MIR Medical Research MIR059 Spirobank with Bluetooth SMART User Manual spiro

MIR Medical International Research Spirobank with Bluetooth SMART spiro

User Manual

 Spirobank II                         Page 1 of 34 Rev.1.1 User manual    Spirobank II Bluetooth low energy             User manual rev. 1.1 Issue date    20.11.2014 Approval date    20.11.2014
 Spirobank II                         Page 2 of 34 Rev.1.1 User manual   INDEX  1. INTRODUCTION .............................................................................................................................................................................................. 4 1.1 Intended use ............................................................................................................................................................................................ 4 1.1.1 User category ........................................................................................................................................................................................... 4 1.1.2 Ability and experience required .................................................................................................................................................................... 4 1.1.3 Operating Environment ............................................................................................................................................................................. 4 1.1.4 Homecare usage ........................................................................................................................................................................................ 4 1.1.5 Patient effect on the use of the device ........................................................................................................................................................... 5 1.1.6 Limitations of use - Contraindications .......................................................................................................................................................... 5 1.2 Important safety warnings .......................................................................................................................................................................... 5 1.2.1 Danger of cross-contamination.................................................................................................................................................................... 5 1.2.2 Turbine ................................................................................................................................................................................................... 6 1.2.3 Mouthpiece .............................................................................................................................................................................................. 6 1.2.4 Oximetry sensors ...................................................................................................................................................................................... 6 1.2.5 Device..................................................................................................................................................................................................... 7 1.3 Lithium-ion battery pack warning................................................................................................................................................................. 7 1.4 Labels and symbols ................................................................................................................................................................................... 9 1.4.1 Identification label ..................................................................................................................................................................................... 9 1.4.2 CE mark for medical devices ....................................................................................................................................................................... 9 1.4.3 Electrical safety symbol ............................................................................................................................................................................ 10 1.4.4 Warning symbol for the USB .................................................................................................................................................................... 10 1.4.5 Warning symbol for the SpO2 port for oximetry .......................................................................................................................................... 10 1.4.6 Warning symbol for the WEEE ................................................................................................................................................................. 10 1.4.7 FDA and FCC Warnings .......................................................................................................................................................................... 10 1.4.8 (ESD) Electrostatic discharge sensitivity symbol ........................................................................................................................................... 10 1.4.9 Information regarding the protection against the ingress of liquids................................................................................................................... 11 1.4.10 Symbol for devices that include RF transmitter ........................................................................................................................................ 11 1.5 Product description ................................................................................................................................................................................. 11 1.6 Technical specification ............................................................................................................................................................................. 12 1.6.1 Features of the spirometer ........................................................................................................................................................................ 13 1.6.2 Oximeter features.................................................................................................................................................................................... 13 1.6.3 Other features ........................................................................................................................................................................................ 14 2. FUNCTIONING OF THE SPIROBANK II ......................................................................................................................................................... 14 2.1 switch on and switch off the device ............................................................................................................................................................ 14 2.2 Energy saving ......................................................................................................................................................................................... 15 2.3 Main screen ............................................................................................................................................................................................ 15 2.4 Symbols and Icons .................................................................................................................................................................................. 15 2.5 Service menu .......................................................................................................................................................................................... 16 2.5.1 Turbine calibration .................................................................................................................................................................................. 18 2.6 Patient Data ........................................................................................................................................................................................... 19 2.6.1 Inserting data of a new patient ................................................................................................................................................................... 20 2.6.2 Patient data modification .......................................................................................................................................................................... 20 2.7 Visualization of memory data .................................................................................................................................................................... 20 2.7.1 Database research modality ....................................................................................................................................................................... 20 2.7.2 Visualization of database info .................................................................................................................................................................... 21 2.8 On line mode ......................................................................................................................................................................................... 21 2.9 Spirometry testing ................................................................................................................................................................................... 21 2.9.1 FVC test ................................................................................................................................................................................................ 22 2.9.2 POST test, after drug administration .......................................................................................................................................................... 22 2.10 Viewing the spirometric results .................................................................................................................................................................. 23 2.10.1 Spirometry test interpretation ............................................................................................................................................................... 23 2.11 Oximetry Testing .................................................................................................................................................................................... 24 2.11.5 Instructions for Adult Single Patient Sensor ............................................................................................................................................ 26 3. DATA TRANSMISSION .................................................................................................................................................................................... 27 3.1 PC connection via USB port ..................................................................................................................................................................... 27 3.2 Internal software upgrade ......................................................................................................................................................................... 27 4. MAINTENANCE ............................................................................................................................................................................................. 27 4.1 Oximetry sensor cleaning ......................................................................................................................................................................... 27 4.2 Changing the adhesive wrap sensor ............................................................................................................................................................ 28 4.3 Battery charging ...................................................................................................................................................................................... 28 5. PROBLEM SOLVING ....................................................................................................................................................................................... 28 LIMITED WARRANTY CONDITIONS ..................................................................................................................................................................... 31 ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT ..................................................................... 32
 Spirobank II                         Page 3 of 34 Rev.1.1 User manual Thank you for choosing a MIR product MEDICAL INTERNATIONAL RESEARCH  Spirobank  II  is  sold  in  three  different  configurations;  the  following  table  describes  these  three  configuration  and  the  relevant functions:  Spirobank II ® Basic Advanced Advanced Plus     Additional parameters    POST Bronchodilator test    Bluetooth 2.1    Oximeter    Battery charger     Standard   Optional   Not Available   WARNING  The paper mouthpiece, the nose clip and the disposable turbine with mouthpiece in the equipment should be considered disposable products.  Before using your SPIROBANK II  Read carefully your User Manual and pay attention to all the warnings and labels including all relevant information included with the product.  Set the device configuration (date, hour, predicted set, language,  etc etc) as described in paragraph 2.5   WARNING Before  connecting  the  SPIROBANK  II  to  another  device,  the  application  must  be  installed  correctly  in  the  device.  The device  may  be  connected  to  the  PC  only  after  the  winspiroPRO  software  has  been  installed.  Once  the  new  hardware  is "recognized" by the PC the device may now be used with the winspiroPRO software.  Keep the original packaging! In the unlikely event that you have a  problem with your device please use the  original packaging and return it to the distributor or manufacturer.  Should this be the case, please follow these guidelines:   Return the complete device in the original packaging.  Shipping costs and any customs duties must be paid by the sender.  Manufacturer’s address:  MIR SRL VIA DEL MAGGIOLINO, 125 00155 ROME (ITALY)  Tel ++ 39 0622754777 Fax ++ 39 0622754785 Web site: www.spirometry.com Email: mir@spirometry.com  MIR has a policy of continuous product development and improvement. MIR reserves the right to modify and update the information  in  this  User’s  Manual  as  deemed  necessary.  Any  suggestions  and  or  comments  regarding  this  product  are appreciated and may be sent via email to: mir@spirometry.com.  MIR accepts no responsibility for any loss or damage caused by the user of the device due to instructions contained in this Manual and/or due to incorrect use of the product. Please  note  that  due  to  printing  limitations,  the  screenshots  shown  in  this  manual  may  differ  from  the  display  of  the machine and/or from the keyboard icons.
 Spirobank II                         Page 4 of 34 Rev.1.1 User manual Copying this manual in whole or in part is strictly forbidden.  FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN  1. INTRODUCTION  1.1 Intended use  The SPIROBANK II spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician. The device is intended to test lung function and can make:   spirometry testing in people of all ages, excluding infants and neonates  oximetry testing in people of all ages.  It can be used in any setting, excluding during patient transport outside a healthcare facility.  1.1.1 User category SPIROBANK II spirometer + oximeter calculates a series of parameters relating to human respiratory function. Typically the doctor “prescribes” a spirometry test and is responsible for analysing and checking the results obtained.  1.1.2 Ability and experience required The correct use of the device, the interpretation of the results and the maintenance of the device all require qualified personnel. In the event that the device is to be operated by a patient, sufficient training must first be given to the patient by the doctor.   WARNING The manufacturer cannot be held responsible for any damage caused by the user of the device failing to follow instructions and warnings in this manual.  If the user of the device is a person considered to be cognitively impaired the operation of the device must be made under the supervision and responsibility of the person legally responsible to supervise the cognitively impaired person.   WARNING When  used  as  a  pulse-oximeter,  the  SPIROBANK  II  is  intended  for  spot-checking,  overnight  sleep  screening  and/or continuous monitoring when used by a trained healthcare professional.  1.1.3 Operating Environment SPIROBANK  II has been  designed for  use in  the  doctor’s  office,  in a  hospital  or directly  by the  patient  to  continuously  monitor her/his  physical  conditions  during  routine  daily  activities.  All  information  necessary  for  the  proper  use  of  the  device  in  an electromagnetic environment (as required by the EN 60601-1-2 Standard). Used  at  home,  at  work,  at  school  or  during  physical  activity,  day  after  day  the  device  records  data  and  functional  respiratory parameters for weeks or even months, helping the patient  to better assess her/his own health. The  procedures  for  using  the  device  at  home  are  described  according  to  the  type  of  test  to  be  made;  the  display  will  show  all instructions (messages, suggestions etc.) step-by-step, which allows the patient to correctly perform tests and obtain correct results, to be analysed by the doctor. The device is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents, nor in the presence of inflammable anaesthetic gases (oxygen or nitrogen). The device is not designed to be used in direct air drafts (e.g. wind), sources of heat or cold, direct sunlight or other sources of light or energy, dust, sand or any chemical substances.  The user and/or doctor is responsible for ensuring that the device is stored and used in appropriate environmental conditions; in this regard reference is made to the specifications described in paragraph 1.6.3 below.   WARNING Exposure to unsuitable environmental conditions may cause the device to malfunction, and to provide incorrect results.  1.1.4 Homecare usage The device requires installation by qualified personnel. The doctor will configure the device before handing it over to the patient for homecare use.
