Reader Unit for Telemetrical Shunt Sensor Instructions for Use FV900X March 2011.pdf
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Aesculap Neurosurgery
Instructions for use/Technical description
Reader unit for telemetrical Shunt Sensor
Gebrauchsanweisung/Technische Beschreibung
Lesegerät für telemetrischen Shuntsensor
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Aesculap Neurosurgery
Reader unit for telemetrical Shunt Sensor
Legend
Symbol
ON/OFF switch
2 Display
3 Antenna socket
4 Antenna
5 SD card slot
6 Function keys
7 Connector socket for power supply
8 Connector (for reader unit)
9 Control lamp
10 Power supply
Explanation
1
Symbols on product and packages
Symbol
Explanation
Caution, general warning symbol
Caution, see documentation supplied with the product
Follow the instructions for use
Non-ionized radiation
Labeling of electric and electronic devices according to
Directive 2002/96/EC (WEEE), see Chapter Disposal
ON/OFF switch
Function key
The options on the display can be selected by using the
4 function keys
IP44
IP44
Housing protection class to DIN EN 60529
Reader unit FV900X
Power supply FV902X
Protection class II (protective insulation)
(Power supply FV902X only)
Antenna symbol
Socket for antenna
SD card
SD card slot
2
DCIN socket for power supply
Contents
1.
2.
2.1
2.2
2.2.1
2.2.2
2.3
2.4
2.4.1
3.
3.1
3.2
3.2.1
3.2.2
3.3
3.4
3.4.1
3.4.2
3.4.3
3.4.4
3.4.5
4.
4.1
4.2
4.3
4.4
4.4.1
4.5
4.6
5.
5.1
6.
6.1
6.2
7.
8.
8.1
9.
10.
11.
12.
Safe Handling ................................................................................................ 3
Product Description ..................................................................................... 3
Reader unit System Components............................................................. 3
Intended Use.................................................................................................. 3
Indications...................................................................................................... 4
Contraindications ......................................................................................... 4
Operating Principle ...................................................................................... 4
Symbols ........................................................................................................... 4
Display Symbols ............................................................................................ 4
Using the reader unit .................................................................................. 5
System Set-Up .............................................................................................. 5
Connecting the Power Supply .................................................................. 5
Connecting the Antenna ............................................................................ 6
Inserting the SD Card.................................................................................. 6
Function Checks............................................................................................ 6
Operation ........................................................................................................ 7
General Operating Instructions ................................................................ 7
Info Menu....................................................................................................... 8
Taking Measurements ................................................................................. 9
Managing Data/Displaying Measurements........................................ 12
Settings ........................................................................................................ 16
Validated Reprocessing Procedure ....................................................... 21
General Information ................................................................................. 21
Preparations at the Place of Use........................................................... 21
Cleaning/Disinfection............................................................................... 21
Manual Cleaning/Disinfection ............................................................... 22
Wipe Disinfection for Electrical Devices Without Sterilization ... 22
Inspection .................................................................................................... 22
Storage ......................................................................................................... 22
Maintenance/Calibration ........................................................................ 23
Calibration of BARD Sensor.................................................................... 23
Troubleshooting ......................................................................................... 24
Malfunctions Displayed with an Error Message............................... 24
Other Malfunctions................................................................................... 27
Technical Service ....................................................................................... 28
Technical Data............................................................................................ 28
Ambient Conditions .................................................................................. 29
CE Marking.................................................................................................. 29
Storage and Transport.............................................................................. 29
Disposal ........................................................................................................ 29
Distributor in the US/Contact in Canada for product information
and complaints........................................................................................... 29
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1. Safe Handling
DANGER
WARNING
Risk of contamination if the reader unit or
antenna is not used correctly in the surgical environment!
¾ Caution with sterile and non-sterile areas.
Risk of injury due to incorrect operation of the
product!
¾ Attend appropriate product training before
using the product.
