Intended Use - Starkey Custom Charger User Manual

Intended use

Intended Use
These hearing aid chargers are intended to charge lithium-ion
rechargeable hearing aids, and are to be used with the patient's
selected hearing aid solution. For information about your hearing aid,
please consult the hearing aid specific user manual.
Your charger is designed to operate in public and residential
environments and is designed to comply with international
Electromagnetic Compatibility emissions and immunity standards for
medical devices. However, it is still possible that you may experience
interference caused by power line disturbances, airport metal
detectors, electromagnetic fields from other medical devices, radio
signals and electrostatic discharges.
If you use other medical devices or wear implantable medical devices
such as defibrillators or pacemakers and are concerned that your
hearing instruments might cause interference with your medical
device, please contact your physician or the manufacturer of your
medical device for information about the risk of disturbance.
Your charger should not be used during an MRI procedure or in a
hyperbaric chamber or other oxygen-rich environments.
Your charger is classified as a Type B applied part under the IEC
60601-1 medical device standard.
Your charger is not formally certified to operate in explosive
atmospheres such as may be found in coal mines or certain chemical
factories.
Your charger should be stored and transported
95% rH 45 C
within the temperature, humidity, and pressure
10% rH -10 C
ranges of -10°C (14°F) to +45°C (113°F),10%-95%
rH, and 70 kPa – 106 kPa (equivalent to altitudes
from 1,200 ft (380 m) below sea level to 10,000 ft
(3,000 m).
The charging temperature range is between 10°C (50°F) and 40°C
(104°F) and between 10%-95% RH and 70 kPa-106 kPa.
CAUTION:
• If the product is hot, do not touch it until cool.
• If the product is not working, do not disassemble.
Due to a shock hazard, contact the manufacturer and send the
device in for repair.
• Keep out of reach from children. Do not ingest anything
in the package, including desiccant, cleaning tool, etc.
• Any cords and AC adapters must be approved or listed
by a Nationally Recognized Testing Laboratory.
Clinical benefit
The charger itself does not provide a direct clinical benefit.
An indirect clinical benefit is provided by enabling the parent device
(rechargeable hearing aids) to achieve their intended purpose.
20 | Additional guidance
Intended use
We are required by regulations to provide the following warnings:
WARNING:
Use of wireless charger directly next to other
electronic equipment should be avoided because it could result in
improper performance. If such use is necessary, note as to whether
your hearing aids and the other equipment are operating normally.
WARNING:
Use of accessories, components or replacement
parts other than those provided by the manufacturer of your charger
could result in increased electromagnetic emissions and decreased
electromagnetic immunity and could result in degradation of
performance.
WARNING:
If Portable Radio Frequency communications
equipment is used closer than 30 cm (12 inches) from your charger,
degradation of the performance of your charger could result. If this
occurs, move away from the communications equipment.
DO NOT OPEN CHARGER, NO USER-
SERVICEABLE PARTS INSIDE
The Custom Charger and Premium Custom Charger have a rating of
IP 22 per IEC 60529. This means the unit is protected against solid
objects over 12 mm, such as fingers and falling water drops, such as
condensation.
Do not connect the charger to any devices not described in this user
manual. The service life of both the Custom Charger and Premium
Custom Charger is 3 years.
The Custom Charger and Premium Custom Charger have been tested
to, and have passed, the following emissions and immunity tests:
• IEC 60601-1-2 radiated and conducted emissions requirements
for a Group 1 Class B device as stated in CISPR 11.
• Harmonic distortion and voltage fluctuations affecting the power
input source as stated in Table 2 of IEC 60601-1-2.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and
2.7 GHz as well as higher field levels from communications devices
as stated in Table 9 of IEC 60601-1-2.
• Immunity to power frequency magnetic fields at a field level of
30 A/m and proximity magnetic fields as stated in Table 11 of IEC
60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15
kV air discharge.
• Immunity to Electrical fast transients on the power input at a level
of +/- 2 kV at a 100 Hz repetition rate.
• Immunity to Surges on the power input of +/- 1 kV line to line.
• Immunity to conducted disturbances induced by RF fields on the
power input as stated in Table 6 of IEC 60601-1-2.
• Immunity to voltage dips and interruptions on the power input as
stated in Table 6 of IEC 60601-1-2.
21 | Additional guidance