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Operating instructions
ATMOS
Diagnostic Cube
512.0000.B
2013-08 Index: 11
Table of Contents
1.0
1.1
1.2
1.3
1.4
1.5
1.6
2.0
3.0
3.1
3.2
3.3
3.3.1
3.3.2
3.4
3.4.1
3.4.2
3.5
3.5.1
3.5.2
3.5.3
ATMOS
4.0
4.1
4.2
4.3
4.7.3.3
4.7.4
4.7.4.1
4.7.4.2
4.7.5
5.0
5.1
5.2
5.3
6.0
6.1
7.0
7.1
7.1.1
7.1.2
8.0
9.0
10.0
Disposal ...................................................................... 50
11.0
12.0
Declaration of conformity.......................................... 54
4.4
4.5
4.5.1
4.5.2
4.5.3
4.5.4
4.5.4.1
4.5.5
4.6
4.6.1
4.6.2
4.6.3
4.6.4
4.7
4.7.1
4.7.1.1
4.7.1.2
4.7.2
4.7.3
4.7.3.1
4.7.3.2
1.0
Introduction
REF
512.0000.0
REF
REF
512.1000.0
512.1600.0
Rhinomanometry module
Windows versions WinXP / Win7 Prof 32 Bit/64 Bit / Win8 64 Bit
ATMOS Sono 31
REF
512.1200.0
REF
512.1100.0
1.0
1.2
Introduction
Intended use
ATMOS Tymp 31
ATMOS Rhino 31
Designation:
Designation:
Main function:
determination of the
nasal flow resistance
Main function:
Application:
Application:
- determination of the
nasal flow resistance
Specification of the
main functions:
Specification of the
main functions:
nose
Duration of application:
temporarily
Application environment:
clinic or practice
Contraindication:
none
ATMOS Sono 31
Designation:
Main function:
Application:
Specification of the
main functions:
Application organ:
paranasal cavities
Duration of application:
temporarily
Application environment:
clinic or practice
Contraindication:
none
Application organ:
ear
Duration of application:
temporarily
Application environment:
clinic or practice
Contraindication:
1.0
1.3
Introduction
Function
ATMOS Rhino 31
The ATMOS Rhino 31 is used for determining the respiration
flow, this is performed by means of an annular diaphragm spiroceptor which is connected to the patient by means of a breathing
mask or nasal olives. The differential pressure determination
is then taken by means of the anterior method (choana versus
mask interior pressure/olive pressure).
Data are shown in real time as a rhinogram and afterwards
as a flow-pressure-diagram, as a value table and bar graph.
The data processing is done by the ATMOS Rhino 31 software
and the obtained values and results are saved. For printing a
Windows printer connected to the device can be used.
For an easy evaluation of the results up to three examinations
can be graphically displayed simultaneously. For easy evaluation a comparison of the curves is shown both tabularly and graphically. The results of the calculation include a patented data
processing system CAR (computer aided rhinomanometry).
This process supports the rejection of artefacts. This provides
the examiner with more objective examination results.
The results are saved in an individual patient data file out of
which they can be printed via a Windows printer. The Rhino
31 diagnostic software is network-compatible and can be integrated into a patient EDP or a hospital information system.
ATMOS Sono 31
The quick and easy to perform ultrasound examination with
the Sono 31 computer module is a fully harmless examination
method for detecting the condition of the maxillary sinuses.
For each of the four cavities there is a corresponding graph
which shows the echo performance of the ultrasound. Echoes
develop when the acoustic impedance changes, this occurs
on the border between bones, tissue, liquids (secretion) and
air. The bigger the impedance difference, the stronger is the
reflection. An ultrasound probe is used both as a sender and
receiver for ultrasonic waves.
Ultrasonic waves are almost completely reflected on the
transition areas between bones or tissue and air. This fact is
used for the diagnostic evaluation. Consequently in a healthy
and air-filled frontalis or maxillary sinus only a front wall echo
can be seen. Mucosal swelling, secretion accumulation, cysts
or neoplastic changes produce additional characteristic late
echoes.