¾ For information regarding such training, please
contact your national B. Braun/Aesculap
agency.
¾ Clean the new product thoroughly after removing from the transport
packaging, see Chapter Manual Cleaning/Disinfection.
¾ Ensure that the product is in perfect condition and fully functional
prior to use, see Chapter Inspection.
¾ Observe the "Notes on Electromagnetic Compatibility (EMC)", see
TA022130.
¾ To prevent damage as a result of incorrect installation or operation,
and in order not to compromise warranty and manufacturer liability:
– Use the product only as specified in these instructions for use.
– Observe all safety information and maintenance instructions.
– Use only Aesculap products in combination, see Chapter Reader unit
System Components.
¾ Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
¾ Keep the instructions for use accessible to the user.
2. Product Description
2.1 Reader unit System Components
Description
Product no.
Reader unit shunt sensor
FV900X
Antenna reader unit shunt sensor
FV901X
Power supply reader unit shunt sensor
FV902X
2.2 Intended Use
The reader unit is used together with the telemetric sensor in shunt function diagnostic tests and permits reliable and non-invasive detection and
localization of occlusions in ventricular drainage systems (with no intervention or X-ray diagnostics) as well as identification of mechanical damage to shunt valves.
Fig. 1
The working distance for telemetric data transfer, i.e. the distance
between antenna and shunt sensor, is 10-30 mm, see Fig. 1.
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Reader unit for telemetrical Shunt Sensor
2.2.1
Indications
• Functional diagnosis of implanted ventricular drainage systems
(shunts)
• Detection and localization of occlusions in ventricular drainage systems
• Checking of shunt valve function
2.2.2
•
•
•
•
Contraindications
Intracranial pressure measurement
Intracranial pressure management based on measured values
Intracranial pressure measurement without shunt
Functional diagnosis of extracorporeal liquor drainage systems (traumatic brain injury)
2.3 Operating Principle
The telemetric system is used to measure liquor pressure levels, the characteristics or relative time-dependent modification of which permit conclusions to be made regarding the function of an implanted ventricular
drainage system. Diagnostic methods can be used to provoke and subsequently interpret a change in the level of pressure in the shunt. Using the
reader unit, the data measured by the shunt sensor can be retrieved and
displayed. The measured data are saved automatically on the SD card and
can thus be analyzed at a later point. Based on the relative course of the
liquor pressure in the shunt, conclusions can be drawn as to its function.
As a result, it is possible to identify and localize any occlusion in the shunt
as well as a loss of mechanical function in the shunt valves using noninvasive methods.
Starts measurement
Stops the present measurement
For deleting a saved measurement in the menu <Data
management>
For placing a marker during continuous measurement
To call up the diagram processing menu
To activate the zoom function
To activate the cursor function
For adjusting the presentation of the min. and max. values of the pressure axis
For returning to the diagram processing menu
For returning to the diagram processing menu
Navigate forward
Navigate backward
On
Off
2.4 Symbols
Confirm
2.4.1
Display Symbols
Display symbols
For displaying additional information or starting with the
info menu
For starting with the selection menu
Fast measurement - Fast measurement can be quickly
started without having to select further options
Upward navigation of the cursor
Downward navigation of the cursor
For quitting the current menu
Activates or confirms the selected function
4
For maximizing the display of a sequence in the menu
<Data management>
For minimizing the display of a sequence in the menu
<Data management>
For deactivating the acoustic signal
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3. Using the reader unit
DANGER
WARNING
WARNING
WARNING
CAUTION
CAUTION
Risk of contamination if the reader unit or
antenna is not used correctly in the surgical environment!
¾ Caution with sterile and non-sterile areas!
Limited accuracy and no storage of measured data
if operated without the SD card!
¾ Insert the SD card designated for use with the
shunt sensor into the reader unit.
¾ The SD card designated for use with the
implant (see patient pass) is recognizable by its
identification number (ID).
¾ Measured data can be saved only on the designated SD card.
