions should be
observed:
-Persons should be earthed by means of a wrist strap.
-Ground all electrical equipment, workbench etc.
Also make sure that you have not left any tools inside and all screws including their washers are again fixed in the original
place.

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Note
Where not otherwise indicated, the reinstallation of a part is in reverse order of the removal procedure.
After every repair a functional test must be performed.
Caution
If any soldering (especially on SMD-parts) is to be made, make sure that your tools are suitable for such
precision work.
4.2. Cover
The spirodoc case consists of several parts as illustrated in the
image beside.
The display is housed inside its casing which is made up of two parts
held together with three screws.
4.2.1. Opening the device
To open spirodoc :
1. Switch off the device and make sure that the turbine housing is
removed from the main body of the device
2. Place the device on a flat surface with bottom part face-up
3. Remove the battery compartment cover using the case opener
all around the perimeter to drop the clips and then remove the
label . Pay attention to not damage the
plastic material.
4. Remove the battery pack by dropping the connector using a
screwdriver or a tweezers
5. Completely remove the three screws using a screwdriver
3
4
5

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6. Remove the lower case using the same method for the battery compartment
cover; insert the case opener in the space between the white and the orange part
and drop the clips. Pay attention to not damage the plastic material.
7. Remove the upper case with the same method described above; the upper case
is attached with the reinforcement sheet.
Caution
Pay attention to the display flat cables connected to the main PCB and
passing through the reinforcement sheet.
Disconnect the two cables from the PCB.
8. The PCB now is only inserted in the middle case (orange). To remove the PCB
take the PCB with both hands and operate a horizontal movement to separate
the case and the PCB (see the following images).
Caution
During this phase do not break the elements shown below
At the end we have the following parts disassembled of the device:

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4.3. PCBs and components
4.3.1. Removing and replacing the display
Open spirodoc as described in Paragraph 4.2.1; once the
PCB is separated from the upper casing, remove the
reinforcement sheet and the damaged display from the
upper casing.
Then apply a new display in the correct position on the
upper casing; apply again the reinforcement sheet. The
position of this element is mandatory so check the correct
housing as indicated in the image alongside.
Connect the two flat cables of the display to the PCB. First
apply the square connector to CON 12: apply pressure with
one finger until a click is heard; then apply the other
connector to CON 2. After the connector is inserted then
close the brown wings to block the connector.
Do not apply an excessive bend to the flats of the display
near to the connecter, as this could cause breakage or
malfunction. The picture below shows an excessive
bending:

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At this time it is possible to close the device following the instruction described in point 4.2.1 in reverse order.
From may 2014 it is available a new spirodoc display with more high resolution. The new one shows the traffic light on the
right side.
It is possible to replace the new one to the older, but it is mandatory to update the internal firmware for the correct
working.
The new display has the following id code: 660580_HR
The new firmware version to update should be greater than or equal to ver. 3.0.
The winspiroPRO software version should be greater than or equal to ver. 5.7.4.
After replacing the new display on the device and closed it as
described in point 4.2.1, than connect it to a PC where it is
available a correct winspiroPRO version. Update the internal
firmware as described in point 4.3.5. During this procedure choose
a firmware to install with version greater than or equal to ver.3.0.
The software will recognize the display change on the device and
will show a warning message as follow:
Choose what type of display is now on the device: the first one is
the new high resolution display, and the second one is the old
display. Check one of the square in the upper left corner and click
on “OK”. If the selection is right, then will start the upload
procedure, else winspiroPRO will show a warning message for the
incompatibility of hardware and firmware version.
4.3.2. Touch screen calibration
This function is used to check the proper response of the touch screen; the device initially request a confirmation, touching
OK icon the calibration begin
There are four phases as follows:
Touch three times the top left-hand point of the display
Touch three times the top right-hand point
Touch three times the bottom right hand point
Touch three times the bottom right hand point
The reference area is the one inside the flashing outline.
This procedure will then be set up in function of the dimensions of the
display.
This procedure must be carried out using the tip of a touch-screen “pointer” held vertically at 90 degrees to the display.
if the calibration is made correctly then the device shows:
Calibration is OK