Free text comments can be added to the graphical display
of the examination results, whereby here a dialogue field for
each individual sinus is available. Furthermore there is also
a dialogue field for the overall assessment. All test readings
and evaluations are saved in a database and are available
for later viewing. For printing a Windows printer connected to
the device can be used. The Sono 31 diagnostic software is
network-compatible and can be integrated into a patient EDP
or a hospital information system.
ATMOS Tymp 31
The ATMOS Tymp 31 is a diagnostic device for the objective
measurement and examination of the eardrum, ossicular
chain, stapedius reflex and the eustachian tube. Here the ear
of the test subject is exposed to precise pressure conditions
and is filled with acoustic sound in different frequencies and
levels. The aim of this examination is to determine the flexibility
(compliance, reciprocal value of the acoustic impedance), the
pressure in the middle ear at maximum impedance (peak), the
minimum triggering level of the stapedius reflex by four different
frequencies (500, 1000, 2000 and 4000 Hz) and in order to
determine the function of the eustachian tube.
In order to perform this diagnostic investigation a probe is
placed into the entrance of the subjects auditory canal. It is
then sealed with the help of an adapter. A tone is sent via the
probe into the ear (probe tone). At the same time it is exposed
to an increase and decrease in pressure. The reflected echoes
are determined and calculated by the ATMOS Tymp 31 software and are shown both as a graph and in tabular form. According to the preselected examination method, a result is shown
on the monitor. Due to a variety of adjustment possibilities, it
can be adapted to suit the examination on the physiology of
the test subjects as well as the preferences of the examiner. In
the everyday clinical life freely selectable standard parameters
simplify the application of the Tymp 31.
The results are saved in an individual patient data file out of
which they can be printed via a Windows printer. It is easy to
integrate the data into the practice or clinics EDP system.
The ATMOS Tymp 31 corresponds with the current requirements for correct accounting with the insurance companies,
all data is available for assessment and is documented electronically for verification.
The ATMOS Tymp 31 diagnostic software is network-compatible and can be integrated into a patient EDP or a hospital
information system.
1.0
Introduction
General information
Numeration
Subnumeration
Please observe
hygiene requirements!
Replace
Check
click
Warning,
especial diligent notice !
Important information
~
2
Alternating current
This product is not re-sterilisable.
Repeated reuse of components
which are marked with a 2 is
forbidden. In case of repeated reuse
these components lose their function
and there is a high infection risk.
DC connection
Serial number
REF
Order number
Manufacturing date
The CE sign shows that this product
meets the appropriate requirements
of the EC guidelines.
Protection class II
Fuse
Please observe operating instruction!
1.0
1.5
Introduction
Scope of supply
Prior to dispatch, this ATMOS Diagnostic Cube was subjected to an extensive functional test and has been carefully
packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt
(see delivery note).
ATMOS Diagnostic Cube equipped with the relevant module respectively modules, probe support, installation CA and operating instructions.
Connection cable kit comprising mains cable, power supply unit with unit
cable and USB cable
iHandle (intelligent probe support, optional accessory) for automatic starting of diagnostics by removing the measuring
probe from the support (figure shows maximum equipment).
1.0 Introduction
ATMOS Rhino 31
or
ATMOS Sono 31
Ultrasonic gel
ATMOS Tymp 31
1.0 Introduction
1.6
Ambient conditions
Transport/Storage:
-10...+50 C;
30...95 % air humidity
non-condensing at air
pressure 500...1060 hPa
Operation:
+15...+35 C;
30...95 % air humidity
non-condensing at air
pressure 700...1060 hPa
2.0
Important
safety instructions
The ATMOS Diagnostic Cube is not designed for operation within areas where there is a risk of explosion
(M and G). Areas that are at risk from explosions can
arise due to the use of combustible anaesthetics, skin
cleaning and skin disinfecting materials.
Please do not lean on the swivel arm. It has only a limited loading capacity and no locking device.
the plug from the wall socket. Only then disconnect the
connection cable from the device. Never touch the plug
or cable with wet hands.
be strictly observed.
rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich
environments.
Warning: ultrasonic devices should not be used in HFsurgery if possible. Thus the risks of burnings can be
excluded
10
3.0
Front view
Diagnostic Cube
probes
iHandle, intelligent probe support
connection ATMOS Tymp 31 probe
connection ATMOS Rhino 31 probe
connection ATMOS Sono 31 probe
LED status display
3.2
Rear view
11
3.0
3.3
3.3.1
2.