 Spirobank II                         Page 5 of 34 Rev.1.1 User manual 1.1.5 Patient effect on the use of the device A spirometry test should only be carried out when the patient is at rest and in good health, in suitable testing conditions. A spirometry test requires the full collaboration of the patient since she/he must perform a complete forced expiration, in order to obtain a reliable test result.   1.1.6 Limitations of use - Contraindications An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the patient’s clinical condition. A detailed clinical history of the patient is also required together with the results of any other test(s) suggested by a doctor. Test comments, a test interpretation and suggested therapeutic treatment must be given by a doctor. Any symptoms that the patient has at the time of the test must be carefully considered before a spirometry test is made. The user is responsible to assess both the mental and the physical condition of the patient in order to perform a proper test, furthermore, in the evaluation of test results, the user must also assess the degree of collaboration of each test carried out. A spirometry test requires the  full collaboration of the patient. The results depend on the person’s ability to inspire as mu ch air as possible and  to  expire all of the  air as  fast and for as long  as possible.  If these fundamental conditions  are not respected then the results obtained during spirometry testing will not be considered accurate, and therefore the test results are “not acceptable”. The acceptability of a test is the responsibility of the doctor. Special attention should be given when testing elderly patients, children and handicapped people. The device should not be used if any conceivable or actual anomalies or malfunctions appear which may compromise the accuracy of the results.   WARNING When  used  as  a  pulse  oximeter  the  SPIROBANK  II  has  limited  alarms,  therefore  the  device  requires  frequent  display observation of SpO2 and pulse rate.  1.2 Important safety warnings  SPIROBANK  II  has  been  examined  by  an  independent  laboratory  which  has  certified  the  compliance  of  the  device  to  the European  Safety  Standards  EN  60601-1  and  guarantees  the  EMC  Requirements  within  the  limits  laid  down  in  the  European Standard EN 60601-1-2. SPIROBANK  II  is  continuously  checked  during  manufacturing  and  therefore  the  product  complies  with  the  established  security levels and quality standards laid down by the Council Directive 93/42/EEC for MEDICAL DEVICES. After removing the device from its packaging, check to see that there is no visible damage. In case  of damage do not use the device and return it to the manufacturer for repair.   WARNING  The safety and the correct performance of the device can only be assured if the user respects all of the relevant safety rules and regulations.  The manufacturer will not be held responsible for damage due to user’s neglect to correctly to follow these instructions.  The  device  must  be  used  only  and  exclusively  as  a spirometer  following  the  indications  given  by  the  manufacturer  with particular attention to the paragraph on INTENDED USE, and utilizing only original spare parts and accessories. Use of non-original  parts  such  as  the  turbine  flow  sensor  and  oximetry  sensor  or  other  accessories  may  cause  errors  in measurement and/or compromise the correct functioning of the device, and is therefore not permitted. The device should not be used beyond the declared life span.. In normal conditions the lifespan of the device is estimated to be around 10 years.  The  device  constantly  monitors  the  state  of  charge  of  this  battery  and  a  message  informs  the  user  when  the  battery  is discharged.  In the event of any incident or accident of any kind resulting from the use of the device, the user is required to inform the manufacturer  without  delay,  this  procedure  is  laid  down  in  Article.9  of  the  European  Regulations  No.  46/1997,  which implemented the EC Directive No. 93/42.  1.2.1 Danger of cross-contamination In order to avoid exposing the patient to the critical danger of cross-contamination use a single-patient disposable turbine , then a new one must be used for each patient.
 Spirobank II                         Page 6 of 34 Rev.1.1 User manual 1.2.2 Turbine  Disposable turbine  WARNING For spirometry testing with  a  disposable turbine  it is important to use a new turbine  for  each  new  patient.  The  accuracy  and  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 regulations and norms in force.  The turbine must never be held under running water or direct air pressure and must never come into contact with hot fluids.  Do not allow dust or foreign matter to enter the turbine sensor which may alter the correct functioning and possibly cause damage. The presence of any impurities such as hair, sputum, threads etc. within the body of the turbine sensor may seriously compromise measurement accuracy.  1.2.3 Mouthpiece Any  disposable  mouthpieces  included  with  the  spirometer  are  only  to  be  used  as  a  reference  guide  to  purchase  the  correct  size mouthpiece  required.  These  mouthpieces are  clean but  not  sterile.  To  purchase appropriate mouthpieces,  generally  either  paper  or plastic, single-use/disposable, we suggest that you contact your local distributor.   WARNING  Use  a  bio-compatible  mouthpiece  to  avoid  any  problems  to  the  patient;  unsuitable  materials  could  cause  the  device  to malfunction, consequently providing incorrect test results.  The  user  is  responsible  for  obtaining  the  proper  mouthpieces  for  the device.  The  required mouthpiece  is  a  standard  type  with  an outside diameter of 30 mm, is of common use and in general easily procured.    WARNING To avoid  environmental contamination caused by the disposal of used  mouthpieces, the user must follow all the relevant local regulations.  1.2.4 Oximetry sensors The included sensor code 919024_INV and the following oximetry sensors can be used with SPIROBANK II:  Manufacturer Code Description BCI 1300 adult disposable sensor  BCI 3026 wrap-around reusable sensor for infants BCI 3043 Universal reusable Y sensor BCI 3078 Reusable ear sensor BCI 3178 pediatric finger sensor, reusable BCI 3444 adult sensor reusable (Comfort Clip) BCI 3044 adult finger sensor, reusable  These sensors require the use of an extension cable (product code 919200) for a proper connection to SPIROBANK II. Two cable lengths are available:  Cod. 919200_INV    length 1.5 m Cod. 919210_INV    length 0.5 m  Prolonged  use  and/or the patient’s  condition may  require changing the  sensor site  periodically. Change  sensor site and  check  skin integrity, blood circulation, and correct sensor alignment at least every 4 hours.    WARNING  Incorrectly applied oximetry sensors or damaged cables may cause inaccurate readings. Using a damaged oximetry sensor may cause inaccurate readings, possibly resulting in patient injury or death. Inspect each oximetry sensor before use. If an oximetry sensor appears damaged, do not use it. Use another oximetry sensor or contact your authorized repair center for assistance. Use  only  MIR  oximetry  sensors  supplied  with,  or  specifically  intended  for  use  with  SPIROBANK  II.  Use  of  oximetry sensors not intended for use with the SPIROBANK II may cause inaccurate readings. Oximetry measurements may be inaccurate in the presence of high ambient light. Shield the sensor area (with a surgical towel, for example) if necessary.
 Spirobank II                         Page 7 of 34 Rev.1.1 User manual   WARNING Dyes  introduced  into  the  bloodstream  (for  example;  to  perform  a  diagnostic  tests)  such  as  methylene  blue,  indocyanine green, indigo carmine, patent blue V (PBV), and fluorescein may adversely affect the accuracy of the oximetry reading.   Any condition that restricts blood flow, such as the use of a blood pressure cuff or a device for systemic vascular resistance, may cause the inability to determine accurate pulse rate and SpO2 readings. Remove  fingernail  polish  and/or  false  fingernails  before  applying  SpO2  sensors.  Both  may  cause  inaccurate  oximetry measurements.  Significant levels  of dysfunctional  hemoglobins, such  as carboxyhemoglobin or  methemoglobin,  may adversely  affect  the accuracy of the oximetry measurement.  Optical cross-talk can occur when two or more sensors are placed in close proximity. Optical cross-talk may adversely affect the accuracy of the oximetry readings. The danger can be eliminated by covering each site with opaque material. Obstructions or dirt on the sensor’s emitter and/or detector may cause a sensor failure or inaccurate readings. Make sure there are no obstructions and the sensor is clean.  Autoclaving, ethylene oxide sterilizing, may cause sensor damage. Do not attempt to sterilize the sensor.  Unplug  the  sensor  from  SPIROBANK  II  before  cleaning  or  disinfecting  to  prevent  damaging  sensor  or  device,  and  to prevent safety hazards for the user.  1.2.5 Device  WARNING The maintenance operations detailed in this manual must be fully and accurately carried out. If these instructions are not followed this may cause measurement errors and/or an incorrect test interpretation.  Do not modify this equipment without authorization of the manufacturer. Any modifications, adjustments, repairs or reconfigurations must be made by the manufacturer or by personnel authorised by the manufacturer. Never attempt to make a repair on your own. The set-up of configurable parameters should only be made by qualified personnel. However, an incorrect set-up of the parameters in no way endagers the patient’s health. Technical description indicates, manufacturer will provide circuit diagrams, component part lists, descriptions,  calibration instructions to assist to service personnel in parts repair. High-frequency emissions from “electronic” devices may interfere with the correct operation of the device. For this reason, certain  minimum  clearances  (a  few  meters)  should  be  observed  when  high-frequency  appliances  such  as  a  TV,  radio, portable phone, etc. and other electronic units are operated at the same time in the same room.  The  device  may  give  inaccurate  readings  if  operated  in  the  presence  of  strong  electromagnetic  sources,  such  as electrosurgical equipment, or in the presence of computed tomography (CT) equipment. The  use  of  accessories  and  cables  other  than  those  specified  by  the  manufacturer  may  result  in  increased  emissions  or decreased immunity of the device.  SPIROBANK II should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, SPIROBANK II should be observed to verify normal operation in the configuration in which it will be used. Do not use  the  device in the  presence of  magnetic resonance  imaging  (MRI) equipment. MRI  equipment may  cause an induced current to the oximetry sensor, resulting in patient injury. If the device is  connected  to  other instruments, to satisfy the  safety  requirements of the  system required by  the standard CEI EN 60601-1, it is necessary to use exclusively devices compliant to the safety standard. Therefore the PC or the printer which the SPIROBANK II is connected must be compliant to the standard CEI EN 60601-1. To dispose of the SPIROBANK II, the accessories, any plastic consumable materials (mouthpieces) as well as the battery, use only appropriate containers or return all such parts to the dealer or to a recycling center. All applicable local regulations must be followed.  If any  of these rules are not followed then MIR will decline all responsibility for any direct  or indirect damages, however caused. To supply power to the device use only the battery type indicated in the § Technical specifications. The device may be powered through a PC by a USB cable. By this means, the device works both on line with the PC, or individually powered by the PC. Keep the device out of reach of children and of any person with mental handicap.  1.3 Lithium-ion battery pack warning  The device is powered by a rechargeable lithium-ion battery pack with a supply voltage of 3.7 V. For proper use of the battery pack please read carefully the warning below      WARNING
 Spirobank II                         Page 8 of 34 Rev.1.1 User manual 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  who  comply  with  the  characteristics  defined  in  point  1.6.3  of  this  manual  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.  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.