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Otherwise, the user is requested to repeat the calibration procedure.
The procedure cannot be cancelled once started, so the user must carry perform the procedure correctly to return to the
service menu.
In event the touch screen doesn’t work correctly, it is possible to follow the following procedure to reset this function:
Switch off the device pressing the ON/OFF key until the device is
switched off.
Now, open the device as described in point 4.2.1 in order to remove
the battery pack.
Press the ON/OFF key 3 or 4 times to discharge capacitors.
Re-connect the battery pack.
Close and switch on the device.
The first display will appear as the screen on the right.
Touch for at least 4 times the icon “touch calibration” at the top of the display and follow the directions; the
procedure is the same described above. This procedure allows to enter in the touch calibration even if the display is
not calibrated or broken.
4.3.3. Removing and replacing the internal battery pack
Open spirodoc as described in Paragraph 4.2.1 up to point 3.
Remove the battery pack, only after the device is switched off, by dropping the connector using a screwdriver or a
tweezers.
Replace the battery with a new one.
Caution
Insert the connector in the correct position all the way to the stop. Do not force the connector.
Place the cable of the battery bended as shown in the image above; the cable must be blocked between the
battery and the upper casing.
Warning
Handle battery pack with care. Contact between battery poles with the circuit board can cause permanent
damage to the circuit board itself.
Close the device as described in point 4.2.1.
Caution
Inserting the battery cover do not crush the battery cable.

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Note
Batteries must be disposed of properly, according to the local regulations.
For proper use of the battery pack please read carefully the warning below.
WARNING
Use only battery packs supplied by MIR
Improper use of the battery pack may cause acid leakage, overheating, smoke, breakage, an explosion and/or
fire. Consequently the battery pack may be damaged or suffer a drop in overall performance. The internal battery
pack safety sensor could also be damaged as well by any of the above events. Furthermore the user of the device
could be harmed and other nearby appliances could be damaged as well.
Please read the following instructions carefully.
DANGER
Do not disassemble or modify the battery pack. The battery pack comes with an internal safety sensor; which if
tampered with may cause acid leakage, overheating, smoke, breakage, an explosion and/or fire.
Do not short-circuit the positive(+) and negative (-) poles with any metal objects.
Do not carry the battery pack in your pocket or in a bag with other metallic objects like necklaces, hairpins, coins
or screws.
Do not store the battery pack near any such objects.
Do not warm-up or throw the battery pack in a fire.
Do not use or store the battery pack near a fire or in a vehicle where the temperature may reach 60°C or higher
Do not immerge the battery pack in water or salt-water, and do not leave it wet.
Such events may damage the internal battery safety sensor, thus causing the battery to be charged at a higher
voltage, triggering abnormal chemical reactions leading to acid leakage, overheating, smoke, an explosion
and/or fire
Do not charge the battery pack near a fire or in an extremely hot environment. High temperature may activate
the internal battery safety sensor thus inhibiting the charge. The high temperature may also damage the internal
battery safety sensor causing extremely high current surge; and consequently causing abnormal chemical
reactions in the battery pack triggering acid leakage, overheating, smoke breakage, an explosion and/or fire.
Use only the battery charger supplied by MIR to recharge the battery pack. Recharging with an unsuitable
charger in unconforming conditions may cause the battery pack to overcharge or the charging current to be
extremely high thus causing abnormal chemical reactions in the battery pack triggering acid leakage,
overheating, smoke breakage an explosion and/or fire.
Do not puncture the battery pack with sharp objects such as a nail.
Do not hammer, step-on, throw or cause a forceful impact to the battery-pack.
A damaged or deformed battery pack may cause internal short-circuits thus creating the possibility for acid
leakage, overheating, smoke, breakage and/or fire.
Do not use a heavily scratched or deformed battery back as this may be cause for acid leakage, overheating,
smoke, breakage and/or fire.
Do not solder directly on the battery pack.
Do not mount the battery pack inside the device with the + and –poles inverted.

