Micro Direct MicroLoop Bedienungsanleitung
MicroLoop
Operating Manual
Federal (USA) law restricts this device to sale by or on
the order of a physician or licensed practitioner.
Micro Direct, Inc.
803 Webster Street
Lewiston, ME 04240
1-800-588-3381
www.mdspiro.com
105-62
Issue 1.2
June 2016
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Indications for Spirometry
Spirometry has been used extensively to measure lung function capability and to
recognize and treat many diseases associated with the impairment of healthy lung
functions. Spirometry today provides great insight into the status of any person’s
health.
Generally speaking, spirometry is a simple diagnostic tool used to define a subject’s
lung condition. The major indications for spirometry are:
Dyspnea (shortness of breath)
Exercise induced coughing
Chest tightness
Smokers over 45 years of age (NLHEP recommendations)
Obesity
Pre-operative testing
Occupational exposure to dust and/or chemicals
Ongoing assessment of patients receiving bronchodilator treatments
Determination and/or documentation of pulmonary disability
Asthma diagnosis
Pre-existing pulmonary disease
Frequent colds
Assessment of congestive heart failure
CPT Codes for Spirometry
94010 - Spirometry Complete
Includes graphic record total and timed vital capacity, expiratory flow rate
measurement (s) with or without maximal voluntary ventilation
94060 - Bronchodilation Responsiveness
Spirometry as in 94010, pre and post bronchodilator or exercise
94070 - Bronchospasm Provocation Evaluation
Multiple spirometric determinations after bronchodilator with spirometry as in
94010
94150 - Vital Capacity
Total (separate procedure)
94200 - Maximal Voluntary Ventilation
Maximum breath capacity
94375 - Flow Volume Loop
Respiratory Flow Volume Loop
95070 - Inhalation Bronchial Challenge Testing
(Not including necessary pulmonary function tests), with histamine, methacholine
or similar compounds.
94464 - Bronchodilator Administration
Demonstration and/or evaluation of patient utilization of an aerosol generator,
nebulizer and meter dose inhaler or IPPB device
Diagnosis and ICD-9-CM Codes on back cover
Table of Contents
Introduction.................................................................................... 1
Contraindications........................................................................... 2
Warning and Cautions................................................................... 2
Overview........................................................................................ 4
Intended Use.................................................................................. 5
Getting Started............................................................................... 5
Calibration Check (Verification) ................................................... 16
Customization.............................................................................. 18
Administration Mode.................................................................... 19
Switching Off................................................................................ 20
Charging Procedure..................................................................... 20
PC connection using SPCS......................................................... 21
Looking after your Spirometer ..................................................... 22
Product Lifetime........................................................................... 22
Cleaning Instructions ................................................................... 22
External Surfaces of the Spirometer............................................ 22
Cleaning Accessories .................................................................. 23
Cleaning the Transducer ............................................................. 23
Servicing...................................................................................... 24
Troubleshooting Information........................................................ 24
Safety Designation per IEC 60601-1 ........................................... 26
Electromagnetic Compatibility (EMC) to EN60601-1:2007.......... 27
Symbols....................................................................................... 33
Specifications............................................................................... 34
Spirometry Measurements........................................................... 34
Consumables / Supporting Products ........................................... 36
ICD-10 Codes for Spirometry ...................................................... 37
1
Introduction
The MicroLoop is a mains/battery operated portable spirometer
with the unique combination of ease of use and sophistication.
Ease of use is assured through the use of context sensitive help
screens, accessed at a touch of a button, that explain every
MicroLoop feature.
The MicroLoop is supplied with a cradle that may be connected
with the USB cables supplied, to a PC. The cradle also connects
to the mains adapter so that the MicroLoop’s batteries may be
charged while it is placed in the cradle. The blue lights on the
cradle indicate that it is being powered either by a PC connection
or by the mains adapter. When either of these sources of power is
connected to the cradle, it is ready to charge your MicroLoop.
The MicroLoop utilizes a single patient use disposable
mouthpiece or filter that must be disposed of after use.
The MicroLoop provides a suggested interpretation that must be
supported by clinical judgment.