 Spirobank II                         Page 9 of 34 Rev.1.1 User manual If the battery pack gives off a bad smell, if it generates heat, if it fades/deformes 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 center.  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.  1.4 Labels and symbols  1.4.1 Identification label   The label shows:  Serial number of the device (SN)  Product name (REF)  Antenna symbol for devices whom include RF transmission  Name and address of the manufacturer  Electrical safety symbol  CE mark in compliance with the Directive 93/42 EEC.  WEEE symbol  FCC ID identification according to FCC standard  Symbol for FDA regulation (Rx ONLY)  Index protection against the penetration of external agents (IPX1)  1.4.2 CE mark for medical devices 0476 This product is certified to conform to the Class II requirements of the 93/42/EEC medical device directive.
 Spirobank II                         Page 10 of 34 Rev.1.1 User manual 1.4.3 Electrical safety symbol  In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity.  1.4.4 Warning symbol for the USB  To connect to other devices such as PC or printer.  Use only the USB cable supplied by the manufacturer and observe the safety regulations of IEC 60601-1-1.  1.4.5 Warning symbol for the SpO2 port for oximetry SpO2 1.4.6 Warning symbol for the WEEE  As  laid  down  in  the  European  Directive  2002/96/EEC  requirements  regarding  the  disposal  of  electrical  and  electronic  devices (WEEE), at the end of its useful life this device must not be thrown away together with normal domestic waste as it contains materials which would cause damage to the environment and/or represent a health risk. Instead it must be delivered to a WEEE authorised collection center, where the device will then be disposed of correctly.  An alternative is to return the device without charge to the dealer or distributor, when a new equivalent device is purchased. Due  to  the  materials  used  in  the  manufacturing  of  the  device,  disposing  it  as  a  normal  waste  product  could  cause  harm  to  the environment and/or health. Failure to observe these regulations can lead to prosecution.  1.4.7 FDA and FCC Warnings SPIROBANK II complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions: (1) this device must not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation.  Any modifications not expressly approved by this company could void the user's authority to operate the equipment. NOTE: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.  These  limits  are  designed  to  provide  reasonable  protection  against  harmful  interference  in  a  residential  installation.  This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However,  there  is  no  guarantee  that  interference  will  not  occur  in  a  particular  installation.  If  this  equipment  does  cause  harmful interference  to  radio  or  television  reception,  which  can  be  determined  by  simply  turning  the  equipment  off  and  on,  the  user  is encouraged to try to correct the interference with one or more of the following ways:   Reposition the receiving antenna.  Increase separation between the equipment and receiver.  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.  Consult the dealer or an experienced radio/TV technician for assistance.  Labels and symbols are displayed on the device as shown in the following images:        SpO2           1.4.8 (ESD) Electrostatic discharge sensitivity symbol   The  (ESD)  symbol  required  by  the  international  standard  EN  60601-1-2  is  used  in  the  vicinity  of  any  connector  which  has  not undergone electrostatic discharge testing.
 Spirobank II                         Page 11 of 34 Rev.1.1 User manual   WARNING Pins of connectors identified with the ESD warning symbol should not be touched and the connections should not be made to these connectors unless ESD precautionary procedures are used.  Precautionary procedures are the following:  Environmental procedures as: air conditioning, humidification, conductive floor coverings, non-synthetic clothing  User procedures as: discharging one’s body to a large metal object, using wrist strap connected to earth.  It  is  recommended  that  all  staff  involved  receive  an  explanation  of  the  ESD  warning  symbol  and  training  in  ESD  precautionary procedures.  the electrostatic discharge is defined as an electric charge at rest. It is the sudden flow of electricity between two objects caused by contact,  an  electrical  short,  or  dielectric  breakdown.  ESD  can  be  caused  by  a  buildup  of  static  electricity  by  tribocharging,  or  by electrostatic induction. At lower relative humidity, as the environment is drier, charge generation will increase significantly. Common plastics generally will create the greatest static charges.  Typical electrostatic voltage values:  Walking across a carpet 1.500 – 35.000 volts Walking over untreated vinyl floor 250 – 12.000 volts Vinyl envelope used for work instructions 600 – 7.000 volts Worker at a bench 700 – 6.000 volts  If two items are at different electrostatic charge levels, as they approach one another, a spark or Electrostatic Discharge (ESD) can occur. This rapid, spontaneous transfer of electrostatic charge can generate heat and melt circuitry in electronic components. A  latent  defect  can  occur  when  an  ESD  sensitive  item  is  exposed  to  an  ESD  event  and  is  partially  degraded.  It  may  continue  to perform its intended function, so may not be detected by normal inspection. Intermittent or permanent failures may occur at a later time. Static dissipative material will allow the  transfer of charge to ground or to  other conductive  objects. The transfer  of charge from a static dissipative material will generally take longer than from a conductive material of equivalent size. Some well known insulators are common plastics, and glass. An insulator will hold the charge and cannot be grounded and conduct. the charge away. Both conductors and insulators may become charged with static electricity and discharge. Grounding is a very effective ESD control tool, however, only conductors (conductive or dissipative) can be grounded. The fundamental ESD control principles are:   Ground all conductors including people  Remove insulators, substitute with ESD protective versions  neutralize with ionizers  ESDS outside the EPA (ESD protected area) to be in packaging having ESD shielding property  1.4.9 Information regarding the protection against the ingress of liquids The label   IPX1  The symbol describes the protection of the device against the ingress of liquids. The device is protected from the vertical fall of water drop.  1.4.10 Symbol for devices that include RF transmitter    The symbol is required from the standard CEI EN 60601-1-2: 2007 point 5.1.1, for devices that include RF transmitters.  1.5 Product description  The SPIROBANK II is a pocket spirometer, with an optional pulse oximetry module. It can operate either in stand-alone mode or it can be connected to a PC or to a printer using any one of several methods: USB, Bluetooth.