Unexpected termination of measurement if the SD
card is full!
¾ Check the available memory prior to starting
measurement.
¾ Delete any data that are no longer needed.
Danger from use of MRI!
¾ Only operate the reader unit outside of the
MRI field of use!
The reader unit cannot be operated if the battery
status is low!
¾ Check the battery status.
¾ If the battery is low, connect to the power supply.
Note
If the temperature of the telemetrical sensor is below 19°C, it is necessary
to fall back on the "Measurement without SD Card".
Operation will take place with less precision and it is not possible to save
measurement data.
The following error messages occur during measurement with the SD card:
– During a long-term measurement: Pressure values invalid,
measurement will continue
– During an individual or collective measurement: Temperature values
invalid, measurement will not continue
For a more detailed description of errors, see Troubleshooting
3.1 System Set-Up
The reader unit is equipped with a battery which, when fully charged, permits wireless operation for up to 5 hours. The battery must be charged
when first installing the device.
The power supply is used for charging the reader unit battery. It takes
about 6 hours to fully charge the battery. The reader unit can also be operated while it is being charged (with connected power supply).
Note
Charging is not possible at an ambient temperature of >35 °C!
3.2 Connecting the Power Supply
DANGER
Damage to the reader unit from incorrect accessories and/or risk to the safety of user and patient!
¾ Use only the original power supply belonging to
the reader unit shunt sensor (FV902X).
The mains voltage must be consistent with the voltage range stated on the
label of the power supply for the reader unit shunt sensor.
Communication poor or non-existent!
The telemetric link between the reader unit and
implant may be disrupted by the operation of a
further scanning device.
¾ Increase the distance between the scanning
devices.
¾ The telemetric link between the antenna and
implant may be disrupted by a further implant
in the vicinity of the antenna. Increase the distance between the implants.
¾ The telemetric link between the antenna and
implant may be disrupted by metal components
in the vicinity of the implant. Increase the distance from metal components!
Fig. 1
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Reader unit for telemetrical Shunt Sensor
¾ Insert the power supply connector of the device into the connector
socket of the reader unit, see Fig. 1.
¾ Connect power supply by inserting into a wall socket.
3.2.1
Connecting the Antenna
¾ Insert the SD card designated for use with the relevant shunt sensor
(see patient pass) into the reader unit until it locks in firmly, see Fig. 3.
Note
Press the card lightly to remove.
3.3 Function Checks
¾ Check that the entire unit is in good condition and fully functional
prior to each use.
¾ To check the battery status, check the function without using the
power supply.
¾ Ensure that the device and antenna used for the function check are not
visibly damaged.
¾ Check the function of the following components in the given order:
– Activate the ON/OFF switch
.
– Automatic self-test after activation, including display and volume
The following screen content is displayed in chronological order:
Fig. 2
¾ Connect antenna to reader unit, see Fig. 2.
3.2.2
Inserting the SD Card
Damage to SD card if not used correctly!
¾ Do not touch the contact strips of the SD card.
CAUTION
Fig. 3
6
Fig. 4
¾ Check battery status, connect reader unit to mains power supply if
necessary to charge the battery.
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The following is displayed on the screen when operating the reader unit
with mains supply:
Fig. 5
Legend
A Display during power supply operation of reader unit
Note
The control lamp of the reader unit power supply must be illuminated!
¾ Check system time, correct if necessary, see Chapter Settings.
¾ Activate the ON/OFF switch
.
3.4 Operation
Fig. 6
Legend
A Date
B Time
C SD card
D Memory map (on SD card)
E Battery status
F Info key
G Fast measurement
H Menu key
¾ Activate reader unit with ON/OFF switch
.
Start screen content is displayed, see Fig. 6.
3.4.1
General Operating Instructions
Menu-controlled operation of the device is facilitated by a total of
4 function keys .
The context-related function of these soft keys is indicated by the symbols
shown on the display for each of the keys.