3.
4.
5.
6.
12
3.0
ATMOS Rhino 31
Simply attach the hose of the rhinomanometer probe to the
front side of the device. This is done by pressing down the
metal lever on the connector of the rhino module.
By pressing down on the metal lever the probe-hose is then
easily connected to the module. When the catch has clicked
in, you may then test for the correct fit by pulling gently on the
hose. In order to obtain a correct fit, the connector must sit
firmly in the socket.
ATMOS Rhino 31
ATMOS Sono 31
ATMOS Sono 31
Press the connector to the socket with the guide pin turn
to the right as far as it will go then the connector clicks into
the socket. When the catch has clicked in the correct fit can
be tested by gently pulling on the connector. In order to obtain
a correct fit the connector must sit firmly in the socket. In the
same way press the ultrasound head and ultrasound cable
until it clicks into place.
ATMOS Tymp 31
Connect the jack to the device and fasten the screws in order
that the jack fits tightly you may then test for the correct fit by
pulling gently on the hose. The connector must sit firmly in
the socket
ATMOS Tymp 31
13
3.0
Rear side
14
3.0
3.4
3.4.1
Required tools:
Crosstip screwdriver (PH2), hexagon socket screw key (2.5),
Allen key, ball-shaped (3), 1 small side cutter, 1 cable tie
15
3.0
iHandle-Software conguration
16
iHandle and foot switch are controlled via the Windows "human
interface device". For further information regarding the installation
of the control port which is required for the function, please see
the separate installation instructions.
3.0
17
3.0
As a user of diagnostics you are responsible for the data protection. We assume no liability in the case of data loss! For the
integration in the practice software there is usually a partition
available on the server for this purpose. Here the diagnostics
data is saved and the practice software is integrated in the
routine back-up. Please ask your service software supplier for
information regarding this.
Network settings and GDT settings have to be made by a
trained technician.
18
4.0
Operation
4.1 Starting the diagnostic software
Depending on the level of integration into the practice EDP
or which device configuration you have chosen, the ATMOS
Diagnostic Cube software can be started in various ways.
After the installation of the Diagnostic Cube the technician
will explain to you the relevant start-up options.
Single-user
without EDP integration
Network
without EDP integration
Network
with EDP integration
Measuring station
without the iHandle
Measuring station
with the iHandle
Viewer station
(without diagnostics)
19
4.0
Operation
4.2
Patient management
20
4.0
Operation
!
4.3
Entering examiner
4.4
21
4.0
Operation
ATMOS Rhino 31
In the register card measurement the type of probe used for
the software is defined. In addition the analysis results (print
parameters) for the evaluation can be adopted. The default
value 75,150 and 300 pa complies with the standard German
norm.
ATMOS Rhino 31
ATMOS Sono 31
In the register card "measurements" the standard adjustments
of the gain can be adjusted.
ATMOS Sono 31
ATMOS Tymp 31
In the register card measurement the age control for the
automatic parameter settings can be defined. In addition the
pressure values as well as the probe frequencies for certain
age groups are adjusted. There are three age groups available these are defined by the upper and lower age groups:
ATMOS Tymp 31
22
4.0
Operation
4.5
The filters and nose adapters should only be used once for
All parts which come into contact with the patient must be
disinfected.
Function test:
test block
Test block
Connection for measuring hose
Handpiece
23
4.0
Contra olive
Operation
It is recommended that when the probe is placed on the
person they should breathe in and out several times. This
will help them get used to the slightly increased breathing resistance. When you feel the person has a normal breathing
rate and a normal breathing intensity then the measurement
can be started by pressing the foot switch.
It is recommended that the measurement is conducted for
at least the duration of the recording of the flow-process. By
renewed pressing of the footswitch all measurements are
held, the measuring values are adopted in the value table
and an automatic change of sides can be initiated.
After the person is prepared for the measurement on the
other side (usually the left) the footswitch is pressed and the
recording of the nasal breathing is restarted. The measurement is saved only after the second measurement is
completed and if applicable an annotation in the dialogue
field was made.