 Spirobank II                         Page 12 of 34 Rev.1.1 User manual  The device is specifically designed to measure a range of respiratory parameters and to monitor the saturation of oxygen in the blood and the heart beat. A quality control check is carried out internally on the measured parameters and the device has an internal memory sufficient for approximately 10.000 spirometry tests or at least 900 hours of oximetry monitoring.  SPIROBANK II is a powerful and compact measurement device, intended for use by a respiratory specialist or by a suitably trained general practitioner. The spirometer calculates up to 30 functional respiratory parameters providing the pharmacodynamic effects, i.e. the data comparison  after  the administration of a  drug  (PRE/POST) for  a  bronchodilator test or for a  bronchial challenge  test.  A comparison of data is made between POST (after-drug) and PRE (before drug administration).  The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principle. This transducer ensures the accuracy and the reproducibility of the measurements, without requiring periodic calibration.  The sensor features are listed below:   Accurate measurement even at very low flow rates (end of expiration)  Not affected by relative humidity and air density   Shockproof and unbreakable  Inexpensive to replace.   To ensure that the characteristics of the turbine remain unaltered over time replace always it from one patient to the other.  For a correct interpretation of a spirometry test, the measured values must be compared either to the so-called normal or predicted values  which  are calculated  from the  anthropometric details  of  the patient  or,  alternatively, to the  personal  best values from the clinical history of the subject. The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects.  SPIROBANK II can also be connected to a PC (or to another computerised system) to configure the instrument. All spirometry test data  including the related patient details stored inside the device can be transferred from the device to the PC and then viewed on the PC (Flow/volume curves, spirometry parameters, plus optional oximetry parameters). The connection to the winspiroPRO can be made via USB connection.  SPIROBANK II can perform FVC, test, and calculates an index of test acceptability (quality control) plus the reproducibility of the spirometry  tests  carried  out.  The  automatic  test  interpretation  follows  the  latest  11  level  ATS  (American  Thoracic  Society) classification. Each test can be repeated as required. The best parameters are always available for review. The normal (predicted) values can be selected from several normal “sets”. For example, within the European Union the majority of doctors use the ERS (European Respiratory Society) predicted values.  Oximetry function The oximetry sensor has 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.  This measurement principle ensures accuracy and reproducibility, without requiring regular calibration.  The oximetry sensor can be disinfected with isopropilic alcohol.  1.6 Technical specification  A comprehensive description of the main features of the device, the flow and volume measurement turbine and also of the oximetry sensor follows:
 Spirobank II                         Page 13 of 34 Rev.1.1 User manual 1.6.1 Features of the spirometer Measured parameters: Symbol Description Units *FVC Best FVC L *FEV1 Best FEV1 L *PEF Best PEF L/s FVC Forced Vital Capacity L FEV1 Volume expired in the 1st second of the test L FEV1/FVC FEV1/FVC x 100 % PEF Peak expiratory flow L/s FEF2575 Average flow between 25% and 75% of the FVC L/s *= best values  Flow/volume measurement system Bi-directional digital turbine Temperature sensor semiconductor (0-45°C) Measurement principle  Infrared interruption Volume range 10 L Flow range  16 L/s Volume accuracy  3% or 50 mL Flow accuracy  5% or 200 mL/s Dynamic resistance at 12 L/s <0.5 cmH2O/L/s  1.6.2 Oximeter features Definitions: Desaturation Event Desaturation events SpO2 fall  4% in a limited period of 8-40 sec and successive rise  2% within a total period of 150 sec. Total  Pulse  rate Variation Pulse rate rise  10 BPM in limited period  of 8-40 sec and successive fall  8 BPM during a total period of 150 sec.  Parameters for the oximetry test: Symbol Description Units %SPO2 min Minimum SPO2 during the test % %SPO2 max Maximum SPO2 during the test % BPM min Minimum BPM during the test BPM BPM max Maximum BPM during the test BPM %SPO2 mean Average SPO2 % BPM mean Average BPM BPM  =DELTA  Parameters requested for six minute walk test analysis  Measurement method: Red and infrared absorption Range of measurement %SpO2: 0 – 99% (with 1% increments) SpO2 Resolution 1% %SpO2 accuracy:  2% between 70-100% SpO2 Average number of heart beats for the %SpO2 calculation: 8 beats Range of measurement of cardiac pulse: 18 – 300 BPM (with 1 BPM increments) Cardiac pulse resolution 1 BPM Accuracy of cardiac pulse:  2 BPM or 2% whichever is greater Average interval for the calculation of cardiac pulse: 8 seconds Signal quality indication: 0 - 8 segments on display  Acoustic signals:  “Beep” with frequency of the cardiac pulse  “Beep” with  special alarm frequency in  the  case of either %SpO2  or  cardiac  pulse  going outside  of  the  programmed  levels of alarm  “Beep” with special alarm frequency during oximetry measurement in the case of a low battery level.  If  the  patient’s  finger  is not  inserted  correctly  or  the  connecter  is  not  properly  attached  there  will  be  an  intermittent  beeping sound for 10 seconds  If the test has been interrupted due to unexpected event an intermittent beeping will be heard for 5 seconds when the device is switched on again
 Spirobank II                         Page 14 of 34 Rev.1.1 User manual  The specifications for both the oximetry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry sensors is used.  1.6.3 Other features Memory Memory capacity for over 10000 spirometric tests The  precise  number  depends  on  the  individual  configuration,  so  it  cannot  be determined more closely keyboard membrane keyboard with 6 keys  Display Display LCD 160x80 monochromatic  Interface USB, Bluetooth Bluetooth interface frequenzy range = 2402-2480 MHz rated RF power output = 7.5 dBm maximum trasmit power type of antenna = drawn on the board  Duration of the 3,7V lithium battery Approx 500 charge cycles, under normal conditions of use Power supply Battery pack Li-ion 3.7 V 1100mAh Battery charger Voltage = 5VDC Current = 500 mA or higher Connector = micro USB type B Dimensions 160x55.2x25mm;  Weight Central unit 140g (including batteries) Type of electrical protection Class II device Type of electrical protection BF Grade of protection against water ingress IPX1 device, protected against water drops Safety level in the presence of inflammable anaesthetic gas, oxygen or nitrogen Device not suitable Conditions of use Device for continuous use Storage conditions Temperature: MIN -20 °C, MAX + 60 °C Humidity :MIN 10% RH; MAX 95%RH Transport condition 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 Applied norms Electrical Safety Standard IEC 60601-1 Electro Magnetic Compatibility IEC 60601-1-2 Essential performances (according to EN 60601-1:2007) Accuracy of spirometry parameters compliant to ATS standard Measure of the oximetry parameters with accuracy defined in table on page 13  2. FUNCTIONING OF THE SPIROBANK II  2.1 switch on and switch off the device  To switch on the SPIROBANK II push    The first screen shows the manufacturer logo, information of date and hour set on the device.If no key are touched, after a few seconds the device shows the main screen.
 Spirobank II                         Page 15 of 34 Rev.1.1 User manual The second screen shows the information as in the image beside. He key   allows  to  visualize  the  service  menu;  with  these  voices  it  is  possible  to configure the device in the correct way. If any keys are touched, then the device goes to the main screen.  To switch off the device push  .  WARNING SPIROBANK  II  does  not  switch  off  completely  but  goes  in  stand  by  status  with  a  very  low  power  consumption.  Some functions are ready and the device updates date and hour or to switch on the device using other remote controllers when required. For this the symbol in use is   corresponding to the stand by status.  2.2 Energy saving  WARNING  When  the  device  is  turned  on  after  approximately  1  minute  of  disuse  the  display  enters  energy  saving  mode  thereby automatically lowering the display contrast level. If the device remains in disuse for approximately 5 minutes and is not connected to a PC or battery charger; the device will emit an acoustic warning signal and turn off.  When the device is turned on the battery charge level is shown with the symbol:    This image indicates that the battery pack is fully charged(6 indicators). A drop of the battery pack charge is displayed with a reduction of the indicators.  2.3 Main screen   On the main screen, while in Doctor Mode the following areas can be accessed :   patient data management area  spirometry area  oximetry area   archive area    This screen allows the patient to access more quickly the dedicated functions. For further information please view paragraph 3.6.1.  2.4 Symbols and Icons  The icons used in the various function screens  are shown in the following table:  ICON DESCRIPTION  To access the default settings (service menu)  To access patient data from the main display  To perform a new test of a patient recalled from the patient records.  To insert new patient data  To modify patient data.  To display the most recent tests of a patient  To show the last test performed  To access the database of the performed tests.  To search a test with the date of birth of a patient
 Spirobank II                         Page 16 of 34 Rev.1.1 User manual ICON DESCRIPTION  To search a test starting from a specific date onwards..(partial database)  To flick through a database from beginning to end and viceversa (complete database)  Male sex patient selection   Female sex patient selection   To access all oximetry test options / To perform an SpO2/BPM test  To access spirometry testing type  to perform a forced vital capacity test FVC/search FVC tests in memory  To perform a spirometry test with a broncodilator  To check the alarms and alarm thresholds during oximetry testing   To check the alarms and alarm thresholds during oximetry testing when at least one parameter is turned OFF  Enabled alarm waring during oximetry testing To temporarily disable the alarm  Disabled alarm warning during oximetry testing To temporarily enable the alarm  2.5 Service menu  To enter the service menu press the key   on the second screen corresponding to the icon   It is also possible to enter in the service menu when the device showa the main screen, pressing the key   and then the key  . The service menu shows the following list of voices:    Change date/time  LCD settings  Bluetooth suspend  Select language  Delete memory  Select predicted  Turbine calibration  Oximetry setup  Date format  Unit format  Info firmware  To select the desired voice use the keys   and  , then enter using the key  .  Change date/time When setting the date and time, the cursor  indicates the data item which is being modified. Use the keys   and   to modify the data item of interest, move on to the next data item by pressing  . Press   so that the new settings will take effect and to return to the service menu. To return to the service menu without modifying the item data press  .  LCD settings Change and set brightness and contrast using   e   keys. It is possible to switch from a parameter to the other using   and . To return to the service menu press  .  Bluetooth suspend The Bluetooth function is automatically activated when the device switchs on. With this menu voice it is possible to suspend the function, the Bluetooth will come active automatically at the next device switch on.  Select language Select  the  desired item  using the   and    keysand press  , the language  is now  set  and  the device will return  to  the Service Menu.  Delete Memory To delete the memory of the device insert the following password by touching the numbers shown below:             If the password was not properly inserted the message below is shown:
 Spirobank II                         Page 17 of 34 Rev.1.1 User manual WARNIG Password Error Press OK to try again  If the user fails to enter the correct password three consecutive times the device will automatically turn off. If instead the password was properly inserted the message below will be displayed:  WARNIG Please wait  erasing memory  After approximately 30 seconds the following message will appear:   WARNIG Memory deleted  Press   to return to the service menu.  Select standard Select the standard to be used (ATS/ERS, or NHANES III) with the keys   and  , then press  , the setting takes effect and the device returns to the Service Menu.   WARNING If the NHANES III standard is selected it is not possible to set or modify the predicted values.  Select predicted A list of predicted values is shown; select the Predicted value desired.  Adult Pediatric ERS Knudson Knudson Knudson USA Knudson ERS Zapletal MC-Barcelona Zapletal JRS Knudson Pereira  Pereira  Select with   and   the pair to use and press  . The Predicted values are set and the device returns to the Service Menu.  Turbine calibration Select the Turbine Calibration item and choose from the following options:   show current values  modify calibration  factory defaults  Selection of the first item shows the percent correction applied in that moment. The item “modify calibration” allows to insert new calculated values  referred to a new test with a calibration sirynge. A password is required to access this option;insert the following password starting from left to right:             The  item  “factory  defaults”  erases  the  previous  calibration  values  and  restores  the  two  percentage  corrections  to  zero  percent correction factor; in this case a password is required as explained above.  To perform this procedure correctly please refer to paragraph 2.5.1.  Oximetry setup When entering the Oximetry Setting menu the following items are shown:   Alarms Setting  Default alarms
 Spirobank II                         Page 18 of 34 Rev.1.1 User manual Alarms setting Access to this function allows to setup the parameters linked to the oximetry  First parameter  is  the  alarm intensity: it  can  be  possible to  set  the  type  and volume. Use   and   to switch from a parameter to the other, then   e   are useful to set the desired value: the select icon is the grey one. Press  to change screen. Step following steps allow to set the threshold value for %SpO2 and BPM. An acoustic alarm will warn the user if the SpO2 and BPM  during  a  test  fall  below  the  minimum  threshold  or  rise  above  the maximum threshold of the SpO2 and BPM values previously set.   Use keys   and   to decrease/increase the values and  select moving the arrow with the keys   and  . At the end press   to return to the service menu.    WARNING If the maximum value of a  %SpO2/BPM parameter is set lower or  equal to the minimum  value the setting will not take effect. The device will emit an acoustic warning and automatically return to the setting of the minimum value.  UNIT format The voice allows to choose one of the following option: Imperial   (in,lb) Metric    (cm kg)  Select  the  desired format with    or    and press  ; the selection  will  be  saved automatically and the device  will  return  to the service menu.  Info firmware In this menu the user may view information regarding the components version presents in the device:   Bluetooth version  Bluetooth PIN  Oximeter  After  approximately  10  seconds  the  device  will  automatically  return  to  the service menu, otherwise press  . Once all of the items in the service menu have been set it is possible to exit the menu by pressing  .   2.5.1 Turbine calibration  WARNING The turbine flow sensor does not require calibration, however regular cleaning of the turbine is necessary .  The disposable turbine is check before the application of the external packaging, for this reason it doesn’t requires a periodic calibration. If a calibration must be performed the following guidelines should be carefully noted.
 Spirobank II                         Page 19 of 34 Rev.1.1 User manual Turbine  calibration  is  performed  with  a  calibration  syringe  to  simulate  a FVC  test  for  the  expired  parameters  and  a  FIVC  test  for  the  inspired parameters.  To  enter  the  calibration  function,  select  the  “Turbine  Calibration”  option from  the  Service  Menu  (as  explained  in  paragraph  2.5).  To  enter  the  new calibration  values  choose  the  item  “Modify  calibration”  in  the  submenu, enter  the  password  and  insert  the  new  calibration  values.  Make  three manoeuvres  with  a  sirynge  as  described  by  the  screen  on  the  device,  then SPIROBANK II calculates the FVC and FIVC values.  Press  .   The screen requires to insert the volume of the syringe in use; SPIROBANK II so calculates the correction percentage between the reference and the calculated value. It can be  possible to change the syringe volume using   and  , then press  . At this point two new correction values are shown. Press   to apply these correction, otherwise press   to set the factory calibration values (0%).  If the FVC and FIVC correction factors are > 10% the following message appears on the screen:   WARNING The calibration  Is out of range  The FVC and FIVC values will not be accepted. This means that the device is not capable of correcting such a large calibration error In this case:  - Check the correct functioning of the SPIROBANK II with a new turbine and/or - Clean the turbine.  To erase the calibration in use and to reset the original factory calibration, use the item “Factory defaults” from the Calibration menu   WARNING  In line with the publication "Standardised Lung Function Testing" of the European Respiratory Society (Vol 6, Supplement 16, March 1993), the air expired from the mouth is at a temperature of circa 33/34 °C. The expired flow and volume, to be converted to BTPS conditions (37 °C) must be increased by 2.6% - this is derived from the BTPS factor of 1.026 at a temperature of 33°C, which represents a correction of 2.6%. In practice the BTPS factor for the expired flow and volumes is therefore constant and equal to 1.026. For  the  inspired  volumes  and  flows,  the  BTPS  factor  depends  upon  the  ambient  temperature  as  the  air  inspired  is  at ambient temperature. For  instance  at  an  ambient  temperature  of  20°C  with  relative  humidity  at  50%,  the  BTPS  factor  is  1.102,  a  correction  of  +10.2%. The correction of the inspired volumes and flows is made automatically as the machine has an internal temperature sensor; the BTPS values are thus calculated. If a 3L syringe is used to make the calibration and if the SPIROBANK II is calibrated correctly then the FVC (syringe) value will be: 3.00  (FVC)  x  1.026  (BTPS)  =  3.08  L  (FVC at BTPS). If the ambient temperature is 20°C, the FIVC (syringe) value will be: 3.00  (FIVC)  x  1.102  (BTPS)  =  3.31  L  (FIVC at BTPS). The user must be aware that the volume of the syringe shown by the machine is converted to BTPS conditions, so that the "increase" of the results with respect to the expected values does not constitute an error.  For instance, if the calibration procedure is carried out with measured data: FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20°C the resulting correction factor becomes: EXPIRATION    .00% INSPIRATION   .00% This does not represent an error, but is a logical consequence of the above detailed explanation.  2.6 Patient Data From the main screen the user can access the patient data management by using  . By entering this menu it is possible to:  Insert a new patient   Modify current patient data *
 Spirobank II                         Page 20 of 34 Rev.1.1 User manual 2.6.1 Inserting data of a new patient Press   and insert the patient information in the required sequence.  First screen (date of birth, weight, height and sex) Use   and   to set the correct value; use instead   and   to switch from one to another parameter. Set the day, month, year of birth, height and weight of the patient. The last data to insert is the sex of the patient, which can be chosen by selecting one of the following icons:   Male  Female  Second screen (ethnic group) Setting of the correction factor: these values allow to adjust the test data as a function of the ethnic group of the patient (it is possible to opt for “without correction”);  Standard ATS/ERS  Standard NAHNES III Group % correction   Without correction 100%  Caucasian Caucasian 100%  Mexican-American Oriental 100%  Afro-American Hong Kong Chinese 100%  Other Giapanese 89%   polinesian 90%   North Indian 90%   South Indian 87%   Pakistani 90%   African descendant 87%   Aboriginal 85%    When using ATS/ERS standards, the correction is applied to the predicted values of the following parameters:  FVC, FEV1, FEV3, FEV6, FIVC, FIV1, EVC, IC, VC, ERV, TV, TV/ti  When using NAHNES III standards, the correction is based on several theoretical formulas (as per NAHNES III standards). Once the ethnic group is set the device saves the data and automatically returns to the main screen.  To interrupt the data insertion, press    and the device will automatically return to the main screen.  2.6.2 Patient data modification The key   allows to modify current patient data; by entering in this function  the patient data is presented on the various screens; modify the data by using the   and   key which are shown time and again. Press   icon to return to the main screen without modifying any data     WARNING A new patient is not created from the previous patient when selecting this function. Patient info however can be modified. Future tests will be associated to the patient always identified by the same ID code, unique to that specific patient.  2.7 Visualization of memory data  2.7.1 Database research modality  From the main screen it is possible to access the database of the device by using the   icon (key  ). Three methods of research are available:   Reseach by patient date of birth.  Research by the date of testing.  Visual of all tests in the database starting form the most recent.  Research by patient date of birth: patient date of birth must be inserted; after all the data has been inserted press   All data visualized concerns tests performed by patients whose date of birth corresponds to the inserted date of birth.
