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Table 2: Immunity (Stimulation mode) table according to IEC 60601-1-2

Guidance and manufacturer’s declaration – electromagnetic immunity

Spirohome

battery-operated spirometer devices are intended for use in the

electromagnetic environment specified below. Users of these devices should assure that it

is used in such an environment.

Immunity Test

Standard

IEC 60601 test

level

Compliance

level

Recommended separation

distance

Electrostatic
discharge (ESD)
IEC 61000-4-2

±2 kV
±4 kV
±6 kV
±8 kV
±15 kV

±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air

Floor should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.

Electrostatic fast
transient / burst
IEC 61000-4-4

N/A

Surge IEC
61000-4-5

Voltage dips,
short interruptions
and voltage
variations on
power supply
lines IEC
61000-4-11

Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8

30 A/m

Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical domestic,
commercial or hospital
environment.

First Pub. Date: 24.09.2018

R.9-1 / 10.03.2020

Summary of Contents for Spirohome Clinic 02000

Page 1: ... application please ensure that you have read this user manual and labels and information on the product This user manual is for these models Spirohome Clinic 02000 Spirohome Clinic 02010 Spirohome Clinic 02020 Inofab can provide user manual physical print or digital from İnofab Apps and İnofab websites ...

Page 2: ...ometry Test with The Spirohome Clinic 10 Types of Breathing Maneuvers 12 End of the Tests 16 UNDERSTANDING THE TEST QUALITY 17 SIGNS AND SYMBOLS 19 TECHNICAL FEATURES 20 SAFETY WARNINGS AND PRECAUTIONS 20 MAINTENANCE 22 CALIBRATION CHECK 23 Preparation of Calibration Check 23 CLEANING AND DISINFECTION 24 THE SPIROWAY DISPOSABLE 25 BATTERIES 25 DISPOSAL OF SPIROHOME 26 TROUBLESHOOTING 27 ORDERABLE ...

Page 3: ...downloaded on Apple s App Store Google Play Store Microsoft Store The device is powered by 2 x AAA batteries The Spirohome Clinic works with the Spiroway Disposable mouthpiece 2 2 WHAT S IN THE BOX Your Spirohome Clinic box contains Spirohome Clinic Device Spirohome Clinic Cap Quick start guide Calibration Certificate Caution Please check to ensure that there is no visible damage on any of the com...

Page 4: ...s described in this manual Failure to perform a correct maneuver may lead to inaccurate and unacceptable results The device should not be used if the accuracy and reliability of test results may be jeopardized by external factors Performing spirometry can be physically demanding The forced expiratory maneuver used in spirometry increases intrathoracic intraabdominal and intracranial pressures Pote...

Page 5: ...eases in intrathoracic and intraabdominal pressure Presence of pneumothorax Thoracic surgery within 4 wk Abdominal surgery within 4 wk Late term pregnancy Infection control issues Active or suspected transmissible respiratory or systemic infection including tuberculosis Physical conditions predisposing to the transmission of infections such as hemoptysis significant secretions or oral lesions or o...

Page 6: ...t 25 of vital capacity synonymous with MEF 75 L s FEF 50 Forced Expiratory Flow at 50 of vital capacity synonymous with MEF 50 L s FEF 75 Forced Expiratory Flow at 75 of vital capacity synonymous with MEF 25 L s FEF 25 75 Forced Expiratory Flow from 25 to 75 of vital capacity synonymous with MMEF L s MET 25 75 Mi d Expi ratory Ti me synonymous with FET25 75 s FEV 0 75 FEV 6 The ratio of FEV 0 75 t...

Page 7: ...n is 3 however the user may perform up to 8 trials The best values obtained from the spirometry tests performed in one session are displayed on the app interface Users and healthcare professionals have the option to view the results of each spirometry trial performed in a spirometry session separately The device also provides a reference value obtained from large epidemiological studies based on t...

Page 8: ...pirohome Clinic should not be used in the presence of flammable liquids or detergents nor in the presence of inflammable anesthetic gases oxygen or nitrogen The device should not be used in direct air currents e g wind sources of heat or cold direct sun rays or other sources of light or energy dust sand or any other chemical substances 3 2 SETTING UP YOUR DEVICE 1 Download the Spirohome Clinic app...