2.
3.
4.
5.
6.
Handpiece
To exchange the filter, screw the one olive from the support
and with the help of the bayonet catch pull the other olive
from the probe body. The filter can be removed with the help
of tweezers.
Attention: When exchanging the filter of the probe the new
filter should be inserted no deeper than to the sealing ring
(rubber ring)!
24
4.0
Operation
4.5.2 Measurement with nose mask
It the measurement is performed with a nose mask, then
attention should be paid to the following:
1.
2.
3.
2.
3.
4.
25
4.0
Operation
12
11
12
11
The performed measurements can be recorded either in putting the measuring probe back into the iHandle, clicking on the
"save" button or confirming the security query with "yes" when
the Rhino 31 software is closed down.
26
4.0
Operation
4.5.4 Illustration of a measurement curve
27
4.0
Operation
4.5.4.1
Illustration of a number of
measuring curves
28
4.0
Operation
4.5.5 Loading saved measurements
ATMOS Rhino 31
Depending on the equipment and the system configuration all
saved measurements can be displayed again. If integration
into the practice PC system has been done, a measurement
can be opened in the patient file by a click on the entry.
Without integration, with a click on the button Load on the
software surface all patient-related measurements will be displayed in chronological order. Up to three measurements can
be chosen from this list. These measurements will be displayed on the screen with date and in different colours.
This is how to activate saved measurements
29
4.0
Operation
4.6
maxilaris, right
12
A
frontalis to 4 cm, maxilaris to 8 cm
deactivated
11
30
Function test:
Apply ultrasonic gel onto the ultrasonic probe and put the "UStester-coupler-2 cmm" onto the probe (see figure on the left).
The peak of the curve must be at 2 cm.
4.0
Operation
4.6.1 To change parameters during a
measurement
After start-up of the programme the measurement parameters
are set as shown on the left. These are the standard values for
a maxillaris measurement. By clicking on the + and - symbols
the overall gain can be changed. The gain curve is chosen in
accordance with the maxilaris.
Gain curve 2:
Depth regulation for a frontalis examination
Gain curve 3:
Centre amplification for cysts, inclusions (bell-shaped curve)
31
4.0
Operation
4.6.3 Measurement
Please handle the Sono probe with special care! It is a sensitive measuring instrument which may be destroyed in case of
any vibration, shock or any other mechanical impact.
A sufficient amount of Sono gel must be applied to the probe.
Without Sono gel the ultrasonic waves cannot invade loss-free
into the body. After the measurement the ultrasonic probe must
be cleaned carefully from all gel residues!
The ATMOS Sono 31 software offers the possibility to get
through the measurement sequence either by the user surface
or via foot switch. Both procedures are described below.
The software starts automatically with the setting for the examination of the right maxillaris. The picture can either be recorded
by using the foot switch or through clicking on the Start/Stop
button on the software surface.
When the next, not yet selected sinus will be chosen, the
ATMOS Sono 31 is directly in the measurement mode. If the
activation has been done via clicking on the software surface,
and an already made record should be overwritten, a further
click on the start/stop button or using the foot switch is necessary in order to activate the measurement mode.
32
4.0
Operation
4.6.4 Loading saved measurements
ATMOS Sono 31
Depending on the equipment and the system configuration all
saved measurements can be displayed again. If integration
into the practice PC system has been done, a measurement
can be opened in the patient file by a click on the entry.
Without integration, with a click on the button Load on the
software surface all patient-related measurements will be
displayed in chronological order. Up to three measurements
can be chosen from this list.
This is how to activate saved measurements
33
4.0
Operation
4.7
4.7.2
!
34
Functional tests
Prior to each use the user must check the functional safety
and the overall condition of the device. For this purpose the
test medium which is included in the delivery (test-volume on
the probe holder 0.85-1.0 ccm) is available.
Never press used ear plugs to the test volume at the probe
support! There is a risk of contamination.
4.0
Operation
4.7.3 Compliance, peak and
stapedius reex measurement
This measurement is the most common diagnostic which is
performed with a clinical impedance meter Therefore, it is
also the measurement mode which after the activation of the
module is automatically opened and marked Tymp.
