GERATHERM Diffustik Manuel utilisateur
Diffustik
User Manual
Version 1.2.2
Date 17th October, 2014
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 2
1. WELCOME TO BLUE CHERRY.................................................................. 3
2. DIFFUSTIK .......................................................................................... 4
2.1 DESCRIPTION AND SCOPE OF DELIVERY .................................................... 4
2.1.1 DESCRIPTION...................................................................................... 4
2.1.2 SCOPE OF DELIVERY ............................................................................. 5
2.2 SETUP ............................................................................................... 6
2.2.1 ELECTRONIC UNIT................................................................................ 8
2.2.2 SHUTTER UNIT.................................................................................... 9
2.2.3 INSTALLATION OF THE DEMAND VALVE ..................................................... 9
2.2.4 FLOW SENSOR INSTALLATION ............................................................... 10
2.2.5 CONNECTION ON DIFFUSTIK ................................................................ 11
2.2.6 POWER ON THE DIFFUSTIK .................................................................. 11
2.3 SECURITY ......................................................................................... 12
2.3.1 GENERAL SECURITY INFORMATION........................................................ 12
2.3.1.1 NORMS AND GUIDELINES.................................................................... 12
2.3.1.2 ELECTROMAGNETIC COMPATIBILITY....................................................... 13
2.3.2 SECURE USE OF DIFFUSTIK ................................................................... 13
2.3.3 CLEANING AND DISINFECTING THE FLOW SENSOR AND SHUTTER .................. 15
2.3.4 COMBINATION WITH OTHER DEVICES..................................................... 16
2.3.5 DISPOSAL......................................................................................... 18
2.3.6 PRODUCT LABELLING DIFFUSTIK............................................................ 18
2.3.7 PRODUCT LABELLING ANALYZER............................................................ 19
2.3.8 USED SYMBOLS................................................................................. 20
2.4 MAINTENANCE ................................................................................. 21
3. WARRANTY ...................................................................................... 22
3.1 GENERAL DESCRIPTION....................................................................... 22
3.2 WARRANTY EXCLUSION....................................................................... 22
3.3 PACKING AND SHIPPING ...................................................................... 22
4. TECHNICAL DATA DIFFUSTIK ................................................................ 23
5. TECHNICAL DATA ANALYSER ................................................................ 24
User Manual
Diffustik
DIFFUSTIK_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 Diffustik. 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 Device, 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 info@geratherm-respiratory.com
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
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 4
2. Diffustik
2.1 Description and Scope of Delivery
2.1.1 Description
The medical device Diffustik is a PC based system, which is used for the
determination of the diffusion capacity in lung function measurements.
It could be used as a single device or in combination with other
products of Geratherm Respiratory.
The Diffustik consists of a gas analyzer for carbon monoxide (CO) and
methane (CH4), a demand valve with shutter unit as well as a housing
with integrated electronic. The Diffustik connects to a PC via the
integrated USB interface. The established Ergoflow Flow sensor
principle is used for flow measurement.
The Diffustik can only be used with the medical cart authorized by
Geratherm Respiratory. The galvanic isolation of the electric power
system is done by the medical cart. All peripheral equipment like
computers, printers or monitors should only be connected to the
electric power system of the cart.
The Software Blue Cherry is delivered with the Diffustik. Its Standard
version contains Measurements for SVC, FVC, CO-Diffusion as well as
Pre/Post analysis and trend analysis. Furthermore it contains a powerful
database for patient and test information and has a modular design,
which offers the possibility of combination with other measurements.
The modular and flexible software concept allows user specific
configuration of Blue Cherry. A user may add to the predefined
medication list, select between different predicted equations sets and
add further predicted equations, define new parameters, configure
results table and change patient data input view.
Blue Cherry can be connected to office information software via a GDT
interface. There are different export possibilities into Excel and XML.
Using the standard Microsoft ®clipboard, all charts may be imported
into standard software such as MS Word or MS PowerPoint.
The protocol printing happens by the Windows Printer Interface. Every
Windows compatible printer can be used. All test readings and
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 5
graphical data can be displayed and printed. The main application of the
Diffustik is PFT measurement used in clinical environment.
