Phyaction GUIDANCE-E - Explosion Safety Guidelines; Operational Safety and Usage Instructions; EMC and Medical Device Directive Compliance

2.3.2 Explosion safety.
The equipment is not suitable for use in areas where flammable gasses or vapours are present.
Therefore, remove the mains plug from the socket before the area in which the equipment is located is
disinfected, since some disinfecting solutions evaporate and subsequently form an explosive mixture.
2.3.3 Operational safety.
- Using the equipment in the vicinity of short wave or microwave equipment can influence the
output of the unit. Using this equipment when high frequency surgical equipment is connected to
the patient at the same time can result in burning under the electrodes.
- Patients who have electrical implants (i.e. pacemaker) may only be treated following medical
advice.
- The equipment is not suitable for use in damp areas.
- The equipment may not be disinfected or sterilised.
- The equipment contains a number of safety systems that operate independently of the
microprocessor.
When the safety system detects a fault during electrotherapy the delivery of current is interrupted
within a few milliseconds and it is impossible to perform treatment using the equipment. The
safety of the patient is therefore guaranteed. Whenever the equipment is switched on (using the
main switch) the microprocessor checks the entire safety system for correct operation.
2.3.4 Use of the appliance.
The equipment and accessories should only be used by authorised personnel and in accordance with all
instructions included in these operating instructions. The Phyaction Guidance is only to be used for
electrotherapy.
2.3.5 Product documentation.
We strongly recommend reading the Guidance Guideline carefully, in order to understand and solve
questions of the end user.
2.3.6 Radio interference suppression and electromagnetic compatibility.
This equipment meets the guidelines for ISM equipment relating to electromagnetic compatibility and is
radio interference suppressed according to VDE 0871-B. Also see paragraph 1.2.3 Operational safety,
concerning the use of the equipment in the vicinity of short wave and microwave equipment.
2.3.7 Medical device directive (MDD)
This device complies with the essential requirements of the Medical Device Directive of the
European Committee (93/42/CEE ) as most recently changed.
Phyaction Guidance E/C – service manual version 0.5 Page 6