The device is immediately ready to measure and the set or
automatically set parameters (chapter 4.4) are used for the
following measurements. The ipsilateral measurement of the
stapedius reflex is automatically activated as a standard.
35
4.0
Operation
4.7.3.3
36
4.0
Operation
When all the measurements are completed the curve of the
tympanogram and the stapedius reflex measurement are
shown and the compliance, peak and the volume are diagrammed.
Tympanogram
37
4.0
Operation
4.7.4.2 Commencing the measurement
The measurement starts with a normal clinical impedance
meter without any reflex part.
Afterwards the patient has to perform the valsalva manoeuvre
(Valsalva manoeuvre is performed by moderately forceful
attempted exhalation against a closed airway, usually done by
closing one's mouth and pinching one's nose shut).
For the third part of the measurement the patient is asked to
swallow this is the last performed measurement.
During the measurement sequence the manual switch over
from "Tymp" to "Valsalva" and finally to "Swallow" is important.
After completion of the measuring sequence the curves for the
3 tympanograms for the right and the left ear are shown and
the values for compliance, peak and the volume are shown in
a table.
The proceddings for printing out, recording and the possibility
to enter comments are identical like in chapter 4.7.3.3.
38
4.0
Operation
4.7.5 Loading of stored
measurements ATMOS Tymp 31
Depending on the equipment and the system configuration all
saved measurements can be displayed again. If integration
into the practice PC system has been done, a measurement
can be opened in the patient file by a click on the entry.
Without integration, with a click on the button Load on the
software surface all patient-related measurements will be
displayed in chronological order. With a click on the ok button
the measurements are shown on the screen.
39
5.0
if
necessary
Disconnect the power cord from the mains prior to cleaning and disinfection of the device surface.
The unit itself can be wiped off with a moist (not wet) cloth.
The surfaces of the ATMOS Diagnostic Cube can be cleaned / disinfected with products of the following active irgredients:
QAV (quartanary ammonium compounds)
Do not use
Disinfectants containing concentrated organic or anorganic acids or bases, since these may cause corrosion damages.
Disinfectants containing chloramides or phenol derivatives since these may cause stress cracks in the material used for
the housing of the unit.
Discolouration may result if disinfectants containing aldehydes and amines are used on the same object.
After each measurement all parts which have come into direct contact with the patient must always be cleaned and
disinfected (ATMOS Green & Clean MK or ATMOS Green & Clean SK). In addition the filters in the adapters for the
rhinomanometry must be exchanged. All parts which are marked as single-use products (filter) may not be reused (see
chapter 5.3 "Cleaning and disinfection plan")!
After reporcessing all parts have to pass through visual inspection with regard to any residues or any contamination.
40
5.0
Disinfection
Who
Monthly
Cleaning
Recommendations
Weekly
When
Daily
Parts to be reprocessed
How
After each
procedure
What
ATMOS Rhino 31
Test block
Measuring olive
X
X
Nose adapter
Annular diaphragm
spiroceptor
Hose system
X
X
X
X
X
X
single-use product
single-use product
ATMOS Sono 31
Ultrasonic probe
ATMOS Tymp 31
Handle
Ear plugs
X
X
Manual cleaning and disinfection: immerse in cleaning and disinfectant solution; pay attention to the manufacturer`s instructions regarding the duration of
effect. Rinse with demineralized water, if necessary clean the hollow spaces with a small brush.
Recommended disinfectants
Surface disinfection
for coated surfaces:
Other surfaces:
Tested:
Green & Clean SK (ATMOS)
Experience with:
Dismozon pur (Bode Chemie)
Kohrsolin FF (Bode Chemie)
Perform (Schlke & Mayr)
Terralin Protect (Schlke & Mayr)
Dismozon pur (Bode Chemie)
Kohrsolin FF (Bode Chemie)
Bacillocid rasant (Bode Chemie)
Mikrobac forte (Bode Chemie)
Perform (Schlke & Mayr)
Terralin Protect (Schlke & Mayr)
Surface disinfectant FD 312 (Drr Dental)
Quick disinfection B 30 (Orochemie)
Machine disinfection of instruments:
Dismoclean 28 alka one (Bode Chemie)
Dismoclean twin basic/twin zyme (Bode Chemie)
Thermosept alka clean forte (Schlke & Mayr)
Thermosept RKN-zym (Schlke & Mayr)
For concentrations, contact time, temperature, material compatibility, please see the relevant information from the
manufacturer.