2
The MicroLoop uses a Digital Volume Transducer, an extremely
stable form of volume transducer, which measures expired air
directly at B.T.P.S (Body Temperature and Pressure with
Saturated water vapor) thus avoiding the inaccuracies of
temperature corrections. The transducer is insensitive to the
effects of condensation and temperature and avoids the need for
individual calibration prior to performing a test.
Test results may be uploaded to a PC using the Spirometry PC
Software and patient details may be downloaded to the MicroLoop.
Contraindications
Acute disorders affecting test performance (e.g. vomiting,
nausea, vertigo)
Recent eye surgery (increases in intraocular pressure during
spirometry)
Oral or facial pain exacerbated by a mouthpiece
Recent myocardial infarction
Post-operative thoracic surgery
Hyperventilation syndrome
Note: Extensive exhalation might lead to syncope.
Warning and Cautions
The following terms are used as follows in this manual
CAUTION: Possibility of injury or serious damage
WARNING: Conditions or practices that could result in personal
injury
Note: Important information for avoiding damage to the
instrument or facilitating operation of the instrument.
Note: Patients below the age of four (4) may struggle to perform
spirometry correctly and reproducibly.
Note: The device should be used by trained and qualified
personnel.
3
CAUTION: Read the manual before use.
WARNING: The instrument is not suitable for use in the presence
of explosive or flammable gases, flammable anesthetic mixtures
or in oxygen rich environments.
CAUTION: Mouthpieces are single patient use. If used on more
than one patient, there is a risk of cross-infection. Repeat use may
degrade materials and lead to an incorrect measurement.
CAUTION: Pulmonary filters are single patient use. If used on
more than one patient, there is a risk of cross-infection. Repeat
use may increase air resistance and lead to an incorrect
measurement.
PLEASE NOTE: The product you have purchased
should not be disposed of as unsorted waste. Please
utilize your local recycling facility for the disposal of this
product.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0.
WARNING: To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth.
4
Overview
The MicroLoop uses a touch
screen with icons representing
each function available. A stylus,
housed in the left hand side of the
unit, is provided for icon screen
activation.
Touch the displayed time to adjust
time and date.
Unused icons may be disabled by
touching the blue background and
selecting from the list displayed.
Touch the toolbox icon to adjust
volume and brightness.
Four levels of battery charge are
indicated by the segmented
battery icon.
When this icon turns red the
battery is nearly exhausted and
the batteries must be charged –
see Charging Procedure. The
complete functionality is
described on the help screen.
This is obtained by pressing the
help button (?).
Help text exists for every screen
viewed during the operation of the
MicroLoop.
You are recommended to make
full use of the extensive Help
screens provided.
5
Intended Use
The MicroLoop spirometer is intended for prescription use only, to
measure the maximal volume and flow of air that can be moved in
and out of a patient’s lungs. The system is intended for use with
pediatric (4 to 17 years of age) and adult (18 to 99 years of age)
patients in hospitals, physician offices, laboratories and
occupational health testing environments.
Getting Started
When performing a spirometry
test the recommended
workflow is to enter the
patient’s details, or retrieve
them from memory, perform
the required test and then print
and save the results.
6
Please ensure that the turbine
transducer is plugged in to
either of the two sockets on
the top of the instrument.
Select the ‘Patients’ icon to
enter the patient database.
The required patient may be
selected from the stored patient
list.
If the patient details have not
been previously stored then
select ‘Add’ to enter the new
patient’s details. The patient
details may also be downloaded
from the Spirometry PC
Software.
Once selected, the patient’s
name will appear at the bottom
of the screen.
Use the help button to obtain
further information.
7
To add a patient to the
database, use the on screen
keyboard to type a unique
patient ID and then touch the
enter key. You will then be
prompted for Last Name, First
Name, Sex, Ethnic Origin,
Height, Weight, date of Birth
and Factor.
A factor can be applied when
testing individuals of other
ethnic origins who would not
normally be tested against the
countries set of predicted
values (e.g. ECCS predicted
values are used but Non
Caucasian individuals tested.)
The factor alters the predicted
value set on volume indices by
the percentage applied. If
NHANES predicted values are
selected, then the ethnic origin
field should be chosen but a
factor correction is not required.
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