MIR Spirotel User manual

Spirotel®
Page 1 of 37
Rev.1.0
Service Guide
Spirotel®
Service guide
Rev. 1.0
Date issued 01.07.2013
Date of approval 28.02.2014

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Rev.1.0
INDEX
1. INTRODUCTION ...........................................................................................................................................4
1.1. INTRODUCTORY REMARKS 4
1.1.1. General Aspects 4
1.1.2. Safety Aspects 4
1.1.3. Legal Aspects 4
1.1.4. Environmental Aspects 4
1.2. DATA REGISTRATION 5
1.2.1. Equipment and customer registration / Service file 5
1.2.2. Configuration register 5
1.2.3. Product documentation 5
1.2.4. Technical modifications 5
1.2.5. Product evaluation 5
1.2.6. Additional Information 5
1.2.7. Installation 6
1.3. GENERAL 6
1.3.1. Technical Data 6
1.3.1.1. New spirotel unit 6
1.3.1.2. Battery charger 7
1.4. STANDARDS APPLIED 7
2. HARDWARE DESCRIPTION.........................................................................................................................7
2.1. MAINBOARD MODULE 7
2.1.1. Charging controller for battery pack (IC7 LTC 4067) 8
2.1.2. Room temperature sensor 8
2.1.3. USB communication port 8
2.1.4. Oximetry port 8
2.2. DISPLAY MODULE 9
2.3. TURBINE FLOWMETER 9
3. MAINTENANCE ........................................................................................................................................... 10
3.1. GENERAL 10
3.2. TEST EQUIPMENT 10
3.3. CHECKLIST 10
3.3.1. Functional test 10
3.3.1.1. Self test 11
3.3.1.2. Software version 11
4. REPLACEMENT PROCEDURES ................................................................................................................ 11
4.1. General 11
4.2. Cover 11
4.2.1. Opening the device 12
4.3. PCBs and components 13
4.3.1. Removing and replacing the turbine sensor strip 13
4.3.2. Removing and replacing the display 14
4.3.3. Touch Screen Calibration 14
4.3.4. Removing and replacing the internal battery pack 15
4.3.5. Turbine 17
4.3.5.1. Cleaning the reusable turbine 17
4.3.5.2. Calibration of the reusable turbine 18
4.3.6. Internal software upgrade procedure 18
4.4. Oximeter module 19
4.4.1. Replacing of the oximetry module 19
4.5. Testing procedures 20
4.5.1. Testing procedures for devices with oximeter 20
4.5.2. Testing procedures for devices without oximeter 25
5. SPARE PARTS ................................................................................................................................................26
5.1. ORDERING 26
5.2. DELIVERY 26
5.2.1. Ordering PCBs 26
5.2.2. Warranty claims 26
5.3. RETURN SHIPMENTS 26
6. TROUBLESHOOTING .................................................................................................................................27
6.1. The device does not switch on 27
6.2. The LCD does not display 27

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Rev.1.0
6.3. The battery pack is not working correctly 28
6.4. The Bluetooth printer does not print 28
6.5. The device does not measure spirometry at all 29
6.6. The device does not measure spirometry correctly 29
6.7. The device does not measure oximetry at all 30
6.8. The device does not measure oximetry correctly 30
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 (Product Change Notes).....................................................................................35
APPENDIX C ..........................................................................................................................................................36
ANNEX....................................................................................................................................................................37

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Rev.1.0
1. INTRODUCTION
1.1. INTRODUCTORY REMARKS
1.1.1. General Aspects
The spirometers from the product group MIR043 are marketed under the label new spirotel.
This manual has been written for technicians involved in the service of the new spirotel. 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 electronic devices. Inside the new spirotel,
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.
All components (housing, PCBs, batteries, electronic and disposable parts, etc.) must be disposed of according to the
relevant local regulations.

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Rev.1.0
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 new spirotel 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
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:

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Rev.1.0
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 new spirotel, check internal battery pack charge level.
turn on the NEW SPIROTEL by pressing and release
the power key placed in the middle on the bottom of the
device
Check battery level on the upper right of the display as
shown in the image.
1.3. GENERAL
New spirotel 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)
New spirotel 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. New spirotel unit
Max. current inside the unit (GSM switched OFF)
120 mA (with LCD at the maximum brightness)
Max. current inside the unit (GSM switched ON)
200 mA (with LCD at level 7 of 31)
Internal batteries
Rechargeable Battery pack Li-ion 3.7 V 1100mAh
Approval
CE 0476 EC mark for Medical Devices
FDA
Dimensions
88x74x38 mm
Weight
Central unit 151g (including battery pack)
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

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Rev.1.0
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 new spirotel, the description is on a block diagram level.
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 or sent to e-mail or a server via GSM module. Spirometry
test data are stored into memory or on the server and are available for later use.

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Rev.1.0
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
-GSM Module
2.1.1. Charging controller for battery pack (IC7 LTC 4067)
The charging controlling circuit used in the new spirotel 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:
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 new spirotel 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:

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Rev.1.0
Mechanical part
Finger
Electrical part
Two light emitting diodes (LEDs), one emits in the visible spectrum 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 haemoglobin. 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:
30-pin flat-cable for digital connection, display lamp and touch controller (CON 12)
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:
-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.

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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 new spirotel on an annual basis.
For cleaning of the new spirotel and the accessories please see the User Manual.
3.2. TEST EQUIPMENT
For the repair and maintenance procedures of the new spirotel 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
-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 919023)
-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 new
spirotel 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