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User Manual 

Spirostik

 

SPIROSTIK_MAN_ENG_V1.2.2_REV01.DOCX 

Page 8 

 

 

2.2.2

 

Safe Use of Spirostik 

Spirostik is part of a PC based medical device. It is highly recommend 
that the user observes all warning notices in order to ensure a safe 
use of the device.  

 

The Spirostik complete should not be used in conjunction with 
multiple connection plug sockets or extension leads.

 

 

Spirostik must only be used in combination with peripheral 
devices which fulfill the Norm DIN EN 60950 for office devices or 
the norm DIN EN 60601 for medical electrical devices. Always 
ensure the minimum requirements for the computer are met 
(see technical specification). Non-Medical devices should not be 
used close to a patient always ensure a minimum distance of 
1.5m between patient and non-medical computer systems.

 

 

Flow sensors and pressure tubes must not be cleaned! Humidity 
inside the pressure tube may affect the accuracy of the 
measurement. Replace the pressure tube in case of 
contamination. Replace the flow sensor after each patient. 
Always observe instructions in the disinfection and cleaning 
section.

 

 

The User must not touch the patient and the signal output of the 
computer. The device should not be used in association with a 
mobile power strip or extension cable.

 

 

Large quantities of saliva and/or. Humidity in the flow sensor may 
impair the flow measurement. The flow sensor should be 
replaced in these conditions. In addition extreme temperature as 
well as extreme altitude may impair the flow measurement. 
Consider the site conditions indicated in the technical data.

 

 

This device must not be modified without the approval of the 
manufacturer.

 

 

Power supply can be disconnected by releasing the USB plug 
connection. 

 

 

Summary of Contents for Spirostik

Page 1: ...Spirostik User Manual Version 1 2 2 Date 24th October 2014...

Page 2: ...ectromagnetic Compatibility 7 2 2 2 Safe Use of Spirostik 8 2 2 2 1 Connecting Spirostik double hose and handle 9 2 2 2 2 Replace handle 10 2 2 2 3 Connecting the Flow sensor into the handle 11 2 2 2...

Page 3: ...integrated into even the largest of requirements This document contains important information for the operation of Blue Cherry and Spirostik We strongly recommend reading this manual carefully in ord...

Page 4: ...y software has a modular design to allow the addition of further options in the future such as MVV or Pulse Oximetry measurements The main application of Spirostik is in the diagnosis of pulmonary dis...

Page 5: ...ncludes the following components Component Name and Description USB Spirostik Electronic module connecting to USB port Pressure tube Connects flow sensor to pressure transducer Single use flow sensors...

Page 6: ...ains instructions on how to use the software and how to handle the device but must not be seen as a training course for technicians or engineers Before using the device all users should read this manu...

Page 7: ...EN 60601 1 Medical electrical device DIN EN 60601 1 1 General safety requirements DIN EN 60601 1 2 EMV DIN EN 60601 1 4 Programmable electrical medical devices DIN EN ISO 14971 Risk management DIN EN...

Page 8: ...atient and non medical computer systems Flow sensors and pressure tubes must not be cleaned Humidity inside the pressure tube may affect the accuracy of the measurement Replace the pressure tube in ca...

Page 9: ...r to ensure the continued function of the equipment this connection should be examined once per day Please read the following carefully The double hose should be securely connected to the sealing rubb...

Page 10: ...n of the Spirostik the handle needs to be changed after not more than 12 months On the back plate of the Spirostik device there are 2 connectors where the handle tubing can be directly connected Make...

Page 11: ...e the flow sensor is straight and the two guidance ribs are either side of the connector with a firm pressure push the flow sensor into the handle this should snap into place with the connector holes...

Page 12: ...handle In order to protect the user from cross contamination the flow sensor can be removed from the handle with a single hand without touching the used flow sensor Please read the following procedur...

Page 13: ...OSTIK_MAN_ENG_V1 2 2_REV01 DOCX Page 13 Gently pushing the upper part of the handle with the thumb opens the mouth of the handle so that the flow sensor can fall out This procedure can be done directl...

Page 14: ...and cables are connected properly when using the measurement device together with other devices All connected devices must comply with legal regulations and the total leakage current must not exceed...

Page 15: ...A within patient area and resource B in medical used room Resource A within patient area and resource B in medical used room See remarks below table Resource A within patient area and resource B in a...

Page 16: ...t in accordance with local directives 2 2 5 Product labelling Example of a typical product labelling SN designates the serial number for the device The first 2 digits define the manufacturing year The...

Page 17: ...o and electronic devices IPX0 Indicates no protection against dripping water Manufactured according RoHS directive 2002 95 EC 0494 Geratherm Respiratory devices carry this CE no according to directive...

Page 18: ...be provided by Geratherm Respiratory or an authorized service partner of Geratherm Respiratory Geratherm Respiratory will not accept warranty claims on any unauthorised repairs 3 2 Warranty exclusion...

Page 19: ...esolution Sample rate Accuracy GR Spiraflow Differential pressure 16l s 0 09kPa l s 15l s 20ml 1ml s 125 Hz 3 or 20ml s Volume Volume Accuracy 0 20L 3 or 50mL Operating conditions Temperature Air humi...

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