User Manual ToFscan
4
About this product
This operating manual provides the instructions on how to configure and use the ToFscan from
IDMED. It also describes the specific procedures to clean and verify the device as part of the
necessary maintenance. This manual is intended to be used only by qualified medical personnel.
Keep this operating manual with the ToFscan. A service manual is available for the technicians in
charge of maintenance.
Before you start, please make sure you read carefully and understand the safety information
contained in this manual.
Indications for use
The ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a
patient in the operating theatre, recovery room or intensive care unit.
The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the
acceleration of the muscle movement (acceleromyography) or by visually observing
muscle contractions consequent to electrical stimulation. The ToFscan has a three-dimensional
acceleration sensor (accelerometer) to detect and quantify a patient’s muscle movement. For the
thumb (contracting adductor pollicis), the sensor is directly integrated into the finger’s splint, making
it possible to obtain its optimal and reproducible positioning. For the eyebrow and big toe sensors, a
correct sensor position allows for optimal and reproducible measurement.
Expected performance
The following features are essential performance of the device:
- Stimulation of an anesthetized patient with electrical pulse: repeated or single 200µs square pulse,
20mA to 60mA intensity. All values /- 10%
- Allow several stimulation sequences in accordance to usual practice, TOF, PTC, ATP, DBS, TET, ST.
- Measure the muscle response of the thumb, big toe of the foot or the corrugator muscle of the
eyebrow following electrical stimulation. The result of this measurement is to detect a movement
generated by the muscle concerned and the ratio of the amplitude of the first and last movement to
the during the same stimulation.
Clinical benefits
The following characteristics are the clinical benefits of the ToFscan:
- Intra-operative: Enable practitioners to monitor patients’ intra-operative muscle relaxation
- Post-operative: To diagnose residual blockade of the patient
Important Information about the use of this device
The compact ToFscan is intended for use by health professionals (anaesthetists, doctors or fully
qualified nurse anaesthetists) specially trained in the use of this instrument. The device and all of the
settings associated with it are designed for use on adult and paediatric patients in hospital or health
institutions so that the patient’s neuromuscular block level can be monitored.
The ToFscan measurements of the patient’s muscular response can be used to monitor the effects
of neuromuscular blocking agents.
The interpretation of ToFscan results must always be subjected to clinical assessment and
compared against other observed clinical signs. Sole reliance on the results or values rendered by
the ToFscan for the monitoring of curare-administered patients, is strongly discouraged. The values
measured in patients with neurological disorders, nervous system disorders, Bell’s palsy, myasthenia
or general neuromuscular disorders must be carefully interpreted.
The ToFscan is compliant with the European directive on medical devices and with the current
regulatory requirements of the countries where it is distributed.
