Protection Against Incorrect Dosage; Validated Reprocessing Procedure; General Safety Instructions - Braun Aesculap GN060 Instrucciones De Manejo

Aesculap
High frequency surgical device GN060
4.5

Protection against incorrect dosage

Self-test of the microprocessor
As faultless function of the microprocessor is a requirement for flawless
work with the HF device and all control and monitoring functions, a so-
called self-test is carried out after every time the HF device is switched on.
This test comprises a CPU, RAM, EPROM and watchdog test.
Monitoring the program process
In order to monitor the correct temporal program process, the HF device
has a watchdog timer that must be triggered during the normal course of
the program at regular intervals. If the trigger signal stays off for longer
than 10 ms, the activation of the HF output is blocked via an independent
piece of control hardware.
Monitoring the dosage
While the HF output is activated, the actual values of the parameters deci-
sive for the applied power are (voltage and duty cycle) are recorded on an
ongoing basis and compared with corresponding target values. If an error
is recognized in the comparison of these values, the HF output is immedi-
ately blocked via several channels. Dependent on the respectively recog-
nized error, the corresponding error code is shown in the display.
Continued work is then possible only after the HF device has been
switched off and back on again.
Monitoring the RAM values
The target values entered via the membrane keyboard (dosage, operating
and activation type) are stored in duplicate in the RAM memory and
checked on an ongoing basis. Within this, the corresponding values must
be the same and be in the approved value range.
Monitoring the storage values
The target values belonging to the stored dosage values (dosage and oper-
ating type) are stored in duplicate in a non-volatile memory (EEPROM) and
checked upon memory retrieval. Within this, the corresponding values
must be the same and be in the approved value range.
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5.

Validated reprocessing procedure

5.1

General safety instructions

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it
gives better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing techni-
cian is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material compatibility see
also the Aesculap extranet at www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.