Key Contents of the SGS Test Report of Aidastra SPIN

I. Basic Information of the Report

Report No.: GZHL250903986401MD

Report Date: December 2, 2025

Client: Shanghai Fulin Technology Co., Ltd. (AIDASTRA), Address: Room 307B, Building 14, No. 777 Guangzhong West Road, Jing’an District, Shanghai

Sample Information: Product Name: AIDASTRA Rotation Bed; Model: SPIN PRO; Date Received: September 10, 2025; Quantity Received: 1 unit; Maximum User Weight: 300 lbs; Intended Use Environment: Class 5

Testing Details: Testing Period: September 10, 2025 – December 2, 2025; Test Standard: IEC 60601-2-52:2009 + A1:2015 "Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds"; Testing Organization: SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch

II. Core Test Items and Results

     The report covers a range of tests on the basic safety and essential performance of medical beds. The results are categorized as "Pass", "Not Applicable (NA)", or "Not Tested (NT)". The core test items are as follows:

(1) Markings, Labels, and Documentation (Clause 201.7)

    Includes requirements for markings such as manufacturer information, maximum patient weight, safe working load, removable parts, and warnings related to mattress/side rail compatibility. The user manual must also contain information on the intended use environment, target patient group, maintenance, and calibration. All related test results: Not Tested (NT).

(2) Protection Against Electrical Hazards (Clause 201.8)

    Focuses on power cord requirements, including length (minimum 2.5 meters from plug to bed frame periphery), type (HD22.10 H05-BQ-F or equivalent mechanical strength), strain relief and bending protection, and waterproof plugs. Result: Pass.

(3) Protection Against Mechanical Hazards (Clause 201.9)

• • Entrapment Prevention: Openings/areas of non-moving parts must meet dimensional and structural requirements; gaps between moving parts must be <8 mm or >25 mm. Result: Pass.
  • Trapping Zone Protection: Analysis and gap requirements for potential entrapment zones such as under-bed areas and finger-reachable spaces. Result: Pass.
  • Controls: Bed movement must require continuous activation of control devices and return to "stop" or "off" position upon release; design to prevent accidental activation. Result: Pass.
  • Stability: Includes lateral and longitudinal stability tests, tipping prevention under horizontal/vertical force, and transport stability tests (items not applicable to non-patient transport beds). All results: Pass.
  • Support System Strength: Static/dynamic load tests for mattress support platform, side rails, lifting columns, etc.; 30,000-cycle side rail open/close test; 3,000-cycle lifting mechanism test. Core strength and reliability items: Pass.
  • Fall Prevention: Side rails must meet minimum height requirements. Result: Pass.

(4) Other Safety Protections (Clauses 201.10–201.17)

• • Temperature and Ingress Protection: Enclosure must have an IPX4 rating for water and dust resistance. Result: Pass.
  • Power Interruption Response: In emergencies, key performance functions defined by the manufacturer must remain operable via alternative means; backrest can be lowered or other emergency positions reached within 30 seconds. Result: Pass.
  • Usability and Fault Protection: Design considerations for usability by operators and patients, e.g., height of mattress support platform; no uncontrolled bed movement should occur under single fault conditions; control components must maintain high integrity. Result: Pass.
  • Structure and Components: Pendant controller must function safely after 1,000 free-fall drops; mattress must remain in place during normal use. Both results: Pass. Some items specific to certain use environments or structures (e.g., transportable electric beds, detachable headboards) were Not Applicable (NA).

III. Additional Notes

• Testing Location: Room 101, Building 3, No. 1501 Kai Chuang Avenue, Huangpu District, Guangzhou, Guangdong Province, China
• Conformity Judgment Rule: Based on the simple acceptance rule binary statement (w=0) specified in ILAC-G8:09/2019
• Disclaimer: The sample-related test items and information were provided and confirmed by the client. SGS assumes no responsibility for their accuracy, applicability, reliability, and/or completeness