MIR MiniSpir Light User Manual Download Page 9

MiniSpir

 

User manual

 

 

 

 

MINISPIR 

User manual 

Rev 1.9   

page 9 of 18 

 

 

Symbol 

Description 

 

Humidity limitation: indicates the range of humidity to which the medical device can be safely exposed 

 

Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed 

 

1.4.2 

(ESD) Electrostatic discharge sensitivity symbol 

 

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 

 

1.5 

Product description 

 

MiniSpir

 is a spirometer spirometer that can also features a pulse oximeter feature (optional), and is connected to a Personal 

Computer using a USB cable. 
 

 

 
The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart beat.  

Summary of Contents for MiniSpir Light

Page 1: ...MiniSpir User manual MINISPIR User manual Rev 1 9 page 1 of 18 User Manual Rev 1 9 Issued on 09 10 2020 Approved on 09 10 2020...

Page 2: ...the PC The device can then be used with the winspiroPRO software Keep the original packaging In the event that your device requires attention then always use the original packaging to return it to th...

Page 3: ...n electromagnetic environments 7 1 3 Unforeseen errors 8 1 4 Labels and symbols 8 1 4 1 Identification label 8 1 4 2 ESD Electrostatic discharge sensitivity symbol 9 1 5 Product description 9 1 6 Tech...

Page 4: ...e for ensuring that the device is stored and used in appropriate environmental conditions as specified in paragraph 1 6 3 WARNING If the device is exposed to unsuitable environmental conditions this c...

Page 5: ...ned before each spirometry test and a new disposable mouthpiece must always be used for each subject The use of an anti bacterial filter is at the discretion of the doctor If a disposable turbine is u...

Page 6: ...rect functioning of the device and thus of incorrect test results and create inconvenience to the patient The user is responsible for obtaining the correct type of mouthpieces for the device Those req...

Page 7: ...igurable parameters should only be made by qualified personnel However an incorrect set up of the parameters does not put the patient at risk When connected to other devices to preserve the safety oft...

Page 8: ...nnect 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 SpO2 Warning symbol for the SpO2 port for oximetry...

Page 9: ...ope 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 Dischar...

Page 10: ...from healthy subjects MiniSpir is connected to a PC trough a USB port Data measured by MiniSpir are transferred to the PC in real time The Windows winspiroPro software allows to view the spirometric...

Page 11: ...e mL FIVC Forced inspiratory volume L FIV1 Volume inspired in the 1st second of the test L FIV1 FIVC FIV1 FIVC x 100 PIF Peak inspiratory flow L s FIF25 Maximum flow at 25 of FIVC L s FIF50 Maximum fl...

Page 12: ...he analysis period BPM Recording time Total time measure of SpO2 hh mm ss Analysis Time Total time of analysis hh mm ss T90 Time passed with SpO2 90 hh mm ss T89 Time passed with SpO2 89 hh mm ss T88...

Page 13: ...liant with EN 60601 1 2005 A1 2012 Error of displayed numeric value Flow measurement percentage error 5 Oximetry parameters measuring with accuracy defined in table on 1 6 2 Emission limits CISPR 11 G...

Page 14: ...struction or restriction plus one level of normal spirometry as shown in the following table normal mild moderate moderately severe severe very severe Through an analysis applied to some of the indice...

Page 15: ...de by the individual doctor Re usable finger sensor This sensor is recommended for patients weighing 20 Kg with limited activity Carry out an oximetry test as follows Connect the sensor to the instrum...

Page 16: ...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 direct...

Page 17: ...he turbine such as threads or hair Any such deposit could brake or block the rotation of the turbine blade and thus compromise the measurement accuracy To clean the reusable turbine remove it from its...

Page 18: ...le turbine included 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 imprope...

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