Service manual

IQmark Digital Spirometer Operation Manual
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Device Labeling Information
Indications For Use
The IQmark Digital Spirometer is indicated for use with male/female adult patients and
male/female pediatric patients to evaluate, assess, describe, measure, or monitor the status of
pulmonary health, diseases, or conditions.
Intended Use
The IQmark Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic
Spirometer for pulmonary function evaluation and data management. The Spirometer is for use
in hospitals or physician/clinician offices.
Contraindications
The Disposable Pneumotach Mouthpieces are clean but not sterile and should not be placed over
open wounds that are prone to infection. There are no other known medical contraindications
other than the physical limitations of the patient.
Warnings
To ensure accurate patient testing, you must replace the Midmark Diagnostics Group accessories
used with this device with accessories manufactured by Midmark Diagnostics Group.
The American Thoracic Society (ATS) Standardization of Spirometry recommends the use of
rubber gloves when replacing Disposable Pneumotach Mouthpieces (DPM), and hand washing
after touching DPMs.
Precautions
Read and observe the following precautions to ensure the proper operation of this device.
1. Familiarize yourself thoroughly with the operational procedures of the device prior to use. It
is recommended that the user be trained in the methods of administrating Spirometry tests to
a patient by an organization that is certified by a recognized agency.
2. Installation location and maintenance of the device.
a) Avoid installing the device in direct sunlight. Install and keep the device away from
splashing fluids.
b) Do not install the device where it may be affected by significant or extreme changes in
humidity, ventilation, airborne particles containing dust, salt, sulfur, etc.
3. Prepare the device for operation according to instructions in this operation manual.
4. Precaution while using device - Observe the patient closely. If any abnormality is observed,
proper action, which may include stopping the test, should be taken immediately.
5. Precaution after using device - The software turns off the device power according to
programmed procedures. Keep the device clean at all times to ensure trouble-free operation.
6. In case of a malfunction, call Customer Service and precisely describe the problem.
7. Perform routine inspection on the device. Keep all items in a clean environment.
8. Do not make any modifications to the device; any modifications made will void the warranty.
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