Page 8 of 87 DGH 55B-INS-OMENG Rev: 3
3. General Cautions and Warnings, Prescription Device
Statement and Operator Qualifications
3.1 General Cautions and Warnings
WARNING: EXPLOSION HAZARD. Do not use in the presence of flammable
anesthetics, gases or in oxygen-rich atmosphere.
WARNING: ELECTRICAL SHOCK HAZARD. Do not open the unit. Refer servicing to
qualified service personnel.
3.2 Prescription Device Statement
WARNING: The DGH 55B (Pachmate 2) is a prescription device and is only to be used
by, or under the supervision of, a licensed physician.
3.3 Operator Qualifications
This DGH 55B is intended to be used by trained medical professionals. The medical professional
operating the DGH 55B must have a general knowledge of the use of ultrasonic medical devices.
Use of the DGH 55B requires adequate dexterity to position the probe safely. The DGH 55B
uses audio feedback to inform the operator of the scan status.
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