Welch Allyn SureTemp PlusModule - User Manual - Manual (Page 27)

SureTemp Plus Module OEM Implementation Regulatory
Welch Allyn OEM Technologies Confidential 27
6 - Regulatory
Introduction
The Welch Allyn SureTemp Plus board can meet or exceed the following standards when
properly implemented:
• UL 2601-1 (leakage current as measured with probe cover on probe)
• IEC 60601-1, IEC 60601-1-2 (Mounting configuration dependent)
• CAN/CSA 22.2 No. 601.1 (Mounting configuration dependent)
• ASTM E 1112-00 (2000 revision) Accuracy and temperature ranges
• 93/42/EEC Medical Device Directive
OEM Responsibility
An additional consideration is the inclusion of an isolated power supply. Although the probe is
required to have a probe cover applied during use, the probe can come into inadvertent patient
contact, and may require an isolated power supply to meet patient safety requirements.
The responsibility of the OEM include (but are not limited to) the following:
• The end-use product (the host system) must comply with all appropriate safety
requirements of IEC60601-1 (EN60601-1), its amendments and applicable standards.
• It is recommended that the power supplied to the SureTemp module be fused or provided
similar protection in the event of a short circuit.
• Creepage and clearance distances from primary to ground and secondary circuits, as
defined in IEC60601-1 (EN60601-1), must be maintained after installation to preserve the
intended safety.
• Minimum isolation/insulation clearances specified in IEC 60601-1 (EN60601-1) when
mounting the SureTemp Plus module and any off-board components must be maintained
after installation to preserve the intended safety.
• The end-user operator manual must include instructions for decontaminating, cleaning
and/or safe disposal of all accessories.
• Completion of all regulatory testing after full implementation into the final form or device.
The SureTemp Plus module has undergone clinical testing for adults and pediatric patients in a
representative host system, as well as testing for EMC and vibration and mechanical shock in a
Welch Allyn reference device.
The table below offers, as a guideline, a summary of the relevant regulatory requirements for a
medical device with a predictive thermistor-based thermometer.