Page 9: ... the smart device or PC and pair the Spirohome Clinic with the smart device or PC following the instructions on the app 3 3 DEVICE INDICATORS There are 3 LED lights located on the front of the device The LED lights may be turned on or flashing various colors and or in various patterns The LED lights indicate the current status of the device Please see the following information for guidance on LED ...

Page 10: ...w level adjustment has been unsuccessful All LEDs are flashing red There is a foreign object between the sensors Check device error in troubleshooting section LEDs are consecutively flashing yellow Over the air connection is being established LED number 3 flashes red three times Battery low warning LEDs flash in reverse order and remain switched off The device is switching off 3 4 PERFORMING A LUN...

Page 11: ...the mouthpiece with bare hands Hold the mouthpiece with the upper part of the plastic package Insert the mouthpiece all the way into the Spirohome Clinic device in the correct orientation 3 A click will be heard when the mouthpiece is inserted correctly all the way into the device 4 Open the Spirohome App on your smart device or PC If you are not registered register to the Spirohome app by creatin...

Page 12: ...ce on a flat surface and allow the zero flow level adjustment to be completed Make sure that there is no airflow around the device during the zero flow level adjustment process 7 The app will prompt the operator to start a spirometry test Let the patient sit with his back straight and his feet resting on the ground The patient must place the mouthpiece in their mouth past their teeth necessary for...

Page 13: ...f his her lips 6 If it takes more than 15 seconds to empty all the air from his her lungs with the right performance the test will be completed automatically The patient may use a nose clip to help him her to exhale only through his her mouth during the forced exhalation maneuver 7 The patient may remove the mouthpiece from his her mouth and resume normal breathing once the breathing maneuver has ...

Page 14: ...a few times at the beginning of the test and data is recorded as soon as a forced expiration is detected whereas in FVC test mode the test is initiated directly with a forced expiratory maneuver The Flow Volume Loop FVL Test Breathing Maneuver 1 Ensure that the device is connected Select the FVL test mode and the test screen will appear 2 Enter the required ambient conditions makes sure you entere...

Page 15: ...ath filling his her lungs as much as possible 5 Keeping his her lips sealed tightly around the mouthpiece the patient must blow out this inhaled air and empty his her lungs as hard and fast as the patient can into the mouthpiece 6 After the patient exhales whole air from the lungs without breaking the seal of his her lips the patient must inhale completely to fill his her lungs When performing thi...

Page 16: ...lator or the current post bronchodilator testing set The Maximum Voluntary Ventilation MVV Test Breathing Maneuver 1 Ensure that the device is connected Select the MVV test mode and the test screen will appear 2 Enter the required ambient conditions makes sure you entered the correct values as the measurement may be significantly affected by a wrong value like temperature and relative humidity and...

Page 17: ...ust make sure to keep blowing until the patient feels like the patient has completely emptied his her lungs 7 The test can also be performed by performing the breath maneuver in the opposite direction When the test starts the patient should inhale and exhale normally at least 4 times then the patient should exhale as deep as the patient can and empty his her lungs completely After that the patient...

Page 18: ...ity and Usability Criterion Required for Acceptability Required for Usability FEV 1 FVC FEV 1 FVC Must have BEV 5 of FVC or 0 100 L whichever is greater Yes Yes Yes Yes Must have no evidence of a faulty zero flow setting Yes Yes Yes Yes Must have no cough in the first second of expiration Yes No Yes No Must have no glottic closure in the first second of expiration Yes Yes Yes Yes Must have no glot...

Page 19: ...mouthpiece before a plateau For within maneuver acceptability the FVC must be greater than or within the repeatability tolerance of the largest FVC observed before this maneuver within the current prebronchodilator or the current post bronchodilator testing set Although the performance of a maximal forced inspiration is strongly recommended its absence does not preclude a maneuver from being judge...

Page 20: ...dress of the manufacturer adjacent to the symbol Single use only Sign of Conformity Type BF of Medical Electrical Equipment Disposal in Compliance with WEEE SN Serial Number Temperature Limit Lot Number Humidity Limit Ref Number Atmospheric pressure limitation IP IP Number Do not use if the package is damaged The device includes RF transmitters Keep away from sunlight The instruction manual bookle...