The above stated hygiene requirements are based on the regulations according to the Medical Devices Act, the Medical Devices Operator Ordinance, 18 IfSG and the recommendations of the Robert
Koch Institute.
Definition of the required reprocessing steps result from the recommendations of the Robert Koch Institute: Requirements for the reprocessing of medical products. The medical products were categorised in the risk groups uncritical, semicritical and critical. The reprocessing steps stated in this diagram have to be performed. Any additional reprocessing measures are at the operators discretion.
All the recommended disinfectants which are stated herein are listed disinfectants (VAH/RKI) and have been tested on their suitability of use on the ATMOS Diagnostic Cube ATMOS MedizinTechnik
cannot be hold liable for any damage caused by wrong concentration of the disinfectants or by the application of any other disinfectants.
Patients with suspicion of a clinical disease or who developed a transmissible spongiform encephalopathy (CJK, vCJK, etc.) have to be treated at facilities which are able to provide for the necessary
preventive measures against infection. The reprocessing of the reusable instruments and material may only be performed at facilities which have an externally certified QM Management acc. to DIN
EN ISO 13485/13488.
The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250 always have to be considered.
41
6.0
6.1
42
7.0
Troubleshooting
Description
Possible reasons
Measures
Start-up software
ATMOS Tymp 31
connection has any leakage (ear plugs)
ATMOS Tymp 31
probe must be applied either at the bottom of the ear canal or the upper part of
the ear canal.
Incomplete measurement
The already opened measuring programme is started a second time via the
iHandle.
For any other malfunctions please switch-off the diagnostic software and disconnect the ATMOS Diagnostic Cube immediately
from the power supply. Contact the Customer service of the manufacturer.
43
7.0
Troubleshooting
7.1
44
7.0
Troubleshooting
7.1.2 Windows XP
Please activate system control Windows XP and with a double
click on system you will get to the system properties.
45
8.0
512.1054.0
512.1058.0
512.1055.0
512.1059.0
512.1056.0
512.1060.0
105.2014.5
105.2012.5
ATMOS Tymp 31
Contra lateral headset
512.1120.0
Included in delivery:
Headset and connection set
Integration accessories diagnostic room / treatment unit
iHandle support for handle with automatic switching
Specification:
Automatic software control if the relevant measuring probe is removed from the
support.
Built-in sensors in the probe supports, USB control electronics in additional
casing
Medical Touch Screen PC
Windows PC with touchscreen
512.0500.0
512.1400.0
Included in delivery:
Touch Screen PC 17", power supply, IEC mains cable, operating instructions
Technical data:
100240 V, 50/60 Hz
Intel Core 2 duo mobile 2.2 GHz
2 GB memory, 500 GB HDD
Microsoft Windows 7 Pro 32-bit / 64-bit
english
Integration in the existing practice software
via GDT interface
Support arm for integration into ATMOS S 61 Servant
Support arm for monitor/PC via VESA adapter
Technical data:
Maximum load-bearing capacity 25 kg
Support arm for integration into ATMOS C 21 /C 31/ Servant 5
Support arm for monitor/PC via VESA adapter
Technical data:
Maximum load-bearing capacity 25 kg
46
512.1500.0
512.1300.0
512.1350.0
8.0
512.1030.0
512.1040.0
512.1061.0
512.1062.0
512.1063.0
ATMOS Sono 31
Ultrasonic contact gel
507.0603.1
bottle 250 ml
ATMOS Tymp 31
Set of earplugs
512.1120.0
24 different earplugs
(5 pieces of size 2, 3, 4, 5 plus 2 pieces of size 1 and 6)
1 x cleaning filament
312.1031.0
Spare parts
Rhino Measuring probes
Measuring probe with measuring olives
512.1020.0
Included in delivery:
Measuring probe with connecting hose,
