uspmt-banner

Specifications

FDA Approval:

Description of the Device and Indications for Use:

Descripton of the Device: The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operated through a FM remote control device. The probe is stored in a cradle on the side of the remote control and is activated upon removal from the cradle.

Indications for-use: The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND  MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1, CAN/CSA C22.2 No. 601.1

Mode of Operations: Continuous

Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.

IPX0 rating (no protection from dust and liquid ingress)
iec_info

Electrical Properties

Output Current: 0-70mA
Pulse Width: 200uS at 1%
Frequency: 12.5Hz and 50 Hz
Power Source: PMT trainer:  One- 3.6 volt lithium battery
Wireless controller: Three-  AAA batteries
Output Type: Constant voltage over range of 100 to 1000 Ohms
Output Isolation:>100 meg Ohms

Transportation and Storage

Ambient temperature range: -40 degrees C to 70 degrees C. (-40 degrees F to 158 degrees F)

Relative Humidity range: 10% to 100% including condensation Atmospheric pressure range: 500hPa to 1060hPa. (7.25 PSI to 15.36 PSI)

Federal Communications Commision (FCC) Compliance Notices:

Pelvic Muscle Trainer (Wireless Control Unit)

FCC ID: RMLE03946001

    This device complies with Part 15 of the FCC Rules.  Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation

    Warning - Any changes or modifications not expressly approved by the party responsible for compliance (i.e. Athena Feminine Technologies) could void the user's authority to operate this equipment.

This unit was authorized under the FCC Certification Procedure
fcc

Pelvic Muscle Trainer (Trainer Unit)
Athena Feminine Technologies
ATHENA PMT-II

This device complies with Part 15 of the FCC Rules.  Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 

        Warning - Any changes or modifications not expressly approved by the party responsible for compliance (i.e. Athena Feminine Technologies) could void the user's authority to operate this equipment.

        This unit was authorized under the FCC Declaration of Conformity Procedure.


    Responsible Party:
    Athena Feminine Technologies
    21 Orinda Way, C246
    Orinda, CA 94563
    (925) 254-2121