Page 21: ...ny damage or harm to the device or user which has resulted from the user s failure to follow the warnings and guidelines given in this manual or in other instructional materials provided with the device Please note that special WARNING should be given by handlers of the device to elderly pediatric or differently abled users before the use of the device The patient should be informed that maximal i...

Page 22: ...uthpiece is attached Also ensure that you select the new patient or add a new patient if that patient does not already have an account on the Spirohome Clinic App before performing a spirometry session with the device The Spirohome Clinic must only be used with the original accessories specified and provided by the manufacturer Use of the mouthpieces or other accessories that are not recommended b...

Page 23: ...ified by the manufacturer it may avoid interference to radio communications 4 MAINTENANCE Handle the Spirohome Clinic and Spiroway Disposable mouthpiece with care Do not use the device or its accessories if they are visibly damaged particularly if there is damage to the filters on the mouthpiece Store the Spirohome Clinic in dust dirt and moisture free conditions The pouch provided with the device...

Page 24: ...on check procedures 2 Ensure that the temperature inside the syringe and the room are the same This is necessary to prevent failed calibration check due to temperature differences You can push and draw the piston of the 3 L calibration syringe a few times to balance the temperature inside and outside the piston NOTE Avoid placing the body of the syringe near heat sources or warming its casing with...

Page 25: ...contaminants as shown below Please be extra careful and gentle when cleaning the sensors to avoid any damage to them You should clean the Spirohome Clinic body between each new patient Wipe all accessible surfaces of the device using moderate pressure as shown CAUTION Care must be taken to prevent any excess liquids contained within the wipes from entering the components of the Spirohome Clinic Ne...

Page 26: ...sinfection procedure described for the device must be performed between each new user AND a new Spiroway Disposable mouthpiece must be used for each new user This is important to prevent any risk of cross contamination between users To purchase a new mouthpiece you can contact your local distributors if there is no local distributor or you can not reach them you can reach İnofab at https www inofa...

Page 27: ...cap off and store the device according to the storage requirements until the next use 4 5 DISPOSAL OF SPIROHOME This product is not to be discarded as regular household waste but should be discarded as electronic waste in accordance with local regulations and returned to a collection point of recycling for electric and electronic devices Used batteries should be disposed of in designated battery r...

Page 28: ...it is to be used by the same patient clean the Spiroway Disposable Mouthpiece to ensure that the lumen is not obstructed or replace with a new mouthpiece Spiroway mouthpiece is damaged Replace Spiroway Spirometry test was performed incorrectly Refer to Performing a Lung Function Test in the user manual or refer video tutorial on app Spiroway mouthpiece is installed incorrectly Refer to the user ma...

Page 29: ...his user manual Measurement error screen showed up Flow limit exceeded This device is intended to measure 0 14 L s Spiroway mouthpiece is dirty Replace Spiroway Spiroway mouthpiece is damaged Replace Spiroway Device malfunction Contact manufacturer Device error screen showed up Spiroway mouthpiece is installed incorrectly Refer to user manual for proper installation of Spiroway There is a foreign ...

Page 30: ...ge or missing components at the time of purchase or delivery and claims must be made in writing to the manufacturer The customer must return goods for replacement or repair at the customer s expense to the authorized supplier or manufacturer Please provide with the returned product a clear written explanation of the fault or problem This warranty does not apply at the discretion of the manufacture...

Page 31: ...d for use in the electromagnetic environment specified below Users of these devices should assure that it is used in such an environment Emission Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Spirohome battery operated devices use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in...

Page 32: ...charge ESD IEC 61000 4 2 2 kV 4 kV 6 kV 8 kV 15 kV 8 kV contact 2 kV air 4 kV air 8 kV air 15 kV air Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrostatic fast transient burst IEC 61000 4 4 N A NA Surge IEC 61000 4 5 NA NA Voltage dips short interruptions and voltage variations on power supply lines IEC...

Page 33: ...s as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note1 At 80 MHz and 800 MHz the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from stru...

Page 34: ... 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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...

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