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Box spring Hilo
TECHNICAL MANUAL
page 56 of 62
XV. CONFORMITY AND IDENTIFICATION
The Hilo bed is produced in accordance with ISO 9001:2015 and ISO 13485:2016 and complies with
the regulation medical devices EU 2017/745 and all applicable European harmonized norms:
EN 60601-1
Medical electrical equipment - Part 1 : General requirements for basic safety and
essential performance.
EN 60601-1-2
Medical electrical equipment - Part 1-2 : General requirements for basic safety and
essential performance - Collateral standard : Electromagnetic compatibility -
Requirements and tests.
EN ISO 14971
Medical devices - Application of risk management to medical devices.
15.1 UDI-DI (GTIN)
15.2 Explanation CE-label and Identification-label
Summary of Contents for Hilo
Page 2: ...Box spring Hilo OPERATING INSTRUCTIONS page 2 of 62 ACTIVATION SUMMARY...
Page 3: ...Box spring Hilo OPERATING INSTRUCTIONS page 3 of 62 ASSEMBLY SUMMARY...
Page 34: ...Box spring Hilo TECHNICAL MANUAL page 34 of 62 TECHNICAL MANUAL...
Page 61: ...Box spring Hilo APPENDIX page 61 of 62 APPENDIX 3 TRAINING CERTIFICATE...