Indications; Absolute Contraindications; Relative Contraindications; Safe Handling - Aesculap Acculan 4 GA334 Instrucciones De Manejo

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2.3

Indications

Type and area of application depend on the selected tool.
2.4

Absolute contraindications

The product is not approved for use in the central nervous system or cen-
tral circulatory system.
2.5

Relative contraindications

The safe and effective use of the product depends greatly on factors that
only operators themselves can control. The information provided therefore
only represents general conditions.
The clinically successful use of the product depends on the knowledge and
experience of the surgeon. They must decide which structures can be sen-
sibly treated and must take the safety information and warnings in the
instruction for use into account.
3.

Safe handling

WARNING
Risk of injury and material damage if this product is not used as
intended!
►
Use the product only for its intended purpose.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
►
Follow the instructions for use of all products used.
■
General risk factors associated with surgical procedures are not
described in this documentation.
■
It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■
The operating surgeon must have a thorough understanding of both the
hands-on and conceptual aspects of the established operating tech-
niques.
►
Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►
Check the functionality and proper condition before using the product.
►
Observe "Guidance on Electromagnetic Compatibility (EMC) for
Acculan Components" TA022450, see B. Braun eIFU at eifu.bbraun.com
►
To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►
Keep the instructions for use accessible for the user.
►
Comply with valid standards.
►
Ensure that the electrical installation of the room is consistent with the
requirements of IEC/DIN EN.
►
Do not operate the product in explosion-hazard areas.
►
Sterilize product before use.
►
When using ECCOS holder systems, observe relevant instructions for
use TA009721, see B. Braun eIFU at eifu.bbraun.com
Note
The user must report all serious incidents occurring in connection with the
product to the manufacturer and to the competent authority of the country
in which the user is registered.
4
4.

Product description

4.1

Scope of supply

Art. no. Designation
GA334 Reciprocating saw
GA674890 Rinsing adapter installed
GA678 Sterile funnel
GB440215 Cleaning template
TA014545 Instructions for use of reciprocating saw GA334 (flyer)
4.2

Components required for operation

■
NiMH battery long GA676 (charged)
■
Sterile funnel GA678
■
Lid GA675
■
Support foot GB436R (as required)
■
Saw blade
4.3

Operating principle

The product 1 contains an electric motor, which is powered by a replace-
able battery 7.
The charged non-sterile battery 7 is inserted into the product 1 via the
sterile funnel 6 and sealed with the lid 8 so that it is sterile.
The oscillation frequency is controlled electronically and can be continu-
ously regulated with the trigger 2.
The product 1 has a coupling 14, which allows for the attachment of var-
ious saw blades 11. These saw blades 11 lock automatically when
attached to the product 1.
The saw blade 11 can be removed by activating a rotating sleeve 12.
The product 1 has an interface, which allows for the attachment of sup-
port foot 16.
5.

Preparation

Aesculap assumes no liability if the following rules are not followed:
►
Do not use products from open or damaged sterile packaging.
►
Prior to use, inspect the product and its accessories for any visible dam-
age.
►
Use the products and their accessories only if they are in perfect tech-
nical condition.
6.

Working with the device

WARNING
Risk of infection and contamination!
Product is delivered unsterilized!
►
Sterilize the product before use pursuant to the operating instruc-
tions.
WARNING
Risk of injury and material damage due to accidental activation of the
product!
►
Products which are not being actively used must be secured against
accidental activation (position OFF).