Specifications, Approvals – Welch Allyn KleenSpec Vaginal Specula Illumination System - User Manual User Manual

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Specifications

Classification (REF 73410)

Class II, Type BF Applied Part

Input:

120V ~ 60Hz, 100mA

Output:

4.7 VAC, 850mA

Category:

Not AP/APG Equipment

Physical Specifications:

Illuminator:

91.4 cm (36 in)

Transformer:

183 cm (72 in)

Illumination:

Lamp Life:

100 hours

Lamp Voltage:

4.6 V

Lamp:

Welch Allyn part no. 08800

IPX Rating:

Illuminator:

IPX7

Transformer:

IPXØ

Environment

Operating:

+10° C to + 35° C (50° F to 95° F), 95% RH

500 hPa to 1060 hPa

Transport/Storage:

-20° C to +49° C (-2° F to 120° F), 95% RH,

500 hPa to 1060 hPa

Intermittent Operation

Vag Spec and Illuminator

10 minutes on max; 5 minutes off min

Approvals

CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1

CONFORMS TO: IEC 60601-1, IEC60601-1-2, UL 60601-1 STD 2601-1

The CE Mark on this product indicates it has been tested to and
conforms with the provisions noted with the 93/42/EEC Medical
Device Directive.

Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland

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