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If the battery leads do not connect easily to the battery charger or to the device do not apply excessive force.
Check to see that the leads are properly aligned. If the leads are inverted, an inverse polarity connection may
provoke acid leakage, overheating, smoke, breakage and/or fire.
Do not connect the battery pack leads to a wall socket or to the car lighter. Under high voltage the battery may
leak acid, overheat, emit smoke, explode and/or catch fire.
Do not use the battery pack for any other purpose other than those specified otherwise its features may be
compromised, and its useful life reduced
If the battery acid inadvertently enters the eyes do not rub the eyes, instead wash the eyes with clean running
water and call a doctor immediately.
WARNING
Do not leave the battery pack charging longer than the average charging length of time specified.
Do not place the battery in a micro-wave oven or in a pressurized container. Rapid overheating or loss of
proofing may cause acid leakage, overheating, smoke, breakage and/or fire.
If the battery pack gives off a bad smell, if it generates heat, if it fades/deforms or if anything abnormal happens
during storage, usage and recharging immediately remove the battery pack from the device or the battery
charger and do not use it any longer, as any of these events may cause acid leakage, overheating, smoke,
breakage and/or fire.
NOTE
The battery pack includes an internal safety protector. Do not use the battery pack where static electricity is
present(higher than what is declared by the manufacturer.
If acid from the battery pack comes into contact with skin or clothing immediately wash with running water to
avoid skin inflammation
Store the battery pack away from children’s reach to avoid any accidental swallowing.
If a child uses the battery pack an adult must explain the proper use to the child.
Before using the battery pack read the manual carefully paying attention to all the recommendations for proper
handling.
Please read the manual carefully to insert and remove of the battery pack in the device properly.
Before charging the battery pack read the manual carefully.
The battery pack life cycle is definite-. If you notice a much shorter time usage between charges please
substitute the battery pack with a new one.
Remove the battery pack if its cycle life has expired.
When the battery pack has been removed from the device, ensure that the (+) and (-) leads have been isolated
with electrical tape; to properly dispose of the battery pack please follow the local regulations or hand over the
battery pack to a battery recycling centre.
Prior to storage or for long periods of disuse of the device remove the battery pack and store in a place where the
temperature and humidity fall within specified ranges.
If the battery pack leads are dirty clean with a dry cloth prior to usage.
The battery pack can be charged within a temperature range between 0°C and approximately 40°C
The battery pack may be used within a temperature range between -20°C and approximately 60°C.
The battery pack may be stored within a temperature range between -20°C and approximately 60°C.
4.3.4. Turbine
There are two types of flow and volume measurement sensors used on spirodoc, single-patient disposable and reusable.

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Note
The spirodoc turbine measurement system is calibrated in the factory and does not require any adjustments or
calibrations.
Warning
Disposable Turbine
If you are going to perform the spirometry test with a “single-
patient” disposable turbine it is important to use a new turbine for
every new patient. The characteristics, accuracy and the hygiene of
the disposable turbine can only be guaranteed if it has been
conserved beforehand in its original sealed packaging.
The disposable turbine is made of plastic and its disposal after use
should adhere to the local authority guidelines / norms.
Reusable Turbine
The correct functioning of the re-usable turbine can only be
guaranteed if it has been cleaned in the correct manner and is free
from foreign bodies which could alter its movement. If the turbine
has not been cleaned sufficiently this could cause cross
contamination from one patient to another. Periodic cleaning
should only be done when the instrument is for personal use and
will only be used by one patient. The cleaning of the turbine
should be done following the guidelines in the User’s Manual.
The following information applies to both turbine models.
Do not expose the turbine to a direct jet of water or air, and avoid contact with high temperature liquids.
Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect functioning and possible
damage. The presence of any impurities (such as hair, sputum, threads etc.) within the body of the turbine sensor may
seriously compromise the accuracy of the measurements.
The turbines ensure high precision in measurements and have the great advantage of requiring no periodic calibration. In
order to maintain the characteristics of the turbine a simple cleaning is required prior to each use (only for the reusable
turbine). This operation will also guarantee perfect hygiene and the highest possible safety conditions for the patients.
Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after
use.
4.3.4.1. Cleaning the reusable turbine
Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after
use.
Turbine operation check:
Turn on SPIRODOC and setup the device to perform a spirometry test (for example FVC).
Hold the SPIRODOC with one hand and move it slowly sideways, having the air pass through the turbine.
If the rotor spins properly the device will emit a series of acoustic signals “beeps”. The beeping frequency is a function
of the air flow passing through the turbine.
If no beeps are heard while moving the device, proceed to clean the turbine
CAUTION
Periodically check the inside of the turbine to ensure that there are no impurities, corpuscles, or any foreign
matter like hairs which could inadvertently block or even slow down the mobile equipment in the turbine and as
a consequence compromise spirometry measurement accuracy.
To clean the reusable turbine, first remove it by pulling it gently from the spirodoc turning it anti-clockwise and pressing
lightly. It can be helpful to push it gently from underneath with one finger from the bottom of the turbine to lift it out of
its housing.

