otometrics HDA 300 User manual

HDA 300 High-Frequency
Audiometric Headphones
User Guide
Doc. No. 7-50-1570-EN/01
Part No. 7-50-15700-EN

Copyright notice
© 2014,2019Natus MedicalDenmark ApS. All rights reserved. ®
Otometrics, the OtometricsIcon, AURICAL, MADSEN, Otoscan,
ICS and HORTMANN are registered trademarks of Natus
MedicalDenmark ApS in the U.S.A. and/or other countries.
Version release date
2019-06-04 (213984)
Technical support
Please contact your supplier.
2 Otometrics - HDA 300

Table of Contents
1 Device Description and Intended Use 4
2 Typographical conventions 4
3 Unpacking 4
4 Product overview 5
5 Connecting the HDA 300 5
6 Using HDA 300 6
7 Storage and handling 6
8 Service, cleaning and maintenance 7
9 Technical specifications 8
10 Manufacturer 9
11 Warning notes 10
12 Definition of symbols 11
Otometrics - HDA 300 3

1 Device Description and Intended Use
HDA 300 headphones are closed circumaural dynamic headphones designed for use
with audiometers. HDA 300 headphones are suitable for high-frequency audi-
ometry.
The intended users are audiologists, ENTs, hearing instrument dispensers and other
health care professionals.
For information regarding use of the HDA 300 headphones together with an audi-
ometer, see the user guide for the relevant audiometer.
2 Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the
device or software, the manual uses precautionary statements as follows:
Warning •Indicates that there is a risk of death or serious injury to the user or
patient.
Caution •Indicates that there is a risk of injury to the user or patient or risk of
damage to data or the device.
Note •Indicates that you should take special notice.
3 Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, it is a good idea to keep the
packing material in which they were delivered. If you need to send the device
in for service, the original packing material will protect against damage during
transport, etc.
4 Otometrics - HDA 300

2. Visually inspect the equipment for possible damage.
If damage has occurred, do not put the device into operation. Contact your local
distributor for assistance.
3. Check with the packing list to make sure that you have received all necessary
parts and accessories. If your package is incomplete, contact your local dis-
tributor.
4 Product overview
A. Headband padding
B. Headband
C. Ear cup, right (red)
D. Ear pads
E. Ear cup, left (blue)
F. Plug, right (red)
G. Plug, left (blue)
H. Connection cable
5 Connecting the HDA 300
To connect the headphones to the audiometer, do the following:
Otometrics - HDA 300 5

• Insert the red headphone plug into the red headphone socket in the audi-
ometer connection panel.
• Insert the blue headphone plug into the blue headphone socket in the audi-
ometer connection panel.
Note •Blue corresponds to Left and Red corresponds to Right.
For more information, see the Reference Manual for the audiometer.
6 Using HDA 300
1. Ask the test person to remove glasses, earrings or any other items that might
keep the headphones from fitting properly.
2. Place the headphones on the test person with the red ear cup on the right
ear.
3. Adjust the headphones so that the ears are completely inside the ear pads.
The test person should feel even, gentle pressure around their ears and the head-
band should fit closely to the head.
The headphones are in constant contact with the patient, and should therefore be
kept clean. See the cleaning instructions in Cleaning ►7.
7 Storage and handling
• Do not store the headphones in a position that straightens the headband. If the
headband is straightened, it can lose elasticity, and the pressure of the head-
phones against the ears can be reduced.
• Do not position the headphones so that someone is likely to trip over the
cable.
6 Otometrics - HDA 300

• Do not twist, bend, or damage the cable. Accidental damage and incorrect hand-
ling can have a negative effect on the functionality of the device. Contact your
supplier for advice.
8 Service, cleaning and maintenance
Service
For the sake of safety and in order not to void the warranty, service and repair of elec-
tro-medical equipment should be carried out only by the equipment manufacturer or
by service personnel at authorized workshops. In case of any defects, make a detailed
description of the defect(s) and contact your supplier. Do not use a defective device.
8.1 Cleaning
Always follow any established infection control procedures for the setting in which
you are working.
Caution •Keep the unit away from liquids. Do not allow moisture inside the
unit. Moisture inside the unit can damage the instrument and it may result in a
risk of electrical shock to the user or patient.
Clean the headband padding and the ear pads only with the cleansing agents recom-
mended below. Follow the instructions from the manufacturer of the cleansing
agent.
Caution •Do not spray liquids directly on the product. Use a soft cloth
dampened with the cleansing agent or disinfectant.
Otometrics - HDA 300 7

