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Idiomas disponibles
Idiomas disponibles
Remove device before using the toilet.
Do not use the device if it is damaged or
altered in any way.
Do not pierce, cut or slice the device.
Do not clean the device with chemical or
abrasive products.
Do not put device in dishwasher.
Do not sterilize the device in boiling water.
Keep device away from heat sources.
Keep out of reach of children and pets.
Do not use the device in a bath or shower.
Do not lend or share the device with anyone.
Do not insert the device into any part of the
body other than the vagina (intravaginal device
only).
Leave the outer part of the device outside the
vagina.
Do not have sexual intercourse while the
device is inserted.
Any serious incident involving the device must
be reported to Fizimed and to the competent
authority of the member state in which the user
is established.
Contraindications
If you are pregnant or have given birth less
than 7 weeks ago.
If you experience constant pain when using or
inserting the device.
If you currently have health problems related
to your pelvic floor.
If you suffer from genitourinary cancer.
If you suffer from extra-urethral incontinence
(fistula, ectopic ureter).
If you suffer from severe urinary retention.
If you have any doubts about your ability to
use this device, please consult a healthcare
professional.
Warranty
The legal warranty on the Emy device covers
all manufacturing and operating defects for 2
years from the date of purchase shown on the
invoice, subject to the following two conditions:
• Communication of device serial number,
• Use in accordance with instructions.
The warranty does not cover:
• Damage due to abnormal use or use outside
the scope of the originally intended use,
• Damage caused by negligence or accident,
• Damage caused by improper cleaning not in
accordance with the instructions,
• Damage caused by an electrical storm,
• Unauthorized maintenance, attempts to open
or repair the device.
To trigger the warranty, contact your vendor's
customer service department, who will register
your claim.
Service life
The lifetime of a medical device is a mandatory
piece of information whose purpose is to
estimate the point at which a product becomes
obsolete. After this period, the product may
no longer function properly, or may represent
a risk. Product life may vary according to
EN
maintenance, conditions of use and storage.
Fizimed estimates this life to be 5 years if all
conditions of use, storage and cleaning have
been respected. If the product is damaged or
compromised in any way, it is imperative to
end-of-life the device.
The Emy device must not be disposed
of with general household waste. It
is your responsibility to dispose of
this item by taking it to an authorized
collection point for the recycling of electrical
and electronic equipment. Consult your local
authorities for the location of these facilities.
Please note that the device's lithium battery is
a fire hazard and may explode if incinerated.
Product marking
This medical device is a regulated healthcare
product and, in accordance with these
regulations, bears the CE mark. The EMY
device is a medical device designed to offer
women a pelvic floor re-education method
combining a device and a mobile application
to improve their quality of life.
FCC
All products sold in countries requiring FCC
certification are FCC compliant. This device
complies with Part 15 of the FCC rules.
Its operation is subject to the following two
conditions:
• This
device
may
not
cause
interference, and
• This device must accept any interference
received, including interference that may
cause undesired operation.
FCC RF Exposure Statement
This equipment complies with FCC radiation
exposure limits established for an uncontrolled
environment. End-users must follow specific
operating instructions to meet RF exposure
compliance. This transmitter complies with
the limits for portable and mobile devices
as
demonstrated
by
the
RF
exposure analysis and SAR test report. This
transmitter must not be co-located or operated
in conjunction with any other antenna or
transmitter, except in accordance with FCC
procedures for multi-transmitter products.
Manufacturer's responsibility to comply
with FCC regulations
The transmitter module must not be co-located
or operated in conjunction with any other
antenna or transmitter, except in accordance
with FCC procedures for multi-transmitter
products.
EMY
EMY contains:
A transmitter module:
FCC ID: QOQ-BGM220S2
4
Protection class
The device is IP67: fully protected against
dust.
Protected
against
immersion to a depth of 1 m.
Storage, transport and
use conditions
When using the Emy device, the following
operating conditions must be observed:
• Operating temperature: 0°C to 38°C,
• Relative humidity range from 10% to 95%,
non-condensing, but not requiring a partial
water vapour pressure greater than 50 hPa,
• Atmospheric pressure range from 700 hPa
to 1060 hPa.
Transport and storage conditions between
uses are as follows:
• -20°C to +70°C without relative humidity
control,
• +5°C to +35°C with relative humidity up to
95%, non-condensing,
• Atmospheric pressure range from 700 hPa
to 1060 hPa.
Emy device electronic features
The Emy device is designed for home use. It
is an internally powered medical device. The
product contains a rechargeable Lithium Ion
battery. The product is rechargeable only via
the cable supplied. The device supply current
is: DC 5V / 0.5A.
harmful
The device is approved to the EN 60601-
1-2 electromagnetic compatibility standard
for medical equipment. As such, the Emy
device must be used in accordance with the
information and instructions provided in this
manual.
This electromedical device contains an
internal power supply.
The applied part is type BF (IEC 60601-1).
EMC information
radiation
• RF emissions from the Emy device are very
low and are not likely to cause interference in
nearby electronic equipment,
• The Emy device is suitable for use in
domestic premises,
• The
Emy
device
communications in the following frequency
bands:
Bluetooth
-2.485GHz],
• The Emy device complies with the limits of
ETSI EN 300 328 V2.1.1,
• The Emy device complies with the limits of
standard EN 55011 (2010),
• The Emy device complies with the limits of
EN 61000-6-3 (2007 +A1/2011),
• The Emy device complies with the limits
of IEC 60601-1-2 Ed.4.0 (2014) and EN
61000-4-3 and EN 61000-4-8 for immunity to
magnetic fields,
• The Emy device complies with the Class B
requirements of ETSI EN 301 489-1, ETSI
EN 301 489-17 and EN 55022 for radiated
emissions,
• The
Emy
device
requirements of ETSI EN 301 489-1, ETSI
EN 301 489-17 and EN 61000-4-2 for
the
effects
of
electrostatic discharge.
• The Emy device meets the requirements of
ETSI EN 301 489-1, ETSI EN 301 489-17
and EN 61000-4-3 for immunity to radiated
electromagnetic fields (see Appendix 1).
• The Emy device complies with the limits of
IEC 60601-1-2 Ed.4.0 and EN 61000-4-
2 with regard to immunity to electrostatic
discharge (see Appendix 1).
All EMC results tables are available on request
from the Manufacturer.
Clinical benefits of the EMY device
The clinical benefit of the Emy device is
improved quality of life for patients.
Emy device performance
The Emy device is sensitive enough to detect
very weak contractions of the pelvic floor
muscles, so it can be used for postpartum
rehabilitation or in cases where the perineal
muscles have lost their tone.
Glossary of symbols
CE marking
Manufacturer
Electromagnetic
field
Non-ionizing
radiation
uses
wireless
Serial number
BLE:
[2.400GHz
Unique device
identifier
Catalog number
Type BF protection
against electric shock
It is essential
to consult the
precautions for use.
Refer to operating
instructions
Made in Europe
One patient,
many use
Swiss agent
5
complies
with
the
Attention
Moisture resistant
The waste must
be collected by a
specific channel
and must not be
disposed of in the
usual garbage can.
Temperature limit
Humidity limit
Atmospheric
pressure limit
Direct current
Medical devices
Class II equipment
Fragile:
handle with care
Date of
manufacture
EN
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