Maico MA 1 Manual de usuario
MAICO Diagnostics | 10393 West 70th Street | Eden Prairie, MN 55344, USA | Toll Free 888.941.4201
MA 1
Operating Manual
MA 1 Operating Manual
i
8100216-3 (D-0105503)
1. Introduction ............................................................................. 2
2. Intended Use............................................................................ 3
3. Description............................................................................... 3
3.1. Important Safety Note ....................................................................4
3.2. Unpacking and Checking the MA 1 ................................................5
3.3. Standard Accessories ......................................................................5
4. MA 1 Connections.................................................................... 6
5. Battery Operation.................................................................... 6
6. Front Panel Controls and Display............................................ 7
7. Audiometric Testing ................................................................ 8
7.1. Instructing the Patient:....................................................................8
7.2. Test Environment: Ambient Noise ...................................................8
7.3. Conducting the Test .......................................................................9
8. Warranty and Disclaimer....................................................... 10
9. Care and Maintenance........................................................... 11
10. Recalibration .......................................................................... 12
11. Safety Regulations................................................................. 13
11.1. Measurement Safety:....................................................................13
11.2. Instrument Handling: ....................................................................13
11.3. Operation: ....................................................................................13
12. Technical Data........................................................................ 14
13. Regulatory Symbols............................................................... 15
MA 1 Operating Manual
1
8100216-3 (D-0100192)
Title: MA 1 Operating Manual
MAICO Diagnostics
10393 West 70th Street
Eden Prairie, MN 55344
Tel.: 888.941.4201
Fax: 952.278.4481
E-mail: info@maico-diagnostics.com
Internet: www.maico-diagnostics.com
Copyright © 2015 MAICO Diagnostics. All rights reserved. No part of this
publication may be reproduced or transmitted in any form or by any means
without the prior written permission of MAICO. The information in this
publication is proprietary to MAICO.
Compliance
MAICO Diagnostics is an ISO 13485 certified corporation.
MA 1 Operating Manual
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8100216-3 (D-0100192)
1. Introduction
Thank you for selecting one of our quality products from the MAICO family range. The
MA 1 is designed and manufactured to meet all quality and safety requirements.
Particular attention has been taken during the designing phase of MA 1 to ensure its
user-friendliness, meaning that its operation is simple, easy to learn and to understand.
The MA 1 is an ultra-portable audiometer and a perfect choice for on-the-go hearing
professionals.
This operating manual aims to make learning and understanding the different MAICO
MA 1 functions as quick and as easy as possible. Should you encounter any problems
or have ideas for any further improvements, we are only a phone call away. Please do
not hesitate to contact us.
Your MAICO-Team
MA 1 Operating Manual
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8100216-3 (D-0100192)
2. Intended Use
The MA 1 audiometer is intended to be used by an audiologist, hearing healthcare
professional, or trained technician in a quiet environment for the purpose of hearing
screening.
The instrument is intended for all patient populations including children able to respond
to a test signal.
The instrument is intended for professional use in clinics, hospitals or schools.
3. Description
The MA 1 screening audiometer is designed to be a device for screening for hearing
loss. Output and specificity of this type of device are based on the test characteristics
defined by the user, and may vary depending on environmental and operating
conditions. The screening for hearing loss using this kind of audiometer depends on the
interaction with the patient. As with any type of hearing screening, a “pass” result
should not overrule any additional concerns regarding hearing ability. A full audiologic
evaluation should be administered if concerns about hearing sensitivity persist.
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3.1. Important Safety Note
The MA 1 should always be operated in a quiet room with minimal magnetic influence,
to ensure that examinations are not disturbed by external noise.
Electro-medical instruments that emit strong electromagnetic fields (e.g. microwaves,
radiotherapy devices) can affect the operation of the MA 1
Therefore, the operation of these instruments in close proximity to the MA 1 should be
avoided at all times.
The examination room should have a normal temperature between 15˚C/ 59˚F and
35˚C/ 95˚F. If the instrument has cooled down during transportation, please wait for it
to warm up to room temperature before operation.
Attention
PLEASE READ THE ENTIRE MANUAL CAREFULLY BEFORE OPERATING THIS
INSTRUMENT.
Please only use this instrument as described in the manual.
Please familiarize yourself with the instrument and its operation before using.
Should defects or damages be suspected, please do not, under any circumstances, use
or attempt to fix the instrument yourself.
Calibration of the instrument: The audiometer and the headphone complement each
other and share the same serial number (i.e. 63252). Therefore, the instrument shall
not be used with any other headphone prior to recalibration. Recalibration also needs
to be conducted, when a defective headphone is replaced.
NOTE: Uncalibrated instruments may lead to faulty measurements.
Take note to ensure that all the accessories have been properly connected.
To avoid person-to-person cross contamination of communicable diseases, parts that
come in direct contact with the patient (i.e. earphone cushions) should be
disinfected using commercial disinfectant after each use.
In accordance with the Electronic Equipment Act for disposal of electronic
equipment, the customer is obliged to dispose of the used consumables,
according to appropriate regulation at own cost.
This equipment is intended to be connected to other equipment thus forming a
Medical Electrical System. External equipment intended for connection to signal input,
signal output or other connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical
equipment. In addition, all such combinations –Medical Electrical Systems –shall
comply with the safety requirements stated the general standard IEC 60601-1, edition
MA 1 Operating Manual
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3, clause 16. Any equipment not complying with the leakage current requirements in
IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the
patient support or shall be supplied via a separation transformer to reduce the leakage
currents. Any person who connects external equipment to signal input, signal output or
other connectors has formed a Medical Electrical System and is therefore responsible
for the system to comply with the requirements. If in doubt, contact qualified medical
technician or your local representative.
3.2. Unpacking and Checking the MA 1
Checking for packaging and content damage
Thoroughly inspect the exterior of the shipping box for any sign of damage or
tampering. Should any damage be noted, please notify the carrier immediately. If the
content box has been damaged during transportation, the instrument should be
checked for any electrical or mechanical defects. Should any defects be identified,
please contact the responsible dealer. Keep all original packaging to facilitate any
insurance claims against the damages.
PLEASE KEEP ALL ORIGINAL PACKAGING FOR FUTURE USE!
The MA 1 is packaged in a specially-designed box. Please keep the box as it will be
useful for sending the instrument for the annual instrument check-up.
Please contact your nearest responsible dealer should the annual instrument check-up
be needed.
3.3. Standard Accessories
DD 45 Audiometric Headset with HB7 Headband
Operation Manual
Audiogram Pad
Carry Case
2x AA Batteries
MA 1 Stand
MA 1 Operating Manual
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8100216-3 (D-0100192)
Figure 1
4. MA 1 Connections
The MA 1 has a single socket for both right and left earphones. While the instrument
is off, insert the headphone into the socket ensuring is is completely seated prior to
turning the device on.
Position:
Function:
1
Socket for headphone
5. Battery Operation
To install batteries:
1. Pull the tab on the battery compartment and
remove panel.
2. Insert 2 AA batteries oriented as shown.
3. Reposition the panel and snap the tab back
into place.
Battery Life
Maico Recommends using AA Alkaline Batteries
Figure 2
Batteries will last approximately 30,000 tone presentations. The MA 1 has an
auto shut-off to conserve battery life. The device will power off after 30 seconds
of inactivity. When batteries get too low to produce the proper signal, the unit
will shut off and will not turn back on until batteries are replaced.
1
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