2.1.2 Scope of Delivery
The standard scope of supply for the Diffustik includes the following
components:
Item
Description
Diffustik
Electronic unit with USB connector
Gas analyzer for CO and CH4
Housing with integrated electronic
Blue Cherry Software CD
Modular diagnostic platform operating under Microsoft Windows environment
Quick User Guide
Flow sensor
for measurement of flow
Flow and Shutter Unit with Demand valve
Nose clip
Neumofilt
bacteria and virus filter for lung function measurement with integrated snout
Power supply cable
USB cable
Silicone adapter
to connect flow sensor to calibration pump. Note user manual for indications
for the conduct of the calibration.
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 6
2.2 Setup
It is recommended to install the system in a way that allows an optimal
use of the complete system.
It is recommended to the operator to perform all described methods to
clean, setup, sterilize and disinfect the device.
The connectors of the Diffustik are located at the back side of the
device.
Connect a grounded power supply cable to the AC 230V input (1). Now
connect one of the bus connector (2) with the bus connector of the gas
analyser and the remaining bus connector with the flow electronic. The
USB connector (3) must be connected to your PC while using the
delivered USB cable.
The connectors of the analyzer can be found on the right side of the
rear panel.
1
2
3
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 7
Connect a grounded power supply cable to the AC 230V input (1). Now
connect the bus cable to connector (2) of the analyzer. The gas sample
hose has to be connected to the blue Luer connector of the analyzer (3).
Connect the system only to AC sources which are
connected to a reliable protective earth conductor (3-
pin cable, grounded) and which specifications meet the
details described on the label on the rear of the
housing.
Extension cords must not be used.
On request Geratherm Respiratory provides diagrams,
parts lists, descriptions, setting instructions as well as
other documents, which could help the operator to
setup, maintain and repair the device.
The analyzer needs a warm up time of 15 minutes.
Make sure not to start any test before.
1
2
3
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 8
2.2.1 Electronic Unit
Connect the closing head (2) of the shutter unit to the dovetail groove
at the holder plate of the stand (3). After this plug the body of the
electric unit (1) as far as it will go onto the closing head and connect the
connection cable of the electric unit with the jack at the bottom of the
stand.
Ensure that all connections are connected accurately
and without too much power.
1
2
3
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 9
2.2.2 Shutter Unit
Now move the shutter (1) as far as it will go into the closing head (2).
After that, connect the junction cable to the jack of the electric unit.
2.2.3 Installation of the demand valve
If the Bodystik includes the option CO Diffusion the demand valve has
to be connected additionally. Therefore move the demand valve (1) as
far as it will go into the closing head, just like shown in picture (2).
After that, connect the junction cable of the demand valve with the jack
of the electric unit.
1
2
1
2
User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 10
At last connect the gas sample hose (1) with the Luer Connection of the
closing head and after that the gas supply hose (2) with the compressed
air supply of the stand.
Ensure that all connections are connected accurately
and without too much power.
The gas supply hose must only be connected to gas
bottles with the following content:
-up to 0.3% CH4
-up to 0.3% CO
-up to 0.3% C2H2 (optionally)
-21% O2, rest N2
Open the gas bottle carefully after all connections have
been established like described.
2.2.4 Flow sensor installation
Open the cap of the sensor attachment and carefully plug the flow
sensor in its designated adapter (1). Ensure that the sensors connection
2
1
Autres manuels pour Diffustik
1
Table des matières
Autres manuels GERATHERM Équipement médical
GERATHERM
GERATHERM Spirostik Manuel utilisateur
GERATHERM
GERATHERM Bodystik Manuel utilisateur
GERATHERM
GERATHERM Diffustik Manuel utilisateur
GERATHERM
GERATHERM Safestik Manuel utilisateur
GERATHERM
GERATHERM Ergostik Manuel utilisateur
GERATHERM
GERATHERM Ambistik Manuel utilisateur
GERATHERM
GERATHERM Spirostik Manuel utilisateur
GERATHERM
GERATHERM Spirostik Manuel utilisateur
GERATHERM
GERATHERM Bodystik Manuel utilisateur
GERATHERM
GERATHERM Oxy Control Manuel utilisateur
