Data Characteristics for This Category
Rehabilitation device registration data has distinct characteristics. Data sources primarily include official documents such as medical device registration certificates, product technical requirements, clinical evaluation reports, risk management reports, instruction manuals, and labels. These documents have a relatively low update frequency, typically updating with product model iterations, regulatory revisions, or significant safety events. Document structures are mainly PDF, Word, and XML formats. They contain extensive structured and semi-structured text, including tables, diagrams, and technical parameters. Fields include numerous standardized medical device classification codes, performance indicators, testing methods, and safety warnings, as well as non-standardized clinical use descriptions and user feedback. Units involve physical quantities like millimeters, kilograms, watts, hertz, and newtons, as well as International System of Units (SI) and specific industry standard units.
Constraints on Tool Calling and Plugins from These Characteristics
The characteristics of rehabilitation device registration documents impose specific requirements on tool calling and plugins. First, low update frequency means data synchronization tools do not need frequent triggers, but each synchronization must ensure data integrity and version consistency. Second, diverse document formats and complex internal structures require tools with robust document parsing capabilities. Tools must accurately extract table data, identify key information in diagrams, and extract critical fields from unstructured text. For example, accurate parsing of the performance indicators table in product technical requirements directly impacts subsequent compliance comparisons. Third, the involvement of physical quantity units and industry standard units requires tools to perform unit conversion and dimensional verification during data processing and comparison, preventing misjudgments due to inconsistent units. For instance, maximum output power comparisons between different devices require unit standardization. Finally, precise matching of standardized fields like medical device classification codes requires tools to efficiently integrate with external authoritative databases.
Configuration Settings
| Configuration Item | Recommended Value | Rationale |
|---|---|---|
maxContext | 8000 tokens | Individual paragraphs or tables in rehabilitation device registration documents may contain significant information. This ensures context completeness. |
Chunk size | 500 characters | Balances semantic completeness and recall efficiency. This prevents information loss after splitting long texts. |
Recall count | Top 10 entries | Highly relevant information in registration documents is often concentrated. Increasing recall covers potential associations. |
Similarity threshold | 0.75 | Medical device regulatory texts are precisely worded. A high similarity match ensures accuracy. |
PARSE_FILE_TIMEOUT_SECONDS | 600 seconds | Parsing large PDF or Word documents can be time-consuming. This provides sufficient timeout. |
EXTERNAL_API_RETRY_COUNT | 3 times | External regulatory databases or standard query interfaces may experience transient network fluctuations. Retries improve stability. |
Three Common Pitfalls
- Calling an external regulatory query interface returns an
HTTP 502 Bad Gatewayerror. This may be due to the interface service being temporarily unavailable or a gateway configuration issue. - When extracting the
adverse event incidence ratefield from aclinical evaluation report, the field is empty. This may be because the document parser did not correctly identify the table structure or field naming was inconsistent. - Comparing
electrical safety requirementsinproduct technical requirementsresults in a non-compliance alert, but manual verification shows consistency. This may be because the tool did not perform unit normalization, for example, failing to convertmAtoA.
How to Confirm Correct Configuration
- Upload a rehabilitation device instruction manual containing complex tables and diagrams to the platform. Observe if
PARSE_FILE_STATUSdisplaysSUCCESS. - For the
medical device classification codefield, use the tool to query an external database. Verify if the returned classification results match expectations. - Randomly select 5 different types of performance indicators from
product technical requirements. Use the tool to perform a compliance comparison. Observe if theCOMPLIANCE_STATUScomparison results align with actual regulatory requirements.
The values provided are common starting points and should be measured against the reader's own samples.
Question material comes from public community discussions. Configuration values are common starting points and should be measured against your own samples. Verified on 2026-09-21.