Chapter 5: Specifications; Standards Compliance - Philips RESPIRONICS EverFlo Manual Del Paciente

EverFlo / EverFlo Q User Manual

Chapter 5: Specifications

Environmental
Relative Humidity
Physical
Expected Service Life of
Device and Accessories
Maximum Outlet Pressure
Operating Pressure 69.7 kPa to 101 kPa

Standards Compliance

This device is designed to conform to the following standards:
- IEC 60601-1 Medical Electrical Equipment, Part 1: General requirements for basic safety and essential
performance
- IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirement for Basic Safety and Essential
Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General Requirements for Basic Safety and Essential
Performance - Collateral Standard: Usability
- IEC 60601-1-8 Medical electrical equipment – Part 1-8: General Requirements for Basic Safety and Essential
Performance – Collateral Standard: General requirements, tests, and guidance for alarm systems in medical
electrical equipment and medical electrical systems
- IEC 60601-1-11 Medical electrical equipment – Part 1-11: General Requirements for Basic Safety and
Essential Performance – Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
- ISO 80601-2-69, Medical Electrical Equipment, Part 2-69: Particular Requirements for Basic Safety and
Essential Performance of Oxygen Concentrator Equipment
- ISO 8359 Oxygen Concentrators for Medical Use - Safety Requirements
- IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing (Biocompatibility)
16
Temperature
55 to 90° F (13 to 32° C)
15 to 95%, noncondensing
Altitude
Dimensions 23" x 15" x 9" (58 cm x 38 cm x 24 cm)
Weight 31 to 33 lbs.(14 to 15 kg)
5 years
6.5 PSIG (44.8 kPa)
Sound Level Device: 50 dBA or less
Alarm: 60 dBA or greater
Operating
0 to 2286 m.
Transport & Storage
-29 to 160° F (-34 to 71° C)
15 to 95%, noncondensing
N/A