 Spirobank II                         Page 21 of 34 Rev.1.1 User manual Database by date of testing: requires the insertion of the date when the test was performed; once all the date information has been inserted press  . The data returned by the device are all the test sessions performed during that specific day.  Complete database: shows data starting from the most recent session. The end of the database is signalled by a double beep. The database search is resumed from the last session.  2.7.2 Visualization of database info The  result  of  a  search  performed  in  one  of  the  described  methods  in paragraph 2.7.1 can be viewed in the adjacent image. By selecting the desired session one may access the performed tests Use the keys   and   to select the desired test. Once a testing session has been selected the database screen will show the adjacent image. The two icons on the lower part of the screen allow access to the following functions:  (key  ) to make a new test on the current patient  (key  ) to show the parameters of the selected test   The user may return to the previous screen by using  .  2.8 On line mode   In the on-line mode the SPIROBANK II becomes a fully functional laboratory device which works in real-time connected to a device us a tablet. The connection is wireless via Bluetooth.  The SPIROBANK II becomes an intelligent transducer for the measurement of volume and flow while the tablet controls the device including the on and off function. Opening the application automatically starts the Bluetooth connection with spirobank II and  the connection remains active until the application is closed. Even if the Spirobank II is switched off, starting the application the Bluetooth will automatically turn on it again. This application enables complete control of the device. Connected to a tablet the SPIROBANK II can be used for epidemiological studies conducted in occupational environment, schools, etc etc..  Other than the usual spirometric parameters and the F/V in real-time the SPIROBANK II also plots the most refined indices such as the ventilatory profile and the extrapolated volume (Vext). The application on the tablet incorporates the most up to date bronchial provocation protocols displaying the dose-response and time-response of the FEV1  For more details on the correct use of the application please refer to the relevant user manual.  WARNING  When the device is connected to the table it can be only remotely controlled. The default settings of the tablet software will be transferred to the device and will remain in the device even when used in stand-alone mode.   2.9 Spirometry testing  In order to perform proper spirometry testing the following instructions are to be followed carefully.   Insert the turbine in the appropriate housing until it reaches the mechanic stop and successively rotate the turbine clockwise until it stops. Insert the mouthpiece at least 0.5 cm inside the groove of the turbine.  Place the noseclips on the nose so as not to let any air out of the patient’s nostrils.  Hold the SPIROBANK II with both hands or grasp it like a mobile phone. The display must always face the patient taking the test.   Place the upper part of the mouthpiece in the mouth making sure that no air leaks from the sides of the mouth.   WARNING  Correct positioning of the mouthpiece extending under the dental arch in the patient’s mouth is fundamental so as to avoid any turbulence which could erroneously affect the spirometry results.   WARNING  If possible it is recommended to stand up while performing the test. During expiration it is recommended  to bend forward the upper part of the body so as to release all the air out with the aid of the abdominal muscles.  By pressing   relative to    icon, the user may access the spirometry testing area which includes the following tests:
 Spirobank II                         Page 22 of 34 Rev.1.1 User manual   FVC spirometry testing   VC type spirometry test   MVV type spirometry test   test with broncodilator (POST)  Once a test is selected the screen will display information concerning the type of turbine in use including the necessary information to complete the test in the correct manner.  To end a test press   key   2.9.1 FVC test  Proper execution of a FVC test must take into account the phases as described on the screen, more specifically:  INSPIRE all the air EXPIRE fully with force INSPIRE fully with force  It is possible (and may be helpful) to start the test by breathing at rest for a few moments. When ready to start inspire slowly as much air as possible (made easier by raising the arms wide apart) and then make a complete expiration as fast as possible. Then with the mouthpiece always held  firmly  in  the  mouth,  complete  the  cycle  by  inspiring  again  as  quickly  as  possible.  This  final  inspiration  may  be  left  out  if  the inspiratory parameters (FIVC, FIV1, FIV1%, PIF) are not of interest. The optional initial inspiration phase can also be performed before inserting the mouthpiece in the mouth. After inspiring slowly and deeply, the following expiration must be made with the maximum effort by expiring all the air in the lungs as fast as possible. After 6 seconds of expiration the device will emit a continuous beep, this helps the user to understand whether the minimum expiry time has been reached, as recommended by the main international respiratory institutions.   WARNING  Accurate spirometry testing requires that the patient expire all the air in the lungs.  The  test  may  be  carried  out  several  times  by  repeating  the  cycle  without  taking  the  mouthpiece  out  of  the  mouth,  in  which  case SPIROBANK II recognises the best test (largest FVC+FEV1) and will automatically display the results of the best test. To end the test press  . During  the  test  the  SPIROBANK  II  emits  "beeps",  the  frequency  of  which  are  directly  proportional  to  the  inspired  and  expired velocity  of  the  air.  This  helps  the  doctor  understand  when  the  velocity  of  the  air  is  approaching  zero,  and  the  patient  has  almost exhausted all of the inspired or expired volume. In the maintenance section an explanation is given as to how this feature can also function as a very simple checking system for the correct operation of the mobile “rotor” of the turbine. For the FVC test to be judged as acceptable, besides breathing as deep as possible, it is also required that the forced expiratory time (FET) is sufficiently long to allow for the complete expiration of all air contained in the lungs.  2.9.2 POST test, after drug administration  WARNING  To carry out a POST test it is necessary to have carried out at least one PRE FVC  test the same day; it is not possible to do a POST test  on the  PRE VC or  MVV tests; it  is however possible  to do a POST  VC or  MVV test  if  the database already contains at least one PRE test carried out on the same day. To carry out a POST test please access to the spirometry area pressing   and subsequently pressing  .  A  POST  test  is  a spirometry test  following the  administration  of  a  drug  of  some  kind,  usually  a  bronchodilator.  The sign  “POST Phase”  is  shown  on  the screen  of the  device  (center)  on the first  screen of  the  spirometry area.. The  following  tests made  by  the patient show the following parameters:   Those values related to the test performed  Those values related to the best PRE test performed by the same patient the same day.(that is in the same test session)  The percentage variation between the PRE and POST values (in the CHG column)   It is not possible to perform a POST test with a patient whose PRE testing was not carried out on the same day.  If during a POST session a new patient is inserted or another is recalled from the archive the device will automatically exit the current POST session.
 Spirobank II                         Page 23 of 34 Rev.1.1 User manual 2.10 Viewing the spirometric results  Following a FVC test, the spirometry test results are shown. The first screen displays a Flow/Volume graph of the Forced Vital Capacity pressing    it  is  be  possible  visualize  the  best  value  of  FVC,  FEV1, FEV1%  and  PEF  with  the  percentage  change  compared  to  the  predicted values.  By scrolling with   and   it is possible to view all the parameters next to the chosen predicted values.  2.10.1 Spirometry test interpretation Spirometry  test  interpretation  is  based  on  the  Forced  Vital  Capacity  (FVC)  test.  The  test  interpretation  is  indicated  with  one  the following messages:    Normal spirometry  obstruction/restriction mild  obstruction/restriction moderate  obstruction/restriction moderate severe  obstruction/restriction severe  obstruction/restriction very severe  A last level of interpretation is “restriction+obstruction”; the indication on the traffic lights will be the worst case between restriction and obstruction.  Through the use of a mathematical analysis applied to certain indices and parameters calculated in the FVC test , the SPIROBANK II is capable of producing a list of quality control comments useful to assess the quality and reproducibility of the manouvers performed.  The quality control check assigns a letter for the current spirometry session as described below:  PRE test A = At least to acceptable manouvers, with the highest two FEV1 values matching to within 100 mL and the largest two FEV6 values within 100 mL B= At least two acceptable manoeuvres, with the FEV1 values matching to within 101 to 150 mL C= At least two acceptable manoeuvres, with FEV1 values matching to within 151 to 200 mL  D= only one acceptable manoeuvres, or more than one, but the FEV1 values not matching to within 200 mL (with no interpretation). F= No acceptable manoeuvres (with no interpretation).  POST test A = two acceptable FEV1 values matching within 100 mL B= two acceptable FEV1 values matching within 200 mL C= two acceptable FEV1 values that do not match within 200 mL D= only one acceptable FEV1 manoeuvre  F= No acceptable FEV1 manoeuvres  An acceptable manoeuvre means: good start and satisfactory exhalation (duration and flow)  Several comments related to the single test are calculated, however SPIROBANK II will only point out the most relevant to facilitate the test interpretation.   ERROR IN Vext and PEFT If the extrapolated volume Vext is greater than 500 mL or more than 5% of the FVC, or if the PEFT (time to peak flow) is greater than 200 ms, this message is shown:  Repeat test and blow faster  FET ERROR If the FET is less than the minimum (6 seconds), this message is shown:  Expiry time insufficient < 6s FLOW ERROR If the last point of the F/V curve is greater than 200 mL/s, this indicates that the expiration was not complete and thus this message is shown: Blow out all air in lungs
