Renovia leva Manual Download Page 4

 

What’s in the Box?

 

Your leva 

PDHS

 includes the following:

 

Storage case and battery

Vaginal probe and battery

Quick Start Guide

What’s not in the Box?

 

The leva PDHS requires use of a mobile application (

Renovia App

and mobile device (i.e., smartphone) to visualize pelvic floor 

exercise during device use. The user is required to download the 

Renovia App

 onto their mobile device.

  

What Features does the leva PDHS have?

 

Your leva PDHS was designed as a soft, flexible vaginal device. The leva 

PDHS has a raised indicator line along the front of the vaginal probe to 

ensure proper positioning. The leva PDHS operates on batteries located in 

the base of both the case and the probe. 

The leva PDHS is provided with a sturdy storage case. This case serves two 

purposes: it protects the device during storage and also serves as a 

communications bridge between your leva and your mobile phone (i.e. a 

relay). Because of its communication function, the case also operates on 

Summary of Contents for leva

Page 1: ...Pelvic Digital Health System...

Page 2: ...ting the leva Probe 12 Starting Your Session 14 Removing the leva Probe 15 Technical Specifications 16 Expected Service Life 17 Maintenance 17 Radio Frequency Wireless Technology 18 Replacing Batterie...

Page 3: ...ystem leva PDHS to ensure that your use of the device is safe and effective As you begin to familiarize yourself with the leva PDHS it is normal to have questions If at any time you have questions or...

Page 4: ...hat Features does the leva PDHS have Yourleva PDHS was designed as a soft flexible vaginal device The leva PDHS has a raised indicator line along the front of the vaginal probe to ensure proper positi...

Page 5: ...as Prescribed by Your Physician Recommended use two and one half minutes twice daily Remove after use Contraindications Situations in which the device should not be used because the risk of use clearl...

Page 6: ...be used The use of accessories transducers and cables other thanthose specified withthe exceptionof transducers and cables sold by Renovia Inc as replacement parts forinternalcomponents ifany mayresu...

Page 7: ...on or could damage the electronics Always wash your hands before inserting the device to prevent harmful bacteria which may be present on your hands from entering your vagina Always ensure there are n...

Page 8: ...8...

Page 9: ...create your account Note The storage case contains relay electronics that allow communication between your leva PDHS and smartphone To ensure connection verify the probe is removed from the case and...

Page 10: ...10...

Page 11: ...everalscreens that can be reached from the Dashboard Renovia App Dashboard Practice Mode More Training Mode About You Tests Device Information Support Education Frequently Asked Questions FAQs Reminde...

Page 12: ...propped up on a stool or something of similar height so one leg is higher than the other Inserting the probe is much easier if you are relaxed The process is much like inserting a tampon Always ensur...

Page 13: ...fortably go Stop inserting the device if you feel uncomfortable or when the probe is flush with the perineum vaginal opening If you feel resistance do notforce the probe in If you have inserted the pr...

Page 14: ...perly lift and relax your pelvic floor Training should be used during your daily sessions Each training session can be completed in 2 5 minutes To access the Training mode click on the large button at...

Page 15: ...u right from the Dashboard You can view a shorter or longer period of progress time by selecting different timepoints in the Progress view You can also click on the plot to see the daily average for a...

Page 16: ...ular to the floor the Angle is 90 The Angle measure is updated at a rate of 10 times per second and the value displayed is the current Angle TheSessionTimereferstothe duration of yourPractice session...

Page 17: ...e 5 C to 40 C Humidity 90 RH non condensing Pressure 700hPa to 1060hPa Operating Range 3 2 ft 1 meter Expected Service Life The expected service life of the leva PDHS is 1 year The leva PDHS requires...

Page 18: ...02 case includes two microcontrollers a 915 MHz band ISM radio and a 2 4 GHz band Bluetooth Low Energy BLE radio The effective RF radiated power output mW associated with the o 915 MHz band ISM radio...

Page 19: ...d case contain battery packs that are intended to be replaced as a set The batteries should be changed when indicated by the leva PDHS on the Renovia App To purchase replacement batteries please conta...

Page 20: ...20 Step 3 Attach the replacement battery pack by pressing it toward the vaginal insert and rotating it clockwise Step 1 Step2 Step 3 Attach replacement battery pack Remove sticker Remove battery pack...

Page 21: ...e case by rotating the base of the battery counterclockwise Step 3 Attach the replacement battery pack by pressing it toward the vaginal insert and rotating it clockwise Battery and Device Disposal Th...

Page 22: ...e will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is...

Page 23: ...n electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz...

Page 24: ...iations on power supply inputline IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Not applicable3 Mains power...

Page 25: ...at if adjacent or stacked use is necessary the leva PDHS should be observed to verify normal operation in the configuration in which it will be used The leva PDHS should not be used closer than 12 inc...

Page 26: ...tion Temperature Limitation Humidity Limitation Federal law USA restricts the sale of this device by or on the order of a Physician This product contains electrical and electronic components that may...

Page 27: ...ssages contain information on how to troubleshoot as well as a support phone number to contact The Error messages are included here Bluetooth Disconnect Bluetooth Connection Failure Please ensure leva...

Page 28: ...ct Renovia Inc support for assistance if needed in setting up using or maintaining the equipment or to report unexpected operations or events Renovia Inc Corporate Headquarters 866 735 8424 Women s Ce...

Page 29: ...29 2019 Renovia Inc All Rights Reserved...

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