This manual provides the technically qualified service person with troubleshooting information, repair procedures, and calibration and performance verification instructions. This manual is written for qualified technical service personnel familiar with the operation and design of the TOF3D and who have been authorized and trained by MIPM to service the system.
TOF3D 1.4 Safety and Essential Performance The TOF3D has to be evaluated to the applicable general, collateral and particular requirements (standards) for safety and essential performance of Medical Electrical Equipment (IEC 60601-x). There are no essential performances specified in the relevant particular standards (IEC60601-2-10 and IEC60601-2-40).
TOF3D 3. Intended Use The TOF3D is intended to be used to quantitatively monitor the level of neuromuscular transmission during surgery or in the intensive care unit by means of acceleromyography. The device will be operated by medical staff and will aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.
It is advisable to clean and disinfect the device's external surfaces before any maintenance operation in order to protect the operator. The TOF3D contains electrostatic sensitive components. You must wear a wrist grounding strap when handling components and place on an anti-static pad. Failure to comply may result in damage to equipment due to electrostatic discharge.
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Project/Product: Service Manual TOF3D Slide out the lower housing shell _________________________________________________________________________________________________________________ Service Manual TOF3D Neuromuscular Monitoring Device All rights reserved – MIPM GmbH (Version 1.0)
Project/Product: Service Manual TOF3D 6.2 Replacing Enclosure upper part Unplug flat ribbon cable from PCB Remove all screws _________________________________________________________________________________________________________________ Service Manual TOF3D Neuromuscular Monitoring Device All rights reserved – MIPM GmbH (Version 1.0)
Connect testbox with resistor to the surface electrode stimulation cable and connect an oscilloscope across the two terminals of the resistor. Connect the surface electrode stimulation cable and the AMG sensor cable to the TOF3D Switch the device ON and check that all functions and associated display information are functional and as described in the user manual.
TOF3D Thumb adapter x50 5750101 (single use) Adapter for fixation of the acceleration sensor on thumb TOF3D USB Interface cable 5750103 (multi use) USB Cable for Data Transmission _________________________________________________________________________________________________________________ Service Manual TOF3D Neuromuscular Monitoring Device All rights reserved – MIPM GmbH (Version 1.0)
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Adapter to mount the device to an IV-pole Adapter for IV Pole 5750110 (multi use) (Variant B) Adapter to mount the device to an IV-pole _________________________________________________________________________________________________________________ Service Manual TOF3D Neuromuscular Monitoring Device All rights reserved – MIPM GmbH (Version 1.0)
TOF3D Acceleration 5750105 sensor (multi use) Cable with Acceleration sensor for measurement of the patient response Battery (single use) 6450044 4xAA, Power supply _________________________________________________________________________________________________________________ Service Manual TOF3D Neuromuscular Monitoring Device All rights reserved – MIPM GmbH (Version 1.0)
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Cover to seal an open port on the split connector TOF3D Interface sealing 5750109 plug (multi use) Cover to seal an open interface port on TOF3D TOF3D Battery Lid 5750111 (multi use) Cover to seal the battery compartment of TOF3D (incl.:...
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TOF3D Housing lower 5750115 shell including: - TOF3D Battery Lid Lower half of housing incl. battery lid, 6x screws, 6x sealing plugs and 4x bumpers _________________________________________________________________________________________________________________ Service Manual TOF3D Neuromuscular Monitoring Device All rights reserved – MIPM GmbH (Version 1.0)
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