Disposal; Warranty; Spare And Wearing Parts; Complaints - MEDintim Active 3 Mode D'emploi

If you have a cardiovascular disease, you should
ask your doctor before you first use the product in
order to clarify possible risks.
If you are not sure whether you can apply the erec-
tion aid without any problem for your health, ask
your doctor or health care professional.

6. Disposal

Repair and disposal information:
You must not repair the device yourself. Proper
functioning will then no longer be guaranteed.
The pump head must not be opened.
In the interest of the environment, the pump head
must not be disposed of with household waste at
the end of its service life. Disposal may be arranged
at suitable collection points in your country. Dis-
pose of the pump head in accordance with the
WEEE Guideline (Waste Electrical and Electronic
Equipment). In case of questions, please contact
the authority responsible for disposal.

7. Warranty

Almost all parts have a 2-year warranty, as pre-
scribed by applicable law.
The warranty does not apply:
· in case of damage resulting from incorrect use.
· for wearing parts such as constriction rings
· in the case of the customer's own fault
· once the device has been opened
You should send in the erection aid, if possible,
every 3 years for technical inspection. The serial
number can be found on the underside of the

pump head.

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8. Spare and wearing parts

Use only original accessory parts.
For charging, use only the charging cable and the
USB mains components supplied. You can order the
replacement and wearing parts from the service
address. To get the current reordering list, please
contact service@medintim.de or your dealer.

9. Complaints

In case of complaints or questions regarding our
service, please contact the following:
Phone: +49 (0) 6105- 20 37 20
Email: service@medintim.de
www.medintim.de
If we ask you to send the defective product, please
send the product to the following address.
KESSEL Medintim GmbH
Nordendstr. 82 - 84
64546 Mörfelden-Walldorf
Germany
Outside Germany, please contact the dealer where
you purchased the device.
Specifications
Dimensions: Pump head: height 87.5 mm,
outer diameter 60 mm
Cylinder: height 200 mm,
outer diameter 60 mm
Weight: 900 g
Power supply: 4.5 V (3×1.5 Volt AAA Alkaline)
Protection against ingress of liquid: IP 22
Battery lifespan: 1000 charge cycles
Safety and electromagnetic compatibility
When operated in accordance with the manufacturer's instructions, the Active
of medical electrical equipment in accordance with IEC Standard 60601-1 and the Supplementary Standard IEC 60601-1-2, Electromagnetic Compatibility.
The battery life is 6 hours.
Electromagnetic compatibility
The device has been tested and found to comply with the limits for medical devices pursuant to IEC 60601-1-2. These limits are designed to provide sufficient
protection against harmful interference in a typical medical facility and a domestic environment.
Guidelines and manufacturer's declaration – electromagnetic immunity

The Active

3® Erection System is intended for use in the following electromagnetic environment.
The customer or user of the Active 3® Erection System should ensure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic discharge (ESD) ± 6 kV contact
IEC 61000-4-2 ± 8 kV air
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to 2.7 GHz
Conducted RF 3 Vrms 150 kHz to 80 MHz
IEC 61000-4-6
Electrical fast transients ± 2 kV supply output
IEC 61000-4-4 ± 1 kV input/output power
Voltage output ± 1 kV Differential mode
IEC 61000-4-5 ± 2 kV Common mode
Mains frequency magnetic field 50 Hz
IEC 61000-4-8 3 A/m (root mean square)
Voltage dips, short interruptions and <5 % UT (> 95% UT drop) for 0.5 cycles
voltage variations of the power supply
40 % UT (60% UT drop) for 5 periods
input lines
IEC 61000-4-11
70 % UT (30% UT drop) for 25 periods
<5 % UT (> 95% UT drop) for 5 seconds
Guidance and manufacturer's declaration – electromagnetic emissions
The device Active 3® Erection System is intended for use in the following electromagnetic environment.
The customer or user of the device Active 3® Erection System should ensure that it is used in such an environment.
Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR11
Harmonic currents Not applicable
IEC 61000-3-2
Voltage fluctuations/ Not applicable
flicker emissions
Maximum negative pressure: 350 mmHG
Patient protection: type BF
Storage / Transport: -25 - (+) 70°C , ≤ 90% relative
humidity (non-condensing)
Operating environment: (+) 5 - (+)40 °C,
15 - 90 % relative humidity
Conformity: IEC 60601-1:
IEC 60601-1-2:2014
IEC 60601-1-11:2015
EU 93/42/EEC
3® Erection System complies with the general requirements for the safety
Compliance level Electromagnetic environment –
guidelines
Compliant Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Compliant
Not applicable
(no electrical cables)
Not applicable
The medical electrical device is
operated exclusively by battery
Not applicable
power.
Compliant Magnetic fields should be within the
normal range of a typical location.
Not applicable The medical electrical device is
operated exclusively by battery
power.
Electromagnetic environment – guidance
The medical electrical device uses RF energy only for internal functions.
For this reason, the RF emissions are very low and it is not likely that they
would cause interference to electronic equipment nearby.
Compliant
The medical electrical device is operated exclusively by batteries.
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