The exact meaning of the symbols is explained in the list "Display symbols".
The pre-selected submenu is highlighted within a frame. For improved
navigation, the position currently selected in the submenu is highlighted
by a scroll bar in addition to the frame. The keys
and
are used for standard operation.
Note
When the reader unit is not in use it switches into standby-mode. Depending on the setting: 1-5 minutes.
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Reader unit for telemetrical Shunt Sensor
3.4.2
Info Menu
The following information can be retrieved from the info menu:
• Hotline & Service
• System specifications
• Manufacturer specifications
¾ To reach the Info menu, press
.
The following information is displayed on the screen, see Fig. 7.
Content of 3 submenus:
hotline & service
Hotline & Service
Phone: +49 7461 95-1601
system details
product name:
article number:
serial number:
software version:
service date:
Shunt Sensor reader unit
FV900X
00001
2.0
14.12.2011
manufacturer info
manufacturer
Aesculap AG
Am Aesculap-Platz
78532 Tuttlingen
Germany
Fig. 7
Legend
A Pre-selected submenu
B Scroll bar
Using the keys
and
, the desired submenu can be pre-selected
and confirmed by pressing
.
Return to the previous menu by pressing
.
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3.4.3
Taking Measurements
• Fast measurement
Here, the sequence of unaveraged single measurements at the max.
available measurement rate (approx. 40 measurements per second) is
displayed in a time diagram and saved to the SD card.
Fig. 8
¾ To reach the submenu, press
.
The following information is displayed on the screen:
Single measurement:
Fig. 9
¾ To reach the measurement menu, press
.
The following information is displayed on the screen:
Fig. 11
¾ Start a single measurement by pressing
.
¾ Return to the Selection menu by pressing
.
During single measurement, the following information is displayed on
the screen.
Fig. 10
There are three types of measurement:
• Single measurement
The mean of 8-10 measurements is displayed and saved to the SD card.
• Continuous measurement
Here, the sequence of single measurements at the selected measurement intervals is displayed in a time diagram and saved to the SD card.
¾ Use
to select the single measurement menu.
The following information is displayed on the screen:
Fig. 12
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Reader unit for telemetrical Shunt Sensor
Continuous measurement:
¾ Select the continuous measurement menu by pressing the keys
and
, and confirm by pressing
.
The following information is displayed on the screen:
Symbols for reception quality
Symbol
Explanation
Communication started
Distance antenna to measuring unit good
Distance antenna to measuring unit small - increase distance
Distance antenna to measuring unit too far - reduce distance
Fast measurement
There are two ways to start fast measurement:
¾ Press the
key on the start screen and then start measurement
with the
key.
- or ¾ By pressing the
key, the following submenu appears.
Fig. 13
¾ Start continuous measurement by pressing
.
¾ Return to the selection menu by pressing
.
The following information is displayed on the screen:
Fig. 15
¾ To reach the measurement menu, press
.
¾ Select the fast Measurement menu by pressing the keys
, and confirm by pressing
.
Fig. 14
Legend
A Symbol for reception quality
¾ A marker can be placed by pressing
.
¾ Multiple markers can be placed during one measurement.
¾ Stop measurement by pressing
.
Note
The markers permit circumstantial analysis of the measured data.
10
and
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During fast measurement, the following information is displayed on
the screen:
Fig. 16
¾ The following information is displayed on the screen:
Fig. 18
Legend
A Symbol for reception quality
¾ Stop measurement by pressing
.
Symbols for reception quality
Symbol
Explanation
Communication started
Distance antenna to measuring unit good
Fig. 17
¾ Start fast measurement by pressing
.
¾ Return to the selection menu by pressing
Distance antenna to measuring unit small - increase distance
.
