GERATHERM Spirostik User Manual Download Page 3

User Manual 

Spirostik

 

SPIROSTIK_MAN_ENG_V1.2.2_REV01.DOCX 

Page 3 

 

1.

 

Welcome to Blue Cherry 

 
Thank you for choosing the Blue Cherry diagnostic platform, we are sure you will be very happy 
with your choice, and find the advanced functionality offered by Blue Cherry a great benefit in 
your diagnostic activities. 
 

 

The Blue Cherry diagnostic platform offers its user a level of functionality which is unsurpassed, 
providing multiple diagnostic measurements from within a single software platform. Addition 
of further diagnostic measurements couldn’t be easier: simply purchase the required hardware 
and plug it into a spare USB 2.0 port on the PC. The Blue Cherry system will recognise the new 
device and testing will become available within the diagnostic platform. 
 
The Blue Cherry platform works well as a standalone device for the smallest of requirements, 
however expansion for the future is simple. The software has been designed to allow 
connection of multiple units to a single Blue Cherry Database to allow centralisation of data, for 
the purposes of reporting or statistical analysis, further with the ability to interconnect with 
many Hospital information systems using the HL7 format, the diagnostic system can be 
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 order to avoid incorrect use or 
damage to the device.  Geratherm Respiratory does not take responsibility for any direct or 
indirect damage to the Spirostik, if it is not operated in accordance with this manual. Users 
must observe precautions, warnings and instructions.  
 
Geratherm Respiratory does not take liability for mistakes in this documentation. The liability 
for direct or indirect losses related to the use of this document is excluded, as long as this is 
allowed by law. 
The copyright for Blue Cherry is owned by Geratherm Respiratory. Permission is given to use 
the Blue Cherry software provided on the installation CD upon acceptance of the EULA. (see 
appendix) Blue Cherry™ and Spirostik™ remain trademarks of Geratherm Respiratory.  
 
This user manual is according to EN 60601-1 an integral part of the product. Geratherm 
Respiratory reserves the right to make changes to the contents without prior notice. All 
changes made are in accordance with the guidelines for manufacturing medical devices. 
 
 

 
 

Geratherm Respiratory GmbH 
 
Sparkassenpassage 1   

 

 

[email protected] 

D-97688 Bad Kissingen 

 

 

www.geratherm-respiratory.com 

Tel. +49 (0)971 7857043-0 

 

 

Fax +49 (0)971 7857043-30 

 

© Copyright 2007 Geratherm Respiratory GmbH 

 

 

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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