Products recommended for cleaning and disinfecting ear pads and
headband padding:
Manufacturer Suitable product
Bode Bacillol AF; Bacillol Tissues
Dreve OtoVita Cleaning Spray; OtoVita Cleaning Wipes
Egger Cedis; Cedis med WB; Cedis N-Pro Cleansing Spray/Wipes
Reckitt Benckiser Sagrotan hygiene spray; Sagrotan hygiene cleaner
After cleaning HDA 300, let the headphones dry before using them.
8.2 Maintenance
HDA 300 requires no preventive maintenance.
Calibration
When you receive the headphones with your audiometer, they have been cal-
ibrated at the factory.
Annual calibration
The audiometer, headphones, bone oscillators, and sound field speakers must be
calibrated once a year by your authorized service department.
Caution •Calibration is also necessary if you acquire new headphones or if the
climatic conditions change.
9 Technical specifications
Type 1098
Transducer type Dynamic
Ear coupling Circumaural
8 Otometrics - HDA 300

Contact pressure 8.8 N (± 0.5 N)
Weight with cable approx. 490 g
Cable length approx. 2.2 m
Standards IEC 60645-1, IEC 60645-2
ANSI S3.6-2010
System-related technical specifications can be found in the user guide for your audi-
ometer.
10 Manufacturer
Natus MedicalDenmark ApS
Hoerskaetten 9, 2630 Taastrup
Denmark
+45 45 75 55 55
www.natus.com
10.1 Responsibility of the manufacturer
The manufacturer is to be considered responsible for effects on safety, reliability, and
performance of the equipment only if:
• All assembly operations, extensions, re-adjustments, modifications or repairs are
carried out by the equipment manufacturer or personnel authorized by the man-
ufacturer.
• The electrical installation to which the equipment is connected complies with
EN/IEC requirements.
• The equipment is used in accordance with the instructions for use.
The manufacturer reserves the right to disclaim all responsibility for the operating
safety, reliability and performance of equipment serviced or repaired by other
parties.
Otometrics - HDA 300 9

11 Warning notes
This manual contains information and warnings, which must be followed to ensure
the safe performance of the devices and software covered by this manual. Local gov-
ernment rules and regulations, if applicable, should also be followed at all times.
• For the sake of safety and in order not to void the warranty, service and repair
of electro-medical equipment should be carried out only by the equipment
manufacturer or by service personnel at authorized workshops. In case of any
defects, make a detailed description of the defect(s) and contact your supplier.
Do not use a defective device.
• Never use the headphones on broken skin.
• The product generates magnetic fields - also when not in use. Always maintain
a distance of at least 10 cm (3.94 inches) between the ear cups and a cardiac
pacemaker or implanted defibrillator.
• Keep the unit away from liquids. Do not allow moisture inside the unit. Mois-
ture inside the unit can damage the instrument and it may result in a risk of
electrical shock to the user or patient.
• Do not expose the device to extreme temperatures (close proximity to a
heater, extended exposure to sunlight, etc.). Noncompliance can have neg-
ative effects on performance or cause degradation of device components.
10 Otometrics - HDA 300

12 Definition of symbols
Electronic equipment covered by the Directive 2002/96/EC on waste
electrical and electronic equipment (WEEE).
All electrical and electronic products, batteries, and accumulators must
be taken to separate collection at the end of their working life. This
requirement applies in the European Union. Do not dispose of these
products as unsorted municipal waste.
You can return your device and accessories to Natus MedicalDenmark
ApS, or to any Natus MedicalDenmark ApS supplier. You can also con-
tact your local authorities for advice on disposal.
Manufacturer and date of manufacture.
Complies with Medical Devices Directive 93/42/EEC and RoHS Dir-
ective (2011/65/EC).
Consult instructions for use.
Otometrics - HDA 300 11

Table of contents