Distance antenna to measuring unit too far - reduce distance
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Reader unit for telemetrical Shunt Sensor
3.4.4
Managing Data/Displaying Measurements
¾ By pressing
on the start screen, the following submenu appears:
Fig. 19
¾ Select the data management menu by pressing the keys
, and confirm by pressing
.
and
The data files are listed chronologically (time of starting measurement)
and displayed as follows:
Fig. 21
¾ Select the desired file by pressing the keys
firm by pressing
.
The files are labeled as follows:
Symbol
and
, and con-
Explanation
Single measurement
Continuous measurement
Fast measurement
Note
When loading a continuous or fast measurement, an hour glass appears
and the loading time is displayed in seconds.
Fig. 20
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Single measurement
Fig. 22
¾ The data file can be deleted by pressing
Fig. 23
¾ Deletion must be confirmed by pressing
shown above by pressing
.
¾ Return to the selection menu by pressing
Continuous measurement
Fig. 24
¾ The measurement can be deleted by pressing
. Deletion must be
confirmed by pressing
. Return to the screen shown above by
pressing
.
¾ Return to the selection menu by pressing
.
¾ By pressing
, the diagram processing menu appears.
The following information is displayed on the screen
.
. Return to the screen
.
Fig. 25
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Reader unit for telemetrical Shunt Sensor
¾ By pressing
, the zoom menu appears.
Fig. 26
The
and
keys enable the display of a measurement sequence
to be expanded or compressed (zoom).
¾ Return to the diagram processing menu by pressing
.
¾ Return to the main display for continuous measurement by pressing
.
¾ By pressing the
key in the diagram processing menu, the following screen appears:
¾ By pressing the
ing screen appears:
Fig. 28
Legend
A Cursor
¾ Keys
and
can be used to adjust the max. and min. scale
values at the cursor position. Using the
key, the cursor can be
switched between maximum, minimum and automatic. If the "automatic" function is selected ( ), the axes are scaled automatically in
line with the measured data. If the "automatic" function is selected
( ), the max. and min. value setting becomes irrelevant.
¾ Return to the display of measured values by pressing
.
Fast measurement
Fig. 27
¾ Return to the diagram processing menu by pressing
.
¾ The
or
keys enable the time axis to be shifted to the left
and right, respectively.
¾ Return to the main display for continuous measurement by pressing
.
Fig. 29
14
key in the diagram processing menu, the follow-
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¾ The measurement can be deleted by pressing
. Deletion must be
confirmed by pressing
. Return to the screen shown above by
pressing
.
¾ Return to the selection menu by pressing
.
¾ By pressing
, the diagram processing menu appears. The following information is displayed on the screen:
Fig. 30
¾ By pressing
, the zoom menu appears.
Fig. 31
¾ The
and
keys enable the display of a measurement
sequence to be expanded or compressed (zoom).
¾ Return to the diagram processing menu by pressing
.
¾ Return to the main display for continuous measurement by pressing
.
Note
Switching between displays can take a few seconds, depending on the file
size.
¾ By pressing the
ing screen appears:
key in the diagram processing menu, the follow-
Fig. 32
¾ Return to the diagram processing menu by pressing
.
The
or
keys enable the time axis to be shifted to the left
and right, respectively.
¾ Return to the main display for continuous measurement by pressing
.
¾ By pressing the
key in the diagram processing menu, the following screen appears:
Fig. 33
Legend
A Cursor
¾ Keys
and
can be used to adjust the max. and min. scale
values. Using the
key, the cursor can be switched between maximum, minimum and automatic.
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Reader unit for telemetrical Shunt Sensor
¾ If the "automatic" function is selected ( ), the axes are scaled automatically in line with the measured data. If the "automatic" function
is selected ( ), the max. and min. value setting becomes irrelevant.
¾ Return to the display of measured values by pressing
.
3.4.5
The following information is displayed on the screen:
Settings
¾ By pressing
on the start screen, the following submenu appears:
Fig. 36
Date/time
¾ To display the date/time menu, press
.
The following information is displayed on the screen:
Fig. 34
¾ Select the settings menu by pressing the keys
Fig. 35
¾ To display the settings menu, press
.
and
.