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Immerse the turbine in a cold liquid solution and move it within the liquid to remove any impurities which may be
deposited inside. Leave the turbine immersed for the time specified in the instruction of the solution.
Rinse the turbine by immerging it in clean water (not hot).
Shake off the excess water from the turbine and leave it to dry, standing it vertically on a dry surface.
To ensure that the turbine is functioning correctly before replacing it inside the instrument, it is good practice to make a
visual check of the rotation blade. Placing the turbine tube horizontally and moving it gently from left to right and vice
versa, the rotation blade (rotor) must rotate freely. Otherwise, accurate measurement is no longer guaranteed and the
turbine must be replaced.
Once the turbine has been cleaned insert the turbine tube in its place following the instructions indicated by the closed
lock symbol printed on the plastic casing of the spirodoc.
To insert the turbine correctly push it and then turn it clockwise until it reaches the stop, which ensures that the tube has
been blocked inside the casing.
4.3.4.2. Calibration of the reusable turbine
Only reusable turbines can be calibrated.
See instructions in the Calibration section of the User Manual of the device.
The turbines used on spirodoc do not require periodic calibration as they are already calibrated.
4.3.5. Internal software upgrade procedure
In order to upgrade the software winspiroPRO must already be installed and the PC must have an internet connection for
downloading the upgrades and firmware of the spirodoc from www.spirometry.com.
Launch winspiroPRO on the PC and connect spirodoc to the PC using the USB cable.
winspiroPRO can check the correct functioning of the USB port from the
“options” menu; before downloading any newer releases make sure that the
device is correctly connected to the PC software, the software will
automatically recognize the device if it has already been connected to the PC
and then carry out the following instructions.
To check the connection between the device and the PC, ensure that the led
on the device is illuminated and check the correct functioning from the
“options, communication” menu. On the display of spirodoc appears the
following message:
External control
To download the new internal software version
click on "Tools" menu, and then on "Upgrade
Device Internal Software"

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This wizard helps the user to select the method used to connect the
device to the PC and then, with the “TEST” icon, the user can check
the connection (see image).
Search for the .tsk file to be downloaded into the spirometer. Choose
either auto-install or manual file search; browse system resources
through list of folders, select .tsk file and then click on Next.
From the “Select file .tsk” search window select the firmware of your
device; click on the spirodoc folder and then on the selected file to
automatically launch the upgrading procedure of the internal software
of the spirometer.
4.4. Oximeter module
To check the oximeter module used on the device, refer to Annex 4.
CAUTION
Make sure before operating on the oximetry module to
switch off the device or disconnect the battery charger.
4.4.1. Replacing of the oximetry module
Open the device as described in point 4.2.1 up to point 6. The
visible face of the PCB shows on the right the housing of the
oximetry module.
Remove the oximetry module using the hand.
CAUTION
The module is fixed to the PCB so move gently until the
module is completely removed.
Replace the oximetry module.
CAUTION
OXIMETRY
MODULE