vPoke in Action

The vPoke software interface uses both images and text to assist operators with mechanical assembly sequences. The large image on the right side of the vPoke screen shows the operator how the device should look when the sequence is finished. Depending on the information available, the operator may also see smaller images that provide more detailed views of the sequence or a picture of the parts tray with the parts for the current sequence highlighted. The large image on the left side of the vPoke screen shows the actual device the operator is assembling. At the bottom of the screen the operator sees text instructions for the current sequence, a list of parts used in the sequence, and, if applicable, an image of the tool required.

Unprecedented mistake-proofing and 100% traceability of complex medical device system assemblies based on the Japanese concept of poka-yoke

In this example below (see Figure 1), the operator must install a tube holder using four screws attached in the order shown in the reference image. vPoke displays a picture of the hardware kit in the top right corner of the screen with a green rectangle highlighting the specific parts required for the current sequence. vPoke also shows a picture of the torque screwdriver the operator should use. The operator must scan the screwdriver’s bar code to verify that it’s the correct tool and in calibration before vPoke will activate the tool and allow the operator to proceed. The system can sense when each screw is installed with the appropriate torque and makes an audible announcement when all four screws are in place. Only then can the operator call up the next sequence.

In the sequence below (see Figure 2) the operator must connect two cables. The reference image shows the cable assembly part numbers and the installation locations. The smaller images on the far right provide detailed views of the shrouded shunts where the operator must insert the cables. Following the text instructions in the lower left portion of the screen, the operator installs the cables and completes a pull test for each. Then, the operator records the completed sequence by taking a picture and announcing to the system that he performed the pull test. vPoke, in turn, acknowledges the validation and permits the operator to call up the next sequence.

vPoke is an extremely powerful tool with far-reaching benefits. For example, suppose inspectors find a problem during an out-of-box audit. With 100 units sitting on the dock, the typical response would be to open every box and inspect each unit individually. With vPoke, the inspector would analyze the device history record of the defective unit to identify the step in the process where the defect was introduced. Then, the inspector would scan the serial number on each subsequent box and validate the device by examining the vPoke image associated with the problem step.

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