FSP PMP135F Series Switching Power Adapter Safety Certification Report
Company: FSP Group Inc. (全漢企業股份有限公司)
Report Reference: E178020, Vol. 2, Sec. 2
Issue Date: 2011/03/03 | Revised Date: 2016/09/02
Certification Issue Date: 2017/08/24
Product Overview
This document outlines the safety certification report for the FSP PMP135F series of switching power adapters. These adapters are designed for use in medical electrical equipment.
Product Type: Switching Power Adapter
Trade Mark: PROTEK POWER
Safety Certification Type: UL/cUL Medical Category
Remarks: PMP135F series, Medical, UL Certificate
Model Series and Specifications
The PMP135F series includes multiple models, primarily differing in transformer secondary winding, output rating, and model designation. The general model format is PMP135F-xyyyy, where 'x' indicates voltage/variant (e.g., 12, 12-1, 13, 13-1, 13-3, 14, 15, 16, 17, 18) and 'y' denotes configuration options (0-9, A-Z, hyphen, or blank).
Input Rating: 100-240Vac, 1.6-0.8A, 47-63 Hz
Detailed Product Ratings
| Models | Output Voltage | Output Current | Max. Power |
|---|---|---|---|
| PMP135F-12yyyy | 12 Vdc | 10.00A | 120W |
| PMP135F-12-1yyyy | 13 Vdc | 9.23A | 120W |
| PMP135F-13yyyy | 14-16 Vdc | 9.29A | 130W |
| PMP135F-13-1yyyy | 18-19 Vdc | 7.50A | 135W |
| PMP135F-13-3yyyy | 20-21 Vdc | 6.75A | 135W |
| PMP135F-14yyyy | 24-25 Vdc | 5.63A | 135W |
| PMP135F-15yyyy | 28-29 Vdc | 4.83A | 135W |
| PMP135F-16yyyy | 30-32 Vdc | 4.50A | 135W |
| PMP135F-17yyyy | 36-38 Vdc | 3.75A | 135W |
| PMP135F-18yyyy | 46-50 Vdc | 2.94A | 135W |
Safety Standards and Compliance
The product was investigated according to the following standards:
- IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) (Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance)
- ANSI/AAMI ES 60601-1:2005, 1st Edition (includes National Differences for USA)
- CAN/CSA-C22.2 No. 60601-1:08, 2nd Edition (includes National Differences for Canada)
The product is designed as a switching type power supply with electronic components mounted on a Printed Wiring Board (PWB) and housed in a plastic enclosure for Class II medical electrical equipment.
It features two Means of Patient Protection (MOPP) insulations between primary and secondary circuits, and one MOPP between the primary/secondary and Protective Earth (PE).
The secondary output circuit of the product is Safety Extra Low Voltage (SELV).
Transformer T1 employs a Class B (130°C) insulation system.
Technical Considerations and Engineering Conditions
Classification of Installation and Use: N/A Recognized Component.
Mode of Operation: Continuous.
Maximum Operating Temperature: 40-60°C. At ambient temperatures above 40°C, the output load condition is de-rated linearly by 50% of the full load capacity.
Software: Software is not relied upon for meeting safety requirements related to mechanical, fire, and shock.
Flammable Anesthetics: The product is not suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide.
Engineering Conditions of Acceptability:
- For use only in or with complete equipment where the acceptability of the combination is determined by Underwriters Laboratories Inc.
- Creepage and clearances are based on the First Edition of the Standard for Medical Electrical Equipment, ANSI/AAMI ES 60601-1, Sub clause 8.9, and CAN/CSA-C22.2 No. 60601-1:08, 2nd Edition.
- The power supply has been evaluated as a Class II, continuous operation, ordinary Equipment.
- It has not been evaluated for use in the presence of a flammable anesthetic mixture.
- Additional evaluation may be necessary if the power supply is intended for use in other than Class II equipment.
- The power supply was tested on a 20 A branch circuit. If used on a branch circuit greater than this, additional testing may be necessary.
MOPP Insulation Details:
- 2 MOPP provided between Primary to Secondary.
- 1 MOPP provided between Primary and T1 Core.
- 1 MOPP provided between T1 Core and Secondary.
End-Product Evaluation Tests: Temperature Test, Dielectric Voltage Withstand Tests, and Leakage Test.
Reference Voltage for Dielectric Voltage Test (End Product): 260 Vrms, 464 Vpk for T1.
Patient Connected Applications: This power supply has not been evaluated for patient connected applications.
Markings Test: Will be evaluated with the end product.
Exclusions and Additional Information
The following clauses were not evaluated by Underwriters Laboratories Inc.:
- Clause 11.7: Biocompatibility
- Clause 10.5, 17: Electromagnetic Compatibility (EMC)
- Clause 12.2: Usability
Risk Management report, according to ISO/IEC 14971:2007, was provided by the client and reviewed.
US/CANADA deviations were provided in Enclosure - National Differences.
Production-Line Testing Requirements:
The following models are exempt from the indicated tests:
- Grounding Continuity Test
- Dielectric Voltage Withstand Test
- Patient Circuit Dielectric Voltage Withstand Test
Solid-State Component Test Exemptions are noted.
The applicant is authorized to reproduce the referenced Test Report provided it is reproduced in its entirety.