Fig. 37
Legend
A Cursor
¾ The position of the cursor can be moved by pressing
.
¾ Using the keys
and
, the values at the position of the cursor
can be amended.
¾ Return to the display of measured values by pressing
.
Note
Modified values are saved immediately.
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Measurement interval
Units
¾ Select the units menu in the settings menu using the keys
.
and
Fig. 38
¾ To display the units menu, press
.
The following information is displayed on the screen:
Fig. 39
¾ Select the desired unit using the keys
pressing
.
¾ Return to the settings menu by pressing
and
.
These settings function only in the continuous measurement mode.
¾ Select the measurement interval menu in the settings menu using the
keys
and
.
Fig. 40
¾ To reach the measurement interval menu, press
.
The following information is displayed on the screen:
, and confirm by
Fig. 41
¾ Select the desired measurement interval using the keys
, and confirm by pressing
.
The available settings are 1-300.
The available memory map on the SD card is also displayed.
¾ Return to the settings menu by pressing
.
and
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Reader unit for telemetrical Shunt Sensor
Measurement display
Language
¾ Select the display data menu in the settings menu using the keys
and
.
¾ Select the language menu in the settings menu using the keys
and
.
Fig. 42
¾ To reach the display data menu, press
.
The following information is displayed on the screen:
Fig. 44
¾ To reach the language menu, press
.
The following information is displayed on the screen.
Fig. 43
¾ The measurement display can be selected by pressing
¾ Return to the settings menu by pressing
.
18
or
.
Fig. 45
¾ Select the preferred language using the keys
confirm by pressing
.
¾ Return to the settings menu by pressing
.
and
, and
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Volume
¾ Select the volume menu in the settings menu using the keys
.
Standby-mode
and
¾ Select the standby-mode menu in the settings menu using the keys
and
.
Fig. 46
¾ To reach the volume menu, press
.
The following information is displayed on the screen:
Fig. 48
¾ To reach the standby-mode menu, press
.
The following information is displayed on the screen:
Fig. 47
¾ Select the desired volume using the keys
and
, and confirm
by pressing
.
The available settings are 1-5. An acoustic signal will be emitted as the
volume is changed.
¾ Return to the settings menu by pressing
.
Fig. 49
¾ Select the preferred time at which the reader unit should switch into
standby-mode using the keys
and
and confirm by pressing
.
The available settings are 1-5 minutes.
¾ Return to the settings menu by pressing
.
Note
The setting determines the volume of the warning signals. Warning signals
are, as a rule, emitted at volume level 5.
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Brightness
Contrast
¾ Select the brightness menu in the settings menu using the keys
and
.
¾ Select the contrast menu in the settings menu using the keys
and
.
Fig. 50
¾ To reach the brightness menu, press
.
The following information is displayed on the screen:
Fig. 52
¾ To reach the contrast menu, press
.
The following information is displayed on the screen:
Fig. 51
¾ Select the desired brightness of the background illumination using the
keys
and
, and confirm by pressing
.
The available settings are 000-100 (in increments of 5).
¾ Return to the settings menu by pressing
.
Fig. 53
¾ Select the desired contrast of the display using the keys
, and confirm by pressing
.
The available settings are 000-100 (in increments of 5).
¾ Return to the settings menu by pressing
.
20
and
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4. Validated Processing Procedure
4.2 Preparations at the Place of Use
¾ Remove any visible surgical residues to the extent possible with a
damp, lint-free cloth.
Note
Adhere to national statutory regulations, national and international standards and directives, and local hygiene instructions for processing procedures.
Note
Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net
Note
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing procedure. This is the responsibility of the operator/technician.
Due to process tolerances, the manufacturer’s specifications can only serve
as an approximate guide for assessing the processing procedures applied by
the individual operator/technician.