 Spirobank II                         Page 24 of 34 Rev.1.1 User manual Between tests, the SPIROBANK II  checks the repeatability of the following parameters:   If FVC is > 1.0 L then: FEV1  repeatable when the difference between the two largest FEV1 is ≤ 150 mL; FVC  repeatable when the difference between the two largest FVC is ≤ 150 mL;  if FVC is ≤ 1.0 L then: FEV1  repeatable when the difference between the two largest FEV1 is ≤ 100 mL; FVC  repeatable when the difference between the two largest FVC is ≤ 100 mL;  2.11 Oximetry Testing   WARNING Check if the oximetry function is available in the device, this function is an option in some models.   WARNING The oximetry sensor used in the manual is only one of the different types of sensors which can be used listed in paragraph 2.2.4. MIR does not recommend any particular sensor; the doctor will chose the sensor which she/he believes to be more suitable.  During oximetry testing the SPIROBANK II cannot be turned off. To turn off the device the oximetry test must be stopped first. This has been implemented so as to avoid any unwanted interruptions which could compromise the accuracy of the data.  For  the  non-invasive  measurement  of  SpO2  oxygen  saturation  and  blood pulse  rate,  utilize  the  re-usable  finger sensor.  This  sensor  is recommended for patients weighing more than 20 Kg while remaining still during testing. For the 6 minute walk test other types of sensors are recommended which are less influenced by the movement of the hand. To carry out an oximetry test:   Connect  the  sensor  to  the  device:  insert  the  connector  with  the  arrow (printed on the connector) face-up, as shown:  Choose a high perfusion site, easily adaptable to the sensor.   Insert  the  finger  into  the  sensor  until  the  finger  touches  the  end  of  the probe.  Ensure  that  the  bottom  part  of  the  finger  completely  covers  the detector.  If  the  finger  cannot  be  placed  properly  inside  the  sensor  try another finger.   Place  the  sensor  so  that  the  cable  rests  on  the  back  of  the  hand.  This ensures that the light source rests. On the side of the  nail and the reader on the lower part of the hand.    Select one of the tests that can be performed with SPIROBANK II To access the oximetry area press   on the main screen; the test starts immediately   If the following message appears upon start-up:  WARNING OXIMETER NOT PRESENT  This means that your device does not have this function.   WARNING Before carrying out a test, if the power supply value is low the following message will appear:
 Spirobank II                         Page 25 of 34 Rev.1.1 User manual Low battery level  Press the   key to exit the test, otherwise after a seconds will start the test. In the event that a test is interrupted due to a complete battery discharge, the next time the device is turned on the following message is displayed:  WARNING Wrong interruption of last oximetry test  At the same time an intermittent beep is emitted for 4 seconds. Subsequently the SPIROBANK II returns to the main screen.  WARNING Avoid twisting the sensor’s cable as this may compromise measurement accuracy and the integrity of the sensor itself, also do not apply excessive force when using, connecting, disconnecting or storing the oximetry sensor.   The first few seconds are used to find the best signal possible; after which the SPIROBANK II timer resets itself and the device starts recording data. For any type of oximetry test if the sensor is not properly connected the following message will be displayed on screen after a few seconds:   Sensor unplugged   At the same time SPIROBANK II emits an acoustic alarm (if previously set in the service menu). If the sensor has been connected properly but the finger has not been properly inserted in the sensor the following message will be displayed on screen.  Finger Not inserted   At the same time SPIROBANK II emits an acoustic alarm (if previously set in the service menu). If the signal reaches the sensor properly, after a few seconds the device will emit an acoustic signal while also displaying the values on screen. The alarms can be customized, the procedure is described in paragraph 2.5. During oximetry  testing  if  the SpO2  and blood  pulse rate fall  below  the  bottom threshold or raise  above  the  upper  threshold,  the SPIROBANK II will emit an acoustic alarm ‘(if previously set in the service menu.)’ until such situation persists. For sleep oximetry testing the heart rate tone is always disabled.   WARNING A  test  is  saved  with  the  code  of  the  last  patient  displayed.  If  a  test  refers  to  a  previously  saved  patient,  then  prior  to performing a test the user must recall that patient from the database as described in paragraph 2.7.2   WARNING  During oximetry testing the display will always show the battery pack level; thus providing an estimate of the actual charge level which can vary as a function of whether the device is in energy saving mode or with the backlight display at max level.  During a test the display will show the following information:
 Spirobank II                         Page 26 of 34 Rev.1.1 User manual   To end an oximetry test press   key.   2.11.5 Instructions for Adult Single Patient Sensor  WARNING The oximetry sensor used in the manual is only one of the different types of sensors which can be used with SPIROBANK II listed in paragraph 1.2.4. MIR does not recommend any one particular sensor, the decision is left to the doctor who will choose the sensor which she/he believes to be more suitable.   To perform a  non-invasive continuous monitoring of arterial oxygen saturation  it is recommended to use the reusable "wrap" type sensor.    WARNING  The  materials  used  for  manufacturing  the  sensor  are  NATURAL  LATEX  PROTEIN  FREE,  and  are  subject  to biocompatibility tests.   WARNING The adult single patient sensor is ideal for patients weighing more than 30 kg. It should not be used on patients who suffer from allergic reactions to adhesive tape. The sensor is specifically designed for single use only.   Choose  an  application site  on the  patient’s  finger or  toe  where  the  light source  will  be directly  over  and  in-line  with  the  detector.  The  preferred  sites  are  the  forefinger  or smaller thumb.   Remove nail polish or artificial fingernails.  Insert  the  patient’s  digit  in  the  sensor  nail-side  up,  lining  up  the  digit’s  pad  over  the detector. The sensor’s positioning line runs across the mid axis of the fingertip    Wrap the bottom adhesive around the digit, being careful not to cover the nail.   Fold the sensor’s top over the digit, making sure the light source is directly over and in-line with the detector. Wrap the adhesive around the finger or toe to secure the sensor. Route the cable along the palm or the bottom of the foot, and secure with adhesive tape if necessary.   Connect  the  sensor  to  the  device:  insert  the  connector  with  the arrow  on  the  connector  face-up  and  check  the  proper
 Spirobank II                         Page 27 of 34 Rev.1.1 User manual functioning of the sensor according to the previous instructions.   WARNING Do not twist the cable or use excessive force when using, connecting, disconnecting, or storing the sensor. Avoid over tightening the adhesive tape; a sensor wrapped too tightly can produce inaccurate saturation measurements. To reduce chances of entanglement it is recommended to fasten the cable to the wrist with a bandage.  3. DATA TRANSMISSION  WARNING  Please read carefully and make sure to have properly understood the instructions before commencing the data trasmission.   3.1 PC connection via USB port  WARNING Before connecting the SPIROBANK II via USB to the PC, the WinspiroPRO software must be installed on the PC first to enable the software to interface with the device.  Before initiating the following procedure it is important to know the operating system version installed on the PC used for the  connection  (from  control  panel  click  on  “System”,  where  the  type  of  operating  system  installed  on  the  PC  can  be checked). If winspiroPRO is already installed on the PC then a new installation is not required.  To  make  the  connection,  insert  the  mini  USB  connector  supplied  with SPIROBANK II as shown in the picture and attach the other connector to the USB port of the PC. When  initially  making  a  connection,  depending  on  the  version  of  the operating system, the PC will either make an automatic driver installation (for Windows 98, 2000, ME) or request some information (for Windows XP, Vista and Seven). To avoid making any errors at this stage please read the Advanced section of the winspiroPRO User Manual carefully.  3.2 Internal software upgrade SPIROBANK II internal software can be upgraded from a PC via USB connection. Upgrades can be downloaded by registering on www.spirometry.com. For further information on software upgrading please read the “winspiroPRO” software manual.  4. MAINTENANCE  SPIROBANK II requires very little maintenance  The operations to perform periodically are:    Changing the disposable turbine before each test.  Cleaning the oximetry sensor (for reusable sensors).  Changing the adhesive tape of the oximetry wrap sensor.  Recharging the internal battery pack.  The maintenance operations described in the User’s Manual must be carried out with extreme care. Failing to observe the instructions may cause errors in measurement or the  misinterpretation of the measured values. Modifications, adjustments, repairs, and reconfigurations must be carried out by the manufacturer or by qualified personnel. In the unlikely event of a problem do not attempt to repair the unit. The  parameter  configuration  setup  must  be  carried  out  by  qualified  personnel.  In  any  case  the  risks  pertaining  to  an  incorrect configuration setting in no way endangers the patient.  4.1 Oximetry sensor cleaning  The reusable finger sensor must be cleaned every patient change, so clean the sensor before to use this on a new patient. Clean the sensor with a soft cloth moistened with water or a mild soap solution. To disinfect the sensor, rub with isopropylic alcohol. Allow the sensor to dry completely after cleaning. Do not use any abrasive or caustic material to clean the sensor.  WARNING Do not sterilize by irradiation, steam or by using ethylene oxide. Unplug the sensor from the device before cleaning or disinfecting it.
 Spirobank II                         Page 28 of 34 Rev.1.1 User manual The sensor included with the SPIROBANK II is made with latex free material.  4.2 Changing the adhesive wrap sensor  The disposable adhesive tape is made with latex-free material.   Gently remove the used adhesive tape from the sensor and dispose of it.  The back of the sensor has alignment pins. Place the sensor with the alignment pins facing the adhesive part of the tape and align the pins to the holes on the tape.  Push the sensor so as to insert the pins into the holes of the tape. Lift both the sensor and the tape and check that the pins of the sensor are properly aligned.   WARNING It is highly suggested to use a new piece of adhesive tape for each patient, or as required.  4.3 Battery charging  Turn on SPIROBANK II and the following icon will appear on the main screen showing the charge level of the battery pack:   The maximum charge level is displayed with all 6 bars inside the battery.  If only one bar is shown or if the device will not even turn on the battery pack must be recharged in the following manner:   Plug the battery charger into a socket and the battery charger cable into the micro USB connector of the device; the device in this phase is always turned on  When the charging is complete the battery icon will display all six bars.  At this point disconnect the battery charger from the device.  SpO2             WARNING It is recommended not to use the device while the battery is charging. Always disconnect the battery charger from the device when the charge cycle has terminated.  5. PROBLEM SOLVING  PROBLEM MESSAGE POSSIBLE CAUSES REMEDY SPIROBANK II does not turn on \ The battery pack could be discharged Connect the device to the battery charger. \ The battery pack has not been properly inserted in the device Contact a technical service center \ The device may have lost its internal software Connect  the device to the PC with the USB cable and update the internal software; For more detailed information please consult the winspiroPRO software user manual available  on line within the software itself. Problem when turning on the device Error in ram memory Recovering data Please wait Memory data within the device has been damaged  If the data has been restored correctly the standard turn-on process will complete itself. If this process does not finalize contact an authorized technical service center. The device turns off and subsequently turns on again. \ An internal error has occurred. Check on the following website www.spirometry.com for a more recent internal software release of the device. Update the internal software by downloading the latest release by using the winspiroPRO software For further information consult the winspiroPRO manual available on line within the software itself.
