Service manual

IQmark Digital Spirometer Operation Manual
vii
9. Do not open the device handle. Refer servicing to qualified service personnel.
Adverse Reactions
The IQmark Digital Spirometer is a non-invasive device and is safe in both construction and
use. This has been confirmed by the performance of Verification and Validation Testing,
Biocompatibility Testing, Risk Assessment Analysis, and ATS testing.
The following minor complications can occur with all diagnostic Spirometers:
1. Infection or injury due to the use of a non-sterile mouthpiece over open wounds
2. Skin or mucous membrane abrasion caused by prolonged rubbing or excessive use of the
mouthpiece (not related to biocompatibility issues)
3. Nasal, oral, or dental pain
4. Drying of oral or pharyngeal mucosa
5. Congestion or irritation of Eustachian tubes
6. Gastric distention or flatulence from ingested air
7. Slight discomfort during test procedures
8. Decreased secretion clearance during test procedures
9. Aspiration of secretions
10. Hyperventilation and possible dizziness
Patients may become light-headed, dizzy, or even faint during a test maneuver. Be sure to watch
the patient closely and place a chair behind the patient before beginning any procedure.
Electrical, Safety, Biocompatibility Standards
This Spirometer has been tested to comply with the following standards:
UL STD 2601-1 CAN/CSA STD C22.2 601.1-M90
IEC 601-1 (Electrical) IEC 60601-1-1 (Safety)
EN 60601-1-2 (EMC, 2nd Ed. 2001)
ISO 10993-5 (Cytotoxicity) ISO 10993-10 (Irritation and Sensitization)
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