measuring olives in 3 sizes, 1 pair of each size,
set of filter plates (50 x large, 50 x small) REF 512.1030.0
Measuring probe with nose mask for adults
512.1010.0
Included in delivery:
Measuring probe with connecting hose, nose adapter,
nose mask large, filter plates (50 x large) REF 512.1040.0
47
9.0
Technical specications
12 V DC, max. 5 A
Current consumption
power supply
max. 60 W
Fuses
Power cable
Device variations
Interfaces
System requirements PC
48
PC software in general
ATMOS Rhino 31
ATMOS Sono 31
- Ultrasonic A-mode
- Pulse frequency ultrasonic probe 100 Hz
- Probe measuring frequency 3.5 MHz
- Transmitting performance: 0.06 mW/cm
- Amplification setting: 80dB
- Switching between the depth ranges 8 and 4 cm within the
automatic measuring sequence control or manually
- Permanent 4-picture presentation
- Comment line (diagnosis and finding/measurement picture)
9.0
Technical specications
ATMOS Tymp 31
Support arm
Operating time
Continuous operation
max. 0.1
max. 0.5 mA
max. 0.1 mA
max. 0.1 mA
Ambient conditions
Transport/storage
-10+50C
30.95% air humidity without condensation at air pressure 5001060 hPa
Operation
+10.+35C
Dimensions: HxWxD
Diagnostic Cube
Power Supply
35 x 60 x 120 mm
Support arm
Weight
Diagnostic Cube
Power supply
Foot switch
Support arm (w/o equipment)
II, protective ground wire connection of power supply only for EMC protection
Degree of protection
Protection type
IP X0
Class IIa
CE marking
CE 0124
GMDN code
UMDNS code
Ident No.
512.0000.0
512.1000.0 (ATMOS Rhino 31)
512.1200.0 (ATMOS Sono 31)
512.1100.0 (ATMOS Tymp 31)
49
10.0 Disposal
The ATMOS Diagnostic Cube is not comprised of any hazardous materials.
The materials of the housing can be recycled completely.
Prior to disposal, device and accessories must be decontaminated.
The materials are to be separated carefully.
Pay attention to country-specific regulations for disposal (e. g. waste incineration).
Disposal within the EC
The device is a high-quality medical product with a long service life. After its life cycle it must be disposed of professional.
According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please observe
existing national laws and rules for disposal of old devices.
Disposal within the Federal Republic of Germany
In the Federal Republic of Germany the law for electrical devices (ElektroG) rules the disposal of electrical devices. It must
be assumed that those devices could be contaminated. Therefore, this type of device is excluded from the law for electrical
devices. In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional disposal.
Prior to disposal respectively before transport all hoses must be removed. The device surface must be disinfected.
50
Emissions Test
Compliance
RF Emissions
CISPR 11
Group 1
RF Emissions
CISPR 11
Class B
Class A
Flicker
IEC 61000-3-3
match
Compliance Level
ESD
IEC 61000-4-2
6 kV Contact
6 kV Contact
8 kV Air
8 kV Air
EFT
IEC 61000-4-4
2 kV Mains
1 kV I/Os
2 kV Mains
inapplicable
1 kV I/Os
Surges
IEC 61000-4-5
1 kV Differential
2 kV Common
1 kV Differential
2 kV Common
Power Frequency
50/60 Hz
Magnetic field
IEC 61000-4-8
3 A/m
applicable
3 A/m
Immunity Test
51
NOTE
Compliance Level
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
40 % UT
(60% Dip of the UT)
for 5 Cycles
40 % UT
(60% Dip of the UT)
for 5 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
< 5 % UT
(>95 % Dip of the UT)
for 5 s
< 5 % UT
(>95 % Dip of the UT)
for 5 s
Immunity Test
Conducted RF
IEC 61000-4-6
V1 = 3 Veff
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
E1 = 3 V/m
80 MHz to 2,5 GHz
Compliance Level
3V
3 V/m
Recommended distances:
d = [ 3,5 / V1] P
d = [ 3,5 / E1 ] P
80 MHz to 800 MHz
d = [ 7,0 / E1 ] P
800 MHz to 2500 MHz
where P is the max. power in watts (W)
and D is the recommended separation
distance in meters (m).
