Scalpel repair procedure, skalperin korjaus

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SCALPEL REPAIR PROCEDURE

Each scalpel has a cord, connector, and multiple internal components.
Failure of one item will cause the entire scalpel to fail. We can identify a
damaged cord, connector, or housing by a visual inspection. However, for
all other problems we must disassemble the scalpel and evaluate the internal
components to determine the cause(s) of failure. Also, many scalpels with
cord, connector, or housing problems also have damaged internal
components, which cannot be detected until the repair is performed.

In order to replace any component (including connector or cord) the entire
handpiece must be completely taken apart and re-assembled. The internal
components, wire, and connector all break down over time. To replace one
component without replacing the other components will lead to repeated
handpiece failures (and repairs) as the remaining parts break down. To
avoid multiple handpiece failures we perform a comprehensive
cleaning/repair procedure.

When a scalpel is repaired it begins by being completely disassembled into
its individual component parts. This involves removing the transducer
assembly from the housing. The transducer is subsequently disassembled
and the replaceable parts are discarded. The other transducer components
and housings are inspected, assigned lot control and cleaned ultrasonically.
The transducer is reassembled using new parts and tested. The transducer
assembly is mated to a tested connector /cable assembly. This
transducer/cable assembly is again tested. The transducer/cable assembly is
then put back into the housing. The completed scalpel is then autoclaved and
re–tested prior to packaging and shipment. The results of the testing
performed both in-process and at final assembly, are documented in Device
History Records per the ISO standard.

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Scalpel repair procedure, skalperin korjaus

1. SCALPEL REPAIR PROCEDURE Each scalpel has a cord, connector, and multiple internal components. Failure of one item will cause the entire scalpel to fail. We can identify a damaged cord, connector, or housing by a visual inspection. However, for all other problems we must disassemble the scalpel and evaluate the internal components to determine the cause(s) of failure. Also, many scalpels with cord, connector, or housing problems also have damaged internal components, which cannot be detected until the repair is performed. In order to replace any component (including connector or cord) the entire handpiece must be completely taken apart and re-assembled. The internal components, wire, and connector all break down over time. To replace one component without replacing the other components will lead to repeated handpiece failures (and repairs) as the remaining parts break down. To avoid multiple handpiece failures we perform a comprehensive cleaning/repair procedure. When a scalpel is repaired it begins by being completely disassembled into its individual component parts. This involves removing the transducer assembly from the housing. The transducer is subsequently disassembled and the replaceable parts are discarded. The other transducer components and housings are inspected, assigned lot control and cleaned ultrasonically. The transducer is reassembled using new parts and tested. The transducer assembly is mated to a tested connector /cable assembly. This transducer/cable assembly is again tested. The transducer/cable assembly is then put back into the housing. The completed scalpel is then autoclaved and re–tested prior to packaging and shipment. The results of the testing performed both in-process and at final assembly, are documented in Device History Records per the ISO standard.

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