 Spirobank II                         Page 29 of 34 Rev.1.1 User manual PROBLEM MESSAGE POSSIBLE CAUSES REMEDY Spirometry test results are unreliable \ The turbine may contain dirt or foreign matter.  Clean the turbine as explained in paragraph 5.1; if necessary replace the turbine with a new one. \ The test was not performed correctly. Repeat  the test and follow closely the indications shown on the screen. Certain spirometry and/or oximetry parameters are not shown at the end of a test. \ Personalized parameter setting in the service menu. Check the parameter setting in the item “PARAMETER setting” within the Service Menu as explained in paragraph 2.5 During an oximetry test values are returned at irregular intervals, intermittent or simply wrong. \ The sensor is positioned incorrectly or the patient perfusion is insufficient. Riposition the oximetry sensor. \ The patient has moved. To obtain accurate oximetry readings it is important that the patient must not move abruptly. During oximetry testing the screen is barely readable \ After a few minutes the screen backlight turns off automatically to save battery energy. None Problem during battery pack recharging Damaged battery pack The battery pack could be damaged or simply mispositioned. Contact a technical service center Unforseeable error of the memory Error in memory Data in archive is damaged. Contact a technical service center The device has frozen due to an unforseeable event \ \ Press the power   key 3 times and wait approximately four seconds after which the device will reset itself and turn on again   WARNING Before  contacting  a  technical  service  center,  please  try  downloading  the  database  from  the  device  to  the  PC  using  the winspiroPRO software. This procedure is necessary to save a backup in case all the data is accidentally lost during device repair. Furthermore the database could be of confidential nature and  as  such  not accessible by authorized personnel and also subject to privacy laws.
 Spirobank II                         Page 30 of 34 Rev.1.1 User manual  Via del Maggiolino 125, 00155 Roma - ITALY  DECLARATION OF CONFORMITY CE (annex II excluding par.4)   We hereby declare that the following device:  Type        Spirometer/Oximeter Brandname      MIR Medical International Research Device name      spirobank II Class        IIa  Complies  with  the  Essential  Requirements  of  directive  93/42/EC  concerning  Medical  Devices,  and  its  amendments,  and  its transposition in the Member States. This statement is made on the basis of the CE Certificate n. MED 9826 issued by Cermet, Notified Body n. 0476.      Rome 01.01.2014         Paolo Sacco Boschetti The Chairman
 Spirobank II                         Page 31 of 34 Rev.1.1 User manual LIMITED WARRANTY CONDITIONS  SPIROBANK II, together with its standard accessories is guaranteed for a period of:  12 months if intended for professional use (doctors, hospitals, etc.)  24 months if the product has been purchased directly by the end user. The warranty is effective from the date of purchase shown on the relevant sales invoice or proof of purchase.  The warranty is effective from date of sale which must be shown on the relevant sales invoice or proof of purchase.  The device must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing to the manufacturer.  This warranty covers the repair or the replacement (at the  discretion of the manufacturer) of the product or  of  the defective  parts without charge for the parts or for the labour.  All batteries and other consumable parts,  are specifically excluded from the terms of this guarantee.  This warranty is not valid, at the discretion of the manufacturer, in the following cases:   If the fault is due to an improper installation or operation of the machine, or if the installation does not conform to the current safety norms in the country of installation.  If the product is utilised differently from the use described in the User’s Manual.  If any alteration, adjustment, modification or repair has been carried out by personnel not authorised by the manufacturer.  If the fault is caused by lack of or incorrect routine maintenance of the machine.  If the machine has been dropped, damaged or subjected to physical or electrical stress.  If the fault is caused by the mains, or by a product to which the device has been connected.  If the serial number of the device is missing, tampered with and/or not clearly legible.  The repair or replacement described in this warranty is supplied for goods returned at the customers’ expense to our certified service centers. For details of these centers please contact your local supplier of the spirometer or contact the manufacturer directly.  The customer is responsible for the transportation and for  all transport and customs charges as well  as for delivery  charges  of the goods both to and from the service center.  Any device or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found. If units are to be returned to the manufacturer then written or verbal permission must be received before any devices are returned to MIR.  MIR – Medical International Research reserves the right to modify the device if required, and a description of any modification made will be sent along with the returned goods.
 Spirobank II                         Page 32 of 34 Rev.1.1 User manual ANNEX 3  INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT  Guidance and manufacturer’s declaration – electromagnetic emissions  The SPIROBANK II is intended for use in the electromagnetic environment specified below.  The customer or the user of the SPIROBANK II should assure that it is used in such an environment. Emissions test  Compliance  Electromagnetic environment – guidance RF emissions CISPR 11  Group 1  The SPIROBANK II uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B  The  SPIROBANK  II  is  suitable  for  use  in  all  establishments,  including  domestic establishments  and  those  directly  connected  to the  public low  voltage  power  supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions  IEC 61000-3-3 Not applicable  Guidance and manufacturer’s declaration – electromagnetic immunity The SPIROBANK II is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIROBANK II should assure that it is used in such an environment. Immunity test  IEC 60601 test level Compliance level  Electromagnetic environment – guidance Electrostatic discharge (ESD)  IEC 61000-4-2 ±6 kV contact  ±8 kV air ±6 kV contact  ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. In  the  event  of  disruption  due  to  ESD  during  oximetry  test,  the  device recovers from any disruption within 30 s. (according to ISO 9919). Electrical fast transient/burst  IEC 61000-4-4 ±1 kV for input/output lines  Mains  power  quality  should  be  that  of  a  typical  commercial  or  hospital environment. Surge  IEC 61000-4-5 ±1 kV differential mode  ±2 kV common mode Not Applicable Mains  power  quality  should  be  that  of  a  typical  commercial  or  hospital environment. Voltage  dips, short interruptions and voltage variations on  power supply input lines  IEC  61000-4-11 <5 % UT (>95  %  dip  in UT) for 0,5 cycle  40 % UT (60 % dip in UT) for 5 cycles  70 % UT (30 % dip in UT) for 25 cycles  <5 % UT (>95  %  dip  in UT) for 5 sec Not Applicable  Power frequency (50/60 Hz) magnetic field  IEC 61000-4-8 3 A/m  3 A/m  Power  frequency  magnetic  fields  should  be  at  levels  characteristic  of  a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
 Spirobank II                         Page 33 of 34 Rev.1.1 User manual Guidance and manufacturer’s declaration – electromagnetic immunity The SPIROBANK II is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIROBANK II should assure that it is used in such an environment.              Conducted RF  IEC 61000-4-6   Radiated RF  IEC 61000-4-3              3 Vrms  150  kHz  to  80 MHz   3 V/m  80  MHz  to  2,5 GHz              [3 ] V     [3 ] V/m Portable  and  mobile  RF  communications  equipment  should  be  used  no closer  to  any  part  of  the  SPIROBANK  II,  including  cables,  than  the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance  d=[ 3.5   ]  √P         3   d=[ 3.5   ]  √P  80 MHz to 800 GHz       3  d=[ 7    ]  √P  800 MHz to 2,5 GHz       3  where P is the maximum output power rating of the transmitter in watts (W) according  to  the  transmitter  manufacturer  and  d  is  the  recommended separation distance in metres (m).  Field  strengths  from  fixed  RF  transmitters,  as  determined  by  an electromagnetic site survey,  should be less than the compliance level in each frequency range.  Interference  may  occur  in  the  vicinity  of  equipment  marked  with  the following symbol:  NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.  NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.  a)  Field  strengths  from  fixed  transmitters,  such  as  base  stations  for  radio  (cellular/cordless)  telephones  and  land  mobile  radios, amateur  radio,  AM  and  FM  radio  broadcast  and  TV  broadcast  cannot  be  predicted  theoretically  with  accuracy.  To  assess  the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SPIROBANK II is used exceeds the applicable RF compliance level above, the SPIROBANK II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SPIROBANK II.  b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.  Recommended separation distances between portable and mobile RF communications equipment and the SPIROBANK II The SPIROBANK II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer  or  the  user  of  the  SPIROBANK  II  can  help  prevent  electromagnetic  interference  by  maintaining  a  minimum  distance between  portable  and  mobile  RF  communications  equipment  (transmitters)  and  the  SPIROBANK  II  as  recommended  below, according to the maximum output power of the communications equipment.   Rated maximum output power of transmitter W  Separation distance according to frequency of transmitter m 150  kHz  to  80 MHz  d=[ 3.5   ]  √P         3 80  MHz  to  800 MHz  d=[ 3.5   ]  √P         3 800 MHz to 2,5 GHz   d=[   7   ]  √P         3 0.01 0.12 0.24 0.24 0.1 0.37 0.37 0.74 1 1.17 1.17 2.34 10 5.28 5.28 1.056 100 11.66 11.66 23.32
 Spirobank II                         Page 34 of 34 Rev.1.1 User manual For  transmitters  rated  at a  maximum output  power not  listed  above, the  recommended  separation  distance  d in  metres  (m)  can  be estimated  using  the  equation  applicable  to  the  frequency  of  the  transmitter,  where  P  is  the  maximum  output  power  rating  of  the transmitter in watts (W) according to the transmitter manufacturer.  NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.  NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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