Field strengths from fixed transmitters, as
determined by an electromagnetic site (a)
survey, should be less than the compliance level (b).
Interference may occur in the vicinity of
equipment containing following symbol.
52
With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.
The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio
equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly.
To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to
be considered. If the measured field strength at the location where the ATMOS Diagnostic Cube is used
exceeds the above compliance level, the ATMOS Diagnostic Cube is to be observed to verify the intended
use.
If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed
arrangement or another location for the device.
Within the frequency range of 150 kHz to 80 MHz the field strength is to be below 3 V/m.
d = [ 3,5 / 3] P
d = [ 3,5 / 3] P
d = [ 7,0 / 3] P
0.01
0.12
0.12
0.233
0.1
0.37
0.37
0.74
1.16
1.16
2.33
10
3.69
3.69
7.38
100
11.66
11.66
23.33
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended
separation distance d in meters (m) can be determined using the equation belonging to the respective column
whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturers specification.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.
53
MedizinTechnik
1. General:
terms and conditions which are contrary to or deviate from our General
Standard Terms and Conditions are not recognised unless their validity
the goods
7. Delivery - Familiarisation
which require assembly and/or familiarisation for the final customer using
specialist trade personnel (such as Ear, Nose and Throat Apparatus and
the relevant specialist traders. Should the trader not carry out assembly
and/or familiarisation for the final customer, this is carried out by us. In
until the cheque received by us has been paid in, and does not expire
such cases, we reserve the right to charge the client for the additionally
through our credit upon receiving the clients cheque. In the case of
3. Orders
that, if necessary, our products can be traced to the final customer. The
us. We have the right to utilise the product after its repossession, whilst
4. Prices
handling the goods with care. Should maintenance and inspection work
the income form such use is balanced against the clients arrears, after
Unless otherwise stated in the order confirmation, our prices in the
be necessary, the client must carry these out punctually at his own cost.
to the client as soon as the goods leave the factory or the client is in
Our client is entitled to sell the goods he has bought from us in a proper
to the legal rate on the invoice date. We reserve the right to change
claims to the value of the final invoice sum (including value added tax)
responsible for disposing the packaging at its own cost. Our deliveries are
collect this claim even after such assignment. Our right to collect the
client on request.
our clients. In the case of transport damage, claims are only handled if
client should the realisable value of the our securities be more than 10
are payable with a 3% discount within 10 days (except for repair and
assembly services) or within 21 days from the invoice date net cash;
9. Warranty
money receipts is decisive for complying with this term. We are entitled
to charge interest after the due date at a rate 2% above the relevant
basic interest rate of the German Federal Bank. Should the client have
The client must receive explicit written permission before passing these
5% above the relevant basic interest rate of the German Federal Bank.
entitled to claim these. The client only has the right to balance invoices
years. Our client can make use of the warranty as follows, so long as
he can provide first buyer proof (in the form of an invoice or delivery
law or recognised by us. The client does not have the right of retention
note) and provided that the product still has the original, unchanged
serial number:
6. Delivery Periods
the contracts closed with clients under them. This jurisdiction excludes
We, however, are entitled to bring charges against our client at their
notified by us.
costs incurred up to that time without setting a further deadline. The right
to make further claims is reserved. Furthermore, in such cases, the risk
79853 Lenzkirch/Germany
partly or entirely dissolve the delivery contract. This does not give the
client the right to claim damages. We have fulfilled delivery periods if the
delivery goods have left our factory or the client has been informed of
the goods readiness for delivery within such delivery periods. Delivery
by us unless they
for which we are liable, the client is entitled to claim that his interests
approved;
vibrations.
for that case. We are liable according to the legal terms and conditions if
and in so far as the delivery delay for which we are responsible is caused
other objects apart from our product itself, except in the case of any
This document is copyrighted. Duplication, translations, microfilming and savings on electronic systems, particularly for commercialpurposes
are illegal without prior agreement of the manufacturer. All compiled data are based on manufacturers instructions. All logos,
product names and designations used in this document are property of the respective manufacturer.
We do not take over any warranty and liability in the case of missing inscriptions. Subject to modifications and amendments.