Welch Allyn Diagnostic system - India CDSCO Medical Device Registration

Product Information

The GS 777 Wall Transformer is intended to provide power to Welch Allyn 3.5V instruments. The device is intended for use in ambulatory and acute care settings. It is intended to be used by medically qualified, trained healthcare professionals on neonatal, pediatric and adult patients of any gender. Each device intended use integrated with the system provided below: • The Welch Allyn SureTemp Plus thermometer measures patient’s temperature in the oral, axillary, and rectal body sites of adult, pediatric, and newborn patients. The device is not designed, sold, or intended for use except as indicated. • Welch Allyn non-automated sphygmomanometers are noninvasive blood pressure measurement devices intended for use in conjunction with an inflatable cuff and stethoscope to determine blood pressure in pediatric through adult patients. • Welch Allyn Otoscopes are hand-held, battery-powered devices that are intended to be used by trained clinicians during a patient health assessment to inspect the external ear, ear canal and tympanic membrane under illumination and magnification. Secondary uses of the Otoscopes are to provide general illumination of the throat and/or nasal cavities. The Pneumatic Otoscope is also used to assess flexibility of the tympanic membrane. The Operating Otoscope is designed to be used during minor otoscopic procedures. • The Ophthalmoscope is intended for use by clinicians and medically qualified personnel for pediatric and adult patients of any gender in both ambulatory and acute care settings to view the back of the eye, commonly called the fundus. The fundus is where the nerves and blood vessels converge, and it is the only place these structures can be seen without surgically entering the patient. The Ophthalmoscope is used to support the diagnosis of ocular structure conditions and for viewing ocular abnormalities that may be indicative of conditions elsewhere in the body.