4.3 Cleaning/Disinfection
DANGER
CAUTION
4.1 General Information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion of stainless steel. To avoid this, the time
interval between application and processing should not exceed 6 h, and
neither fixating pre-cleaning temperatures >45°C nor any fixating disinfectants (active ingredients: aldehyde, alcohol) used.
Only use process chemicals which have been tested and approved (e.g.
VAH/DGHM or FDA-certified or CE marking), and recommended by the
chemical manufacturer as being compatible with the given materials. All
the chemical manufacturer's application specifications regarding temperature, concentration and contact time should be strictly observed. Failure
to do so may result in the following problems:
• Optical deterioration, e.g. fading or discoloration of titanium or aluminum surfaces. As regards aluminum, visible surface changes may occur
if the application/working solution has a pH level of >8.
• Material damage such as corrosion, cracks, fractures, premature deterioration or swelling.
Please see www.a-k-i.org for more detailed information on hygienically
safe reprocessing methods which serve to protect the materials as well as
retain their value.
CAUTION
Risk of electric shock and fire!
¾ Disconnect from the mains before cleaning.
¾ Do not use flammable or explosive detergents
or disinfectants.
¾ Ensure that no fluids can infiltrate the product.
Damage to, or destruction of the product caused
by mechanical cleaning/disinfection!
¾ Only clean and disinfect the product manually.
¾ Never sterilize the product.
Damage to the product due to inappropriate
detergents/disinfectants!
¾ Clean the surfaces only with approved detergents/disinfectants as specified by the manufacturer.
¾ Observe specifications regarding concentration,
temperature and contact time.
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4.4 Manual Cleaning/Disinfection
4.4.1
Wipe Disinfection for Electrical Devices Without Sterilization
Phase
I
RT:
Step
Wipe disinfection
T
[°C/°F]
t
[min]
Conc.
[%]
Water quality
RT
≥1
-
-
Room temperature
Phase I
¾ Remove any visible residues with a disposable disinfectant wipe.
¾ Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
¾ Observe the specified contact time (1 minute minimum).
4.5 Inspection
¾ After each complete cleaning/disinfection cycle, check the product for
damage.
¾ Set aside the product if it is damaged.
4.6 Storage
¾ Store reprocessed products protected from dust in a dry, dark and cool
room which is exposed to as little bacterial contamination as possible.
22
Chemical
Meliseptol HBV wipes
50% propan-1-ol
Page 25
5. Maintenance/Calibration
The reader unit requires no maintenance.
5.1 Calibration of BARD Sensor
The reader unit is equipped with a barometric pressure sensor (BARD sensor). To ensure that pre-defined tolerance limits are upheld, calibration is
necessary on an annual basis.
¾ For the purposes of calibration, the device should be sent each year to
the following address:
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95-1601
Fax:
+49 7461 14-939
E-Mail: ats@aesculap.de
Note
When undergoing calibration, the device will also be subjected to thorough
functional and technical safety inspection.
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Reader unit for telemetrical Shunt Sensor
6. Troubleshooting
If an error occurs, it will be displayed on the screen.
Example of an error message:
Fig. 54
Legend
A Error message
Additional information can be retrieved by pressing
¾ Return to the previous menu by pressing
.
.
6.1 Malfunctions Displayed with an Error Message
Note
The table is sorted alphabetically by the initial letter of the error message
appearing on the display.
A
B
Message displayed
Cause
Detection/remedy
Battery flat
Battery capacity exhausted (0%)
All data are saved after 2 min. The reader unit
switches off automatically.
Connect power supply.
Battery voltage incompatible use original power supply
Battery voltage of reader unit is too low Reader unit switches off automatically after
20 seconds.
Connect original power supply.
Low battery voltage low
Battery voltage too low
Flashing, crossed-through antenna symbol Antenna faulty
:
Antenna error
24
The backlight switches off after 3 seconds.
Connect power supply.
Current measurements will not be interrupted.
Deactivate and reactivate the device.
If the error persists, please contact Technical Service.