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The gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.

The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed incision device for acquiring blood samples from the patient's finger to obtain sufficient blood volumes for capillary blood draws. The gentleheel Adult Incision Device utilizes a blade resulting in improved blood flow requirements. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with a human fingertip. The user is instructed to remove the trigger lock. When the gentleheel Adult Incision Device is placed against the patient's finger and the user presses the trigger mechanism it automatically makes the incision the blade in a continuous motion from inside the housing, into the fingertip, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel Adult Incision Devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The intended use of this device is for newborn babies of any ethnicity where a blood sample is desired, and a self-retracting safety feature is desired to protect the clinician performing the blood sampling.

The gentleheel® is designed to be an easy to use, safe, one handed heel incision device for acquiring blood samples from the heels of newborns. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with an infant's foot. The user is instructed to remove the trigger lock. When the gentleheel is placed against the infant's heel and the user presses the trigger mechanism it automatically makes the incision by starting the blade in a continuous motion from inside the housing, into the infant's heel, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method. The gentleheel comes in models for Newborn (NGH), Preemie (PGH), Micro-Preemie (MPGH), and Toddler (TGH). The models are differentiated by the styles and colors of the housing (see following definitions).